d*1*0'**,
*JwL \ UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
J^y ? WASHINGTON, D.C. 20460
CBRTIFIBD MXIL OFFICE OF
PESTICIDES AND TOX.:
SUBSTANCES
Dear Registrant:
Enclosed is a Reregistration Eligibility Document (RED) for
the pesticide active ingredient warfarin and its sodium salt.
The RED is the Environmental Protection Agency's evaluation of
the warfarin and its sodium salt data base and presents the
Agency's conclusions on which uses are eligible for
reregistration and under what conditions and requirements. Also
enclosed is the Pesticide Reregiatration .Handbook which provides
instructions to registrants on how to respond to any labeling and
data requirements specified in the RED and how to reregister
products.
The RED identifies outstanding product specific data
requirements for end-use products and manufaturing-use products.
These requirements are listed on the Requirements Status and
Registrant's Response Form, which, along with the Data Call-in
Response Form, listing all of your company7 s products subject to
the RED, is included as an Appendix. Instructions for completing
both forms are contained in the RED package. All product
specific data must be submitted and found acceptable by EPA
before a product can be reregistered.
Generic data requirements usually will have been fulfilled
prior to making a reregistration eligibility decision. However,
there may be some instances where a iditional generic data are
required. If generic data requirements remain to be fulfilled,
all registrants must complete the appropriate Data Call-in
Response Form and Requirementa. Status and Registrant7 s Response
Form. These forms are in the appendices to the RED.
The RED identifies any specific labeling requirements such
as restricted use classification, groundwater hazard statements,
endangered species precautions, etc., necessary for
reregistration based on a review of the generic data for the
active ingredient. In addition, in order to be reregistered all
product labeling must be in compliance with format and content
labeling as described in 40 CFR 156.10 and all labeling changes
imposed by Pesticide Regulatory (PR) Notices.
Printed on Recycled Paper
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The Pesticide Reregistration Handbook contains detailed
instructions for compliance with the RED and must be followed
carefully. There are several key points to remember in preparing
your response to the RED:
o If generic or product specific data are required,
registrants must submit an initial response within
90 days of receipt of the RED. Forms for generic
data must be completed separately from forms for
product specific data and must be marked with
different internal distribution codes, (see page 6
of the Reregistration Handbook). Preprinted forms
for each product have been included in the RED
package.
o If expedited labeling changes are required,
registrants must submit them within the time frame
specified in the RED. Normally, however, labeling
changes and applications for reregistration must
be submitted within 8 months from the issuance of
the RED. Refer to pages 3-5 of the Reregistration
Handbook for instructions.
o Cite-aJLl is no longer a valid response for
fulfilling product-specific data requirements.
You must commit to generate the data, cite
srecific data or select other allowable options.
If you cite data, you must provide Master Record
Identification Numbers (MRID) for each data
requirement for each product. For previously
submitted data each registrant must determine that
the study meets the Agency's acceptance criteria
for data, which are enclosed. If the data do not
meet these criteria then the registrant must
commit to generate data or ch sose an appropriate
response option on the Requirements Status and
Registrant's Response Form.
o Grouping of Products for Acute Toxicological
Testing - In order to reduce the costs of testing,
the Agency has "grouped" identical or similar
products together for purposes of acute toxicity
testing. This is discussed on page 9 of the
Handbook and in an appendix to the data tables in
the RED.
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, o The data requirements in the RED are issued under
the authority of Section 3(c)(2)(B) of FIFRA.
Failure to adequately respond to the data
requirements specified in the RED within the
timeframe provided may result in the issuance of a
Notice of Intent to Suspend affecting products
containing warfarin and its sodium salt.
Compliance Dates; 1) Submission of Labeling - revised labels
of warfarin products amended in accordance with Section V of the
RED must be submitted by February 6, 1992. 2) Existing Stocks -
Registrants of warfarin products are permitted to sell or
distribute products bearing old labeling (or composition or
packaging) until September 6,1993.Persons other than registrants are
permitted to sell or distribute warfarin products bearing old
labeling until September 6, 1995.
Questions on product specific data requirements and labeling
(both End-Use Products and Manufacturing Use Products) should be
directed to the Registration Division Product Manager Team for
warfarin and its sodium salt (Marilyn Mautz, 703-557-785).
Questions on generic data requirements and labeling should be
directed to the Review Manager in the Special Review and
Reregistration Division (Herman T. Toma, 703-308-8055).
The Agency is prepared to meet with any registrants who have
questions about responding to the warfarin and its sodium salt
RED. If you want to meet with the Agency, you must contact
Herman T. Toma within two weeks of receipt of the RED. The
Agency intends to have one combined meeting with interested
registrants. If there are any requests for such a meeting, the
Agency will notify all registrants who requested a meeting of the
location and date. Requests for a meeting will not extend the 90
day or 8 month response deadlines.
Sincerely yours,
Allan S. Abramson, Ph.D.
Acting Director
Special Review and Reregistration Division
Enclosures
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REREGISTRATION ELIGIBILITY DOCUMENT
WARFARIN AND ITS SODIUM SALT
LIST A
MAY 1991
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
WASHINGTON, D.C.
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TABLE OF CONTENTS
PAGE
GLOSSARY iv
EXECUTIVE SUMMARY vi
I- INTRODUCTION 1
11 » ACTIVE INGREDIENTS CO¥SR£D BY THE REKEGI3TRA.TION
DECISIQN DOCUMENT
A. Identification of Active Ingredient 2
B. Use Profile 3
C. Regulatory History 4
III- AGENCY ASSESSMENT OF ACTIVE INGREDIENT
A. Human Health Assessment 5
1 . Toxicology Data 5
2 . Dietary Exposure 7
3, Product Chemistry 7
B. Environmental Assessment 7
1 , Environmental Fate Assessment 8
2, Ecological Effects Assessment 8
IV". RSRSQISTRATION DECISION , FOR WARFARIN AMD ITS
SQD^UM
A. Determination of Eligibility 10
B, Additional Generic Requirements 15
C, Labeling Requirements 15
V. PRODUCT REREGI3TRATION
A. Determination of Eligibility 16
B» Existing Stock Requirements 17
C. Product -Specific Data Requirements 17
D. Labeling Requirements 17
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TABLE OF CONTENTS (cont'd)
VI. APPENDICES
A. APPENDIX A - Generic Data Requirements for
Reregistration of Warfarin and its Sodium Salt and Data
Citations Supporting Reregistration
1. Guide to Appendix A 21
2. Product Chemistry 23
3. Toxicology 25
4, Environmental Fate 26
5. Ecological Effects 27
6. Non-dietary Exposure 30
7. Residue Chemistry 31
B. APPENDIX B - Bibliography
1. Guide to Appendix B 32
2. Bibliographic Citations 36
C. APPENDIX C - PESTICIDE REREGISTRATION HANDBOOK
D. APPENDIX D - DATA CALL-IN
1, Attachment A: Data Call-in Chemical Status Sheet
2. Attachment B: Generic Data Call-in Response Form
Generic Requirement Status/
Registrant's Response Form
3. Attachment C: Product Specific Data Call-in
Response Form Product Specific
Requirement Status Registrant's
Response Form
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4. Attachment Ds Formatted/Sample Labels
D-l: Warfarin Tracking Powder
D-2: Warfarin Dry Concentrate
D-3; Sodium Salt of Warfarin
Conncentrate (Liquid Bait)
D-4: Ready-To-Use Warfarin Dry Bait
5. Attachment 1: EPA Grouping of Ind-Uge Products for
Meeting Acute Toxicology Data
Requirements/Reregistration
6. Attachment F; EPA Acceptance Criteria
7. Attachment G: List of All Registrants sent This Data
Call-in Notice
8, Attachment H: Cost Share & Data Compensation Forms
(Generic i Product specific Data)
Product Specific Data Report Form,
111
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aXBCUTIVg 3DMKARY
Warfarin and its sodium salt are rodentieides registered in
the United States to control commensal rodents in domestic
dwellings (indoor and out), animal premises, agricultural
premises and equipment, commercial and industrial sites. The
predominant formulations are warfarin baits which are dry {meal,
pelleted, paraffinized); and a 1.0% dust for use as a tracking
powder; and the sodium salt formulations diluted with water to
make liquid baits.
A Registration Standard for warfarin and its sodium salt wag
issued in August 1981. The Registration Standard summarized the
available data supporting the registration of warfarin and its
sodium salt and required additional data to assure that the
proper use of the pesticide posed no potential adverse effects to
man or the environment.
In 1989, the Agency completed a review of the warfarin data
base including the data submitted in response to the 1981
Registration Standard and issued a "Draft Warfarin
Reregistration Document" for public comment. The Agency found
that it had sufficient information on the health effects of
warfarin and on its potential for causing adverse effects to the
environment to conclude that few additional studies were needed
to characterize the risk of warfarin or its sodium salt. The
"Draft" document was never issued in final because it has been
superseded by the current Reregistration Eligibility Document*
The Agency has determined that all uses of warfarin and its
salt will not cause unreasonable risk to man or the environment
and are eligible for reregistration. However, the Agency la
requiring product chemistry data, and fish and aquatic
invertebrate data on the sodium aalt. The product chemistry data
are being required to replace unacceptable studies. The fish and
aquatic invertebrate data are being required in order to conduct
a complete risk assessment for the sodium salt. Because of the
sodium salt use patterns (i.e. use only in and around buildings)
the Agency believes there is little possibility for- aquatic
organism exposure and the sodium salt can be reregistered at this
time. Warfarin data cannot be used as a substitute for the
sodium aalt data because of significant differences in solubility
between the two compounds.
Because tracking powder uses in food and feed handling
establishments are now considered to be food uses, registrants
will have to adopt labeling language limiting the placement of
tracking powder to inaccessible areas in order to be eligible for
reregistration. If registrants do not adopt the restrictive
vi
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label language specified in this document, they will be required
to develop residue chemistry data and possibly establish
tolerances.
Before reregistering each product, the Agency is requiring
that product specific data and revised labeling be submitted
within 8 months of the issuance of this document. In an effort
to reduce time, resources, and number of animals needed to
fulfill the acute toxicology data requirements for warfarin
containing end use products, the Agency has "batched" products
considered to be similar with respect to acute toxicity testing
requirements. After reviewing these data and the revised labels,
the Agency will determine whether to reregister a product based
on whether or not that product meets the requirements in Section
3 (c)(5) of FIFRA. End use products containing warfarin in
combination with other active ingredients will not be
reregistered until the Reregistration Eligibility Documents for
all active ingredients contained in that product are issued.
However, product specific data for these products are being
called in at this time.
vii
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI
a.i.
ARC
CAS
CSF
EEC
EP
EPA
FIFRA
FFDCA
HDT
K+CWHR
LC30
t-0A
LOT
LEL
MP
MPT
Acceptable Daily Intake. Also known as the Reference
Dose or RfD .
Active Ingredient
Anticipated Residue Contribution
Chemical Abstracts Service
Confidential Statement of Formula
Estimated Environmental Concentration. The estimated
pesticide concentration in an environment, such as a
terrestrial ecosystem,
End-Use Product
U.S. Environmental Protection Agency
Federal Insecticide, Fungicide, and Rodenticide
Act
Federal Food, Drug, and Cosmetic Act
Highest Dose Tested
Kernel plus Cob with Husk Removed
Median lethal concentration - a statistically derived
concentration of a substance that can be expected to
cause death in 50% of test animals. It is usually
expressed as the weight of substance per weight or
volume of water or feed, e.g., mg/1 or ppm.
Median lethal dose - a statistically derived single
dose that can be expected to cause death in 50% of the
test animals, when administered by the route indicated
{oral, dermal, inhalation) . It is expressed as a
weight of substance per unit weight of animal, e.g.fm
mg/Jcg.
Lowest Dose Tested
Lowest Effect Level
Manufacturing Use Product
Maximum Permissible Intake
IV
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MRID
Master Record Identification (number). EPArs system of
recording and tracking studies submitted to the Agency.
HIDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
ppra Parts per Million
RfD Reference Dose
RS Registration Standard
TMRC Theoretical Maximum Residue Contribution
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I- INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide
Act (FIFRA) was amended to accelerate the reregiatration 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 9 years. There
are five phases to the reregiatration process. The first four
phases of the process focus on identification of data
requirements to support the reregistration of an active
ingredient and the generation and submission of data to fulfill
the requirements. The fifth phase is a review by the U.S.
Environmental Protection Agency (referred to as "the Agency") of
all data submitted to support reregistration,
FIFRA section 4(g)(2)(A) states that in Phase 5 "the
Administrator shall determine whether pesticides containing such
active ingredient are eligible for reregistration'1 before calling
in data on products and either reregistering products or taking
"other appropriate regulatory action." Thus, rsregistration
involves a thorough review of the scientific data base underlying
a pesticide's registration. The purpose of the Agency's review
ia 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 FIFBA.
This document presents the Agency's decision regarding the
reregistration of warfarin and its sodium salt. The document
consists of six sections. Section I is this introduction.
Section II describes warfarin and its sodium salt, its uses and
regulatory history. Section III discusses the human health and
environment assessment baaed on the data available to the Agency,
Section IV discusses the reregistration decision for warfarin and
its sodium salt. Section V discusses the (Che)reregistration
requirements for Warfarin and its sodium salt. Section VI is the
Appendices which support this reregistration eligibily document.
Additional details concerning the Agency's review of available
data are available on request.1
s reviews of data on the set of registered uses
considered for EPA's analyses may be obtained from the OFF Public
Docket, Field Operations Division (H75Q6C), Office of Festicide
Programs, EPA, Washington, DC 20460.
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I. ACTIVE INGREDIENTS COVERED BY THISREREGISTRATION DECISION
DOCUMENT
A- Identification of Active Ingredient
The following active ingredient is covered by this
Reregistration Eligibility Document:
Common Name; Warfarin and its sodium salt
Chemical Name: 3-(alpha-acetonylbenzyl)-4-
hydro xycoumar i n
Chemical Family: Coumarin anticoagulants
CAS Registry Number: 81-81-2
Office of Pesticide Programs Chemical Code Number:
086002 (warfarin)
OS6003 (sodium salt of warfarin)
Empirical Formula; C19H16°4
C*19H15Na°4 (sodium salt of
warfarin)
Trade Names: Warfarin, Coumarin, Coumafene, Co-Rax,
Cov-R-Tox, Kypfarin, Liqum-Tox, Rodex,
Rax, Rodex Blox, Tox-Hid
Physical Characteristics; The folio-wing information is
on technical warfarin unless otherwise indicated.
Molecular Weight: 308,4
330,1 (sodium salt of warfarin)
Color: White powder or crystal
Odor: None
Melting Points 159 to 165 *sC
Solubility: 0.196 mg/mL water at 25 HC, up to 8% in
acetone, up to 24 in ethanol. The sodium
salt formulation is readily soluble in
water.
Dissociation Constant: pKa - 4,9
Octanol/Water Partition Coefficient: Log Kow =2.37
pH: 7.2 to 8.3 in water
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Stability: Stable under normal conditions
Corrosion Characteristics: Non-corrosive
Uae Profile
Type of Pesticide: Rodenticide
Mechanism of Action; Blood anticoagulant
that leads to internal bleeding and hemorrhaging.
Ose Sites: Domestic dwellings (indoor and out),
animal premises (cattle feed lots, stockyards, poultry
houses)/ agricultural premises and equipment,
commercial and industrial sites (including food
processing, handling and storage areas, meat and
poultry processing plants),
Pests: Baits for commensal rodents.
Commensal rodents are species which live in close
association with humans and obtain much of their diets
from human food. In the United States, commensal
rodents include the Norway rat (Rattug norveaicua),
roof rat (Rattus rattus), and house mouse (Mus
musculus).
Formulation Types Registered:
Warfarin? 0.3, 0.4, 0.5, and 2 percent concentrates
for preparing dry baits; 0.025 to 0,054 percent ready-
to-use meal, pelleted, or paraffinized baits; 1.0
percent dust for use as a tracking powder.
Concentrates to be dilutad with bait materials at rates
of 12 to 79 parts bait to 1 part concentrate to yield
solid baits that are 0.025 percent warfarin,
SodiumSalt of. Warfarin; 0.0127 to 0.54 percent salt
formulations to be diluted with water to make 0.005
percent sodium salt of warfarin liquid bait solutions;
0.54 percent liquid concentrates to be diluted with
water to make 0.025 percent: sodium salt of warfarin
liquid baits.
Methods and Rates of Application:
Solid Baits: Individual bait placements of 1/4
to 2 ounces (or equivalent) for house mice, spaced
at intervals of 8 to 12 feet; individual bait
placements of 3 to 16 ounces for Norway rats and
roof rats. Baits are to be protected by tamper-
resistant bait stations when applied in sites
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accessible to children, pets, domestic animals,
and nontarget wildlife.
Liquid Baits; Individual placements in chick founts or
other suitable liquid dispensers or in covered bait
stations adapted for containing and dispensing liquid
baits. At least 1 pint of bait is used per placement
for Norway rats and roof rats and 4 to 8 ounces for
house mice. Baits applied in areas accessible to
children, pets, domestic animals, and nontarget
wildlife are to be protected by tamper-resistant bait
stations adapted for confining and dispensing liquid
baits.
Tracking Powders; For dusting of burrows or small
patches of indoor surfaces; treatment rates are 1 ounce
dust per 2.5 square feet of runway area for house mice
and 2 ounces per 2.5 square feet of runway for rats.
These products are to be used only in areas not
accessible to children, pets, domestic animals, and
nontarget wildlife.
C. Regulatory History
Warfarin and its sodium salt were Federally registered
in 1952 for use as a rodenticide. A Registration Standard
for warfarin and its sodium salt was issued in August 1981,
That document identified unfilled data requirements in
product chemistry, acute toxicity, ecological effects, and
product efficacy that were necessary for reregiatration.
This document reflects a reassessment of all data submitted
in response to the registration standard and used to
support the reregistration of warfarin and its sodium salt.
A copy of the Registration Standard can be purchased
from the National technical Information Service, 5285 Fort
Royal Roadr Springfield, VA 22161, under the NTIS Stock No.
PB 82-140716.
The Agency iaaued. a "Draft Warfarin Reregister at ion
Document" in April 1989. Notice of availability of the
document was published in the FEDERAL REGISTER May 10,
1989 (54 FR 20197). Comments were received from three
persons. Copies of those comments and the Agency's
response are available from EPA's Freedom of Information
Office, 401 M Street SW., Washington, DC 20460,
Mmilcode: H7502C.
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III. AGENCY ASSESSMENT OF ACTIVE INGREDIENT
This section discusses the Agency's assessment of the
scientific data base of warfarin and its sodium salt for
purposes of determining the reregistration eligibility for
the subject pesticide. The reregistration decision and
supporting regulatory position and rationales are contained
in Section IV.
A. Human Health Assessment
!« Toxicology Data Base
This section discusses data available to the
Agency for the toxicological evaluation of warfarin and
and itg sodium salt. All generic toxicology data
requirements are satisfied.
Warfarin, a synthetic analogue of Vitamin K,
functions as an antivitamin. Warfarin is a member of
the coumarin family of chemicals of blood
anticoagulants. The sodium salt of warfarin is used as
an anticoagulant in the treatment of huinana with
hypercoagulation problems. The toxicity, mechanism of
action, and treatment of overdoses of warfarin are part
of the basic training of physicians. The Agency has
based its determinations relative to human safety in
this document on this body of human evidence and
experience.
There is a delay of 12 to 72 hours between the
ingesticm of a single toxic dose of warfarin and the
appearance of the toxic effects (hypocoagulation). The
length of this delay is dependent on the normal half-
life of the vitamin K-dependent coagulation factors and
is not significantly decreased by administering larger
dosea of warfarin. The mechanism of action explains
the occurrence of toxic effects from daily ingestion of
small doses of warfarin.
Warfarin toxicity is manifested in an increase in
prothrombin and partial thromboplastin times and a
decrease in the Vitamin K-dependent clotting factors,
II, VII, IX, and X. Bleeding time, clot retraction,
platelet counts, thrombin time, and euglobulin lysis
times are usually normal. Signs of toxicity include
cutaneous bleeding, heinaturia, melena or hematochezia,
hematoses, uterine bleeding in women, epistaxis, and
gingival bleeding. Death, follows excessive external or
internal bleeding.
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The high toxicity of technical warfarin clearly
places it in Toxicity Category I. Because of the
physical chemistry of warfarin, dermal and inhalation
toxicity are not significant. Human experience with
administration of warfarin by both oral and injection
routes haa produced no reports of allergic or
sensitization problems.
Warfarin has clearly been established as a human
teratogen at clinical doses. Birth defects have been
observed as a result of exposure to coumarin
anticoagulants during any trimester of pregnancy.
Coumarin derivative use or abuse in pregnant women
results in one-sixth of pregnancies ending in abortion
or stillbirth. As stated previously, warfarin'a
toxicity, and mechanism of action in humans are well
established. But the concentration of warfarin
Contained in bait material in products registered for
homeowner use is low (0.025 to 1.0% active ingredient).
Therefore, there is little potential for human toxicity
from a single ingestion of treated bait from these
products. Based on the availability and completeness
of human information and the registered use patterns of
warfarin, additional toxicology studies are not
required.
Many incidents or suspected incidents of human
exposure to anticoagulant rodenticides are reported
annually to poison control centers. However,
accidental ingestions of warfarin seldom result in
life-threatening or disabling symptoms that can be
attributed directly to warfarin, and there does not
appear to be any evidence of significant health effects
from single ingestions of warfarin.
The exact number of annual pet exposure incidents
or suspected incidents that result from the use of
warfarin againat commensal rodents is unknown but many
incidents are reported annually. Dog incidents account
for most o£ the reported nontarget animal exposures.
Deaths occur in some pet exposure incidents involving
warfarin,
These reported human and pet poisoning incidents
point to the need to require tamper-resistant bait
stations when baits are applied in areas accessible to
children and nontarget animals. Warfarin's use
patterns do not trigger the data requirements for
applicator or reentry exposure studies.
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2 . Dietary Exposure
Currently, there are no tolerances or exemptions
from the requirement of tolerances for residues of
warfarin in or on food/ feed items. When the
Registration Standard for warfarin was issued in August
1981, no residue chemistry data were required because
none of the Federally registered uses was regarded as a
food/ feed use. Since that time the guidelines for
residue chemistry have been issued. The Agency has
subsequently determined that the use of tracking powder
formulations in agricultural premises and in
commercial, industrial, and institutional sites have
the potential to contaminate food/feed products from
rodents, insects and human tracking residues from
treated areas.
The registrants of tracking powder formulations
are required either to place additional use
restrictions on their product labeling to reduce the
likelihood of food or feed contamination, or to develop
data to demonstrate whether warfarin can contaminate
food/ feed products from the currently registered use
{refer to the residue chemistry data requirement
tables) . If a registrant elects to retain the current
label with no additional restrictions and the required
residue data confirm that warfarin can be transferred
to food/feed products, appropriate food/feed additive
regulations, supported by a full complement of
toxicology and residue chemistry data, will be
required. These data requirements can be avoided by
the registrants of tracking powders if their product
labels are modified to limit the use of tracking
powders to areas where food contamination is unlikely.
There are no Codex Maximum Residue Levels for
residues of warfarin in or on food/ feed items.
3 . Produq^ Chemistr
Since the issuance of the 1981 Standard, certain
product -specific chemistry data have been submitted to
the Agency. Further data are still required. These
data are specifically identified in Appendix D.
B. Environmental Assessment
This section discusses the data available for
assessing the environmental impact of warfarin and its
sodium salt. All previously required data have been
submitted and found acceptable except for Guidelines
72-la and b (fish toxicity - bluegill sunfish and
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rainbow trout) and 72-2 (invertebrate toxicity) using
the sodium salt. Because of differences in solubility
between warfarin and warfarin sodium salt,, fish and
in-vertebrate toxicity studies with the sodium salt are
required in addition to the existing data for warfarin,
The absence of these studies will not adversely affect
the reregistration eligibility of warfarin and its
sodium salt since the Agency does not expect
significant exposure to occur in the aquatic
environment from the currently registered uses ( indoor
and near buildings) . However, these ecological effects
data are still needed to confirm the Agency' s
expectation that no unacceptable risk will be poaed to
fish and aquatic invertebrates.
1- Environmental f a-fre Assessment
Based on the registered use patterns of warfarin,
it is anticipated that there is insignificant
environmental exposure from the chemical . Aa warfarin
ia not applied as a ground spray or aerially, it does
not trigger any spray drift data requirements.
Groundwafrer Concerns
Relatively little environmental exposure of
warfarin baita ia expected when the chemical ia used
according to label directions , No groundwater
monitoring data have been required.
2. Ecologica 1 __Effects Aaaesamenfc
Avian Studies
An acute study on bobwhite quail showed that
warfarin has an LDso > 2000 mg/kg. There is sufficient
information to characterize warfarin as practically
nontoxic to game birds.
In subacute dietary tests, warfarin waa found to
be moderately toxic to practically nontoxic to upland
game birds (LC of 625 ppm and 6690 ppm with bobwhite
quail) . In watPerfowl, warfarin was also found to be
moderately toxic to practically nontoxic (LC of 890
ppm and > 5000 ppm with mallard ducks) , Whi3?e these
studies show variability, the Agency concludes that use
of warfarin end-use products according to current use
directions and restrictions would preclude significant
exposures of wild avian apecieg to warfarin.
Therefore, no additional testing for warfarin or its
sodium salt is required.
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Aquatic, -Studies
Studies have been submitted showing the LC50
values for Paphnia maana, bluegill sunfish and rainbow
trout. However, the LCsof a greatly exceed the
established solubility of warfarin in water. The
solubility of warfarin, which varies with water
temperature, was reported to be 17 ppm in the Daphnia
study, 16 ppm in the trout study and 17.5 ppm in the
bluegill study. Thus, the Agency is considering the
LC50 values for purposes of risk assessment to be the
limits of solubility. At its maximum concentration in
water, warfarin is not known to be toxic or only
slightly toxic to fish.
The Agency is not requiring a repeat of the
warfarin aquatic tests, even though certain questions
remain, because of the nonaquatic use pattern, the
insolubility of warfarin, and long field experience
that has not shown any potential for hazards to aquatic
organisms.
Studies are being required to assess the toxicity
of the sodium salt of warfarin since it is more soluble
than warfarin in water. However, the sodium salt of
warfarin is eligible for reregistration, even while
these data are being developed, since significant
exposure is not expected to occur from currently
registered uses.
Secondary Poiawning lazards
Most applications of warfarin are made under the
following use patterns; terrestrial non-food crop
(commercial, institutional, industrial premises/
equipment); residential outdoor {household/domestic
dwellings); indoor non-food (farm/barns, poultry and
rabbit houses, food/meat processing plant premises/
equipment, food distribution/storage facilities); and
indoor residential (household/domestic dwellings,
veterinary premises), In addition, warfarin baits are
placed directly at a site, i.e. not broadcast, sprayed
or applied aerially, which greatly limits the potential
for any secondary exposure.
