United States Prevention, Pesticides EPA 738-R-96-028
Environmental Protection And Toxic Substances September 1995
Agency (7508W)
&EPA Reregistration
Eligibility Decision (RED)
Bis(trichloromethyl) sulfone
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USE2.*
\, oon1^N° WASHINGTON, D.C. 20460
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case
Bis (trichloro methyl) sulfone. The enclosed Reregistration 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 reregistration. The RED
includes the data and labeling requirements for products for reregistration. It may also include
requirements for additional data (generic) on the active ingredient to confirm the risk
assessments.
To assist you with a proper response, read the enclosed document entitled "Summary
of Instructions for Responding to the RED." This summary also refers to other enclosed
documents which include further instructions. You must follow all instructions and submit
complete and timely responses. The first set of required responses are due 90 days from
the receipt of this letter. The second set of required responses are due 8 months from the
receipt of this letter. Complete and timely responses will avoid the Agency taking the
enforcement action of suspension against your products.
Please note that this RED was finalized and signed prior to August 3, 1996. On that
date, the Food Quality Protection Act of 1996 ("FQPA") became effective, amending portions
of both the pesticide law (FIFRA) and the food and drug law (FFDCA). This RED does not
address any issues raised by FQPA, and any tolerance-related statements in the RED did not
take into account any changes in tolerance assessment procedures required under FQPA. To
the extent that this RED indicates that a change in any tolerance is necessary, that
determination will be reassessed by the Agency under the standards set forth in FQPA before a
proposed tolerance is issued. To the extent that the RED does not indicate that a change in the
tolerance is necessary, that tolerance, too, will be reassessed in the future pursuant to the
requirements of FQPA.
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 Jeff
Billingslea at (703) 308-8004. Address any questions on required generic data to the Special
Review and Reregistration Division representative Bill Wooge at (703) 308-8794.
Sincerely yours,
Lois A. Rossi, Director
Special Review
and Reregistration Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1 DATA CALL-IN (PCI) OR "90-DAY RESPONSE" If generic data are required for
reregistration, a DCI letter will be enclosed describing such data. If product specific data are
required, another DCI letter will be enclosed listing such requirements. If both generic and
product specific data are required, a combined Generic and Product Specific letter will be
enclosed describing such data. Complete the two response forms provided with each DCI
letter (or four forms for the combined) by following the instructions provided. You must
submit the response forms for each product and for each DCI within 90 days of the date
of this letter (RED issuance date); otherwise, your product may be suspended.
2. TIME EXTENSIONS AND DATA WAIVER REQUESTS No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for data waivers must be submitted as part of the
90-day response. Requests for time extensions should be submitted in the 90-day response,
but certainly no later than the 8-month response date. All data waiver and time extension
requests must be accompanied by a full justification. All waivers and time extensions must be
granted by EPA in order to go into effect.
3. APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregistration) separately. You may delete uses
which the RED says are ineligible for reregistration. For further labeling guidance, refer to
the labeling section of the EPA publication "General Information on Applying for Registration
in the U.S., Second Edition, August 1992" (available from the National Technical Information
Service, publication #PB92-221811; telephone number 703-487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that they meet
the Agency's acceptance criteria (attached to the DCI).
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
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concentration. You have two options for submitting a CSF: (1) accept the standard certified
limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by the analysis
of five batches. If you choose the second option, you must submit or cite the data for the five
batches along with a certification statement as described in 40 CFR §158.175(e). A copy of
the CSF is enclosed; follow the instructions on its back.
e. Certification With Respect to Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product.
4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE-Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5 WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS-EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.
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REREGISTRATION ELIGIBILITY DECISION
Bis(trichloromethyl) sulfone
LISTB
CASE 2055
ENVIRONMENTAL PROTECTION AGENCY
OFFICE OF PESTICIDE PROGRAMS
SPECIAL REVIEW AND REREGISTRATION DIVISION
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TABLE OF CONTENTS
BIS(TRICHLOROMETHYL) SULFONE REREGISTRATION ELIGIBILITY DECISION
TEAM i
EXECUTIVE SUMMARY v
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Regulatory History 4
III. SCIENCE ASSESSMENT 5
A. Physical Chemistry Assessment 5
B. Human Health Assessment 6
1. Toxicology Assessment 6
a. Acute Toxicity 6
b. Subchronic Toxicity 7
c. Developmental Toxicity 7
d. Mutagenicity 8
e. Reference Dose 9
f. Toxicity Endpoints of Concern 9
2. Exposure Assessment 9
a. Dietary Exposure 9
b. Occupational and Residential Exposure 10
3. Risk Assessment 14
a. Dietary 14
b. Occupational and Residential 14
C. Environmental Assessment 17
1. Ecological Toxicity Data 18
a. Toxicity to Terrestrial Animals 18
b. Toxicity to Aquatic Animals 19
2. Environmental Fate 20
a. Environmental Fate Assessment 20
b. Water Resources 21
3. Exposure and Risk Characterization 22
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 22
A. Determination of Eligibility 22
1. Eligibility Decision 23
2. Eligible and Ineligible Uses 23
B. Regulatory Position 23
1. Additional Generic Data Requirements 23
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2. Risk Mitigation Measures 24
a. Personal Protective Equipment/Engineering Controls for
Handlers 24
b. Post-Application/Entry Restrictions 26
c. Other Labeling Requirements 26
V. ACTIONS REQUIRED OF REGISTRANTS 27
A. Manufacturing-Use Products 27
1. Additional Generic Data Requirements 27
2. Labeling Requirements for Manufacturing-Use Products 27
a. General Labeling Requirements 27
b. Specific Labeling Amendments 28
B. End-Use Products 28
1. Additional Product-Specific Data Requirements 28
2. Labeling Requirements for End-Use Products 28
a. PPE/Engineering Control Requirements for Pesticide Handlers
28
b. Labeling Requirements for Products Intended Primarily for
Occupational Use 30
c. Clarification of Oil Drilling Mud Use 31
d. Directions For Use 31
e. Clarification of Industrial/Commercial Water Cooling Systems
32
3. Existing Stocks 32
VI. APPENDICES 33
APPENDIX A. Table of Use Patterns Subject to Reregistration 35
APPENDIX B. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 49
APPENDIX C. Citations Considered to be Part of the Data Base Supporting the
Reregistration of Bis(trichloromethyl) sulfone 53
APPENDIX D. Product Specific Data Call-In 59
Attachment 1. Chemical Status Sheets 71
Attachment 2. Product Specific Data Call-In Response Forms Plus
Instructions 73
Attachment 3. Product Specific Requirement Status and Registrant's
Response Forms and Instructions 75
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 85
Attachment 5. List of All Registrants Sent This Data Call-In Notice
89
Attachment 6. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions .... 91
APPENDIX E. List of Available Related Documents 99
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LIST OF TABLES
Table 1 - Acute Toxicity Studies 6
Table 2 -Pump Liquid (Closed System) Scenario Calculations - Handlers 12
Table 3 - Pour Liquid (Open System) Scenario Calculations - Handlers 12
Table 4 - Risk Calculation for Closed Systems Using Liquids - Handlers 15
Table 5 - Risk Calculation for Open Pour Application - Handlers 15
Table 6 - Avian Acute and Subacute Oral Toxicity Findings 18
Table 7 - Freshwater Fish Acute Toxicity Findings 19
Table 8 - Freshwater Invertebrate Toxicity Findings 19
Table 9 - Estuarine/Marine Acute Toxicity Findings 20
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BIS(TRICHLOROMETHYL) SULFONE REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Division
Michelle Cottrill
Frank Hernandez
Phyllis Johnson
Environmental Fate and Effects Division
Ann Stavola
Laura Parsons
Karen Angulo
Health Effects Division
Laura Morris
Arliene Aikens
Stephen Dapson
Registration Division
Marianne Clark
Ruth G. Douglas
Tina Levine
Special Review and Reregistration Division
Kathy Davis
Bill Wooge
Office of the General Counsel:
Kevin Lee
Office of Enforcement and Compliance:
Rick Colbert
Biological Analysis Branch
Economic Analysis Branch
LUIS
Ecological Effects Branch
Environmental Fate and Groundwater Branch
Science Analysis and Coordination Staff
Occupational and Residential Exposure Branch
Risk Characterization & Analysis Branch
Toxicology Branch II
Antimicrobial Program Branch
Antimicrobial Program Branch
Registration Support Branch
Accelerated Reregistration Branch
Accelerated Reregistration Branch
Pesticides Branch
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11
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI
AE
a.i.
ARC
CAS
CI
CNS
CSF
DFR
DRES
DWEL
EEC
EP
EPA
FDA
FIFRA
FFDCA
FOB
GLC
GM
GRAS
HA
HOT
LC
LD
LD10
LEL
LOG
LOD
LOEL
MATC
MCLG
mg/L
MOE
MP
MPI
MRID
N/A
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
111
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GLOSSARY OF TERMS AND ABBREVIATIONS
NOEC No effect concentration
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
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 ® of FIFRA)
TC Toxic Concentration. The concentration at which a substance produces a toxic effect.
TD Toxic Dose. The dose at which a substance produces a toxic effect.
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography
TMRC Theoretical Maximum Residue Contribution
torr A unit of pressure needed to support a column of mercury 1 mm high under standard
conditions.
FAO/WHO Food and Agriculture Organization/World Health Organization
WP Wettable Powder
WPS Worker Protection Standard
IV
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EXECUTIVE SUMMARY
As required under the Federal Insecticide, Rodenticide, and Fungicide Act, as amended
in 1988, the U.S. Environmental Protection Agency has completed its reregistration eligibility
decision for the pesticide active ingredient bis(trichloromethyl) sulfone. This decision includes
a comprehensive reassessment of the required target data base and use patterns of currently
registered products. The Agency has determined that the uses of bis(trichloromethyl) sulfone
as prescribed in this document will not cause unreasonable risk to humans or the environment
and these uses are eligible for reregistration. The Agency is requiring additional mutagenicity
and neurotoxicity studies for confirmatory purposes and it is imposing the use of Personal
Protective Equipment (PPE) and closed-loading and application systems to reduce risks to
workers.
Use Patterns
Bis (trichloro methyl) sulfone is primarily used to control microbes, algae, and fungi in
cooling water systems, waste disposal systems, pulp and paper mill water systems, oil
extraction systems, and other industrial settings.
Human Health Assessment
From its review of the toxicology data, the Agency determined that
bis(trichloromethyl) sulfone was slightly toxic to non-toxic in acute oral and dermal toxicity
tests. However, bis(trichloromethyl) sulfone was determined to be highly toxic in eye
irritation, dermal irritation and inhalation acute toxicity studies. In a subchronic dermal rabbit
toxicity study, the No Observed Effect Level (NOEL) was 2.0 mg/kg/day. From evidence of
changes in the blood and clinical chemistry values, the systemic NOEL is established at 2.0
mg/kg/day for males. The systemic NOEL is equal to or greater than 5.0 mg/kg/day for
females.
The toxicological endpoints of concern for occupational and residential exposure to
bis(trichloromethyl) sulfone are systemic toxicities from a rat developmental study and from a
rat subchronic dermal study. The calculated Margins of Exposure (MOE = NOEL/exposure)
for bis(trichloromethyl) sulfone product handlers are not of concern (greater than 100) for
most exposure scenarios. However, the MOEs for handlers using open pouring in cooling
towers and drilling muds are of concern. To protect these workers, closed system loading and
application are required.
Environmental Assessment
Bis (trichloro methyl) sulfone is practically non-toxic to birds, and highly to very highly
toxic to freshwater and estuarine/marine organisms. Marginal data are available to estimate
the environmental fate of bis (trichloro methyl) sulfone. These data suggest that the primary
route of dissipation is through microbial action, with a half-life of less than 0.5 days. While
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the hazard to aquatic organisms from bis(trichloromethyl) sulfone has been characterized, a
quantitative risk assessment has not been conducted. The risks to aquatic environments from
this use are regulated under the NPDES permitting program of EPA's Office of Water. The
Agency currently requires that labels for all bis(trichloromethyl) sulfone products require that
discharges to aquatic environments comply with an NPDES permit.
Product Reregistration
Before reregistering the products containing bis(trichloromethyl) sulfone , the Agency
is requiring that product specific data, revised Confidential Statements of Formula (CSF) and
revised labeling be submitted within eight months of the issuance of this document. In
addition, registrants must comply with the generic data requirements as outlined in Section V
of this document. These data include product chemistry for each registration and acute
toxicity testing. After reviewing these data and any revised labels and finding them acceptable
in accordance with Section 3(c)(5) of FIFRA, the Agency will reregister a product. Those
products that contain other active ingredients will be eligible for reregistration only when the
other active ingredients are determined to be eligible for reregistration.
VI
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I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended to accelerate the reregistration of products with active ingredients registered prior to
November 1, 1984. The amended Act provides a schedule for the reregistration process to be
completed in nine years. There are five phases to the reregistration process. The first four
phases of the process focus on identification of data requirements to support the reregistration
of an active ingredient and the generation and submission of data to fulfill the requirements.
The 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 registered uses of bis(trichloromethyl) sulfone . The document consists of six sections.
Section I is the introduction. Section II describes bis(trichloromethyl) sulfone, 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 bis(trichloromethyl) sulfone. Section V discusses the reregistration requirements
for bis(trichloromethyl) sulfone. 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.
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II. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility
Decision:
• Common Name: Bis(trichloromethyl) sulfone
• Chemical Name: Hexachlorodimethyl sulfone;
Sulfonyl bis(trichloromethane)
• CAS Registry Number: 3064-70-8
• OPP Chemical Code: 35601
• Empirical Formula: C5HUNO
• Trade and Other Names: N-1386
• Basic Manufacturer: Verichem, Inc.
B. Use Profile
The following is an overview of the use profile, including the application sites
and methods, of the currently registered products formulated with bis (trichloro methyl)
sulfone as an active ingredient. A detailed table of these uses is in Appendix A.
For Bis (trichloro methyl) sulfone:
Type of Pesticide: Algaecide, Bacteriostat, Fungicide,
Microbicide/Microbiostat (Slime-forming bacteria, fungi,
and algae)
Use Sites:
INDOOR FOOD
Food Packaging (regulated by FDA)
INDOOR NON-FOOD:
Adhesives, Industrial
Coatings, Industrial
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Emulsions, Resin/Latex/Polymer*
Oil Recovery Drilling Muds/Packer Fluids
Paper/Paper Products
Pasteurizer/Warmer/Cannery Cooling Water systems
Specialty Industrial Products
Wet-End Additives/Industrial Processing Chemicals
* The sole registrant of this use has requested the Agency to cancel the
use in paints from the product registration.
AQUATIC NON-FOOD INDUSTRIAL:
Commercial/Industrial Water Cooling Systems
Evaporative Condenser Water Systems
Heat Exchanger Water Systems
Industrial Auxiliary Water Systems
Industrial Scrubbing System
Industrial Waste Disposal Systems
Oil Recovery Drilling Muds/Packer Fluids
Pulp/Paper Mill Water Systems
Secondary Oil Recovery Injection Water
Sewage Systems
TERRESTRIAL NON-FOOD CROP:
Oil Recovery Drilling Muds/Packer Fluids
Target Pests: Slime-forming bacteria, algae, and fungi
Formulation Types Registered:
TYPE: End-use, Manufacturing-use, Technical grade
FORM: Soluble concentrate/liquid, Liquid-ready to use, Soluble
concentrate/solid
Method and Rates of Application:
TYPES OF TREATMENT:
Industrial preservative treatment, Preservative treatment, Water
treatment (recirculating system), Impregnation treatment, Surface
treatment.
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Equipment - Not specified, Rollcoater
Method and Rate -
Indoor Non-Food
2.4 to 285 ppm active ingredient by weight, 27 to 267
ppm active ingredient by volume
Aquatic Non-Food Industrial
0.3 to 285 ppm active ingredient by weight
Terrestrial Non-Food
29 to 285 ppm active ingredient by weight
Timing - Not specified, during manufacture, continuous feed
(initial), continuous feed (subsequent), intermittent (slug,
initial), intermittent (slug, subsequent)
Use Practice Limitations: Preclean claim. Preclean for heavily soiled areas.
Do not apply in marine and/or estuarine oil fields,
or discharge effluent into lakes, streams, ponds or
public water (NPDES license restriction). Do not
discharge effluent containing this pesticide into
sewage systems without notifying the sewage
treatment plant authority. Do not discharge
effluent containing this product into lakes,
streams, ponds, estuaries, oceans, or public water.
C. Regulatory History
Bis(trichloro)methyl sulfone was first registered in the U.S. in 1967 as a
fungicide. In 1968 another registration was issued for a product containing this
chemical. Bis(trichloro)methyl sulfone is registered for use as a
microbiocide/microbiostat in industrial systems such as waste disposal systems, food
processing water systems, sewage systems, heat exchanger water systems, evaporative
condenser water systems and commercial and industrial water cooling tower systems.
