United States Prevention, Pesticides EPA738-R-96-022
Environmental Protection And Toxic Substances June 1996
Agency (7508W)
&EPA Reregistration
Eligibility Decision (RED)
Mitin FF
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, B.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case Mitin FF which
includes the active ingredient Sodium 5-chloro-2-(4-chloro-2- [(3,4-dichlorophenyl)ureido]
phenoxy) benzenesulfonate. The enclosed Reregistration Eligibility Decision (RED) contains
the Agency's evaluation of the data base for this chemical, its conclusions of the potential
human health and environmental risks of the current product uses, and its decisions and
conditions under which these uses and products will be eligible for reregistration. The RED
includes the data and labeling requirements for products for reregistration. It may also include
requirements for additional data (generic) on the active ingredient to confirm the risk
assessments.
To assist you with a proper response, read the enclosed document entitled "Summary
of Instructions for Responding to the RED." This summary also refers to other enclosed
documents which include further instructions. You must follow all instructions and submit
complete and timely responses. The first set of required responses is due 90 days from the
receipt of this letter. The second set of required responses is due 8 months from the
receipt of this letter. Complete and timely responses will avoid the Agency taking the
enforcement action of suspension against your products.
Please note that this RED was finalized and signed prior to August 3, 1996. On that
date, the Food Quality Protection Act of 1996 ("FQPA") became effective, amending portions
of both the pesticide law (FIFRA) and the food and drug law (FFDCA). This RED does not
address any issues raised by FQPA, and any tolerance-related statements in the RED did not
take into account any changes in tolerance assessment procedures required under FQPA. To
the extent that this RED indicates that a change in any tolerance is necessary, that
determination will be reassessed by the Agency under the standards set forth in FQPA before
a proposed tolerance is issued. To the extent that the RED does not indicate that a change in
the tolerance is necessary, that tolerance, too, will be reassessed in the future pursuant to the
requirements of FQPA.
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If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregistration Division representative
Veronica Dutch (703) 308-8585.
Sincerely yours,
Lois Rossi, Division Director
Special Review
and Reregistration Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1. DATA CALL-IN (PCI) OR "90-DAY RESPONSE" If generic data are required for
reregistration, a DCI letter will be enclosed describing such data. If product specific data
are required, a DCI letter will be enclosed listing such requirements. If both generic and
product specific data are required, a combined Generic and Product Specific DCI letter will
be enclosed describing such data. However, if you are an end-use product registrant only and
have been granted a generic data exemption (GDE) by EPA, you are being sent only the
product specific response forms (2 forms) with the RED. Registrants responsible for generic
data are being sent response forms for both generic and product specific data requirements (4
forms). You must submit the appropriate response forms (following the instructions
provided) within 90 days of the receipt of this RED/DCI letter; otherwise, your product
may be suspended.
2. TIME EXTENSIONS AND DATA WAIVER REQUESTS No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for time extensions for product specific data
should be submitted in the 90-day response. Requests for data waivers must be submitted as
part of the 90-day response. All data waiver and time extension requests must be accompanied
by a full justification. All waivers and time extensions must be granted by EPA in order to go
into effect.
3. APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE" You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregistration) separately. You may, but are not
required to, delete uses which the RED says are ineligible for reregistration. For further
labeling guidance, refer to the labeling section of the EPA publication "General Information
on Applying for Registration in the U.S., Second Edition, August 1992" (available from the
National Technical Information Service, publication #PB92-221811; telephone number 703-
487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that they meet
the Agency's acceptance criteria (attached to the DCI).
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d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard certified
limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by the analysis
of five batches. If you choose the second option, you must submit or cite the data for the five
batches along with a certification statement as described in 40 CFR §158.175(e). A copy of
the CSF is enclosed; follow the instructions on its back.
e. Certification With Respect to Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product.
4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5. WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS—EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.
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REREGISTRATION ELIGIBILITY DECISION
Mitin FF
LISTC
CASE 3097
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
REREGISTRATION ELIGIBILITY DECISION TEAM FOR MITIN FE
EXECUTIVE SUMMARY
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Data Requirements 3
D. Regulatory History 3
III. SCIENCE ASSESSMENT 3
A. Physical Chemistry Assessment 4
B. Human Health Assessment 4
1. Toxicology Assessment 4
a. Acute Toxicity 4
b. Subchronic Toxicity 5
c. Chronic Toxicity/Carcinogenicity 5
d. Developmental Toxicity 6
e. Mutagenicity 6
f. Metabolism 6
g. Other Toxic Endpoints(Less Than Lifetime) 6
h. Reference Dose 7
2. Exposure Assessment 7
a. Occupational and Residential 7
3. Risk Assessment 9
a. Occupational and Residential 9
C. Environmental Assessment 9
1. Ecological Toxicity Data 9
a. Toxicity to Terrestrial Animals 9
b. Toxicity to Aquatic Animals 10
2. Environmental Fate 11
3. Exposure and Risk Characterization 11
a. Exposure and Risk to Nontarget Organisms 11
b. Endangered Species 12
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 12
A. Determination of Eligibility 12
B. Determination of Eligibility Decision 13
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1. Eligibility Decision 13
2. Eligible and Ineligible Uses 14
C. Labeling Rationale/Risk Mitigation Measures 14
V. ACTIONS REQUIRED OF REGISTRANTS 14
A. Manufacturing-Use Products 14
1. Additional Generic Data Requirements 14
2. Labeling Requirements for Manufacturing-Use Products 14
B. End-Use Products 15
1. Additional Product-Specific Data Requirements 15
2. Labeling Requirements for End-Use Products 16
C. Existing Stocks 17
VI. APPENDICES 19
APPENDIX A. Table of Use Patterns Subject to Reregistration 21
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 23
APPENDIX C. Citations Considered to be Part of the Data Base Supporting
the Reregistration of Mitin FF 27
APPENDIX D. Product Specific Data Call-In 33
Attachment 1. Chemical Status Sheets 45
Attachment 2. Product Specific Data Call-In Response Forms (Form
A inserts) Plus Instructions 46
Attachment 3. Product Specific Requirement Status and Registrant's
Response Forms (Form B inserts) and Instructions 49
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 57
Attachment 5. List of All Registrants Sent This Data Call-In (insert)
Notice 58
Attachment 6. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 60
APPENDIX E. List of Available Related Documents 67
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REREGISTRATION ELIGIBILITY DECISION TEAM FOR MITIN FF
Office of Pesticide Programs:
Environmental Fate and Effects Risk Assessment
William Rabert
Jose Melendez
David Farrar
Health Effects Risk Assessment
Winston Dang
Sanjivani Diwan
Registration Support
Marianne Clark
Biological and Economic Assessment
Gabe Patrick
John Faulkner
John Dupuy
Risk Management
Rieman P. Rhinehart
Bruce Sidwell
Office of Compliance Monitoring
Rick Colbert
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Science Analysis and Coordination Staff
Occupational and Residential Exposure Branch
Toxicology Branch II
Antimicrobial Program Branch
Biological Analysis Branch
Economic Analysis Branch
Economic Analysis Branch
Accelerated Reregi strati on Branch
Accelerated Reregi strati on Branch
Pesticide Enforcement Policy Branch
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11
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. A now defunct term for reference dose (RfD).
AE Acid Equivalent
a.i. Active Ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
CSF Confidential Statement of Formula
DFR Dislodgeable Foliar Residue
ORES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e.
drinking water) lifetime exposure at which adverse, non carcinogenic health effects are not
anticipated to occur.
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an
environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FOB Functional Observation Battery
GLC Gas Liquid Chromatography
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory (HA). The HA values are used as informal guidance to municipalities and
other organizations when emergency spills or contamination situations occur.
HOT Highest Dose Tested
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be
expected to cause death in 50% of test animals. It is usually expressed as the weight of
substance per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in
50% of the test animals when administered by the route indicated (oral, dermal, inhalation). It
is expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
LDlo Lethal Dose-low. Lowest Dose at which lethality occurs.
LEL Lowest Effect Level
LOG Level of Concern
LOD Limit of Detection
LOEL Lowest Observed Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
Hg/g Micrograms Per Gram
mg/L Milligrams Per Liter
MOE Margin of Exposure
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of recording and tracking studies
submitted.
N/A Not Applicable
NOEC No effect concentration
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GLOSSARY OF TERMS AND ABBREVIATIONS
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
OP Organophosphate
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice
Q*! The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
SLN Special Local Need (Registrations Under Section 24 (c) of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
FAO/WHO Food and Agriculture Organization/World Health Organization
WP Wettable Powder
WPS Worker Protection Standard
IV
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EXECUTIVE SUMMARY
This Reregi strati on Eligibility Decision (RED) addresses the eligibility for
reregi strati on of the pesticide product containing the active ingredient Mitin FF (sodium 5-
chloro-2-(4-chloro-2-[(3,4-dichlorophenyl) ureido] phenoxy) benzenesulfonate). Mitin FF is
used to moth-proof wool. It is used in the textile industry as an 80 percent formulation of the
active ingredient applied to wool during the dyeing/manufacturing process. Only one product
containing Mitin FF as the sole active ingredient is currently registered.
The Agency has completed its review of the target database for Mitin FF and has
determined that the use of Mitin FF as labeled and specified in the RED will not cause
unreasonable risk to humans or to the environment and its one use is eligible for
reregi strati on.
The Agency has identified no human toxicological endpoints of regulatory concern for
Mitin FF. While the hazard to nontarget organisms from Mitin FF has been characterized, a
risk assessment has not been conducted. The risk to aquatic-environments from Mitin FF is
regulated under the NPDES permitting program of the Agency's Office of Water. No
additional data are required by the Agency to confirm its conclusions. Supporting data
demonstrates this chemical has low to moderate acute mammalian toxicity, and does not
cause significant subchronic, mutagenic, or developmental effects. Environmental data shows
Mitin FF has low to moderate acute toxicity to wildlife species. Mitin FF was found to be
stable to hydrolysis.
