\
United States Prevention, Pesticides EPA 738-R-93-031
Environmental Protection And Toxic Substances December 1993
Agency(7S08W)
&EPA Reregistration
Eligibility Decision (RED)
r
' Flower and Vegetable Oils
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United States Prevention, Pesticides EPA-738-F-i3-027
Environmental Protection And Toxic Substances December 1993
Agency (7IOiW)
&EFA R.E.D. FACTS
Flower and
Vegetable Oils
Pesticide All pesticides sold or distributed in the United States must be ,(
Reregistratlon registered by EPA, based on scientific studies showing that they can be
used without posing unreasonable risks to people or the environment.
Because of advances in scientific knowledge, the law requires that
pesticides which were first registered years ago be reregistered to ensure
that they meet today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human
health and environmental effects of each pesticide. The Agency imposes
any regulatory controls that are needed to effectively manage each
pesticide's risks. EPA then reregisters pesticides that can be used without
posing unreasonable risk to human health or the environment.
When a pesticide is eligible for reregistration, EPA announces this
and explains why in a Reregistration Eligibility Decision document, or
RED. This fact sheet summarizes the information in the RED document
for the case Flower and Vegetable Oils, which contains the active
ingredients essential oils (covering 24 substances), oil of lemongrass, oil of
eucalyptus, soybean oil, oil of mustard, and oil of anise.
Use Profile The reregistration case Flower and Vegetable Oils is composed of a
group of compounds that are natural components of plants. These oils are
active ingredients in pesticide products registered for use as animal
repellants, feeding depressants, insecticides and miticides. Some of the
essential oils also are included as active ingredients in antimicrobial
pesticide products (disinfectants, sanitizers, bacteriostats, microbiocides
and fungicides). However, since the essential oils have no independent
pesticidal activity in antimicrobial products, these uses are not eligible for
reregistration. Many of the flower and vegetable oils have other, more
significant, non-pestieidal uses as food additives, flavorings, and
components of cosmetics, soaps, perfumes, plastics, resins, and other
products.
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Regulatory
History
The case Flower and Vegetable Oils originally included eleven active
ingredients. However, five of these active ingredients were not supported
by their manufacturers for reregistration (cottonseed oil, linseed oil, sesame
oil, hydrogenated castor oil, and oil of geranium). The following six
active ingredients are being supported for reregistration.
Essential oils, defined as any volatile oil that gives distinctive odor
or flavor to a plant, flower or fruit, were first registered as pesticide active
ingredients in 1947. A total of 24 distinct chemicals are covered under this
active ingredient. EPA now requires that registrants identify the particular
oil(s) contained in their products, rather than naming "essential oils" as the
active ingredient. Approximately 25 pesticide products currently are
registered which contain essential oils as active ingredients. These
products are used as repellants, feeding depressants, insecticides and
miticides, as well as antimicrobials. They are marketed as liquid sprays,
crystals and pellets.
Oil of lemongrass was first registered in 1962 as a dog repellant.
Currently, two products are registered which contain this active ingredient;
both are formulated as pellets and used to repel cats and dogs from
ornamentals, shade trees, patio furniture and garbage cans.
Oil of eucalyptus was first registered in 1948 as an insecticide and
miticide. Currently, only one product (an herbal flea collar for pets) is
registered which contains oil of eucalyptus,
OU of mustard (allyl isotMocyanate) was first registered in 1962 as a
dog repellant. Five products currently are registered; four are used
outdoors either to repel cats and dogs from lawns, flowers, bushes, shade
trees and refuse containers, or to kill insects. The fifth product is used
indoors in a carpet freshener to repe! pets. Products are formulated as
liquids or pellets/tablets.
Soybean oil was first registered in 1959 for use as an insecticide and
miticide. Three products currently are registered. They are emulsifiable
concentrate formulations used to control insects and mites on citrus fruits
and a variety of ornamentals.
Oil of anise was first registered in 1952 for use as an insecticide and
miticide. Only one product currently is registered, a liquid spray used on
soil near lawns, gardens and flower beds to repel cats and dogs.
Human Health and
Environmental
Assessment
The flower and vegetable oils are among those pesticides for which
EPA believes a broadly reduced set of generic data requirements is
appropriate for reregistration. The Agency therefore has waived most
generic data requirements, except certain technical chemistry information,
for most of the chemicals included in mis RED. In evaluating the flower
and vegetable oils' potential risks to human health and the environment,
EPA relied on information commonly available in scientific literature.
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Generally, these chemicals are of low acute toxicity (except for oil of
mustaid). Many are Generally Recognized as Safe (GRAS) by the Food
and Drag Administration, are exempted from the requirement of food
additive tolerances, and are used in food preparation. As pesticides, they
employ a non-toxic mode of action. Since they are formulated in low
concentrations into products that are used at low volumes in the United
States, exposure to humans and the environment is expected to be very
low. EPA has received no incident reports of adverse effects for these
chemicals. In summary, the flower and vegetable oils are not likely to
result in adverse effects in humans or the environment.
Outdoor use of the pelleted formulation of oil of mustaid could result
in exposure and adverse effects to nontarget organisms, particularly birds
ingesting these pellets. However, since all presently registered products
contain low concentrations of oil of mustard, exposure and risk to
terrestrial species are believed to be low.
The use of essential oils for antimicrobial purposes is ineligible for
reregistration. Essential oils normally have no independent pestlcidal
activity when included in antimicrobial products; these products contain
one or more other chemicals that perform as the active ingredients.
Essential oils in antimicrobial products must instead be classified as inert
ingredients, or must be deleted from the product formulations.
The Agency concludes that the use of flower and vegetable oils as
active ingredients in currently registered pesticide products should not
result in unreasonable adverse effects to human health or the environment.
Additional Data Although EPA has waived most generic studies, the Agency is
Required requiring additional physical chemistry studies for all active ingredients in
this case, as confirmatory data. EPA also is requiring product-specific
data including product chemistry and acute toxicity testing, as well as
revised Confidential Statements of Formula and revised labeling for
reregistration.
Product Labeling The labels of all registered pesticide products containing flower and
Changes Required vegetable oils must comply with EPA's current pesticide labeling
requirements. In addition,
° All registrants who have a mixture of essential oils listed as the active
ingredient on their product label (and the product is not an antimicrobial)
must list separately on the label each essential oil and its percentage of the
product's composition.
0 All registrants with antimicrobial products containing essential oils must
either delete that active ingredient from their product formulations or
convert that active ingredient to an inert.
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Regulatory
Conclusion
The use of currently registered pesticide products containing flower
and vegetable oils in accordance with approved labeling will not pose
unreasonable risks or adverse effects to humans or the environment.
Therefore, all current uses of these products are eligible for reregistration
except the use of essential oils in antimicrobial products, which is not
eligible for reregistration. Essential oils must either be deleted from or
converted to inert ingredients in antimicrobial products.
The eligible flower and vegetable oils products will be reregistered
once the required physical chemistry studies, terrestrial ecological effects
data for oil of mustard, product-specific data, revised Confidential
Statements of Formula and revised labeling are received and accepted by
EPA, Products also containing other active ingredients will be reregistered
only when the other active ingredients are eligible for reregistration.
For More
Information
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for Flower and Vegetable Oils during a 60 day
time period, as announced in a Notice of Availability published in the
Federal Register. To obtain a copy of the RED or to submit written
comments, please contact the Pesticide Docket, Public Response and
Program Resources Branch, Field Operations Division (7506C), Office of
Pesticide Programs (OPP), US EPA, Washington, DC 20460, telephone
703-305-5805.
Following the comment period, the Flower and Vegetable Oils RED
will be available from the National Technical Information Service (NTIS),
5285 Port Royal Road, Springfield, VA 22161, telephone 703^87-4650.
For more information about EPA's pesticide reregistration program,
the Flower and Vegetable Oils RED, or reregistration of individual
products containing the active ingredients covered by this RED, please call
the Special Review and Reregistration Division (7508W), OPP, US EPA,
Washington, DC 20460, telephone 703-308-8000.
For information about the health effects of pesticides, or for
assistance in recognizing and managing pesticide poisoning symptoms,
please contact the National Pesticides Telecommunications Network
(NPTN). Call toll-free 1-800-858-7378, 8:00 am until 6:00 pm Central
Time, Monday through Friday.
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REREGISTRATION ELIGIBILITY DECISION
Flower and Vegetable Oils
LISTD
CASE 4097
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
FLOWER AND VEGETABLE OILS REREGISTRATION ELIGIBILITY
DECISION TEAM I
GLOSSARY OF TERMS AND ABBREVIATIONS . II
EXECUTIVE SUMMARY IV
I. INTRODUCTION 1
n. CASE OVERVIEW 2
A. Chemical Overview .^ 2
B. Use Profile 4
C. Data Requirements 10
D. Regulatory History 10
IB. SCIENCE ASSESSMENT 11
A. Physical Chemistry Assessment 11
B. Human Health and Environmental Assessment 14
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 18
A. Determination of Eligibility 18
B. Risk Management Decision 19
1. Eligibility Decision 20
2. Eligible and Ineligible Uses 20
C. Regulatory Position 21
V. ACTIONS REQUD1ED BY REGISTRANTS 21
A. Manufacturing-Use Products 21
1. Additional Generic Data Requirements 21
2. Labeling Requirements for Manufacturing-Use Products 22
B. End-Use Products 22
1. Additional Product-Specific Data Requirements .......... 22
2. Labeling Requirements for End-Use Products 22
C. Existing Stocks 23
VI. APPENDICES •. . . 25
APPENDIX A. Table of Use Patterns Subject to Reregistration 27
APPENDIX B. Table of the Generic Data Requirements and Studies Used
to Make the Reregistration Decision 53
APPENDIX C. Citations Considered to be Part of the Data Base Supporting
the Reregistration of Flower and Vegetable Oils 69
APPENDIX D. List of Available Related Documents 75
APPENDIX E. ............. t 79
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PR Notice 86-5 81
PR Notice 91-2 101
APPENDIX F, Generic Data Call-in 107
Attachment 1. Chemical Status Sheet 127
Attachment 2. Generic DCI Response Forms Inserts (Form A) plus
Instructions 131
Attachment 3. Requirements Status and Registrants' Response Forms
Inserts (Form B) plus Instructions . 136
Attachment 4. List of Registrant(s) sent this DCI (Insert) 143
APPENDIX G. Product Specific Data Call-in 145
Attachment 1. Chemical Status Sheet 161
Attachment 2. Product Specific Data Call-In Response Forms (Form
A inserts) Plus Instructions 163
Attachment 3. Product Specific Requirement Status and Registrant's '>
Response Forms (Form B inserts) and Instructions 167
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 175
Attachment 5. EPA Acceptance Criteria 181
Attachment 6. List of All Registrants Sent This Data Call-In (insert)
Notice 195
Attachment 7. Cost Share Data Compensation Form, and Confidential
Statement of Formula Form 197
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FLOWER AND VEGETABLE OILS REREGISTRATION ELIGIBILITY DECISION
TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Janet Andersen
Steve Jarboe
Environmental Fate and Effegts Division
William Schneider
Laura Dye
Brian Montague
Patrick Hannan
Health-Effects-Division
Arliene Aikens
Tom McClintock
Registration Division
Robert Forrest
Walter Francis
Van Seabaugh
Valdis Goncarvos
Special Review and Reregistration Division
Virginia Dietrich
Bruce Sidwell
Biological Analysis Branch
Biological Analysis Branch
Science Analysis and Coordination Staff
Science Analysis and Coordination Staff1
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Chemical Coordination Branch
Science Analysis Branch
Insecticide-Rodenticide Branch
Antimicrobial Program Branch
Registration Support Branch
Antimicrobial Program Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch
Office of Compliance Monitoring:
Phyllis Flaherty
Pesticides Enforcement Policy Branch
Office of General Counsel::
Kevin Lee
Pesticides Branch
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GLOSSARY OF TERMS AND ABBREVIATIONS
a.i. Active Ingredient
CAS Chemical Abstracts Service
CSF Confidential Statement of Formula
EEC Estimated Environmental Concentration, The estimated pesticide concentration
in an environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency '<
FDA Food and Drag Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
GRAS Generally Recognized As Safe as designated by FDA
HDT Highest Dose Tested
LC30 Median Lethal Concentration. A statistically derived concentration of a substance
that can be expected to cause death in 50% of test animals. It is usually
expressed as the weight of substance per weight or volume of water, air or feed,
e.g., mg/1, mg/kg orppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to
cause death in 50% of the test animals when administered by the route indicated
(oral, dermal, inhalation). It is expressed as a weight of substance per unit
weight of animal, e.g., mg/kg.
LDto Lethal Dose-low. Lowest Dose at which lethality occurs
LEL Lowest Effect Level
LOEL Lowest Observed Effect Level
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
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GLOSSARY OF TERMS AND ABBREVIATIONS
MOE Margin Of Exposure (PAD)
MRED Master Record Identification (number). EPA's system of recording and tracking
studies submitted.
N/A Not Applicable
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
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OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
ppm Parts Per Million
Q*L The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk
Model
RED Reregistration Eligibility Decision
RfD Reference Dose
RS Registration Standard
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TC Toxic Concentration. The dose at which a substance produces a toxic effect.
TMRC Theoretical Maximum Residue Contribution.
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EXECUTIVE SUMMARY
The Agency has determined that the uses of Flower and Vegetable Oils as currently
registered (except for the use of essential oils as perfumes in antimicrobial products) will not
cause unreasonable risk to humans or the environment and these uses are eligible for
reregistration. The Agency is requiring additional studies on the generic physical chemistry for
all active ingredients in this case. When essential oils are present in pesticide products solely
as perfumes, they are not considered as "active ingredients," Pesticide labels and confidential
statements of formula (CSF) must be revised as necessary to reflect this.
Before reregistering the products containing Flower and Vegetable Oils, the Agency is
requiring that product specific data, revised CSF and revised labeling be submitted within eight
months of the issuance of this document. These data include product chemistry and acute toxicity
testing for each registration. After reviewing these data and any revised labels and finding tftem
acceptable in accordance with Section 3(c)(5) of FIFKA, the Agency will reregister a product.
Those products which contain other active ingredients will be eligible for reregistration only
when the other active ingredients are determined to be eligible for reregistration.
Flower and Vegetable Oils is composed of a group of compounds that are natural
components of plants. Some essential oil mixtures may also contain solvents and other
components (salts, etc.). Oils in this case are used in pesticidal products for diverse pesticidal
uses: insecticide, miticide, disinfectant, fungicide, bacteriostat, mierobiocide, repellant or
feeding depressant, and sanitizer.
IV
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended
to accelerate the reregistration of products with active ingredients registered prior to November
1, 1984. The amended Act provides a schedule for the reregistration process to be completed
in nine years. There are five phases to the reregistration process. The first four phases of the
process focus on identification of data requirements to support the reregistration of an active
ingredient and the generation and submission of data to fulfill the requirements. The fifth phase
is a review by the U.S. Environmental Protection Agency (referred to as "the Agency") of all
data submitted to support reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine whether
pesticides containing such active ingredient are eligible for registration" before calling in data
on products and either reregistering products or taking "other appropriate regulatory action."
Thus, reregistration involves a thorough review of the scientific data base underlying a
pesticide's registration. The purpose of the Agency's review is to reassess the potential hazards
arising from the currently registered uses of the pesticide; to determine the need for additional
data on health and environmental effects; and to determine whether the pesticide meets the "no
unreasonable adverse effects" criterion of FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility of the
registered uses of flower and vegetable oils . The document consists of six sections. Section I
is the introduction. Section n describes flower and vegetable oils, their uses, data requirements
and regulatory history. Section HI discusses the human health and environmental assessment
based on the data available to the Agency. Section IV presents the reregistration decision for
flower and vegetable oils . Section V discusses the reregistration requirements for flower and
vegetable oils . Finally, Section VI is the Appendices which support this Reregistration
Eligibility Decision. Additional details concerning the Agency's review of applicable data are
available on request.
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H. CASE OVERVIEW
A. Chemical Overview
The following active ingredients are covered by this Reregistration Eligibility
Decision. The common name "essential oils" refers to a number of compounds,
including alcohols, aldehydes, esters, and acids, that are derived from plants. Under this
reregistration decision, the Agency recognizes the following specific substances as
essential oils.
Chemical overview for the group Essential oils (chemical code 40501)
Common Name
Beigamot Oil
Oil of Rue
Oil of Orange
Trans-alpha-ionone
Geraniol
Dihydro abietyl alcohol
AEyl caproate
Allyl heptoate
Isoamyl isovalerate
Geranyl butyrate
Phenyl ethyl isovalerate
Benzo isovalerate
Geranyl acetate
Iso amyl formate
Iso amyl acetate
Citronellyl Butyrate
Oil of Orange-five fold
Geranyl formate
Cinnamyl isovalerate
Acetyl methyl carbinol
Vanillin
Isobutyric acid
Methyl phenylaeetate
Acetyl anisole
CAS Registry Number OFF Chemical Code
8007-75-8
8014-29-7
8008-57-9
127-41-3
106-24-1
none
none
none
none
none
none
none
none
110-45-2
123-92-2
none
none
none
none
none
121-33-5
79-31-2
none
none
129029
40519
40517
129030
597501
none
none
none
none
none
none
none
none
none
none
none
none
none
none
none
115801
101502
none
none
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Chemical overview for the remaining active ingredients in the case flower and vegetable oils
• Common Name: Oil of Lemongrass
• CAS Registry Number: 8007-02-01
• OPP Chemical Code: 40502
* Common Name: Oil of Eucalyptus
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» CAS Registry Number: 8000-48-4
• OPP Chemical Code: 40503
* Common Name: Soybean oil
• CAS Registry Number: 8001-22-7
» OPP Chemical Code: 31605
* Common Name: Oil of mustard
» Chemical Name: Allyl isothiocyanate
• CAS Registry Number: 57-06-7
• OPP Chemical Code: 4901
• Trade and Other Names: Allyl isosulfocyanate, Isothiocyanic acid (allyl
ester), 2-Propenyl isothiocyanate, allyl mustard oil,
3-isothiocy anto-1 -propene
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• Common Name: Oil of Anise
« CAS Registry Number: 8007-70-3
• OPP Chemical Code: 4301
« Trade and Other Names: Aniseed oil, Star Anise oil
B, Use Profile
The following is information on the current registered uses of this case with an
overview of use sites and application methods. A detailed table of the uses of essential
oils, oil of lemongrass, oil of eucalyptus, soybean oil, aUyl isothiocyanate, and oi! of
anise is in Appendix A.
1. For Essential Oils:
Type of Pesticide: Types eligible for reregistration - feeding depressant,
insecticide, repellant.
Types not eligible for reregistration - disinfectant,
fungicide, tuberculocide, virucide, baeteriostat.
Use Sites: Use sites eligible for reregistration - cats (adults/kittens),
dogs/canines (adults/puppies), household/domestic dwellings
contents, household/domestic dwellings indoor premises,
household/domestic dwellings outdoor premises, ornamental and/or
shade trees, ornamental herbaceous plants, ornamental lawns and
turf, ornamental woody shrubs and vines.
Use sites not eligible for reregistration - hatchery equipment,
hatcheries, food processing, handling and storage plants/areas,
eating establishments (all or unspecified), eating establishment
equipment and utensils, hospitals and related institutions (all or
unspecified), hospital critical premises (e.g. operating rooms),
hospital patient premises (e.g. clinics, wards), hospital non-critical
premises (e.g. labs, waiting rooms), hospital critical items (items
enter blood or living tissue), hospital semicritical items (items
contact mucosal membrane), hospital noncritical items (items
contact only unbroken skin), hospital janitorial equipment, barber
and beauty shop equipment, morgues, mortuaries and funeral home
premises, equipment and instruments, commercial, institutional and
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industrial areas/premises, commercial, institutional or industrial
equipment, laundry (hospital, commercial, household), diapers
(presoak, hospital, commercial, household), laundry equipment,
bathroom premises, toilet bowls and urinals, toilet tanks or water
closets, air treatment, surfaces treatments (all or unspecified), hard
non-porous surface treatments, hard porous surface treatments,
wood surface treatments (seasoned/unpainted),
Target Pests: Target pests eligible for reregistration - clothes moth,
dog, cat, flea.
Target pests not eligible for reregistration - ammonia-producing
bacteria, animal pathogenic bacteria (G- and G-f vegetative),
Pseudomonas spp., Mycobacterium spp. (tubercle bacilli), animal
pathogenic fungi, animal viruses, adenoviruses, vaccinia virus,
herpes simplex virus, influenza virus, and mold and mildew.
Formulation Types
Registered: crystals, liquid ready-to-use, pressurized liquid, impregnated
collar/tag, impregnated material, pelleted/tableted.
Methods and Rates of Application:
Equipment - aerosol can, by hand, pump spray bottle, sprayer.
Method and Rate -
cats and dogs (animal treatment [spray], animal wound
treatment), rate not calculated due to lack of data (on
label).
flea collar for "pets", 7.813x10;! Ib/aniinal.
household domestic dwellings indoor premises and contents
(fumigation, spot treatment, spray, contact and/or surface
treatment), 0.001563 lb/50 cu. ft to 0.02 lb/90 cu. ft.
household domestic dwellings outdoor premises (sprinkle),
0.002pellets/sq.ft; (rub-on, scent post application), rate not
calculated due to lack of data (on label).
ornamental and/or shade trees (sprinkle), 0.002 peUets/sq.
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ft; (scent post application), rate not calculated due to lack
of data (on label).
ornamental herbaceous plants (scent post application), rate
not calculated due to lack of data (on label),
ornamental lawns and turf (sprinkle), 0.002 pellets/sq.ft
ornamental woody shrubs and vines (sprinkle), 0.002
pellets/sq.ft; (scent post application), rate not calculated
due to lack of data (on label).
Ijmisg - when needed
Use Practice Limitations: none
2. For Oil of Lemongrass:
Type of Pesticide: repellant
Use Sites: ornamental herbaceous plants, ornamental woody shrubs and vines,
ornamental and/or shade trees.
Target Pests: dogs and cats
Formulation Types Registered: impregnated material
Method and Rates of Application:
Equipment - sprinkle by hand
Method and Raje - up to 10 pellets per square foot
Tjmjjig - when needed
Use Practice Limitations: none
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3. For Oil of Eucalyptus:
Type of Pesticide: repellent and insect feeding depressant
Use Sites: pets
Target Pests: fleas
Formulation Types Registered: impregnated material (collar)
Method and Rates of Application:
Equipment - by hand
Method and Rate - up to one ounce per animal
Timing - as needed
Use Practice Limitations: none
4. For Soybean Oil:
Type of Pesticide: acaricide and insecticide
Use Sites: citrus fruits, household/domestic dwellings outdoor premises,
ornamental and/or shade trees, ornamental and/or shade trees,
ornamental herbaceous plants, ornamental nonflowering plants,
ornamental woody shrubs and vines, recreational areas.
Target Pests: citrus rust mite, clover mite, Texas citrus mite, citrus red mite,
European red mite, two-spotted spider mite, thrips, anobiid beetles, cerambycid
bark beetles, lyctid beetles, rose chafer, Japanese beetle, gnats, rose midge,
midges, mosquitoes, homopterans, whiteflies, aphids, leafhoppers, mealybugs,
roseslug, gypsy moth (eggs).
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Formulation Types Registered: emulsifkble concentrate
Method and Rates of Application;
Equipment - high volume ground sprayer, sprayer,
Method and Rate - up to 10.67 gallons per acre or up to 0.5 fluid ounces
in 1 gallon of water diluent.
Timing - when needed or foliar or potted
Use Practice Limitations; none
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5. For AUyl Isothiocyanate:
Type of Pesticide; insecticide, repellant, miticide and feeding depressant
Use Sites: household/domestic dwellings contents, household domestic
dwellings indoor premises, household/domestic outdoor dwellings
outdoor premises, ornamental and/or shade trees, ornamental kwns
and turf, ornamental woody shrubs and vines, farm or agricultural
structures/premises, bird feeding areas (for vertebrate pests only),
and refuse and solid waste containers.
Target Pests: centipedes, millipedes, spiders, earwigs, silverfish, ants,
cockroaches, waterbugs, crickets, squirrels, dog, raccoon,
cats, and deer.
Formulation Types Registered; peEeted/tableted, impregnated material,
liquid ready-to-use, and pressurized liquid,
and dust.
Method and Rates of Application:
Equipment - aerosol can, sprayer, by hand, and trigger spray bottle.
Method and Rate - by hand 0.2 -10 pellets per square foot, trigger spray
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at up to 0,20 fluid ounces per square foot, dust at 2 grams per square
foot.
Timing - when needed
Use Practice Limitations: none
6. For Oil of Anise:
Type of Pesticide: repellant
Use Sites: vegetables, household/domestic dwellings outdoor premises,
ornamental herbaceous plants, ornamental lawns and turf,
ornamental woody shrubs and vines.
Target Pests: ticks, lice, fleas, dogs, and cats.
Formulation Types Registered: ready-to-use solution
Method and Rates of Application:
Equipment - sprayer
Method and Rate - spot application at 16 fluid ounces per 300 square feet
Timing - no minimum interval between spot treatments
Use Practices Limitations: none
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C. Data Requirements
The Agency has waived most of the generic data requirements for most active
ingredients in this case. In some cases the Agency has reEed on commonly available
information on the active ingredients in this case. Appendix B includes all data
requirements identified by the Agency for currently registered uses needed to support
reregistration.
D. Regulatory History
Originally, the reregistration case, Flower and Vegetable Oils, included eleven
active ingredients. The following active ingredients were not supported for reregistration
by their registrants; cottonseed oil, linseed oil, sesame oil, hydrogenated castor oil, and
oil of geranium. The remaining active ingredients are being supported.
Essential oils are commonly defined as any volatile oil that gives distinctive odor
or flavor to a plant, flower, or fruit. Essential oil mixtures may also contain other
components other than oils such as alcohols, and chemical variations of the oil such as
a salt, aldehyde, alcohol or ester. Only certain essential oils or mixtures of essential oils
are being reregistered at this time. The Agency now requires that registrants must
specify the specific essential oil(s) contained in their products and no longer allows the
registrants simply to list "essential oils" as the name of their active inpedient. Each
specific component of mixtures formerly listed as "essential oils" are now being
identified. (For this reason the number of active ingredients in this case has increased
to twenty-four.) These essential oils are listed below in Section m. A. Physical
Chemistry Assessment. Products containing essential oils as an active ingredient were
first registered in 1947 as an insecticide and miticide for use on domestic animals.
