United States Prevention, Pesticides EPA-738-R-96-007
Environmental Protection And Toxic Substances August 1996
Agency (7508W)
&EPA Reregi strati on
Eligibility Decision (RED)
4,4-Dimethyloxazolidine
-------
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
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 chemical case 4,4-
dimethyloxazolidine. The enclosed Reregi strati on Eligibility Decision (RED) contains the
Agency's evaluation of the data base of this chemical, its conclusions of the potential human
health and environmental risks of the current product uses, and its decisions and conditions under
which these uses and products will be eligible for reregi strati on. The RED includes the data and
labeling requirements for products for reregistration. 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 is due 90 days from the receipt of this
letter. The second set of required responses is due 8 months from the receipt of this letter.
Complete and timely responses will avoid the Agency taking the enforcement action of
suspension against your products.
Please note that this RED was finalized and signed prior to August 3, 1996. On that date,
the Food Quality Protection Act of 1996 (FQPA) became effective, amending portions of both
the pesticide law (FIFRA) and the food and drug law (FFDCA). This RED does not address any
issues raised by FQPA, and any tolerance-related statements in the RED do not take into account
any changes in tolerance assessment procedures required under FQPA.
If you have questions on the product specific data requirements or wish to meet with the
Agency, please contact the Special Review and Reregistration Division representative Jean
Holmes at (703) 308-8008. Address any questions on required generic data to the Special
Review and Reregistration Division representative Marie Boucher at (703) 308-8178.
Sincerely yours,
Lois Rossi, Division Director
Special Review
and Reregistration Division
Enclosures
-------
SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1 DATA CALL-IN (PCD 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, a DCI letter will be enclosed listing such requirements. If both generic and product
specific data are required, a combined Generic and Product Specific DCI letter will be enclosed
describing such data. However, if you are an end-use product registrant only and have been
granted a generic data exemption (GDE) by EPA, you are being sent only the product specific
response forms (2 forms) with the RED. Registrants responsible for generic data are being sent
response forms for both generic and product specific data requirements (4 forms). You must
submit the appropriate response forms (following the instructions provided) within 90 days
of the receipt of this RED/DCI letter; otherwise, your product may be suspended.
2 TIME EXTENSIONS AND DATA WAIVER 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 time extensions for product specific data should
be submitted in the 90-day response. Requests for data waivers must be submitted as part of the
90-day response. All data waiver and time extension requests must be accompanied by a full
justification. All waivers and time extensions must be granted by EPA in order to go into effect.
3 APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original application
form. Mark it "Application for Reregistration." Send your Application for Reregistration (along
with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregi strati on) separately. You may, but are not
required to, 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
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.
-------
-------
REREGISTRATION ELIGIBILITY DECISION
4,4 - Dimethyloxazolidine
LISTC
CASE 3095
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
-------
-------
TABLE OF CONTENTS
4,4 - DIMETHYLOXAZOLIDINE REREGISTRATION ELIGIBILITY TEAM i
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Data Requirements 4
D. Regulatory History 4
III. SCIENCE ASSESSMENT 4
A. Physical Chemistry Assessment 4
B. Human Health Assessment 5
1. Toxicology Assessment 5
a. Acute Toxicity 5
b. Subchronic Toxicity 6
c. Chronic toxicity and Carcinogenicity 8
d. Developmental Toxicity 8
e. Reproductive Toxicity 8
f. Mutagenicity 8
g. Metabolism 9
h. Toxicological Endpoints of Concern 9
2. Exposure and Risk Assessment 10
a. Dietary Exposure 10
b. Occupational and Residential Exposure 10
3. Risk Assessment 11
a. Dietary 11
b. Occupational and Residential 11
C. Environmental Assessment 11
1. Ecological Toxicity Data 11
a. Toxicity to Terrestrial Animals 11
b. Toxicity to Aquatic Animals 12
c. Toxicity to Terrestrial, Semi-Aquatic and Aquatic Plants ... 14
2. Environmental Fate 14
3. Exposure and Risk Characterization 15
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 16
A. Determination of Eligibility 16
B. Determination of Eligibility Decision 16
1. Eligibility Decision 16
2. Eligible and Ineligible Uses 17
-------
C. Labeling Rationale/Risk Mitigation Measures 17
V. ACTIONS REQUIRED OF REGISTRANTS 18
A. End-Use Products 19
1. Additional Product-Specific Data Requirements 19
2. Labeling Requirements for End-Use Products 19
B. Existing Stocks 21
VI. APPENDICES 23
APPENDIX A. Table of Use Patterns Subject to Reregistration 25
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 30
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of 4,4-dimethyloxazolidine 34
APPENDIX D. Product Specific Data Call-In 41
Attachment 1. Chemical Status Sheets 53
Attachment 2. Product Specific Data Call-In Response Forms (Form A
inserts) Plus Instructions 54
Attachment 3. Product Specific Requirement Status and Registrant's
Response Forms (Form B inserts) and Instructions
56
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 67
Attachment 5. List of All Registrants Sent This Data Call-in (insert)
Notice 69
Attachment 6. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions 70
APPENDIX E. List of Available Related Documents 76
-------
4,4 - DIMETHYLOXAZOLIDINE REREGISTRATION ELIGIBILITY TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Assessment
Rafael Prieto
Alan Halvorson
Margaret Cogdell
Environmental Fate and Effects Assessment
Karen Angulo
Brian Montague
Jim Breithaupt
Health Effects Assessment
Tom Campbell
Paul Chin
Tom Myers
Registration Support
Marion Johnson, Jr.
Martha Terry
Sami Malak
Risk Management
Bruce Sidwell
Marie Boucher
Office of Enforcement and Compliance
Biological Analysis Branch
Economic Analysis Branch
Biological Analysis Branch
Science Analysis and Coordination Staff
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Occupational and Residential Exposure Branch
Toxicology Branch I
Risk Characterization and Analysis Branch
Antimicrobial Program Branch
Antimicrobial Program Branch
Registration Support Branch
Accelerated Reregi strati on Branch
Accelerated Reregi strati on Branch
Rick Colbert
-------
GLOSSARY OF TERMS AND ABBREVIATIONS
ADI
AE
a.i.
ARC
CAS
CI
CNS
CSF
DFR
ORES
DWEL
EEC
EP
EPA
FDA
FIFRA
FFDCA
FOB
GLC
GM
GRAS
HA
HOT
LC50
LD50
LDlo
LEL
LOG
LOD
LOEL
MATC
MCLG
mg/L
MOE
MP
MPI
MRID
N/A
NOEC
Acceptable Daily Intake. A now defunct term for reference dose (RfD).
Acid Equivalent
Active Ingredient
Anticipated Residue Contribution
Chemical Abstracts Service
Cation
Central Nervous System
Confidential Statement of Formula
Dislodgeable Foliar Residue
Dietary Risk Evaluation System
Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e. drinking
water) lifetime exposure at which adverse, non carcinogenic health effects are not anticipated to
occur.
Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
such as a terrestrial ecosystem.
End-Use Product
U.S. Environmental Protection Agency
Food and Drug Administration
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Functional Observation Battery
Gas Liquid Chromatography
Geometric Mean
Generally Recognized as Safe as Designated by FDA
Health Advisory (HA). The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur.
Highest Dose Tested
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.
Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50%
of the test animals when administered by the route indicated (oral, dermal, inhalation). It is expressed
as a weight of substance per unit weight of animal, e.g., mg/kg.
Lethal Dose -low. Lowest Dose at which lethality occurs.
Lowest Effect Level
Level of Concern
Limit of Detection
Lowest Observed Effect Level
Maximum Acceptable Toxicant Concentration
Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
Micrograms Per Gram
Milligrams Per Liter
Margin of Exposure
Manufacturing-Use Product
Maximum Permissible Intake
Master Record Identification (number). EPA's system of recording and tracking studies submitted.
Not Applicable
No effect concentration
111
-------
GLOSSARY OF TERMS AND ABBREVIATIONS
NPDES National Pollutant Discharge Elimination System
NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level
OP Organophosphate
OPP Office of Pesticide Programs
PADI Provisional Acceptable Daily Intake
PAG Pesticide Assessment Guideline
PAM Pesticide Analytical Method
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice
Q*! The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RS Registration Standard
SLN Special Local Need (Registrations Under Section 24 (c) of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
FAO/WHO Food and Agriculture Organization/World Health Organization
WP Wettable Powder
WPS Worker Protection Standard
IV
-------
ABSTRACT
EPA has completed its reregi strati on eligibility decision regarding the pesticide 4,4-
dimethyloxazolidine, case 3095. This decision includes a comprehensive reassessment of the
required target data base supporting the use patterns of currently registered products. 4,4-
Dimethyloxazolidine is an antimicrobial used in oil recovery drilling muds, packer fluids, secondary
oil recovery injection water, adhesives, metalworking cutting fluids, latex paints, resin emulsions,
wet-end additives/industrial processing chemicals and specialty industrial products to control
bacteria and fungi. The Agency has concluded that all products registered for all uses are eligible
for reregi strati on.
The Agency has identified no toxicological or ecological endpoints of regulatory concern for
4,4-dimethyloxazolidine. No additional data are required by the Agency to confirm its conclusions.
Supporting data demonstrate this chemical has low to moderate acute mammalian toxicity (except
for eye irritation), and does not cause significant subchronic or developmental effects. Most
mutagenicity studies were negative and mutagenicity hazards are expected to be minimal for the
currently registered uses. Environmental data show 4,4-dimethyloxazolidine has low to moderate
toxicities to wildlife species and it rapidly degrades in water.