Before reregistering the product containing Mitin FF, the Agency is requiring that
product specific data, revised Confidential Statement of Formula (CSF) and revised labeling
be submitted within eight months of the issuance of this document. These data include
product chemistry and acute toxicity testing. After reviewing these data and any revised labels
and finding them acceptable in accordance with Section 3(c)(5) of FIFRA, the Agency will
reregister the product.
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended to accelerate the reregi strati on of products with active ingredients registered prior to
November 1, 1984. The amended Act provides a schedule for the reregi strati on process to be
completed in nine years. There are five phases to the reregi strati on process. The first four
phases of the process focus on identification of data requirements to support the reregi strati on
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 reregi strati on.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine
whether pesticides containing such active ingredient are eligible for reregi strati on" before
calling in data on products and either reregistering products or taking "other appropriate
regulatory action." Thus, reregi strati on involves a thorough review of the scientific data base
underlying a pesticide's registration. The purpose of the Agency's review is to reassess the
potential hazards arising from the currently registered uses of the pesticide; to determine the
need for additional data on health and environmental effects; and to determine whether the
pesticide meets the "no unreasonable adverse effects" criterion of FIFRA.
This document presents the Agency's decision regarding the reregi strati on eligibility of
the registered uses of Mitin FF. The document consists of six sections. Section I is the
introduction. Section II describes Mitin FF, its uses, data requirements and regulatory history.
Section III discusses the human health and environmental assessment based on the data
available to the Agency. Section IV presents the reregi strati on decision for Mitin FF. Section
V discusses the reregi strati on requirements for Mitin FF. Finally, Section VI is the
Appendices which support this Reregi strati on Eligibility Decision. Additional details
concerning the Agency's review of applicable data are available on request.
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II. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregi strati on Eligibility
Decision:
• Common Name: Mitin FF
• Chemical Name: Sodium 5-chloro-2-(4-chloro-2- [(3,4-dichlorophenyl)
ureido] phenoxy) benzenesulfonate
• CAS Registry Number: 3567-25-7
• OPP Chemical Code: 58802
• Structural formula:
HH-CO-HH-
tl
• Trade and Other Names: Mitin FF
• Basic Manufacturer: Ciba-Geigy Corporation
B. Use Profile
The following is information on the currently registered use with an overview
of use sites and application methods. A detailed table of this use of Mitin FF is in
Appendix A.
Mitin FF is used to moth-proof wool. It is supplied to the textile industry as an
80 percent active ingredient formulated fine powder. It is mixed into an aqueous
solution by dissolving the powder in boiling water, and applied to wool during the
dyeing/manufacturing process.
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Type of Pesticide: Moth-proofing of wool
Use Sites: Textile Manufacture
Target Pests: Moth larvae
Formulation
Types Registered: Wettable powder
Method and Rates of Application:
Equipment Added to dyebath for textile to be treated
Method and Rate Use 1 to 1.5% Mitin FF (80%) calculated on the
dry weight of the wool to be treated. Dissolve
Mitin FF separately in the proportion of one
pound Mitin (80%) to 5 gallons of water.
C. Data Requirements
The Agency required data to support reregi strati on through a Data Call-In
(10/27/92) for Mitin FF during Phase IV of reregi strati on. Requirements included
studies on ecological effects, product chemistry, environmental fate, and toxicology.
These data were required to assess the potential risk from use identified on the current
label. Appendix B includes all data requirements, identified by the Agency for
currently registered uses, needed to support reregi strati on.
D. Regulatory History
The first and only pesticide product containing Mitin FF as an active ingredient
was registered in 1948. Currently, there is one registered manufacturing-use/ end-use
product. In 1992 the Agency issued a Data Call-in requiring the registrant to provide
appropriate data described above for this active ingredient to support reregi strati on.
III. SCIENCE ASSESSMENT
Below is a summary of physical and chemical properties of Mitin FF. The specific
studies reviewed for guidelines 61-1 through 63-13 are referenced in Appendix B.
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A. Physical Chemistry Assessment
Color: White
Physical State Powder
Melting Point 208°C -decomposes during melting.
Density 1690 kg/cubic meter
Solubility 2% in water at 100°C
Vapor Pressure 1.9 X 10"9 Pascal
Octanol/Water
Partition Coefficient 78.51 +/- 10.6
pH 7.46
Stability Decomposes during melting
B. Human Health Assessment
1. Toxicology Assessment
The toxicology data base for Mitin FF is adequate for reregi strati on
eligibility. Toxicology studies indicate that Mitin FF (80%) has moderate
(oral) to low acute toxicity and that there are no toxicological characteristics
associated with this active ingredient that lead to significant concerns.
a. Acute Toxicity
Table 1 MAMMALIAN ACUTE TOXICITY
TEST
Oral LD50-- rats
Dermal LD50--rats
Inhalation LC50--rats
Eye irritation—rabbits*
Dermal irritation—rabbits*
Dermal sensitization— puinea nips
RESULTS
849 mg/kg (tf); 476 mg/kg (¥); 645 mg/kg (tf & ¥)
> 2000 mg/kg (tf & ¥)
>4.82mg/L
Slight to moderate, transient ocular irritation clearing in 14 days.
non-irritating
non-sensiti?er
CATEGORY
II
III
IV
III
IV
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* This study is a requirement for manufacturing-use and end-use products (40 CFR 158). The Mitin FF data have been
generated for the TGAI and are presented here for informational purposes.
All acute toxicity studies performed with Mitin FF (a.i. 80%) are
acceptable and fulfill the guideline requirements. The clinical signs of
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toxicity most commonly seen in these studies were sedation, ruffled fur,
hunched posture and uncoordinated movements. The estimated acute
oral LD50 for Mitin FF in both sexes of rats was 645 mg/kg (LD50 for
males = 849 mg/kg; LD50 for females = 476 mg/kg), placing Mitin FF in
toxicity category II (guideline 81-1; MRID 42249401). In an acute
dermal toxicity study, the LD50 for Mitin FF was > 2000 mg/kg b.w. for
both sexes, placing Mitin FF in toxicity category III (guideline 81-2;
MRID 42249402). The 4-hour inhalation LC50 in both sexes of rats was
4.82 mg/L, placing Mitin FF in toxicity category III (guideline 81-3;
MRID 42249403).
In a primary eye irritation study in rabbits, Mitin FF produced
slight to moderate, transient ocular irritation. This cleared in 14 days
(guideline 81-4; MRID 42249404). Mitin FF, in a primary dermal
irritation study with Chbblbm: NZW (SPF) rabbits, produced no skin
irritation. Therefore, it was placed in category IV (guideline 81-5;
MRID 42249405). In a dermal sensitization study, Mitin FF was tested
with female guinea pigs and it was found to be a non-sensitizer
(guideline 81-6; MRID 42249406).
b. Subchronic Toxicity
In a 90-day dermal toxicity study, Mitin FF was administered in
doses of 0, 10, 100, or 1000 mg/kg/day to Wistar/HAN rats. The
systemic toxicity LOEL in both sexes was >1000 mg/kg/day because
the observed effects (marginal increase in body weight gain, and
elevated total plasma bilirubin levels) were not biologically significant.
The NOEL for systemic toxicity was > 1000 mg/kg/day. The dermal
toxicity LOEL was 1000 mg/kg/day based on increased incidence of
general, patchy, and focal erythema, scaling and necrosis of the skin in
both sexes. The NOEL for dermal toxicity was 100 mg/kg/day. The
study (guideline 82-3; MRID 41595001) was acceptable as Core-
minimum data.
c. Chronic Toxicity/Carcinogenicity
As this is a non-food use chemical, chronic toxicity and
carcinogenicity studies are only triggered if the subchronic studies
indicate NOELs of concern, and/or exposure is determined to be chronic
in nature. Thus the Agency has not required these studies for Mitin FF.
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d. Developmental Toxicity
In a developmental toxicity study, Mitin FF Technical was
administered at doses 0, 5, 20, or 80 mg/kg by gavage to Wistar/HAN
rats on gestation days 6 through 15, inclusive. The maternal toxicity
NOEL is greater than or equal to 80mg/kg/day and the study was
classified as unacceptable and non-upgradable because of failure to
achieve significant maternal toxicity at 80 mg/kg/day. The
developmental toxicity NOEL was >80 mg/kg/day and the LOEL was
>80 mg/kg/day (guideline 83-3a; MRID 41157501).
In a developmental toxicity study in Russian Chbb.HM rabbits,
Mitin FF was administered by gavage during gestation days 7-19
(inclusive) at dose levels of 0, 2, 6, 18, or 36 mg/kg/day. The maternal
toxicity LOEL was 36 mg/kg/day (HDT) based on increased incidence
of mortality (9 of 18 does) and clinical signs of toxicity. The maternal
NOEL was 18 mg/kg/day. No developmental toxicity was noted at the
dose levels tested. Therefore, the developmental LOEL was >36
mg/kg/day. The developmental NOEL was >36 mg/kg/day. The study
(guideline 83-3b; MRID 43465101) was acceptable as Core-minimum
data.
e. Mutagenicity
All three mutagenicity assays were negative. In a reverse gene
mutation assay using strains of Salmonella typhimurium (TA1535,
TA1537, TA1538, TA98, and TA100) Mitin FF was negative up to
cytotoxic levels (guideline 84-2a; MRID 41050901). In mouse
micronucleus test (guideline 84-4; MRID 41027801) and rat hepatocyte
UDS assay (guideline 84-4; MRID 41027802), no chromosomal
aberrations or DNA damage were detected up to cytotoxic levels. These
studies are acceptable and fulfill guidelines 84-2a and 84-4.
f. Metabolism
A metabolism study is not required to support non-food uses of
Mitin FF because of the expected absence of oral exposure.
g. Other Toxic Endpoints(Less Than Lifetime)
The Office of Pesticide Programs (OPP) Less Than Lifetime
Committee concluded (11/7/95) that since Mitin FF is a non-food
chemical an acute dietary risk assessment was not required.
