I
REREGISTRATION ELIGIBILITY DOCUMENT
ALLIUM SATIVUM
(GARLIC)
LIST D
CASE 400?
JUNE 1992
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
WASHINGTON, D.C.
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ALLIUM SATIVUM (GARLIC) REREGISTRATION ELIGIBILITY TEAM
Office of Pesticide Programs:
Biological
Steve Jarboe
Paul Guillebeau
G, All
and Economic Analysis Branch
Biological Analysis Branch
Biological Analysis Branch
Economic Analysis Branch
Environmental Fate and Effects Division
Regina Hirsh
Les Touart
Heather Mansfield
David Bays
Harold Day
Bernice Slutsky
Health Effects Division
Tom McClintock
Jim Yowell
Ecological Effects Branch
Ecological Effects Branch
Ecological Effects Branch
Ecological Effects Branch
Environmental Fate and Ground Water
Science Analysis and Coordination Staff
Science Analysis and Coordination Branch
Program Management and Support Division
Information Services Branch
Registration Division
Pat Critchlow
Dan Peacock
Sarai Malak
Mary Waller
Registration Support Branch
Insecticide-Rodenticide Branch
Registration Support Branch
Registration Support Branch
Special Review andReregistratipn Division
Bruce Sidwell Accelerated Reregistration Branch
Margarita Collantes Accelerated Reregistration Branch
Policy and Special Projects Staff
Kennan Garvey
Office of General counsel:
Alan Carpien
Office of Compliance Monitoring:
Beverly Updike
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TABLE OF CONTENTS
PAGE
GLOSSARY OF TERMS AND ABBREVIATIONS i
EXECUTIVE SUMMARY ii
I, INTRODUCTION 1
II. ACTIVE INGREDIENTS COVERED BY THE REREGISTRATION DECISION 2
DOCUMENT
A. IDENTIFICATION OF ACTIVE INGREDIENT 2
B. USE PROFILE 2
C. REGULATORY HISTORY 4
III. AGENCY ASSESSMENT OF ACTIVE 4
INGREDIENT
A. DESCRIPTION OF ACTIVE INGREDIENTS AND SUMMARY OF
PRODUCT CHEMISTRY 4
B. ENVIRONMENTAL AND HUMAN HEALTH ASSESSMENT 5
IV. REREGISTRATION DECISION FOR ALLIUM SATIVUM 7
A. DETERMINATION OF ELIGIBILITY 7
B. ADDITIONAL GENERIC DATA REQUIREMENTS 7
C. TOLERANCE ASSESSMENT 8
D. LABELING REQUREMENTS FOR MANUFACTURING - 8
USE PRODUCTS OF ALLIUM SATIVUM
V. PRODUCT REREGISTRATION 8
A. DETERMINATION OF ELIGIBILITY 8
B. PRODUCT-SPECIFIC DATA REQUIREMENTS 8
C. LABELING REQUIREMENTS 8
VI. APPENDICES
A. APPENDIX A - USE PATTERNS SUBJECT TO REREGISTRATION 10
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B. APPENDIX B - GENERIC DATA REQUIREMENTS FOR
REREGISTRATION OP ALLIUM SATIVUM (GARLIC) SUPPORTING
REREGISTRATION 34
1. GUIDE TO APPENDIX B 35
2. PRODUCT IDENTIFICATION fALLIUM SATIVUM) 36
3. ECOLOGICAL EFFECTS fALLIUM SATIVUM) 37
4. TOXICOLOGY fALLIUM SATIVUM) 37
5. ENVIRONMENTAL FATE fALLIUM SATIVUM) 37
6. RESIDUE CHEMISTRY fALLIUM SATIVUMJ 37
7. OCCUPATIONAL EXPOSURE (ALLIUM SATIVUM} 37
C. APPENDIX C - BIBLIOGRAPHY
1. GUIDE TO APPENDIX C 38
2. BIBLIOGRAPHIC CITATIONS 42
D. APPENDIX D - PR NOTICE 91-2 43
E. APPENDIX E - DATA CALL-IN 46
1. ATTACHMENT A - CHEMICAL STATUS SHEET 60
2. ATTACHMENT B - PRODUCT SPECIFIC DATA CALL-IN 63
RESPONSE FORM
3. ATTACHMENT C - PRODUCT SPECIFIC REQUIREMENT 68
STATUS AND REGISTRANT'S RESPONSE
FORM
4. ATTACHMENT D - EPA GROUPING OF END-USE PRODUCTS 77
FOR MEETING DATA REQUIREMENTS FOR
REREGISTRATION
5. ATTACHMENT E - EPA ACCEPTANCE CRITERIA 80
6. ATTACHMENT F - LIST OF ALL REGISTRANTS SENT 103
THIS DATA CALL-IN NOTICE
7. ATTACHMENT G - COST SHARE AND 104
DATA COMPENSATION FORMS
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i
GLOSSARY OF TERMS AND ABBREVIATIONS
a.i. Active Ingredient
Agency U.S. Environmental Protection Agency
CAS Chemical Abstracts Service
CFR Code of Federal Regulations
CSF Confidential Statement of Formula
EP End-Use Product
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
GRAS Generally Recognized As Safe
MP Manufacturing Use Product
MRID Master Record Identification (number). EPA's system of
recording and tracking studies submitted to the Agency.
RED Reregistration Eligibility Document
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Executive Summary
The U.S. Environmental Protection Agency ("EPA" or "the
Agency") first registered a pesticide product containing Allium
sativum in 1983. Currently, there are a total of four registered
products for this active ingredient. Three of these products
also contain capsicum (red pepper) as an active ingredient. All
currently registered products are repellents against birds and/or
insects. The end- use products are either soluable concentrates
applied by aerial application or dust formulations applied
directly into furrows or by broadcast with ground applicators.
These products prevent pests from attacking and damaging seeds
and seedlings of vegetables, fruits, grains, ornamental plants
and shrubbery.
Based on the results from the reregistration review, the EPA
has determined that the data base for Allium sativum is
sufficient to conduct a risk assessment. All product
identity/chemistry data requirements have been satisfied. All
applicable toxicology, residue chemistry, worker exposure,
ecological and environmental effect data requirements have been
waived for the subject compound. The potential risks, if any, to
humans from both nondietary/dietary and occupational exposures
are considered negligible because of the long history of use by
humans as a food additive and or component. The potenial risks
to the environment are considered negligible due to garlic's non-
toxic mode of action and non-persistence in the environment.
Accordingly, EPA has determined that the registered uses of
Allium sativum are eligible for reregistration. The decision to
reregister specific products will be made after appropriate
labeling are submitted and/or cited. After reviewing these
labels the EPA will determine whether or not the conditions of
FIFRA 3(c)(5) have been met, that is, whether product labeling
are acceptable and their uses will not cause unreasonable adverse
effects to humans or the environment. If these conditions are
met, EPA will reregister the products. Those products which
contain other active ingredients will be eligible for
reregistration only when the other active ingredients are
determined to be eligible for reregistration.
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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.
Section 4(g)(2)(A) of FIFRA states that in Phase 5 "the
Administrator shall determine whether pesticides containing
such active ingredient are eligible for reregistration"
before calling in data on products, section 4(g)(2)(B), and
either reregistering products or taking "other appropriate
regulatory action," under section 4(g)(2)(C) and (D). Thus,
reregistration involves a thorough review of the scientific
data base underlying a pesticide's registration. The
purpose of the Agency's review is to reassess the potential
hazards arising from the currently registered uses of the
pesticide; to determine the need for additional data on
health and environmental effects; and to determine whether
the pesticide meets the "no unreasonable adverse effects"
criterion of FIFRA, section 3(c)(5).
This document presents the Agency's decision regarding
the reregistration eligibility of the active ingredient
Allium sativum (garlic). The document consists of five
sections. Section I is this introduction. Section II
describes Allium sativuro. its uses and regulatory history.
Section III discusses the human health and environmental
assessments based on the data available to the Agency.
Section IV discusses the reregistration decision for Allium
sativum and Section V discusses product reregistration.
Additional details concerning the review of available data
are available on request.
EPA's reviews of specific reports and information on the
set of registered uses considered for EPA's analyses may
be obtained from: EPA, Freedom of Information, 401 M
St. S.W., Washington, D.C. 20460.
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I
II. ACTIVE INGREDIENTS COVERED BY THIS RER1GISTRATION
ELIGIBILITY DECISION DOCUMENT
A. IDENTIFICATION OF ACTIVE INGREDIENT
1. Chemical Name: Allium sativum (Garlic)
CAS Number: 8000-78-0
Office of Pesticide Programs Chemical Code Number:
128827
Empirical Formula: Not Applicable
B. USE PROFILE
Type of Pesticide: biochemical pesticide, insect and
bird repellent
Pests Controlled: birds, mites and insects
Registered Use Groups: (See Appendix A for
detailed specific use
sites).
Terrestrial Food/Feed - vegetables, fruits, nuts
and grains
Terrestrial Non-food - ornamental plants and
shrubs
Indoor Residential - ornamental plants
Formulation Types Registered:
BIRDS -
Dust: 12% ground red pepper (Capsicum spp.)
5% ground garlic (Allium sativum)
IKSECTS -
Soluble concentrate/liquid: 36% red pepper extract
24% garlic extract
Soluble concentrate/liquid: 100% garlic water
Methods and Rates of Applications
Dusts are applied as a banded furrow
treatment at planting or applied broadcast to
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foliage and fruit of plants. Product may be
applied aerially or by ground equipment.
There is no maximum rate on the label; a
minimum rate is 20 to 50 Ibs formulated
material per acre (A). For seedlings,
maturing produce and grains, the product is
applied at a minimum rate of 30 Ibs/A at 7 to
9 days before harvest.
Soluble concentrates are applied broadcast to
foliage by air or ground equipment. There is
no maximum rate for the 24% garlic: 36%
capsaicin product.
100% garlic water product is applied up to 2 times per
season at one gallon/A.
Use practice limitations: Application at bloom may
repel pollinators.
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i
C. REGULATORY HISTORY
The Agency first registered a product (EPA Reg.
No. 47319-1) with garlic, on December 29, 1983, to the
Sevana Company of Fresno, California. This product is
used in combination with ground red peppers (Active
Ingredient Code 070701; Case Name; Capsaicin;
Reregistration Case No. 4018). The mode of action is
that of a bird repellent. On July 2, 1985, the Agency
registered a similar second bird repellent product (EPA
Reg. No. 47319-2) to the Sevana Company.
The Agency registered a third repellent product to
Sevana (EPA Reg. No. 47319-4) on November 4, 1988.
This product also contains a combination of garlic and
red pepper, however, it is an insect repellent, rather
than bird, repellent and is a liquid formulation.
The most recent product was registered by the
Agency on February 7, 1991 to the Guardian Spray
Company of Lebec, California. This product contains a
single active ingredient, garlic, and is a liquid
formulation.
Until recently, Allium sativum was classified by
the Agency as a conventional chemical pesticide. Since
these four formulations consist of a food additive
and/or component and cleared inert ingredients, the
Agency only required minimal basic product and chemical
identity data. Now the Agency has reclassified the
subject compound as a biochemical pesticide because it
is a naturally occurring biological substance and has a
non-toxic mode of action.
III. AGENCY ASSESSMENT OF THE ACTIVE INGREDIENT
EPA has reviewed the scientific data base for Allium
sativum, primarily relying on information from published
literature submitted by the registrant. These are cited in
Appendix C.
A. DESCRIPTION OF ACTIVE INGREDIENT AND SUMMARY OF PRODUCT
CHEMISTRY
Garlic, as a pesticide active ingredient,
consists of either a powder or a distilled extract
from the fresh or dehydrated bulb or cloves
obtained from Allium sativum. Natural derivatives
of garlic include essential oils, oleoresins, and
extracts. One such derivative is finely ground
garlic bulbs (known as garlic powder).
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I
When fresh garlic cloves are extracted
and distilled, a range of color from a light
orange to amber liquid color is observed.
Fresh garlic has an extremely pungent and
highly concentrated aroma and flavor. Garlic
is dispersible in water (polar carriers) and
oil (non-polar carriers) with agitation.
B. ENVIRONMENTAL AND HUMAN HEALTH ASSESSMENT
EPA has developed a normative set of data
requirements, set forth in the regulations (40 CFR Fart
158) and the Agency's Reregistration Phase 2 Technical
Guidance Document to be addressed for pesticide
reregistration. These regulations and the guidance
document specify the necessary data based on factors
including use sites, potential environmental and human
(dietary and occupational) exposures, product
formulation types, and product application methods.
Due to the diverse nature and characteristics of
pesticide products and their uses subject to
reregistration, the Agency also recognizes the
necessity to modify the data requirements for specific
pesticides, including waiving certain data requirements
because such requirements are inappropriate or
unnecessary for reregistration.
The case-specific approach to waive individual
data requirements has served to identify the
appropriate data requirement sets for pesticide
products. Further, the Agency believes there is a
category of pesticide active ingredients for which a
broadly reduced set of data requirements are
appropriate for reregistration. Specifically, products
in this category would be exempt from the generic data
requirements for toxicology, residue chemistry, human
exposure, ecological effects, and environmental fate on
the active ingredient. The Agency believes there are
considerations which, when taken together, can form the
basis for a conclusion that such a reduction in data
requirements is appropriate for a particular pesticide
active ingredient, while not compromising human health
or environmental safety.
There are, however, certain data requirements
which are essential and not likely to be waived. Basic
product identity/chemistry information on the active
ingredient and formulated products is required for
pesticides in this category so that the Agency has
reasonable certainty of the pesticide's identity and
chemical and physical characteristics. Also, acute
toxicology studies for formulated and manufacturing-use
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products are required for the Agency to determine
appropriate product labeling for potential hazards to
those who handle or apply such products. However,
these toxicology studies may be waived if an assessment
of the product formulation, including the inert
ingredients, indicates that such studies are
unnecessary to prescribe appropriate labeling.
In considering garlic for reregistration
eligibility the Agency believes it is an active
ingredient that should be considered for this broad
waiver of the generic data reguirements. The
considerations that lead the Agency to this conclusion
are as follows.
Garlic is widely distributed and commercially
available for flavoring and seasoning throughout the
United States for nonpesticidal uses. Garlic is
generally recognized as safe (GRAS) under 21 CFR 182.10
(spices and other natural seasonings and flavorings)
and 182.20 (ssential oils, oleoresins [solvent-free]
and natural extractives [including distillates]) as
affirmed in 184.1317 ([garlic and its derivatives]).
Garlic is formulated as either a powder or a
distilled extract from garlic cloves and is used to
repel birds and insects in certain fruit, nut, and
citrus trees, vegetables, vine crops, berries, grains,
roses, flowers, and shrubs. This active ingredient has
a non-toxic mode of action for target pests. Moreover,
garlic can be presumed to be non-persistent based on
knowledge of its composition; e.g., organic material
known to be rapidly degraded in the environment to
elemental constituents by normal biological, physical,
and/or chemical processes that can be reasonably
expected to exist where the pesticide is applied.
No reports of adverse effects have been submitted
to the Agency for this active ingredient and EPA has
not identified any indication of significant adverse
effects from garlic to humans or the environment
associated with its use as a pesticide. This includes
consideration of information in the literature, or in
any incident reports by the registrant or the public.
Based on these factors the Agency does not believe
generic data, beyond those data required to satisfy
basic product identity and chemistry questions (refer
to Appendix B), are necessary to determine whether the
current registered uses of this active ingredient pose
unreasonable risks to humans or the environment.
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i
Therefore, the Agency has waived all generic data
requirements except basic product identity and
chemistry data. The Agency believes that, based on the
above factors, the registered uses of garlic do not
pose unreasonable risks to humans or the environment.
IV. REREGISTRATION DECISION FOR ALLIUM SATIVPM
A. DETERMINATION OF ELIGIBILITY
Section 4(g)(2)(A) of FIFRA requires the Agency to
determine, after consideration of relevant data concerning
an active ingredient whether products containing the active
ingredient are eligible for reregistration. For products
containing garlic as an active ingredient the Agency has
waived all generic data requirements except for certain
basic product identity and chemistry. In addition to these
data the Agency has considered the factors discussed above
in Section III regarding the natural occurrence of garlic,
common use as a food item, and the lack of reported adverse
effects information. The Agency has completed its
consideration of these data and other factors and has
determined this information is sufficient to support
reregistration of products containing garlic as an active
ingredient. The reregistration of particular products is
addressed in Section V. of this document.
Although the Agency has concluded that products
containing garlic are eligible for reregistration, the
Agency may take regulatory actions in the future that would
affect the continued registration of garlic-containing
products if new and/or significant information about this
active ingredient and/or its products comes to the Agency's
attention. Such regulatory action could include requiring
the submission of additional data if the data requirements
for registration (or the guidelines for generating such
data) change.
B. ADDITIONAL GENERIC DATA REQUIREMENTS
The generic data base supporting the reregistration of
products containing Allium sativum and the registered use
patterns, has been reviewed and determined to be
substantially complete for reregistration.
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i
C. TOLERANCE ASSESSMENT
End-use products are registered for application to a
variety of food crops however, no finite residues for
tolerance or exemption from tolerances have been established
in 40 CFR Part 180. As discussed above in Section III, the
Agency does not believe any dietary exposure to residues on
crop commodities from the application of these products
would present a health concern and as such has waived
toxicology and residue chemistry data requirements on the
active ingredient. However, to meet tolerance requirements
in the regulations, the Agency will propose a tolerance
exemption for Allium sativum under 40 CFR Part 180 for all
currently registered uses on food/feed crops.
D. LABELLING REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS OF
ALLIUM SATI¥UM
No manufacturing-use products are registered.