Subsequently, products containing essential oils have been registered for use as a
disinfectant, fungicide, fungistat, tuberculocide, sanitizer, virucide, and a repeUant.
Further products have also been subsequently registered for the original use as an
insecticide and miticide. A total of 24 products containing essential oils are currently
registered. The concentration of essential oils in these products ranges from 0.18-5.0%,
of which each specific oil or compound appears at a much lesser percentage.
A product containing oil of lernongrass was first registered in 1962 for use as a
dog repellant. Products were subsequently registered for the following uses: sanitizer,
virucide, fungicide, bacteriostat, micobiostat, microbiocide. However, only two products
are currently registered. They are used as domestic animal repellents. The concentration
of oil of ILemongrass contained in these products ranges from 0.01-0.025%. These
registrations are for products in the form of impregnated solid material or pellets used
to repel cats and dogs from out-of-door areas.
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i
Products containing oil of eucalyptus were first registered in 1948 for insecticide
and miticide use. Products were subsequently registered for the following uses; repellant
or feeding depressant, disinfectant, sanitizer, and fungicide. The only currently active
registration is used as an insecticide and a miticide containing one percent oil of
eucalyptus.
The first product containing oil of mustard was registered in 1962 for use as a
dog repellant. Several other products were subsequently registered for the same use.
Seven products are currently registered; five are registered as repellant and feeding
depressants and two are registered as an insecticide and miticide. Each of these products
contains 0.2 % oil of mustard,
A product containing soybean oil was first registered in 1959 for use as an
insecticide and a miticide. Three products are currently registered for this same tise.
Two of the products contain 40% soybean oil and four and seven other active
ingredients, respectively. The other product contains 93 % soybean oil as its only active
ingredient.
A product containing oil of anise was registered in 1952 for use as an insecticide
and miticide. Subsequent products were also registered for this use. However, only one
product is currently registered. Oil of anise comprises 1.6% of this product's
formulation.
ffl. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Essential oils, specifically:
Dihydro abietyl alcohol. Abietic Acid is a widely available organic acid, prepared
by isomerization of rosin. It is used in the manufacture of esters, vinyl and glyceral
esters for use in lacquers and varnishes. It is also used in the manufacture of "metal
resinates", soaps, plastics and paper sizes. It is insoluble in water but soluble in organic
solvents (3).
Ally! caproate. N-Caproic Acid or hexanoic acid occurs naturally in milk fats,
in coconut oil, various palm and other oils. It is manufactured using many methods
including catalytic reduction of the corresponding B-lactone, the catalytic oxidation of n-
hexanol and ozonolysis of tall oil unsaturated fatty acids among others. It is used in the
manufacture of esters for artificial flavors. It is slightly soluble in water and readily
soluble in ethanol and ether. It has a characteristic goat-like odor (3).
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i
Allyl heptoate, Heptanoic acid is an oily liquid that has been found in rancid oils
and in fusel oils in appreciable amounts. It is prepared by the oxidation of heptaldehyde
with potassium permanganate in dilute sulfuric acid. It has a disagreeable rancid odor.
It is soluble in ethanol and ether and other organic solvents (3).
Isoamyl isovalerate. Valeric acid is a colorless liquid with an unpleasant odor.
It is used as an intermediate in perfumery. It is prepared industrially by oxidation of
amyl alcohol or by a fermentation process. It is freely soluble in alcohol and ether (3).
Geranyl butyrate. Geraniol is an olefinic terpene alcohol constituting the chief part
of oil of rose and oil of palmarosa. It is also found in many other essential oils such as
citronella, and lemongrass. It is an oily liquid with a sweet rose odor. It is practically
insoluble in water but very soluble in alcohol. It is used in perfumery (3).
!i
Ethyl pelargrate. Pelargonic acid occurs as an ester in oil of pelargonium. It
is a colorless oily liquid. It is practically insoluble in water and soluble in organic
solvents. It is used in the production of lacquers and plastics (3).
Phenyl ethyl isovalerate. See valeric acid.
Benzo isovalerate. See valeric acid.
Geranyl acetate. See geranM.
Iso amyl formate is a colorless liquid with a fruity odor. It is miscible with
alcohol and ether and soluble in 3000 parts water. It is used in artificial fruit syrups (3).
Iso amyl acetate is also known as pear oil or banana oil. It is a colorless liquid
with a pear-like odor and taste. It is soluble in 400 parts water and miscible with many
organic solvent. It is used in an alcohol solution for a wide variety of non-pesticidal uses
including as a pear flavoring, a solvent for old oil colors, for tannins, celluloid,
manufacturing artificial silk and dyeing and finishing textiles (3).
CitroneUyl butyrate. CitroneUal is a chief constituent of citronella oil and is also
found in many other volatile oils, such as lemon, lemongrass, and melissa. It is soluble
in alcohols and very slightly soluble in water. It is used in soaps and perfumes (3).
Geranyl formate. See geranioi
Cinnamyl isovalerate. Cinnamol is a colorless to yellowish oily liquid. It is
sparingly soluble in water and soluble in organic solvents. It is used in the manufacture
of plastics; synthetic rubber, resins and insulation (3).
Vanillin is a white or very slightly yellow soEd powder. It occurs naturally in
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i
vanilla and in potato parings. It can be synthesized from eugenol or guaiacol and also
from the waste lignin of the wood pulp industry. It is soluble in water and is freely
soluble in organic solvents (3),
Isobutyric acid is a liquid with a pungent odor. It is soluble in six parts water and
is miscible with alcohol and other organic solvents (3).
Acetyl anisole. Anisole is a liquid with an agreeable aromatic odor. It is
insoluble in water and soluble in alcohol and ether. It is used in perfumery and organic
synthesis (3).
Oil of Rue is a naturally occurring mixture of compounds extracted from the plant
Ruta graveolens L, (3).
'!
Trans-alpha-ionone (Msone) from the volatile oil of the plant Boronia megastigma
Nees., Rutaceace.: or can also be produced synthetically (3).
Oil of Bergamot is a volatile oil expressed from the rind of fresh fruit of Citrus
aurantium L., var. bergamia. (3).
Oil of Orange is a volatile oil expressed from fresh peel or ripe fruit of the orange
(Citrus aurantium var. sinensis L.. Rutaceae. It consists of about 90% d-limonene,
citral, decyl aldehyde, methyl anthranilate, linalool, and terpineol (3).
For the remaining active ingredients in this case:
Oil of Lemoflgrass is a volatile oil expressed from the grasses Cymbopogon
Andropogon) citrates or Cymbopogon flexuosus. It is used as a source of citral which
in turn is used in the synthesis of vitamin A. It is a reddish-yellow or brownish-red
liquid. It has a strong odor of verbena. It is slightly soluble in water and soluble in
alcohol, chloroform and ether. It is composed mostly (75-85%) of citral,
methylheptenone, citronellal, geraniol, limonene, and dipentane (3).
Oil of Eucalyptus is a volatile oil from the fresh leaves of Eucalyptus globulus
and of some other species of jpcajyptuj. It is almost insoluble in water, but soluble in
alcohol. It is miscible with absolute alcohol, oils and fats. It is composed mostly (70-
80%) of eucalyptol, alpha pinene, phellandrene, terpineol, citronellal geranyl acetate,
eudesmol, eudesmyl acetate, piperitone, and volatile isovaleric aldehydes (3).
Soybean oil is obtained from soybeans, Glycine max., by solvent extraction using
petroleum hydrocarbons or, to a lesser extent, by expression using continuous screw
press operations. The oil is usually refined with alkali. It is a pale yellow to brownish-
yellow oil. It is miscible with organic solvents (3).
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i
Oil of Mustard (allyl isothiocyanate) is isolated from the black mustard seed,
Brassica nigra L. (Family; Cruciferae). It may also be prepared from allyl iodide and
potassium thiocyanate. It is a colorless to pale yellow liquid. It is slightly soluble in
water and miscible with alcohol and most organic solvents. The allyl moiety, which is
a component of numerous odoriferous compounds, probably contributes to the odor of
the compound which forms the basis of its repeEent action toward insects and animals.
Upon hydrolysis, isothiocyanate gives rise to disubstituted thioureas (3).
Oil of Anise is a volatile oil from dried ripe fruit of Pimpinella anisum L. or from
Dliciuni verum L.. It is a colorless to pale yellow Equid. It is slightly soluble in water,
soluble in alcohol and freely soluble in chloroform and ether (3).
B. Human Health and Environmental Assessment
The Agency has waived the generic data requirements, except for certain technical
chemistry information, for certain essential oils, oil of lemongrass, oil of eucalyptus,
soybean oil, and oil of anise because of their natural occurence, their GRAS status and
low exposure. EPA is relying on commonly available information about these substances
and their uses to reach a decision about their potential risks to the environment associated
with the current uses of registered products.
Generally, these substances have low acute toxicky, except for allyl
isothiocyanate, as described below. Also, many have GRAS (Generally Recognized As
Safe) status by FDA under 21 CFR 172, 173, and 182 and are used in food preparation.
Exposure to humans and the environment from the individual ingredients is expected to
be very low. For example these products are formulated in very low concentrations
(most at 1 percent or less) and the products are used at low volumes in the United States.
Only the three current soybean oil-containing products are formulated with significant
amounts (40, 40 and 93 percent). Since people are exposed to this compound from food
or other sources, the incremental exposure from the pesticide products is expected to be
negligible.
Toxicological information about the essential oils is listed below and is grouped
by uses (or products).
The foEowing essential oil active ingredients are used in one product, Holiday
Chew Stop. This product is a liquid animal repellent intended to be sprayed on
household contents (e.g. furniture, shoes, etc.) or on bandages or fur to prevent cats and
dogs from chewing. The mode of action is non-toxic — repellent. Many of the
components have non-pesticidal uses; some are used in foods. The total concentration
of essential oils in the product is five percent. Each component comprises a small
portion of the total formulation (see below); exposure to people and the environment is
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expected to be low. The concentration in the formulated product and the known
lexicological properties of the components are listed below.
Allyl caproate. (0.0125%) Oral LD50 in rats (3) is 3000 mg/kg. GRAS (2).
Allyl heptoate. (0.003%) LD50 of heptanoic acid is approximately 1200 mg/kg (3).
Geranyl butyrate. (0.003%) GRAS (2).
Phenyl ethyl isovaierate. (0.0075%) (GRAS (2).
Geranyl acetate. (0.0075%) GRAS (2).
Iso amyl formate, (0.0075%) LD50 in rats is 9840 mg/kg (3). GRAS (2).
Iso amyl acetate. (0.0075%) GRAS (2).
Citronellyl Butyrate. (0.00075%) GRAS (2).
Geranyl formate. (0.000375%) GRAS (2). *•
Vanillin. (0.000375%) Oral LD50 in rats is 1580 mg/kg (3). GRAS, as vanillin
acetate (2),
Isobutyric acid. (0.000375%) GRAS (2).
Methyl phenylacetate. (0.000375%) GRAS (2).
Dihydro abietyl alcohol (0.0125%)
Iso amyl isovaierate (0.003%)
Benzo isovaierate (0.0015%)
Ethyl pelargrate (0.000375%)
Oil of orange five-fold (0.00075%)
Acetyl methyl carbinaol (0.000375%)
Acetyl anisole (0.0007%)
The following essential oil active ingredients are used in two products used out-of-
doors as animal repellants.
Oil of bergamot is an ingredient in two active registrations. These products are
formulated as impregnated solid material or pellets to repel cats and dogs from areas near
ornamentals (shrubs, vines and plants), shade trees, patio furniture and garbage cans. The
oil of bergamot concentration in these registrations is 0.11 %. Oil of bergamot is used in
cosmetics as a perfume and is listed by FDA as GRAS (21 CFR 182.20). The acute oral
LD50 for oil of bergamot in the rat is reportedly 11520 mg/kg (4). No adverse incident
reports exist in EPA files for oil of bergamot. Human exposure to oil of bergamot is
expected to be minimal from pesticide products and appears unlikely to result in adverse
human health effects, based upon available reports and information.
Trans-alpha-ionone, also known as irisone, is an ingredient in same two products
as oil of bergamot. It is present at 0,01 %. These registrations are for the use of
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products in the fonn of impregnated solid material or pellets to repel cats and dogs from
areas near ornamentals (shrubs, vines and plants), shade trees, patio furniture and
garbage cans. Irisone is used in cosmetics as a perfume, Alpha-ionone
(4-(2,6,6-trimethyl-2-cyclohexen-l-yl)-3buten-2-one] is also allowed in food for human
consumption as a direct food additive (2). The oral UD50 for irisone is reportedly 4590
mg/kg. There are no incident reports of adverse effects on file with EPA for irisone.
Human exposure is expected to be minimal from products in this registration. The active
ingredient irisone in the registered product is not likely to result in adverse human health
effects, based upon available reports and information.
Oil of orange is an essential oil in the same two products mentioned above.
Considering its use, and its low concentration in pesticide products, human and
environmental exposure is expected to be negligible.
Geraniol is also an essential oil in the above two products at 0.04 percent. It is
an olefinic terpene alcohol constituting the chief part of oil of rose (GRAS 182.20) and
oil of palmarosa. It is also found in many other essential oils such as citronella (GRAS
182.20), and lemongrass (GRAS 182.20). Minimum exposure to geraniol in the
registered products is not likely to result in adverse human health or environmental
effects.
The following essential oil active ingredient is used in one products as a flea
collar.
Oil of rue is an ingredient in one active product registration, for use in the same
herbal flea collar as eucalyptus. Oil of me is present in the end-use product at 0.125 %.
Oil of rue contains 70-75 % geraniol and citronelloi. Oil of rue is used as a flavoring in
medicines and in cosmetics at levels of 0.001-0.15% and was proposed for GRAS status
by the Fragrance and Essence Manufacturers Association (EEMA) in 1965. The oral
LD5Q for o0 of rue in the rat is reportedly greater than 5000 mg/kg (5). There are no
incident reports on file with EPA for products containing oil of rue. Minimum exposure
to oil of me in the registered product is not likely to result in adverse human health
effects.
Below is the lexicological information for the remaining active ingredients.
Oil of anise is the active ingredient in one current registration for use on soil near
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ornamentals and lawns as a dog and cat repellent. The active ingredient in the registered
product is food grade oil of anise. The resulting end-product contains less than 2 % of the
active ingredient in liquid form (maximum application rate of 0.0533 gal ai/1000 sq. ft.),
The product is applied to soil on areas from which defecated materials are removed. The
odor of the registered product, when applied in the manner described, is said to repel
cats and dogs and thereby prevent further defecation on lawns, gardens and flower beds.
FDA considers oil of anise as GRAS as cited in 21 CFR 182.20. Oil of anise is
commonly used as flavoring in food and medicine. The acute oral LD50 for oil of anise
in the rat is reportedly 2250 mg/kg (4). There are no incident reports of adverse effects
on file at EPA for oil of anise. Human exposure to oil of anise is expected to be minimal
from products in this registration. The active ingredient oil of anise in the registered
product is not likely to result in adverse human health effects, based upon available
reports and information.
Oil of lemongrass, also known as citral, is the ingredient in two registrations. It
is formulated as an impregnated solid material or pellets used to repel cats and dogs from
areas near ornamentals (shrubs, vines and plants), shade trees, patio furniture and
garbage cans. The concentration of the lemongrass active ingredient in the registrations
is 0.01-2.0 %. Oil of lemongrass, is commonly used in food flavoring and cosmetics and
is listed by FDA as GRAS (21 CFR 182.20). The acute oral LD50 for oil of lemongrass
in the rat is reportedly 5600 mg/kg (4). There are no incident reports of adverse effects
on file with EPA for oil of lemongrass. Human exposure to oil of lemongrass is
expected to be minimal from pesticide products currently registered. The active
ingredient oil of lemongrass in the registered products is not likely to result in adverse
human health effects, based upon available reports and information.
Eucalyptus oil is an ingredient in one active registration for use as an herbal flea
collar for pets. Eucalyptus oil is present in the end-use product at 1.00%. Oil of
eucalyptus is used in medicine as an expectorant, anthelmintic and local antiseptic. Oil
of eucalyptus contains 70-80% cineole (eucalyptol). Eucalyptol is allowed in food as a
direct food additive (21 CFR 172.515). The oral LD 50 for eucalyptus oil in the rat is
reportedly 2480 mg/kg (4). There are no incident reports of adverse effects on file with
EPA for products containing eucalyptus oil. Human exposure to eucalyptus oil is
expected to be minimal from products in this registration. The active ingredient
eucalyptus oil in the registered product is not likely to result in adverse human health
effects, based upon available reports and information.
17
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Allyl isothiocyanate, also known as volatile oil of mustard, has a very pungent
irritating odor and acrid taste. It is used therapeuticaUy as a counterinitant. The oral
LD50 in rats is 339 mg/kg (3), There are no incident reports on file with EPA for oil of
mustard. Human exposure to oil of mustard is expected to be minimal from products
in this registration. The active ingredient oil of mustard in the registered product is not
likely to result in adverse human health effects, based upon available reports and
information.
There are seven currently registered products containing o0 of mustard in
combination with other ingredients. Five of these products can be used out-of-doors to
either repel cats and dogs from ornamental lawns, flowers, bushes and shade trees, and
refuse containers, or to kill insects. One of these registrations is formulated into pellets.
The out-of-doors-use and pelleted formulation types may expose nontarget organism! to
oil of mustard. The Agency has some concerns about terrestrial species (especially
birds) ingesting pellets and causing adverse effects. All of the presently registered
products containing oil of mustard are formulated with less than 0.3% of the oil of
mustard. The exposure and risk to terrestrial species is likely to be low. In addition,
EPA has reviewed a summary of an acute avian oral study (MRID 104087) that reported
an LCjo of 1500 ppm of formulated product for bobwhite quail. Therefore, EPA has
waived the requirements for terrestrial species toxicity testing for products containing
mustard oil in percentages below 0.5 %. Any new products containing higher percentages
of mustard oil may require additional toxicity data submissions. The remaining product
is used indoors in a carpet freshener to repel pets. The Agency generally expects that
there will be negligible exposure to the environment and to nontarget organisms from use
in indoor domestic dwellings.
Soybean oil is used in three currently registered products for use as an insecticide
and miticide on citrus fruits and a variety of ornamentals. Soybean oil is considered to
be GRAS by FDA (21 CFR 173.340 and 182.70). It is commonly used as a human
food. It is widely ditributed in commerce and available to the general public throughout
the United States for nonpesticidal uses. There are no incident reports on file for
soybean oil. Soybean oil has a non-toxic mode of action for the target pests. It is an
organic compound known to be rapidly degraded in the environment to elemental
constituents by normal biological, physical and/or chemical processes that can be
reasonable expected to exist where the pesticide is applied. The active ingredient
soybean oil in the registered product is not likely to result in adverse human health
effects, based upon available reports and information.
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I. RISK MANAGEMENT AND REREGISTRATION DECISION
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
ingredients are eligible for reregistration. As discussed above, the Agency has
determined that the set of generic data requirements that would normally be applicable
to flower and vegetable oils need not be satisfied for the Agency to reach a decision on
potential risks and reregistration eligibility. Rather, it has considered general and
commonly available information. The Agency has determined that flower and vegetable
oils with the exception of ally! isothiocyanate meet criteria as outlined in the document
"Guidance for Making Determinations to Reduce Data Requirements." Flower and
vegetable oils met the criteria due to their use and availability for non-pesticide food
uses; their regulatory status as a chemical classified as GRAS and their exemption from
the requirement of food additive tolerances; their non-toxic mode of action as pesticides;
that there is negligible human and environmental exposure to them as a result of their use
patterns; and, the lack of reports of adverse effects. No data were submitted under
6(a)(2) of FIFRA, no significant incidents have been reported to the Agency, and there
is no indication in the literature that these pesticides pose adverse effects in humans or
to the environment when used in a manner prescribed in end-use product labeling.
Appendix B identifies the sources for this information including submitted studies that
the Agency considered acceptable that the Agency reviewed as part of their determination
of reregistration eligibility of flower and vegetable oils.
The Agency believes this information is sufficient to support reregistration and,
that flower and vegetable oils can be used without resulting in unreasonable adverse
effects to human health and the environment. The Agency therefore finds that all
products other than those used as antimicrobials containing flower and vegetable oils as
the active ingredient are eligible for reregistration. The reregistration of particular
products is addressed in Section V of this document.
The use of essential oils for antimicrobial purposes is ineligible for reregistration.
The Agency has concluded that essential oils normally have no independent pesticidal
activity when included in antimicrobial products but rather would be classified as inert
ingredients (perfume) of such products, within the meaning of FIFRA sec. 2(m). (40
CFR 153.139). These antimicrobial products contain one or more other ingredients that
perform as the active ingredient(s).
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B. Risk Management Decision
In consideration of the above information about flower and vegetable oils, the
Agency finds no reason to impose new risk reduction measures for currently registered
uses. The Agency will however, assess the need for product specific risk reduction
measures upon receipt of data that are being required under the Product Specific Data
Call-in Notice appended to this document.
Section 4(g)(2)(A) of FEFRA calls for the Agency to determine, after submission
of relevant data concerning an active ingredient, whether products containing the active
ingredients are eligible for reregistration. The Agency has previously identified and
required the submission of the generic (i.e. active ingredient specific) data required to
support reregistration of products containing flower and vegetable oil active ingredients.
The Agency has completed its review of these generic data, and has determined that the
data are sufficient to support reregistration of all products containing flower and
vegetable oils. Appendix B identifies the generic data requirements that the Agency
reviewed as part of its determination of reregistration eligibility of flower and vegetable
oils, and lists the submitted studies that the Agency found acceptable.
The data identified in Appendix B were sufficient to allow the Agency to assess
the registered uses of flower and vegetable oils and to determine that flower and
vegetable oils can be used without resulting in unreasonable adverse effects to humans
and the environment. The Agency therefore finds that all products containing flower and
vegetable oils as the active ingredients except essential oils in antimicrobial products, are
eligible for reregistration. The reregistration of particular products is addressed in
Section V of this document.
The Agency made its reregistration eligibility determination based upon the target
data base required for reregistration, the current guidelines for conducting acceptable
studies to generate such data and the data identified in Appendix B. Although the
Agency has found that all uses of flower and vegetable oils except the use of essential
oils in antimicrobials 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 the registration of products containing flower and vegetable
oils, if new information comes to the Agency's attention or if the data requirements for
registration (or the guidelines for generating such data) change.
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredients flower and
vegetable oils, the Agency has sufficient information on the health effects of flower and
vegetable oils and on its potential for causing adverse effects in fish and wildlife and the
environment. Therefore, the Agency concludes that products containing flower and
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vegetable oils for all uses, except the use of essential oils in antimicrobial products, are
eligible for reregistration.
The Agency has determined that flower and vegetable oils products, labeled and
used as specified in this Reregistration Eligibility Decision, will not pose unreasonable
risks or adverse effects to humans or the environment.
2. Eligible and Ineligible Uses
The Agency has determined that all current uses of flower and vegetable
oils products are eligible for reregistration except the use of essential oils in
antimicrobial products. The use of essential oils as an active ingredient in
antimicrobial products (i.e. used as a disinfectant, fungicide, tuberculocitie,
virucide, and bacteriostat) has no independent pesticidal activity when included
in antimicrobial products as perfumes, and is therefore, ineligible for
reregistration.
C. Regulatory Position
The following is a summary of the regulatory positions and rationales for flower
and vegetable oils. Where labeling revisions are imposed, specific language is set forth
in Section V of this document.
1. Essential Oils in Antimicrobial Products: Deletion or Conversion to
Inert Ingredients.
AU registrants with antimicrobial products containing essential oils are
required to either delete that active ingredient from their formulation or to convert
that active ingredient to inert status. Call contact person listed in Appendix G
Attachment A for further information.
V. ACTIONS REQUIRED BY REGISTRANTS
This section specifies the data requirements and responses necessary for the reregistration
of both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
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I
There are currently no registered technical grade products for the flower
and vegetable oils. The generic data base supporting the reregistration of
products containing flower and vegetable oils for the above eligible uses has been
reviewed and determined to be incomplete. Registrants are required to submit the
technical chemistry data corresponding to Series 61 and Series 62 for the analysis
and certification of product ingredients. If the product is United States
Pharmacopoeia (USP) grade, a copy of USP analysis with citation of the
analytical methods used and certification would satisfy the requirement of Series
62.
The Confidential Statement of Formula (CSF) must be supported by
analytical data. The data on the physical and chemical characteristics of the
flower and vegetable oils from the Material Safety Data Sheet (MSDS) for the
product may be compiled by the registrant in the format required by the FIFRA
Accelerated Reregistration Phase 3 Technical Guidance, specifically PR Notice
86-5, to satisfy some of the requirements of Series 63. The generic data
requirements are listed in Appendix F, the Generic Data Call-in Notice.
2. Labeling Requirements for Manufacturing-Use Products
No manufacturing-use products are registered with the EPA at this time.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility
has been made. The product specific data requirements are listed in Appendix
G, the Product Specific Data Call-In Notice.
Registrants must review previous data submissions to ensure that they meet
current EPA acceptance criteria (Appendix F; Attachment E) and if not, commit
to conduct new studies. If a registrant believes that previously submitted data
meet current testing standards, then study MRID numbers should be cited
according to the instructions in the Requirement Status and Registrants Response
Form provided for each product.
2. Labeling Requirements for End-Use Products
The labels and labeling of all products must comply with EPA's current
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regulations and requirements as specified in 40 CFR §156.10.
All registrants that have a mixture of essential oils listed on the label as
the active ingredient (and the product is not an antimicrobial) must list separately
each essential oil and its percentage of the composition on the label. The term
"essential oils" will no longer be acceptable to describe a mixture of oils.
All registrants with antimicrobial products containing essential oils are
required to either delete that active ingredient from their formulation or to convert
that active ingredient to inert status.
