United States Prevention, Pesticides EPA 738-R-95-028
Environmental Protection And Toxic Substances May 1996
Agency (7508W)
&EPA Re registration
Eligibility Decision (RED)
Dimethoxane
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
i -Arf. WASHINGTON, D.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
reregi strati on eligibility review and decisions on the pesticide active ingredient dimethoxane.
The enclosed Reregistration Eligibility Decision (RED) contains the Agency's evaluation of
the data base of these chemicals, 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 reregi strati on. The RED includes the data and
labeling requirements for products for reregi strati on. It may also include requirements for
additional data (generic) on the active ingredients 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 are due 90 days from
the date of this letter. The second set of required responses are due 8 months from the
date of this letter. Complete and timely responses will avoid the Agency taking the
enforcement action of suspension against your products.
If you have questions on the product specific or generic data requirements or wish to
meet with the Agency, please contact the Special Review and Reregistration Division
representative C. P. Moran at (703) 308-8590.
Sincerely yours,
Lois Rossi, 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
reregi strati on, a DCI letter will be enclosed describing such data. If product specific data are
required, another DCI letter will be enclosed listing such requirements. If both generic and
product specific data are required, a combined Generic and Product Specific letter will be
enclosed describing such data. Complete the two response forms provided with each DCI
letter (or four forms for the combined) by following the instructions provided. You must
submit the response forms for each product and for each DCI within 90 days of the date
of this letter (RED issuance date); otherwise, your product may be suspended.
2 TIME EXTENSIONS AND DATA WAIVER REOUESTS-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 data waivers must be submitted as part of the
90-day response. Requests for time extensions should be submitted in the 90-day response,
but certainly no later than the 8-month response date. 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 reregi strati on) separately. You may
delete uses which the RED says are ineligible for reregi strati on. 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)
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
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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 reregi strati on determination within 14 months after the RED
has been issued.
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REREGISTRATION ELIGIBILITY DECISION
DIMETHOXANE
LISTC
CASE 3064
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
DIMETHOXANE REREGISTRATION ELIGIBILITY DECISION TEAM
EXECUTIVE SUMMARY
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Estimated Usage of Pesticide 4
III. SCIENCE ASSESSMENT 5
A. Physical Chemistry Assessment 5
B. Human Health Assessment 5
1. Toxicology Assessment 5
a. Acute Toxicity 6
b. Subchronic Toxicity 6
c. Carcinogenicity 7
d. Developmental Toxicity 7
e. Mutagenicity 7
f. Toxic Endpoints of Concern: 7
g. Reference Dose 8
2. Exposure Assessment 8
a. Occupational and Residential 8
3. Risk Assessment 9
a. Occupational and Residential 9
C. Environmental Assessment 10
1. Ecological Toxicity Data 10
a. Toxicity to Terrestrial Animals 10
b. Toxicity to Aquatic Animals 11
2. Environmental Fate 12
a. Environmental Fate Assessment 12
3. Exposure and Risk Characterization 13
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 13
A. Determination of Eligibility 13
B. Determination of Eligibility Decision 14
1. Eligibility Decision 14
2. Eligible and Ineligible Uses 14
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C. Regulatory Position 14
1. Labeling Rationale 14
V. ACTIONS REQUIRED OF REGISTRANTS 15
A. Manufacturing-Use Products 15
1. Additional Generic Data Requirements 15
B. End-Use Products 15
1. Additional Product-Specific Data Requirements 15
2. Labeling Requirements for End-Use Products 15
C. Existing Stocks 16
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 25
APPENDIX C. Citations Considered to be Part of the Data Base Supporting
the Reregistration of dimethoxane 30
APPENDIX D. Product Specific Data Call-In 36
Attachment 1. Chemical Status Sheets 49
Attachment 2. Product Specific Data Call-In Response Forms (Form
A inserts) Plus Instructions 50
Attachment 3. Product Specific Requirement Status and Registrant's
Response Forms (Form B inserts) and Instructions 52
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 59
Attachment 5. List of All Registrants Sent This Data Call-in (insert)
Notice 60
Attachment 6. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 61
APPENDIX E. List of Available Related Documents 69
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DIMETHOXANE REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Michele Cottrill
Joseph E. Hogue
Phyllis Johnson
Environmental Fate and Effects Division
Sharlene Matten
William Effland
Mah Shamin
Laura Dye
Health Effects Division
Mary Clock
Mikeloannou
Winston Dang
Registration Division
Shyam Mathur
Valdis Goncarovs
Biological Analysis Branch
Economic Analysis Branch
LUIS
Science Analysis and Coordination Staff
Environmental Fate and Groundwater Branch
Environmental Fate and Groundwater Branch
Ecological Effects Branch
Chemical Coordination Branch
Toxicology Branch II
Occupational and Residential Exposure Branch
Registration Support Branch
Antimicrobial Program Branch
Special Review and Reregi strati on Division
C. P. Moran
Barbara Briscoe
Policy, Planning and Operations Branch
Policy, Planning and Operations Branch
Office of General Counsel
Kevin Lee
Pesticides 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 D WEL 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 i s
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
NPDES National Pollutant Discharge Elimination System
111
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GLOSSARY OF TERMS AND ABBREVIATIONS
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
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
Based on the reviews of the generic data for the active ingredient dimethoxane (2,6-
Dimethyl-m-dioxan-4-ol acetate), the Environmental Protection Agency has sufficient
information on the health effects of dimethoxane and on its potential for causing adverse effects
in fish and wildlife in the environment. The Agency has determined that the dimethoxane
product, 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 all uses of the product containing dimethoxane are eligible for reregi strati on.
Dimethoxane (Giv-Gard DXN) is a fungicide, microbiocide/microbiostat formulated as
a liquid soluble concentrate. As an industrial preservative/antimicrobial agent, Giv-Gard DXN,
the only product containing dimethoxane currently registered, is used in the preservation of
numerous types of emulsions and water-based industrial processes and is not used on or in
finished products. This biocidal product offers protection against microbial spoilage or
contamination of another product during its manufacture or processing (i.e., industrial
preservative). It is used in the manufacturing process to control spoilage microorganisms
encountered in industrial emulsions and specialty industrial products, textiles, jet fuels, adhesives
and leather processing liquors.
The toxicological data base for dimethoxane suggests a low toxicity to mammals on an
acute and subchronic basis. Due to the low toxicity, neither short term (1 to 7 days) nor
intermediate term (1 week to several months) toxicological endpoints for occupational risk
assessment were identified. Also, dimethoxane is slightly toxic to practically nontoxic to avian
species on an acute oral and subacute dietary basis, and not more than slightly toxic to freshwater
fish and invertebrates.
Before reregistering the product containing dimethoxane, the Agency is requiring that
product specific data, revised Confidential Statements of Formula (CSF) and revised labeling be
submitted within eight months of the issuance of this document. These data include product
chemistry for each registration 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.
v
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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 which is comprised
of five phases. 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 dimethoxane. The document consists of six sections. Section I is the
introduction. Section II describes dimethoxane, 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 dimethoxane. Section
V discusses the reregi strati on requirements for dimethoxane. 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: Dimethoxane
• Chemical Name: 2,6-dimethyl-m-dioxan-4-ol acetate
• CAS Registry Number: 828-00-2
• OPP Chemical Code: 001001
• Empirical Formula: C8O4H14
• Trade and Other Names: Dimethoxane, Acetomethoxane
• Basic Manufacturer: Givaudan-Roure Corporation
B. Use Profile
The following is information on the currently registered uses with an overview of
use sites and application methods. A detailed table of these uses of dimethoxane is in
Appendix A.