The first product registration, referred to above, was canceled in 1991.
Currently there are five companies that have fourteen active registrations. One of these
products is registered as a technical with an active ingredient declaration of 98%. The
remaining 13 products (with active ingredient declarations ranging from 2.5% to 49%)
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are registered for the following uses in addition to the uses indicated above for the
second product registered in the U.S.: microbiocide/microbiostat, algaecide in
secondary oil recovery/injection water systems, oil recovery drill muds, packer fluids,
pulp and paper mills, food processing water systems, wet-end/industrial processing
chemicals, wood protection treatment, adhesives, specialty products, resin emulsions,
paper and paper products, in-can paints (oil and latexes) and coatings. The use in
paints is being voluntarily deleted from the sole product registration for this use.
Bis(trichloro)methyl sulfone is cleared under the Food Additive Regulations, 21
CFR Section 176.300, as an indirect food additive in the manufacture of paper and
paperboard that contact food. It is also cleared under 21 CFR Section 175.105 for use
as a preservative in adhesives.
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.
III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Color: Off white
Physical State: Solid
Odor: Pungent aromatic
Melting Point: 36 to 38°C
Bulk Density: 125 Ibs /ft3
Solubilities: Solvent % by Weight or ppm
Water 67 ppm
Ethylene glycol 6.2%
Dimethyl sulfoxide 90.0%
Acetonitrile 93.0%
Dissociation Constant: Insoluble in water
Octanol/Water Partition Coefficient: Log P = 3.3
Stability: Stable under ambient conditions. It does not react with
steel or iron.
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B. Human Health Assessment
1. Toxicology Assessment
At present, the toxicology data base for bis(trichloromethyl) sulfone
meets the tiering pattern set for antimicrobials. The data is adequate and will
support a reregistration eligibility determination for currently registered non-
food uses.
a. Acute Toxicity
Table 1 - Acute Toxicity Studies
TEST
Oral LD50 - rat
Dermal LD50 - rabbit
Inhalation LC50 - rat
Eye irritation -rabbit1
Dermal irritation-rabbit1
Dermal sensitization -
guinea pigs1
GUIDELINE #
81-1
81-2
81-3
81-4
81-5
81-6
RESULTS
545 mg/kg males, 535 mg/kg females
>5000mg/kg
0.04 mg/L
corrosive
irritant
not a sensitizer
CATEGORY
III
IV
I
I
I
-
1 This study is a requirement for manufacturing-use and end-use products (40 CFR Section 158). For
bis(trichloromethyl) sulfone data have been generated on the TGAI and are presented here for informational
purposes.
Acute toxicity studies performed with bis(trichloromethyl)
sulfone indicate low to high toxicity. The acute oral LD50 (range) for
males was 545 (475-625) mg/kg and 535 (479-597) mg/kg for females
(MRID # 152875). The acute dermal LD50 is greater than 5000 mg/kg
(MRID # 152875). The acute inhalation LC50 for rats of both sexes was
calculated to be 0.04 mg/L (MRID # 42824801). Bis(trichloromethyl)
sulfone was corrosive to the eyes of New Zealand albino rabbits (MRID
# 152875) and was irritating to the skin of New Zealand albino rabbits
(MRID # 152875). There was no evidence of skin sensitization from a
single application of 0.5% bis(trichloromethyl) sulfone during the
challenge phase (MRID #'s 156813 & 92010015).
In an acute neurotoxicity study, male and female Sprague-Dawley
Crl:CD9(SD)BR rats received either 0, 50, 160, or 500 mg/kg of
bis(trichloromethyl) sulfone in corn oil by a single oral gavage. The
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systemic toxicity LOEL < 50 mg/kg and the systemic toxicity NOEL <
50 mg/kg were based on decreased body weight gain in females,
decreased food consumption in all treated animals, and a decrease in
core body temperature and motor activity in all treated animals at the 50
mg/kg dose (MRID # 43156601 and addendum 43207901). The Agency
has determined that the acute neurotoxicity study in rats is insufficient
but upgradeable pending submission of acceptable positive control data
for FOB evaluations, motor activity and neuropathology.
b. Subchronic Toxicity
In a 21-day dermal toxicity study, bis(trichloromethyl) sulfone
was administered in doses of 0, 0.8, 2.0, or 5.0 mg/kg/day to young
adult rabbits of the Hra:(NZW)SPF strain. The systemic LOEL is 5.0
mg/kg/day for males and greater than 5.0 mg/kg/day for females. The
systemic NOEL is 2.0 mg/kg/day for males and equal to or greater than
5.0 mg/kg/day for females based on hematology and clinical chemistry
changes. The LOEL for dermal irritation is 5.0 mg/kg/day in both
sexes and the NOEL for dermal irritation is 2.0 mg/kg/day based on
dermal irritation scores compared to control (MRID # 40050701).
c. Developmental Toxicity
In a developmental toxicity (teratology) study,
bis(trichloromethyl) sulfone was administered in doses of 0, 2, 10, or 50
mg/kg/day by gavage to Charles River Crl:CD BR albino rats on
gestation days six through fifteen, inclusive. The maternal toxicity
LOEL is 10 mg/kg/day and the maternal toxicity NOEL is 2 mg/kg/day
based on decreased body weight gains and reduced food consumption.
The developmental toxicity LOEL is 50 mg/kg/day with a developmental
toxicity NOEL of 10 mg/kg/day based on decreased fetal body weights
and an increase in skeletal and external anomalies (MRID # 40149101).
In a developmental toxicity study bis(trichloromethyl) sulfone
was administered in doses of 0, 10, 20, or 45 mg/kg/day by gavage to
groups of 20 pregnant New Zealand white rabbits on gestation days six
through eighteen, inclusive. The maternal toxicity LOEL was 45
mg/kg/day and the maternal toxicity NOEL is 20 mg/kg/day based on
the decrease in maternal body weight gain, reduced food consumption
and increased incidence in clinical signs of toxicity. The developmental
toxicity LOEL is greater than 45 mg/kg/day and the developmental
toxicity NOEL is equal to or greater than 45 mg/kg/day as no
compound-related developmental toxicity was noted (MRID #
43156602).
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d. Mutagenicity
In two gene mutation assays (Ames), using strains of Salmonella
typhimurium (TA1535, TA1537, TA1538, TA98, and TA100) and a
strain of Saccharomyces cerevisiae (D4), N-1386 was a positive mutagen
to TA1535 under both nonactivated and S9 activated conditions. There
were also suggestive increases in the numbers of revertants for TA100,
however the criteria for a positive response were not met (MRID #
152330 and 152331).
In another gene mutation assay using strains of Salmonella
typhimurium (TA1535, TA1537, TA1538, TA98, TA100), N-1386 was
found to be a positive mutagen to strain TA-1535 under both
nonactivated and S9 activated conditions and also positive to strain TA-
100 under nonactivated conditions (MRID # 152332).
In a forward mutation assay, with Fischer mouse lymphoma
L5178Y cells, N-1386 did not show a mutagenic response under either
the nonactivated or the S9 activated conditions (MRID # 152333). In a
sister chromatid exchange assay with Fischer mouse lymphoma L5178Y
cells, N-1386 resulted in an increase in sister chromatid exchange under
both S9 activated and nonactivated conditions (MRID # 152335).
In the multiple endpoint assay (gene mutation, chromosomal
aberration, sister chromatid exchange), with Fischer mouse lymphoma
L5178Y cells, N-1386 was an equivocal positive for gene mutations
under nonactivated conditions and negative under S9 activated
conditions. In the chromosomal aberration and the sister chromatid
exchange (SCE) assays, the results were negative; however, the dose
levels used were inadequate for testing full mutagenic potential (MRID #
152334).
In a micronucleus assay in Swiss-Webster mice, N-1386 technical
was tested over an appropriate range of doses and was found to be
nongenotoxic. (MRID# 42372701). An in vitro malignant
transformation assay in BALB/3T3 cells, N-1386 was negative (No
MRID # for submission: Stauffer Project No. T-6351, Litton Bionetics,
Inc., January 1978.). A morphologic transformation assay in
BALB/3T3 cells, N-1386 was negative (MRID # 152335).
The Office of Pesticide Programs' RfD/QA Peer Review
Committee (3/10/95) concluded that the available mutagenicity data
satisfied the non-food antimicrobial pesticide toxicology data
requirements for mutagenicity testing in the categories of gene mutation
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(Guideline 84-2a), structural chromosomal aberrations (Guideline 84-
2b), and other genotoxic effects (Guideline 84-4). However, because the
gene mutation study does not provide unequivocal evidence for either
positive or negative gene mutation under the conditions of the study,
additional data are required with an assay that involves interaction with
germ cells in animals.
These confirmatory data are required to determine whether
carcinogenicity testing must be conducted, since positive findings
occurred. After these data are submitted, the Agency will make a
determination on the requirement for carcinogenicity test data.
e. Reference Dose
The establishment of a reference dose (RfD) for
bis(trichloromethyl) sulfone is not warranted, based on the use patterns
and exposure profile for this active ingredient.
f. Toxicity Endpoints of Concern
The toxicological endpoints of concern for occupational and
residential exposure are a systemic toxicity NOEL of 10 mg/kg/day from
the developmental rat study (? effect) resulting from short-term (1-7
day) exposure and a dermal exposure NOEL of 2 mg/kg/day from the
21-day rat dermal study resulting from intermediate-term (1 week to
several months) exposure (The Office of Pesticide Program's Less than
Lifetime Committee (1/17/95)).
2. Exposure Assessment
a. Dietary Exposure
Administrative guidelines are established for bis(trichloromethyl)
sulfone uses (adhesives and slimicides) in food contact through food
packaging. These uses of bis(trichloromethyl) sulfone in the
manufacture of paper, paperboard (21 CFR §176.300) and adhesives (21
CFR §175.105) which may contact food are regulated under the
jurisdiction of the United States Food and Drug Administration. These
guidelines are not directly regulated by EPA. There are no other
registered food uses of bis(trichloromethyl) sulfone.
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b. Occupational and Residential Exposure
The Agency conducts an occupational and/or residential exposure
assessment for an active ingredient if (1) certain toxicological criteria are
triggered and (2) there is potential exposure to handlers (mixers, loaders,
applicators, etc.) during use or exposure to persons entering treated sites
after application is complete. The Agency believes this is the case for
the use of bis(trichloromethyl) sulfone products. Above the Agency
described its conclusions regarding toxicology endpoints of concern for
bis(trichloromethyl) sulfone. Below there is discussion of potential
exposures from the use of these products.
The Agency is not aware of any pesticide products containing
bis(trichloromethyl) sulfone that are intended primarily for homeowner
use. Many products containing bis(trichloromethyl) sulfone are labeled
for "industrial use only" and are, therefore, intended for occupational
use. None of the registered uses are likely to involve direct applications
of the active ingredient at residential sites. However, many secondary
products, such as adhesives, paper, etc., may contain
bis(trichloromethyl) sulfone as a preservative and are intended for
homeowner use as well as occupational use. Therefore, people using
these products may be secondarily exposed to bis(trichloromethyl)
sulfone residues.
(1) Handler Exposure Scenarios and Assumptions
EPA believes there are potential exposures from direct
applications in commercial and industrial settings and from
secondary applications in commercial, industrial, and residential
settings. These two levels of handler exposures are:
• primary handlers — persons at industrial sites using
(mixing, loading, applying) end-use pesticide products
containing bis(trichloromethyl) sulfone as an active
ingredient.
• secondary handlers — persons using (mixing, loading,
applying or otherwise handling) products, such as
adhesives, to which bis(trichloromethyl) sulfone has been
added.
Exposures to painters from bis(trichloromethyl) sulfone
treated paints would be of concern to the Agency; however, the
registrant has submitted an amendment to cancel the use in paints
from the label. This renders a painter exposure assessment
unnecessary.
10
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(a) Primary Handler Exposure Scenarios
Primary Occupational Handlers: Based on the
use patterns, EPA has identified three major
bis(trichloromethyl) sulfone exposure scenarios for
primary occupational handlers: (1) open-pour applications
with the soluble concentrate or ready-to-use liquid
formulations (open system), (2) metering-pump
applications with the soluble concentrate or ready-to-use
liquid formulations (closed system), and (3) open-pour
applications with the soluble concentrate solid formulation
(open system).
Primary Homeowner Handlers: At this time
there are no end-use pesticide products containing
bis(trichloromethyl) sulfone that are intended for
homeowner use. Therefore, there is no concern for the
primary homeowner handler exposures.
(b) Primary Occupational Handler Exposure
Assumptions
Exposure data specific to bis(trichloromethyl)
sulfone are not available nor is there surrogate exposure
data for all use-patterns. However, the above exposure
scenarios are representative of reasonable worst-case
scenarios. To estimate exposures (unit exposure (UE) and
actual daily exposure (ADE)), the Agency relied on
surrogate data from a study (amended 1992) submitted by
the Chemical Manufacturers Association (CMA) for
antimicrobial pesticide products (MRID #s 41412201,
41742601, and 42587501). Based on these data,
inhalation exposure is believed to be minimal for the
scenarios that were evaluated. Therefore, only dermal
exposures were considered.
The protective clothing scenario for all exposure
assessments from the CMA data base is long-sleeve shirts,
long pants, shoes, socks, and chemical resistant gloves.
In its estimates, the Agency also assumed 100% dermal
absorption for bis(trichloromethyl)sulfone, because data
are not available, and a 60 kg body weight (female) for
the handler. The Agency calculated ADEs by the
following equation:
ADE = (UE x Ibs a.i. used/day) -i- body weight
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The pounds active ingredient used per day by a primary
handler was derived from the units of exposure (CMA
study) and the bis(trichloromethyl) sulfone product label
directions for each scenario.
(c) Estimates of Primary Occupational Handler
Exposures
Exposure estimates for bis(trichloromethyl)
sulfone for primary handlers involved in the above
scenarios are presented in Tables 2 and 3 below. These
estimates are considered worst case and represent workers
handling bis(trichloromethyl) sulfone for short term (1-7
days) or intermediate term (7-90 days) durations.
Table 2 -Pump Liquid (Closed System) Scenario Calculations - Handlers
Setting
Preservative
Pulp & Paper Mill
Water Cooling System
Drill Muds
UE (jKg/lb ai)
7.5
3.9
90
7.5
Ib ai/day
0.54
2
2
100
ADE (jKg/kg/day)
0.0675
0.13
3.00
12.50
Table 3 - Pour Liquid (Open System) Scenario Calculations - Handlers
Setting
Preservative
Pulp & Paper Mill
Water Cooling System
Drill Muds
UE (jKg/lb ai)
140
140
10,230
140
Ib ai/day
0.54
2
2
100
ADE (jtg/kg/day)
1.26
4.66
341.00
233.30
12
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(d) Secondary Handler Exposure Scenarios &
Assumptions
Based on the use patterns, EPA has identified
potential exposures to secondary occupational and
homeowner handlers while mixing and applying adhesives
containing bis(trichloromethyl) sulfone. EPA has
determined that secondary occupational and residential
handler exposures from handling adhesives containing
bis(trichloromethyl) sulfone are not expected to be greater
than those for the general open pouring industrial
preservative use.
(2) Post-Application Exposure Scenarios & Assumptions
EPA has identified two levels of post-application
exposures:
• primary post-application exposures — persons in and near
areas where end-use pesticide products containing
bis(trichloromethyl) sulfone as an active ingredient are
being or have recently been applied;
• secondary post-application exposures — persons in and
near areas where products, such as adhesives, to which
bis(trichloromethyl) sulfone has been added, are being or
have recently been used.
(a) Primary Post-Application Exposures
Primary Occupational Post-Application
Exposures: Based on the use patterns, EPA has
identified two major bis(trichloromethyl) sulfone exposure
scenarios for primary occupational post-application
exposures: exposures following applications of
bis(trichloromethyl) sulfone to open vats of hot liquids,
such as paper-pulp, adhesives, coatings, and emulsions;
and exposures to persons maintaining equipment, such as
water systems and other industrial equipment, which
contain products treated with bis(trichloromethyl) sulfone.
Primary Homeowner Post-Application
Exposures: At this time there are no end-use pesticide
products containing bis(trichloromethyl) sulfone that are
13
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intended for homeowner use. Therefore, there is no
concern for the primary homeowner post-application
exposures.
(b) Secondary Post-Application Exposures
Secondary Occupational & Homeowner Post-
Application Exposures: Based on the use patterns, EPA
has identified a bis(trichloromethyl) sulfone exposure
scenario for secondary occupational and residential post-
application exposures: exposures to persons working or
residing in areas where products such as adhesives
containing bis(trichloromethyl) sulfone are being used or
have been recently applied.