Secondary exposure is considered to be low because
the levels of warfarin in the target animals are
generally too low to be toxic to either a predator or
scavenger except under the most extreme conditions. A
predator or scavenger would have to consume poisoned
target animals for several consecutive days before it
-------
would be poisoned itself.
Endangered Species Concerns
Because of warfarin's established, high mammalian
toxicity and because of its use patterns, the Agency
has identified warfarin as having the potential to
affect endangered and/or threatened mammals adversely.
Therefore, it is in need of further evaluation.
Requirementsf if any, to preclude harm to listed
mammals will be addressed in a forthcoming, formal
consultation with the U, S. Fish and Wildlife Service.
IV. RBREGISTRATION DECISION FOR WARFJUR.IN AMP IfS SODIUM SALT
A. Determinations of Eligibility for Reregistration
Section 4(g)(2)(A) of FIFRA calls for the Agency
to determine, after submission of relevant data
concerning an active ingredient, whether products
containing the active ingredient are eligible for
reregistration. The Agency has previously identified
and required the submittal of all the generic (i.e.,
active ingredient specific) data required to support
reregistrmtion of products containing warfarin and its
sodium salt as an active ingredient. The Agency has
completed its review of these generic data, and has
determined that the data are sufficient to support
reregistration of products containing warfarin and its
sodium salt. Appendix A identifies the generic data
requirements that the Agency reviewed as part of ita
determination of reregistration eligibility of warfarin
and Its sodium salt and lists the submitted studies
that the Agency found acceptable,
The data identified in Appendix A were sufficient
to allow the Agency to conduct a reasonable risk
assessment for all registered uses of warfarin and its
aodium aalt and to determine for all such uaea that
warfarin and its sodium aalt can be used without
resulting in unreasonable adverse effects on the
environment. The Agency finds that all products which
contain warfarin and its sodium salt as an active
ingredient are eligible for reregiatration. The
reregiatration of particular products is addressed in
Section V. of this document ("Product Reregistration").
The Agency made its reregistration eligibility
determination based upon the target data base required
for reregistration, the current guidelines for
conducting acceptable studies to generate such data,
10
-------
and the data identified in Appendix A. Although the
Agency has found that products containing warfarin and
its sodium salt are eligible for reregiatration, it
should be understood that the Agency may take
appropriate regulatory action and/or require the
submission of additional data to support registration
of products containing warfarin and ita sodium salt if
new information comes to the Agency' a attention or if
the data requirements for registration (or the
guidelines for generating such data) change.
The following is a summary of the regulatory
positions and rationales for warfarin and its sodium
salt. Where label revisions are imposed, specific
language is set forth in the labeling sections IV. c.
and V.c. of this document.
1« Eligibility for Reregist ration
The Agency finds that it has sufficient
information on the health effects of warfarin and its
sodium salt and on their potential for causing adverse
effects to fish and wildlife and the environment to
conclude that products containing warfarin and its
sodium salt are eligible for reregistration. Only
certain product chemistry and three acute aquatic
toxicity studies on the salt are still needed.
Tracking powders used in food/ feed handling
establishments are eligible for reregistration provided,
the registrant (a) adopt the restrictive labeling
language required in the RED.
The Agency has reviewed all available data
supporting the registration of products that contain
warfarin. This review shows that additional data are
not needed to support most registered uses of this
chemical . The Agency finds that additional toxicity
data on fish and invertebrates are needed for the
sodium salt of warfarin due to the differences in
solubility between warfarin and the sodium aalt.
Because tracking powdar uses ar-e now considered to toe
potential food uses, data are required to determine
whether tolerances must be established under section
408 or 409 of the Food, Drug, and Cosmetic Act unless
the restrictive labeling cited in section V is adopted.
The Agency has determined that warfarin products,
labeled and used as specified in this Reregistration
Eligibility Document, will not pose unreasonable risks
of adverse effects to man and the environment.
11
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2. Food Uae Restrictions
The Agency is requiring additional use
restrictions on the label or submission of residue
chemistry data to support use of the 1 percent dust
tracking powder formulation in agricultural premises
and food handling establishments.
3. R.e a t r i c t ej| T U s e
The Agency is continuing to require that warfarin
tracking powder end-use products be classified as
Restricted Use pesticides.
Rationale
The use pattern of this formulation, its higher
toxicant levels (in relation to baits), the need for
special training and application equipment, and the
potential for misapplication by users require this
Restricted Use status.
Rationale
Due to the nature of the formulation and its
method of application (patches of dust), the Agency has
determined the current use restrictions are not
adequate to alleviate concern that contamination of
feed stored in agricultural buildings or food in food
handling establishments may result from the use of
tracking powder in these facilities. Examples of
potential avenues of food contamination include: 1)
tracking of" residues from treated areas by rodents,
insects, or humans; 2) distribution of particulate
matter through forced air ventilation systems; and 3)
routine floor cleaning or cleaning specifically to
remove old or excess tracking powder. Registrants may
avoid the requirement to conduct residue chemistry
testing by amending their product registrations to
limit the use of tracking powder to areas where food
contamination is unlikely. Placement of tracking
powders would be limited to concealed inaccessible
places such as those between floors and walls.
Application of tracking powders along walls, in
corners, in open floor area or on rafters of rooms in
which feed or food is handled or stored is prohibited.
The Agency believes these measures will significantly
reduce the potential for food/feed contamination and
will eliminate thte need for residue data. An
acceptatole label statement for this purpose ia found in
Section V, subsection D, item 2.
12
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4. Bait Station Requirement
The Agency will require expansion of label
statements regarding the use of protective bait
stations.
Rationale
Many nontarget exposures of humans and nontarget
animals to anticoagulant rodenticides are reported each
year. EPA believes that most accidental exposure
incidents could have been prevented if products had
been used, stored, and handled according to label
directions. The Agency is currently preparing a PR
Notice describing criteria and requirements for tamper-
resistant bait stations, when completed/ this notice
will be sent to all appropriate registrants. The use
of tamper-resistant bait stations ia required when
baits are applied in areas accessible to children and
nontarget animals.
5. Teratology. Warning
fhe Agency is requiring placement of a teratology
warning statement on the labels of manufacturing-use
products and warfarin concentrates used for preparing
dry baits. Refer to Section IV, subsection C.
Rationale
High doses of warfarin are known to cause
teratogenic effects in humans. The 1981 registration
standard required placement of a teratogen warning on
the labels of manufacturing-use products. The warning
statement is being changed to be more explicit about
this haiard. The warning is required of manufacturing-
use products because workers may receive significant
doses of warfarin when handling these products. This
warning statement is also required on labels of certain
end-use products {concentrates used for preparing
baits) .
6» Format Labels
Labels with special formats should be used for dry
concentrate, sodium salt concentrate, and ready-to-use
dry bait products which are used to control Norway
rats, roof rats, and house mice in and around homes,
industrial buildings, and similar man-made structures.
13
-------
The formats for the labels are given in Appendix D,
Attachment D.
Rationale
Because of the limited use patterns, the high
number of products, and the Agency's extensive
experience with reviewing labels and efficacy data on
these types of products, these format labels provide an
efficient way to achieve consistent, acceptable
labeling.
7, Batching of Warfarin End-Use Products
The Agency has batched warfarin end-use
products to meet the acute toxicity data requirements
for reregistration.
Rationale
In an effort to reduce the time, resources and
number of animals needed to fulfill the acute toxicity
data requirements for reregiatration of the end-use
products containing the active ingredient, warfarin,
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 and labeling {e.g., signal word, use
classification, precautionary labeling). Note that the
Agency is not describing batched products aa
"substantially similar" since some products within a
batch may not be considered chemically similar or have
identical use patterns.
8. E £ fi e acy D ata Requ i r emenfel
The Agency is continuing to require the submission
of efficacy data for manufacturing-use and end-use
products.
Rationale
The pests which warfarin controls are significant
vectors of diseases of public health concern. The
effectiveness of the products is influenced not
only by the amount of the active ingredient, but
also by the quality of the active ingredient and
the flavor of the bait ingredients in a product.
14
-------
Further, inert ingredients vary considerably from
one product formulation to another. Therefore,
efficacy data will continue to be required to
ensure that all registered warfarin products are
effective against commensal rodents. Refer to
Appendix D for additional information on these
testing requirements.
9. Label Amendment Requirements
Registrants of products used for control of
additional pests or at different sites than those
covered on the labels prescribed in Section V,
subsection C (part 1-5) must submit labeling for
the species, sites and application rates, and
method for the product.
Rationale
The Agency must assess the labeling for such products
to determine whether the use is consistent with FIFRA
and other applicable statutes.
B- Additional GenericData Requirements
The generic data base supporting the reregistration of
products containing warfarin and its sodium salt has
been reviewed and determined to be substantially
complete. The remaining generic data that muat be
submitted are certain product chemistry data, three
acute toxicity tests on bluegill sunfish, rainbow
trout, and freshwater invertebrates using the sodium
salt formulation. Residue data from the tracking powder
use in food/feed handling establishments is required
unless the registrant(s) adopt the restrictive labeling
cited in this document which limits placement of
tracking powders to inaccessible locations. Refer to
Appendix D for additional information on the generic
data requirements for warfarin and its sodium salt.
G. Labeling Requirements for Manufacturing-Uae Products
Containing Warfarin and Its Sodium Salt
All products are required to bear appropriate
labeling as specified in 40 CFR 156.10. Specific
information regarding label requirements is included in
the Pesticide Reregiatration Handbook.
All warfarin manufacturing-use product labels must
bear the following statements:
a. "For formulation only into registered end-use
15
-------
rodentIcides used in and around buildings,
similar man-made structures, and in transport
vehicles."
b, "Exposure to warfarin or [sodium salt] during
pregnancy should be avoided. Warfarin may
cause harm to the fetus, including possible
birth defects," [Place in Hazards to Humana
and Domestic Animals™ section of the label.]
c. "Use a dust respirator" [If the product is a
respirable dust]. "Use rubber gloves when
mixing baits containing warfarin",
V. PRODUCT REPEGISTRATION
Baaed on the reviews of the generic data for the
a.i. warfarin and its sodium salt, all products
containing these active ingredients are eligible for
reregistration,
A. Determination of Eligibility
All products currently registered containing the
active ingredient warfarin and its sodium salt are
eligible for reregistration. Section 4 (g)(2) (B) of
FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a
determination of eligibility has been made. The Agency
will review these data and determine whether to
reregister in-dividual products.
B« Sxisting Stock Rfequirjanent&
Registrants of warfarin products are permitted to
sell or distribute products bearing old labeling (or
composition or packaging) for 26 months after the
Issuance of the RID. The issuance date is the stamped
date on the RED cover letter to the registrants.
16
-------
Persons other than registrants are permitted to sell or
distribute warfarin products bearing old labeling for
an additional 24 months, or 50 months from the issuance
date of the RED. The 26 month time frame is composed
of eight months for submission of labeling to the
Agency, six months for Agency review and approval of
labeling and one year of sales and distribution
following the six months allowed for Agency approval.
C. Product-gpecifie Data Requirements
The product-specific data were called in August
1981 when the Warfarin and its Sodium Salt Registration
Standard was issued,
Registrants must review previous data submissions
to ensure that they meet current standards (see
Appendix D, Attachment F - EPA Acceptance Criteria) and
if not, commit to conduct new studies. If the
registrant believes that previously submitted data meet
current testing standards, then he should cite the MRID
numbers of these studies following the instructions in
the Requirement Status and Registrants Response form
provided for each product,
Labe 1 ing Re.qu i r amen tg for End-Use: Product §L::Contain ing
Warfarin and Its Sodium Salt
All products are to bear appropriate labeling mi
specified in 40 CFR 156.10, Specific information
regarding label requirements is included in the
Pesticide Reregistration Handbook.
Tgigtckinq Eowder and
Concentrates Used To Prepare Dry Baits
"Exposure to warfarin during pregnancy should be
avoided. Warfarin may cause harm to the fetus,
including possible birth defects." [Place in
Hazards to Humans and Domestic Animals" section of
the label.]
2. Required Statements for Labels for Tracking Powders
with End-t?se Directions
a."Restricted Use Pesticide"
For retail sale to and use only by certified
applicator or persons under their direct
17
-------
supervision and only for those uses covered by the
certified applicator's certification, [Place in the
box on top of the front panel of the label.]
b, "This rodenticide is lethal to warm-blooded
animals." [Place in "Precautionary Statements"
section of label.]
e, "Tracking powder must be placed in locations
not accessible to children, pets, domestic
animals, or nontarget wildlife. If using
this product in agricultural buildings where
livestock feeds are stored, or in commercial
food service, food manufacturing or food
processing establishmenta,
limit treatments to concealed, inaccessible
places such as spaces between floors and
walls. Do not apply tracking powder along
walls, in corners, in open floor areas, or on
rafters of rooms in which food or feed is
handled or stored." [Place in "Use
Restrictions" portion of the "Directions for
Use" section of label.]
A sample label has been developed for these
products (refer to Section VI, Appendix D, Data
Call-in, Attachment Df Format LaJbel D-l) ,
3, Required Statements for _Labels for Concentrates
itiAfeDirections for Mixing and. ApplYing Warfarin or
SodiumSaIt o f Mar f arjLiLr jSaits^ajtd ...Rsa.dy-t^Hyfa,e
if ar f ar in..._Bait a ILo o a a. Ea i t a)
Sample labels (refer to Appendix D, Attachment D,
Format Label, D-2 and D-3) have been developed for
these types of products. The texts of these labels
are formatted to reflect language required for
these types of warfarin products at the time that
this document was issued as well as other required
language.
Required texts include all of the material in the
following portions of the formated labels; "KEEP
OUT OF REACH OP CHILDREN," "CAUTION," "READ THIS
LABEL," "IMPORTANT," "PRECAUTIONARY STATEMENTS,"
"ENVIRONMENTAL HAZARDS," and "STORAGE AND DISPOSAL"
{for "household" products).
While the text in the other portions of the label
may vary, the organizational format for the "center
panel" (or "front panel," for a box) is required.
18
-------
"STORAGE AND DISPOSAL" statements for "Non-
household Products" may vary only within the
requirements for PR Notice 83-3. "MIXING
DIRECTIONS" necessarily will vary according to the
concentration of warfarin in the product, the
composition of the bait that was tested, and other
factors.
Texts Of "USE RESTRICTIONS," "SELECTION OF
TREATMENT JUIEAS, " "APPLICATION DIRECTIONS"
(including "RATS:," "MICE:," and "RATS/MICE:" are
strongly suggested. Registrants may not depart
substantially from these texts. Requests to add
new use sites to the label may elicit additional
requirements for ecological effects data,
Required Statements for Labelsfor Ready-to-Use
Warfarin Baits with Nonprotective Subpaeking
These products are ready-to-use dry baits
subpackaged in plastic or paper packets ("place
packs," "bait trays," etc.) that are to be used as
measured bait placements for at least one target
species claimed on the product label. Labeling for
the outer container for such products must follow
the format for "loose" ready-to-use dry warfarin
baits except that "APPLICATION DIRECTIONS" for
baiting rats with place packs (or trays) should be
expressed in terms of numbers of subpackaging units
to use rather than as ounces of bait per placement,
If subpackaging units are larger than 2 oz,
instructions for baiting house mice should require
that packs be opened and that appropriate amounts
of bait be used (i.e., 1/4 to 1/2 02 for most
placements and up to 2 oz at locations of extremely
high mouse activity).
Labels for the packs or trays themselves must
include all information on the label of the outer
package except for the "DIRECTIONS FOR USE," which
may be abridged as follows:
"DIRECTIONS FOR USE"
"It is a violation of Federal law to use this
product in a manner inconsistent with its labeling.
Read entire label on the outer package before using
this product. It is illegal to sell these place
packs [or bait trays, if more accurate]
individually. "
19
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5. Required Statementsfor Labels for "Weather-Resistant"
Ready*to-Use Warfarin Baits
warfarin baits claimed to be effective when used in
wet or damp areas must be evaluated in efficacy tests
with fresh and "weathered" baits. EPA'a protocols
1.213 and 1.214 describe procedures for "weathering"
baits. Labels for these products should follow the
outline in the format label for ready-to-use warfarin
baits/ with appropriate adjustments to "USE
RESTRICTIONS" for the various wet and damp use sites.
"APPLICATION DIRECTIONS" may have to be modified to
account for large or atypical bait forms (e.g.,
paraffinized blocks).
The EPA protocols 1.213 and 1.214 should be
obtained from Product Manager 16 of the Registration
Division [H7504C].
20
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APPENDIX A
Generic Data Requirement* foe Haeagletration
of Warfarin and its Sodium Salt and Data Citations
Supporting Reragiatration
21
-------
GUIDE TOAPPENDIX A
Appendix A contains listings of data requirements which
support the reregistration for the pesticide covered by this
Reregistration Eligibility Document.
Appendix A contains generic data requirements that apply to
the pesticide in all productsf including data requirements
for which a "typical formulation" is the test substance.
The data table are generally organized according to the
following format:
1. Data Requirement (Column 1). The data requirements are
listed in the order in which they appear in 40 CFR part 158, The
reference numbers accompanying each test refer to the test
protocols set out in the Pesticide Aaaeaament Guidelines, which
are available from the National Technical Information Service
(NtIS), 5285 Port Royal Road, Springfield, VA 22161.
2. Use Pattern (Column 2). This column indicates the use
patterns to which the data requirement applies. The following
letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food crop
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
0 Indoor 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 (MEID) 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.
22
-------
APPENDIX A
GENERIC DATA REQUIREMENTS FOR REREGISTRATION OF WARFARIN AND ITS SODIUM SALT
AND DATA CITATIONS SOP PORT ING RKRKGI STRATI ON
GUIDELINE
REFERENCE
NUMBER
TITLE Or STUDY
USB
PATTERN
BIBLIOGRAPHIC
CITATION
(SPA MASTER RECORD
ID. DOCUMENT NUMBER)
PRODUCT CHEMISTRY
61-1
61-2 (a)
61-2 (b)
62-2
62-3
63-2
63-3
63-4
63-5
Chemical Identity
Beginning Materials &
Manufacturing Process
Discussion of Impurities
Certification of Limits
Analytical Method
Color
Physical State
Odor
Melting Point
all
all
all
all
all
all
all
all
all
N/A
N/A
N/A
N/A
00002438
00002438
00002438
00002438
00002438, 00163111,
,"v. .** «• •-* -*\ ft M r* r\f\r\/\*mif*if^*~f
63-6
Boiling Point
all
00133948, 00002387
N/A
23
-------
APPENDIX A
GENERIC DATA REQUIREMENTS FOR REREGI STRATI ON OF WARFARIN AND ITS SODIUM SALT
AND DATA CITATIONS SUPPORTING REKEGI3TRATION
GUIDELINE TITLE OF STUDY
REFERENCE
NUMBER
PRODUCT
63-7
63-8
63-9
63-10
63-11
CHEMISTRY (Continued)
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol /Water Partition
OSS
PATTERN
all
all
all
all
all
BIBLIOGRAPHIC
CITATION
(SPA MASTER RE, RD
ID, DOCUMENT NUMBER)
N/A
00002438
N/A
00133948
00142539
63-12
Coefficient
pH
all
00002438
24
-------
APPENDIX A
GENERIC DATA REQUIREMENTS FOR RKRKGI3TRATION OF MARFARIN AMD ITS SODIUM SALT
AND DATA CITATIONS SUPPORTING REREGI3TRATION
GUIDELINE
REFERENCE
NUMBER
TITLE Of STUDY
USE
PATTERN
BIBLIOGRAPHIC
CITATION
(EPA MASTER RECORD
ID. DOCUMENT NUMBER)
TOXICOLOGY
o The toxicology of warfarin, its mechanism of action and treatment of overdose in humans are
well established. Based on the available human information, animal toxicity studies in
warfarin are not required. Thus, the toxicological teata which are normally required for
pesticides under the existing warfarin use pattern are waived.
25
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APPENDIX A
GENERIC DATA REQUIREMENTS FOR REREGISTRATION OF WARFARIN AND ITS SODIUM SAL?
AND DATA CITATIONS SUPPORTING REREGISTRATION
GOIDSLINK
REFERENCE
NUMBER
TITLE Of STUDY
USE
PATTERN
BIBLIOGRAPHIC
CITATION
(KPA MASTER RECORD
ID. DOCUMENT HUMBKR>
ENVIRONMENTAL FATE
The environmental fate data requirements are waived since the use pattern and label
recommendation of these pesticides indicate that significant residues of concern are not
expected to be introduced into the environment. The two spray drift requirements, droplet size
spectrum and drift field evaluation, are not applicable because warfarin and its sodium salt
are not applied by aerial or ground sprays.
26
-------
APPENDIX A
GENERIC DATA KSQOIRKHKNTS FOR RKRSCI3TRATION OF MARFARIN AND ITS SOD I DM SALT
AND DATA CITATIONS SUPPORTING RKREGI3TRATION
GUIDELINE
RKFERKNOE
NUMBER
TITLK OF STUDY
USB
PATTKBN
BIBLIOGRAPHIC
CITATION
(BPA MASTER RECORD
ID. DOCUMENT NUMBER!
ECOLOGICAL EFFECTS
71-1 Acute Avian Oral - Quail /Duck
71-2(a)
71-2(b)
71-3
71-4
71-5
72-1(a)
72-1(b)
Acute Avian Dietary - Quail
Acute Avian Dietary - Duck
Wild Mammal Toxicity
Avian Reproduction
Simulated and Actual Field
Testing with Mammals and Birds
Fish Toxicity - Bluegill
(WARFARIN)
Fish Toxicity - Bluegill - TIP
(WARFARIN)
C,KfH,I.M
C,K,H, I,M
C,K,H,I,M
CfK / H, I ,M
N/A
N/A
C,K,H,I,M
N/A
00117979,00156284
00153369,00153366
00156285,00157812
00156283
00153366,
00156285,001578121
00002469
N/A
N/A
001179761,00153363
00156287
N/A
27
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APPENDIX A
GENERIC DATA REQUIREMENTS FOR REREGISTRATION OF WARFARIN AND ITS SODIUM SALT
AND DATA CITATIONS SUPPORTING REREGISTRATION
GUIDELINE
REFERENCE
NUMBER
TITXiB OF STUDY
USE
PATTERN
BIBLIOGRAPHIC
CITATION
(EPA MASTER RECORD
ID. DOCUMENT NUMBER)
ECOLOGICAL EFFECTS (Continued)
72-l{c)
72-1(d)
72-2(b)
72-3
72-4
72-5
72-6
Fish Toxicity - Rainbow Trout
(WARFARIN)
Ci K,H, I ,
Fisii Toxicity - Rainbow Trout-TEP N/A
(HP LaserJet Series II (Additional)ELSEIIAD.PRS%P
Invertebrate Toxicity - TEP
Acute LCM for Estuarine
and Marine Organisms
Fish Early Life Stage and
Aquatic Invertebrate Life
Cycle
Fish Life Cycle
Aquatic Organism Accumulation
N/A
N/A
N/A
N/A
N/A
QQ1179771, 00153364
00156286
N/A
N/A
N/A
N/A
N/A
N/A
28
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APPENDIX A
GENERIC DATA REQUIREMENTS FOR REREGISTRATION Of WARFARIN AMD ITS SODIUM SALT
AND DATA CITATIONS SUPPORTING REREGISTRATION
GUIDELINE
REFERENCE
NUMBER
TI-TL! QV STUDir
USE
PATTERN
BIBLIOGRAPHIC
CITATION
(EPA MASTER RECORD
ID. DOCUMENT NUMBER)
(Continued)
Simulated or Actual Field
Testing
N/A
N/A
1 The percent active ingredient was not given,
1 These LC50s are greater than the known solubility of warfarin (Snyder, 1953 in Turner, 1987)
The study will meet guideline requirements if the LC50a are reduced to the solubility of
warfarin in water.
The nontarget area phytoxicity and nontarget insect testing data are not
required under the existing use patterns.
29
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APPENDIX A
GENERIC DATA REQUIREMENTS FOR REREGISTRATION OF WARFARIN AND ITS SODIUM SALT
AND DATA CITATIONS SUPPORTING RERSGISTR&TION
GUIDELINE
REFBRENCB
NUMBER
TXTU OF STDDTf
OSS
PATTERN
BIBLIOGRAPHIC
CITATION
(EPA MASTER RECORD
ID. DOCUMENT HUMBSR1
NON-DIETARY EXPOSURE
Based on the existing use pattern and lack of toxicological concerns, the non-dietary exposure
requirements are waived.
30
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APPENDIX A
GENERIC DATA REQUIREMENTS FOR RERKGISTRATION OF WARFARIN AND ITS SOD I OH SALT
AND DATA CITATIONS SUPPORTING RKREGISTRATION
GDIDELINK
REFERENCE
NUMBER
or STOD*
USE
PATTERN
BIBLIOGRAPHIC
CITATION
(EPA MASTER RECORD
ID. DOCUMENT NUMBER)
RESIDUE CHEMISTRY
171-4 Magnitude of Residue in Food Handling L
If the registrant accepts the label restrictions specified in this document, residue chemistry
data are not reejuired. However if the registrant does not adapt the restrictions then the data
identified in the Requirements Status and Registrant Response Form are required.
31
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APPENDIX B
WARFARIN AND ITS SODIUM SALT BIBLIOGRAPHY
Citations Considered to be Part of the
Data Base Supporting Reregistration
32
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GUIDE TO APPENDIX B
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 SPA and its
predecessor agencies in support of past regulatory
decisions. Selections from other sources including the
published literature, in those instances where they
have been considered, will be included.
UNITS OF ENTRY. The unit of entry in this bibliography
is called a "study". In the case of published
materials, this corresponds closely to an article. In
the case of unpublished materials submitted to the
Agency the Agency has sought to identify documents at a
level parallel to the published article from within the
typically larger volumes in which they were submitted.
The resulting "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.
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 uaed at any time specific
reference ia required, It is not related to the six-
digit "Accession Number" which haa been used to
identify volumes of submitted studies; see paragraph
4 (d) (4) below for further explanation. In a few cases,.
entries added to the bibliography late in the review
may be preceded by a nine-character temporary
identifier. These entries are listed after all MRID
entries. This temporary identifier number is also to
be used whenever specific reference is needed.
FORM OF ENTRY. In addition to the Master Record
Identifier (MRID), each entry consists of a citation
containing standard elements followed, in the case of
material submitted to EPA, by a description of the
earliest known submission. Bibliographic conventions
used reflect the standards of the American National
Standards Institute (ANSI), expanded to provide for
certain special needs.
33
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a. Author. Whenever the Agency could confidently
identify one, the Agency has chosen to show a
personal author. When no individual was
identified, the Agency hag shown an identifiable
laboratory or testing facility as author, As a
last resort, the Agency has shown the first
submitter as author.
b. Document date. When the date appears as four
digits with no question marks, the Agency took it
directly from the document. When a four-digit date
is followed by a question mark the bibliographer
deduced, the date from evidence in the document.