For dimethoxane:
Type of Pesticide: Microbiocide/Microbiostat (slime-forming bacteria and fungi),
Bacteriostat, Fungicide
Use Sites:
INDOOR NON-FOOD:
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The intent of this biocidal product is to offer protection against microbial
spoilage or contamination of another product during its manufacture or processing
(i.e. industrial preservative). As an industrial preservative/antimicrobial agent,
Giv-Gard DXN has been found to be important in the preservation of numerous
types of emulsions and water-based industrial processes. These registered uses
include the following:
1) Emulsions (latex, PVA (polyvinyl alcohol), silicone, oil, acrylic,
polyethylene, PVC (polyvinyl chloride), etc.).
2) Paints (emulsion)
3) Coatings, industrial, preservatives
4) Specialty industrial products/preservatives (e.g., pigment slurries,
dyestuffs, inks, thickeners/gums, lignosulfonates)
5) Textile chemicals and finishes (such as dye levelers, textile auxiliaries,
softeners, lubricants, antistats, sizings, print pastes, etc.)
6) Adhesives, industrial/preservatives
7) Leather processing liquors (e.g., wet processing leather finishes)
9) Distillate fuels
PVA
Giv-Gard DXN is added to PVA emulsions to protect these emulsions from
damage caused by microbial organisms. The emulsions in turn are used as
components in the manufacture of industrial adhesives.
Silicone
Giv-Gard DXN is added to silicone emulsions to protect these emulsions
from damage caused by microbial organisms. The emulsions in turn are used in
either the manufacture of caulks, sealants, etc. for the construction industry or
incorporated into softeners, lubricants, etc., utilized by the textile industry during
the manufacture of fibers/yarns.
Thickeners/Gums
Giv-Gard DXN is added to thickeners/gums to protect these materials from
damage caused by microbial organisms. These materials are used in the
production (i.e., manufacture) of carpets and fabrics as dyeing and printing
auxiliaries such as print pastes, pigment pastes, or adhesives.
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Textile Auxiliaries
Giv-Gard DXN is added to "auxiliaries" used in the production of textiles
to protect these agents from damage caused by microbial organisms. These
industrial auxiliaries include dyestuffs, softeners, sizings, print pastes and
lubricants.
Target Pests: Spoilage microorganisms, gram positive and gram negative
bacteria, yeast, and fungi.
Formulation Types Registered: Soluble concentrate/liquid; 87%
Method and Rates of Application:
Equipment - Not specified
Method and Rate - For industrial preservative treatment of emulsions,
paints, coatings, specialty industrial products, textile chemicals and
finishes, industrial adhesives and leather processing liquors - 870 ppm to
1740 ppm active ingredient by weight.
For preservative treatment of distillate fuels - 870 ppm to 1740 ppm active
ingredient by weight.
Timing - During manufacture, not specified
Use Practice Limitations:
Compatibility with systems containing amides or amines warrants careful
examination because product may cause discoloration in such systems.
C. Estimated Usage of Pesticide
The only source available which can provide a quantitative estimate of usage of
dimethoxane is The Federal Insecticide, Fungicide, and Rodenticide Act as Amended,
Section 7 data, which is Confidential Business Information and cannot be published since
currently there is only one registrant. One source, Kline and Co. Inc., which addresses
specialty biocides, gives usage estimates only for major active ingredients or products.
Kline does not provide a quantitative estimate of dimethoxane use or list it as a major
chemical on any site. Kline does state that dimethoxane's greatest usage is as a
preservative of aqueous emulsions used in the textile industry.
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D Regulatory History
The first product containing dimethoxane, 2,6-Dimethyl-m-dioxan-4-ol acetate,
as an active ingredient was registered in the United States in 1962. Currently, one product
is registered for use. The 1987 antimicrobial Data Call-In (DCI) required the submission
of a variety of subchronic and chronic toxicology and occupational exposure studies. The
reregi strati on Phase IV DCI was issued in 1992.
III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Color: Clear yellow to light amber
Physical State: Liquid
Odor: Characteristic halide odor. Strong odor at 25 °C
Boiling Point: 66-68°C at 3 mm Hg
Density: 1.060 - 1.075 at 25 °C
Solubility: > 2 gm in Methanol, Hexane & Water @ 25 °C. Not stable
in water. The approximate saturation point of test sample:
Methanol: 3.11 x 103
Hexane: 2.25 x 103
Water: 2.38 x 103
Vapor Pressure 0.111 mm Hg at 23 °C
pH: 5.8at25°C
Stability: Stable after exposure to Zinc foil (a reducing agent). Not
stable at:
(a) low temperatures (-2 to 9°C) after 48 hours
(b) high temp. (53-54°C) for 2 weeks.
(c) simulated sunlight (Xenon) for 24 hours.
B. Human Health Assessment
1. Toxicology Assessment
Adequate animal toxicological data on dimethoxane are available and will
support reregistration eligibility as a non-food use pesticide. The data are reported
below.
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a. Acute Toxicity
TEST
Oral LDffl-rat
Dermal LDffl-rat
Inhalation LCffl-rat
Eye Irritation-rabbit*
Dermal Irritation-rabbit*
Dermal Sensitization-guinea pig*
*Note: Data pertaining to eye intation, dennal irntation and
RESULTS
>2000 mg/kg
>2000 mg/kg
>4.0 mg/L
mild irritation
slight irritation
strong sensitizer
dermal sensitization are not required to support tne reregistration ot tne
CATEGORY
III
III
III
III
IV
--
GAI. Ihese data are presented lor international purposes.
An acute oral toxicity study in rats found the LD50 was greater than
2000 mg/kg which is toxicity category III (guideline 81-1, MRID
43528501). An acute dermal toxicity study with rats found the LD50 was
greater than 2000 mg/kg, which is toxicity category III (guideline 81-2,
MRID 42667701). In an acute inhalation study with rats, the LD50 was
greater than 4.0 mg/L, which is toxicity category III (guideline 81-3,
MRID 41936702).
In a primary eye irritation study, rabbits had mild transient ocular
irritation, which is toxicity category III (guideline 81-4, MRID 41641102).
In a primary dermal irritation study with rabbits, there was slight erythema,
with irritation clearing in all but one animal by 48 hours. This is toxicity
category IV (guideline 81-5; MRID 41641101).
When a dermal sensitization study was conducted with guinea pigs,
dimethoxane was shown to be a strong sensitizer (guideline 81-6; MRID
41936703).
b. Subchronic Toxicity
Dimethoxane was administered dermally to Sprague Dawley rats
for three months. The doses were 0, 100, 300, or 1000 mg/kg/day. Some
dermal irritation was observed at the dose site in the 1000 mg/kg/day
group. The two highest dose groups had, in males, reduced body weight
gains and in females, an increased incidence of hepatic changes, including
necrosis, inflammation, and hemorrhage. The NOEL was 100 mg/kg/day.