The Agency has concluded that all uses, as prescribed in this document, will not cause
unreasonable risks to humans or the environment and therefore, all products are eligible for
reregistration. For product reregistration, labeling will be upgraded with additional precautions and
more explicit directions for use.
-------
I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended to
accelerate the reregistration of products with active ingredients registered prior to November 1,1984.
The amended Act provides a schedule for the reregistration process to be completed in nine years.
There are five phases to the reregistration process. The first four phases of the process focus on
identification of data requirements to support the reregistration of an active ingredient and the
generation and submission of data to fulfill the requirements. The fifth phase is a review by the U. S.
Environmental Protection Agency (referred to as "the Agency") of all data submitted to support
reregistration.
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine whether
pesticides containing such active ingredient are eligible for reregistration" before calling in data on
products and either reregistering products or taking "other appropriate regulatory action." Thus,
reregistration involves a thorough review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to reassess the potential hazards arising from the
currently registered uses of the pesticide; to determine the need for additional data on health and
environmental effects; and to determine whether the pesticide meets the "no unreasonable adverse
effects" criterion of FIFRA.
This document presents the Agency's decision regarding the reregistration eligibility of the
uses of currently registered products containing the active ingredient 4,4-dimethyloxazolidine in the
case Methyloxazolidine. This document does not address trimethyloxazolidine or any of its uses in
products since all have been voluntarily cancelled. The document consists of six sections. Section
I is the introduction. Section II describes 4,4-dimethyloxazolidine, 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 reregistration decision for 4,4-
dimethyloxazolidine. Section V discusses the reregistration requirements for 4,4-
dimethyloxazolidine. Finally, Section VI is the Appendices that support this Reregistration
Eligibility Decision. Additional details concerning the Agency's review of applicable data are
available on request.
-------
II. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregi strati on Eligibility Decision:
• Common Name: Methyloxazolidine
• Chemical Name: 4,4 - Dimethyloxazolidine
• CAS Registry Number: 51200-87-4
• OPP Chemical Code: 114801
• Empirical Formula: C5HUNO
• Molecular Weight: 101.14
• Trade and Other Names: Bioban: CS-1135 Antimicrobial
Agent: Angus Chemical Company.
Cosan 101: Hulls America.
Troysan 192: Troy Chemical Company.
B. Use Profile
The following is information on currently registered uses with an overview of use
sites and application methods. A detailed table of uses of 4,4-dimethyloxazolidine is in
Appendix A.
For 4.4 - Dimethyloxazolidine:
Type of Pesticide: Bacteriostat, Microbiocide/Microbiostat (slime-forming
bacteria and fungi)
Use Sites: AQUATIC NON-FOOD INDUSTRIAL
*Oil Recovery Drilling Muds/Packer Fluids
Secondary Oil Recovery Injection Water
TERRESTRIAL NON-FOOD INDUSTRIAL
*Oil Recovery Drilling Muds/Packer Fluids
INDOOR NON-FOOD
Industrial Adhesives
Resin/Latex/Polymer Emulsions
-------
Metalworking Cutting Fluids
Latex Paints (In-Can Preservative)
Specialty Industrial Products
Wet-End Additives/Industrial Processing Chemicals
*Registrants must specify on labels, as per Section V of this document,
whether the product is used on off-shore and/or terrestrial sites.
Target Pests: Slime-forming bacteria and fungi, sulfate-reducing bacteria, iron-
oxidizing bacteria
Formulation Types Registered:
TYPE: End-use
FORM: Soluble concentrate/liquid
Method and Rates of Application:
Types of Treatment - Industrial preservative treatment, preservative
treatment, water treatment (secondary oil recovery
injection water)
Equipment - Metering pump (secondary oil recovery injection water), not
specified (registrant must specify on labeling; see Section V
for labeling requirements)
Use Rate - Aquatic Non-Food Industrial
3.7 to 736 ppm active ingredient by weight
Terrestrial Non-Food Industrial
368 to 736 ppm active ingredient by weight
Indoor Non-Food
460 to 3850 ppm active ingredient by weight
Timing - During manufacture (i.e., adhesives, paints), Initial,
Subsequent/maintenance, Continuous feed (initial), Feed
(subsequent), Shock/slug, Not Specified (registrant must
specify on labeling)
Use Practice Limitations: Do not discharge effluent containing this product into
lakes, streams, ponds, estuaries, oceans, or public
waters unless in accordance with the appropriate
NPDES permit. Do not discharge effluent containing
this product to sewer systems without previously
notifying the sewage treatment plant authority.
-------
C. Data Requirements
The Agency required registrants to supply additional data to support reregi strati on
in a Data Call-In Notice issued in September of 1992 and in the Antimicrobial Data Call-in
Notice of March 1987. Appendix B includes all data requirements identified by the Agency
to support reregi strati on of currently registered uses.
D. Regulatory History
In 1982, the Agency first registered 4,4-dimethyloxazolidine in the United States as
an active ingredient for use as a microbiocide and bacteriostat. There are currently 6 active
products registered as a preservative in adhesives, paints, resin emulsions, and metalworking
cutting fluids and as a microbiocide in secondary oil recovery injection water and oil
recovery drill muds. In 1987 the Agency issued the Antimicrobial Data Call-In Notice for
chronic and subchronic toxicity data requirements for this chemical and other antimicrobial
chemicals. Another Data Call-In Notice was issued in September 1992 for 4,4-
dimethyloxazolidine requiring additional data in support of reregi strati on.
III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Color:
Physical State:
Odor:
Melting Point:
Boiling Point:
Bulk Density:
Solubility:
Vapor Pressure:
Dissociation
Constant:
Colorless to slightly yellow
Liquid
An amine odor (fishy)
N/A for liquid
100.9°C
0.99 gm/ml
Miscible with water in all proportions. It is also miscible
with methanol, ethanol, propanol, and acetone.
100mmHgat70°C
pKa = 9.35
Octanol/Water
Partition Coefficient: log P = 0.73
-------
pH:
Stability:
Analytical Method:
11.0
Stable under ambient conditions. It does not react with steel
or iron.
The technical grade active ingredient can be determined by
the use of gas chromatography method using a column packed
with 20% carbowax 20M. The method consists of adding
measured amounts of 2-amino-2-methyl-l-propanol (AMP)
to an aliquot of the sample and determining the excess AMP
by gas chromatography. Uncombined formaldehyde in the
sample reacts on an equal molar basis with the AMP to form
oxazolidine. When uncombined formaldehyde is present, the
difference between the amount of AMP added to the sample
and the amount found after addition is calculated as
uncombined formaldehyde.
B. Human Health Assessment
1. Toxicology Assessment
The toxicological data base for 4,4-dimethyloxazolidine is based on the
requirements for antimicrobial pesticides. The data are adequate and will support a
reregi strati on eligibility determination for the currently registered non-food uses.
a. Acute Toxicity
Results of the acceptable acute toxicity studies conducted with
technical 4,4-dimethyloxazolidine are summarized below in Table 1:
-------
Table 1. Acute Toxicity Values of Technical 4,4-Dimethyloxazolidine
Route
Oral
Dermal
Inhalation
Eye Irritation*
Skin Irritation*
Dermal Sensitization*
Snecies
Rat
Rat
Rat
Rabbit
Rabbit
Guinea Pig
Results
LD50:
Males 1308 mg/kg
Females 1037 mg/kg
LD,n = >2000 mg/kg
LC,n= 1.1 mg/L
Severe irritant
Slight dermal irritant
Non-sensitizer
Toxicitv Catesorv
III
III
III
I
IV
N/A
This study is a requirement for manufacturing-use and end-use products (40 CFR Section 158). For 4,4-
dimethyloxylzolidine, data have been generated on the TGAI and are presented here for informational purposes.
The acute oral LD50 in rats is 1308 mg/kg for males and 1037 mg/kg
for females. This places 4,4-dimethyloxazolidine in Toxicity Category III
(MRID 41706707). It is also placed in Toxicity Category III for acute dermal
LD50 in rats at >2000 mg/kg (MRID 41706708) and for acute inhalation LC50
in rats at 1.1 mg/L (MRID 41706709).
Placed in Toxicity Category I as a primary eye irritant in rabbits
(41706710), 4,4-dimethyloxazolidine is also considered a Toxicity Category
IV dermal irritant in rabbits (MRID 41706711), and is not a skin sensitizer
in guinea pigs (MRID 41706712).
b. Subchronic Toxicity
The toxicological data requirement (GDLN 82-3) for a 90-day dermal
toxicity study in rodents is satisfied by two 13-week dermal toxicity studies
in rats. In the first 90-day dermal toxicity study, male and female CD
(Sprague-Dawley derived) Crl:CD®BRVAF/Plus® rats, 10/sex/group, were
administered dermal doses of aqueous solutions of 4,4-dimethyloxazolidine
technical (75.95% a.i.) to yield dosage levels of 0, 1, 30, or 100 mg/kg/day.
The test site was occluded, and exposure continued for 6 hours. Animals
were treated once daily, five days per week, for a total of 4 or 13 weeks. Due
to extreme dermal reactions, all animals in the 100 mg/kg/day dosage group
were sacrificed for humane reasons after 4 weeks. The remaining animals
were sacrificed after 13 weeks. There were no unscheduled mortalities.