3. Risk Assessment
a. Dietary
The potential dietary exposure to bis(trichloromethyl) sulfone
from food uses in food-grade paper, paperboard, and adhesives is
regulated by the Food and Drug Administration.
b. Occupational and Residential
(1) Risk From Handler Exposures
(a) Risk From Primary Occupational Handler
Exposures
The EPA has conducted an assessment of the
potential risks associated with handler exposures to
bis(trichloromethyl) sulfone. The toxicological endpoints
of concern for occupational and residential exposure are a
systemic toxicity NOEL of 10 mg/kg/day from the rat
developmental study (? effect) resulting from short-term
exposure and a dermal exposure NOEL of 2 mg/kg/day
from the 21-day dermal rat study, resulting from
intermediate-term exposure.
The risk in terms of Margins of Exposure (MOEs), a ratio
of the NOEL to the exposure, is calculated as follows and
the values and are presented in Tables 4 and 5 below.
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Margin of Exposure (MOE) = NOEL (10 mg/kg/day)
(For short-term exposure) ADE (Actual Daily Exposure)
Margin of Exposure (MOE) = NOEL (2 mg/kg/day)
(For intermediate exposure) ADE (Actual Daily Exposure)
Table 4 - Risk Calculation for Closed Systems Using Liquids - Handlers
Scenario
Preservative
Pulp & Paper Mill Water System
Cooling Water Systems
Oil Drilling Muds/Packer Fluids
Margin of Exposure
Short Term
142,857
76,923
3,333
833
Intermediate
28,571
15,384
667
167
Table 5 - Risk Calculation for Open Pour Application - Handlers
Scenario
Preservative
Pulp & Paper Mill Water System
Cooling Water Systems
Oil Drilling Muds/Packer Fluids
Margin of Exposure
Short Term
7,936
2,128
29
43
Intermediate
1,587
425
6
9
Margins of Exposure range from 6 for
intermediate exposures to bis(trichloromethyl) sulfone
handlers in cooling tower applications to nearly 143,000
for short term exposures to workers in pulp and paper
mill water system settings. In general the MOEs are
lower for intermediate term exposures, as a result of the
lower NOEL for intermediate term. A Margin of
Exposure of less than 100 is of concern to the Agency.
15
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(b) Risk From Primary Residential (Homeowner)
Handler Exposures
At this time there are no end-use products
containing bis(trichloromethyl) sulfone that are intended
for homeowner use. Therefore, there is no risk concern
for the primary homeowner handlers.
(c) Risk From Secondary Occupational Handler
Exposures
EPA has determined that risk from secondary
occupational handler exposures from handling adhesives
containing bis(trichloromethyl) sulfone is not expected to
be greater than those for the general open pouring
industrial preservative use.
(d) Risk from Secondary Residential (Homeowner)
Handler Exposures
Based on the use patterns, the Agency has
identified a potential secondary homeowner handler
exposure scenario: exposure while handling
bis(trichloromethyl) sulfone-containing adhesives. Based
on the low volatility, use patterns, amount applied, and
frequency and duration of exposure, the Agency believes
that secondary homeowner handler exposure and risk
from uses of such as adhesives to be minimal.
(2) Risk From Post-Application Exposures
(a) Risk From Primary Occupational Post-
Application Exposures
No post-application data are available to directly
assess post-application exposures in the occupational
setting. However, post-application dermal exposures
resulting from bis(trichloromethyl) sulfone use-patterns
are likely be minimal, since the exposures are to highly
diluted bis(trichloromethyl) sulfone not the concentrate,
and the exposures are likely to be brief, since the post-
application tasks do not involve prolonged contact with
bis(trichloromethyl) sulfone-surfaces. Post-application
inhalation exposures to bis(trichloromethyl) sulfone also
16
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are likely to be minimal, since bis(trichloromethyl)
sulfone has very low vapor pressure and is, therefore,
unlikely to generate sufficient vapor to cause a concern to
workers performing post-application tasks. Since post-
application dermal and inhalation exposures resulting
from bis(trichloromethyl) sulfone use-patterns are likely
be minimal, no risk assessment is required.
(b) Risk From Primary Residential (Homeowner)
Post-Application Exposures:
At this time there are no end-use products
containing bis(trichloromethyl) sulfone that are intended
for homeowner use. Therefore, there is no concern for
the primary homeowner post-application exposures.
(c) Risk From Secondary Occupational and
Residential (Homeowner) Post-Application Exposures
The Agency has identified possible
bis(trichloromethyl) sulfone scenarios for secondary
occupational and homeowner post-application exposures
involving exposures while occupying areas where
bis(trichloromethyl) sulfone-containing adhesives have
been used. Based on the low volatility, use patterns,
amount applied, and frequency and duration of exposure,
the Agency believes that secondary post-application
exposure and risk from uses such as adhesives to be
minimal.
C. Environmental Assessment
While the hazard to aquatic organisms from bis(trichloromethyl) sulfone has
been characterized below, a quantitative risk assessment has not been conducted. The
risks to aquatic environments associated with bis(trichloromethyl) sulfone uses are
regulated under the NPDES permitting program of EPA's Office of Water. The
Agency currently vrequires, through product labeling, that all bis(trichloromethyl)
sulfone discharges to aquatic environments be in compliance with NPDES permits.
17
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1. Ecological Toxicity Data
a. Toxicity to Terrestrial Animals
(1) Birds, Acute and Subacute
In order to establish the toxicity of bis(trichloromethyl)
sulfone to birds, the following tests are required for industrial
microbiocides using the technical grade material: one avian
single-dose oral (LD50) study on one species (preferably the
bobwhite quail or mallard duck) and one subacute dietary study
(LC50) on one species (preferably the bobwhite quail). These
studies have been submitted and the results presented below.
Table 6 - Avian Acute and Subacute Oral Toxicity Findings
Species
LDSO (mg/kg)
MRID#
Toxicity Category
Avian Acute Oral Toxicity Findings
Mallard Duck
>2,250mg/kg
156817
practically non-toxic
Avian Subacute Dietary Toxicity Findings
Northern Bobwhite Quail
Mallard Duck
>5,620
>5,000
156818
156820
practically non-toxic
practically non-toxic
These results (Table 6) indicate that bis(trichloromethyl)
sulfone is practically non-toxic to avian species on an acute oral
and subacute dietary basis. The guideline requirements are
fulfilled (MRID #'s 156817, 156818 and 156820).
(2) Mammals
Wild mammal testing is required on a case-by-case basis,
depending on the results of the lower tier studies such as acute
and subacute testing, intended use pattern, and pertinent
environmental fate characteristics. In most cases, however, an
acute oral LD50 from an acute oral toxicity study is used to
determine toxicity to mammals. The acute LD50 for rats (small
mammal surrogate), discussed in the Human Health Assessment
above, was determined to be 535 mg/kg (MRID #152875). This
result indicates that bis(trichloromethyl) sulfone is slightly toxic
to small mammals on an acute oral basis.
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(3) Insects
A honey bee acute contact LD50 study is required if the
proposed use will result in honey bee exposure. However, due to
the nature of the bis(trichloromethyl) sulfone use patterns, a
honey bee study is not required.
b. Toxicity to Aquatic Animals
(1) Freshwater Fish
In order to establish the toxicity of this pesticide to
freshwater fish, the minimum data required on the technical
grade of the active ingredient is one freshwater fish toxicity
study. The study should use the rainbow trout (cold water
species) or the bluegill sunfish (warm water species).
Table 7 - Freshwater Fish Acute Toxicity Findings
Species
Rainbow trout
Bluegill sunfish
LDSO (ppb)
290
580
MRID#
156814
156815
Toxicity Category
very highly toxic
very highly toxic
The results of the 96-hour acute toxicity studies (Table 7)
indicate that bis(trichloromethyl) sulfone is very highly toxic to
both cold and warm water fish. The guideline requirements are
fulfilled (MRID #s 156814 and 156815).
(2)
Freshwater Invertebrates
The minimum testing required to establish the toxicity of
a microbiocide to freshwater invertebrates is a freshwater aquatic
invertebrate toxicity test, preferably using first instar Daphnia
magna or early instar amphipods, stoneflies, mayflies, or
midges.
Table 8 - Freshwater Invertebrate Toxicity Findings
Species
Daphnia magna
ECSO (ppm)
0.173
MRID#
156816
Toxicity Category
Highly Toxic
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There is sufficient information to characterize
bis(trichloromethyl) sulfone as highly toxic to aquatic
invertebrates (Table 8). The guideline requirement is
fulfilled (MRID # 156816).
(3)
Estuarine and Marine Animals
Acute toxicity testing with estuarine and marine
organisms is required to support microbiocides used in once-
through cooling towers, oil recovery drilling muds/packer fluids,
secondary oil recovery injection waters, and pulp and paper mill
water systems because of the proximity of the above installations
to estuarine and marine environments.
The requirements under this category include a 96-hour
LC50 for an estuarine fish, a 96-hour LC50 for shrimp, and either
a 48-hour embryo-larvae study or a 96-hour shell deposition
study with oysters.
Table 9 - Estuarine/Marine Acute Toxicity Findings
Species
Sheepshead Minnow
Quahog Clam
(Embryo-Larvae)
% A.I.
99%
99.9%
LCSO/ECSO (ppb)
400
9.2
MRID#
40138102
40193201
Toxicity Category
highly toxic
very highly toxic
2.
There is sufficient information to characterize bis
(trichloromethyl) sulfone as highly toxic to marine/estuarine fish
and very highly toxic to marine/estuarine mollusca. The
guideline requirements are fulfilled for marine mollusca and
marine/estuarine fish only (MRID #s 40138102 and 40193201).
Data for marine/estuarine invertebrates were not acceptable
(MRID # 40138101). However, considering the results of the
aquatic studies referenced above, the Agency is not requiring a
new study for marine/estuarine invertebrates.
Environmental Fate
a.
Environmental Fate Assessment
Based on indoor non-food and aquatic non-food industrial use
patterns, hydrolysis is the only data requirement for bis(trichloromethyl)
20
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sulfone. Acceptable data show that bis(trichloromethyl) sulfone did not
hydrolyze in sterile aqueous buffered solutions at pH 4, 7, or 9 (MRID #
41888701). The fate data requirements for bis(trichloromethyl) sulfone
are therefore fulfilled.
Although not required, additional studies were submitted and
reviewed. These data are of uncertain value due to flaws in
methodology and are cited here as a best estimate of the dissipation and
fate of this compound in the environment. These studies do not need to
be repeated. An anaerobic aquatic metabolism study shows that the
major route of dissipation of bis(trichloromethyl) sulfone is rapid
microbial degradation with an estimated half-life of <0.5 days (MRID #
40317101). Two metabolites are pentachlorodimethylsurfone and
hexachloroethane. However, product yield and additional metabolites
were not provided (MRID # 40317103). In a photodegradation in water
study, bis(trichloromethyl) sulfone photodegraded when irradiated with
a non-specified sunlamp. Photodegradation half-lives were 16 days in
water and 6 days in water sensitized with 1% acetone (TRID 470147-
009). In a leaching adsorption/desorption study, Freundlich Kad values
from five (autoclaved) U.S. soils ranged from 6-52 mL/g, which
indicates low mobility (TRID 470146-030).
One aquatic dissipation study was submitted. This study
followed the dissipation of bis (trichloro methyl) sulfone in a pulp/paper
mill from paper machine water, to mill water, and further to lagoon
water that was then released to a stream. The water going into the paper
machine was treated at 4.84 x 102 ppb bis (trichloro methyl) sulfone.
Effluent from the machine contained 34 ppb, water samples from the
mill contained 7-8 ppb, and lagoon water contained 2 ppb
bis(trichloromethyl) sulfone. One degradate, pentachlorodimethyl-
sulfone, ranged from 5-6 ppb in machine water, mill water, and lagoon
water. The second degradate, hexachloroethane, was not recovered
from any of the samples during the study (MRID # 40317103).
b. Water Resources
(1) Ground and Surface Waters
Because bis (trichloromethyl) sulfone is used in pulp and
papermill process water systems, water cooling systems,
secondary oil-recovery injection water systems, and as a
preservative in adhesives, it is discharged to surface waters. As
an indoor non-food and aquatic non-food industrial use
compound, a NPDES permit is required for discharge.
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3. Exposure and Risk Characterization
At the present time, the Office of Pesticide Programs does not conduct
risk assessments for industrial microbiocides unless products have once-through
cooling water system uses. Currently registered products with
bis(trichloromethyl) sulfone do not have once-through water cooling system
uses. Data requirements are limited to essential data needed for making a
hazard assessment for labeling purposes, especially if there are unanticipated
accidents, spills, or inappropriate disposals or uses. In the case of
bis(trichloromethyl) sulfone, data submitted by the registrant showed that this
chemical is practically non-toxic to birds, very highly toxic to freshwater fish,
highly toxic to freshwater invertebrates, and highly toxic to estuarine/marine
fish, and very highly toxic to estuarine/marine mollusca. The risk resulting
from the use of this microbiocide will be considered in the issuance of NPDES
permits.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after
submission of relevant data concerning an active ingredient, whether products
containing the active ingredients are eligible for reregistration. The Agency has
identified and required the submission of the generic (i.e. active ingredient specific)
data required to support reregistration of products containing bis(trichloromethyl)
sulfone as an active ingredient. The Agency has completed its review of these generic
data, and has determined that the data are sufficient to support reregistration of all
products containing bis(trichloromethyl) sulfone. Appendix B identifies the generic
data requirements that the Agency reviewed as part of its determination of
reregistration eligibility of bis(trichloromethyl) sulfone, and lists the submitted studies
that the Agency found acceptable.
The Agency finds that all currently registered uses of bis(trichloromethyl)
sulfone can be used as specified in this document without resulting in unreasonable
adverse effects to humans and the environment.
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, the data identified in Appendix B, published
scientific literature, and other available information. Although the Agency has found
that all currently registered uses of bis(trichloromethyl) sulfone, as specified in this
document, 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 bis(trichloromethyl) sulfone, if new
22
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information comes to the Agency's attention or if the data requirements for registration
(or the guidelines for generating such data) change.
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredient
bis(trichloromethyl) sulfone, the Agency has sufficient information on the health
effects of bis (trichloromethyl) sulfone and on its potential for causing adverse
effects in fish and wildlife and the environment for all uses. The Agency has
determined that bis(trichloromethyl) sulfone products, labeled and used as
specified in this Reregistration Eligibility Decision document will not pose
unreasonable risks or adverse effects to humans or the environment. The
Agency concludes that all products containing bis(trichloromethyl) sulfone are
eligible for reregistration upon submission of offers to compensate.
However, the Agency recognizes that not all registrants subject to
generic data requirements have met their obligations. As explained in the
Human Health Assessment, Section III, the Agency found it necessary to
conduct exposure assessments. EPA relied on submitted data from the
Chemical Manufactures Association. For registrants of bis(trichloromethyl)
sulfone products who have not paid or made offers to pay compensation for the
use of that data, or who have not submitted their own acceptable worker
exposure data, they must do so to gain product reregistration. EPA issued a
Data Call-in Notice August 22, 1995, to registrants imposing these obligations.
2. Eligible and Ineligible Uses
The Agency has determined that all uses of bis(trichloromethyl) sulfone
are eligible for reregistration.
B. Regulatory Position
The following is a summary of the regulatory positions and rationales for
bis(trichloromethyl) sulfone. Where labeling revisions are imposed, specific language
is set forth in Section V of this document.
1. Additional Generic Data Requirements
The Agency is requiring registrants to submit additional data that will
confirm mutagenicity and neurotoxicity of bis (trichloro methyl) sulfone.
Confirmatory data from gene mutation and sister chromatid exchange
studies are required to provide unequivocal evidence for either positive or
negative gene mutation. These new data must include an assay to involve
23
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interaction with animal germ cells. These data are required to determine the
need for Tier 3 data, carcinogenicity testing.
Additional acute neurotoxicity study data are required to characterize
bis(trichloromethyl) sulfone's effects on motor activity that was suggested in the
current study.
Data generated by the Antimicrobial Task Force of the Chemical
Manufacturers Association have been used to address these exposures in this
document; however, the Agency requires offers of compensation be made for
the use of these data or new, adequate data be submitted. A Data Call-in has
been issued to the registrants of bis(trichloromethyl) sulfone requiring these
actions.
2. Risk Mitigation Measures
a. Personal Protective Equipment/Engineering Controls for
Handlers
For each end-use product, PPE requirements for pesticide
handlers are set during reregistration in one of two ways:
1. If EPA determines that no regulatory action must be taken as the
result of the acute effects 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 must be established using the process described in
PR Notice 93-7 or more recent EPA guidelines.
2. If EPA determines that regulatory action on an active ingredient
must be taken as the result of 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 requirements that
pertain to all or most 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 the end-use product.
24
-------
• 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 chemical-resistant
gloves are required, then long-sleeve shirts, long pants, socks, and shoes
are assumed and 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.