The LOEL was 300 mg/kg/day, based on these effects (guideline 82-2;
MRID 42952201).
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c. Carcinogenicity
The National Toxicology Program (NTP) conducted
carcinogenicity studies with commercial grade dimethoxane. With F344/N
rats, the males were given 0, 62.5, or 125 mg/kg/day and the females were
given 0, 125 or 250 mg/kg/day by gavage for two years. Acanthosis and
hyperkeratosis were increased in the forestomach of high dose rats. With
B6C3F1 mice, the males and females were given 0, 250, or 500 mg/kg/day
by gavage for two years. Acanthosis, hyperkeratosis, focal hyperplasia,
and chronic inflammation were increased in the forestomach of dosed
mice. With an increased incidence of squamous cell papillomas of the
forestomach in high dose male mice, NTP concluded that there was
equivocal evidence of carcinogenicity for male mice. However, there was
no evidence of dimethoxane carcinogenicity in female mice or in male or
female rats. (NTP, 1989).
d. Developmental Toxicity
Sprague Dawley rats were given doses of 0, 60, 300, or 900
mg/kg/day of dimethoxane by gavage on gestation days 6-15. The NOEL
for maternal toxicity was 300 mg/kg/day. The LOEL was 900 mg/kg/day,
based on reduced body weight gain and reduced food consumption. The
NOEL for developmental toxicity was 900 mg/kg/day, the highest dose
tested (guideline 83-3; MRID 41151401).
e. Mutagenicity
Dimethoxane is not mutagenic in the standard Ames battery of
bacterial strains, with or without activation (MRID 41144101).
Dimethoxane did not cause DNA damage or induce repair in the rat
hepatocyte unscheduled DNA synthesis assay (MRID 41144103).
However, the chemical was clastogenic in Chinese hamster ovary cells
with activation but was negative without activation (guideline 84-2; MRID
41144102).
f. Toxic Endpoints of Concern:
Based upon the review of the toxicology data base for dimethoxane,
neither short term (1 to 7 days) nor intermediate term (1 week to several
months) toxicological endpoints for occupational/residential risk
assessment were identified due to low toxicity and minor effects.
Therefore, no assessment is required for acute dietary risk or occupational
risk.
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g. Reference Dose
This chemical has no food uses, therefore, no RfD value has been
identified for dimethoxane.
2. Exposure Assessment
a. Occupational and Residential
1. Use Patterns
As indicated, dimethoxane is a fungicide,
microbiocide/microbiostat and bacteriostat formulated as a liquid
soluble concentrate. It is used as a preservative in
commercial/industrial formulation of in-can latex paints
(approximate 0.1% by weight as maximum dosage), in fuel/oil
storage tank bottom water (approximate 0.1% by weight as
maximum dosage), emulsion paints and inks, specialty industrial
products/preservatives, textile presevatives, adhesives, leather
processing liquors, and distillate fuels.
Giv-Gard DXN, the only product containing dimethoxane
currently registered (Reg. No. 824-7), contains 87% dimethoxane.
This product is registered only for use in industrial settings. Both
open-pour and closed delivery systems are acceptable application
methods for dimethoxane. There are no residential uses registered
for the dimethoxane product.
There are no registered uses of dimethoxane within the
scope of the Agency's Worker Protection Standard for Agricultural
Pesticides (WPS); i.e., no uses registered for use in the production
of food, feed, fiber, ornamental, turf, or tree crops.
2. Handler (Mixer/Loaders and Applicators) Exposure
Dimethoxane exposure to handlers is possible when workers
handle the preservative in industrial settings. For those handlers
using open pouring application methods, there is the potential for
respiratory, dermal, and eye exposure. By comparison, potential
exposure to handlers using closed delivery systems is expected to
be significantly reduced.
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3. Post Application Exposure
There are several types of potential exposure to persons
after application is complete. These include:
a. Potential exposure, especially inhalation exposure,
to industrial/manufacturing workers immediately
after dimethoxane use.
b. Potential exposure, including dermal and inhalation
exposure, when substances (such as paints)
containing dimethoxane are used.
Based on dimethoxane use patterns, exposure to workers in
the industrial setting is possible immediately following
dimethoxane use. Due to the chemical properties of dimethoxane
(low vapor pressure, etc.), post-application inhalation exposure to
workers is expected to be minimal. Also, exposure to individuals
who use dimethoxane products (such as paints) is possible, but the
amount of dimethoxane contained in these products is so small that
resulting toxic effects are expected to be negligible.
3. Risk Assessment
a. Occupational and Residential
All uses of dimethoxane are outside of the scope of the Agency's
Worker Protection Standard and there are no special toxicological
concerns about dimethoxane that warrant the establishment of active-
ingredient-based personal protective equipment (PPE).
Based on the available toxicity information and use patterns for
dimethoxane, the Agency has completed a qualitative assessment of
exposure and cancer risk based on the National Toxicology Program
studies and conservative occupational exposure assumptions. The
assessment indicates no significant human cancer risk.
Based on the existing use patterns of dimethoxane, post-application
exposure data are not required. Due to the chemical properties of
dimethoxane (low vapor pressure, etc.), post-application inhalation
exposure to workers is expected to be minimal. Also, exposure to
individuals who use dimethoxane products (such as paints) is possible, but
-------
the amount of dimethoxane contained in these products is so small that
resulting toxic effects are expected to be negligible.
C. Environmental Assessment
1. Ecological Toxicity Data
The ecotoxicological data base is adequate to characterize the toxicity of
dimethoxane to nontarget terrestrial and aquatic organisms when used as an
indoor, nonfood use microbiostat/fungistat. There is no direct use or application
of this peticide outdoors. Any significant hazard would presumably result from
a transportation accident, spill, or purposeful discharge into the environment. Any
such environmental contamination would have minimal impact on avian and
aquatic species given the results of the studies described below.
a. Toxicity to Terrestrial Animals
(1) Birds, Acute and Subacute
In order to establish the toxicity of dimethoxane to birds, the
following tests are required using the technical grade material: one
avian single-dose oral (LD50) study on one species (preferably
mallard or bobwhite quail); one subacute dietary study (LC50) on
one species of waterfowl (preferably the mallard duck) or one
species of upland game bird (preferably bobwhite quail or ring-
necked pheasant).
Avian Acute Oral Toxicity Findings
Species
Bobwhite Quail
% Test
Material
(TGAI)
92.0
LD50 mg/kg
1585
Conclusion
slightly toxic
10
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Avian Subacute Dietary Toxicity Findings
Species
Bobwhite Quail
Mallard Duck
% Test
Material
92.0
92.0
LC50 ppm
>5620
>5620
Conclusions
practically nontoxic
practically nontoxic
These results indicate that dimethoxane is slightly toxic to
practically nontoxic to avian species on an acute oral and subacute dietary
basis. The guideline requirements are fulfilled. (MRID 41962502,
41962503 and 41962504)
b. Toxicity to Aquatic Animals
(1) Freshwater Fish
In order to establish the toxicity of dimethoxane to
freshwater fish, the minimum data required on the technical grade
of the active ingredient is one freshwater fish toxicity study. The
study should use a coldwater species (preferably the rainbow trout)
or a warmwater species (preferably the bluegill sunfish).