All registrants that have "pets" as the use site for their pesticide product
must specify which pets are to be treated. The "pets" use site is too general and
not eligible for reregistratioE, *
Worker Protection Standard
Any product whose labeling reasonably permits use in the production of
an agricultural plant on any farm, forest, nursery, or greenhouse must comply
with the labeling requirements of PR Notice 93-7, "Labeling Revisions Required
by the Worker Protection Standard (WPS), and PR Notice 93-11, "Supplemental
Guidance for PR Notice 93-7, which reflect the requirements of EPA' s labeling
regulations for worker protection statements (40 CFR part 156, subpart K).
These labeling revisions are necessary to implement the Worker Protection
Standard for Agricultural Pesticides (40 CFR part 170) and must be completed
in accordance with, and within the deadlines specified in, PR Notices 93-7 and
93-11. Unless otherwise specifically directed in this RED, all statements required
by PR Notices 93-7 and 93-11 are to be on the product label exactly as instructed
in those notices.
After April 21, 1994, except as otherwise provided in PR Notices 93-7
and 93-11, all products within the scope of those notices must bear WPS PR
Notice complying labeling when they are distributed or sold by the primary
registrant or any supplementally registered distributor.
After October 23, 1995, except as otherwise provided in PR Notices 93-7
and 93-11, all products within the scope of those notices must bear WPS PR
Notice complying labeling when they are distributed or sold by any person.
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling
for 26 months from the date of the issuance of a Reregistration Eligibility Decision
23
K*'.°
-------
i
(RED). Persons other than the registrant may generally distribute or sell such products
for 50 months from the date of the issuance of a RED. However, existing stocks time
frames will be established case-by-case, depending on the number of products involved,
the number of label changes, and other factors. Refer to "Existing Stocks of Pesticide
Products; Statement of Policy"; Federal Register. Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell [add chemical
names here] products bearing old labels/labeling for 26 months from the date of issuance
of a RED. Persons other than the registrant may distribute or sell such products for 50
months from the date of the issuance of a RED.
24
-------
i
VI. APPENDICES
25
-------
i
26
-------
I
APPENDIX A. Table of Use Patterns Subject to
Reregistration
27
-------
i
28
-------
Date 12/28/93 - Time 09:18
APPENDIX A - CASI 4097, [Vegetable and flower oils] Chemical 040501 [Essential oils!
Page 1
SITE Application Type, Application
Timing, Application Eejuipment -
Surface Type & Efficacy Influen-
cing Factor (Antimicrobial only)
IIIMlPljiilsilWpiilliilil^
NON - FOOD/ NON- FEED
:-:<-v-:v- *:•"<•: .v^"':-'""V"VAv.v.^\^:^
Animal treatment (spray)., When needed..
Aerosol can.
Animal wound treatment., When needed..
Aerosol can.
Animal treatment (spray)., Uhen needed.,
Aerosol can.
Animal wound treatment., When needed.,
Aerosol can.
Fumigation., When needed., By hand.
H
Fumigation., Uhen needed., Not on (abet.
Form Minimum Maximum Soil Max. Maximum Dose Min. Restr. Geographic Geographic Use
Application Application Text Apps /crop cycle, Interv Entry Allowed Disallowed Limitations
Rate Rates (Max 3 Max or /year (days) Interv Codes
Dse) Rate (days)
PRL NA UC * NS MS AN NS
PRL NA UC * NS NS AN NS
PRL NA UC * NS NS AN NS
PRL NA UC * NS NS AH NS
CR NA .0007813 lb 20 * NS NS AN NS
cu.ft
.001563 lb 50 *
cu.ft
CR NA .0003125 lb 4 * NS NS NS NS
cu.ft
CR NA .02 lb 90 cu.ft * NS MS NS NS
-------
Date 12/28/93 - Time 09:18
APPENDIX A - CASE 4097, [Vegetable and flower oils] Chemical 040501 [Essential oils]
Page 2
SITE Application Type, Application
Timing, Application Equipment -
Surface Type & Efficacy Influen-
cing Factor (Antimicrobial only)
WON-FOOD/NON-FEED (con't)
Form Minimum
Maximum Soil Max. Maximum Dose Hin. Restr. Geographic
Application Application Text Apps /crop cycle, Jnterv Entry Allowed
Rate Rates (Kax 3 Max or /year (days) Interv
Dse) Rate (days)
Geographic
Disal lowed
Use
Limitations
Codes
Spot treatment., When needed., Aerosol can. PRL NA UC * NS
Spot treatment., When needed.. Pump spray RTU HA
battle.
Spray., When needed., Sprayer. RTU MA
Contact and/or surface treatment., When RTU MA
needed.. Sprayer.
UC
NS
UC * NS
Fumigation., Uhen needed.. By hand.
Space spray., When needed.. Sprayer.
CR MA
CR NA
RTU NA
UC * NS
.0007813 Ib 20 * NS
cu.ft
.001563 Ib 50 *
cu.ft
.0003125 Ib 4 * MS
cu.ft
UC
NS
NS AN NS
NS 1 NS
NS NS NS
NS NS NS
NS AN NS
NS NS NS
NS AN NS
-------
Date 12/28/93 - Time 09:18
APPENDIX A - CASE 4097, [Vegetable and flower oils) Chemical 040501 [Essential oils]
Page 3
ALL DISINFECTANT, FUNGICIDE, TUBERCULOCIDE, BACTERIOSTAT, AND VlRUCIDi USES ON THE FOLLOWING SITES:
HATCHERY EQUIPMENT
HATCHERIES
HOUSEHOLD/DOMESTIC DWELLINGS INDOOR PREMISES
HOUSEHOLD/DOMESTIC DWELLINGS CONTENTS
FOOD PROCESSING, HANDLING AND STORAGE PLANTS/AREAS
EATING ESTABLISHMENTS (ALL OR UNSPECIFIED)
EATING ESTABLISHMENTS EQUIPMENT AND UTENSILS
HOSPITALS AMD RELATED INSTITUTIONS (ALL OR UNSPECIFIED)
HOSPITAL CRITICAL PREMISES (E.G. OPERATING ROOMS)
HOSPITAL PATIENT PREMISES (E.G. CLINICS, WARDS)
HOSPITAL BON-CRITICAL PREMISES (E.G. LABS, WAITING ROOMS)
HOSPITAL CRITICAL ITEMS (ITEMS ENTER BLOOD OR LIVING TISSUE)
HOSPITAL SEMICRITICAL ITEMS (ITEMS CONTACT MUCOSAL MEMSRANE)
HOSPITAL NONCRITICAL ITEMS (ITEMS CONTACT ONLY UNBROKEN SKIN)
HOSPITAL JANITORIAL EQUIPMENT
BARBER AND BEAUTY SHOP EQUIPMENT
MORGUES, MORTUARIES AMD FUNERAL HOME PREMISES
MORGUES, MORTUARIES AND FUNERAL HOME EQUIPMENT
MORGUES, MORTUARIES AND FUNERAL HOME INSTRUMENTS
COMMERCIAL INSTITUTIONAL AND INDUSTRIAL AREAS/PREMISES
COMMERCIAL, INSTITUTIONAL OR INDUSTRIAL EQUIPMENT
LAUNDRY (HOSPITAL, COMMERCIAL, HOUSEHOLD)
DIAPERS (PRESOAK, HOSPITAL, COMMERCIAL, HOUSEHOLD)
LAUNDRY EQUIPMENT
BATHROOM PREMISES
TOILET BOWLS AND URINALS
TOILET TANKS, OR WATER CLOSETS
HEW (FDA/BUREAU OF VETERINARY MEDICINE) (FOR PEST CLAIMS ADMINISTERED BY FDA OR BUREAU OF VETERINARY MEDICINE)
AIR TREATMENTS
SURFACE TREATMENTS (ALL OR UNSPECIFIED)
HARD NON-POROUS SURFACE TREATMENTS
HARD POROUS SURFACE TREATMENTS
SURFACE TREATMENTS (SEASONED/UNPAINTED)
HEADER ABBREVIATIONS
Max. Apps 3 Max Rate
Min. Interv (days)
Restr. Entry Interv (days)
Maximum number of Applications at Maximum Dosage Rate
Minimum Interval between Applications (days)
Restricted Entry Interval (days)
SOIL TEXTURE FOR MAX APP. RATE
* Non-specific
C Coarse
M Medium
F Fine
0 Others
FORMULAT ON CODES
CR CRYSTALLINE
PRL PRESSURIZED LIQUID
RTU LIQUID-READY TO USE
ABBREVIA IONS
AN
As Needed
-------
NS
UC
Hot Specified (on label)
Unconverted due to lack of data (on label)
Page 4
APPLICAT OM RATE
OGBC Dosage Can Not be Calculated
No Calc No Calculation cart be made
U PPM calculated by weight
V PPM Calculated by volume
cut Hundred Weight
nr€-xx nn times (10 power -xx); for instance,
"1.234E-04" is equivalent to ".0001234"
-------
Date 01/04/94 - Time 08:04
APPENDIM A - CASE 4097, [Vegetable and flower oils} Chemical 597501 [Gersniol]
Page 1
SITE Application Type, Application
Timing, Application Equipment -
Surface Type & Efficacy Influen-
cing Factor (Antimicrobial only)
Form Mini nun
Application
Rate
Maximum Soil Max. Max!nun Dose Min. Restr. geographic Geographic Use
Application Text Apps /crop cycle, Interv Entry Aliened Disallowed Limitations
Rates (Max 8 Max or /year (days) Interv Codes
Ose) Rate (days)
NON-FOOD/NON-FEED
Rub-on., When needed., By hand. IMPR HA "" * ""
Scent post application.. When needed,, By IHPR NA
hand.
P/T MA
UC * NS
UC * NS
NS NS
NS NS
NS
NS
.002 pellets * NS
sq.ft
Sprinkle,, When needed., 8y hand.
Scent post application.. When needed., By IMPR NA
hand.
P/T NA
NS 10 NS
„ JSiSa*
tt:_Wr
UC * NS
.002 pellets * NS
.ft
hand.
Sprinkle., When,needed., By hand.
&\^ . < *.
Scent post application., When needed., By IMPR NA
hanrf
le., Mien needed., By hand. P/T NA ,002 pellets * NS
sq.ft
Scent post application.. When needed., By IMPR NA
hand.
Sprinkle., When needed., By hand. P/l NA
NS NS NS
NS 10 NS
NS NS NS
UC * NS
NS 10 NS
.002 pellets * NS
sq.ft
NS NS
NS 10
NS
NS
-------
i
-------
Date 01/04/94 - Time 08:04
1
APPENDIX A - CASE 409?, [Vegetable and flower oils} Chemical 040517 [OH of oranae]
Page
SITE Application Type, Application
Timing, Application Equipment -
Surface Type & Efficacy Influen-
cing Factor (Antimicrobial only)
Form Minimum
Application
Rate
Maximum Soil Max. Maximum Dose Win. Restr. Geographic Geographic Use
Application Text Apps /crop cycle, Interv Entry Allowed Disallowed Limitations
Rates (Max S Max or /year (days) Interv codes
Dse) Rate (days)
NON-FOOD/NON-FEED
IMPS MA DC * NS NS US
UC * NS
Rub-on., When needed., By hand.
Scent post application.. When needed.. By IMPR MA
hand.
Sprinkle., When needed., By hand.
P/T NA
.002 pellets * NS
sq.ft
MS NS
NS 10
NS
NS
NS
Scent post application.. When needed., By IHPR HA
hand.
Sprinkle., When needed., By hand.
P/T NA
.002 pellets * NS
sq.ft
NS NS
NS 10
NS
Scent post application.. When needed.. By IMPR NA
hand.
UC
NS
NS NS
V *'*%£*'
Sprinkle., When needed., 8y hand.
.002 pellets * NS
sq.ft
NS
Scent post application.. When needed., By IMPR NA
hand.
Sprinkle., When needed.. By hand.
P/T NA
.002 pellets * NS
sq.ft
NS NS
NS 10
-------
Date 01/04/94 -
2
Time 08:04
APPENDIX A - CASE 4097, [Vegetable and flower oils] Chemical 040517 [Oil of orange]
Page
LEGEND
HEADER ABBREVIATIONS
Max. Apps 1 Max Rate
Min. Interv (days)
Restr. Entry Interv (days)
Maximum number of Applications at Maximum Dosage Rate
Minimum Interval between Applications (days)
Restricted Entry Interval {days)
SOIL TEXTURE FOR MAX APP. RATE
Non-specific
C Coarse
M Medium
¥ Fine
0 Others
FORMULA! OH CODES
IMPR IMPREGNATED MATERIAL
P/T PELLETED/TABLETED
ABBREVIA IONS
AN
NA
NS
UC
As Needed
Mot Applicable
Mot Specified (on label)
Unconverted due to lack of data (on label)
APPLICAT ON RATE
DCNC Dosage Can Not be Calculated
No Calc No Calculation can be made
U PPM calculated by weight
V PPM Calculated by volume
cut Hundred Weight
nnE-xx nn times (10 power -MX); for instance,
"1.234E-04" is equivalent to ".0001234"
-------
Date 01/04/94 - Time 08:13
Page
APPENDIX A - CASE 4097, £3 Chemical 040519 toil of Rue]
SITE Application Type, Application
Timing, Application Equipment -
Surface Type & Efficacy Influen-
cing Factor (Antimicrobial onlyj
Form Minimum
Haximun Soil Max. Maximum Dose Hin. Restr. Geographic
Application Application Text Apps /crop cycle, Interv Entry Allowed
Hate Rates (Max a Max or /year (days) Interv
Dse) Rate (days)
Geographic
Disallowed
Use
Limitations
Codes
HON-FOOD/NON-FEED
Flea collar., When needed,, By hand, IC/T NA
7.813E-05 Ib *
animal
NS
NS NS
MS
-------
Date 01/04/94 -
2
Time 08:13
APPENDIX A - CASE , [] Chemical 040519 [Of I of Rue]
Page
LEGEND
HEADER ABBREVIATIONS
Max. Apps a Max Rate
Min. Ifrterv (days)
Restr. Entry Interv (days)
Maximum number of Applications at Maximum Dosage Rate
Minimum Interval between Applications (days)
Restricted Entry Interval (days)
SOIL TEXTURE FOR MAX APP. RATE
* Non-specific
C Coarse
M Medium
f Fine
0 Others
FORMULAT OH CODES
IC/T IMPREGNATED COLLAR/TAG
ABBREVIA IONS
AN
NA
NS
UC
As Needed
Not Applicable
Mot Specified (on label)
Unconverted due to lack of data (on label}
APPLICAT ON RATE
DCNC Dosage Can Not be Calculated
No Calc No Calculation can be made
U PPM calculated by weight
V PPM Calculated by volume
cut Hundred Weight
nnE-xx nn times (tO power -xx); for instance,
"1.234E-04" is equivalent to «.0001234"
-------
Date 12/28/93 - Time 09:35
APPENDIX A - USE 4097, [Vegetable and flower oils] Chemical 004901 {Allyl isothiocyanate]
Page 1
SITE Application Type, Application
Timing, Application Equipment -
Surface Type & Efficacy Influen-
cing factor (Antimicrobial only)
NON-FOOO/NON-FEED
Form Minimum
Application
Rate
Maximum Soil Max, Maximum Dose Kin. Restr. Geographic Geographic Use
Application Text Apps /crop cycle, Interv Entry Allowed Disallowed Limitations
Rates (Wax 8 Max or /year (days) Interv " Codes
Dse) Rate (days)
Spot treatment., Uhen needed.. Sprayer. RTU NA UC * NS NS AN NS
Sprinkle., Uhen needed., Not on label.
,y~.:.y.v,y.".y:~vx.:<.":v-:^
Contact and/or surface treatment., Uhen
needed.. Trigger spray bottle.
Outdoor general surface spray., Uhen
needed., Trigger spray bottle.
Perimeter treatment., Uhen needed., Sprayer.
Perimeter treatment., When needed.. Trigger
spray bottle.
fru^Mj, Uhen needed., By hand.
Scent post application.. When needed., By
hand.
Spot treatment., Uhen needed., Sprayer.
Spray., Hhen needed.. Trigger spray bottle.
D
RTU
RTU
RTU
RTU
IMPR
IMPR
RTU
RTU
NA
KA
NA
NA
NA
NA
NA
NA
NA
9.524E-06 lb
sq.ft
,;^-,y.-.v.'.v.'.v.-.;.:.v.:-y.'tX.'.;-:.'.;.>;.:.-.. :.:-•.'.;.•.>:<.;.;<,;
.0005469 gal
sq.ft
.0005469 gal
sq.ft
UC
.001563 gal sq.ft
UC
UC
UC
.0007813 gal
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
11111
HS
iiiiiil
NS
NS
NS
NS
NS
NS
NS
1.5
AN
AN
AN
7
NS
NS
AN
7
NS
HS
NS
NS
NS
NS
NS
NS
NS
Sprinkle., Uhen needed., iy hand.
sq.ft
P/T NA .02 pellets sq.ft * NS NS 10 NS
Perimeter treatment., When needed.. Sprayer. RTU NA UC * NS NS AN NS
UC * NS NS NS NS
Scent post application., Uhen needed.. By IMPR NA
hand.
Spot treatment., When needed.. Sprayer. RTU NA
Spray., When needed.. Trigger spray bottle. RTU NA
UC
.0005469 gal
sq.ft
NS
NS
NS AN
NS AN
NS
NS
-------
i
c
Cl
•I
.M
C
L.
Q.
-------
Date 12/28/93 - Time 09:35
APPENDIX A - CASE 4097, [Vegetable and flower oils] Chemical 004901 [Ally! isothiocyanate]
Page 2
SITE Application Type, Application
Timing, Application Equipment -
Surface Type & Efficacy Influen-
cing Factor (Antimicrobial only}
NOM-FOOD/MOM-FEED Ccon't)
Form Minimum
Application
Rate
Maximum Soil Max. Maximum Dose Hin. Restr. Geographic Geographic Use
Application Text Apps /crop cycle, tnterv Entry Allowed Disallowed Limitations
Rates (Max S Max or /year (days) Interv Codes
Dse) Rate (days)
Scent post application., Wen needed., By JHPR
hand.
Perimeter treatment.. When needed., Sprayer. RTU
Perimeter treatment., When needed., Trigger RTU
spray bottle.
Scent post application., Uhen needed., By IMPR
hand.
Sprinkle., When needed., By hand. P/T
fa
Perimeter treatment,. When needed., Sprayer. RTU
Scent post application., When needed., By IMPR
hand.
Spot treatment., When needed., Sprayer, RTU
Sorav., When needed., Trigger spray bottle. RTU
*XMf>k
MA
NA
MA
NA
NA
DC * NS NS NS NS
m * MS
NS
.0007813 gal
sq.ft
UC
NS
pellets sq.ft * NS
KS AN KS
NS 7 NS
NS NS KS
NS 10 NS
NA
NA
NA
NA
UC *
UC *
UC *
.0005469 gal *
sq.ft
NS
NS
NS
NS
NS AN
NS NS
NS AN
NS AN
NS
NS
NS
NS
I - ff^J* *•
Sp*rtf*le., When needed., By hand.
P/T NA
.02 pellets sq.ft
NS
NS 10
NS
-------
-------
Date 12/28/93
Time 09:35
APPENDIX A - CASE 4097, [Vegetable and flower of Is} Chemical 004901 [Ally I isothiocyanatej
Page 3
LEGEND
HEADER ABBREVIATIONS
Max. Apps i Max Rate
Mm. Interv (days)
Restr. Entry Interv (days)
Maximum number of Applications at Maximum Dosage Rate
Minimum Interval between Applications (days)
Restricted Entry Interval (days)
SOIL TEXTURE FOR MAX APP. RATE
*
c
M
F
0
FORNULAT
D
INPR
P/T
RTU
ABBREV1A
AN
NA
NS
UC
APPLICAT
OCNC
No Cain
y
V
cut
nnE-xx
Non-specific
Coarse
Medium
Fine
Others
ON CODES
DUST
IMPREGNATED MATERIAL
PELIETED/TABLETEO
LIQUID-READY TO USE
IONS
As Needed
Not Applicable
Not Specified (on label)
Unconverted due to lack of
OH RATE
data
Dosage Can Not be Calculated
No Calculation can be made
PPM calculated by weight
PPM Calculated by volume
Hundred Weight
nn times (10 power -xx);
for i
(on label)
instance, "1.234E-04" Is equivalent to '',0001234"
-------
)ete 12/28/93 - Time 09:43
1
APPENDIX A - CASE 4097. [Vegetable and flower oils] Chemical 031605 [Soybean oil}
Page
SITE Application Type, Application
Timing, Application Equipment -
Surface Type & Efficacy Influen-
cing Factor (Antimicrobial only)
Form Minimum
Application
Rate
Maximum Soil Max. Maximum Dose Min. Restr. Geographic Geographic Use
Application Text Apps /crop cycle, Interv fntry Allowed Disallowed Limitations
Rates (Max 9 Max or /year (days) Interv Codes
Dse) Rate (days)
FOOD/FEED USES
High volume spray (dilute).. Foliar., High OIL NA 118.2 Ib A * NS NS NS NS
volume ground.
MON-FOCO/NON-FEED
.Z501 gal A *
.7662 Ib A *
NS
NS AN
NS
Dutdoor premise treatment.. When needed., EC NA
Sprayer.
Spray., Foliar., Sprayer. EC NA UC * NS NS AH NS
Spray., Potted., Sprayer. EC NA UC * NS NS AN NS
Foliar., Sprayer. EC NA
EC
NA
UC
UC
NS
NS
NS AN
NS AN
Spray., Potted,, Sprayer.
EC NA UC * NS
NS
NS
NS
UC
UC
UC
NS AH
NS AN
NS
NS
Spray., Foliar., Sprayer,
Spray., Potted., Sprayer. EC NA
Spray., Foliar., Sprayer. EC NA
Jpray., Potted., Sprayer. EC NA
Spray., Foliar., Sprayer. EC NA UC * NS
Spray., Potted., Sprayer. EC NA UC * MS
NS
NS
NS AN
NS AN
NS AN
NS AN
NS
NS
NS
NS
-------
i
-------
i
I 5
CO w
_
Q.
tA
O
a.
-------
Date 12/28/93 - Time 09:43 APPENDIX A - CASE 4097, [Vegetable and ftoner oils! Chemical 031605 [Soybean oil! Page
2
SITE Application Type, Application Form Minimum Maxinun Soil Max. Maximum Oose Min. Restr. Geographic Geographic Use
Timing, Application Equipment - Application Application Text Apps /crop cycle, Irtterv Entry Allowed Disallowed Limitations
Surface Type £ Efficacy Influen- Rate Rates (Max 3 Max or /year (days) Interv Codes
cin§ Factor (Antimicrobial only) Dse) Rate (days)
NON-FQOO/NQN-FEED (con't)
Spray., Foliar., Sprayer. EC NA UC * NS NS AM US
Spray., Potted., Sprayer. EC NA UC * NS NS AN NS
Spray., Foliar., Sprayer. EC NA UC * NS NS AN NS
Spray., Potted., Sprayer. EC NA UC * NS NS A« NS
Outdoor premise treatment.. When needed., EC NA .2501 gal A * NS NS AN NS
Sprayer. .7662 Ib A *
-------
i
-------
Date 12/28/93 - Time 09:43
APPENDIX A - CASE 4097, [Vegetable and flower oils] Chemical 031605 [Soybean oil]
Page 3
LEGEND
HEADER ABBREVIATIONS
Max. Apps 0 Max Rate ; Maximum number of Applications at Maximum Dosage Rate
Min. Interv (days) : Minimum Interval between Applications (days)
Restr. Entry Interv (days) : Restricted Entry Interval (days)
SOIL TEXTURE FOR MAX APP. RATE
Non-specific
C Coarse
H Medium
F Fine
0 Others
FORMULA! OH CODES
EC EMULSIFIABLE CONCENTRATE
OIL OILS-HO ADDED PESTICIDE
AB8REV1A IONS
AN
NA
NS
UC
APPLICAT ON RATE
DCNC
No Calc
W
V
cut
nnE-xx
As Needed
Not Applicable
Not Specified (on label)
Unconverted due to lack of data (on label)
Dosage Can Not be Calculated
No Calculation can be made
PPM calculated by weight
PPM Calculated by volume
Hundred Weight
rm times (10 power -xx); for instance, "1,2346-04" is equivalent to ".0001234"
Date 12/28/93 - Time 10:04
APPENDIX A - CASE 4097, [Vegetable and flower oils] Chemical 040502 [Oil of lemongrass]
Pa§e I
Application Type, Application
Timing, Application Equipment -
Surface Type £ Efficacy Influen-
cing Factor (Antimicrobial only)
Form Minimum
Application
Rate
Maximum Soil Max. Maximum Dose Kin. Restr. Geographic Geographic Use
Application Text Apps /crop cycle, Interv Entry Allowed Disallowed Limitations
Rates (Max 3 Max or /year (days) Interv Codes
Dse) Rate ' (days)
NON-FOOD/NQN-FEED
Spot treatment., When needed.. Sprayer. RTU NA
Perimeter treatment,. When needed., Sprayer. RTU NA
Rub-on., When needed., By hand. IMPR NA
UC * NS NS AN US ^
UC * NS NS AN NS
UC * MS NS NS NS
-------
Scent post application., Uhen needed., By 1MPR NA UC * NS US MS NS
hand.
Spot treatment., When needed.. Sprayer. RTU NA UC * NS NS AN NS
Sprinkle., When needed., By hand. P/T KA .2 pellets sq.ft * NS NS 10 NS
Perimeter treatment., When needed.. Sprayer. RTU NA UC * NS NS AN NS
Scent post application., When needed., By IHPR NA UC * NS NS NS NS
hand.
Spot treatment., When needed., Sprayer. RTU NA UC * NS MS AN NS
Sprinkle., Uhen needed., By hand. P/T NA .2 pellets sq.ft * NS NS 10 NS
Scent post application., When needed.. By IHPR NA UC * NS NS NS NS
hand.
Perimeter treatment., Uhen needed., Sprayer. RTU NA UC * NS NS AN ttS
Scent post application., Uhen needed., By IHPR NA UC * NS NS NS NS
hand.
Sprinkle., Uhen^needed,, By hand. P/f NA .2 pellets sq.ft * NS NS 10 NS
Perimeter treatment.. When needed., Sprayer. RTU NA UC * NS NS AN NS
Scent post application., Uhen needed.. By IHPR NA UC * NS NS NS NS
hand.