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No quantitative risk assessment is needed for short-term (1 to 7
days), intermediate-term (1 week to several months), or chronic (several
months to lifetime) occupational or residential exposure for the
following reasons:
1) No systemic toxicity was observed in a 90-day dermal toxicity
study in rats at the highest dose tested (1000 mg/kg/day).
2) No developmental effects were observed in a rat developmental
study at the highest dose tested (80 mg/kg/day) or in a rabbit
developmental study at the highest dose tested (36 mg/kg/day).
The rat developmental study was classified as unacceptable due
to the failure to achieve maternal toxicity at 80 mg/kg/day;
however, the rabbit study was deemed acceptable (maternal
toxicity LOEL = 36 mg/kg/day).
These studies, considered together, indicate that dermal
absorption and, thus, systemic exposure to Mitin FF is minimal.
h. Reference Dose
The OPP RfD/QA Peer Review Committee recommended
(10/19/95) not to establish a reference dose because of the non-food use
patterns and exposure profile for this chemical. At this time the Joint
FAO/WHO meeting on Pesticide Residues has not considered Mitin FF.
2. Exposure Assessment
a. Occupational and Residential
An occupational and/or residential exposure assessment is
required for an active ingredient if (1) certain toxicological criteria are
triggered and (2) there is potential exposure to handlers (mixers,
loaders, applicators, etc.) during use or to persons entering treated sites
after application is complete (i.e, factory workers exposed to Mitin FF
residue after treatment of wool and the public exposed to residue on
treated textile).
Occupational-use products and homeowner-use products
At this time no products containing Mitin FF are intended for
homeowner use. All products containing Mitin FF are intended for
occupational use.
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Handler Exposures
EPA has determined that there is a potential exposure to handlers
during usual use-patterns associated with Mitin FF. There are potential
exposures to mixers/loaders preparing aqueous solutions of Mitin FF
and to applicators treating textiles with the prepared solution, and
processing the treated textiles.
Based on the use pattern and potential exposures described
above, The Agency has identified four major exposure scenarios for
Mitin FF related to this application: (1) weighing the formulation; (2)
mixing/loading the concentrated formulation into dyeing vats; (3)
applying the formulation to textiles; and (4) processing the treated
textiles.
One chemical-specific handler exposure study has been
submitted to EPA in support of the Mitin FF reregi strati on (MRID
43498001, K.A. Hosteller). Estimation of Potential Consumer and
Worker Exposure to Mitin FF (Revised). This study estimated potential
consumer exposure (dermal) and occupational exposure (inhalation
only) to Mitin FF. The study indicated that there is not significant
inhalation or dermal exposure. Inhalation exposure to handlers of Mitin
FF is unlikely due to the low vapor pressure (1.4 X 10"8 mm Hg or 1.9 X
10-9KPa).
Post-Application Exposure
EPA has determined that there are potential post-application
exposures. Workers handle the treated textiles and the general public
come in contact with woolen products (e.g. clothes and carpets) made
from the treated textiles. Except for the above referenced study on
exposure, post-application exposure and residue dissipation data have
not been submitted to EPA in support of the Mitin FF reregi strati on and
are not required since there are no identified toxicological endpoints of
concern and the above cited consumer and worker exposure study
indicates low exposure.
-------
3.
Risk Assessment
a. Occupational and Residential
Risk From Handler Exposures
The Agency believes that the handler exposures associated with
the application of the Mitin FF product will not pose an adverse risk to
workers. There is no identified toxicological endpoint of concern and
the worker exposure (inhalation) is assumed to be low.
Risk From Post-Application Exposures
The Agency believes that the risks from post-application
exposures, as indicated in the above cited study, will not be adverse to
the workers and the general public. Again, there is no identified
toxicological endpoint of concern (for dermal exposure) and exposures
are assumed to be low.
C.
Environmental Assessment
Table 2
1. Ecological Toxicity Data
The Agency requires only a limited set of ecotoxicology and
environmental fate studies for industrial biocides. The data requirements for
Mitin FF are fulfilled by studies submitted to the Agency. Based on review of
these studies, Mitin FF is slightly toxic to birds, moderately to slightly toxic to
mammals, and moderately toxic to fish and aquatic invertebrates.
a. Toxicity to Terrestrial Animals
An acute oral toxicity study using the technical grade of the
active ingredient is required to establish the toxicity of a pesticide to
birds. The preferred test species is either mallard duck or bobwhite
quail. Results of this testing are tabulated below.
Avian Acute Oral Toxicity Findings
Surrogate Species
Northern Bobwhite
Colinus virginianus
(male and female)
Mallard Duck
Anas platyrhynchos
(male and female)
% AI
84%
84%
LD50 ing/kg ai
(95% CL)
801
(682 - 942)
1,806
not applicable
Toxicity
Category
slightly toxic
slightly toxic
MRID No.
Author/Year
43273201
Helsten & Solatycki 1994
43273202
Helsten & Denk 1994
Study
Classification*
Core
Core
* Core=Acceptable (Study satisfies guidelines/Concur); S=Supplemental (Study provided useful information, but Guideline was not satisfied);
N=Unacceptable (Study was rejected)/Nonconcur
-------
Table 3
The results for these formulations (84 % active ingredient)
suggest that technical grade Mitin FF is slightly toxic to avian species
on an acute oral basis. The guideline requirement (71-1) is fulfilled
(MRID 43273201, 43273202).
One subacute dietary study using the technical grade of the
active ingredient is required to establish the toxicity of a pesticide to
birds. The preferred test species are mallard duck (a waterfowl) or
bobwhite quail (an upland gamebird). Results of this testing are
tabulated below.
Avian Subacute Dietary Findings
Surrogate Species
Northern Bobwhite
Colinus virginianus
% AI
84%
LC50 ppin ai
(95% CL)
4,200
2, 100 -infinity
Toxicity
Category
slightly toxic
MRID No.
Author/Year
43273203
Helsten & Denk 1994
Study
Classification
Core
The results for these formulations (84 % a.i.) suggest that
technical grade Mitin FF is slightly toxic to avian species on a subacute
basis. The guideline requirement (71-2) is fulfilled. (MRID 43273203).
b. Toxicity to Aquatic Animals
(1) Acute Toxicity to Freshwater Fish
One freshwater fish toxicity study using the technical
grade of the active ingredient is required to establish the toxicity
of a pesticide to fish. The preferred test species is rainbow trout
(a coldwater fish) or bluegill sunfish (a warmwater fish). Results
of these tests are tabulated below.
Table 4 Freshwater Fish 96-Hour LC50 Toxicity Findings
Surrogate Species
Bluegill Sunfish
Lepomis macrochirus
(static, measured)
Fathead Minnow
Pimephales promelas
(static, measured)
Rainbow Trout
Oncorhyncus mykiss
(static, measured)
% AI
83.4 %
83.4 %
80 %
LC50 ppin ai
(95% CL)
4.8
(2.4-9.6)
6.1
(4.5 - 8.2)
6.8
(5.3- 10.1)
Toxicity
Category
moderately
toxic
moderately
toxic
moderately
toxic
MRID No.
Author/Year
40098001
Mayer & Ellersieck 1986
40098001
Mayer & Ellersieck 1986
42720101
Grade, R. 1993
Study
Classification
Core
Core
Core
These results suggest that technical grade Mitin FF is
moderately toxic to coldwater and warmwater fish species in
10
-------
Table 5
formulations of 80% to 84% ai. The guideline requirement (72-
1) is fulfilled (MRID 40098001, 42720101).
(2) Acute Toxicity to Freshwater Invertebrates
A freshwater aquatic invertebrate toxicity test using the
technical grade of the active ingredient is required to establish
the toxicity of a pesticide to invertebrates. The preferred test
species is Daphnia magna. Results of this test are tabulated
below.
Freshwater Invertebrate EC50/LC50 Toxicity Findings
Surrogate Species
Waterflea
Daphnia magna
(static, nominal)
% AI
84 %
LC50 ppm ai
(95% CL)
9.46
(7.89-11.34)
Toxicity
Category
moderately
toxic
MRID No.
Author/Year
42270102
Ellgehausen & Wuethrich 1987
Study
Classification
Core
2.
These results suggest that technical grade Mitin FF is
moderately toxic to freshwater aquatic invertebrates for the
formulation tested. The guideline requirement (72-2) is fulfilled.
(MRID 42270102).
Environmental Fate
The only data requirement that applies to this chemical is hydrolysis,
guideline (161-1). A hydrolysis study has been received and found to be
acceptable.
The submitted study indicates that Mitin FF is stable to hydrolysis under
the conditions of the study: [14C] Mitin FF was stable in pH 5, 7, and 9
buffered solutions when incubated in the dark at 25.0-25.1°C. Mitin FF was
97.2-97.8% of applied at all pHs immediately following treatment and 97.3-
97.4% after 31 days. Two minor components were detected in all three
solutions, accounting for not more than 2.4% of the chemical applied. These
were not identified. Recoveries were acceptable at all test intervals. There was
measurable 14CO2 after 31 days of incubation, accounting for not more than
2.16% of the applied (MRID 43503301).
3.
Exposure and Risk Characterization
Exposure and Risk to Nontarget Organisms
a.