Freshwater Fish Acute Toxicity Findings
Species
Rainbow trout
% Test
Material
(TGAI)
88.5
LC50 ppm a.i.
>37.0
Conclusions
not more than slightly
toxic
Although the submitted 96-hour acute toxicity study did not define a
precise LC50 value, the results did demonstrate that dimethoxane is not more than
slightly toxic to both cold and warm water fish. The study was scientifically
sound, but the test deviated from specified methods in the EPA standard guideline
protocol such that in lieu of a calculated LC50, the test indicated the LC50 to be
greater than 37 ppm of active ingredient. A greater than 100 ppm toxicity
category indicates that the pesticide's toxicity category is practically nontoxic to
aquatic organisms. The No Observed Effect Concentration (NOEC) was
11
-------
determined to be 1 ppm. The guideline requirement is not fulfilled; however, at
this time, dimethoxane is registered only for indoor uses. As a result, minimal
exposure to wildlife is expected. Therefore, the data are sufficient for the indoor
use pattern such that the study does not need to be repeated. (MRID 41936701)
(2)
Freshwater Invertebrates
The minimum testing required to assess the hazard of
dimethoxane to freshwater invertebrates is a freshwater aquatic
invertebrate toxicity test, preferably using first instar Daphnia
magna or early instar amphipods, stoneflies, mayflies, or midges.
Freshwater Invertebrate Toxicity Findings
Species
Daphnia
magna
% Test
Material
(TGAI)
88.5
EC50 ppm a.i.
>24.0
Conclusions
not more than slightly
toxic
Although the submitted 48-hour acute toxicity study did not define a
precise EC50 value, the results did demonstrate that dimethoxane is not more than
slightly toxic to aquatic invertebrates. The study was scientifically sound, but the
test deviated from specified methods in the EPA standard guideline protocol such
that in lieu of a calculated EC50, the test indicated the EC50 to be greater than 24
ppm of active ingredient. A greater than 100 ppm toxicity category indicates that
the pesticide's toxicity is practically nontoxic to aquatic organisms. The No
Observed Effect Concentration (NOEC) was determined to be 13 ppm. The
guideline requirement is not fulfilled; however, at this time, dimethoxane is
registered only for indoor uses. As a result, minimal exposure to wildlife is
expected. Therefore, the data are sufficient for the indoor use pattern such that the
study does not need to be repeated. (MRID 41962501)
2.
Environmental Fate
a.
Environmental Fate Assessment
The Agency has waived the requirement for a hydrolysis study.
The available data indicate that the major route of degradation is abiotic
hydrolysis aided by microbial mediated degradation. Further, the data
indicate that dimethoxane is highly unstable in water with over 50% of the
compound hydrolyzed in 2 hours. Dimethoxane is purported to react with
12
-------
water to form acetic acid and a transient intermediate, dioxinol. The
dioxinol then breaks down into acetaldehyde and aldol. The breakdown
into acetic acid and dioxinol is completed in 14 hours.
3. Exposure and Risk Characterization
Risk assessments are not conducted on nontarget organisms for
microbiocides having indoor nonfood uses without effluents. The
preservative uses of dimethoxane in emulsion paints, emulsion inks, jet
fuels, leather processing liquors, coatings, specialty industrial products,
textiles and adhesives are expected to result in minimal to no exposure to
the environment. The jet fuel use of dimethoxane, however, is associated
with periodic releases into the environment based on purging of jet fuel
storage tanks of "water bottoms" (small areas of condensation on the
bottom of the tank, which if not removed could cause leakage from rust
formation weakening the tank wall). However, the hazard to wildlife and
aquatic organisms from these registered indoor nonfood uses is expected
to be minimal because dimethoxane is not more than slightly toxic to fish
and aquatic invertebrates, and slightly to practically nontoxic to birds.
Tank bottom water must be disposed of in accordance with the U.S.
Environmental Protection Agency's Resource Conservation and Recovery
Act (RCRA).
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
ingredients 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 products containing dimethoxane active ingredients. The
Agency has completed its review of these generic data, and has determined that the data
are sufficient to support reregistration of all products containing dimethoxane. Appendix
B identifies the generic data requirements that the Agency reviewed as part of its
determination of reregistration eligibility of dimethoxane, and lists the submitted studies
that the Agency found acceptable.
The data identified in Appendix B were sufficient to allow the Agency to assess
the registered uses of dimethoxane and to determine that dimethoxane can be used
without resulting in unreasonable adverse effects to humans and the environment. The
Agency therefore finds that all products containing dimethoxane as the active ingredients
13
-------
are eligible for reregi strati on. The reregi strati on of particular products is addressed in
Section V of this document.
The Agency made its reregistration eligibility determination based upon the target
data base required for reregistration, the current guidelines for conducting acceptable
studies to generate such data, published scientific literature, etc. and the data identified
in Appendix B. Although the Agency has found that all uses of dimethoxane are eligible
for reregistration, it should be understood that the Agency may take appropriate
regulatory action, and/or require the submission of additional data to support the
registration of products containing dimethoxane, 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 ingredients
dimethoxane, the Agency has sufficient information on the health effects of
dimethoxane and on its potential for causing adverse effects in fish and wildlife
and the environment. The Agency has determined that dimethoxane products,
labeled and used as specified in this Reregistration Eligibility Decision, will not
pose unreasonable risks or adverse effects to humans or the environment.
Therefore, the Agency concludes that all uses for the product containing
dimethoxane are eligible for reregistration.
2. Eligible and Ineligible Uses
The Agency has determined that all uses of dimethoxane are eligible for
reregistration.
C. Regulatory Position
The following is a summary of the regulatory positions and rationales for
dimethoxane. Where labeling revisions are imposed, specific language is set forth in
Section V of this document.
1. Labeling Rationale
Dimethoxane is classified as a strong skin sensitizer. Therefore, the
Agency requires a precautionary statement about skin sensitization to be placed
on the labeling. The minimum personal protective equipment (PPE) for users of
14
-------
Giv-Gard DXN is long-sleeved shirt, long pants, shoes, socks, and chemical-
resistant gloves.
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 dimethoxane for the
above eligible uses has been reviewed and determined to be substantially
complete. However, an hydrolysis study is required as confirmatory data.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility
has been made. The product specific data requirements are listed in Appendix G,
the Product Specific Data Call-In Notice.
Registrants must review previous data submissions to ensure that they meet
current EPA acceptance criteria (Appendix F; Attachment E) and if not, commit
to conduct new studies. If a registrant believes that previously submitted data
meet current testing standards, then study MRID numbers should be cited
according to the instructions in the Requirement Status and Registrants Response
Form provided for each product.
2. Labeling Requirements for End-Use Products
Labeling Requirements
The Agency is requiring the following labeling statements to be located on the
product:
"This product has not been cleared under the Federal Food Drug and
Cosmetic Act for use in the manufacture of adhesives and coatings that
may come in contact with food."