-------
Date 1Z/28/93 - Time 10:04 APPENDIX A - CASE 4097, [Vegetable and flower oils] Chemical 040502 [Oil of lemongrass] Page 2
SITE Application Type, Application Form Minimum Maximum Soft Max. Maximum Dose Hin. Restr. Geographic Geographic Use
Timing, Application Equipment - Application Application Text Apps /crop cycle, Interv Entry Allowed Disallowed Limitations
Surface Type & Efficacy Influen- Rate Rates (Max i Max or /year (days) Interv Codes
cing Factor {Antimicrobial only) Dse) Rate (days)
NON-FOOO/NDN-FEED (con't)
Spot treatment., Men needed.. Sprayer. RTU NA UC * NS KS AN MS
Sprinkle., When needed., By hand. P/T NA ,2 pellets sq.ft * MS NS 10 MS
-------
i
-------
Date 12/28/93 - Time 10i04
APPENDIX A - CASE 4097, [Vegetable and flower oils! Chemical 040502 [Oil of lemongrass]
Page 3
LEGEND
HEADER ABBREVIATIONS
Max. Apps i Max Rate
Min. Irtterv (days)
Restr. Entry Interv (days)
Maximum number of Applications at Maximum Dosage Rate
Minimum Interval between Applications (days)
Restricted Entry Interval (days)
SOIL TEXTURE FOR MAX APP. RATE
* Non-specific
C Coarse
M Medium
F Fine
0 Others
FORMULA! ON
IMPS
P/T
RTU
ABBREVIA IONS
AN
NA
NS
UC
CODES
IMPREGNATED MATERIAL
PELLETED/TABLETED
LIQUID-READY TO USE
As Needed
Not Applicable
Not Specified (on label)
Unconverted due to lack of data (on label)
APPLICAT ON RATE
DCNC Dosage Can Not be Calculated
No Calc No Calculation can be made
w PPH calculated by Height
V PPH Calculated by volume
cut Hundred Weight
nnE-xx nn times (10 power -xx); for
instance, "1.Z34E-04" is equivalent to ".0001234"
-------
-------
Date 12/26/93 - Time 09:57 APPENDIX A - CASE 4097, [Vegetable and f toner oils] Chemical 040503 [Oil of eucalyptus] Page 1
SITE Application Type, Application Form Minimum Maximum Soil Max. Maximum Dose Win, Restr, Geotraphic Geographic Use
Timing, Application Equipment - Application Application Text Apps /crop cycle, Inter* Entry Allowed Disallowed Limitations
Surface Type 5 Efficacy Influen- Rate Rates (Hax a Max or /year (days) Interv Codes
cing Factor (Antimicrobial only} Dse) Rate (days)
NQN-FOOO/NON-FEEO
Enclosed premise treatment., Uhen needed., D NA UC * NS NS NS NS
Shaker can.
Animal treatment (dust)., When needed.,
Brush.
Animal treatment (dust)., When needed..
Brush.
Spot treatment., When needed., Shaker can. 0 NA UC * NS NS AN NS
Spot treatment., When needed., Shaker can. D NA UC * NS NS AN NS
SpttJRVreatment., When needed., By hand. RTU NA UC * NS NS NS NS
Animal bedding treatment.. When needed., 0 NA UC * NS NS NS NS
Shaker can.
Spot treatment., When needed., Not on label. RTU NA UC * NS NS NS NS
Spot treatment.. When needed., Shaker can. D NA UC * NS NS NS NS
Flea collar., When needed., By hand. IC/T NA UC * NS NS NS NS
.000625 Ib animal *
Rub-on., When needed.. By hand. RTU NA UC * NS NS NS NS
-------
Date 12/28/93 - Time 09:57
APPENDIX A - CASE 4097, [Vegetable and flower oils] Chemical 040503 £0it of eucalyptus}
Page 2
LEGEMD
HEADER ABBREVIATIONS
Max. Apps 8 Max Rate : Maximum number of Applications at Maximum Dosage Rate
Hin. Interv (days) : Minimum Interval between Applications {days)
Restr. Entry Interv (days) : Restricted Entry Interval (days)
SOIL TIXTURE FOR MAX APP. RATE
* Non-specific
C Coarse
M Medium
F Fine
0 Others
FORMULA! ON CODES
D DUST
IC/T IMPREGNATED COLLAR/TAG
RTU LIQUID-READY TO USE
ABBREVIA IONS
AN
NA
NS
DC
As Needed
Not Applicable
Not Specified (on label)
Unconverted due to lack of data {on label)
APPLICAT ON RATE
Dosage Can Not be Calculated
No Calculation can be made
PPM calculated by weight
PPM Calculated by volume
Hundred Weight
nn times (10 power -xx); for
instance, "1.2341-04" is equivalent to ".0001234"
-------
Date 12/28/93 - Time 09:28
APPENDIX A - CASE 4097, [Vegetable and flower oils] Chemical 004301 [Oil of anise]
Page 1
SiTE Application Type, Application
Timing, Application Equipment -
Surface Type & Efficacy Influen-
cing Factor {Antimicrobial only}
Form Minimum
Maximum Soil Max, Maximum Dose Min. Restr. Geographic
Application Application Text Apps /crop cycle, Interv Entry Allowed
Rate Rates (Max a Max or /year (days) Interv
Dse) Rate (days)
FOOD/FEED USES
Geographic
Disallowed
Use
Limitations
Codes
Spot treatment., When needed.. Sprayer. RTU NA
.05333 Ib IK * NS NS AN NS
sq.ft
NON-FOOD/NON-FEEO
Spot treatment., When needed.. Sprayer. RTU NA .05333 Ib 1K * NS NS NS NS
sq.ft
.05333 Ib 1K * NS
sq.ft
Spot treatment.. When needed., Sprayer. RTU NA .032 Ib IK sq.ft * NS MS AN NS
Spot treatment., When needed., Sprayer. RTU NA .05333 Ib IK * NS NS AN NS
-------
Date 12/28/93 - Time 09:28
APPENDIX A - CASE 4097, [Vegetable and flower oils] Chemical 004301 [Oil of anise]
Page 2
LEGEND
HEADER ABBREVIATIONS
Max. Apps 8 Max Rate
Kin. Interv (days)
Restr. Entry Interv (days)
Maximum number of Applications at Maximum Dosage Rate
Minimum Interval between Applications (days)
Restricted Entry Interval (days)
SOIL TEXTURE FOR MAX APP. RATE
* Non-specific
C Coarse
M Medium
F Fine
0 Others
FORMULA! ON CODES
RTU LIQUID-READY TO USE
ABBREVIATIONS
AN
NA
NS
DC
As Needed
Not Applicable
Not Specified (on label)
Unconverted due to lack of data (on label)
APPLICAT ON RATE
DCNC Dosage Can Mot be Calculated
No Catc No Calculation can be made
W PPH calculated by weight
V PPMtalculated by volume
cut Hundred Weight
nnE-Kx nn times (10 power -xx); for instance,
"1.234E-04" is equivalent to ",0001234"
-------
i
-------
i
-------
i
APPENDIX B. Table of the Generic Data Requirements
and Studies Used to Make the Reregistration Decision
55
-------
i
56
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case Flower and Vegetable Oils covered by this Reregistration
Eligibility Decision Document. It contains generic data requirements that apply to Flower and
Vegetable Oils in all products, including data requirements for which a "typical formulation"
is the test substance.
The data table is organized in the following format:
1. pata 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 in the Pesticide Assessment Guidelines, which are available from the
National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703)
487-4650.
2. |JsePattern (Column 2), This column indicates the use patterns for which the
data requirements apply. The following letter designations are used for the given use
patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
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 (MRCD) number, but may be a "GS" number if no MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
57
-------
58
-------
APPENDIX B
Data Supporting Guideline Requirements for the Registration of Essential Oils
;c«'jy
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-1
61-2A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
Chemical Identity
Start, Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition
PH
Stability
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
ECOLOGICAL EFFECTS
59
-------
Data Supporting Guideline Requirements for the Reregistration of Essential Oils
REQUIREMENT
71-1A
71 -2 A
72-1A
72- 1C
72-2A
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
84-2A
84-2B
84-4
Acute Avian Oral - Quail/Duck
Avian Dietary - Quail
Fish Toxicity Bluegill
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -
Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization - Guinea Pig
Gene Mutation (Ames Test)
Structural Chromosomal Aberration
Other Genotoxic Effects
USE PATTERN
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
CITATION(S)
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
ENVIRONMENTAL FATE
161-1
Hydrolysis
ALL
WAIVED
60
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Oil of Lemongrass
REQUIREMENT
PRODUCT CHEW
61-1
61-2A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
ECOLOGICAL El
JSTRY
Chemical Identity
Start, Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition
pH
Stability
JTECTS
USE PATTERN
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
CFTATION(S)
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
*f"
61
-------
Data Supporting Guideline Requirements for the Reregistration of Oil of Lemongrass
REQUIRE3VIENT
71-1A
71-2A
72-1 A
72-1C
72-2A
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
84-2A
84-2B
84-4
Acute Avian Oral - Quail/Duck
Avian Dietary - Quail
Fish Toxicity Bluegill
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -
Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization - Guinea Pig
Gene Mutation (Ames Test)
Structural Chromosomal Aberration
Other Genotoxic Effects
USE PATTERN
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
CITATION(S)
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
ENVIRONMENTAL FATE
161-1
Hydrolysis
ALL
WAIVED
62
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Oil of Eucalyptus
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-1
61-2A
61-2B
62-1
62-2
62-3
63-2
6,3-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
Chemical Identity
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition
pH
Stability
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
ECOLOGICAL EFFECTS
63
-------
Data Supporting Guideline Requirements for the Reregistration of Oil of Eucalyptus
REQUIREMENT
71-1A
7 1-2 A
72-1 A
72- 1C
72-2A
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
84-2A
84-2B
84-4
Acute Avian Oral - Quail/Duck
Avian Dietary - Quail
Fish Toxicity BluegiU
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -
Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Bye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization - Guinea Pig
Gene Mutation (Ames Test)
Structural Chromosomal Aberration
Other Genotoxic Effects
WE PATTERN
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
CITATION(S)
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
ENVIRONMENTAL FATE
161-1
Hydrolysis
ALL
WAIVED
64
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Soybean Oil
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-1
61-2A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
Chemical Identity
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
OctanoI/Water Partition
PH
Stability
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
ECOLOGICAL EFFECTS
65
-------
Data Supporting Guideline Requirements for the Reregistration of Soybean Oil
REQUIREMENT
71-1A
71-2A
72-1 A
72- 1C
72-2A
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
84-2A
84-2B
84-4
Acute Avian Oral - Quail/Duck
Avian Dietary - Quail
Fish Toxicity Bluegill
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -
Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Bye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization - Guinea Pig
Gene Mutation (Ames Test)
Structural Chromosomal Aberration
Other Genotoxic Effects
USE PATTERN
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
CITATION(S)
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
ENVIRONMENTAL FATE
161-1
Hydrolysis
ALL
WAIVED
66
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Oil of Mustard (Allyl
isothiocyanate)
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-1
61-2A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
Chemical Identity
Start, Mat, & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition
PH
Stability
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
BATAGAP
67
-------
Data Supporting Guideline Requirements for the Reregistration of Oil of Mustard (Allyl
isothiocyanate)
REQUIREMENT
ECOLOGICAL EFFECTS
71-1 A Acute Avian Oral - Quail/Duck
7 1-2 A Avian Dietary - Quail
72-1 A Fish Toxicity Bluegill
72-1 C Fish Toxicity Rainbow Trout
72-2A Invertebrate Toxicity
TOXICOLOGY
81-1 Acute Oral Toxicity - Rat
81-2 Acute Dermal Toxicity -
Rabbit/Rat
81-3 Acute Inhalation Toxicity - Rat
81-4 Primary Eye Irritation - Rabbit
81-5 Primary Dermal Irritation - Rabbit
81-6 Dermal Sensitization - Guinea Pig
84-2A Gene Mutation (Ames Test)
84-2B Structural Chromosomal Aberration
84-4 Other Genotoxic Effects
ENVIRONMENTAL FATE
161-1 Hydrolysis
USE PATTERN
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
CITATION(S)
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
68
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Oil of Anise
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-1
61 -2 A
61-2B
62-1
62-2
62-3
63-2
63-3
r*
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
Chemical Identity
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition
pH
Stability
ALL
ALL
ALL-
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
DATAGAP
ECOLOGICAL EFFECTS
69
-------
Data Supporting Guideline Requirements for the Registration of Oil of Anise
REQUIREMENT
71-1A
71-2A
72-1 A
72-1C
72-2A
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
84-2A
84-2B
84-4
Acute Avian Oral - Quail/Duck
Avian Dietary - Quail
Fish Toxicity Bluegill
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -
Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Bye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitkation - Guinea Pig
Gene Mutation (Ames Test)
Structural Chromosomal Aberration
Other Genotoxic Effects
USE PATTERN
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
CITATION(S)
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
ENVIRONMENTAL FATE
161-1
Hydrolysis
ALL
WAIVED
70
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APPENDIX C. Citations Considered to be Part of the
Data Base Supporting the Reregistration of Flower and
Vegetable Oils
71
-------
I
72
-------
i
GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all
studies considered relevant by EPA in arriving at the positions and conclusions stated
elsewhere in the Reregistration Eligibility Document. Primary sources for studies in
this bibliography have been the body of data submitted to EPA and its predecessor
agencies in support of past regulatory decisions. Selections from other sources
including the published literature, in those instances where they have been considered,
are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In
the case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically large*
volumes in which they were submitted. The resulting "studies" generally have a
distinct title (or at least a single subject), can stand alone for purposes of review and
can be described with a conventional bibliographic citation. The Agency has also
attempted to unite basic documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID number". This number is unique
to the citation, and should be used whenever a specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identify volumes
of submitted studies (see paragraph 4(d)(4) below for further explanation). In a few
cases, entries added to the bibliography late in the review may be preceded by a nine
character temporary identifier. These entries are listed after all MRID entries. This
temporary identifying number is also to be used whenever specific reference is
needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the
Agency has shown an identifiable laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the
first submitter as the author.
b. Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced
73
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i
the date from the evidence contained in the document. When the date appears
as (19??), the Agency was unable to determine or estimate the date of the
document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to
create or enhance a document title. Any such editorial insertions are contained
between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the
trailing parentheses include (in addition to any self-explanatory text) the
following elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received." ''
(2) Administrative number. The next element immediately following the
word "under" is the registration number, experimental use permit
number, petition number, or other administrative number associated
with the earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume
in which the original submission of the study appears. The six-digit
accession number follows the symbol "CDL," which stands for
"Company Data Library." This accession number is in turn followed
by an alphabetic suffix which shows the relative position of the study
within the volume.
74
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i
BIBLIOGRAPHY
MRID
CITATION
00104087
1. Code of Federal Regulations, Title 40, part 158, revised as of July 1,
1992. Published by the Office of the Federal Register National Archives and
Records Administration, Washington, D.C., U.S.A.
2. Code of Federal Regulations, Title 21, part 172, section 515, part 182,
section 186 revised as of July 1, 1992. Published by the Office of the Federal
Register National Archives and Records Administration, Washington, D.C.,
U.S.A.
3. The Merck Index; An Encyclopedia of Chemicals, Drugs, and Biologicals.
Windholz, Martha, editor, et. al. Tenth Edition. Published in 1983 by Merck
and Company, Rahway New Jersey, U.S.A.
4. Registry of Toxic Effects of Chemical Substances, 1980.
5. Registry of Toxic Effects of Chemical Substances: bChembank CD ROM,
1991.
Lay, T.; Peterson, A. (1976) Report on Dietary LC50 in Bobwhite Quail:
Scent-off Twist-ons: laboratory Nos. G-1065-66. (Unpublished study
received Aug 24, 1979 under 5332-8; prepared by Wells Laboratories, Inc.,
submitted by Plantabbs Corp., Timonium, MD; CDL:241053-A)
75
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i
76
-------
i
APPENDIX D. List of Available Related Documents
77
-------
i
78
-------
i
The following is a list of available documents related to Flower and Vegetable Oils.
It's purpose is to provide a path to more detailed information if it is needed. These
accompanying documents are part of the Administrative Record for Flower and Vegetable
Oils and are included in the BPA's Office of Pesticide Programs Public Docket.
1. Health and Environmental Effects Science Chapters
2. Detailed Label Usage Information System (LUIS) Report
3. Flower and Vegetable Oils RED Fact Sheet
4. PR Notice 86-5 (included in this appendix)
5. PR Notice 91-2 (included in this appendix) pertains to the Label Ingredient
Statement
79
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i
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i
APPENDIX E. PR Notices 86-5 and 91-2
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I
82
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PR Notice 86-5
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i
84
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
July 29, 1986
OFFICI OF
PR NOTICE 86-5 PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
NOTICE TO PRODUCERS, FORMUIiATORS, DISTRIBUTORS
AND REGISTRANTS
Attention: Persons 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)(1) . This Notice
does not apply to commercial, financial, or production
information, which are, and must continue to be, submitted
differently under separate cover.
III. Effective Date
This notice is effective on November l, 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 §158.32), and Procedures for Claims of
Confidentiality of Data (40 CFR §158.33). These regulations
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specify the format for data submitted to EPA under•Section 3 of
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 from their use before the
entire proposed regulation becomes final. Adequate lead time is
being provided for submitters to comply with the new
requirements,
V. Relationship of this. Notice to Other ..OPP Policy and Guidance
While this Notice contains requirements for organizing and
formatting submittals of supporting data, it does not address the
substance of test reports themselves. "Data reporting" guidance
is now under development in OPP, and will specify how the study
objectives, protocol, observations, findings, and conclusions are
organized and presented within the study report. The data '
reporting guidance will be compatible with submittal format
requirements described in this Notice.
OPP has also promulgated a policy (PR Notice 86-4-dated
April 15, 1986) that provides for early screening of certain
applications for registration under FIFRA §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
deadlines for inserting into the docket documents submitted in
connection 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 requirement is not altered by this notice, which
applies only to data submitted with an application.
VI. FormatRequirements
A more detailed discussion of these format requirements
follows the index on the next page, and samples of some of the
requirements are attached. Except for the language of the two
alternative 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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I
- INDEX-
Text Exampl
Page Page
A. Organization of the Submittal Package 3 l
B. Transmittal Document 4 1:
C. Individual Studies ........ 4
C. 1 Special Considerations for Identifying Studies . . 5
D. Organization of each Study Volume 6 1'
D. 1 Study Title Page 7 i:
D. 2 Statement of Data Confidentiality Claims
(based on FIFRA §10(d)(1)) ........ 8 i:
D. 3 Confidential Attachment 8 l!
D. 4 Supplemental Statement of Data Confidentiality
Claims (other than those based on FIFRA §10(d)(l)} 8 l<
D. 5 Good Laboratory Practice Compliance Statement . . '§ l(
E. Reference to Previously Submitted Data 9
F. Physical Format Requirements & Number of Copies .... 9
G. Special Requirements for Submitting Data to the Docket 10
**************
A. Organization of Submittal Package
A "submittal package" consists of all studies submitted at
the same time for review in support of a single regulatory
action, along with a transmittal document and other related
administrative material (e.g. the method of support statement,
EPA Forms 8570-1, 8570-4, 8570-20, etc.) as appropriate.
Data submitters must organize each submittal package as
described in this Notice. The transmittal and any other admin-
istrative material must be grouped together in the first physical
volume. Each study included in the submittal package must then
be bound separately.
Submitters sometimes provide additional materials that are
intended to clarify, emphasize, or otherwise comment to help
Product Managers and reviewers better understand the submittal.
If such materials relate to one study, they should be
included as an appendix to that study.
- If such materials relate to more than one study (as for
example a summary of all studies in a discipline) or to the
submittal in general, they must be included in the submittal
package as a separate study (with title page and statement
of confidentiality claims) .•
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B. Transmittal- Document
The first item in each submittal package must be a trans-
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, §6(a)(2) submittal, or a special review; the transmittal
date; and a list of all- individual studies included in the
package in the order of their appearance, showing (usually by
Guideline reference number) the data requirement(s) addressed by
each one. The EPA-assigned number for the regulatory action
(e.g. the registration, EUP, or tolerance petition number) should
be included in the transmittal document as well, if it is known
to the submitter. See Attachment 1 for an example of an
acceptable transmittal document.
The list of included studies in the transmittal of a data
submittal package supporting a registration application should be
subdivided by discipline, reflecting the order in which data
requirements appear in 40 CPR 158.
The list of included studies in the transmittal of a data
submittal package supporting a petition for tolerance or an
application for an EUP should be subdivided into sections A, B,
C, .... of the petition or application, as defined in 40 CFR 180.7
and 158.125, (petitions) or Pesticide Assessment Guidelines,
Subdivision I (EUPs) as appropriate.
When a submittal package supports a tolerance petition and
an application for a registration or an EUP, list the petition
studies first, then the balance of the studies. Within these two
groups of studies follow the instructions above.
C. Individual Studies
A study is the report of a single scientific investigation,
including all supporting analyses required for logical complete-
ness. A study should be identifiable and distinguishable by a
conventional bibliographic citation including author, date, and
title. Studies generally correspond in scope to a single Guide-
line requirement for supporting data, with some exceptions dis-
cussed in section C.I. Each study included in a submittal
package must be bound as a separate entity. (See comments on
binding studies on page 9.)
Each study must be consecutively paginated, beginning from
the title page as page 1. The total number of pages in the com-
plete study must^be shown on the study title page. In addition
{to ensure that inadvertently separated pages can be reassociated
with the proper study during handling or review) use either of
the following:
- Include the total number of pages in the complete study on
each page (i.e., 1 of 250, 2 of 250, ...250 of 250).
- Include a company name or"mark and study number on each
page of the study, e g , Company Name-1986-23. Never reuse
a study number for marking the pages of subsequent studies.
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When a single study is extremely long, binding it in mul-
tiple volumes is permissible so long as the entire study is pag-
inated in a single series, and each volume is plainly identified
by the study title and its position in the multi-volume sequence.
C.I Spe_cial 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 Sfcudigs.' 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 the1
primary study as appendices. When such supplemental reports are
submitted independently of the primary report, take care to fully
identify the primary report to which they pertain.
Batteries of acute toxicity tests, performed on the same end
use product and covered by a single title page, may be bound
together and reported as a single study.
b. Product Chemistry Studies. All product chemistry data
within a submittal package submitted in support of an end-use
product produced from registered manufacturing-use products
should be bound as a single study under a single title page.
Product chemistry data submitted in support of a technical
product, other manufacturing-use product, an experimental use
permit, an import tolerance petition, or an end-use product
produced from unregistered source ingredients, should be bound as
a single study for each Guideline series (61, 62, and 63) for
conventional pesticides, or for the equivalent subject range for
biorational pesticides. The first of the three studies in a
complete product chemistry submittal for a biochemical pesticide
would cover Guidelines 151-10, 151-11, and 151-12; the second
would cover Guidelines 151-13, 151-15, and 151-16; the third
would cover Guideline 151-17. The first study for a microbial
pesticide would cover Guidelines 151-20, 151-21, and 151-22; the
second would cover Guidelines 151-23 and 151-25; the third would
cover Guideline 151-26.
Note particularly that product chemistry studies are likely
to contain Confidential Business Information as defined in FIFRA
§10(d)(l)(A), (B), or (C), and if so must be handled as described
in section D.3. of this notice.
89 m
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c. Residue. Chemistry Studies. Guidelines 171-4, 153-3,
and 153-4 are extremely broad in scope; studies addressing
residue chemistry requirements must thus be defined at a level
below that of the Guideline code. The general principle,
however, of limiting a study to the report of a single inves-
tigation still applies fully. Data should be treated as a single
study and bound separately for each analytical method, each
report of the nature of the residue in a single crop or animal
species, and for each report of the magnitude of residues
resulting from treatment of a single crop or from processing 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 "example" 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
When Required Example
Always Page 12
One of the two alternative Page 13
forms of this statement
is always required
If study reports laboratory Page 16
work subject to GLP require-
ments
For certain toxicology studies (When
flagging requirements are finalized.)
Always - with an English language
translation if required.
At submitter's option
If CBI is claimed under FIFRA
§10 (d) (l) (A) , (B) , or (C)
CBI Attachment
Supplemental Statement
of Data Confidentiality
Claims
If CBI is claimed under FIFRA
§lO(d)(l)(A), (B), or (C) Page 15
Only if confidentiality is Page 14
claimed on a basis other than
FIFRA §10{d}(1)(A), (B) , or (C)
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D.l. 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 INCLOTE CBI ON THE TITLE PAGE.
An example of an acceptable title page is on page 12 of this
notice. The following information must appear on the title page:
a. Study title. The study title should be as descriptive as •
possible It must clearly identify the substance (a) tested and
correspond to the name of the data requirement as it appears in
the Guidelines.
b. Data, requirement addressgd . Include on the title page the
Guideline number (s) of the specific requirement (s) addressed by
the study.
c. Author (s) . Cite only individuals with primary intellectual
responsibility for the content of the study. Identify them
plainly as authors, to distinguish them from the performing *
laboratory, study sponsor, or other names that may also appear on
the title page.
d. Study Date. The title page must include a single date for
the study. If parts of the study were performed at different
times, use only the date of the latest element in the study.
e. Performing Laboratory Identification. If the study reports
work done by one or more laboratories, include on the title page
the name and address of the performing laboratory or
laboratories, and the laboratory's internal project number (s) for
the work. Clearly distinguish the laboratory's project
identifier from any other reference numbers provided by the study
sponsor or submitter.
f. Supplemental Submissions. If the study is a commentary on
or supplement to another previously submitted study, or if it
responds to EPA questions raised with respect to an earlier
study, include on the title page elements a. through d. for the
previously submitted study, along with the EPA Master Record
Identifier (MRID) or Accession number of the earlier study if you
know these numbers. {Supplements submitted in the same submittal
package as the primary study should be appended to and bound with
the primary study. Do not include supplements to more than one
study under a single title page) .
g. Fac t s of : Publ icat ion . If the study is a reprint of a pub-
lished document, identity 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 FIFRA
§10(d)(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 FIFRA §10(d)(l)(A), (B), or (C). Use
the appropriate alternative form of the statement either to
assert a claim of §10(d)(l) data confidentiality (§158.33(b)} or
to waive such a claim (§158.33(c)}. In either case, the
statement must be signed and dated, and must include the typed
name and title of the official who signs it. Do not make CBI
claims with respect to analytical methods associated with pet-
itions for tolerances or emergency exemptions (see NOTE Pg 13}.
