United States Prevention, Pesticides EPA 738-R-97-005
Environmental Protection And Toxic Substances August 1997
Agency (7508W)
&EPA Reregistration
Eligibility Decision (RED)
Methylene bis(thiocyanate)
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, B.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case methylene
bis(thiocyanate). The enclosed Reregistration Eligibility Decision (RED) contains the
Agency's evaluation of the data base of these chemicals, its conclusions of the potential human
health and environmental risks of the current product uses, and its decisions and conditions
under which these uses and products will be eligible for reregistration. The RED includes the
data and labeling requirements for products for reregistration.
To assist you with a proper response, read the enclosed document entitled "Summary
of Instructions for Responding to the RED." This summary also refers to other enclosed
documents which include further instructions. You must follow all instructions and submit
complete and timely responses. The first set of required responses is due 90 days from the
receipt date of this letter. The second set of required responses is due 8 months from
receipt date of this letter. Complete and timely responses will avoid the Agency taking the
enforcement action of suspension against your products.
If you have questions on the product specific data requirements or wish to meet with
the Agency, please contact the Special Review and Reregistration Division representative
Karen Jones (703) 308-8047. Address any questions regarding the RED to the Special
Review and Reregistration Division representative Walter Waldrop at (703) 308-8062.
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, a DCI letter will be enclosed listing such requirements. If both generic and
product specific data are required, a combined Generic and Product Specific DCI letter will
be enclosed describing such data. However, if you are an end-use product registrant only and
have been granted a generic data exemption (GDE) by EPA, you are being sent only the
product specific response forms (2 forms) with the RED. Registrants responsible for generic
data are being sent response forms for both generic and product specific data requirements (4
forms). You must submit the appropriate response forms (following the instructions
provided) within 90 days of the receipt of this RED/DCI letter; otherwise, your product
may be suspended.
2. TIME EXTENSIONS AND DATA WAIVER REQUESTS No time extension requests
will be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for time extensions for product specific data
should be submitted in the 90-day response. Requests for data waivers must be submitted as
part of the 90-day response. All data waiver and time extension requests must be accompanied
by a full justification. All waivers and time extensions must be granted by EPA in order to go
into effect.
3. APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE" You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
a. Application for Reregistration (EPA Form 8570-1). Use only an original
application form. Mark it "Application for Reregistration." Send your Application for
Reregistration (along with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements. Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregistration) separately. You may, but are not
required to, delete uses which the RED says are ineligible for reregistration. For further
labeling guidance, refer to the labeling section of the EPA publication "General Information
on Applying for Registration in the U.S., Second Edition, August 1992" (available from the
National Technical Information Service, publication #PB92-221811; telephone number 703-
487-4650).
c. Generic or Product Specific Data. Submit all data in a format which complies
with PR Notice 86-5, and/or submit citations of data already submitted and give the EPA
identifier (MRID) numbers. Before citing these studies, you must make sure that they meet
the Agency's acceptance criteria (attached to the DCI).
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d. Two copies of the Confidential Statement of Formula (CSF) for each basic and
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal
concentration. You have two options for submitting a CSF: (1) accept the standard certified
limits (see 40 CFR §158.175) or (2) provide certified limits that are supported by the analysis
of five batches. If you choose the second option, you must submit or cite the data for the five
batches along with a certification statement as described in 40 CFR §158.175(e). A copy of
the CSF is enclosed; follow the instructions on its back.
e. Certification With Respect to Data Compensation Requirements. Complete and
sign EPA form 8570-31 for each product.
4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5. WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES (90-DAY) AND
APPLICATIONS FOR REREGISTRATION (8-MONTH RESPONSES)
By U.S. Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS—EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data
waiver and time extension requests within 60 days. EPA will also try to respond to all 8-
month submissions with a final reregistration determination within 14 months after the RED
has been issued.
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REREGISTRATION ELIGIBILITY DECISION
Methylene bis(thiocyanate)
LISTB
CASE 2415
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TABLE OF CONTENTS
METHYLENE BIS(THIOCYANATE) REREGISTRATION ELIGIBILITY
DECISION TEAM i
ABSTRACT v
I. INTRODUCTION 1
II. CASE OVERVIEW 2
A. Chemical Overview 2
B. Use Profile 2
C. Regulatory History 6
III. SCIENCE ASSESSMENT 6
A. Physical Chemistry Assessment 6
B. Human Health Assessment 6
1. Toxicology Assessment 6
a. Acute Toxicity 7
b. Subchronic Toxicity 8
c. Chronic Toxicity/Carcinogenicity 10
d. Developmental Toxicity 12
e. Reproductive Toxicity 13
f. Mutagenicity 14
g. Metabolism 17
h. Dermal Absorption 19
i. Other Toxicological Information 19
2. Toxicological Endpoints for Risk Assessment 19
a. Reference Dose (RfD) 20
b. Carcinogenic Classification 20
c. Other Toxicological Endpoints 20
3. Dietary Exposure and Risk Assessment/Characterization 20
4. Toxicological Endpoints for Risk Assessment 21
a. Occupational and Residential Exposure 21
b. Occupational and Residential Risk Assessment and
Characterization 26
5. Other Considerations 31
C. Environmental Assessment 34
1. Ecological Toxicity Data 34
a. Toxicity to Terrestrial Animals 34
b. Toxicity to Aquatic Animals 35
2. Environmental Fate 37
a. Environmental Fate Assessment 37
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b. Environmental Fate, Chemistry and Transport 39
3. Exposure and Risk Characterization 40
IV. RISK MANAGEMENT AND REREGISTRATION DECISION 41
A. Determination of Eligibility 41
B. Determination of Eligibility 43
1. Uses Eligible at This Time 43
2. Uses for Which a Reregistration Decision Cannot be Made .... 44
C. Regulatory Position 44
1. Occupational and Residential Labeling Rationale/Risk Mitigation
Measures 44
V. ACTIONS REQUIRED OF REGISTRANTS 48
A. Manufacturing-Use Products 48
1. Additional Generic Data Requirements 48
2. Labeling Requirements for Manufacturing-Use Products 50
B. End-Use Products 51
1. Additional Product-Specific Data Requirements 51
2. Labeling Requirements for End-Use Products 51
C. Existing Stocks 54
VI. APPENDICES 55
APPENDIX A. Table of Use Patterns Subject to Reregistration 56
APPENDIX 1. Table of the Generic Data Requirements and Studies Used to
Make the Reregistration Decision 99
APPENDIX B. Citations Considered to be Part of the Data Base Supporting the
Reregistration of Methylene bis(thiocyanate) 105
APPENDIX C. Product Specific Data Call-in 113
Attachment 1. Chemical Status Sheet 125
Attachment 2. Product Specific Data Call-in Response Forms (Form A
inserts) Plus Instructions 126
Attachment 3. Product Specific Requirement Status and Registrant's
Response Forms (Form B inserts) and Instructions 129
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 137
Attachment 5. List of Registrants Sent This Data Call-in Notice . 144
Attachment 6. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions ... 145
APPENDIX E. List of Available Related Documents 151
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METHYLENE BIS(THIOCYANATE) REREGISTRATION ELIGIBILITY
DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Assessment
Edward Brandt
Rafael Prieto
Anita Hanson
BEAD/Economic Analysis Branch
BEAD/Biological Analysis Branch
BEAD/Biological Analysis Branch
Environmental Fate and Effects Risk Assessment
Sharlene Matten
David Bays
Jose Luis Melendez
Health Effects Risk Assessment
Paula Deschamp
Arliene Aikens
Bill Greear
Marion Copley
Alan Nielsen
Winston Dang
Registration Support
Jim Stone
Valdis Goncarovs
Bipin Gandhi
Tina Levine
Risk Management
Kathleen Depukat
Ron Kendall
EFED/Science Analysis and Coordination Staff
EFED/Ecological Effects Branch
EFED/Environmental Fate and Groundwater Branch
HED/Risk Characterization Assessment Branch
HED/Risk Characterization Assessment Branch
HED/Toxicology Branch I
HED/Toxicology Branch I
HED/Occupational Residential Exposure Branch
AD/Risk Assessment and Science Support Branch
RD/Fungicide and Rodenticide Branch
AD/Registration Branch
RD/Registration Support Branch
RD/Registration Support Branch
SRRD/Accelerated Reregistration Branch
SRRD/Accelerated Reregistration Branch
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI Acceptable Daily Intake. A now defunct term for reference dose (RfD).
AE Acid Equivalent
a.i. Active Ingredient
ARC Anticipated Residue Contribution
CAS Chemical Abstracts Service
CI Cation
CNS Central Nervous System
CSF Confidential Statement of Formula
DFR Dislodgeable Foliar Residue
ORES Dietary Risk Evaluation System
DWEL Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e. drinking
water) lifetime exposure at which adverse, non carcinogenic health effects are not anticipated to
occur.
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
FAO/WHO Food and Agriculture Organization/World Health Organization
FDA Food and Drug Administration
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
FOB Functional Observation Battery
FQPA Food Quality Protection Act
GLC Gas Liquid Chromatography
GM Geometric Mean
GRAS Generally Recognized as Safe as Designated by FDA
HA Health Advisory (HA). The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur.
HOT Highest Dose Tested
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be
expected to cause death in 50% of test animals. It is usually expressed as the weight of substance
per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50%
of the test animals when administered by the route indicated (oral, dermal, inhalation). It is
expressed as a weight of substance per unit weight of animal, e.g., mg/kg.
LDlo Lethal Dose-low. Lowest Dose at which lethality occurs.
LEL Lowest Effect Level
LOG Level of Concern
LOD Limit of Detection
LOEL Lowest Observed Effect Level
MATC Maximum Acceptable Toxicant Concentration
MCLG Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
pg/g Micrograms Per Gram
mg/L Milligrams Per Liter
MOE Margin of Exposure
MP Manufacturing-Use Product
MPI Maximum Permissible Intake
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
N/A Not Applicable
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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
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts Per Million
PRN Pesticide Registration Notice
Q*j 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
RUP Restricted Use Pesticide
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.
ug/L Micrograms per liter
WP Wettable Powder
WPS Worker Protection Standard
IV
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ABSTRACT
The U. S. Environmental Protection Agency has completed its reregistration eligibility
decision of the pesticide methylene bis(thiocyanate). This decision includes a comprehensive
reassessment of the required target data base and the use patterns of currently registered products.
Additionally, the Agency has examined information concerning the exposure and susceptibility
of infants and children to methylene bis(thiocyanate), and available information concerning
aggregate exposure to methylene bis(thiocyanate) as well as the potential for cumulative effects
from methylene bis(thiocyanate) and other substances that have a common mode of toxicity.
Methylene bis(thiocyanate) is an antimicrobial used as a microbiocide/microbiostat,
fungicide/fungistat, and algicide in water cooling systems (recirculating), paint manufacturing,
metalworking cutting fluids, pulp and paper mills, oil drilling/mud fluids, leather processing,
wood pressure treatments (forest products), wood protection treatments to buildings/products, and
latex paints (in-can). Methylene bis(thiocyanate) is also used in residential settings as a wood
preservative stain to combat wood rot/decay.
The Agency is concerned about possible effects from inhalation exposure to methylene
bis(thiocyanate) based on the only methylene bis(thiocyanate) inhalation data available, an acute
study, which showed very high toxicity. Cyanide is a metabolite of methylene bis(thiocyanate)
and both cyanide and formaldehyde are potential degradates of methylene bis(thiocyanate). It is
possible that the thiocyanate ion would degrade to cyanide, but degradation data are lacking that
would indicate whether this occurs in the working environment and, if so, under what conditions.
However, notwithstanding these concerns, the Agency believes many uses of methylene
bis (thiocyanate) are eligible for reregistration. The existing acute inhalation study is of very poor
quality and can only be used for establishing a labeling toxicity category and not for risk
assessment. Surrogate data for industrial biocide uses show that dermal exposure is 2 or 3 orders
of magnitude greater than inhalation exposure and that inhalation exposure for some use scenarios
is below the limit of detection. In addition, the Agency is requiring all methylene bis (thiocyanate)
end-use product labels in Toxicity Category I or II to require the use of a respirator because of
acute inhalation toxicity. The Agency is also requiring a subchronic inhalation study and air
monitoring data that will quantitate amounts of cyanide and formaldehyde that might be present
during application and post-application.
Generally, methylene bis (thiocyanate) uses that showed acceptable Margins of Exposure
(MOE) from dermal exposure have been determined to be eligible for reregistration. The Agency
could not make a decision for those uses for which there was neither dermal exposure data or a
way to determine if these uses posed any worse exposure than uses where data are available. The
Agency also determined that it could not make a decision on the use of paint and ready-to-use
products that are applied with a paint brush, roller or compressed sprayer even though MOE's
are very low for occupational handlers. Those uses for which a reregistration decision cannot be
made are: Wood or wood structure protection treatments to both seasoned and unseasoned forest
products; Wood or wood structure protection treatments; Wood protection treatment to
buildings/products; Leather processing liquids; Leather/leather products; and Paints (in-can).
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Before a decision can be made, additional data along with information on what types of paints
contain methylene bis(thiocyanate) and what levels of post-application exposure (dermal and
inhalation) result from painting and applications of ready-to-use products are necessary. The
eligibility of specific uses is detailed in Part IV.
There were no developmental effects seen in two developmental toxicity studies and no
adverse effects on offspring in a reproductive study, therefore, an additional uncertainty factor
for estimating risk to infants and children is not warranted. The aggregate exposures from all
non-occupational sources are not likely to be of concern, and the cumulative risks will be assessed
when methodologies for determining common mode of toxicity and for performing cumulative
risk assessment are finalized. The Agency does not anticipate any exposure of concern to fish,
wildlife, and/or endangered species providing that all methylene bis(thiocyanate) products are
handled and applied as specified in the product labeling and that discharges to the environment
comply with all Federal disposal laws and NPDES.
Before reregistering the products containing methylene bis(thiocyanate), the Agency is
requiring that product specific data, revised Confidential Statements of Formula (CSF) and
revised labeling be submitted within eight months of the issuance of this document. These data
include product chemistry for each registration and acute toxicity testing. After reviewing these
data and any revised labels and finding them acceptable in accordance with Section 3(c)(5) of
FIFRA, the Agency will reregister a product. Those products which 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.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-
170) was signed into law. FQPA amends both the Federal Food, Drug, and Cosmetic Act
(FFDCA), 21 U.S.C. 301 et seq., and the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), 7 U.S.C. 136 et seq. The FQPA amendments went into effect immediately. Among
other things, FQPA amended the FFDCA by establishing a new safety standard for the
establishment of tolerances. Because methylene bis(thiocyanate) has no food uses, and therefore,
no tolerances have been established, the specific considerations outlined in FQPA are not required
for this chemical. Nevertheless, EPA believes that consideration of available data relating to the
special sensitivity of infants and children, the potential for aggregate exposures and cumulative
effects is prudent for methylene bis(thiocyanate).
This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of methylene bis(thiocyanate). The document consists of six sections. Section
I is the introduction. Section II describes methylene bis(thiocyanate), 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 methylene
bis(thiocyanate). Section V discusses the reregistration requirements for methylene
bis(thiocyanate). Finally, Section VI is the Appendices which 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: Methylene bis(thiocyanate)
Methylene dithiocyanate
Thiocyanic acid, methylene ester
• Chemical Name: Methylene bis(thiocyanate)
• CAS Registry Number: 6317186
• OPP Chemical Code: 068102
• Empirical Formula: C3H2N2S2
• Molecular Weight: 130.2
• Trade and Other Names: Slimicide MC
Busan 110
Nalco D-1994
Antiblu 3737
Cytox
• Basic Manufacturers: Buckman Laboratories International, Inc.