15
-------
Handler (Mixer, Loader, Applicator, Etc.) Personal Protective Equipment
(PPE): The PPE for pesticide handlers will be based on the acute toxicity of the
end-use product.
Application Restrictions:
"Do not apply this product in a way that will contact workers or other
persons. Only protected handlers amy be in the area during application."
Engineering Controls:
"When handlers use closed metering systems, the handler requirements
may be reduced or modified to long-sleeve shirt, long pants, shoes, and
socks."
User Safety Requirements:
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no
such instructions for washing, use detergent and hot water. Keep and wash
PPE separately from other laundry."
User Safety Recommendations:
"Users should remove clothing immediately if pesticide gets inside. Then
wash thoroughly and put on clean clothing."
"Users should remove PPE immediately after handling this product. Wash
the outside of gloves before removing. As soon as possible, wash
thoroughly and change into clean clothing."
Skin Sensitization Statement: [insert in the "Hazards to Humans (and Domestic
Animals)" section of the Precautionary Statements]
"This product may cause skin sensitization reaction in some people."
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 the
dimethoxane product bearing old labels/labeling for 26 months from the date of issuance
16
-------
of this RED. Persons other than the registrant may distribute or sell the product 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
-------
18
-------
VI. APPENDICES
19
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20
-------
Report Run Date: 11/14/95 ) Time 10:53
PRD Report Date: 03/10/94
Case 3064[Dimethoxane]
44444444444444444444444444
SITE Application Type, Application
Timing, Application Equipment )
APPENDIX A REPORT
Form(s) Min. Appl.
Rate (AI un-
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
less noted
otherwise)
LUIS 2.2 - Page:
Chemical 001001[Dimethoxane]
4444444444444444444444444444444444
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Rate (AI Tex. ® Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
(days) Interv Codes
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle
/crop
cycle
/year
[day(s)]
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON- FEED
ADHESIVES, INDUSTRIAL
Industrial preservative treatment, During SC/L
manufacture, Not on label, Not
Applicable, Not applicable for this use
COATINGS, INDUSTRIAL
Industrial preservative treatment, During SC/L
manufacture, Not on label, Not
Applicable, Not applicable for this use
EMULSIONS, RESIN/LATEX/POLYMER
Industrial preservative treatment, During SC/L
manufacture, Not on label, Not
Applicable, Not applicable for this use
FUELS/OIL STORAGE TANK BOTTOM WATER ADDITIVE
Preservative treatment, Not on label, Not SC/L
on label, Not Applicable, Not applicable
for this use
LEATHER PROCESSING LIQUORS
Industrial preservative treatment, During SC/L
manufacture, Not on label, Not
Applicable, Not applicable for this use
PAINTS (IN-CAN)
Industrial preservative treatment, During SC/L
manufacture, Not on label, Not
Applicable, Not applicable for this use
PAINTS, LATEX/OIL/VARNISH (APPLIED FILM)
Use Group: INDOOR NON-FOOD
W 1740 * NS NS NS
Use Group: INDOOR NON-FOOD
W 1740 * NS NS NS
Use Group: INDOOR NON-FOOD
W 1740 * NS NS NS
Use Group: INDOOR NON-FOOD
W 1740 * NS NS NS
Use Group: INDOOR NON-FOOD
W 1740 * NS NS NS
Use Group: INDOOR NON-FOOD
W 1740 * NS NS NS
Use Group: INDOOR NON-FOOD
A42, CIS, C24
A42, CIS, C24
A42, CIS, C24
A42, CIS, C24
A42, CIS, C24
A42, CIS, C24
21
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Report Run Date: 11/14/95
PRD Report Date: 03/10/94
Case 3064[Dimethoxane]
) Time 10:53
APPENDIX A REPORT
SITE Application Type, Application Form(s) Min. Appl.
Timing, Application Equipment ) Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
- Page:
Chemical 001001[Dimethoxane]
4444444444444444444444444444444444
Max. Appl. Soil Max. tt Apps Max. Dose [(AI
Rate (AI Tex. © Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
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 (con't)
PAINTS, LATEX/OIL/VARNISH (APPLIED FILM) (con't)
Preservative treatment, During SC/L W 870
manufacture, Not on label, Not
Applicable, Not applicable for this use
SPECIALITY INDUSTRIAL PRODUCTS
Industrial preservative treatment, During SC/L W 870
manufacture, Not on label, Not
Applicable, Not applicable for this use
WET-END ADDITIVES/INDUSTRIAL PROCESSING CHEMICALS
Industrial preservative treatment, During SC/L W 870
manufacture, Not on label, Not
Applicable, Not applicable for this use
Use Group: INDOOR NON-FOOD (con't)
W 1740 * NS NS NS NS NS
Use Group: INDOOR NON-FOOD
W 1740 * NS NS NS NS NS
Use Group: INDOOR NON-FOOD
W 1740 * NS NS NS NS NS
A42, CIS, C24
A42, CIS, C24
A42, CIS, C24
22
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Report Run Date: 11/14/95
PRD Report Date: 03/10/94
Case 3064[Dimethoxane]
) Time 10:53
APPENDIX A REPORT
- Page:
Chemical 001001[Dimethoxane]
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/L : SOLUBLE CONCENTRATE/LIQUID
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"
USE LIMITATIONS CODES
A42 : This use has not been cleared under the Federal Food, Drug, and Cosmetic Act for use in the manufacture of adhesives and coatings that may come in contact with food.
23
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Report Run Date: 11/14/95
PRD Report Date: 03/10/94
Case 3064[Dimethoxane]
) Time 10:53
APPENDIX A REPORT
- Page:
Chemical 001001[Dimethoxane]
USE LIMITATIONS CODES (Cont.)
CIS : Do not discharge effluent containing this pesticide into sewage systems without notifying the sewage treatment plant authority (POTW).
C24 : Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or public water. (NPDES license restriction)
* NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
24
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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 dimethoxane covered by this Reregi strati on Eligibility Decision
Document. It contains generic data requirements that apply to dimethoxane 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.