D.3. Confidential Attachment
If the claim is made that a study includes confidential
business information as defined by the criteria of FIFRA *'
§10(D) (l) (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." An appropriately
annotated photocopy of the parent study title page may be used as
this cover sheet. Paginate the Confidential Attachment
separately from the body of the study, beginning with page l of X
on the title page. Each passage confined to the Confidential
Attachment must be associated with a specific cross reference to
the page(s) in the main body of the study on which it is cited,
and with a reference to the applicable passage(s) of FIFRA
§10(d)(1) on which the confidentiality claim is based.
D.4. Supp1emental Statement of Data Confidentiality Claims (See
Attachment 4)
If you wish to make a claim of confidentiality for any
portion of a submitted study other than described by FIFRA §10(d)
(1)(A), (B), or (C), the following provisions apply:
- The specific information to which the claim applies must
be clearly marked in the body of the study as subject to a
claim of confidentiality.
- A Supplemental Statement of Data Confidentiality Claims
must be submitted, identifying each passage claimed confi-
dential and describing in detail the basis for the claim.
A list of the points to address in such a statement is
included in Attachment 4 on Pg 14.
- The Supplemental Statement of Data Confidentiality Claims
must be signed and dated and must include the typed name and
title of the official who signed it.
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D.5. Good Laboratory Practice Compliance Statement-
This statement is required if the study contains laboratory
work subject to GLP requirements specified in 40 CFR 160. Sam-
ples of these statements are shown in Attachment 6.
E. Reference to Previously Submitted Data
DO HOT RESUBMZT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED
FOE ANOTHER PURPOSE unless EPA specifically requests it. A copy
of the title page plus the MRID number (if known) is sufficient
to allow us to retrieve the study immediately for review. This
prevents duplicate entries in the Agency files, and saves you
the cost of sending more copies of the study. References to pre-
viously submitted studies should not be included in the transmit-
tal document, but should be incorporated into the statement of
the method of support for the application.
F. Physical Format Requirements
'!
All elements in the data submittal package must be on
uniform 8 1/2 by 11 inch white paper, printed on one side only in
black ink, with high contrast and good resolution. Bindings for
individual 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:
• Do not include frayed or torn pages.
• Do not include carbon copies, or copies in other than
black ink.
• Make sure that photocopies are clear, complete, and
fully readable.
• Do not include oversize computer printouts or fold-out
pages.
» Do not bind any documents with glue or binding tapes.
» Make sure that all pages of each study, including any
attachments or appendices, are present and in correct
sequence,
Number of Copies Required - All submittal packages except
those associated with a Registration Standard or Special Review
(See Part G below) must be provided In three complete, identical
copies. (The proposed regulations specified two copies,- three
are now being required to expedite and reduce the cost of
processing data into the OPP Pesticide Document Management System
and getting it into review.)
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f
G. Special Requirements for Submitting Data tothe Docket
Data submittal packages associated with a Registration Stan-
dard or Special Review must be provided in four copies, from one
of which all material claimed as CBI has been excised. This
fourth copy will become part of the public docket for the RS or
SR case. If no claims of confidentiality are made for the study,
the fourth copy should be identical to the other three. When
portions of a study submitted in support of an RS or SR are
claimed as CBI, the first three copies will include the CBI
material as provided in section D of this notice. The following
special preparation is required for the fourth copy.
» Remove the "Supplemental Statement of Data
Confidentiality Claims".
• Remove the "Confidential Attachment".
» Excise from the body of the study any information you
claim as confidential, even if it does not fall within
the scope of FIFRA §10(d) (1) (A) , (B), or (C). Do not
close up or paraphrase text remaining after this
excision.
» Mark the fourth copy plainly on both its cover and its
title page with the phrase "Public Docket Material -
contains no information claimed as confidential".
V. For Further Information
For further information contact John Carley, Chief,
Information Services Branch, Program Management and Support
Division, (703) 305-5240.
nts W. Akcnun
Acting slrtctor.
Division
Attachment 1. Sample Transmittal Document
Attachment 2. Sample Title Page for a Newly Submitted Study
Attachment 3. Statements of Data Confidentiality Claims
Attachment 4. Supplemental Statement of Data Confidentiality
Claims
Attachment 5. Samples of Confidential Attachments
Attachment 6. Sample Good Laboratory Practice Statements
Attachment 7. Format Diagrams for Submittal Packages and Studies
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ATTACHMENT 1
ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*
1. Name and address of submitter (or all joint submitters**)
+Smith Chemical Corporation Jones Chemical Company
1234 West Smith Street -and- 5678 Wilson Blvd
Cincinnati, OH 98765 Covington, KY 56789
+Smith Chemical Corp will act as sole agent for all submitters.
2. Re_gulatory action in support^ofl which this package is
submitted
Use the EPA identification number (e.g. 359-EUP-67) if you know
it. Otherwise describe the type of request (e.g. experimental
use permit, data call-in - of xx-xx-xx date).
3, Transmittal date
4. List o_f_ submitted studies
Vol 1. Administrative materials - forms, previous corres-
pondence with Project Managers, and so forth.
Vol 2. Title of first study in the submittal (Guideline
No.)
Vol n Title of nth study in the submittal (Guideline
No.)
* Applicants commonly provide this information in a tran-
smittal letter. This remains an acceptable practice,so
long as all four elements are included.
* Indicate which of the joint submitters is empowered to
act on behalf of all joint submitters in any matter
concerning data compensation or subsequent use or
release of the data.
Company Official:,
Name Signature
Company Name: ,
Company Contact:
Name Phone
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ATTACHMENT 2
SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY
Study Title
(Chemical name) - Magnitude of Residue on Corn
Data Requirement
Guideline 171-4
Author
John C. Davis
Study, Completed On
January 5, 1979
Performing Laboratory
ABC Agricultural Laboratories
940 West Bay Drive
Wilmington, CA 39897
Laboratory Project ID
ABC 47-79
Page 1 of x
(X is the total number of pages in the study)
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ATTACHMENT 3
STATEMENTS OP DATA CONFIDENTIALITY CLAIMS
1. No claim of confidentiality under FIFRA §10(d)(1)(A),(B), or
(C) .
STATEMENT OF NO DATA CONFIDENTIALITY CLAIMS
No claim of confidentiality is made for any information
contained in this study on the basis of its falling within
the scope of FIFRA 6S10(d)(1)(A), (B), or (C).
Company
Company Agent:
Title
Typed Name
Date:
_S_ignature
2. Claim of confidentiality under FIFRA §10(d) CD (A), (B) , or
(C).
STATEMENT OF DATA CONFIDENTIALITY CLAIMS
Information claimed confidential on the basis of its falling
within the scope of FIFRA §10(d)(1)(A), (B)» or (C) has been
removed to a confidential appendix, and is cited by
cross-reference number in the body of the study.
Company:
Company Agent:
Title
Typed Name
Date:
Signature
NOTE: Applicants for permanent or temporary tolerances should
note that it is OPP policy that no permanent tolerance, temporary
tolerance, or request for an emergency exemption incorporating an
analytical method, can be approved unless the applicant waives
all claims of confidentiality for the analytical method. These
analytical methods are published in the FDA Pesticide Analytical•
Methods Manual, and therefore cannot be claimed as confidential.
OPP implements this policy by returning submitted analytical
methods, for which confidentiality claims have been made, to the
submitter, to obtain the confidentiality waiver before they can
be processed.
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ATTACHMENT 4
SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
For any portion of a submitted study that is not described
by FIFRA §10(d)(1}(A), (B), or (C), but for which you claim
confidential treatment on another basis, the following informa-
tion must be included within a Supplemental Statement of Data
Confidentiality Claims:
» Identify specifically by page and line number(s) each
portion of the study for which you claim
confidentiality.
» Cite the reasons why the cited passage qualifies for !
confidential treatment.
» Indicate the length of time--until a specific date or
event, or permanently--for which the information should
be treated as confidential.
» identify the measures taken to guard against undesired
disclosure of this information.
• Describe the extent to which the information has been
disclosed, and what precautions have been taken in con-
nection with those disclosures.
» Enclose copies of any pertinent determinations of
confidentiality made by EPA, other Federal agencies, of
courts concerning this information.
• 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.
• If you assert that the information in voluntarily sub-
mitted, indicate whether you believe disclosure of this
information might tend to lessen the availability to
EPA of similar information in the future, and if so,
how.
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ATTACHMENT 5
EXAMPLES OF SEVERAL CONFIDENTIAL ATTACHMENTS
Example l. (Confidential word or phrase that has been deleted
from the study)
CROSS REFERENCE NUMBER l This cross reference number is used in the study
in place of the following words or phrase at the
indicated volume and page references.
DELETED WORDS OR PHRASE:-
PAGE LINE REASON .FOR THE DELETION
/-n1
6
12
100
14
25
19
Identity of Inert Ingredient
FIFRA REFERENCE
§10Cd)(1)(C)
•i
Example 2. (Confidential paragraph(B) that have been deleted from the study)
CROSS REFERENCE NUMBER 5 This cross reference number is used in the study
in place of the following paragraph(s) at the
indicated volume and page references.
DELETED PARAGRAPH{S):
PAGE
20.
Reproduce the deleted paragraph(s) here
LIKES REASON FOR THE DELETION FIFRA REFERENCE
2-17 Description of the quality control process §10(d)(l)(C)
Example3. (Confidential pages that have been deleted from the study)
CROSS REFERENCE NUMBER 2 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.
DELETED PAGE(S): are attached immediately behind this page.
PAGE LINES REASON,. FOR THE DELETION FIFRA REFERENCE
20. 2-17 Description of the product manufacturing process §10(d)(1)(A)
99
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•
ATTACHMENT 6.
SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
Example 1.
This study meets the requirements for 40 CFR Part 160
Submitter —
Sponsor . —
Study Director
Example 2.
This study does not meet the requirements of 40 CFR Part 160, and differs
in the following ways:
3.
Submitter_
Sponsor
Study Director,
Example 3.
The submitter of this study was neither the sponsor of this study nor
conducted it, and does not know whether it has been conducted in
accordance with 40 CFR Part 160.
Submitter
100
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i
ATTACHMENT 7.
FORMAT Or THE SUBMIfTAL PACKAGE
Traniraittal Document,
Belated Administrative M«t*ri«ls
, Method of Support Statement, ate.)
Othar aateri*!* about tha aubwittal
fa.gtj •umjnari«8 of groups of
to aid in thtir raviav).
Stutiias, mubBltttti at unique
physic*! •nttti««/ according
to th« format below. h
FORMAT Of SOiMlTtED 8TUDI1S
LEGEND
Statamant of Confidantiility Cltins.
and flagging* *tata»anti - as appropriate.
Body of tha study, with English
translation If raquirad.
to tha study.
Titla tag* Ol tti« Confidential
Attachment.
Confidantial Att«cfvm«nt.
Supplamantal Statamant
of Confidantiality Claims,
* Whan flagging raquiraaants
ara finalizad.
Document* which Must ba aa bait tad as
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PR Notice 91-2
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I UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
"/ WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
WO TOXIC SUBSTANCES
PR NOTICE 91-2
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS,
AND REGISTRANTS OF PESTICIDES
ATTENTION: Persons Responsible for Federal Registration of ,t
Pesticide Products.
SUBJECT: Accuracy of Stated Percentages for Ingredients
Statement
I. PURPOSE:
The purpose of this notice is to clarify the Office of
Pesticide Program's policy with respect to the statement of
percentages in a pesticide's label's ingredient statement.
Specifically, the amount (percent by weight) of ingredient(s)
specified in the ingredient statement on the label must be stated
as the nominal concentration of such ingredient(s), as that term
is defined in 4-0 CFR 158.153(1). Accordingly, the Agency has
established the nominal concentration as the only acceptable
label claim for the amount of active ingredient in the product.
II. BACKGROUND
For some time the Agency has accepted two different methods
of identifying on the label what percentage is claimed for the
ingredient(s) contained in a pesticide. Some applicants claimed a
percentage which represented a level between the upper and the
lower certified limits. This was referred to as the nominal
concentration. Other applicants claimed the lower limit as the
percentage of the ingredient(s) that would be expected to be
present in their product at the end of the product's shelf-life.
Unfortunately, this led to a great deal of confusion among the
regulated industry, the regulators, and the consumers as to
exactly how much of a given ingredient was in a given product.
The Agency has established the nominal concentration as the only
acceptable label claim for the amount of active ingredient in the
product.
Current regulations require that the percentage listed in
the active ingredient statement be as precise as possible
reflecting good manufacturing practices 40 CFR 156.10(g)(5). The
certified limits required for each active ingredient are intended
to encompass any such "good manufacturing practice" variations 40
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CFR 158.175(C)(3).
The upper and lower certified limits, which must be proposed
in connection with a product's registration, represent the
amounts of 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 12(a)(1)(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 pesticide ingredient Statements must
be changed to nominal concentration.
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IV. PRODUCTS THAT REQUIRE EFFICACY DATA
All pesticides are required to be efficacious. Therefore,
the certified lower 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 153.640,
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 l, 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.
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(3) All other, products/applications that are not subject to
(1) and (2) above will have until July l, 1997, to
comply with this Notice. Such applications should note
"Conversion to Nominal Concentrations on the
application form. These types Or amendments will not be
handled as "Past 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) 308-7031.
C. - fw-XL*_j.it
Ann* fi. Liodaay, Director
Registration Division (H-7505
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I
APPENDIX F. Generic Data Call-in
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CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient(s) identified in Attachment 1 of this Notice, the Data Call-In Chemical Status Sheet.
to submit certain data as noted herein to the U.S. Environmental Protection Agency (EPA, the
Agency). These data are necessary to maintain the continued registration of your produces)
containing this active ingredient(s). Within 90 days after you receive this Notice you must
respond as set forth in Section HI below. Your response must state:
1. how you wiU comply with the requirements set forth in this Notice and its Attachments
1 through 4; or,
2. why you believe you are exempt from the requirements listed in this Notice and in
Attachment 3, Requirements Status and Registrant's Response Form, (see section ffl-B);
or,
3. why you believe EPA should not require your submission of data in the manner specified
by this Notice (see section m-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s) subject to this Notice will be subject to suspension. We have provided a list of
all of your products subject to this Notice in Attachment 2, Data Call-In Response Form, as well
as a list of all registrants who were sent this Notice (Attachment 4).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (F1FRA), 7 U.S.C. section 136a(e)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107
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(expiration date 12-31-92).,
This Notice is divided into six sections and five Attachments. The Notice itself contains
information and instructions applicable to all Data Call-in Notices, The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section n - Data Required By This Notice
Section in - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable
Adverse Effects
Section VI - Inquiries And Responses To This Notice
*»
The Attachments to this Notice are:
Attachment 1 - Data Call-In Chemical Status Sheet
Attachment 2 - Data Call-In Response Form
Attachment 3 - Requirements Status And Registrant's Response Form
Attachment 4 - List Of All Registrants Sent This Data Call-in Notice
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient(s) and reevaluated the
data needed to support continued registration of the subject active ingredient(s). This
reevaluation identified additional data necessary to assess the health and safety of the continued
use of products containing this active ingredient(s). You have been sent this Notice because you
have product(s) containing the subject active ingredient(s),
SECTION H. DATA REQUIRED BY THIS NOTICE
A. DATA REQUnUjD
The data required by this Notice are specified in Attachment 3, Requirements
Status and Registrant's Response Form. Depending on the results of the studies required
, in this Notice, additional testing may be required.
B. srffRDTTLB FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements
specified in Attachment 3, Requirements Status and Registrant's Response Form, within
the time frames provided.
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C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test
standards outlined in the Pesticide Assessment Guidelines for those studies for which
guidelines have been established.
These EPA Guidelines are available from the National Technical Information
Service (NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel;
703-487-4650).
Protocols approved by the Organization for Economic Cooperation and
Development (OECD) are also acceptable if the OECD-recommended test standards
conform to those specified in the Pesticide Data Requirements regulation (40 CFR §
158.70). When using the OECD protocols, they should be modified as appropriate so
that the data generated by the study will satisfy the requirements of 40 CFR § 158.
Normally, the Agency will not extend deadlines for complying with data requirements
when the studies were not conducted in accordance with acceptable standards. The
OECD protocols are available from OECD, 1750 Pennsylvania Avenue N.W.,
Washington, D.C. 20006.
All new studies and proposed protocols submitted in response to this Data Call-In
Notice must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
D. REGISTRANTS RECEIVING PREVIOUS SECTION 3fc)(2)fB) NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-In does not in any way supersede
QJ: change the requirements of any previous Data Call-In(s). or any other agreements
entered into with the Agency pertaining to such prior Notice. Registrants must comply
with the requirements of all Notices to avoid issuance of a Notice of Intent to Suspend
their affected products.
SECTION HI. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice must be submitted to
the Agency within 90 days after your receipt of this Notice. Failure to adequately
respond to this Notice within 90 days of your receipt will be a basis for issuing a Notice
of Intent to Suspend (NOIS) affecting your products. This and other bases for issuance
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of NOIS due to failure to comply with this Notice are presented in Section IV-A and IV-
B.
B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice are; 1) voluntary cancellation, 2) delete
use(s), (3) claim generic data exemption, (4) agree to satisfy the data requirements
imposed by this Notice or (5) request a data waiver(s).
A discussion of how to respond if you chose the Voluntary Cancellation option,
the Delete Use(s) option or the Generic Data Exemption option is presented below. A
discussion of the various options available for satisfying the data requirements of this
Notice is contained in Section ni-C. A discussion of options relating to requests for data
waivers is contained in Section ffl-D. '
There are two forms that accompany this Notice of which, depending upon your
response, one or both must be used in your response to the Agency. These forms are
the Data-Call-in Response Form (Attachment 2) and the Requirements Status and
Registrant's Response Form (Attachment 3). The Data Call-In Response Form must be
submitted as part of every response to this Notice. Please note that the company's
authorized representative is required to sign the first page of the Data Call-in Response
Form and Requirements Status and Registrant's Response Form (if this form is required)
and initial any subsequent pages. The forms contain separate detailed instructions on the
response options. Do not alter the printed material. If you have questions or need
assistance in preparing your response, call or write the contact person identified in
Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice
by requesting voluntary cancellation of your product(s) containing the active
ingredient(s) that is the subject of this Notice. If you wish to voluntarily cancel
your product, you must submit a completed Data Call-in Response Form.
indicating your election of this option. Voluntary cancellation is item number 5
on the Data Call-in Response Form. If you choose this option, this is the only
form that you are required to complete.
If you choose to voluntarily cancel your product, further sale and
distribution of your product after the effective date of cancellation must be in
accordance with the Existing Stocks provisions of this Notice which are contained
in Section IV-C.
2. Use Deletion - You may avoid the requirements of this Notice by
eliminating the uses of your product to which the requirements apply. If you
wish to amend your registration to delete uses, you must submit the Requirements
Status and Registrant^ Response Form, a completed application for amendment,
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a copy of your proposed amended labeling, and all other information required for
processing the application. Use deletion is option number 7 on the Requirements
Status and Registrant's Response Form. You must also complete a Da|a.Calljhi
Response Form by signing the certification, item number 8. Application forms for
amending registrations may be obtained from the Registration Support and
Emergency Response Branch, Registration Division, (703) 308-8358.
If you choose to delete the use(s) subject to this Notice or uses subject to
specific data requirements, further sale, distribution, or use of your product after
one year from the due date of your 90 day response, must bear an amended label.
3. Generic Data Exemption - Under section 3(c)(2)(D) of F1FRA, an
applicant for registration of a product is exempt from the requirement to submit
or cite generic data concerning an active ingredient(s) if the active ingredient(s)
in the product is derived exclusively from purchased, registered pesticide products
containing the active ingredient(s). EPA has concluded, as an exercise of its
discretion, that it normally will not suspend the registration of a product which
would qualify and continue to qualify for the generic data exemption in section
3(c)(2)(D) of FIFRA. To qualify, ajl of the following requirements must be met:
a. The active ingredient(s) in your registered product must be present
solely because of incorporation of another registered product which
contains the subject active ingredient(s) and is purchased from a source
not connected with you; and,
b. every registrant who is the ultimate source of the active
ingredient(s) in your product subject to this DCI must be in compliance
with the requirements of this Notice and must remain in compliance; and
c. you must have provided to EPA an accurate and current
"Confidential Statement of Formula" for each of your products to which
this Notice applies.
To apply for the Generic Data Exemption you must submit a completed
Data Call-in Response Form, Attachment 2 and all supporting documentation.
The Generic Data Exemption is item number 6a on the Data Call-in Response
Fonn. If you claim a generic data exemption you are not required to complete
the Requirements Status and Registrant's Response Form. Generic Data
Exemption cannot be selected as an option for product specific data. :
If you are granted a Generic Data Exemption, you rely on the efforts of
other persons to provide the Agency with the required data. If the registrant(s)
who have committed to generate and submit the required data fail to take
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appropriate steps to meet the requirements or arc no longer in compliance with
this Data Call-in Notice, the Agency will consider that both they and you are not
in compliance and will normally initiate proceedings to suspend the registrations
of both your and their product(s), unless you commit to submit and do submit the
required data within the specified time. In such cases the Agency generally will
not grant a time extension for submitting the data.
4. Satisfying the Data Requirements of this Notice - There are various
options available to satisfy the data requirements of this Notice. These options
are discussed in Section DI-C of this Notice and comprise options I through 6 on
the Requirements Status and Registrant's Response Form and option 6b and 7 on
the Data Call-in Response Form. If you choose option 6b or 7, you must submit
both forms as well as any other information/data pertaining to the option chosen
to address the data requirement. •
5- Request for Data Waivers. Data waivers are discussed in Section m-D
of this Notice and are covered by options 8 and 9 on the Requirements Status and
Registrant's Response Form. If you choose one of these options, you must
submit both forms as well as any other information/data pertaining to the option
chosen to address the data requirement.
C. SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-in Response Form that you agree to satisfy
the data requirements (i.e. you select option 6b and/or 7), then you must select one of
the six options on the Requirements Status and Registrant's Response Form related to
data production for each data requirement. Your option selection should be entered
under item number 9, "Registrant Response." The six options related to data production
are the first six options discussed under item 9 in the instructions for completing the
Requirements Status and Registrant's Response Forrn. These six options are listed
immediately below with information in parentheses to guide registrants to additional
instructions provided in this Section. The options are:
1. I will generate and submit data within the specified time frame
(Developing Data),
2. I have entered into an agreement with one or more registrants to develop
data jointly (Cost Sharing),
3. I have made offers to cost-share (Offers to Cost Share),
4. I am submitting an existing study that has not been submitted previously
to the Agency by anyone (Submitting an Existing Study),
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5, I am submitting or citing data to upgrade a study classified by EPA as
partially acceptable and upgradeable (Upgrading a Study),
6. I am citing an existing study that EPA has classified as acceptable or an
existing study that has been submitted but not reviewed by the Agency
(Citing an Existing Study).
Option 1. Developing Data ~
If you choose to develop the required data it must be in confonnance with
Agency deadlines and with other Agency requirements as referenced herein and
in the attachments. All data generated and submitted must comply with the Good
Laboratory Practice (GLP) rule (40 CFR Part 160), be conducted according to the
Pesticide Assessment Guidelines (PAG), and be in confonnance with the
requirements of PR Notice 86-5. In addition, certain studies require Agency
approval of test protocols in advance of study initiation. Those studies for which
a protocol must be submitted have been identified in the Requirements Status and
Registrant^ Response Form and/or footnotes to the fonn. If you wish to use a
protocol which differs from the options discussed in Section n-C of this Notice,
you must submit a detailed description of the proposed protocol and your reason
for wishing to use it. The Agency may choose to reject a protocol not specified
in Section n-C. If the Agency rejects your protocol you will be notified in
writing, however, you should be aware that rejection of a proposed protocol will
not be a basis for extending the deadline for submission of data.
A progress report must be submitted for each study within 90 days from
the date you are required to commit to generate or undertake some other means
to address that study requirement, such as making an offer to cost-share or
agreeing to share in the cost of developing that study. A 90-day progress report
must be submitted for all studies. This 90-day progress report must include the
date the study was or will be initiated and, for studies to be started within 12
months of commitment, the name and address of the laboratory (ies) or individuals
who are or will be conducting the study.
In addition, if the time frame for submission of a final report is more than
1 year, interim reports must be submitted at 12 month intervals from the date you
are required to commit to generate or otherwise address the requirement for the
study. In addition to the other information specified in the preceding paragraph,
at a minimum, a brief description of current activity on and the status of the study
must be included as well as a full description of any problems encountered since
the last progress report.
The time frames in the Requirements_Status and Registrant's JLesponse
Form are the time frames that the Agency is allowing for the submission of
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completed study reports or protocols. The noted deadlines run from the date of
the receipt of this Notice by the registrant. If the data are not submitted by the
deadline, each registrant is subject to receipt of a Notice of Intent to Suspend the
affected registration(s).
If you cannot submit the data/reports to the Agency in the time required
by this Notice and intend to seek additional time to meet the requirement(s), you
must submit a request to the Agency which includes: (1) a detailed description
of the expected difficulty and (2) a proposed schedule including alternative dates
for meeting such requirements on a step-by-step basis. You must explain any
technical or laboratory difficulties and provide documentation from the laboratory
performing the testing. While EPA is considering your request, the original
deadline remains. The Agency will respond to your request in writing. If EPA
does not grant your request, the original deadline remains. Normally, extensions
can be requested only in cases of extraordinary testing problems beyond the
expectation or control of the registrant. Extensions will not be given in
submitting the 90-day responses. Extensions will not be considered if the request
for extension is not made in a timely fashion; in no event shall an extension
request be considered if it is submitted at or after the lapse of the subject
deadline.
Option 2. Agreement to Share in Cost tg Develop Data —
If you choose to enter into an agreement to share in the cost of producing
the required data but will not be submitting the data yourself, you must provide
the name of the registrant who will be submitting the data. You must also
provide EPA with documentary evidence that an agreement has been formed.