When the date appears as <19??), the Agency was
unable to determine or estimate the date of the
document,
c. Title. In some cases, it has been necessary for
Agency bibliographers to create or enhance a
document title. Any such editorial insertions are
contained between square brackets.
d. Trailing parentheses. For studies submitted to the
Agency in the past, the trailing parentheses
include (in addition to any self-explanatory text)
the following elements describing the earliest
known submission:
(1) Submission date. The date of the earliest
known submission appears immediately following the
word "received."
(2)Administrative number. The next element,
immediately following the word "under,w is the
registration number, ©Kperimental 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)Voluine Identification (Accession Numbers) . The
final element in the trailing parentheses
identifies the EPA accession number of the volume
in which the original submission of the study
appears. The six-digit accession number follows
the symbol "CDL," standing for "Company Data
Library." This accession number is in turn
followed by an alphabetic suffix which shows the
34
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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-S; and the 27th, 123456-AA,
35
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OFFICE 0? PHSTICIDS PROGRAMS
WARFARIN AMD ITS 3ODIDM SALT BIBLIOGRAPHY
RORBGISTRATION ELIGIBILITY DOCUMENT
MRID CITATION
00002354 florent M.L. Schruvera (1971) Dicusat—Techn. Grade.
(Unpublished study received Oct 13, 1971 under
6720-171; prepared by Chemoaweb AB, m subsidiary of
Ferrosan--Sweden, submitted by Southern Mill Creek
Products Co., Inc., Tampa, Fla.; CDL;102155-A)
00002387 Schering AS (1972) Warfarin Techn.: Specification No.
180; Schering Information. Includes methods dated
Apr 6, 1972. (Unpublished study received Apr 26,
1972 under 6900-130; submitted by J.J. Dill Co.,
Kalamazoo, Mich.; CDL:1G2157-A)
00002438 Wisconsin Alumni Reaerach Foundation (1967) Warfarin
Physico-Chemical Specifiications and Analytical
Procedures. MAdison, Wl: WARF (Also in unpublished
submission received Nov. 24, 1975 under 655-543;
submitted by Prentis Drug & Chemical Co., Inc.,
New York, NY; CDL: 231461-R)
00002450 S.B. Fenicfc & Company (19??) Physical Properties of Wa
rfcoat 1/1 Encapsulated Warfarin. (Unpublished
study received Jun 5, 1S74 under 432-535;
CDL:022992-A)
00002469 Evans, J.| Ward, A.L. (1S67) Secondary Poisoning
associated with anticoagulant killed nutria. J. of
Am, Vet. Med. Assoc, 151(7): 856-861,
00003281 Wisconsin Alumni Research Foundation (1973) The
Coating Process. (Unpublished study received Mar
2, 1973 under 2521-10; CDL:OQ6685-A)
00022551 Chavkin, R.E. (1971) Dicusat Sodium (Warfarin Sodium).
(Unpublished study received Jan 1, 1957 under
10442-4; submitted by Blddle Sawyer Corp.,
New York, N.Y.; CDL:240812-A)
00024140 Biddle Satryer Corporation (1970) [Dicuaat (Techn.
Grade)]. (Unpublished study received Jun 2, 1970
under 10442-5; CDL:240752-A)
00055541 Bell Laboratories (1975) Determination of Warfarin by
Ultraviolet Spectroscopy; Warfarin EPA-2. Method
dated Nov 1975. (Unpublished study received Jun
17, 1980 under 12455-26; CDL:243963-B)
36
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OFFICE O? PEST1CIDS PROGRAMS
WARFARIN AMD ITS SODIUM SALT BIBLIOGRAPHY
KERBGISTRATXON ELIGIBILITY DOCUMENT
MRID CITATION
00109230 Southern Mill Creek Products Co., Inc. (1982)
[Chemistry of Warfarin Concentrate]. (Compilation;
unpublished study received Apr 30, 1982 under
6720-53; CDL:247866-A)
00117975 Shapiro, R. (1982) Static Acute Bioassay for the
Toxicity of Wincon... to Daphnia magna: Report No.
T-2391. (Unpublished study received Sep 3, 1982
under 3282-32; prepared by Nutrition
international,Inc., submitted by D-Con Co., Inc.
Montvale, NJ; CDL;248782-A)
00117976 Shapiro, R. (1982) Static Acute Bioassay for the
foxieity of Wincon... to Bluegill Sunfish ...:
Report No. T-2387. (Unpublished study received
Sep 3, 1982 under 3282-32; prepared by Nutrition
International, Inc., submitted by D-Con Co., Inc.,
Montvale, NJ; CDL:248782-B)
00117977 Shapiro, R, (1982) Static Acute Bioassay for the
Toxicity of Wincon ... to Rainbow Trout ...: Report
No. T-2392. (Unpublished study received Sep 3,
1982 under 3282-32; prepared by Nutrition
International, Inc., submitted by D-con Co., Inc.,
Montvale, NJ; CDL:248782-C)
00117979 Roth, R.,- Shapiro, R. (1982) Avian Dietary LCJO Study
with Bob White Quail: Report No. T-2402.
(Unpublished study received Sep 3, 1982 under
3282-32; prepared by Nutrition International,
Inc., submitted by D-Con Co., Inc., Montvale, NJ;
CDIi:248782-E)
00133948 Biddl» Sawyer Corp, C1978) Warfarin, Technical:
[Chemistry]. (Compilation; unpublished study
received Jul 13, 1978 under 10442-5; CDLs234494-A)
00142539 Opong-Mensmh,K.; Porter, W. (19??) n-Octanol-Water
Partition Coefficient of Warfarin. Unpublished
study received Feb 8,1982; prepared by Univ. of
Wisconsin, School of Pharmacy. 27 p.
00143602 Smith, R. (1984) Report of Analysis for Warfarin and
Sulfaquinoxaline. Unpublished compilation received
Sept 18, 1984; prepared by Motomco, Ltd. 6 p.
37
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OFFICE OF PSSTICIDS PROGRAMS
WARFARIN AMD ITS SODIUM SALT BIBLIOGRAPHY
RERSGISTRATION ELIGIBILITY DOCUMENT
MRID CITATION
00143603 Smith, R. (1984) Report of Analysis for Warfarin.
Unpublished study recieved Sept 18, 1984 prepared
by Motomco, Ltd. 6 p.
00146240 Zoecon Industries, Inc. (1977) Product Chemistry Data
for Mouse and Rat Bait. Unpublished study received
July 5, 1985. 4 p.
00146381 Zoecon Industries, Inc. (1982) Product Chemistry for
Starbar SMAX Rat and Mouse Bait Station,
Unpublished study received April 28, 1982. 27 p.
00148099 Mohan, G.; Carvel, W.; Dombrowski, L. (1985) Water
Solubility of Warfarin Reference to Report No.
TP-509-015-05. Unpublished study received May 6,
1985,- prepared by Sterling-Winthrop Research
Institute. 2 p.
00153363 McAllister, W.; Bowman, J.; Cohle, P. (1985) Acute
Toxieity of Technical Warfarin to Bluegill Sunfish
(Lepomismacrochirus): Report §33306. Unpublished
study received Nov 18, 1985; prepared by Analytical
Bio-Chemistry Laboratories, Inc. 54 p.
00153364 McAllister, W.; Bowman, J.; Cohle, P. (1985) Acute
Toxieity of Technical Warfarin to Rainbow Trout
(Salmo gairdneri): Study No. 33304. Unpublished
study received Nov 18, 1985; prepared by Analytical
Bio-Cheroistry Laboratories, Inc. 55 p.
00153366 Fletcher, D. (1985) 19-Day Dietary LC50 Study with
Technical Warfarin in Mallard Ducklings; Study No.
85 DC 56. Unpublished study received Nov. 18,
1985; prepared by Bio-Life Associates, Ltd. 41 p.
00153367 Bell Laboratories, Inc. (197?) Product Chemistry of
Warfarin. Unpublished study received Noir, 18,
1985; 5 p.
38
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OFF I OB Of" PESTICIDE PROGRAMS
WARFARIN AND ITS SODIUM SALT BIBLIOGRAPHY
REREGISTRATIOH ELIGIBILITY DOCUMENT
MRID CITATION
00153368 Forbis, A.; Georgie, L.; Burgeaa, D. (1985) Acute
Toxicity of Technical Warfarin to Daphnia magna;
Report 133305, Unpublished study received Nov. 18,
1985; prepared by Analytical Bio-Chemistry
Laboratories, Inc. 44 p.
00153369 Fletcher, D, (1985) Acute Oral Toxicity Study with
Technical Warfarin in Bobwhite Quail: Final Report:
Study No. 85 QD 56. Unpublished study received
Nov. 18, 1985; prepared by Bio-Life Associates,
Ltd. 41 p.
00156283 Beavers, J. (1985) A Dietary LC$0 Study in the
Bobwhite with Warfarin: Final Report! Project No.
205-101. Unpublished study received Feb. 15, 1985;
prepared by Wildlife International Ltd. 20 p.
00156284 Beavera, J. (1985) An Acute Oral Toxicity Study in the
Bobwhite with Warfarin: Final Report: Project No.
205-103. Unpublished study received Feb. 15, 1985;
prepared by Wildlife International Ltd. 16 p.
00156285 Beavers, J. (1985) A Dietary LCJO Study in the Mallard
with Warfarini Final ReportJ Project No. 205-102,
Unpublished itudy received Fab, 15, 1985,* prepared
by Wildlife International Ltd. 16 p.
00156286 McAllister, W.,' Cohle, P. (1984) Acute Toxicity of
Warfarin Technical to Rainbow Trout (Saline
gairdneri): Report No. 32461. Unpublished study
received Feb. 15, 1985? prepared by Analytical Bio-
chemistry Labs, Inc. 53 p.
00156281 McAllister, W.; Cohle, P. (1984) Acute Toxicity of
Warfarin Technical to Bluegill Sunfish (Lepomis
macrochirus): Report No. 32460. Unpublished study
received Feb. 15, 1985; prepared by Analytical Bio-
Chemistry Labs, Inc. 53 p.
39
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OFFICE Off PESTICIDE PROGRAMS
WARFARIN AND ITS SODIUM SALT BIBLIOGRAPHY
RSREGISTOATION ELIGIBILITY DOCUMENT
MR1D CITATION
00156288 Forbis, A.; Georgia, L.; Burgess, D. (1984) Acute
Toxicity of Warfarin Technical to Daphnia magna:
Report No. 32462. Unpublished study received Feb.
15, 1985; prepared by Analytical Bio-Chemistry
Labs, Inc. 38 p.
00157812 Shapiro, R. (1986) Avian Dietary LCSO Study with
Mallard Ducks: Wincon (Warfarin): Report No.
T-5513. Unpublished study received Mar. 20, 1986;
prepared by Wildlife International, Ltd. 31 p.
00163111 Bell Laboratories Inc. (1986) Analysis for Six Batches
of Warfarin and Analytical Methods used.
Unpublished compilation received Sept. 8, 1986; 6
P-
00163112 Snyder, J. (1953) Solubilities of Warfarin, Dicumarol,
and Cyclocumarol in Water, Unpublished thesis
received Sept. 0, 1986; prepared by University of
Wisconsin. 10 p.
40
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APPENDIX C
PESTICIDE REREGISTRATION HANDBOOK
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APPENDIX D
DATA CALL-IN
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
DATA CALL-IN NOTICE
CERTIFIED MAIL
OFFICE OF
PESTICIDES AND TCX.<
SUBSTANCES
Dear Sir or Madam;
This Notice requires you and other registrants of pesticide
..products containing the active ingredient identified in
Attachment A of this Notice, the Data Call-in,,Chemical Status
Sheetf to submit certain data as noted herein to the U.S.
Environmental Protection Agency (EPA, the Agency). These data
are necessary to maintain the continued registration of your
product(s) containing this active ingredient. Within 90 days
after you receive this Notice you must respond as set forth in
Section III below. Your response must state:
1. how you will comply with the requirements set forth in
this Notice and its Attachments A through H; or
2. why you believe you are exempt from the requirements
listed in this Notice and in Attachment B, (for generic
data) and Attachment C (for product specific data),
Requirementa S fr at u a an d Rggi31rant's Reaponse Forjg, (see
section III-B); or
3, why you believe EPA should not require your submission
of 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 (generic) and Attachment C (product
specific), Data Call-in Response Form, as well aa a list of all
registrants who were sent this Notice (Attachment G).
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
Printed on Recycled Paper
-------
information is authorized under the Paperwork Reduction Act by
OMB Approval No. 2070-0107 {expiration date 12-31-92).
This Notice is divided into six sections and eight
Attachments. The Notice itself contains information and
instructions applicable to all Data Call-In Notices. The
Attachments contain specific chemical information and
instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
Section III - Compliance With Requirements Of This
Notice
Section IV - Consequences Of Failure To Comply With
This Notice
Section V - Registrants' Obligation To Report
Possible Unreasonable Adverse Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice aret
A - Data Call-in ...Chemical Status Sheet
B ~ Data Call-in ..Response Form and Requirement Status
and Registrant/s,^Jlesponse form _for Generic Data
C - Data Call-inResponse Form and Requirements Status
and .Registrant'a Response Form for Product Specific
D - Formatted/5ample Labels
E - EPA_ Grouting, of End-Use Products for Meeting Acute
Toxicology Data Recpjj.reme.ntg .for Rereoi strati on
F - EPA Acceptance_grite r i a
G - List of Registrants Receiving.. This Notice
H - Coat Share and DataCompenaation Forma forGeneric
and Product SpecificData, and Product Specific Data
Report Form
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active
ingredient and reevaluated the data needed to support continued
registration of the subject active ingredient. This reevaluation
identified additional data necessary to asseal the health and
safety of the continued use of products containing this active
ingredient« You have been sent this Notice because you have
product(s) containing the subject active ingredient.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The data required by this Notice are specified in Attachment B
(for generic data) and Attachment C (for product specific data),
Requirements Status and Registrant's Response Form.
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Depending on the results of the studies required in this Notice,
additional testing may be required.
II-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwj.se satisfy the
data requirements specified in Attachment B (for /cmferic data) and
Attachment C (for product specific data) , Requirements Status and
Registrant' sJReaponse Form, within the timefrmmes provided.
II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in
accordance with test standards outlined in the Pesticide Assessment
Guidelines for those studies for which guidelines have been
established,
These EPA Guidelines are available from the National Technical
Information Service (NTIS) , Attn: Order Desk, 5285 Port Royal Roadf
Springfield, Va 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic
Cooperation and Development (OECD) are also acceptable if the OECD-
recommended test standards conform to those specified in the
Pesticide Data Requirements regulation (40 CFR 158.70), When
using the OECD protocols,, they should be modified as appropriate so
that the data generated by the study will satisfy the requirements
of 40 CFR 158. Normally, the Agency will not extend deadlines
for complying with data requirements when the studies were not
conducted in accordance with acceptable standards. The OSCD
protocols are available from OECD, 1750 Pennsylvania Avenue N.W.,
Washington, D.C. 20006.
All new studies and proposed p... jtocols 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 3 (c) 12) IB) NOTICES
BY,,, THE
Unless otherwise noted herein, this Data Call-in doei_not in
any way aupergede or change the requirements of any previous Data
Call-in fa) f 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.
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SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice
for generic and product specific data must be submitted to the
Agency within 90 days after your receipt of this Notice. Failure
to adequately respond to this Notice within 90 days of your receipt
will be a basis for issuing a Notice of Intent to Suspend (NOIS}
affecting your products. This and other bases for issuance of NOIS
due to failure to comply with this Notice are presented in Section
IV-A and IV-B.
III-B. OPTIONS FOR RESPONDING TO THE AGENCY
1 * Generic Data
The options for responding to this Notice for generic data are:
(a) voluntary cancellation, (b) delete use(s), (c) claim generic
data exemption, (d) agree to satisfy the generic data requirements
imposed by this Notice or (e) request a data waiver(g).
A discussion of how to respond if you chose the Voluntary
Cancellation option, the Delete Use(s) option or the Generic Data
Exemption option is presented below. A discussion of the various
options available for satisfying the generic data requirements
of this Notice is contained in Section III-C. A discussion of
options relating to requests for data waivers is contained in
Section III-D.
There are two forms that accompany this Notice of which,
depending upon your response, one or both must be used in your
response to the Agency. These forms are the Data-Call-in Response
Form, and the Requirements gfea.t-U-S.^nd.Regas.j^rant' »- Response Form,
Attachment B (for generic data) and Attachment C (for product
specific data). The Data Call-In Response Form must be submitted as
part of every response to this Notice. Please note that the
company's authorized representative is required to sign the first
page of the Data Call-in Response Form and jteguirements Status^and
Registrant's Response Form (if this form is required) and initial
any subsequent pages. The forms contain separate detailed
instructions on the response options. Do not alter the printed
material. If you have questions or need assistance in preparing
your response, call or write the contact person(s) identified in
Attachment A.
a. Voluntary Cancellation - You may avoid the requirements of
this Notice by requesting voluntary cancellation of your product(s)
containing the active ingredient that is the subject of this
Notice. If you wish to voluntarily cancel your product, you must
submit a completed Data Call-In Response Form, indicating your
election of this option. Voluntary cancellation is item number 5
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on the Data Call-In Response Form. If you choose this option, this
is the only form that you are required to complete.
If you chose to voluntarily cancel your product, further sale
and distribution of your product after the effective date of
cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
b. Use Deletion - You may avoid the requirements of this
Notice by eliminating the uaea of your product to which the
requirements apply. If you wish to amend your registration to
delete uses, you must submit the Requirements Status and
Registrant's Response Form, a completed application for amendment,
a copy of your proposed amended labeling, and all other information
required for processing the application. Use deletion is option
number 7 on the Requirements Status and Registrant's Response Form.
You must also complete a Data Call-In Response Form by signing the
certification, item number 8. Application forma for amending
registrations may be obtained from the Registration Support and
Emergency Response Branch, Registration Division, (703) 557-2126,
If you choose to delete the use(s) subject to this Notice or
uses subject to specific data requirements, further sale,
distribution, or use of your product after one year from the due
date of your 90 day response, must bear an amended label,
c. Generic Data Exemption - Under section 3 (c)(2)(D) of FIFR&,
an applicant for registration of a product is exempt from the
requirement to submit or cite generic data concerning an active
ingredient if the active ingredient in the product is derived
exclusively from purchased, registered pesticide products
containing the active ingredient. EPA has concluded, as an
exercise of its discretion, that it normally will not suspend the
registration of a product which would qualify and continue to
qualify for the generic data exemption in section 3(c)(2)(D) of
FIFRA. To qualify, all of the following requirements must be met:
(i). The active ingredient in your registered product must
be present solely because of incorporation of another
registered product which contains the subject active
ingredient and is purchased from a source not connected^
with you;
(ii). Every registrant who is the ultimate source of the
active ingredient in your product subject to this DCI
must be in compliance with the requirements of this
Notice and must remain in compliance; and
(iii). You must have provided to EPA an accurate and current
"Confidential Statement of Formula" for each of your
products to which this Notice applies.
To apply for the Generic Data Exemption you must submit a
completed Data Call-in Response Form. Attachment B and all
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supporting documentation. The Generic Data Exemption is item
number 6a on the Data Call-in Response Form. If you claim a
generic data exemption you are not required to complete the
Requirements Status and Registrants Response Form. Generic Data
Exemption cannot be selected as an option for product specific
data.
If you are granted a Generic Data Exemption, you rely on the
efforts of other persons to provide the Agency with the required
data. If the registrant(a) who have committed to generate and
submit the required data fail to take appropriate steps to meet the
requirements or are no longer in compliance with this Data Call-in
Notice, the Agency will consider that both they and you are not in
compliance and will normally initiate proceedings to suspend the
registrations of both your and their product{s), unless you commit
to submit and do submit the required data within the specified
time. In such cases the Agency generally will not grant a time
extension for submitting the data.
d. S_atigfying the Generic Data Requirements of this Notice
There are various options available to satisfy the data
requirements of this Notice. These options are discussed in
Section III-C.l. of this Notice and comprise options 1 through 6 on
the Requirements Status and Registrant'3 Response Form and option
6b and 7 on the Data Call-In Response Form. If you choose option 6b
or 7f you must submit both forms 33 well as any other
information/data pertaining to the option chosen to address the
data requirement.
e. Re.queat for Generic Data Waivera. Waivers for generic data
are discussed in Section III-D.l. of this Notice and are covered by
options 8 and 9 on the Requirements Status and.Registrant'3
Response Form. If you choose one of these options, you must submit
both forms as well as any other information/data pertaining to the
option chosen to address the data requirement.
2. Product Specific Data
The options for responding to this Notice for product specific
data are: (a) voluntary cancellation, (t>) 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 ia presented below. A discussion of the
various options available for satisfying the product specific data
requirements of this Notice is contained in Section III-C.2. A
discussion of options relating to requests for data waivers is
contained in Section III-D.2.
There are two forms that accompany this Notice of which,
depending upon your response, one or both must be used in your
response to the Agency. These forms are the Data-Call-in Response
Form, and the Requirements Status and Registrant* s Response Form,
-------
Attachment B (for generic data) and Attachment C (for product
specific data). The Data Call-In_Reappnae. Form must be submitted as
part of every response to this Notice. In additionf one copy of
the Requirements Status and Registrant's Response Form must be
submitted for each product listed on the Data Call-in Response, Form
unless the voluntary cancellation option is selected. Please note
that the company's authorized representative is required to sign
the first page of the Data Call-in Response.Form and Requiremen13
Status and Registrant's Response Form (if this form is required)
and initial any subsequent pages. The forms contain separate
detailed instructions on the response options. Do not alter the
printed material. If you have questions or need assistance in
preparing your response, call or write the contact person (a)
identified in Attachment A.
a. Voluntary Cancellation - You may avoid the requirements of
this Notice by requesting voluntary cancellation of your product(s)
containing the active ingredient that is the subject of this
Notice. If you wish to voluntarily cancel your product, you must
.submit a completed Data,,Call-In Response Form, indicating your
election of this option. Voluntary cancellation is item number 5
on the Data Call-In Response Form. If you choose this option, this
is the only form that you are required to complete,
If you choose to voluntarily cancel your product, further sale
and distribution of your product after the effective date of
cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
b. Satisfying the Product...Specific Data Requirements of .thia
Notice. There are various options available to satisfy the product
specific data requirements of this Notice. These options are
discussed in Section IXI-C.2. of this Notice and comprise options 1
through 7 on the Requirements Status and Registrant' 9 Response gorm
and item numbers 7a and 7b on the Data C a 11 - In Response F.O r.m. Note
that the options available for addressing product specific data
requirements differ slightly from those options for fulfilling
generic data requirements, Deletion of a use(s) and the low
volume/minor use option are not valid options for fulfilling
product specific data requirements. it is important to ensure
that you are using the correct forma and instructions when
completing your response to the Reregistration Eligibility
Document.
d. Request for Product Specific DataWaivera. Waivers for
product specific data are discussed in Section III-D.2. of this
Notice and are covered by option 7 on the Requirements Status and
Registrant'a Response Form. If you choose this option, you must
submit both forms as well as any other information/data pertaining
to the option chosen to address the data requirement.
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III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
1• Generic Data
If you acknowledge on the Data Call-In_Regpon3e Form that you
agree to satisfy the generic data requirements {i.e. you select
item number 6b and/or 7), then you must select one of the six
options on the Requirements Status and Registrani:_'_3.. Response Form
related to data production for each data requirement. Your option
selection should be entered under item number 9, "Registrant
Response." The six options related to data production are the
first six options discussed under item 9 in the instructions for
completing the Requirements Status and Registrant's Response 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) I ajm 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)
Option I,.... J?e vfel-Qping_Da£g -- If you choose to develop the
required data it must be in conformance with Agency deadlines and
with other Agency requirements as referenced herein and in the
attachments. All data generated and submitted must comply with the
Good Laboratory Practice (GLP) rule (40 CFR Part 160), be conducted
according to the Pesticide Assessment Guidelines (PAG), and be in
conformance with the requirements of PR Notice 86-5. In addition,
certain studies require Agency approval of test protocols in
advance of study initiation. Those studies for which a protocol
must be submitted have been identified in the Requirements Status
and Registrant's Response Form and/or footnotes to the form. If
you wish to use a protocol which differs from the options discussed
in Section II-C of this Notice, you must submit a detailed
description of the proposed protocol and your reason for wishing to
use it. The Agency may choose to reject a protocol not specified
in Section II-C. If the Agency rejects your protocol you will be
notified in writing, however, you should be aware that rejection of
a proposed protocol will not be a basis for extending the deadline
for submission of data.
A progress report must be submitted for each study within 90
days from the date you are required to commit to generate or
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undertake gome other means to address that study requirement, such
as making an offer to cost share or agreeing to share in the cost
of developing that study. A 90-day progress report must be
submitted for all studies. This 90-day progress report must
include the date the study was or will be initiated and, for
studies to be started within 12 months of commitment, the name and
address of the laboratory(ies) or individuals who are or will be
conducting the study.
In addition, if the time frame for submission of a final report
is more than 1 year, interim reports must be submitted at 12 month
intervals from the date you are required to commit to generate or
otherwise address the requirement for the study.
In addition to the other information specified in the preceding
paragraph, at a minimum, a brief description of current activity on
and the status of the study must be included as well as a full
description of any problems encountered since the last progress
report,
The time frames in the Requirements Status and Registrant' s
Response Form are the time frames that the Agency is allowing for
the submission of completed study reports or protocols. The noted
deadlines run from the date of the receipt of this Notice by the
registrant. If the data are not submitted by the deadline, each
registrant is subject to receipt of a Notice of Intent to Suspend
the affected registration(s).
If you cannot submit the data/reports to the Agency in the time
required by this Notice and intend to seek additional time to meet
the requirements (s) t FO-U roust submit a request to the Agency which
includes: (I) a detailed description of the expected difficulty
and (2) a proposed schedule including alternative dates for meeting
such requirements on a step-by-step basis, You must explain any
technical or laboratory difficulties and provide documentation from
the laboratory performing the testing. While EPA is considering
your request, the original deadline remains. The Agency will
respond to your request in writing. If SPA does not grant your
request, the original deadline remains. Normally, extensions can
b© requested only in casea 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 ia not made in a timely
fashion,* in no event shall an extension request be considered if it
is submitted at or after the lapse of the subject deadline.
Option. 2, Agreement to Share in Cost to Develop Data -- If you
choose to enter into an agreement to share in the cost of producing
the required data but will not be submitting the data yourself, you
must provide the name of the registrant who will be submitting the
data. You must also provide EFA 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
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not specify all of the terms of the final arrangement between the
parties or the mechanism to resolve the terms. Section 3(c) (2) {Bl
provides that if the parties cannot resolve the terms of the
agreement they may resolve their differences through binding
arbitration.