25
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Dimethoxane
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-1 Chemical Identity
61-2A Start. Mat. & Mnfg. Process
61-2B Formation of Impurities
62-1 Preliminary Analysis
62-2 Certification of limits
62-3 Analytical Method
63-2 Color
63-3 Physical State
63-4 Odor
63-5 Melting Point
63-6 Boiling Point
63-7 Density
63-8 Solubility
63-9 Vapor Pressure
63-10 Dissociation Constant
63-11 Octanol/Water Partition
63-12 pH
63-13 Stability
63-14 Oxidizing/Reducing Action
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
42389901,41678203
41678206
41678207
43256301
43104601, 41691401, 42389901
41691401,42389901
93090001
93090001
41678202
Inapplicable
93090001
93090001
41678201
41678205
Inapplicable
Inapplicable
41641106
41678204
Inapplicable
26
-------
Data Supporting Guideline Requirements for the Reregistration of Dimethoxane
REQUIREMENT
63-15
63-16
63-17
63-18
63-19
63-20
63-21
64-1
Flammability
Explodability
Storage stability
Viscosity
Miscibility
Corrosion characteristics
Dielectric breakdown volt
Submittal of Samples
USE PATTERN
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
CITATION(S)
41691402
Inapplicable
42267501
41641105
Inapplicable
41678203
Inapplicable
Inapplicable
ECOLOGICAL EFFECTS
71-1A
71-2A
72-1A
72-1C
72-2A
72-3A
72-3B
72-3C
Acute Avian Oral - Quail/Duck
Avian Dietary - Quail
Fish Toxicity Bluegill
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
Estuarine/Marine Toxicity - Fish
Estuarine/Marine Toxicity -
Mollusk
Estuarine/Marine Toxicity -
Shrimp
M
M
M
M
M
M
M
M
41962502
41962503
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
TOXICOLOGY
81-1
Acute Oral Toxicity - Rat
M
43528501
27
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Data Supporting Guideline Requirements for the Reregistration of Dimethoxane
REQUIREMENT
81-2
81-3
81-4
81-5
81-6
82-3
83-2A
83-2B
83-3A
83-3B
83-4
84-2A
84-2B
84-4
85-1
85-2
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
Oncogenicity - Rat
Oncogenicity - Mouse
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
Gene Mutation (Ames Test)
Structural Chromosomal
Aberration
Other Genotoxic Effects
General Metabolism
Dermal Penetration
USE PATTERN
M
M
M
M
M
M
M
M
M
M
M
M
M
M
M
M
CITATION(S)
42667701
41936702
41641102
41641101
41936703
42952201
WAIVED
WAIVED
41151401
WAIVED
WAIVED
41144101
41144102,41144103
41144103
WAIVED
WAIVED
28
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Data Supporting Guideline Requirements for the Reregistration of Dimethoxane
REQUIREMENT
USE PATTERN
CITATION(S)
OCCUPATIONAL/RESIDENTIAL EXPOSURE
133-3 Dermal Passive Dosimetry M
Exposure
133-4 Inhalation Passive Dosimetry M
Exposure
ENVIRONMENTAL FATE
160-5 Chemical Identity M
161-1 Hydrolysis M
161-2 Photodegradation - Water M
162-3 Anaerobic Aquatic Metabolism M
162-4 Aerobic Aquatic Metabolism M
163-1 Leaching/Adsorption/Desorption M
WAIVED
WAIVED
Letter reviewed 9/9/94, 42389901, 41678203
WAIVED
WAIVED
WAIVED
WAIVED
WAIVED
29
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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
as (19??), the Agency was unable to determine or estimate the date of the
document.
30
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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.
31
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BIBLIOGRAPHY
MRID
CITATION
41040501 Schroeder, R. (1989) A Range-finding Study to Evaluate the Toxicity of Giv
2-0494 in the Pregnant Rat: Proj. No. 88-3321. Unpublished study prepared by
190 p.
41144101 Valentine, D.; Lawlor, T. (1989) Mutagenicity Test on GIV 2-0494 in the Ames
Salmonella/Microsome Reverse Mutation Assay: Project ID 10696-0-401.
Unpublished study prepared by Hazelton Laboratories of America, Inc. 36 p.
41144102 Murli, H. (1989) Mutagenicity Test on GIV 2-0494 in an In Vitro Cytogenetic
Assay Measuring Chromosomal Aberration Frequencies in Chinese Hamster
Ovary (CHO) Cells: Project ID 10696-0-437. Unpublished study prepared by
Hazelton Laboratories America, Inc. 33 p.
41144103 Cifone, M. (1989) Mutagenicity Test on GIV 2-0494 in the Rat Primary
Hepatocyte Unscheduled DNA Synthesis Assay: Project ID 10696-0-447.
Unpublished study prepared by Hazelton Laboratories America, Inc. 25 p.
41151401 Schroeder, R. (1989) A Teratogenicity Study in Rats with Giv 2-0494: Project No.
88-3322. Unpublished study prepared by Bio/dynamics, Inc. 397 p.
41641101 Blaszcak, D. (1990) Primary Dermal Irritation Study in Rabbits with Giv 3-0494:
Final Report: Lab Project Number: 5754-89. Unpublished study prepared by
Bio/dynamics, Inc. 17 p.
41641102 Blaszcak, D. (1990) Primary Eye Irritation Study in Rabbits with Giv 2-0494:
Final Report: Lab Project Number: 5755-89. Unpublished study prepared by
Bio/dynamics, Inc. 21 p.
41641105 Pesselman, R. (1990) Determination of Viscosity of Giv 2-0494: Final Report: Lab
Project Number: HLA 6001-563. Unpublished study prepared by Hazleton
Laboratories America, Inc. 28 p.
41641106 Pesselman, R. (1990) pH Value Determination of Giv 2-0494: Lab Project
Number: HLA 6001-561. Unpublished study prepared by Hazleton Laboratories
America, Inc. 26 p.
32
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BIBLIOGRAPHY
MRID
CITATION
41678201 Pesselman, R. (1990) Solubility Determination of Giv 2-0494: Final Report: Lab
Project Number: HLA 6001-559. Unpublished study prepared by Hazleton Labs
America, Inc. 37 p.
41678202 Pesselman, R. (1990) Odor Determination of Giv 2-0494: Final Report: Lab
Project Number: HLA 6001-558. Unpublished study prepared by Hazleton Labs
America, Inc. 25 p.
41678203 Pesselman, R. (1990) Determination of Corrosion Characteristics of Givaudan
2-0494: Final Report. Lab Project Number: HLA 6001564. Unpublished study
prepared by Hazleton Labs America, Inc. 25 p.
41678204 Pesselman, R. (1990) Stability Determination of Giv 2-0494: Final Report: Lab
Project Number: HLA 6001-562. Unpublished study prepared by Hazleton Labs
America, Inc. 27 p.
41678205 Pesselman, R. (1990) Vapor Pressure Determination of Giv 2-0494: Final Report:
Lab Project Number: HLA 6001-560. Unpublished study prepared by Hazleton
Labs America, Inc. 37 p.
41678206 Virgilio, J. (1990) GivGard DXN: Manufacturing Process: Lab Project Number:
DXN 10/90A. Unpublished study prepared by Givaudan Corp. 7 p.
41678207 Virgilio, J. (1990) Discussion of the Formation of Impurities in GivGard DXN:
Lab Project Number: DXN 10/90B. Unpublished study prepared by Givaudan
Corp. 27 p.
41691401 Virgilio, J. (1990) Analysis and Certification of Product Ingredients for GivGard
DXN (Brand of Dimethoxane), ... Containing the Active Ingredient
Dimethyl-m-dioxan-4-ol acetate: Lab Project Number: DXN-10/90C.
Unpublished study prepared by Givaudan Corp. 7 p.
41691402 Lewis, B. (1990) Determination of the Flammability (Flash Point) of GivGard
DXN (Brand of Dimethoxane), ... Containing the Active Ingredient
Dimethyl-m-dioxane-4-ol acetate: Lab Project Number: DXN-10/90D.
Unpublished study prepared by Givaudan Corp. lip.
33
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BIBLIOGRAPHY
MRID
CITATION
41895001 Leak, T.; Mihalik, R. (1991) Method Validation for the Analysis of Giv-Gard
DXN in Aquatic Test Water: Lab Project Number: 39170. Unpublished study
prepared by ABC Labs, Inc. 94 p.