-------
No treatment-related dermal effects were observed in animals in the
1 mg/kg/day treatment group. In the 30 mg/kg/day and 100 mg/kg/day
treatment groups, histopathology revealed lymphoid proliferation and
plasmacytosis in axillary and/or inguinal lymph nodes in males and females
and sinus histiocytosis in males. In addition, microscopic examination of
treated skin revealed inflammation, ulceration, and acanthosis in both males
and females in these two treatment groups, confirming the clinical
observations of scabs on the skin and necrotic patches. Blood neutrophil
levels were increased in both males (146% control value; not statistically
significant) and females (160% control value; p < 0.05) at 30 mg/kg/day; at
100 mg/kg/day, these values were also increased in males (212% control
value) and females (338% control value), but no statistical tests were
performed for this dosage level. Body weight gain was statistically decreased
(p < 0.01) only for males in the 100 mg/kg/day group at 4 weeks. The weight
of the adrenal glands was increased (112% control value; p < 0.05) only in
females in the 30 mg/kg/day treatment group; however, the histopathology
of this organ was normal. The dermal NOEL is 1 mg/kg/day and the dermal
LOEL is 30 mg/kg/day, based on the microscopically observed changes in
the skin. The microscopic changes observed in the axillary and/or inguinal
lymph nodes and the elevated neutrophil counts are probably secondary
effects (e.g., infections) related to the severe dermal effects elicited by this
chemical and are not considered to be test substance-related. No systemic
effects were apparent after dermal administration of this chemical at the
stated doses for 90 days; therefore, the systemic NOEL > 100 mg/kg/day
(HOT) and the systemic LOEL > 100 mg/kg/day (MRID 43322601).
In the second 90-day dermal toxicity study, male and female Sprague-
Dawley rats, 15/sex/group, were administered dermal doses of aqueous-
ethanolic solutions of Bioban CS 1135 preservative (4,4-dimethyloxazolidine
technical, 78% a.i.) to yield dosage levels of 0 (1:1, water/ethanol vehicle),
1.95, 19.5, or 195 mg/kg/day. Animals were treated once daily, five days per
week, for a total of 13 weeks. Animals in the 195 mg/kg/day dosage group
showed moderate and severe skin reaction that included thickening and
ulcerations. In the 195 mg/kg/day treatment group, histopathology revealed
severe ulcerative response in the skin. In addition, these animals had
enlarged lung, heart, liver, spleen and adrenals. There were no unscheduled
mortalities. No treatment-related dermal effects were observed in animals in
the 1.95 and 19.5 mg/kg/day treatment groups. Based on these data, the
dermal and systemic NOEL is 19.5 mg/kg/day and the dermal and systemic
LOEL is 195 mg/kg/day (MRID 00138227).
-------
c. Chronic toxicity and Carcinogenicity
The Chronic Toxicity Study in Rodents (GDLN 83-la) and Non-
Rodents (GDLN 83-Ib), and the Carcinogenicity Study in Mice (GDLN 83-
2a) and Rats (GDLN 83-2b) are not required (40 CFR 158.340) because the
occupational/residential exposure and the non-food use pattern of 4,4-
dimethyloxazolidine will not result in significant chronic human exposure.
d. Developmental Toxicity
In an acceptable dermal developmental toxicity study (GDLN 83-3),
New Zealand rabbits were administered dermal doses of 0, 30, 100 or 300
mg/kg/day on days 7 through 19 of gestation. The maternal toxicity NOEL
was not determined. The maternal toxicity LOEL was 30 mg/kg/day based
on local dermal irritation. Local dermal irritation was demonstrated at all
dosage levels and was dose related. The local irritation included erythema,
edema, atonia, desquamation, coriaceousness, eschar and bruising.
Developmental toxicity was not demonstrated at the doses tested (MRID
00157806).
e. Reproductive Toxicity
The Two-Generation Reproduction study (GDLN 83-4) is not
required because the occupational/residential exposure and the non-food use
pattern of 4,4-dimethyloxazolidine will not result in significant chronic
human exposure.
f. Mutagenicity
Among the available studies, four studies were classified as
acceptable and two studies were not classified. The four acceptable studies
satisfy the guideline requirements for mutagenicity studies (GDLNs 84-2 and
84-4) for 4,4-dimethyloxazolidine.
The four acceptable studies are as follows:
4,4-dimethyloxazolidine was tested in the L5178 Y Mouse lymphoma
assay with mutagenic potential up to 0.01 to 0.28 |il/mL with or without
activation (MRID 00126353). Another study used 4,4-dimethyloxazolidine
in the chromosomal aberration assay in Chinese hamster ovary cells finding
mutagenic potential up to 0.16 to 0.28 |il/mL with or without activation
(MRID 00126352). Also tested in the micronucleus test in mouse bone
marrow, 4,4-dimethyloxazolidine proved no apparent mutagenic potential at
500 mg/kg (only dosage tested). The test substance appears to suppress
-------
hematopoiesis as indicated by a decrease in ratio of polychromatic to
normochromatic erythrocytes over a 72 hour time period (MRID 41577003).
In a fourth acceptable study, 4,4-dimethyloxazolidine was tested for
unscheduled DNA synthesis in rat hepatocytes with no apparent mutagenic
potential at 10 to 5000 |ig/mL. Also, 4,4-dimethyloxazolidine produced
cytotoxicity at 333 |ig/mL and above (MRID 41577002).
The two unclassified studies are as follows:
Two studies showed that 4,4-dimethyloxazolidine was tested in the
Ames test with no apparent mutagenic potential in S. typhimurium strains
TA-1535, TA-1537, TA-1538, TA-98 and TA-100 up to 10 |ig/plate, both
with or without activation (MRIDs 00076976 and 00076977).
One unacceptable study is as follows:
4,4-Dimethyloxazolidine was tested in the chromosome aberration
assay in in vivo (metaphase analysis) with no apparent mutagenic potential
up to 20, 40, or 80 mg/kg. However, the mutagenic potential of 4,4-
dimethyloxazoline in in vivo assay is not confirmed because the dose range
tested was insufficient because there was no indication of clinical or bone
marrow toxicity at any of the dosages (MRID 41577004).
4,4-Dimethyloxazolidine was negative in most mutagenicity tests.
Therefore, the overall results suggest that mutagenicity health hazards from
4,4-dimethyloxazolidine in the expected usage are minimal.
g. Metabolism
A metabolism study is not required to support the non-food uses of
4,4-dimethyloxazolidine because of the expected absence of oral exposure
and because the current use pattern scenarios will not result in significant
human exposure.
h. Toxicological Endpoints of Concern
The Toxicity Endpoint Selection Committee of the Agency's Office
of Pesticide Programs, Health Effects Division, has concluded the following:
Risk assessment is not required because 4,4-dimethyloxazolidine is
a non-food use chemical. Based upon review of the toxicology database for
4,4-dimethyloxazolidine, there are no identified toxicological endpoints of
concern for short-term (1-7 days) or intermediate-term (7-90 days)
occupational or residential exposures. Furthermore, there were no systemic
-------
effects reported at doses of up to 300 mg/kg/day in a dermal developmental
toxicity study in rabbits; maternal toxicity effects were limited to local
dermal irritation. No systemic effects were apparent in rats following dermal
administration for 90-days. While 4,4-dimethyloxazolidine is a Category I
eye irritant (rabbits), this effect is more appropriately addressed at the
individual product level where formulation and dilution affect the degree of
irritation and necessity for eye protection. Therefore, a risk assessment is not
warranted.
2. Exposure and Risk Assessment
a. Dietary Exposure
The Agency considers the uses of 4,4-dimethyloxazolidine to be non-
food. Therefore, a dietary exposure and risk assessment is not needed.
b. Occupational and Residential Exposure
An occupational and/or residential exposure assessment is required
for an active ingredient if: (1) certain toxicological criteria are triggered and
(2) there is potential exposure to handlers (mixers, loaders, applicators)
during use or to persons entering treated sites after application is complete.
While there are potential application and post-applications exposures from
the use of 4,4-dimethyloxazolidine in commercial, industrial, and residential
settings, the Agency has decided that an occupational/residential
mixer/loader/applicator exposure analysis is not warranted at this time due
to the absence of toxicological endpoints of concern.
Since formaldehyde is a degradate of 4,4-dimethyloxazolidine, the
Agency has also looked at potential formaldehyde exposure to products
containing 4,4-dimethyloxazolidine. Post-application settings are addressed
for formaldehyde by the Occupational Safety and Health Administration.
OSHA has a comprehensive workplace standard for formaldehyde for the
protection of workers in the industrial setting due to formaldehyde-release in
the workplace. The OSHA formaldehyde standard was established as a rule
in May 1992, and set a permissable exposure level (PEL) of 0.75 ppm in the
workplace. The standard also prescribes that certain actions should be taken
if monitoring shows levels of 0.50 ppm. This standard requires monitoring
before workers enter the premises following use of formaldehyde, or when
potential ambient formaldehyde is generated from other chemicals.
10
-------
3.
Risk Assessment
a. Dietary
Based on the non-food use pattern of 4,4-dimethyloxazolidine,
residues in/on food and/or feed are not expected to occur. Therefore, a
dietary risk assessment is not needed.
b. Occupational and Residential
A risk assessment was not conducted for the occupational and
residential exposures of 4,4-dimethyloxazolidine due to the absence of
toxicological endpoints of concern.