V. PRODUCT REREGISTRATION
A. DETERMINATION OF ELIGIBILITY
Based on the reviews of the generic data for the
active ingredient, Allium sativum. the products
containing them are eligible for reregistration.
Section 4(g)(2)(B) of FIFRA calls for the Agency to
obtain any needed product-specific data regarding the
pesticide after a determination of eligibility has been
made. The Agency will review these data when they have
been submitted and/or cited and determine whether to
reregister individual products.
B. PRODUCT SPECIFIC DATA REQUIREMENTS
The product-specific data requirements are listed
in Appendix D, Attachment D. These requirements
include product chemistry, acute toxicology, and
efficacy studies.
C. LABELING REQUIREMENTS FOR END-USE PRODUCTS
CONTAINING ALLIUM SATIVUM
The labels and labeling of all products must
comply with EPA's current regulations and requirements,
Follow the instructions in the Product Reregistration
8
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Handbook with respect to labels and labeling.
Based on the lack of toxicological concerns the
Agency has no product precautionary labeling concerns
at this time.
However, certain products lack directions for
application of maximum rates. In reponse to this RED,
registrants must submit draft amended product labels in
which minimum and maximum application rates are
proposed. The Agency will evaluate these proposals and
determine where each label is satisfactory.
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APPENDIX A
USE PATTERNS SUBJECT TO REREGISTRATION
FOR
ALLIUM SATIVUM (GARLIC)
10
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APPENDIX A- Case 4007, [Allium sativum] Chemical 128827 [Allium sativum]
SITE Application Type, Application Timing, Application
Equipment
r
Form
FOOD/FEED USES
Minimum
Application Rate
Maximum
Application flala
Max.*
Apps,
Max.*
Apps.
@
Max.
Rate
Mln. Interval
Between Apps.
@ Max, Rate
(Days)
Restricted
Entry
Interval
(Days)
Geographic
Limitations
Mowed
Disallowed
Use Limitations
Almond Use Groups: Terrestrial Food Crop and Terrestrial Feed Crop
Low volume spray (concentrate), Foliar, Aircraft
Low volume spray (concentrate), Foliar, Low
volume ground
SC/L
SC/L
na
na
.625 Ib ai/A 2 per
Cycle
,825 ib ai/A 2 per
I Cycle
not
spec
not
spec
not spec
not spec
not spec
not spec
Apple Use Groups: Terrestrial Food Crop and Terrestrial Feed Crop
Broadcast, Foliar, Aircraft
Broadcast, Foliar, Ground
Low volume spray (concentrate), Foliar, Aircraft
Low volume spray (concentrate), Foliar, Low
volume ground
Spray, Foliar, Aircraft
Spray, Petal fall, Aircraft
Spray, Foliar, Ground
Spray, Petal fall, Ground
D
D
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
2,5 Ib Al per A
2,5 ib Al per A
na
na
na
na
na
na
not spec
not spec
.825 Ib Al per
A
.825 Ib Al per
A
Dose cannot
be calculated
Dose cannot
be calculated
Oose cannot
be calculated
Dose cannot
be calculated
not
spec
not
spec
2 per
Cycle
2 per
Cycle
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
7
7
not spec
not spec
7
7
7
7
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
7 days
preharvest
interval.
7 days
preharvest
Interval.
15 days
preharvest
interval.
15 days
preharvest
interval.
15 days
preharvest
interval.
15 day s
preharvest
interval.
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APPENDIX A- Case 4007, [Alllum satlvum] Chemical 128827 [Allium satfvum]
SITE Application Type, Application Timing, Application
Ectulpmerrt
Apricot Use Group: Terrestrial Food Crop
Broadcast, Foliar, Aircraft
Broadcast, Foliar, Ground
Low volume spray (concentrate), Foliar, Aircraft
Low volume spray (concentrate), Foliar, Low
volume ground
Spray, Foliar, Aircraft
Spray, Petal fall, Aircraft
Spray, Foliar, Ground
Spray, Petal fall, Ground
Form
D
D
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
Minimum
Application Rate
2,5lbAlperA
2.5 Ib Al per A
na
na
na
na
na
na
Maximum
Application Bate
not spec
not spec
.825 Ib Al per
A
.825 Ib Al per
A
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Mat*
Apps.
not
spec
not
spec
2 per
Cycle
2 per
Cycle
not
spec
not
spec
not
spec
not
spec
Max.*
Apps.
©
Max.
Rate
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
Mln. Interval
Between Apps.
© Max. Rate
(Days)
7
7
not spec
not spec
7
7
7
7
Restricted
Entry
Interval
(Days)
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
Geographic
limitations
Allowed
Disallowed
Use Limitations
7 days
preharvest
Interval,
7 days
preharvest
interval.
15 days
preharvest
interval.
15 days
preharvest
Interval.
15 days
preharvest
interval.
15 days
preharvest
interval.
Beans Use Groups: Terrestrial Food Crop and Terrestrial Feed Crop
High volume spray (dilute), Foliar, Ground
Low volume spray (concentrate), Foliar, Aircraft
Low volume spray (concentrate), Prebloom,
Aircraft
SC/L
SC/L
SC/L
na
na
na
Dose cannot
be calculated
.825 Ib Al per
A
.825 Ib Al per
A
not
spec
2per
Cycle
2 per
Cycle
not
spec
not
spec
not
spec
As needed
not spec
not spec
not spec
not spec
not spec
15 days
preharvest
interval.
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APPENDIX A- Case 4007, [Allium sativum] Chemical 128827 [Allium sativum]
SITE Application Type, Application Timing, Application
Equipment
Low volume spray (concentrate), Foliar, Low
volume ground
Low volume spray (concentrate), Prebloom, Low
volume ground
Spray, Foliar, Aircraft
Spray, Seedling, Aircraft
Spray, Seedling, Ground
Form
SC/L
SC/L
SC/L
SC/L
SC/L
Minimum
Application Rate
na
na
na
na
na
Maximum
Application Rate
.825 Ib Al per
A
.825 Ib Al per
A
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Max, #
Apps.
2 per
Cycle
2 per
Cycle
not
spec
not
spec
not
spec
Max.*
Apps.
@
Max.
Rate
not
spec
not
spec
not
spec
not
spec
not
spec
Mln. Interval
Between Appe.
@ Max. Rate
(Days)
not spec
not spec
As needed
As needed
As needed
Restricted
Entry
Interval
Pays)
not spec
not spec
not spec
not spec
not spec
Geographic
Limitations
Allowed
Disallowed
Use limitations
15 days
preharvest
interval.
15 days
preharvest
interval.
15 days
preharvest
interval.
Beets (Unspecified) Use Groups: Terrestrial Food Crop and Terrestrial Feed Crop
Band treatment, At planting, Mechanical granule
applicator
Broadcast, Foliar, Aircraft
Broadcast, Seedling stage. Aircraft
Broadcast, Foliar, Ground
Broadcast, Seedling stage, Ground
Broadcast, Postemergence, Shaker can
Soil band treatment, At planting, Shaker can
D
D
D
D
D
D
D
1 Ib Al per A
1.5lbA!perA
1.5!bAlper A
1,5 Ib per A
1.5 to per A
na
na
not spec
not spec
not spec
not spec
not spec
Dose cannot
be calculated
Dose cannot
be calculated
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not spec
7
7
7
7
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
7 days
preharvest
interval.
7 days
preharvest
interval.
7 days
preharvest
interval.
7 days
preharvest
interval.
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APPENDIX A- Case 4007, [Allium sativum] Chemical 128827 [Allium sativum]
SITE Application Type, Application Timing, Application
Equipment
Soil treatment, At planting, Shaker can
Form
0
Minimum
Application Rate
na
Maximum
Application Rate
Dose cannot
be calculated
Max.*
Apps.
not
spec
Max.*
Apps,
©
Max.
Rate
not
spec
Mln. Interval
Between Apps.
© Max, Rate
(Days)
not spec
Restricted
Entry
Interval
(Days)
not spec
Geographic
Limitations
Allowed
Disallowed
Use Limitations
Broccoli Use Group: Terrestrial Food Crop
High volume spray, Foliar, Ground
Spray, Folwr, Aircraft
Spray, Seedling stage, Aircraft
Spray, Seedling stage. Ground
Cabbage Use Group: Terrestrial Food Crop
Band treatment, At planting, Mechanical granule
applicator
Broadcast, Foliar, Aircraft
Broadcast, Seedling stage, Aircraft
Broadcast, Foliar, Ground
Broadcast, Seedling stage, Ground
SC/L
SC/L
SC/L
SC/L
na
na
na
na
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
As needed
As needed
As needed
As needed
not spec
not spec
not
spec
not spec
15 days
preharvest
Interval.
15 days
preharvest
Interval.
15 days
preharvest
interval.
15 days
preharvest
interval.
O
D
D
D
D
1 Ib Al per A
LSIbAlperA
1.5lbAlper A
LSIbAlperA
1 ,5 Ib Al per A
not spec
not spec
not spec
not spec
not spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not spec
7
7
7
7
not spec
not spec
not spec
not spec
not spec
7 days
preharvest
Interval.
7days
preharvest
interval.
7 days
preharvest
interval.
7 days
preharvest
interval.
-------
APPENDIX A- Case 4007, [Allium sativum] Chemical 128827 [Alliutn sativum]
SITE Application Type, Application Timing. Application
Equipment
Broadcast, Postemergence, Shaker can
Low volume spray (concentrate), Foliar, Aircraft
Low volume spray (concentrate), Prebloom,
Aircraft
I ow volume spray (concentrate). Foliar, Low
volume ground
Low volume spray (concentrate), Prebloom, Low
volume ground
Soil band treatment, At planting, Shaker can
Soil treatment. At planting, Shaker can
Form
D
sen
SC/L
SC/L
SC/L
D
D
Minimum
Application Rate
na
na
na
na
na
na
na
Maximum
Application flats
Dose cannot
be calculated
.825 Ib Al per
A
.825 Ib Al per
A
.825 Ib Al per
A
.825 Ib Al per
A
Dose cannot
be calculated
Dose cannot
be calculated
Max. #
Apps.
not
spec
2 per
Cycle
2 per
Cycle
2 per
Cycle
2 per
Cycle
not
spec
not
spec
Max.*
Apps.
e
Max.
Rate
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
Mln. Interval
Between Apps,
@ Max, Rate
(Days)
not spec
not spec
not spec
not spec
not spec
not spec
not spec
Restricted
Entry
Interval
(Days)
not spec
not spec
not spec
not spec
not spec
not spec
not spec
Carrot (including tops) Use Group: Terrestrial Food Crop
Band treatment, At planting, Mechanical granule
applicator
Broadcast, Foliar, Aircraft
Broadcast, Seedling stage, Aircraft
Broadcast, Foliar, Ground
Broadcast, Seedling stage. Ground
D
0
0
D
D
1 Ib Al per A
1.5!bAlperA
1.5lbAlperA
UlbAlperA
1 .5 Ib Al per A
not spec
not spec
not spec
not spec
not spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not spec
7
7
7
7
not spec
not spec
not spec
not spec
not spec
Geographic
Limitations
Allowed
Disallowed
Use limitations
7 days
preharvest
interval.
7 days
preharvest
interval.
7 days
preharvest
interval.
7 days
preahrvest
Interval.
-------
APPENDIX A - Case 4007, [Allium sativum] Chemical 128827 [Allium sativum]
SITE Application Type, Application Timing, Application
Equipment
Low volume spray (concentrate), Foliar, Aircraft
Low volume spray (concentrate), Prebloom,
Aircraft
Low volume spray (concentrate), Foliar, Low
volume ground
Low volume spray (concentrate), Prebloom, Low
volume ground
Form
SC/L
sen
sen
SC/L
Minimum
Application Rate
na
na
na
na
Maximum
Application Rate
.825 Ib Al per
A
.825 Ib Al per
A
.825 Ib Al per
A
.825 Ib Al per
A
Max. #
Apps.
2 per
Cycle
2 per
Cycle
2 per
Cycle
2 per
Cycle
Max*
Apps.
a
Max.
Rate
not
spec
not
spec
not
spec
not
spec
Mln. Interval
Between Apps.
@ Max, Bate
(Days)
not spec
not spec
not spec
not spec
Restricted
Entry
Interval
(Days)
not spec
not spec
not spec
not spec
Geographic
Limitations
Allowed
Disallowed
Us« Limitations
Cauliflower Use Group: Terrestrial Food Crop
High volume spray (dilute), Foliar, Ground
Spray, Foliar, Aircraft
Spray, Seedling stage, Aircraft
Spray, Seedling stage, Ground
SC/L
SC/L
SC/L
SC/L
na
na
na
na
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
As needed
As needed
As needed
As needed
not spec
not spec
not spec
not spec
15 days
preharvest
interval.
15 days
preharvest
interval.
15 days
preharvest
interval.
15 days
preharvest
interval.
Celery Use Group: Terrestrial Food Crop
High volume spray (dilute), Foliar, Ground
Spray, Foliar, Aircraft
Spray, Seedling stage, Aircraft
SC/L
SC/L
SC/L
na
na
na
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
As needed
As needed
As needed
not spec
not spec
not spec
15 days
preharvest
interval.
15 days
preharvest
interval.
15 days
preharvest
interval.
-------
APPENDIX A- Case 4007, [Allium sativum] Chemical 128827 [Allium sativum]
SITE Application Type, Application Timing, Application
Equipment
Spray, Seeding stage, Ground
Form
SC/L
Minimum
Application Rate
na
Maximum
Application Rate
Dose cannot
be calculated
Max. *
Apps.
not
spec
Man.*
Apps.
@
Max.
Rate
not
spec
Mln. Interval
Between Apps.
@ Wax. Rate
(Days)
As needed
Restricted
Entry
Interval
(Days)
not spec
QtograpNc
Limitations
Allowed
Disallowed
Use limitations
15 days
preharvest
interval.
Cherry Use Group; Terrestrial Food Crop
Broadcast, Foliar, Aircraft
Broadcast, Foliar, Ground
Broadcast, Foliar, Shaker can
Spray, Foliar, Aiorcraft
Spray, Petal 1st, Aircraft
Spray, Foliar, Ground
Spray, Petal (ad, Ground
D
0
D
SC/L
SC/L
SC/L
SC/L
2.5 Ib M per A
2,5 Ib Al per A
na
na
na
na
na
not spec
not spec
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
7
7
7
7
7
7
7
not spec
not spec
not spec
not spec
not spec
not spec
not spec
7 days
preharvest
Interval.
7 days
preharvest
interval.
2 days
preharvest
Interval.
15 days
preharvest
interval.
15 days
preharvest
Interval.
15 days
preharvest
interval.
15 days
preharvest
Interval,
Com (Unspecified] Use Groups: Terrestrial Food Crop and Terrestrial Feed Crop
Band treatment, At planting. Mechanical
granule applicator
D
1 Ib Al per A
not spec I not
|| spec
not
spec
not spec
not spec
-------
APPENDIX A- Case 4007, [AIMum sativum] Chemical 128827 [AlHum satlvum]
SITE Application Type, Application Timing, Application
Equipment
Broadcast, Foliar, Aircraft
Broadcast, Seedling stage, Aircraft
Broadcast, Foliar, Ground
Broadcast, Seedling stage, Ground
Broadcast, Shaker can, Postemer gence
Low volume spray (concentrate), Foliar, Aircraft
Low volume spray (concentrate), Prebloom,
Aircraft
Low volume spray (concentrate), Foliar, Low
volume ground
Low volume spray (concentrate), Prebloom, Low
volume ground
Soil band treatment, At planting, Shaker can
Soil treatment. At planting, Shaker can
Form
D
D
0
0
D
SC/L
SC/L
SC/L
SC/L
D
D
Minimum
Application Rate
1.5lbAlperA
1.5 Ib AlperA
1,5lbAlperA
1.5 Ib AlperA
na
na
na
na
na
na
na
Maximum
Application Rate
not spec
not spec
not spec
not spec
Dose cannot
be calculated
.825 Ib Al per
A
.825 Ib Al per
A
.825 Ib Al per
A
.825 to Al per
A
Dose cannot
be calculated
Dose cannot
be calculated
Max. *
AppS.
not
spec
not
spec
not
spec
not
spec
not
spec
2 per
Cycle
2 per
Cycle
2 per
Cycle
2 per
Cycle
not
spec
not
spec
Max.*
AppS.
«
Max.
Rate
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
Mln. Interval
Between Apps.
@ Max. Rate
(Days)
7
7
7
7
not spec
not spec
not spec
not spec
not spec
not spec
not spec
Restricted
Entry
Interval
pays)
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
Geographic
Limitations
Allowed
Disallowed
Use Limitations
7 days
preharvest
interval.
7 days
preharvest
interval.
7 days
preharvest
Interval.
7 days
preharvest
interval.
Cucumber Use Group: Terrestrial Food Crop
Spray, Foliar, Aircraft
SC/L
na
Dose cannot
be calculated
not
spec
not
spec
As needed
not spec
15 days
preharvest
interval.
-------
APPENDIX A- Case 4007, [Allium sativum] Chemical 128827 [Allium sativum]
SITE Appllcalton Type, Application Timing, Application
Equipment
Spray, Seedling stage. Aircraft
Spray, Foliar, Ground
Spray, Seedling stage, Ground
Form
SC/L
SC/L
SC/L
Minimum
Application Rate
na
na
na
Maximum
Application Bate
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Max. #
Apps.
not
spec
not
spec
not
spec
Max.*
Apps.
@
Max,
Rate
not
spec
not
spec
not
spec
Mln. Interval
Between Apps.
@ Max. Rate
(Days)
As needed
As needed
As needed
Restricted
Entry
Interval
(Days)
not spec
not spec
not spec
Geographic
Limitations
Allowed
Disallowed
Use Limitations
15 days
preharvest
interval.