Albright and Wilson Ltd.
Akzo Chemicals, Inc.
AmeriBrom, Inc.
B. Use Profile
The following is information on the currently registered uses with an overview of
use sites and application methods. A detailed table of the uses of methylene
bis(thiocyanate) is in Appendix A.
TYPE OF PESTICIDE
Pesticide Type Single Active Ingredient Products:
Fungicide; Microbiocide/Microbiostat (Slime-Forming Algae);
Microbiocide/Microbiostat (Slime-Forming Bacteria); Microbiocide/Microbiostat
(Slime-Forming Fungi)
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Additional Pesticide Types for Multiple Active Ingredient Products:
Insecticide; Molluscicide and Tadpole Shrimp; Repellent/Feeding Depressant
USE SITES:
Terrestrial Non-Food Crop
Industrial preservatives with oil recovery drilling muds/packer fluids
Wood or wood structure protection treatments to both seasoned and unseasoned
forest products.
Aquatic Non-Food Industrial
Aquatic Sites: Air washer water systems; commercial/industrial water cooling
systems (recirculating); evaporative condenser water systems; heat exchanger water
systems; industrial auxiliary water systems; industrial scrubbing system; industrial
waste disposal systems; pulp/paper mill water systems; secondary oil recovery
injection water; sewage systems
Industrial Preservatives: Oil recovery drilling muds/packer fluids
Outdoor Residential
Wood or wood structure protection treatments; Wood protection treatment to
buildings/products
Indoor Non-Food
Aquatic Sites: Pasteurizer/warmer/cannery cooling water systems; reverse osmosis
water systems
Industrial Preservatives: Industrial adhesives, industrial coatings,
resin/latex/polymer emulsions, fuel/oil storage tank bottom water additive, leather
processing liquids, leather/leather products, metalworking cutting fluids, paints (in-
can), paper/paper products, speciality industrial products, wet-end
additives/industrial processing chemicals.
Indoor Residential
Wood or wood structure protection treatments; wood protection treatment to
buildings/products
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TARGET PESTS:
Target pests for single active ingredient: Slime-forming bacteria, algae, and fungi;
fungi associated with sapstain and dry rot; surface mold; spoilage microorganisms; sulfate-
reducing bacteria; yeast; sulfide-producing bacteria.
FORMULATION TYPES REGISTERED:
TGAI Soluble Concentrate/solid 98%
Manufacturing-use Product
Crystalline 99%
Soluble Concentrate/Liquid 98 to 99%
Soluble Concentrate/Solid 97 to 99%
End-use Product
Liquid Ready-to-use 0.2 to 0.5%
Soluble Concentrate/Liquid 1.0 to 14.7%
Soluble Concentrate/Solid 4.9 to 7%
RATES OF APPLICATION:
Terrestrial Non-Food Crop
Industrial Preservatives: 6.5 to 1000 ppm active ingredient.
Wood Protection Treatment to Forest Products (seasoned):
Dip treatment-0.29 gal active ingredient in 100 gal of water.
Nonsoil contact nonfumigation-maximum of 0.05 Ib active
ingredient per 1000 sq.ft.
Soil contact nonfumigation-0.1 gal active ingredient in 19 gal of
water.
Wood Protection Treatment to Forest Products (unseasoned):
Dip treatment-2.4 to 3.2 Ib active ingredient in 100 gal of water.
0.29 gal active ingredient in 100 gal of water.
Spray-2.4 to 3.2 Ib active ingredient in 100 gal of water.
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Aquatic Non-Food Industrial
0.15 to 1000 ppm active ingredient.
Outdoor Residential
Wood Protection Treatment to Buildings/Products Outdoor:
Brush-on, Dip treatment, Spray-Maximum of 0.43 Ib active ingredient per
1000 sq.ft.
Surface treatment- Maximum of 0.43 Ib active ingredient per 1000 sq.ft.
Nonsoil contact nonfumigation- Maximum of 0.05 Ib active ingredient per
1000 sq.ft. 0.1 gal active ingredient in 32.3 gal of water.
Soil contact nonfumigation- 0.1 gal active ingredient in 32.3 gal of water.
Indoor Non-Food
Aquatic Sites: 0.022 to 9.7 ppm active ingredient.
Industrial Preservatives: 0.47 to 20,000 ppm active ingredient.
Indoor Residential
Wood Protection Treatment to Buildings/Products Indoor:
Nonsoil contact nonfumigation-Maximum of 0.055 Ib active ingredient per
1000 sq.ft.
Types of Treatment:
Additive treatment; brush-on; dip treatment; fresh hide treatment; hides and skins
treatment; industrial preservative treatment; make-up fluids treatment; nonsoil contact
nonfumigation; preservative treatment; soil contact nonfumigation; spray; surface
treatment; water related surface treatment; water treatment; water treatment (recirculating
system); wood chip treatment; wood surface treatment
Equipment:
Applicator rolls in paper production; brush; chemical pump; dip tank; drip-feed
device; metering pump; paintbrush; roller; sprayer; sprinkler can; tank; not specified
(registrant must specify on labeling see Section V)
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Timing:
Continuous feed (initial); continuous feed (subsequent); curing manufacture; Initial;
intermittent (slug) (initial); intermittent (slug) (subsequent); shock/slug; subsequent/
maintenance; when needed; not specified (registrant must specify on labeling see Section
V).
C. Regulatory History
Methylene bis(thiocyanate) was first registered in the United States in 1949 as an
active ingredient. Currently, 59 products are registered for uses for incorporation into
products such as adhesives, coatings, fuels, metalworking cutting fluids, plastic products,
resin emulsions, paints, paper products and various other speciality industrial products
primarily as a preservative and as a microbiocide in pulp/paper mills, cooling water
systems (recirculating), oil field operations, leather processing and industrial water supply
systems. The compound is also used to treat wood products (seasoned/unseasoned forest
products and various finished wood products).
An Antimicrobial Data Call-in was issued in March 1987. A second Data Call-In
was issued as part of the Phase 4 reregistration in June 1991. The Agency issued a third
Data Call-In in June 1993 for additional environmental fate data on aquatic exposure. A
fourth Data Call-In was issued in March 1997 for additional inhalation toxicity data. This
Reregistration Eligibility Decision (RED) reflects a reassessment of all data which were
submitted voluntarily by the registrants or in response to the above Data Call-Ins.
III. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Methylene bis(thiocyanate) is a methane group containing two thiocyanate groups.
Technical methylene bis (thiocyanate) is a yellow granular solid with a sulphur like smell.
It has a density of 0.820 g/mL and boils at 105.4° to 106.2° C. The vapor pressure is 1.22
x 104 torr at room temperature. It is more soluble in methanol compared to water and
octanol. Its solubilities are 0.28, 0.35 and 5.1 g/mL for water, octanol and methanol,
respectively.
B. Human Health Assessment
1. Toxicology Assessment
The toxicological database for methylene bis (thiocyanate) is not complete
for all current use patterns. The Agency is requiring additional data to further
support the reregistration eligibility decisions set forth in this document. A hazard
has been identified for inhalation exposure but data are insufficient to conduct a
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quantitative risk assessment for this route of exposure. The Agency is requiring
a 90-day inhalation study in order to quantify the level of hazard posed by
exposure via the inhalation route. Although there are two supplementary
metabolism studies, there is still a data gap for metabolism primarily due (but not
limited) to inadequate metabolite identification. One study is potentially
upgradable. The outstanding metabolism data is required as confirmatory data.
Additionally, handler and post-application air monitoring studies for various use
scenarios as described in this document are being required to confirm the
registrants' assertions that there are no exposures to methylene bis(thiocyanate) as
a result of the registered uses.
a. Acute Toxicity
Table 1 below summarizes the results of acute toxicity studies on
methylene bis(thiocyanate) and the toxicity categories for the different
routes of administration.
TABLE 1: ACUTE TOXICITY DATA FOR METHYLENE BIS(THIOCYANATE) (TGAI)
Test (MRID)
Oral LD50- rat (MRID 41592901)
Dermal LD50 - rat (MRID 42873101)
Inhalation LC50 (MRID 41201601)
Eye Irritation* (study waived)
Dermal Irritation* (MRID 43699601)
Dermal Sensitization* (MRID 00159567)
Result
LD50 (male) = 84.9(73.4 - 98.2) mg/kg
LD50 (female) = 68.3(49.4 - 94.3) mg/kg
LD50 > 2.0g/kg
LC50 = 0.0077(0.0061 - 0.011) mg/L
Corrosive
Moderate to severe, corrosive in 1 male.
Positive skin sensitizer
Toxicity Category
III
III
I
I
I
N/A
* This study is a requirement for manufacturing-use and end-use products(40 CFR 158.340). The methylene
bis(thiocyanate) data have been generated on the TGAI and are presented here for informational purposes.
In an acute oral study (GDLN 81-1) in CD (BR) rats, 5 animals/sex
were administered concentrations of 60, 75, or 90 mg/kg test material to
males and 40, 60, and 90 mg/kg to females. The LD50 was 84.9 mg/kg for
males and 68.3 mg/kg for females. The study satisfies the data
requirements for GDLN 81-1. (MRID 41592901)
In an acute dermal study (GDLN 81-2) in Crl rats, 6 animals/sex
were dermally exposed to 2.0 g/kg for 24 hours. The LD50 is greater than
2.0 g/kg and the study satisfies the data requirements for GDLN 81-2.
(MRID 42873101)
In an acute inhalation study (GDLN 81-3) in CD (Sprague-Dawley)
rats, 20 animals/sex were exposed to nominal concentrations of 0, 14, 22,
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36 or 53 mg/L test material for 4 hours. The LC50 (95% confidence limits)
were 0.0078 (males), 0.0077 (females) and 0.0077 (combined) for 4 hours.
The study is of poor quality and would not usually be acceptable because
(1) there were extreme differences in chamber concentration for
measurements made at intervals for each and all exposures; (2) the mass
median diameters of the particles were too large; (3) the relative humidity
was too high suggesting that the airflow may have been inadequate; (4) the
difference between the nominal and analytical values were 5000 fold; and
(5) since this was whole body exposure, there could have been considerable
oral exposure. However, a repeat of this study was not required for
labeling purposes since the results place methylene bis(thiocyanate) in
Toxicity Category I (highest toxicity category). (MRID 41201601)
A waiver was granted for the primary eye irritation data
requirement (GDLN 81-4). Information was provided showing methylene
bis(thiocyanate) is a severe eye irritant. Data on eye irritation is not
required for this reregistration eligibility decision.
A primary dermal irritation study (GDLN 81-5) in adult male New
Zealand White rabbits by the Draize method produced a Primary Irritation
Index (PII) score of _>_ 2 and <_ 5 which showed that methylene
bis(thiocyanate) is a moderate to severe dermal irritant and is placed in
Toxicity Category I for primary dermal irritation. (MRID 43699601)
In a dermal sensitization study (GDLN 81-6) with Hartley Albino
guinea pigs, positive skin sensitization was observed. Therefore,
methylene bis(thiocyanate) is classified as a skin sensitizer. (MRID
00159567)
b. Subchronic Toxicity
Oral Study in Rats: In a subchronic oral study (gavage), 6 week old
F344/N rats (10/sex/groups) were administered 0, 1, 2, 4, 8 or 16
mg/kg/day of methylene bis(thiocyanate) (98% a.i.) 5 times per week for
13 weeks. Deaths occurred beginning in the 2 mg/kg/day group in males
(as early as week 2) and in the 4 mg/kg/day group in females (week 5).
The animals showed signs similar to cyanide poisoning, dyspnea, abnormal
respiratory sounds, hunched posture and chromodacryorrhea. Anemia was
observed in males in the 4, 8 and 16 mg/kg/day groups and in females in
the 8 and 16 mg/kg/day groups. Hyperplasia and hyperkeratosis of the
forestomach were increased in males and females in the 8 and 16
mg/kg/day groups. Hyperplasia was also observed in one female in the 4
mg/kg/day group. Ulceration of the forestomach was present in one male
and one female in the 16 mg/kg/day group. An acute exudate and
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epithelial necrosis of the nasal cavity and trachea were observed in males
in the 8 and 16 mg/kg/day groups. An acute exudate and epithelial
necrosis of the nasal cavity were also seen in one male in the 4 mg/kg/day
group. Total protein was decreased in males and females in the 8 and 16
mg/kg/day groups accompanied by slight decreases in albumin in males in
the 8 and 16 mg/kg/day group, an indication of dysproteinemia. Males in
the 4 and 8 mg/kg/day groups exhibited a modest decrease in sperm
motility. The LOEL is 2 mg/kg/day based on mortality. The NOEL is 1
mg/kg/day. (MRID 43420001)
Oral Study in Mice: In a subchronic oral study in mice, 6 week old
BgCjFj mice (10/sex/groups) were administered 0, 1, 2, 4, 8 or 16
mg/kg/day of methylene bis(thiocyanate) (98% a.i.), 5 times per week for
13 weeks. Deaths occurred in males in the 8 (week 9) and 16 mg/kg/day
groups and in females in the 16 mg/kg/day group (week 9). One male in
the 16 mg/kg/day group exhibited hypothermia, dyspnea and hypoactivity
at week 10. Pathology was limited to hyperplasia and/or hyperkeratosis of
the forestomach in males and females in the 4, 8 and 16 mg/kg/day groups,
and an acute exudate epithelial necrosis of the nasal cavity in a few animals
in the 16 mg/kg/day group. Also an acute exudate and epithelial necrosis
of the trachea was observed infrequently in females in the 16 mg/kg/day
group. The LOEL is 4 mg/kg/day based on hyperplasia and hyperkeratosis
of the forestomach in females. The NOEL is 2 mg/kg/day. (MRID
43420001)
Dermal Study in Rats: In a 3-week subchronic dermal toxicity study
Crl:CD(SD)BR (5 rats/sex/group) were dermally administered 0, 10, 30
or 60 mg/kg/day methylene bis(thiocyanate) in 0.4% aqueous
carboxymethyl cellulose. The rats were exposed for 6 hours/day, 4 or 5
days/week, for 3 weeks. No deaths occurred. There were no abnormal
clinical signs and no effect on body weight gain, food consumption, clinical
pathology values and organ weights. The systemic LOEL is greater than
60 mg/kg/day. The systemic NOEL is greater than or equal to 60
mg/kg/day. Dose-related signs of dermal irritation included erythema,
edema, desquamation, fissuring, subcutaneous hemorrhage, necrotic
appearance, atonia, eschar, exfoliation and pustules/papules. The LOEL
for dermal effects is 10 mg/kg/day based on skin irritation. The NOEL for
dermal effects is less than 10 mg/kg/day. (MRID 41111901)
Inhalation Study in Rats: There are no subchronic inhalation studies
with methylene bis(thiocyanate). A subchronic inhalation study is required
due to the high acute toxicity (LC50 = 0.0077 mg/L toxicity category I)
identified in the acute inhalation study and the potential for daily
occupational/residential exposure. A hazard was identified by the
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Toxicological Endpoint Selection Committee (TESC) based on the high
toxicity (mortality) from this chemical to test animals by this route of
exposure. Data were not readily available to further characterize or
quantify the hazard due to inhalation exposure of methylene
bis(thiocyanate).
c. Chronic Toxicity/Carcinogenicity
Oral Study in Rats: In a chronic (24 month) toxicity/oncogenicity
study, methylene bis(thiocyanate) suspended in 0.5% carboxymethyl
cellulose was administered once daily by gavage to groups of Sprague-
Dawley rats (70/sex/groups) at 0, 0.4, 1.2, or 4.0 mg/kg/day. Twenty
male and 20 female rats from each dose group were designated for a 52-
week interim kill. An increase in the incidence of tracheal inflammation,
thymic lymphocytolysis, breathing abnormalities, and an increase in
mortality was observed in both males and females at 4.0 mg/kg/day. The
mortality was 54% for males and 40% for females at the high dose (4.0
mg/kg/day) by week 70 at which time the high dose groups were
terminated. Increased incidence of focal alveolitis was observed in males
at all dose levels. These effects may be consequences of the dosing method
that resulted from aspiration of the test material into the respiratory tract
and the action of the material as an irritant on these tissues. However,
these signs (including breathing abnormalities) are typical of cyanide
poisoning and may not be solely due to the dosing method resulting in
aspiration of the test material. There was an increase in benign and
malignant (when combined) adrenal pheochromocytomas in males, but no
statistically significant trend was seen. Exempting the probable effects
associated with the gavage dosimetry, the NOEL for systemic effects in
male and female rats was 1.2 mg/kg/day, and the LOEL was 4.0
mg/kg/day based on increased mortality. The Agency's Office of Pesticide
Program's (OPP) RfD Committee (February 1, 1996) considered there to
be a possible treatment related increase in adrenal pheochromocytomas in
males. Although, there were fewer than 50% survivors in the high-dose
group at 18 months of treatment, the mid-and low-dose groups were
adequate to assess the carcinogenic potential of methylene bis(thiocyanate).