C. Environmental Assessment
1. Ecological Toxicity Data
The ecotoxicological data base is adequate to characterize the acute toxicity
of 4,4-dimethyloxazolidine to nontarget terrestrial and aquatic organisms when used
to control pests in aquatic or terrestrial industrial and indoor nonfood sites.
a. Toxicity to Terrestrial Animals
Birds, Acute and Subacute
In order to establish the toxicity of 4,4-dimethyloxazolidine to birds,
the following tests are required using the technical grade of the active
ingredient: one avian single-dose oral LD50 study on one species (preferably
mallard or bobwhite quail); two subacute dietary LC50 studies on one species
of waterfowl (preferably the mallard duck); and one species of upland game
bird (preferably bobwhite quail or ring-necked pheasant) (GDLNs 71-1 and
71-2). The following summaries give the results of these studies.
Table 2: Avian Acute Oral Toxicity Findings
Species tested
Bobwhite Quail
Mallard duck
% AI
76
78
LDsn
705 mg/kg
HOmg/kg
MRID Author (year)
42967201 Pederson (1993)
0076970 Bodden (1979)
Conclusion
Slightly toxic
Moderately
toxic
11
-------
The results of the studies, summarized in Table 2, show that 4,4-
dimethyloxazolidine displays slight to moderate toxicity to birds. The
guideline requirement for the avian acute oral LD50 study has been met.
(MRIDs 42967201, 0076970).
Table 3: Avian Subacute Dietary Toxicity Findings
Species tested
Bob white Quail
Mallard duck
% AI
78%
78%
LC^n
>3250 ppm
>4008 ppm
MRID Author (year)
00102975 Bodden (1979)
00102976 Bodden (1979)
Conclusion
Slightly toxic
Slightly toxic
The results of the studies, summarized in Table 3, show that on a
subacute dietary basis (GDLN 71-2), 4,4-dimethyloxazolidine is slightly
toxic to birds. The two studies, one on the mallard duck and one on the
bobwhite quail, produced LC50s >3000 ppm. The guideline requirement has
been met. (MRIDs 00102975, 00102976).
b. Toxicity to Aquatic Animals
(1) Freshwater Fish
In order to establish the toxicity of a pesticide to freshwater
fish, the minimum data required on the technical grade of the active
ingredient are two freshwater fish toxicity studies (GDLN 72-1). At
least one study should use a coldwater species (preferably the
rainbow trout) and the other should use a warmwater species
(preferably the bluegill sunfish).
Table 4: Freshwater Fish Acute Toxicity Findings
Species tested
Bluegill sunfish
Rainbow trout
% AI
77.2%
Technical
L'Cso
59 ppm
95 ppm
MRID Author (year)
00076969 Thompson
(1979)
00068770 Lee
(1974)
Conclusion
Slightly toxic
Slightly toxic
12
-------
The results of the 96-hour acute toxicity studies, summarized
in Table 4, indicate that 4,4-dimethyloxazolidine displays slight
toxicity to both cold and warm water fish. The guideline requirement
has been met. (MRIDs 00076969 and 00068770).
(2)
Freshwater Invertebrates
The minimum testing required to assess the acute hazard of a
pesticide to freshwater invertebrates is an aquatic invertebrate toxicity
test (GDLN 72-2), preferably using first instar Daphnia magna or
early instar amphipods, stoneflies, mayflies, or midges.
Table 5:
Species tested
Daphnia magna
% AI
77%
Freshwater Invertebrate Toxicity Findings
LC^n
45 (32-56) ppm
MRID Author (year)
00076968 Thompson
(1979)
Conclusion
Slightly toxic
Results of aquatic invertebrate testing, summarized in Table
5, indicate that 4,4-dimethyloxazolidine is slightly toxic to Daphnia
magna. The guideline requirement has been met. (MRID 00076968).
(3) Estuarine and Marine Animals
Acute toxicity testing with estuarine and marine organisms is
required (GDLN 72-3) when an end-use product is intended for direct
application to the marine/estuarine environment or is expected to
reach this environment in significant concentrations. The aquatic
industrial use patterns of oil recovery for 4,4-dimethyloxazolidine
may result in exposure to the estuarine environment.
The requirements under this category include a 96-hour LC50
for an estuarine fish, a 96-hour LC50 for shrimp or mysid, and either
a 48-hour embryo-larva study or a 96-hour shell deposition study
with an acceptable shellfish species.
13
-------
Table 6: Estuarine/Marine Acute Toxicity Findings
Species tested
Sheepshead
minnow
Pink shrimp
Eastern oyster
% AI
82%
77%
82.5%
LC
-------
studies (30 days for hydrolysis and 6 days for photolysis). AMP was present
attime=0 samples in concentrations of 191-207 ppm (96.4-97.3% of dosing
rate). Screening level modeling for the determination of expected
environmental concentrations (EECs) was performed and is available in
documents from the Agency. (MRIDs 41664801, 41960701).
3. Exposure and Risk Characterization
The Agency requires only a limited set of ecotoxicology and environmental
fate studies for microbiocides. 4,4-Dimethyloxazolidine is slightly toxic to
moderately toxic to birds, slightly toxic to freshwater fish and invertebrates, and
practically non-toxic to moderately toxic to estuarine and marine organisms.
The actual component responsible for target organism control is unclear. It
is apparent that 4,4-dimethyloxazolidine rapidly degrades to 2-amino-2-methyl-
propanol (AMP) and formaldehyde in water. Therefore, it must be assumed that
aquatic organisms exposed to the 4,4-dimethyloxazolidine in the acute toxicity tests
were exposed to the degradates as well over the 48-96 hour exposure durations. In
all cases, except the oyster study, the 4,4-dimethyloxazolidine was introduced
statically and the resulting toxicity levels were considered low. The oyster study
used a constant flow system to deliver the chemical and the resulting toxicity levels
were moderate. Therefore, it appears that both 4,4-dimethyloxazolidine and its
degradates display low to moderate toxicity to aquatic organisms.
The oil recovery drilling mud (aquatic and terrestrial) uses are expected to
result in minimal to no exposure if proper procedures are employed in the disposal
of the contaminated drilling muds.
While the hazard to aquatic organisms from 4,4-dimethyloxazolidine has been
characterized, a quantitative risk assessment has not been conducted. The risks to
aquatic environments from all uses are regulated under the National Pollution
Discharge Elimination System (NPDES) permitting program of EPA's Office of
Water. The labels for all 4,4-dimethyloxazolidine products must require that
discharges to aquatic environments comply with an NPDES permit.
Endangered Species
The Agency does not anticipate any exposure of concern to fish and wildlife,
providing that all 4,4-dimethyloxazolidine products are handled and applied as
specified in the product labeling and that discharges to the environment comply with
all Federal disposal laws and NPDES.
15
-------
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether products containing the active
ingredient are eligible for reregistration. The Agency has previously identified and required
the submission of the generic (i.e. active ingredient specific) data required to support
reregistration of products containing 4,4-dimethyloxazolidine. 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 4,4-dimethyloxazolidine. Appendix B identifies the
generic data requirements that the Agency reviewed as part of its determination of
reregistration eligibility of 4,4-dimethyloxazolidine, 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 4,4-dimethyloxazolidine and to determine that 4,4-dimethyloxazolidine
can be used without resulting in unreasonable adverse effects to humans and the
environment. The Agency therefore finds that all products containing 4,4-
dimethyloxazolidine as the active ingredients are eligible for reregistration. The
reregistration 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, and the data identified in Appendix B.
Although the Agency has found that all uses of 4,4-dimethyloxazolidine 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 4,4-dimethyloxazolidine, if new information comes to the Agency's attention or
if the data requirements for registration (or the guidelines for generating such data) change.
B. Determination of Eligibility Decision
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredient 4,4-
dimethyloxazolidine, the Agency has sufficient information on the health effects of
4,4-dimethyloxazolidine and on its potential for causing adverse effects in fish and
wildlife and the environment. The Agency has determined that 4,4-
dimethyloxazolidine 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 products containing 4,4-
dimethyloxazolidine for all current uses are eligible for reregistration.
16
-------
2. Eligible and Ineligible Uses
The Agency has determined that all current uses of 4,4-dimethyloxazolidine
are eligible for reregi strati on.
C. Labeling Rationale/Risk Mitigation Measures
The Worker Protection Standard
At this time all registered uses of 4,4-dimethyloxazolidine are outside the
scope of the Worker Protection Standard for Agricultural Pesticides (WPS). The
Agency is not establishing any new entry restrictions at this time for occupational
uses of 4,4-dimethyloxazolidine end-use products because no toxicological endpoints
of concern were identified and no additional risk mitigation measures are warranted.
However, the Agency has concluded that it is prudent to require a continuation of
current minimal label precautions to afford product users protection from
unnecessary exposure. These label requirements are specified below in Section V
and must be retained and/or added since there may be potential for application and
post application exposure.
Personal Protective Equipment/Engineering Controls for Handlers
For each end-use product, PPE/engineering control requirements for pesticide
handlers will be set during reregi strati on in one of two ways.
1 . If EPA has no special concerns about the acute or other adverse effects of an
active ingredient, the PPE for pesticide handlers will be based on the acute toxicity
of the end-use product. For occupational-use products, PPE will be established using
the process described in PR Notice 93-7 or more recent EPA guidelines.