15 days
preharvest
interval.
15 days
preharvest
interval.
Cereal Grains Use Groups; Terrestrial Food Crop and Terrestrial Feed Crop
Band treatment, At planting, Mechanical granule
applicator
Broadcast, Foliar, Aircraft
Broadcast, Seedling stage, Aircraft
Broadcast, Foliar, Ground
Broadcast, Seedling stage, Ground
D
D
D
D
D
1 IbAlperA
1,5 Ib AlperA
1.5 to Al per A
1.5 Ip AlperA
1.5 IbAlperA
not spec
not spec
not spec
not spec
not spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not spec
7
7
7
7
not spec
not spec
not spec
not spec
not spec
V-
JU.
7 days
preharvest
interval.
7 days
preharvest
interval.
7 days
preharvest
interval.
7 days
preharvest
interval.
7 days
preharvest
interval.
Fig Use Group: Terrestrial Food Crop
Broadcast, Foliar, Aircraft
D
2.5 Ib Al per A
not spec
not
spec
not
spec
7
not spec
7 days
preharvest
interval.
-------
APPENDIX A- Case 4007, [Allium sativum] Chemical 128827 [Allium satlvum]
SITE Application Type. Application Timing, Application
Equipment
Broadcast, FoNar, Ground
Form
D
Minimum
Application Bate
2.S Ib A) per A
Maximum
Application Rate
not spec
Max. *
Apps.
not
spec
Max. #
Apps.
9
Max.
Rate
not
spec
Mln, Interval
Between Apps.
@ Max. Rate
(Days)
7
Restricted
Entry
Interval
(Days)
not spec
Geographic
Limitations
Allowed
Disallowed
Use Limitations
7 days
preharvest
interval.
Grapes Use Groups; Terrestrial Food Crop and Terrestrial Feed Crop
Broadcast, Foliar, Aircraft
Broadcast, Foliar, Ground
Broadcast, Foliar, Shaker can
Low volume spray (concentrate). Foliar, Aircraft
Low volume spray (concentrate), Foliar, Low
volume ground
Spray, Foliar, Ground
Spray, Foliar, Aircraft
Kiwi Use Group: Terrestrial Food Crop
Low volume spray (concentrate), Foliar, Aircraft
Low volume spray, Foliar, Low volume ground
D
D
D
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
1.5 to At per A
f .5 Ib Al per A
na
na
na
m
na
na
na
not spec
not spec
Dose cannot
be calculated
.625 Ib Al per
A
.825 Ib Al per
A
Dose cannot
be calculated
Dose cannot
be calculated
not
spec
not
spec
not
spec
2 per
Cyde
2 per
Cyde
not
spec
not
spec
.825 Ib Al per
A
.825 Ib Al per
A
2 per
Cyde
2 per
Cycle
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
7
7
7
not spec
not spec
7
7
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
7 days
preharvest
interval.
7 days
preharvest
Interval.
2 days
preharvest
interval.
15 days
preharvest
interval.
15 days
preharvest
interval.
Lemon Use Groups: Terrestrial Food Crop and Terrestrial Feed Crop
Low volume spray (concentrate), Foliar, Aircraft
SC/L
na
.825 Ib Al per
A
2 per
Cycle
not
spec
not spec
not spec
10
-------
APPENDIX A- Case 4007, [Allium sativum] Chemical 128827 [Allium sativum]
SITE Application Type, Application Timing, Application
Equipment
Low volume spray (concentrate), Foliar, Low
volume ground
Form
sen
Minimum
Application Rate
na
Maximum
Application Rate
.825 Ib Al per
A
Max. *
Apps,
2 per
Cycle
Max.*
Apps.
@
Max.
Rate
not
spec
Mln. Interval
Between Apps.
® Max. Hate
(Days)
not spec
Restricted
Entry
Interval
(Days)
not spec
Geographic
Limitations
Allowed
Disallowed
Use Limitations
Lettuce Use Group: Terrestrial Food Crop
Band treatment, At planting, Mechanical granule
applicator
Broadcast, Foliar, Aircraft
Broadcast, Seedling stage, Aircraft
Broadcast, Foliar, Ground
Broadcast, Seedling stage, Ground
Broadcast, Postemergence, Shaker can
High volume spray (dilute), Foliar, Ground
Low volume spray (concentrate), Foliar, Aircraft
Low volume spray (concentrate), Prebloom,
Aircraft
Low volume spray (concentrate), Foliar, Low
volume ground
Low volume spray (concentrate), Prebloom,
Low volume ground
0
D
D
D
0
D
SC/L
SC/L
SC/L
SC/L
SC/L
1 to Al per A
1,5 Ib AlperA
1.5lbAlperA
1 .5 Ib AlperA
1.5 Ib AlperA
na
na
na
na
na
na
not spec
not spec
not spec
not spec
not spec
Dose cannot
be calculated
Dose cannot
be calculated
.825 Ib Al per
A
.825 Ib Al per
A
.825 Ib Al per
A
.825 Ib Al per
A
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
2 per
Cycle
2 per
Cycle
2 per
Cycle
2 per
Cycle
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not spec
7
7
7
7
not spec
As needed
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
7 days
pre harvest
interval.
7 days
preharvest
interval.
7 days
preharvest
htervat.
7 days
preharvest
interval.
15 days
preharvest
interval.
11
-------
APPENDIX A- Case 4007, [Allium sativum] Chemical 128827 [Allium sativum]
SITE Application Type, Application Timing, Application
Equipment
Soil band treatment, At planting, Shaker can
Soil treatment. At planting, Shaker can
Spray, Foliar, Aircraft
Spray, Seedling stage, Aircraft
Spray, Seedling stage, Ground
Form
D
D
SC/L
SC/L
SC/L
Minimum
Application Rate
na
na
na
na
na
Maximum
Application Rate
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Max. *
Apps.
not
spec
not
spec
not
spec
not
spec
not
spec
Max.*
Apps.
@
Max.
Rate
not
spec
not
spec
not
spec
not
spec
not
spec
Min. Interval
Between Apps.
@ Max. Rate
(Days)
not spec
not spec
As needed
As needed
As needed
Restricted
Entry
Interval
(Pays)
not spec
not spec
not spec
not spec
not spec
Qeographlo
Limitations
Allowed
Disallowed
Use Limitations
15 days
preharvest
interval.
15 days
preharvesl
interval.
15 days
preharvest
interval.
Melons Use Groups: Terrestrial Food Crop
Band treatment, At planting. Mechanical
granule applicator
Broadcast, Foliar, Aircraft
Broadcast, Seedling stage, Aircraft
Broadcast, Foliar, Ground
Broadcast, Seedling stage, Ground
Broadcast, Postemergence, Shaker can
Low volume spray (concentrate), Foliar, Aircraft
D
D
D
D
D
D
SC/L
1 Ib Al per A
1.5lbAlperA
1,5 Ib Al per A
1,5 to A) per A
1.5 to Al per A
na
na
not spec
not spec
not spec
not spec
not spec
Dose cannot
be calculated
.825 Ib Al per
A
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
2 per
Cycle
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not spec
7
7
7
7
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
7 days
preharvest
interval.
7 days
preharvest
interval.
7 days
preharvest
interval.
7 days
preharvest
interval.
12
-------
APPENDIX A- Case 4007, [Allium sativum] Chemical 128827 [Allium sativum]
SITE Application Type, Application Timing, Application
Equipment
Low volume spray (concentrate), Prebloom,
Aircraft
Low volume spray (concentrate), Foliar, Low
volume ground
Low volume spray (concentrate), Prebloom, Low
volume ground
Soil band treatment, At planting. Shaker ran
Soil treatment. At planting, Shaker can
Spray, Foliar, Aircraft
Spray, Seedling stage, Aircraft
Spray, Foliar, Ground
Spray, Seedling stage, Ground
Form
SC/L
SC/L
SC/L
D
0
SC/L
SC/L
SC/L
SC/L
Minimum
Application Rate
na
na
na
r»i
na
na
na
na
na
Maximum
Application Rate
.825 Ib Al per
A
.825 Ib Al per
A
.825 Ib Al per
A
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Max. #
Apps.
2 per
Cycle
2 per
Cycle
2 per
Cycle
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
Max *
Apps.
0
Max.
Rate
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
Mtn, Interval
Between Apps.
@ Max. Rate
(Days)
not spec
not spec
not spec
not spec
not spec
As needed
As needed
As needed
As needed
Restricted
Entry
Interval
(Days)
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
Geographic
Limitations
Allowed
Disallowed
Use Limitations
15 days
preharvest
interval.
15 days
preharvest
interval.
15 days
preharvest
interval.
15 days
preharvest
interval.
Melons, Cantaloupe Use Group: Terrestrial Food Crop
Low volume spray (concentrate), Foliar,
Aircraft
Low volume spray (concentrate), Prebloom,
Aircraft
Low volume spray (concentrate), Foliar,
Low volume ground
Low volume spray (concentrate), Prebloom,
Low volume ground
SC/L
SC/L
SC/L
SC/L
na
na
na
na
.825 Ib Al per
A
.825 Ib Al per
A
.825 Ib Al per
A
.825 Ib Al per
A
2 per
Cycle
2 per
Cycle
2 per
Cycle
2 per
Cycle
not
spec
not
spec
not
spec
not
spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
13
-------
APPENDIX A- Case 4007, [Allium sativum] Chemical 128827 [Atlium sativum]
SITE Application Type, Application Timing, Application
Equipment
Spray, Foliar, Aircraft
Spray, Seedling stage, Aircraft
Spray, Foliar, Ground
Spray, Seedling stage, Ground
Form
sen
sen
SC/L
SC/L
Minimum
Application Rate
na
na
na
na
Maximum
Application Rate
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Max.*
Apps.
not
spec
not
spec
not
spec
not
spec
Max. *
Apps.
a
Max.
Rate
not
spec
not
spec
not
spec
not
spec
Min. Interval
Between Apps.
@ Max. Rate
[Days)
As needed
As needed
As needed
As needed
Restricted
Entry
Interval
(Days)
not spec
not spec
not
spec
not spec
Geographic
Limitations
Allowed
Disallowed
Use Limitations
15 days
preharvest
interval.
15 days
preharvest
interval.
15 days
preharvest
Interval.
15 days
preharvest
Interval.
Nectarine Use Group: Terrestrial Food Crop
Broadcast, Foliar, Aircraft
Broadcast, Foliar, Ground
0
D
2.5 Ib Al per A
2,5 Ib Al per A
not spec
not spec
not
spec
not
spec
not
spec
not
spec
7
7
not spec
not spec
7 days
preharvest
interval.
7 days
preharvest
interval.
Onion Use Group: Terrestrial Food Crop
Low volume spray (concentrate). Foliar, Aircraft
Low volume spray (concentrate), Prebloom,
Aircraft
Low volume spray (concentrate). Foliar, Low
volume ground
Low volume spray (concentrate), Prebloom, Low
volume ground
SC/L
SC/L
SC/L
SC/L
na
na
na
na
.825 Ib Al per
A
,825 to Al per
A
.825 Ib Al per
A
.825 Ib Al per
A
2 per
Cycle
2 per
Cycte
2 per
Cycle
2 per
Cycle
not
spec
not
spec
not
spec
not
spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
Orchards (Unspecified) Use Group: Terrestrial Food Crop
14
-------
APPENDIX A- Case 4007, [Allium sativum] Chemical 128827 [Allium sativum]
SITE Application Type, Application Timing, Application
Equipment
Broadcast, Foliar, Aircraft
Broadcast, Foliar, Ground
Broadcast, Foliar, Shaker can
Spray, Foliar, Aircraft
Spray, Petal fall. Aircraft
Spray, Foliar, Ground
Spray, Petal fall, Ground
Form
D
D
D
SC/L
SC/L
SC/L
SC/L
Minimum
Application Rate
2.5 Ib Al per A
2.5 Ib Al per A
na
na
na
na
na
Maximum
Application Rate
not spec
not spec
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Max, #
Apps.
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
Max.*
Apps.
©
Max.
Rate
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
Win. Interval
Between Apps.
@ Max. Rate
(Days)
7
7
7
not spec
not spec
not spec
not spec
Restricted
Entry
Interval
(Days)
not spec
not spec
not spec
not spec
not spec
not spec
not spec
Geographic
Limitations
Allowed
Disallowed
Use Limitations
7 days
preharvest
interval.
7 days
preharvest
interval.
2 days
preharvest
Interval.
15 days
preharvest
interval.
15 days
preharvest
interval.
15 days
preharvest
interval.
15 days
preharvest
interval.
Orange Use Groups: Terrestrial Food Crop and Terrestrial Feed Crop
Spray, Foliar, Aircraft
Spray, Petal fall, Aircraft
Spray, Foliar, Ground
SC/L
SC/L
SC/L
na
na
na
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
7
7
7
not spec
not spec
not spec
15 days
preharvest
Interval.
15 days
preharvest
Interval.
15 days
preharvest
interval.
15
-------
APPENDIX A- Case 4007, [Allium sativum] Chemical 128827 [Allium sativum]
SITE Application Type, Application Timing, Application
Equipment
Spray, Petal fall. Ground
Low volume spray (concentrate), Foliar,
Aircraft
Low volume spray (concentrate), Foliar, Low
volume ground
Form
SC/L
SC/L
SC/L
Minimum
Application Rate
na
na
na
Maximum
Application Ran
Dose cannot
be calculated
,825 Ib Al per
A
.825 Ib Al per
A
Max.*
Apps.
not
spec
2 per
Cycle
2 per
Cycle
Max.*
Apps.
8
Max.
Rate
not
spec
not
spec
not
spec
Mia Interval
Between Apps.
@ Max. Rate
(Days)
7
not spec
not spec
Restricted
Entry
Interval
(Days)
not spec
not spec
not spec
Geographic
UmHatlons
Allowed
Disallowed
Use Limitations
15 days
preharvest
interval.
Peach Use Group; Terrestrial Food Crop
Broadcast, Foliar, Aircraft
Broadcast, Foliar, Ground
Low volume spray (concentrate). Foliar,
Aircraft
Low volume spray (concetrate), Foliar,
Low volume ground
Spray, Foliar, Aircraft
Spray, Petal fat. Aircraft
Spray, Foliar, Ground
Spray, Petal fall, Ground
0
D
SC/L
sen
SC/L
SC/L
SC/L
SC/L
2.5 Ib Al per A
2.5lbAlperA
na
na
na
na
na
na
not spec
not spec
£25 Ib Al per
A
,825 Ib Al per
A
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
not
spec
not
spec
2 per
Cycle
2 per
Cycle
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
7
7
not spec
not spec
7
7
7
7
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
7 days
preharvest
Interval
7 days
preharvest
interval.
15 days
preharvest
interval.
15 days
preharvest
Interval.
15 days
preharvest
interval.
15 days
preharvest
interval.
Pear Use Group: Terrestrial Food Crop
16
-------
APPENDIX A- Case 4007, [Allium sativum] Chemical 128827 [Allium sativum]
SITE Application Type, Applteatlon Timing, Application
equipment
Low volume spray (concentrate), Foliar,
Aircraft
Low volume spray (concentrate), Foliar, Low
volume ground
Form
sen
SC/L
Minimum
Application Rate
na
na
Maximum
Application Rate
.825 Ib Al per
A
.825 to Al per
A
Max.*
Apps.
2 per
Cycle
2 per
Cycle
Max.*
Apps.
@
Max.
Rate
not
spec
not
spec
Mln. Interval
Between Apps.
® Max. Rate
(Days)
not spec
not spec
Restricted
Entry
Interval
Pays)
not spec
not spec
Geographic
Urn ttations
Allowed
Disallowed
Use Limitations
Peas (Unspecified) Use Groups: Terrestrial Food Crop and Terrestrial Feed Crop
Low volume spray (concentrate), Foliar, Aircraft
Low volume spray (concentrate), Prebloom,
Aircraft
Low volume spray (concentrate), Foliar, Low
volume ground
Low volume spray (concentrate), Prebloom,
Low volume ground
SC/L
SC/L
SC/L
SC/L
na
na
na
na
,825 to Al per
A
,825 to Al per
A
.625 Ib Al per
A
.825 Ib Al per
A
2 per
Cycle
2 per
Cycle
2 per
Cycle
2 per
Cycle
not
spec
not
spec
not
spec
not
spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
Plum Use Group: Terrestrial Food Crop
Low volume spray (concentrate), Foliar, Aircraft
Broadcast, Foliar, Aircraft
Broadcast, Foliar, Ground
Low volume spray (concentrate), Foliar, Low
volume ground
Spray, Foliar, Aircraft
Spray, Petal fall, Aircraft
SC/L
D
D
SC/L
SC/L
SC/L
na
2,5 Ib Al per A
2,5 Ib At per A
na
na
na
.625 tb Al per
A
not spec
not spec
.825 Ib Al per
A
Dose cannot
be calculated
Dose cannot
be calculated
2 per
Cycle
not
spec
not
spec
2 per
Cycle
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not spec
7
7
not spec
7
7
not spec
not spec
not spec
not spec
not spec
not spec
7 days
preharvest
interval.
7 days
preharvest
interval.
15 days
preharvest
interval.
15 days
preharvest
interval.
17
-------
APPENDIX A- Case 4007, [Allium sativum] Chemical 128827 [Allium sativum]
SITE Application Type. Application Timing, Application
Equipment
Spray, Foliar, Ground
Spray, Petal (all, Ground
Form
SC/L
SC/L
Minimum
Application flate
na
na
Maximum
Application Rate
Dose cannot
be calculated
Dose cannot
be calculated
Max.*
Apps.
not
spec
not
spec
Max.*
Apps.
&
Max.