(1) Occupational-Use Products
Primary Occupational Handlers: EPA has determined
that regulatory action regarding the establishment of active-
ingredient-based minimum PPE and engineering requirements for
occupational handlers must be taken for bis (trichloromethyl)
sulfone. The Margins of Exposure (MOEs) are less than 100 for
both the short-term and intermediate-term exposures for the
open-pouring use of bis(trichloromethyl) sulfone in water cooling
systems and oil drilling muds/packer fluids. Therefore, EPA is
requiring meter-pump loading and application of
bis(trichloromethyl) sulfone for the following uses:
pasteurizer/warmer/cannery cooling water systems, commercial/
industrial water cooling systems, evaporative-condenser water
systems, heat-exchanger water systems, and oil recovery drilling
muds/packer fluids (see Table 4). This use limitation will
adequately mitigate risks to workers in these use settings.
For all other uses of bis(trichloromethyl) sulfone, the
MOEs were greater than 100, but EPA is establishing active
ingredient based minimum PPE requirements for primary
occupational handlers. Since these MOEs are based on units of
exposure from the CMA exposure study in which handlers wore
chemical resistant gloves, such chemical-resistant gloves are
required for occupational handlers of bis (trichloro methyl)
sulfone.
Secondary Occupational Handlers: EPA has
determined that no regulatory action regarding the establishment
25
-------
of active-ingredient-based minimum PPE and engineering-control
requirements must be taken for secondary occupational handlers,
such as persons using adhesives that contain bis(trichloromethyl)
sulfone.
(2) Homeowner-Use Products
Primary Homeowner Handlers: There are no
bis(trichloromethyl) sulfone end-use pesticide products intended
primarily for homeowner use.
Secondary Homeowner Handlers: For products
intended for homeowner use, such as adhesives, that contain
bis(trichloromethyl) sulfone as an additive, EPA has determined
that no regulatory action regarding the establishment of active-
ingredient-based minimum PPE and engineering-control
requirements must be taken.
b. Post-Application/Entry Restrictions
EPA has determined that no regulatory action must be taken to
reduce occupational or residential (homeowner) post-application
exposures to bis(trichloromethyl) sulfone, since post-application dermal
and inhalation exposures are already likely to be minimal.
c. Other Labeling Requirements
The Agency is requiring other use and safety information to be
placed on the labeling of all end-use products containing
bis(trichloromethyl) sulfone in order to provide product users with more
specific directions for use. For the specific labeling statements, refer to
Section V of this document.
One product is currently labeled for use in paints. The registrant
has applied to cancel the use of bis(trichloromethyl) sulfone in paints
from the registrant's labels.
In addition, because reference to paints on the manufacturing-use
product label will not be a use registered for an end-use product, it must
be removed for the manufacturing-use product label.
26
-------
V. ACTIONS REQUIRED OF REGISTRANTS
This section specifies the data requirements and responses necessary for the
reregistration of both manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of
bis(trichloromethyl) sulfone for the above eligible uses has been reviewed and
determined to be substantially complete. The following data have been required
and are considered confirmatory:
EPA Guideline # Study Name
81-8-SS Acute Neurotoxicity in Rats (upgrade old study)
84-2(a) Gene Mutation
84-4 Sister Chromatid Exchange
Also, registrants must meet data requirements for the worker exposure
data as explained above.
2. Labeling Requirements for Manufacturing-Use Products
a. General Labeling Requirements
To remain in compliance with FIFRA, manufacturing use
product (MP) labeling must be revised to comply with all current EPA
regulations, PR Notices and applicable policies. The MP labeling must
bear the following statement under Directions for Use:
"Only for formulation into a microbiocide for the following uses
A MP registrant may, at his/her discretion, add one of the following
statements ((a) or (b)) to an MP label under "Directions for Use" to
permit the reformulation of the product for a specific use or all
additional uses supported by a formula tor or user group:
(1) "This product may be used to formulate products for
specific use(s) not listed on this label if the formulator,
user group, or grower has complied with U.S. EPA
27
-------
submission requirements regarding support of such
use(s)."
(2) "This product may be used to formulate products for any
additional use(s) not listed on this label if the formulator,
user group, or grower has complied with U.S. EPA
submission requirements regarding support of such
use(s)."
b. Specific Labeling Amendments
The reference to latexes on the manufacturing-use product (EPA
Reg. No. 67869-16) must be removed.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of eligibility
has been made. The product specific data requirements are listed in Appendix
G, the Product Specific Data Call-in Notice.
Registrants must review previous data submissions to ensure that they
meet current EPA acceptance criteria (Appendix F; Attachment E) and if not,
commit to conduct new studies. If a registrant believes that previously
submitted data meet current testing standards, then study MRID numbers should
be cited according to the instructions in the Requirement Status and Registrants
Response Form provided for each product.
2. Labeling Requirements for End-Use Products
a. PPE/Engineering Control Requirements for Pesticide
Handlers
For sole-active-ingredient end-use products that contain
bis(trichloromethyl) sulfone, the product labeling must be revised to
adopt the handler personal protective equipment/engineering control
requirements set forth in this section. Any conflicting PPE/engineering
control requirements on the current labeling must be removed.
For multiple-active-ingredient end-use products that contain
bis(trichloromethyl) sulfone, the handler personal protective
equipment/engineering control requirements set forth in this section must
28
-------
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.
Products Intended Primarily for Occupational Use
(1) Minimum (Baseline) Engineering Control
Requirements
EPA is establishing minimum (baseline) engineering
controls for some occupational uses of bis(trichloromethyl)
sulfone end-use products. Products with bis(trichloromethyl)
sulfone must be labeled to require pump engineering controls
during loading and application for the following uses: oil
recovery drilling muds/packer fluids, pasteurizer/warmer/cannery
cooling water systems, commercial/industrial water cooling
systems, evaporative-condenser water systems, and heat
exchanger water systems.
In the "Directions For Use" portion of the label referring
to these uses, registrants must insert the following language:
"This product must be loaded and applied only using a
meter-pump system or a closed loading/application system
for the following uses: {list uses}. Open pouring is
prohibited."
(2) Minimum (Baseline) Personal Protective Equipment
Requirements
EPA is establishing active-ingredient-based minimum
(baseline) PPE for bis(trichloromethyl) sulfone end-use products
that are intended for occupational use. Product labels must be
amended to include the following statement:
"Applicators and other handlers must wear: chemical
resistant gloves*, long pants, a long sleeved shirt, shoes
and socks."
* For the glove statement, use the statement established for
bis(trichloromethyl) sulfone through the instructions in
Supplement 3 of PR Notice 93-7.
29
-------
Placement in labeling: The PPE 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.
Determining PPE Requirements for End-Use Product Labels:
The PPE that would be established on the basis of the acute toxicity
category of the end-use product must be compared to the active-
ingredient-based minimum (baseline) PPE specified above. The more
protective PPE must be placed on the product labeling. For guidance on
which PPE is considered more protective, its placement, format, and
wording refer to PR Notice 93-7. NOTE: If the end-use product is
classified as toxicity category I or II for eye irritation potential,
protective eyewear is also required.
b. Labeling Requirements for Products Intended Primarily for
Occupational Use
The Agency is requiring the following labeling statements to be
located on all end-use products containing bis(trichloromethyl) sulfone
that are intended primarily for occupational use.
Application Restrictions
"Do not apply this product in a way that will
contact workers or other persons."
User Safety Requirements
—Registrants: add the following statements if coveralls are
required for pesticide handlers on the end-use product label:
"Discard clothing or other absorbent materials that have
been drenched or heavily contaminated with this product's
concentrate. Do not reuse them."
—Registrants: add the following statements always:
"Follow manufacturer's instructions for
cleaning/maintaining PPE. If no such instructions
for washables, use detergent and hot water. Keep
and wash PPE separately from other laundry."
30
-------
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."
• "Users should remove PPE immediately
after handling this product. Wash the
outside of gloves before removing. As
soon as possible wash thoroughly."
c. Clarification of Oil Drilling Mud Use
To clarify the intent of the oil recovery drilling muds/packer
fluids use (as an indoor or outdoor use pattern) the following statement
must be added to the labels for terrestrial non-food oil/gas drilling muds
and packer fluids:
"For use on terrestrial oil wells only."
And the following statement must be added to the precautionary
labeling:
"Do not apply in marine and/or estuarine oil fields."
The following statement must be added to the labels for aquatic
non-food industrial drilling muds and packer fluids:
"For use on offshore oil wells only."
For use in both terrestrial and offshore oil drilling muds and
packer fluids, the following statement must be added:
"This product may be used for terrestrial and offshore oil drilling
muds and packer fluids."
d. 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).
31
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e. Clarification of Industrial/Commercial Water Cooling
Systems
To clarify that water cooling uses do not include once-through
systems, the following statement must be added:
"This product may not be used in once-through cooling systems."
3. Existing Stocks
Registrants may generally distribute and sell products bearing old
labels/labeling for 26 months from the date of the issuance of this Reregistration
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
bis(trichloromethyl) sulfone 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.
32
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VI. APPENDICES
33
-------
Page Intentionally Blank
34
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Report Run Date: 07/14/95 — Time 13:13
PRD Report Date: 01/25/95
APPENDIX A - CASE 2055, [Bis(trichloromethyl)sulfone] Chemical 035601 [Bis(trichloromethyl) sulf
LUIS 2.1 - Page 1
SITE Application Type, Application
Timing, Application Equipment —
Fo rm ( s ;
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON- FOOD/NON-FEED
ADHESIVES, INDUSTRIAL
Industrial preservative treatment.,
During manufacture., Not on label., Not
Applicable., Not applicable for this use.
Preservative treatment., Not on label.,
Not on label., Not Applicable., Not
applicable for this use.
COATINGS , INDUSTRIAL
Industrial preservative treatment.,
During manufacture., Not on label., Not
Applicable., Not applicable for this use.
Preservative treatment., Not on label.,
Not on label .
Preservative treatment., Not on label.,
Not on label., Not Applicable., Not
applicable for this use.
SC/L
SC/S
SC/L
SC/L
SC/L
SC/L
SC/S
RTU
SC/L
SC/L
SC/L
i Min. Appl . Max. Appl. Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
Use Group:
W 34 W 170 *
W 5 W 25 *
W 36 W 144 *
W 40 W 160 *
W 40 W 100 *
Use Group:
W 34 W 170 *
W 5 W 25 *
NA UC *
W 36 W 144 *
W 40 W 160 *
W 40 W 100 *
Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
@ Max. Rate unless noted Interv Entry Allowed
/crop /year otherwise) /A] (days) Interv
cycle /crop /year [day(s)]
cycle
: INDOOR NON- FOOD
NS NS NS NS NS NS
NS NS NS NS NS NS
NS NS NS NS NS NS
NS NS NS NS NS NS
NS NS NS NS NS NS
: INDOOR NON- FOOD
NS NS NS NS NS NS
NS NS NS NS NS NS
NS NS NS NS NS NS
NS NS NS NS NS NS
NS NS NS NS NS NS
NS NS NS NS NS NS
Disallowed Limitations
Codes
C12, CIS
C12, CIS
CIS, C24
C12, CIS
CIS, C24
C12, CIS
C12, CIS
C12, CIS
CIS, C24
C12, CIS
CIS, C24
COMMERCIAL/INDUSTRIAL WATER COOLING SYSTEMS
Water treatment (recirculating system)., SC/L
Continuous feed (initial)., Not on
label., Not Applicable., Not applicable
for this use.
SC/L
Use Group: AQUATIC NON-FOOD INDUSTRIAL
W 12 * NS NS NS NS NS
A08, C12, CIS
A30, CIS, C24
35
-------
SC/L
A08, C12, CIS
36
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Report Run Date: 07/14/95 - Time 13:13
PRD Report Date: 01/25/95
APPENDIX A - CASE 2055, [Bis(trichloromethyl)sulfone] Chemical 035601 [Bis(trichloromethyl) sulfo
LUIS 2.1 - Page 2
SITE Application Type, Application
Timing, Application Equipment —
Form(s) Min. Appl .
Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
COMMERCIAL/INDUSTRIAL WATER COOLING SYSTEMS (con't)
Water treatment (recirculating system) .,
Continuous feed (subsequent) . , Not on
label., Not Applicable., Not applicable
for this use.
Water treatment (recirculating system) .,
Intermittent (slug) (initial) ., Not on
label., Not Applicable., Not applicable
for this use.
Water treatment (recirculating system) .,
Intermittent (slug) (subsequent) ., Not on
label., Not Applicable., Not applicable
for this use.
EMULSIONS, RESIN/LATEX/POLYMER
Industrial preservative treatment.,
During manufacture., Not on label., Not
Applicable., Not applicable for this use.
Preservative treatment., Not on label.,
Not on label., Not Applicable., Not
applicable for this use.
SC/L W 2 .4
SC/L W 3 .1
SC/L W 6
SC/L W 2 .4
SC/L W 6
SC/L W 6 .1
SC/L W 2 .4
SC/L W 3 .1
SC/L W 6
SC/L W 34
SC/S W 5
SC/L W 36
SC/L W 40
SC/L W 40
Max. Appl. Soil
Rate (AI Tex.
unless noted Max.
otherwise) Dose
Use Group:
W 7.2 *
W 10 *
W 9 *
W 12 *
W 12 *
W 20 *
W 7.2 *
W 10 *
W 9 *
Use Group:
W 170 *
W 25 *
W 144 *
W 160 *
W 100 *
Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations
© Max. Rate unless noted Interv Entry Allowed Disallowed
/crop /year otherwise) /A] (days) Interv
cycle /crop /year [day(s)]
cycle
: AQUATIC NON-FOOD INDUSTRIAL (con't)
NS NS NS NS NS NS
NS NS NS NS NS NS
NS NS NS NS NS NS
NS NS NS NS NS NS
NS NS NS NS NS NS
NS NS NS NS NS NS
NS NS NS NS NS NS
NS NS NS NS NS NS
NS NS NS NS NS NS
: INDOOR NON-FOOD
NS NS NS NS NS NS
NS NS NS NS NS NS
NS NS NS NS NS NS
NS NS NS NS NS NS
NS NS NS NS NS NS
Use
Limitations
Codes
A08,
A08,
A30,
A08,
A30,
A08,
A08,
A08,
A30,
C12,
C12,
CIS,
C12,
CIS,
C12,
C12,
CIS,
C12,
CIS,
C12,
C12,
C12,
CIS,
CIS
CIS
C24
CIS
C24
CIS
CIS
C24
CIS
C24
CIS
CIS
CIS
C24
37
-------
EVAPORATIVE CONDENSER WATER SYSTEMS
Use Group: AQUATIC NON-FOOD INDUSTRIAL
38
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PRD Report Date: 01/25/95
APPENDIX A - CASE 2055, [Bis(trichloromethyl)sulfone] Chemical 035601 [Bis(trichloromethyl) sulfo
LUIS 2.1 - Page 3
SITE Application Type, Application
Timing, Application Equipment —
Fo rm ( s )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
EVAPORATIVE CONDENSER WATER SYSTEMS (con
Water treatment (recirculating system) .,
Continuous feed (initial) ., Not on
label., Not Applicable., Not applicable
for this use.
Water treatment (recirculating system) .,
Continuous feed (subsequent) . , Not on
label., Not Applicable., Not applicable
for this use.
Water treatment (recirculating system) .,
Intermittent (slug) (initial) ., Not on
label., Not Applicable., Not applicable
for this use.
Water treatment (recirculating system) .,
Intermittent (slug) (subsequent) ., Not on
label., Not Applicable., Not applicable
for this use.
't)
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
Min. Appl . Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Rate (AI un- Rate (AI Tex. © Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
less noted unless noted Max. /crop /year otherwise) /A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
W 2.4 W 12 * NS NS NS NS NS NS A08, C12, CIS
W 6 W 12 * NS NS NS NS NS NS A30, CIS, C24
W 6.1 W 20 * NS NS NS NS NS NS A08, C12, CIS
W 2.4 W 7.2 * NS NS NS NS NS NS A08, C12, CIS
W 6 W 9 * NS NS NS NS NS NS A30, CIS, C24
W 2.4 W 12 * NS NS NS NS NS NS A08, C12, CIS
W 6 W 12 * NS NS NS NS NS NS A30, CIS, C24
W 6.1 W 20 * NS NS NS NS NS NS A08, C12, CIS
W 2.4 W 7.2 * NS NS NS NS NS NS A08, C12, CIS
W 3.1 W 10 * NS NS NS NS NS NS A08, C12, CIS
W 6 W 9 * NS NS NS NS NS NS A30, CIS, C24
HEAT EXCHANGER WATER SYSTEMS
Water treatment (recirculating system).,
Continuous feed (initial)., Not on
label., Not Applicable., Not applicable
for this use.