The Agency requires only a limited set of ecotoxicology and
environmental fate studies for industrial biocides. Mitin FF is slightly
11
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toxic to birds, moderately to slightly toxic to mammals, and moderately
toxic to fish and aquatic invertebrates and, it can be stable to hydrolysis
While the hazard to nontarget organisms from Mitin FF has been
characterized, a risk assessment has not been conducted. The risks to
aquatic environments from industrial effluent from this use are regulated
under the NPDES permitting program of the Agency's Office of Water.
All labels for Mitin FF must require that discharges to aquatic
environments comply with an NPDES permit.
b. Endangered Species
The Agency does not anticipate any exposure of concern to
endangered species offish and wildlife, providing that the Mitin FF
product is handled and applied as specified in the product labeling and
that discharges to the environment comply with Federal disposal laws
and NPDES permits.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after
submission of relevant data concerning an active ingredient, whether products
containing the active ingredient are eligible for reregi strati on. The Agency has
previously identified and required the submission of the generic (i.e. active ingredient
specific) data required to support reregi strati on of the product containing Mitin FF as
an active ingredient. The Agency has completed its review of these generic data and
has determined that the data are sufficient to support reregi strati on of the product.
Appendix B identifies the generic data requirements that the Agency reviewed as part
of its determination of reregi strati on eligibility of Mitin FF and lists the submitted
studies that the Agency found acceptable.
The data identified in Appendix B were sufficient to allow the Agency to assess
the registered use of Mitin FF and to determine that Mitin FF can be used without
resulting in unreasonable adverse effects to humans and the environment. The Agency
therefore finds that the one product containing Mitin FF as the active ingredient is
eligible for reregi strati on. The reregi strati on of this product is addressed in Section V
of this document.
The Agency made its reregi strati on eligibility determination based upon the
target data base required for reregistration, the current guidelines for conducting
acceptable studies to generate such data, published scientific literature, etc. and the
data identified in Appendix B. Although the Agency has found that all uses of Mitin
12
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FF are eligible for reregi strati on, it should be understood that the Agency may take
appropriate regulatory action, and/or require the submission of additional data to
support the registration of products containing Mitin FF, if new information comes to
the Agency's attention or if the data requirements for registration (or the guidelines for
generating such data) change.
B. Determination of Eligibility Decision
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredient Mitin
FF, the Agency has sufficient information on the potential health effects of
Mitin FF and on its potential for causing adverse effects in fish and wildlife and
the environment. The Agency has determined that Mitin FF products, labeled
and used as specified in this Reregi strati on Eligibility Decision, will not pose
unreasonable risks or adverse effects to humans or the environment. Therefore,
the Agency concludes that the product containing Mitin FF for all uses is
eligible for reregi strati on.
More specifically the Agency bases its decision of eligibility on the
following conclusions about Mitin FF, which have been presented above
throughout the document.
• Mitin FF has use and therefore benefits in the protection of woolen
textile from insect damage.
• The toxicology database, although limited in its scope, suggests Mitin
FF has low mammalian toxicity. Technical Mitin FF has low acute and
subchronic toxicities from dermal and inhalation exposure;
developmental toxicology studies in two species were negative for
developmental effects; and, Mitin FF did not cause mutagenic effects in
a battery of studies.
• Exposures to workers and the general public are expected to be low
based on available although limited data. This coupled with the lack of
concern for toxicity leads the Agency to conclude that risks to humans
are negligible.
• Mitin FF's acute toxicity to wildlife species is low to moderate.
• Potential environmental exposures from the current use are limited to
those from industrial effluents. Any associated risks are controlled
through the NPDES permitting program.
13
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2. Eligible and Ineligible Uses
The Agency has determined that all uses of Mitin FF are eligible for
reregi strati on.
C. Labeling Rationale/Risk Mitigation Measures
Worker Protection
While the Agency has concluded the risk to applicators and other workers are
negligible it is prudent to require a continuation of current minimal label precautions to
afford product user protection from unnecessary exposure. These label requirements
are specified below in section V and must be retained and/or added since there may be
potential for application and post application exposure.
Personal Protective Equipment/Engineering Control for Handlers
Currently, there is no toxicological basis from Mitin FF per se, to impose
requirements of personal protective equipment (PPE) or engineering controls for
applicators and other workers. However, the acute toxicity of the current formulated
end-use product and future products may be such that the requirements and use of PPE
and/or engineering controls may be appropriate on a product-specific basis. This is
described further below in Section V.
V. ACTIONS REQUIRED OF REGISTRANTS
This section specifies the data requirements and responses necessary for the
reregi strati on of both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregi strati on of Mitin FF for the
above eligible use has been reviewed and determined to be complete. No
additional generic data is required at this time.
2. Labeling Requirements for Manufacturing-Use Products
To remain in compliance with FIFRA, manufacturing use product (MP)
labeling must be revised to comply with all current EPA regulations, PR
Notices and applicable policies. The MP labeling must bear the following
statement under Directions for Use:
14
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"Only for formulation into an Insecticide or the applicable term which
describes the type of pesticide use for the following use by MP
registrant."
An MP registrant may, at his/her discretion, add one of the following
statements to an MP label under
"Directions for Use" to permit the reformulation of the product
for a specific use or all additional uses supported by a formulator
or user group:
(a) "This product may be used to formulate products for specific
use(s) not listed on the MP label if the formulator, user group, or
grower has complied with U.S. EPA submission requirements
regarding support of such use(s)."
(b) "This product may be used to formulate products for any
additional use(s) not listed on the MP label if the formulator,
user group, or grower has complied with U.S. EPA submission
requirements regarding support of such use(s)."
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility
has been made. The product specific data requirements are listed in Appendix
G, the Product Specific Data Call-in Notice.
Registrants must review previous data submissions to ensure that they
meet current EPA acceptance criteria (Appendix F; Attachment E) and if not,
commit to conduct new studies. If a registrant believes that previously
submitted data meet current testing standards, then study MRID numbers
should be cited according to the instructions in the Requirement Status and
Registrants Response Form provided for each product.
15
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2. Labeling Requirements for End-Use Products
PPE/Engineering Control Requirements
EPA is not establishing active-ingredient-based minimum (baseline)
PPE/engineering control requirements for Mitin FF end-use products that are
intended primarily for occupational use.
Any necessary PPE for each Mitin FF occupational end-use product will
be established on the basis of the end-use product's acute toxicity category.
NOTE: All end-use products are required to specify a long-sleeved shirt, long
pants, socks and shoes as minimum work attire for all handlers. If the end-use
product is classified as toxicity category I or II for eye irritation potential,
protective eyewear is also required.
The personal protective equipment requirements must be placed on the
end-use product labeling in the location specified in PR Notice 93-7, and the
format and language of the PPE requirements must be the same as is specified
in PR Notice 93-7.
Entry Restrictions
For end-use products that contain Mitin FF the product labeling must be
revised to remove entry restrictions on the current labeling. As discussed above
there is no toxicological basis to impose entry restrictions of the current use of
Mitin FF.
Other Labeling Requirements
The Agency is requiring the following labeling statements to be located
on all end-use products containing Mitin FF.
Application Restrictions
"Do not apply this product in a way that will contact workers or
other persons."
User Safety Recommendations
• "Users should wash hands before eating, drinking,
chewing gum, using tobacco, or using the toilet."
16
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• "Users should remove clothing immediately if pesticide
gets inside. Then wash thoroughly and put on clean
clothing."
The labels and labeling of all products must comply with EPA's current
regulations and requirements as specified in 40 CFR §156.10 and other
applicable notices.
C. Existing Stocks
Registrants may generally distribute and sell products bearing old
labels/labeling for 26 months from the date of the issuance of this Reregi strati on
Eligibility Decision (RED). Persons other than the registrant may generally distribute
or sell such products for 50 months from the date of the issuance of this RED.
However, existing stocks time frames will be established case-by-case, depending on
the number of products involved, the number of label changes, and other factors. Refer
to "Existing Stocks of Pesticide Products; Statement of Policy"; Federal Register.
Volume 56, No. 123, June 26, 1991.
The Agency has determined that registrants may distribute and sell Mitin FF
products bearing old labels/labeling for 26 months from the date of issuance of this
RED. Persons other than the registrant may distribute or sell such products for 50
months from the date of the issuance of this RED. Registrants and persons other than
registrants remain obligated to meet pre-existing Agency imposed label changes and
existing stocks requirements applicable to products they sell or distribute.
17
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18
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VI. APPENDICES
19
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20
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Report Run Date:
PRD Report Date:
04/17/96
09/14/95
) Time 12:34
LUIS 3.0 - Page:
APPENDIX A REPORT
Case 3097[Mitin FF (*)] Chemical 058802[Sodium 5-chloro-2-(4-chloro-2-(3-(3,4-dichlorophenyl)ureido)pheno]
SITE Application Type, Application Form(s)
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI
Rate (AI un- Rate (AI Tex. © Max. Rate unless noted
less noted unless noted Max. /crop /year otherwise)/A]
otherwise) otherwise) Dose cycle /crop /year
cycle
Min. Restr. Geographic Limitations Use
Interv Entry Allowed Disallowed Limitations
(days) Interv Codes
[day(s)]
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED
TEXTILES/TEXTILE FIBERS/CORDAGE
Impregnation treatment, During
manufacture, Dyebucket
SC/S
.012 Ib Ib
wool
Use Group: INDOOR NON-FOOD
NS NS NS
21
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Report Run Date: 04/17/96 ) Time 12:34 LUIS 3.0 - Page: 2
PRD Report Date: 09/14/95
APPENDIX A REPORT
Case 3097[Mitin FF (*)] Chemical 058802[Sodium 5-chloro-2-(4-chloro-2-(3-(3,4-dichlorophenyl)ureido)pheno]
44444444
LEGEND
444444
Sort: Uses Eligible or Ineligible for Re-registration, Food/Feed or Non-Food/Non-Feed Uses, Alpha Site Name, Use Group Name, Alpha Application Type/Timing/Equipment
Description, Formulation, Maximum Application Rate Unit/Area Quantity, Minimum Application Rate, Maximum Number of Applications at Maximum Rate, Maximum Dose per Crop
Cycle or per Year, Minimum Interval Between Applications (Days), Restricted Entry Interval (Days), Allowed/Disallowed Geographical Areas, Use Limitations Codes.