Rate
not
spec
not
spec
Potato, White/Irish Use Groups; Terrestrial Food Crop and Terrestrial Feed Crop
Low volume spray (concentrate). Polar, Aircraft
Low volume spray (concentrate), Prebloom,
Low volume ground
Low volume spray {concentrate). Foliar, Low
volume ground
Low volume spray (concentrate), Prebloom,
Aircraft
Pumpkin Use Group: Terrestrial Food Crop
Low volume spray (concentrate), Foiar, Aircraft
Low volume spray (concentrate), Prebloom,
Aircraft
Low volume spray (concentrate) .Foliar, Low
volume ground
Low volume spray (concentrate), Prebloom,
Low volume ground
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
na
na
na
na
na
na
na
na
J25 to Al per
A
.825 (fa Ai per
A
.825 to Al per
A
.825 to Al per
A
2 per
Cycle
2 per
Cycle
2 per
Cycle
2 per
Cycle
not
spec
not
spec
not
spec
not
spec
Mln, Interval
Between Apps.
@ Max. Rate
(Days)
7
7
not spec
not spec
not spec
not spec
Restricted
Entry
Interval
(Days)
not spec
not spec
Geographic
Limitations
AHowed
not spec
not spec
not spec
not spec
Disallowed
Use limitations
15 days
preharvest
Interval.
15 days
preharvest
Interval.
,825 Ib Al per
A
.825 tb Al per
A
.825 to Al per
A
.825 Ib Al per
A
2 per
Cycle
2 per
Cycle
2 per
Cycle
2 per
Cycle
not
spec
not
spec
not
spec
not
spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
Radish Use Group: Terrestrial Food Crop
Broadcast, Postemergence, Shaker can
Soil treatment. At planting, Shaker can
0
0
na
na
Dose cannot not
be calculated | spec
Dose cannot not
be calculated | spec
not
spec
not
spec
not spec
not spec
not spec
not spec
18
-------
APPENDIX A- Case 4007, [Allium sativum] Chemical 128827 [Allium satlvum]
SITE Application Type, Application Timing. Application
Equipment
Soil band treatment, At planting, Shaker can
Form
D
Minimum
Application Rate
na
Maximum
Application Rate
Dose cannot
be calculated
Max.*
Apps.
not
spec
Max.*
Apps.
©
Max.
Rate
not
spec
Mln. Interval
Between Apps.
@ Max. Rate
(Days)
not spec
Restricted
Entry
Interval
(Days)
not spec
Small Fruits Use Group: Terrestrial Food Crop
Broadcast, Foliar, Aircraft
Broadcast, Foliar, Ground
Spray, Foliar, Aircraft
Spray, Foliar, Ground
0
D
SC/L
SC/L
2.5 to Al per A
2.5 fc Al per A
na
na
not spec
not spec
Dose cannot
be calculated
Dose cannot
be calculated
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
7
7
7
7
not spec
not spec
not spec
not spec
Geographic
Limitations
Allowed
Disallowed
Use U rotations
7 days
preharvest
Interval.
7 days
preharvest
Interval.
15 days
preharvest
Interval.
15 days
preharvest
Interval.
Spinach Use Group: Terrestrial Food Crop
High volume spray (dilute), Foliar, Ground
Spray, Foliar, Aircraft
Spray, Seedling stage, Aircraft
Spray, Seedling stage, Ground
SC/L
SC/L
SC/L
SC/L
na
na
na
na
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
not
spec
not
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
As needed
As needed
As needed
As needed
not spec
not spec
not spec
not spec
15 days
preharvest
interval.
15 days
preharvest
Interval.
15 days
preharvest
interval.
15 days
preharvest
interval.
Sunflower Use Groups: Terrestrial Food Crop and Terrestrial Feed Crop
19
-------
APPENDIX A- Case 4007, [Allium sativum] Chemical 128827 [AMium sativum]
SITE Application Type, Application Timing, Application
Equipment
Band treatment, At planting. Mechanical
granule applicator
Broadcast, Foliar, Aircraft
Broadcast, Seedling stage, Aircraft
Broadcast, Foliar, Ground
Broadcast, Seedling stage, Ground
Form
D
D
D
D
D
Minimum
Application Rate
1 to Al per A
1.5lbAlperA
1.5lbAlperA
1 .5 Ib Al per A
UtbAiperA
Maximum
Application Rate
not spec
not spec
not spec
not spec
not spec
Max.*
Apps.
not
spec
not
spec
not
spec
not
spec
not
spec
Max.*
Apps.
©
Max.
Rate
not
spec
not
spec
not
spec
not
spec
not
spec
Mln. Interval
Between Apps.
@ Max, Rat*
(Days)
not spec
7
r
7
7
Restricted
Entry
Interval
(Days)
not spec
not spec
not spec
not spec
not spec
Geographic
Limitations
Allowed
Disallowed
Use Limitations
7 days
preharvest
interval.
7 days
preharvest
interval.
7 days
preharvest
interval.
/days
preharvest
interval.
Tomato Use Groups: Terrestrial Food Crop and Terrestrial Feed Crop
Broadcast. At planting, Mechanical granule
applicator
Broadcast, Foliar, Aircraft
Broadcast, Seedling stage. Aircraft
Broadcast, Seedling stage, Ground
Broadcast, Postemergence, Shaker can
High volume spray (dilute). Foliar, Ground
D
D
D
D
D
SC/L
1,5lbAlperA
LSIbAlperA
UlbAlperA
1.5lbAlperA
na
na
not spec
not spec
not spec
not spec
Dose cannot
be calculated
Dose cannot
be calculated
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
7
7
7
7
not spec
As needed
not spec
not spec
not spec
not spec
not spec
not spec
7 days
preharvest
interval.
7 days
preharvest
interval.
7 days
preharvest
interval.
7 days
preharvest
interval.
15 days
preharvest
Interval.
20
-------
APPENDIX A- Case 4007, [AHium sativum] Chemical 12882? [Allium sativum]
SITE Application Type, Application Timing, Application
Equipment
Soil band treatment, At planting, Shaker can
Soil treatment, At planting, Shaker can
Spray, Foliar, Aircraft
Spray, Seedling stage. Aircraft
Spray, Seedling stage. Ground
Form
0
D
SC/L
SC/L
SC/L
Minimum
Application Rate
na
na
na
na
na
Maximum
Application Rate
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Max.*
Apps,
not
spec
not
spec
not
spec
not
spec
not
spec
Max. *
Apps.
©
Max.
Rate
not
spec
not
spec
not
spec
not
spec
not
spec
Mln. Interval
Between Apps.
@ Max Rate
(Days)
not spec
not spec
As needed
As needed
As needed
Restricted
Entry
interval
(Days)
not spec
not spec
not spec
not spec
not spec
Geographic
limitations
Allowed
Disallowed
Use Limitations
IS days
preharvest
interval.
15 days
pretiarvest
interval.
15 days
preharvest
interval.
Tree Nuts Use Group: Terrestrial Food Crop
Broadcast, Foliar, Aircraft
Broadcast, Foliar, Ground
D
D
Vegetables (Unspecified) Use Group: Terrestrial Food Crop
Band treatment, At planting, Mechanical granule
applicator
Broadcast, Foliar, Aircraft
Broadcast, Seedling stage, Aircraft
Broadcast, Foliar, Ground
D
D
D
D
2.5 Ib A) per A
2.5 Ib Al per A
not spec
not spec
1 Ib Al per A
UlbAlperA
1.5lbA!perA
1.5lbAlperA
not spec
not spec
not spec
not spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
7
7
not spec
not spec
not spec
7
7
7
not spec
not spec
not spec
not spec
7 days
preharvest
interval.
7 days
preharvest
Interval.
7 days
preharvest
interval.
7 days
preharvest
interval.
7 days
preharvest
interval.
21
-------
APPENDIX A- Case 4007, [Allium sativum] Chemical 128827 [Allium sativum]
SITE Application Type, Application Timing, Application
Equipment
Broadcast, Seeding stage, Ground
Broadcast, Post emergence, Shaker can
High volume spray (dilute), Foliar, Ground
Soil band treatment, At planting, Shaker can
Soil treatment, At planting. Shaker can
Spray, Foliar, Aircraft
Spray, Seedling stage, Aircraft
Spray, Seedling stage, Ground
Foftr*
D
D
SC/L
D
D
SC/L
SC/L
SC/L
Minimum
Application Rate
1 .5 Ib Al per A
na
na
na
na
na
na
na
Maximum
Application Rate
not spec
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Max.*
Apps.
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
Max.*
Apps.
©
Max.
Rate
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
Mln, Interval
Between Apps.
6 Max. Rate
(Days)
7
not spec
As needed
not spec
not spec
As needed
As needed
As needed
Restricted
Entry
Interval
(Days)
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
Geographic
Limitations
Allowed
Disavowed
Use Limitations
7 days
preharvest
interval.
15 days
preharvest
interval.
15 days
preharvest
interval.
15 days
preharvest
Interval.
15 days
preharvest
interval.
Walnut (English/Black) Use Group: Terrestrial Food Crop
Low volume spray (concentrate). Foliar, Aircraft
Low volume spray (concentrate), Foliar, Low
volume ground
SC/L
SC/L
na
na
.825 to Al per
A
.825 Ib Al per
A
2 per
Cycle
2 per
Cycle
not
spec
not
spec
not spec
not spec
not spec
not spec
NONFOOD/NONFEED USES
Ornamental Herbaceous Plants Use Groups; Terrestrial Non-Food Crop and Outdoor Residential
Spray, Foliar, Aircraft
SC/L
na
Dose cannot [I not
be calculated || spec
not
spec
As needed
not spec
22
-------
APPENDIX A- Case 4007, [Allium sativum] Chemical 12882? [Allium satlvum]
SITE Application Type. Application Timing, Application
Equipment
Spray, Foliar, Ground
Form
SC/L
Minimum
Application Rate
na
Maximum
Application Rate
Dose cannot
be calculated
Max.*
Apps.
not
spec
Ma*,*
Apps.
@
Max.
Rate
not
spec
Mln. Interval
Between Apps.
@ Max. Rate
(Days)
As needed
Restricted
Entry
Interval
(Days)
not spec
Gtographlc
Limitations
Allowed
Disallowed
Use Limitations
Ornamental Woody Shrubs and Vfaes Use Groups: Terrestrial Non-Food Crop and Outdoor Residential
Spray, Foliar, Aircraft
Spray, Foliar, Ground
SC/L
SC/L
na
na
Dose cannot not
be calculated || spec
Dose cannot | not
be calculated || spec
not
spec
not
spec
As needed
As needed
not spec
not spec
Abbreviations used
Header: max=max!mum; m!n=minlmutTi; apps=app!ications; not spee^ot specified; na=not applicable
Form: D=dust; SC/L=soluble coneentratefliquid
Rate: ai=active ingredient; A=acre
-------
i
APPENDIX B
Generic Data Requirements for Reregistration
of Allium Sativum (Garlic) and Data Citations
Supporting Reregistration
34
-------
^^^w
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which
support the reregistration for the pesticide covered by this
Reregistration Eligibility Document.
Appendix B contains generic data requirements that apply to
the pesticide in all products, including data requirements for
which a "typical formulation" is the test substance.
The data table are generally organized according to the
following format:
1. Data Requirements (Column 1). The data requirements
are listed in the order in which they appear in 40 CFR Part 158.
The reference numbers accompanying each test refer to the test
protocols set out in the Pesticide Assessment Guidelines, which
are available from the National Technical Information Service,
5285 Port Royal Road, Springfield, VA 22161.
2. Use Pattern (Column 2). This column indicates the use
patterns to which the data requirement applies. The following
letter designations are used for use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
K Residential
Any other designations will be defined in a footnote to the
table.
3, Bibliographic citation (Column 3). If the Agency has
acceptable data in its files, this column lists the identifying
number of each study. This normally is the Master Record
Identification (MRID) number, but may be a GS number if no MRID
number has been assigned. Refer to the Bibliography Appendices
for a complete citation of the study.
35
-------
APPENDIX B
GENERIC DATA REQUIREMENTS FOR REREGISTRATION OF ALLIUM SATIVPM
AND DATA CITATIONS SUPPORTING REREGISTRATION
GUIDELINE
CITATION
TITLE OF
STUDY
USE
PATTERNS
BIBLIOGRAPHIC
CITATION
Product Chemistry
61-1
61-2 (a)
61-2 (b)
62-1
62-3
63-2
63-3
63-4
63-5
63-7
63-8
Product Identity
Begin. Mat. and Mfg. Process
Discussion of Impurities
Preliminary Analysis
Analytical Method
Color
Physical State
Odor
Melting Point
Density
Solubility
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
ABCK
470028026
satisfied
satisfied
satisfied
satisfied
satisfied
satisfied
satisfied
satisfied
satisfied
satisfied
36
-------
63-10 Dissociation Constant ABCK satisfied
63-12 pH ABCK satisfied
63-13 Stability ABCK satisfied
Ecological Effects;
EPA waived all of these guidelines as discussed in sections III and IV.
Toxicology:
EPA waived all of these guidelines as discussed in sections III and IV.
Environmental Fate;
EPA waived all of these guidelines as discussed in section III and IV.
Residue Chemistry;
EPA waived all of these guidelines as discussed in section III and IV.
Occupational Exposure;
EPA waived all of these guidelines as discussed in section III and IV.
37
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APPENDIX C
SATIVUM (GARLIC)
Citations Considered to be Part of the
Data Base Supporting Reregistration
38
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GUIDE TO APPENDIX C
CONTENT 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, will be included.
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
larger volumes in which they were submitted. The resulting "studies11 generally have
a distinct title (or at least a single subject), can stand alone for purposes of
review, and can be described with a conventional bibliographic citation. The Agency
has attempted also to unite basic documents and commentaries upon them, treating
them as a single study.
IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically
by Master Record Identifier, or MRID number. This number is unique to the citation,
and should be used at any time specific reference is required. It is not related to
the six-digit "Accession Number" which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for further explanation. In a few cases,
entries added to the bibliography late in the review may be preceded by a nine-
character temporary identifier. These entries are listed after all MRID entries.
This temporary identifier number is also to be used whenever specific reference is
needed.
FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
39
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a. Author. Whenever the Agency could confidently identify one, the Agency has
chosen to show a personal author. When no individual was identified, the Agency
has shown an identifiable laboratory or testing facility as author. As a last
resort, the Agency has shown the first submitter as author.
b. Document date. When the date appears as four digits with no question marks, the
Agency took it directly from the document. When a four-digit date is followed
by a question mark the bibliographer deduced the date from evidence in the
document. When the date appears as (19??), the Agency was unable to determine
or estimate the date of the document.
c. Title. In some cases, it has been necessary for Agency
bibliographers to create or enhance a document title. Any such editorial
insertions are contained between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the
trailing parentheses include (in addition to any self-explanatory text) the
following elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element, immediately following the word
"under," is the registration number, experimental use permit number,
petition number, or other administrative number associated with the
earliest known submission.
(3) Submitter. The third element is the submitter, following the phrase
"submitted by." When authorship is defaulted to the submitter, this
element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume in
which the original submission of the study appears. The six-digit
accession number follows the symbol "CDL," standing for "Company Data
Library." This accession number is in turn followed by an alphabetic
suffix which shows the relative position of the study within the volume.
40
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For example, within accession number 123456, the first study would be
123456-A; the second, 123456-B; the 26th, 123456-Z; and the 27th, 123456-
AA.
41
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OFFICE OF PESTICIDE PROGRAMS
REREGISTRATION ELIGIBILITY DOCUMENT
BIBLIOGRAPHY
470028026 Supplementary To The List Of Data Requirements. Unpublished study submitted by Sevana
Company.
42
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I
APPENDIX D
PR NOTICE 91-2
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UNfTID STATES ENVIRONMENTAL PflOTECTlON AGENCY
WASHWOTON.D.C. IMM
MAY 2
SUUTANCfS
NOTICE TO MANUFACTURERS, PRODUCERS, FORMULATORS ,
AND REGISTRANTS OF PESTICIDES
ATTENTION: Persons Responsible for Federal Registration of
Pesticide Products.
SUBJBCTt 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 40 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 CPU 156.10(g) (5). .The certified
limits required for each active ingredient are intended to
encompass any such "good manufacturing practice11 variations 40 CFR
158.175(0}(3).
d& Print*} on fiKycto
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i
IV. WfcODUCTl THXT UQOZll EfflCACf DATA
All pesticides ara required to be efficacious. Therefore,
the certified lower limits may net be lower then the minimum
level to achieve affleecy. This is extremely important for
products which ere Intended to control peets which threaten the
public health, 0.9., certain Antimicrobial and rodentieide
products. Refer to 40 CFR 1SI.€40.
In thosa casas vhara afficacy limits hava baan astablishad,
tha Afancy will not aceapt cartifiad lovar limits which ara balov
that laval for tha sbalf lifa of tha product,
V. COKPLIAHCZ tCHIDCIX
As dascribad aarliar, tha purposa of this Notica is to maka
tha ragistration procaas mora uniform and mora manafaabla for
both tha aganey and tha ra^ulatad community. It is tha Afaney'a
intantion to implamant tha raquiramants of this notica as
smoothly as poasibla so as net to disrupt or dalay tha Afancy *s
high priority programs, i.a., raragiatratlonf naw chamical, or
fast track (FZFKA aaction 3(c)(3)(B). Tharafora,
applicants/ragistrants ara axpactad to comply with tha
raquiraHants of this Notica as fellowss
(1) Beginning July 1, 1991, all nav product
ragistrations submittad to tha Afancy
ara to comply with tha raquirtianta of thi*
Notiea.
(2) Kagistrants having products subjact to
raragistmtion undar FIFRA aaction 4 (a) ara to
. comply with tha raquiramants of tills Notiea whan
spaeif ie products ara called in by tha Agency
under Phaaa V of tha Haragiatration Program.