This study is acceptable and satisfies the guideline requirements for a
chronic toxicity study and oral oncogenicity study in rats. (MRID
42777601)
Oral Study in Mice: In a carcinogenicity study, methylene
bis(thiocyanate) (99.3%) in 0.5% carboxymethyl cellulose was
administered by gavage to CD-I mice (50/sex/groups) at doses of 0, 0.4,
1.2, or 4/3 mg/kg/day for 78 weeks. The high dose of 4 mg/kg/day was
reduced to 3 mg/kg/day during week 4 because of the death of six males;
10
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five of the six deaths were due to dosing injury and not to treatment with
the test material. The resulting time-weighted-average (TWA) dose was 3
mg/kg/day. No statistically and biologically significant effects occurred in
male mice receiving methylene bis(thiocyanate) at doses of 0.4 or 1.2
mg/kg/day. The occurrence of lymphocytolysis in female mice was
considered to be a result of dosing injury. No other significant effects were
noted in female mice receiving 0.4 or 1.2 mg/kg/day. At 3 mg/kg/day,
mean body weights were significantly reduced at various time points
throughout the study in male (93-98% of control value) and female mice
(89-97% of control value); net body weight gain showed a corresponding
reduction (23% for males and 25% for females). No nonneoplastic lesions
occurred with biologically and statistically significant increased incidence
in mice receiving 3 mg/kg/day. The incidence of generalized and organ-
specific amyloidosis was reduced in treated mice due to unknown causes.
The mucosa of the stomach was not a target in the long-term study as
indicated by the short-term range-finding studies. There was an increase
in males in alveolar adenomas in the lung, with increasing dose, statistically
significant at the mid dose only at p < 0.05. The LOEL for this study is 3
mg/kg/day (TWA dose) based on reduced body weight and body weight
gain in both sexes. The NOEL is 1.2 mg/kg/day. The Agency's OPP RfD
Committee (February 1, 1996) considered there to be a possible increase
in alveolar adenomas in males. (MRID 42777301)
Oral Study in Dogs: In a chronic oral study, encapsulated methylene
bis(thiocyanate) (99.4%) was administered once daily to Beagle dogs
(4/sex/groups) at doses ofO, 0.5, 2.0 or 5.0 mg/kg/day for 52 consecutive
weeks. Amounts administered were adjusted weekly based on individual
body weights. Toxic effects were consistent with a mild local irritation of
the stomach. There was a dose-related increase in emesis in treated
animals, with 3-fold, 15-fold and 30-fold increases at the 0.5, 2.0 and 5.0
mg/kg/day dose levels, respectively, compared to the control group; in the
5.0 mg/kg/day dose group, fecal inconsistency and salivation were
observed in a few animals. Hemoglobin, red blood cell count and
hematocrit were marginally lower in the 5.0 mg/kg/day group. White
blood cell counts were slightly elevated in all treated groups throughout the
study. Reductions in albumin levels were statistically significant at 51
weeks at both the 2.0 and 5.0 mg/kg/day doses; marginal reductions in
total protein and albumin/globulin ratios were also observed. In male
dogs, a mild inflammatory cell infiltrate in the lamina propria of the
stomach was dose related. In females the incidence was not dose related.
Examination of the bone marrow revealed a statistically nonsignificant
increased incidence of hematopoiesis in male dogs in the 5.0 mg/kg/day
dose group (3 of 4 animals); one intermediate group animal was also
affected. Incidence in the treated female groups (3/group) were mild and
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were not dose related. The LOEL of 2.0 mg/kg/day was identified based
on the marginal changes in blood chemistry and pathology findings in the
stomach and bone marrow. The NOEL was 0.5 mg/kg/day. (MRID
41463201)
d. Developmental Toxicity
Oral Study in Rats: In a developmental toxicity study, 4 groups of
25 female Crl:CD BR rats were administered 0, 1, 3 or 6 mg/kg/day of
methylene bis(thiocyanate) (99%) during gestation days 6-15. Due to an
error in dosing only 14 control, 12 low dose, 11 mid dose and 17 high dose
group dams were "fully dosed". Dams partially dosed (from gestation day
(GD)) included 10, 12, 11 and 5 females from the control, low, mid and
high dose groups, respectively. No maternal mortality was observed.
When the data were analyzed regardless of the dosing error, maternal body
weight, body weight gain, or feed consumption were slightly decreased at
the 6 mg/kg/day dose level. The test material did not induce any gross
pathological alterations. Pregnancy rate, average numbers of corpora
lutea, implantations, percent of pre- and post-implantation loss,
resorptions, fetuses/litter, viable number of fetuses/dam, fetal body weight,
and percentage of male fetuses/litter were comparable between groups.
The maternal LOEL is 6 mg/kg/day based on a slight decrease in maternal
body weight gain and a small increase in the incidence of rales. The
maternal NOEL is 3 mg/kg/day. The LOEL for developmental toxicity
was greater than 6 mg/kg/day. The NOEL for developmental toxicity is
greater than 6 mg/kg/day. (MRID 41171901)
Oral Study in Rabbits: In a second study the developmental toxicity
potential of methylene bis(thiocyanate) (99%) was studied by dosing
pregnant Hra:(NZW)SPF rabbits, (20/group) by stomach tube, with 0, 1,
3, 5(7) mg/kg/day. The highest dose tested caused 5 deaths (25% of total)
and was reduced after the fifth death to 5 mg/kg/day. Five treatment-
related deaths were observed in the high dose group following 1, 2, 3, 4
and 5 dosings at 7 mg/kg/day. All five dead rabbits were pregnant. The
conceptuses of the three that died after 3-5 dosings appeared normal for
their developmental age. The viability state of the in utero implantations
of the two that died after 1-2 dosings could not be determined because of
the early developmental stage. All four high-dose does that died after 2-5
dosings showed severe gastric ulceration and/or gastric mucosal sloughing
and hemorrhage at necropsy. No further mortality was observed after the
reduction of the high dose level. Clinical signs preceding the five deaths
included respiratory difficulty, ataxia, decrease in motor activity, loss of
righting reflex, tremors, convulsions and/or dry feces. After the high dose
was reduced, two survivors in the group showed single incidence of tremor
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(day 15 and day 17) and eight showed incidences of dry feces lasting 2-4
days, six of those during the period from day 8 to 12. Body weight gain
and food consumption in the high dose group was significantly decreased,
but only during the period when the high dose was at 7 mg/kg/day. The
LOEL for maternal toxicity was 5 mg/kg/day based on mortality and
decreased body weight gain. The NOEL was 3 mg/kg/day. Methylene
bis(thiocyanate) at 1, 3, and 5/7 mg/kg/day did not affect pregnancy rate,
average numbers of corpora lutea, implantations, early and late resorptions,
fetuses/litter, viable number of fetuses/litter, fetal body weight, and
percentage of male fetuses. These doses did not cause external, soft tissue,
or skeletal malformations or variations in the fetuses, and incidences of
fetal changes were not statistically significantly increased in any of the
treated groups. The developmental LOEL for methylene bis(thiocyanate)
in pregnant rabbits was greater than 5 mg/kg/day, and the developmental
NOEL was 5 mg/kg/day. (MRID 41171902)
e. Reproductive Toxicity
Oral Study in Rats: The reproductive toxicity potential of methylene
bis(thiocyanate) (99.3%), was studied by dosing SD (CD) (28/sex/group)
rats by oral gavage, through two generations (Eg-F^ Fj-F^, with one
mating period per generation. The doses used were 0, 1.0, 2.5, and
initially 5.0 mg/kg/day. The initial high-dose caused four F0 rats (1 male
and 3 females) to be sacrificed in extremis within the first 16 days of
dosing, and was reduced to 4.0 mg/kg/day (definitive high-dose) from
dosing day 17 to the end of the study. The NOEL for parental systemic
effects was 1.0 mg/kg/day and the LOEL was 2.5 mg/kg/day (mid-dose),
based on one F1 (female) mortality associated with necropsy findings of
cecum distention with gas. The initial high dose (5 mg/kg/day) caused 4
deaths (see above), most of which were preceded by adverse clinical signs
of breathing difficulty, piloerection, and swollen abdomen, and were
associated with necropsy findings of gastrointestinal distention by gas. The
definitive high-dose (4 mg/kg/day) was also associated with one F1 (male)
death. Some of the above described clinical signs were also observed in a
few surviving mid-dose and high-dose F0 rats. Methylene bis(thiocyanate)
at 1-4 mg/kg/day did not adversely affect body weight, body weight gain,
food consumption, or any reproductive parameter (precoital interval,
oestrus state, male/female fertility indexes, duration of gestation, gestation
index, number of implants/pregnancy, number of pups born dead or alive
per dam) in either the F0 or F1 parental groups. Methylene bis(thiocyanate)
at 1-4 mg/kg/day did not adversely affect any of the litter parameters
(number of live pups/litter at lactation day 0, 4, 14, or 21, birth, live birth,
viability, lactation, and overall survival indexes, male/female pup body
weight, and litter weight during the entire lactation period) in either the F1
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or F2 litter groups. The LOEL was greater than 4 mg/kg/day. The NOEL
for reproductive effect was 4.0 mg/kg/day (high dose). (MRID 42028601)
f. Mutagenicity
The studies satisfy current mutagenicity initial testing battery
guidelines. No further testing is required at this time.
59-activated methylene bis(thiocyanate) was mutagenic in mouse
lymphoma cells, but only at cytotoxic doses. The evidence of clastogenic
activity in cultured mammalian cells, which occurred only at cytotoxic
doses with or without S9 activation, was not confirmed. It was concluded,
however, that requesting a repeat study would not add substantively to the
overall database for methylene bis(thiocyanate). This decision is based on
the similarity of the response between these two mammalian cell assays
(i.e., positive results only at cytotoxic doses) in conjunction with the
negative findings from the two acceptable whole animal somatic cell assays.
Additionally, the suggestive evidence of test material/target cell interaction
noted in one of the two micronucleus assays (MRID 41003702) provides
some confidence that the lack of a response was likely not due to a failure
of the test material to reach the bone marrow. Hence, while the in vitro
data indicate that the test material is a mutagen and presumably a clastogen,
the negative in vivo data suggests that methylene bis(thiocyanate) lacks in
vivo mutagenic potential. This assumption is further supported by the
findings that methylene bis(thiocyanate) did not cause significant
reproductive or developmental toxicity attributable to a mutagenic mode of
action (i.e., decreased total implants, increased resorptions). Based on the
available toxicity data, it is concluded that methylene bis(thiocyanate) has
intrinsic genotoxicity activity which is only expressed in vitro.
The mutagenic potential of methylene bis(thiocyanate)(99%) was
studied in 5 histidine auxotrophs bacterial strains derived from Salmonella
typhimurium (TA98, TA100, TA1535, TA1537, and TA1538), according
to the reverse mutation test method of Ames. Positive controls were 2-
aminoanthracene (2 //g/plate) for mutagenic testing with metabolic
activation in all 5 strains, and sodium azide (1 //g/plate), 9-amino acridene
(75 //g/plate), or 2-nitro fluorene (3 //g/plate), for mutagenic testing
without metabolic activation, sodium azide in the TA100 and TA 1535
strains, 9-amino acridene in the TA1537 strain, and 2-nitro fluorene in the
TA1538 and TA98 strains. Methylene bis(thiocyanate) at concentrations
of 0.1-20 //g/plate in assays without metabolic activation or 0.3-50 //g/plate
in assays with metabolic activation was negative in the Ames reverse
mutation test with all 5 strains studied. The dosage ranges used were based
on a range finding study with TA100, in which concentrations of methylene
14
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bis(thiocyanate)> 33 //g/plate (without metabolic activation) or ^67
//g/plate (with metabolic activation) were 100% cytotoxic. The positive
controls all induced positive reverse mutation in the bacterial strains
studied. No positive mutagenic response was obtained under the conditions
of this test. In a second Ames test methylene bis(thiocyanate) was tested
at dose levels ranging from 0.005-5 //g/plate with and without metabolic
activation in strains TA98, TA100, TA1537 and TA1538. No positive
mutagenic response was obtained under the conditions of the second test.
(MRID 41003701, 00151925)
The mutagenic potential of methylene bis(thiocyanate)(99%) was
studied using the mouse lymphoma mutation assay. Dose levels used ranges
from 1-4 mg/mL with activation and 0.4-24 mg/ml without activation.
Cytotoxic concentrations of methylene bis(thiocyanate) induced a positive
mutagenic effect in the mouse lymphoma L5178Y tk+/tk cells line. In the
presence of metabolic activation, concentrations of methylene
bis(thiocyanate) of 2, 3, and 4 //g/mL caused significant increases in both
the mean tk+/tk mutant counts and the mean mutant fraction values
(respective increases of mean mutant fraction were 1.6, 2, and 2.5 fold
over controls). All 3 doses were greatly cytotoxic, causing respective
decreases in cells survival (relative total growth) of 72, 90, and 99%. The
positive mutagenic effect of methylene bis(thiocyanate) at 4 //g/mL was
confirmed in a repeat assay. In the absence of metabolic activation, dose-
related significant increases in both the mean mutant count and the mean
mutant fraction were observed with 1 and 1.5 //g/mL (respective increases
of mean mutant fraction were 2.3 and 15.2 folds over controls). These two
doses caused 59 and 94% decreases in cells survival. Mutagenic effects in
the absence of metabolic activation were not reproduced in the
confirmatory trial with a dose range of 0.4-2.4 //g/ml. The mutant count
of the vehicle cultures were within historical ranges. Both reference
chemicals, EMS (without S9 mix) and 3-MC (with S9 mix), induced
positive increases in both the mean mutant count and the mean mutant
fraction values. A positive mutagenic response was obtained in the
presence of S9. (MRID 41503802)
The mutagenic potential of methylene bis(thiocyanate)(99%) was
studied using the chromosomal aberrations assay with Chinese hamster
ovary (CHO) cells in vitro. Under the experimental conditions of the study
no numerical chromosome aberrations were observed with methylene
bis(thiocyanate) at any of the doses used (0.25, 0.5, 1.0, 2.0, and 4 //g/mL
culture medium). Non-cytotoxic concentrations of methylene
bis(thiocyanate) (< 1 //g/mL) caused a dose-related positive increase in
structural aberrations (mainly simple breaks and gaps), both with and
without metabolic activation. This positive clastogenic effect is considered
15
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a "presumptive" effect since it was not confirmed in a repeat (complete)
assay. Cytotoxic concentrations of methylene bis(thiocyanate) (2 and 4
//g/mL) caused a dose-related positive increase in structural aberrations
(mainly simple breaks and gaps), both with and without metabolic
activation. This positive clastogenic effect is considered a "presumptive"
effect since it was not confirmed in a repeat (complete) assay. The
frequencies of chromosome aberrations in both vehicle and untreated
control cultures were within the historical ranges. The reference chemicals
CP, 2-AAF, and MMS all induced positive increases in structural
chromosomal aberrations. Numerical chromosomal aberrations (number
of cells with endoreplicated chromosomes) were increased by only 2-AAF.