Option3_, Offer, tO_ Share in the Cost of Data Development -- If
you have made an offer to pay in an attempt to enter into an
agreement or amend an existing agreement to meet the requirements
of this Notice and have been unsuccessful, you may request EPA (by
selecting this option) to exercise its discretion not to suspend
your registration(s), although you do not comply with the data
submission requirements of this Notice. EPA has determined that as
m. 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(3)
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 Coat Share in the Development of
Data, Attachment H. 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 FIFR& 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, tlie data required by this Notice by submitting a
Data Call-In Response Form and a Requirements Status and
Registrant/s Response Form committing to develop and submit the
data required by this Notice.
In order for you to avoid suspension under this option, you may
not withdraw your offer to share in the burdens of developing the
data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this
Notice. If the other registrant fails to develop the data or for
some other reason is subject to suspension, your registration as
well as that of the other registrant will normally be subject to
initiation of suspension proceedings, unless you commit to submit,
and do submit the required data in the specified time frame. In
such cases, the Agency generally will not grant a time extension
for submitting the data.
Option 4. Submitting an Existing Study -- If you choose to
submit an existing study in response to this Notice, you must
determine that the study satisfies the requirements imposed by this
Notice. You may only submit a study that has not been previously
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submitted to the Agency or previously cited by anyone. Existing
studies are studies which predate issuance of this Notice. Do not
use this option if you are submitting data to upgrade a study, (See
Option 5).
You should be aware that if the Agency determines that the
study is not acceptable, the Agency will require you to comply with
this Notice, normally without an extension of the required date of
submission. The Agency may determine at any time that a study is
not valid and needs to be repeated.
To meet the requirements of the DCI Notice for submitting an
existing study, all of the following three criteria must be clearly
met:
a. You muat 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
necessary for the reconstruction and evaluation of the report
of that study. In the event that exact transcripts of raw data
have been prepared (e.g., tapes which have been transcribed
verbatim, dated, and verified accurate by signature), the exact
copy or exact transcript may be substituted for the original
source as raw data. 'Raw data' may include photographs,
microfilm or microfiche copies, computer printouts, magnetic
media, including dictated observations, and recorded data from
automated instruments," The term "specimens", according to 40
CFR 160,3{k), means "any material derived from a test system
for examination or analysis."
b. Health and safety studies completed after May 1984 must also
contain all GLP-required quality assurance and quality control
information, pursuant to the requirements of 40 CFR Part 160.
Registrants must also certify at the time of submitting the
existing study that such GLP information is available for post-
May 1984 studies by including an appropriate statement on or
attached to the study signed by an authorized official or
representative of the registrant.
c. You must certify that each study fulfills the acceptance
criteria for the Guideline relevant to the study provided in
the FIFRA Accelerated Reregistration Phase 3 Technical Guidance
and that the study has been conducted according to the
Pesticide Assessment Guidelines (PAG) or meets the purpose of
the PAG {both available from NTIS). A study not conducted
according to the PAG may be submitted to the Agency for
consideration if the registrant believes that the study clearly
meets the purpose of the PAG. The registrant is referred to 40
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CFR 158.70 which states the Agency's policy regarding
acceptable protocols. If you wish to submit the study, you
must, in addition to certifying that the purposes of the PAG
are met by the study, clearly articulate the rationale why you
believe the study meets the purpose of the PAG, including
copies of any supporting information or data. It has been the
Agency's experience that studies completed prior to January
1970 rarely satisfied the purpose of the PAG and that necessary
raw data are usually not available for such studies.
If you submit an existing study, you must certify that the
study meets all requirements of the criteria outlined above.
If EPA has previously reviewed a protocol for a study you are
submitting, you must identify any action taken by the Agency on the
protocol and must indicate, as part of your certification, the
manner in which all Agency comments, concerns, or issues were
addressed in the final protocol and study.
If you know of a study pertaining to any requirement in this
Notice which does not meet the criteria outlined above but does
contain factual information regarding unreasonable adverse effects,
you must notify the Agency of such a study. If such study is in
the Agency's files, you need only cite it along with the
notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5.
Option 5, Upgrading a Study -- If a study hag been classified
as partially acceptable and upgradeable, you may submit data to
upgrade that study. The Agency will review the data submitted and
determine if the requirement is satisfied. If the Agency decides
the requirement is not satisfied, you may still be required to
submit new data normally without any time extension. Deficient,
but upgradeable studies will normally be classified as
supplemental. However, it is important to note that not all
studies classified as supplemental are upgradeable. If you have
questions regarding the classification of a study or whether a
study may be upgraded, call or write the contact person listed in
Attachment A. If you submit data to upgrade an existing study you
must satisfy or supply information to correct all deficiencies in
the study identified by EPA, You must provide a clearly
articulated rationale of how the deficiencies have been remedied or
corrected and why the study should be rated as acceptable to EPA.
Your submission must also specify the MRID number(s) of the study
which you are attempting to upgrade and must be in conformance with
PR Notice 86-5.
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
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data submission as well as the MRID number of the study being
upgraded.
The criteria for submitting an existing study, as specified in
Option 4 above, apply to all data submissions intended to upgrade
studies. Additionally your submission of data intended to upgrade
studies must be accompanied by a certification that you comply with
each of those criteria as well as a certification regarding
protocol compliance with Agency requirements,
Option 6. Citing Existing Studies -- If you choose to cite a
study that has been previously submitted to EPA, that study must
have been previously classified by EPA as acceptable or it must be
a study which has not yet been reviewed by the Agency. Acceptable
toxicology studies generally will have been classified as "core-
guideline" or "core minimum." For ecological effects studies, the
classification generally would be a rating of "core." For all
other disciplines the classification would be "acceptable." With
respect to any studies for which you wish to select this option you
.must provide the MRID number of the study you are citing and, if
the study has been reviewed by the Agency, you must provide the
Agency's classification of the study.
If you are citing a study of which you are not the original
data submitter, you must submit a completed copy of EPA Form
8570-31, Certification with Respect to Data Compensation
Requirements.
2. Product Specific Data
If you acknowledge on the Pat a C a11-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,, Form
related to data production for each data requirement. Your option
selection should be entered under item number i, "Registrant
Response." The six options related to data production are the
first six options discussed under item 9 in the instructions for
completing the Requirements Status and Registrant'^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) I am submitting an existing study that has not been
submitted previously to the Agency by anyone (Submitting
an Existing Study)
(5) I am submitting or citing data to upgrade a study
classified by EPA as partially acceptable and upgradeable
(Upgrading a Study)
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(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)
Opt ion .!_, Developing, Data -- The requirements for developing
product specific data are the same as those described for generic
data (see Section III.C.I, Option 1) except that normally no
protocols or progress reports are required.
Option 2, Agree to Share in Cost to Develop Data -- If you
enter into an agreement to cost share, the same requirements apply
to product specific data as to generic data (see Section III.C.I,
Option 2). However, registrants may only choose this option for
acute toxicity data and certain efficacy data and only if EPA has
indicated in the attached data tables that your product and at
least one other product are similar for purposes of depending on
the same data. If this is the case, data may be generated for just
one of the products in the group. The registration number of the
product for which data will be submitted must be noted in the
agreement to cost share by the registrant selecting this option,
Option 3f Offer to Share in the Cost of DataDevelopment
The same requirements for generic data (Section III.C.I., Option 3)
apply to this option. This option only applies to acute toxicity
and certain efficacy data as described in option 2 above.
Option 4. Submitting an Existing Study -- The same requirements
described for generic data (see Section III.C.I., Option 4) apply
to this option for product specific data.
Option 5, Upgrading a Study — The same requirements described
for generic data (see Section III.C.I., Option 5) apply to this
option for product specific data.
Option 6, Citing Existing Studies — The same requirements
described for generic data (see Section III.C.I., Option 6) apply
to this option for product specific data.
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, and in the generic data requirements
section (III.C.I.), as appropriate.
III-D REQUESTS FOR DATA WAIVERS
1. Generic Data
There are two types of data waiver responses to this Notice.
The first is a request for a low volume/minor use waiver and the
second is a waiver request based on your belief that the data
requirement(s) are inapplicable and do not apply to your product.
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a. Low Volume/Minor Use Waiver -- Option 8 on the Requirements
Status and Registrant's Response Form. Section 3(c)(2)(A) of FIFRA
requires EPA to consider the appropriateness of requiring data for
low volume, minor use pesticides. In implementing this provision
EPA considers as low volume pesticides only those active
ingredients whose total production volume for all pesticide
registrants is small. In determining whether to grant a low
volume, minor use waiver the Agency will consider the extent,
pattern and volume of use, the economic incentive to conduct the
testing, the importance of the pesticide, and the exposure and risk
from use of the pesticide. If an active ingredient is used for
both high volume and low volume uses, a low volume exemption will
not be approved. If all uses of an active ingredient are low
volume and the combined volumes for all uses are also low, then an
exemption may be granted, depending on review of other information
outlined below. An exemption will not be granted if any registrant
of the active ingredient elects to conduct the testing. Any
registrant receiving a low volume minor use waiver must remain
within the sales figures in their forecast supporting the waiver
request in order to remain qualified for such waiver. If granted a
waiver, a registrant will be required, as a condition of the
waiver, to submit annual sales reports. The Agency will respond to
requests for waivers in writing.
To apply for a low volume, minor use waiver, you must submit
the following information, as applicable to your product(s), as
part of your 90-day response to this Notice:
(i). Total company sales (pounds and dollars) of all
registered product(s) containing the active ingredient.
If applicable to the active ingredient, include foreign
sales for those products that are not registered in this
country but are applied to sugar (cane or beet)t coffee,
bananas, cocoa, and other such crops. Present the above
information by yea*" for each of the past five years.
(ii). Provide an estimate of the sales {pounds and dollars)
of the active ingredient for each major use site.
Present the above information by year for each of the
past five years.
{iii) . Total direct production cost of product(s) containing
the active ingredient by year for the past five years.
Include information on raw material cost, direct labor
cost, advertising, sales and marketing, and any other
significant costs listed separately.
(iv). Total indirect production cost (e.g. plant overhead,
amortized plant and equipment) charged to product(s)
containing the active ingredient by year for the past
five years. Exclude all non-recurring costs that were
directly related to the active ingredient, such as
costs of initial registration and any data development.
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(v). A list of each data requirement for which you seek a
waiver. Indicate the type of waiver sought and the
estimated coat to you (listed separately for each data
requirement and associated test) of conducting the
testing needed to fulfill each of these data
requirements.
(vi). A list of each data requirement for which you are not
seeking any waiver and the estimated cost to you (listed
separately for each data requirement and associated
test) of conducting the testing needed to fulfill each
of these data requirements.
(vii). For each of the next ten years, a year-by-year fore-
cast of company sales (pounds and dollars) of the
active ingredient, direct production costs of product(s)
containing the active ingredient {following the
parameters in item 2 above), indirect production costs
of product(s) containing the active ingredient
(following the parameters in item 3 above), and costs of
data development pertaining to the active ingredient,
(viii). A description of the importance and unique benefits of
the active ingredient to users. Discuss the use patterns
and the effectiveness of the active ingredient relative
to registered alternative chemicals and non-chemical
control strategies. Focus on benefits unique to the
active ingredient, providing information that is as
quantitative aa possible. If you do not have
quantitative data upon which to base your estimates, then
present the reasoning used to derive your estimates. To
assist the Agency in determining the degree of importance
of the active ingredient in terms of its benefits, you
should provide information on any of the following
factors, as applicable to your product(s): (a)
documentation of the usefulness of the active ingredient
in Integrated Pest Management, (b) description of the
beneficial impacts on the environment of use of the
active ingredient, as opposed to its registered
alternatives, (c) information on the breakdown of the
active ingredient after use and on its persistence in
the environment/ and (d) description of its usefulness
against a pest(s) of public health significance.
Failure to submit sufficient information for the Agency to make
a determination regarding a request for a low volume/minor use
waiver will result in denial of the request for a waiver,
b. Request for Waiver of Data — Option 9 on the Requirements
Status and Registrant's Response Form. This option may be used if
you believe that a particular data requirement should not apply
because the corresponding use is no longer registered or the
requirement is inappropriate. You must submit a rationale
explaining why you believe the data requirements should not apply.
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You must also submit the current label(s) of your product(s) and,
if a current copy of your Confidential Statement of Formula is not
already on file you must submit a current copy.
You will be informed of the Agency's decision in writing. If
the Agency determines that the data requirements of this Notice do
not apply to your product(s) f you will not be required to supply
the data pursuant to section 3{c)(2)(B). If SPA determines that
the _data are required for your product (s) 4._ you must choose a method
of meeting the requirements of_this Notice—^within the time frame
provided by thia_Notice. Within 30 days of your receipt of the
Agency' s written decision, you must submit a revised Requirement a
Status and Registrant's Response Form indicating the option chosen.
2. Product Specific Data
If you request a waiver for product specific data because you
believe it is inappropriate, you must attach a complete
justification for the request, including technical reasons, data
and references to relevant EPA regulations, guidelines or policies.
_(Note: any supplemental data must be submitted in the format
required by PR Notice 86-5) . This will be the only opportunity to
state the reasons or provide information in support of your
request. If the Agency approves your waiver request, you will not
be required to supply the data pursuant to section 3(c)(2)(B) of
FIFRA. If the Agency denies your waiver request, you must choose
an option for meeting the data requirements of this Notice within
30 days of the receipt of the Agency's decision. You must indicate
and submit the option chosen on the Requirements Sfcatug and
Registrant/ gi Response Form. Product specific data requirements for
product chemistry, acute toxicity and efficacy (where appropriate)
are required for all products and the Agency would grant a waiver
only under extraordinary circumstances. You should also be aware
that submitting a waiver request will not automatically extend the
due date for the study in question. Waiver requests submitted
without adequate supporting rationale will be denied and the
original due date will remain in force.
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
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)
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2. Failure to submit on the required schedule an acceptable
proposed or final protocol when such is required to be
submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate
progress report on a study as required by this Notice.
4. Failure to submit on the required schedule acceptable
data as required by this Notice.
5. Failure to take a required action or submit adequate
information pertaining to any option chosen to address the data
requirements (e.g., any required action or information
pertaining to submission or citation of existing studies or
offers, arrangements, or arbitration on the sharing of costs or
the formation of Task Forces, failure to comply with the terms
of an agreement or arbitration concerning joint data
development or failure to comply with any terms of a data
waiver).
6. Failure to submit supportable certifications as to the
conditions of submitted studies, as required by Section 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 or failure of a
registrant on whom you rely for a generic data exemption either
to:
a. inform EPA of intent to develop and submit the data
required by this Notice on a Data Cal,l-In Response Form and a
Requirements Status and Registrant's_Response Formj
b. fulfill the commitment to develop and submit the data aa
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.
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IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within
the required time) is unacceptable and constitutes a basis for
issuance of a Notice of Intent to Suspend. The grounds for
suspension include, but are not limited tof failure to meet any of
the following;
I. 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, aex and distribution of animals,
dose and effect levels to be tested or attained, duration of
test, and, as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols,
including the incorporation of any changes required by the
Agency following review.
3. EPA requirements regarding the reporting of data, including
the manner of reporting, the completeness of results, and the
adequacy of any required supporting {or raw) data, including,
but not limited to, requirements referenced or included in this
Notice or contained in PR 86-5. All studies must be submitted
in the form of a final report; a preliminary report will not be
considered to fulfill the submission requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR 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 sKisting stocfca for a suspended registration when a section
3(c)(2)(B) data request is outstanding would generally not be
consistent with the Act's purposes. Accordingly, the Agency
anticipates granting registrants permission to sell, distribute, or
use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing stocks
of your product(s) which may be suspended for failure to comply
with this Notice should be permitted, you have the burden of
clearly demonstrating to EFA 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
-------
20
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(a) as a
response to this Notice and your product is in full compliance with
all Agency requirements, you will have, under most circumstances,
one year from the date your 90 day response to this Notice is due,
to sell, distribute, or use existing stocks. Normally, the Agency
will allow persons other than the registrant such as independent
distributors, retailers and end users to sellf distribute or use
such existing stocks until the stocks are exhausted. Any sale,
distribution or use of stocks of voluntarily cancelled products
containing an active ingredient for which the Agency has particular
risk concerns will be determined on case-by-case basis.
Requests for voluntary cancellation received after the 90 day
response period required by this Notice will not result in the
Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was
due unless you demonstrate to the Agency that you are in full
compliance with all Agency requirements, including the requirements
of this Notice. For example, if you decide to voluntarily cancel
your registration six months before a 3 year study is scheduled to
be submitted, all progress reports and other information necessary
to establish that you have been conducting the study in an
acceptable and good faith manner must have been submitted to the
Agency, before SPA will consider granting an existing stocks
provision*
SECTION V. REGISTRANTS'1 OBLIGATION TO REPORT POSSIBLE
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(9)
listed in Attachment A, the Data Call-in Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation
requests and generic data exemption claims) must include a
-------
21
completed Data Call-In Response Form and a completed Requirements
Status and Registrant's Response Form (Attachment B for generic
data and Attachment C for product specific data) and any other
documents required by this Notice, and should be submitted to the
contact person(s) identified in Attachment A. If the voluntary
cancellation or generic data exemption option is chosen, only the
Data Call-in Response Form need be submitted.
The Office of Compliance Monitoring (OCM) of the Office of
Pesticides and Toxic Substances (OPTS), EPA, will be monitoring the
data being generated in response to this Notice.
Sincerely yours,
Allan S. Abramson, Ph.D.
Acting Director
Special Review and Reregistration Division
Attachments
A - Data Call-in Chemical Status Sheet
B - Data Call-In Response^Form and Requirement Status
and Registrant' s Response form for Gener_ic_Dajba
C - Data Call-In Response Form and Requirements Status
and Registrant'a Response Fprm^fgr Product Specific
D - Formatted/Sample Labels
E - EPA Grouping of End-Use Products for Meeting Acute
Toxicology Data Requirements for Reregistration
F - EPA Acceptance Criteria
G - List of Registrants Receiving This Notice
H - Coat Share and Data Compensation Forms for Generic
and Product Specific Data, and Product Specific Data
Report Form
-------
ATTACHMENT A
DATA CALL-IN CHEMICAL STATUS SHEET
-------
ATTACHMENT A
WARFARIN £ ITS SODIUM SHiT; DATA CALL-IN CHEMICAL STATUS
INTRODUCTION
You have been sent this Data Call-in Notice because you have
products containing warfarin and its sodium salt.
This attachment, the Data Call-in Chemical Status Sheet.
contains the reregistration regulatory history of warfarin and its
sodium aaltr an overview of data required by this notice, and 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, and the Requirements Status and
Regiatrantra Response Form for generic data, (3) Attachment C, the
Data Call-In Response Form, and the Requirements Status and
Registrant^ Response Form for product specific data, (4)
Attachment D, Formatted/Sample Labels, (5) Attachment E, EPA
Grouping of End-tTae Products for Meeting Acute Toxicology Data
Requ irements for Reregistration, (6) Attachment W, EPA Acceptance,
.Cjciteria. (7) Attachment G, List of All Registrants sent this Data
Ca_ll-In Notice, and (8) Attachment H, the Cost Share and Data
Compensation Forms for generic and product specific data and
Product Specific, Data Report Form for use in replying to this
Warfarin and its sodium salt Data Call-in. Instructions and
guidance accompany each form.
BJBRJSSIST.B&XIQN HISTORY
In 1981 EPA issued a Registration Standard for warfarin and
its sodium salt which summarized the available data supporting its
registration and concluded that additional scientific data were
needed to fully evaluate the pesticide. Subsequently the Agency
reviewed the additional data and revised its scientific and
regulatory conclusions in light of the expanded data requirements
promulgated in 1964 for registration and reregistration of all
pesticides. In April 1989, EPA issued a second Registration
Standard in draft for public comment which provided an updated
assessment Of warfarin and its sodium salt and the data needed to
support its continued registration,
DATA REQUIRED BY THIS NOTICE
The Agency has concluded that additional data on product
chemistry are needed on warfarin and its sodium salt and fish
toxicity studies and an invertebrate toxieity study are needed only
on the sodium salt. The Agency has fish and invertebrate toxicity
data on warfarin but not on the sodium salt. Because of
differences in solubility between warfarin and the sodium salt
these ecological effects data are required. The required
additional generic data are listed in Attachment B and the required
product specific data are listed in Attachment C.
-------
Depending on the results of the studies required, in this
Notice, as well aa those required in the Registration Standard,
additional testing nay be required.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and
procedures established by this Notice, please contact;
for the generic data - Herman T. Toma at {703)308 - 8055.
for the product specific data - Robert A. Forrest (703)557 -
2600.
All written responses to this Notice pertaining to the generic
data requirements should be submitted to;
Herman T. Toma, Review Manager
Reregistration Branch
Special Review and Reregistration Division H7508C
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, DC 20460
REs Warfarin and its aodium salt
All written responses to this Notice pertaining to the product
specific data requirements should be submitted to:
Robert A. Forrest, Product Manager 14
Insecticide 6 Rodenticide Branch
Registration Division H7505C
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, DC 20460
RE: Warfarin and its sodium salt
-------
ATTACHMENT B
GENERIC DATA CALL-IN RESPONSE FORM
AND
GENERIC REQUIREMENT STATUS AND REGISTRANT'S
RESPONSE FORM
-------
SPECIFIC INSTRUCTIONS FOR
THE DATA CALL-IN RESPONSE FORM
This form is designed to be used to respond to call-ins for
generic and product specific data for the purpose of
reregistering pesticides under the Federal Insecticide Fungicide
and Rodenticide Act. Pill out this form each time you are
responding to a data call-in for which EPA has sent you the form
entitled "Requirements Status and Registrant's Response.11
Items 1 -4 will have been preprinted on the form. Items 5
through 7 must be completed by the registrant as appropriate.
Items 8 through 11 must be completed by the registrant before
submitting a response to the Agency.
Public reporting burden for this collection of information
is estimated to average 15 minutes per response, including time
for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and
reviewing the collection of information. Send comments regarding
the burden estimate or any other aspect of this collection of
information, including suggesting for reducing this burden, to
Chief, Information Policy Branch, PM-223, U.S. Environmental
Protection Agency, 401 M St., S.W., Washington, D.c. 20460; and
to the office of Management and Budget, Paperwork Reduction
Project 2070-0107, Washington, D.C. 20503.
INSTRUCTIONS
Item 1. This item identifies your company name, number and
address.
Item 2. This item identifies the case number, case name, EPA
chemical number and chemical name,
Item 3. This item identifies the date and type of data call-in.
Item 4. This item identifies the EPA product registrations
relevant to the data call-in. Please note that you are
also responsible for informing the Agency of your
response regarding any product that you believe may be
covered by this data call-in but that is not listed by
the Agency in Item 4. You must bring any such apparent
omission to the Agency's attention within the period
required for submission of this response form,
Item 5. Check this item for each product registration you wish
to cancel voluntarily. If a registration number is
listed for a product for which you previously requested
voluntary cancellation, indicate in Item 5 the date of
that request. You do not need to complete any item on
-------
Requirements Status and Registrant's Response Form
for any product that is voluntarily cancelled.
Item 6a. Check this item if this data call-in is for generic
data as indicated in Item 3 and if you are eligible for
a Generic Data Exemption for the chemical listed in
Item 2 and used in the subject product. By electing
this exemption, you agree to the terms and conditions
of a Generic Data Exemption as explained in the Data
Call-in Notice.
If you are eligible for or claim a Generic Data
Exemption, enter the EPA registration Number of each
registered source of that active ingredient that you
use in your product.
Typically, if you purchase an EPA-registered product
from one or more other producers (who, with respect to
the incorporated product, are in compliance with this
and any other outstanding Data Call-in Notice), and
incorporate that product into all your products, you
may complete this item for all products listed on this
form. If, however, you produce the active ingredient
yourself, or use any unregistered product (regardless
of the fact that some of your sources are registered),
you may not claim a Generic Data Exemption and you may
not select this item,
Item ib. Check this Item if the data call-in is a generic data
call-in as indicated in Item 3 and if you are agreeing
to satisfy the generic data requirements of this data
call-in. Attach the Requirements Status and
Registrant'sResponse Form that indicates how you will
satisfy those requirements.
Item 7a. Check this item if this call-in is a data call-in as
indicated in Item 3 for a manufacturing use product
(HUP)» and if your product is a manufacturing use
product for which you agree to supply product-specific
data. Attach the Requirements Status and Registrants'
Response Form that indicates how you will satisfy those
requirements.
Item 7b. Check this item if this call-in is a data call-in for
an end use product (EUP) as indicated in Item 3 and if
your product is a end use product for which you agree
to supply product-specific data. Attach the
Requirements Statusand Registrant's Response Form that
indicates how you will satisfy those requirements.
Item 8. This certification statement must be signed by an
authorized representative of your company and the
-------
person signing must include his/her title. Additional
pages used in your response must be initialled and
dated in the space provided for the certification.
Item 9. Enter the date of signature.
Item 10. Enter the name of the person EPA should contact with
questions regarding your response.
Item 11. Enter the phone number of your company contact.
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Page 1 of 1
United States Environmental Protection Agency
Washington, D.C. 20460
DATA CALL-IN RESPONSE
Font Approved
OMB No. 2070-010?
Approval Expires 12-31-92
INSTRUCTIONS: Please type or print In Ink. Please read carefully the attached Instruct lam and supply the Information requested on this form.
Use additional sheet If necessary
1. Company rvne and Address 003282 2. CM* # and Name
D-CON COMPANY INC 0011 Warfarin 1 its Na salt
225 SUMMIT AVENUE chenicil f >nd *aa» 086002
MQNTVALE NJ, O7645 UarfaHn
4. EPA Product
Registration
3282-3
3282-4
3282-15
3282-32
5. 1 wish to
cancel this
product r«gU-
t rot ion volun-
tarily
6. Generic Data
6a. 1 an claiming a Generic
Data Exemption because I
obtain the active Ingredient
f rot the source EPA regis-
tration nuifcer listed below.
6b. 1 agree to satisfy Generic
Data requirements as indicated
on the attached fora entitled
"Requirements Status and
Registrant's Response."
1, Date and Type of DCI
GENERIC
7. Product Specific Data
7a. My product is an HUP end
I agree to satisfy the HUP
requi resKnts en the attached
forn entitled "Requirements
Status and Resist rant's
Response. *
8. Certification
1 certify that the statements made on this fora and ill attachments ore true, accurate, end conplete.
1 acknowledge that any knowingly false or Misleading statement my be punishable by fine, inprisorment
or both under applicable to*.
Signature and Title of Conpany's Authorized Representative
10. Name of Company Contact
7b. My product is an EUP and
I agree to satisfy the fUP
requirements CTI the attached
fon» entitled "Requirements
Status end Registrant 'a
Response."
9. Date
11.