SC/L
SC/L
Use Group: AQUATIC NON-FOOD INDUSTRIAL
W 12 * NS NS NS NS NS
A08, C12, CIS
A30, CIS, C24
39
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SC/L
A08, C12, CIS
40
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Report Run Date: 07/14/95 - Time 13:13
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APPENDIX A - CASE 2055, [Bis(trichloromethyl)sulfone] Chemical 035601 [Bis(trichloromethyl) sulfo
LUIS 2.1 - Page 4
SITE Application Type, Application
Form(s) Min. Appl.
Timing, Application Equipment — Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr.
Rate (AI Tex. © Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle /crop /year
cycle
Interv Entry Allowed
(days) Interv
[day(s) ]
Geographic Limitations
Disallowed
Limitations
Codes
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
HEAT EXCHANGER WATER SYSTEMS (con't)
Water treatment (recirculating system).,
Continuous feed (subsequent)., Not on
label., Not Applicable., Not applicable
for this use.
Water treatment (recirculating system).,
Intermittent (slug)(initial)., Not on
label., Not Applicable., Not applicable
for this use.
Water treatment (recirculating system).,
Intermittent (slug)(subsequent)., Not on
label., Not Applicable., Not applicable
for this use.
INDUSTRIAL AUXILIARY WATER SYSTEMS
Water treatment., Intermittent
(slug)(initial)., Not on label., Not
Applicable., Not applicable for this use.
Water treatment., Intermittent
(slug)(subsequent)., Not on label., Not
Applicable., Not applicable for this use.
INDUSTRIAL SCRUBBING SYSTEM
Water treatment (recirculating system).,
Continuous feed (initial)., Not on
label., Not Applicable., Not applicable
for this use.
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
W 7 .2 * NS NS NS NS NS NS
W 3 .1
W 6
W 2 .4
W 6
W 6 .1
W 2 .4
W 3 .1
W 6
W 10 * NS
W 9 * NS
W 12 * NS
NS
NS
NS
NS
NS
NS
NS NS
NS NS
NS NS
W 12 * NS NS
W 20 * NS NS
W 7 .2 * NS NS
NS NS NS
NS NS NS
NS NS NS
W 10 * NS NS NS NS NS
W 9 * NS NS NS NS NS
Use Group: AQUATIC NON-FOOD INDUSTRIAL
W 12 * NS NS NS NS NS
W 9 * NS NS
NS NS NS
Use Group: AQUATIC NON-FOOD INDUSTRIAL
W 12 * NS NS NS NS NS
NS
NS
NS
NS
NS
NS
NS
NS
A08, C12, CIS
A08, C12, CIS
A30, CIS, C24
A08, C12, CIS
A30, CIS, C24
A08, C12, CIS
A08, C12, CIS
A08, C12, CIS
A30, CIS, C24
CIS, C24
CIS, C24
A08, C12, CIS
41
-------
SC/L
A30, CIS, C24
42
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Report Run Date: 07/14/95 - Time 13:13
PRD Report Date: 01/25/95
APPENDIX A - CASE 2055, [Bis(trichloromethyl)sulfone] Chemical 035601 [Bis(trichloromethyl) sulfo
LUIS 2.1 - Page 5
SITE Application Type, Application Form(s) Min. Appl . Max. Appl. Soil Max. tt Apps Max. Dose [ (AI Min. Restr. Geographic
Timing, Application Equipment — Rate (AI un- Rate (AI Tex. © Max. Rate unless noted Interv Entry Allowed
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise) /A] (days) Interv
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
INDUSTRIAL SCRUBBING SYSTEM (con't)
Water treatment (recirculating system) .,
Continuous feed (subsequent) . , Not on
label., Not Applicable., Not applicable
for this use.
Water treatment (recirculating system) .,
Intermittent (slug) (initial) ., Not on
label., Not Applicable., Not applicable
for this use.
Water treatment (recirculating system) .,
Intermittent (slug) (subsequent) ., Not on
label., Not Applicable., Not applicable
for this use.
INDUSTRIAL WASTE DISPOSAL SYSTEMS
Water treatment., Continuous feed
(initial)., Not on label., Not
Applicable., Not applicable for this use.
Water treatment., Continuous feed
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
SC/L W 6.1 W 20 * NS NS NS NS NS NS
SC/L W 2.4 W 7.2 * NS NS NS NS NS NS
SC/L W 3.1 W 10 * NS NS NS NS NS NS
SC/L W 6 W 9 * NS NS NS NS NS NS
SC/L W 2.4 W 12 * NS NS NS NS NS NS
SC/L W 6 W 12 * NS NS NS NS NS NS
SC/L W 6.1 W 20 * NS NS NS NS NS NS
SC/L W 2.4 W 7.2 * NS NS NS NS NS NS
SC/L W 3.1 W 10 * NS NS NS NS NS NS
SC/L W 6 W 9 * NS NS NS NS NS NS
Use Group: AQUATIC NON-FOOD INDUSTRIAL
SC/L W 1.7 W 57 * NS NS NS NS NS NS
SC/L W 4.9 W 24 * NS NS NS NS NS NS
SC/L W 1.7 W 14 * NS NS NS NS NS NS
Limitations Use
Disallowed Limitations
Codes
A08, C12, CIS
A08, C12, CIS
A08, C12, CIS
A30, CIS, C24
A08, C12, CIS
A30, CIS, C24
A08, C12, CIS
A08, C12, CIS
A08, C12, CIS
A30, CIS, C24
A08, C12, CIS
A08, C12, CIS
A08, C12, CIS
(subsequent)., Not on label., Not
Applicable., Not applicable for this use.
SC/L
NS NS NS
A08, C12, CIS
43
-------
Water treatment., Intermittent
(slug)(initial)., Not on label., Not
Applicable., Not applicable for this
SC/L
A08, C12, CIS
44
-------
Report Run Date: 07/14/95 - Time 13:13
PRD Report Date: 01/25/95
APPENDIX A - CASE 2055, [Bis(trichloromethyl)sulfone] Chemical 035601 [Bis(trichloromethyl) sulfo
LUIS 2.1 - Page 6
SITE Application Type, Application
Form(s) Min. Appl.
Timing, Application Equipment — Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr.
Rate (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle /crop /year
cycle
Interv Entry Allowed
(days) Interv
[day(s)]
Geographic Limitations
Disallowed
Limitations
Codes
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
INDUSTRIAL WASTE DISPOSAL SYSTEMS (con't)
Water treatment., Intermittent
(slug) (subsequent) ., Not on label., Not
Applicable., Not applicable for this use.
Use Group: AQUATIC NON-
SC/L
SC/L
SC/L
SC/L
SC/L
W
W
W
W
W
4.9
6
1.7
2 .4
6
W 24
W 12
W 20
W 19
W 9
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
-FOOD INDUSTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
(con't)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
A08,
CIS,
A08,
A08,
CIS,
C12,
C24
C12,
C12,
C24
CIS
CIS
CIS
OIL RECOVERY DRILLING MUDS/PACKER FLUIDS
Preservative treatment., Not on label., SC/L
Not on label., Not Applicable., Not
applicable for this use.
Industrial preservative treatment., Not SC/L
on label., Not on label., Not
Applicable., Not applicable for this use.
Preservative treatment., Not on label., SC/L
Not on label., Not Applicable., Not
applicable for this use.
Preservative treatment., Not on label., SC/L
Not on label., Not Applicable., Not
applicable for this use.
PAPER/PAPER PRODUCTS
Impregnation treatment., Not on label., RTU
Rollcoater.
Industrial preservative treatment., SC/L
During manufacture., Not on label., Not
Applicable., Not applicable for this use.
Use Group: AQUATIC NON-FOOD INDUSTRIAL
W 285 * NS NS NS NS NS NS
Use Group: INDOOR NON-FOOD
V 267 * NS NS NS NS NS NS
W 285 * NS NS
NS NS NS NS
Use Group: TERRESTRIAL NON-FOOD CROP
W 285 * NS NS NS NS NS NS
Use Group: INDOOR NON-FOOD
UC * NS NS NS NS NS NS
W 170 * NS NS
NS NS NS NS
C12, CIS
C12, CIS
C12, CIS
C12, CIS
C12, CIS
C12, CIS
45
-------
sc/s
46
-------
Report Run Date: 07/14/95 - Time 13:13
PRD Report Date: 01/25/95
APPENDIX A - CASE 2055, [Bis(trichloromethyl)sulfone] Chemical 035601 [Bis(trichloromethyl) sulfo
LUIS 2.1 - Page 7
SITE Application Type, Application Form(s)
Timing, Application Equipment —
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
PAPER/ PAPER PRODUCTS (con't)
Preservative treatment., Not on label., SC/L
Not on label., Not Applicable., Not
applicable for this use.
SC/L
SC/L
Surface treatment., Not on label., Not on RTU
label.
PASTEURIZER/WARMER/CANNERY COOLING WATER SYSTEMS
Water treatment (recirculating system) ., SC/L
Continuous feed (initial) ., Not on
label., Not Applicable., Not applicable
for this use.
SC/L
SC/L
Water treatment (recirculating system) ., SC/L
Continuous feed (subsequent) . , Not on
label., Not Applicable., Not applicable
for this use.
SC/L
SC/L
Water treatment (recirculating system) ., SC/L
Intermittent (slug) (initial) ., Not on
label., Not Applicable., Not applicable
for this use.
SC/L
SC/L
Water treatment (recirculating system) ., SC/L
Min. Appl . Max. Appl. Soil
Rate (AI un- Rate (AI Tex.
less noted unless noted Max.
otherwise) otherwise) Dose
Use Group:
W 36 W 144 *
W 40 W 160 *
W 40 W 100 *
NA UC *
Use Group:
W 2 .4 W 12 *
W 6 W 12 *
W 6 .1 W 20 *
W 2 .4 W 7.2 *
W 3 .1 W 10 *
W 6 W 9 *
W 2 .4 W 12 *
W 6 W 12 *
W 6 .1 W 20 *
W 2 .4 W 7.2 *
Max. tt Apps
© Max. Rate
/crop /year
cycle
Max. Dose [ (AI
unless noted
otherwise) /A]
/crop /year
cycle
Min.
Interv
(days)
Restr. Geographic Limitations
Entry Allowed Disallowed
Interv
[day(s) ]
Use
Limitations
Codes
: INDOOR NON-FOOD (con't)
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS
NS
NS
NS
NS
NS
NS
NS
CIS,
C12,
CIS,
C12,
C24
CIS
C24
CIS
: INDOOR NON-FOOD
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
A08,
A30,
A08,
A08,
A08,
A30,
A08,
A30,
A08,
A08,
C12,
CIS,
C12,
C12,
C12,
CIS,
C12,
CIS,
C12,
C12,
CIS
C24
CIS
CIS
CIS
C24
CIS
C24
CIS
CIS
Intermittent (slug)(subsequent)., Not on
label., Not Applicable., Not applicable
47
-------
for this use.
SC/L
A08, C12, CIS
48
-------
Report Run Date: 07/14/95 - Time 13:13
PRD Report Date: 01/25/95
APPENDIX A - CASE 2055, [Bis(trichloromethyl)sulfone] Chemical 035601 [Bis(trichloromethyl) sulfo
LUIS 2.1 - Page
SITE Application Type, Application
Form(s) Min. Appl.
Timing, Application Equipment — Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr.
Rate (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle /crop /year
cycle
Interv Entry Allowed
(days) Interv
[day(s)]
Geographic Limitations
Disallowed
Limitations
Codes
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
PASTEURIZER/WARMER/CANNERY COOLING WATER SYSTEMS
SC/L
(con't)
W 6
PULP/PAPER MILL WATER SYSTEMS
Preservative treatment., Not on label.,
Not on label., Not Applicable., Not
applicable for this use.
Water treatment., Continuous feed
(initial)., Not on label., Not
Applicable., Not applicable for this use.
SC/L
Water treatment., Continuous feed
(subsequent)., Not on label., Not
Applicable., Not applicable for this use.
Use Group: INDOOR NON-FOOD (con't)
W 9 * NS NS NS NS NS
Use Group: AQUATIC NON-FOOD INDUSTRIAL
W 211 * NS NS NS NS NS
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/S
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/S
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
11
12
12
18
20
40
.6
2
4.3
4.8
12
18
20
40
.3
W 22
W 24
W 24
W 270
W 100
W 100
W 9
W 6 .1
W 43
W 24
W 18
W 67
W 75
W 75
W 1.5
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
A30, CIS, C24
C12, CIS
C12, CIS
A30, CIS, C24
A30, C12, CIS
A30, CIS, C24
A30, CIS, C24
A30, C12, CIS
A30, CIS, C24
A08, C12, CIS
C12, CIS
A30, CIS, C24
A30, C12, CIS
A30, CIS, C24
A30, CIS, C24
A30, C12, CIS
A30, CIS, C24
A08, C12, CIS
49
-------
50
-------
Report Run Date: 07/14/95 - Time 13:13
PRD Report Date: 01/25/95
APPENDIX A - CASE 2055, [Bis(trichloromethyl)sulfone] Chemical 035601 [Bis(trichloromethyl) sulfo
LUIS 2.1 - Page 9
SITE Application Type, Application Form(s) Min. Appl .
Timing, Application Equipment — Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
PULP/PAPER MILL WATER SYSTEMS (con't)
Water treatment., Intermittent
(slug) (initial) ., Not on label., Not
Applicable., Not applicable for this use.
Water treatment., Intermittent
(slug) (subsequent) ., Not on label., Not
Applicable., Not applicable for this use.
Water treatment., Not on label., Not on
label., Not Applicable., Not applicable
for this use.
Max. Appl. Soil Max. # Apps Max. Dose [ (AI Min.
Rate (AI Tex. © Max. Rate unless noted Interv
unless noted Max. /crop /year otherwise) /A] (days)
otherwise) Dose cycle /crop /year
cycle
Use Group: AQUATIC NON-
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/S
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/S
RTU
SC/L
SC/L
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
4.1
11
12
12
18
20
40
.6
2
4.3
4.8
9
10
12
40
.3
5.3
6 .2
36
W 20
W 43
W 24
W 24
W 270
W 100
W 100
W 9
W 10
W 22
W 12
W 180
W 75
W 18
W 75
W 9
W 26
W 37
W 144
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
* NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
-FOOD INDUSTRIAL
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
Restr. Geographic
Entry Allowed
Interv
[day(s) ]
Limitations Use
Disallowed Limitations
Codes
(con't)
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
C12,
A30,
A30,
A30,
A30,
A30,
A30,
A08,
C12,
A30,
A30,
A30,
A30,
A30,
A30,
A08,
C12,
CIS,
A30,
CIS
CIS,
C12,
CIS,
CIS,
C12,
CIS,
C12,
CIS
CIS,
C12,
CIS,
C12,
CIS,
CIS,
C12,
CIS
C24
CIS,
C24
CIS
C24
C24
CIS
C24
CIS
C24
CIS
C24
CIS
C24
C24
CIS
C24
51
-------
SC/L
A30, C12, CIS
52
-------
Report Run Date: 07/14/95 - Time 13:13
PRD Report Date: 01/25/95
APPENDIX A - CASE 2055, [Bis(trichloromethyl)sulfone] Chemical 035601 [Bis(trichloromethyl) sulfo
LUIS 2.1 - Page 10
SITE Application Type, Application
Form(s) Min. Appl.
Timing, Application Equipment — Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr.
Rate (AI Tex. @ Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle /crop /year
cycle
Interv Entry Allowed
(days) Interv
[day(s)]
Geographic Limitations
Disallowed
Limitations
Codes
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
PULP/PAPER MILL WATER SYSTEMS (con't)
SECONDARY OIL RECOVERY INJECTION WATER
Water treatment., Continuous feed
(initial)., Not on label., Not
Applicable., Not applicable for this use.
SC/L
SC/L
Water treatment., Continuous feed
(subsequent)., Not on label., Not
Applicable., Not applicable for this use.
Water treatment., Intermittent
(slug)(initial)., Not on label., Not
Applicable., Not applicable for this use.
Water treatment., Intermittent
(slug)(subsequent)., Not on label., Not
Applicable., Not applicable for this use.