(3) All other products/applications that are
not subject to (1) and (2) above will nave until
July 1* 1997, to comply vita this Notice.
Such applications should note "Conversion
to Nominal Concentration" en the application
fora. These types of amendments will not be
bandied as "fast Track0 applications but
will be bandied as routine requests.
VI. fOX fDWHDT XNTOJWATION
Contact Tyrone Aikan for information or questions concerning
this notice on (703) 337-5024.
Anno 1. Lindsay, Director
Ragiatration Division (H-7305
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APPENDIX 1
DATA CALL-IN
Product Specific data call-in and attachments
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I
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WAKWOTON.D.C. 10460
DATA CALL-IN NOTICE
«mCJD« AND TOXIC
•UWWNOES
Dear Sir or Madam;
This Notice requires you and other registrant* of pesticide
products containing the active ingredient identified in
Attachment A of this Notice, the Data Call-in Chemical Status
sheet. to submit certain product specific data as noted herein to
the U.S. Environmental Protection Agency (EPA, the Agency).
These data are necessary to maintain the continued registration
of your product(s) containing this active ingredient. Within 90
days after you receive this Notice you must respond as set forth
in Section III below. Your response Bust 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 C,
Requirements Status and Registrant's Response Form, (see
section III-B); or
3. Why you believe EPA should not require your submission
of product specific data in the manner specified by this
Notice (see section III-D).
If you do not respond to this Notice, or if you do not
satisfy EPA that you will comply with its requirements or should
be exempt or excused from doing so, then the registration of your
product(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 B, aata Call-In Responee Form, mm well as a
list of all registrants who were sent this Notice (Attachment F).
The authority for this Notice is section 3(c)(2)(B) of the
Federal Insecticide, Fungicide and Rodenticide Act as amended
(FIFRA), 7 U.S.C. section 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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i
This Notice is divided into mix sections and seven
Attachments. The Notic* itself contain* information and
instructions applicable to all Data Call-In Notices. The
Attachments contain specific chemical information and
instructions. Toe six sections of the Notice are:
Section Z - Why You Are Receiving This Notice
Section ZI - Data Required By This Notice
Section ZZZ - 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:
A — Data Call— In Che^m^ea.! _ States ........... Sfreet
B - Da^a,, ..... Cqll-In Response form "* . .
C - Requirements Status and Registrant's Response Fora
D - EPA Grouping of End-Use Products for Meeting Acute
Toxicology Data Regu^j emenljs for Rerepistration
E -* EPA Acceptance Criteria
F — List of Registrants Receiving This Notice
G *• Cost Share and Data Compensation Forms . and Product
Specific Data Report Form
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
. The Agency has reviewed existing data for this active
ingredient and reevaluated the data needed to support continued
registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product
specific data. No additional generic data requirements are being
imposed. You have been sent this Notice because you have '
product(s) containing the subject active ingredient.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The product specific data required by this Notice are
specified in Attachment C, Requirements Status and Registrant's
Response Form. Depending on the results of the studies required in
this Notice, additional testing aay be required.
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II-B. pCH^PPfiB FPfi SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the
data requirements specified in Attachment C, Requirements statue
and Registrant's Response Fora. within the timeframes provided.
II-C. TESTTNG PROTOCOL
., Ml studies required under this notice mist 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 S 158.70). When
using the OECD protocols, they should be modified as appropriate wo
that the data generated by the study vill satisfy the requirements
of 40 CFR f 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)3.
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3fcif21fBl NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, thisData Call-in doesnotin
any way supersede or change the requirements of any previous Data
Call-lnfsl. or any other agreements entered into with the Agency
pertaining to such prior Notice, Registrants must comply with the
requirements of all Notices to avoid issuance of a Notice of Intent
to Suspend their affected products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OP THIS NOTICE.
III-A. ffCHBEPLB FOB IESPONOING TO THE AGENCY
The appropriate responses initially required by this Notice
for product specific data oust be submitted to the Agency within 90
days after your receipt of this Notice. Failure to adequately
respond to this Notice within 90 days of your receipt will be a
basis for issuing a Notice of Intent to Suspend (NOIS) affecting
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i
your products* This and other bases for issuance of NOXS due to
failure to comply with this Notice are presented in Section ZV-A
and ZVHB.
ZII-B. fMPTIOKS FOR RESPONDING TO TOE fcCgNCY
The options for responding to this notice for product specific
data are: (a) voluntary cancellation, (b) agree to satisfy the
product specific data requirement* imposed by this Notice or (c)
request a data waiver (s). ...
A discussion of how to respond if you choose the Voluntary
Cancellation option is presented below. A discussion of the
various options available for satisfying the product specific data
requirements of this Notice is contained in Section III-C. A
discussion of options relating to requests for data waivers is
contained in Section III-D.
There are two fonts that accompany this Notice of which,
depending upon your response, one or both Bust be used in your
response to the Agency. These forms are the Data-Call-in Response
Fora, and the Requirements Status and Registrant'sResponse Form.
Attachment B ar.*i Attachment C. The Data Sail-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 Fora must be submitted for each product listed on the
Da^a Call-inResponse Form unless the voluntary cancellation option
is selected or unless the product is identical to another (refer to
the instructions for completing the Data Call-In Response Form in
Attachment B}. Please note that the company' s authorized
representative is required to sign the first page of the pat a Call-
in ResponseForm and Requirements Status and Registrant's Response
yona (if this form is required) and initial any subsequent pages.
The forms contain separate detailed instructions on the response
options. Do not alter the printed material, if you have questions
or need assistance in preparing your response, call or write the
contact person (s) identified in Attachment A.
1.'Voluntary Cancellation - You may avoid the requirements of
this Notice by requesting voluntary cancellation of your product(s)
containing the active ingredient that is the subject of this
Notice. Zf you wish to voluntarily cancel your product, you must
submit a completed Data Call-In ResponseForm, indicating your
election of this option. Voluntary cancellation is item number 5
on the gata Call-In Response Form. Zf you choose this option, this
is the only form that you are required to complete.
Zf you choose to voluntarily cancel your product, further sale
and distribution of your product after the effective date of
cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section iv-c.
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2. Satisfying the Product: Specific Data Requirements of this
notice. There ara various options available to satisfy the product
•pacific data requirements of this Notica. Tbasa options ara
diseussad in Saction III-C of this Notica and comprise options l
through 6 on tha Raauirajifnfrf Status and Registrant's Response Form
and item numbers 7a and 7b on tha Data call-in Ra§pon«* Form.
Dalation of a use(s) and tha low volume/minor use option ara not
valid options for fulfilling product spacific data raquiraments.
3. Request for Product Specific Data Waivers. Waivars for
product specific data ara diseussad in Saction III-D of this notice
and ara covarad by option 7 on tha BtMlrtBants status and
Registrant's Response Fora. If you choose this option, you Bust
submit both forms as vail as any other inforaation/data pertaining
to. tha option chosen to address tha data raquireaent.
III-C SATJtSFVINS TOE DATA REQUIREMENTS OF THIS HQflCE
If you acknowledge on tha Data Call-In Response Fora that you
agree to satisfy tha product apecific data requirements (i.e. you
select option 7a or 7b), than you aust select one of tha six
options on tha Requirements Status and Registrant*s Response Form
related to data production for each data requirement. Your option
selection should be entered under itaa number 9, "Registrant
Response." The six options related to data production ara the
first six options discussed under itaa 9 in tha instructions for
completing the Requirements status and Registrant'sResponse Form.
These six options ara listed immediately below with information in
parentheses to guide registrants to additional instructions :
provided in this Saction. Tha options ara:
(X-) I will generate and submit data within tha specified
timeframe (Developing Data)
(2) I have entered into an agreement with ona or aore
registrants to develop data jointly (Cost Sharing)
(3) I have aada offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been
submitted previously to tha 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)
(€) I am citing an existing study that EPA has classified as
acceptable or an existing study that has been submitted
but not reviewed by tha Agency (Citing an Existing Study)
Option 1. Developing Pata — If you choose to develop tha
required data it aust be in conformance with Agency deadlines and
with other Agency requirements as rafarancad herein and in tha
attachments. All data generated and submitted aust comply with the
Good Laboratory Practice (GLP) rule (40 CFR Part 160), be conducted
according to tha Pesticide Assessment Guidelines (PAG), and be in
conformance with tha requirements of PR Notice 86-5.
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The time trames in the Requirements Status a,n.d 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).
Zf you cannot submit the data/reports to the Agency in the time
required by this Notice and intend to seek additional tine to meet
the requirement* (»), you must submit a request to the Agency which
includes: (i) 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 vill
respond to your request in writing. Zf EPA does not grant your
request, the original deadline remains. Normally, extensions can
be requested only in eases 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 i in no event shall an extension request be considered if it
is submitted at or after the lapse of the subject deadline.
Option 2. Acnree to Share in Cost to Develop Data --Registrants
nay JBUlX 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. Zf this is the case,
data may be generated for just one of the products in the group.
The registration pmifter of the product for which data will be
submitted pust be noted in the agreement to cost share by the
registrant selecting this option. Zf 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. Zf you have made an offer to
pay in an attempt to enter into an agreement or amend an existing
agreement to meet the requirements of this Notice and have been
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unsuccessful, you may request SPA (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 vill not suspend the registration
of a product of a registrant who has in good faith sought and
continues to seek to enter into a joint data development/cost
sharing program, but the other registrant's) developing the data
has refused to accept your offer. To qualify for this option, you
must' submit documentation to the Agency proving that you have made
an offer to another registrant (who has an obligation to submit
data) to share in the burden of developing that data. You must
also submit to the Agency a completed EPA Form 8570-32,
Certification of Offer to Cost Share in the Development of Data,
Attachment 6. In addition, you must demonstrate that the other
registrant to whom the offer was made has not accepted your offer
to enter into a costsharing agreement by including a copy of your
offer -and proof of the other registrant's receipt of that ofi*r
(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
bidding arbitration as provided by FIFRA section 3 (c) (2) (B) (iii)
ana must not qualify this offer. The other registrant must also
inform EPA of its election of an option to develop and submit the
data required by this Notice by submitting a Data Call -In Response
form and a Requirements Status and Registrant's Response Form
committing to develop and submit the data required by this Notice.
t ' '" *'
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. SybjBllttinff 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.
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I
8
To meet the requirements of the DCI Notice for submitting an
existing study, all of the tollowiny three criteria must be clearly
*
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 clone in accordance with
the requirements of the Good Laboratory Practice (CLP)
regulation, 40 CFR Part 160. As stated in 40 CFR 160.3(j)
* '[r]aw data* Miens 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. Zn 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 o~ exact transcript Bay 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*1, according to 40
CFR 160.3(k), means "any material derived from a test system
for examination or analysis.1*
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 FIFRA Accelerated Reregistration Phase 3 Technical Guidance
and that the study has been conducted according to the
Pesticide Assessment Guidelines (PAG) or meets the purpose of
the PAG (both available from NTIS). A study not conducted
according to the PAG may be submitted to the Agency for
consideration if the registrant believes that the study clearly
meets the purpose of the PAG. The registrant is referred to 40
CFR 158.70 which states the Agency's policy regarding
acceptable protocols. If you wish to submit the study, you
must, in addition to certifying that the purposes of the PAG
are met by the study, clearly articulate the rationale why you
believe the study meets the purpose of the PAG, including
copies of any supporting information or data. Zt 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 you know of a study partaining to any requirement In this
notice which does not meet tha criteria outlinad above but doas
contain factual information ragarding unraasonabla advarsa affacts,
you vust notify tha Agency of such a study. If such study is in
tha Agancy'• filas, you naad only cita it along with tha
notification. If not in tha Agancy'a filas, you Bust submit a
summary and copias as required by PR Notica 86-5.
v
Option S, Upgrading m. study — If a study has baan classifiad
as partially accaptabla and upgradeable, you may submit data to
upgrada that study. Tha Agancy will raviaw tha data submittad and
determine if tha requirement is satisfiad. If tha Agancy dacidas
the requirement is not satisfiad, you may still be raguirad to
submit naw data normally without any tima extension. Deficient,
but upgradaable studias will normally ba clasjified as
supplamantal. However, it is important to nota that not all
studias classifiad as supplamantal ara upgradaabla. If you have
questions ragarding tha classification of a study or whathar a
tudy may ba upgraded, call or write tha contact parson listed in
Attachment A* If you submit data to upgrada 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 bean remedied or
corrected and why the study should ba rated as acceptable to IPA.
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.
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 KRID 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 ExistingStudies — 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
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10
toxicology studies generally vill 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 vlsb to select this option you wist 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.
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 Requirementsstatus and
Registrant's Response Form, as appropriate.
III-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 onlv opportunity to
state the reasons or provide information in support of your
request. Zf the Agency approves your waiver request, you will not
be required to supply the data pursuant to section 3(c)(2)(B) of
FIFRA. Zf the Agency denies your waiver request, you must choose
an option for meeting the data requirements of this Notice within
30 days of the receipt of the Agency's decision. You must indicate
and submit the option chosen on the Requirements status and
Registrant*s Response Form. Product specific data requirements for
product chemistry, acute toxicity and efficacy (where appropriate)
are required for all products and the Agency will grant a waiver
only under extraordinary circumstances. You should also be aware
that submitting a waiver request will not automatically extend the
due date for the study in question. Waiver requests submitted
without adequate supporting rationale will be denied and the
original due date will remain in force.
IV* CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
TV-A NOTICE OP INTENT TO StTSPlND
The Agency say 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
FIFRA section 3(c) (2) (B). Events which may be the basis for
issuance of a Notice of Intent to Suspend include, but are not
limited to, the following:
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I
11
1. Failure to respond mm required by this Notice within 90
day* of your receipt of this Notice.
2. Failure to submit on the required schedule en acceptable
proposed or final protocol if such is required to be submitted
to the Agency for review.
3. Failure to submit on the required, schedule an adequate
progress report on a study if required by this Notice.
4. Failure to submit on the required schedule acceptable
data as required by this Notice.
S. 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 Ili-c
of this Notice.
7. Withdrawal of an offer to share in the cost of developing
required data.
8. Failure of the registrant to whom, you have tendered an offer
to share in the cost of developing data and provided proof of
the registrant's receipt of such offer either to:
a. Inform EPA of intent to develop and submit the data
required by this Notice on a Data Call-In Response Form and a
Requirements Status and Registrant's Response Form;
b. Fulfill the commitment to develop and submit the data as
required by this Notice; or
c. Otherwise take appropriate steps to meet the requirements
stated in this Notice, unless you commit to submit and do
submit the required data in the specified time frame.
9. Failure to take any required or appropriate steps, not
mentioned above, at any time following the issuance of this
Notice. :
XV— B. BASIS FOR DETERMINATION THAfy SUBMITTED STUDY IS
The Agency may determine that a study (avan if submitted within
the required time) is unacceptable and constitutes a basis for
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i
12
issuance of a Notice of Intent to suspend. The grounds for
suspension include, but are not limited to, failure to meet any of
the following:
1. EPA requirement* specified in the Data Call-In notice or
other documents incorporated toy reference (including, as
applicable, EPA Pesticide Assessment Guidelines, Data Reporting
Guidelines, and GeneTox Health Effects Test Guidelines)
regarding the design, conduct, and reporting of required
studies. Such requirements include, but are not limited to,
' those relating to test material, test procedures, selection of
species, number of animals, sex and distribution of animals,
dose and effect levels to be tested or attained, duration of
test, and,-as applicable. Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols (if
applicable), including the incorporation of any changes
required by the Agency following review.
3. EPA requirements regarding the reporting of data, including
the manner of reporting, the completeness of results, and the
adequacy of any required supporting (or raw) data, including,
but not limited to, requirements referenced or included in this
Notice or contained in PR 86-5. All studies must be submitted
in the form of a final reporti a preliminary report will not be
considered to fulfill the submission requirement.
JV-C EXISTING STOCKS OF SUSPENDED OR CAJFgSIiIfFp 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
quantity of existing stocks and your estimate of the time required
for their sale, distribution, and use. Unless you meet this burden
the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after
suspension.
If you request a-voluntary cancellation of your product(s) as a
response to this Notice and your product is in full compliance with
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13
all Agency requirements, you vill have, under most circumstances,
on« year from the date .your 90 day response to this Notice is .due,
to Mil, distribute, or use existing stocks. Normally, the Agency
vill allow persons other than the registrant such a» 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 vill be determined on a case-by-case basis.
. Requests for voluntary cancellation received Af&lE the 90 day
response period required by .this notice vill not result in the
Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was
due unless you demonstrate to the Agency that you are in full
compliance with all Agency requirements, Including the requirements
of this Notice. For example, if you decide to voluntarily cancel
your registration six months before a 3 year study is scheduled to
be submitted, all progress reports and other information necessary
to establish that you have been conducting the study in an
acceptable and good faith manner must have been submitted to the
Agency, before EPA vill consider granting an existing stocks
provision.
SECTION V. REGISTRANTS* OBLIGATION TO REPORT
ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6 (a) (2) states that
if at any time after a pesticide is registered a registrant has
additional factual information regarding unreasonable adverse
effects on the environment by the pesticide, the registrant shall
submit the Information to the Agency. Registrants must notify the
Agency of any factual information they have, from whatever source,
including but not limited to interim or preliminary results of
studies, regarding unreasonable adverse effects on man or the
environment. This requirement continues as long as the products
are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and
procedures established by this Notice, call the contact person (s)
listed in Attachment A, the Data Call-In Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation
requests) must Include a completed Data Call -In Response Form and a
completed Requirements Status apd Registrant's Response Form
(Attachment B and Attachment C) and any other documents required by
this Notice, and should be submitted to the contact person (s)
identified in Attachment A. If the voluntary cancellation option is
chosen, only the Pata Call-in Respqnse Form need be submitted.
