United States Office of Prevention, PesticteSs xx
Environmental Protection And Toxic Substances June 1992
Agency (H-7508W)
&EPA Registration
Eligibility Document
(RED)
Allium sativum
(Garlic)
-------
REREGISTRATION ELIGIBILITY DOCUMENT
ALLIUM SATIVUM
(GARLIC)
LISTD
CASE 4007
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
WASHINGTON, D.C.
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EPA ALLIUM SATIVUM REREGISTRATION ELIGIBILITY TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Brancji
Steve Jaiboe Biological Analysis Branch
Paul Guillebeau Biological Analysis Branch
G. Ali Economic Analysis Branch
Fate and Effects Division
Doug Urban Ecological Effects Branch
Harold Day Environmental Fate and Ground Water
Bemice Slutsky Science Analysis and Coordination Staff
Health Effects Division
Tom McClintock Science Analysis and Coordination Branch
Jim Yowell Occupational and Residential Exposure Branch
Prograrp ^an886TTient ^d Support Division
Information Services Branch
Registration Division
Pat Critchlow Registration Support Branch
Dan Peacock Insecticide-Rodenticide Branch
Sami Malak Registration Support Branch
Mary Waller Registration Support Branch
Special Review and Reregistration 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 iv
EXECUTIVE SUMMARY y
I. INTRODUCTION 1
n. CASE OVERVIEW
A. CHEMICAL OVERVIEW 2
B. USE PROFILE 2
C. REGULATORY HISTORY 3
HI. SCIENCE ASSESSMENT OF ALLIUM SATIVUM 4
A. PRODUCT CHEMISTRY ASSESSMENT
B. ENVIRONMENTAL AND HUMAN HEALTH ASSESSMENT 4
TV. RISK MANAGEMENT AND REREGISTRATION DECISION 6
A. DETERMINATION OF ELIGIBILITY 7
B. ADDITIONAL GENERIC DATA REQUIREMENTS 7
C. TOLERANCE ASSESSMENT 7
D. LABELING REQUREMENTS FOR MANUFACTURING -
USE PRODUCTS OF ALLIUM SATIVUM 7
V. ACTIONS REQUIRED BY REGISTRANTS OF END-USE PRODUCTS 7
A. DETERMINATION OF EUGIBILrrY 7
1. Product-Specific Data Requirements 8
2. Labeling Requirements For End-Use Products 8
u
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PAGE
VI. APPENDICES
APPENDIX A - USE PATTERNS SUBJECT TO REREGISTRATION 9
APPENDIX B - GENERIC DATA REQUIREMENTS FOR
REREGISTRATION OF ATflrTTTM SATWUM
(GARLIC) AND DATA CITATIONS
SUPPORTING REREGISTRATION 33
APPENDK C - BIBLIOGRAPHY 37
APPENDIX D - PR NOTICE 91-2 42
APPENDIX E - PESTICIDE REREGISTRATION HANDBOOK 46
APPENDK F - PRODUCT SPECIFIC DATA CALL-IN 83
1. ATTACHMENT A - CHEMICAL STATUS SHEET
2. ATTACHMENT B - PRODUCT SPECIFIC DATA CALL-IN RESPONSE
FORMS (FORM A) AND INSTRUCTIONS
3. ATTACHMENT C - REQUIREMENT STATUS AND REGISTRANTS'
RESPONSE FORMS (FORM B) AND
INSTRUCTIONS
4, ATTACHMENT D - EPA GROUPING OF END-USE PRODUCTS FOR
MEETING DATA REQUIREMENTS FOR
REREGISTRATION
5. ATTACHMENT E - EPA ACCEPTANCE CRITERIA
6. ATTACHMENT F - LIST OF ALL REGISTRANTS SENT
THIS DATA CALL-IN NOTICE
7. ATTACHMENT G - COST SHARE/DATA COMPENSATION FORMS
APPLICATION FOR REGISTRATION
iii
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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
FtFRA 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
IV
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EXECUTIVE SUMMARY
The U.S. Environmental Protection Agency ("EPA" or "the Agency") first registered a
pesticide product containing Ailium satiyjun in 1983. Currently, there are a total of four
registered products for this active ingredient Three of these products also contain capsaicin
(red pepper) as an active ingredient. All currently registered products are repellents against
birds and/or insects. The end-use products are either soluble 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 die results from the reregistration review, the EPA has determined that the data
base for Ailium sativum is sufficient to make a reregistration decision. 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 potential 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 Allilim satixum
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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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended to accelerate the reregistration of products with active ingredients registered
prior to November 1, 1984. The amended Act provides a schedule for the
reregistration process to be completed in nine years. There are five phases to the
reregistration process. The first four phases of the process focus on identification of
data requirements to support the reregistration of an active ingredient and the
generation and submission of data to fulfill the requirements. The filth 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 n describes Allium sativum. its
uses and regulatory history. Section m 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.1
EPA's reviews of specific reports and information on the
set of registered uses considered for EPA's analyses nay
be obtained from: EPA, Freedom of Information, 401 M
St. S.W., Washington, D.C. 20460.
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n. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Document:
Chemical Name: Allium sfltJYUlT) (Garlic)
CAS Registry Number: 8000-78-0
Office of Pesticide Programs Chemical Code: 128827
Empirical Formula: Not Applicable
B. USE PROFILE
The following is information on the registered use with specific sites and
application methods. A detail table of eligible uses of Allium sativum is in Appendix A.
j
Type of Pesticide: Biochemical pesticide, Insect and Bird Repellent
Use Sites: Terrestrial Food/Feed - vegetables, fruits, nuts
and grains
Terrestrial Non-food - ornamental plants and
shrubs
Indoor Residential - ornamental plants
Pests: birds, mites and insects
Formulation Types Registered:
BIRDS-
Dust: 12% ground red pepper (Capsicum sop.)
5% ground garlic (Allium sativum)
-------
INSECTS -
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 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.
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 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 rather than a
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, Alliiun salmim was classified by the Agency as a
conventional chemical pesticide. Since these four formulations consist of a
food additive and/or component and approved inert ingredients, the Agency
only required 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 it is assumed to have a non-toxic
mode of action.
HI. SCIENCE ASSESSMENT OF ALMDM SATTVUM
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. Product Chemistry Assessment
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, extracts and two antibacterials allicin
and alliin. One such derivative is finely ground garlic bulbs (known as
garlic powder).
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 Part 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 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 requirements. 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 (^FR 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. Therefore, EPA is not requiring the submission
of additional generic data for the active ingredient garlic. However, EPA is
requiring the submission of product specific data (chemistry, acute toxicity and
efficacy). 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. RISK MANAGEMENT AND REREGISTRATION DECISION
A. DETERMINATION OF KL.TGTBTLITY
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 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 m
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
Hie generic data base supporting the reregistration of products containing
Alliltm sajXHUD and the registered use patterns has been reviewed and determined to
be substantially complete for reregistration.
C. TOT JRHANPE ASSESSMENT
End-use crops are registered for application to a variety of food crops;
however, no tolerance or exemption from tolerances for residues of Allium
have been established in 40 CFR Part 180. As discussed above in Section m, 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 satimm under 40 CFR Pan 180 for all currently
registered uses on food/feed crops.
D. LABELING REQUIREMENTS FOR MANUFACTURING-USE PRODUCTS
OF ALLIUM SATTVUM
No manufacturing-use products are registered.
V. ACTION REQUIRED BY REGISTRANTS OF END-USE PRODUCTS
A. DETERMINATION OF FT.TfiTBTLTTY
Based on the reviews of the generic data for the active ingredient,
Allium satiyjun, fie products containing them are eligible for reregistration.
Section 4(g)(2)(B) of FTFRA 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.
1. PRODUCT SPECIFIC DATA
The product-specific data requirements are listed in Appendix E,
Attachment C. These requirements include product chemistry, acute
toxicology, and efficacy studies.
2. LABELING REQUIREMENTS FOR END-USE PRODUCTS CONTAINING
ALLIUM SATTVUM
The labels and labeling of all products must comply with EPA's current
regulations and requirements. Instructions to comply with these requirements
are found in the Product Reregistration Handbook with respect to labels and
labeling.
Due to deficiencies regarding protection of workers and aquatic species,
the Agency states that label changes are necessary to support the Agency's
conclusion that the use of Allium saifflim products would not cause
unreasonable risks. These label requirements are:
a.) For products containing Allium satjyum as the sole active
ingredient the environmental precaution is:
"This product may be toxic to aquatic organisms." The following
statements will be required in the use directions on the label: "Do not apply
to or allow runoff to reach lakes, streams and ponds. Do not contaminate
water by cleaning of equipment or disposal of wastes."
b.) For labels with no maximum application limit of Allium sarivum
on the labels, registrants must include proposed maximum application rates for
terrestrial food/feed and terrestrial non-food uses.
fi
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APPENDIX A
Allium sativum Use Patterns Subject to Registration
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APPENDIX A- Case 4007, [Allium satlvum] Chemical 128827 [AlHum satlvum]
SITE Appttcadoo Typ*. Appfc«Mo
-------
APPENDIX A . Case 4007, [Allium sativum] Chemical 428827 [Alllum satlvum]
STO Aj>pfca*xiTyp«.A|]pac«ttonT1mfcio.APP»catton
Equipment
Apricot Use Group: Terrestrial Food Crop
Broadcast. Foiar. Aircraft
BroadcutFoBar, Ground
Low volume spray (concentrate), Fofar, Aireraft
Low volume spray (conueiitiatej, rotor. Low
volume ground
Spray, Fot*r, Aircraft
Spray. Petal fal Aircraft
Spray, Foto, Qround
Spray. Petal ML Ground
Farm
•
0
D
SCA.
SCA.
SCA.
SC/L
SC/L
SC/L
Minimum
AppJCiitton ftata
2.5 fc Al per A
2.5bAlperA
na
na
na
na
na
na
Maximum
Application Hate
not spec
not spec
.825 to Al per
A
.825 b Al per
A
Dose cannot
be cafcutoled
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Max.*
App».
not
spec
not
spec
2 per
Cycle
2per
Cyde
not
spec
not
spec
not
spec
not
spec
Max.*
App».
O
Max.
Hat«
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
OBfWVCfl npp9<
• Max. Rate
(Days)
7
7
not spec
not spec
7
7
7
7
vWVvVCMQ
Entry
Intent*
(Oay«|
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
geographic
Umltatkxw
••aTMaaail
WtuWVU
Dtaatowed
U«« Limitations
7 days
Interval.
7 days
pfcnwvosi
Interval.
15 days
pVBtlftfWSf
Interval.
15 days
prenamsi
interval.
15d-ys
I,,. |
•tier VOL
15 days
Interval.
Beans Use Groups: Terrestrial Food Crop and Terrestrial Feed Crop
High volume spray ((flute), Fofar. Ground
Low volume spray (concentrate), Fotar. Abcrafl
Low volume spray (concentrate). Prebtoom.
Alroralt
SCA.
SC/L
SC/L
na
na
na
DosocBnnot
be calculated
.SZSibAlper
A
.825 b Al per
A
not
spec
2par
Cyde
Zper
Cyde
not
spec
not
spec
not
spec
As needed
not spec
not spec
not spec
not spec
not spec
IS days
Interval.
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APPENDIX A- Case 4007, [Alllum sativum] Chemical 128827 [Alllum satfvum]
CQpUlpfVtdll
Low volume spray (concentrate). Polar. Low
volume ground
»»f\_».ii
Low voiumo spiny (concentrate), froblooin. Low
volume ground
Spray, Foaar, Aircraft
Spray, Seedang. Aircrafl
Spray, Seedang. Ground
Form
sen.
sen.
SC/L
sen.
sen.
fc^lfcMktJ*_
iVHnnnuin
AppNc4tlon Rstc
na
na
na
na
na
Maximum
Application Hate
.625 1> A! per
A
.625 to Al per
A
Dose cannot
be calculated
Qoso cflftnot
be calculated
Dose cannot
be calculated
Max.*
App*
2per
Cycle
2per
Cyde
not
spec
not
spec
not
spec
M*JL*
Apps.
•
Mu.
MM
not
spec
not
spec
not
spec
not
spec
not
spec
Mln. Men*
BSnAMMtlt nppft*
0 Man. Rat*
(0«y»)
not spec
not spec
As needed
As needed
As needed
e«»
Inttrvri
(fey*)
not spec
not spec
not spec
not spec
not spec
jrk — _ ^•^•afcj —
iMo^aprec
UmftMtara
Alowod
Beets (Unspeealed) Use Groups: Terrestrial Food Crop and Terrestrial Feed Crop
appfcator
tla inmttnmMt ^-«" flbj n
isroaQcaa^roaar. jurcran
Broadcast, Fotar, Ground
Broadcast Seodang stags, Ground
Sol band treatment. At planting. Shaker can
D
D
D
D
D
D
0
IbAlperA
LSbAlperA
1.9 to Al per A
LSbperA
1.5 b 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
DMkxMd
Use Umtetkxa
15 days
preharvest
Interval.
15 days
pratuuvest
Interval.
IS days
pratuuvest
MervaJ.
•
7 days
pienajveM
Interval.
7 days
pfOfwTV69l
MervaJ.
7 days
Interval.
7 days
preharvest
Interval.
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APPENDIX A -
SITE Appfcaflon Type. AppRcatton Timing, Application
Equipment
Sol treatment. At planting, Shaker can
Case 4001
^^^^^•mMViummiMW.
Form
D
r, [Alllum a
-(••••••••••••••••^^
Minimum
Appfcatton Rate
na
atlvum] Ch<
MflxtflHIfTl
Application Rate
Dose cannot
be calculated
jmlca
Max.*
Appa.
not
spec
I12M
Mu.«
A«w.
«
Max
Rat*
not
spec
27 [Alllun
Mki. Interval
Between Afips.
« Max. Rat*
(Days)
not spec
nsatlvu
•••••••••••••^^MMllllll
Restricted
entry
Mervml
<0a»s>
not spec
m]
Geographic
limitations
Mowed
Obolowed
*
ipii*«««««««^^
UseUimtMkxn
Broocol Use Group: Terrestrial Food Crop
High vohmw spray, Polar, Ground
Spray, Potter, Aircraft
Sony, Seedtog stage. Aircraft
Spray, Seeding stage. Ground
SC/L
SC/L
SC/L
sen.
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
prCfrarVOSi
Interval.
Cabbage Us* Group: Terrestrial Food Crop
Band treatment. At planting. Mechanical granule
applcator
Broadcast, Polar, Aircraft
BmoirteMt Seeriann slam Akrnft
Broadcast. Foiar, Ground
Broadcast. Seedang stage, Ground
0
D
0
D
D
IbAlperA
1.5 b Al per A
LSbAlperA
1.5bAlperA
LSbAlperA
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
/days
pretufv04i
Interval.
7 days
preharvest
Interval.
7 days
preharvest
Interval.
7 days
pfefMUVWI
Interval.
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APPENDIX A- Case 4007, [Allium sativum] Chemical 128827 [Alllum satlvum]
SITE Appfcartkxi Type. Appltcatkm Timing, Application
Equipment
DTOBQCaSI, rOstraiHjrgcnce, OfiaKer Can
Low volume spray (concentrate). Foftar. Aircraft
Law volume spray (concentrate). Prebloom.
All mail
low volume spray (concentrate). Fetor. Low
volume ground
Low vohiiiw spray (concentrate), Ptebtoorn, Low
volume ground
Sol bend treatment. At pknUng. Shaker can
Qnflt ^~~~^miHit Aft tilfHifbin ^«h>li'aM <"*•<•
Form
D
sen.
sen.
BCfl,
SC/L
D
D
Minimum
AppUcatkxiRate
na
na
na
na
na
na
na
Moirtmum
ApplcMlon Rate
Dose cannot
be calculated
.625 to Al per
A
.825 fc Al per
A
.825 to Al per
A
.625 b Al per
A
Dose cannot
be calculated
Dose cannot
Ka fwlMitolArf
Max*
*PPS.
not
spec
2 per
Cyde
2psr
Cyde
2per
Cyde
Zper
Cyde
not
spec
not
spec
Max.*
APRS-
*
Max.
Rate
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
Mta. Interval
Between Apps.
OMax.R«te
(Day.)
not spec
not spec
not spec
not spec
not spec
not spec
not spec
RMtrtctwJ
Ertry
liJMiiaal
InlfnW
(D^S)
not spec
not spec
not spec
not spec
not spec
not spec
not spec
feograpMc
UnriUHons
Mowed
OtMlowml
UMUmHMloM
Carrot (Inducing tops) Use Group: Terrestrial Food Crop
UtVKi ireninwnii MI pmnunfj, MOCIWIIMU granuw
•ppicstor
BroadcaslFoftar. Aircraft
Broadcast.Seedang stage, Akcrtft
Broadcast, Fdar, Ground
Broadcast, Seeding stage, Qround
0
D
D
D
D
IbAlperA
LSbAtperA
LSbAlperA
LSbAlperA
1.5bAlperA
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
/days
pfeharvest
Interval.
7 days
prehjuvest
Interval.
/days
pcenarvesi
Interval.
7 days
preahrvest
Interval.
-------
APPENDIX A- Case 4007, [Alllum sativum] ChemlcaM28827 [Alllum sativum]
STTE App»c«tJixiTyp«,AppBcaUontln*»B.Af3pic«»oo
CQUtpflMIlt
LOW vowme spray (concenireie), r onv, Mrcran
Low volume spray (concentrate), Prebloom.
Aircraft
Low volume spray (concentFBte). Fofer. Low
volume ground
^
Low vwUrne spray (concentrate). Mcbtootn, Low
volume ground
CauMlower Use Group: Terrestrial Food Crop
High volume spray (oDute), Foliar, Ground
Spray. Fotar. Aircraft
Spray, Seeding stage, Aircraft
Spray. Oeadlig stage, Ground
Celery Use Group: Terrestrial Food Crop
High volume spray (dhite). Fofer. Ground
Spray, Fofar. Aircraft
Spray. Seeding stage, Aircraft
Form
sen.
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SCVL
SC/L
M'Hinuni
AppicMtan Rale
na
na
na
na
MAxIftnnn
Appfcatton Rite
.825 Ib Al per
A
.825 to Al per
A
.825 to Al per
A
.825 Ib Al ;wr
A
na
na
na
na
na
na
na
Dose can not
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
DOSCt CflflflOt
be calculated
Max.*
AppS.
2per
Cycle
2per
Cyde
2per
Cyde
2per
Cyde
not
spec
not
spec
not
spec
not
spec
Max.*
Apf».
e
Max.
Rote
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
MkUntcn*
f%ff My in fi Arwut
• Max. Me
<0«»9)
not spec
not spec
not spec
not spec
§% a ^^1^1 * ^
nB9U PLIVQ
EfMfy
MCTMl
(D^»)
not spec
not spec
not spec
not spec
As needed
As needed
As needed
As needed
As needed
As needed
As needed
not spec
not spec
not spec
not spec
not spec
not spec
not spec
OeagrapMc
Umtetton*
Mowed
Otetoweil
UM UmlUMtora
15 days
praharvest
Interval.