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
W 4.9
W 11
W 11
W 1.7
W 2 .4
W 11
W 11
W 1.7
W 4.9
W 11
W 11
W 1.7
W 2 .4
W 11
W 11
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
W 100 * NS NS NS NS NS NS
Use Group: AQUATIC NON-FOOD INDUSTRIAL
W 57 * NS NS NS NS NS NS
W 24 * NS NS
W 43 * NS NS
W 21 * NS NS
W 14 * NS NS
W 19 * NS NS
W 34 * NS NS
W 17 * NS NS
W 57 * NS NS
W 24 * NS NS
W 43 * NS NS
W 21 * NS NS
W 20 * NS NS
W 19 * NS NS
W 34 * NS NS
W 17 * NS NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
A30, CIS, C24
A08, C12, CIS
A08, C12, CIS
A30, C12, CIS
A30, CIS, C24
A08, C12, CIS
A08, C12, CIS
A30, C12, CIS
A30, CIS, C24
A08, C12, CIS
A08, C12, CIS
A30, C12, CIS
A30, CIS, C24
A08, C12, CIS
A08, C12, CIS
A30, C12, CIS
A30, CIS, C24
53
-------
Page Intentionally Blank
54
-------
Report Run Date: 07/14/95 - Time 13:13
PRD Report Date: 01/25/95
APPENDIX A - CASE 2055, [Bis(trichloromethyl)sulfone] Chemical 035601 [Bis(trichloromethyl) sulfo
LUIS 2.1 - Page 11
SITE Application Type, Application
Form(s) Min. Appl.
Timing, Application Equipment — Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr.
Rate (AI Tex. © Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle /crop /year
cycle
Interv Entry Allowed
(days) Interv
[day(s) ]
Geographic Limitations
Disallowed
Limitations
Codes
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
SEWAGE SYSTEMS
Water treatment (recirculating system).,
Continuous feed (initial)., Not on
label., Not Applicable., Not applicable
for this use.
Water treatment (recirculating system).,
Continuous feed (subsequent)., Not on
label., Not Applicable., Not applicable
for this use.
Water treatment (recirculating system).,
Intermittent (slug)(initial)., Not on
label., Not Applicable., Not applicable
for this use.
Water treatment (recirculating system).,
Intermittent (slug)(subsequent)., Not on
label., Not Applicable., Not applicable
for this use.
Water treatment., Intermittent
(slug)(initial)., Not on label., Not
Applicable., Not applicable for this use.
Water treatment., Intermittent
(slug)(subsequent)., Not on label., Not
Applicable., Not applicable for this use.
SPECIALITY INDUSTRIAL PRODUCTS
Industrial preservative treatment.,
During manufacture., Not on label., Not
Applicable., Not applicable for this use.
Preservative treatment., Not on label.,
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/S
SC/L
Use Group: AQUATIC NON-FOOD INDUSTRIAL
W 12 * NS NS NS NS NS NS
W 6 .1
W 2 .4
W 3 .1
W 2 .4
W 6 .1
W 2 .4
W 3 .1
W 6
W 20 * NS NS
W 7 .2 * NS NS
W 10 * NS NS
W 12 * NS NS
W 20 * NS NS
W 7 .2 * NS NS
W 10 * NS NS
W 12 * NS NS
W 9 * NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
Use Group: INDOOR NON-FOOD
W 25 * NS NS NS NS NS NS
W 144 * NS NS
NS NS NS NS
A08, C12, CIS
A08, C12, CIS
A08, C12, CIS
A08, C12, CIS
A08, C12, CIS
A08, C12, CIS
A08, C12, CIS
A08, C12, CIS
CIS, C24
CIS, C24
C12, CIS
CIS, C24
55
-------
Not on label., Not Applicable., Not
applicable for this use.
56
-------
Report Run Date: 07/14/95 - Time 13:13
PRD Report Date: 01/25/95
APPENDIX A - CASE 2055, [Bis(trichloromethyl)sulfone] Chemical 035601 [Bis(trichloromethyl) sulfo
LUIS 2.1 - Page 12
SITE Application Type, Application
Form(s) Min. Appl.
Timing, Application Equipment — Rate (AI un-
Surface Type (Antimicrobial only) & Effica- less noted
cy Influencing Factor (Antimicrobial only) otherwise)
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr.
Rate (AI Tex. © Max. Rate unless noted
unless noted Max. /crop /year otherwise)/A]
otherwise) Dose cycle /crop /year
cycle
Interv Entry Allowed
(days) Interv
[day(s) ]
Geographic Limitations
Disallowed
Limitations
Codes
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
SPECIALITY INDUSTRIAL PRODUCTS (con't)
SC/L
SC/L
WET-END ADDITIVES/INDUSTRIAL PROCESSING CHEMICALS
Industrial preservative treatment.,
During manufacture., Not on label., Not
Applicable., Not applicable for this use.
Preservative treatment., Not on label.,
Not on label., Not Applicable., Not
applicable for this use.
SC/L
SC/S
SC/L
SC/L
SC/L
W 5
W 36
W 40
W 40
Use Group: INDOOR NON-FOOD (con't)
W 160 * NS NS NS NS NS
W 100 * NS NS NS NS NS
Use Group: INDOOR NON-FOOD
W 170 * NS NS NS NS NS
W 25 * NS NS
W 144 * NS NS
W 160 * NS NS
W 100 * NS NS
NS
NS
NS
NS
NS NS
NS NS
NS NS
NS NS
NS
NS
NS
NS
NS
NS
C12, CIS
CIS, C24
C12, CIS
C12, CIS
CIS, C24
C12, CIS
CIS, C24
57
-------
Report Run Date: 07/14/95
PRD Report Date: 01/25/95
- Time 13:13
APPENDIX A - CASE 2055, [Bis(trichloromethyl)sulfone] Chemical 035601 [Bis(trichloromethyl) sulfo
LUIS 2.1 - Page 13
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)
: Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).
: Maximum number of Applications at Maximum Dosage Rate. Example: "4 applications per year" is expressed as "4/1 yr"; "4 applications per 3
years" is expressed as "4/3 yr"
: Maximum dose applied to a site over a single crop cycle or year. System calculated.
Soil Tex. Max. Dose
Max. # Apps © Max. Rate
Max. Dose [(AI unless
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
RTU LIQUID-READY TO USE
SC/L SOLUBLE CONCENTRATE/LIQUID
SC/S SOLUBLE CONCENTRATE/SOLID
ABBREVIATIONS
AN
NA
NS
UC
As Needed
Not Applicable
Not Specified (on label)
Unconverted due to lack of data (on label), or with one of following units: bag, bait, bait block, bait pack, bait station, bait station(s), block, briquet,
briquets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser, drop, eartag, grains, lure, pack, packet, packets, pad, part,
parts, pellets, piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick, strip, tab, tablet, tablets, tag, tape, towelette, tray, unit, - -
APPLICATION RATE
DCNC
No Calc
W
V
U
cwt
nnE-xx
Dosage Can Not be Calculated
No Calculation can be made
PPM calculated by weight
PPM Calculated by volume
Unknown whether PPM is given by weight or by volume
Hundred Weight
nn times (10 power -xx); for instance, "1.234E-04"
is equivalent to ".0001234"
USE LIMITATIONS CODES
A08 : Preclean claim.
A30 : Preclean for heavily soiled areas.
C12 : Do not apply in marine and/or estuarine, oil fields, or discharge effluent into lakes, streams, ponds or public water. (NPDES license restriction)
CIS : Do not discharge effluent containing this pesticide into sewage systems without notifying the sewage treatment plant authority.
C24 : Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or public water. (NPDES license restriction)
* NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS, DAYS, ETC.) DESCRIBED IN THE LIMITATION.
58
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59
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60
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active
ingredients within the case Bis(trichloromethyl) sulfone covered by this Reregistration Eligibility
Decision Document. It contains generic data requirements that apply to Bis(trichloromethyl)
sulfone 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.
61
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62
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APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Bis(trichloromethyl) Sulfone
REQUIREMENT
PRODUCT
61-1
61-2A
61-2B
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
63-12
63-13
CHEMISTRY
Chemical Identity
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition
PH
Stability
USE PATTERN
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
All
CITATION(S)
152327, 156932
162129
152327
152327, 156932
152327
152327
152327
152327
152327
152327
Inapplicable
152327
152327, 42384501
Inapplicable
Inapplicable
156932
Inapplicable
152327
ECOLOGICAL EFFECTS
71-1A
71-2A
71-2B
Acute Avian Oral - Quail/Duck
Avian Dietary - Quail
Avian Dietary - Duck
C, F
C, F
C
156817
156818
156820
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Data Supporting Guideline Requirements for the Reregistration of Bis(trichloromethyl) Sulfone
REQUIREMENT
72-1A
72-1C
72-2A
72-3A
72-3B
Fish Toxicity Bluegill
Fish Toxicity Rainbow Trout
Invertebrate Toxicity
Estuarine/Marine Toxicity - Fish
Estuarine/Marine Toxicity - Mollusk
USE PATTERN
C, F
C, F
C, F
CITATION(S)
156815
156814
156816
40138102
40193201
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
81-8-SS
82-2
83-3A
83-3B
84-2A
84-2B
84-4
Acute Oral Toxicity - Rat
Acute Dermal Toxicity - Rabbit/Rat
Acute Inhalation Toxicity - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization - Guinea Pig
Acute Neurotoxicity - Rat
21-Day Dermal - Rabbit/Rat
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
Gene Mutation (Ames Test)
Structural Chromosomal Aberration
Other Genotoxic Effects
All
All
All
All
All
All
L
L
C, F, L, M
C, F, L, M
C, F, L, M
152875
152875
42824801
152875
152875
156813
43156601, 43207901
40050701
40149101
431566602, 43156603
152330, 152331, 152332, 152333, 152334
42372701
152335
ENVIRONMENTAL FATE
160-5
161-1
Chemical Identity
Hydrolysis
All
All
152327
41888701
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GUIDE TO APPENDIX C
1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere
in the Reregistration Eligibility Document. Primary sources for studies in this
bibliography have been the body of data submitted to EPA and its predecessor agencies
in support of past regulatory decisions. Selections from other sources including the
published literature, in those instances where they have been considered, are included.
2. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the
case of published materials, this corresponds closely to an article. In the case of
unpublished materials submitted to the Agency, the Agency has sought to identify
documents at a level parallel to the published article from within the typically larger
volumes in which they were submitted. The resulting "studies" generally have a distinct
title (or at least a single subject), can stand alone for purposes of review and can be
described with a conventional bibliographic citation. The Agency has also attempted to
unite basic documents and commentaries upon them, treating them as a single study.
3. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted
numerically by Master Record Identifier, or "MRID number". This number is unique to
the citation, and should be used whenever a specific reference is required. It is not related
to the six-digit "Accession Number" which has been used to identify volumes of submitted
studies (see paragraph 4(d)(4) below for further explanation). In a few cases, entries
added to the bibliography late in the review may be preceded by a nine character
temporary identifier. These entries are listed after all MRID entries. This temporary
identifying number is also to be used whenever specific reference is needed.
4. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry
consists of a citation containing standard elements followed, in the case of material
submitted to EPA, by a description of the earliest known submission. Bibliographic
conventions used reflect the standard of the American National Standards Institute (ANSI),
expanded to provide for certain special needs.
a Author. Whenever the author could confidently be identified, the Agency has
chosen to show a personal author. When no individual was identified, the Agency
has shown an identifiable laboratory or testing facility as the author. When no
author or laboratory could be identified, the Agency has shown the first submitter
as the author.
b. Document date. The date of the study is taken directly from the document. When
the date is followed by a question mark, the bibliographer has deduced the date
from the evidence contained in the document. When the date appears as (19??),
the Agency was unable to determine or estimate the date of the document.
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c. Title. In some cases, it has been necessary for the Agency bibliographers to create
or enhance a document title. Any such editorial insertions are contained between
square brackets.
d. Trailing parentheses. For studies submitted to the Agency in the past, the trailing
parentheses include (in addition to any self-explanatory text) the following elements
describing the earliest known submission:
(1) Submission date. The date of the earliest known submission appears
immediately following the word "received."
(2) Administrative number. The next element immediately following the word
"under" is the registration number, experimental use permit number,
petition number, or other administrative number associated with the earliest
known submission.
(3) Submitter. The third element is the submitter. When authorship is
defaulted to the submitter, this element is omitted.
(4) Volume Identification (Accession Numbers). The final element in the
trailing parentheses identifies the EPA accession number of the volume in
which the original submission of the study appears. The six-digit accession
number follows the symbol "CDL," which stands for "Company Data
Library." This accession number is in turn followed by an alphabetic
suffix which shows the relative position of the study within the volume.
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BIBLIOGRAPHY
MRID
CITATION
00152327 Stauffer Chemical Co. (1985) Bis(trichloromethyl)Sulfone: N-1386 Technical: Product Chemistry.
Unpublished study. 62 p.
00152330 Brusick, D. (1976) Mutagenicity Evaluation of Sample #300: FN-1386 Technical": Final Report:
Project No.: 2683: Stauffer No.: T-6083. Unpublished study prepared by Litton Bionetics, Inc.
13 p.
00152331 Brusick, D. (1976) Mutagenicity Evaluation of Sample #400: FN-1386 Technical": Final Report:
Project No.: 2683: Stauffer No.: T-6084. Unpublished study prepared by Litton Bionetics, Inc.
12 p.
00152332 Majeska, J. (1980) Mutagenicity Evaluation in Salmonella typhimurium: |=N-1386": Study No.:
T-10042. Unpublished study prepared by Stauffer Chemical Co. 13 p.
00152333 Matheson, D. (1978) Mutagenicity Evaluation of N-1386 in the Mouse Lymphoma Forward
Mutation Assay: Final Report: Project No.: 20839: Stauffer No.: T-6352. Unpublished study
prepared by Litton Bionetics, Inc. lip.
00152334 Majeska, J. (1980) Mutagenicity Evaluation in Mouse Lymphoma Multiple Endpoint Test: Report
No.: T-10138. Unpublished study prepared by Stauffer Chemical Co. 19 p.
00152335 Stetka, D. (1979) Mutagenicity Evaluation of N-1386 in the Sister Chromatid Exchange Assay in
L5178Y Mouse Lymphoma Cells: Final Report: Project No.: 20990: Stauffer No.: T-6352.
Unpublished study prepared by Litton Bionetics, Inc. 22 p.
00152875 Castles, T. (1978) Toxicity Evaluation: N-1386 Tech Composite: FAcute Oral and Dermal LD50,
Skin and Eye Irritation": Lab. Report No. T-6213. Unpublished compilation prepared by Stauffer
Chemical Co. 40 p.
00156813 Davis, G.; Mutter, L.; Castles, T (1986) Dermal Sensitization Test with N-1386 Technical:
T-12375. Unpublished study prepared by Stauffer Chemical Co. 54 p.
00156814 McAllister, W.; Bowman, J. (1985) Acute Toxicity of N-1386 to Rainbow Trout (Salmo
gairdneri): Static Acute Toxicity Report #33759: T-12368. Unpublished study prepared by
Analytical BioChemistry Laboratories, Inc. 51 p.
00156815 McAllister, W.; Bowman, J. (1985) Acute Toxicity of N-1386 to Bluegill Sunfish (Lepomis
macrochirus): Static Acute Toxicity Report #33758: T-12369. Unpublished study prepared by
Analytical BioChemistry Laboratories, Inc. 56 p.
00156816 Forbis, A.; Burgess, D. (1985) Acute Toxicity of N-1386 to Daphnia magna): Static Acute
Toxicity Report #33760: T-12370. Unpublished study prepared by Analytical Bio-Chemistry
Laboratories, Inc. 38 p.
67
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BIBLIOGRAPHY
MRID
CITATION
0156817 Grimes, J. (1986) N-1386: An Acute Oral Toxicity Study with the Mallard: Final Report: Project
No.: 144-133: T-12371. Unpublished study prepared by Wildlife International Ltd. 17 p.
00156818 Grimes, J. (1986) N-1386: A Dietary LC50 Study with the Bobwhite: Final Report: Project No.:
144-131: T-12373. Unpublished study prepared by Wildlife International Ltd. 16 p.
00156820 Grimes, J. (1986) N-1386: A Dietary LC50 Study with the Mallard: Final Report: Project No.:
144-132: T-12372. Unpublished study prepared by Wildlife International Ltd. 16 p.
00156932 Stauffer Chemical Co. (19??) ^Product Chemistry Data: Racer 2-E". Unpublished study. 15 p.
00162129 Stauffer Chemical Co. (1986) Bis(trichloromethyl)sulfone: N-1386 Technical: Product Chemistry:
^Statement of Composition and Manufacturing Process*. Unpublished compilation. 24 p.
40050701 Sauerhoff, M.; Mackenzie, K. (1987) 21-Day Dermal Toxicity Study in Rabbits with N-1386
Technical Biocide: HLA 6142-102. Unpublished study prepared by Hazleton Laboratories
America, Inc. and Stauffer Chemical Co. 169 p.
40138102 Bowman, J. (1986) Acute Toxicity of N-1386 to Sheepshead Minnows (Cyprinodon variegatus):
Project No. 35012. Unpublished study prepared by Analytical Bio-Chemistry Laboratories, Inc.
60 p.
40149101 Nemec, M. (1987) A Teratology in Rats with N-1386 Biocide Technical: Final Report: Laboratory
Project ID. WIL-27038. Unpublished study prepared by WIL Research Laboratories, Inc. 252
P-
40193201 Surprenant, D. (1987) Acute Toxicity of N-1386 to Embryos-larvae of the Quahog Clam
(Mercenaria mercenaria): Bionomics Report No. BW-87-3-2288. Unpublished study prepared by
Springborn Bionomics, Inc. 16 p.