41936702 Hoffman, G. (1991) An Acute Inhalation Toxicity Study of DXN in the Rat: Final
Report: Lab Project Number: 90-8303. Unpublished study prepared by
Bio/dynamics, Inc. 87 p.
41936703 Blasczak, D. (1991) Guinea Pig Maximization Test with DXN (Method of
Magnusson and Kligman): Lab Project Number: 5995-91. Unpublished study
prepared by Bio/dynamics, Inc. 29 p.
41962502 Campbell, S.; Grimes, I; Lynn, S.; et al. (1991) DXN: An Acute Oral Toxicity
Study with the Northern Bob white: Lab Project Number: 233-106. Unpublished
study prepared by Wildlife International, Ltd. 35 p.
41962503 Beavers, I; Grimes, I; Lynn, S. (1991) DXN: A Dietary LC50 Study With the
Mallard: Lab Project Number: 233-105. Unpublished study prepared by Wildlife
International, Ltd. 36 p.
41962504 Beavers, I; Grimes, I; Lynn, S. (1991) DXN: A Dietary LC50 Study With the
Bobwhite: Lab Project Number: 233-104. Unpublished study prepared by
Wildlife International, Ltd. 36 p.
42267501 Pesselman, R (1992) Determination of Storage Stability of Giv 2-0494: Lab
Project Number: HLA 6001-581. Unpublished study prepared by Hazleton
Laboratories America, Inc. 35 p.
42389901 Lewis, B. (1992) Chemical Identity, Analysis and Certification of Product
Ingredients for Giv-Gard DXN (Brand of Dimethoxane), EPA Registration No
824-7, Containing the Active Ingredient Dimethyl-m-dioxan-4-ol acetate:
Supplemental Data for MRID 41691401: Lab Project Number: DXN-6/92.
Unpublished study prepared by Givaudan-Roure Corp. lip.
42667701 Blaszcak, D. (1993) Acute Dermal Toxicity Study of DXN in Rats: Final Report:
Lab Project Number: 92-0672. Unpublished study prepared by Bio/dynamics, Inc.
19 p.
34
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BIBLIOGRAPHY
MRID
CITATION
42952201 Blaszcak, D. (1993) A Subchronic (3-Month) Dermal Toxicity Study of DXN in
the Rat: Final Report: Lab Project Number: 92-2203. Unpublished study prepared
by Pharmaco LSR, Inc. 498 p.
43104601 Lewis, B. (1994) Chemical Identity, Analysis and Certification of Product
Ingredients for Giv-Gard DXN (Brand of Dimethoxane), EPA Registration No.
824-7, Containing the Active Ingredient Dimethyl-m-dioxan-4-ol acetate: Revised
Final Report: Lab Project Number: DXN/6/92/R. Unpublished study prepared by
Givaudan-Roure Corp. lip.
43256301 Lewis, B. (1994) Revision of MRID #43104601»Chemical Identity, Analysis and
Certification of Product Ingredients for Giv-Gard DXN (Brand of Dimethoxane)
Containing the Active Ingredient Dimethyl-m-dioxan-4-ol acetate: Lab Project
Number: DXN/5/94. Unpublished study prepared by Givaudan-Roure Corp. 14
P-
43326901 Guo, C.; Guo, M. (1994) Feasibility Studies on Synthesis and HPLC Separation
of Giv-Gard DXN on Small Scale in Support of Pending Hydrolysis Study: Lab
Project Number: 41488. Unpublished study prepared by ABC Laboratories, Inc.
27 p.
43528501 Blaszcak, D. (1994) Acute Oral Toxicity Study with GIV-GARD DXN in Rats:
Final Report: Lab Project Number: 94/1016. Unpublished study prepared by
Pharmaco LSR Inc. 36 p.
93090001 Lewis, B.; Manowitz, M. (1990) Givaudan Phase 3 Reformat of MRID 00022270.
Physical and Chemical Characteristics of 2,6-Dimethyl-m-dioxan4-ol acetate.
Prepared by GIVAUDAN CORP. 9 p.
35
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$
_ ° UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
%j"
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), 1 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-
0107 (expiration date 12-31-92).
36
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This Notice is divided into six sections and seven Attachments. The Notice itself
contains information and instructions applicable to all Data Call-in Notices. The Attachments
contain specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section 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, and Product Specific Data Report
Form
SECTION I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient and reevaluated the
data needed to support continued registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product specific data. No additional
generic data requirements are being imposed. You have been sent this Notice because you
have product(s) containing the subject active ingredient.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The product specific data required by this Notice are specified in Attachment 3,
Requirements Status and Registrant's Response Form. Depending on the results of the studies
required in this Notice, additional testing may be required.
37
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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
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the OECD
protocols, they should be modified as appropriate so that the data generated by the study will
satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend deadlines for
complying with data requirements when the studies were not conducted in accordance with
acceptable standards. The OECD protocols are available from OECD, 1750 Pennsylvania Avenue
N.W., Washington, D.C. 20006.
All new studies and proposed protocols submitted in response to this Data Call-in Notice
must be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
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
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The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice or
(c) request a data waiver (s).
A discussion of how to respond if you chose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product specific
data requirements of this Notice is contained in Section 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.
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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
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
40
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request for extension is not made in a timely fashion; in no event shall an extension request be
considered if it is submitted at or after the lapse of the subject deadline.
Option 2, Agreement to Share in Cost to Develop Data — Registrants may only choose
this option for acute toxicity data and certain efficacy data and only if EPA has indicated in the
attached data tables that your product and at least one other product are similar for purposes of
depending on the same data. If this is the case, data may be generated for just one of the products
in the group. The registration number of the product for which data will be submitted must be
noted in the agreement to cost share by the registrant selecting this option. If you choose to enter
into an agreement to share in the cost of producing the required data but will not be submitting
the data yourself, you must provide the name of the registrant who will be submitting the data.
You must also provide EPA with documentary evidence that an agreement has been formed. Such
evidence may be your letter offering to join in an agreement and the other registrant's acceptance
of your offer, or a written statement by the parties that an agreement exists. The agreement to
produce the data need not specify all of the terms of the final arrangement between the parties or
the mechanism to resolve the terms. Section 3(c)(2)(B) provides that if the parties cannot resolve
the terms of the agreement they may resolve their differences through binding arbitration.
Option 3, Offer to Share in the Cost of Data Development — This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. If you have made an offer
to pay in an attempt to enter into an agreement or amend an existing agreement to meet the
requirements of this Notice and have been unsuccessful, you may request EPA (by selecting this
option) to exercise its discretion not to suspend your registration(s), although you do not comply
with the data submission requirements of this Notice. EPA has determined that as a general
policy, absent other relevant considerations, it will not suspend the registration of a product of a
registrant who has in good faith sought and continues to seek to enter into a joint data
development/cost sharing program, but the other registrant(s) developing the data has refused to
accept your offer. To qualify for this option, you must submit documentation to the Agency
proving that you have made an offer to another registrant (who has an obligation to submit data)
to share in the burden of developing that data. You must also submit to the Agency a completed
EPA Form 8570-32, Certification of Offer to Cost Share in the Development of Data, Attachment
7. In addition, you must demonstrate that the other registrant to whom the offer was made has
not accepted your offer to enter into a cost sharing agreement by including a copy of your offer
and proof of the other registrant's receipt of that offer (such as a certified mail receipt). Your
offer must, in addition to anything else, offer to share in the burden of producing the data upon
terms to be agreed or failing agreement to be bound by binding arbitration as provided by 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
41
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you commit to submit, and do submit the required data in the specified time frame. In such cases,
the Agency generally will not grant a time extension for submitting the data.