15 days
ffM*AtUfwA4t
|H0IM|VV9[
InterviJ.
15 days
preharvest
Interval.
IS days
prehsfvest
Interval*
15 days
preharvest
Interval.
13 days
preharvest
Interval.
15 days
preharvest
Interval.
-------
APPENDIX A - Case 4007, [Allium satlvum] Chemical 128827 [Alllum satlvum]
SCTE *«>lc«tk»Trp«./«4Jp«c«tonTJmlno.A»ipicrtlon
Equipment
Spray, Seeulng stage, Ground
Forai
SC/L
MMmum
Application ROM
na
Maximum
Application Rote
Dose cannot
be calculated
Cherry Use Group: Terrestrial Food Crop
BiMdcMt,Folv,Ahcreft
Broadcast, Fofar. Ground
Broadcast. Foliar, Shaker can
Spray. Fofar. Akxwatt
Spray. Petal idL Aircraft
Spray. Fofcr . Ground
Spray. Petal fal. Ground
D
D
D
SC/L
SC/L
SC/L
SC/L
2.5 to Al per A
2.5 to Al per A
na
na
na
na
na
not spec
not spec
Dose cannot
be calculated
DofiA CAflflAf
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Max*
AW*.
not
spec
Max.*
APP».
•
Max.
Rale
not
spec
MbiMerva!
Dfltwccn Aoofi.
OMu.Rste
(Days)
As needed
Restricted
Entry
Intent)
(D*m>
not spec
OaooraoNc
Umftatlona
Mowed
CXMlowed
UMUmltattoin
IS days
prcfwivesi
Interval.
*
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
7daya
preharvesl
Interval.
7 days
pFBnWVSt
Interval.
2 days
Merval.
15 days
preharvest
Interval.
15 days
prafiwwt
Interval.
IS days
preharvest
Interval.
13 days
preharvest
Interval.
Com (Unspecified) Use Groups: TemstrWFood Crop and Terrestrial Feed Crop
Band treatment. At planting. Mechanical
granule apptcalor
D
1 bAlperA
not spec 1 not
|spec
not
spec
not spec
not spec
-------
APPENDIX A- Case 4007, [Allium sativum] Chemlca
SITC appfcrtonTypa. Appfcattm Timing. Appiotton
EcMpmant
Broadcast. Fotar. Aircraft
Broadcast, Seeding stage, Aircran
Broadcast, Fotar. Ground
Broadcast, Seadbig stage. Ground
oioaucasi, onaKer can, Kosicmeigeiiie
Low volume spray (concentrate), Polar. Aircran
Low volume spray (concentrate), PreMoom,
Aircraft
Low volume spray (concentrate), FoRar. Low
volume ground
Low volume spray (concentrate), PreMoom, Low
volume ground
Sol IMIIO ireatmeni, n planting, bnaKer can
Sol treatment At planting, Shaker can
Form
D
D
D
D
D
SC/L
SC/L
SC/L
SC/L
0
D
Minimum
Application Rule
I.StoAlperA
1.5t>AlperA
1.5 to Al per A
LSfcAlperA
na
na
na
na
na
na
na
MAJOlfttffn
Appftcatlon Rote
not spec
not spec
not spec
not spec
Dose cannot
be calculated
.ezSbAlper
A
.BZSbAlper
A
.825bAlper
A
.SZSfcAlper
A
Dose cannot
be calculated
Dose cannot
be calculated
Mn. *
*«"»-
not
spec
not
spec
not
spec
not
spec
not
spec
2 per
Cycle
2 per
Cyde
2per
Cycte
2per
Cyde
not
spec
not
spec
1£8827 [Allium sativum]
MO.*
*»*».
•
Max.
Rate
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
Cucumber Use Group: Terrestrial Food Crop
Spray, Polar, Aircran
SC/L
na
P%__— MM*MBMA I
I/O9O miirivi i
be calculated |
not
spec
not
spec
Mkilntcrwl
Between Appa.
• Max. Rite
(Days)
7
7
7
7
not spec
not spec
not spec
not spec
not spec
not spec
not spec
rtoAttttled
EfHiy
Interval
(DW
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
QooQrAphlc
t j^ M • M • • •
uifmBnonc
Ultrmm^tt
nvowrm
.
OtsUowed
UH UmttMlona
7 days
preharvest
Interval.
7daye
naMlietrifnarf
|MdKHV4HII
interval
7 days
prehafvest
(ntervel.
7 days
prehaWGSt
Werval.
As needed
not spec
15 days
ptofuiivcst
MervaL
-------
APPENDIX A- Case 4007, [Allium sativum] Chemical 128827 [Alllum satlvum]
SfTF ArmftTiflllnn TVRA /Umimflnn Tlminn AmftrjAkm
Equfttnl
Spray, Seeding stage, Aircraft.
Spray, Polar. Ground
Spray, Seeding stage, Ground
Form
SC/L
SC/L
SC/L
Uliiiila^i .-^
Mil HI IIUII 1
Appication Rate
na
na
na
Cereal Qralm Use Groups: Terrestrial Food Crop and Terrestrial Feed Crop
Band treatment At planting, Mechanical granule
•rmknalnr
•IV^*"*
BroadcaslFotar, Alrcratt
Broadcast. Seeding stage. Afroraft
Broadcast,Foaar. Ground
BroMtemt.Scedlng stage, Ground
D
D
D
D
D
IbAlperA
I.SbAlperA
LSbAlperA
I.SbAlperA
LSbAlperA
Maximum
Appicatloo Rale
Dose cannot
be calculated
Dose cannot
be calculated
»>_
uose cannot
be calculated
not spec
not spec
not spec
not spec
not spec
Max.*
Apps.
not
spec
not
spec
not
spec
Mix.*
Apps.
O
Max.
MM
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
Mn. (nun*)
6 Max. Rate
ml
wllGfVBl.
-------
APPENDIX A - Case 4007, [Alllum sativum] Chemical"! 28827 [AMIum satlvum]
SOt Ap»*crtooTyp«,Api)fcrtonT1n*ig.A«iicrtoo
Equtxnmi
Broadcast, Folar. Ground
Form
D
Minimum
AppfcaUon Rale
2.5 to At per A
Maximum
AppNCAtton Rata
not spec
Max.*
*W».
not
spec
Grapes Use Groups: Terrestrial Food Crap and Terrestrial Feed Crop
BroadcastFotar. Aircraft
Broadcast, Folar, Ground
Broadcast Fotar. Shaker can
LOW volume spray (conceniraie), rotar, /urcran
Low volume spray (concentrate), Fotar. Low
volume ground
Spray, Fotar, Ground
Spray. Fdar. Aircraft
D
D
D
SC/L
SC/L
SC/L
SC/L
1.5bAlperA
LSbAlperA
na
na
na
na
na
not spec
not spec
Dose cannot
be calculated
.825 b Al per
A
.825 to Al per
A
LJOSvCanfiOi
be calculated
uose CHrinoi
be calculated
not
spec
not
spec
not
spec
Zper
Cyde
2per
Cyde
not
spec
not
spec
Max.*
Ann.
0
Max.
Ratt
not
spec
MhMwval
f1< IMM mi Jlnm
O Max. Rate
<0«y«)
7
•
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
7
7
7
not spec
not spec
7
7
iwMilclMd
Entry
Interval
(Oay«)
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
^i _ _ ^_ — •_•—
UCKJyVprK
UmttflDuiw
Mtowvd
f%BBBniIIBrt
mwvww
UMUnlMlans
7 days
preharvest
Interval.
•
•
7 days
pivnaivesi
Interval.
7 days
pfBflflfVQSl
Interval.
2 days
ftMUAAt
larvesi
kiterval.
15 days
preharvest
Interval.
15 days
preharvest
Interval.
KM Use Group: Terrestrial Food Crop
Low volume spray (concentrate). FoBar, Aircraft
Low volume spray, Folar, Low volume ground
SC/L
SC/L
na
na
Lemon Use Groups: Terrestrial Food Crop and Terrestrial Feed Crop
Low volume spray (concentrate), Folar, Aircraft
SC/L
na
.825 to Al per
A
.825 to Al per
A
Zper
Cyde
Zper
Cyde
not
spec
not
spec
not spec
not spec
not spec
not spec
.825 to Al per 0 2 per
A fl Cycle
not
spec
not spec
not spec
-------
APPENDIX A- Case 4007, [Allium satlvum] Chemical 128827 [Alllum satlvum]
STJI fVffc*^T^*f**xtoTto^*pi*on
EqutHMM
volunw ground
Form
SC/L
UfeJfMtm
wmifiuin
AppBcaUonBate
na
MAntlUlM
AppBcattoo Rate
.625 to Al per
A
Max.*
AppS.
2per
Cycte
M*IL#
Apps.
«
Max.
Rote
not
spec
Mln.lnMrwl
• Max. Rote
-------
APPENDIX A . Case 4007, [AHlum sativum] Chemlca
SITE Applca1ta»T»p«.Appltartk*)1TmlnaApp»c««wi
Eminent
Sol band treatment At planting. Shaker can
Sol treatment. At planting. Shaker can
Spray. FoHar. Akxraft
Spray, Seedfctg stage, Ahcraft
Spray, Seedfcig ataga, Ground
Melons Use Groups: Terrestrial Food Crop
Band treatment. At planting. Mechanical
oranuto applcator
BroadcaatFolar, Alrcmfl
Broadcast. Oaedang stage, Aircraft
Broadcast, Polar, Ground
Broadcast, Seedftig stage. Ground
Broadcast. Postemergence. Shaker can
Low volume spray (concentrate). Foliar, Aircraft
Form
D
0
SCA.
SCA.
SCA.
D
D
D
0
D
0
SCA.
Minimum
Application Rat*
na
na
na
na
na
Maximum
Application flote
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Max.*
AppB.
not
spec
not
spec
not
spec
not
spec
not
spec
IbAlperA
LSbAlperA
LSbAlperA
LSbAlperA
LSbAlperA
na
na
not spec
not spec
not spec
not spec
not spec
Dose cannot
be calculated
.825 to A) per
A
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
2 per
Cyde
128827 [AHlum sativum]
Max.*
App*.
O
Max
Rite
not
spec
not
spec
not
spec
not
spec
not
spec
Mftklnterttl
Between Apps.
• Max. Rate
-------
APPENDIX A- Case 4007, [Alllum salivum] Chemical 128827 [Alllum sativum]
SITE Apf*caflcmTnM.*jv«ealionTbnhi»A|if*Mflon
Equipment
LOW vownw spray few icemraiej, rnxNOom,
Alrcmfl
LOW vowine spray {conceniraie|« rosar. LOW
volume ground
Low volume spray (concentrate), tabtoom, Low
vdufns ojrouno
soi Dorra ueciHiew, AI pitning, bnnket can
Sot trastment At planting. Shaker can
Spray, FOMT , Aircraft
Spray, Oeedang stage, Aircraft
Spray, Polar. Ground
Spray, Seeding stage. Ground
Form
SC/L
sen.
SC/L
0 .
0
SC/L
SC/L
SC/L
SC/L
MlrNflHIAl
Apefcatton Rrte
na
na
na
na
na
na
na
na
na
Maximum
Appfeatton Rote
.825 to AI per
A
.825 fc AI per
A
.625fcAlper
A
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dosecennot
be calculated
Dose cannot
be calculated
Max.*
ADOS.
Zper
Cycle
2per
Cycle
2per
Cycle
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
Man.*
A«».
0
Max.
Rat*
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
MkwtMerval
Btttwvtcfl Accra
• Ma*.Rat«
(0*y»)
not spec
not spec
not spec
not spec
not spec
As needed
As needed
As needed
As needed
n+ •j^j ^i • j
imiifcwu
Entry
Interval
(Oay»|
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
OaograpMc
• •• M
•mown
Obatowtd
UMUmRatloM
15 days
Interval.
15 days
Interval.
15 days
prenanest
Interval.
15 days
nfWi*s*M«t
^JIClHBH W0V
Interval.
Melons, Cantaloupe Use Group: Terrestrial Food Crop
Low volume apray (concentrate). Polar,
Aircraft
Low volume spray (concentrate), Prebtoom.
Abuafl
Low volume apray (concentrate), Polar,
Low volume ground
. . > n . .
Low vownw spray (concentrate), Preblooin,
Low volume ground
SC/l
SC/L
SC/L
SC/L
na
na
na
na
.825t»Alper
A
.825 to AI per
A
.825 to AI per
A
.025 fc AI per
A
Zper
Cycle
Zper
Cycle
Zper
Cycle
Zper
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
-------
APPENDIX A- Case 4007, [Alllum satfvum] Che mlcgl. 128827 [AlUum satlvum]
Silt Appfcaflon Type. Applk*tk>n Timing. Apptcotloo
Equipment
Spray, Polar. Aircraft
Spray. Seedang stage, Aircraft
Spray. Fofar, Ground
Spray, Goading Mage, Ground
Form
SC/L
SC/L
SC/L
SC/L
nninillvUlit
Application Rate
rta
na
na
na
Maximum
Application Rate
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
MM.*
Apps.
not
spec
not
spec
not
spec
not
spec
Max.*
AppS.
0
Max.
Hate
not
spec
not
spec
not
spec
not
spec
Mln. Intend
• Max. Rate
(Day.)
As needed
As needed
As needed
As needed
Restricted
Entry
Mono!
(D»y»)
not spec
not spec
not
spec
not spec
QcOQFBphlC
Umrtattona
Akmcd
-
Dheaowod
Uaa Umltattafw
IS days
prahaivest
Intefval.
15 days
pref)4vV6Sl
mterval.
IS days
preharvest
Inlervaj.
15 days
— » — ^ — *
prenaivest
interval.
Nectarine Use Group: Terrestrial Food Crop
Broadcast. Fokar, Aircraft
Broadcast Foiar. Qround
D
0
2.SbAlperA
2.5 b 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.
7days
preharvest
Interval.
Onion Use Group: Terrestrial Food Crop
Low volume spray (concentrate), Polar, Aircraft
Low volume spray (concentrate), Ftebkxxn,
Aircraft
1 nu unhinMt nmu IriMti Milrrtnl Fnkr 1 nw
LOW vowim afw«r IVUMU* nime|, r uu , uiw
volume ground
Low volume spray (concentrate). Prebtoom, Low
vohime ground
SC/L
SC/L
SC/L
SC/L
na
na
na
na
.825bAlper
A
.825 b Al per
A
.825 b Al per
A
.825 b Al per
A
2per
Cyde
2 per
Cyde
2per
Cyde
2per
Cyde
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, [AlHum satlvum] Chemical 128827 [Alllum satlvum]
SffiK Appflcflttofi TyfM, ^pp^citton TlininQ, Apfpteatttoti
Equipment
Broadcast. Foaar, Aircraft
Broadcast, Foaar, Ground
Broadcast. Foear. Shaker cm
Spray. Folar, Aircraft
Spray, Petal tel. Aircraft
Spray. Folv. Ground
Spray. Petal ML Ground
Form
D
D
0
SC/L
SC/L
SC/L
SC/L
Minimum
Application Rate
2.5bAlperA
2.5 b Al per A
na
na
na
na
na
Maximum
Applc&tlOA Rattfl
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. *
*PP».
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
Mm*
App*.
O
Max.
Haw
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
Mm. Interval
Botw««n Aupa.
O Max. (tat*
-------
APPENDIX A. Case 4007, [Allium sativum] Chemical 128827 [Alltum sativum]
SITE ApvfcalfcxtTi^ApptcattonTtiTrinaApptcatton
Cqutmmt
Spray, Petal M, Ground
LOW vowme splay iconceniraie), r osar,
Abend
• .. . . - -
Low volume spray (concentrate), Foaw, Low
volume ground
Form
SC/L
SC/L
SC/L
Peach Use Group: Terrestrial Food Crop
Broadcast, Fotar, Alrcrafl
Broadcast.Folar, Ground
Low volume spray (concentrate), row,
Ahxran
Low volume spray (concetrate).Folar,
Low volume ground
Spray, Polar. Alrcrafl
Spray. Petal fal. Aircraft
Spray, Fotar, Ground
Spray, Petal tal. Ground
D
D
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
Minimum
Appicatton flste
na
na
na
2.5 to Al per A
2.5 to Al per A
na
na
na
na
na
na
Maximum
Application Rate
Dose cannot
be calculated
.825bAlper
A
.825 to Al per
A
not spec
not spec
.825 b A) per
A
.825bAlper
A
Dose cannot
oe caicuiaicu
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Max.*
*PP»-
not
spec
2 per
Cycle
2per
Cycle
not
spec
not
spec
2 per
Cycte
2per
Cyde
not
spec
not
spec
not
spec
not
spec
Max*
*PP*.
0
Man.
Rate
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
MM. Men**
0 Max. Rate
(Oay»l
7
not spec
not spec
7
7
not spec
not spec
7
7
7
7
Restricted
Entry
IMenvl
(0«ys)
not spec
not spec
not spec
ffc-i, ^•[•[•fciJM
ueopaprac
UmRntkvKi
A*» — ^ j
NWWQ
fy* aitlri !*•• il
unsvowcv
Ifoa UmdcdORS
15
-------
APPENDIX A- Case 4007, [Alllum sativum] Chemical 128827 [Alllum satlvum]
SITE AfwMcBtion Typft, Appittfton Timing Appicatkm
EqufcmwK
Low vohmw spray (concentrate), FoHv,
Aircraft
Low vohmw apmy (concentrate), Foflar. Low
vohmw pjRMmd
Form
SC/L
SC/L
Minimum
Appicatkxi Rate
rta
na
Mndmum
Applcatkxi Rate
.625 to At per
A
.825bAlper
A
Max.*
*PP».
2 per
Cycle
2per
Cycle
Max.*
Apps.
0
Mtx.
RMe
not
spec
not
spec
MnMen*)
O Mix. RM«
(Days)
not spec
not spec
Pen (Unspodfled) UM Groups: Terrestrial Food Crop and Terrestrial Feed Crop
Low volume spray (concentrate), Foflar, Aircraft
Low vohmw spray (concentrate), Prebnom.
Aircraft
Low vohmw spray (concentrate). Fowl, Low
vohmw ground
Low vohmw spray (concentrate), Prebtoom,
Low vohmw ground
SC/L
SC/L
SC/L
SC/L
na
na
na
na
.SZSbAlper
A
.825bAlper
A
.825 to Al per
A
.825 to Al per
A
2 per
Cycle
2per
Cycle
2 per
Cycle
2per
Cycle
not
spec
not
spec
not
spec
not
spec
not spec
not spec
not spec
not spec
Plum Use Group: Terrestrial Food Crop
Low vohmw spray (concentrate), Fetor, Aircraft
Broedcmt.Fotsr, Akorafl
Broadcast. Fotor, Ground
Low vohmw spray (concentrate), Fotar, Low
vohmw ground
Spray, Foftar, Aircraft
Spray. Petal fal, Aircraft
SC/L
D
D
SC/L
SC/L
SC/L
na
4
2.5bAlperA
2.5 to Al per A
na
na
na
.825 to Al per
A
not spec
not spec
.825 to Al per
A
Dose cannot
be calculated
Dose cannot
be calculated
Zper
Cyde
not
spec
not
spec
Zper
Cyde
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not spec
7
7
not spec
7
7
•^ *- * -•- - -*
ntvfncuo
EMry
• MI • • • at
MlCnni
(D««)
not spec
not spec
f% , ,. i, ____*_*__
ueopopnc
Umltrtom
Allowed
OlHlotwd
UMUmacOons
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
•
7 days
Interval.