2. If EPA has special concerns about an active ingredient due to very high acute
toxicity or to certain other adverse effects, such as allergic effects or delayed effects
(cancer, developmental toxicity, reproductive effects, etc):
• In the RED for that active ingredient, EPA may establish minimum or
"baseline" handler PPE or engineering-control requirements that pertain to
all or most occupational end-use products containing that active ingredient.
• These minimum PPE requirements must be compared with the PPE that
would be designated on the basis of the acute toxicity of each end-use
product.
17
-------
• The more stringent choice for each type of PPE (i.e., bodywear, hand
protection, footwear, eyewear, etc.) must be placed on the label of the end-
use product.
Personal protective equipment requirements usually are set by specifying one
or more pre-established PPE units - sets of items that are almost always required
together. For example, if gloves are required to mitigate risk, then a long-sleeve
shirt, long pants, socks and shoes are also included in the required minimum attire.
If the requirement is for two layers of body protection (coveralls over a long- or
short-sleeve shirt and long or short pants), the minimum must also include (for all
handlers) chemical-resistant footwear and chemical-resistant headgear for overhead
exposures and (for mixers, loaders, and persons cleaning equipment) chemical-
resistant aprons.
At this time there are no engineering control requirements, such as closed
systems, currently required on labeling for end-use products containing 4,4-
dimethyloxazolidine.
Occupational-Use Products
There are no special toxicological concerns about 4,4-dimethyloxazolidine
that warrant the establishment of active-ingredient-based minimum PPE
requirements for occupational handlers.
Homeowner-Use Products
There are no homeowner uses of 4,4-dimethyloxazolidine, except as an
additive in products, such as paints. There are no special toxicological concerns
about 4,4-dimethyloxazolidine that warrant the establishment of active-ingredient-
based minimum PPE requirements for homeowner handlers.
Post-Application/Entry Restrictions
EPA is not establishing entry restrictions at this time for 4,4-
dimethyloxazolidine end-use products, because the anticipated frequency, duration,
and degree of exposure following occupational/residential applications do not
warrant specific risk mitigation measures.
V. ACTIONS REQUIRED OF REGISTRANTS
This section specifies the data requirements and responses necessary for the reregi strati on
of end-use products.
18
-------
A. 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 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.
Method and Rates of Application: the registrant must specify the application
and method, equipment, and timing, i.e., labels must specify equipment to be used
such as metering pump for secondary oil recovery injection water and at what point
should application occur.
2. Labeling Requirements for End-Use Products
PPE/Engineering Control Requirements for Pesticide Handlers
For sole-active-ingredient end-use products that contain 4,4-
dimethyloxazolidine, the product labeling must be revised to adopt the handler
personal protective equipment/engineering control requirements set forth in this
section. For the reason given above, any conflicting PPE requirements on the current
labeling must be removed.
For multiple-active-ingredient end-use products that contain 4,4-
dimethyloxazolidine, the handler personal protective equipment/engineering control
requirements set forth in this section must be compared to the requirements on the
current labeling and the more protective must be retained. For guidance on which
requirements are considered more protective, see PR Notice 93-7.
Minimum (Baseline) PPE/Engineering Control Requirements
Because of the lack of special toxicity endpoints of concern, EPA is not
establishing active-ingredient-based minimum (baseline) PPE/engineering control
requirements for 4,4-dimethyloxazolidine end-use products that are intended
primarily for occupational use. Any necessary PPE for each 4,4-dimethyloxazolidine
occupational end-use product will be established on the basis of the end-use product's
acute toxicity category. NOTE: All end-use products will be required to specify a
19
-------
long-sleeved shirt, long pants, socks and shoes as minimum work attire for all
handlers. If the end-use product is classified as toxicity category I or II for eye
irritation potential, protective eyewear is also required.
Placement in Labeling
The personal protective equipment requirements must be placed on the end-
use product labeling in the location specified in PR Notice 93-7, and the format and
language of the PPE requirements must be the same as is specified in PR Notice 93-
7.
Other Labeling Requirements
The Agency is requiring the following precautionary labeling statements to
be located on all end-use products containing 4,4-dimethyloxazolidine.
Application Restrictions
"Do not use this product in a way that will contact workers or other persons."
User safety requirements
Registrant: add the following statements only if gloves or protective eyewear are
required PPE on the end-use product:
"Follow manufacturer's instructions for cleaning/maintaining personal protective
equipment. If no such instructions for washables, use detergent and hot water. Keep
and wash personal protective equipment separately from other laundry."
User Safety Recommendations
• "Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet."
• "Users should remove clothing immediately if pesticide gets inside. Then
wash thoroughly and put on clean clothing."
Add the following statements only if gloves are required PPE on the end-use
product:
"Users should remove personal protective equipment
immediately after handling this product. Wash the outside of
gloves before removing. As soon as possible wash
thoroughly."
20
-------
Directions for Use
Registrants must specify on labeling the complete directions for use for each
use pattern: site of application, type of application, timing of application, equipment
used for application, and the rate of application (dosage).
Effluent Discharge Labeling Statements
To reduce environmental risk from 4,4-dimethyloxazolidine discharge and
disposal, product labels must continue to have the statements pertaining to effluent
discharge under the National Pollutant Discharge Elimination System (NPDES)
permitting system (refer to PR Notice 93-10 or 40 CFR 152.46(a)(l)) and disposal
under any applicable federal laws.
B. 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 4,4-
dimethyloxazolidine products bearing old labels/labeling for 26 months from the date of
issuance of this RED. Persons other than the registrant may distribute or sell such products
for 50 months from the date of the issuance of this RED. Registrants and persons other than
registrants remain obligated to meet pre-existing Agency imposed label changes and existing
stocks requirements applicable to products they sell or distribute.
21
-------
22
-------
VI. APPENDICES
23
-------
24
-------
Report Run Date: 10/20/95 - Time 13:24
PRO Report Date: 06/08/95
APPENDIX A REPORT
LUIS 2.2 - Page: 1
Case 3095[Methyloxazolidines]
Chemical 114801 [4,4-Dimethyloxazolidine]
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment — Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED
ADHESIVES, INDUSTRIAL
Industrial preservative treatment, During SC/L W 736
manufacture, Not on label, Not
Applicable, Not applicable for this use
SC/L W 770
EMULSIONS, RESIN/LATEX/POLYMER
SC/L W 736
SC/L W 780
SC/L W 950
METAL WORKING CUTTING FLUIDS
Use Group: INDOOR NON-FOOD
W3667 * NS NS NS NS NS NS
A02, CIS, C24
Industrial preservative treatment, During SC/L W 385
manufacture, Not on label, Not
Applicable, Not applicable for this use
W3850 * NS NS NS NS NS NS
Use Group: INDOOR NON-FOOD
W1540 * NS NS NS NS NS NS
CAH
CAH
W3667 * NS NS
W2340 * NS NS
W2850 * NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
CIS, C24
Industrial preservative treatment, During SC/L W 737
manufacture, Not on label, Not
Applicable, Not applicable for this use
Use Group: INDOOR NON-FOOD
W 1474 * NS NS NS NS NS NS
A23(6), CIS, C24
SC/L W780 W2340 * NS NS NS NS NS NS
SC/L W950 W2850 * NS NS NS NS NS NS
V1838 * NS NS NS NS NS NS
Preservative treatment, Initial, Not on SC/L V 920
label, Not Applicable, Not applicable for
this use
Preservative treatment, SC/L V 460
Subsequent/maintenance, Not on label, Not
Applicable, Not applicable for this use
CIS, C24
V460 * NS NS NS NS NS NS
CIS, C24
25
-------
Report Run Date: 10/20/95 - Time 13:24 LUIS 2.2 - Page: 2
PRD Report Date: 06/08/95
APPENDIX A REPORT
Case 3095[Methyloxazolidines] Chemical 114801[4,4-Dimethyloxazolidine]
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment — Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
OIL RECOVERY DRILLING MUDS/PACKER FLUIDS Use Group: AQUATIC NON-FOOD INDUSTRIAL
Preservative treatment, Not on label, Not SC/L V 368 V 736 * NS NS NS NS NS NS CIS, C24
on label, Not Applicable, Not applicable
for this use
Use Group: TERRESTRIAL NON-FOOD CROP
Preservative treatment, Not on label, Not SC/L V 368 V 736 * NS NS NS NS NS NS CIS, C24
on label, Not Applicable, Not applicable
for this use
PAINTS (IN-CAN) Use Group: INDOOR NON-FOOD
Industrial preservative treatment, During SC/L W 736 W 3667 * NS NS NS NS NS NS CIS, C24
manufacture, Not on label, Not
Applicable, Not applicable for this use
SC/L W770 W2310 * NS NS NS NS NS NS CAH
SC/L W780 W2340 * NS NS NS NS NS NS
SC/L W950 W2850 * NS NS NS NS NS NS
SECONDARY OIL RECOVERY INJECTION WATER Use Group: AQUATIC NON-FOOD INDUSTRIAL
Water treatment, Continuous feed SC/L V 15 VI12 * NS NS NS NS NS NS CIS, C24
(initial), Metering pump, Not Applicable,
Not applicable for this use
SC/L W14 W109 * NS NS NS NS NS NS CIS, C24
SC/L W15 WHO * NS NS NS NS NS NS CIS, C24
Water treatment, Continuous feed SC/L V3.8 VI12 * NS NS NS NS NS NS CIS, C24
(subsequent), Metering pump, Not
Applicable, Not applicable for this use
26
-------
Report Run Date: 10/20/95 - Time 13:24
PRO Report Date: 06/08/95
APPENDIX A REPORT
LUIS 2.2 - Page: 3
Case 3095[Methyloxazolidines]
Chemical 114801 [4,4-Dimethyloxazolidine]
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment — Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
SECONDARY OIL RECOVERY INJECTION WATER (con't)
Water treatment, Shock/slug, Metering SC/L V 15
pump, Not Applicable, Not applicable for
this use
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
VI12 * NS NS
NS NS NS NS
SC/L W 14
SC/L W 15
SPECIALITY INDUSTRIAL PRODUCTS
Industrial preservative treatment, During SC/L W 736
manufacture, Not on label, Not
Applicable, Not applicable for this use
W 109 * NS NS NS NS NS NS
WHO * NS NS NS NS NS NS
Use Group: INDOOR NON-FOOD
W3667 * NS NS NS NS NS NS
SC/L W737 W1474 * NS NS NS NS NS NS
SC/L W770 W2310 * NS NS NS NS NS NS
V1838 * NS NS NS NS NS NS
Preservative treatment, Initial, Not on SC/L V 920
label, Not Applicable, Not applicable for
this use
Preservative treatment, SC/L V 460
Subsequent/maintenance, Not on label, Not
Applicable, Not applicable for this use
V460 * NS NS
NS NS NS NS
CIS, C24
CIS, C24
CIS, C24
CIS, C24
A23(6), CIS, C24
CAH
CIS, C24
CIS, C24
WET-END ADDITIVES/INDUSTRIAL PROCESSING CHEMICALS Use Group: INDOOR NON-FOOD
Industrial preservative treatment, During SC/L W 770 W3850 * NS NS NS NS NS NS
manufacture, Not on label, Not
Applicable, Not applicable for this use
CAH
27
-------
Report Run Date: 10/20/95 - Time 13:24 LUIS 2.2 - Page: 4
PRO Report Date: 06/08/95
APPENDIX A REPORT
Case 3095 [Methyloxazolidines] Chemical 114801 [4,4-Dimethyloxazolidine]
LEGEND
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 : Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).