Phone Number
-------
Pau J. of 1
United States Environmental Protection Agency form ^^^
Washington, D.C. 20460 ^ ^^
DMA CALL-IN RESPOMSE ^^ ^^ 12.31.w
INSTRUCTIONS: Please type or print In Ink. Please read carefully tilt attached Instruction* and supply th* information requested on till* fond.
Use additional sheet(s) if necessary
1. Conpeny name and Address OO3282 2. Case f and Nam 3. Date and type of DCI
D-CON COMPANY INC 0011 Warfarin & its Na salt
225 SUMMIT AVENUE a,^ml 9 and Na*e 086003 GENERIC
MONTVALE NJ, 07645 Sodium warfarin
4. EPA Product
Registration
3282-9
i
5. I wish to
cancel this
product ref la-
tent I on volLn-
tarlty
6. Generic Data
6a. 1 aa claiming a Generic
Data Exwption because I
obtain the active ingredient
fro* the source EPA regis-
tration nutter listed below.
66. I agree to satisfy Centric
Data requirement a as Indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7. Product Specific Data
7s. My product is an HUP and
I agree to satisfy the MX>
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
fora entitled "Requirements
Status and Registrant's
Response."
a. Certification 9. Date
I certify that the statement 8 riadt on this form and all attachments ire true, accurate, and collate,
1 acknowledge that any knowingly false or nisi ending statement my be punishable by fine, iaprisorment
or both inder applicable law.
Signature and Title of Company's Authorized Representative
10. Name of Conpany Contact 11. Phone Nuifcer
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SPECIFIC INSTR0CTIOHS FOR COMPLETING
THE REQUIREMENTS STATUS AMD REGISTRANT'S RESPONSE FORM
Generic Data
This form is designed to be used for registrants to respond
to call-ins for generic and product-specific data as part of
EPA's reregistration program under the Federal Insecticide
Fungicide and Rodenticide Act. Although the form is the same for
both product specific and generic data, instructions for
completing the forms differ slightly. Specifically, options for
satisfying product specific data requirements do not include (l)
deletion of uses or (2) request for a low volume/minor use
waiver. These instructions are for completion of generic data
requirements.
EPA has developed this form individually for each data call-
in addressed to each registrant, and has preprinted this form
with a number of items, DO NOT use this form for any other
active ingredient.
Items 1 through 8 (inclusive) will have been preprinted on
the form. ¥ou must complete all other items on this form by
typing or printing legibly.
Public reporting burden for this collection of information
is estimated to average 30 minutes per response, including time
for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and
reviewing the collection of information. Send comments regarding
the burden estimate or any other aspect of this collection of
information, including suggesting for reducing this burden, to
Chief, Information Policy Branch, PM-223, U.S. Environmental
Protection Agency, 401 M St., S.W., Washington, D.C. 20460; and
to the Office of Management and Budget, Paperwork Reduction
Project 2070-0107, Washington, D.C. 20503.
-------
IHSTROCTIOMS
Item 1. This item identifies your company name, number, and
address.
Item 2. This item identifies the case number, case name, EPA
chemical number and chemical name.
Item 3. This item identifies the date and type of data call-in.
Item 4. This item identifies the guideline reference numbers of
studies required to support the product(s) being
reregistered. These guidelines, in addition to
requirements specified in the Data Call-in Notice,
govern the conduct of the required studies.
Item 5. This item identifies the study title associated with
the guideline reference number and whether protocols
and 1, 2f or 3-year progress reports are required to be
submitted in connection with the study. As noted in
Section III of the Data Call-in Notice, 90-day progress
reports are required for all studies.
If an asterisk appears in Item 5, EPA has attached
information relevant to this guideline reference number
to the Requirements Status and Registrant's Response
Form.
Item 6. This item identifies the code associated with the use
pattern of the pesticide. A brief description of each
code follows:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food crop
J Forestry
K Residential
L Indoor food
M Indoor non-food
N indoor medical
0 Indoor residential
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Item 7. This item identifies the code assigned to the substance
that must be used for testing, A brief description of
each code follows:
EP
MP
MP/TGAI
PAI
PAI/M
PAI/PAIRA
PAIRA
PAIRA/M
PAIRA/PM
TEP
TEP %
TEP/MET
TEP/PAI/M
TGAI
TGAI/PAI
TGAI/PAIRA
TGAI/TEP
MET
IMP
DEGR
*
End-Use Product
Manufacturing-Use Product
Manufacturing-Use Product and Technical
Grade Active Ingredient
Pure Active Ingredient
Pure Active Ingredient and Metabolites
Pure Active Ingredient or Pure Active
Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled
Pure Active Ingredient Radiolabelled and
Metabolites
Pure Active Ingredient Radiolabelled and
Plant Metabolites
Typical End-Use Product
Typical End-Use Product, Percent Active
Ingredient Specified
Typical End-Use Product and Metabolites
Typical End-Use Product or Pure Active
Ingredient and Metabolites
Technical Grade Active Ingredient
Technical Grade Active Ingredient or
Pure Active Ingredient
Technical Grade Active Ingredient or
Pure Active Ingredient Radiolabelled
Technical Grade Active Ingredient or
Typical End-Use Product
Metabolites
Impurities
Degradates
Sees guideline comment
Item 8. This item identifies the time frame allowed for
submission of the study or protocol identified in
item 2. The time frame runs from the date of your
receipt of the Data Call-In Notice.
Item 9. Enter the appropriate Response Code or Codes to show
how you intend to comply with each data requirement.
Brief descriptions of each code follow. The Data Call-
in Notice contains a fuller description of each of
these options,
1. {Developing Data) I will conduct a new study and
submit it within the time frames specified in item
8 above. By indicating that I have chosen this
option, I certify that I will comply with all the
-------
requirements pertaining to the conditions for
submittal of this study as outlined in the Data
Call-in Notice and that I will provide the
protocols and progress reports required in item 5
above.
2, (Agreement to Cost Share) I have entered into an
agreement with one or more registrants to develop
data jointly. By indicating that I have chosen
this option, I certify that I will comply with all
the requirements pertaining to sharing in the cost
of developing data as outlined in the Data Call-in
Notice,
3, (Offer to Cost Share) I have made an offer to
enter into an agreement with one or more
registrants to develop data jointly. I am
submitting a copy of the form "Certification of
Offer to Cost Share in the Development of Data"
that describes this offer/agreement. By
indicating that I have chosen this option, I
certify that I will comply with all the
requirements pertaining to making an offer to
share in the cost of developing data as outlined
in the Data Call-in Notice.
4. (Submitting Existing Data) I am submitting an
existing study that has never before been
submitted to EPA. By indicating that I have
chosen this option, I certify that this study
meets all the requirements pertaining to the
conditions for submittal of existing data outlined
in the Data Call-In Notice and I have attached the
needed supporting information along with this
response.
5. (Upgrading a Study) I am submitting or citing data
to upgrade a study that EPA has classified as
partially acceptable and potentially upgradeable.
By indicating that I have chosen this option, I
certify that I have met all the requirements
pertaining to the conditions for submitting or
citing existing data to upgrade a study described
in the Data Call-in Notice. I am indicating on
attached correspondence the Master Record
Identification Number (MRID) that EPA has assigned
to the data that I am citing as well as the MRID
of the study I am attempting to upgrade.
6. (Citing a Study) I am citing an existing study
that has been previously classified by EPA as
acceptable, core, core minimum, or a study that
-------
has not yet been reviewed by the Agency, I am
providing the Agency's classification of the
study.
7, (Deleting Uses) I am attaching an application for
amendment to my registration deleting the uses for
which the data are required.
8. (Low Volume/Minor Use Waiver Request) I have read
the statements concerning low volume-minor use
data waivers in the Data Call-in Notice and I
request a low-volume minor use waiver of the data
requirement. I am attaching a detailed
justification to support this waiver request
including, among other things, all information
required to support the request. I understand
that, unless modified by the Agency in writing,
the data requirement as stated in the Notice
governs.
9. (Reguest for Waiver of Data) I have read the
statements concerning data waivers other than low-
volume minor-use data waivers in the Data Call-in
Notice and I request a waiver of the data
requirement, I am attaching an identification of
the basis for this waiver and a detailed
justification to support this waiver request. The
justification includes, among other things, all
information required to support the request. I
understand that, unless modified by the Agency in
writing, the data requirement as stated in the
Notice governs.
Item 10. This item must be signed by an authorized
representative of your company. The person signing
must include his/her title, and must initial and date
all other pages of this form.
Item 11. Enter the date of signature.
Item 12. Enter the name of the person EPA should contact with
questions regarding your response.
Item 13. Enter the phone number of your company contact.
-------
PC.V..3, 1 Of 1
United States Environmental Protection Agency
Washington, D.c. 20460
REQUIREMENTS STATUS AMD REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested
Use additional sheet (s) if necessary
1. ConfMny nawe and Addreaa 003282
D-CON COMPANY INC
225 SUMMIT AVEHUE
MONTVALE NJ 07645
4. Guideline
Requi rement
61-1
61-2 (aj >:
61-2 (b)
62-1 " :i : l
62-2
62-3
63-2
63~3: '.-' ' ' '
63-4
6'3-7 •'• .•' "'
63-8
63-9 '* •'"' ' '•'•
63-12
63-13.?'' ::;.:>
171-4(1)
5. Study Title
Chemical Identity
Be/gin, aat. ft Hiffli proe .:'••" -"- - '
Discussion of Inpuritfes
Prellmirtiiry Analysis. '•. ' .--;? ' •• • • .
Certification of limits
Analytical Method
Color
Physical State ' -: ••• '".': : :•. .
Odor
Density '. :'••' : '•'•'•• C:""
SolubiHty
Vapor Preisiiri :S ' ':' ';- ' •" '•
pH
•'••' '.• • ••.''.•''• ' •
stability' :•''•• • :'' •
Hag, of rea. food handling
|
X
I
2. Case * and Name
0011 Warfarin fi its Ha salt
Cheiical 1 and Mane 086002
Warfarin
Progress
Report*
1
Y
2
3
6. Use
Pattern
ALL
ALL;: '• ."• -:
ALI*
ALIi-;Br v-r.^'v ••.:
ALL
ALL".' " •" •'••::'::-
ALL
ALL
ALL
ALL'"""' :V':':"-. ' •
ALL
ALL':. . •'?• ' •••'-'^
ALL
ALL
L
7. Test
Substance
TGAI
TGAI -: .'-H
TGAI
TGAI:'- ' '1-v
TGAI
TGAI'-^tlliiil''-
TGAI
TGA^|.-|i'-'ii%
TGAI
TGAfif:':''; --
TGAI
TGAI
TGAI
T'GAI;!*^^-'-
A
10, Ctrtiffcution
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 pmishable by fine, iinpri torment
or both wider applicable lau.
Signature and Title of Coacanv's Author i ted Representative
12. Name of Confiany Contact
8.
Fra
12
12
12
12
12
12
12
12:
12
12
12
12
12
12
24
11.
11.
For* Approved
OMB Ho. 2070-0107
Approval Expire* 12-31-92
on thit forn.
3. Date and Type of DC I
GEHERIC
- / i ^9 /
i>i
Tine
me
mos.
mos.
mos .
mos.
mos.
mos.
mos.
mos.
mos.
mos.
mos.
mos.
mos.
mos.
mos .
P. Refittrant
Response
Date
Phone Number
-------
Pat
of 4
United States Environmental Protection Agency
Washington, D.C. 20460
* COMMENTS FOR GUIDELINE REQUIREMENTS
Cast # and Ne
0011 Warfarin & its Na salt
Chemical I and Name
086002 Warfarin
GUI DEL I ME
COMMENT
61-1 FOOTNOTE A - For EPA Registration Nos. 2749-31, 6720-312, -900-130, and 10813-1, the
following information must be provided: 1) a general characterization of the process
(e.gu, batch or continous) ? 2) the identity of the materials used to produce the
product, their relative amounts, and the order in which they are added? 3) a description
of the equipment used; 4) a description of the conditions (e.g., temperature, pressure,
pH, humidity) that are controlled during each step of the process? 5) a description of
the procedures used to assure consistent composition of the substance produced (quality
control methods) ? 6) the name and address of the producer if different from the
registrant? 7) the brand name, trade nane, or other commercial designation, and
information concerning the composition of each starting material? 8) a flow chart of the
chemical equations of each intended reaction occuring at each step of the process, the
necessary reaction conditions, and the duration of each step of the process and of the
entire process? 9) a description of any purification procedures (including procedures to
recover or recycle starting materials, intermediates or the substance produced). In
addition, the following information must be provided for the specific products listed in
brackets: a general characterization of the process (e.g., batch or continous) [10442-5
and 12455-26]? the relative amounts of the materials used to produce the product
[3282-32 and 12455-26]? the order in which the materials used to produce the product are
added [12455-26]? a description of the equipment used [3282-32 and 12455-26]? quality
control methods [12455-26]? the name and address of the producer and information
concerning the composition of each starting material [3282-32 and 12455-26]? the
duration of each step of the process [10442-5, 3282-32, and 12455-26]? reaction
conditions [12455-26]? and purification procedures {12455-26], These data will satisfy
this requirement for all repackaged products.
61-2 (a) See Footnote A.
61-2(b) For each technical grade of the active ingredient (TGAI) except EPA Registration No.
-------
Of 4
United States Environmental Protection Agency
Washington, D.C. 20460
* COMMENTS FOR GUIDELINE REQUIREMENTS
Case • and Name
OOll Warfarin i its Na salt
Chemical f end None
086002 Warfarin
GUIDELINE
COMMENT
12455-26, a discussion regarding the orgin of the following impurities must be provided:
1) each impurity associated with the active ingredient which was found to be present in
any analysis of the product conducted by or for the registrant, and 2) each impurity
which the registrant has reason to believe may be present in the product at a level
equal to or greater than 0.1% (w/w) based on the composition of each starting material,
intended and side reactions which may occur in the production of the product, the
possible degradation of ingredients in the product after production, post-production
reactions between the ingredients in the product, possible contamination from packaging
materials or production equipment, and process control, purification and quality control
measures. For repackaged products, the discussion of potential impurities nay be
confined to potential postproduction contamination from packaging materials.
62-1 FOOTNOTE B - For each TGAI, except EPA Registration No. 12455-26, the- registrant must
provide preliminary analyses of five or more representative samples to quantify the
active ingredient and identify all impurities present at 0.1%, If the product is
produced by a batch process, each sample should be taken from a different batch of the
product. The preliminary analysis should be conducted at the point in the production
process after which no further chemical reactions designed to produce or purify the
substance are intended. Complete and detailed descriptions of the methods used for
sample analysis must be submitted, including statements of their precision and accuracy.
The preliminary analysis report should include the indentity and quantity of each
ingredient: for which analysis is conducted along, with the mean and relative standard
deviation of the analytical results. Based on the preliminary analysis, a statement of
the composition of the TGAI must be provided. These data will satisfy this requirement
for all repackaged products.
62-2 See Footnote B under Preliminary Analysis, 62-1.
•**-
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of 4
United States Environmental Protection Agency
Washington, D.C. 20460
* COMMENTS TOR GUIDELINE REQUIREMENTS
Cast • and Mane
0011 Warfarin & its Na salt
Chemical * and Now
086002 Warfarin
GUIDELINE
COMMENT
62-3 See Footnote B,
63-3 Data are required for product 12455-26.
63-4 Data are required for products 2749-31 and 10813-1.
63-7 Data are required for products 2749-31, 6900-130, 10813-1, and 12455-26.
63-8 Data are required for solubility inpolar and nonpolar solvents for all technical grade
products except 10442-5.
63-9 Data are required for all technical grade products.
63-12 Data are required for all technial grade products except 10442-5,
63-13 Data are required for all technical grade products.
171-4 (i) TEST SUBSTANCE: PAIRA, TEP, AND METABOLITES. The registrant may either-amend the
current label for the 1% dust tracking powder to include the language as required in the
RED which accompanied this document or supply residue data to support the tracking
powder use. The residue data that would be required are; a) Data depicting the nature of
the residue in representative food products from typical food/feed handling
establishments resulting from known contamination by tlj*c] warfarin (labeled in all
three rings). Characterization of residues must be conducted in samples representing the
range of normal shelf life for the food/feed products; and b) Data depicting the
magnitude of residues of concern in food/feed products resulting from normal application
-------
Page, of 4
United States Environmental Protection Agency
Washington, D.C. 20460
* COKNBNT8 FOR OTJIDBLINB REQDIRKMKMT8
CBS* # and H«m
0011 Warfarin & its Na salt
Chemical « and MM
086002 Warfarin
GUIDELINE
COMMENT
of the 1% D fonnualtian as a tracking powder, at the Ix and exaggerated rates, to
food/feed handling premises (two representative types of each food handling
establishment as listed in Table 1 of Subdivison 0 of the Pesticide Assessment
Guidelines). fest conducted must be representative examples of worst case scenarios for
potential residue contamination of food/feed products which might include, but are not
limited to, some of the following; i) tracking of residues from treated areas by rodents
or insects,* ii) contact of packaged or open foods/feeds with treated surfaces; iii)
distribution of particular matter through forced ventilation systems; and iv) routine
floor cleaning and cleaning specifically designed to remove old excess tracking powder.
Exposure situations in grocery stores and restaurants must include a representative
range of foods such as oily foods, baked cereal products, raw and cooked meats, and
fresh fruits and vegetables. [The registrant is urged to complete and submit the
required food/feed degradation study using radiolabeled material prior to initiation of
these residue trials.]
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1 of 2
United States Environmental Protection Agency
Washington, D.C, 20460
REQUIREMENTS STATUS AMD REQISTRAHT'S RES PONS B
Form Approved
QM Mo. 1070*0107
Approval Expires 12-31-fZ
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this fom.
Use additional sheetls) if necessary
1. ConfMmy TOM and Address 003282
D-CON COMPANY INC
225 SUMMIT AVENUE
MGNTVALE NJ 07645
4« Guideline
Requi renent
Hunger
61-1 *
6-1-2 '(I^>?f -**•'•'.
61-2 (b) *
6i--i *•' '- -' '' *''"
62-2 *
62-3 :'" : **f;
63-2
63 --3- :•• * '•'.;£ :•' •'*'•"
63-4 *
63-7 *
63-8
63-9 ":
63-12
63-13 :*-$-
72-i(a)
72-l(c)
72-2 (a)
5. Study Tftle
ChMical Identity
Begin. Mtk * wfj. proc
Discussion of tapuritiea
Prellninary Analysis:
Certification of Units
Analytical Method
Color
Physical! itiici l- '•'•. :0/.'--:-v:'; ::;;4:-"-
Odor
Density '" '''":•: '• .
Solubility
Vapor/ Pressure ' ' : •
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Invertebrate toxlctty
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I
f
2. case * and Hame 3. Date and Type of DCI
0011 Warfarin & its Na salt GENERIC
Chenlcal * and Nane 086003
Sodiiis warfarin
Progress
Reports
1
2
3
6. Use
Pattern
ALL
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7. Test
substance
TGAI
TGAI
TGAI
TGAI
TGAI
TGAtf! •- :v-lr
TGAI
TGAlHP -?:i::*-l;::-
TGAI
TGAI '?"•• ' -^ ••
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TGAI '^-rrfK^
TGAI
TGAI-";' :^?:ii--l:V
TGAI
Ttj&iVr:1 •'•' -''
TGAI
10. Certification
1 certify that the statements nsde on this fons and all attachments are true, accurate, and conptete.
I acknowledge that eny knowingly fats* or misleading statement may be punishable by fine, inprisonnent
or both wider applt cable lew.
Signature and Title of Company's Authorized Representative
12. Nome of Company Contact
8. TIM
rrsav
12 mos.
12 mos . * s
12 mos.
12 mos.
12 mos .
.* • *\ . . .•''•.•: J^' ' ' • '.'•:•
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9. Registrant
Response
:;: ''/.. '-'^' ?'*"•••:•' '••'• '''•' ' :- "'.''• -: '.. :.
!" - •' - ?.-. : .' -..;• ': f ;" .::j > • f": - :
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11. Date
13. Phone Hunter
-------
^e2 of 2
United States Environmental Protection Agency
Washington, D.C. 20460
REQUIREMENTS STATUS AND ISQXSTRMff *• RESPONSE
INSTRUCT KMS: PI ease type or print in Ink. Please read carefully the attached Instruction* and supply the infomation requested
Us* additional sheet (•} If nece*sory
1. Coapiny name and Addreea 003282
D-COM COMPANY INC
225 SUMMIT AVENUE
MONTVALE NJ 07645
4. Guideline
Requirement
ttunfeer
171-4(1) *
5. Study Titt*
Nag. of ree, food handling
I
f
t, CM« f end HIM
0011 Warfarin i its Na salt
Chemical 1 and Msms 086003
Sodii* warfarin
Progress
Reports
1
¥
2
3
6. Use
Pattern
L
Initial to indicate certification as to information on this page
(full text of certification is on page one).
7. Test
Substance
* •••. '•:-- - :." •":••!•
For* Approved
am no. mn-awr
Approval Expire* 12-31-92
on tkl « for».
3, tat* and Type of DC1
GENERIC
S. Tine
Tram
24
raos.
9. Registrant
Response
Date
-------
Page_J._of__4
United States Environmental Protection Agency
Washington, D.C. 20460
* COMMENTS TOR QUIDBLIKB REQUIREMENTS
Cuse * end Name
0011 Warfarin & its Na salt
Chemical * and Name
086003 Sodium warfarin
GUIDEI[HE
COWENT
61-1 FOOTNOTE A - For EPA Registration Nos. 2749-31, 6720-312, 6900-130, and 10813-1, the
following information must be provided: 1) a general characteriiation of the process
(e,g,, batch or continuous); 2) the identity of the materials used to produce the
product, their relative amounts, and the order in which they are added! 3) a description
of the equipment used? 4) a description of the conditions (e.g., temperature, pressure,
pH, humidity) that are controlled during each step of the process! and 5) a description
of the procedures used to assure consistent composition of the substance produced
(quality control methods) ; 6) the name and address of the producer if different from the
registrant? 7) the brand name, trade name, or other commercial designation, the name and
address of the producer, and information concerning the composition of each starting
material; 8) a flow chart of the chemical equations of each intended reaction occuring
at each step of the process, the necessary reaction conditions, and the duration of
each step of the process and of the entire process! and 9) a description of any
purification procedures (including procedures to recover or recycle starting materials,
intermediates or the substance produced) . In addition, the following information must
be provided for the specific products listed in brackets: a general characterization of
the process (e.g. batch or continous) [10442-5 and 12455-26]; the relative amounts of
the materials used to produce the product [3282-32 and 12455-26]; the order in which the
materials used to produce the product are added [12455-26]; a description of the
equipment used [3282-32 and 12455-26]; quality control methods [12455-26]; the name and
address of the producer and information concerning the composition of each starting
material [3282-32 and 12455-26]; the duration of each step of the process [10442-5,
3282-32, 12455-26]; reaction conditions [12455-26]? and purification procedures
[12455-26], These data will satisfy this requirement for all repackaged products.
61-2(a) See Footnote A.
61-2(b) For each technical grade of the active ingredient (TGAI), except EPA Registration No.
-------
Page 2 of 4
United States Environmental Protection Agency
Washington, D.C. 20460
* COMMENTS TOR GUIDELINE REQUIREMENTS
Case * wid Name
0011 Warfarin & its Na salt
Chemical * and Name
086003 Sodium warfarin
GUIDELINE
COWENT
12455-26, a discussion regarding the orgin of the following potential impurities must be
provided: i) each impurity associated with the active ingredient which was found to be
present in any analysis of the product conducted by or for the registrant, and 2) each
impurity which the registrant has reason to believe may be present in the product at a
level equal to or greater than 0.1% (w/w) based on the composition of each starting
material, intended and side reactions which may occur in the production of the product,
the possible degradation of ingredients in the product after production, post-production
reactions between the ingredients in the product, possible contamination from packaging
materials or production equipment, and process control, purification and quality control
measures. For repackaged products, the discussion of potential impurities may be
confined to potential postproduction contamination from packaging materials.
62-1 FOOTNOTE B - For each TGAI, except EPA Registration No. 12455-26 the registrant must
provide preliminary analyses of five or more representative samples to quantify the
active ingredient and identify all impurities present at o.lt. If the product is
produced by a batch process, each sample should be taken from a different batch of the
product. The preliminary analysis should be conducted at the point in the production
process after which no further chemical reactions designed to produce or purify the
substance are intended. Complete and detailed descriptions of the methods used for
sample analysis must be submitted, including stateaents of their precision and accuracy.
Th« preliminary analysis report should include the identity and quantify of each
ingredient for which analysis is conducted, along with the mean and relative standard
deviation of the analytical results. Based on the preliminary analysis, a statement of
the composition of the TGAI must be provided. These data will satisfy this requirement
for all repackaged products.
62-2 See Footnote B.
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fr^
-------
4 of 4
United States Environmental Protection Agency
Washington, D.c. 20460
* COMHBHT8 FOR QDIDBL1NB REQUIREMENTS
Case * and Nema
0011 Warfarin & its Na salt
Chemical # and Name
086003 Sodium warfarin
GUIDELINE
COMMENT
data that would be required are: a) Data depicting the nature of the residue in
representative food products from typical food/feed handling establishments resulting
from known contamination by [14C] warfarin (labeled in all three rings.)
Characterization of residues must be conducted in samples representing the range of
normal shelf life for the food/feed products; and b) Data depicting the magnitude of
residues concern in food/feed products resulting from normal application of the 1%D
formulation as a tracking powder, at the Ix and exaggerated rates, to food/feed handling
premises (two representative types of each food handling establishment as listed in
Table 1 of Subdivision O of the Pesticide Assessment Guidelines). Tests conducted must
be representative examples of worst case scenarios for potential residue contamination
of food/feed products which might include, but are not limited to, some of the
following: i)tracking of residues from treated areas by rodents or insects; ii) contact
of packaged or open foods/feeds with treated surfaces; iii)distribution of particular
matter through forced ventialation systems; and iv) routine floor cleaning and cleaning
specifically designed to remove old or excess tracking powder. Exposure situations in
grocery stores and restaurants must include a representative range of foods such as oily
foods, baked cereal products, raw and cooked meats, and fresh fruits and vegetables.
[The registrant is urged to complete and submit the required food/feed degradation study
using radiolabeled material prior to initiation of these residue trials.]
-------
ATTACHMENT C
PRODUCT SPECIFIC DATA CALL-IN RESPONSE FORM
AND
PRODUCT SPECIFIC REQUIREMENT STATUS AND
REGISTRANT'S RESPONSE FORM
-------
SPECIFIC INSTRUCTIONS FOR COMPLETING
THE DATA CALL-IN RESPONSE FORM
Product Specific Data
This form is designed to be used to respond to call-ins for
generic and product specific data for the purpose of
reregistering pesticides under the Federal Insecticide Fungicide
and Rodenticide Act. Fill out this form each time you are
responding to a data call-in for which EPA has sent you the torn
entitled "Requirements Status and Registrant's'Response."