7 days
-_*
Muvesi
interval.
IS days
preharvest
Inlerval.
15 days
preharvest
interval.
-------
APPENDIX A - Case 4007, [Allium satlvum] Chemical 128827 [Alllum satlvum]
STOI Applcatton Type. Applcatlon timing. Applcatlon
Equipment
Spray. Foter. Ground
Spray, Petal fsl. Ground
Form
SC/L
SC/L
MwiMviuin
Apptcatkxi Rale
na
na
Maximum
Application flats
Dose cannot
be calculated
Dose cannot
be calculated
Potato. WMle/lrbh Use Groups: Terrestrial Food Crop and Terrestrial Feed Crop
low volume ground
Low volume spray (concentrate), Folar, Low
volume ground
Low volume spray (concentrate), Prebtoom,
Afrcmn
SC/L
SC/L
SC/L
SC/L
na
na
na
na
.825 fo Al per
A
.625 fc Al per
A
.825 to Al per
A
.825 to Al per
A
Pumpkin Use Group: Terrestrial Food Crop
Low volume spray (concentrate), Prebtoom,
Aircraft
Low volume spray (concentrate), Fotar, Low
vonime yiuund
Low volume spray (concentrate). Prebtoom,
Low volume ground
SC/L
SC/l
SC/L
SC/L
na
na
na
na
.825 b Al per
A
.625 to Al per
A
.825 to Al per
A
.825 to Al per
A
Max.*
Apps.
not
spec
not
spec
2 per
Cycte
2per
Cycle
2 per
Cycle
Zper
Cyde
Max.*
Apps.
0
Max.
Rale
not
spec
not
spec
MH. Interval
Between Apps.
• Max. Rate
-------
APPENDIX A- Case 4007, [Alllum sativum] Chemical 128827 [Allium satlvum]
STS AppfcaHonType.ApptattonTtiT*»o,App»catton
Equipment
Sol tMiid treatment. At planting. Shaker can
Srmf Fruits Use Group: Terrestrial Food Crap
BroadcaatFofar, Aircraft
Broadcast, FoBar. Ground
Spray. Foaar, Aircraft
Spray, Folar. Ground
Spinach Use Group: Terrestrial Food Crop
High volume spray (daute), Fotar. Ground
Spray, Fdar, Aircraft
Spray, Seeding stage, Abcraft
Spray. Seedang stage, Ground
Form
0
Minimum
Application Role
na
Maximum
Application Rate
Dose cannot
be calculated
MM.*
*PP».
not
spec
Max.*
APP».
0
Max.
Rate
not
spec
KKMefwl
BvtwBvn ApfMt
O Max. Rate
(Days)
not spec
Entry
Men**
(Dm)
not spec
Geographic
Umftattom
Mo»»d
D
D
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
2.5 b Al per A
2.5
-------
APPENDIX A- Case 4007, [Allium satlvum] Chemical 128827 [Alllum sativum]
WTC AcpfcMonTKM.A|>p«c^ton Timing. AppActflon
Equipment
Band treatment. At planting, Mechanical
granule appfcator
Broadc*st.Folar, Aircraft
Broadcast, Seeding stage. Afcmft
I
Broadcast, Foear. Ground
Broadcast. Seeding stage. Ground
Form
D
D
D
O
0
Mfei'fiufn
ApptcMJonFMo
IbAlperA
LSbAlperA
LSbAlperA
LSbAlperA
1.5bAlperA
Maximum
Apptcatkm Rate
not spec
not spec
not spec
not spec
not spec
Mw.*
AW».
not
spec
not
spec
not
spec
not
spec
not
spec
Max.*
tops.
«
Max
R*W
not
spec
not
spec
not
spec
not
spec
not
spec
Mn. Inter*)
BatwQCfl Apps.
0>M*x.Rate
(Diy*)
not spec
7
7
7
7
j"fc - _ * * ~ » _ j
nvMricwa
Eimy
Intervri
(My*)
not spec
not spec
not spec
not spec
not spec
QragnpMc
Umtttttoiw
Mkwwd
Otaclowed
UseUnHtrtons
7days
pCCIWVvvI
Interval
7days
prenaivesi
Interval.
7 days
preharvest
Interval.
7 days
Interval.
Tomato Use Groups: TemwMal Food Crop and Terrestrial Feed Crop
appfcator
Broadcast. Foter. Aircraft
Broadcast Seedktg stage, Alrcran
Broadcast. Seeolng stage, Ground
High volume spray (dftrte), Fofer, Ground
D
D
D
D
D
SC/L
1.5t>AlperA
IbAlperA
1.5 b Al per A
1.5 b At per A
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
pffihWASf
Interval.
7dtV8
njiotumiABt
pfenwm
Interval.
7 days
preharvest
•ilerval.
15 days
preharvest
interval.
-------
APPENDIX A- Case 4007, [Allium satlvum] Chemical 128827 [Alllum satlvumj
Silt AppfcattonType,A0p»cattc>nTmi^Appicat»on
EtMpmar*
Sol bind treatment. At planting. Shaker can
Sol treatment. At planting. Shaker can
Spray. Polar. Aircraft
Spray. Oeedteg stage, Abcrafl
Spray. Seedtog stage. Ground
Tree Nuts Use Group: Terrestrial Food Crop
BroadcastFolar. Aircraft
Broadcast. Fotar. Ground
Form
D
D
SC/L
SC/L
SCfl.
MMmum
Apptcatfcm Rate
na
na
na
na
na
Maximum
ai •••*>! *•••!«• B^Jb^
•\PPHCBUOCT noW
uosecannoi
becakutaled
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
0
D
2.5bAlperA
2.5bAlperA
not spec
not spec
Max.*
Apps.
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
M«.*
«*».
0
Max.
Rate
not
spec
not
spec
not
spec
not
spec
not
spec
MKMervil
DQltffQCII App9.
• MBX.RCM
-------
APPENDIX A- Case 4007, [Allium sativum] Chemical 128827 [Alllum satlvum]
SITE ^oplotton Typt. *pp»c«Boo Tlmlno. App»LJtloo
EcMpnwnl
Broadcast. Seedfeg stage, Ground
Broadcast. Poslemergence, Shaker can
High volume spray (dfcrte). FoBar, Ground
Sol band treatment. At planting. Shaker can
Sol treatment At planting. Shaker can
Spray. Fetar. Aircraft
Spray. Seeding stage, Aircraft
Spray, Seeding stage. Ground
Vtfabiiit JCn«4«H!Rferbl ll**ftntt«v T^TRMfrM F
Low volume spray (concentrate), Foter, Aircraft
Low volume spray (concentrate). Fotar. Low
volume ground
Form
0
D
SC/L
D
D
SC/L
SC/L
SC/L
Minimum
Application Rote
I.SIbAlperA
na
na
na
na
na
na
na
Mttnnuin
Appfcatton Rate
not spec
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
Dose cannot
be calculated
UOSOCfllwIOI
be calculated
Dose cannot
be calculated
Mix.*
*W».
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
Mot*
*«».
e>
Mf*.
Rote
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
not
spec
Mh. IflttM*
Br fWrfU AvHMt
©Max. Rate
(0«)»)
7
not spec
As needed
not spec
not spec
As needed
As needed
As needed
RttMctKl
Envy
Mcryri
(Days)
not spec
not spec
not spec
not spec
not spec
not spec
not spec
not spec
GeopipMe
UvfiUfttlonc
Mowrt
•
OMfCMWd
Us* Umltotkxw
7 days
prehaivest
Interval.
15 days
prehaivest
Interval.
tSdeys
nmaliMMMMl
prenarvesi
Interval.
15 days
preharvest
Interval.
15 days
«*.*.._«_•.
^Jl Vf l«l TO01
Interval.
ood Crop
SC/L
SC/L
na
na
.825fcAlper
A
.B25toAlper
A
Zper
Cycle
2per
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, Fotor. Aircraft
SC/L
na
not
spec
not
spec
As needed
not spec
-------
APPENDIX A • Case 4007, [Alllum satlvum] Chemical 128827 [Alllum satlvum]
EM^*MVA«4
LIMpflMNII
Spray. Folw , Ground
("tenamMht^ UUVuutu ^hn ,Ha Mut Ub«a« 1 !• m AMU uMt T
umsmeHiai woooy oniuro MM vwm UM uroupa. i
Spray, Fotar, Alrcnfl
Spray, Fohr. Ground
Form
SC/L
* *fa,ia.. M|.
wwinum
AppBcMton H»t«
m
M«odtnum
AppHctttlon Rvt4
Dose cannot
be calculated
errestrfd Non-Food Crop «nd Outdoor ResldenlM
SC/L
SC/L
na
na
Do80 cannot
be calculated
LW90C8nn
-------
APPENDIX B
Generic Data Requirements for Registration of Allium sativum and
Data Citations Supporting Reregistration
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which
support the rcregistration 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.
-------
APPENDIX B
GENERIC DATA REQUIREMENTS FOR REREGISTRATION OF ALLITOt SATIVUM
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
-------
63-10 Dissociation Constant ABCK satisfied
63-12 pH ABCK satisfied
63-13 Stability ABCK satisfied
Ecological Effects;
EPA waived all of these data requirements as discussed in sections III and IV.
Toxicology;
EPA waived all of these data requirements discussed in sections III and IV.
Environmental Fate:
EPA waived all of these data requirements discussed in section III and IV.
Residue Chemistry;
EPA waived all of these data requirements as discussed in section III and IV.
Occupational Exposure;
EPA waived all of these data requirements as discussed in section III and IV.
-------
APPENDIX C
Citations Considered to be Part of the Data Base
Supporting the Reregistration of Allium sativum
-------
GUIDE TO APPENDIX C
1. 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.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the
case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency the Agency has sought to identify
documents at a level parallel to the published article from within the typically
larger volumes in which they were submitted. The resulting "studies" generally have
a distinct title (or at least a single subject), can stand alone for purposes of
review, and can be described with a conventional bibliographic citation. The Agency
has attempted also to unite basic documents and commentaries upon them, treating
them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically
by Master Record Identifier, or MRID number. This number is unique to the citation,
and should be used at any time specific reference is required. It is not related to
the six-digit "Accession Number" which has been used to identify volumes of submitted
studies; see paragraph 4(d)(4) below for further explanation. In a few cases,
entries added to the bibliography late in the review may be preceded by a nine-
character temporary identifier. These entries are listed after all MRID entries.
This temporary identifier number is also to be used whenever specific reference is
needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standards of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
-------
a. Author. Whenever the Agency could confidently Identify one, the Agency has
chosen to show a personal author. When no individual was identified, the Agency
has shown an identifiable laboratory 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.11
(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 "COL," standing for "Company Data
Library." This accession number is in turn followed by an alphabetic
suffix which shows the relative position of the study within the volume.
-------
For example, within accession number 123456, the first study would be
123456-A; the second, 123456-B; the 26th, 123456-Z; and the 27th, 123456-
AA.
-------
OFFICE OF PESTICIDE PROGRAMS
REREGISTRATION ELIGIBILITY DOCUMENT
BIBLIOGRAPHY
470028026 Supplementary To The List Of Data Requirements. Unpublished study submitted by Sevana
Company.
-------
APPENDIX D
PR Notice 91-2
-------
I UNFTID fTATU ENV1RONMEWTAL PROTfCnON ACINCY
•m ^ T^iPJ^pB^BjPaj^gl I %PPV( Bp*^** (HS^aaaji
NmX
f* MOTXCI tl-2 anttv
* "*" ** * KfncotsMOTOIC
fUWTAMCtS
HOTICS TO MANUFACTURERS, PRODUCERS, FORKU1ATORS,
AND REGISTRANTS OP PESTICIDES
ATTZNTION: Parson* Responsible for Federal Registration of
Pesticide Product*.
SUBJECT: Accuracy of Statad Percentages for Ingredients
Stataaant
I. PURPOSE:
Tha purpose of this notica ia to clarify the Of f ica - of
Paaticida Program'a policy with raapact to tha stataaent of
percentages in • peaticide's label's ingredient atataaant.
Spacifically, tha amount (parcant by wight) of ingradiant(a)
spacifiad in tha ingradiant stataaant on tha labal »u*t ba atatad
as tha noainai concentration of such ingradiant (s), as that tara is
dafinad in 40 CTR 131.133(i). Accordingly, tha Agancy has
astablishad tha noainai concantration as tha only accaptabla labal
claia for tha aaount of active ingradiant in tha product.
II. BAOWROUND
For soaa tiaa tha Agancy has accepted two different aethods of
identifying en tha label what percentage ia claiaad for tha
ingradiant(s) contained in a peaticida. Seaa applicanta claiaad a
percentage which repreaented a level between tha upper and the
lower certified liaits. This waa referred to aa the noainai
concentration* Other applicanta claiaed tha lower liait aa the
percentage of tha ingredient (a) that would ba expected to be
preaent in their product at tha end of the product'a ahelf-life.
Unfortunately, this led to a great deal of confusion aaong tha
regulated industry, the regulatora, and the eonauaera aa to exactly
how auch of a given ingredient waa in a given product* Tha Agency
haa established the noainai concentration aa the only acceptable
labal claia for tha amount of active ingredient ia tha product.
Currant regulations require that tha percentage listed in the
active ingradiant stateaent be aa precise as possible reflecting
good manufacturing practicaa 40 CFR lS«.10(g)(S). Tha certified
liaits required for aach active ingredient are intended to
encoapaas any such "good manufacturing practice11 variations 40 CFR
158.175(0)(3).
-------
2.
The upper and lover certified limits, which must torn proposed In
connection with a product *• registration, represent the amount* of
an ingredient that aay legally be preaent 40 CFR 158.175, The lovar
eartifiad limit ia used aa tha enforceable lovar liait for tha
product coapoaition according to FirSA aaetion 12(a)(l)(C), while
tha nominal concantration appearing on tha labal would ba tha
routinaly achiavad coneantration uaad for calculation of doeagae
and dilutions.
Tha noainai coneantration would in fact atata tha greatest
degree of accuracy that ia warranted with raapact to actual product
coapeaition because tha noainal concantration would ba tha amount
of activa ingredient typically found in tha product.
It ia important for ragiatranta to nota that eartifiad liaita
for active ingredienta ara not considered to ba trada aacrat.
information under riTFA aaetion 10(b). In this raapact tha
eartifiad liaita will ba routinaly providad by EPA to Stataa 'for
anforeaaant purposes, ainea tha noainal concentration appearing on
tha labal aay not rapraaant tha enforceable eoapoaition for
purpoaaa of aaetion l2(a)(l)
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XV. PRODUCTS THAT RIQUIRI EFFICACY DATA
All pesticides are required to be efficacious. Therefore
the certified lev*r limits say not be lower than the ainiaua '
level to achieve efficacy. This is extreaaly important for
products which «r* intended to control pests which threaten the
public h**lth, e.g., certain antiaicrobial and rodenticide
products. Refer to 40 CFR 151.640.
In thos* easas where afficacy liaits hava been established,
tha Agency will not aeeapt cartiflad lovar liaits which ara below
that laval for tha shalf lifa of'tha product.
«. COMPLIANCE SCHEDULE
As dascribad aarliar, tha purpose of this Notiea is to aaks
tha registration procass aora unifom and »ora aanageable for
both tha «?aney and tha ra^ulatad coaaunity. It is tha A
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APPENDIX E
Pesticide Reregistration Handbook
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THE HANDBOOK IS NOT INCLUDED IN THIS COPY OF THE DOCUMENT
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APPENDIX F
Product Specific Data Call-In
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,
'g UNPTED STATES ENVIRONMENTAL PROTECTION AGENCY
" WASHINGTON, D.C. 20440
DATA CALL-IN-NOTICE
OFF ICE OF
PCSTCCES AND TOXIC
CERTIFIED MAIL SUKTANCIS
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide
products containing the active ingredient identified in
Attachment A of this Notice, the Data Call-in Chemical status
£&££&, 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 oust respond as set forth
in Section III below. Your response aust 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, Data Call-In Baflttonae Fora, as veil 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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This Notice is divided into six sections and seven
Attachments. The Notice itself contains information and
instructions applicable to all Data Call-In Notices. The
Attachments contain specific chemical information and
instructions. The six sections of the Notice are:
Section X - Why You Are Receiving This Notice
Section II - 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 VZ - Inquiries And Responses To This Notice
• The Attachments to this Notice are:
A - Data Call-In Chemical Status Sheet
& - Data Call-in, Response Fora
C - Requirements Status and Jtejristrant' s Response Fora
D - EPA Grouping of End-Use Products for Meeting Acute
Toxicology Data Requirements for Reregistration
£ • EPA Acceptance Criteria
F - E*ist of Registrant^ Receiving This Notice
G - Cost Share and Data Compensation Forms, and Product
Specific Data Report Fora
SECTION Z. 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.
SECTZON ZZ. DATA REQUIRES BY THIS NOTICE
IZ-A. DATA REQUIRED
The product specific data required by this Notice are
specified in Attachment C, Requirements Status and Registrant, * a
Response form. Depending on the results of the studies required in
this Notice, additional testing may be required.
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II-B. SCHEDULE Fflp SUBMISSION OF
You are required to submit the data or otherwise satisfy the
data requirements specified in Attachment C, Requirements status
and Registrant's Response Fora, within the time frames provided.
JI-C. TESTINC PRQTQCpL
All studies required under this Notice must be conducted in
accordance with test standards outlined in the Pesticide Assessment
Guidelines for those studies for which guidelines have been
established.
These EPA Guidelines are available from the National Technical
Information Service (NTIS), Attn: Order Desk, 5285 Port Royal Road,
Springfield, Va 22161 (tel: 703-487-4650).
$ Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if the OECD-
recommended test standards conform to those specified in the
Pesticide Data Requirements regulation (40 CFR 5 158.70). When
using the OECD protocols, they should be modified as appropriate so
that the data generated by the study will satisfy the requirements
of 40 CFR i 158. Normally, the Agency will not extend deadlines
for complying with data requirements when the studies were not
conducted in accordance with acceptable standards. The OECD
protocols are available from OECD, 1750 Pennsylvania Avenue N.w.,
Washington, D.c. 20006.
All new studies and proposed protocols submitted in response
to this Data Call-In Notice must be in accordance with Good
Laboratory Practices [40 CFR Part 160. 3(a) (6) ] .