Max. # Apps @ Max. Rate : 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"
Max. Dose [(AI unless : Maximum dose applied to a site over a single crop cycle or year. System calculated.
noted otherwise)/A]
Min. Interv (days) : Minimum Interval between Applications (days)
Restr. Entry Interv (days) : Restricted Entry Interval (days)
PRD Report Date : 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 : Dosage Can Not be Calculated
No Calc : No Calculation can be made
W : PPM calculated by weight
V : PPM Calculated by volume
U : Unknown whether PPM is given by weight or by volume
cwt : Hundred Weight
nnE-xx : nn times (10 power -xx); for instance, "1.234E-04" is equivalent to ".0001234"
USE LIMITATIONS CODES
A02 : Inedible product area.
28
-------
Report Run Date: 10/20/95 - Time 13:24 LUIS 2.2 - Page: 5
PRD Report Date: 06/08/95
APPENDIX A REPORT
Case 3095[Methyloxazolidines] Chemical 114801[4,4-Dimethyloxazolidine]
USE LIMITATIONS CODES (Cont.)
A23 : pH (minimum)
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)
CAH : Do not discharge into lakes, streams, ponds, or public water unless in accordance with NPDES Permit.
* NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS.DAYS, ETC.) DESCRIBED IN THE LIMITATION.
29
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregi strati on for active ingredients within the case
4,4-dimethyloxazolidine covered by this Reregistration Eligibility Decision Document. It contains generic data requirements
that apply to 4,4-dimethyloxazolidine 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.
30
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of 4,4-Dimethyloxazolidine
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
ECOLOGICAL EFFECTS
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
42941000, 42941001, 43328100, 43328101
42941000, 42941001, 43328100, 43328101
42941000, 42941001, 43328100, 43328101
42941000, 42941001, 43328100, 43328101
42941000, 42941001, 43328100, 43328101
42941000, 42941001, 43328100, 43328101
42941000, 42941001, 43328100, 43328101
42941000, 42941001, 43328100, 43328101
42941000, 42941001, 43328100, 43328101
42941000, 42941001, 43328100, 43328101
42941000, 42941001, 43328100, 43328101
42941000, 42941001, 43328100, 43328101
42941000, 42941001, 43328100, 43328101
42941000, 42941001, 43328100, 43328101
42941000, 42941001, 43328100, 43328101
42941000, 42941001, 43328100, 43328101
42941000, 42941001, 43328100, 43328101
42941000, 42941001, 43328100, 43328101
31
-------
Data Supporting Guideline Requirements for the Reregistration of 4,4-Dimethyloxazolidine
REQUIREMENT
71-1A
71-2A
71-2B
72-1A
72-1C
72-2A
72-3A
72-3B
Acute Avian Oral - Quail/Duck
Avian Dietary - Quail
Avian Dietary - Duck
Fish Toxicity Bluegill
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
Estuarine/Marine Toxicity - Fish
Estuarine/Marine Toxicity -
USE PATTERN
C,F,M
C,F,M
C
C,F
C,F,M
C,F,M
C,F
C,F
CITATION(S)
42967201, 0076970
00102975
00102976
00076969
00068770
00076968
00102974
00102973
Mollusk
72-3C Estuarine/Marine Toxicity - Shrimp
TOXICOLOGY
81-1 Acute Oral Toxicity - Rat
81-2 Acute Dermal Toxicity - Rabbit/Rat
81-3 Acute Inhalation Toxicity - Rat
81-4 Primary Eye Irritation - Rabbit
81-5 Primary Dermal Irritation - Rabbit
81-6 Dermal Sensitization - Guinea Pig
82-3 90-Day Dermal - Rodent
83-3A Developmental Toxicity - Rat
83-3B Developmental Toxicity - Rabbit
84-2A Gene Mutation (Ames Test)
C,F
ALL
ALL
ALL
ALL
ALL
ALL
C,F,M
C,F,M
ALL
00076967
41706707
41706708
41706709
41706710
41706711
41706712
43322601, 00138227
Waived
00157806
00076976, 00076977
32
-------
Data Supporting Guideline Requirements for the Reregistration of 4,4-Dimethyloxazolidine
REQUIREMENT USE PATTERN CITATION(S)
84-2B Structural Chromosomal
Aberration
ALL
ALL
84-4 Other Genotoxic Effects
OCCUPATIONAL/RESIDENTIAL EXPOSURE
133-3 Dermal Passive Dosimetry
Exposure
133-4 Inhalation Passive Dosimetry
Exposure
ENVIRONMENTAL FATE
161-1 Hydrolysis C,F
161-2 Photodegradation - Water C,F
00126352, 41577003, 41577004
00126353, 41577002
Waived
Waived
41664801
41960701
33
-------
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 Reregi strati on 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.
34
-------
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.
35
-------
BIBLIOGRAPHY
MRID
CITATION
00068770 WARF Institute, Incorporated (1977) Report: WARF Institute No. 4041616.
(Unpublished study received Mar 16, 1978 under 271-31; submitted by
International Minerals & Chemical Corp., Terre Haute, Ind.; CDL:233346-A)
00068771 International Minerals & Chemical Corporation (19??) Product Chemistry--
Physical Properties: [Bioban CS-1135]. (Unpublished study received Mar 16,
1978 under 271-31; CDL:233344-A)
00076967 Heitmuller, T. (1979) Acute Toxicity of Amine CS-1135A(R)= to Pink Shrimp
(-Penaeus duorarum-): Report No. BP-79-9-147. (Unpublished study, including
submitter summary, received Apr 28, 1981 under 271-31; prepared by EG & G,
Bionomics, submitted by International Minerals & Chemical Corp., Terre Haute,
Ind.;CDL:245165-A)
00076968 Thompson, C.M.; Forbis, A.D. (1979) Acute Toxicity of Amine CS1135
to~Daphnia magna-: Static Acute Bioassay Report #24668. (Unpublished study,
including submitter summary, received Apr 28, 1981 under 271-31; prepared by
Analytical Bio Chemistry Laboratories, Inc., submitted by International Minerals
& Chemical Corp., Terre Haute, Ind.; CDL:245165-B)
00076969 Thompson, C.M.; Forbis, A.D. (1979) Acute Toxicity of Amine CS1135 to
Bluegill Sunfish (-Lepomis macrochirus-): Static Acute Bioassay Report #24667.
(Unpublished study, including submitter summary, received Apr 28, 1981 under
271-31; prepared by Analytical Bio Chemistry Laboratories, Inc., submitted by
International Minerals & Chemical Corp., Terre Haute, Ind.; CDL:245165-C)
00076970 Bodden, R.M. (1980) Avian Single Dose Oral LD=50A-Mallard Duck.
(Unpublished study, including submitter summary, received Apr 28, 1981 under
271-31; prepared by Raltech Scientific Services, Inc., submitted by International
Minerals & Chemical Corp., Terre Haute, Ind.; CDL:245165-D)
00076976 Haworth, S.R.; Lawlor, T.E.; Smith, J.K.; et al. (1980) Salmonella/
Mammalian-microsome Plate Incorporation Mutagenesis Assay: Study No.
035-201-430-1. (Unpublished study, including submitter summary, received Apr
28, 1981 under 271-31; prepared by EG & G Mason Research Institute, submitted
by International Minerals & Chemical Corp., Terre Haute, Ind.; CDL:245161-H)
00076977 Haworth, S.R.; Lawlor, T.E.; Smith, J.K.; et al. (1980) Salmonella/
36
-------
BIBLIOGRAPHY
MRID
CITATION
Mammalian-microsome Plate Incorporation Mutagenesis Assay: Study No.