Items 1-4 will have been preprinted on the form. Items 5
through 7 must be completed by the registrant as appropriate.
Items 8 through 11 must be completed by the registrant before
submitting a response to the Agency.
Public reporting burden for this collection of information
is estimated to average 15 minutes per response, including time
for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and
reviewing the collection of information. Send comments regarding
the burden estimate or any other aspect of this collection of
information, including suggesting for reducing this burden, to
Chief, Information Policy Branch, PM-223, U.S. Environmental
Protection Agency, 401 M St., S.W., Washington, D.C. 20460; and
to the Office of Management and Budget, Paperwork Reduction
Project 2070-0107, Washington, D.C. 20503.
-------
INSTRUCTIONS FOR COMPLETING THE "DATA CALL-IN RESPONSE" FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4. Already completed by EPA.
Item 5. If you wish to voluntarily cancel your product, answer
"yes." If you choose this option, you will not have to
provide the data required by the Data Call-in Notice and
you will not have to complete any other forms. Further
sale and distribution of your product after the effective
date of cancellation must be in accordance with the
Existing Stocks provision of the Data Call-in Notice
(Section IV-C).
Item 6. Not applicable since this form calls in product specific
data only. However, if your product is identical to
another product and you qualify for a data exemption, you
roust respond with "yes" to Item 7a (M0P) or ?B (EUPJ on
this form, provide the EPA registration numbers of your
source(a) 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 24e> products which are identical to
federally registered products.
Item 7a. For each manufacturing us» product (MUP) for which you
wish to maintain registration, you must agree to satisfy
the data requirements by responding "y*s.M
Item 7b. For each »nd use product (EUP) for which you wish to
maintain registration, you must agree to satisfy the data
requirements by responding "y»s," If you are requesting
a data v*iv«r, answer My«s" here? in addition, on the
"Requirements Status and Registrant's Response" forn
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.
MOTE: You may provide additional information that does not fit
on this form in a signed letter that accompanies this
form. For example, you may wish to report that your
product has already been transferred to another company
or that you have already voluntarily cancelled this
product. For these cases, please supply all relevant
details so that EPA can ensure that its records are
correct.
-------
INSTRUCTIONS; Please type or jrint in
necessary,
1. CompaRywune and Address
K
the aca
source
Registration numbers listed
below.
United Stales Environmental Protection Agency
Washington, D.C, 20460
DATA CALL-IN RESPONSE
Foim Approved
OMB No. 20704)101
Approval Expires 12-3192
Please read carefully the attached instructions and supply ihe information requested on Ms form. Use additional sheet(s) if
2, Case*andNime
0011 Warfarin
Chemical # and Name 086002
Warfarin
6b. I agree to satisfy Generic
Daia requirements as indicaied
on the attached form entitled
"Requirements Status and
Registrants' Response."
H.A,
3. Daie and Type of DC!
PRODUCT SPECIFIC
7. Product Specific Data
7a. My product is a MUP and I
agree 10 satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrants'
Response."
iat 1 have made on ihis form and all anachmenls ihertio are true, accurate, and complete.
se or misleading staicmenl may be punishable by fine or imprisonment or both
under applicable law.
Signature and Title of Company's Authorized Representative,, .,. _^__^__ - ___
7b. My product is an EUP and I
agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrants'
Response."
9, Dale
10, Name of Company Coniacl
11. Phone Number
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SPECIFIC INSTRUCTIONS FOR COMPLETING
THE REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE FORM
Product Specific Data
This form is designed to be used for registrants to respond
to call-ins for generic and product-specific data as part of
EPA's reregistration program under the Federal Insecticide
Fungicide and Rodenticide Act. Although the form is the same for
both product specific and generic data, instructions for
completing the forms differ slightly. Specifically, options for
satisfying product specific data requirements do not include (l)
deletion of uses or (2) request for a low volume/minor use
waiver. These instructions are for completion of product
specific data, requirements,
EPA has developed this form individually for each data call-
in addressed to each registrant, and has preprinted this form
with a number of items. DO NOT use this form for any other
.active ingredient.
Items l through 8 (inclusive) will have been preprinted on
the form. You must complete all other items on this form by
typing or printing legibly.
Public reporting burden for this collection of information
is estimated to average 30 minutes per response, including time
for reviewing instructions, searching existing data sources,
gathering and maintaining the data needed, and completing and
reviewing the collection of information. Send comments regarding
the burden estimate or any other aspect of this collection of
information, including suggesting for reducing this burden, to
Chief, Information Policy Branch, PM-223, U.S. Environmental
Protection Agency, 401 M St., s,W.r Washington, D.C. 20460,* and
to the Office of Management and Budget, Paperwork Reduction
Project 2070-0107, Washington, D.c. 20503,
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INSTRUCTIONS FOR COMPLETING THE " REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE" FORM FOR PRODUCT SPECIFIC DATA
Item 1-3 Completed by EPA. Note the unique identifier number
assigned by EPA in Item 3. This number must be used IB
the transmittal document for any data submissions in
response to this Data Call-in Notice*
Item 4, The guideline reference numbers of studies required to
support the product's continued registration are
identified. These guidelines, in addition to the
requirements specified in the Notice, govern the conduct
of the required studies. Note that series 61 and 62 in
product chemistry are now listed under 40 CFR 158.155
through 158. 180, Subpart C.
Item 5. The study title associated with the guideline reference
number is identified.
I tern 6. The use pattern (sj of the pesticide associated- with the
product specific requirements is (are) identified. For
most product specific data requirements, all use patterns
are covered by the data requirements. In the case of
efficacy data, the required studies only pertain to
products vhich have the use sites and/or pests indicated.
Item 7. The substance to be tested is identified by EPA. For
product specific data, the product as formulated for sale
and distribution is the test substance, except in rare
Item a. The due date for submission of each study is identified.
It is normally based on 8 months after issuance of the
Reregistration Eligibility Document unless EPA .determines
that a longer time period is necessary.
Item 9. Enter only enj of the following response codes for ..... each
da t a r ecru i rement to show now you Intend to comply with
the data requirements listed in this table. Fuller
descriptions of aach option are contained in the Data
Call-in Notice,
1. I vill generate and submit data by the specified due date
(Developing Data) , By indicating that I have chosen this
option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal
of this study as outlined in the Data Call-In Notice.
2. I have entered into an agreement with one or more
registrants to develop data jointly (Coat Sharing) . I
an submitting a copy of this agreement and a completed
"Certification With Respect To Data Compensation
Requirements" fora. I understand that this option is
available only for acute toxicity or certain efficacy
-------
data and only if EPA indicates in an attachment to this
Notice that my product is similar enough to another
product to qualify for this option. I certify that
another party in the agreement is committing to submit
or provide the required data; if the required study is
not submitted on time, my product may be subject to
suspension.
3. I have made offers to share in the cost to develop data
(Offers to Cost Share). I understand that this option
is available only for acute toxicity or certain efficacy
data and only if EPA indicates in an attachment to this
Data Call-in Notice that my product is similar enough to
another product to qualify for this option. I am
submitting evidence that I have mad* an offer to another
registrant (who has an obligation to submit data) to
share in the cost of that data. I am also submitting a
completed "Certification of Offer to Cost Share in the
Development Data" form. I am including a copy of my
offer and proof of the other registrant's receipt of that
offer. I am identifying the party which is committing
to submit or provide the required dataj if the required
study is not submitted on time, my product may be subject
to suspension. I understand that other terms under
Option 3 in the Data Call-in Notice (Section Ill-c.l.)
apply as well.
4. By the specified due date, I will submit an existing
study that has not been submitted previously to the
Agency by anyone (Submitting aa Existing Study), I
certify that this study will meet all the requirements
for submittal of existing data outlined in Option 4 in
the Data Call-In Notice (Section XIX-C.l.) and will meet
the attached acceptance criteria (for acute toxicity and
product chemistry data). I will attach the needed
supporting information along with this response. I also
certify that I have determined that this study will fill
the data requirement for which I have indicated this
choice.
5. By the specified due date, I will submit or cite data to
upgrade a study classified by the Agency as partially
acceptable and upgradable (Upgrading a Study). I will
submit evidence of the Agency's review indicating that
the study may be upgraded and what information is
required to do so. I will provide the MRID or Accession
number of the study at the due date. I understand that
the conditions for this option outlined Option 5 in the
Data Call-in Notice (Section XIX-C.l.} apply.
6. By the specified due date, I will cite an existing study
that the Agency has classified as acceptable or an
existing study that has been submitted but not reviewed
by the Agency (Citing an Existing Study) . If I am citing
-------
another registrant's study, I understand that this option
is available only for acute toxicity or certain efficacy
data and only if the cited study was conducted on my
product, an identical product or a product which EPA has
"grouped" with one or more other products for purposes
of depending on the sane data. I may also choose this
option if I am citing ny own data. In either case, I
will provide the MSID or Accession number(•) for the
cited data on a "Product Specific Data Report" form or
in a similar format. If I cite another registrant's
data, I will submit a completed "Certification Witfc
Respect To Data Compensation Requirements" form.
7. I request a waiver for this study because it is
inappropriate for ny product (Waiver Request). I am
attaching a complete justification for this request,
including technical reasons, data and references to
relevant EPA regulations, guidelines or policies. [Note:
any supplemental data nust be submitted in the format
required by P.R. Notice 86-5]. 1 understand that this
is my only opportunity to state the reasons or provide
*- information in support of my request. If the Agency
approves my waiver request, I will not be required to
supply the data pursuant to Section 3(cJ(2)(B) of FIFRA.
If the Agency denies my waiver' request, I must choose a
method of meeting the data requirements of this Notice
by the due date stated by this Notice. In this case, I
must, within 30 days of my receipt of the Agency's
written decision, submit a revised "Requirements Status
and Registrant's Response" Form indicating the option
chosen. I also understand that the deadline for
submission of data as specified by the original data
call-in notice will not change.
«**
Items 10-13. Self-explanatory.
HOTJr You may provide additional information that does not fit
on this form in a signed letter that accompanies this
form. For example, you may wish to report that your
product has already been transferred to another company
or that you have already voluntarily cancelled this
product. For these cases, please supply all relevant
details so that EPA can ensure that its records are
correct.
-------
another registrant's study, I understand that this option
is available only for acute toxieity or certain efficacy
data and only if the cited study was conducted on ny
product, an identical product or a product which EPA has
"grouped" with one or more other products for purposes
of depending on the sane data. I nay also choose this
option if I an citing ny own data. In «ither case, I
will provide the KHID or Accession number(s) for the
cited data on a "Product Specific Data Report" fora or
in a similar format. If I cite another registrant's
data, I will submit a completed "Certification with
Respect To Data Compensation Requirements" form.
7. I request a waiver for this study because it is
inappropriate for my product (Waiver Request). I an
attaching a complete justification for this request,
including technical reasons, data and references to
relevant EPA regulations, guidelines or policies* [Note:
any supplemental data must be submitted in the format
required by P.R. Notice 86-5]. I understand that this
is my only opportunity to state the reasons or provide
information in support of my request. If the Agency
approves my waiver request, I will not be required to
supply the data pursuant to Section 3(e)(2)CB) of FIFRA,
If the Agency denies my waiver request, I must choose a
method of meeting the data requirements of this Notice
by the due date stated by this Notice. In this case, I
must, within SO dafs of my receipt of the Agency's
written decision, submit a revised "Requirements Status
and Registrant's Response11 Form indicating the option
chosen* I also understand that the deadline for
submission of data as specified by the original data
call-in notice will not change.
^
Items 10-13. Self-explanatory,
You may provide additional information that does not fit
on this form in a signed letter that accompanies this
form. For example, you may wish to report that your
product has already been transferred to another company
or that you have already voluntarily cancelled this
product. For these cases, please supply all relevant
details so that EPA can ensure that its records are
correct.
-------
^^k ^mm mrn^ m United States Environmental Protection Agency
tSip? P™ E9 /\ Washington, D.C.
^ly* ^" • f+ REQUIREMENTS STATUS AND REGISTRANTS RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested ontMsfgrm,
necessary.
1, Company name and Address
NOTT MANUFACTURING COMPANY INC.
BOX 685
PLEASANT VALLEY, NY. 12569
4, Guideline
Requirement
Number
61-1
6i-2(a)
61-2(b)
62-1
S2-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
5, Study Title
Product identity
Begin, mat. & mfg. proc.
Discussion of Impurities
Preliminary analysis
Certification ol limits
Analytical method
Color
Physical state
Odor
Melting point
Boiling point
Density, bulk density or sp. gr.
Solubility
Vapor pressure
Dissociation constant
Oct/Water partition coef.
PH
Stability
3
q
$
P
2. Case* and Name 0011 Warfarin
Chemical f and Name
086002 Warfarin
EPA Reg. No. 358-128
Progress
Reports
!•«
^
M
u
y»
1
6. Use
Pattern
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
_^ ^IMWPB^^wi
_!J|p^"^
Form Approved
OMB No. 2070-0107
Approval Expires 12-31-92
Use additional aheei(s) if
^"•IJIIIi
^|3. Dale and Type of DCI ^|
^^^VM8«l9HPHBHHIi
| IDf 358-1
I
7. Test
Substance
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
10. Certification
I certify that the submenu ihst I have made on this fonn and all attachments thereto are inie, accuraie, and complete.
1 acknowledge thai any knowingly false or misleading statement may be punishable by fine or imprisonment or both
under applicable law.
Sivn.uurc anil Title ol 'Company's Authori/cd Representative „. .
\2 N.HIK »*t ('>un|>:my Contact
8. Time
Frame
LHJEIiJift^
il D " 3 50
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
9. Registrant
Response
11, Due
13. Phone Number
-------
^Mk H^H MM^ A United States Environmental Protection Agency
fSW7 1" ^J m\ Washington, D.C. 20460
^fcVlMT EH 1^ ^^ REQUIREMENTS STATUS AND REGISTRANTS RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached insmictions and supply the information requested on this form.
necessary.
1. Company name and Address 2. Case # and Name
NOTT MANUFACTURING COMPANY INC. W11 Warfarin
BOX 885 Chemical ff and Name 086002 Warfarin
PLEASANT VALLEY, NY. 12569 EPA Reg. No. 358-1 28
4, Guideline
Requirement
Number
63-14
63-15
63-16
63-17
§3-18
63-19
63-20
63-21
81-1
81-2
81-3
81-4
81-5
81-6
96-10(c)
5. Study
Title
Oxidizing/Reducing Action
Flammabillty
Explodablllty
Storage stability
Viscosity
MIsclbillty
Corrosion characteristics
Dielectric breakdown voltage
Acute oral tox. rat
Acute dermal tox. rabt./rat/g.plg
Acute Inhal. tox rat
Primary eye irritation-rabbit
Primary dermal Irritation
Dermal sensltlzatlon
Product performance
Laboratory efficacy studies
Norway rat, house mouse
3
9
^
o
r
Progress
Reports
l_l
H
N>
^
w
t*J
^
S
6. Use
Pattern
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
7. Test
Substance
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
EP
Form Approved
OMB No. 2070-0107
Approval Expires 12-31-92
Use additional sheei(s) if
3. Date and Type of DCI
PRODUCT SPECIFIC
ID* 358-RD-350
8. Time
Frame
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
8 mos.
9. Registrant
Response
luili.il It) iiuiiuiie vtrlit'icalHiii as to information on Cliis p;ij>e Ihiie
(J'liH Itxt of ciTlil'ii';iti(»«i is on fiage mie)
-------
INSTRUCTIONS FOR COMPLETING EFFICACY DATA REQUIREMENTS FORM
For product performance data, requirements, 96-10C, registrants
must use the Efficacy_Data Requirements Status and Registrants
Response Form, that is attached directly to the Registrants
Status and Requirements Response Form. In responding, you must
circle the test number of every study that is appropriate to your
product. In the Column next to "TEST NUMBER", you must indicate
how you will statisfy the requirement. The options available are
the same as those available for all product specific data
requirements.
-------
EFFICRCY DATA
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
FOR END-USE PRODUCTS OF WARFARIN AM3 ITS SOOHK SALT
Test No.'*' Response Column1*
1.201
1.202
1.203
1.204
Test Name'7
Standard Norway Rat Anticoagulant Liquid Bait
laboratory Test Method
Standard House Mouse Anticoagulant Liquid Bait
Laboratory Test Method
Standard Norway Bat Anticoagulant Dry Bait
Test Method
Standard House Mouse Anticoagulant Dry Bait
Test Method
Type of Claim
Liquid baits for control of Norway rats
and/or roof rats.
Liquid baits for control of house mice.
Ready-to-use dry baits (lacking
"waterproof" claims) for control of Norway
and/or roof rats.
Ready-to-use dry baits (ladcing
"waterproof" claims) for control of house
mice.
CERTIFICATION
I certify that the statements that I have made on this form and all attachments thereto are true, accurate, and complete. I
acknowledge that any knowingly false or misleading statanent may be punishable by fine or iiqprisciment or both under applicable
law. I also certify that I have reviewed all of the label claims for my proudct and indicated how I will satisfy all efficacy
data requirements.
SIGNATURE AND TITLE OF COMPANY'S AUTHORIZED REPRESENTATIVE
DATE
COMPANY CONTACT
NUMBER
-------
EFFICACY DATA
REQDXRQlQirS STRTDB AND REGISTRANT'S RESPONSE
FOR EMD-DSE PRODUCTS OF WARFARIN AMD ITS BODItM SAW
Test No.6^ Response Column Test Name1^ ' Type of Claim
1.205 Standard Norway Rat Anticoagulant Tracking Tracking powders for control of Norway
Powder Efficacy laboratory Test Method and/or roof rats.
1.212 Standard House House Anticoagulant Tracking Tracking powders for control of house mice.
Powder Efficacy laboratory Test Method
1.213 Standard Norway Rat Anticoagulant Wax Block All Norway and/or roof rat ready-to-use and
Wax Pellet laboratory Test Method baits claimed to be "waterproof", "suitable
for use in wet or damp areas", "wold-
resistant11, "weatherproof", "suitable for
use in sewers", "weatherproof11, "weather-
protected" , etc,
CERTIFICATION
I certify that the statements that I have made on this form and all attachments thereto are true, accurate, and conplete. I
acknowledge that any knowingly false or misleading stattimait may be punishable by fine or iflprisciinent or both under applicable
law. I also certify that I have reviewed all of the label claims for w/ proudct and indicated how I will satisfy all efficacy
data requirements.
SIGNATURE AND TITLE OF COMPANY'S AUTHORIZED REPRESENTATIVE DATE
COMPANY CONTACT PHONE NUMBER
-------
EFFICACY DKIA r
REQUIREMENTS STATUS AMD REGISTRANT'S RESPONSE
PCR END-USE PRODUCTS OP HARTORIN AH) ITS BCDIIM SAl/T
Test No.v Response Column**
1.214
1.217
1.218
Test Namec/
Standard House House Anticoagulant Wax Block
and Wax Pellet Laboratory Test Method
Standard Rat Anticoagulant Place-Pack Dry Bait
Laboratory Test Method
Standard House Mouse Anticoagulant Place-Pack
Dry Bait laboratory Test Method
Type of Claim
All house mouse ready-to-use baits claimed
to be'Vaterproof", "suitable for use in wet
or damp areas", "mold-resistant", "weather-
proof", "suitable for use in sewers",
"weather-proof", "weattier-protected", etc.
For all ready-to-^use Norway and/or roof
rat baits sold in place-packs, this test is
required in addition to 1.203.
For all ready-to-^use house mouse baits sold
in place-^packs, this test is required in
addition to 1.204.
CERTIFICATION
I certify that the statements that I have made on this form and all attachments thereto are true, accurate, and complete. I
acknowledge that any knowingly false or misleading statement may be punishable by fine or imprisonment, or both under applicable
law. I also certify that I have reviewed all of the label claims for my proudct and indicated how I will satisfy all efficacy
data requirements.
SIGNATURE AND TITLE OF COMPANY'S AUTHORIZED REPRESENTATIVE
DATE
COMPANY CONTACT
PHONE NUMBER
-------
X DATA
RBQOIKEMEWrS STKTUS AH) REQISTRANT'B RESPONSE
FOR END-USE FRODDCTS OF HARTORIN AMD ITS SODIUM BRUT
Test No.^ Response Column1* Test Name*^ Type of Claim
1.221 Proposed Norway Rat Anticoagulant Technical and All solid concentrates with end-use
Concentrated Dry Bait Laboratory Test Method directions for control of Norway and/or
roof rats.
1.225 Proposed House Mouse Anticoagulant Technical and All solid concentrates with end-use
Concentrated Dry Bait Laboratory Test Method directions with claims for control of house
mice.
CERTIFICATION
I certify that the statements that I have made on this form and all attachments thereto are true, accurate, and complete. I
acknowledge that any knowingly false or misleading statement may be punishable by fine or imprisonment or both under applicable
law. I also certify that I have reviewed all of the label claims for my proudct and indicated how I will satisfy all efficacy
data requirements.
SIGNATURE AND TITLE OF COMPANY'S AUTHORIZED REPRESENTATIVE DATE
COMPANY CONTACT PHONE NUMBER
-------
EF. Ct DftTA
REQUIREMENTS STHTJS 1MD RBSISIKMITB RESPCKSE
PCR END-USE PRODUCTS OF WARFARIN AND ITS SCDUM SALT
a/ Circle the test number of each efficacy study which applies to your product based on all labeling claims.
b/ For each test number circled, indicate in the Response column how you will fulfill the requirement. The options
available 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 (agreement to cost sharing); (3) I have made
offers to cost-share; (4) I am submitting an existing study that has not been submitted previously to the Agency by
anyone (submitting an existing study) j (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 B»A has classified as
acceptable or an existing study that has been submitted but not reviewed by the Agency (citing an existing study); and
(7) I am requesting a data waiver.
c/ Registrant has 9 months to submit all laboratory test data and 18 months to submit all field test data. Only laboratory
testing is required for commensal rodents (i.e., house mice and Norway rats).
CERTIFICATION
I certify that the statements that I have made on this form and all attachments thereto are true, accurate, and complete. I
acknowledge that any knowingly false or misleading statement may be punishable by fine or imprisonment or both under applicable
law. I also certify that I have reviewed all of the label claims for my proudct and indicated how I will satisfy all efficacy
data requirements.
SIGNATURE AND TITLE OF COMPANY'S AUTHORIZED REPRESENTATIVE DATE
COMPANY CONTACT PHONE NUMBER
-------
AtTACHMSNt D
FOBMAT TED/SAMPLE LABELS
-------
[FORMAT LABEL - READY-TO-USE WARFARIN DRY BAIT}
IFront Panel]
[PRODUCT NAME]
Kills Norway Rats, Roof Rats, and House Mice
ACTIVE INGREDIENT!:
Warfarin [3-(alpha-Acetonylbenzyl)-
4-hydroxycournarin] '
INERT INGREDIENTS
TOTAL 100.00%
KEEP OUT OF REACH OF CHILDREN [12 pt1]
CAUTION [18 pt1]
SEE RIGHT PANEL FOR ADDITIONAL PRECAUTIONARY
STATEMENTS
[Company Name and Address]
Reg. No,
EPA Est. No.
NET CONTENTS
Assumes a front panel of over 30 sq. in.
-------
[POIWT IABEL - READY-TQ-IEE WARFARIN DRY BAIT]
[Left Panel]
DIRECTIONS FOR USE
It is a. violation of Federal law to use this product in a manner inconsistent
with its labeling.
RJEM) THIS IABEL: Read this entire label and follow all use directions and
use precautions,
IMTOFTANT: Do not expose children, pets, or other nontarget animals to
rodenticides. To help to prevent accidents:
1. Store product not in use in a location out of reach of children and pets.
2. Apply bait in locations out of reach of children, pets, domestic animals
are? nontarget wildlife, or in tamper-resistant bait stations. These
stations must be resistant to destruction by dogs and by children under
six years of age, and must be used in a manner that prevents such children
from reaching into bait compartments and obtaining bait. If bait can
be shaken from stations when they are lifted, units must be secured or
-otherwise immobilized. Even stronger bait stations are needed in areas
open to hoofed livestock, raccoons, bears, or other potentially destructive
animals, or in areas prone to vandalism.
3. Dispose of product container, and unused, spoiled, and uneonsuroed bait as
specified on this label.
USE RESI1ICTIOI® - For control of Norway rats, roof rats, and house mice in
and around hones, industrial buildings, and similar man-made structures. Do
not place bait in areas where there is a possibility of contaminating food
or surfaces that come in direct contact with food. Do not broadcast bait.
SELECTION OF TREATMENT AREAS - Determine areas where rats or mice will most
likely find and consume the bait. Generally, these are along walls, by gnawed
openings, in or beside burre s, in corners and concealed places, between
floors and walls, or in locations where rodents or their signs have been seen.
Protect bait from rain or snow. Remove as much alternative food as possible.
APPLICATION DIRECTIONS
lATSs Apply 4 to 16 oz, of bait per placement. Maintain an uninterrupted
supply of fresh bait for at least 10 days.
MICE: Apply 1/4 to 1/2 oz. (1-2 level tablespoons) of bait at 8- to 12-foot
intervals. Larger placements (up to 2 oz.J may be needed at points of
very high mouse activity. Maintain an uninterrupted supply of fresh
bait for at least 15 days.
-------
IPOBMAT IABEL - READY-TO-USE WARFARIN DRY BAIT]
[Right Panel]
APPLICATION DIRECTIONS (Continued from left panel)
RATS/ Replace contaminated or spoiled bait immediately. Collect and dispose of
MICE: all dead animals and leftover bait properly. To prevent reinfestation,
limit sources of rodent food, water, and harborage as much as possible.
If reinfestation does occur, repeat treatment. Where a continuous source
of infestation is present, establish permanent bait stations and replenish
as needed.
[For Household Products]
STORAGE ANDDISPOSAL [12 pt1]
Storage: Store only in original container, in a dry
place inaccessible to children and pets.
Disposal: Do not reuse empty container.^ Securely
••••'' wrap In newspaper' and' discard' 'in trash'..'
[For Non-Household Products]
AND DISPOSAL [12 pt1]
Do not contaminate water, food or feed by storage or disposal.
STORAGE: [Develop statements based on "Storage Instructions" factors
1-5 in PR Notice 83-3, pp 2-3,]
PESTICIDE DISPOSAL: [Use paragraph 4 on p. 4 of PR Notice 83-3.
COMm'INEP DISPOSAL: (See Appendix A on p.1 7 of' PR' Notice 83-3.1
PRECAUTIONARY STATEMENTS:
HAZARD TO HUMANS AND DOMESTIC ANIMALS
CAUTION* Keep away from humans, domestic animals and pets. If swallowed, this
aiaterial may reduce the clotting ability of the blood and cause bleeding.
NOTE TO PHYSICIAN - If ingested, administer Vitamin K], intramuscularly or
orally, as indicated in bishydroxyeoumarin overdoses. Repeat as necessary based
on monitoring of prothronbin times.