41888701 Bicking, M. (1991) Hydrolysis Testing For N-1386 Biocide: Lab Project Number: 46/90-ACC.3.
Unpublished study prepared by Twin City Testing Corp. 31 p.
42372701 O'Loughlin, K. (1992) Bone Marrow Erythrocyte Micronucleus Assay of N-1386 Technical in
Swiss-Webster Mice: Lab Project Number: 3377-C100-92. Unpublished study prepared by SRI
International. 73 p.
42384501 Desai, L. (1992) Analytical Solubility Study of N-1386 Technical in Two Non-Polar Solvents.:
Final Report: Lab Project Number: 92-GR-0002. Unpublished study prepared by Toxikon Corp.
163 p.
42824801 Ferguson, J. (1993) Acute Inhalation Toxicity Study of N-1386 Technical in Rats: Final Report:
Lab Project Number: L08430. Unpublished study prepared by IIT Research Institute. 49 p.
68
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BIBLIOGRAPHY
MRID CITATION
3156601 Beyrouty, P. (1994) An Acute Study of the Potential Effects of Orally Administered N-1386
Technical on Behavior and Neuromorphology in Rats: Lab Project Number: 97243. Unpublished
study prepared by Bio-Research Labs., Ltd. 592 p.
43156602 Mercieca, M. (1993) A Developmental Toxicity Study in Rabbits with N-1386 Technical: Final
Report: Lab Project Number: 3243.19. Unpublished study prepared by Springborn Labs., Inc. 249
P-
43156603 Mercieca, M. (1994) A Range-Finding Developmental Toxicity Study in Rabbits with N-1386
Technical: Final Report: Lab Project Number: 3243.18. Unpublished study prepared by
Springborn Labs., Inc. 127 p.
43207901 Beyrouty, P. (1994) A Time of Peak Behavioral Effects Study of a Single Oral Administration of
N-1386 Technical in Rats: Ancillary Study: Lab Project Number: 97242. Unpublished study
prepared by Bio-Research Laboratories, Ltd. 79 p.
69
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1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
/ WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the
active ingredient identified in Attachment 1 of this Notice, the Data Call-In Chemical Status
Sheet, to submit certain product specific data as noted herein to the U.S. Environmental
Protection Agency (EPA, the Agency). These data are necessary to maintain the continued
registration of your product(s) containing this active ingredient. Within 90 days after you
receive this Notice you must respond as set forth in Section III below. Your response must
state:
1. How you will comply with the requirements set forth in this Notice and its
Attachments 1 through 6; or
2. Why you believe you are exempt from the requirements listed in this Notice and
in Attachment 3, Requirements Status and Registrant's Response Form, (see
section III-B); or
3. Why you believe EPA should not require your submission of product specific
data in the manner specified by this Notice (see section III-D).
If you do not respond to this Notice, or if you do not satisfy EPA that you will comply
with its requirements or should be exempt or excused from doing so, then the registration of
your product(s) subject to this Notice will be subject to suspension. We have provided a list
of all of your products subject to this Notice in Attachment 2, Data Call-In Response Form, as
well as a list of all registrants who were sent this Notice (Attachment 6).
71
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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 I. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient and reevaluated the
data needed to support continued registration of the subject active ingredient. The Agency has
concluded that the only additional data necessary are product specific data. No additional
generic data requirements are being imposed. You have been sent this Notice because you
have product(s) containing the subject active ingredient.
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The product specific data required by this Notice are specified in Attachment 3,
Requirements Status and Registrant's Response Form. Depending on the results of the studies
required in this Notice, additional testing may be required.
II-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified
in Attachment 3, Requirements Status and Registrant's Response Form, within the time frames
provided.
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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(s), or any other agreements entered into
with the Agency pertaining to such prior Notice. Registrants must comply with the requirements
of all Notices to avoid issuance of a Notice of Intent to Suspend their affected products.
SECTION III. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
III-A. SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for product specific data must
be submitted to the Agency within 90 days after your receipt of this Notice. Failure to
adequately respond to this Notice within 90 days of your receipt will be a basis for issuing a
Notice of Intent to Suspend (NOIS) affecting your products. This and other bases for issuance of
NOIS due to failure to comply with this Notice are presented in Section IV-A and IV-B.
III-B. OPTIONS FOR RESPONDING TO THE AGENCY
The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice or
(c) request a data waiver(s).
A discussion of how to respond if you chose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product
specific 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.
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There are two forms that accompany this Notice of which, depending upon your
response, one or both must be used in your response to the Agency. These forms are the Data-
Call-in Response Form, and the Requirements Status and Registrant's Response Form,
Attachment 2 and Attachment 3. The Data Call-In Response Form must be submitted as part of
every response to this Notice. In addition, one copy of the Requirements Status and Registrant's
Response Form must be submitted for each product listed on the Data Call-in Response Form
unless the voluntary cancellation option is selected or unless the product is identical to another
(refer to the instructions for completing the Data Call-in Response Form in Attachment 2).
Please note that the company's authorized representative is required to sign the first page of the
Data Call-in Response Form and Requirements Status and Registrant's Response Form (if this
form is required) and initial any subsequent pages. The forms contain separate detailed
instructions on the response options. Do not alter the printed material. If you have questions or
need assistance in preparing your response, call or write the contact person(s) identified in
Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by requesting
voluntary cancellation of your product(s) containing the active ingredient that is the subject of
this Notice. If you wish to voluntarily cancel your product, you must submit a completed Data
Call-in Response Form, indicating your election of this option. Voluntary cancellation is item
number 5 on the Data Call-In Response Form. If you choose this option, this is the only form
that you are required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
2. Satisfying the Product Specific Data Requirements of this Notice There are various
options available to satisfy the product specific data requirements of this Notice. These options
are discussed in Section III-C of this Notice and comprise options 1 through 6 on the
Requirements Status and Registrant's Response Form and item numbers 7a and 7b on the Data
Call-in Response Form. Deletion of a use(s) and the low volume/minor use option are not valid
options for fulfilling product specific data requirements.
3. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section III-D of this Notice and are covered by option 7 on the Requirements Status
and Registrant's Response Form. If you choose one of these options, you must submit both
forms as well as any other information/data pertaining to the option chosen to address the data
requirement.
III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-in Response Form that you agree to satisfy the
product specific data requirements (i.e. you select item number 7a or 7b), then you must select
one of the six options on the Requirements Status and Registrant's Response Form related to
data production for each data requirement. Your option selection should be entered under item
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
74
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in parentheses to guide registrants to additional instructions provided in this Section. The
options are:
(1) I will generate and submit data within the specified time frame (Developing Data)
(2) I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing
study that has been submitted but not reviewed by the Agency (Citing an Existing
Study)
Option 1, Developing Data — If you choose to develop the required data it must be in
conformance with Agency deadlines and with other Agency requirements as referenced herein
and in the attachments. All data generated and submitted must comply with the Good
Laboratory Practice (GLP) rule (40 CFR Part 160), be conducted according to the Pesticide
Assessment Guidelines (PAG), and be in conformance with the requirements of PR Notice 86-5.
The time frames in the Requirements Status and Registrant's Response Form are the time
frames that the Agency is allowing for the submission of completed study reports. The noted
deadlines run from the date of the receipt of this Notice by the registrant. If the data are not
submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to Suspend
the affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by this Notice
and intend to seek additional time to meet the requirements(s), you must submit a request to the
Agency which includes: (1) a detailed description of the expected difficulty and (2) a proposed
schedule including alternative dates for meeting such requirements on a step-by-step basis. You
must explain any technical or laboratory difficulties and provide documentation from the
laboratory performing the testing. While EPA is considering your request, the original deadline
remains. The Agency will respond to your request in writing. If EPA does not grant your
request, the original deadline remains. Normally, extensions can be requested only in cases of
extraordinary testing problems beyond the expectation or control of the registrant. Extensions
will not be given in submitting the 90-day responses. Extensions will not be considered if the
request for extension is not made in a timely fashion; in no event shall an extension request be
considered if it is submitted at or after the lapse of the subject deadline.
Option 2, Agreement to Share in Cost to Develop Data — Registrants may only choose
this option for acute toxicity data and certain efficacy data and only if EPA has indicated in the
attached data tables that your product and at least one other product are similar for purposes of
depending on the same data. If this is the case, data may be generated for just one of the
products 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
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submitting the data. You must also provide EPA with documentary evidence that an agreement
has been formed. Such evidence may be your letter offering to join in an agreement and the
other registrant's acceptance of your offer, or a written statement by the parties that an
agreement exists. The agreement to produce the data need not specify all of the terms of the
final arrangement between the parties or the mechanism to resolve the terms. Section 3(c)(2)(B)
provides that if the parties cannot resolve the terms of the agreement they may resolve their
differences through binding arbitration.
Option 3, Offer to Share in the Cost of Data Development — This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. If you have made an
offer to pay in an attempt to enter into an agreement or amend an existing agreement to meet the
requirements of this Notice and have been unsuccessful, you may request EPA (by selecting this
option) to exercise its discretion not to suspend your registration(s), although you do not comply
with the data submission requirements of this Notice. EPA has determined that as a general
policy, absent other relevant considerations, it will not suspend the registration of a product of a
registrant who has in good faith sought and continues to seek to enter into a joint data
development/cost sharing program, but the other registrant(s) developing the data has refused to
accept your offer. To qualify for this option, you must submit documentation to the Agency
proving that you have made an offer to another registrant (who has an obligation to submit data)
to share in the burden of developing that data. You must also submit to the Agency a completed
EPA Form 8570-32, Certification of Offer to Cost Share in the Development of Data,
Attachment 7. In addition, you must demonstrate that the other registrant to whom the offer was
made has not accepted your offer to enter into a cost sharing agreement by including a copy of
your offer and proof of the other registrant's receipt of that offer (such as a certified mail
receipt). Your offer must, in addition to anything else, offer to share in the burden of producing
the data upon terms to be agreed or failing agreement to be bound by binding arbitration as
provided by FIFRA section 3(c)(2)(B)(iii) and must not qualify this offer. The other registrant
must also inform EPA of its election of an option to develop and submit the data required by this
Notice by submitting a Data Call-in Response Form and a Requirements Status and Registrant's
Response Form committing to develop and submit the data required by this Notice.
In order for you to avoid suspension under this option, you may not withdraw your offer
to share in the burdens of developing the data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this Notice. If the other registrant
fails to develop the data or for some other reason is subject to suspension, your registration as
well as that of the other registrant will normally be subject to initiation of suspension
proceedings, unless you commit to submit, and do submit the required data in the specified time
frame. In such cases, the Agency generally will not grant a time extension for submitting the
data.
Option 4, Submitting an Existing Study — If you choose to submit an existing study in
response to this Notice, you must determine that the study satisfies the requirements imposed by
this Notice. You may only submit a study that has not been previously submitted to the Agency
or previously cited by anyone. Existing studies are studies which predate issuance of this
Notice. Do not use this option if you are submitting data to upgrade a study. (See Option 5).
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
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required date of submission. The Agency may determine at any time that a study is not valid
and needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data
and specimens from the study are available for audit and review and you must
identify where they are available. This must be done in accordance with the
requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR Part
160. As stated in 40 CFR 160.3(j) " 'raw data' means any laboratory worksheets,
records, memoranda, notes, or exact copies thereof, that are the result of original
observations and activities of a study and are necessary for the reconstruction and
evaluation of the report of that study. In the event that exact transcripts of raw
data have been prepared (e.g., tapes which have been transcribed verbatim,
dated, and verified accurate by signature), the exact copy or exact transcript may
be substituted for the original source as raw data. 'Raw data' may include
photographs, microfilm or microfiche copies, computer printouts, magnetic
media, including dictated observations, and recorded data from automated
instruments." The term "specimens", according to 40 CFR 160.3(k), means "any
material derived from a test system for examination or analysis."
b. Health and safety studies completed after May 1984 must also contain all GLP-
required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants must also certify at the time of
submitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study
signed by an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
Technical Guidance and that the study has been conducted according to the
Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG (both
available from NTIS). A study not conducted according to the PAG may be
submitted to the Agency for consideration if the registrant believes that the study
clearly meets the purpose of the PAG. The registrant is referred to 40 CFR
158.70 which states the Agency's policy regarding acceptable protocols. If you
wish to submit the study, you must, in addition to certifying that the purposes of
the PAG are met by the study, clearly articulate the rationale why you believe the
study meets the purpose of the PAG, including copies of any supporting
information or data. It has been the Agency's experience that studies completed
prior to January 1970 rarely satisfied the purpose of the PAG and that necessary
raw data are usually not available for such studies.
If you submit an existing study, you must certify that the study meets all requirements of
the criteria outlined above.
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If you know of a study pertaining to any requirement in this Notice which does not meet
the criteria outlined above but does contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study. If such study is in the Agency's files, you
need only cite it along with the notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5.
Option 5, Upgrading a Study — If a study has been classified as partially acceptable and
upgradeable, you may submit data to upgrade that study. The Agency will review the data
submitted and determine if the requirement is satisfied. If the Agency decides the requirement is
not satisfied, you may still be required to submit new data normally without any time extension.
Deficient, but upgradeable studies will normally be classified as supplemental. However, it is
important to note that not all studies classified as supplemental are upgradeable. If you have
questions regarding the classification of a study or whether a study may be upgraded, call or
write the contact person listed in Attachment 1. If you submit data to upgrade an existing study
you must satisfy or supply information to correct all deficiencies in the study identified by EPA.
You must provide a clearly articulated rationale of how the deficiencies have been remedied or
corrected and why the study should be rated as acceptable to EPA. Your submission must also
specify the MRID number(s) of the study which you are attempting to upgrade and must be in
conformance with PR Notice 86-5.
Do not submit additional data for the purpose of upgrading a study classified as
unacceptable and determined by the Agency as not capable of being upgraded.
This option should also be used to cite data that has been previously submitted to upgrade
a study, but has not yet been reviewed by the Agency. You must provide the MRID number of
the data submission as well as the MRID number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply to all
data submissions intended to upgrade studies. Additionally your submission of data intended to
upgrade studies must be accompanied by a certification that you comply with each of those
criteria as well as a certification regarding protocol compliance with Agency requirements.
Option 6, Citing Existing Studies — If you choose to cite a study that has been previously
submitted to EPA, that study must have been previously classified by EPA as acceptable or it
must be a study which has not yet been reviewed by the Agency. Acceptable toxicology studies
generally will have been classified as "core-guideline" or "core minimum." For all other
disciplines the classification would be "acceptable." With respect to any studies for which you
wish to select this option you must provide the MRID number of the study you are citing and, if
the study has been reviewed by the Agency, you must provide the Agency's classification of the
study.
If you are citing a study of which you are not the original data submitter, you must
submit a completed copy of EPA Form 8570-31, Certification with Respect to Data
Compensation Requirements.
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.
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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.
SECTION IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due
to failure by a registrant to comply with the requirements of this Data Call-In Notice, pursuant
to FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent
to Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of
this Notice.
2. Failure to submit on the required schedule an acceptable proposed or final
protocol when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a study
as required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this
Notice.
5. Failure to take a required action or submit adequate information pertaining to any
option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task
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).
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6. Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost
of developing data and provided proof of the registrant's receipt of such offer or
failure of a registrant on whom you rely for a generic data exemption either to:
a. inform EPA of intent to develop and submit the data required by this
Notice on a Data Call-in Response Form and a Requirements Status and
Registrant's Response Form;
b. fulfill the commitment to develop and submit the data as required by this
Notice; or
c. otherwise take appropriate steps to meet the requirements stated in this
Notice, unless you commit to submit and do submit the required data in
the specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any
time following the issuance of this Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds
for suspension include, but are not limited to, failure to meet any of the following:
1. EPA requirements specified in the Data Call-in Notice or other documents
incorporated by reference (including, as applicable, EPA Pesticide Assessment
Guidelines, Data Reporting Guidelines, and GeneTox Health Effects Test Guidelines)
regarding the design, conduct, and reporting of required studies. Such requirements
include, but are not limited to, those relating to test material, test procedures, selection
of species, number of animals, sex and distribution of animals, dose and effect levels to
be tested or attained, duration of test, and, as applicable, Good Laboratory Practices.
2. EPA requirements regarding the submission of protocols, including the incorporation
of any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting,
the completeness of results, and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or included in this Notice or
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.
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IV-C EXISTING STOCKS OF SUSPENDED OR CANCELED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing
stocks of a pesticide product which has been suspended or canceled if doing so would be
consistent with the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding would generally not
be consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing stocks of your product(s) which may
be suspended for failure to comply with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be consistent with the Act.