035-201-431-1. (Unpublished study received Apr 28, 1981 under 271-31;
prepared by EG & G Mason Research Institute, submitted by International
Minerals & Chemical Corp., Terre Haute, Ind.; CDL:245161-1)
00102973 Ward, S.; Parekh, C. (1982) Acute Toxicity of Amine CS-1135 to Eastern Oysters
(Crassostrea virginica): Report No. BP-82-3-24. (Unpublished study received
May 18, 1982 under 271-31; prepared by EG & G Bionomics, submitted by
International Minerals & Chemical Corp., Terre Haute, IN; CDL:247551-A)
00102974 Ward, S.; Parekh, C. (1981) Acute Toxicity of Amine CS-1135 to Sheepshead
Minnows (Cyprinodon variegatus): Report No. BP-81-11177. (Unpublished
study received May 18, 1982 under 271-31; prepared by EG & G Bionomics,
submitted by International Minerals & Chemical Corp., Terre Haute, IN;
CDL:247551-B)
00102975 Bodden, R.; Thomson, G. (1979) Avian Dietary LC50-Bobwhite Quail.
(Unpublished study received May 18, 1982 under 271-31; submitted by
International Minerals and Chemical Corp., Terre Haute, IN; CDL:247551-C)
00102976 Bodden, R.; Thomson, G. (1979) Avian Dietary LC50-Mallard Duck.
(Unpublished study received May 18, 1982 under 271-31; submitted by
International Minerals and Chemical Corp., Terre Haute, IN; CDL:247551-D)
00126352 Thilagar, A.; Kumaroo, P.; Pant, K.; et al. (1982) Cytogenicity Study-Chinese
Hamster Ovary (CHO) Cells in vitro: [Dimethyl Oxazolidine Solution]: Study No.
T1840.338. (Unpublished study received Mar 1, 1983 under 48301-8; prepared
by Microbiological Assoc., submitted by Angus Chemical Co., Northbrook, IL;
CDL: 249687-A)
00126353 Kirby, P.; Pizzarello, R.; Rogers-Back, A.; et al. (1983) L5178Y TK+/Mouse
Lymphoma Mutagenesis Assay: [Dimethyl Oxazolidine Solution]: Study No.
T1840.701001. (Unpublished study received Mar 1, 1983 under 48301-8;
prepared by Microbiological Assoc., submitted by Angus Chemical Co.,
Northbrook, IL; CDL:249687-B)
00138227 Troy, W.; Pennisi, S.; Felton, K.; et al. (1980) Thirteen Week Subchronic Dermal
Toxicity Study in Albino Rats: The Safety Evaluation of an Antimicrobial Raw
37
-------
BIBLIOGRAPHY
MRID
CITATION
Ingredient: Amine CS-1135: Study Project Code AT0156. Final rept.
(Unpublished study received Apr 13, 1984 under 48301-8; prepared by Avon
Products, Inc., submitted by Angus Chemical Co., Northbrook, IL;
CDL:252955-A)
00157806 Arnold, K. (1986) Dermal Teratology Study in Rabbits: Oxaban: Study No.
509-002. Unpublished study prepared by International Research and
Development Corp. 92 p.
41577002 Enninga, I. (1990) Evaluation of the DNA Repair Inducing Ability of Oxaban-A
(Bioban CS-1135): Lab Project Number: 020327. Unpublished study prepared by
RccNotox. 30 p.
41577003 Enninga, I. (1989) Micronucleus Test in Bone Marrow Cells of the Mouse with
Oxaban-A (Bioban CS-1135): Lab Project Number: 0112522. Unpublished study
prepared by RCC Notox. 21 p.
41577004 Asquith, I. (1984) Cytogenic Analysis of the Bone Marrow of Rats Treated with
HP 60/83 (Oxaban-A or Bioban CS-1135): Lab Project Number: SR374.
Unpublished study prepared by Toxicol Laboratories, Ltd. 267 p.
41664801 Chang, T. (1990) 4,4-Dimethyloxazolidine and 3,4,4-Trimethyloxazolidine:
Hydrolysis Study as a Function of pH at 25 (degree C): Project Number: BR
111 :90. Unpublished study prepared by Bolsa Research Associates. 31 p.
41706707 Cuthbert, I.; Carr, S.; lackson, D. (1986) Compound 192: Acute Oral Toxicity
(LD50) Test in Rats: Lab Project Number: 235634: 6401. Unpublished study
prepared by Inveresk Research International. 31 p.
41706708 Cuthbert, I.; Carr, S.; lackson, D. (1986) Compound 192: Acute Dermal Toxicity
(LD50) Test in Rats: Lab Project Number: 235634: 6402. Unpublished study
prepared by Inveresk Research International. 20 p.
41706709 McDonald, P.; Anderson, B. (1989) Troysan 192: Acute Inhalation Toxicity
Study in Rats: Lab Project Number: 641996. Unpublished study prepared by
Inveresk Research International. 43 p.
41706710 Cuthbert, I.; Carr, S.; lackson, D. (1986) Troysan 192: Acute Eye Irritation Study
38
-------
BIBLIOGRAPHY
MRID
CITATION
in Rabbits: Lab Project Number: 641996. Unpublished study prepared by
Inveresk Research International. 21 p.
41706711 Cuthbert, 1; Carr, S.; Jackson, D. (1986) Compound 192: Acute Dermal Irritation
Test in Rabbits: Lab Project Number: 235634: 6403. Unpublished study prepared
by Inveresk Research International. 19 p.
41706712 Cuthbert, I.; Carr, S.; lackson, D. (1986) Compound 192: Magnusson -Kligman
Maximization Test in Guinea Pigs: Lab Project Number: 135634: 6405.
Unpublished study prepared by Inveresk Research International. 26 p.
41960701 Chang, T. (1990) Photolysis Study with 4,4-Dimethyloxazolidine and
3,4,4-Trimethyloxazolidine in Aqueous Solution under Simulated Light
Conditions: Lab Project Number: BR 112:90. Unpublished study prepared by
Bolsa Research Associates. 34 p.
42864001 Siemann, L. (1993) Supplemental Data to MRID No. 41706706: 4,4-
Dimethyloxazolidine Stability: Lab Project Number: 3329-F: TCCREREG 192
93 Al: 192 93 Al. Unpublished study prepared by Midwest Research Institute. 18
P-
42941001 Wassink, C. (1993) Supplemental Chemistry Data for MRID #'s 41706707,
41706708, 41706710, 41706711, 41706712: Lab Project Number: 192-AC-l:
TCCREREG 93 192A1. Unpublished study prepared by Troy Corp. 68 p.
42967201 Pedersen, C.; Kauth, M. (1993) 4,4-Dimethyloxazolidine: 14-Day Acute Oral
LD50 Study in Bobwhite Quail: Lab Project Number: 135-001-03: TCCREREG
192B1. Unpublished study prepared by Bio-Life Associates, Ltd. 54 p.
43322601 Allan, S.; Hawkins, A.; Crook, D.; et al. (1994) Thirteen-week Dermal Toxicity
Study in Rats with 4,4-Dimethyloxazolidine: Final Report: Lab Project Number:
TCC/3/931087: 3/931087: 94/192Al. Unpublished study prepared by
Huntingdon Research Centre Ltd. 261 p.
43328100 Troy Chemical Corp. (1994) Submission of Product Chemistry Data in Support of
Registration of Troysan 192 Formula II. Transmittal of 1 Study.
43328101 Bollmeier, A. (1990) Product Chemistry for 4,4-Dimethyloxazolidine.
39
-------
BIBLIOGRAPHY
MRID CITATION
Unpublished study prepared by Angus Chemical Co. 27 p.
93150009 Pennisi, S. (1990) Angus Chemical Company Phase 3 Reformat of MRID
00076974 and Related MRIDs 00138227. Thirteen Week Subchronic Dermal
Toxicity Study in Rats: AMINE CS-1135: Project AT0156. Prepared by AVON
Products, Inc. 180 p.
40
-------
U3B
\
I UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
£
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment 1 of this Notice, the Data Call-In Chemical Status Sheet, to
submit certain product specific data as noted herein to the U.S. Environmental Protection Agency
(EPA, the Agency). These data are necessary to maintain the continued registration of your
product(s) containing this active ingredient. Within 90 days after you receive this Notice you must
respond as set forth in Section III below. Your response must state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 6; or
2. Why you believe you are exempt from the requirements listed in this Notice and in
Attachment 3, Requirements Status and Registrant's Response Form, (see section
III-B); or
3. Why you believe EPA should not require your submission of product specific data
in the manner specified by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply with
its requirements or should be exempt or excused from doing so, then the registration of your
41
-------
product(s) subject to this Notice will be subject to suspension. We have provided a list of all of
your products subject to this Notice in Attachment 2, Data Call-In Response Form, as well as a list
of all registrants who were sent this Notice (Attachment 6).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide and
Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107
and 2070-0057 (expiration date 03-31-96).