ENVIRONMENTAL HAZARDS
This product is toxic to mammals and birds. Do not apply this product to water,
swamps, bogs, or potholes.
* Assumes a panel of over 30 sq. in.
2 if container is a bottle, can, or jar, add "Rinse container thoroughly." here.
-------
[FORMAT LABEL - WARFARIN CONCENTRATE WITH MIXING AND
USE DIRECTIONS TOR DRY BAITS]
[Front Panel]
[PRODUCT NAME]
A Concentrate for Preparing Baits to Kill
Iforway Rats, Roof Rats, and House Mice
ACTIVE INGREDIENT:
Warfarin [3-(alpha-Acetonylbenzyl)-
4-hydroxycoumarin]
TOTAL 100,00%
KEEP OUT OF REACH OF CHILDREN [12 pt1]
CAUTION [18 pt1]
SEE RIGHT PANEL FOR ADDITIONAL PRECAUTIONARY
STATIMENTS
{Company Name and Address!
EPA Reg, No.
EPA Est. NO.
NET CONTENTS
Assumes a front panel of over 30 sq. in.
-------
[FORMAT LABEL - WARFARIN CONCENTRATE FOP MIXING, OS IMG DRY BAITS, Left Panel]
DIRECTIONS FOR USE
It is a violation of Federal law to use this product in a manner inconsistent
with its labeling.
READ THIS LABEL: Read this entire label and follow all use directions and use
precautions,
IMPORTANT: Do not expose children, pets, or other nontarget animals to
rodenticides. To help to prevent accidents:
1. Store product not in use in a location out of reach of children and pets.
2. Apply bait in locations out of reach of children, pets, domestic animals
and nontarget wildlife, or in tamper-resistant bait stations. These
stations must be resistant to destruction by dogs and by children under
SIM years of age, and must be used in a manner that prevents such children
from reaching into bait ccmpartments and obtaining bait. If bait can
be shaken from stations when they are lifted, units must be secured or
otherwise immobilized. Even stronger bait stations are needed in areas
open to hoofed livestock, raccoons, bears, or other potentially destructive
animals, or in areas prone to vandalism.
3. Dispose of product container, and unused, spoiled, and unoonsumed bait as
*~ specified on this label.
USE RESTRICTIONS - For control of Norway rats, roof rats, and house mice in
and around homes, industrial buildings, and similar nan-made structures. Do
not place bait in areas where there is a possibility of contaminating food or
surfaces that come in direct contact with food. Do not broadcast bait.
SELECTION CF TREATMENT AREAS - Determine areas where rats or mice will most
likely find and consume the bait. Generally, these are along walls, by gnawed
openings, in or beside burrows, in corners and concealed places, between floors
and walls, or in locations where rodents or their signs have been seen. Protect
bait from rain or snow. Remove as much alternative food as possible.
MIXTKG
Thoroughly mix one part of concentrate with [specify number] parts of suitable
bait materials (cereal grains, fish, meats, vegetables, etc.) plus binding agents
and sweeteners, if needed. For example, mix one part of concentrate with [provide
recipe for mixing a bait formulation has performed adequately in laboratory
efficacy tests with rats and mice.].
Bait materials resembling human foods must be altered in form by crushing,
balling, or palletizing so that they are not readily recognizable as foods.
APPLICATION DIRECTIONS
RATS: Apply 4 to 16 oz. of bait per placement. Maintain an uninterrupted supply
of fresh bait for at least 10 days.
MICE: Apply 1/4 to 1/2 oz. {1-2 level tablespoons) of bait at 6- to 12-foot
intervals. Larger placements (up to 2 oz.) may be needed at points of
very high mouse activity. Maintain an uninterrupted supply of fresh bait
for at least 15 days.
-------
[TOIKAT LABEL - WARFARIN OOICENTSRATE TOR MIXING, USING DRY BAITS, Right Panel]
APPLICATION DIRECTIONS (Continued from left panel)
RATS/ Replace contaminated or spoiled bait immediately. Check perishable
MICE: baits daily. Collect and dispose of all dead animals and leftover bait
properly, fo prevent reinfestation, limit sources of rodent food, water,
and harborage as much as possible. If reinfestation does occur, repeat
treatment. Where a continuous source of infestation is present, establish
permanent bait stations and replenish as needed.
[For Household Products!
STORAGE AND DISPOSAL [12 pt*]
Storage: Store only in original container, in a dry
place inaccessible to children and pets.
Disposals Do not reuse empty container,2 Securely
wrap_jLn hewspape^ in _ trash ^
[For Non-Household Products]
[12
Do not contaminate water, food or feed by storage or disposal.
STORAGE: [Develop statements based on "Storage Instructions" factors
1-5 in PR Notice 83-3, pp 2-3.]
PESTICIDE DISPOSAL: [Use paragraph 2 or 4 on p. 4, of PR Notice 83-3.
Use u 2 if product contains >0.3% active ingredient.
Use 1 4 if product contains £0.3% active ingredient.)
CONTAINER DISPOSAL: [See_ Appendix A on p. J of PR Notice 83.3.1 _
PRECAUTIONARY STATEMENTS:
HAZARD TO HUMANS AND DOMESTIC ANIMALS
CAUTION: Keep away from humans, domestic animals and pets. Exposure during
pregnancy should be avoided. Warfarin may cause harm to the fetus, including
possible birth defects. If swallowed, this material may reduce the clotting
ability of the blood and cause bleeding. When mixing baits, wear dust respirator^
and rubber gloves. If product contacts skin, wash with soap or water.
NOTE TO PHYSICIAN - If ingested, administer Vitamin KI intramuscularly or
orally, as indicated in bishydroxycoumarin overdoses. Repeat as necessary based
on monitoring of prothrombin times.
ENVTROIWENTAL HAZARDS
This product is toxic to mammals and birds. Do not apply this product to water,
swamps, bogs, or potholes.
1 Assumes a panel of over 30 sq. ii.»
2 if container is a bottle, can, or jar, add "Rinse container thoroughly." here.
3 Use the words "dust respirator and" if the product is a respirable dust.
-------
[TORWAT LAffiL - SALT OF WARFARIN CONCENTRATE
WITH MIXING AND ENEKJSE DIRECTIONS TOR LIQUID BAITS}
[Front PanelJ
[PRODUCT NAME]
A Concentrate for Preparing Liquid Baits to Kill
Norway Rats, Roof Rats, and House Mice
ACTIVE INGREDIENT;
Sodium Salt of Warfarin [ 3-{alpha-ace tony 1 benzyl )-
4-hydroxyeoumarin, sodium salt]
INERT INGREDIENTS
TOTAL 100.00%
KEEP OUT OF REACH OF CHILDREN [12 pt:1]
CAUTION [18 pt1]
SEE RIGHT PANEL FOR ADDITIONAL PRECAUTIONARY
STATEMENTS
[Ccanpany Name and Address]
EPA Reg. No. ^_^_
EPA Est. No.
NET CONTENTS
1 Assumes a front panel of over 30 sq. in.
-------
[FDJWAT IABEL - SODIUM SALT CF WRRFARIN CONCENTRATES, Left Panel]
DIRECTIONS FOR USE
It is a violation of Federal law to use this product in a manner inconsistent
with its labeling.
KEM> THIS LABEL? Read this entire label and follow all use directions and
use precautions.
IMPORTANT? Do not expose children, pets, or other nontarget animals to
rodenticides. To help to prevent accidents:
1* Store product rot in use in a location out of reach of children and pets.
2. Apply bait in locations out of reach of children, pets, domestic animals
and nontarget wildlife, or in tamper-resistant bait stations. These
stations must be resistant to destruction by dogs and by children under
six years of age, and must be used in a manner that prevents such children
from reaching into bait compartiRents and obtaining bait. If bait can
be shaken from stations when they are lifted, units must be secured or
otherwise immobilized. Even stronger bait stations are needed in areas
.. open to hoofed livestock, raccoons, bears, or other potentially destructive
animals, or in areas prone to vandalism.
3. Dispose of product container, and unused, spoiled, and unoonsumed bait as
specified on this label.
USE RESTRICTIONS - For control of Norway rats, rcof rats, and house mice in and
around homes, industrial buildings, and similar man-made structures. Do not
apply bait in areas where there is a possibility of contaminating food or
surfaces that come in direct contact with food.
SELECTION OF TREATMENT AREAS - Determine areas where rate or mice will most
likely find and consume the bait, Generally, these are along walls, by gnawed
openings, in or beside burrows, in corners and concealed places, between floors
and walls, or in locations where rodents or their signs have been seen. Protect
bait from rain or snow. Limit alternative sources of water as much as possible,
MIXING DIRECTIONS
Mix oz. of concentrate per quart of water, [If sweetener was used for
efficacy tests, indicate the sweetener to use and how much to add per quart.]
APPLICATION DIRKTIOE
RATS; Use a minimum of 1 pint of liquid bait per placement. Apply liquid bait
in dispensers such as chick founts or covered bait stations adapted for
containing and dispensing liquid baits. Maintain an uninterrupted supply
of fresh bait for at least 10 days.
Hid! Use 4-8 fluid ounces of liquid bait per placement. Apply liquid bait
in dispensers such as chick founts or covered bait stations adapted for
containing and dispensing liquid baits. Maintain an uninterrupted supply
of fresh bait for at least 15 days.
-------
[TOPMAT LABEL - SOD TOW SALT OF WARFARIN CONCENTRATES, Right Panel]
APPLICATION DIRECTIONS (Continued from left panel)
BATS/ Replace contaminated or spoiled bait immediately. Collect and dispose of
MICE: all dead animals and leftover bait properly. To prevent reinfestation,
limit sources of rodent food, water, and harborage as much as possible.
If reinfestation does occur, repeat treatment. Where a continuous source
of infestation is present, establish permanent bait stations and replenish
as needed.
[For Household Products]
grpQj^gg AND DISPOSAL [12 pt1]
Storage: Store only in original container, in a dry
place inaccessible to children and pets
Disposal; Do not reuse empty container.2 Securely
___^ wragri in_newsgaper _ahd'jisicard' In' trash.
[For Non-Household Products]
STORAGE AND DISPOSAL [12 pt1]
Do not contaminate water, food or feed by storage or disposal,
STORAGE: [Develop statements based on "Storage Instructions" factors
1-5 in PR Notice 83-3, pp 2-3.]
[Use paragraph 2 or 4 on p. 4 of PR Nbtice 83-3.
Use f 2 if product contains >0.3% active ingredient.
Use 11 4 if product contains ^<0.3I active ingredient.]
1 CDNTA'IMER DISPOSAL: (See Appendix A' on p. 7' of'PR Notice '83'. '3,] T _
PRECAUTIONARY STATEJ-JENTS:
HAZARD TO HUMANS AND DOMESTIC ANIMALS
CAUTION; Keep away from humans, domestic animals and pets. If swallowed, this
material nay reduce the clotting ability of the blood and cause bleeding,
NOTE TO PHYSICIAN - If ingested, administer Vitamin % intramuscularly or
orally, as indicated in bishydroxycoumarin overdoses. Repeat as necessary
based on monitoring of prothrombin times.
ENVIRONMENTAL HAZAJUS
This product Is toxic to mammals and birds. Do not apply bait made from this
product to water, swamps, bogs, and ponds.
* Assumes a panel of over 30 sg. in,
2 if container is a bottle, can, or jar, add "Rinse container thoroughly." here.
-------
[FORMAT LABEL - WARFARIN TRACKING POWDER)
[Front Panel]
RESTRICTED PESTICIDE
Due to Need for Specialized Training
to Ensure Proper Use,
For retail sale to and use only by certified
applicators or persons under their direct
supervision and only for those uses covered
by the certified applicator's certification.
[PRODUCT NAME]
Kills Norway Rats, Roof Rats, and House Mice
FOR INDOOR USE ONLY
ACTIVE INGREDIENT:
Warfarin [3-(alpha-Acetonylbenzyl)-
4-hydroxycoumarin] ^
INERT INGREDIENTS
TOTAL 100,00%
KEEP OUT OF REACH OF CHILDREN
CAUTION
SEE SIDE PANELS FOR
ADDITIONAL PRECAUTIONARY STATEMENTS
[Company Name and Address]
EPA Reg. No.
EPA Est. No. ^_
NET CONTENTS
-------
[FORMAT LABEL - WARFARIN TRACKING ICOTER]
[Left Panel]
PRECAUTIONARY STATEMENTS
HAZARDS TO HDMANS AND DOMESTIC ANIMALS
CAUTION
Harmful if swallowed. Do not inhale powder. Wear dust respirator.
This product can be absorbed through the skin so it should be handled
with gloves. Keep away from humans, domestic animals, or pets. This
material may reduce the clotting ability of the blood and cause
bleeding. Exposure to warfarin during pregnancy should be avoided.
Warfarin may cause harm to the fetus, including possible birth defects.
NOTE TO PHYSICIAN - If ingested, administer Vitamin K^ intramuscularly
or orallyf as indicated in bishydroxycourmarin overdoses. Repeat as
necessary based on monitoring of prothrombin times.
ENVIROWENTAL HAZARDS
Ttiis product is toxic to mammals and birds. Do not apply this product
to water, swaps, bogs, or potholes.
AND
Do not contaminate water, food or feed by storage or
disposal
STORAGE! [Develop statements based on "Storage
Instructions" factors 1-5 in FR Notice 83-3, pp 2-3.
PESTICIDE DISPOSAL: •
Pesticide wastes are acutely hazardous. Improper
disposal or discharge or excess pesticide or rinsate is
a violation of Federal Law. If these wastes cannot be
disposed of by use according to label directions, contact
your State Pesticide or Environmental Control Agency, or
the Hazardous Waste representative at the nearest EPA
Regional Office for guidance.
CONTAINER DISPOSAL: [See Appendix A on p. 7 of PR Notice
83-3.]
-------
LABEL - WRFARIN TRACKING POWCEE]
[Right Panel]
D1RHCTIOIE TOR USE
It is a violation of Federal law to use this product in a manner inconsistent
with its labeling.
USE RESTRICTIONS; Use to control Norway rats, roof rats, and house mice
inside homes, industrial and agricultural buildings, and similar man-made
structures. Tracking powder may also be dusted into rat burrows that are
located along the periphery of buildings and that are likely to serve as
routes of entry into these structures.
Tracking powder must be placed in locations not accessible to children,
pets, domestic animals, or nontarget wildlife. If using this product in
agricultural buildings where livestock feeds are stored, or in commercial
feed service, food manufacturing or food processing establishments, limit
treatments to concealed, inaccessible places such as spaces between floors
and walls. Do not apply tracking powder along walls, in corners, in open
floor areas, or on rafters of rooms in which food or feed is handled or
stored.
SELECTION OF TREATMENT AREAS: Determine dry areas where rats and mice will
most likely pick up the powder on their feet or fur and ingest it during
grooming. Generally, these areas are in spaces between floors and walls, by
gnawed openings and burrows, in concealed places, along walls and in corners
(where permitted}, or in other appropriate locations where signs of rodents
have been observed. Remove goods piled directly on the floor and place on
skids. Use boxes or other obstacles to force rodenti to travel through
constricted areas. Give special attention to the climbing ability of roof
rats. For this species {where permitted), use cardboard tubes or wooden
tunnels securely attached to rafters or other horizontal surfacei where rats
will pass. Employ tubes long enough to minimize spillage of powder through
the ends.
."JPH/ICATICK DIRECTIONS: For house mice, use at the rate ot 1 oz. powder per
2.5 sq. ft. of runway area. For Norway and roof rats, use at the rate of
2 oz. powder per 2.5 sq. ft. of runway area. Apply the powder into rodent
burrow holes or within walls with a hand bulb or similar duster. Do not use
power dusting devices. Sprinkle the powder in patches in such a manner as
to expose th« rodent to it. Patch size may be (but need not be limited to)
6" X 12* and should be adapted to each situation. For burrows that are
located along the periphery of buildings and that are likely to serve as
routes of entry into these structures, place about 5 grams of tracking powder
in each burrow with a foot-pump duster (about 15 pumps). Close burrows with
soil* loose leaves, or paper. Retreat if burrows are re-opened.
Maintain powder in treated areas for at least 20 days. Collect and dispose
of all dead animals. Dispose of used powder when control program is finished.
Remove as many sources of food, water, and harborage as possible. Repeat
treatment if reinfestation occurs.
-------
ATTACHMENT E
EPA GROUPING OF END-USE PRODUCTS FOR MEETING
ACUTE TOXICOLOGY DATA REQUIREMENTS
FOR STRATION
-------
EPA'S BATCHING OF WARFAJIIN END-USE PRODUCTS FOR MEETING ACUTE
TOXICITY DATA REQUIREMENTS FOR REREGISTRATION
In an effort to reduce the time, resources and number of
animals needed to fulfill the acute toxicity data requirements for
reregistration of end-use products containing the active ingredient
warfarin, 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
for«ulationf
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 regist-
rants, 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 accep-
tance 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 require-
ments, registrants must follow the directions given in the Data
Call-in Notice and its attachments appended to the RED. The DCI
Notice contains two response forms which are to be completed and
submitted to the Agency within 90 days of receipt. The first form,
"Data Call-In Response," asks whether the registrant will meet the
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 toxic-
ity 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
-------
-2-
batch of products, he/she must select one of the following options:
Developing Data (Option 1), Submitting an Existing Study (Option
4), Upgrading an Existing Study (Option 5) or Citing an Existing
Study (Option 6). If a registrant depends on another's data, he/she
must choose among: Cost Sharing (Option 2), Offers to Cost Share
(Option 3) or Citing an Existing Study (Option 6). If a registrant
does not want to participate in a batch, the choices are Options 1,
4, 5 or 6. However, a registrant should know that choosing not to
participate in a batch does not preclude other registrants in the
batch from citing his/her studies and offering to cost share
(Option 3) those studies.
The following table shows 4 batches including 85 products
containing the active ingredient warfarin. Note that another 3
products were either considered not to be similar for purposes of
acute toxicity or the Agency lacked sufficient information for
decision making and were not placed in any batch. Registrants of
the products not listed are responsible for meeting the acute
toxicity data requirements for each product.
Table
Batch
No.
% Warfarin
EPA Reg. No.
Formulation Type
l.
655-318
2393-447
3282-32
6720-171
10442-5
12455-26
99.85
100.
98.
100.
100.
99.9
Technical
Technical
Technical
Technical
Technical
Technical
2.
655-
655-
655-
655-
2393-
2393-
2393-
2393-
3282-
5887-
6720-
6720-
7276-
10370-
12455-
12455-
12455-
19
246
443
503
19
149
387
483
•3
42
53
291
8
119
22
27
•28
0.5
0.5
1.0
0.5
0.5
0.5
0.5
0.5
0.3
0.
0,
0.5
0.54
0.5
0.54
0.5
0.5
,5
,5
Manufacturing-use
Manufacturing-use
Powder
Manufacturing-use
* Concentrate
* Concentrate
Manufacturing-use
* Concentrate
* Concentrate
Manufacturing-use
* Concentrate
* Concentrate
* Concentrate
* Concentrate
* Liquid concentrate
Manufacturing-use
* Concentrate
* These products are concentrates used for making baits.
-------
Ta
bl^J Continued)
Batch
No. EPA Red. NO.
3.
4.
*~
407-435
655-502
655-504
3282-4
3487-19
7122-35
8580-1
12455-15
584-5
602-255
602-266
655-515
655-539
690-28
690-32
746-124
995-41
1304-19
2006-43
2006-48
2393-145
2393-166
2393-363
2393-388
2393-452
2724-154
2724-444
2724-445
3282-4
3282-9
3282-15
3536-4
3941-21
3941-26
4271-7
5836-3
5887-30
5887-51
5887-98
6383-1
6653-1
6720-44
6720-319
6720-333
6720-345
7276-1
7276-11
This is a concentrate
baits.
-3-
% Warfarin
0.025
0.025
0.5
0.25
0.025
0.025
0.025
0.025
0.025
0.025
0.025
0.025
0.025
0.025
0.025
0.025
0.025
0.025
0.025
0.025
0.025
0.025
0.025
0.025
0.025
0.025
0.025
0.025
0.025
0.054
0.025
0.025
0.025
0.025
0.025
0.025
0.025
0.025
0.025
0.025
0.025
0.025
0.025
0.025
0.025
0.025
0.025
with directions
Formulation Type
Bait
Bait
•Concentrate
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
for mixing, and applying
-------
-4-
Table
Batch
No.
*>--
(Continued)
EPA Reg, No.
7276-14
7276-16
7276-17
7455-12
7537-2
8845-39
8848-2
9561-3
9691-1
10370-120
17975-1
34274-2
45722-1
47000-38
56176-1
% Warfarin
0.025
0.025
0.025
0,025
0.025
0.025
0.025
0.025
0.025
0.025
0.025
0.025
0.025
0.025
0.025
Formulation Type
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
Bait
-------
ATTACHMENT F
EPA ACCEPTANCE CRITERIA
-------
SUBDIVISION D
61 Product Identity tnd Composition .,,,.,,,.,,,.. 4
62 Analysis and Certification of Product Ingredients 6
63 Physical and Chemical Characteristics 8
C-3
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Subdivision D
Guideline Ref, No. 61
December 24, 1989
61 Product Identify and Composition
ACCEPTANCE CRITERIA
Docs your study meet the following acceptance criteria?
I- . Name of technical material tested (include product name and trade name, if appropriate)
2- Name, nominal concentration, and certified limits (upper and lower) for each active
ingredient and each intentionally-added inert ingredient
3. , Name and upper * e -fied limit for each impurity or each group of impurities present at >
0.1% by weight arc certain totjcologically significant impurities (e.g., diorins,
nitrosamines) pres^ <0.1%
4. Purpose of each a igredieni and each intentionally-added inert
5. Chemical name fh ,-mical Abstracts Index of Nomenclature and Chemical Abstracts
Service (CAS) Reg! Dumber for each active ingredient and, if available, for each
intentionally-added inert
6. Molecular, structural, and empirical formulas, molecular weight or weight range, and any
company assigned experimental or internal code numbers for each active ingredient
?, Description of each beginning material in the manufacturing process
EPA Registration Number if registered; for other beginning materials, the following:
___ Name and address of manufacturer or supplier
._,__„_ Brand name, trade name or commercial designation
__ Technical specifications or data sheets by which manufacturer or supplier describes
composition, properties or toxiciry
8. __ Description of manufacturing process
Statement of whether batch or continuous process
___ Relative amounts of beginning materials and order in which they are added
„..__„ Description of equipment
___ Description of physical conditions (temperature, pressure, humidity) controlled in
each step and the parameters that are maintained
__ Statement of whether process involves intended chemical r;a< tioni
__^ Flow chart with chemical equations for each intended chemical reaction
Duration of each step of process
_ Description of purification procedures
Description of measures taken to assure quality of final product
9. Discussion of formation of impurities based on established chemical theory addressing (1)
each impurity which may be present at > 0.1% or was found at > 0,1% by product analyses
and (2) certain lexicologically significant impurities (see
Criteria marked with a * are supplemental and may not be required for every study.
C-4
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Subdivision D
Guideline Ref. No. 61
December 24, 1989
61 Product Identity and Composition
GUIDANCE FOR SUMMARIZING STUDIES
The following criteria apply to the technical grade of the active ingredient being reregistered. Items 1,
2, 3, and 5 can be satisfied for most registered products by submission of the Certified Statement of
Formula Ingredients Page (EPA Form 8570-4), Items 7 and 8 can be satisfied for most technical grade
active ingredients (TGAls) by submission of a flow chart with chemical equations for each intended
chemical reaction. The flow chart should include complete chemical structures and names for each
reaccant and product of all the reactions.
Items in summary should include the items diseased in Chapter 2 of this package and the specific Items
listed below.
1, Name of technical material (include product name and trade name, if appropriate).
2. Description of each active and intentionally-added inert ingredient, including name, concentration,
and certified limits.
3. Name and upper limit for all impurities present at £ 0.1% and those lexicologically significant
impurities present at < 0.1%,
4 The purpose of each active and intentionally-added inert ingredient
5, Chemical name and Registry Number for each active and intentionally-added inert ingredient (if
available).
6. Molecular, structural, and empirical formulas, molecular weight, and any experimental or internal
code number for each active ingredient.
7. Description of each beginning material in the manufacturing process.
8. Description of manufacturing process,
9. Discussion of formation of impurities based on established chemical theory.
C-5
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Subdivision D
Guideline Ref. No. 62
December 24, 1989
62 A&afyita aod Certification of Product Ingredients
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered. Use a
table to present the information in items 6, 7, and &
Does your study meet the following acceptance criteria?
!• __ Pi*1* or morc representative samples (batches in case of batch process) analyzed for each
active ingredient and all impurities present at £ 0,1%
2, Degree of accountability or closure 2 a 98%
3. Analyses conducted for certain trace toxic impurities at lower than 0.1% (examples,
nitrosamines in the case of products containing dinitroanilines or containing secondary or
tertiary amines/alkanolamines plus nitrites; poiyhalogenated dibenzodioxins and
dibenzofurans) [Note that in the case of nitrosamines both fresh and stored samples must be
analyzed.]
4. Complete and detailed description of each step in analytical method used to analyze above
samples
5. Statement of precision and accuracy of analytical method used to analyze above samples
& _ tdentities and quantities (including mean and standard deviation) provided for each analyzed
ingredient
"• ___ Upper and lower certified limits proposed for each active ingredient and intentionally added
inert along with explanation of how the limits were determined
8. ___ Upper certified limit proposed for each impurity present at j> 0.1% and for certain
toncologically significant impurities at <0.1% along with explanation of how limit
determined
9, Analytical methods to verify certified limits of each active ingredient and impurities (latter
not required if exempt from requirement of tolerance or if generally recognized as safe by
FDA) are fully described
10- _ Analytical methods (as discussed in #9) to verify certified limiis validated as to ihtir
precision and accuracy
Criteria marked with a * are supplemental and may not be required for every study.
C-6
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Subdivision D
Guideline Ref, No. 62
December 24, 1989
62 Analysis and Certification of Product Ingredients
GUIDANCE FOR SUMMARIZING STUDIES
The following criteria apply to the technical grade of the active ingredient being reregistered.
Items in summary should include the items discussed in Chapter 2 of this package and the specific items
listed beta*.
1. Number of representative samples analyzed for all active ingredients and all impurities present at >
0.1%.
2. Degree of accountability or closure in analyses in item #1.
3. Chemical names of tone impurities which were analyzed for levels =0.1% and certain toxicologies lly
significant impurities at <0,1% with brief explanation of how limits were determined,
9. Brief description of analytical methodfs) used to verify certified limits (if same methods as item #4,
may reference latter).
10. Statement of precision and accuracy of meihod(s) in item #9 (may reference item #5 if applicable).
C-7
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Subdivision D
Guideline Ref, No. 63
December 24, 1989
63 Physical tad Chemical Ountcteristici
ACCEPTANCE CRITERIA
The following criteria apply to the technical grade of the active ingredient being reregistered.