Such evidence may be your letter offering to join in an agreement and the other
registrant's acceptance of your offer, or a written statement by the parties that an
agreement exists. The agreement to produce the data need not specify all of the
terms of the final arrangement between the parties or the mechanism to resolve
the terms. Section 3(c)(2)(B) provides that if the parties cannot resolve the terms
of the agreement they may resolve their differences through binding arbitration.
Option 3. Offer to Share in the Cost ofJPata Development —
If you have made an offer to pay in an attempt to enter into an agreement
or amend an existing agreement to meet the requirements of this Notice and have
been unsuccessful, you may request EPA (by selecting this option) to exercise its
discretion not to suspend your registration(s), although you do not comply with
the data submission requirements of this Notice. EPA has determined that as a
general policy, absent other relevant considerations, it will not suspend the
registration of a product of a registrant who has in good faith sought and
continues to seek to enter into a joint data development/cost sharing program, but
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the other registrant(s) developing the data has refused to accept your offer. To
qualify for this option, you must submit documentation to the Agency proving
that you have made an offer to another registrant (who has an obligation to submit
data) to share in the burden of developing that data. You must also submit to the
Agency a completed EPA Form 8570-32, Certification of Offer to Cost Share in
the Development of Data. In addition, you must demonstrate that the other
registrant to whom the offer was made has not accepted your offer to enter into
a cost sharing agreement by including a copy of your offer and proof of the other
registrant's receipt of that offer (such as a certified mail receipt). Your offer
must, in addition to anything else, offer to share in the burden of producing the
data upon terms to be agreed or failing agreement to be bound by binding
arbitration as provided by FIFRA section 3(c)(2)(B)(iii) and must not qualify this
offer. The other registrant must also inform EPA of its election of an option to
develop and submit the data required by this Notice by submitting a Data CalMn
Response Form and a Requirements Status and Registrant's Response Form
committing to develop and submit the data required by this Notice.
In order for you to avoid suspension under this option, you may not
withdraw your offer to share in the burdens of developing the data. In addition,
the other registrant must fulfill its commitment to develop and submit the data as
required by this Notice. If the other registrant fails to develop the data or for
some other reason is subject to suspension, your registration as well as that of the
other registrant will normally be subject to initiation of suspension proceedings,
unless you commit to submit, and do submit the required data in the specified
time frame. In such cases, the Agency generally will not grant a time extension
for submitting the data.
Option 4. Submitting an Existing Study --
If you choose to submit an existing study in response to this Notice, you
must determine that the study satisfies the requirements imposed by this Notice.
You may only submit a study that has not been previously submitted to the
Agency or previously cited by anyone. Fjtisting studies are studies which predate
issuance of this Notice. Do not use this option if you are submitting data to
upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not
acceptable, the Agency will require you to comply with this Notice, normally
without an extension of the required date of submission. The Agency may
determine at any time that a study is not valid and needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing
study, all of the following three criteria^must be clearly met:
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a. , You must certify at the time that the existing study is submitted
that the raw data and specimens from the study are available for audit and
review and you must identify where they are available. This must be
done in accordance with the requirements of the Good Laboratory Practice
(GLP) regulation, 40 CFR Part 160. As stated in 40 CFR 160.3(7)" raw
data means any laboratory worksheets, records, memoranda, notes, or
exact copies thereof, that are the result of original observations and
activities of a study and are necessary for the reconstruction and
evaluation of the report of that study. In the event that exact transcripts
of raw data have been prepared (e.g., tapes which have been transcribed
veitoatim, dated, and verified accurate by signature), the exact copy or
exact transcript may be substituted for the original source as raw data.
Raw data may include photographs, microfilm or microfiche copies,
computer printouts, magnetic media, including dictated observations, ind
recorded data from automated instruments." The term "specimens",
according to 40 CFR 160.3(7), means "any material derived from a test
system for examination or analysis."
b. Health and safety studies completed after May 1984 must also
contain all GLP-required quality assurance and quality control
information, pursuant to the requirements of 40 CFR Part 160.
Registrants must also certify at the time of submitting the existing study
that such GLP information is available for post-May 1984 studies by
including an appropriate statement on or attached to the study signed by
an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for
the Guideline relevant to the study provided in the P1FRA Accelerated
Reregistration Phase 3 Technical Guidance and that the study has been
conducted according to the Pesticide Assessment Guidelines (PAG) or
meets the purpose of the PAG (both available from NTIS). A study not
conducted according to the PAG may be submitted to the Agency for
consideration if the registrant beEeves that the study clearly meets the
purpose of the PAG. The registrant is referred to 40 CFR 158.70 which
states the Agency's policy regarding acceptable protocols. If you wish to
submit the study, you must, in addition to certifying that the purposes of
the PAG are met by the study, clearly articulate the rationale why you
believe the study meets the purpose of the PAG, including copies of any
supporting information or data. It has been the Agency's experience that
studies completed prior to January 1970 rarely satisfied the purpose of the
PAG and that necessary raw data are usually not available for such
studies.
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If you submit an existing study, you must certify that the study
meets all requirements of the criteria outlined above.
If EPA has previously reviewed a protocol for a study you are
submitting, you must identify any action taken by the Agency on the
protocol and must indicate, as part of your certification, the manner in
which all Agency comments, concerns, or issues were addressed in the
final protocol and study.
If you know of a study pertaining to any requirement in this Notice
which does not meet the criteria outlined above but does contain factual
information regarding unreasonable adverse effects, you must notify the
Agency of such a study. If such a study is in the Agency's files, you
need only cite it along with the notification. If not in the Agency's files,
you must submit a summary and copies as required by PR Notice 86-5.
Option 5. Upgrading a Study —
If a study has been classified as partially acceptable and upgradeable, you
may submit data to upgrade that study. The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the
requirement is not satisfied, you may still be required to submit new data
normally without any time extension. Deficient, but upgradeable studies will
normally be classified as supplemental. However, it is important to note that not
all studies classified as supplemental are upgradeable. If you have questions
regarding the classification of a study or whether a study may be upgraded, call
or write the contact person listed in Attachment 1. If you submit data to upgrade
an existing study you must satisfy or supply information to correct aM deficiencies
in the study identified by EPA. You must provide a clearly articulated rationale
of how the deficiencies have been remedied or corrected and why the study
should be rated as acceptable to EPA. Your submission must also specify the
M8ID numbers) of the study which you are attempting to upgrade and must be
in conformance with PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study
classified as unacceptable and determined by the Agency as not capable of being
upgraded.
This option should also be used to cite data that has been previously
submitted to upgrade a study, but has not yet been reviewed by the Agency. You
must provide the MRID number of the data submission as well as the MRID
number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4
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above, apply to all data submissions intended to upgrade studies. Additionally
your submission of data intended to upgrade studies must be accompanied by a
certification that you comply with each of those criteria as well as a certification
regarding protocol compliance with Agency requirements.
Option 6. Citing Existing Studigs --
If you choose to cite a study that has been previously submitted to EPA,
that study must have been previously classified by EPA as acceptable or it must
be a study which has not yet been reviewed by the Agency. Acceptable
toxicology studies generally will have been classified as "core-guideline" or "core
minimum.*1 For ecological effects studies, the classification generally would be
a rating of "core." For all other disciplines the classification would be
"acceptable." With respect to any studies for which you wish to select this option
you must provide the MRID number of the study you are citing and, if the study
has been reviewed by the Agency, you must provide the Agency's classification
of the study.
If you are citing a study of which you are not the original data submitter,
you must submit a completed copy of EPA Form 8570-31, Certification with
Respect to Data Compensation Requirements.
D. REQUESTS FOR DATA WAIVERS
There are two types of data waiver responses to this Notice. The first is a request
for a low volume/minor use waiver and the second is a waiver request based on your
belief that the data requirement(s) are inapplicable and do not apply to your product.
1 • Low Volume/Minor Use Waiver - Option 8 on the Requirements Status
and Registrant's Response Form. Section 3(c)(2)(A) of FIFRA requires EPA to
consider the appropriateness of requiring data for low volume, minor use
pesticides. In implementing this provision EPA considers as low volume
pesticides only those active ingredient(s) whose total production volume for all
pesticide registrants is small. In determining whether to grant a low volume,
minor use waiver the Agency will consider the extent, pattern and volume of use,
the economic incentive to conduct the testing, the importance of the pesticide, and
the exposure and risk from use of the pesticide. If an active ingredient(s) is used
for both high volume and low volume uses, a low volume exemption will not be
approved. If all uses of an active ingredient(s) are low volume and the combined
volumes for all uses are also low, then an exemption may be granted, depending
on review of other information outlined below. An exemption will not be granted
if any registrant of the active ingredient(s) elects to conduct the testing. Any
registrant receiving a low volume minor use waiver must remain within the sales
figures in their forecast supporting the waiver request in order to remain qualified
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for such waiver. If granted a waiver, a registrant will be required, as a condition
of the waiver, to submit annual sales reports. The Agency will respond to
requests for waivers in writing.
To apply for a low volume, minor use waiver, you must submit the
following information, as applicable to your product(s), as part of your 90-day
response to this Notice:
a. Total company sales (pounds and dollars) of all registered
product(s) containing the active ingredient(s). If applicable to the active
ingredient(s), include foreign sales for those products that are not
registered in this country but are applied to sugar (cane or beet), coffee,
bananas, cocoa, and other such crops. Present the above information by
year for each of the past five years. '»
b. Provide an estimate of the sales (pounds and dollars) of the active
ingredient(s) for each major use site. Present the above information by
year for each of the past five years.
c. Total direct production cost of product(s) containing the active
ingredient(s) by year for the past five years. Include information on raw
material cost, direct labor cost, advertising, sales and marketing, and any
other significant costs listed separately.
d. Total indirect production cost (e.g. plant overhead, amortized plant
and equipment) charged to product(s) containing the active ingredient(s)
by year for the past five years. Exclude all non-recurring costs that were
directly related to the active ingredient(s), such as costs of initial
registration and any data development.
e. A list of each data requirement for which you seek a waiver.
Indicate the type of waiver sought and the estimated cost to you (listed
separately for each data requirement and associated test) of conducting
the testing needed to fulfill each of these data requirements.
f . A list of each data requirement for which you are not seeking any
waiver and the estimated cost to you (listed separately for each data
requirement and associated test) of conducting the testing needed to fulfill
each of these data requirements,
g. For each of the next ten years, a year-by-year forecast of company
sales (pounds and dollars) of the active ingredient(s), direct production
costs of product(s) containing the active ingredient(s) (following the
parameters in item c above), indirect production costs of product(s)
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containing the active ingredient(s) (following the parameters in item d
above), and costs of data development pertaining to the active
ingredient(s).
h. A description of the importance and unique benefits of the active
ingredient(s) to users. Discuss the use patterns and the effectiveness of
the active ingredient(s) relative to registered alternative chemicals and
non-chemical control strategies. Focus on benefits unique to the active
ingredient(s), providing information that is as quantitative as possible. If
you do not have quantitative data upon which to base your estimates, then
present the reasoning used to derive your estimates. To assist the Agency
in determining the degree of importance of the active ingredient(s) in
terms of its benefits, you should provide information on any of the
following factors, as applicable to your product(s): '
(1) documentation of the usefulness of the active ingredient(s)
in Integrated Pest Management, (b) description of the beneficial impacts
on the environment of use of the active ingredient(s), as opposed to its
registered alternatives, (c) information on the breakdown of the active
ingredient(s) after use and on its persistence in the environment, and (d)
description of its usefulness against a pest(s) of public health significance.
Failure to submit sufficient information for the Agency to make a determination
regarding a request for a low volume minor use waiver will result in denial of the request
for a waiver.
2. Request for Waiver of Data —Option 9 on the Requirements Status and
Registrant's Response Form. This option may be used if you believe that a
particular data requirement should not apply because the corresponding use is no
longer registered or the requirement is inappropriate. You must submit a
rationale explaining why you believe the data requirements should not apply.
You must also submit the current kbel(s) of your product(s) and, if a current
copy of your Confidential Statement of Formula is not already on file you must
submit a current copy.
You will be informed of the Agency's decision in writing. If the Agency
determines that the data requirements of this Notice do not apply to your
product(s), you will not be required to supply the data pursuant to section
3(c)(2)(B). If EPA determines that the data are required for your productfs). you
must choose_a method of meeting the requirements of this Notice within the time
frame provided by this Notice. Within 30 days of your receipt of the Agency's
written decision, you must submit a revised Requirements Status and Registrant's
Response Form indicating the option chosen.
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IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
A. NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this
Notice due to failure by a registrant to comply with the requirements of this Data Call-In
Notice, pursuant to FXFMA section 3(c)(2)(B). Events which may be the basis for
issuance of a Notice of Intent to Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your
receipt of this Notice.
2. Failure to submit on the required schedule an acceptable proposed or final
protocol when such is required to be submitted to the Agency for review,
3. Failure to submit on the required schedule an adequate progress report on
a study as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by
this Notice.
5. Failure to take a required action or submit adequate information pertaining
to any option chosen to address the data requirements (e.g., any required
action or information pertaining to submission or citation of existing
studies or offers, arrangements, or arbitration on the sharing of costs or
the formation of Task Forces, failure to comply with the terms of an
agreement or arbitration concerning joint data development or failure to
comply with any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of
submitted studies, as required by Section ffl-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in
the cost of developing data and provided proof of the registrant's receipt
of such offer, or failure of a registrant on whom you rely for a generic
data exemption either to:
a. inform EPA of intent to develop and submit the data required by
this Notice on a Data Call-in Response Form and a Requirements Status
and Registrant's Response Form: or,
b. fulfill the commitment to develop and submit the data as required
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by this Notice; or,
c. otherwise take appropriate steps to meet the requirements stated in
this Notice, unless you commit to submit and do submit the required data
in the specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at
any time following the issuance of this Notice.
B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required
time) is unacceptable and constitutes a basis for issuance of a Notice of Intent to
Suspend. The grounds for suspension include, but are not limited to, failure to meet any
of the foEowing:
1. EPA requirements specified in the Data Call-In Notice or other documents
incorporated by reference (including, as applicable, EPA Pesticide Assessment
Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test
Guidelines) regarding the design, conduct, and reporting of required studies.
Such requirements include, but are not limited to, those relating to test material,
test procedures, selection of species, number of animals, sex and distribution of
animals, dose and effect levels to be tested or attained, duration of test, and, as
applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the
incorporation of any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner
of reporting, the completeness of results, and the adequacy of any required
supporting (or raw) data, including, but not limited to, requirements referenced
or included in this Notice or contained in PR 86-5. All studies must be submitted
in the form of a final report; a preliminary report will not be considered to fulfill
the submission requirement.
C. EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of
existing stocks of a pesticide product which has been suspended or canceEed if doing so
would be consistent with the purposes of the Federal Insecticide, Fungicide, and
Rodenticide Act.
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The Agency has determined that such disposition by registrants of existing stocks
for a suspended registration when a section 3(c)(2)(B) data request is outstanding would
generally not be consistent with the Act's purposes. Accordingly, the Agency anticipates
granting registrants permission to sell, distribute, or use existing stocks of suspended
product(s) only in exceptional circumstances. If you believe such disposition of existing
stocks of your product(s) which may be suspended for failure to comply with this Notice
should be permitted, you have the burden of clearly demonstrating to EPA that granting
such permission would be consistent with the Act. You must also explain why an
"existing stocks" provision is necessary, including a statement of the quantity of existing
stocks and your estimate of the time required for their sale, distribution, and use. Unless
you meet this burden the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to flu's
Notice and your product is in full compliance with all Agency requirements, you will
have, under most circumstances, one year from the date your 90 day response to this
Notice is due, to sell, distribute, or use existing stocks. Normally, the Agency will allow
persons other than the registrant such as independent distributors, retailers and end users
to sell, distribute or use such existing stocks until the stocks are exhausted. Any sale,
distribution or use of stocks of voluntarily cancelled products containing an active
ingredient(s) for which the Agency has particular risk concerns will be determined on
case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period
required by this Notice will not result in the Agency granting any additional time to sell,
distribute, or use existing stocks beyond a year from the date the 90 day response was
due unless you demonstrate to the Agency that you are in full compliance with all
Agency requirements, including the requirements of this Notice. For example, if you
decide to voluntarily cancel your registration six months before a 3 year study is
scheduled to be submitted, all progress reports and other information necessary to
establish that you have been conducting the study in an acceptable and good faith manner
must have been submitted to the Agency, before EPA will consider granting an existing
stocks provision.
QNABLE
SECTION V. REGISTRANT
ATION TO REPORT POSSIBLE
ADVERSE EFFRTTS
Registrants are reminded that MFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information
to the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies, regarding
unreasonable adverse effects on man or the environment. This requirement continues as long
as the products are registered by the Agency,
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SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person listed in Attachment 1, the Data Call-In Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-in Response Form (Attachment 2) and
a completed Requirements Status and Registrant's Rejponge Form (Attachment 3) and any other
documents required by this Notice, and should be submitted to the contact person identified in
Attachment 1, If the voluntary cancellation or generic data exemption option is chosen, only the
Data Call-in Response Form need be submitted.
The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this Notice,
Sincerely yours,
Daniel M. Barolo, Director
Special Review
and Reregistration Division
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Attachment 1. Chemical Status Sheet
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FLOWER AND VEGETABLE OILS DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data CalUn Notice because you have product(s)
containing flower and vegetable oils.
This Generic Data CaMn Chemical Status Sheet, contains an overview of data required
by this notice, and point of contact for inquiries pertaining to the reregistration of flower and
vegetable oils. This attachment is to be used in conjunction with (1) the Generic Data Call-In
Notice, (2) the Generic Data Call-In Response Form (Attachment 2), (3) the Requirements Status
and Registrant's Form (Attachment 3), (4) a list of registrants receiving this DCI (Attachment
4), (5) the EPA Acceptance Criteria (Attachment 6), and (6) the Cost Share and Data
Compensation Forms in replying to this flower and vegetable oils Generic Data Call*In
(Attachment 6). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the generic database for Flower and
Vegetable Oils are contained in the Requirements Status and Registrant's Response. Attachment
3. The Agency has concluded that additional product chemistry data on Flower and Vegetable
Oils are needed. These data are needed to folly complete the reregistration of all eligible flower
and vegetable oils products.
TO THIS NOTICE
If you have any questions regarding the generic data requirements and procedures
established by this Notice, please contact Virginia Dietrich at (703) 308-8157.
All responses to this Notice for the generic data requirements should be submitted to:
Virginia Dietrich, Chemical Review Manager
Accelerated Reregistration Branch
Special Review and Registration Division (H7508W)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Flower and Vegetable Oils
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Attachment 2. Generic DCI Response Forms Inserts (Form
A) plus Instructions
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SPECIFIC INSTRUCTIONS FOR THE GENERIC DATA CALMN RESPONSE FORM
This Form is designed to be used to respond to call-ins for generic and product specific
data for the purpose of reregistering pesticides under the Federal Insecticide Fungicide and
Rodenticide Act. Fill out this form each time you are responding to a data call-in for which EPA
has sent you the form entitled "Requirements Status and Registrant's Response."
Items 1-4 will have been preprinted on the form Items 5 through 7 must be completed
by the registrant as appropriate Items 8 through 11 must be completed by the registrant
before submitting a response to the Agency.
Public reporting burden for this collection of information is estimated to average 15
minutes per response, including time for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and reviewing the collection*of
information. Send comments regarding the burden estimate or any other aspect of this collection
of information, including suggesting for reducing this burden, to Chief, Information Policy
Branch, PM-223, U S Environmental Protection Agency, 401 M St, S W , Washington, D C
20460; and to the Office of Management and Budget, Paperwork Reduction Project 2070-0107,
Washington, D C 20503.
INSTRUCTIONS
Item 1. This item identifies your company name, number and address.
Item 2. This item identifies the ease number, ease name, EPA chemical number
and chemical name.
Item 3. This item identifies the date and type of data call-in.
Item 4, This item identifies the EPA product registrations relevant to the data
call-in. Please note that you are also responsible for informing the
Agency of your response regarding any product that you believe may be
covered by this data call-in but that is not listed by the Agency in Item 4.
You must bring any such apparent omission to the Agency's attention
within the period required for submission of this response form.
Item 5. Cheek this item for each product registration you wish to cancel
voluntarily. If a registration number is listed for a product for which you
previously requested voluntary cancellation, indicate in Item 5 the date of
that request. You do not need to complete any item on the Requirements
Status and Registrant's Response Form for any product that is voluntarily
cancelled.
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Item 6a. Check this item if this data call-in is for generic data as indicated in Item
3 and if you are eligible for a Generic Data Exemption for the chemical
listed in Item 2 and used in the subject product. By electing this
exemption, you agree to the terms and conditions of a Generic Data
Exemption as explained in the Data Call-In Notice.
If you are eligible for or claim a Generic Data Exemption, enter the EPA
registration Number of each registered source of that active ingredient that
you use in your product.
Typically, if you purchase an EPA-registered product from one or more
other producers (who, with respect to the incorporated product, are in
compliance with this and-any other outstanding Data Call-In Notice), and
incorporate that product into all your products, you may complete this
item for all products listed on this form If, however, you produce the
active ingredient yourself, or use any unregistered product (regardless of
the fact that some of your sources are registered), you may not claim a
Generic Data Exemption and you may not select this item.
Item 6b, Check this Item if the data call-in is a generic data call-in as indicated in
Item 3 and if you are agreeing to satisfy the generic data requirements of
this data call-in. Attach the Requirements Status and Registrant's
Response Form that indicates how you will satisfy those requirements.
Item 7a. Check this item if this call-in if a data call-in as indicated in Item 3 for a
manufacturing use product (MUP), and if your product is a manufacturing
use product for which you agree to supply product-specific data. Attach
the Requirements Status and Registrants' Response Form that indicates
how you will satisfy those requirements.
Item 7b. Check this item if this call-in is a data call-in for an end use product
(EUP) as indicated in Item 3 and if your product is an end use product for
which you agree to supply product-specific data. Attach the Requirements
Status and Registrant's Response Form that indicates how you will satisfy
those requirements.
Item 8. This certification statement must be signed by an authorized representative
of your company and the person signing must include his/her title.
Additional pages used in your response must be initialled and dated in the
space provided for the certification.
Item 9. Enter the date of signature.
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Item 10, Enter the name of the person EPA should contact with questions regarding
your response.
Item 11. Enter the phone number of your company contact.
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Attachment 3. Requirements Status and Registrants'
Response Forms Inserts (Form B) plus Instructions
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SPECIFIC INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANTS RESPONSE FORM
Generic Data
This form is designed to be used for registrants to respond to call-in- for generic and
product-specific data as part of EPA's reregistration program under the Federal Insecticide
Fungicide and Rodenticide Act. Although the form is the same for both product specific 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 generic data
requirements.
EPA has developed this form individually for each data call-in addressed to each registrant, ind
has preprinted this form with a number of items. DO NOT use this form for any other active
ingredient.
Items 1 through 8 (inclusive) will have been preprinted on the form. You must complete all
other items on this form by typing or printing legibly.
Public reporting burden for this collection of information is estimated to average 30 minutes per
response, including time for reviewing instructions, searching existing data sources, gathering
and maintaining the data needed, and completing and reviewing the collection of information.
Send comments regarding the burden estimate or any other aspect of this collection of
information, including suggesting for reducing this burden, to Chief, Information Policy Branch,
PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, B.C. 20460;
and to the Office of Management and Budget, Paperwork Reduction Project 2070-0107,
Washington, B.C. 20503.
INSTRUCTIONS
Item 1. This item identifies your company name, number, and address.
Item 2. This item identifies the case number, case name, EPA chemical number and
chemical name.
Item 3. This item identifies the date and type of data call-in.
Item 4. This item identifies the guideline reference numbers of studies required to support
the product(s) being reregistered. These guidelines, in addition to requirements
specified in the Data Call-In Notice, govern the conduct of the required studies.
Item 5. This item identifies the study title associated with the guideline reference number
and whether protocols and 1, 2, or 3-year progress reports are required to be
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submitted in connection with the study. As noted in Section HI of the Data
Call-In Notice, 90-day progress reports are required for all studies.
If an asterisk appears in Item 5, EPA has attached information relevant to
this guideline reference number to the Requirements Status and
Registrant's Response Form.
Item 6. This item identifies the code associated with the use pattern of the pesticide. A
brief description of each code follows:
A. Terrestrial food
B. Terrestrial feed
C. Terrestrial non-food
D. Aquatic food *
E. Aquatic non-food outdoor
F. Aquatic non-food industrial
G, Aquatic non-food residential
H. Greenhouse food
I. Greenhouse non-food crop
J. Forestry
K. Residential
L. Indoor food
M, Indoor non-food
N. Indoor medical
O. Indoor residential
Item 7. This item identifies the code assigned to the substance that must be used for
testing. A brief description of each code follows.
EP End-Use Product
MP Manufacturing-Use Product
MP/TGAI Manufacturing-Use Product and Technical Grade
Active Ingredient
PAI Pure Active Ingredient
PAI/M Pure Active Ingredient and Metabolites
PAI/PAERA Pure Active Ingredient or Pure Active Ingredient
Radiolabelled
PACRA Pure Active Ingredient Radiolabelled
PADRA/M Pure Active Ingredient Radiolabelled and Metabolites
PAffiA/PM Pure Active Ingredient Radiolabelled and Plant
Metabolites
TEP Typical End-Use Product
TEP _ * Typical End-Use Product, Percent Active Ingredient
Specified
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TEP/MET Typical End-Use Product and Metabolites
TEP/PAI/M Typical End-Use Product or Pure Active Ingredient
and Metabolites
TGAI/PAIRA Technical Grade Active Ingredient or Pure Active
Ingredient Radiolabelled
TGAI Technical Grade Active Ingredient
TGAI/TEP Technical Grade Active Ingredient or Typical
End-Use Product
TGAI/PAI Technical Grade Active Ingredient or Pure Active
Ingredient
MET Metabolites
IMP Impurities
DEGR Degradates
•i
*See: guideline comment
Item 8. This item identifies the time frame allowed for submission of the study or
protocol identified in item 2. The time frame runs from the date of your receipt
of the Data Call-In Notice.
Item 9. Enter the appropriate Response Code or Codes to show how you intend to comply
with each data requirement. Brief descriptions of each code follow. The Data
Call-In Notice contains a fuller description of each of these options.
1. (Developing Data) I will conduct a new study and submit it within the
time frames specified in item 8 above. By indicating that I have chosen
this option, 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 and that I will provide the protocol and progress
reports required in item 5 above.