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3feW21fBl NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-In does not in
anv way supersede or change the requirements of anv prfyjlous pata
Call-lnfsi . 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 OF THIS NOTICE
JII-A. PEDVItg FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice
for product specific data must be submitted to the Agency within 90
days after your receipt of this Notice. Failure to adequately
respond to this Notice within 90 days of your receipt will be a
basis for issuing a Notice of Intent to Suspend (NOIS) affecting
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your products. This and other bases for issuance of HOIS due to
failure to comply with this Notice are presented in Section IV-A
and IV-B.
JII-B. OPTIONS FOE RESPONDING TO THE AGENCY
The options for responding to this Notice for product specific
data are: (a) voluntary cancellation, (b) agree to satisfy the
product specific data requirements imposed by this Notice or (c)
request a data waiver(s).
A discussion of how to respond if you choose the Voluntary
Cancellation option is presented belov. 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 vaivers is
contained in Section III-D.
There are two forms that accompany this Notice of which,
depending upon your response, one or both must be used in your
response to the Agency. These forms are the Data-Call-in Response
fora, and the Requirements Status and Registrant's Response Fqrm.
Attachment B and Attachment C. The Data Call-In Response Form must
be submitted as part of every response to this Notice. In
addition, one copy of the Requirements status and jReaistrant*s
Response Form must be submitted for each product listed on the
Data Call-In Response Form unless the voluntary cancellation option
is selected or unless the product is identical to another (refer to
the instructions for completing the Data call-in Response Form in
Attachment B). Please note that the company's authorized
representative is required to sign the first page of the Data Call-
in Response Fora and Requirements s^atjus and Registrant's Response
Form (if this form is required) and initial any subsequent pages.
The forms contain separate detailed instructions on the response
options. Do not alter the printed material. If you have questions
or need assistance in preparing your response, call or write the
contact person(s) identified in Attachment A.
1. Voluntary Cancellation - You may avoid the requirements of
this Notice by requesting voluntary cancellation of your product(s)
containing the active ingredient that is the subject of this
Notice. . It you wish to voluntarily cancel your product, you must
submit a completed Data Call-in Response Form, indicating your
election of this option. Voluntary cancellation is item number 5
on the Pata call-lrt Response Fora. If you choose this option, this
is the only form that you are required to complete.
If you choose to voluntarily cancel your product, further sale-
and distribution of your product after the' effective date of
cancellation must be in accordance with the Existing Stocks
provisions of this Notice which art contained in Section iv-c.
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2. Satisfying the. Product Specific DataRequirements of
Notice. There are various options available to satisfy the product
specific data requirements of this Notice. These options are
discussed in Section III-C of this Notice and comprise options l
through 6 on the Requirementa Status and Registrant's Response Form
and itea numbers 7a and 7b on the Data Call-In Response Porn.
Deletion of a use(s) and the low volume/minor use option are not
valid options for fulfilling product specific data requirements.
3. Request for Product Specifie Data Waivers. Waivers for
product specific data are discussed in Section III-D of this Notice
and are covered by option 7 on the Requirements status and
Registrant * s Response form. If you choose this option, you must
submit both forms as veil as any other information/data pertaining
to the option chosen to address the data requirement.
Iir-C SATISFYING THE DATA REQUIREMENTS OP THIS NOTICE
If you acknowledge on the Dat;a gall-In Response Form that you
agree to satisfy the product specific data requirements (i.e. you
select option 7a or 7b), then you must select one of the six
options on the Requirements Status and Registrant's Response Porn
related to data production for each data requirement. Your option
selection should be entered under item number 9, "Registrant
Response.1* The six options related to data production are the
first six options discussed under item 9 in the instructions for
completing the Requirements Status and Registrant's Response Form.
These six options are listed immediately below with information in
parentheses to guide registrants to additional instructions
provided in this Section. The options are:
(1) I will generate and submit data within the specified
timeframe (Developing Data)
(2) I have entered into an agreement with one or more
registrants to develop data jointly (Cost Sharing) •
(3) I have made offers to cost-share (Offers to Cost Share)
(4) X am submitting an existing study that has not been
submitted previously to the Agency by anyone (Submitting
an Existing study)
(5) I am submitting or citing data to upgrade a study
classified by EPA as partially acceptable and upgradeable
(Upgrading a Study)
(6) I am citing an existing study that EPA has classified as
acceptable or an existing study that has been submitted
but not reviewed by the Agency (Citing an Existing Study)
Potion l. Developina Data — If you choose to develop the
required data it must be in conformance with Agency deadlines and
with other Agency requirements as referenced herein and in the
attachments. All data generated and submitted must comply with the
Good Laboratory Practice (GLP) rule (40 CTR Part 160), be conducted
. according to the Pesticide Assessment Guidelines (PAG), and be in
f conformance with the requirements of PR Notice 86*5.
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The time frames in the Requirements Status and Registrant's
Response Form are the tine 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
reg istration(s).
If you cannot submit the data/reports to the Agency in the time
required by this Notice and intend to seek additional time to meet
the requirements (s), you must submit a request to the Agency which
includes: (1) a detailed description of the expected difficulty and
(2) a proposed schedule including alternative dates for meeting
such requirements on a step-by-step basis. You must explain any
technical or laboratory difficulties and provide documentation from
the laboratory performing the testing. While EPA is considering
your request, the original deadline remains. The Agency will
respond to your request in writing. Zf EPA does not grant your
request, the original deadline remains. Normally, extensions can
be requested only in cases of extraordinary testing problems beyond
the expectation or control of the registrant. Extensions will not
be given in submitting the 90-day responses. Extensions will not
be considered if the request for extension is not made in a timely
fashion; in no event shall an extension request be considered if it
is submitted at or after the lapse of the subject deadline.
Potion 2. Agree to Share in Coat to Develop Data —Registrants
may onlv 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 n"mh«T- of the product for which data w^l be
submitted must 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 vho 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 nay resolve their
differences through binding arbitration.
Option 3. Offer to Share in the Cost of Data Development —
This option only applies to acute toxicity and certain efficacy
data as described in option 2 above. If you have made an offer to
pay in an attempt to enter into an agreement or amend an existing
agreement to meet the requirements of this Notice and have been
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unsuccessful, you may request EPA (by selecting this option) to
exercise its discretion not to suspend your registration(s),
although you do not comply with the data submission requirements of
this Notice. EPA has determined that as a general policy, absent
other relevant considerations, it will not suspend the registration
of a product of a registrant who has in good faith sought and
continues to seek to enter into a joint data development/cost
sharing program, but the other registrant(s) developing the data
has refused to accept your offer. To qualify for this option, you
must submit documentation to the Agency proving that you have made
an offer to another registrant (who has an obligation to submit
data) to share in the burden of developing that data. You must
also submit to the Agency a completed EPA Form 8570-32,
Certification of Offer to Cost Share in the Development of Data,
Attachment G. In addition, you must demonstrate that the other
registrant to whom the offer was made has not accepted your offer
to enter into a costsharing agreement by including a copy of your
offer.and proof of the other registrant's receipt of that offer
(such as a certified mail receipt). Your offer must, in addition
to anything else, offer to share in the burden of producing the.
data upon terms to be agreed or failing agreement to be bound by
binding arbitration as provided by FIFRA section 3(c)(2)(B)(iii)
and must not qualify this offer. The other registrant must also
inform EPA of its election of an option to develop and submit the
data required by this Notice by submitting a Data Call-in Response
Fora and a Requirements Status ajjd Registrant's Response Foipn
committing to develop and submit the data required by this Notice.
In order for you ttf 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.
'Qptlon 4» {fujpffittino 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
penis Notice, normally without an extension of the required date of
submission. The Agency aay determine at any time that a study is
not valid and needs to be repeated.
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8
To meet the requirements of the DCI Notice for submitting an
existing study, all of the falloying three criteria^must be clearly
met:
a. You must certify at the time that the existing study is
submitted that the raw data and specimens from the study are
available for audit and review and you must identify where they
are available. This must be done in accordance with
the requirements of the Good laboratory Practice (GLP)
regulation, 40 CFR Part 160. As stated in 40 CFR 160.3(j)
* '(r}aw data* means any laboratory worksheets, records,
memoranda, notes, or exact copies thereof, that are the result
of original observations and activities of a study and are
V necessary for the reconstruction and evaluation of the report
of that study. In the event that exact transcripts of raw data
. -have been prepared (e.g., tapes which have been transcribed
verbatim, dated, and verified accurate by signature), the exact
copy or exact transcript may be substituted for the original
source as raw data. 'Raw data1 may include photographs,
microfilm or microfiche copies, computer printouts, magnetic
media, including dictated observations, and recorded data from
automated instruments." The term "specimens", according to 40
CFR 160.3(k), means "any material derived from a test system
for examination or analysis."
b. Health and safety studies completed after May 1984 must also
contain all GLP-required quality assurance and quality control
information, pursuant to the requirements of 40 CFR Part ISO.
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 authorired official or
representative of the registrant.
c. You must certify that each study fulfills the acceptance
criteria for the Guideline relevant to the study provided i
the FIFRA Accelerated Reregistration Phase 3 Technical Guidance
and that the study has been conducted according to the
Pesticide Assessment Guidelines (PAG) or aeets 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. Zf you wish to submit the study, you
must, in addition to certifying that the purposes of the PAG
are met by the study, clearly articulate the rationale why you
believe the study meets the purpose of the PAG, including
copies of any supporting information or data. It has been the
Agency's experience that studies completed prior to January
1970 rarely satisfied the purpose of the PAG and that necessary
raw data are usually not available for such studies.
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It you submit an existing study, you must certify that the
study meets all requirements of the criteria outlined above.
It you Know of a study pertaining to any requirement in this
Notice which does not meet the criteria outlined above but does
contain factual information regarding unreasonable adverse effects,
you must notify the Agency of such a study. Zf such study is in
the Agency's files, you need only cite it along with the
notification. Zf not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5.
Option S. Upgrading a Study — Zf a study has been classified
as partially acceptable and upgradeable, you may submit data to
upgrade that study. The Agency will reviev the data submitted and
determine if the requirement is satisfied. Zf the Agency decides
the requirement is not satisfied, you may still be required to
submit new data normally without any time extension. Deficient,
but upgradeable studies will normally be classified as
supplemental. However, it is important to note that not all
studies classified as supplemental are upgradeable. Zf you have
questions regarding the classification of a study or whether a
study may be upgraded, call or write the contact person listed in
Attachment A. Zf you submit data to upgrade an existing study you
must satisfy or supply information to correct all deficiencies in
the study identified by EPA. You must provide a clearly
articulated rationale of how the deficiencies have been remedied or
corrected and why the study should be rated as acceptable to EPA.
Your submission must also specify the 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 MRID number of the study being
upgraded.
The criteria for submitting an existing study, as specified in
Option 4 above, apply to all data submissions intended to upgrade
studies. Additionally your submission of data intended to upgrade
studies must be accompanied by a- certification that you comply with
each of those criteria as well as a certification regarding
protocol compliance with Agency requirements.
Option 6. Citing Existing Studies •- Zf you choose to cite a
study that has been previously submitted to EPA, that study must
have been previously classified by EPA as acceptable or it must be
a study which has not yet been reviewed by the Agency. Acceptable
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10
toxicology studies generally will have been classified as "core-
guideline" or "core minimum." For all other disciplines the
classification would be "acceptable." With respect to any studies
for which you wish to select this option you must provide the KRZD
number of the study you are citing and, if the study has been
reviewed by the Agency, you must provide the Agency's
classification of the study.
If you are citing a study of which you are not the original
data submitter, you must submit a completed copy of EPA Form
8570-31, Certification with Respect to Data Compensation
Requirements.
Registrants who select one of the above 6 options must meet all
of the requirements described in the instructions for completing
the Data call,-In Response Form and the Requirements Status and
Registrant's Response Form, as appropriate.
III-D REQUESTS FOR DATA WAIVERS
Zf 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. If the Agency approves your waiver request, you will not
be required to supply the data pursuant to section 3(c)(2)(B) of
FIFRA. 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 na£ 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 FAIIffRE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products
subject to this Notice due to failure by a registrant to comply
with the requirements of this Data Call-In 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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11
1. Failure to respond as required by this Notice within 90
days of your receipt of this Notice.
2. Failure to submit on the required schedule an acceptable
proposed or final protocol if such is required to be submitted
to the Agency for review.
3. Failure to submit on the required schedule an adequate
progress report on a study if required by this Notice.
4. Failure to submit on the required schedule acceptable
data as required by this Notice.
5. Failure to take a required action or submit adequate
information pertaining to any option chosen to address the data
requirements (e.g., any required action or information
pertaining to submission or citation of existing studies or
offers, arrangements, or arbitration on the sharing of costs or
the formation of TasX Forces, failure to comply with the terns
. 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 III-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 Ca^l-In jtesoonae Fora 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 DETERM^WATION THAT SUBMITTED STPPY IS
The Agency may determine that a study (even if submitted within
the required time) is unacceptable and constitutes a basis for
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12
issuance of a Notice of Intent to Suspend. The grounds for
suspension include, but are not limited to, failure to neet any of
the following:
1. EPA requirements specified in the Data Call-In Notice or
other documents incorporated by reference (including, as
applicable, EPA Pesticide Assessment Guidelines, Data Reporting
Guidelines, and GeneTox Health Effects Test Guidelines)
regarding the design, conduct, and reporting of required
studies. Such requirements include, but are not limited to,
those relating to test material, test procedures, selection of
species, number of animals, sex and distribution of animals,
' dose and effect levels to be tested or attained, duration of
, test, and, as applicable, Good Laboratory Practices.
. 2. EPA requirements regarding the submission of protocols (if
• applicable), including the incorporation of any changes
required by the Agency following review.
3. EPA requirements regarding the reporting of data, including
the manner of reporting, the completeness of results, and the
adequacy of any required supporting (or raw) data, including,
but not limited to, requirements referenced or included in this
Notice or contained in PR 86-5. All studies must be submitted
in the fora of a final report; a preliminary report will not be
considered to fulfill the submission requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale,
distribution and use of existing stocks of a pesticide'product
which has been suspended or cancelled if doing so would be
consistent with the purposes of the Act.
The Agency has determined that such disposition by registrants
of existing stocks for a suspended registration when a section
3(c)(2)(B) data request is outstanding would generally not be
consistent with the Act's purposes. Accordingly, the Agency
anticipates granting registrants permission to sell, distribute, or
use existing stocks of suspended product(•) 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 will have, under most circumstances,
one year from the date your 90 day response to this Notice is due,
to sell, distribute, or use existing stocks. Normally, the Agency
will allow persons other than the registrant such as independent
distributors, retailers and end users to sell, distribute or use
such existing stoclcs until the stocks are exhausted. Any sale,
distribution or use of stoclcs of voluntarily cancelled products
containing an active ingredient for which the Agency has particular
risk concerns will be determined on a case-by-case basis.
Requests for voluntary cancellation received aj£ej: the 90 day
response period required by .this Notice will not result in the
Agency granting any additional tiae to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was
due unlesg you demonstrate to the Agency that you are in full
compliance with all Agency requirements, including the requirements
of this Notice. For example, if you decide to voluntarily cancel
your registration six months before a 3 year study is scheduled to
be submitted, all progress reports and other information necessary
to 'establish that you have been conducting the study in an
acceptable and good faith manner must have been submitted to the
Agency, before EPA will consider granting an existing stocks
provision.
SECTION V, REGISTRANTS * OBLIGATION TO REPORT POSglftlJ^
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that
if at any time after a pesticide is registered a registrant has
additional factual information regarding unreasonable adverse
effects on the environment by the pesticide, the registrant shall
submit the information to the Agency. Registrants' must notify the
Agency of any factual information they have, from whatever source,
including but not limited to interim or preliminary results of
studies, regarding unreasonable adverse effects on man or the
environment. This requirement continues as long as the products
are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
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 and 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. Xf the voluntary cancellation option is
chosen, only the pata Call-In Response Fora need be submitted.
-------
14
The Office of Compliance Monitoring (OCM) of the Office of
Pesticides and Toxic Substances (OPTS), EPA, will be monitoring the
data being generated in response to this Notice.
Sincerely yours,
A -
B •
C •
D •
E -
F -
C -
.Daniel M. Barolo, Director
Special Review and
Reregistration Division
Attachments
Data Call-in Chemical Status Sfree^
Data Call-In Response Fern
Requirements Status and Registrant's Response Form
EPA grouping of End-Use Products for Meeting Acute
Toxicology Data Requirements for Rereoistration
EPA Acceptance Criteria
List of Registrants Receiving This Notice
Cost Share and Data Compensation Forms, and Product
Specific Data Report Form
-------
ATTACHMENT A
Chemical Status Sheet
-------
ATTACHMENT A
ALLIEM BATIVUMl DATA CALL-IN CHEMICAL STATUS SHUT
INTRODUCTION
You have been sent this Data Call-In Notice because you have
products containing *,i 1 imp
attachment, the Data Call— in Qjemieal Status Sheet.
contains a point of contact for inquiries. This attachment is to
be used in conjunction with (1) the Data Call-in Notice. (2)
Attachment B, the Data call-in Response Form. (3) Attachment C, the
Requirement Status and Registrant's Response Form for product
specific data, (4) Attachment D, EPA Grouping of End-Use Products
for Meeting Acute Toxicology Data Requirements for Rereaistration.
(5) Attachment E, EPA Acceptance Criteria. (6) Attachment F, List
of All Registrant t si sent this Data Call-in Notice, and (7)
Attachment G, the Coat Share and Data Compensation Forma for
product specific data, and Product Specific Data Report Form for
use in replying to this Allium sativua 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 sativum 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 eat- ivy?1- 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
-------
If you- have any questions regarding the generic data
requirements and procedures established by this Hotice, 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
-------
ATTACHMENT B
PRODUCT SPECIFIC DATA CALL-IN RESPONSE FORMS (Form A)
PLUS INSTRUCTIONS
-------
SPECIFIC INSTRUCTIONS FOR COMPLETING
THE DATA CALL-IN RESPONSE FORK
Product Specific Pat*
This font is designed to b« used to respond to call-ins for
generic and product specific data for the purpose of
reregistering pesticides under the Federal Insecticide Fungicide
and Rodenticide Act. Fill out this form each tine you are
responding to a data call-in for which EPA has sent you the form
entitled "Requirements Status and Registrant's Response."
Items 1-4 will have been preprinted on the form. Items 5
through 7 oust be completed by the registrant as appropriate.
Items 8 through 11 aust be completed by the registrant before
submitting a response to the Agency.
Public reporting burden for this collection of information
is estimated to average 15 minutes per response, including time
for reviewing instructions, searching existing data sources, . .
gathering and maintaining the data needed, and completing and
reviewing the collection of information. Send comments regarding
the burden estimate or any other aspect of this collection of
information, including suggesting for reducing this burden, to
Chief, Information Policy Branch, PM-223, U.S. Environmental
Protection Agency, 401 M St., S.W., Washington, D.C. 20460; and
to the Office of Management and Budget, Paperwork Reduction
Project 2070-0107, Washington, D.C. 20503.