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14
The Offie* 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.
*
B
C
£
F
6
Daniel N. Barolo, Director
. • Special Review and
Reregistration Division
Attachments
Data Call-In Chemical Status Sheet
Data Call-InResponse Form
Requirements Status and Feqriytrant * s Response Form
EPA Grouping of End-Use Products for Meeting Acute
Toxicology Data Requirements for Reregistration
1PA Acceptance Criteria
List of Registrants Receiving This Notice
Cost Share and Data Compensation Forms, and Product
Specific Data Report Form
-------
ATTACHMENT A
DATA CALL-IN CHEMICAL STATUS SHEET
-------
ATTACHMENT A
ALLIUM SATIVTJM; DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Data Call-in Notice because you have
products containing Allium sativuiiu
This attachment, the Data Call-in Chemical Status Sheet.
contains a point of contact for inquiries. This attachment is to
be used in conjunction with (1) the Data Call-in Notice. (2)
Attachment B, the Data Call-in Response Form. (3) Attachment C, the
Requirement Status andRegistrant's Response Form for product
specific data, (4) Attachment D, EPA Grouping of End-Use Products
for Meeting Acute Toxicology Data Requirements for Rereqistration,
(5) Attachment E, EPA Acceptance Criteria, (6) Attachment F, List
of All Registrantfs) sent this Data Call-in Notice, and (7)
Attachment G, the Cost Share and Data Compensation Forms for
product specific data, and Product Specific Data Report Form for
use in replying to this All JUKI sativum Data Call-in. Instructions
and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the
database for Allium sativuro are listed in the Requirements Status
and Registrant's Response Form. Attachment C.
The Agency has concluded that product specific data are needed
for Allium sativum. The required additional data are listed in
Attachment C.
Depending on the results of the studies required in this
Notice, additional testing may be required.
INQUIRES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the product specific data
requirements and procedures established by this Notice, please
contact Rob Forrest at (703) 305-6600. All responses to this
Notice should be submitted to:
Document Processing Desk (RED/RD/PM-14)
Office of Pesticide Programs
U.S. Environmental Protection Agency
401 M Street S.W.
Washington, D.C. 20460
RE: Allium sativum
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If you- have any questions regarding the generic data
requirements and procedures established by this Notice, please
contact Margarita Collantes at (703) 308-8583. All responses to
this Notice should be submitted to:
Chemical Review Manager Margarita Collantes
Accelerated Reregistration Branch (H7508W)
Special Review and Reregistration Division
Office of Pesticide Programs
U.S. Environmental Protection Agency
401 M Street S.W.
Washington, D.C. 20460
RE: Allium sativum
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I
ATTACHMENT B
PRODUCT SPECIFIC DATA vALL-IN RESPONSE FORM
-------
i
§ „ «.
SPECIFIC INSTRUCTIONS FOR COMPLETING
TUB DATA CALL-IN RESPONSE FORM
product gpeeif-fe Pat*
This font is designed to be need 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 font each time you are
responding to a data call-in for which EPA has sent you the fora
entitled "Requirements Status and Registrant's Response.*1
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 IS 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.
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f
INSTRUCTIONS FOR COMPUTING 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 will 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 fora 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*1 to Item 7a (MP)
or 7b (EP) on this form, provide the EPA registration
numbers of your source(s) and complete and submit the
"Generic Data Exemption*1 form; 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 (HP) for which you
wish to maintain registration, you must agree to.
satisfy the data requirements by-responding "yes."
Item ?b. For each end use product (EP) 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.
H22SS 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
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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DRAFT COPY
Page 1 of
United States Environmental Protection Agency Form Approved
Washington, D. C. 20460 OHB NO. 2070-0107
DATA CALL-IN RESPONSE
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary, • '
1. Company name and Address 2. Case # and Name 3, Date and Type of BC1
SAMPLE COMPANY 4007 Alliuni sativum PRODUCT SPECIFIC
MO STREET ADDRESS
NO CITY, XX 00000
4. EPA Product
Registration
6 2998- 1
5. I wish to
cancel this
product regis-
tration volun-
tarily.
6. Generic Data
6a. 1 am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
N.A.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
N.A.
7. Product Specific Data
7a. My product is a HUP and
I agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the. attached
form entitled "Requirements
Status and Registrant's
Response,"
8. Certification 9. Date
I certify that the statements made on this form and all attachments are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable lay.
* i ' • ' i
Signature and Title of Company's Authorized Representative
10. Name of Company Contact 11. Phone Number
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DRAFT COPY
Page 1 of
United States Environmental Protection Agency
Washington, D. C. 20460
DATA CALL-IN RESPONSE
Form Approved
OMB No. 2070-0107
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1, Company name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case # and Name
4007 Allium sativum
3. Date and Type of DCI
PRODUCT SPECIFIC
4. EPA Product
Registration
5. I wish to
cancel this
product regis-
tration volun-
tari ly.
6. Generic Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response,"
7, Product Specific Data
7a. My product is a NUP and
I agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response,"
?b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
47319-4
47319-2
N.A.
N.A.
8. Certification
1 certify that the statements made on this form and all attachments are true, accurate, and complete.
I acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
9. Date
10. Name of Company Contact
11. Phone Number
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ATTACHMENT C
PRODUCT SPECIFIC REQUIREMENT STATUS AND REGISTRANT'S RESPONSE FORM
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•ticzrie INSTRUCTIONS roil COM*LZTIMO
TKl llQQllZXtireA STATUS XKD IBOXITIIMT'* &E8POHSB VOKX
roduct
This form i« designed to b* used for registrant* to respond
,to call-in* for generic and product-specific data as part of
EPA's reregistratien program under th* Federal Insecticide
Fungicide and Rodenticide Act. Although the fern is the same for
both product specif ic and generic data, instructions for
completing the forms differ slightly. Specifically/ options for
satisfying product specif ic data requirements do not include (1)
deletion of uses or (2) request for a lev volume/minor use
waiver. These Instructions are for completion of product
specific dg^a requirements.
EPA has developed this fora individually for each data call-
in addressed to each registrant, and has preprinted this form
with a number of items. PQ NOT use this form for any other
active ingredient.
Items 1 through • (inclusive) will have been preprinted on
the form. You must complete all other itlms 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 tine
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.
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i
INSTRUCTZOHS fOR COMPLETING THE "1EQOIREMENTS STATUS AND
REGISTRANT'S RESPONSE" FORM FOR PRODOCT SPECIFIC
Itea 1-3 Completed by EPA. Vote the unique identifier number
assigned by EPA in Item 3. This number must fee uaed in
the transmittal document for anj data subaisaiona in
V_ response to this Data Call-In Notice.
Item 4. The guideline reference numbers of studies required to
support the product's continued registration ara
identified. These guidelines, in addition to tha
requirements specified in the Notice, govern the conduct
of the required studies. Note that series 61 and 62 in
product chemistry are new listed under 40 CFR 158.155
through 158.180, subpart C.
Ztea S. The study title associated with the guideline reference
number is identified.
Itam €* The use pattern(a) of the pesticide as«ociatad with tha
product specific requirements is (are) identified. For
.*! . most product specific data requirements, all use patterns
are covered by th* data requirement*. In the case of
efficacy data, the required studies?- only pertain to
products which have the use sites and/or pests indicated.
Ztea 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.
Ztea t. Th* due date for submission of each study is identified.
Zt is normally based on • month*, after iaauance of the
~| , • Feregiatration Eligibility Document unless EPA .determines
that a longer tine period is necessary.
Ztea 9. later only one of the following response codes for each
flafa_ requirement to ahow how you intend to eoaply with
the data requirements listed in this table* Fuller
'- descriptions of each option ar* contained in the Data
Call-In Notice.
1. Z will generate and submit data by the specified due date
(Developing Data). By indicating that Z have chosen this
option, Z certify that Z will eoaply with all the
requirements pertaining to the conditions for submittal
of this study as outlined in the Data Call-In Notice.
•*»
2* Z have entered into an agreement with one or more
registrants to develop data jointly (Cost Sharing). I
aa submitting a copy of this agreement and a completed
"Certification With Respect To Data Compensation
Requirements" fora. Z understand that this option is
available only for acute toxiclty or certain efficary
•8
-------
data and only if IPX indicates in an attachment to this
Notice that my product is similar enough to anothtr
product to qualify for this option. X certify that
anothar party in tha agreement is committing to submit
or provida tha required data; if tha required study is
; • not submitted on time, my product may ba subject to
/ - '• suspension.
i* 1 hava made offars to shara in tha cost to davalop data
(Offers to Cost ihara). I understand that this option
is available only for acute toxicity or certain efficacy
data and only if EPA indicates in an attachment to this
Data Call-in Notice that ay product is similar enough to
another product to qualify for this option. I aa
submitting evidence that Z have Bade aa offer to another
registrant (who has an obligation to submit data) to
v share in the cost of that data. Z am also-submitting a
completed "Certification of Offer to Cost Share in the
Development Data1* form. Z am including * copy of cy
- offer and proof of the other registrant's receipt of that
offer. Z em identifying the party which is committing
to submit ;*r provide the required data; if the. required
study '.- not submitted on time, my product may be subject
to suspension. Z understand that ether terms under
Option 3 in the Data Call-in notice (Section III-c.l.)
apply as veil.
; 4. By the specified due date, Z will submit an existing
study that has net been submitted previously to the
Agency by anyone (Submitting aa Existing Study). I
certify that this study vill meet all the requireaents
for submittal of existing d*f-* outlined in Option 4 in
& the Data Call-In Notice (Section III-C.l.) and vill seat
the attached acceptance, criteria (for acute toxicity and
product chemistry data). Z vill attach the needed
supporting information along with this response. I also
certify that Z have determined that this study vill fill
the data requirement for which Z have indicated this
choice.
5* By the specified due date, Z vill submit or cite data to
upgrade a study classified by tha Agency as partially
acceptable and upgradable (Upgrading a Study). Z will
submit evidence ef the Agency's reviev indicating that
the study may be upgraded and what information is
'-. required to do so. Z will provide the MRXD or Accession
% number of the study at the due date. Z understand that
• the conditions for this option outlined Option 5 in the
Data Call-In Notice (Section III-c.l.) apply.
§. By the specified due date, Z vill cite an existing study
that the Agency has classified as acceptable or ar.
•xisting study that has been submitted but net reviev«i
by the Agency (Citing an Existing Study). Zf Z am citir.z
-------
another registrant's study, Z understand that this option
is available only for acute toxicity or certain efficacy
data and only if the cited study was conducted on ay
product, an identical product or a product which EPA has
"grouped" with one or acre other products for purposes
of depending on the came data. I nay also choose this
option if I am citing ay own data. Zn either case, I
will provide the NXIO or accession auaberU) for the
cited data on a "Product Specific Data Report* fora or
in a similar format. If Z cite another registrant'*
data, Z will submit a completed "Certification with
lespaet To Data Compensation Requirements" fora.
7. Z request a waiver for this study because it is
inappropriate for ay product (Waiver Request). I an
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 t€~S|. Z understand that this
is my only opportunity to state the reasons or provide
information in support of my.request. If the Agency
• '" approves ay waiver request, X; will not be required to
supply the data pursuant to Section 3(c)(2) (B) of FIFRA.
Zf the Agency denies ay waiver request, Z must choose a
method of meeting the data requirements of this notice
by the due date stated by this Notice. Zn this ease, I
aust, within 30 days of ay receipt of the Agency's
written decision, submit a revised "Requirements Status
and Registrant's Response11 Fora indicating the option
chosen. 1 also understand that the deadline for
submission of data as specified by the original data
call-in notice will not change.
Items 10*13. Self-explanatory. *
You may provide additional information that does not fit
on this font in a signed letter that accompanies this
fora. For example, you aay 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, pleas* supply all relevant
detail* 00 that EPA can ensure that its records are
correct.
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DRAFT COPY
Page 1 of 2
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully
Use additional sheet(s) if necessary.
1. Company name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
151B-10
151B-11
151B-12
151B-15
151B-16
151B-17(b)
151B-17(f)
151B-17(i)
151B-17{ltt)
152B-13
152B-14
the attached instructions and supply the information requested on this form.
2. Case # and Name 3. Date and
Form Approved
OMB No. 2070-0107
Approval Expires 12-31-92
Type of OCI
4007 Alliurn sativum PRODUCT SPECIFIC
ID# NNNNNN-RD-NNNN
EPA Reg. No. NNNNNN-NNNNN
5. Study Title
Prod Chan - Biochemical
Product identity
Manufacturing process (50}
Discussion of formation of (51)
unintentional ingrdients
Certification of limits
Analytical methods (52)
Physical state
Density
pH (6)
Viscosity (8)
Acute Toxic -Biochemical
Primary eye irritation (53)
Primary dermal irritation (53)
10. Certification
R
0
0
I
Progress
Reports
1
2
3
6. Use
Pattern
ABC O
ABC 0
ABC 0
ABC O
ABC O
ABC O
ABC 0
ABC O
ABC O
ABC O
ABC 0
7. Test
Substance
EP
EP
EP
EP
IP
EP
EP
EP
EP
EP
EP
8, Time
Frame
8 mos.
8 »OS.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
11. Date
9. Registrant
Response
1 certify that the statements made on this form and all attachments are true, accurate, and complete.
1 acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
12. Name of Company Contact
13. Phone Number
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DRAFT
O P Y
Page 2 of 2
United States Environmental Protection Agency
Washington, D. C, 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS; Please type or print in ink. Please read carefully
Use additional sheet(s) if necessary.
1 . Company name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requi retnent
Number
96-6
5. Study Title
!ifMca^:5-5^t^a^:c^tFSl;;*aeWs:-::^^
Avian repellents (1,54)
the attached instructions and supply the information requested
2. Case i and Name
4007 Allium sativum
EPA Reg. No. NNNNNN-NNNNN
R
0
0
Progress
Reports
1
2
3
6. Use
Pattern
ABC
Initial to indicate certification as to information on this page
(full text of certification is on page one).
0
7. Test
Substance
on this form.
Form Approved
OMB No. 2070-0107
Approval Expires 12-31-92
3. Date and Type of DCI
PRODUCT SPECIFIC
ID# NNNNNN-RD-NNNN
EP
8. Time
Frame
8 BIOS.
9. Registrant
Response
Date
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DRAFT COPY Page 1 of 1
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 4007 Allium sativum
Key: MP = manufacturing-use product; EP = end-use product; provided formulators purchase their active ingredient(s) from a registered source, they need not submit or cite
data pertaining to the purchased product.[NOTE: If a product is a 100 percent repackage of another registered product that is purchased, and any use for the product does
not differ from those of the purchased and registered source, users are not subject to any data requirements identified in the tables.]; TEP = typical end-use product;
TGAI = technical grade of the active ingredient; PAl = "pure" active ingredient; PAIRA = "pure" active ingredient, radiotabeled.
Use Categories Key:
A - Terrestrial food crop B - Terrestrial food feed crop C - Terrestrial nonfood crop D - Aquatic food crop E - Aquatic nonfood outdoor
F - Aquatic nonfood Industrial G - Aquatic nonfood residential H - Greenhouse food crop I - Greenhouse nonfood crop J - Forestry
K - Residential outdoor L - Indoor food H - Indoor nonfood N - Indoor Medical 0 - Indoor residential
Footnotes: [The following notes are referenced in column two (5. Study Title) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
Prod Chea - Biochemical
6 Required if test substance is dispersible with water.
8 Required if product is a liquid.
S"0
£i
Acute Toxic - Biochemical
f3
Efficacy - Vertebrate Control Agents
1 The agency has waived all requirements to submit efficacy data for vertebrate control agents unless the pesticide product bears a claim to control vertebrates (such
as rodents, birds, bats, canids, and skunks) that may directly or indirectly transmit diseases to humans. However, each registrant must ensure through testing that
his products are efficacious when used in accordance with label directions and commenly accepted pest control practices. The registrant must develop and maintain
the relevant data upon which the determination of efficacy is based. The Agency reserves the right to require, on a case-by-case basis (e.g., significant new uses
or benefits data in cases of special reviews) submission of efficacy data for any pesticide product, registered or proposed for registration when necessary.
-------
Footnotes for Garlic Product Specific Data Tables (6/10/92)
description of the manufacturing process must include the steps taken to insure the integrity
of the starting materials and to limit extraneous contamination during manufacturing. Also, the
description must include the quality control methods used to insure a uniform product.
applicant must provide a discussion of the unintentional ingredients that may be present in the
product and why they may be present. Examples of such ingredients might include residues of
contaminants that remain following the extraction or purification process. If these contaminants
are not of toxicological significance (e.g., small quantities of dirt retained on garlic bulbs
after washing) , there is no need for further discussion.
Agency recognizes the difficulty of establishing methods for analysis and verification of the
certified limits of naturally occurring products. Such methods could include analytical, bio-assay,
microscopic, or any other method that would allow the Agency to verify the limits.
tests are required for products that combine garlic and red peper (Capsaicin) . They are not
required for products that contain only garlic,
data currently available to the Agency on the effectiveness of these products as bird repellents
are either inconclusive or have suggested a lack of effectiveness. Therefore, registrants of
bird control products must establish those claims during reregistration through citation or
submission of data. If registrants develop new data, they must submit their protocols to the
Agency with the 90 day response.
If tests suggest that efficacy is highly variable, the registrant will need to develop methods
for quantifying the biological activity of the active ingredients so that consistent results can
be obtained.