You must also explain why an "existing stocks" provision is necessary, including a statement of
the quantity of existing stocks and your estimate of the time required for their sale, distribution,
and use. Unless you meet this burden the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.
If you request a voluntary cancellation of your product(s) as a response to this Notice
and your product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 90 day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use such
existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of
voluntarily cancelled products containing an active ingredient for which the Agency has
particular risk concerns will be determined on case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required by
this Notice will not result in the Agency granting any additional time to sell, distribute, or use
existing stocks beyond a year from the date the 90 day response was due unless you demonstrate
to the Agency that you are in full compliance with all Agency requirements, including the
requirements of this Notice. For example, if you decide to voluntarily cancel your registration
six months before a 3 year study is scheduled to be submitted, all progress reports and other
information necessary to establish that you have been conducting the study in an acceptable and
good faith manner must have been submitted to the Agency, before EPA will consider granting
an existing stocks provision.
SECTION V. REGISTRANTS' OBLIGATION TO REPORT POSSIBLE UNREASONABLE
ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a
pesticide is registered a registrant has additional factual information regarding unreasonable
adverse effects on the environment by the pesticide, the registrant shall submit the information to
the Agency. Registrants must notify the Agency of any factual information they have, from
whatever source, including but not limited to interim or preliminary results of studies, regarding
unreasonable adverse effects on man or the environment. This requirement continues as long as
the products are registered by the Agency.
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SECTION VI. INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment 1, the Data Call-In Chemical Status Sheet.
All responses to this Notice (other than voluntary cancellation requests and generic data
exemption claims) must include a completed Data Call-In Response Form and a completed
Requirements Status and Registrant's Response Form (Attachment 2 and Attachment 3 for
product specific data) and any other documents required by this Notice, and should be submitted
to the contact person(s) identified in Attachment 1. If the voluntary cancellation or generic data
exemption option is chosen, only the Data Call-In Response Form need be submitted.
The Office of Compliance Monitoring (OCM) of the Office of Pesticides and Toxic
Substances (OPTS), EPA, will be monitoring the data being generated in response to this
Notice.
Sincerely yours,
Lois A. Rossi, Division Director
Special Review and
Reregistration Division
Attachments
1 - Data Call-In Chemical Status Sheet
2 - Product-Specific Data Call-In Response Form
3 - Requirements Status and Registrant's Response Form
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - List of Registrants Receiving This Notice
6 - Cost Share and Data Compensation Forms and the Confidential Statement of
Formula Form
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BIS(TRICHLOROMETHYL) SULFONE DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have
product(s) containing bis(trichloromethyl) sulfone.
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 reregistration of
bis(trichloromethyl) sulfone. This attachment is to be used in conjunction with (1) the Product
Specific Data Call-In Notice, (2) the Product Specific Data Call-In Response Form
(Attachment 2), (3) the Requirements Status and Registrant's Form (Attachment 3), (4) EPA's
Grouping of End-Use Products for Meeting Acute Toxicology Data Requirement (Attachment
4), (5) a list of registrants receiving this DCI (Attachment 5) and (6) the Cost Share and Data
Compensation Forms in replying to this bis(trichloromethyl) sulfone Product Specific Data
Call-In (Attachment (6)). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the database for
bis(trichloromethyl) sulfone are contained in the Requirements Status and Registrant's
Response, Attachment 3. The Agency has concluded that additional data on
bis(trichloromethyl) sulfone 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 reregistration of all eligible bis(trichloromethyl) sulfone products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding this product specific data requirements and
procedures established by this Notice, please contact Jeffrey Billingslea at (703) 308-8004.
All responses to this Notice for the Product Specific data requirements should be
submitted to:
Jeffrey Billingslea
Chemical Review Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch 7508W
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: Bis(trichloromethyl) sulfone
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORM FOR
PRODUCT SPECIFIC DATA
Item 1-4. Already completed by EPA.
Item 5. If you wish to voluntarily cancel your product, answer "yes." If you choose
this option, you will not have to provide the data required by the Data Call-In
Notice and you will not have to complete any other forms. Further sale and
distribution of your product after the effective date of cancellation must be in
accordance with the Existing Stocks provision of the Data Call-In Notice
(Section IV-C).
Item 6. Not applicable since this form calls in product specific data only. However, if
your product is identical to another product and you qualify for a data
exemption, you must respond with "yes" to Item 7a (MUP) or 7B (EUP) on
this form, provide the EPA registration numbers of your source(s); you
would not complete the "Requirements Status and Registrant's Response" form.
Examples of such products include repackaged products and Special Local
Needs (Section 24c) products which are identical to federally registered
products.
Item 7a. For each manufacturing use product (MUP) for which you wish to maintain
registration, you must agree to satisfy the data requirements by responding
"yes."
Item 7b. For each end use product (EUP) for which you wish to maintain registration,
you must agree to satisfy the data requirements by responding "yes." If you are
requesting a data waiver, answer "yes" here; in addition, on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with
Option 7 (Waiver Request) for each study for which you are requesting a
waiver. See Item 6 with regard to identical products and data exemptions.
Items 8-11. Self-explanatory.
NOTE: You may provide additional information that does not fit on this form in a
signed letter that accompanies this form. For example, you may wish to report
that your product has already been transferred to another company or that you
have already voluntarily canceled this product. For these cases, please supply
all relevant details so that EPA can ensure that its records are correct.
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DATA CALL-IN RESPONSE Page 1 of 1
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INSTRUCTIONS FOR COMPLETING THE REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORM FOR PRODUCT SPECIFIC DATA
Item 1-3 Completed by EPA. Note the unique identifier number assigned by EPA in
Item 3. This number must be used in the transmittal document for any data
submissions in response to this Data Call-In Notice.
Item 4. The guideline reference numbers of studies required to support the product's
continued registration are identified. These guidelines, in addition to the
requirements specified in the Notice, govern the conduct of the required studies.
Note that series 61 and 62 in product chemistry are now listed under 40 CFR
158.155 through 158.180, Subpart C.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use pattern(s) of the pesticide associated with the product specific
requirements is (are) identified. For most product specific data requirements,
all use patterns are covered by the data requirements. In the case of efficacy
data, the required studies only pertain to products which have the use sites
and/or pests indicated.
Item 7. The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in
rare cases.
Item 8. The due date for submission of each study is identified. It is normally based on
8 months after issuance of the Reregistration Eligibility Document unless
EPA determines that a longer time period is necessary.
Item 9. Enter only one of the following response codes for each data requirement to
show how you intend to comply with the data requirements listed in this
table. Fuller descriptions of each option are contained in the Data Call-In
Notice.
1. I will generate and submit data by the specified due date (Developing Data).
By indicating that I have chosen this option, I certify that I will comply with all
the requirements pertaining to the conditions for submittal of this study as
outlined in the Data Call-In Notice. By the specified due date, I will also
submit: (1) a completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed
copies of the Confidential Statement of Formula (EPA Form 8570-4).
2. I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing). I am submitting a copy of this agreement. I
understand that this option is available only for acute toxicity or certain efficacy
data and only if EPA indicates in an attachment to this Notice that my product
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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 submit: (1) a completed
"Certification With Respect To Data Compensation Requirements" form
(EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
3. I have made offers to share in the cost to develop data (Offers to Cost Share).
I understand that this option is available only for acute toxicity or certain
efficacy data and only if EPA indicates in an attachment to this Data Call-in
Notice that my product is similar enough to another product to qualify for this
option. I am submitting evidence that I have made an offer to another
registrant (who has an obligation to submit data) to share in the cost of that
data. I am also submitting a completed "Certification of Offer to Cost Share
in the Development Data" form. I am including a copy of my offer and proof
of the other registrant's receipt of that offer. I am identifying the party which is
committing to submit or provide the required data; if the required study is not
submitted on time, my product may be subject to suspension. I understand that
other terms under Option 3 in the Data Call-In Notice (Section III-C.l.) apply
as well. By the specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation Requirements" form
(EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
4. By the specified due date, I will submit an existing study that has not been
submitted previously to the Agency by anyone (Submitting an Existing
Study). I certify that this study will meet all the requirements for submittal of
existing data outlined in Option 4 in the Data Call-In Notice (Section III-C.l.)
and will meet the attached acceptance criteria (for acute toxicity and product
chemistry data). I will attach the needed supporting information along with this
response. I also certify that I have determined that this study will fill the data
requirement for which I have indicated this choice. By the specified due date, I
will also submit a completed "Certification With Respect To Data
Compensation Requirements" form (EPA Form 8570-29) to show what data
compensation option I have chosen. By the specified due date, I will also
submit: (1) a completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed
copies of the Confidential Statement of Formula (EPA Form 8570-4).
5. By the specified due date, I will submit or cite data to upgrade a study classified
by the Agency as partially acceptable and upgradable (Upgrading a Study). I
will submit evidence of the Agency's review indicating that the study may be
upgraded and what information is required to do so. I will provide the MRID
or Accession number of the study at the due date. I understand that the
conditions for this option outlined Option 5 in the Data Call-In Notice (Section
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III-C.l.) apply. By the specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation Requirements" form
(EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
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.
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REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE Page 1 of 2
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REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE Page 2 of 2
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FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS Page 1 of 2
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FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS Page 2 of 2
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The EPA's Batching of Products Containing Bis(trichloromethyl) sulfone as the Active
Ingredient for Meeting Acute Toxicity Data Requirements for Reregistration
In an effort to reduce the time, resources and number of animals needed to fulfill the
acute toxicity data requirements for reregistration of products containing the active ingredient
bis(trichloromethyl) sulfone, the Agency has batched products that can be considered similar
in terms of acute toxicity. Factors considered in the sorting process include each product's
active and inert ingredients (identity, percent composition and biological activity), type of
formulation (e.g., liquid, wettable powder, aerosol, 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 if the data base is complete and valid by today's standards (see acceptance criteria
attached), the formulation tested is considered by the 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 it's 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 that are to be completed and submitted to the Agency
within 90 days of receipt. The first form, "Data Call-In Response," asks whether the
registrant will meet the data requirements for each product. The second form, "Requirements
Status and Registrant's Response," lists the product specific data required for each product,
including the standard six acute toxicity tests. A registrant who wishes to participate in a
batch must decide whether he/she will provide the data or depend on someone else to do so. If
a registrant supplies the data to support a batch of products, he/she must select one of the
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
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know that choosing not to participate in a batch does not preclude other registrants in the batch
from citing his/her studies and offering to cost share (Option 3) those studies.
Table 1 displays the batches for bis(trichloromethyl) Sulfone.
Table 1.
Batch
1
2
Reg. No.
3876-90
45017-27
68329-11
3876-61
68329-15
Percent Active Ingredient
Bis (trichloro methyl) sulfone ...17.0%
Methylenebis (thiocyanate) ...5.0%
Bis (trichloro methyl) sulfone ...17.0%
Methylenebis (thiocyanate) ...5.0%
Bis (trichloro methyl) sulfone ...17.0%
Methylenebis (thiocyanate) ...5.0%
Bis(trichloromethyl) Sulfone . . . 20.0 %
Methylenebis (thiocyanate) ...5.0%
Bis(trichloromethyl) Sulfone . . 20.0 %
Methylenebis (thiocyanate) ...5.0%
Form
liquid
liquid
liquid
liquid
liquid
Table 2 lists the products the Agency was unable to batch. These products were considered
not to be similar to other products for purposes of acute toxicity. The registrants of these
products are responsible for meeting the acute toxicity data requirements for these products.
Table 2
Reg. No.
1706-162
1706-169
45017-15
45017-33
45017-36
45017-39
67869-14
67869-15
67869-16
Percent of Active Ingredients
Bis(trichloromethyl) sulfone
l-Alkyl-3-Amino-3-Aminopropane monoacetate
Bis(trichloromethyl) sulfone
2-(Thiocyanomethylthio) Benzothiazole
Bis(trichloromethyl) sulfone
N-Alkyl Dimethyl Ammonium Chloride
Bis(trichloromethyl) sulfone
N-Alkyl Dimethyl Benzyl Ammonium Chloride .
Bis(trichloromethyl) sulfone
&eta-Bromo-&eta-Nitrostyrene
Bis(trichloromethyl) sulfone
N-Alkyl Dimethyl Benzyl Ammonium Chloride
Bis(trichloromethyl) sulfone
Bis(trichloromethyl) sulfone
Bis(trichloromethyl) sulfone
...5%
...36%
...5.3%
..15.6%
..20.0%
..15.2%
..18.0%
..15.2%
...2.5%
..10.0%
..10.0%
...8.0%
...98%
..34.3%
..49.0%
Form
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
liquid
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LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE Page 1 of 2
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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used. Two legible, signed
copies of the form are required. Following are basic instructions:
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of the responsible
party must be provided.
d. All applicable information which is on the product specific data submission
must also be reported on the CSF.
e. All weights reported under item 7 must be in pounds per gallon for liquids and
pounds per cubic feet for solids.
f. Flashpoint must be in degrees Fahrenheit and flame extension in inches.
g. For all active ingredients, the EPA Registration Numbers for the currently
registered source products must be reported under column 12.
h. The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and
all common names for the trade names must be reported.
i. For the active ingredients, the percent purity of the source products must be
reported under column 10 and must be exactly the same as on the source
product's label.
j. All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or
grams. In no case will volumes be accepted. Do not mix English and metric
system units (i.e., pounds and kilograms).
k. All the items under column 13.b. must total 100 percent.
1. All items under columns 14.a. and 14.b. for the active ingredients must
represent pure active form.
m. The upper and lower certified limits for ail active and inert ingredients must
follow the 40 CFR 158.175 instructions. An explanation must be provided if the
proposed limits are different than standard certified limits.
n. When new CSFs are submitted and approved, all previously submitted CSFs
become obsolete for that specific formulation.
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104
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105
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106
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?/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. N«.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However, my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
offer to be bound by arbitration decision under section 3(c)(2)(B)(iii) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firm(s) on the following
date(s):
Name of Firm(s)
Date of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized Representative
Date
Name and Title (Please Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA Form 8580, which is obsolete
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United States Environmental Protection Agency
Washington, DC 20460
CERTIFICATION WITH RESPECT TO
DATA COMPENSATION REQUIREMENTS
,
"**/
Form Approved
OMB No. 2070-0107,
2070-0057
Approval Expires
3-31-96
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including time for
reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding the burden estimate or any other aspect of this collection of information,
including suggestions for reducing this burden to, Chief Information Policy Branch, PM-233, U.S. Environmental Protection
Agency, 401 M St., S.W., Washington, DC 20460; and to the Office of Management and Budget, Paperwork Reduction Project
(2070-0106), Washington, DC 20503.
Please fill in blanks below.
Company Name
Product Name
Company Number
EPA Reg. No.
I Certify that:
1. For each study cited in support of registration or reregistratiion under the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the written permission of the original
data submitter to cite that study.
2. That for each study cited in support of registration or reregistration under FIFRA that is NOT an exclusive use study, I am the
original data submitter, or I have obtained the written permission of the original data submitter, or I have notified in writing the
company(ies) that submitted data I have cited and have offered to: (a) Pay compensation for those data in accordance with sections
3(c)(1)(F) and 3(c)(2)(D) of FIFRA; and (b) Commence negotiation to determine which data are subject to the compensation
requirement of FIFRA and the amount of compensation due, if any. The companies I have notified are. (check one)
[ ] The companies who have submitted the studies listed on the back of this form or attached sheets, or indicated on the attached
"Requirements Status and Registrants' Response Form,"
3. That I have previously complied with section 3(c)(1)(F) of FIFRA for the studies I have cited in support of registration or reregistration
under FIFRA.
Signature
Date
Name and Title (Please Type or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with
regard to the registration or reregistration of my products, to the extent required by FIFRA section
3(c)(1)(F)and3(c)(2)(D).
Signature
Date
Name and Title (Please Type or Print)
EPA Form 8570-31 (4-96)
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The following is a list of available documents for bis(trichloromethyl) sulfone that may
further assist you in responding to this Reregistration 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 Jeffrey Billingslea at (703)-308-8004.
1. PR Notice 86-5.
2. PR Notice 91-2 (pertains to the Label Ingredient Statement).
3. A full copy of this RED document.
4. A copy of the fact sheet for Bis(trichloromethyl) sulfone.
The following documents are part of the Administrative Record for bis(trichloromethyl)
sulfone and may included in the EPA's Office of Pesticide Programs Public Docket. Copies
of these documents are not available electronically, but may be obtained by contacting the
person listed on the Chemical Status Sheet.
1. Health and Environmental Effects Science Chapters.
2. Detailed Label Usage Information System (LUIS) Report.
The following Agency reference documents are not available electronically, but may be
obtained by contacting the person listed on the Chemical Status Sheet of this RED document.
1. The Label Review Manual.
2. EPA Acceptance Criteria
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