2. (Agreement to Cost Share) I have entered into an agreement with one or
more registrants to develop data jointly. By indicating that I have chosen
this option, I certify that I will comply with all the requirements
pertaining to sharing in the cost of developing data as outlined in the Data
Call-in Notice.
3. (Offer to Cost Share) I have made an offer to enter into an agreement with
one or more registrants to develop data jointly. I am submitting a copy of
the form "Certification of Offer to Cost Share in the Development of
Data" that describes this offer/agreement. By indicating that I have
chosen this option, I certify that I wUl comply with all the requirements
pertaining to making an offer to share in the cost of developing data as
outlined in the Data Call-in Notice.
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4. (Submitting Existing Data) I am submitting an existing study that has
never before been submitted to EPA. By indicating that I have chosen this
option, I certify that this study meets all the requirements pertaining to the
conditions for submittal of existing data outlined in the Data Call-In
Notice and I have attached the needed supporting information along with
this response.
5. (Upgrading a Study) I am submitting or citing data to upgrade a study that
EPA has classified as partially acceptable and potentially upgradeable. By
indicating that I have chosen this option, I certify that I have met all the
requirements pertaining to the conditions for submitting or citing existing
data to upgrade a study described in the Data Call-In Notice. I am
indicating on attached correspondence the Master Record Identification
Number (MRED) that EPA has assigned to the data that I am citing as w«ll
as the MRID of the study I am attempting to upgrade.
6, (Citing a Study) I am citing an existing study that has been previously
classified by EPA as acceptable, core, core minimum, or a study that has
not yet been reviewed by the Agency. I am providing the Agency's
classification of the study.
7. (Deleting Uses) I am attaching an application for amendment to my
registration deleting the uses for which the data are required.
8. (Low Volume/Minor Use Waiver Request) I have read the statements
concerning low volume-minor use data waivers in the Data Call-In Notice
and I request a low-volume minor use waiver of the data requirement. I
am attaching a detailed justification to support this waiver request
including, among other things, all information required to support the
request. I understand that, unless modified by the Agency in writing, the
data requirement as stated in the Notice governs.
9. (Request for Waiver of Data) I have read the statements concerning data
waivers other than low volume minor-use data waivers in the Data Call-in
Notice and I request a waiver of the data requirement. I am attaching an
identification of the basis for this waiver and a detailed justification to
support this waiver request. The justification includes, among other
things, all information required to support the request. I understand that,
unless modified by the Agency in writing, the data requirement as stated
in the Notice governs.
Item 10. This item must be signed by an authorized representative of your company. The
person signing must include his/her title, and must initial and date all other pages
of this form.
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Item 11. Enter the date of signature.
Item 12. Biter the name of the person EPA should contact with questions regarding your
response,
Item 13. Enter the phone number of your company contact.
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Attachment 4. List of Registrant^) sent this DCI (Insert)
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APPENDIX G. Product Specific Data Call-In
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DATA CALL-IN NOTICE
CERTIFIED
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment 1 of this Notice, the Data^Calljn Chemical Status Sheet, to
submit certain product specific data as noted herein to the U.S. Environmental Protection
Agency (EPA, the Agency). These data are necessary to maintain the continued registration of
your product(s) containing this active ingredient. Within 90 days after you receive this Notice
you must respond as set forth in Section in below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments A through G; or
2, Why you believe you are exempt from the requirements listed in this Notice and
in Attachment 3, Requirements Status _and Registrant's Response Form, (see
section ffl-B); or
3. Why you believe EPA should not require your submission of product specific
data in the manner specified by this Notice (see section M-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s) subject to this Notice will be subject to suspension. We have provided a list of
all of your products subject to this Notice in Attachment 2, Data Call-In Response Form, as well
as a list of all registrants who were sent this Notice (Attachment 6).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B), Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No, 2070-0107
(expiration date 12-31-92).
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This Notice is divided into six sections and seven Attachments, The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section n - Data Required By This Notice
Section 1H- Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants* Obligation To Report Possible Unreasonable Adverse
Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are: '«
1 - Data Call-in Chemical Status Sheet
2 - Product-Specific Data Call-In Response Form
3 - Requirements Status^nd Registrant's Response Form
4 - EPA Grouping of End^Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - EPA Acceptance Criteria
6 - list of Registrants Receiving This Notice
7 - Cost Share and Data Compensation Forms, and Product Specific Data Report
Form
SECTION I. WHY YOU ARE RECETVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient and reevaluated the data
needed to support continued registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product specific data. No additional
generic data requirements are being imposed. You have been sent this Notice because you have
product(s) containing the subject active ingredient.
SECTION n, DATA REQUIRED BY THIS NOTICE
n-A, DATA REQUIRED
The product specific data required by this Notice are specified in Attachment 3,
Requirements Status and Registrant's Response Form. Depending on the results of the studies
required in this Notice, additional testing may be required.
H-B. srHHDTJLE FOR SUBMISSION OF DATA
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You are required to submit the data or otherwise satisfy the data requirements specified in
Attachment 3, Requirements Status and Registrant's Response Form, within the time frames
provided.
H-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650).
'i
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the OECD
protocols, they should be modified as appropriate so that the data generated by the study will satisfy
the requirements of 40 CFR § 158. Normally, the Agency will not extend deadlines for complying
with data requirements when the studies were not conducted in accordance with acceptable
standards. The OECD protocols are available from OECD, 1750 Pennsylvania Avenue N.W.,
Washington, D.C. 20006.
All new studies and proposed protocols submitted in response to this Data Call-In Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
n-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3fc¥2tfBl NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, thisData Call-in does not in any way supersede or change the
requirements of any previous Data Call-Infsl. or any other agreements entered into with the Agency
pertaining to such prior Notice. Registrants must comply with the requirements of all Notices to
avoid issuance of a Notice of Intent to Suspend their affected products.
SECTION
ffl-A.
)NDING TO THE AGEN(
The appropriate responses initially required by this Notice for product specific data must
be submitted to the Agency within 90 days after your receipt of this Notice. Failure to adequately
respond to this Notice within 90 days of your receipt will be a basis for issuing a Notice of Intent
to Suspend (NOIS) affecting your products. This and other bases for issuance of NOIS due to
failure to comply with this Notice are presented in Section IV-A and IV-B.
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ffl-B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice for product specific data are; (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice or
(c) request a data waiver(s),
A discussion of how to respond if you chose the Voluntary Cancellation option is presented
below. A discussion of the various options available for satisfying the product specific data
requirements of this Notice is contained in Section ffl-C. A discussion of options relating to
requests for data waivers is contained in Section ffl-D.
There are two forms that accompany this Notice of which, depending upon your response,
one or both must be used in your response to the Agency. These forms are the Data-Call-in
Response Form, and the Requirements Status and Registrant's Response Form. Attachment'2 and
Attachment 3. The Data Call-In Response Form must be submitted as part of every response to this
Notice. In addition, one copy of the Requirements Status and Registrant's Response Form must
be submitted for each product listed on the Data Call-in Response Form unless the voluntary
cancellation option is selected or unless the product is identical to another (refer to the instructions
for completing the Data Call-in Response Form in Attachment 2). Please note that the company's
authorized representative is required to sign the first page of the Data Call-in Response Form and
Requirements Status and Registrant's Response Form (if this form is required) and initial any
subsequent pages. The forms contain separate detailed instructions on the response options. Do not
alter the printed material. If you have questions or need assistance in preparing your response, call
or write the contact person(s) identified in Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by requesting
voluntary cancellation of your product(s) containing the active ingredient that is the subject of this
Notice. If you wish to voluntarily cancel your product, you must submit a completed DataCall-In
Response Form, indicating your election of this option. Voluntary cancellation is item number 5
on the Data Call-In Resfjonse Form. If you choose this option, this is the only form that you are
required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your product
after the effective date of cancellation must be in accordance with the Existing Stocks provisions
of this Notice which are contained in Section IV-C.
2. Satisfying the Product Specific Data Requirements of this Notice There are various
options available to satisfy the product specific data requirements of this Notice. These options are
discussed in Section ffl-C of mis Notice and comprise options 1 through 6 on the Requirements
Status and Registrant's Response Form and item numbers 7a and 7b on the Data Call-In Response
Form. Deletion of a use(s) and the low volume/minor use option are not valid options for fulfilling
product specific data requirements.
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3, Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section ffl-D of this Notice and are covered by option 7 on the Requirements Status
and Registrant's Response Form. If you choose one of these options, you must submit both forms
as well as any other information/data pertaining to the option chosen to address the data
requirement,
ffl-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form that you agree to satisfy the product
specific data requirements (i.e. you select item number 7a or 7b), then you must select one of the
six options on the Requirements Status and Registrant's Response Form related to data production
for each data requirement. Your option selection should be entered under item number 9,
"Registrant Response," The six options related to data production are the first six options discussed
under item 9 in the instructions for completing the Requirements Statiyis and^epstranfs Rejponge
Form. These six options are listed immediately below with information in parentheses to guide
registrants to additional instructions provided in this Section. The options are:
(1) I will generate and submit data within the specified time frame (Developing Data)
(2) I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been submitted but not reviewed by the Agency (Citing an Existing
Study)
QptioiLl,Developing Data — If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced herein and
in the attachments. All data generated and submitted must comply with the Good Laboratory
Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide Assessment
Guidelines (PAG), and be in conformance with the requirements of PR Notice 86-5.
The time frames in the Requirements Status and Registrant's Response Form are the time
frames that the Agency is allowing for the submission of completed study reports. The noted
deadlines run from the date of the receipt of this Notice by the registrant. If the data are not
submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to Suspend the
affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by this Notice and
intend to seek additional time to meet the requirements(s), you must submit a request to the Agency
which includes: (1) a detailed description of the expected difficulty and (2) a proposed schedule
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including alternative dates for meeting such requirements on a step-by-step basis. You must explain
any technical or laboratory difficulties and provide documentation from the laboratory performing
the testing. While EPA is considering your request, the original deadline remains. The Agency
will respond to your request in writing. If EPA does not grant your request, the original deadline
remains. Normally, extensions can be requested only in cases of extraordinary testing problems
beyond the expectation or control of the registrant. Extensions will not be given in submitting the
90-day responses. Extensions will not be considered if the request for extension is not made in a
timely fashion; in no event shall an extension request be considered if it is submitted at or after the
lapse of the subject deadline,
Option 2. Agreement to Share in Cost to Develop Data -- Registrants may only choose this
option for acute toxicity data and certain efficacy data and only if EPA has indicated in the attached
data tables that your product and at least one other product are similar for purposes of depending
on the same data. If this is the case, data may be generated for just one of the products In the
group. The registration number of the product for which data will be submitted must be noted in
the agreement to cost share by the registrant selecting this option. If you choose to enter into an
agreement to share in the cost of producing the required data but will not be submitting the data
yourself, you must provide the name of the registrant who will be submitting the data. You must
also provide EPA with documentary evidence that an agreement has been formed. Such evidence
may be your letter offering to join in an agreement and the other registrant's acceptance of your
offer, or a written statement by the parties that an agreement exists. The agreement to produce the
data need not specify all of the terms of the final arrangement between the parties or the mechanism
to resolve the terms. Section 3(c)(2)(B) provides that if the parties cannot resolve the terms of the
agreement they may resolve their differences through binding arbitration.
Option 3. Offer to Share^in the Cost of Data Development -- This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. If you have made an offer
to pay in an attempt to enter into an agreement or amend an existing agreement to meet the
requirements of this Notice and have been unsuccessful, you may request EPA (by selecting this
option) to exercise its discretion not to suspend your registration(s), although you do not comply
with the data submission requirements of this Notice. EPA has determined that as a general policy,
absent other relevant considerations, it will not suspend the registration of a product of a registrant
who has in good faith sought and continues to seek to enter into a joint data development/cost
sharing program, but the other registrant(s) developing the data has refused to accept your offer.
To qualify for this option, you must submit documentation to the Agency proving that you have
made an offer to another registrant (who has an obligation to submit data) to share in the burden
of developing that data. You must also submit to the Agency a completed EPA Form 8570-32,
Certification of Offer to Cost Share in the Development of Data, Attachment 7, In addition, you
must demonstrate that the other registrant to whom the offer was made has not accepted your offer
to enter into a cost sharing agreement by including a copy of your offer and proof of the other
registrant's receipt of that offer (such as a certified mail receipt). Your offer must, in addition to
anything else, offer to share in the burden of producing the data upon terms to be agreed or failing
agreement to be bound by binding arbitration as provided by FEPRA section 3(c)(2)(B)(iii) and must
not qualify this offer. The other registrant must also inform EPA of its election of an option to
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develop and submit the data required by this Notice by submitting a Data Call-In Response Form
and a Requirements Status and Registrant's Response Form committing to develop and submit the
data required by this Notice.
In order for you to avoid suspension under this option, you may not withdraw your offer
to share in the burdens of developing the data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this Notice. If the other registrant fails
to develop the data or for some other reason is subject to suspension, your registration as well as
that of the other registrant will normally be subject to initiation of suspension proceedings, unless
you commit to submit, and do submit the required data in the specified time frame. In such cases,
the Agency generally will not grant a time extension for submitting the data.
Option 4. Submitting an Existing Study — If you choose to submit an existing study in
response to this Notice, you must determine that the study satisfies the requirements imposed by
this Notice. You may only submit a study that has not been previously submitted to the Agency
or previously cited by anyone. Existing studies are studies which predate issuance of this Notice.
Do not use this option if you are submitting data to upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the required
date of submission. The Agency may determine at any time that a study is not valid and needs to
be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data and
specimens from the study are available for audit and review and you must identify
where they are available. This must be done in accordance with the requirements
of the Good Laboratory Practice (GLP) regulation, 40 CFR Part 160. As stated in
40 CFR 160.3(1) " 'raw data' means any laboratory worksheets, records,
memoranda, notes, or exact copies thereof, that are the result of original
observations and activities of a study and are necessary for the reconstruction and
evaluation of the report of that study. In the event that exact transcripts of raw data
have been prepared (e.g., tapes which have been transcribed verbatim, dated, and
verified accurate by signature), the exact copy or exact transcript may be substituted
for the original source as raw data. 'Raw data' may include photographs, microfilm
or microfiche copies, computer printouts, magnetic media, including dictated
observations, and recorded data from automated instruments." The term
"specimens", according to 40 CFR 160.3(k), means "any material derived from a
test system for examination or analysis."
b. Health and safety studies completed after May 1984 must also contain all GLP-
required quality assurance and quality control information, pursuant to the
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requirements of 40 CFR Part 160. Registrants must also certify at the time of
submitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study signed
by an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FEFRA Accelerated Reregistration Phase 3
Technical Guidance and that the study has been conducted according to the Pesticide
Assessment Guidelines (PAG) or meets the purpose of the PAG (both available from
NHS). A study not conducted according to the PAG may be submitted to the
Agency for consideration if the registrant believes that the study clearly meets the
purpose of the PAG. The registrant is referred to 40 CFR 158.70 which states the
Agency's policy regarding acceptable protocols. If you wish to submit the study, you
must, in addition to certifying that the purposes of the PAG are met by the tody,
clearly articulate the rationale why you believe the study meets the purpose of the
PAG, including copies of any supporting information or data. It has been the
Agency's experience that studies completed prior to January 1970 rarely satisfied the
purpose of the PAG and that necessary raw data are usually not available for such
studies.
If you submit an existing study, you must certify that the study meets all requirements of
the criteria outlined above.
If you know of a study pertaining to any requirement in this Notice which does not meet
the criteria outlined above but does contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study. If such study is in the Agency's files, you
need only cite it along with the notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5.
Option 5, Upgrading a Study — If a study has been classified as partially acceptable and
upgradeable, you may submit data to upgrade that study. The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the requirement is
not satisfied, you may still be required to submit new data normally without any time extension.
Deficient, but upgradeable studies will normally be classified as supplemental. However, it is
important to note that not all studies classified as supplemental are upgradeable. If you have
questions regarding the classification of a study or whether a study may be upgraded, call or write
the contact person listed in Attachment 1. If you submit data to upgrade an existing study you must
satisfy or supply information to correct all deficiencies in the study identified by EPA. You must
provide a clearly articulated rationale of how the deficiencies have been remedied or corrected and
why the study should be rated as acceptable to EPA. Your submission must also specify the MRID
number(s) of the study which you are attempting to upgrade and must be in conformance with PR
Notice 86-5.
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Do not submit additional data for the purpose of upgrading a study classified as unacceptable
and determined by the Agency as not capable of being upgraded.
This option should also be used to cite data that has been previously submitted to upgrade
a study, but has not yet been reviewed by the Agency, You must provide the MRED number of
the data submission as well as the MRID number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply to all
data submissions intended to upgrade studies. Additionally your submission of data intended to
upgrade studies must be accompanied by a certification that you comply with each of those criteria
as well as a certification regarding protocol compliance with Agency requirements.
Option 6, Citing Existing Studies — If you choose to cite a study that has been previously
submitted to EPA, that study must have been previously classified by EPA as acceptable or i^ must
be a study which has not yet been reviewed by the Agency. Acceptable toxicology studies
generally will have been classified as "core-guideline" or "core minimum." For all other
disciplines the classification would be "acceptable." With respect to any studies for which you wish
to select this option you must provide the MRBD number of the study you are citing and, if the
study has been reviewed by the Agency, you must provide the Agency's classification of the study.
If you are citing a study of which you are not the original data submitter, you must submit
a completed copy of EPA Form 8570-31, Certification with Respect to Data Compensation
Requirements.
Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-in Response Form and the Requirements
Status and Registrant's Response Form, as appropriate.
m-D REQUESTS FOR DATA WAIVERS
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request, including technical reasons,
data and references to relevant EPA regulations, guidelines or policies. (Note: any supplemental
data must be submitted in the format required by PR Notice 86-5). This will be the only
opportunity to state the reasons or provide information in support of your request. If the Agency
approves your waiver request, you will not be required to supply the data pursuant to section
3(c)(2)(B) of FIFRA. If the Agency denies your waiver request, you must choose an option for
meeting the data requirements of this Notice within 30 days of the receipt of the Agency's decision.
You must indicate and submit the option chosen on the Requirements Status and Registrant's
Response Form. Product specific data requirements for product chemistry, acute toxicity and
efficacy (where appropriate) are required for all products and the Agency would grant a waiver only
under extraordinary circumstances. You should also be aware that submitting a waiver request will
noj; automatically extend the due date for the study in question. Waiver requests submitted
without adequate supporting rationale will be denied and the original due date will remain in force.
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IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOI1CE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due to
failure by a registrant to comply with the requirements of this Data Call-in Notice, pursuant to
FXFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent to
Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of this
Notice,
2. Failure to submit on the required schedule an acceptable proposed or final protocol
when such is required to be submitted to the Agency for review. ''
3. Failure to submit on the required schedule an adequate progress report on a study
as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this Notice.
5. Failure to take a required action or submit adequate information pertaining to any
option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task Forces,
failure to comply with the terms of an agreement or arbitration concerning joint data
development or failure to comply with any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of submitted studies,
as required by Section ffl-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost of
developing data and provided proof of the registrant's receipt of such offer or failure
of a registrant on whom you rely for a generic data exemption either to:
a. inform EPA of intent to develop and submit the data required by this Notice
on a Data Call-in Response Form and a Requirements Status and Registrant's
Response Form:
b, fulfill the commitment to develop and submit the data as required by this
Notice; or
c. otherwise take appropriate steps to meet the requirements stated in this
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Notice, unless you commit to submit and do submit the required data in the
specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds for
suspension include, but are not limited to, failure to meet any of the following:
1. EPA requirements specified in the Data Call-In Notice or other documents incorporated
by reference (including, as applicable, EPA Pesticide Assessment Guidelines, Data
Reporting Guidelines, and GeneTox Health Effects Test Guidelines) regarding the design,
conduct, and reporting of required studies. Such requirements include, but are not limited
to, those relating to test material, test procedures, selection of species, number of animals,
sex and distribution of animals, dose and effect levels to be tested or attained, duration of
test, and, as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation of
any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting,
the completeness of results, and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or included in this Notice or contained
in PR 86-5. All studies must be submitted in the form of a final report; a preliminary
report will not be considered to fulfill the submission requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANrFJLT.Kn PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing stocks
of a pesticide product which has been suspended or cancelled if doing so would be consistent with
the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not be
consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing stocks of your product(s) which may be
suspended for failure to comply with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be consistent with the Act. You
must also explain why an "existing stocks" provision is necessary, including a statement of the
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quantity of existing stocks and your estimate of the time required for their sale, distribution, and
use. Unless you meet this burden the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 90 day response to this Notice is due, to sell, distribute,
or use existing stocks. Normally, the Agency will allow persons other than the registrant such as
independent distributors, retailers and end users to sell, distribute or use such existing stocks until
the stocks are exhausted. Any sale, distribution or use of stocks of voluntarily cancelled products
containing an active ingredient for which the Agency has particular risk concerns will be
determined on case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result in the Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was due unless you demonstrate
to the Agency that you are in full compliance with all Agency requirements, including the
requirements of this Notice. For example, if you decide to voluntarily cancel your registration six
months before a 3 year study is scheduled to be submitted, all progress reports and other
information necessary to establish that you have been conducting the study in an acceptable and
good faith manner must have been submitted to the Agency, before EPA will consider granting an
existing stocks provision,
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIPRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable adverse
effects on the environment by the pesticide, the registrant shall submit the information to the
Agency. Registrants must notify the Agency of any factual information they have, from whatever
source, including but not limited to interim or preliminary results of studies, regarding unreasonable
adverse effects on man or the environment. This requirement continues as long as the products are
registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment 1, the DataJ^all-In Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-in Response Form and a completed
Requirements Status and Registrant* s Response Form (Attachment 2 and Attachment 3 for product
specific data) and any other documents required by this Notice, and should be submitted to the
contact person(s) identified in Attachment 1. If the voluntary cancellation or generic data
exemption option is chosen, only the Data Call-in Response JPorm need be submitted.
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i
The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
Daniel M. Barolo, Director
Special Review and
Reregistration Division
Attachments *•
1 - Data Call-In Chemical Status Sheet
2 - Product-Specific Data Call-in Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Grouping of End-Use^ Products^ for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - EPA Acceptance Criteria
6 - List of Registrants Receivingjrhis NotiQe
7 - Cost Share and Data Compensation Forms, and Product Specific Data Report Form
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Attachment 1. Chemical Status Sheet
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FLOWER AND VEGETABLE OILS DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-in Notice because you have
product(s) containing Flower and Vegetable Oils.
This Product Specific Data Call-in Chemical Status Sheet, contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregistration of
flower and vegetable oils. This attachment is to be used in conjunction with (1) the Product
Specific Data Call-In Notice, (2) the Product Specific Data Call-in Response Form (Attachment
2), (3) the Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of
End-Use Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the
EPA Acceptance Criteria (Attachment 5), (6) a list of registrants receiving this DCI (Attachment
6) and (7) the Cost Share and Data Compensation Forms in replying to this flower and *
vegetable oils Product Specific Data Call-In (Attachment 7). Instructions and guidance
accompany each form.
DATA REQTTreP.n BY THIS NOTICE
The additional data requirements needed to complete the database for flower and
vegetable oils are contained in the Requirements Status and Registrant's Response. Attachment
3. The Agency has concluded that additional data on flower and vegetable oils are needed for
specific products. These data are required to be submitted to the Agency within the time frame
listed. These data are needed to fully complete the reregistration of all eligible flower and
vegetable oils products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of flower and vegetable oils,
please contact Virginia Dietrich at (703) 308-8157.
If you have any questions regarding the product specific data requirements and
procedures established by this Notice, please contact Frank Rubis (703) 308-8184.
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Accelerated Reregistration Branch, Chemical Review Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Flower and Vegetable Oils
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Attachment 2. Product Specific Data Call-In Response
Forms (Form A inserts) Plus Instructions
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INSTRUCTIONS FOR COMPLETING THE "DATA CALL-IN RESPONSE" FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4. Already completed by EPA.
Item 5. If you wish to voluntarily cancel your product, answer "yes". If you choose this
option, you wiH not have to provide the data required by the Data Call-In Notice and
you will not have to complete any other forms. Further sale and distribution of your
product after the effective date of cancellation must be in accordance with the
Existing Stocks provision of the Data Call-in Notice (Section IV-C).
Item 6. Not applicable since this form calls in product specific data only. However, if your
product is identical to another product and you qualify for a data exemption, you
must respond with "yes" to Item 7a (MUP) or 7B (EUP) on this form, provide the
EPA reregistration numbers of your source (s); you would not complete the
requirements status and registrant's response" form. Examples of such products
include repackaged products and Special Local Needs (Section 24c) products which
are identical to federally registered products.
Item 7a. For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding "yes."
Item 7b. For each end use product (EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes." if you are
requesting a data waiver, answer "yes" here; in addition, on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with option
7 (Waiver Request) for each study for which you are requesting a waiver. See item
6 with regard to identical products and data exemptions.
Items 8-11. Self-explanatory.
Note: You may provide additional information that does not fit on this form in a signed letter
that accompanies this form. For example, you may wish to report that your product has
already been transferred to another 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 3. Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and
Instructions
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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 guidelines 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 patters (s) of the pesticide associated with the product specific requirements
is (are) identified. For most product specific data requirements, all use patterns are
covered by the data requirements. In the case of efficacy data, the required studies
only pertain to products which have the use sites and/ or pests indicated.
Item 7. The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in rare
cases.
Item 8. The due date for submission of each study is identified. It is normally based on 8
months after issuance of the Reregistration Eligibility Documents unless EPA
determines that a longer time period is necessary.
Item 9. Enter Only one of the following response codes for^each data requirement to show
how you intend to comply with the data requirements listed hi this table. Fuller
descriptions of each option are contained in the Data Call-in Notice.
1. I will generate and submit data by the specified due date (Developing Data).
By indicating that I have chosen this option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal of this study as outlined in
the Data Call-In Notice.
2. I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing). I am submitting a copy of this agreement. I understand that
this option is available on for acute toxicity or certain efficacy data and only if EPA
indicates in an attachment to this notice that my product is similar. Enough to
another product to qualify for this option. I certify that another party in the
agreement is committing to submit or provide the required data; if the required study
is not submitted on time, my product my be subject to suspension.