HEADER ABBREVIATIONS
Min. Appl. Rate (AI unless : Minimum dose for a single application to a single site. System calculated. Microbial claims only.
noted otherwise)
Max. Appl. Rate (AI unless : Maximum dose for a single application to a single site. System calculated.
noted otherwise)
Soil Tex. Max. Dose
Max. # Apps © Max. Rate
Max. Dose [(AI unless
noted otherwise)/A]
Min. Interv (days)
Restr. Entry Interv (days)
PRD Report Date
Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).
Maximum number of Applications at Maximum Dosage Rate. Example: "4 applications per year" is expressed as "4/1 yr"; "4 applications per 3
years" is expressed as "4/3 yr"
Maximum dose applied to a site over a single crop cycle or year. System calculated.
Minimum Interval between Applications (days)
Restricted Entry Interval (days)
LUIS contains all products that were active or suspended (and that were available from OPP Document Center) as of this date. Some products
registered after this date may have data included in this report, but LUIS does not guarantee that all products registered after this date have
data that has been captured.
SOIL TEXTURE FOR MAX APP. RATE
* : Non-specific
C : Coarse
M : Medium
F : Fine
O : Others
FORMULATION CODES
SC/S : SOLUBLE CONCENTRATE/SOLID
ABBREVIATIONS
AN : As Needed
NA : Not Applicable
NS : Not Specified (on label)
UC : Unconverted due to lack of data (on label), or with one of following units: bag, bait, bait block, bait pack, bait station, bait station(s), block, briquet,
briquets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser, drop, eartag, grains, lure, pack, packet, packets, pad, part,
parts, pellets, piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick, strip, tab, tablet, tablets, tag, tape, towelette, tray, unit, --
APPLICATION RATE
DCNC
No Calc
W
V
U
cwt
nnE-xx
Dosage Can Not be Calculated
No Calculation can be made
PPM calculated by weight
PPM Calculated by volume
Unknown whether PPM is given by weight or by volume
Hundred Weight
nn times (10 power -xx); for instance, "1.234E-04"
is equivalent to ".0001234"
22
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregi strati on for active ingredients within the case
Mitin FF covered by this Reregi strati on Eligibility Decision Document. It contains generic data requirements that apply
to Mitin FF in all products, including data requirements for which a "typical formulation" is the test substance.
The data table is organized in the following format:
1. 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 in the Pesticide Assessment
Guidelines, which are available from the National Technical Information Service, 5285 Port Royal Road, Springfield,
VA 22161 (703)487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data requirements apply. The
following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files, this column lists the
identifying number of each study. This normally is the Master Record Identification (MRID) number, but may be a
"GS" number if no MRID number has been assigned. Refer to the Bibliography appendix for a complete citation of
the study.
23
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24
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APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Mitin FF
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition
All
All
All
All
All
All
All
All
All
All
All
All
All
42357001
42357001
43174201
42270101
42270101
42270101
42270101
42270101
42270101
42270101
42270101
42270101
42270101
ECOLOGICAL EFFECTS
71-1A
71-1B
7 1-2 A
71-2B
Acute Avian Oral - Quail/Duck
Acute Avian Oral - Quail/Duck
TEP
Avian Dietary - Quail
Avian Dietary - Duck
All
All
All
All
43273201, 43273202
43273201, 43273202
40098001,42720101
42270102
25
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Data Supporting Guideline Requirements for the Reregistration of Mitin FF
REQUIREMENT
USE PATTERN
CITATION(S)
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
82-3
83-3B
84-2A
84-4
Acute Oral Toxicity - Rat
Acute Dermal Toxicity -
Rabbit/Rat
Acute Inhalation Toxicity Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation Rabbit
Dermal Sensitization Guinea Pig
90-Day Dermal - Rodent
Developmental Toxicity - Rabbit
Gene Mutation (Ames Test)
Other Genotoxic Effects
All
All
All
All
All
All
All
All
All
42249401
42249402
42249403
42249404
42249405
42249406
41595001
43465101
41050901
41027801,41027802
ENVIRONMENTAL FATE
161-1
Hydrolysis
All
43503301
26
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GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated
elsewhere in the Reregistration Eligibility Document. Primary sources for studies in
this bibliography have been the body of data submitted to EPA and its predecessor
agencies in support of past regulatory decisions. Selections from other sources
including the published literature, in those instances where they have been considered,
are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the
case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically 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 also
attempted to unite basic documents and commentaries upon them, treating them as a
single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID number". This number is unique
to the citation, and should be used whenever a specific reference is required. It is not
related to the six-digit "Accession Number" which has been used to identify volumes of
submitted studies (see paragraph 4 (d) (4) below for further explanation). In a few
cases, entries added to the bibliography late in the review may be preceded by a nine
character temporary identifier. These entries are listed after all MRID entries. This
temporary identifying number is also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute
(ANSI), expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the
Agency has shown an identifiable laboratory or testing facility as the author.
When no author or laboratory could be identified, the Agency has shown the
first submitter as the author.
b. Document date. The date of the study is taken directly from the document.
When the date is followed by a question mark, the bibliographer has deduced
the date from the evidence contained in the document. When the date appears
27
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as (19??), the Agency was unable to determine or estimate the date of the
document.
c. Title. In some cases, it has been necessary for the Agency bibliographers to
create or enhance a document title. Any such editorial insertions are contained
between square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the
trailing parentheses include (in addition to any self-explanatory text) the
following elements describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the
word "under" is the registration number, experimental use permit
number, petition number, or other administrative number associated
with the earliest known submission.
(3) Submitter. The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume
in which the original submission of the study appears. The six-digit
accession number follows the symbol "CDL," which stands for
"Company Data Library." This accession number is in turn followed by
an alphabetic suffix which shows the relative position of the study within
the volume.
28
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BIBLIOGRAPHY
MRID
CITATION
41027801 Uhl, S. (1988) Micronucleus Assay in Bone Marrow Cells of the Mouse with
Fat 81,011/J (Mitin FF High Cone): Proj. No. 133424. Unpublished study
prepared by Cytotest Cell Research GmbH & Co. KG. 29 p.
41027802 Uhl, S. (1988) Unscheduled DNA Synthesis in Primary Hepatocytes of Male
Rats in vitro with Fat 81,011/J (Mitin FF High Cone): Proj. No. 133435.
Unpublished study prepared by Cytotest Cell Research GmbH & Co. KG. 28
P-
41050901 Uhl, S. (1988) Salmonella Typhimurium Reverse Mutation Assay with Fat
81,011/J f/SMitinFF High Cone.*: CCR Project: 133413. Unpublished study
prepared by Cytotest Cell Research. 36 p.
41595001 Ullmann, L. et al. (1989) Subchronic 90-Day Repeated Dose Dermal Toxicity
Study with FAT 81 011/J in Rats: Lab Project Number: RCC Project 208708.
Unpublished Study Prepared by Research and Consulting Company AG. 453
P-
42249401 Ullmann, L.; Althaus, P.; and Hoff, N. (1991) Acute Oral and Toxicity Study
with Fat 81,011/J in Rats: Lab Project Number: 289506. Unpublished study
prepared by RCC, Research and Consulting Co. A. G. 60 p.
42249402 Ullmann, L.; Althaus, P.; and; Hoff, N. (1991) Acute Dermal Toxicity Study
with Fat 81,011/J in Rats: Mitin FF High Concentrate: Lab Project Number:
289517. Unpublished study prepared by RCC, Research and Consulting Co. A.
G. 35 p.
42249403 Duchosal, F. (1990) 4-hour, Acute Inhalation Toxicity Study with Fat 81,011/J
in Rats: Mitin FF High Concentrate: Lab Project Number: 289438.
Unpublished study prepared by RCC, Research and Consulting Co. A. G. 44 p.
42249404 Ullmann, L.; Lucini, P.; and Hoff, N. (1991) Primary Eye Irritation Study with
Fat 81,011/J in Rabbits: Mitin FF High Concentrate: Lab Project Number:
289528. Unpublished study prepared by RCC, Research and Consulting
Company A. G. 33 p.
29
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BIBLIOGRAPHY
MRID
CITATION
42249405 Ullmann, L.; Porricello, T.; and Hoff, N. (1991) Primary Skin Irritation Study
with Fat 81,011/J in Rabbits (4-hour Semi-Occlusive Application): Lab Project
Number: 289563. Unpublished study prepared by RCC, Research and
Consulting Company A. G. 33 p.
42249406 Ullmann, L.; Krolling, C.; and Boni, C.; et al. (1991) Contact Hypersensitivity
to Fat 81,011/J in Albino Guinea Pigs Maximization Test: Mitin FF High
Concentrate: Lab Project Number: 289574. Unpublished study prepared by
RCC, Research and Consulting Company A. G. 50 p.
42270101 Lomenzo, J. (1986) Physical and Chemical Characteristics: Mitin FF High
Cone. Unpublished study prepared by Ciba-Geigy. 50 p.
42270102 Ellgehausen, H.; Wuethrich, V. (1987) 48-Hour Acute Toxicity of Fat
81,011/H to Daphnia magna: Mitin FF High Cone: Lab Project Number:
075881. Unpublished study prepared by RCC Research & Consulting Co.,
AG. 33 p.