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i
ATTACHMENT D
EPA GROUPING OF END-US.* PRODUCTS FOR MEETING
DATA REQUIREMENTS FOR REREGISTRATION
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EPA'S BATCHING OF MUUM SMTVUM (GARLIC) HMD-USE ERDDUCTS FOR MEETING ACUTE
•DOXICHY DATA KECJUIKEMEmS FOR REREGZS'mATION
In an effort to reduce the time, resources and number of animals needed to
fulfill the acute toxicity data requirements for reregistration of end-use
products containing the active ingredient Alliumjsativum (Garlic)» 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., emilsifiable concentrate, aerosol, wettable powder, granular,
etc.), and labeling (e.g., signal word, use classification, precautionary
labeling, etc.). Note that the Agency is not describing batched products as
"substantially similar" since some products within a batch may not be considered
chemically similar or have identical use patterns.
Batching has been accomplished using the readily available information
described above, and frequently acute toxicity data on individual end-use
products has been found to be incomplete. Notwithstanding the batching process,
the Agency reserves the right to require, at any time, acute toxicity data for
an individual end-use product should the need arise.
Registrants of end-use products within a batch nay choose to cooperatively
generate, submit or cite a single battery of six acute toxicological studies to
represent all the products within that batch. It is the registrants' option to
participate in the process with all other registrants, only seme of the other
registrants, or only their own products within a batch, or to generate all the
required acute toxicological studies for each of their own products. If a
registrant chooses to generate the data for a batch, he/she must use one of the
products within the batch as the test material. If a registrant chooses to rely
upon previously submitted acute toxicity data, he/she may do so provided that the
data base is complete and valid by today's standards (see acceptance criteria
attached), the formulation tested is considered by EPA to be similar for acute
toxicity, and the formulation has not been significantly altered since submission
and acceptance of the acute toxicity data.
In deciding how to meet the product specific data requirements, registrants
must follow the directions given in the Data Call-in Notice and its attachments
appended to the RED. Ihe DCI Notice contains two response forms which are to be
completed and submitted to the Agency within 90 days of receipt. The first form,
"Data Call-in Response," asks whether the registrant will meet the data
requirements for each product. The second 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 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.
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i
-2-
Table I shows one batch which of two products. Table II shows the
remaining two products which could not be batched as they were not considered
similar for purposes of acute toxicity. The registrants of these products are
responsible for meeting the acute toxicity data requirements specified in the
data matrix for end-use products.
Table I.
EPA REG. NO.
47319-1
47319-2
% of Garlic & Other Active Ingredients
5.0% -
12.0% -
5.0% -
12.0% -
Garlic
Red Pepper
Garlic
Red Pepper
Formulation Type
Dust
Dust
Table II.
EPA REG. NO.
47319-4
62998-1
% of Garlic & Other Active Ingredients
24.0% - Garlic
36.0% - Red Pepper
5.0% - Garlic
Formulation Type
Liquid
Liquid
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i
ATTACHMENT E
*
EPA ACCEPTANCE CRITERIA
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i
*<•
SUBDIVISION D
61 Product Identity and Composition «... 4
62 Analysis aad Certification of Product Injredient* 6
& Physical and Chemical Chancteristia .. 8
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I
Subdivision D
Guideline Ret No. 61
December 24,1989
€1 Product Identity and Qoapoaftfoa .
ACCEPTANCE CRITERIA
Doei jour staff 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 tapurities present at %
0,1% by weight and for certain toricoIogicaUy significant impurities (e.g^ dtadns,
nitrosamines) present at <0tl%
*• — Purpose of each active Ingredient and each intentionally-added inert
& — Chemical name from Chemical Abstracts Index of Nomenclature and Chemical Abstracts
Service (CAS) Registry Number for each active ingredient and, if available, for each
intentionally-added inert
& , .. Molecular, structural, and empirical formulas, molecular weight or weight range, and any
company assiped experimental or internal code numbers for each active ingredient
?. ___ Description of each beginning material in the manufacturing process
__ EPA Registration Number if registered; for othe. 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 toriciry
8. __jr 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
_J::I Duration of each step of process
,. Description of purification procedures
mi Description of measures taken to assure quality of final product
9- _ Discussion of formation of Impurities eased on established chemical theory addressing (I)
each Impurity which may be present at i 0.1% or was found at I 0.1% by product analyse*
and (2) certain toodcoJogicaUy significant impurities (see if 3)
Criteria marked with a * are supplemental and nay not be required for every study.
C4
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D
Guideline Ret No. 61
December 24,1989
61 Product Identity and GomposttioB
GUIDANCE FDR SUMMARIZING STUDIES
• The following criteria tpply to the technical grade of the active Ingredient being reregistered. Items 1,
2,3, and 5 an be satisfied tor mott registered product* by submission of the Certified Statement of
Formula Ingredients Page (EPA Form 8570-4), Items 7 and 8 can be satisfied for most technical grade
active ingredients (TGAls) by submission of a flow chart with chemical equations for each intended
chemical reaction. The flow chart should include complete chemical structure* and names for each
reactant and product of all the reactions.
Items in summary should indode the hens discussed ID Chapter 2 of this package and the specific hems
fc'cd below.
1. Name of technical material (include product name and trade name, If appropriate).
2. Description of each active and intentionally-added inert ingredient, including name, concentration,
and certified limits.
3. Name and upper limit for all imparities present at 2 0.1% and those tcndcologically signih int
impurities present at <0.1%.
4. The purpose of each active and intentionaDy*addad inert ingredient.
5. Chemical name and Registry Number for each active and intentionally-added inert ingredient (if
available).
£ Molecular, structural, and empirical formulas, molecular weight, and any experimental or internal
code number for each active Ingredient.
?. Description of each beginning material In the manufacturing process.
8. Description of manufacturing process.
9. Discussion of formation of impurities based on established chemical theory.
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I
Subdivision D
Guideline Ret No. 62
December 24,1989
€2 Analysis and Certification of Product Ingredients
ACCEPTANCE CRITERIA
The following criteria apply to ibe technical grade of the active Ingredient being reregistered U»e •
table to present the laforaatlon Is Items 6, 7, and &.
Does your study Beet the foOowing amfptance criteria?
1* —. Five or more representative samples (batches In case of batch process) analyzed for each
active Ingredient and ail impurities present at | 0.1%
2- __ Degree of accountability at closure | a 98%
3. __ Analyses conducted for certain trace toxic impurities at lower than 0.1% (examples,
nitrosamines In the ease of products containing dinitroanHines or containing secondary or
tertiary aminet/alkanoUmines pins nitrites; potyhalog*nated dibenzodioxtas and
dibenzofunns) (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 wed to analyze above
samples
& . Statement of precision and accuracy of analytics^ method used to analyze above samples
& ___ 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
& — Upper certified limit proposed for each impurity present at 2 0-1* and for certain
toxicologically significant impurities at <0.1% along with explanation of bow limit
determined
9. r Analytical methods to verity 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
Criteria marked with a * are supplemental and may not be required for every study.
C4
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Subdivision D
Guideline Ret Ho. 62
December 24,1989
G2 Analysil aad Certi&catiOB of Product Ingredients
GUIDANCE FOR SUMMARIZING STUDIES
lie following criteria apply to the technical grade of die active ingredient bein| reregistered.
'* : v
Iionf in summary ihouJd tadnde the item discussed n Oupter 2 of tlife pectege aod the specific hems
feted below.
L Number of representative samples analyzed for an active Ingredients and an Imparities present at 2
0.1%.
2. Degree of accountability or dosore in analyse* In item #1.
3. Chemical names of toxic impurities which were analyzed for levels <0.1%.
4 Brief description^) of analytical method(») used to measure aative ingredients and impurities in
Items *l and *3.
5. Statement of precision and accuracy of method($) In Item #4.
& Oiemfca! name and quantities observed (range, mean, standard deviation) for each ingredient
(actives and impurities) analyzed in Item #1.
f. > •
7. Proposed upper and lower certified limits for each active ingredient and intentionally added inert
with brief explanation of how limits were determined.
1. Proposed upper certified limit for each imparity present at >»0.1% and certain toxteologicalty
significant impurities at <
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i
Subdivision D
Guideline Ret No, 63
December 24,1989
63 Physical and Qemieal Characterfctka
ACCEPTANCE CRITERIA
He following criierii apply to tbe technical frade of the active ingredient being reregistered.
Duet your study saect the following xrrpfiace criteria?
i . - •
*W Color
___ Verbal description of coloration (or lack of It)
__ Any intentional coloration also reported la terms of Munsell color system
§3-3 Physical State
__ Verbal description of physical stale provided using terms such as "solid, granular,
volatile liquid'
__ £«ed on visual inspection at about 20»2fPC
B-4 Odor
_ Verbal description of odor (or Jack of ft) using terms such as •garUc&ke,
characteristic of aromatic compounds'
Observed at room temperature
63-5 Melting Point
__ Reported in "C
__ Any observed decomposition reported
CM Boiling Point
__ Reported In *C
, „ Pressure under which BJ». measured reported
___ Any observed decomposition reported
63-7 Density, Bulk Density, Specific Gravity
__ Measured at about 20»2S*C
.„, Density of lechnkal grade active ingredient reported in g/ml fit the apedfic gravity of
liquids reported with reference to water at £fC [Note: Bulk density of registered
products may be reported In Ibs/ft' or Ibs/gallon.]
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 2£>2S*C
__ Reported in g/lOOml (other units like ppm acceptable If sparingly soluble)
Ckteria marked with a * are supplemental and may not be required for every study.
CS
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i
Subdivision D
Guideline Ret No. £3
December 24,1989
63-9 Vapor Pressure
__ Measured at «2S*C (or calculated by extrapolation from measurements made at
higher temperature if pressure too tow 10 measure at 2S*Q
__ Experimental procedure described
_ Reported in mm Hg (torr) or other conventional units
€3-10 Dissociation Constant
__ Experimental method described
__ Temperature of measurement specified (preferably about 20-2f*Q
13-11 Octanol/water Partition Coefficient
__ Measured at about 20»2S*C
__ Experimentally determined and description of procedure provided (preferred method-
45 Fed. Register 77350) ^ .
__ Data supporting reponed value provided
£3-12 pH
_ Measured at about M-25*C
_ Measured following dilution or dispersion in distilled water
£3-13 Stability
__ Sensitivity to metal ions and metal determined
., Stability at normal and elevated temperatures
___ Sensitivity to sunlight determined
Criteria marked with a * are supplemental and nay not be required for ever; study.
C-9
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Subdivision D
Guideline Ret No. 63
December 24, 1989
€1 Physical and Chemical Characaeristia
GUIDANCE FOR SUMMARIZING STUDIES
tilt following criteria apply to ihe technical gride of the active Ingredient beinf reregistered.
Items in summary should include the items dhcBSfgtf |§ Chapter 2 of this package and the specific items
listed below.
- m
1. Deseript ton of eotor.
2. Description of physical state.
3. Description of odor.
4. Indication of melting point (in *C).
5. Indication of boiling point (in *C).
6. Indication of density, bulk density, and specific gravity.
?. Indication of solubility.
8. Indication of vapor pressure.
9. Indication of dissociation constant.
10. Indication of ocunol/witer partition coefficient.
II. Indication of pH.
12. Description of stability.
C-10
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SUBDIVISION F
81-1 Acute Oral Toridry in the Rat 84
81-2 Acute Dermal Toridty in the Rat, lUbbit or Guinea Pig 86
81-3 Acute Inhalation Tbxidty in the Rat 88
81-4 Primary Eye Irritation in die Rabbit .......90
81-5 Primary Dermal Irritation Study * .92
81-6 Dermal Seasiiization in the Guinea Fig • • • 94
81-7 Acute Neurotoxidty in the Hea 96
824 Subchronic Feeding fa the Rodent tad Nonrodent 98
82*2 Repeated Dose Dermal Toridty (21-day) in die Rat, Rabbit or Guinea Pi| 101
82*3 Repeated Dose Dermal Toridty (90-day) In die Rat, Rabbit or Guinea Kg 103
82-4 Subchronk Inhalation Toridty (9CMlay) in the Rat 106
82-5 Subchronic Neurotoxidty (904**) la the Hen 109
83-1 Chronic Feeding in die Rodeat ace" Noarodent Ill
83-2 Oncogenidry in Rats or Mice 114
83-3 Teratology Studies 117
83-4 Reproduction 119
83*5 Chronic Feeding/Oncogenidty is die Rat 121
84-2 Mutageaidiy Studies 124
854 Metabolism Studies 127
C83
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I
Subdivision F
Guideline Ret NO. SM
24, 1989
Sl-1 Ante On! Tmidty la the Hat
ACCEPTANCE CRITERIA
Does joor atodf BOM ike toflowtag acceptance criteria?
t _ Technical form of die active ingredient tested, (for reregistnitk>& only)
2.* At least 5 young adult ratsAex/groop
3- ___ Doslaf, sickle oral may be administered oner 24 fen.
4* Veh/de control If other tkam water.
5. ..... . ._ Doses tested, snffident u> determine a toxidty catefoiy or a limit dose (5000 mj/kg).
& ..... : lodividual observations at least once a day,
?• — Observation period to last at least 14 days, or until all test animals appear normal whichever
is longer.
S. __ Individual daily observations,
f.» _ Individual body weights,
Ml* Gross necropsy on all animals.
Qiteria marked with a * are supplemental and nay not be required for every study.
C-84
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i
Subdivision F
Guideline Ret No. 814
December 24,1989
S14 Acute Onl Ttcdpity to the Rat
GUIDANCE FOR SUMMARIZING STUDIES
Hew to sBminaiy stool* indnde the ttom dbamed la CaafWer 2 of tMs ptctafe i«d the specific items
toted below.
L The fora of pesticide tested, eg, sciIM, UqoM, percent Al in technical, etc
1 He •limber of anlaalsMose/iex teited.
3. Dosing route and regimen.
4. Vehicle med
5. Doses tested and results
6. Ifidrvidual observation! OB day of doting.
?. Individual observations on day of doling and for at least 14 days or until all animals appear normal
(whichever is longer).
8. See items 6 and 7
9. Summarization nf body weights
10. Summarization 01 pots necropsy
11. Significance of changes from the Acceptance Criteria
OSS
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Subdivision F
Guideline Ret No. 81-2
December 24,1969
81-2 Acate Denial Tbridty to the Rat, RabMt or Guinea fig
ACCEPTANCE CRITERIA.
Docs foor study meet the following acceptance criteria?
1* ., Technical form of die active ingredient tested (for reregistntiOB only)
2.* At least 5 animalsAex/group
3.* Rats 200-300 gm» rabbits 10-343 k| or guinea pip 350450 gm.
4 ___ Dosing, tingle dermal
5. .. Dosing duration at least 24 noun.
6.* Vehicle control, only if toxfcity of vehicle is unknown.
7. _ Doses tested, sufficient to determine a toxicity category or • limit dose (2000 mg/kg).
*• UL, 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 nonirritatin* cover to retain lest material and :o
prevent ingestfon. ^
H- nnl- Individua] observations at least once a day.
12. ___ Observation period to last at least 14 days, or until all test animals appear normal whichever
is longer.
^ __ Individual daffy ->bservations.
14.» Individual body weights.
15.* Gross necropsy on all animals.
Criteria marked with • * are supplemental and may not be required lot every study.
C-S6
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i
Subdivision F
Guideline Ret No. 81-2
December 24,1989
81-2 Acute Dermal Tbridty fa the Hal, Rabbit or Guinea Pif
GUIDANCE FOR SUMMARJZINO STUDIES
Hen* IB sunnily saoold taKtode the item dbcossed fa Cfcaptet 2 of tnis f«eii§e iad tae specilk flea*
feted beJov.
L The fora of pesticide teated, ej, solid, liquid, percent AJ IB technical, esc.
2. file oomber of animalsAexAiote
3. Weight range of animals
4. Verification of single, dermal exposure
5. Duration of dermal exposure
& Statement of vehicle control
7. Doses let ted and results
& Preparation of application site
9. Area of application site (percent bod; surface)
10. Occlusion of test material on application site
11. Individual observations OB day of dosing
12. b IMdual observations on day of dosing and for at least 14 days or until all animals appear normal
(whichever is longer)
13. See items 11 and 12
14. Summarization of body weights
15. Summarization of frost necropsy
16. Significance of changes from Acceptance Criteria
CS7
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i
Subdivision f
Guideline Ret Ho. 81-3
December 24,1989
91-3 Ante tahitotioa Tteidtj it the Rat
V
ACCEPTANCE CRITERIA
Does joor study nee* the following acceptance criteria?
> ** — Technical form of the active ingredient tasted, (tot reregbtratton only)
2, _ Product is a fas, a tobd which may produce a significant vapor hazard based on tcnddty and
expected use or contain* panicles of inhalable size for nan (aerodynamic diameter IS tun or
less).
3.* .. At least 5 younf adult iattAat%roop
4.* Dosinf, at least 4 hours by inhalation.
5.* Chamber air flow dynamic, at least 10 air chinges/hour, at least 19% oxygen content.
& _ Chamber temperature, 22* C (±2*), relative humidity 4040%.
?• _»__ Monitor rate of air flow
S- — Monitor actual concentrations of test material in breathing »ne.
9. ___ Monitor aerodynamic panicle size for aerosols.
10. _ Doses tested, sufficient to determine a toricity category or a limit dose (S mj/L actual
concentration of respirable suHtance).
H- , , Individual observations at least once a day.
12. _, :J, Observation period to last at least 14 days, or until an test animals appear normal whichever
is longer.
13- Individual daOy observations.
14.» Individual body weights,
IS.* . Gross necropsy on all
Criteria marked with a • are supplemental and may not be required tot every study.
CSS
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Subdivision P
Guideline Ret Ho. 81-3
December 24, 1989
tl-3 Acute Inhalatkx) Itafcfty fa the Eat
GUIDANCE FOE SUMMARIZING STUDIES
fa summary should mdnde the hem dbomed fa Oupter 2 of this package aad the specific ileus
below.
t
L Tie form of pesticide tested, e.g., solid, Kquld, percent AI fa technical, etc.