Although unconfirmed, a presumptively positive mutagenic response was
observed. (MRID 41503801)
LACA mice were treated with 8.94, 17.89 or 35.78 mg/kg of
methylene bis(thiocyanate) which represented 20, 40 and 80% of the LD50
dose, respectively. There were no significant increases in the number of
micronucleated polychromatic erythrocytes in methylene bis(thiocyanate)
treated mice when compared to the vehicle control. Thus, methylene
bis(thiocyanate) did not show a mutagenic response. The mutagenic
potential of methylene bis(thiocyanate) (99%) was tested in a second mouse
micronucleus study. ICR mice of both sexes were injected IP with single
doses of methylene bis(thiocyanate) (0.3, 1.3, or 2.6 mg/kg). The
selection of this HDT was based on the results of a preliminary acute
toxicity test showing that the LD50 was approximately 3.2 mg/kg. Vehicle
controls were injected with 1% carboxy methyl cellulose and positive
controls with triethylenelamine (TEM, 0.25 mg/kg). Five males and 5
females treated with TEM were sacrificed 24 hours after dosing. Five
mice/sex in all the other groups were sacrificed each time at 24, 48 or 72
hours after dosing. Bone marrows from the animals' femurs were prepared
for microscopy under oil immersion, and 1000 polychromatic erythrocytes
(PE) per mouse were scored for incidence of micronucleated polychromatic
erythrocytes (MPE). Slight declines in the PCE:NCE ratio in both sexes of
the high dose group at the 24 hour sacrifice and high dose males at 48
hours suggests possible bone marrow cytotoxicity. Under the experimental
conditions of the study, methylene bis(thiocyanate) did not exhibit any
mutagenic potential in the mouse micronucleus assay, at any dose, and at
any of the three observation times. In contrast, the reference chemical
TEM exhibited a positive mutagenic effect at 24 hours. A negative
mutagenic response was obtained. (MRID 00151926, 41003702)
The mutagenic potential of methylene bis(thiocyanate) (99%) was
studied using the test of Unscheduled DNA Synthesis (UDS) in primary
hepatocytes from male adult Fisher 344 rats. The primary hepatocytes (5
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x 105 viable cells/culture dish) were prepared according to the methods of
Williams and Bradlaw. The following experimental groups (3
cultures/group) were incubated (37± 1° C, humid atmosphere containing
5±1% C02) with 3H-thymidine (10 //Ci/mL medium) for 18-20 hrs:
medium control, vehicle control (with DMSO 10 //1/mL medium), test
(with 10 levels of Methylene bis(thiocyanate) from 0.03-10 //g/mL
medium), and positive control (DMBA 3 and 5 //g/mL medium). The
methylene bis(thiocyanate) dose range selection was based on a preliminary
test in which methylene bis(thiocyanate) 5 //g/mL medium was shown to
cause a significant increase in the level of cytotoxic enzyme marker LDH
in the incubation medium. Following the incubation period, the
hepatocytes were treated for autoradiography, fixed, and stained. The
incorporation of 3H-thymidine into the hepatocytes DNA (a measure of
DNA repair) was measured by the number of net nuclear grains/cell
nucleus. The number of cells in repair (>5 net nuclear grains/nucleus)
were also reported. Under the experimental conditions of the study,
methylene bis(thiocyanate) did not exhibit any mutagenic potential in the
UDS test. Methylene bis(thiocyanate) levels of 0.3-1.5 //g/mL induced
neither any change in the number of net nuclear grains/nucleus, nor any
increase in the number of cells in repair. Levels of 3-10 //g/mL induced
a decrease in relative survival rate greater than 50%. In contrast, both
doses of the reference chemical DMBA were devoid of cytotoxic action but
significantly increased both the number of net nuclear grains/nucleus, and
the number of cells in repair. A negative mutagenic response was
obtained. (MRID 41003703)
g. Metabolism
Although there are two metabolism studies noted below, there is
still a data gap for metabolism primarily due (but not limited) to inadequate
metabolite identification. The first study is potentially upgradable. The
additional metabolism data remains outstanding and should be submitted as
confirmatory data.
The disposition and metabolism of [14C] methylene bis(thiocyanate)
([14C] methylene bis(thiocyanate)) was studied after oral (gavage)
administration to Sprague-Dawley rats (1-9/sex/group). Male and female
rats were dosed with [14C] methylene bis(thiocyanate) at single oral doses
of 3 and 30 mg/kg and at repeated doses (14 daily doses) of 3 mg/kg.
[14C] methylene bis(thiocyanate) was rapidly absorbed, extensively
metabolized, and rapidly excreted. Over a 4-day period, most (94.87-
99.95%) of the test compound administered was excreted from the animals.
The radioactivity recovered in the urine, feces, and C02 in the exhaled air
was 63-71, 14-19 and 11-14 percent of the administered dose, respectively.
17
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Peak plasma concentrations of radioactivity occurred 1 to 2 hours after the
administration of the test compound. A number of radioactive components
(none of which co-chromatographed with [14C]methylene bis(thiocyanate))
were observed in the urine. Radiolabeled components found in fecal
extracts from rats treated with a low dose did not co-chromatograph with
[14C]methylene bis(thiocyanate), but one component found in fecal extracts
from rats treated with a high dose did. However, the data provided on the
identification of the metabolites of methylene bis(thiocyanate) in the urine,
feces, expired air, and tissues is incomplete. The characterization of the
unidentified radioactive components, the purity and composition of the
unlabeled test material, and a statement of the adverse affect observed
which validated the use of 30 mg/kg as the high dose in this study must be
provided. (MRID 41088501)
A second metabolism study was conducted consisting of two
experiments. In the first experiment, groups of three Fisher 344 rats were
administered oral doses of 0.2, 1.0 or 10 mg/kg of [14C]methylene
bis(thiocyanate)(99%). In a second experiment, methylene bis(thiocyanate)
was administered orally to rats at a high dose of 10 mg/kg. In the first
experiment, urine was the primary route of excretion (52-62%) followed
by fecal elimination (14-28%) and expired C02 (9-11%). Total recovered
radioactivity ranged from 92.29-98.96% at 48 hours. No radioactivity was
found as volatile organics. Tissue levels ranged from 2.57-6.48% of the
administered dose. Total radioactivity in the blood, blood cyanide and
plasma thiocyanate exhibited biphasic elimination from the blood. The
terminal elimination phase started 1 hour after dosing and had a half-life of
7 hours. When methylene bis (thiocyanate) was administered at 10 mg/kg,
whole blood cyanide increased dramatically (64.9-198.2 mg/mL) over
background levels at 0.5-1.0 hour post-dosing. Plasma thiocyanate was at
a maximum concentration of 9.66 //g/mL at 2 hours post-dosing. These
values decreased but did not reach background levels by 24 hours post-
dosing. Two mechanisms may explain the reactions. One is the reaction
of alkylmono thiocyanates with a soluble liver enzyme fraction containing
glutathione S-transferase and glutathione (GSH). A second reaction
involves P-450 isozymes. The additional thiocyanate group may make the
methylene carbon suitable for oxygen insertion producing the
corresponding aldehyde with the release of thiocyanate. Further oxidation
of the aldehyde to the corresponding acid followed by decarboxylation
would yield C02. The authors propose that the toxicity of methylene
bis (thiocyanate) may be due to 1) cyanide release, 2) glutathione depletion,
and 3) toxic metabolites other than cyanide and thiocarbamates.
The study is supplementary and cannot be upgraded. This study,
while taking into account previously submitted studies, does not satisfy the
18
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guideline 85-1 requirement for a metabolism study because 1) the single
highest dose of 10 mg/kg (1/10 LD50) did not produce a pharmacological
or toxicological response, 2) too few animals had any data reported for
them, and 3) metabolite analyses were incomplete and limited to C02,
cyanide and thiocyanate measurements (no chromatography, etc. methods
were employed). (MRID 41774501)
h. Dermal Absorption
In the absence of data on dermal absorption, a 5% absorption factor
was calculated. The estimate of dermal absorption was made using the
comparison between the rat developmental toxicity study (MRID 41171901)
and the rat 21-day dermal toxicity study (MRID 41111901). In the
developmental study the NOEL was 3 mg/kg/day with clinical signs
occurring at 6 mg/kg/day. This NOEL is supported by results in the
developmental range finding study where one death occurred at 10
mg/kg/day after 6 doses and two deaths occurred at 30 mg/kg/day after two
doses. The 21-day dermal study had a NOEL of 60 mg/kg/day (high
dose). Comparing the NOELs from the two studies indicates that dermal
absorption is less than 5%.
i. Other Toxicological Information
Cyanide is a metabolite of methylene bis (thiocyanate). It appears
that much of the toxicity of methylene bis (thiocyanate) is consistent with
that of Cyanide. The August 1995 draft for public comment of the
Toxicological Profile for Cyanide, U.S. Department of Health and Human
Services, Public Health Service, Agency for Toxic Substances and Disease
Registry (ATSDR) reported that cyanide is extremely toxic by all routes of
exposure. Systems affected include, but are not limited to, the central
nervous system (potentially resulting in death), the respiratory system, the
cardiovascular system, and the gastrointestinal system. Cyanide is
regulated by many Agencies. The oral minimal risk level (MRL) for
exposure durations of 15-365 days was determined by the ATSDR to be
0.05 mg/kg/day. The MCL in water is 0.2 mg/L as free cyanide. In
1994, IRIS placed cyanide in the "D" carcinogenicity category, listed the
RfD for HCN and free cyanide as 2x102 mg/kg/day and listed the RfC for
HCN as 3xl03 mg/m3. ATSDR also listed an RfD of 5xtO , but the
source of this value is not given.
Qualitatively methylene bis (thiocyanate) and cyanide have similar
toxicity. However, quantitatively their toxicity appears to be different.
2. Toxicological Endpoints for Risk Assessment
19
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a. Reference Dose (RfD)
The Agency's OPP/RfD Peer Review Committee established the
RfD for methylene bis(thiocyanate) at 0.005 mg/kg/day. An uncertainty
factor (UF) of 100 was used. The NOEL from the chronic toxicity study
in dogs is 0.5 mg/kg/day. The effects at the LOEL of 2 mg/kg/day are
marginal changes in blood chemistry and pathology changes in the stomach
and bone marrow. Although no dietary exposure is expected from the
current non-food use pattern, the RfD is presented in the event that some
future use results in the need to evaluate oral exposure.
b. Carcinogenic Classification
On February 2, 1996, the OPPRfD/Peer Review Committee
determined that methylene bis(thiocyanate) should be classified as a "Group
D", not classifiable as to human carcinogenicity. This is based on
questionable increases in male rat adrenal pheochromocytomas and male
mouse alveolar/bronchiolar tumors.
c. Other Toxicological Endpoints
The Agency's OPP Toxicology Endpoint Selection (TES)
Committee considered the toxicity data available for this chemical at a
meeting held on February 6, 1996. Based upon a review of the toxicology
database for methylene bis(thiocyanate), toxicology endpoints and dose
levels of concern have been identified for use in occupational and
residential risk characterization; they are listed in Table 2.
TABLE 2. Summary of Toxicological Endpoints for methylene bis(thiocyanate).
EXPOSURE DURATION
EXPOSURE
ROUTE
NOEL AND ENDPOINT
Short/Intermediate-Term
(1 to 21 days)
Occupational/Residential
DERMAL
60 mg/kg/day (systemic NOEL from the 21-day dermal rat
study; HTD; no systemic effects at the highest tested dose)
MRID41111901
Chronic Exposure
Occupational/Residential
(greater than 21 days)
DERMAL
0.5 mg/kg/day (chronic oral NOEL from the one-year dog
study for marginal changes in blood chemistry and pathology
findings in the stomach and bone marrow seen at the LOEL of
2 mg/kg/day); assume 5% dermal absorption. MRID 41463201
3. Dietary Exposure and Risk Assessment/Characterization
There are currently no registered food-uses of methylene bis(thiocyanate);
therefore, a dietary exposure and risk assessment/characterization is not required.
20
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4. Toxicological Endpoints for Risk Assessment
a. Occupational and Residential Exposure
An occupational and/or residential exposure assessment is required
for an active ingredient if (1) certain toxicological criteria are triggered and
(2) there is potential exposure to handlers (mixers, loaders, applicators,
etc.) during use or to persons entering treated sites after application is
complete.
The first toxicological criteria which triggered the Agency's concern
for occupational or residential inhalation exposure was the acute inhalation
toxicity study (MRID 41201601) which identified high toxicity (mortality)
of this chemical via the inhalation route of exposure. The only available
information on inhalation toxicity is the acute inhalation study which is of
poor quality and would usually be unacceptable. In addition, data are not
readily available to further characterize the hazard due to inhalation
exposure of methylene bis(thiocyanate).
A second toxicological criteria which triggered the Agency's
concern for short- and intermediate-term occupational or residential
exposure (1 to 7 days; 1 week to 21 days, respectively) was the dose
related signs of dermal irritation. The dermal LOEL in the three-week
subchronic dermal toxicity study is 10 mg/kg/day based on skin irritation.
The dermal NOEL is less than 10 mg/kg/day. But the systemic NOEL of
greater than or equal to 60 mg/kg/day will be used for risk assessment
purposes. This value is supported by using the 3 mg/kg/day from the rat
developmental study as a short-term NOEL with a dermal absorption of
5%. The 21-day endpoint is considered appropriate since there was no
evidence of systemic toxicity at the highest dose. It cannot be determined
whether the toxicity observed in longer oral studies would occur following
dermal exposure of greater duration than 21 days. The toxicity has been
observed to be cumulative with repeated oral exposure.
Lastly, the toxicological criteria which triggered the Agency's
concern for chronic occupational or residential exposure (greater than 21
days) was the chronic one-year oral study in the dog (MRID 41463201)
described in a previous section of this RED. The LOEL is 2.0 mg/kg/day
based on the marginal changes in blood chemistry and pathology findings
in the stomach and bone marrow. These effects observed at the LOEL are
consistent with local gastric irritation and cyanide toxicity which include
mild inflammation in the lamina propia of the stomach, increased
hematopoiesis of the bone marrow, decreased albumin, total protein and
21
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albumin/globulin ratio. The NOEL was 0.5 mg/kg/day. This endpoint is
considered appropriate for exposures greater than 21 days.