42357001 LoMenzo, J. (1992) Mitin FF High Concentrate: Analysis and Certification of
Product Ingredients. Unpublished study prepared by Ciba-Geigy Corp. 22 p.
42720101 Grade, R. (1993) Report on the Acute Toxicity Test of Fat 81,011/J to Rainbow
Trout: Mitin FF High Cone: Lab Project Number: 928448. Unpublished study
prepared by Ciba-Geigy Ltd. 21 p.
43174201 Vogel, A. (1994) Mitin FF High Cone Analytical Method: Lab Project
Number: 81'011/K: FC-93/9T.AC. Unpublished study prepared by Ciba-Geigy
Ltd. 16 p.
43273201 Helsten, B.; Solatycki, A. (1994) 21-Day Acute Oral LC50 Study with Sample
S9318TC (Mitin FF High Cone.) in Bobwhite Quail: Lab Project Number:
102-026-03. Unpublished study prepared by Bio-Life Assoc., Ltd. 55 p.
43273202 Helsten, B.; Denk, D. (1994) 14-Day Acute Oral LC50 Study with Sample
S9318TC (Mitin FF High Cone.) in Mallard Ducks: Lab Project Number:
102-027-04. Unpublished study prepared by Bio-Life Assoc., Ltd. 39 p.
30
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BIBLIOGRAPHY
MRID CITATION
43465101 Khalil, S. (1994) FAT 81011/K: Rabbit Oral Teratogenicity: Final Report: Lab
Project Number: 935133: 366052. Unpublished study prepared by Ciba-Geigy,
Ltd. 260 p.
43503301 Burgener, A.; Mamouni, A. (1994) Hydrolysis Determination of (carbon 14)
Mitin-FF at Different pH Values: Lab Project Number: 361653. Unpublished
study prepared by RCC Umweltchemie Ag. 50 p.
31
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32
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment 1 of this Notice, the Data Call-in Chemical Status Sheet, to
submit certain product specific data as noted herein to the U.S. Environmental Protection
Agency (EPA, the Agency). These data are necessary to maintain the continued registration of
your product(s) containing this active ingredient. Within 90 days after you receive this Notice
you must respond as set forth in Section III below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 6; or
2. Why you believe you are exempt from the requirements listed in this Notice and
in Attachment 3, Requirements Status and Registrant's Response Form, (see
section III-B); or
3. Why you believe EPA should not require your submission of product specific
data in the manner specified by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s) subject to this Notice will be subject to suspension. We have provided a list of
all of your products subject to this Notice in Attachment 2, Data Call-In Response Form, as
well as a list of all registrants who were sent this Notice (Attachment 6).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-
0107 and 2070-0057 (expiration date 03-31-96).
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This Notice is divided into six sections and six 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 are:
1 - Data Call-In Chemical Status Sheet
2 - Product-Specific Data Call-In Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - List of Registrants Receiving This Notice
6 - Cost Share and Data Compensation Forms
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient and reevaluated the
data needed to support continued registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product specific data. No additional
generic data requirements are being imposed. You have been sent this Notice because you
have product(s) containing the subject active ingredient.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The product specific data required by this Notice are specified in Attachment 3,
Requirements Status and Registrant's Response Form. 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 otherwise satisfy the data requirements specified in
Attachment 3, Requirements Status and Registrant's Response Form, within the time frames
provided.
II-C. TESTING PROTOCOL
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All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the OECD
protocols, they should be modified as appropriate so that the data generated by the study will
satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend deadlines for
complying with data requirements when the studies were not conducted in accordance with
acceptable standards. The OECD protocols are available from OECD, 2001 L Street, N.W.,
Washington, D.C. 20036 (Telephone number 202-785-6323; Fax telephone number 202-785-
0350).
All new studies and proposed protocols submitted in response to this Data Call-in Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES
ISSUED BY THE AGENCY
Unless otherwise noted herein, this Data Call-In does not in any way supersede or change the
requirements of any previous Data Call-In(s), or any other agreements entered into with the
Agency pertaining to such prior Notice. Registrants must comply with the requirements of all
Notices to avoid issuance of a Notice of Intent to Suspend their affected products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for product specific data must
be submitted to the Agency within 90 days after your receipt of this Notice. Failure to adequately
respond to this Notice within 90 days of your receipt will be a basis for issuing a Notice of Intent
to Suspend (NOIS) affecting 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
The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice or
(c) request a data waiver (s).
A discussion of how to respond if you chose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product specific
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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 Status and Registrant's Response Form, Attachment 2 and
Attachment 3. The Data Call-in Response Form must be submitted as part of every response to
this Notice. In addition, one copy of the Requirements Status and Registrant's Response Form
must be submitted for each product listed on the Data Call-in Response Form unless the voluntary
cancellation option is selected or unless the product is identical to another (refer to the instructions
for completing the Data Call-in Response Form in Attachment 2). Please note that the company's
authorized representative is required to sign the first page of the Data Call-in Response Form and
Requirements Status and Registrant's Response Form (if this form is required) and initial any
subsequent pages. The forms contain separate detailed instructions on the response options. Do
not alter the printed material. If you have questions or need assistance in preparing your
response, call or write the contact person(s) identified in Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by requesting
voluntary cancellation of your product(s) containing the active ingredient that is the subject of this
Notice. If you wish to voluntarily cancel your product, you must submit a completed 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 chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
2. Satisfying the Product Specific Data Requirements of this Notice There are various
options available to satisfy the product specific data requirements of this Notice. These options
are discussed in Section III-C of this Notice and comprise options 1 through 6 on the
Requirements Status and Registrant's Response Form and item numbers 7a and 7b on the Data
Call-in Response Form. Deletion of a use(s) and the low volume/minor use option are not valid
options for fulfilling product specific data requirements.
3. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section III-D of this Notice and are covered by option 7 on the Requirements Status
and Registrant's Response Form. If you choose 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.
III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form that you agree to satisfy the
product specific data requirements (i.e. you select item number 7a or 7b), then you must select
one of the six options on the Requirements Status and Registrant's Response Form related to data
production for each data requirement. Your option selection should be entered under item
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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 time frame (Developing Data)
(2) I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been submitted but not reviewed by the Agency (Citing an Existing
Study)
Option 1, Developing Data — If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced herein and
in the attachments. All data generated and submitted must comply with the Good Laboratory
Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide Assessment
Guidelines (PAG), and be in conformance with the requirements of PR Notice 86-5.
The time frames in the Requirements Status and Registrant's Response Form are the time
frames that the Agency is allowing for the submission of completed study reports. The noted
deadlines run from the date of the receipt of this Notice by the registrant. If the data are not
submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to Suspend the
affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by this Notice and
intend to seek additional time to meet the requirements(s), you must submit a request to the
Agency which includes: (1) a detailed description of the expected difficulty and (2) a proposed
schedule including alternative dates for meeting such requirements on a step-by-step basis. You
must explain any technical or laboratory difficulties and provide documentation from the
laboratory performing the testing. While EPA is considering your request, the original deadline
remains. The Agency will respond to your request in writing. If EPA does not grant your
request, the original deadline remains. Normally, extensions can be requested only in cases of
extraordinary testing problems beyond the expectation or control of the registrant. Extensions
will not be given in submitting the 90-day responses. Extensions will not be considered if the
request for extension is not made in a timely fashion; in no event shall an extension request be
considered if it is submitted at or after the lapse of the subject deadline.
Option 2, Agreement to Share in Cost to Develop Data — Registrants may only choose
this option for acute toxicity data and certain efficacy data and only if EPA has indicated in the
attached data tables that your product and at least one other product are similar for purposes of
depending on the same data. If this is the case, data may be generated for just one of the products
37
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in the group. The registration number of the product for which data will be submitted must be
noted in the agreement to cost share by the registrant selecting this option. If you choose to enter
into an agreement to share in the cost of producing the required data but will not be submitting
the data yourself, you must provide the name of the registrant who will be submitting the data.
You must also provide EPA with documentary evidence that an agreement has been formed. Such
evidence may be your letter offering to join in an agreement and the other registrant's acceptance
of your offer, or a written statement by the parties that an agreement exists. The agreement to
produce the data need not specify all of the terms of the final arrangement between the parties or
the mechanism to resolve the terms. Section 3(c)(2)(B) provides that if the parties cannot resolve
the terms of the agreement they may resolve their differences through binding arbitration.
Option 3, Offer to Share in the Cost of Data Development — This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. If you have made an offer
to pay in an attempt to enter into an agreement or amend an existing agreement to meet the
requirements of this Notice and have been unsuccessful, you may request EPA (by selecting this
option) to exercise its discretion not to suspend your registration(s), although you do not comply
with the data submission requirements of this Notice. EPA has determined that as a general
policy, absent other relevant considerations, it will not suspend the registration of a product of a
registrant who has in good faith sought and continues to seek to enter into a joint data
development/cost sharing program, but the other registrant(s) developing the data has refused to
accept your offer. To qualify for this option, you must submit documentation to the Agency
proving that you have made an offer to another registrant (who has an obligation to submit data)
to share in the burden of developing that data. You must also submit to the Agency a completed
EPA Form 8570-32, Certification of Offer to Cost Share in the Development of Data, Attachment
7. In addition, you must demonstrate that the other registrant to whom the offer was made has
not accepted your offer to enter into a cost sharing agreement by including a copy of your offer
and proof of the other registrant's receipt of that offer (such as a certified mail receipt). Your
offer must, in addition to anything else, offer to share in the burden of producing the data upon
terms to be agreed or failing agreement to be bound by binding arbitration as provided by FIFRA
section 3(c)(2)(B)(iii) and must not qualify this offer. The other registrant must also inform EPA
of its election of an option to develop and submit the data required by this Notice by submitting a
Data Call-In Response Form and a Requirements Status and Registrant's Response Form
committing to develop and submit the data required by this Notice.