1 Statemeet of the inhalability of tett iubsunoe
3L He Bomber of
4 Dundon of tnhiUtion expocure
& Number of clumber air clwngesAottr and the percent oxyjen conteot of dumber air
ft. Rinfcs for clumber air temperature and relative humidity
2. Air flow rate
& Analytical concentrations of ten material IB breathing raae
ft Results of aerosol particle-size determination
•L Doses tested (or limit dose of Smg/L or highest attainable)
11 Individual observations on day of dosing
12, Indiviuaal observations oa day of dosing aad for at least 14 days or until all animals appear normal
(whichever is longer)
n. See items 11 and 12
ML Summarization of body weights
IS. Summarization of gross necropsy
lit Significance of changes from Acceptance Criteria
C49
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I
Subdivision F
Ret No. 81-4
24,1969
$1-4 Primary Eye Irritation IB Ike Rabbtt
ACCEPTANCE CRITERIA
Does four study meet the foDowug acceptance criteria?
t. Technical form of die active ingredient tested, (for rcregisuition only)
2-... Study not required if oxiteriil is corroiive, causes severe dermal irritation or has a pH of ,<
2 or i 1U.
3L» 6 adult nbbitt
*• ,. Do»io|, instflUtion feto the oonjunctivil sac of one eye per aoimaL
5-* Dose, ttl ml if a liquid; a 1 ml or not more than 100 mg If a solid, paste or paniculate
substance.
& — SoUd or granular test material ground to a fine dust
7. „ Eyes not washed for at least 24 hours.
S... Eyes examined and graded for irritation before dosing and at 1, 24,48 sad 72 hi, then dairy
until eyes are normal or 21 days (whichever is shorter).
*.•____ Individual observations for the entire day of dosing.
Ifl* Individual daily observations.
Qfeerii marked with § * are supplemental and may not be required for every study.
C-90
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s
Subdivision F
Guideline Ret No. 8M
December 24,1989
tl-4 Primary Eye Mutton to the Rabbit
GUIDANCE FOR SUMMARIZING STUDIES
HOBS in summary shooJd todode tbe items dfacaated to Chapter I of this package and the specific it«n*
total beta*.
% "
S. The form of pesticide tested, «,£, solid, liquid, percent AI in technical, etc
2. State of material Is corrosive, came severe derail irritation or has a pH of <2 or »UJ
3. Number of adult rabbits tested
4, State method of dosinf, Le^ iastfliatk>D iato tbe oonjunctrval sac of oae eye per animal
5. Dose administered
6. Note whether solid or fraaalar test material lias been ground to t fine dust
7, State whether eyes were washed and at what time post instillation ;
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Subdivision P
Guideline Ret No. tl-S
December 24,1989
tl-5 Primary Derma! Irritation Study
ACCEPTANCE OUTCRIA
Does jour atadj neet the following acceptance criteria?
*• — Technical form of the active ingredient tested (for ^registration onjy)
X Study not required if material is corrosive or bis t pH of £ 2 or £ IU.
3.* 6 adult tnlmtte.
<• —. Doslnj, siajle demuL
5,... Dosing duration 4 bran.
& __ Application site thaved or clipped at least 24 bow prior to dotlaf.
7. ^ Application site approximately 6 cm*.
& _ Application site covered with a puze patch field in place with ooniniutinf tape
9. .. Material removed, washed with water, without trauma to application tilt
1°- - _- Application site examined and graded for irritation at i, 24,48 and 72 hr, then daily until
normal or 14 days (whichever is shorter).
II.* Individual observations for the entire day of dosing.
11* Individual daily observations.
Criteria narked with a * arc supplemental and may not be required for every study.
C-92
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i
Subdivision F
Guideline Ret No. 81-5
December 24,1989
tl-5 Primary Derail frritactaa Study
GUIDANCE FOR SUMMARIZING STUDIES
Itctni IB sunnily ibook* fododc tbe item dbenssed ii Chapter 2 of ihfc MCfcafe tad the specific liens
toted below. v
L Tbe form of pesticide toned, «.*, »olkl, liquid, percent AI ia tecftalai, etc.
2. State If miierUI is corrosive, bu • pH <2 or >11J, or hu a dermal LD-50 <200 mj/kg
3. Number of adult animab tested
4 Amount applied
S. Duration of dermal exposure
6. Preparation of application site (shaved or dipped at specified tine before dosing)
?. Area of application site
8, Method for occlusion of application site
9. Note removal of test material and if skin was washed with water
10. State tines post application when site was graded tor irritation
11. Individual observations for entire ^y of dosing,
11 Individual observations for entire day of dosing and individual dairy observations thereafter
13. Significance of changes from Acceptance Criteria.
O93
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i
F
Guideline Ret No. Sl-6
24,1989
§1-6 Dermal Sen-Wadon ia the Guinea Pif
ACX3JPTANCE CRITERIA
Do« jour study meet the toaowtaj acceptane* oiusiaf
t — Technical fonn of the active ingredient tested, (for terefbtntioa only)
2. __ Study not required if material is. corrosive or his t pH of S 2 or j»
& —. One of the followtng methods b ntOized;
_____ Freund'i complete adjuvmnt test
Ouicei pic Biixiiniz_tioB tett
____ Split adjuvant technique
____, Buehler test
_ . Open epicuttneous test
_____ Mtuer optimization ten
_____ Footpad techm'que In guinea pif
_____ Other test accepted by OECD ftpeciIVY
4 .. Complete description of lest
S.* Reference for test.
6. _____ Test followed t :
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i
Subdivision F
Guideline Ret No. Sl-6
December 24, 1989
SI-6 Dermal SevWatioi.il the Guinea flg
GUIDANCE FOR SUMMARIZING STUDIES
hem* in rammaif should include the item* dbomed fa Qapur 1 of lUi netafe and the fpedfic hem*
toted below.
L Hie font of pesticide tested, c,|^ »IW, liquid, percent AI in technical, esc.
2. State If material is corrotive or kas pH <2 or >1SJ).
3. State specific method utilized
4 Complete description of specific method
S. Reference for the specific method employed
& Note adherence of the protocol to th~t in the reference for the specific method vtilted
7. State the positive control tested
8. Significance of changes from Acceptance Criteria
C-95
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i
tubdMstottF
Guideline Ret No. 81-7
December 24,1969
tl-7 Ante Neorworidty b the Hen
ACCEPTANCE CRITERIA
Does yoor nodi Meet fee toflowmg acrrpunce criteria? .
1* —— Study performed mi «o organophoiphate cholinesterase inhibiting compound,
2, • Technical font of the active ingredient toted.
1* Positive control itflted.
*> -m. Spedes utilized, domestic hying ben 8-14 months of age.
& — Dosinj oral by (tvi|e or capsule (dennil or inhalation nay be Mad).
& _ AD acute oral LDn is determined,
7. _ Dose tested equal to an acute oral U>M or a limit test of 5000 nf/kf.
&* Dosed animali may be protected with airopine and/or 2-PAM.
9- _ SuOcieet t4tt animals so that at least 6 survive.
10- —_ Negative (vehicle} control froup of at least 6 kens
1L* Positive control of at least 4 bens, (if used)
12- — Test ^o** repeated if no sips of delayed neurotoridty observed by 21 days after dosing.
**•, Observation period 21 days af-j each dose.
!*• _. Individual daily observations.
IS. Individual body weifnts.
*&• Individual necropsy not required.
*7- — Histopatholo0 performed on all animals. Tissue to be fixed 61 rta preferably using whole
animal perfuslon techniques. At least three sections of each of the following tissues:
brain, including medulla oblongau
' ' * —»P5 cord; upper cervical, mid-thoracic and lumbro-sacral regions
libial nerve; proximal regions and branches
sciatic nerve
Criteria narked with a * ate supplemental aid nay aot be required far every study.
CM
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i
ATTACHMENT F
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
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ATTACHMENT F
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Case Number and Name
4007 Allium sativuro (Garlic)
COMPANY
NUMBER
COMPANY
NAME
Sevana
Guardian Spray
ADDRESS, CITY
AND STATE ZIP
5336 East Easterby Drive
Fresno, California 93727
900 Lancer Way
Lebec, California 93242
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i
ATTACHMENT 6
COST SHARE AND DATA COMPENSATION F^RMS
-------
i
r/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
Form Approved
OMS N*. M70-0105
Appr*vsi
Pubic reporting burden for this collection of information is estimated to average 15 minutes par response, including
time lor reviewing instmctions, starching txisting data sources, gathtring and maintaining tha data netdtd, and
completing and reviewing tht coSectton of information. Send comments regarding the burden estimate or any other
aspect of tNs collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Bianch. PU-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20480; and to the Office
of Management and Budget. Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please in In blanks below.
we^ee^pieM*y e^^e^tew
Product Haat
EPA leg. Ho.
1 Certify thai:
1. For each study cited in support of registration or reregistratton under the Federal Insecticide, Fungicide and
Rodentcide Act (FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the
written permission of the original data submitter to cite that study.
2.
That for each study died in support of registration or ^registration under FIFRA that is NOT an exclusive use
study, I am the original data submitter, or I have obtained the written permission of the original data submitter, or l
have notr«tf»n writing the company{ies} that submitted data I have cited and have offered to: (a) Pay
compensation for those data in accordance with sections 3(C)(1)(D) and 3(c)(2)(D) of FIFRA; and (b) Commence
negotiation to determine which data are subject to the compensation requirement of FIFRA and the amount of
compensation due, I any. The companies I have notified are:
U Thecompanies who have submitted the studies isted on the back of this form or attached
sheets, or indicated on the attached •Requirements Status and Registrants' Response Form,"
3. That I haw previously complied wtth section 3(c)(i }(D) of FIFRA for the studies I have cfted in support of
registration or reregistratton under FIFRA.
Sleutur*
Dal*
NMM Mi Tltte {MM** Typ* *r Print)
> •
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, wtth regard to the
registration or reregtetraiton of my products, to the extent required by FIFRA sections 3(c)(l}(D) and 3(c)(2)(D).
Signature
Oat*
Nam* v* fill* (M*M* Ty»* *r Print)
CPA far* SS7S-S1 (4.M)
-------
v/EPA
United States Environmental Protection Agency
Washington, DC 10460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Furm Approved
OUB No. M7&41H
Approval Expiro*
Pubfc reporting burden for this ooBecHon of information to estimated to average 15 minutes ptr response, including
ttnt for reviewing instructions. Marching existing data sourots, 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 tMs 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 20480; and to the Office
of Management and Budget, Paperwork Reduction Project {20704)106), Washington, DC 20503.
Please mi in blanks below.
Company Nun*
Product Kane
EPA Reg. 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 Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was Irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA tf final agreement on alt
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Mama of nra(a)
D*t* *f Offer
Certification:
I certify trial i am duty authored to repttsert ft* c^^ have made on
this form and ai attachments therein are tnie, accurate, and complete. I acknowledge that any knowingly faise or
misleading statement may be punishable by fine or irnprisorarant or bom under applicable law.
Signature of Comptny'v Authorlioo* R«prt»onutlvo
D«t*
Mamo and TlUo |Piaa»* Typo or MM)
tFA Form M70*32
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US invironrnantai Pwtaetion Agency Atgiatration Standard Ion
tttahingtert. DC 20460
&EPA .Product Specific
OuMoNntNe.
$«€. 158.120
Product
•1-1
fl-3(m)
• ei-2 f bt
82-1
82-2
824
83-2
63-3
63-4
63-3
834
83-?
•34
•34
83-10
63-11
63-12
83-13
63-14
63-15
83-16
83-17
83*18
83-18
63-20
63-21
Sec. 158.135
ToxicoloQY
•1-1
•1-2
•14
•1-4
•14
•14
NamtofTMt
Utntty of tnomdtvrm
StatMfwnt of oompeaKion
Ditotttion el termaflort of tnpjradianta
Prattmina/y ana»yti»
CafWeationofHmra
Analytical methods tor *ntoro»m*nt Hmtts
Cotor
Phpteatttate
Odor
Mattino point
Boiling point
Oanaity, buHK-tntMy, or apteme oravKy
SoiuWWy
Vapor pr***ur*
Oisaociatfon oonuant
Oetanoj/watw oartttion eo*fAe)*nt
pH
Stability
Oxidixmo/rvduemfi rtaetfon
flammabitity
Exptodability
Stor«Qt ttability
VltosaKy
MteiMity
Corrosion Cnaraetarittiea
DMtetrle braakdown woRaga
Acvtt oral »Ktetty, rat
Acutt darmal hwicrty, rabbit /r«t /R . pig
Aeuta InhalathMi toxterty, rat
Pflmafy aya Hiliailoni rabolt
Primary darmal Irrltttion
n * - _t»» -^
raquiradtormy
poduetlatad
atoova
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EPAAigiatniion Numbar
J am oompJyJrtfl wrth
Bat* Baoulttmantt bv «
CWng MR 10 No.
SufemrttiftQ Data
"*•
DMB #2070X3057
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EPA RED FACTS
ALLIUM SATIVPM (GARLIC)
PESTICIDE REREGISTRATION
All pesticides sold or used in the United States must be
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,
showing the human health and environmental effects of each
pesticide. The Agency imposes any regulatory controls that are
needed to effectively manage each pesticide's risks. EPA then
reregisters pesticides that can be used without posing undue
hazards to human health or the environment.
When a pesticide is eligible for reregistration, EPA
announces this and explains why in a Reregistration Eligibility
Document, or RED. This fact sheet summarizes the information in
the RED for Allium sativum (garlic).
USE PROFILE
Allium sativum or garlic, formulated as a powder or a
distilled extract from garlic cloves, is an active ingredient in
four registered pesticide products; three of these products also
contain the active ingredient capsaicin (red pepper). The garlic
pesticides are applied aerially or by ground equipment, and are
used to repel birds and/or insects and thus prevent them from
damaging seeds and seedlings of vegetable plants, fruit trees,
grain crops, ornamental plants and shrubbery.
REGULATORY HISTORY
EPA registered the first two pesticide products containing
garlic as an active ingredient in 1983 and 1985. Both products
also contain red pepper, and are used to repel birds. A third
garlic and red pepper product, used to repel insects, was
registered in 1988. The fourth product, which contains garlic as
a single active ingredient, was registered in February 1991, also
to control insects.
EPA previously classified garlic as a conventional chemical
pesticide. However, the Agency now is reclassifying garlic as a
biochemical pesticide since it is a naturally-occurring substance
and has a non-toxic mode of action.
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HUMAN HEALTH AND ENVIRONMENTAL ASSESSMENT
Although EPA has developed a set of data requirements for
reregistration, the Agency believes there is a category of
pesticides for which a greatly reduced set of data requirements
are appropriate. Such pesticides may be exempt from the usual
generic data requirements for toxicology, residue chemistry,
human exposure, ecological effects and environmental fate,
without compromising human health or environmental safety.
However, some data requirements (such as basic product identity
and product chemistry data and acute toxicology studies) usually
are essential, and generally will not be waived.
Garlic is in this category of pesticides, and EPA is waiving
most of the generic data requirements for its reregistration.
The bulb of a plant, its primary use in the United States is non-
pesticidal; it is used widely to flavor and season foods. Garlic
is "generally recognized as safe," or GRAS, as a natural
seasoning or flavoring (see 21 CFR 182.10, 182.20 and 184.1317).
Used as a pesticide, garlic has a non-toxic mode of action
for repelling target birds and insects. Garlic is presumed to be
non-persistent since it is material known to rapidly degrade in
the environment. EPA has received no reports of adverse effects
resulting from its use. The Agency believes that no significant
adverse effects to humans or the environment are associated with
the use of garlic as a pesticide.
ADDITIONAL DATA REQUIRED
EPA has waived all generic data requirements for garlic
except basic product identity and product chemistry studies.
These are being required now, through the RED.
PRODUCT LABELING CHANGES REQUIRED
The labels of the four registered garlic pesticide products
must comply with EPA's current pesticide labeling requirements.
No other labeling changes are being required at this time.
REGULATORY CONCLUSION
» The registered bird and insect repellent uses of garlic
are not likely to cause unreasonable adverse effects in people or
the environment, and are eligible for reregistration.
* The registered product that contains garlic as its only
active ingredient will be reregistered once product-specific data
and amended labeling are received and accepted by EPA.
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i
• The other three registered products that contain both
garlic and red pepper as active ingredients will be reregistered
after red pepper also is determined to be eligible for
reregistration.
FOR MORE INFORMATION
EPA is requesting public comments on the Reregistration
Eligibility Document (RED) for garlic during a 60-day time
period, as announced in a Notice of Availability published in the
Federal Register. To obtain a copy of the RED or to submit
written comments, please contact the Public Response and Program
Resources Branch, Field Operations Division (H-7506C), Office of
Pesticide Programs (OPP), US EPA, Washington, DC 20460, telephone
703-305-5805.
In the future, the garlic RED will be available from the
National Technical Information Service (NTIS), 5285 Port Royal
Road, Springfield, VA 22161, telephone 703-487-4650.
For more information about garlic or about EPA's pesticide
reregistration program, please contact the Special Review and
Reregistration Division (H-7508W), OPP, US EPA, Washington, DC
20460, telephone 703-308-8000. For information about
reregistration of individual garlic products, please contact the
Registration Division (H-7505C), OPP, US EPA, Washington, DC
20460, telephone 703-305-5447.
For information about the health effects of pesticides, or
for assistance in recognizing and managing pesticide poisoning
symptoms, please contact the National Pesticides
Telecommunications Network (NPTN). Call toll-free 1-800-858-
7378, 24 hours a day, seven days a week, or Fax your inquiry to
806-743-3094.
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