-------
Page 1 of 1
United States Environmental Protection Agency Form Approved
Washington, D. C. 20460
^ OMB 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 end 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 DC1
GUARDIAN SPRAY CO. 4007 Allium sativum PRODUCT SPECIFIC
900 LANCER WAY
LEBEC CA 93243
4. EPA Product
Registration
62998-1
S. I wish to
cancel this
product regis-
tration volun-
tarily.
6. Generic Data
6a. I an claiming a Generic
Data Exemption because 1
obtain the active ingredient
from the source EPA regis-
tration muter listed belou.
N.A.
6b. 1 agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
N.A.
7. Product Specific Data
7a. My product is a HUP and
1 agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My product is an EUP and
1 agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response.*
8. Certification 9. Date
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
10. Mame of Company Contact 11. Phone Nunfcer
-------
Page 1 of 1
United States Environmental Protection Agency
Washington, D. C. 20460
DATA CALL-IN RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested
Use additional sheet (s) if necessary.
1. Company name and Address 2. Case t and Name
SEVANA CO. 4007 Allium sativura
5336 E. EASTERBY DR.
FRESNO CA 93727
4. EPA Product
Keg 1st rat ton
47319-4
5. 1 wish to
cancel this
product regis-
tration volun-
tarily.
6. Generic Data
6a. 1 am claiming a Generic
Data Exemption because 1
obtain the active ingredient
from the source EPA regis-
tration nutter listed below.
N.A.
6b. ! agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
•Requirements Status and
Registrant's Response."
N.A.
7. Product Specific
Form Approved
OMB No. 2070-010?
Approval Expires 12-31-92
on this form.
3. Pate and Type of DCI
PRODUCT SPECIFIC
Data
7a. My product is a HUP and
1 agree to satisfy the NUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
8. Certification
1 certify that the statements made on this form and all attachments are true, accurate, and complete.
1 acknowledge that any knowingly false or misleading statement may be punishable by fine, imprisonment
or both under applicable lay.
SI mature and Title of Conoanv's Authorized Representative
10. Name of Company Contact
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."
9. Date
11.
Phone Umber
-------
Page 1 of 1
United States Environmental Protection Agency Form Approved
Washington, 0. C. 20460
CUB 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 DCI
SEVANA CO. 4007 Allium sativum PRODUCT SPECIFIC
5336 E. EASTERBY DR.
FRESNO CA 93727
*. EPA Product
Registration
47319-2
5. I wish to
cancel this
product regis-
tration volun-
tari ty.
6. Generic Data
6a. 1 an claiming a Generic
Data Exenption because 1
obtain the active ingredient
from the source EPA regis-
tration nunber listed below.
N.A.
t
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
1 agree to satisfy the EUP
requirements on the attached
fora entitled "Requirements
Status and Registrant's
Response."
8. Certification 9. Date
1 certify that the statements made on this form and alt 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
10. Name of Company Contact 11. Phone Number
-------
Page 1 of
United States Environmental Protection Agency
Washington, D. C. 20460
DATA CALL-IN RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested
Use additional sheet if necessary.
1. Company name and Address 2. Case * and Name
SEVANA CO. 4007 Allium sativum
5336 E. EASTERBY DR.
FRESNO CA 93727
*. EPA Product
Registration
47319-1
5. 1 wish to
cancel this
product regis-
tration volun-
tarily.
6. Generic Data
oa. 1 am claiming a Generic
Data Exemption because 1
obtain the active ingredient
from the source EPA regis-
tration number listed below.
N.A.
6b. 1 agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
N.A.
7. Product Specific
Form Approved
OMB No. 2070-0107
Approval Expires 12-31-92
on this form.
3. Date and Type of DC I
PRODUCT SPECIFIC
Data
7a. My product is a HUP and
1 agree to satisfy the HUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
-
8. Certification
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.
S i ana t Lire and Title of Company's Authorized Representative
10. Name of Company Contact
7b. My product is an EUP and
1 agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
9. Date
11.
Phone Number
-------
INSTRUCTIONS FOR COMPLETING THE "DATA CALL-IN RESPONSE" FORK 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 vill not have to complete any other forms.
Further sale and distribution of your product after the
effective date of cancellation must be in accordance
with the Existing Stocks provision of the Data Call-In
Notice (Section IV-C).
Item 6. Not applicable since this form calls in product
specific data only. However, if your product is
identical to another product and you qualify for a data
exemption, you must respond with "yes" to Item 7a (MP)
or 7b (EP) on this form, provide the EPA registration .
numbers of your source(s) and complete and submit the
"Generic Data Exemption" 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 (MP) for which you
wish to maintain registration, you must agree to
satisfy the data requirements by responding "yes."
Item -7b. For each end use product (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.
NOTE: You nay provide additional information that does not
fit on this form in a signed letter that accompanies
this form. For example, you nay 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.
-------
ATTACHMENT C
PRODUCT SPECIFIC REQUIREMENT STATUS AND REGISTRANT'S RESPONSE
(FORMS B) PLUS INSTRUCTIONS
AND
PR NOTICE 86-5
-------
•PECIFIC INSTRUCTIONS FOR COMPLITIHO
THB »IQUI«E«ENTf iTATUi AKD REGISTRANT'• RESPONSE FORK
Product SpecificData
• This fora it designed to be used for registrants to respond
to call-in* for generic and product-specific data as part of
EPA's reregistration prograa undar the Federal Insecticide
Fungicida and Rodenticide Act. Although tha Ifi£m i* th« saaa for
both product spaeific and ganaric data, i««truetiens for
ceapleting tha forms diffar slightly. Specifically, options for
satisfying product spaeific data reguireaents do not includa (i)
dalation of usas or (2) raquast for a low voluaa/ainor u»a
vaivar. Thasa instructions ara for coaplation of product
•o«eifie data requirements.
EPA has davalopad this fora individually for aach data call-
in addrassad to aach registrant, and has praprintad this fora
with a nuabar of itaas. PO MOT usa this fora for any othar
activa ingradiant.
Xtaas i through • (inclusiva) will hava baan praprintad en
tha fora. You Bust conplata all othar itaas on this fora by
typing or printing lagibly.
Public reporting burdan for this collection of information
is astiaatad to average 30 ainutas per response, including tiae
for reviewing instructions, searching existing data sources,
gathering and aaintaining 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
inforaation, including suggesting for reducing this burden, to
Chief, Information Policy Branch, FM*223, U.S. Environmental
Frotection Agency, 401 M St., S.W., Washington, D.C. 20460; and
to the Office of Manageaent and Budget, Paperwork Reduction
Project 2070-0107, Washington, D.C. 20509.
-------
Page1 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.
t. Company name and Address
SEVANA CO.
5336 E. EASTERBY DR.
FRESNO CA 93727
4. Guideline
Requirement
Nuiter
151B-10
1518^11
151B-12
'• ''•.-. ',-••*'•- -%'-•;•• '.-"' ^>. "" • •
151B-15
151B-16 ' .'',-. •• . &«-.
151B-17(b)
15 1B-17 ( f ) C
-------
United States Environmental Protection Agency
Washington, D. C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Picas* type or print In ink. Please read carefully
Use additional sheet(s) if necessary.
1. Conpany nane and Address
SEVANA CO.
5336 E. EASTERBY DR.
FRESNO CA 93727
4. Guideline
Requirement
Nwtoer
152B-16: -y*j ,.,:
;"--~V:: •;,«•••.. ,.:
x -... . . •• •<:•:• •••-
96^~6;'."^f;v.v -v*. ';
the attached instructions and supply the information requested
2. Case * and Name
4007 Allium sativum
EPA Reg. No. 47319-1
5. Study Title
; Hyper sensltlvit y incidents (5)
Efficacy - Vertebrate Control Aaents
:!;>; Avian repellents , ; (1.54)
•
i
i
Progress
Reports
1
2
3
6. Use
Pattern
ABC
ABC
Initial to indicate certification as to information on this page
(full text of certification is on page one).
0
on this fora.
Page 2 of 2
Form Approved
OMB No. 2070-0107
Approval Expires 12-31-92
3. Date and Type of PCI
PRODUCT SPECIFIC
ID# 47319-RD-2284
7. Test
Substance
: ' • •. :; "
•-: .*•>- '
- •'. .• . .-'i' "'
Vn •-;. ": -r •;:> '• -. ; ;=;;
••:'•'•
-, • •'' .
:•;• -V
8. Time
Frame
8 mos.
8 DOS.
9. Registrant
Response
Date
-------
Page
United States Environmental protection Agency
Washington, D. C. 20460
FOOTNOTES MID KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 4007 Allium sativum
Key: HP * 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; PAI c "pure" active ingredient; PAIRA = "pure" active ingredient, radiotabeled.
UM Categories Key:
A • Terrestrial food crop B - Terrestrial food feed crop C * Terrestrial nonfood crop 0 - 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 tuo (5. Study Title) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
Product Chemistry - Biochemical
6 Required If test substance is dispersible with water.
8 Required If product is a liquid.
Acute Toxic)ty - Biochemical
5 Incidents oust be reported, if they occur.
Efficacy - Vertebrate Control Agents
SO The description of the manufacturing process must include the steps taken to insure the integrity of the starting materials end to limit
extraneous contamination during manufacturing. Also, the description must include the quality control methods used to insure a uniform product.
51 The 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 ere not of toxtcologlcal significance (e.g., small quantities of dirt retained on garlic bulbs after washing), there is no need for
further discussion.
52 The Agency recognizes the difficulty of establishing methods for analysis and verification of the certified limits of naturally occurring
products. Such methods could Include analytical, bioassay, microscopic, or any other method that would allow the Agency to verify the limits.
53 These tests are required for products that combine garlic and red pepper (Capsaicin). They are not required for products that contain only
garlic.
0
54 The 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.
-------
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
SEVAN A CO.
5336 E. EASTERBY DR.
FRESNO CA 93727
4. Guideline
Requirement
Number
?$^iJ!iS&r'tP:
1516-10
15IB-li* .ifif: E--? ':
151B-12
lily 1»V;1 'lllilf 1 Wffi,
151B-15
15 1B^161:K;1 .C & : '
151B-17(b)
l51B-17(f)
151B-17(i)
151B-17 (a)
,
1528-13
152B-14
5. Study Title
Prod them - Biochemical
• •';• ' :
Product identity
Manufacturing procesi": • (50)
Discussion of formation of (51)
inuntentidnal ingrdiehts
Certification of limits
;..? Analytical •ethoda^^.:*^ : (52).'. .;
Physical state
. ' Density ..• .. : . ': V'v-'->:;i: ' . '£ ,? :' -/-
pH (6)
/•"viscosity • ; • ' '/vv- :'•"* '•'•,
Acute Toxic - Biochemical
Primary eye irritation /: (53)
Primary dermal irritation (53)
10. Certification
the attached instructions and supply the information requested on this form.
2. Case * and Name 3. Date and
Form Approved
OMB No. 2070-010?
Approval Expires 12-31-92
Type of DCI
4007 Allium sativum PRODUCT SPECIFIC
ID# 47319-RD-2285
EPA Reg. NO. 47319-2
s
o
c
p
Progress
Reports
1
-
•••';
2
: '•;
•':. '}- •:
"•• '•'•'.•
3
".-.-''
':'"/
• -:^
• i'-..
. ".'•:
6. Use
Pattern
• :'•.'.:;; • •'" • '•
ABC O
ABC O
ABC O
•"•' • .. ••• .-•,••/' -:i;/ •:••.'.;:•:: ;
ABC 0
ABC. •' • ':."•> :/?::.::.././ O
ABC 0
ABC 0
ABC 0
ABC O
''.-;/ • ••••/'
ABC O
ABC O
7. Test
Substance
. .' •'•••: /•;••./• :'-v/-;//.*::
Ep •
EP/^l:^-:: ;--i:..-::::::.;:;V'-;''-/ '
Ep- - •-• - •-••••"•••
^^M^^-^fS?^
EP
EP:W-;b¥ '':s?.: ::/':1&.l:l \
Ep- - - -••- •••''•"'•'•"•""
EP/-';:.-;7^pr:'""-;:-/-':';^- •'
Epi
EP;^v-::-t:^--"::
: 'C'" ^':-^f- -•." :\ •••":•:.
Er 1- . ' '
EP
8. Time
Frame
:::-:ii;
'•. • .
8 mos.
; 8 mos.
8 mos.
-•;//••:.
/••:.- •'''. -
8 mos.
;|I-: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.
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
12. Mame of Company Contact
13. Phone Nunber
-------
Page 2 o'f
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
SEVANA CO.
5336 E. EASTERBY DR.
FRESNO CA 93727
*. Guide tine
Requirement
Number
152B-16;;piK.^^:;S"
?&miimm-^
5. Study Title
Hypefaemltlvity incidents (5)
^ff fcacv - Vertebrate Control Agent*
'^•^^f^i^^^^^.^ ;.
the attached instructions and supply the Information requested
2. Case * and Name
4007 Allium sativum
EPA Reg. No. 47319-2
R
0
Progress
Reports •
1
2
3
6. Use
Pattern
ABC • • ' *^f
ABC' •'..••••*£'<
initial to indicate certification as to information on this page
(full text of certification is on page one).
tteo
7. Test
Substance
o . :. ...'"'.• . '. :
. •;•••••: •.-..-;-
EPW-^.^:
on this form.
Form Approved
OMB No. 2070-0107
Approval Expires 12-31-92
3. Date and Type of OCI
PRODUCT SPECIFIC
ID# 47319-RD-2285
8. Time
Frame
8 mos.
8 nibs.
9. Registrant
Response
- : "• . ••:::: -• "
'•-::;-•
•: - . .- •
Date
-------
Page 1 of 1
United States Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case f and Name: 4007 Allium sativum
Key: HP « manufacturing-use product; EP » end-use product; provided formulators purchase their active ingredient(s) from « 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;
TGA1 « technical grade of the active ingredient; PAI * "pure" active ingredient; PAIRA * "pure" active ingredient, radiolabeled.
UM Categories Key:
A - Terrestrial food crop B - Terrestrial food feed crop C - Terrestrial nonfood crop 0 • 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 I - Indoor food H • Indoor nonfood H - 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.}
Product Chen!stry - Biochemical
6 Required If test substance Is dispersible with water.
8 Required if product
-------
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) ff necessary.
t . Company name and Address
SEVANA CO.
5336 E. EASTERBY DR.
FRESNO CA 93727
4. Guideline
Requf rement
Nuifcer
151B-10
151B-11
151B-12
4s> ' .;¥^ *:,: > • -
- OS'. '•:• •:*'.. '•;.<>
151B-15
151B-16
151B-17(b)
l51B-17(f)
151B-17(i)
151B-17 (m)
£$£&$-•'. gi.iy. 0- v
.-£;£•. r:|r ' ;.;>;:;•;:•:-•..;.. - •
i52B-13
152B-14
5. Study Title
Prod Che* - Biochemical
Product identity
Manufacturing process (SO)
Discussion of formation of (51)
unintentional ingrdfentc
Certification of limits
Analytical methods (52)
Physical state
Density . /
pH (6)
Viscosity (B)
Acute Toxic * Biochemical
Primary eye irritation (55)
Primary dermal irritation (53)
10. Certification
the attached instructions and supply the information requested
2. Case * and Name
4007 Allium sativum
EPA Reg. No. 47319-4
5
Q
I
c
f
Progress
Reports
1
2
3
6. Use
Pattern
ABC O
ABC O
ABC 0
ABC 0
ABC O
ABC O
ABC O
ABC 0
ABC O
ABC O
ABC O
7. Test
on this form.
3. Date and
Form Approved
OMB No. 2070-010?
Approval Expires 12-31-92
Type of DCI
PRODUCT SPECIFIC
ID* 47319-RD-2286
Substance
EP
EP H,
EP
. •'"-; '.-..;
EP
EP
EP
EP
EP
EP
- . • ••
EP
EP
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
12. Name of Company Contact
•
11.
13.
••••••MMHHHIl
6. Time
Fran
le
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
Date
Phone Number
lHH*MBHIhl*hHIMMPaBIH*IIIHIVVWtoB*IIBMM
9. Registrant
Response
•""""""""""""-•••ii^ — ^ ta^M^.^
-------
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
SEVAN A CO.
5336 E. EASTERBY DR.
FRESNO CA 93727
4. Guideline
Requirement
Hunter
1528*16
".•' •''-:'. -.':•'-''••'. • ' •
.•;••' -.:o-, . -;.,- •-
: : A-:- ••'•;.•
96-6 -VTV-
5. Study Title
Hypersenaltfvlty incidents (5)
^fficacy - Vertebrate Control, Aaents
Avian repellents (1,54)
the attached instructions and supply the information requested
2. Case * and Mame
4007 Allium sativum
EPA Reg. No. 47319-4
1 1
Q
1 )
Progress
Reports
1
2
3
6. Use
Pattern
ABC
ABC
Initial to indicate certification as to information on this page
(full tent of certification is on page one).
o
7. Test
Substance
on this fom.
Page 2 of 2
Fom Approved
OMB No. 2070-0107
Approval Expires 12-31-92
3. Date and Type of DC!
PRODUCT SPECIFIC
ID# 47319-RD-2286
EP
8. Time
Frame
8 mos.
8 mos.
9. Registrant
Response
•
Date
-------
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 satiwun
Ceys HP • manufacturing-use product; EP = end-use product; provided fortnulators 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;
TCAI • technical grade of the active ingredient; PAI * "pure" active ingredient; PAIRA * "pure" active ingredient, radiolabeled.
UM Categoric* Key:
A - Terrestrial food crop B - Terrestrial food feed crop C - Terrestrial nonfood crop 0 - Aquatic food crop E - Aquatic nonfood outdoor
f • Aquatic nonfood Industrial G - Aquatic nonfood residential H - Greenhouse food crop 1 - Greenhouse nonfood crop J - Forestry
K • Residential outdoor I - Indoor food M - Indoor nonfood N - Indoor Medical 0 - Indoor residential
Footnotes: [The following notes are referenced in col urn two (5. Study Title) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.)
Product Chemistry - Biochemical
6 Required If test substance is disperstble with Mater.
8 Required If product la a liquid.
Acute Toxlcity • Biochemical
5 Incidents auit be reported, if they occur.
Efficacy * Vertebrate Control Agents
SO The description of the manufacturing process oust 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.
51 The 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 lexicological significance (e.g., small quantities of dirt retained on garlic bulbs after washing), there is no need for
further discussion.
52 The Agency recognlies the difficulty of establishing methods for analysis and verification of the certified limits of naturally occurring
products. Such methods could include analytical, bioassay, microscopic, or any other method that would allow the Agency to verify the limits.
53 These tests are required for products that combine garlic and red pepper (Capsaicin). They are not required for products that contain only
garlic.
*
54 The date 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.
-------
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
GUARDIAN SPRAY CO.