Option 4, Submitting an Existing Study — If you choose to submit an existing study in
response to this Notice, you must determine that the study satisfies the requirements imposed by
this Notice. You may only submit a study that has not been previously submitted to the Agency
or previously cited by anyone. Existing studies are studies which predate issuance of this Notice.
Do not use this option if you are submitting data to upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the
required date of submission. The Agency may determine at any time that a study is not valid and
needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data
and specimens from the study are available for audit and review and you must
identify where they are available. This must be done in accordance with the
requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR Part 160.
As stated in 40 CFR 160.3(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
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which states the Agency's policy regarding acceptable protocols. If you wish to
submit the study, you must, in addition to certifying that the purposes of the PAG
are met by the study, clearly articulate the rationale why you believe the study
meets the purpose of the PAG, including copies of any supporting information or
data. It has been the Agency's experience that studies completed prior to January
1970 rarely satisfied the purpose of the PAG and that necessary raw data are
usually not available for such studies.
If you submit an existing study, you must certify that the study meets all requirements of
the criteria outlined above.
If 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
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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.
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.
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3. Failure to submit on the required schedule an adequate progress report on a study
as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this
Notice.
5. Failure to take a required action or submit adequate information pertaining to any
option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task
Forces, failure to comply with the terms of an agreement or arbitration concerning
joint data development or failure to comply with any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost of
developing data and provided proof of the registrant's receipt of such offer or
failure of a registrant on whom you rely for a generic data exemption either to:
a. inform EPA of intent to develop and submit the data required by this Notice
on a Data 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
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to, those relating to test material, test procedures, selection of species, number of animals,
sex and distribution of animals, dose and effect levels to be tested or attained, duration of
test, and, as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation
of any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting,
the completeness of results, and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or included in this Notice or
contained in PR 86-5. All studies must be submitted in the form of a final report; a
preliminary report will not be considered to fulfill the submission requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR 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.
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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
whatever source, including but not limited to interim or preliminary results of studies, regarding
unreasonable adverse effects on man or the environment. This requirement continues as long as
the products are registered by the Agency.
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SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(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 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 Product Specific Data Report Form
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DIMETHOXANE DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing dimethoxane.
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
dimethoxane. This attachment is to be used in conjunction with (1) the Product Specific Data Call-
in Notice, (2) the Product Specific Data Call-In Response Form (Attachment 2), (3) the
Requirements Status and Registrant's Form (Attachment 3), (4) EPA's Grouping of End-Use
Products for Meeting Acute Toxicology Data Requirement (Attachment 4), (5) the EPA Acceptance
Criteria (Attachment 5), (6) a list of registrants receiving this DCI (Attachment 6) and (7) the Cost
Share and Data Compensation Forms in replying to this dimethoxane Product Specific Data Call-In
(Attachment 7). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for dimethoxane are
contained in the Requirements Status and Registrant's Response. Attachment 3. The Agency has
concluded that additional data on dimethoxane 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 dimethoxane products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the generic database of dimethoxane, please contact C
PMoran at (703) 308-8590.
All responses to this Notice for the Product Specific data requirements should be submitted
to:
C P Moran
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: dimethoxane
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4. Already completed by EPA.
Item 5. If you wish to voluntarily cancel your product, answer "yes." If you choose this
option, you 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 information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another company or that you have already
voluntarily canceled this product. For these cases, please supply all relevant details
so that EPA can ensure that its records are correct.
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Insert Part A of the DCI here and remove this page.
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INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORM FOR PRODUCT SPECIFIC DATA
Item 1-3 Completed by EPA. Note the unique identifier number assigned by EPA in Item
3 This number must be used in the transmittal document for any data
submissions in response to this Data Call-In Notice.
Item 4. The 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 Document unless EPA
determines that a longer time period is necessary.
Item 9. Enter only one of the following response codes for each data requirement to
show how you intend to comply with the data requirements listed 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 Compensation 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
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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 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).
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 offer to another registrant (who has an
obligation to submit data) to share in the cost of that data. I am also submitting a
completed "Certification of Offer to Cost Share in the Development Data" form
I am including a copy of my offer and proof of the other registrant's receipt of that
offer. I am identifying the party which is committing to submit or provide the
required 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 Compensation
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 Study). I certify that
this study will meet all the requirements for submittal of existing data outlined in
Option 4 in the Data Call-In Notice (Section 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 (EPA 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 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).
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 Compensation Requirements" form (EPA Form 8570-29) and (2) two
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7.
completed and signed copies of the Confidential Statement of Formula (EPA
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 Compensation Requirements" form (EPA Form 8570-29) and (2) two
completed and signed copies of the Confidential Statement of Formula (EPA
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 information that does not fit on this form in a signed
letter that accompanies this form. For example, you may wish to report that your
product has already been transferred to another company or that you have already
voluntarily canceled this product. For these cases, please supply all relevant details
so that EPA can ensure that its records are correct.
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Insert Page 1 of Part B here and remove this page.
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Insert PageZ of Part B here and remove this page.
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Insert Page 3 of Part B here and remove this page.
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Insert Page 4 of Part B here and remove this page.
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THERE IS NO BATCHING FOR THIS CASE
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ATTENTION CRM::: PLEASE NOTE:::
REMOVE THIS PAGE AND INSERT THE LIST OF
REGISTRANTS RECEIVING THIS DCI
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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.
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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 Name
Company Number
Product Name
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
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United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
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)
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The following is a list of available documents that may further assist you in responding
to this Reregistration Eligibility Decision Document. These documents may be obtained by
the following methods listed below:
1. Printed copies of this RED and fact sheet may be obtained from EPA's National
Center for Environmental Publications and Information (EPA/NCEPI), PO Box 42419,
Cincinnati, OH 45242-0419, telephone 513-489-8190, fax 513-489-8695.
2. Health and Environmental Effects Science Chapters: You must request copies
of these documents by writing to the individual listed on the Chemical Status
Sheet.
3. Detailed Label Usage Information System (LUIS) Report: You must request
copies of these documents by writing to the individual listed on the Chemical
Status Sheet.
3. The Label Review Manual: You must request this document by writing to
the individual listed on the Chemical Status Sheet.
The following documents may also be obtained electronically by the following
methods:
They can downloaded from the Pesticide Special Review and Reregistration
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.
4. PR Notice 86-5 [Standard format for data submitted under the Federal
Insecticide, Fungicide, and Rodenticide Act (FIFRA) and certain providsions of
the Federal Food, Drug, and Cosmetic Act (FFDCA)].
5. PR Notice 91-2 [Accuracy of Stated Percentages for Ingredients Statement].
6. Fact Sheet document for this case.
7. The RED document for this case.
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