This Notice is divided into six sections and six Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You Are Receiving This Notice
Section II - Data Required By This Notice
Section III - Compliance With Requirements Of This Notice
Section IV - Consequences Of Failure To Comply With This Notice
Section V - Registrants' Obligation To Report Possible Unreasonable Adverse
Effects
Section VI - Inquiries And Responses To This Notice
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2 - Product-Specific Data Call-In Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - List of Registrants Receiving This Notice
6 - Cost Share and Data Compensation Forms
SECTION! 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.
42
-------
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, 2001 L Street, N.W., Washington, D.C. 20036
(Telephone number 202-785-6323; Fax telephone number 202-785-0350).
All new studies and proposed protocols submitted in response to this Data Call-In Notice must
be in accordance with Good Laboratory Practices [40 CFR Part 160.3(a)(6)].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(c)(2)(B) NOTICES ISSUED BY
THE AGENCY
Unless otherwise noted herein, this Data Call-In does not in any way supersede or change the
requirements of any previous Data Call-In(sX 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
43
-------
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.
44
-------
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 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.
45
-------
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 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
46
-------
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 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
47
-------
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 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.
48
-------
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.
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
49
-------
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 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.
50
-------
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.
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
51
-------
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a pesticide
is registered a registrant has additional factual information regarding unreasonable adverse effects on
the environment by the pesticide, the registrant shall submit the information to the Agency.
Registrants must notify the Agency of any factual information they have, from whatever source,
including but not limited to interim or preliminary results of studies, regarding unreasonable adverse
effects on man or the environment. This requirement continues as long as the products are registered
by the Agency.
SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment 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 the Confidential Statement of Formula
Form
52
-------
4,4-DIMETHYLOXAZOLIDINE DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing 4,4-dimethyloxazolidine.
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 4,4-
dimethyloxazolidine. 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 4,4-dimethyloxazolidine 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 4,4-dimethyloxazolidine
are contained in the Requirements Status and Registrant's Response. Attachment 3. The Agency has
concluded that additional data on 4,4-dimethyloxazolidine 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 4,4-dimethyloxazolidine products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding this product specific data requirements and procedures
established by this Notice, please contact Jean Holmes at (703) 308-8008.
All responses to this Notice for the Product Specific data requirements should be submitted to:
Jean Holmes
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: 4,4-Dimethyloxazolidine
53
-------
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.
54
-------
55
-------
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
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
56
-------
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. 1.) 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. 1.) 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. 1.) 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 completed and signed copies
of the Confidential Statement of Formula (EPA Form 8570-4)
57
-------
6. By the specified due date, I will cite an existing study that the Agency has classified as
acceptable or an existing study that has been submitted but not reviewed by the Agency
(Citing an Existing Study). If I am citing another registrant's study, I understand that
this option is available only for acute toxicity or certain efficacy data and only if the
cited study was conducted on my product, an identical product or a product which EPA
has "grouped" with one or more other products for purposes of depending on the 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)
7. 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.
58
-------
59
-------
60
-------
61
-------
62
-------
63
-------
64
-------
65
-------
66
-------
EPA'S BATCHING OF 4,4-DIMETHYLOXAZOLIDINE PRODUCTS FOR MEETING ACUTE
TOXICITY DATA REQUIREMENTS FOR REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the acute
toxicity data requirements for reregi strati on of products containing 4,4-dimethyloxazolidine as the
active ingredient, the Agency has batched products which can be considered similar for purposes of
acute toxicity. There are six active products containing 4,4-dimethyloxazolidine as follows: 1100-87,
5383-60, 5383-61, 5383-82, 48301-8, 48301-12. All of these products are expected to have the same
acute toxicity profile as the technical material described in the RED and may cite that data for
reregi strati on.
Factors considered in the batching process include each product's active and inert ingredients
(identity, percent composition and biological activity), type of formulation (e.g., emulsifiable
concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g., signal word, use classification,
precautionary labeling, etc.). Note that the Agency is not describing batched products as "substantially
similar" since some products within a batch may not be considered chemically similar or have identical
use patterns.
Using available information, batching has been accomplished by the process described in the
preceding paragraph. Notwithstanding the batching process, the Agency reserves the right to require,
at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite a
single battery of six acute toxicological studies to represent all the products within that batch. It is the
registrants' option to participate in the process with all other registrants, only some of the other
registrants, or only their own products within a batch, or to generate all the required acute toxicological
studies for each of their own products. If a registrant chooses to generate the data for a batch, he/she
must use one of the products within the batch as the test material. If a registrant chooses to rely upon
previously submitted acute toxicity data, he/she may do so provided that the data base is complete and
valid by today's standards (see acceptance criteria attached), the formulation tested is considered by
EPA to be similar for acute toxicity, and the formulation has not been significantly altered since
submission and acceptance of the acute toxicity data. Regardless of whether new data is generated or
existing data is referenced, registrants must clearly identify the test material by EPA Registration
Number. If more than one confidential statement of formula (CSF) exists for a product, the registrant
must indicate the formulation actually tested by identifying the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-In Notice and its attachments appended to the RED. The DCI Notice
contains two response forms which are to be completed and submitted to the Agency within 90 days
of receipt. The first form, "Data Call-In Response," asks whether the registrant will meet the data
requirements for each product. The second form, "Requirements Status and Registrant's Response,"
lists the product specific data required for each product, including the standard six acute toxicity tests.
A registrant who wishes to participate in a batch must decide whether he/she will provide the data or
depend on someone else to do so. If a registrant supplies the data to support a batch of products, he/she
67
-------
must select one of the following options: Developing Data (Option 1), Submitting an Existing Study
(Option 4), Upgrading an Existing Study (Option 5) or Citing an Existing Study (Option 6). If a
registrant depends on another's data, he/she must choose among: Cost Sharing (Option 2), Offers to
Cost Share (Option 3) or Citing an Existing Study (Option 6). If a registrant does not want to participate
in a batch, the choices are Options 1, 4, 5 or 6. However, a registrant should know that choosing not
to participate in a batch does not preclude other registrants in the batch from citing his/her studies and
offering to cost share (Option 3) those studies.
68
-------
Attachment 5. List of All Registrants Sent This Data Call-In (insert) Notice
69
-------
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.
70
-------
3t
O)
I
2
Q.
X
UJ
§
Q.
Q.
O
o
9
8
6
Z
co
O
TJ
1
O
Q.
Q.
g
°
.^
U)
£
O
5i
Q
(Q
^
^
*•
c
a
u
V)
"5
c
•a
^
i
o
O
1
o
Q
formation:
•8
8
•S
3
OQ
Confidentia
m
c
o
(A
C
0
~
3
.
c
o
u
CD
i
0)
a
2
%
3
1
<
LU
IT)
1
to
^
6
Z
c
0
n
1
tr
c
o
U)
2
UJ
0)
£
(Q
U.
C
"o
0.
£
(A
JO
u_
m
X
0.
GO
S
1
OQ
0
5
'ounds/
a.
. Product Name
PO
c
- c
S H
li
3 C
Q- 5
""
t:
E
| -1
"D '""
|5 =
« .D ^
. o
^ a
>b
^
1
c ^
0) aP
ir
§3
U g_
s-si
uJ c £
^
*~ (D
6
Z
OB
ID
tr
a.
UJ
ri
»
1
00
£
ffl
z
O
Q.
3
CO
^
11
ist as actually i
lonly accepted
ar.)
n Formulation IL
\ion. Give comrr
i, and CAS numb
ill
0-2 1
E^ fc
°~ c
sis
_i
Z
o
UJ
co
0.
UJ
*
o
*~
2
5*
1
ID
O
(^
^
"s
§
o>
c
g
a.
£
"5
ID
a
Z
a.
(b
CD
Q
OJ
— ^
"S
Q
O
ns
w
1
^
o
Z
?
0
a.
o
CN
0
i=
a>
"(5
u
O
c
>
a.
a
"S
«
S
c
g>
CO
S:
S
c
s
CL
**-
***
,
g
1
^
_c
'C*
2.
S:
o
o
.2
IT
^
UJ
S
,TZ
§
.
Q_
O
o
o
1
m
c
(D
E
1
I
a.
tn
£
Q.
x
o
0
£
C
1
-
0
0
s
J3
O
editions are
) Previous
e
o>
CN
^
>
cc
""
in
-------
72
-------
?/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
Product Name
Company Number
EPA Reg. No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Name of Flrm(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
73
-------
74
-------
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)
75
-------
76
-------
The following is a list of available documents for 4,4-dimethyloxazolidine that may further
assist you in responding to this Reregi strati on Eligibility Decision document. These documents may
be obtained by the following methods:
Electronic
File format: Portable Document Format (.PDF) Requires Adobe® Acrobat or compatible reader.
Electronic copies can be downloaded from the Pesticide Special Review and
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., or
contact Jean Holmes at (703)-308-8008.
1. PR Notice 86-5.
2. PR Notice 91-2 (pertains to the Label Ingredient Statement).
3. A full copy of this RED document.
4. A copy of the fact sheet for 4,4-dimethyloxazolidine.
The following documents are part of the Administrative Record for 4,4-dimethyloxazolidine
and may be included in the EPA's Office of Pesticide Programs Public Docket. Copies of these
documents are not available electronically, but may be obtained by contacting the person listed on
the Chemical Status Sheet.
1 .Health and Environmental Effects Science Chapters.
2.Detailed Label Usage Information System (LUIS) Report.
The following Agency reference documents are not available electronically, but may be
obtained by contacting the person listed on the Chemical Status Sheet of this RED document.
1. The Label Review Manual.
2. EPA Acceptance Criteria
77
------- |