900 LANCER WAY
LEBEC CA 93243
4. Guideline
Requirement
Number
151B-10
151B-11? •:••
151B-12
" • "'*;:•"[ '•:
151B-15
151B-16 ; ",•
151B-17(b)
151B-i7(fy?-
151B-17(i)
151B-l7(m) s?
. ~": *"•' •;..' ' ;;s;:;.\ ;...',;.;• • ;".-
152B-ir-r?,;:;
152B-14
5. Study Title
Prod Cheat • Biochemical
Product identity
Manufacturing process • • (SO)
Discussion of formation of (51)
unintentional ingrdients ;. ...
Certification of limits
Analyt ical methods (52)
Physical state
' . Density ' • ...-,.-.' -':-'. '•'"•;•,.
pH (6)
Viscosity (8)
Acute Toxic * Biochemical
; Primary eye Irritation • (53)
Primary dermal irritation (S3)
10. Certification
the attached instructions and supply the information requested
2. Case f and Name
4007 Alliuro sativum
EPA Reg. No. 62998-1
.-
R
o
c
o
I
Progress
Reports
1
2
•••
3
6. Use
Pattern
ABC O
ABC O
ABC O
ABC 0
ABC 0
ABC O
ABC O
ABC O
ABC 0
ABC O
ABC 0
7. Test
on this form.
3. Date and
Form Approved
0KB No. 2070-0107
Approval Expires 12-31-92
Type of DC I
PRODUCT SPECIFIC
IDf 62998-RD-2287
Substance
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
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 nay be punishable by fine, imprisonment
or both under applicable law.
Signature and Title of Company's Authorized Representative
12. Name of Company Contact
11.
13.
• '.:
•
8. Time
Frai
te
8 mos.
8 mos .
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
Date
Phone Number
9. Registrant
Response
-------
Page 2 of 2
United States Environmental Protection Agency
Washington, 0. 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
GUARDIAN SPRAY CO.
900 LANCER WAY
LEBEC CA 93243
4. Guideline
Requirement
Hunter
152B-16
'-*• • • '••- •:-. ••}:•• --••,-,
•9 6-6^-;K*;^r .'-/•
5. Study Title
HypersensltMty Incident* (5)
Efficacy - Vertebrate Control Agents
Avian repellents (1,54)
the attached instructions and supply the information requested
2. Case * and Name
4007 Allium sativum
EPA Reg. No. 62998-1
i*
Progress
Reports
1
2
3
6. Use
Pattern
ABC
ABC
Initial to indicate certification as to information on this page
(full text of certification is on page one).
0
T. Test
Substance
on this fora.
Form Approved
(MB No. 2070-010?
Approval Expires 12-31-92
3. Date and Type of DC I
PRODUCT SPECIFIC
ID* 62998-RD-2287
EP ' < . ' ' -
8. Time
Frame
8 mos.
8 mos.
9. Registrant
Response
Date
-------
^ • Page 1 of
United states Environmental Protection Agency
Washington, D. C. 20460
FOOTNOTES AND KEY DEFINATIONS FOR GUIDELINE REQUIREMENTS
Case f and Name: 4007 Allium sativum
Key: NP « 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.]; TCP = typical end-use product;
TGAl « technical grade of the active ingredient; PAI = "pure" active ingredient; PAIHA = "pure" active ingredient, radiolabeled.
Use Categoric* Key:
A - Terrestrial food crop B - Terrestrial food feed crop C • Terrestrial nonfood crop 0 • Aquatic food crop E • Aquatic nonfood outdoor
F - Aquatic nonfood industrial C - Aquatic nonfood residential K - 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 cotuwi two (5. study Title) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
Product Chemistry - Biochemical
6 Required If test substance is disperslble uith Mater.
8 Required if product is a liquid.
Acute Toxiclty - Biochemical
5 Incidents must be reported, if they occur.
Efficacy • Vertebrate Control Agents
50 The description of the manufacturing process must include the steps taken to insure the integrity of the atart ing materials and to limit
extraneous contamination during manufacturing. Also, the description must include the quality control methods used to insure a uniform product.
51 The applicant must provide a discussion of the unintentional ingredients that may be present in the product and why they may be present.
Example* of such ingredients might include residues of contaminants that remain following the extraction or purification process. If these
contaminants ere not of toxicological significance (e.g., small quantities of dirt retained on garlic bulbs after washing), there is no need for
further discussion.
52 The Agency recognizes the difficulty of establishing methods for analysis and verification of the certified limits of naturally occurring
products. Such methods could include analytical, bioassay, microscopic, or any other method that would allow the Agency to verify the limits.
53 These tests are required for products that combine garlic and red pepper (Capsaicln). They are not required for products that contain only
garlic.
54 The 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 rereglstratlon 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.
-------
INSTRUCTIONS FOR -COMPLETING TOT "REQUIREMENTS STATUS
REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC CATA ..
* »•«»». • *
Ittm 1-3 Coapleted by ZPA. Not* the unique identifier auabtr
assigned by EPA in Xtea 3* This number Bust be use* is
tbe tr&ataittal doeuaent fez any date subaissioas in
response to this Data Cm 11-In Notice.
* * - „ *
Itta 4.. The guideline reference nuabers of studies required to
support the product's continued registration ere
identified. These guidelines, in addition to the
requireaents specified in the Notice, govern the conduct
of the required studies. Note thtt series 61 and 92 in
product cheaistry are nov listed under 40 CFR 151.155
through 151.180, Subpart C.
Xtea 5. The study title associated vita the guideline reference
number is identified.
Xtea 6. The use pattern(s) of the pesticide associated with the
product specific requireaents is (are) identified. For
aost product specific data requirements, all use patterns
are covered by the data requireaents. Xn the case of
efficacy data, the required studies only pertain to
product/ which have the use sites and/or pests indicated.
Xtea 7. The substance to be tested is identified by EPA. For
product specific data, the product as foraulated for sale
and distribution is the test substance, except in rare
cases. . . - ••
Xtea I. The due date for subaission of each study is identified.
Xt is normally based en • aontbs. after issuance of the
Reregistration Eligibility Docuaeat unless EFA,deteraines
that a longer tiae period is necessary.
Xtea 9. Eater onlvene of tae following response codes for eaea
data reguirtaent to saov bow you intend to COBply Viti
the data requireaeats listed ia this table. Puller
descriptions of etch option are contained in the Data
Call-In-Notice.
1. X will generate and submit data by the specified due date
(Developing Data). By indicating that X have chosen this
option,. X certify that X will coaply with all the
requireaents pertaining to the conditions for subaittal
of this study as outlined in the Data Call-In Notice.
*
2* X have entered into an agreeaent with one or Bore
registrants to develop data jointly (Cost ihariag). X
aa subaitting a copy of this agreeae&t and a completed
"Certifieatioa Wits Xespeet To fiata Coapeasatioa
Xequireaeats" form. X understand that this option is
available oaly for acute toxicity or certain efficacy
-------
data and only if EPA indicate* in an attachacnt to this
Notice that ay product is siailar enough to anothtr
product to qualify for this option. . X certify that
anothtr party in the agreement is comaittinf to subait
or provide the required data; if the required study is
not subaitted en time, ay product aay be subject to
suspension. ' • • . . ' .'
3. 2 have aade offers to share in the cost to develop data
{Offers to Cost Share). Z understand that1 this option
is available only for acute toxieity or certain efficacy
data and only if IPX indicates in an attaehaent to this
Data Call-In Notice that ay product is siallar enough to
another product to qualify for this option. Z aa
subaitting evidaaee that Z have Bade aa offer to another
registrant (who has an obligation to submit data) to
share in the cost of that data. Z aa also subaitting a •
cospleted "Certification of Offer to Cost Share is the
Cevelopmeat Data1* fora. Z aa including a copy of ay
offer and proof of the other registrant's receipt of that
offer. Z aa identifying the party which is committing
to submit or provide the required data; it the required
study is not subaitted en time, ay product aay be subject
to suspension* Z understand that other tens under
Option 3 in the Cat a Call-In Notice (Section III-C.l.) *
apply as veil.
4. By the specified due date, Z vill subait an existing
study that has not been submitted previously to the
Agency by anyone (Subaitting aa Zxisti&g study). Z
certify that this study vill aeet all the requireaents
for subnittal of existing data outlined in Option 4 in
the Data Call-In Notice (Section III-C.l.) and vill Beet
the attached acceptance criteria (for acute toxieity and
product eheaistry data). Z vill attach the needed
supporting inforaation along vith this response. Z also
certify that Z have deterained that this study vill fill
the data requireaent for vhich Z have indicated this
choice.
•
S. By the specified due data, Z vill subait or eita data to
upgrade a study classified by the Agency as partially
acceptable and upgradable (Upgrading a Study).- Z vill
subait evideaee of the Agency's review indicating that
the study aay be upgraded and what inforaation is
required te do so. Z vill provide the MR ID or Accession
number of the ttud«r at the due data. Z understand that
the conditions for this option outlined Option S in the
Data Call-in Notice (Section III-C.l.) apply.
«. By the'specif ied due data, Z vill eita an existing study
that the Agency has classified as acceptable er an
•xisting study that has been subaitted but not reviewed
by the Agency (Citing aa Bxistiag Study). Zf z aa citing
-------
mother registrant's study, Z understand that this option
•is available ealy for acute toxieity or certain efficacy
data and ealy if the cited study was conducted on ay
product, an identical product or a product vhich £?A has
•grouped" with one or sore other products for purposes
of depending en the saae data. Z aay also choose this
option if x aa citing ay own data. Zn either case, I
trill provide the X*ID or Aceessioa auaber(s) for the
cited, data on a "Product Specific Data Report" fora or
in * simiUr format. Zf Z cite another, registrant's
data, Z vill submit a coapleted "Certification With
Respect To Data Coa^easatioa Requireaeats" Cora.
* • *
7. Z request a vaiver for. this study because it is
inappropriate for ay product (Waiver neediest}. Z aa
attaching a coaplete justification for this request,
Including technical reasons, data and references to
relevant EPA regulations, guidelines or policies. (Note:
any suppleaental data Bust be submitted in the foraat
required by ?.R. Notice »6-SJ. Z understand that this
is ay only opportunity to state the reasons or provide
' information in support of ay request. Zf the Agency
approves ay vaiver request, Z will sot be required* to
supply the data pursuant to Section 3(e) (2) (B) of mitt.
Zf the Agency denies ay vaiver request, Z aust choose a
aethod of aeeting the data requireaents of this notice
by the due date stated by this Notice. Zn this case, Z
aust, vithin 90 days of ay receipt of the Agency's
written decision, subait a revised "Requireaents Status
and Registrant's Response" fora indicating the option
chosen. • Z also understand that the deadline for
subaission of data as specified by the original data
call-in notice vill hot change.
Items 10-13. Self-explanatory.
££££: You say provide additional i&foraatioa that does not fit
on this fora in a signed letter that accoapanits this
fora. Tor exaapls, you aay vish to report that your
product has already been transferred to another ceapany
or that you bave already voluntarily cancelled this
product. Tor these cases, please supply all relevant
details so that X?A can ensure that its records are
correct.
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WAiHtNGTON, O.C. Z04IO
JJL29W
PR NOTICE 86-5 MWCW
NOTICE TO PRODUCERS, PORMULATORS, DISTRIBUTORS
AND REGISTRANTS
Attention! Persons responsible for Pederal registration of
pesticides.
Subject* Standard format for data submitted under the Federal
Insecticide, fungicide, and Rodentieide Act (PXFRA)
and certain proviaiona of the Pederal Pood* Drug,
and Coc..ietic Act (PPDCA).
I. Purpose
To require data to be submitted to the Environmental
Protection Agency (EPA) in a standard format. This Notice alao
providea additional guidance about, and illustrations of, the
required formats.
XX. Applicability
This PR Notice applies to all data that are submitted to EPA
to satisfy data requirements for granting or maintaining pesticide
registrations, experimental use permits, tolerances, and related
approvals under certain provisions of PXFRA and PPDCA. These
data are defined in PXFRA SlO(d)d). This Notice does not apply
to commercial, financial, or production information, which are,
and must continue to be, submitted differently under separate
cover.
III. Effective Date
This notict it effective on November 1, 1986, Data formatted
according to this notice may be submitted prior to the effective
date. As of the effective date, submitted data packages that do
not conform to these requirements may be returned to the submitter
for necessary revision.
IV. Background
On September 26, 1984, EPA published proposed regulations
in the Pederal Register (49 PR 37956) vh}ch include Requirements
for Data Submission (40 CPR $158.32), and procedures for Claims
of confidentiality of Data (40 CFR $158.33). These regulation*
-------
•pacify the format for data submitted to EPA under Section 3 of
FIFRA and sections 408 and 409 of FFDCA, and procedures which
must be followed to make and substantiate claims of confid*n-
- ality. NS «ntitl .its .•> li^a •? -£ide.-'rialic/ ace cha-.,3d,
either by the proposed regulation or by this notice.
OPP is making these requirements mandatory through this
Notice to gain resource-saving benefits from their use before the
entire proposed regulation becomes final. Adequate lead time is
being provided for submitters to comply with the new requirements.
V- Relationship of this Notice to Other OPP Policy and Guidance
While this Notice contains requirements for organizing and
'formatting submittals of supporting data, it does not address
the substance of test reports themselves. "Data reporting"
guidance is now under development in OPP, and will specify how
the study objectives, protocol, observations, findings, and
conclusion; are organized and presented within the study report.
The data reporting guidance will be compatible with submittal
format requirements described in this Notice.
OPP has also promulgated a policy (PR Notice B6-4 dated
April 15, 1986) that provides for early screening of certain
applications for registration under FIFRA S3. The objective of
the screen is to avoid the additional costs and prolonged delays
associated with handling significantly incomplete application
packages. As of the effective date of this Notice, the tcreen
will include in its criteria for acceptance of application
packages the data formatting requirements described herein.
OPP has als6 established a public docket which imposes dead-
line.* for inserting into the docket documents submitted in con-
nection with Special Reviews and Registration standards (see
40 CFR $154.15 and $155.32). To meet these deadlines, OPP is
requiring an additional copy of any data submitted to the docket.
Please refer to Page 10 for more information about this requirement,
For several years, OPP has required that each application for
registration or other action include a list of all applicable
data requirements and an indication of how each is satisfied--the
statement of the method of support for the application. Typically,
many requirements are satisfied by reference to data previously
submitted—either by the applicant or by another party. That re-
quirement is not altered by this notice, which applies only to
data submitted with an application.
VI. Format Requirements
A more detailed discussion of these format requirements
follows the index on the next page, and samples of some of the
requirements are attached. Except for the language of the two
alternative forms of the Statement of Data Confidentiality Claims
(shown in Attachment 3) which cannot be altered* these samples
are illustrative. As long as the required information is included
and clearly identifiable, the form of the samples may be altered
to reflect the submitter's preference.
-------
- INDEX -
A. Organisation of the Subnlttal Package ........ 3 i?
B. Transmittal Document ................ 4 11
C. Individual Studies ........... . ..... 4
C.I Special Consideration! for Identifying Studies. . 5
p. Organisation of each Study Volume .......... € I?
D.I Study Title Page ........ ........ 7 12
D.2 Statenent of Data Confidentiality Claims
(based on FIFRA SlO(dXD) ....... .... 8 13
D.3 Confidential Attachment ....... ...... 6 IS
D.4 Supplemental Statement of Data Confidentiality
Claims (other than those based on PIFRA §10(d)(lH 8 14
D.S Good Laboratory Practice Compliance Statement . . 9 IS
E. Reference to Previously Submitted Data .«.«... 9
P. Physical Format Requirements « Number of Copies ... 9
G. Special Requirements for Submitting Data to the Docket 10
•*••***•*••••*
A. Organization of Submittal package
A 'submittal package1 consists of all studies submitted at
the same time for review in support of a single regulatory action,
along with a transnittal document and other related administrative
material (e.g. the method of support statement , EPA forms 8570-1*
8570-4, 8570-20, etc.) as appropriate.
Data submitters must organize each submittal package as
described in this notice. The transmittal and any other admin-
istrative material must be grouped together in the first physical
volume. Each study included in the submittal package must then
be bound separately.
Submitters sometimes provide additional materials that are
intended to clarify, emphasise, or otherwise comment to help
Product Managers and reviewers better understand the submittal.
- If such materials relate to one study, they should be
included as an appen'dix to that study.
- If such materials relate to more than one study (as for
example a summary of all studies in a discipline) or to the
submittal in general, they must be included in the submittal
package as a separate study (with title page and statement
of confidentiality claims).
-------
B. Tran _tm it t a 1 Doe ume n t
The first item in each submittal package must be a trans-
.Tit*--1! .'-:*-•*.:. ~ri- -:1 "*<*•: ii-jnniiies the a-SmUt ?r 3r a*.I
joint submitters; the regulatory action in support of which the
package is being submitted—i.e., a registration application,
petition, experimental use permit (EUP), S3(c)(2)(B) data call-in,
$6(a)(2) submittal, or a special review; the transmittal date;
and a list of all individual studies included in the package in
the order of their appearance, showing (usually by Guideline
reference number) the data requirements) addressed by each one.
The EPA-assigned number for the regulatory action (e.g. the
registration, EUP, or tolerance petition number) should be
included in the transmittal document as well, if it is known to
the submitter. See Attachment 1 for an example of an acceptable
transmittal document.
The list of included studies in the transmittal of a data
submittal package supporting a registration application should
be subdivided by discipline, reflecting the order in which data
requirements appear in 40 CFF 158.
The list of included studies in the transmittal of a data
submittal package supporting a petition for tolerance or an
application for an EUP should be subdivided into sections A, B,
C,.... of the petition or application, as defined in 40~CFR
180.7 and 158.125, (petitions) or Pesticide Assessment Guidelines,
Subdivision I (EUP*) as appropriate.
When a submittal package supports a tolerance petition and
an application for a registration or an EUP, list the petition
studies first, then the balance of the studies. Within these
two groups of studies follow the instructions above.
C. Individual Studies
A study is the report of a single scientific investigation,
including all supporting analyses required for logical complete-
ness. A study should be identifiable and distinguishable by a
conventional bibliographic citation including author, date, and
title. Studies generally correspond in scope to a.single Guide-
line requirement for supporting data, with some exceptions dis-
cussed in section C.I. Each study included in a submittal package
must be bound as a separate entity. (See comments on binding
studies on page 9.)
Each study must be consecutively paginated, beginning from
the title page as page 1. The total number of pages in the com*
plete study must be shown on the study title page. In addition
(to ensure that inadvertently separated pages can be reassociated
with the proper study during handling or review) use either of
the following;.
• Include the total number of pages in the complete study
on each page (ie., 1 of 250, 2 of 250, ...250 of 2SO).
• Include a company name or mark and study number on each
page of the study, e.g., Company Name-1986-23. Never reuse
a study number for marking the pages of subsequent studies.