In addition, the Agency has determined that there is a potential for
exposures to mixers, loaders, applicators, or other handlers during usual
use-patterns associated with methylene bis(thiocyanate) and from use in
commercial, industrial, and residential settings. The following levels of
handler exposures have been identified:
Primary Occupational Handlers
(1) mixing/loading the SC/L formulation using the open-pour technique;
(2) mixing/loading the SC/L formulation using the pump-meter or
automatic-dispensing technique;
(3) applying the SC/L formulation using a dip-tank, including removing
materials (such as leather) from treatment solutions;
(4) applying the SC/L formulation as a spray;
(5) applying the ready-to-use (RTU) liquid formulation as a spray;
(6) applying the RTU liquid formulation with a brush;
(7) applying the RTU liquid formulation with a roller; and
(8) mixing/loading the SC/S formulation (crystalline/pellets) using the
open-pour technique.
Secondary Occupational Handlers
(1) exposures while handling methylene bis(thiocyanate)-containing paint;
(2) exposures while handling methylene bis (thiocyanate)-containing
adhesives;
(3) exposures while handling methylene bis (thiocyanate)-containing water
repellent for wood or forestry products; and
(4) exposures while handling methylene bis (thiocyanate)-containing
metalworking cutting fluids.
Homeowner Handlers
(1) exposures while handling methylene bis (thiocyanate)-containing liquid
RTU products for wood treatment;
(2) exposures while handling methylene bis (thiocyanate)-containing paint;
and
(3) exposures while handling methylene bis (thiocyanate)-containing
adhesives.
All handler use patterns were assessed for dermal exposure only.
Although a potential inhalation hazard based on the high toxicity (mortality)
22
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of this chemical by the inhalation route has been identified, no data are
available to quantitatively assess inhalation toxicity or exposure.
Therefore, the 90-day inhalation study is required and upon receipt, review
and acceptance of that data, an inhalation risk assessment will be
conducted.
The Agency has also determined two levels of potential exposure
concerns relating to post-application exposure to methylene bis(thiocyanate)
following applications in commercial, industrial, and residential settings
(e.g., dermal from mist, steams and inhalation). They are:
Primary Occupational Post-Application Exposure
(1) exposures following applications of methylene bis(thiocyanate) to open
vats of liquids, such as paper-pulp, adhesives, coating, emulsions, and
paints;
(2) exposures during and immediately after indoor spray applications to
seasoned and unseasoned wood; and
(3) exposures to persons maintaining equipment, such as water systems and
other industrial equipment, which contains product treated with methylene
bis(thiocyanate).
Secondary Occupational Post-Application Exposure
(1) exposures to persons occupying areas recently painted with methylene
bis(thiocyanate)-containing paint and wood-treatment products;
(2) exposures in areas where methylene bis (thiocyanate)-containing paper
products are being manufactured;
(3) exposures to methylene bis (thiocyanate)-treated wood products; and
(4) exposures to methylene bis (thiocyanate)-treated leather.
Secondary Homeowner Post-Application Exposure
(1) exposures while occupying areas recently painted with RTU methylene
bis (thiocyanate) wood treatment products;
(2) exposures while occupying areas recently painted with methylene
bis (thiocyanate)-containing paint and wood treatment products;
(3) exposures while occupying areas where methylene bis (thiocyanate)-
containing adhesives have been used;
(4) exposures to methylene bis (thiocyanate)-treated wood products (indoor
furniture, and picnic tables/deck); and
(5) exposures to methylene bis (thiocyanate)-treated leather products.
23
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Table 3 below provides some examples of primary and secondary
exposures in occupational and residential settings and Table 4 provides
exposure estimates for use of methylene bis(thiocyanate) in various
industrial/residential settings.
Therefore, because the toxicological criteria have been triggered
and potential exposure to handlers during use or to persons entering treated
sites after application exists, short-term, intermediate-term and chronic risk
assessments are required.
Table 3. Examples of Primary and Secondary Exposures in Occupational and
Residential Settings.
Type of Exposure
Occupational Settings
Examples
Residential Settings Examples
Handler
Exposure
Primary
Adding methylene bis(thiocyanate)
to a vat of liquid (paint or water
repellent for wood/forestry
products)
Exposure to homeowner applying a
methylene bis (thiocyanate) -containing
RTU product to wood or wood structures
(decking treatment)
Secondary
Handling methylene
bis (thiocyanate)-containing paint
or wood treatment products
Exposure to homeowner using methylene
bis (thiocyanate)-containing paint
Post-application
Exposure
Primary
Secondary
Standing near a vat where
methylene bis (thiocyanate) was
added or in an area where
seasoned and unseasoned wood
was treated
Exposure to homeowner applying a
methylene bis (thiocyanate) -containing
RTU product to wood or wood structures
(decking treatment)
Being in a room recently painted
with methylene bis (thiocyanate)-
containing paint or with a wood
treatment product
Being in a room recently painted with
methylene bis (thiocyanate) -containing
paint or with a wood treatment product
24
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Table 4. Exposure Estimates/Assumptions of Methylene bis(thiocyanate) for Liquid Concentrates and Ready-To-Use Applications
Setting*
Oil well injection fluid*
Cooling systems*
Paint manufacturing*
Metalworking cutting fluid*
Pulp and paper mills*
Oil drilling/mud fluids
Wood pressure treatment with dipping*
and/or spray application method, and
wood protection treatment to forest
products.
Process preservative uses*
Uses in leather processing liquors, *
leather processing, and leather products
Painting with a brush*
Painting with an airless sprayer (siphon*
sprayer with 5 hp gasoline-powered
engine; spray nozzle is attached to a hose)
Painting with a roller*
Pounds ai used
Assumes 1000 barrels (42,000 gallons) treated per day and 75 pounds of product (BETZ ENCHEM 41-J2, EPA Reg. 48525-2, with 10%
active ingredient) is used per 42,000 gallons of injection fluid. The total active ingredient handled per day is 7.5 pounds.
Assumes 20,000 gallons (4000 gallons for smaller systems) of water are treated per day and 14.8 fluid ounces of end-use product (M-202,
EPA Reg. 1448-148 with 10% active ingredient — equal to 14.8 fl. oz/128 fl.oz per gal. x 9 pounds/gal, x 0.1 = 0.11 pounds of active
ingredient) equaling 0.11 pounds of active ingredient is used per 1000 gallons of water. The total active ingredient handled per day is 2.2
pounds (0.44 pounds for smaller systems).
Assumes 300 gallons (2,700 pounds) of paint are treated per day and one pound of end-use product (Slime-trol RX-31, EPA Reg. 45017-28
with 5% active ingredient) equaling 0.5 pounds active ingredient is used per 1000 pounds of paint (1000 ppm). The total active ingredient
handled per day is 0.14 pounds.
Assumes 300 gallons of metalworking cutting fluid are treated per day and 0.4 gallons (0.4 gal. x 9.2 Ibs/gal = 3.68 pounds) of end-use
product (AMA-10W, EPA Reg. 9386-31 with 10% active ingredient) equaling 0.37 pounds active ingredient is used per 1000 gallons of
metalworking cutting fluid. The total active ingredient handled per day is 0.11 pounds.
Assumes 100 tons of pulp are treated per day and one pound of end-use product (Nalcon 7620-WB with 10% active ingredient) equaling 0.1
pounds active ingredient is added per ton of pulp. The total active ingredient handled per day is 10 pounds.
Assumes 1,000 barrels of mud fluids are treated per day and 500 pounds of end-use product (Enchem 41-J5, EPA Reg. 48525-10 with 5%
active ingredient) equaling 25 pounds of active ingredient is added per 1,000 barrel of mud fluids. The total active ingredient handled per
day is 25 pounds.
the Agency has no data at this time.
Assumes a total of 10,000 pounds of slurry are treated per day and 10 pounds of the end-use product (Betx Slime-trol RX-32P EPA Reg.
45017-19 with 7% active ingredient) equaling 0.7 pounds (1,000 ppm by weight) of active ingredient is added per 10,000 pounds of slurry.
The total active ingredient handled per day is 0.7 pounds.
The Agency has no data at this time.
Assumes that an occupational painter uses five gallons of paint per day and a homeowner uses one gallon of paint per day, that each gallon
contains 0.5 percent of active ingredient, and that one gallon of paint weighs 10 pounds. The total active ingredient handled per day is 0.25
pounds for occupational painters and 0.05 pounds for homeowner painters.
Assumes that an occupational painter uses fifty gallons of paint per day and a homeowner users five gallons per day, that each gallon contains
0.5 percent active ingredient, and that one gallon of paint weighs approximately 10 pounds. The total active ingredient handled per day is
2.5 pounds for occupational painters and 0.25 pounds for homeowner painters.
The Agency has no data at this time.
The Agency assumes that the scenarios designated above represent exposures to mixers, loaders, and applicators handling methylene bis(thiocyanate) which are reasonably worst-case.
25
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b. Occupational and Residential Risk Assessment and Characterization
Short-term, intermediate-term, and chronic risk assessments are required
for exposure to methylene bis(thiocyanate). The Agency typically considers the
exposure to primary occupational handlers in settings such as pulp and papermill,
oil well injection fluid, metalworking cutting fluid, and water cooling systems to
be short- to intermediate-term exposures. Commercial painters and general
preservative uses (worst case, paint manufacturing) would typically be subject to
chronic exposures. Homeowner handlers are assumed to be exposed less than 7
days per year.
In the case of methylene bis(thiocyanate), risk assessments for
short/intermediate term exposure durations up to 21 days have been conducted for
the homeowner handler using the NOEL of 60 mg/kg/day based on a 21-day
dermal study. Methylene bis(thiocyanate) risk assessments for chronic exposure
durations greater than 21 days have been conducted for the occupational handler
in industrial settings using the NOEL of 0.5 mg/kg/day based on a one-year oral
study. Exposure durations of 0-21 days and >21 days have typically not been
used by the Agency to define short/intermediate and chronic exposure scenarios.
However, in the case of methylene bis(thiocyanate), toxicity data indicate that
exposure to methylene bis(thiocyanate) for 21 days or longer may produce the
same toxic effects seen in the chronic oral study. This partition of exposure
durations most accurately reflects the toxic effects likely to be caused by use of this
pesticide, therefore, the NOEL for the chronic study is used for exposures >21
days. The actual daily exposure (ADE) for chronic exposures has been adjusted
for 5% dermal absorption to account for route-to-route extrapolation. A MOE of
100 serves as a reference point for occupational/residential exposures.
(1) Risk from Dermal Exposures to methylene bis(thiocyanate)
Short/intermediate-term and chronic toxicity endpoints related to dermal
exposures to methylene bis(thiocyanate) have been identified. An MOE of greater
than 100 for methylene bis(thiocyanate) is considered to indicate no risk concern.
The risk assessment for dermal exposures is calculated as follows:
Amount Daily Dermal Exposure (mg/day)
= unit exposure (UE) (mg/lb ai) X daily use (Ib ai/day)
Actual Daily Exposure (ADE) (mg/kg/day)
= Amount Exposed (mg/day) + body weight (kg)
MOE=NOEL^nglkgldoy)_
ADEmglkglday
Tables 5 and 6 contain the calculations of exposure and risk for both primary and
secondary handler dermal exposures.
26
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Table 5. Short/Intermediate (up to 21 days) Exposure and Risk Assessment for
methylene bis(thiocyanate) Application Scenarios.
Handlers
Primary and
Secondary
Handlers
Setting
Brush Painting
Spray Painting (Airless/
compressed-air sprayer)
Roller Painting
UE*
mg/lb ai
182
39
No Data
Lbai/
used**
(H) 0.05
(H) 0.25
No Data
Amount
Exposed
mg/day***
(H)9
(H) 9.75
No Data
Actual****
Daily Exposure
(mg/kg/day)
(H) 0.13
(H) 0.14
No Data
MOE
(NOEL = 60
mg/kg/day)
(H) 464
(H) 429
No Data
*UE = Unit Exposure: For brush painting, UE dermal exposure (without gloves) derived from PHED (VI. 1 Data Validation,
March 28, 1996) and is based on 15 replicates, acceptable grades, medium confidence for using brush as wood painting application.
For airless spray painting, UE dermal exposure (without gloves) derived from PHED (VI. 1) based on 15 replicates, acceptable
grades, high confidence.
**Lb ai/used was derived from the pesticide product labels.
***Amount Exposed (mg/day) = (UE x Ib ai/used)
****ADE = Actual Daily Exposure (dermal) = Amount Exposed/ BW (70 kg) = mg/kg/day
(H) = Homeowner calculations assume 1 gal used for brush painting and 5 gal for airless sprayer painting, 10 Ibs/gal of RTU wood
preservative and 5,000 ppm ai.
MOE = NOEL/ADE NOEL for exposures up to 21 days is 60 mg/kg/day from a rat 21-day dermal study.
NOTE: Primary handler exposures may result from applications with RTU formulations (wood protection treatments) and secondary
handler exposures may result from applications of paints containing methylene bis(thiocyanate) as a preservative.
27
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Table 6. Exposure (greater than 21 days) and Risk Assessment for methylene bis(thiocyanate) Application Scenarios.
Handlers
Primary
Handlers
Primary and
Secondary
Handlers
Operation
Open-pour Liquid
Open-pour Liquid
Pump Liquid
Open-pour Liquid
Open-pour Liquid
Open-pour Liquid
Pump Liquid
Open-pour Solid
Open-pour Solid
Open-pour Liquid
Wood Treatment
Wood Treatment
Spray Application (other
than wood treatment)
Dip Application
(leather processing)
Painting
Painting
Painting
Setting
Oil Well Injection Fluid
Cooling System
Cooling System
Cooling System (small)
Paint Manufacturing
Metal Fluid
Pulp and Paper mill
Pulp and Paper mill
Process Preservative
Drilling Mud
Spray
Dipping
Spray
No Data
Brush Painting*
Spray* (Airless/
compressed-air sprayer)
Roller Painting
UE*
mg/lb ai
0.14
10.23
0.09
10.23
0.14
0.133
0.0039
0.479
0.479
0.14
No data
No data
No data
No data
182*
(21)
39*
(8.7)
No data
Lbai/
used**
7.5
2.2
2.2
0.44
0.14
0.11
10
10
0.7
25
No data
No data
No data
No data
(0) 0.25
(0) 2.5
No data
Amount
Exposed
mg/day***
1.05
22.51
0.2
4.5
0.0196
0.0146
0.039
4.79
0.34
3.5
No data
No data
No data
No data
(0)45
(5.25)
(0) 97.5
(21.75)
No data
Actual****
Daily Exposure, ADE
(mg/kg/day)
0.015
0.32
0.003
0.064
0.00028
0.00021
0.00056
0.068
0.0048
0.05
No data
No data
No data
No data
(0) 0.64
(0.075)
(0) 1.4
(0.31)
No data
Adjusted ADE
(mg/kg/day)with 5% dermal
absorption
7.5 X 10"
0.016
1.4x 10-4
0.0032
1.4X105
1.0X105
2.8X 10 5
3.4X103
2.4x 10"
2.5xl03
No data
No data
No data
No data
0.032
(0.00375)
0.07
(0.016)
No data
MOE
(NOEL = O.Smg/
kg/day)
667
31
3524
155
35,714
47,847
17,949
146
2088
200
No data
No data
No data
No data
(0) 16
(133)
(0) 7.1
(31)
No data
* UE = Unit Exposure (dermal + inhalation) was derived from the CMA antimicrobial exposure data base (open-pour and pump liquid with gloves). Although the unit exposure values from
the CMA data base represent combined dermal and inhalation exposure, the inhalation contribution is low (typically below the limit of detection) and will therefore not significantly affect the estimated
exposure values used in this dermal exposure assessment. However, because of the high inhalation toxicity, inhalation exposure and toxicity data are required to allow accurate assessment of inhalation
risk concerns.