Does your study meet the following acceptance criteria?
63-2 Color
Verbal description of coloration (or lack of it)
__ Any intentional coloration also reported in terms of Munsell color system
63-3 Physical Slate
Verbal description of physical state provided using terms such as "solid, granular,
volatile liquid"
Based on visual inspection at about 20-2S*C
.63-4 Odor
Verbal description of odor (or lack of it) using terms such as *garlic-Hke,
characteristic of aromatic compounds*
— Observed at room temperature
63-5 Melting Point
Reported in "C
_ Any observed decomposition reported
63-6 Boiling Point
;. Reported in "C
_._mf Pressure under which B.P, measured reported
mjm Any observed decomposition reported
63-7 Density, Bulk Density, Specific Gravity
_rmi Measured at about 20-25dC
Density of technical grade active ingredient reported in g/ml or the specific gravity of
liquids reported with reference to water at 20°C, [Note: Bulk density of registered
products may be reported in lbs/ftj or Ibs/gallon,]
63-8 Solubility .
Determined in distilled wner ind representative polar ind non-polar solvents,
including those used in formulations and analytical methods for the pesticide
Measured at about 20-25"C
Reported in g/100ml (other units like ppm acceptable if sparingly soluble)
Criteria marked with a * are supplemental and may not be required for every study.
C-8
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Subdivision D
Guideline Rcf. No. 63
December 24, 1989
63-9 Vapor Pressure
Measured it *25°C (or calculated by extrapolation from measurements made at
higher temperature if pressure too low to measure at 25°C)
Experimental procedure described
-__ Reported in mm Hg (torr) or other conventional units
63-10 Dissociation Constant
Experimenta! method described
__ Temperature of measurement specified (preferably about 20-25*C)
63-11 Octanol/water Partition Coefficient
Measured at about 20-25"C
Experimentally determined and description of procedure provided (preferred method*
45 Fed. Register 77350)
Data supporting reported value provided
"63-12 pH
Measured at about 20-25eC
Measured following dilution or dispersion in distilled water
63-13 Stability
Sensitivity to metal ions and metal determined
Stability at normal and elevated temperatures
Sensitivity to sunlight determined
Criteria marked with a * are supplemental and may not be required for every study.
C-9
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Subdivision D
Guideline Ref. No. 63
December 24, 1989
63 Physical and Chemical Quraoerittia
GUIDANCE FOR SUMMARIZING STUDIES
The following criteria apply to the technical grade of the active ingredient being reregistered.
Items la summary should include the items discussed in Chapter 2 of Urn package and the specific items
listed beiow.
t Description of color.
2. Description of physical state,
3, Description of odor.
4. Indication of melting point (in *Q,
5. Indication of boiling point (in °C).
6. Indication of density, bulk density, and specific gravity.
7. Indication of solubility.
8. Indication of vapor pressure.
9. Indication of dissociation constant.
10. Indication of oaanolAvater partition coefficient.
11. Indication of pH.
12. Description of stability.
C-10
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SUBDIVISION F
81-1 Acute Oral Toxicity in the Rat 84
81-2 Acute Dermal Toxicity in the Rat, Rabbit or Guinea Pig ,.,.,,.,,...,...,,,..,,.., 86
81-3 Acute Inhalation Toxicity in the Rat 88
81-4 Primary Eye Irritation in the Rabbit 90
81-5 Primary Dermal Irritation Study 92
81-6 Dermal Sensitization in the Guinea Pig 94
81-7 Acute Neurotoxiciry ta tie Hei 96
82-1 Subchronic Feeding in the Rodent and Nonrodent 98
82-2 Repeated Dose Dermal Taxitiiy (21-day) in the Rat, Rabbit or Guinea Pig 101
82-3 Repeated Dose Dermal Toxicity (90-day) in the Rat, Rabbit or Guinea Pig 103
82-4 Subchronic Inhalation Toricity (90-day) in the Rat 106
82-5 Subchronic Neurotoxiciry (90-day) in the Hen 109
83-1 Chronic Feeding in the Rodent and Nonrodent Ill
83-2 Oncogenlcity in Rats or Mice 114
83-3 Teratology Studies 117
83-4 Reproduction ,.......,.,.. 119
83-5 Chronic Feeding/Oncogenicity in the Rat 121
84-2 Mutagenicity Studies 124
.85-1 Metabolism Studies 127
C-83
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Subdivision F
Guideline Ref. No. 81-1
December 24, 1989
81-1 Acute On! Tondty in the Kit
ACCEPTANCE CRITERIA
Does your study meet UK following acceptance criteria?
I. Technical form of the active ingredient tested, (for reregistraiion only)
2.* At least S young adult rats/sex/group
3. Dosing, single oral may be administered over 24 ors.
4.* Vehicle control if other than water.
5. Doses tested, sufficient to determine a toritity category or a limit dose (5000 mg/kg),
6. Individual observations at least once a day.
7. Observation period to last at least 14 days, or until all test animals appear normal whichever
is longer.
8. Individual daily observations.
9.* Individual body weights.
10.* Gross necropsy on all animals.
Criteria marked with a " are supplemental and may not be required for every study.
C-84
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Subdivision F
Guideline Ret No, 81-1
December 24, 1989
81*1 Acute Oral Tondty in the Rat
GUIDANCE FOR SUMMARIZING STUDIES
Items in summary shook! include the items discussed in Chapter 2 of this package and the specific items
listed below.
1. The form of pesticide tested, e.g. solid, liquid, percent AJ in technical, etc.
2, The number of animals/dose/sex tested.
3. Dosing route and regimen.
4. Vehicle used
5. Doses tested and results
6. Individual observations on day of dosing.
7. Individual observations on day of dosing and for at least 14 days or until all animals appear normal
(whichever is longer).
8. See items 6 and 7
9. Summarization of body weights
10. Summarization of gross necropsy
11. Significance of changes from the Acceptance Criteria
C-85
-------
Subdivision F
Guideline Ref. No. 81-2
December 24, 1989
81-2 Acute Dermal Toncity in the Rat, Rabbit or Guinea Pig
ACCEPTANCE CRITERIA
Does jour study meet the following acceptance criteria?
I. Technical form of tbe active ingredient tested, (for reregistration only)
2-*— At least 5 aninals/sex/group
3.* Rats 200-300 gm, rabbiis 2,0-3,0 kg or guinea pigs 350-450 gm,
4. Dosing, single dermal.
5. Dosing duration at least 24 hours.
6.* Vehicle control, only if torieiry of vehicle is unknown,
7, Doses tested, sufficient to determine a toriciry category or a limit dose (2000 mgAg).
8- _____ Application site clipped or shaved at least 24 hours before dosing
9, Application site at least 10% of body surface area.
10. Application site covered with a porous nonirritating cover to retain test material and to
prevent ingestion.
,11, Individual observations at least once a day.
12. Observation period to last at least 14 days, or until all test animals appear normal whichever
is longer.
13, Individual daily observations.
14.* Individual body weights.
15.* Gross necropsy on all animals.
Criteria marked with a * are supplemental and may not be required for every study.
C-86
-------
Subdivision F
Guideline Ref. No. 81-2
December 24, 1989
81-2 Acute Dermal Toritity in the Rat, Rabbit or Guinea Pig
GUIDANCE FOR SUMMARIZING STUDIES
Items in summary should include the items discussed in diapier 2 of tills package and tne specific items
lilted below.
1, The form or pesticide tested, e.g., solid, liquid, percent AI in technical, etc.
2. Hie number of animals£ex/dose
3. Weight range of animals
4. Verification of single, dermal exposure
5, Duration of dermal exposure
6. Statement of vehicle control
7. Doses tested and results
8, Preparation of application site
9. Area of application site (percent body surface)
10, Occlusion of test material on application site
»11. Individual observations on day of dosing
12. Individual observations on day of dosing and for at least 14 days or until all animals appear normal
(whichever is longer)
13. See items 11 and 12
14. Summarization of body weights
15. Summarization of gross necropsy
16. Significance of changes from Acceptance Criteria
C-87
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Subdivision F
Guideline Ref. No. 81-3
December 24, 1989
81-3 Acute Inhalation Ternary in the Rat
ACCEPTANCE CRITERIA
Does your study meet the following acceptance criteria?
I. = Technical form of the active ingredient tested, (for reregistraiton only)
2. Product is a gas, a solid which may produce a significant vapor hazard based on toxicity and
expected use or contains panicles of inhalable size for man (aerodynamic diameter 15 urn or
less),
3.* At least 5 young adult rais/sex/group
4.* Dosing, at least 4 hours by inhalation.
5,* Chamber air flow dynamic, at least 10 air changes/hour, at least 19% oxygen content.
6. Chamber temperature, 22* C (±2°), relative humidity 40-60%.
7. Monitor rate of air flow
8. Monitor actual concentrations of test material in breathing zone.
9. __^_ Monitor aerodynamic panicle size for aerosols.
10, Doses tested, sufficient to determine a loxiciry catagory or a limit dose (5 mg/L actual
concentration of respirable substance),
II, Individual observations at least once a day.
12. Observation period to last at least 14 days, or until all test animals appear normal whichever
is longer.
13. Individual daily observations.
14,* Individual body weights.
15.* Gross necropsy on all animals.
Criteria marked with a * are supplemental and may not be required for every study.
C-8S
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Subdivision F
Guideline Ref. No, 81-3
December 24, 1989
81-3 Acute Inhalation Taritity in the Rat
GUIDANCE FOR SUMMARIZING STUDIES
Items in summary should include the items discussed in Chapter 2 of this package and the specific items
listed below.
I. The form of pesticide tested, e.g., solid, liquid, percent AI in technical, etc.
2. Statement of the inhalabiliry of test substance
3, The number of animaWsex/dose
4. Duration of inhalation exposure
5. Number of chamber air changes/hour and the percent oxygen content of chamber air
6, Ranges for chamber air temperature and relative humidity
7. Air flow rate
8. Analytical concentrations of test material in breathing zone
9, Results of aerosol particle-size determination
10. Doses tested (or limit dose of 5mg/L or highest attainable)
II. Individual observations on day of dosing
12. Individual observations on day of dosing and for at least 14 days or until all animals appear normal
(whichever is longer)
13. See items 11 and 12
14. Summarization of body weights
15, Summarization of gross necropsy
16. Significance of changes from Acceptance Criteria
C-89
-------
Subdivision F
Guideline Ref. No, 81-4
December 24, 1989
81-4 Primary Eye Irritation in the Rabbit
ACCEPTANCE CRITERIA
Does jooi study meet the following acceptance criteria?
1- _— Technical form of the active ingredient tested, (for reregistraiion only)
2. Study not required if material is eorrosivi, caui€s severe dermal irritation or has a pH of <.
2 or >. 11.5.
3,* 6 adult rabbits
4. Dosing, instillation into the conjunctival sac of one eye per animal.
5* Dose, 0.1 ml if a liquid; 0,1 ml or not more than 100 mg if a solid, paste or paniculate
substance.
6. Solid or granular test material ground to a fine dust.
7. Eyes not washed for at least 24 hours.
8. Eyes examined and graded tor 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 observations for the entire day of dosing.
.JO.* Individual daily observations.
Criteria marked with a * are supplemental and may not be required for every study.
C-90
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Subdivision F
Guideline Rcf, No. 814
December 24, 1989
81-4 Primal} Eye Irritation fa UK Rabbit
GUIDANCE FOR SUMMARIZING STUDIES
Items in summary should include UK items discussed in Chapter 2 of ibis package and the specific items
listed below.
I. The form of pesticide tested, e.g., solid, liquid, percent A! in technical, etc
2. State of material is corrosive, cause severe dermal irritation or has a pH of <2 or >11.5
3. Number of adult rabbits tested
4, State method of dosing, i.e., instillation into the conjunctiva! sac of one eye per animal
5, Dose administered
6. Note whether solid or granular test material has been ground to a fine dust
7, State whether eyes were washed and at what time post instillation (not less than 24 hours)
8. State whether eyes were examined and graded for irritation before dosing and at what periods after
doting
9. Individual observations for entire day of dosing
10. individual observations for entire day of dosing and individual daily observations afterwards, until
eyes are normal or for 21 days
11. Sipificance of changes from Acceptance Criteria
C-91
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Subdivision F
Guideline Ret No. 81-5
December 24, 1989
81-5 Primary Derma] Irritation Study
ACCEPTANCE CRITERIA
Does your stud; meet the following acceptance criteria?
I. Technical form of the active ingredient tested, (for reregistration only)
1 Study not required if material is corrosive or has a pH of <. 2 or >. 11.5.
3.* 6 adult animals.
4. Dosing, single dermal.
5. Dosing duration 4 hours.
6. Application site shaved or clipped at least 24 hour prior to dosing.
7. n Application site approximately 6 cnr.
8. Application site covered with a gauze pitch held in place with nonlrritatin| tape
9. Materiil 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).
41* f Individual observations for ihe entire day of dosing,
11* Individual daily observations.
Criteria marked with i * are supplemental and may not be required for every study.
C-92
-------
Subdivision F
Guideline Ref. No, 81-5
December 24, 1989
81-5 Primary Denoii Irritation Study
GUIDANCE FOR SUMMARIZING STUDIES
Items in summary should include the items discussed in Chapter 2 of this package and the specific items
listed below.
I, The form or pesticide tested, e.g., solid, liquid, percent AJ in technical, etc.
2. State if material is corrosive, has a pH <2 or >11.5, or has a dermal LD-50 <200 mg/kg
3. Number of adult animab tested
4. Amount applied
5. Duration of dermal exposure
6. Preparation of application site (shaved or clipped at specified time before dosing)
7. Area of application site
S. Method for occlusion of application site
9. Note removal of test material and if skin was washed with water
JO. State limes post application when site was graded for irritation
11. Individual observations for entire day of dosing,
12, Individual observations for entire day of dosing and individual daily observations thereafter
13. Significance of changes from Acceptance Criteria.
C-93
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Subdivision F
Guideline Ref. No. 81-6
December 24, 1989
81-6 Dermal Sensitizatioo in the Guinea Kg
ACCEPTANCE CRITERIA
Doe your study meet tbe following acceptance criteria?
1- _ Technical form of the active ingredient tested, (for reregistration only)
2. Study not required if material is corrosive or has a pH of <. 2 or >. 11.5.
3. One of the following methods is utilized;
Freund's complete adjuvant test
Guinea pig maximization test
Split adjuvant technique
Buehler test
Open epicutaneous test
Mauer optimization test
Footpad technique in guinea pig
Other test accepted by OECD (specify)
4. Complete description of test
5.*. Reference for test.
6 Test followed essentially as described in reference document,
7.* Positive control included.
Criteria marked with a * are supplemental and may not be required for every study.
C-94
-------
Subdivision F
Guideline Ref. No. 81-6
December 24, 1989
81-6 Dermal Seasituatjon in ibe Guinea Pig
GUIDANCE FOR SUMMARIZING STUDIES
Items in summary sbouW iodude UK items 4jgmeMt4 in Chapter 2 of this package aod the specific items
listed below.
I. The form of pesticide tested, e.|., solid, liquid, percent Al in technical, etc.
1 State if material is corrosive or has pH <2 or >11.5),
3. Slate specific method utilized
4. Complete description of specific method
5. Reference for the specific method employed
6. Note adherence of the protocol to that in the reference for the specific method utilized
1. Slate the positive control tested
8. Significance of changes from Acceptance Criteria
C-95
-------
ATTACHMENT G
LIST OF ALL REGISTRANT(S) SENT THIS DATA CALL-IN NOTICE
-------
List of All Registr?
nt This Data Call-In Notice
Case Nmtoer and Maine
0011
Usrfarin A its Na salt
Chemical Nmtoer and Name
086002 3-(alpfia-ftcetonrlbenzyL}-4-hydroxycoui»rfn
Company
Nuitoer Conpany None
Additional He
Address
City t State
Zip
000407 IMPERIAL INC
000584 JACK M, CLARK, INC.
000602 PURINA HILLS, INC.
000655 PRENTISS DRUG I CHEMICAL COMPANY IN
000690 PERK PRODUCTS AND CHEN1CAL CO., INC
000746 IMPERIAL INC.
000995 MACKUIN COMPANY
001304 FURST NCNESS COMPANY
002006 GOOD-VAY INSECTICIDE INC
002393 HACO, INC
002724 ZOECON CORPORATION
003282 D-CON COMPANY INC
003487 BACON PRODUCTS COMPANY INC
003536 P1PESTONE PRODUCTS CO. INC.
003941 ATHENA CORPORATION
004271 R & H EXTERN INC
005036 UlHOLER PEST CONTROL
005887 WILBUR-ELLIS COMPANY
006383 FERRET LABORATORIES INC.
006653 GOULDS DELL PROD
006720 SOUTHERN HILL CREEK PRODUCTS
007122 THE ARCHEN CORP.
007276 RHC PROD COMPANY
007455 AGRICULTURAL PRODUCTS DIVISION
007537 HOBBY'S RAT I MOUSE BAIT, INC.
000580 HILL1ARD PRODUCTS INC
008845 THE SPECTRUM GROUP DIVISION OF
006848 SAFEGUARD CHEMICAL CORP
009561 KELLEY'S PROFESSIONAL RODENT CONTRO
010370 FORD'S CHEMICAL AND SERVICE, INC.
010442 B1DDLE SAWYER CORPORATION
012455 PROVORNY, JACOBT t ROBINSON
017975 DEAN JERRT EXTERMINATING CO.
034274 BLUE RIBBON FEED HILL
045722 J.B. CODER CO.
056176 DE I GE PRODUCTS INC
AGENT FOR: UFA OIL CO.
D/B/A/ HOPKINS AGRICULTURAL CHEH1CA
A SAHDOZ COMPANY
INTERNATIONAL MULTIFOOOS
UNITED INDUSTRIES CORPORATION
AGENT FOR: BELL LABORATORIES, INC.
BOX 98
BOX 566
BOX 66812
21 VERHON ST._C.B. 2000
BOX 100585
BOX 98
25 NCCONNON DR.
120 E CLARK ST
BOX 276B
BOX 7190
12200 DENTOH DRIVE
225 SUMMIT AVENUE
BOX 22187
P.O. BOX 36
1919 LONE STAR DR.
S. 24212 »D» ST.
116 E 5TH ST
BOX 9518
120 STORCK STREET BOX 437
1318 COMMERCE PARK DR
5414 NORTH 56TH STREET
1514 ELEVENTH ST
BOX 848
MULT I FOODS TOUER BOX 2942
635 FOREST PARK DR.
1453 DIVISION HUT
BOX 15842
806 E. 144 ST.
RT. 3 BOX 86F
2739 PASADENA BLVD.
2 PENN PLAZA
1350 CONNECTICUT AVENUE, H.U., SUIT
307 E. 8TH ST
RT 2
10290 S.E. CINDY LANE
BOX 634
SHENANDOAH IA
HUSTONTOUN PA
ST LOUIS MO
FLORAL PARK NY
NASHVILLE, TK
SHENANDOAH IA
UINONA HN
FREEPORT IL
WHEELING IL
MADISON U]
DALLAS TX
NONTVALE NJ
CHATTANOOGA TN
TROSICY NN
DALLAS TX
CHENEY UA
FOULER IN
FRESNO CA
SLINGER Ul
WILLIAM SPORT PA
TAMPA FL
PORTSMOUTH OH
FT DODGE IA
MINNEAPOLIS MH
BERNE IN
NEU HOLLAND PA
ST LOUIS NO
BRONX NY
EOINBURG TK
PASADENA TX
NEU YORK NY
UASHINGTOH DC
SPENCER IA
CELINA OH
BORING OR
DEMISC* IA
51601
17229
63166
11001
37210
51601
55987
61032
60090
53707
75234
07645
37422
56177
75212
99004
47944
93792
53086
17701
33610
45662
50501
55402
46711
17557
63114
10454
78539
77502
10001
20036
51301
45822
97009
51442
-------
Case Nmtoer and Mamo
0011 uarfarin ft its Na salt
Hunker and Nane
086003 Itarftrin sodfun salt
Liit of All Regism it This Data Call-In Notie*
Company
Nuifcer Cnftany Nan* Additional Name Address City I State Zip
003282 D-IXM COMPANY INC Z2S SUMMIT AVENUE HCMTVALE NJ OW45
007276 RHC PROD COMPANY BOX 648 FT DODGE 1A 50501
0124S5 PROVORHY, JACOBV 1 ROfltMSON AGENT fQR: BELL LAB08ATOA1ES, INC. 1350 CONNECTICUT AVENUE, N.W.. SUIT UASHIHGTOH DC 20056
-------
ATTACHMENT H
COST SHARE AND DATA COMPENSATION FORM FORMS
(FOR GENERIC AND PRODUCT SPECIFIC DATA)
AND
PRODUCT SPECIFIC DATA REPORT FORM
-------
&EPA
United States Environmtntal Protection Afltney
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
Form Approvtd
CHI Ne. 1070-0106
Appraval Itplrtt 12.31*2
reporting burden for this collection of information is estimated to average 1S minutes per response, including
time for reviewing instructions, searching existing date sources, gathering and maintaining the data needed, ana
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, Including suggestions for reducing this burden, to Chief, Information Policy
iruieri, PM-223, U.S. Environmental Protection Agency, 401 M St.. S.W., Washington. DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070*0106), Washington, DC 20503.
Please fill In blanks below.
Company Ntm*
Produce Nam«
EPA Reg. No.
I Certify that:
I. For each study tiled in support of registration or re registration under the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA} that is an exclusive use study, I am the original data submitter, or t have obtained the
written permission of the original data submitter to cite that study.
That for each study efted in support of registration or ^registration under FIFRA that is NOT an exclusive use
study, I am the original data submitter, or I have obtained the written permission of the original data submitter, or I
have notified in writing the company(ies} that submitted data I have cited and have offered to: (a) Pay
compinsalten tor those data !n accordance with sections 3{c)(i)(D) and 3(c)(2)(D} of FiFRA; and (b) Commence
negotiation lo determine which dita art subject to the compensation requirement of FIFRA and the amount of
compensation due, I any, The companies I have notified are;
f I The companies who have submitted tht studies lisied on the back of (his form or attached
sheets, or indicated on the attached 'Requirements Status and Registrants' Response Form,"
3. That I have previously complied with section 3(c}(i)(D) of FIFRA for the studies I have eMed in support of
registration or ^registration under FIFRA.
Signature
Dm
Name ml flllt (Pleiie Type or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to thf
registration or reregisiralton of my products, to tht extent required by FIFRA sections 3(C)(1)(D) and 3(c)(2)(D).
•tur*
DtU
Name and TTlti (Pt»n« Typi or Print)
EPA Fn.m »«•»«-«« '• —«
-------
r/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OH1 No. 3070-0106
Eipir*» 13.31-12
PubOc reporting burden for this collection of information is estimated to average 15 minutes per response, including
lime 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 arty other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-01 OS}, Washington, DC 20503.
Please flfl In blanks below.
Cwnpinjr HUM
Product Name
EPA R*g. No.
Certify that:
Ay company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop Jointly or share In the cost of developing
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3{c)(2}(B)(iii) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
turn* si Flm(i)
Date of Offer
Certification:
(cerufy that I am duly authorized to represent me company named above, and that the statements that I have made on
iha form and all attachments therein are lorn, accurate, and complete. I acknowledge that any knowingly false or
-lisfeading statement may be punishable by fine or imprisonment or both under applicable law.
el Comptny'* Authorized Rtpro«nt«llv«
Dtl*
Nun* »nd TTtI§
Typ* »r Print)
-------
jyEPA
Unitad States Environmental Proteettert A§»ncy
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
Form Approved
O1IB No. 2070.0108
Approvit Ezplr** 12-3t>S2
Public reporting burden for this collection o( information is estimated to average 15 minutes per response, including
timi for reviewing instructions, starching 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 ol information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 4Q1 M St., S.W., Washington, DC 104§0; and to the OBlct
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please nil In blinks below.
Company Mama
Chtmlcil Nan*
Company Number
EPA Ch*mlc»l Nutnbw
i Certify that;
i. For each study cited in support of registration or re registration under the Federal Insecticide, Fungicide and
Rodenticide Act (FiFflA) that is an exclusive use study, t am the original data submitter, or I have obtained the
written permission of the original data submitter to cite that study.
!, That for each study cited in support of registration or rtregistration under FiFRA that !$ NOT an exclusive use
*tudy, i am the original data submitter, or i have obtained the written permission of the original data submitter, or i
• notified in writing the companies) that submitted data I have cited and havt offered to: (a) Pay
pensation for those data in accordance with sections 3{c)(i)(D) and 3{c)(2)(D) of RFflA; and (b) Commence
negotiation to determine which data are subject to the compensation requirement of FIFRA and the amount of
compensation due, 1 any. The companies I have notified are: (check one)
11 Ail companies on (hi data subrniners" fist for the active Ingrtdient listed on this form (Crta-AJI
Method or Cite-All Option under the Selective Method). (Also sign the General Offer to Pay
below.)
[ I The companies who havt submitted the studies itsted on the back of {his form or attached
sheets, or indicated on the attached "Requirements Status and Registrants' Response Form,"
. That I hav* previously compfTed with section 3{c)(1 )(0} of FIFRA for the studies! have cited in support of
registration or ^registration under FIFRA.
Signature
Dal*
«
-------
f/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
QMS Na, 2070-Oioa
Apprsvil Ixplrcs 12.31-12
Public reporting burden for this collection of information is estimated to average 15 minutts per response, Including
time tor reviewing totiuctions, searching existing data sources, gathering and maintaining the data needed, and
compftitng and reviewing the eoileetton of information. Send comments regarding the buiden estimate or any other
aspect of this collection of information, including suggestions for reducing this Burden, to Chief, Information Policy
Branch, PM-223, U.S. Environmental Protection Agency. 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Plaasa Nil In blanks below.
Corapcny Nim*
Comptny Number
Cfitmful Nin«
EPA Chemical Number
I Certify that:
My company is willing to develop and submit trie data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodentteide Act (FIFflA), If necessary. Howevir, my oompiny woytd priftr to
anjer Into an agreement with one or more rigisirints to develop Jointly or snare in the cost of developing
/
My firm has offered in writing to enter into such an agreement. That offer wi$ Irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if Una! agreement on a!)
terms could not be reached otherwise. This offer was made to tne following firm(s) on the following
date(s):
Nam* p|
0»t« of OfTtr
unification:
certify that I am duly authorized to represent the company named above, and Unit the statements that I have made on
m form and all attachments therein are true, accurate, and complete. 1 acknowledge that any knowingly false or
lisieading statement may be punishable by fine or imprisonment or both under applicable law.
tlgnitur* of Compenf'i Authorised R*prti«nt«ltv*
Dat*
.'; d Till* (Ptti«t Typ* or Print)
A Form H700J (4-»0)
------- |