In order for you to avoid suspension under this option, you may not withdraw your offer
to share in the burdens of developing the data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this Notice. If the other registrant fails
to develop the data or for some other reason is subject to suspension, your registration as well as
that of the other registrant will normally be subject to initiation of suspension proceedings, unless
you commit to submit, and do submit the required data in the specified time frame. In such cases,
the Agency generally will not grant a time extension for submitting the data.
Option 4, Submitting an Existing Study — If you choose to submit an existing study in
response to this Notice, you must determine that the study satisfies the requirements imposed by
this Notice. You may only submit a study that has not been previously submitted to the Agency
or previously cited by anyone. Existing studies are studies which predate issuance of this Notice.
Do not use this option if you are submitting data to upgrade a study. (See Option 5).
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You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the
required date of submission. The Agency may determine at any time that a study is not valid and
needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data
and specimens from the study are available for audit and review and you must
identify where they are available. This must be done in accordance with the
requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR Part 160.
As stated in 40 CFR 160.3(j) " 'raw data' means any laboratory worksheets,
records, memoranda, notes, or exact copies thereof, that are the result of original
observations and activities of a study and are necessary for the reconstruction and
evaluation of the report of that study. In the event that exact transcripts of raw
data have been prepared (e.g., tapes which have been transcribed verbatim, dated,
and verified accurate by signature), the exact copy or exact transcript may be
substituted for the original source as raw data. 'Raw data' may include
photographs, microfilm or microfiche copies, computer printouts, magnetic media,
including dictated observations, and recorded data from automated instruments."
The term "specimens", according to 40 CFR 160.3(k), means "any material
derived from a test system for examination or analysis."
b. Health and safety studies completed after May 1984 must also contain all GLP-
required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants must also certify at the time of
submitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study
signed by an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
Technical Guidance and that the study has been conducted according to the
Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG (both
available from NTIS). A study not conducted according to the PAG may be
submitted to the Agency for consideration if the registrant believes that the study
clearly meets the purpose of the PAG. The registrant is referred to 40 CFR 158.70
which states the Agency's policy regarding acceptable protocols. If you wish to
submit the study, you must, in addition to certifying that the purposes of the PAG
are met by the study, clearly articulate the rationale why you believe the study
meets the purpose of the PAG, including copies of any supporting information or
data. It has been the Agency's experience that studies completed prior to January
1970 rarely satisfied the purpose of the PAG and that necessary raw data are
usually not available for such studies.
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If you submit an existing study, you must certify that the study meets all requirements of
the criteria outlined above.
If you know of a study pertaining to any requirement in this Notice which does not meet
the criteria outlined above but does contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study. If such study is in the Agency's files, you
need only cite it along with the notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5.
Option 5, Upgrading a Study — If a study has been classified as partially acceptable and
upgradeable, you may submit data to upgrade that study. The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the requirement is
not satisfied, you may still be required to submit new data normally without any time extension.
Deficient, but upgradeable studies will normally be classified as supplemental. However, it is
important to note that not all studies classified as supplemental are upgradeable. If you have
questions regarding the classification of a study or whether a study may be upgraded, call or write
the contact person listed in Attachment 1. If you submit data to upgrade an existing study you
must satisfy or supply information to correct all deficiencies in the study identified by EPA. You
must provide a clearly articulated rationale of how the deficiencies have been remedied or
corrected and why the study should be rated as acceptable to EPA. Your submission must also
specify the MRID number(s) of the study which you are attempting to upgrade and must be in
conformance with PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
This option should also be used to cite data that has been previously submitted to upgrade
a study, but has not yet been reviewed by the Agency. You must provide the MRID number of
the data submission as well as the MRID number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply to all
data submissions intended to upgrade studies. Additionally your submission of data intended to
upgrade studies must be accompanied by a certification that you comply with each of those
criteria as well as a certification regarding protocol compliance with Agency requirements.
Option 6, Citing Existing Studies — 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 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.
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Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-in Response Form and the Requirements
Status and Registrant's Response Form, as appropriate.
III-D REQUESTS FOR DATA WAIVERS
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies. (Note: any
supplemental data must be submitted in the format required by PR Notice 86-5). This will be the
only opportunity to state the reasons or provide information in support of your request. If the
Agency approves your waiver request, you will not be required to supply the data pursuant to
section 3(c)(2)(B) of FIFRA. If the Agency denies your waiver request, you must choose an
option for meeting the data requirements of this Notice within 30 days of the receipt of the
Agency's decision. You must indicate and submit the option chosen on the Requirements Status
and Registrant's Response Form. Product specific data requirements for product chemistry, acute
toxicity and efficacy (where appropriate) are required for all products and the Agency would grant
a waiver only under extraordinary circumstances. You should also be aware that submitting a
waiver request will 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)(B). Events which may be the basis for issuance of a Notice of Intent to
Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.
2. Failure to submit on the required schedule an acceptable proposed or final protocol
when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a study
as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this
Notice.
5. Failure to take a required action or submit adequate information pertaining to any
option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task
41
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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 Call-in Response Form and a Requirements Status and
Registrant's Response Form;
b. fulfill the commitment to develop and submit the data as required by this
Notice; or
c. otherwise take appropriate steps to meet the requirements stated in this
Notice, unless you commit to submit and do submit the required data in the
specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds
for suspension include, but are not limited to, failure to meet any of the following:
1. EPA requirements specified in the Data Call-In Notice or other documents incorporated
by reference (including, as applicable, EPA Pesticide Assessment Guidelines, Data
Reporting Guidelines, and GeneTox Health Effects Test Guidelines) regarding the design,
conduct, and reporting of required studies. Such requirements include, but are not limited
to, those relating to test material, test procedures, selection of species, number of animals,
sex and distribution of animals, dose and effect levels to be tested or attained, duration of
test, and, as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation
of any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting,
the completeness of results, and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or included in this Notice or
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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 existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not
be consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing stocks of your product(s) which may be
suspended for failure to comply with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be consistent with the Act. You
must also explain why an "existing stocks" provision is necessary, including a statement of the
quantity of existing stocks and your estimate of the time required for their sale, distribution, and
use. Unless you meet this burden the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice and
your product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 90 day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use such
existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily cancelled products containing an active ingredient for which the Agency has particular
risk concerns will be determined on case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result in the Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was due unless you demonstrate
to the Agency that you are in full compliance with all Agency requirements, including the
requirements of this Notice. For example, if you decide to voluntarily cancel your registration six
months before a 3 year study is scheduled to be submitted, all progress reports and other
information necessary to establish that you have been conducting the study in an acceptable and
good faith manner must have been submitted to the Agency, before EPA will consider granting an
existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that 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
43
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whatever source, including but not limited to interim or preliminary results of studies, regarding
unreasonable adverse effects on man or the environment. This requirement continues as long as
the products are registered by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-In Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment 2 and Attachment 3 for product
specific data) and any other documents required by this Notice, and should be submitted to the
contact person(s) identified in Attachment 1. If the voluntary cancellation or generic data
exemption option is chosen, only the Data Call-In Response 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,
Lois A. Rossi, Division Director
Special Review and
Reregistration Division
Attachments
1 - Data Call-In Chemical Status Sheet
2 - Product-Specific Data Call-In Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - List of Registrants Receiving This Notice
6 - Cost Share and Data Compensation Forms and the Confidential Statement of
Formula Form
44
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MITIN FF DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing Mitin DD.
This Product Specific Data Call-In Chemical Status Sheet contains an overview of data
required by this notice, and point of contact for inquiries pertaining to the reregi strati on of Mitin FF.
This attachment is to be used in conjunction with (1) the Product Specific Data Call-In Notice, (2)
the Product Specific Data Call-In Response Form (Attachment 2), (3) the Requirements Status and
Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use Products for Meeting Acute
Toxicology Data Requirement (Attachment 4), (5) a list of registrants receiving this DCI
(Attachment 5) and (6) the Cost Share and Data Compensation Forms in replying to this Mitin FF
Product Specific Data Call-In (Attachment (6)). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for Mitin FF are contained
in the Requirements Status and Registrant's Response. Attachment 3. The Agency has concluded
that additional data on Mitin FF are needed for specific products. These data are required to be
submitted to the Agency within the time frame listed. These data are needed to fully complete the
reregi strati on of all eligible Mitin FF products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding this product specific data requirements and procedures
established by this Notice, please contact Jeffrey Billingslea at (703) 308-8004.
All responses to this Notice for the Product Specific data requirements should be submitted
to:
Jeffrey Billingslea
Chemical Review Manager Team 81
Product Reregi strati on Branch
Special Review and Reregi strati on Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Mitin FF
45
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMFOR
PRODUCT SPECIFIC DATA
Item 1-4. Already completed by EPA.
Item 5. If you wish to voluntarily cancelyour 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
must respond with "yes" to Item 7a (MUP) or 7B (EUP) on this form, provide the
EPA registration numbers of your source(s) you would not complete the
"Requirements Status and Registrant's Response" form. Examples of such products
include repackaged products and Special Local Needs (Section 24c)products
which are identical to federally registered products.
Item 7a. For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding "yes."
Item 7b. For each end use product (EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes." If you are
requesting a data waiver, answer "yes" here; in addition, on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with Option
7 (Waiver Request) for each study for which you are requesting a waiver. See Item
6 with regard to identical products and data exemptions.
Items 8-11. Self-explanatory.
NOTE: You may provide additional informationthat 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 canceled this product. For these cases, please supply all relevant details
so that EPA can ensure that its records are correct.