* UE for brush painting was derived from PHED (VI. 1 as amended Data Validation, March 28, 1996) dermal exposure only (without gloves), based on 15 replicates, acceptable grades, medium
confidence for using brush as wood painting application. For airless spray painting, UE derived from PHED (V 1.1) dermal exposure only (without gloves) based on 15 replicates, acceptable grades,
high confidence and is equipped with gasoline powered siphon/nozzle sprayer. (Values in parentheses reflect maximum PPE; i.e., coveralls over a single layer clothing and chemical-resistant gloves.)
** Lb ai/used was derived from the pesticide product labels. The occupational painter calculation assumes 5 gal used for brush painting and 50 gal used for airless spray painting, 10 Ibs/gal of
RTU wood preservative and 5,000ppm ai.
*** Amount Exposed (mg/day) = (UE x Ib ai/used)
**** ADE = Actual Daily Exposure (dermal + inhalation for all operations except painting) = Amount Exposed / BW (70 kg) = mg/kg/day.
MOE = NOEL/ADE: NOEL for exposures greater than 21 days is 0.5 mg/kg/day (oral) from chronic dog toxicity study; ADE adjusted for 5% dermal absorption.
NOTE: For painting operations, primary handler exposures may result from applications with RTU formulations and secondary handler exposures may result from applications of paints containing
methylene bis(thiocyanate) as a preservative.
28
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As can be seen in Table 5, non-occupational uses, the primary and
secondary application (dermal exposure) MOEs for exposure durations up
to 21 days are greater than 100 for all scenarios. As seen in Table 6, the
Agency does have concern for the occupational painter where the MOEs
(without gloves) are 16 using a brush and 7.1 using an airless sprayer.
Workers applying ready to use products or liquids with a brush, roller or
sprayer would have the same risks. Additional use information for these
scenarios is necessary before risk mitigation or a determination of
eligibility can be made.
Risk assessments were not conducted for use of methylene
bis(thiocyanate) in wood products manufacturing settings, leather
processing settings, or for paint application using air sprayer or roller
apparatus due to lack of dermal exposure data for primary and secondary
handlers. Exposure data are being required for these scenarios and
additional risk mitigation measures and an eligibility decision will be made
upon receipt and evaluation of the data.
The Agency is concerned about risks to the primary handler open-
pouring liquid formulations for large water cooling systems (> 4000
gallons per day) uses since the MOE is 31 (wearing gloves) for this
application method (See Table 6). However, in large cooling system
settings if a pump-metering system was used, it would significantly reduce
the exposure and risk associated with use of methylene bis(thiocyanate)
(MOE of 3524). Therefore, the Agency is requiring the use of a pump-
metering system for all water cooling systems of > 4000 gallons per day.
For smaller cooling systems (<^4000 gallons per day), the MOE of 155 is
above the Agency's level of concern for exposures due to open pouring
situations and is, therefore, acceptable without further mitigation.
(2) Risk from Inhalation Exposures to Methylene bis(thiocyanate)
At the present time, there is no inhalation toxicity endpoint other
than an LC50 value for acute inhalation toxicity. A hazard was identified
by the TES Committee based on the high toxicity (mortality) of this
chemical by this route of exposure. However, the study would usually not
be acceptable for regulatory purposes because (1) there were extreme
differences in chamber concentration for measurements made at intervals
for each and all exposures; (2) the mass median diameters of the particles
were too large; (3) the relative humidity was too high suggesting that the
airflow may have been inadequate; (4) the difference between the nominal
and analytical values were 5000 fold; and (5) since this was whole body
exposure, there could have been considerable oral exposure. An additional
study was not required following review of this study (MRID 41201601)
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because for labeling purposes, methylene bis(thiocyanate) was classified as
Toxicity Category I (the highest toxicity category). This study is not useful
in the characterization of short and intermediate term risk assessment. The
Agency is requiring a 90-day study to characterize inhalation toxicity and
to determine any potential inhalation risk from methylene bis(thiocyanate).
(3) Risk from Exposures to Methylene bis(thiocyanate) Degradates
The formation of additional degradates of methylene
bis(thiocyanate), specifically formaldehyde and cyanide, is theoretically
possible. Hydrolysis studies indicate that methylene bis(thiocyanate)
degrades to thiocyanate ion, formic acid, and mercapto- (methylenethio
cyanate) at various rates depending on the pH of the medium. The more
alkaline the medium, the faster the degradation occurs. It is possible that
the thiocyanate ion would degrade to cyanide, but degradation data are
lacking that would indicate whether this occurs in the working environment
and, if so, under what conditions. The Agency is concerned about the
potential inhalation hazards from exposure to these degradates in
occupational and residential settings. The Agency has no data upon which
to conduct a risk assessment for primary and secondary handlers potentially
exposed to methylene bis (thiocyanate) degradates. Additional exposure
data are being required which may confirm the registrant's statements that
there are no exposures to degradates of methylene bis (thiocyanate) as a
result of the registered uses. In addition, if the required air monitoring
data indicate the presence of cyanide and formaldehyde, inhalation toxicity
data on cyanide and formaldehyde may be required as appropriate. If
adequate data are available, this may be referenced. Otherwise, new study
data are required.
Many of the occupational handler exposures of concern are in
industrial or manufacturing settings, which are under the OSHA's purview.
The Agency will inform OSHA about our concerns for occupational
handler exposure and formaldehyde and cyanide formation in workplace
settings where methylene bis (thiocyanate) is used. In addition, the Agency
is requiring air monitoring studies for paint manufacturing uses and painter
uses.
(4) Risk From Post-Application Exposures
The Agency is concerned about potential post-application exposures
to methylene bis (thiocyanate) and its degradates in occupational and
residential settings. The registrant indicates that the half-life of methylene
bis (thiocyanate) is very short and should not be a post-application concern,
since most use sites would by nature be alkaline and promote faster
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degradation of the parent. However, the degradates are also a toxicity
concern. The Agency is particularly concerned about potential primary and
secondary post-application inhalation exposures to methylene
bis(thiocyanate) degradates in indoor settings. There are no data upon
which to conduct a risk assessment for post-application exposures to
methylene bis(thiocyanate) or its degradates. Post-application dermal and
inhalation exposure data are being required which may confirm the
registrant's statements that there are no post-application exposures to
methylene bis(thiocyanate) or its degradates.
Most of the occupational post-application exposures of concern are
in industrial or manufacturing settings, which are under OSHA's purview.
Following review of additional data/information the Agency will inform
OSHA about any remaining concerns for potential occupational handler
exposure and formaldehyde and/or cyanide formation in workplace settings
where methylene bis(thiocyanate) is used. In addition, air monitoring
studies for certain uses are being required (See Section V). If adequate
data are available, this may be referenced. Otherwise, new study data are
required.
(5) Incident Reports
Two incidents were reported to the Office of Pesticide Programs
Incident Data System as of February 5, 1996. The first involved a man
who was exposed to the chemical while dipping lumber. He developed
swollen eyes, a rash on his cheeks and insomnia. An update to this case
reported that the man was diagnosed with lupus erythematosis which the
physician said had no probable relationship to the pesticide. In the second
incident, a man was exposed to a multiple active ingredient formulation
containing 10% ai methylene bis(thiocyanate) through a leaking line. He
developed a rash on his arm, shortness of breath and a cough but recovered
within 24 hours.
5. Other Considerations
The Food Quality Protection Act of 1996 amends both the FFDCA and
FIFRA by setting a new safety standard for the establishment of tolerances. In
determining whether or not a tolerance meets the new safety standard, FQPA
directs EPA to consider information concerning the susceptibility of infants and
children to pesticide residues in food; the potential for aggregate exposure from
dietary as well as non-occupational sources, such as pesticide uses in and around
the home; and the potential for cumulative effects from a pesticide and other
substances that have a common mechanism of toxicity.
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Because methylene bis(thiocyanate) has no food uses, and therefore no
tolerances have been established, the specific considerations outlined in FQPA are
not required for this chemical. Nevertheless, EPA believes that consideration of
available data relating to the special sensitivity of infants and children, the potential
for aggregate exposures and cumulative effects is prudent for methylene
bis(thiocyanate).
Potential Risks to Infants and Children
In determining whether or not an additional uncertainty factor is
appropriate for assessing risks to infants and children, EPA takes into account the
completeness and reliability of the toxicity data base, the nature and severity of the
effects observed in pre- and post-natal studies, and other information such as
epidemiological data.
Based on current data requirements, only one developmental study is
usually required for non-food use chemicals. However, for the purposes of
assessing the pre-and post-natal toxicity of methylene bis(thiocyanate), two
developmental and one reproduction study were available and have been evaluated
by EPA. The effects observed in the methylene bis(thiocyanate) developmental
and reproduction studies can be summarized as follows:
In a rat developmental toxicity study, pregnant Crl: CD BR rats were dosed
with 0, 1, 3, or 6 mg/kg/day of methylene bis(thiocyanate) on days 6 through 15
of gestation. Methylene bis(thiocyanate) had no effect on any of the
developmental toxicity parameters examined. No embryo toxicity, fetotoxicity, or
indication of teratogenic effects were noted in the study. The developmental NOEL
and LOEL were greater than 6 mg/kg/day, the highest dose tested. The maternal
LOEL was 6 mg/kg/day based on a slight decrease in maternal body weight gain
and a small increase in the incidence of rales. The maternal NOEL was 3
mg/kg/day.
In a rabbit developmental toxicity study, Hra:(NZW)SPF rabbits were
dosed with 0, 1, 3, or 5(7) mg/kg/day by stomach tube. (The high dose was
reduced from 7 to 5 mg/kg/day after day 5 due to excess mortality.) Methylene
bis(thiocyanate) had no effect on any of the developmental toxicity parameters
examined. No embryo toxicity, fetotoxicity, or indication of teratogenic effects
were noted in the study. The developmental NOEL for methylene bis(thiocyanate)
in rabbits was 5 mg/kg/day, and the developmental LOEL was greater than 5
mg/kg/day. The LOEL for maternal toxicity was 5 mg/kg/day based on mortality
and decreased body weight gain. The NOEL was 3 mg/kg/day for maternal
toxicity.
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In a reproductive toxicity study in SD (CD) rats, the NOEL for parental
systemic effects was 1.0 mg/kg/day and the LOEL was 2.5 mg/kg/day (mid -
dose), based on one Fl (female) mortality associated with necropsy findings of
cecum distention with gas. Methylene bis(thiocyanate) at 1-4 mg/kg/day did not
adversely affect body weight, body weight gain, feed consumption, or any
reproductive parameter (precoital interval, oestrus state, male/female fertility
indexes, duration of gestation, gestation index, number of implants/pregnancy,
number of pups born dead or alive per dam) in either the F0 or Fl parental groups.
Methylene bis(thiocyanate) at 1-4 mg/kg/day did not adversely affect any of the
litter parameters (number of live pups/litter at lactation day 0, 4, 14, or 21, birth,
live birth, viability, lactation, and overall survival indexes, male/female pup body
weight, and litter weight during the entire lactation period) in either the Fl or F2
litter groups. The LOEL for reproductive effects was greater than 4 mg/kg/day;
the NOEL was 4.0 mg/kg/day (high dose).
The developmental data for methylene bis(thiocyanate) indicate
developmental effects did not occur at any dose in the above studies, including
doses which resulted in maternal toxoicity. The Agency would generally be
concerned when developmental/reproductive effects are seen at doses lower than
those which cause maternal effects. The developmental and reproductive toxicity
data do not indicate any additional sensitivity of young organisms to methylene
bis(thiocyanate). Therefore, the Agency concludes that an additional uncertainty
factor is not warranted for methylene bis(thiocyanate) risk assessments at this time.
Aggregate Exposure
In examining aggregate exposure, EPA takes into account available
information concerning exposures from the pesticide residue in food and
other exposures for which there is reliable information. These other
sources of exposure can include drinking water, and non-occupational
exposures, e.g., to pesticides used in and around the home.
There are no food uses for methylene bis(thiocyanate), therefore,
exposure to methylene bis(thiocyanate) in the diet is not expected.
Laboratory data indicate that methylene bis(thiocyanate) degrades quickly
and would not be persistent if it reached the environment. Methylene
bis(thiocyanate) has a very low potential to leach into groundwater or to
run off into surface water under typical use conditions.
Therefore, residential uses are the only sources of exposure which
could be aggregated for methylene bis(thiocyanate). The Agency has
identified several potential exposure scenarios for residential uses including
mixing, handling and applying ready to use products for wood treatment
and handling and applying paints: persons reentering areas recently treated
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with products containing methylene bis(thiocyanate); and exposures to
methylene bis(thiocyanate) treated wood. However, based on the high
dermal exposure MOEs for homeowner applications (See Table 5), the
Agency believes that the aggregate exposures to methylene bis(thiocyanate)
for applicators in the home are not likely to be of concern.
However, the Agency does not have chemical specific post-
application data to quantitatively determine the amount of pesticide to
which a person re-entering a treated area would be exposed to nor chemical
specific exposure data for persons applying methylene bis(thiocyanate)
containing products, and has required data on these exposures.
Cumulative Effects
Consideration has been given to cumulative effects of methylene
bis(thiocyanate) and other substances that have a common mode of toxicity.
However, the Agency has not made a determination whether methylene
bis(thiocyanate) and any other pesticide have a common mode of toxicity
and require cumulative risk assessment. For the purposes of this
Reregistration Eligibility Decision document, the Agency has considered
only risks from methylene bis(thiocyanate). If required, cumulative risks
will be assessed when methodologies for determining common mode of
toxicity and for performing cumulative risk assessment are finalized.
C. Environmental Assessment
The Agency has adequate data to assess the environmental fate of methylene
bis(thiocyanate) and the ecological hazard of methylene bis(thiocyanate) to nontarget
terrestrial and aquatic organisms for the uses specified in the RED.
1. Ecological Toxicity Data
a. Toxicity to Terrestrial Animals
(1) Birds, Acute and Subacute
An oral (LD50) study (preferably mallard or bobwhite quail)
and two subacute dietary (LC50) studies (one species of waterfowl,
preferably the mallard duck and one species of upland game bird,
preferably bobwhite quail) are required to establish the toxicity of
a pesticide to birds. The results reported in Tables 7 and 8 indicate
that methylene bis(thiocyanate) is moderately toxic to avian species
on an acute oral basis and practically nontoxic to avian species on
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a subacute dietary basis. The guideline requirements are fulfilled.
(MRIDs 150231, 150232, and 150233)
Table 7: Avian Acute Oral Toxicity Findings.
Species
Northern Bobwhite Quail
Mallard Duck
%A.I.
99.0
99.4
LD5() (ppm)
50
45-68 (male -female, respectively)
MRID
150232
150231
Toxicity Category
moderately toxic
moderately toxic
Table 8: Avian Subacute Dietary Toxicity Findings.
Species
Northern Bobwhite Quail
Mallard Duck
% A.I.