-------
When a single study is extremely long, binding it in multiple
volumes is permissible so long as the entire 5tu4y is pa~in«t-!*
-••: j. *;r.¥ie ie.ics, ana ea«-n *ol«me is plainly identified by the
study title and its position in the multi-volume sequence.
C.I SpecialConsiderations for Identifying studies
Some studies raise special problems in study identification,
because they address Guidelines of broader than normal scope or
for other reasons.
a. Safety studies. Several Guidelines require testing for
safety in more than one species. In these cases each species
tested should be reported as a separate study, and bound
separately.
Extensive supplemental reports of pathology reviews, feed
analyses, historical control data, and the like are often assoc- •
iated with safety studies, whenever possible these should be
submitted with primary reports of the study, and bound with the
primary study as appendices. When such supplemental reports are
submitted independently of the primary report, take care to fully
.identify the primary report to which they pertain.
Batteries of acute toxicity tests, performed on the same end
use product and covered by a single title page, nay be bound
together and reported as a single study,
b. Product Chemistry Studies. All product chemistry data
within a submittal package submitted in support of an end-use
product produced from registered manufacturing-use products
should be bound as a single study under a single title page.
Product chemistry data submitted in support of a techni-
cal product, other manufacturing-use product, an experimental
use permit, an import tolerance petition, or an end-use prod-
uct produced from unregistered source ingredients, should be
bound as a single study for each Guideline series (61, 62,
and 63} for conventional pesticides, or for the equivalent
subject range for biorational pesticides. The first of the
three studies in a complete product chemistry submittal for
a biochemical pesticide would cover Guidelines 151-10, 151-11,
and 151-12} the second would cover Guidelines 151-13, 151-15,
and 151-16) the third would cover Guideline 151-17. The
first study for a microbial pesticide would covet Guidelines
151-20, 151-21, and 151-22» the second would cover Guidelines
151-23 and 151-25? the third would cover Guideline 151-26.
Note particularly that product chemistry studies are
likely to contain Confidential Business Information as defined
in PIPRA S10(d)(l)(A), (B), or (C), and if ao must be handled
as described in section D.3. of this notice.
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c. Residue Chemistry Studies. Guidelines Hl-4, 153-3,
"H-4 ,»re *xr.r»f"«?V" Inroad in ecooe? stj^ies addressing
residue cnemistry requirements must tn«s oe UctirirU AC d
level below that of the Guideline code. The general principle,
however, of limiting a study to the report of a single inves-
tigation still applies fully. Data should be treated as a
single study and bound separately for each analytical method,
each report of the nature of the residue in a single crop or
animal species, and for each report of the magnitude of resi-
dues resulting from treatment of a single crop or from proces-
sing a single crop. When more than on« commodity is derived
from a single crop (such as beet tops and beet roots) residue
data on all such commodities should be reported as a single
study, when multiple field trials are associated with a
single crop, all such trials should be reported as a single
study.
D. Organization of Each Study Volume
Fech complete study must include all applicable elements in
the list below, in the order indicated. (Also see Page 17.)
Several of these elements are further explained in the following
paragraphs. Entries in the column headed 'example* 'cite the
page number of this notice where the element is illustrated.
Element
Study Title Page
Statement of Data
Confidentiality
Claims
Certification of Good
Laboratory Practice
Flagging statements
Body of Study
Study Appendices
Cover Sheet to Confi-
dential Attachment
CBX Attachment
Supplemental Statement
of Data Confidentiality
Claims
When Require." Example
Always Page 12
One of the two alternative Page 13
forms of this statement
is always required. '
If study reports laboratory Page 16
work subject to GLP require-
ments
For certain toxicology studies. (When
flagging requirements are finalized.)
Always - with an English language
translation if required.
At submitter's option
If CBI is claimed under FIFRA
flO(d)UHA), (B), or (C)
If CBI is claimed under FIFRA
, «10(d)(lHA), (B), or (C)
Only if confidentiality is
claimed on a basis other than
FIFRA SlO(dmHA), (B), or (C)
Page 15
Page 14
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D.I Titl* Page
A title page is always required for each submitted study,
published or unpublished. The title page must always be freely
releasable to requestors; DO NOT INCLUDE C8I ON THE TITLC PAGE,
An example of an acceptable title page is on page 12 of this
notice. The following information must Appear on the title
page:
a. Study title. The study title should be as descriptive as
possible. It must clearly identify the substance(s) tested and
correspond to the name of the data requirement as it appears
in the Guidelines.
b. Data requirement addressee. Include on the title page the
Guideline number!s) of the specific requirement(s) addressed by
the study.
c. Author!s). Cite only individuals with primary intellectual •
responsibility for the content of the study. Identify then
plainly as authors, to distinguish them from the performing
laboratory, study sponsor, or other names that nay also appear on
the title page.
d. Study Date. The title page must include a single date for
the study. If parts of the study were performed at different
times, use only the date of the latest element in the study.
e. Performing Laboratory Identification. 'If tha study reports
work done by one or more laboratories, include on the title page
the name and address of the performing laboratory or laboratories,
and the laboratory's internal project number(s) for the work.
Clearly distinguish the laboratory's project identifier from any
other reference numbers provided by the study sponsor or submitter.
f. Supplemental Submissions. If the study is a commentary on
or supplement to another previously submitted study, or if it
responds to EPA questions raised with respect to an earlier study,
include on the title page elements a. through d. for the previously
submitted study, along with the EPA Master Record Identifier (MRID)
or Accession number of the earlier study if you know these numbers.
(Supplements*submitted in the same submittal package as the primary
study should be appended to and bound with the primary study. Do
not include supplements to more than one study under a single
title page).
» »
g. Pacts of Publication. If the study is a reprint of a pub-
lished document* identify on the title page all relevant facts
of publication, such as the journal title, volume, issue, inclusive
page numbers, and publication date.
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D.2. Statements of Data Confidentiality Claims Under FIFRA flO(d)U).
Each submitted study mast be accompanied by one of the two
alternative forms of the Statement of Data Confidentiality Claims
specified in the proposed regulation in $158.33 (b) and (c).
(See Attachment 3) These statements apply only to claims of data
confidentiality based on FIFRA f 10(d) (1) (AT7TB), or (C). Use
the appropriate alternative form of the statement either to
assert a claim of SlO(dHl) data confidentiality
-------
r-.5 ??c"1 ".at"-*-atr«ry Practi-ra Compliance Statement
This statement is required if the study contains laboratory
vork subject to GLP requirements specified in 40 CFR 160. Sam-
ples of these statements are shown in Attachment 6.
E. Referenceto Previously SubmittedData
00 NOT RESUBMIT A STUDY THAT HAS PREVIOUSLY BEEN SUBMITTED
FOR ANOTHER PURPOSE unless EPA specifically requests it. A copy
of the title page plus the HRID number (if known) is sufficient
to allow us to retrieve the study immediately for review. This
prevents duplicate entries in the Agency files, and saves you
the cost of sending more copies of the study. References to pre-
viously submitted studies should not be included in the transmit-
tal document, but should be incorporated into the statement of
the method of support for the application.
F. Physical Format Requirements
All elements in the data submittal package must-be on uniform
8 1/2 by 11 inch white paper, printed on one side only in black
ink, with high contrast and good resolution. Bindings for indi-
vidual studies must be secure, but easily removable to permit
disassembly for microfilming. Check with EPA for special
instructions before submitting data in any medium other than
paper, such as film or magnetic media.
Please be particularly attentive to the following points:
o Do not include frayed or torn pages.
o Do not include csrbon copies, or copies in other than
black ink.
o Make sure that photocopies are clear, complete, and fully
readable.
o Do not include overs ice computer printouts or fold-out pages.
o Do not bind any documents with glue or binding tapes.
o Make sure that all pages of each study, including any attach-
ments or appendices, are present and in correct seqjence.
Number of Copies Required - All submittal-packages except
those associated with a Registration standard or Special Review
(see Part G below) oust be provided in three complete, identical
copies. (The proposed regulations specified two copies; three
are now being required 'to expedite and reduce the cost of proces-
sing data into the OPP Pesticide Document Management System and
getting it into review.)
-------
G. Special acquirements for Submitting Data to the Docket
Data submittal packages •••ociatcd witn a Registration Stan-
dard or Special Review must be provided in four copies, from one
of which all material claimed as CRI has b«en excised. This
fourth copy will become part of the public docket Cor the RS or
SB case. If no claims of confidentiality are made for the study,
the fourth copy should be identical to the other three. When
portions of a study submitted in support of an RS or SR are
claimed as CBI, the first three copies will include the CBI
materiel as provided in section D of this notice. The following
special preparation is required for the fourth copy.
o Remove the 'Supplemental Statement of Data Ccnfidentiality
Claims'.
o Remove the 'Confidential Attachment'.
o Excise from the body of the study any information you claim
as confidential, even if it does not fall within the scope
of FIFRA S10(d)(l)(A), (B), or (C). Do not close up or
paraphrase text remaining after this excision.
.o Mark the fourth copy plainly on both its cover and its title
page with the phrase "Public Docket Haterial - contains no
information claimed as confidential".
v.
For Further information
For further information contact William C. Grosse, Chief,
Information Services Branch, Program Management and Support
Division, (703-557-2613).
ames W, Akerman
'Acting Director,
Registration Division
Attachment 1.
Attachment 2.
Attachment 3.
Attachment 4.
Attachment S.
Attachment 6.
Attachment 7.
Sample Transmittal Document
Sample Title Page for a Newly Submitted Study
Statements of Data Confidentiality Claims
Supplemental Statement of Data Confidentiality Claims
Samples of Confidential Attachments
Sample Good Laboratory Practice Statements
Format Diagrams for Subtaittal packages and studies
10
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ATTACHMENT 1.
ELEMENTS TO BE INCLUDED IN THE TRANSMITTAL DOCUMENT*
1. Name and address of submitter (or all Joint submitters**)
tSmith Chemical Corporation Jones Chemical Company
1234 west Smith Street -and- 5678 Wilson Blvd
Cincinnati, OH 98765 Coving ton, ICY 56789
TSmith Chemical Corp. will act as sole agent for all submitters
2. Regulatory action in support et which this package is submitted
Use the EPA identification number (e.g. 3S9-EUP-67) if you
know it Otherwise describe the type of request (e.g. experi-
mental use permit, data call-in - of xx-xx-xx date).
3. Transmittal date
4. List of submitted studies
vol 1. Administrative materials - forms, previous corres-
pondence with Project Managers, and so forth.
Vol 2. Title of first study in the submittal (Guideline No.)
*
e •
Vol n. Title of nth study in the submittal (Guideline No.)
* Applicants commonly provide this information in a trans-
mittal letter. This remains an acceptable practice so
long as all four elements are Included.
** Indicate which of the joint submitters is empowered to
act on behalf of all joint submitters in any matter con-
cerning data compensation or subsequent use or release
of the data.
Company Officials
Name Signature
Company Nantet ^^_^^^_«.^^^^^^^M____«M
Company Contacts _ . __ _ ^
Name Phone
11
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ATTACHMENT 2.
SAMPLE STUDY TITLE PAGE FOR A NEWLY SUBMITTED STUDY
Study Title
(Chemical name) - Magnitude of Residue on Corn
Data Requirement
Guideline 171-4
Author
John C. Davis
Study Completed On
January 5, 1979
Perterming Laboratory
ABC Agricultural Laboratorlea
940 West Bay Drive
Wilmington, CA 39897
Laboratory Project ID
ABC 47-79
Page 1 of X
(X is the total number of pages in the study)
-------
r 3.
STATEMENTS Of DATA CONFIDENTIALITY CLAIHS
1. ND claim of confidentiality under PIFRA S10(d)(1)(A),(B), or (C)
STATWENT OF NO DATA OOKFirENTIALTTY CLAIMS
No claim of confidentiality is made for any information contained in this study
on the basis of its filling within the scop* of FIPRA S10(dKlKA>. (A>, (B), or (C).
STATEMENT OP DATA CQNFIDWriALITY CLAIMS
Information claimed confidential on the basis of its falling within the scope
of FIFRA $10
-------
ATTACHMENT 4.
SUPPLEMENTAL STATEMENT OF DATA CONFIDENTIALITY CLAIMS
For any portion of a submitted study that is not d«scrib«d
by FIFRA SlO(d)dHA), (B), or , but for which you claim
confidential treatment on another basis* the following informa-
tion must be included within a Supplemental Statement of Data
Confidentiality Clainsr
o Identify specifically by page and line number(s) each
portion of the study for which you claim confidentiality.
*o Cite the reasons why the cited passage qualifies for
confidential treatment.
o indicate the length of time—until a specific date or
event, or permanently—for which the information should
be treated as confidential.
o Identify the measures taken to guard against undesired
disclosure of this information.
o Describe the extent to which the information has been
disclosed, and what precautions have been taken in con-
nection with those disclosures.
o Enclose copies of any pertinent determinations of confi-
dentiality made by EPA, other Federal agencies, or courts
concerning this information.
p -If you assert that disclosure of this information would
be likely to result in substantial harmful effects to
you, describe those harmful effects and explain why they
should be viewed as substantial.
o If you assert that the information is volontarily sub-
mitted, indicate whether you believe disclosure of this
information might tend to lessen the availability to
EPA of similar information in the future, and if so, how.
-------
.
EXAMPLES OP SEVERAL CONFIDENTIAL ATTACHMENTS
Example l (Confidential word or phrase that has been deleted froti the stjfly)-
CROSS REFERENCE NUMBER 1 This cross reference runber is used in the study
in place of the following words or phrase at the
indicated volume and page references.
DELETED WRDS OR PHRASE I Ethvlene Glycol
BUCE LINE REASON PQR THE DELETION FIFE* REFERENCE
6 14 Identity of Inert Ingredient SlO(d)UHC)
28 25 ' "
100 19 '
Exanole 2 (Confidential paragrapMs) that have been deleted from the study)
CROSS.JEFERBCE NUMBER 5__ This cross reference runber is used in the study
in place of the following paragraph(s) at the
indicated volume and page references.
( Reproduce the deleted paragraph!a) here . )
PAGE -LINES REASON FOR THE DELETION FIFRA REFERENCE
20 *-T7 Description of the Quality control process $10(d)(lHC)
3 ^Confidential pages that have been deleted from the study)
CROSS-KfXBBCE NUMBER 7 This cross reference number noted on a place-holder
~~~" page is used in place of the following whole pages
at the indicated voluns and page references.
DELegDPfCE(STt are attached iranedlately behind this page.
REASON FOR THE DELETION FTFRA REFERENCE
ascription of product manufacturing process SlO(dMlHA)
15
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6.
SAMPLE GOOD LABORATORY PRACTICE STATEMENTS
Example 1.
This study meets the requirements for 40 CFR Part 160
Submitter ...........
Sponsor ___ _____________________________
Study Director
Example 2.
This study does not meet the requirements of 4C CFR
Part 160, and differs in the following wayst
1.
2.
3.
Submitter
Sponsor
Study Director
Example 3.
The submitter of this study was neither the sponsor of this
study nor conducted it, and does not know whether it has
been conducted in accordance with 40 CFR Part 160.
Submitter
16
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ATTACHMENT 7.
FORMAT OP THE SUBMITTAL PACKAGE
Transnittal OocuiMnt.
Related Administrative Material*
(e.g.. Method of Support statement, etc.)
Other materials about the submittal
~ (e.g., summaries of groups of studies
to aid in their review).
Studies, submitted as unique
physical entities, according
to the format below.
FORMAT OF SUBMITTED STUDIES
Study title page.
Statement of Confidentiality Claims.
GLP and flagging* statements - as appropriate.
Body of the study, with English
language translation if required.
Appendices to the study.
Title Page of the Confidential
i ... Attachment.
..-H-i Confidential Attachment.
I
^j- —1 Supplemental Statement
s^ |- of Confidentiality Claims.
L-.-T
-r
""J
LEGEND
* When flagging requirements
are- finalised.
-1
I
Documents which must be submitted as
appropriate to meet established requirements.
Documents submitted at submitter's option.
17
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ATTACHMENT D
EPA GROUPING OF END-USE PRODUCTS FOR MEETING
DATA REQUIREMENTS FOR REREGISTRATION
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EPA'8 BATCHING OF ALLIUM SATIVOM (GARLIC) END-USE PRODUCTS FOR
MEETING ACUTE TOXICITY DATA REQUIREMENTS FOR REREGI8TRATION
In an effort to reduce the tine, resources and number of
animals needed to fulfill the acute toxicity data requirements for
reregistration of end-use products containing the active ingredient
Allium sativum (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., emulsifiable concentrate,
aerosol, wettable powder, granular, etc.), and labeling (e.g.,
signal word, use classification, precautionary labeling, etc.).
Note that the Agency is not describing batched products as
"substantially similar" since some products within a batch may not
be considered chemically similar or have identical use patterns.
Batching has been accomplished using the readily available
information described above, and frequently acute toxicity data on
individual end-use products has been found to be incomplete.
Notwithstanding the batching process, the Agency reserves the right
to require, at any time, acute toxicity data for an individual end-
use product should the need arise.
Registrants of end-use products within a batch may choose to
cooperatively generate, submit or cite a single battery of six
acute toxicological studies to represent all the products within
that batch. It is the registrants' option to participate in the
process with all other registrants, only some of the other
registrants, or only their own products within a batch, or to
generate all the required acute toxicological studies for each of
their own products. If a registrant chooses to generate the data
for a batch, he/she must use one of the products within the batch
as the test material. If a registrant chooses to rely upon
previously submitted acute toxicity data, he/she may do so provided
that the data base is complete and valid by today's standards (see
acceptance criteria attached), the formulation tested is considered
by EPA to be similar for acute toxicity, and the formulation has
not been significantly altered since submission and acceptance of
the acute toxicity data.
In deciding how to meet the product specific data
requirements, registrants must follow the directions given in the
Data Call-In Notice and its attachments appended to the RED. The
DCI Notice contains two response forms which are to be completed
and submitted to the Agency within 90 days of receipt. The first
form, "Data Call-In Response," asks whether the registrant will
meet the data requirements for each product. The second 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
-------
-2-
following options: Developing Data (Option 1), Submitting an
Existing Study (Option 4), Upgrading an Existing Study (Option 5}
or Citing an Existing Study (Option 6). If a registrant depends on
another's data, he/she must choose among: Cost Sharing (Option 2),
Offers to Cost Share (Option 3) or Citing an Existing Study (Option
6). If a registrant does not want to participate in a batch, the
choices are Options 1, 4, 5 or 6. However, a registrant should
know that choosing not to participate in a batch does not preclude
other registrants in the batch from citing his/her studies and
offering to cost share (Option 3) those studies.
Table I shows one batch which contains two products.
Table I.
Batch Nuifcer
1
EPA REG. NO.
47319-1
47319-2
X of Garlic t Other
Active Ingredients
5. OX - Garlic
12. OX - Red Pepper
5.0X - Garlic
12. OX • Red Pepper
Foroulation
Type
Dust
Dust
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 II.
EPA REG. HO.