46
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Part A of the Product Specific DCI is inserted here.
47
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48
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INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMFOR PRODUCT SPECIFIC DATA
Item 1-3 Completed by EPA. Note the unique identifier numberassigned by EPA in Item
3 This number must be used in the transmittal document for any dart
submissions in response to this Data Call-In Notice.
Item 4. The guideline reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the
requirements specified in the Notice, govern the conduct of the required studies.
Note that series 61 and 62 in product chemistry are now listed under 40 CFR 158.155
through 158.180, Subpart C.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use pattern(s) of the pesticide associated with the product specific requirements
is (are) identified. For most product specific data requirements, all use patterns are
covered by the data requirements. In the case of efficacy data, the required studies
only pertain to products which have the use sites and/or pests indicated.
Item 7. The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in rare
cases.
Item 8. The due date for submission of each study is identified. It is normally based on 8
months after issuance of the Reregistration Eligibility Documentmless EPA
determines that a longer time period is necessary.
Item 9 Enter only one of the following response codesfor each data requirementto
show how you intend to comply with the data requirements listed in this table.
Fuller descriptions of each option are contained in the Data Call-In Notice.
1. I will generate and submit data by the specified due date (Developing Data). By
indicating that I have chosen this option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal of this study as outlined in the
Data Call-In Notice. By the specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Cmpensation Requirements" form (EPA
Form 8570-29) and (2) two completed and signed copies of the Confidential
Statement of Formula (EPA Form 8570-4)
2. I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing). I am submitting a copy of this agreement I understand that this
option is available 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
49
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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. By the specified due
date, I will also submit: (1) a completed "Certification With Respect To Daft
Compensation Requirements" form EPA Form 8570-29)and (2) two completed
and signed copies of the Confidential Statement of Formula (EPA Form 8570-4.)
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 made an offerto 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 he 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 data; if the required study is not submitted on time, my product may be
subject to suspension. I understand that other terms under Option 3 in the Data Call-
in Notice (Section III-C.l.) apply as well. By the specified due date, I will also
submit: (1) a completed "Certification With Respect To Data Compensatin
Requirements" form (EPA Form 8570-29)and (2) two completed and signed
copies of the Confidential Statement of Formula (EPA Form 8570-4)
4. By the specified due date, I will submit an existing study that has not been submitted
previously to the Agency by anyone (Submitting an Existing Stud$. I certify that
this study will meet all the requirements for submittal of existing data outlined in
Option 4 in the Data Call-In Notice (Section III-C.l.) and will meet the attached
acceptance criteria (for acute toxicity and product chemistry data). I will attach the
needed supporting information along with this response. I also certify that I have
determined that this study will fill the data requirement for which I have indicated
this choice. By the specified due date, I will also submit a completed "Certification
With Respect To Data Compensation Requirements" form (EA Form 8570-29)
to show what data compensation option I have chosen. By the specified due date, I
will also submit: (1) a completed "Certification With Respect To Daft
Compensation Requirements" form EPA Form 8570-29)and (2) two completed
and signed copies of the Confidential Statement of Formula (EPA Form 8570-4)
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 III-C.l.) apply. By the
specified due date, I will also submit: (1) a completed "Certification With Respect
To Data CompensationRequirements" form (EPA Form 8570-29)and (2) two
50
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7.
completed and signed copies of the Confidential Statement of Formula
Form 8570-4)
By the specified due date, I will cite an existing study that the Agency has classified
as acceptable or an existing study that has been submitted but not reviewed by the
Agency (Citing an Existing Study). If I am citing another registrant's study, I
understand that this option is available only for acute toxicity or certain efficacy data
and only if the cited study was conducted on my product, an identical product or a
product which EPA has "grouped" with one or more other products for purposes of
depending on the same data. I may also choose this option if I am citing my own
data. In either case, I will provide the MRID or Accession number(s)for the cited
data on a "Product Specific Data Report" form or in a similar format. By the
specified due date, I will also submit: (1) a completed "Certification With Respect
To Data CompensationRequirements" form (EPA Form 8570-29)and (2) two
completed and signed copies of the Confidential Statement of Formula (ER
Form 8570-4)
I request a waiver for this study because it is inappropriate for my product (Waiver
Request). I am attaching a complete justification for this request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies.
[Note: any supplemental data must be submitted in the format required by P.R.
Notice 86-5]. I understand that this is my only opportunity to state the reasons or
provide information in support of my request. If the Agency approves my waiver
request, I will not be required to supply the data pursuant to Section 3(c)(2)(B) of
FIFRA. If the Agency denies my waiver request, I must choose a method of meeting
the data requirements of this Notice by the due date stated by this Notice. In this
case, I must, within 30 days of 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. By the specified due date, I will
also submit: (1) a completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29)and (2) two completed and signed
copies of the Confidential Statement of Formula (EPA Form 8570-4)
Items 10-13. Self-explanatory.
NOTE: You may provide additional informationthat 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 canceled this product. For these cases, please supply all relevant details
so that EPA can ensure that its records are correct.
51
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Page 1 of the Product Specific DCI is inserted here.
52
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Page 2 of the Product Specific DCI is inserted here.
53
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Page 3 of the Product Specific DCI is inserted here.
54
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Page 4 of the Product Specific DCI is inserted here.
55
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Page 5 of the Product Specific DCI is inserted here.
56
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There is no tox batching for Mitin FF.
57
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Attachment 5. List of All Registrants Sent This Data Call-In (insert) Notice
58
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Remove this page and insert the list of registrants sent this product specific DCI here.
59
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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed
copies of the form are required. Following are basic instructions:
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of the responsible party
must be provided.
d. All applicable information which is on the product specific data submission must
also be reported on the CSF.
e. All weights reported under item 7 must be in pounds per gallon for liquids and
pounds per cubic feet for solids.
f Flashpoint must be in degrees Fahrenheit and flame extension in inches.
g. For all active ingredients, the EPA Registration Numbers for the currently
registered source products must be reported under column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all
common names for the trade names must be reported.
i. For the active ingredients, the percent purity of the source products must be
reported under column 10 and must be exactly the same as on the source product's
label.
j. All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or
grams. In no case will volumes be accepted. Do not mix English and metric
system units (i.e., pounds and kilograms).
k. All the items under column 13.b. must total 100 percent.
1. All items under columns 14.a. and 14.b. for the active ingredients must represent
pure active form.
m. The upper and lower certified limits for ail active and inert ingredients must
follow the 40 CFR 158.175 instructions. An explanation must be provided if the
proposed limits are different than standard certified limits.
n. When new CSFs are submitted and approved, all previously submitted CSFs
become obsolete for that specific formulation.
60
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62
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r/EPA
United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION OF OFFER TO COST
SHARE IN THE DEVELOPMENT OF DATA
Form Approved
OMB No. 2070-0106
2070-0057
Approval Expires 3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to Chief, Information Policy
Branch, PM-223, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office
of Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please fill in blanks below.
Company Maine
Product Name
Company Number
EPA Reg. No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Name of Firm(s)
Date of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized Representative
Date
Name and Title (Please Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA Form 8580, which is obsolete
63
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64
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United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
2
\
Form Approved
OMB No. 2070-0107,
2070-0057
Approval Expires
3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding the burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden to, Chief Information Policy Branch, PM-233, 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 Name
Product Name
Company Number
EPA Reg. No.
I Certify that:
1. For each study cited in support of registration or reregistratiion under the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the written permission of the original
data submitter to cite that study.
2. That for each study cited in support of registration or reregistration 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 compensation for those data in accordance with sections
3(c)(1 )(F) and 3(c)(2)(D) of FIFRA; and (b) Commence negotiation to determine which data are subject to the compensation
requirement of FIFRA and the amount of compensation due, if any. The companies I have notified are. (check one)
[ ] The companies who have submitted the studies listed on the back of this form or attached sheets, or indicated on the attached
"Requirements Status and Registrants' Response Form,"
3. That I have previously complied with section 3(c)(1)(F) of FIFRA for the studies I have cited in support of registration or
reregistration under FIFRA.
Signature
Date
Name and Title (Please Type or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the registration or
reregistration of my products, to the extent required by FIFRA section 3(c)(1)(F) and 3(c)(2)(D).
Signature
Date
Name and Title (Please Type or Print)
EPA Form 8570-31 (4-96)
65
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66
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The following is a list of available documents for Mitin FF that my further assist you in
responding to this Reregi strati on Eligibility Decision document. These documents may be
obtained by the following methods:
Electronic
File format: Portable Document Format (.PDF) Requires Adobe® Acrobat or compatible
reader. Electronic copies can be downloaded from the Pesticide Special
Review and Reregi strati on Information System at 703-308-7224. They also are
available on the Internet on EPA's gopher server, GOPHER.EPA.GOV, or
using ftp on FTP.EPA.GOV, or using WWW (World Wide Web) on
WWW.EPA.GOV., or contact Jeffrey Billingslea at (703)-308-8004.
1. PR Notice 86-5.
2. PR Notice 91-2 (pertains to the Label Ingredient Statement).
3. A full copy of this RED document.
4. A copy of the fact sheet for Mitin FF.
The following documents are part of the Administrative Record for Mitin FF and may
included in the EPA's Office of Pesticide Programs Public Docket. Copies of these
documents are not available electronically, but may be obtained by contacting the person
listed on the Chemical Status Sheet.
1. Health and Environmental Effects Science Chapters.
2. Detailed Label Usage Information System (LUIS) Report.
The following Agency reference documents are not available electronically, but may be
obtained by contacting the person listed on the Chemical Status Sheet of this RED document.
1. The Label Review Manual.
2. EPA Acceptance Criteria
67
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