99.4
99.4
LCM (ppm)
>5000
>5000
MRID
150233
150232
Toxicity Category
practically nontoxic
practically nontoxic
(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, a rat acute oral LD50 obtained
from the Agency's Health Effects Division (HED) Tox Oneliners
is used as a surrogate for mammalian acute toxicity. This LD50
reported in Table 9 below indicate that methylene bis(thiocyanate)
is moderately toxic to small mammals on an acute oral basis.
Table 9: Mammalian Acute Oral Toxicity Findings.
Species
Rat (small-mammal surrogate)
% A.I.
98
LD50 (mg/kg)
male 84.9 female 68.3
MRID.
41592901
Toxicity Category
III
b. Toxicity to Aquatic Animals
(1) Freshwater Fish
Two freshwater fish toxicity studies using the technical
grade of the active ingredient are required to establish the toxicity
of a pesticide to freshwater fish. One study should use a coldwater
species (preferably the rainbow trout), and the other should use a
warm water species (preferably the bluegill sunfish). The results
reported in Table 10 indicate that methylene bis(thiocyanate) is very
highly toxic to rainbow trout and highly toxic to bluegill sunfish on
an acute basis. The guideline requirement is fulfilled. (MRIDs
40518608 and 40518609)
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Table 10: Freshwater Fish Acute Toxicity Findings.
Species
Rainbow trout
Bluegill sunfish
%A.I.
100.0
100.0
LC50 (ppm)
0.089
0.25
MRID
40518609
40518608
Toxicity Category
very highly toxic
highly toxic
(2)
Freshwater Invertebrates
A freshwater aquatic invertebrate toxicity test using the
technical grade of the active ingredient is required to assess the
toxicity of a pesticide to freshwater invertebrates. The preferred
test organism is Daphnia magna, but early instar amphipods,
stoneflies, mayflies, or midges may also be used. The results
reported in Table 11 indicate that methylene bis(thiocyanate) is very
highly toxic to aquatic invertebrates on an acute basis. The
guideline requirement is fulfilled. (MRID 40518601)
Table 11: Freshwater Invertebrate Toxicity Findings
Species
Daphnid Daphnia magna
%A,L
100.0
LC50 (ppm)
0.061 (0.036-0.10)
MRID No, Author/Year
40518601
Toxicity Category
very highly toxic
(3) Freshwater Invertebrates, Chronic
Chronic freshwater invertebrate data are not required for
methylene bis(thiocyanate). However, data were submitted, and the
results are reported in Table 12. Results indicate a NOEC of 5.8
ppb. The LOEC is 16 ppb. The geometric mean (MATC) is 9.6
ppb which is the estimated low effect level. The effect observed
was to the growth and reproductive processes of Daphnia magna.
This study is acceptable for the guideline requirement. (MRID
42517001)
Table 12: Aquatic Invertebrate Life-Cycle Toxicity Findings
Species
Daphnid
Daphnia magna
%A.L
99.2
NOEC (ppb)*
5.8/16.0
MATC (ppb)*
9.6 (mean)
MRID
42517001
Endpoints Affected
reproductive and growth
processes
Measured in parts per billion.
(4)
Estuarine and Marine Animals
Data from acute toxicity testing with estuarine and marine
organisms (fish, shrimp and oyster embryo-larvae or shell
deposition) using the technical grade of the active ingredient are
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reported in Table 13. The results indicate that methylene
bis(thiocyanate) is very highly toxic to eastern oyster and mysid
shrimp, and highly toxic to sheepshead minnow on an acute basis.
The guideline requirement is fulfilled. (MRIDs 42541601,
42513401, and 42513402)
Table 13: Estuarine/Marine Acute Toxicity Findings
Species
Eastern oyster (shell
deposition or embryo-larvae)
Mysid shrimp
Sheepshead minnow
% A.I.
99.2
99.2
99.2
LC50/EC50 (ppb)*
EC50 = 3.0 (2.75-3.37)
LC50 = 36
LC50 = 606 (529-7 19)
MRID
42541601
42513401
42513402
Toxicity Category
very highly toxic
very highly toxic
highly toxic
* Measured in parts per billion.
2. Environmental Fate
a.
Environmental Fate Assessment
Data on hydrolysis and aqueous availability were submitted for
methylene bis(thiocyanate). The registrant also submitted soil photolysis,
aerobic soil metabolism, anaerobic aquatic metabolism, aerobic aquatic
metabolism, however, these studies are not required for the current use
patterns and did not meet acceptable guideline requirements, so they were
not included in this document. No additional data are required at this time.
Methylene bis(thiocyanate) is susceptible to hydrolysis at higher
pHs, but stable at lower pH's. The major hydrolysate observed is the
thiocyanate ion (SCN). Laboratory experiments conducted to assess the
potential for leaching from wood show extensive leaching after a period of
30 days. Photolysis of methylene bis (thiocyanate) on wood surfaces is
unlikely to occur.
At approximately 28 ppm, 14C-methylene bis (thiocyanate) (material
radiolabeled in the methylene and thiocyanate carbons) hydrolyzed with
registrant calculated half-lives of 6.18 days at pH 7 and 2.22 hours at pH
9. Methylene bis (thiocyanate) was stable at pH 5 after 30 days of
incubation.
The major methylene bis (thiocyanate) hydrolysate observed was the
thiocyanate ion (SCN), which seems to be persistent once it is formed.
Other hydrolysates observed are formic acid, C02, mostly present as the
carbonate ion (C032), and mercaptomethylenethiocyanate (NC-SCH2-SH).
These hydrolysates were present at <26.1% of the Total Test Substance
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(TTS). The percent TTS, is the observed degradate level (in percent initial
radioactivity) following corrections and normalization for the presence of
radioactive material labeled in the methylene and thiocyanate positions.
A significant amount of radioactivity leached from wood pieces
treated with radiolabeled methylene bis (thiocyanate). The drying period
appears to be the factor that most affects the potential for leaching.
Generally, for the samples dried for 30 minutes, the majority (>70%) of
the material leached within the first 3 days. For the samples dried for 21
days, the majority (>70%) of the material leached within the first 7 days.
Bound residues (residues not readily extractable) were slightly greater for
the wood samples dried for 21 days. Generally, leaching was slightly
faster for samples leached in pH 7 and 9 buffered solutions and in synthetic
seawater, compared to the samples leached in distilled water and pH 5
buffered solutions.
In the leaching studies, the degradates profile is similar to the one
observed in the hydrolysis study. Methylene bis (thiocyanate) appeared to
be stable in pH 5 buffer and distilled water. In the pH 7 and synthetic
seawater, thiocyanate (SCN) and carbonate (C032) were observed in small
quantities. At pH 9, methylene bis (thiocyanate) was hydrolyzed to
thiocyanate and carbonate.
[14C] Methylene bis (thiocyanate) was relatively stable both on pine
and oak wood surfaces irradiated with artificial light (xenon arc lamp). In
the pine and oak woods, the photo degradation half-lives were in excess of
48 days.
For the outdoor wood preservative use of methylene
bis (thiocyanate), the potential of environmental exposure of the chemical
under actual use conditions is small. The chemical hydrolyses quickly at
neutral and alkaline pHs. Also, the Agency believes that the extensive
leaching observed in the laboratory study is probably not characteristic of
the end-use (formulated) products of methylene bis (thiocyanate). The end-
use products are applied with a sealant/water repellent. This probably
inhibits the leaching process. Additionally, most of the applications are
residential, which involves little environmental exposure.
Therefore, methylene bis (thiocyanate) degrades quickly and would
not be persistent if it reached the environment. Methylene bis (thiocyanate)
has a very low potential to leach into groundwater or to run off into surface
water under typical use conditions.
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b. Environmental Fate, Chemistry and Transport
(1) Hydrolysis
[14C]methylene bis(thiocyanate) material radiolabeled in the
methylene and the thiocyanate positions, at approximately 28 ppm,
hydrolyzed with registrant calculated half-lives of 6.18 days at pH
7 and 2.22 hours at pH 9. Methylene bis (thiocyanate) was stable
at pH 5 after 30 days of incubation.
The major methylene bis (thiocyanate) hydrolysate observed
was the thiocyanate ion (SCN), which was a maximum of 52.4%
TTS after 30 days in the pH 7 solution, and reached 50.1% TTS
after 24 hours in the pH 9 solution, with little change thereafter.
The hydrolysate formic acid steadily increases at pH 7 to a
maximum of 16.4% TTS at 30 days. In the pH 9 solution, it
reaches a maximum of 26.1% TTS after 720 hours (last test
interval).
C02 was observed mostly as the carbonate ion in solution
(C032) and as volatiles (about 80% of the amount trapped in the
NaOH traps). The carbonate ion was a maximum of 5.9% TTS at
14 days at pH 7, and 15.1% TTS at 24 hours at pH 9.
Unknown No. 1, whose proposed structure based on spectral
data is mercaptomethylenethiocyanate (NC-SCH2-SH), was a
maximum of 20.1% TTS at 30 days in the pH 7 solution and 12.7%
TTS at 24 hours in the pH 9 solution. This study is acceptable and
satisfies the hydrolysis data requirement. No additional data are
required. (MRID 43092101)
(2) Aqueous Availability Degradation
Leaching from Wood. Methylene bis (thiocyanate) was applied to
dried wood pieces of constant weight (within ±1.0 g) by
submersion with periodic agitation for 30 minutes into an aqueous
solution of active ingredient at 1000 and 2000 ppm. The wood
samples were then dried for 30 minutes at room temperature or 21
days at 25±1.0°C and 50% relative humidity (RH). The wood
samples were leached in distilled water, pH 5,7, and 9 buffered
aqueous solutions, and synthetic seawater for up to 30 days at
25±1.0°C in sealed containers.
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A significant amount of radioactivity leached from the wood
pieces. Radiolabelled [14C] material found in the leachates 30 days
after treatment averaged 91.1% for the samples that were dried for
30 minutes, and 85.6% for the samples that were dried for 21 days.
For the samples dried for 30 minutes, the majority (>70%) of the
material leached within the first 3 days. For the samples dried for
21 days, the majority (>70%) of the material leached within the
first 7 days. More than 50% of the initial radioactivity was leached
within one day from all the samples dried for 30 minutes. For the
samples dried for 21 days, 50% of the initial radioactivity leached
within the first 3 days of incubation. Bound residues were slightly
greater for the wood samples dried for 21 days.
Methylene bis(thiocyanate) appeared to be stable in pH 5
buffer and distilled water. In the pH 7 and synthetic seawater,
thiocyanate (SCN) and carbonate (C032) were observed in small
quantities. At pH 9, the methylene bis (thiocyanate) was degraded
to thiocyanate and carbonate, and there was an unknown (7.2-9.9%)
that was speculated to be NCS-CH2-SH, based on the results of the
hydrolysis study. This study satisfies the leaching from wood data
guideline. No additional data are required. (MRIDf 43545601)
Photolysis on Wood. [14C] Methylene bis (thiocyanate) was
relatively stable on wood surfaces irradiated with artificial light
(xenon arc lamp) for 360 hours (12 hours of exposure per day). In
the pine wood, the normalized concentration of methylene
bis (thiocyanate) decreased with an estimated half-life of 734 hours
(61 days). In contrast, the half life was of 2805 hours (234 days)
in the control samples. In the oak wood, the normalized
concentration of methylene bis (thiocyanate) decreased with a half-
life of 578 hours (48 days) and 799 hours (65 days) in the dark
control. The only degradate identified was the thiocyanate ion,
which was <2.948% of time zero [14C] recovery at all test intervals
in the pine samples, <6.20% in the irradiated oak samples, and up
to 18.81 in the non-irradiated sample. This study satisfies the
photolysis on wood data guideline. No additional data are required.
(MRID 43511101)
3. Exposure and Risk Characterization
The Agency requires only a limited set of ecotoxicology and environmental
fate studies for microbiocides. Methylene bis (thiocyanate) is moderately toxic to
practically nontoxic to avian species on an acute basis, very highly toxic to highly
toxic to freshwater fish on an acute basis, and very highly toxic to aquatic
40
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invertebrates on an acute basis. Chronic effects were observed in freshwater fish
and aquatic invertebrates.
While the hazard to aquatic organisms from methylene bis(thiocyanate) 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. Labels for all methylene
bis(thiocyanate) products must require that discharges to aquatic environments
comply with an NPDES permit.
The oil-related aquatic uses (oil recovery drilling muds/packer fluids,
secondary oil recovery injection water) are expected to result in minimal to no
exposure if proper procedures are employed in the disposal of the contaminated
materials.
Based on the environmental fate assessment, wildlife are not expected to be
exposed to methylene bis(thiocyanate) from its wood preservative uses, therefore,
there is little likelihood of adverse effects occurring to wildlife.
The Agency does not anticipate any exposure of concern to fish, wildlife,
and/or endangered species providing that all methylene bis(thiocyanate) products
are handled and applied as specified in the product labeling and that discharges to
the environment comply with all Federal disposal laws and NPDES.
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission
of relevant data concerning an active ingredient, whether products containing the active
ingredient are eligible for reregistration. The Agency has previously identified and
required the submission of the generic (i.e. active ingredient specific) data required to
support reregistration of products containing methylene bis(thiocyanate) 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 some uses of products
containing methylene bis(thiocyanate) at this time. Appendix B identifies the generic data
requirements that the Agency reviewed as part of its determination of reregistration
eligibility of methylene bis(thiocyanate), and lists the submitted studies that the Agency
found acceptable.
The Agency is concerned about possible effects from inhalation exposure to
methylene bis(thiocyanate) based on the only methylene bis(thiocyanate) inhalation data
available, an acute study, which showed very high toxicity. Cyanide is a metabolite of
methylene bis(thiocyanate) and both cyanide and formaldehyde are potential degradates
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of methylene bis(thiocyanate). It is possible that the thiocyanate ion would degrade to
cyanide, but degradation data are lacking that would indicate whether this occurs in the
working environment and, if so, under what conditions. However, notwithstanding these
concerns, the Agency believes many uses of methylene bis (thiocyanate) are eligible for
reregistration. The existing acute inhalation study is of very poor quality and can only be
used for establishing a labeling toxicity category and not for risk assessment. Surrogate
data for industrial biocide uses show that dermal exposure is 2 or 3 orders of magnitude
greater than inhalation exposure and that inhalation exposure for some use scenarios is
below the limit of detection. In addition, the Agency is requiring the use of a respirator
for all methylene bis (thiocyanate) product labels in Toxicity Category I or II because of
acute inhalation toxicity. The Agency is also requiring a subchronic inhalation study and
air monitoring data that will quantitate amounts of cyanide and formaldehyde that might
be present during application and post-application.
Generally, methylene bis (thiocyanate) uses that showed acceptable Margins of
Exposure (MOE) from dermal exposure have been determined to be eligible for
reregistration. The Agency could not make a decision for those uses for which there was
no dermal exposure data and no way to determine if these uses posed no worse exposure
than uses where data were available. The Agency also determined that it could not make
a decision on the use of paints and ready-to-use products that are applied with a paint
brush, roller or compressed sprayer even though MOE's are very low for occupational
handlers. Before a decision can be made information on what types of paints contain
methylene bis (thiocyanate) and what levels of post-application exposure (dermal and
inhalation) result from painting and applications of ready-to-use products are necessary.
The eligibility of specific uses is detailed in Section IV.B.I. below.
To confirm the Agency's assessment and quantify any potential inhalation risk to
methylene bis (thiocyanate) and its degradates, the Agency is requiring the registrants to
conduct a subacute inhalation study which is the appropriate Tier I study to quantify
inhalation toxicity. Additionally, upgraded information to the supplementary metabolism
studies is required. This information, as well as the exposure and post-application data
being required can be used to determine risk and eligibility for those uses for which a
decision cannot be made. The Agency will also notify OSHA if there is a concern for
workers from inhalation exposures to methylene bis (thiocyanate) and it degradates
following review of the subchronic inhalation study and the required exposure data.