47319-4
6299B-1
X of Garlic & Other Active Ingredients
24. OX - Garlic
36. OX - Red Pepper
5.0X - Garlic
Formulation Type
Liquid
Liquid
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ATTACHMENT E
EPA ACCEPTANCE CRITERIA
-------
M
Guideline Ref. No. 15IB-10
December 24. 1989
ISIB-IO Product Identity
ACCEPTANCE CWIBUA
Docs jow study am the Mtowing itrrftmtr criteria?
1. ._ Product sane tad tnde name (if different)
1 - Name, nominal concentration, tnd certified limits (upper tad lower) for each active
ingredient tad each iaten«, microbial toxins.
dioxins. nitroumiaes) present at <0.1%
4. ___ Purpose of each active ingredient and each intentionally-added iaen
5. _ Chemical name from Chemical Abstracts Index of Nomenclature and Chemical Abstracts
Service (CAS) Registry Number for each active ingredient aad, if available, for each
intentionally-added iaen
6. __ Product name, tnde name, and common name (if established) for each active ingredient
7. _ Molecular, structural, and empirical formulas, molecular weight or weight range, and any
company assigned experimental or internal code numbers for each active ingredient
& __ Description of each beginning material in the manufacturing process
__ EPA Registration Number if registered; for other beginning materials, the following:
_nrir Name aad address of manufacturer or supplier
_ Brand name, trade name or commercial designation
_ Technical specifications or data sheets by which manufacturer or supplier u«.xhnts:<
composition, properties or toxicity
9, .. Genus and species (and strain, subspecies, isolate, etc, if applicable) from which the
biochemical was isolated or with which it is commonly associated
10. __ Specificity of biochemical activity, the mode of action, and field rates at which the
biochemical is active/proposed (units ai/A. etc.)
II. __ Similarity to ihe naturally-occurring biochemical, if not derived from a biological em in
12. _ An updated Confidential Statement of Formula must be provided (EPA Form SfU-J u-v.
9*7).
13. _ Any known or suspected hazards of the biochemical to man, the environment, or nontargct
species.
Criteria narked with a * are supplemental and may act be required for every study.
CilS
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Subdivision M
Guideline Ret No. ISIB-U
December 24. 1989
1SIB41 MuBbaaiing PTOOBB
ACCEPTANCE CRITERIA
the iDUOWUg MBBptaDCe Criteria?
1. _. Description of manufrcturing prooeu or extraction/isolation steps if obtained from *
biologic*! entity.
1 __ Statement of whether batch or continuous process, if applicable
3. Relative amount of beginning materials and order in which they are added
4. __ Description of equipment
5. ___ Description of physical conditions (temperature, pH, pressure, humidity) controlled in each
step and the parameters that are maintained
& __ Statement of whether process involves intended chemical reactions
?. __ Flow chan with chemical equations for each intended chemical reaction
& ___ Duration of each step of process
9. __ Description of purification procedures
10. __ Description of measures taken to assure quality of final product including identity of the
biological source, if applicable
IL _. A dear presentation of the stage at which inert* are intentionally added, if and when any
concentration b effected, the material to be used as the manufacturing use product ; V.n),
whether HP registration is sought, and whether a TGAI/MP is sold and/or shipped.
Criteria marked with a • are svppkmenul and may not be required tor every study.
C-216
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M
Guideline Ret No. 1518-12
December 24. 1989
151B-12 DfaomiM of Formation of Unintended Uptdknu
ACCEPTANCE CRITERIA
Dos yoor atady meet tke fettowing iiTTptiiiBP criteria?
1. ._„ Dtsomioa of toimatioa of impurities tesed OB esubUsbed caemical theory addressing < 1)
each impurity which may be pretent at 2 0.1% or was found at i 0.1% by product analysts
and (2) certain laaocolofiGaUy significant impurities present at < 0.1% by weight
Criteria narked with a * are tapptemental and may not be required tor every study.
C-217
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Subdivision M
Guideline Ref. No. ISlB-U
December 24. 1989
1SIB-D Anlyib of Suipki
ACCEPTANCE CRITERIA
Dos yoar sndy Beet the feOavfeg amriHiacr criteria?
1. ___ Five or more representative lunplet (batches in cue of batch process) analyzed for each
active ingredient tad all impurities present at i 0.1%
I _ Degree of accountability or closure £ a 98%
3. ___ Analyses conducted for ceruin trace toxic impurities at lower than 0.1% (examples,
nitrosamines in the case of products containing dinitroaaiiines or containing secondary or
tertiary amiaes/alkanolamines plus nitrites: polyhalogenated dibenzodioqns and
dibenzofurans) (Note that in the case of nitrosamines both fresh and stored samples should
be analyzed.)
4. _.. Complete and detailed description of each step in analytical method used to analyze above
samples
S. __ Statement of precision and accuracy of analytical method used to analyze above samples
6. __ Identities and quantities (including-mean-and-standard-deviation) provided for each analyzed
ingredient
7. . The test material is to be the purest pesticidal grade commercially produced prior to
intentional addition of inens. Generally, this test material is the same as that used f"r
certain nnntarget and human hazard testing and is identical to. or equivalent to the technical
.grade. Any differences from the test substance used for hazard testing should be noted.
Criteria marked with a • are supplemental and may not be required for every study.
C-218
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Subdivision M
Guideline Ref. No. !SIB-IS
December 24.1989
U1B-13 CenificiiJoa of Uniis
ACCEPTANCE CRIT1RIA
Doa joor sndy aeet ike fcOowiag tmptiniT criteria?
1. , Upper ud tower certified limits proposed for each active ingredient and imeaiioiully added
teen along with explanation of bow the limits were determined
2. _ Upper certified limit proposed for each impurity present ai i 0.1% and for certain
toacolofkally rifiifetnt impurities at < 0.1H: aloof with explanation of how each limit is
determined
3. Analytical methods to wily certified limits of each active ingredient and impurities (Utter
not required if exempt from requirement of tolerance or if generally recognized as safe by
FDA) are fully described
4. „_ Analytical methods to verify certified limits validated as to their precision and accuracy
Criteria narked with a • are wpptaneatal and may not be required for every wudy.
• C-219
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Subdivision M
Guideline Ref. No. 1518-1"
December 24. 19D9
151B-17 Ptpiati and denial Properties
ACCEPTANCE CRITERIA
DOS yov mdy meet tte fcOovfng amrptiprr criteria?
A Color
„_ Verbal description of coloration (or tack of it)
_ Any intentional coloration also reported in terns of Munsell color system
B. Physical State
_. Verbal description of physical state provided using terms such as 'solid, granular.
volatile liquid*
, Based oo visual inspection at about 20-25*C
C Odor
__ Verbal description of odor (or lack of it) using terms such as 'garlic-like.
characteristic of aromatic compounds*
, Observed at room temperature
E>. Melting Point
__ Reported in *C
__ Any observed decomposition reported
E. Being Point
,^_ Reported in *C
_ Pressure under which B.P. measured reported
_ Any observed decomposition reported
F» Density. Bulk Density, Specific Gravity
_ Measured at about 2L-15*C
__ Density/bulk density reported in g/ml oj the specific gravity of liquids reported with
reference to water at 2.1*C (NOTE: For a solid in paniculate form a measurement
of bulk density may be substituted for measurement of density.]
G. Solubility
^ Determined la distilled water, a-ocunol and representative polar and non-polar
solvents, including those used in formulations and analytical methods for the
pesticide
Measured at about 20-23*C
_ Reported la g/lOOml (other units like ppm acceptable if sparingly soluble)
R Vapor Pressure
.. Measured at *2TC (or calculated by extrapolation from measurements made at
Criteria narked with a • are supplemental and nay not be required for every study,
C-220
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Subdivision M
Guideline Ret No. 15IB-17
December 24. I9g9
LpH
J. Stability
dither temperature if pressure 100 low to measure at 2S*C)
Experiment*! procedure described
Reponed in mm Hf (lorr) or other conventional writs
Measured at about 20»23*C
Measured following dilution or dispersion in distilled water
Sensitivity to metal tons and metal determined
Subiliiy at normal and elevated temperatures
Sensitivity w sunlight determined
K. Flammability
.„__ Flash point reponed in T or 'C
___ Flame extension or flame projection reponed to nearest centimeterjp nearest jnch
L Storage Stability
M. Viscosity
N. MistibOity
Product stored in its commercial package or smaller one of same construction and
materials
Amount of active ingredient determined in product at beginning and end of text
period (duration of at least one year gi for a product which degrades sufficient
duration to support expiration date)
Any deterioration or degradation products determined
Product examined for physical changes at end of test
Product stored at about 20-25'C (and 50*6 relative humidity if permeable
21 under warehouse conditions reflecting expected storage
Report includes duration and conditions of storage, quantitative analyses of i
ingredient, aad identification of any deterioration, degradation products, or ph^ieal
changes (and consequences of latter on safe handling and use of product)
Determined at about 20-25'C
Reponed ia poises, stokes, or other conventional units
Determined at about 20-25'C
Product mixed with petroleum solvents whose composition refects those on label and
at rate oa label
Mixture cnmiaed for separation after 30 minutes
Criteria marked with a • irt nppkmental and may not be required for «vcty study.
C-22I
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Subdivision M
Outline Ret No isiB.i?
December 24, i989
O. Corrosion Ouracuritiia
Ota on corrosion chirtaeruua provided (experimental method described) or.
reasonable explanation fh*a for lack of corrosivencM based OB nature of product
(t*. toek of cnreme pH; narcaatvej P
•s.
P. OctanolMtter PartfUoa Cbeffident
__ Measured at about 20>2S*C
^ Btperimeatally deiemitted and description of procedure pvjded (preferred method.
45 Fed. Register 77350)
__ Data supportiai reported value provided
Criteria marked with •• are supplement*! and nay aot be required tor every study.
C-222
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Subdivision M
Guideline Ref. No. 1S2B-10
December 24.1989
132B-10 Ante Oral "floridly
ACCEPTANCE CRITERIA
Dos joar study Beet ike Mkivtnf f "rrnift of tote?
I. ___ Technical form of the Kite ingredient tested, (for reregistration only)
2.* rmL_ At least S young adult nuAex/froup
3. _- Dosi&f. tingle onl dose or in ftsctions over 24 noun.
4.* Vehicle control if other than wtter.
5. ^_ Doses tated, sufficient to determine a toa'city augy or * limit dose (5000 mg,*|).
€. ___ Indfvjdtul observations at least once a day.
7. __ Observation period to last at least 14 days, or until all test animals appear normal whichever
is longer.
1 __ Individual daily observations.
9.' Individual body weights.
id* Cross necropsy on all animals.
Criteria narked with a • are supplemental and may not be required for every study.
0223
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Subdivision M
Guideline Ret. No. 1S2B-U
December 24,1989
152B-U Ante Derail Totidty
ACCEPTANCE CRITERIA
study meet tbe Mtaviag acrrpttaxt criteria?
I. •_. Technical form of tbe active iajredieat tested, (for rerefistraiioB only)
l*_. At toast 5 animaJsAex/froup
3.* Rats 200-300 fm. itbbits 2.0-3.0 kf or guinea pip 350450 fOL
4. ___ Dosinf, sia|le denniL
5. _ Dosing duration at least 24 noun.
€.• Vehicle control, only if todcity of vehicle is unknown.
7. _ Doses tested, sufficient to determine a toxicoty caiagory or a limit dose (2000 mglcg;.
8. __ Application site dipped or shaved at least 24 hours before dosinf
9. __ Application site at least 10* of body surface area.
10. __ Application site covered with a porous nonirriuiinc cover to retain test material and to
prevent infesikm.
II. .. Individual observations at least once ?-day.
12. _,— ObservKiaa period to last at least 14 da\*.-or-uMiLalLien.ajiimais ippear normal whichever
is longer.
13. individual daily observations.
14.* Individual body weights.
if." Cross necropsy on all animals.
Criteria marked with a • ire supplemental and may not be required for every study.
C-224
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Subdivision M
Guideline Ref. No. 152B-12
December 24,1989
•
1528-12 Acs* lahalattoo Toncity
ACCEPTANCE CRITERIA
Doa jour stady wet the Mtoviaf •myionp criteria?
L __ Technical (bin of the active ingredient tested, (for rercfistntion only)
Z „__ Product tt a fas, i solid which may produce a lifnificaat vapor hazard based on toricity and
expected OK or contains panicles of inhabble size for man (aerodynamic diameter 15 urn or
less).
3.* At least 5 young adult msAex/poop
4.* Oosinf, at least 4 boon by inhalation.
S.* Chamber air flow dynamic, at least 10 air changes/hour, at least 19% oxygen content.
& __ Chamber temperature, 22* C (±2*). relative humidity 4040%.
7. __ Monitor rate of air flow,
& __ Monitor actual concentrations of test material in breaihinf zone.
„ 9. __„ Motor wrodytumic panicle size for aerosols.
'ia ._ Doses tested, sufficient to determine a toxicity category or a limit dose (5 m^O. aaual
concentration of respirable substance).
U. ___ Individual observations at least once a day.
12. __ Observation period to last at least U days, or until all test animals appear normal
is longer.
13. . Individual daily observations.
14.* Individual body weights.
IS.* Gross necropsy on all animals.
Criteria marked with a • tn supplemental and nay apt be required tot every study.
0225
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Subdivision M
Guideline Ref. NO. IS2B-13
December 24, 1989
I52B-U Primary Eye Irritation
ACCEPTANCE CRITERIA
Doe* your st*dy meet ike toflowing arnrptancr criteria?
1. __ Technical form of the active ingredient tested, (for reregtstration only)
1 ___ Study not required if material is corrosive, causes severe dermal irritation or has a pH of $ 2
or 2 IU.
3 *_ « adult rabbits
4. _ Dosing, instillation into the coajunaival sac of one eye per animal.
S." Dose, at ml if a liquid: 0.1 ml or noi more than 100 mg if a solid, paste or rticulate
substance.
6. _ Solid or granular test material ground to a fine dust.
7.,__,_ Eyes aot washed for at least 24 hours.
8. _ Eyes enminfd and graded for irritation before dosing and at 1, 24. 48 and 72 hr. then daily
until eyes are normal or 21 days (whichever is shorter).
9. __ Individual dairy observations,
Criteria marked with a • an ssppkmenul aad may not be required lor every study.
O226
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Subdivision M
Guideline Ref. No. 1528-14
December 24. 1989
IS2&44 Primary Derail Irritation
ACCEPTANCE CRITERIA
Does yov «r»dy aeet the fctiowing KirptiinB criteria?
1. __ Technical fora of the active ingredient tested (for reregistration only)
2. ._.- Study aot required if auteriil it corrosive or has a pH of $ 2 or 2 H.S.
3.' 6 adult animals.
4. ___ Dosing, single dermal.
S. Dosing duration 4 boars.
& _ Application site shaved or clipped at least 24 hour prior to dosing.
?. Application site approximately 6 cm:.
& __ Application site covered with a gauze patch held in place with nonirritating tape
9. __ Material removed, washed with water, without trauma to application site
10. Application site examined and graded for irritation at 1.24.48 and 72 hr, then daily until
normal or 14 days (whichever is shorter).
It.* Individual observations for the entire day of dosing. •
12.* Individual dairy observations.
Criteria marked with a • *rt supplemental and may not be required for every study.
C-227
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Subdivision M
Guideline Ref. No. 152B-IS
December 24. 1989
IS2B-15 Hypeneositivity
ACCEPTANCE CRITERIA
Dew jour sady meet the Mtovfoj acccpuace criteria?
I. __ Technical form of the active ingredient tested, (for reregistntion only)
2. _ Study not requited if material it corrosive or has a pH of i 2 or 2 11.5.
3. L One of the following methods to utilized;
_ Frenad's complete adjuvant test
_„_ Guinei pig nuutmizitioa test
Split tdjuvint technique
.^_ Buehler test
^^^Open epicuuneous test
___ Mat^r optimiatioa test
__ Footpad technique in fuiae* pig
_ Other test accepted by OECD isoeciM
4. __. Complete description of test
5.V Reference for test
6. ___ Test followed essentially as described in reference document
7.* Positive control included.
Criteria marked with a • tit supplemental and may not be required for every study.
C-228
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ATTACHMENT F
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
-------
Page l of l
United States Environmental Protection Agency
Washington, D. C. 20460
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Case # and Name: 4007 Allium sativum
Co. Nr. Company Name
Additional Name
Address
City & State
Zip
047319 SEVANA CO.
062998 GUARDIAN SPRAY CO.
5336 E. EASTERBY DR.
900 LANCER WAY
FRESNO CA
LE6EC CA
93727
93243
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ATTACHMENT G
COST SHARE AND DATA COMPENSATION FORMS
-------
UnJtttf Stataa tnvlronmantal Protection Agtney
Wwhlngton, DC 10490
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
*•••••* **•* it-am
_ IS mfnuttt par mponat, Including
ttMfcyi*aj«^lntliuafew,ataFerito
ooovltiinBonditvltwlr«thtcoitGttoneflnfc
-------
?/EPA
Unltad Stataa Invlreruntntal Protaetion Agency
Washington, DC M4to
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
ONI N*.
Approval liplTM
Pubte raportng burden for tMi aolectton of Wormattoo to e*knatedloavefaotlSn*wte*peTr*«porw,lrsiu(j^
ttmferrevfewlr«inttrucUom. searching
aspect of thU coflectton of WormaUon. Including sumectior«lorreobdngthiiburo^toCnie1,tr«onn8llonPo6cy
•ranch. PM-223, U.S. Environmental Protection Agency, 401M SL, 8.W, Washington, DC a0460;andto the Oftct
of Management and Budget, Paperwork ReducBon Project (tOTMlOe). Washington. DC 10809.
Please ra to blanks Mow.
Ce-MayftjaM
Product Ea>*
EPA. Rag. Ho.
I Certify that:
My company to wTOlng to dtvttep and tufamh tti« data raquirtd by EPA undtr th« authority of tfw Ftdtrai
inwetiddt, Fungiddt and Rodtntidda Act (FIFRA). H naoatsary. Howavar, my company would prater to
antar Into an agraamant with ona or mora ragistranta to davalop Jointly or ahara in tha cost of davatoping
My Irm has offarad to writing to antar Into auch an agraamant. That offar was Irravocabla and Indudtd an
offer to ba bound by arbitration daettton undar aaetien 3(e)(2)(6)(Ri) of FIFRA If final agraamant on all
tarn* could not ba raachad otharwisa. This offar was mada to tha following firm(s) on tht following
data(s):
«f Oftor
o9rr9ajvnarnadab^ ftavamadton
1 aeknowfidgt that any knowingly falsa or
amnaolno staiamant may ba purtshaWa by flna or Irr^ritonrmnt or bom undtr appGcabit law.
Bat*
m* TW»
-------
&ER& • Product Specific
*PM«-I DataRaoort
r"
T«*«net
J2±
E»amtrue, accurate, and complete. I acknowledge that any knowingly false or misleading
statement may be punishable by fine or fn^nionniam or both under appficabla law.
n
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