3. I have made offers to share in the cost to develop data (Offers to Cost Share).
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I understand that this option is available only for acute toxicity or certain efficacy
data and only if EPA indicates in an attachment to this Data Call-in Notice that my
product is similar enough to another product to qualify for this option. I am
submitting evidence that I have made an offer to another registrant (who has an
obligation to submit data) to share in the cost of that date. I am also submitting a
completed " Certification of offer to Cost Share in the Development Data" form.
I am including a copy of my offer and proof of the other registrant's receipt of that
offer. I am identifying the party which is committing to submit or provide the
require 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 IH-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 ffl-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 fiU the data requirement for which I have
indicated this choice.
5. By the specified due date, I will submit or cite data to upgrade a study
classified by the Agency as partially acceptable and upgrade (upgrading a study).
I will submit evidence of the Agency's review indicating that the study may be
upgraded and what information is required to do so. I will provide the MRED 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 ffl-C.l.) apply.
6. By the specified due date, I will cite an existing study that the Agency has
classified as acceptable or an existing study that has been submitted but not reviewed
by the Agency (Citing an Existing Study). If I am citing another registrant's study,
I understand that this option is available only for acute toxicity or certain efficacy
data and only if the cited study was conducted on my product, an identical product
or a product which EPA has "grouped" with one or more other products for
purposes of depending on the same data. I may also choose this option if I am citing
my own data. In either case, I will provide the MMD or Accession number (s)
number (s) for the cited data on a "Product Specific Data Report" form or in a
similar format. If I cite another registratrant's data, I will submit a completed
"Certification With Respect To Data Compensation Requirements" form.
7. I request a waiver for this study because it is inappropriate for my product
(Waiver Request). I am attaching a complete justification for this request, including
technical reasons, data and references to relevant EPA regulations, guidelines or
policies. [Note: any supplemental data must be submitted in the format required by
P.R. Notice 86-5]. I understand that this is my only opportunity to state the reasons
or provide information in support of my request. If the Agency approves my waiver
*
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request, I will not be require to supply the data pursuant to Section 3(c) (2) (B) of
FEFRA. If the Agency denies my waiver request, I must choose a method of
meeting the data requirements of this Notice by the due date stated by this Notice.
In this case, I must, within 30 days of my receipt of the Agency's written decision,
submit a revised "Requirements Status chosen. I also understand that the deadline
for submission of data as specified by the original data cal-in notice will not change.
Items 10-13. Self-explanatory.
NOTE: You may provide additional information that does not fit on this fbim in a signed
letter that accompanies this form. For example, you may wish to report that your product has
already been transferred to another company or that you have already voluntarily cancelled this
product. For these cases, please supply all relevant details so that EPA can ensure that its records
are correct.
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Attachment 4. EPA Batching of End-Use Products for
Meeting Data Requirements for Reregistration
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EPA'S BATCHING OF PRODUCTS CONTAINING FLOWER AND VEGETABLE OILS
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 products containing flower and vegetable oils, 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., emulsiflable
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.
Using available information, batching has been accomplished by the process described in the
preceding paragraph. Frequently acute toxicity data on individual products has been found td'be
incomplete. Notwithstanding the batching process, the Agency reserves the right to require, at
any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit, or cite
a single battery of six acute lexicological studies to represent ail 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 lexicological 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 acule toxicity data, he/she may do so
provided that the data base is complete and valid by today's standards (see acceptance criteria
attached), the formulation tested is considered by EPA to be similar for acute toxicity, and the
formulation has not been significantly altered since submission and acceptance of the acute
toxicity data. Regardless of whether new data is generated or existing data is cited, the registrant
must clearly identify the material tested by its EPA registration number. If more than one
Confidential Statement Of Formula (CSF) exists for a product registration, the registrant must
indicate the formulation actually tested by identifying the corresponding CSF.
In deciding how to meet the product specific data require- ments, 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 dala requirements for each product. The second form, "Requirements Status and
Registrant's Response," lists the product specific data required for each product, including the
standard six acute toxicity tests. A registrant who wishes to participate in a batch must decide
whether he/she will provide the data or depend on someone else to do so. If a registrant
supplies the data to support a batch of products, he/she must select one of the following options:
Developing Data (Option 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
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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 indicates five batches including eleven products containing flower and/or vegetable
oils.
Table I.
Batch No.
1
2
3
4
EPA Reg. No.
1475-30
1475-67
1475-iO
61966-1
61966-3
769-842
6720-429
10807-94
10807-104
% Active Ingredients); (from
label)
Paradichlorobenzene
(99.75%) & perfume (.25%)
Paradichlorobenzene
(ii.75%) & perfume (.25%)
Paradichlorobenzene
(39.75%) & perfume ( .25%)
Altyl Bothiocyanate (.216%);
capsaicin and related
compounds (.625%)
Ailyl isothiocyanate (.216%);
capsaicin and related
compounds (.625%)
Pyrethrin (.28%); rotertone
(1%); other cube resins
(2%); piperonyl butoxkde
(2%); pine oil (20%);
soybean oil (40%); aromatic
petroleum solvent (29.72%)
Pyrethrin (.28%); rotenone
(1%); other cube resins
(2%); piperonyt butoxide
(2%); pine oil (20%);
soybean oil (40%); aromatic
petroteum solvent (29.72%)
N-alkyi dimethyl benzyl
ammonium chlorides
(1.25%); n-alkyl dimethyl
ethylbenzyl ammonium
chlorides (1 .25%); essential
oil (0.2%); yellow dye
(.001%)
N-alkyl dimethyl benzyl
ammonium chlorides
(t.25%); n-alkyl dimethyl
ethylbenzyl ammonium
chlorides (1.25%); essential
oil (.2%)
Formulation
Crystalline
Crystalline
\
Crystalline
Ready-to-use-solution
Ready-to-use-solution
Emuisffiable concentrate
Emulsrfiable concentrate
Soluble concentrate
Soluble concentrate
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Batch No.
5
EPA Reg. No,
5332-7
5332-8
% Active Ingredient(s); (from
label)
Oil of lemon grass (2,0%);
oil of dtronetla {1.2%);
allylisothiocyanate (.2%); oil
of orange (.02%); methyl
saticylate (.02%); geraniol
(.04%); ionone alpha
(.01%); oil of bergamot
(-11%)
Oil of lemon grass (2.0%);
oil of citronella (1 .2%);
allylisothiocyanate (.2%); oil
of orange (.02%); methyl
salicylate (.02%); geraniol
(.04%); ionone alpha
(.01%); oil of bergamot
(.11%)
Formulation
Impregnated material
Pelleted tablet
\
Table II lists 23 products containing flower and/or vegetable oils, and other ingredients from the label which were not consider-
ed to be similar for purposes of acute toxicity or the Agency lack- ed sufficient information for decision making and were not placed
in any batch. Registrants of these products are responsible for meeting the acute toxicity data requirements for each product.
Table II.
EPA Registration Number
52-215
323-25
402-113
421-16
655-650
1026-4
1270-192
2021-28
3862-97
Active ingredient(s) [from label]
2-(1-methytethoxy) phenol methyl-
carbamate (1 .0%)
N-alkyl dimethyl benzyl ammonium
chloride (4.5%); sodium carbonate
(3.0%); essential oils (0.5%)
O-benzyl para-chlorophenol (3.0%);
orthophenylphenot (2.0%); p-tert.
amylphenol (2.0%).
O-benzyl-p-chtorophenol (4.9%); o-
pnenyiphenol (0.75%)
Pyrethrin (0.28%); rotenone (0.75%);
other cube resins (1.5%); piperonyl
butoxide (2.0%)
P-diisobutylphenoxyethoxyethyl
dimethyl benzyl ammonium chloride
(3.33%); essential oils (.69%)
N-alkyl dimethyl benzyl ammonium
chlorides (0.1%); n-atkyl dimethyl
ethytbenzyl ammonium chlorides
(0.1%); ethanol (53.0%).
N-alkyl dimethyl benzyl ammonium
chlorides (2.25%); n-alkyl dimethyl
ethylbenzyl ammonium chlorides
(2.25%); sodium carbonate (3.0%);
essential oils (1 .38%)
Quaternary ammonium chlorides
(.15%)
Formulation
Ready-to-use-solution
Soluble concentrate
Emutsffiable concentrate
Soluble concentrate
Emulsffiabte concentrate
Emulsifiable concentrate
Pressurized liquid
Soluble concentrate
Pressurized liquid
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EPA Registration Number
4785-51
5813-14
5813-16
8047-22
1077-10
11715-29
11715-30
11715-116
11715-211
12192-2
42443-1
49407-1
57538-11
61966-2
Active tngredient(s) [from label]
Bitter apple essential oils (5.0%);
mineral oil (10.1%)
Tetrasodium ethylenediamine
tetraacetate (1.06%); alkyl dimethyl
benzyl ammonium chloride (.09%);
dimethyl ethyl benzyl ammonium
chloride (.09%); essential oils (.19%)
Alkyl tetrasodium ethylenediamine
tetraacetate (1 .9%); dimethyl benzyl
ammonium chloride (1 .87%); alkyl
dimethyl ethyl benzyl ammonium
chloride (1.87%); essential oils (.4%)
Alkyl dimethyl benzyl ammonium
chloride (2.0%); isopropanol (1 .0%);
essential oils (.25%)
Drisobutyphenoxyethoxyethyi dimethyl
benzyl ammonium chioride (25%);
isopropanol (15.3%)
N-alkyl dimethyl benzyl ammonium
chlorides (.1%); n-alkyl dimethyl ethyl-
benzyt ammonium chlorides (.1%);
tetrasodium ethylenediamine
tetraacetate (1,6%); essential oils
(.2%); sodium metasiiicate (.25%)
N-alkyl dimethyl benzyl ammonium
chlorides (.1%); n-alkyl dimethyl
ethylbenzyl ammonium chloride (.1%);
isopropanol (53.0%); essential oil (.5%)
Triethytene glycol (15.36%);
dipropytene glycol (3.84%); alkyl
dimethyl benzyl ammonium chloride
(.192%); essential oils (.96%); ethyl
alcohol (30.148%)
BenzykJiethyl [(2,6-xylylcarbamoyl)
methyl ammonium benzoate (.065%);
thymol (1 .3%); essential oils (1.3%)
N-alkyl dimethyl benzyl ammonium
chlorides (6%); n-aikyl dimethyl
ethylbenzyl ammonium chlorides (6%);
2-propanol (5%); essential oils (.32%)
Oil of citronella (.5%); oil of eucalyptus
(1%); cedarwood oil (.5%); oil of
pennyroyal (2%); rue oils (.125%)
Oil of anise (1.6%)
Soybean oil (93%)
Allyl isothiocyanate (.216%); capsaicin
(.625%)
Formulation
Pressurized liquid
Pressurized liquid
Soluble concentrate
Soluble concentrate
'i
Ready-to-use-solution
Pressurized liquid
Pressurized liquid
Pressurized liquid
Ready-to-use-solution
Ready-to-use-solution
Impregnated material
Ready-to-use-solution
Emulsffiable concentrate
Oust
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Attachment 5. EPA Acceptance Criteria
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SUBDIVISION D
Guideline ' Study Title
Series 61 Product Identity and Composition
Series 62 Analysis and Certification of Product Ingredients
Series 63 Physical and Chemical Characteristics
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61 Product Identity and Composition
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1, Name of technical material tested (include product name and trade name, if appropriate).
2. Name, nominal concentration, and certified limits (upper and lower) for each active ingredient and each
intentionally-added inert ingredient.
3. Name and upper certified limit for each impurity or each group of impurities present at >_ 0.1% by
weight and for certain toxicologically significant impurities (e.g., dioxins, nitrosamines) present at
<0.1%.
I
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 intentionaUy-added inert.
6. Molecular, structural, and empirical formulas, molecular weight or weight range, and any company
assigned experimental or internal code numbers for each active ingredient.
7. Description of each beginning material in the manufacturing process.
EPA Registration Number if registered;
for other beginning materials, the following:
Name and address of manufacturer or supplier.
Brand name, trade name or commercial designation.
Technical specifications or data sheets by which manufacturer or supplier describes composition,
properties or toxicity.
8. Description of manufacturing process.
Statement of whether batch or continuous process.
Relative amounts of beginning materials and order in which they are added.
Description of equipment.
Description of physical conditions (temperature, pressure, humidity) controlled in each step and
the parameters that are maintained.
Statement of whether process involves intended chemical reactions.
Flow chart with chemical equations for each intended chemical reaction.
Duration of each step of process.
Description of purification procedures.
Description of measures taken to assure quality of final product.
9. Discussion of formation of impurities based on established chemical theory addressing (1) each impurity
which may be present at >_ 0.1% or was found at ^. 0.1% by product analyses and (2) certain
toxicologically significant impurities (see #3).
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62 Analysis and Certification of Product Ingredients
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered. Use a table to present
the information in items 6,7, and 8.
Does your study meet the following acceptance criteria?
1. Five or more representative samples (batches in case of batch process) analyzed for each active ingredient
and all impurities present at > 0.1%.
2. Degree of accountability or closure J>. ca 98%.
3. Analyses conducted for certain trace toxic impurities at lower than 0.1 % (examples, nitrosamines in the
case of products containing dinitroanilines or containing secondary or tertiary amines/alkanolamines plus
nitrites; polyhalogenated dibenzodioxins and dibenzofurans). [Note that in the case of nitrosamines both
fresh and stored samples must be analyzed.]. »,
4. Complete and detailed description of each step in analytical method used to analyze above samples.
5. Statement of precision and accuracy of analytical method used to analyze above samples,
6. Identities and quantities (including mean and standard deviation) provided for each analyzed ingredient.
7, Upper and lower certified limits proposed for each active ingredient and intentionally added inert along
with explanation of how the limits were determined.
8. Upper certified limit proposed for each impurity present at >_ 0.1% and for certain lexicologically
significant impurities at <0.1% along with explanation of how limit determined.
9. Analytical methods to verify certified limits of each active ingredient and impurities (latter not required
if exempt from requirement of tolerance or if generally recognized as safe by FDA) are fully described,
10. Analytical methods (as discussed in #9) to verify certified limits validated as to their precision and
accuracy.
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63 Physical and Chemical Characteristics
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered.
Does your study meet the following acceptance criteria?
63-2 Color
Verbal description of coloration (or lack of it)
Any intentional coloration also reported in terms of Munsell color system
63-3 Physical State
_ Verbal description of physical state provided using terms such as "solid, granular, volatile liquid"
_ Based on visual inspection at about 20-25° C
•i
63-4 Odor
_ Verbal description of odor (or lack of it) using terms such as "garlic-like, characteristic of aromatic
compounds*
_ Observed at room temperature
63-5 Melting Point
_ Reported in °C
_ Any observed decomposition reported
63-6 Boiling Point
_ Reported in °C
_ Pressure under which B.P. measured reported
_ Any observed decomposition reported
63-7 Density, Bulk Density, Specific Gravity
Measured at about 20-25° C
Density of technical grade active ingredient reported in g/ml or the specific gravity of liquids reported
with reference to water at 20° C. [Note: Bulk density of registered products may be reported in Ibs/ft3
or Ibs/gallon.]
63-8 Solubility
_ Determined in distilled water and representative polar and non-polar solvents, including those used in
formulations and analytical methods for the pesticide
_ Measured at about 20-25° C
_ Reported in g/ 100 ml (other units like ppm acceptable if sparingly soluble)
63-9 Vapor Pressure
Measured at 25° C (or calculated by extrapolation from measurements made at higher temperature if
pressure too low to measure at 25° C)
Experimental procedure described
_ Reported in mm Hg (torr) or other conventional units
63-10 Dissociation Constant
_ Experimental method described
_ Temperature of measurement specified (preferably about
20-25 °C)
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63-11 Oetanol/water Partition Coefficient
Measured it about 20-25° C
Experimentally determined and description of procedure provided (preferred method-45 Fed. Register
77350)
Data supporting reported value provided
63-12 pH
Measured at about 20-25° C
Measured following dilution or dispersion in distilled water
63-13 Stability
Sensitivity to metal ions and metal determined
Stability at normal and elevated temperatures
Sensitivity to sunlight determined
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SUBDIVISION F
Guideline Study Title
81-1 Acute Oral Toxicity in the Rat
81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig
81-3 Acute Inhalation Toxicity in the Rat
81-4 Primary Eye Irritation in the Rabbit
81-5 Primary Dermal Irritation Study
81-6 Dermal Sensitization in the Guinea Pig
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81-1 Acute Oral Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. At least 5 young adult rats/sex/group.
3. Dosing, single oral may be administered over 24 hrs.
4." Vehicle control if other than water,
5. Doses tested, sufficient to determine a toxicity category or a limit dose (5000 rag/kg).
6. Individual observations at least once a day.
7. Observation period to last at least 14 days, or until all test animals appear normal whichever is longer.
8. Individual daily observations.
9. Individual body weights. ,,
10. Gross necropsy on all animals.
Criteria marked with an * are supplemental and may not be required for every study.
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81-2 Acute Dermal toxicity in the Rat, Rabbit or Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. At least 5 animals/sex/group.
3.* Rats 200-300 gm, rabbits 2.0-3,0 kg or guinea pigs 350-450 gm,
4. Dosing, single dermal.
5. Dosing duration at least 24 hours,
6.* Vehicle control, only if toxicity of vehicle is unknown.
7. Doses tested, sufficient to determine a toxicity category or a limit dose (2000 mg/kg),
8, Application site clipped or shaved at least 24 hours before dosing,
9. Application site at least 10% of body surface area.
10. Application site covered with a porous nonirritating cover to retain test material and to prevent
ingestion.
11, Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
Criteria marked with an * arc supplemental and may not be required for every study.
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81-3 Acute Inhalation Toxicity in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested {technical, end-use product, etc).
2. Product is a gas, a solid which may produce a significant vapor hazard based on toxicity and expected use
or contains particles of inhalable size for man (aerodynamic diameter IS #*m or less).
3. At least 5 young adult rats/sex/group.
4. Dosing, at least 4 hours by inhalation.
5. Chamber air flow dynamic, at least 10 air changes/hour, at least 19% oxygen content.
6. Chamber temperature, 22° C (±2°), relative humidity 40-60%.
7. Monitor rate of air flow.
8. Monitor actual concentrations of test material in breathing zone. >,
9. Monitor aerodynamic particle size for aerosols.
10. Doses tested, sufficient to determine a toxicity category or a limit dose (5 mg/L actual concentration of
respirable substance).
11. Individual observations at least once a day.
12. Observation period to last at least 14 days.
13. Individual body weights.
14. Gross necropsy on all animals.
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81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. _ Identify material tested {technical, end-use product, etc),
2. _ Study aot required if material is corrosive, causes severe
dermal irritation or has a pH of <2 or >11.S.
3. 6 adult rabbits.
4. _ Dosing, instillation into the conjunctiva! sac of one eye
per flpinial.
5, _ Dose, 0.1 ml if a liquid; 0.1 ml or not more than 100 mg if a solid, paste or paniculate substance.
6. _ Solid or granular test material ground to a fine dust.
7. _ Eyes not washed for at least 24 hours.
8. _ Eyes examined and graded for irritation before dosing and
at 1, 24, 48 and 72 hr, then daily until eyes are normal
or 21 days (whichever is shorter).
9.* _ Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
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81-5 Primary Dermal Irritation Study
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a pH of <2 or >11.5.
3. 6 adult animals.
4. Dosing, single dermal.
5. Dosing duration 4 hours.
6. Application site shaved or clipped at least 24 hours prior to dosing.
7, Application site approximately 6 cm2.
8. Application site covered with a gauze patch held in place with nonirritating tape.
9. Material removed, washed with water, without trauma to application site,
10. Application site examined and graded for irritation at 1, 24, 48 and 72 hr, then daily until normal OP,14
days (whichever is shorter).
11.* Individual daily observations.
Criteria marked with an * are supplemental and may not be required for every study.
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i
Dermal Sensitization in the Guinea Pig
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
1. Identify material tested (technical, end-use product, etc).
2. Study not required if material is corrosive or has a
pH of <2 or .>!!.5.
3. One of the following methods is utilized;
Freund's complete adjuvant test
Guinea pig maximization test
Split adjuvant technique
Buehler test
Open epicutaneous test
Mauer optimization test
Footpad technique in guinea pig.
4. Complete description of test.
5.* Reference for test,
6. Test followed essentially as described in reference document.
7. Positive control included (may provide historical data conducted within the last 6 months).
Criteria marked with an * are supplemental and may not be required for every study.
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Attachment 6. List of All Registrants Sent This Data Call-in (insert)
Notice
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196
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Attachment 7. Cost Share Data Compensation Form, and Confidential
Statement of Formula Form
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198
sex
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Confidential Business tn formation; Dots Not Contain Nitionil S»curit
United Sum Environment*! Protection Agency
_ OTttce of r«ittcK»«Proortnii (75-787)
** r~ Q Jl W*iMngion, OC 2O460
\> C nM Confidential Statement of Formula
1 . N»me and Addreij of Applic*fit/ftagittr*ntr7AeAHto 2W3 CorftV
3. Product Him*
EPA USE ONLY
„
10, CamDOfwnil in f ormulMhm (Litt u tetutlly introduced
imo f>» tenmituion. Gnt cotrvnontr iccepifd stitmfetl
ntrng, tndt ntmt, trxf CAS numtor-l
Information (E.O. 12065)
LJ B««k FormulKion
LJ Alternate Formulation
Form Approved. OMB No, 2070-0060. Approval Expires 2/2&941
t.
P*t«
of
S» Intiroctioni on Back
2, Narrn and Addraw of Producer (Include IIP Codti
4. R*0i*Vition No,/Fil» Symbol
7, Pound«/G«l Of Bulk D»n*ity
1 1 , Supp4ifr N*RM ft AlMr*H
6 EPA Producl Mgr/Tiim No.
8.pH
12, EPA R*fl. No.
1 6. Typad N«mi ol Approving OHic'wt
10. Signaiurt ot Approving Official
•"
13. E*eh Compon*m
in FormulMion
•.Amount t.«M
17. Total Woighl
10. Till*
100%
6, Country Whw* Fo^mulftiad
9. Flish Point/Flame Exwntion
*< . Ccftifwtf Lifnin
%brWfigM
I Uw*> Urn b Uxw l»ni<
IS Pufpast in
FwmMiaiion
20. Ptran* No. /Include Ares Codel
2 T, Date
vo
EPA Form 8570-4 (Rev. 12-90) Prwtoy* edition* ira ob»olei«. If you can photocopy this, pfeas« submd in addittonal copy. White - EPA Fite Copy (original) Yellow- Applicani copy
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i
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I
Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed
copies of the form are required. Following are basic instructions:
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of the responsible party
must be provided,
d. All applicable information which is on the product specific data submission must
also be reported on the CSF. '»
e. All weights reported under item 7 must be in pounds per gallon for liquids and
pounds per cubic feet for solids.
f. Flashpoint must be in degrees Fahrenheit and flame extension in inches.
g. For all active ingredients, the EPA Registration Numbers for the currently
registered source products must be reported under column 12,
h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all
common names for the trade names must be reported.
i. For the active ingredients, the percent purity of the source products must be
reported under column 10 and must be exactly the same as on the source
product's label.
j. All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or
grams. In no case will volumes be accepted. Do not mix English and metric
system units (i.e., pounds and kilograms).
k. All the items under column 13.b. must total 100 percent.
1. All items under columns 14.a. and 14.b, for the active ingredients must represent
pure active form.
m. The upper and lower certified limits for ail active and inert ingredients must
follow the 40 CFR 158.175 instructions. An explanation must be provided if the
proposed limits are different than standard certified limits.
n. When new CSFs are submitted and approved, all previously submitted CSFs
become obsolete for that specific formulation.
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202
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r/EPA
United States Environmental Protection Agency
Washington. DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0106
2070-OOS7
Approve! Explr«» 3 31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070*0106), Washington, DC 20503.
Please fill in blanks below.
Company Namt
Product Nun*
Cmnpwnv Number
i ,
EPA R»S. NO.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodentictde Act (FIFRA), If necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data
My firm has offered in writing to enter into such in agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3{c}(2)(B)(lli) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following ffrm(s) on the following
date(s):
Nam* ol Flrm(»)
D»t* of Off»r
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature ol Company1! Authorlz*rf R*pr*«*ntallv*
Oslo
Nam* and Till* (Pl*a»* Typ* or Print}
EPA Form 8570-32 (5/91) Replaces KPA form 858U, which b ohmtete
203
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204
v3"
A.
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United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
"*• ££££
!»***• J-M-*
PubBc reporting burden (or this coUtdion of Woimatton is estimated te average 15 minutes per response, fcduding
time for reviewing instiucttons, Marching existing data sources, gathering and maintaining (h* data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W.. Washington, DC 20460; and to the Office
of Management and Budget. Paperwork Reduction Project (2070010$, Washington, DC 20503.
Please fill In blanks below.
CMipmy MM*
Product MM
Company Numb«r
•fa, Mf. MO.
iCerWythat; (j
1. For each study cited ki support of registration or ^registration under the Federal insecticide. Fungicide and
Rodentidde Act (FIFRA) mat is an exclusive use study. I ant the original data submitter, or I have obtained the
written permission of the original dau submitter to cite that study.
2, That for each study dad in support of registration or registration under FiFRA that is NOT an exclusive use
study. I am the original data submitter, or l have obtained the written permission of the original data submitter, or I
have notified m writing the company(lei) that submitted data l have tiled and have ottered to: (a) Pay
compensation for those data ki accordance wlh sections 3(c)(i}(D) and 3(0(2X0) of FJFRA*. and (b) Commence
negotiation to determine which data are subject to the compensation reouirement of FIFRA and the amount of
compensation due. • any. The companies 1 have notified am: (check one)
[]
i studies listed on the back of this form or attached
sheets, or indicated en the attached "Requirements Status and Registrants' Response Form,*
3. Thatlriaveprtvic<^»mpBedwtthsectkxi3(c}(^
registration or ^registration under FIFRA,
Sip»ta«
NMM an* Tito (Pta
Drnw
«M T>p* *r PfM$
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the
registration or reregistrsiion of my products, to the •«•« required by FlFRA sections:
SifmtM*
Dux
NMM Mitf Title («••»• Ty*« «r Prtnq
•f*A fmm K?0*i1 (4-10)
205
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