The Agency, therefore, finds that only the specific products containing methylene
bis (thiocyanate) as the active ingredient bearing uses as specified in Section IV.B.I. below
are eligible for reregistration.
The Agency made its reregistration eligibility determination based upon the target
data base required for reregistration, the current guidelines for conducting acceptable
studies to generate such data, published scientific literature, etc. and the data identified in
Appendix B. Although the Agency has found that the uses of methylene bis (thiocyanate)
42
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can not all be assessed for reregistration at this time, 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 methylene
bis(thiocyanate), if new information comes to the Agency's attention or if the data
requirements for registration (or the guidelines for generating such data) change.
B. Determination of Eligibility
1. Uses Eligible at This Time
Based on the reviews of the generic data for the active ingredient methylene
bis(thiocyanate), the Agency has sufficient information on the health effects of
methylene bis(thiocyanate) and on its potential for causing adverse effects in fish
and wildlife and the environment when used for the following uses:
• Industrial preservatives with oil recovery drilling muds/packer fluids (both
off-shore and/or terrestrial sites);
Air washer water systems;
Commercial/industrial water cooling systems;
Evaporative condenser water systems;
Heat exchanger water systems;
Industrial auxiliary water systems;
Industrial scrubbing systems;
Industrial waste disposal systems;
Pulp/paper mill water systems;
Adhesives, industrial;
Coatings, industrial;
Emulsions, resin/latex/polymer
Secondary oil recovery injection water;
Sewage systems;
Pasteurized/warmer/cannery cooling water systems;
Reverse osmosis water systems;
Fuel/oil storage tank bottom water additive;
Metal working cutting fluid;
Paper/paper products;
Speciality industrial products; and
Wet-end additives/industrial processing chemicals.
The Agency has determined that these methylene bis(thiocyanate) products,
labeled and used as specified in this Reregistration Eligibility Decision, will not
pose unreasonable risks or adverse effects to humans or the environment.
Therefore, the Agency concludes that these products containing methylene
bis(thiocyanate) are eligible for reregistration.
43
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2. Uses for Which a Reregistration Decision Cannot be Made
The Agency has determined that a decision cannot be made at this time for
the following products containing methylene bis(thiocyanate) as an active
ingredient until the data required in Section V of this document are provided:
• Wood or wood structure protection treatments to both seasoned and
unseasoned forest products;
Wood or wood structure protection treatments;
Wood protection treatment to buildings/products;
Leather processing liquids;
Leather/leather products; and
Paints (in-can).
C. Regulatory Position
The following is a summary of the regulatory positions and rationales for
methylene bis(thiocyanate). Where labeling revisions are imposed, specific language is
set forth in Section V of this document.
1. Occupational and Residential Labeling Rationale/Risk Mitigation
Measures
During reregistration, the Agency considers handler safety requirements for
occupational and residential uses. The Agency establishes handler safety
requirements when risk assessments or general concerns suggest such requirements
are appropriate. If the Agency determines that no specific handler requirements
are warranted based on the potential acute or other adverse effects of the active
ingredient, the handler safety requirements will be based on the acute toxicity
characteristics of the end-use product.
The Agency is developing standardized requirements for occupational
handlers of industrial biocides, based on the acute toxicity characteristics of each
end-use product. Comments on these requirements should be addressed during the
public comment period for methylene bis(thiocyanate).
The Agency has determined that handlers (mixers, loaders, applicators,etc.)
of all industrial biocides must wear long-sleeve shirts, long pants, shoes, and socks
as minimum work attire. For industrial biocide end-use products that are
classified as toxicity category I or II for acute dermal or skin irritation potential,
handlers are required to wear chemical-resistant gloves and a chemical-resistant
apron in addition to the minimum work attire. For industrial biocide end-use
products classified as toxicity category I or II for eye irritation potential, handlers
are required to wear protective eyewear. For industrial biocide end-use products
44
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classified as toxicity category I or II for acute inhalation toxicity, handlers are
required to wear a respirator. The type of respirator must be established based on
the acute toxicity category and the vapor pressure and must be specified on the
end-use product labeling. The Agency will assist registrants in determining the
appropriate type of respirator during the end-use product stage of reregistration.
Table 14: Personal Protective Equipment Standard Requirements
Route of Concern
Acute Dermal
Toxicity or Skin
Irritation Potential
Eye Irritant
Acute Inhalation
Toxicity
Toxicity
Category I
Long sleeve shirt, long
pants, shoes, socks, &
chemical- resistant
gloves & apron
Protective Eyewear
Respirator
Toxicity
Category II
Long sleeve shirt, long
pants, shoes, socks, &
chemical- resistant
gloves, & apron
Protective Eyewear
Respirator
Toxicity
Category III
Long sleeve
shirt, long pants,
shoes, & socks
No minimum
No minimum
Toxicity
Category IV
Long sleeve
shirt, long pants,
shoes, & socks
No minimum
No minimum
a. Personal Protective Equipment Requirements for Occupational
Handlers
The Agency has determined that active-ingredient based handler
safety requirements must be established due to the acute and other adverse
effects of methylene bis(thiocyanate) as follows:
• Dip Application (e.g., leather or wood processing) The Agency
is requiring the handlers participating in hand-dip applications to
wear chemical-resistant full-front aprons with attached full-sleeve
gloves due to concerns about potentially high dermal exposures
during introduction and removal of materials, such as leather or
wood products, by hand from dip vats.
• Spray Applications The Agency is requiring that persons not
directly participating in spray applications in enclosed or indoor
areas must be excluded from the treated area and from an area
extending at least 25 feet from the perimeter of the treatment site
until application is complete and sprays have settled out of the air
due to inhalation concerns.
The Agency has determined that for all other handler tasks, handler
safety requirements for products containing methylene bis(thiocyanate)
must be determined based on the acute toxicity characteristics of the end-
use products. However, the Agency is concerned about the dermal and
45
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inhalation exposures to occupational handlers in many exposure scenarios
and is requiring data for those scenarios. (See Section V for details).
b. Engineering Control Requirements for Occupational Handlers
The Agency has determined that engineering control requirements
must be established based on unacceptable margins of exposure for the
following use pattern:
• Cooling Water Systems - Open Pouring The Agency is concerned
about risks to the primary handler open-pouring liquid formulations
for large water cooling systems (> 4000 gallons per day) uses since
the MOE is 31 (wearing gloves) for this application method.
However, in large cooling system settings if a pump-metering
system was used, it would significantly reduce the exposure and
risk associated with use of methylene bis(thiocyanate) (MOE of
3524). Therefore, the Agency is requiring the use of a pump-
metering system for all water cooling systems of > 4000 gallons
per day. For smaller cooling systems (<^4000 gallons per day), the
MOE is 155 for exposures due to open pouring situations which is
below the Agency's level of concern. Therefore, no additional
mitigation is required for smaller cooling systems (< 4000 gallons
per day).
c. Post-Application Safety Requirements
The Agency is establishing safety requirements for post-application
exposure to methylene bis(thiocyanate) following applications in
commercial, industrial and residential settings (e.g., dermal (mist, steams)
and inhalation) as follows:
• Spray Applications The Agency is establishing a requirement that
all persons, other than handlers involved in the spray application,
remain at least 25 feet outside the treatment site during application
and until sprays have settled out of the air, due to inhalation
concerns when methylene bis(thiocyanate) is applied as a spray in
indoor or enclosed areas.
• Spray and Dip Applications - Handlers The Agency is requiring
that all persons handling treated materials, such as leather or wood
products, still wet with the application wear a chemical-resistant
apron and chemical resistant gloves due to skin irritation concerns.
46
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The Agency is requiring exposure data and air-monitoring data for
post-application exposures from commercial wood treatment process and
post-application inhalation exposures in occupational and residential settings
from methylene bis(thiocyanate) and its potential degradates. See Section
V for details for all requirements.
d. Other Mitigation Measures
The Agency is also concerned about dermal and inhalation
exposures to occupational handlers in many exposure scenarios and possible
inhalation hazards to homeowner handlers and is requiring air-monitoring
data for all applicable scenarios.
Under section 5 of the Occupational Safety and Health Act, 29
U.S.C. 651 et sec, every employer has a general duty to furnish a place of
employment which is free from recognized hazards that are causing, or are
likely to cause, serious physical harm. Every employer is also required to
comply with occupational safety and health standards promulgated by
OSHA. Operations such as blending and formulating using methylene
bis(thiocyanate) in general industry (i.e., Standard Industrial Codes 20 -
39) may be subject to other Occupational Safety and Health Administration
(OSHA) requirements. There is no OSHA Permissible Exposure Limit
(PEL) for methylene bis(thiocyanate), but particulate exposures to
methylene bis(thiocyanate) in general industry are subject to the OSHA
PEL for Particulates Not Otherwise Regulated, of 15 mg/m3 as an 8-hour
Time-Weighted Average (TWA). In addition, OSHA has established
requirements for hazard communication and use of personal protective
equipment for protection of workers potentially exposed to chemical or
other types of hazards in the workplace.
OSHA's hazard communication standard (29 CFR 1910.1200)
establishes requirements for labeling, preparation and dissemination of
Material Safety Data Sheets (MSDSs), training, etc., for workers
potentially exposed to hazardous chemicals. OSHA requirements for the
selection and use of personal protective equipment (29 CFR 1910, Subpart
I) include an assessment of the workplace to determine if hazards
potentially requiring the use of head, eye, face or foot protection are
present or are likely to be present. If hazards are identified, employers
must select and have employees use appropriate personal protective
equipment (PPE) which has been properly fitted and selected based on the
potential hazard present. Employers are required to provide training on the
proper use of personal protective equipment, when it is required, what PPE
is needed, how to properly don, doff, adjust and wear the PPE, the
47
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limitations of the equipment, and the proper care and maintenance, useful
life, and disposal of the PPE.
For methylene bis(thiocyanate) end-use products, the MSDS
recommends specific personal protective equipment including rubber
gloves, safety glasses or chemical splash goggles, body protective clothing
such as long sleeve shirts and long trousers and protective shoes. Provided
this equipment is appropriately selected, maintained, and used, worker
exposures during operations where methylene bis(thiocyanate) is used in
preservatives, metal working cutting fluids, oil recovery and drilling
mud/packer fluid, and in paper coating are expected to be reduced. For
methylene bis(thiocyanate) the MSDS provides information on the
reactivity of methylene bis(thiocyanate) with strong acids, strong alkali and
strong oxidizers and warns of its possible decomposition products to such
chemicals as cyanide. It should be noted that OSHA generally does not
inspect workplaces with fewer than 10 employees.
f. Other Labeling Requirements
The Agency is requiring additional use and safety information to be
placed on the labeling of all end-use products containing methylene
bis(thiocyanate) to afford supplemental protection to handlers. For specific
labeling statements addressing application restrictions, user safety
requirements and recommendations, and a skin sensitization statement,
refer to Section V of this document.
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
a. Toxicology Studies
The toxicological database for methylene bis(thiocyanate) is not
complete. Data are not available to characterize the risk due to inhalation
exposure of methylene bis(thiocyanate). The Agency has required in a
Data Call-in issued in March 1997, a 90-day inhalation study (GDLN 82-
2) to quantify the level of hazard posed by exposure via the inhalation
route. If the required air monitoring data indicate the presence of cyanide
and formaldehyde, inhalation toxicity data on cyanide and formaldehyde
48
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may be required as appropriate.
Although there are two supplementary metabolism studies, there is
still a data gap for metabolism primarily due (but not limited) to inadequate
metabolite identification. One study is potentially upgradable. The
additional metabolism data remains outstanding and the registrant has been
required to submit information to upgrade this data. In addition to the data
discussed above the Agency will be asking for additional use information
on what types of paints contain methylene bis(thiocyanate) in order to make
an eligibility decision on occupational uses of paint and ready-to-use
products.
b. Handler Studies
EPA is requiring the following data for handler exposures:
• For uses as a wood pressure treatment to forest products;
• For uses in leather processing liquors, leather processing, and
leather products;
• For application as a dip for leather products and for wood
preservation, including removal of products from the dip.
• For painting with a roller;
• Spray treatments for wood and other industrial/manufacturing
treatments.
For each of these exposure scenarios, studies should be conducted
using guideline numbers: 231, 232, 233 and 234. The air monitoring
studies must include monitoring for potential degradates (formaldehyde and
cyanide) as well as monitoring for methylene bis(thiocyanate) itself. For
the wood pressure treatments, data required must include uses by
occupational handlers who (1) operate the solution supply system, (2) use
dip tanks, and (3) drive forklifts or carrier trucks to dip lumber.
c. Post-Application Studies
EPA is requiring data for post-application exposures: (1) in painted
areas where paint is applied by brush, roller, and sprayer; and (2)
associated with wood-product treatments. For these exposure scenarios,
studies should be conducted using guideline numbers: 133-3 and 133-4.
The air monitoring studies for paint uses must include monitoring for
potential degradates (formaldehyde and cyanide) as well as monitoring for
methylene bis(thiocyanate) itself. Data required for use scenarios
associated with wood-product treatments must include exposures to (1)
workers (graders, lumber pullers, etc.) who handle wood wet from the
49
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treatment, (2) workers who handle dry treated wood, and (3) workers who
perform maintenance on any part of the treatment system or machinery.
The above mentioned generic data on occupational and post-application exposures
will be required as part of a subsequent Data Call-in Notice. However, because much of
the exposure data needed for methylene bis(thiocyanate) is generic in nature and will also
be required for other antimicrobial chemicals with similar characteristics and the same
uses, EPA is developing a generic exposure DCI. Methylene bis(thiocyanate) registrants
will receive the generic exposure DCI at the same time as registrants of other chemicals
with similar uses.
2. Labeling Requirements for Manufacturing-Use Products
To remain in compliance with FIFRA, manufacturing use product (MP)
labeling must be revised to comply with all current EPA regulations, PR Notices
and applicable policies. The MP labeling must bear the following statement under
Directions for Use:
An MP registrant may, at his/her discretion, add one of the following
statements to an MP label under
"Directions for Use" to permit the reformulation of the product for a
specific use or all additional uses supported by a formulator or user group:
(a) "This product may be used to formulate products for specific use(s)
not listed on the MP label if the formulator, user group, or grower
has complied with U.S. EPA submission requirements regarding
support of such use(s)."
(b) "This product may be used to formulate products for any additional
use(s) not listed on the MP label if the formulator, user group, or
grower has complied with U.S. EPA submission requirements
regarding support of such use(s)."
Effluent Discharge Labeling Statements
"Do not discharge effluent containing this product into lakes, streams, ponds,
estuaries, oceans or other waters unless in accordance with the requirements of a
National Pollutant Discharge Elimination System (NPDES) permit and the
permitting authority has been notified in writing prior to discharge. Do not
discharge effluent containing this product to sewer systems without previously
notifying the local sewage treatment plant authority. For guidance contact your
State Water Board or Regional Office of the EPA."
50
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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 Occupational Users
For sole-active-ingredient end-use products that contain methylene
bis(thiocyanate), the product labeling must be revised to adopt the handler
personal protective equipment/engineering control requirements set forth
in this section. Any conflicting PPE requirements on the current labeling
must be removed.
For multiple-active-ingredient end-use products that contain methylene
bis(thiocyanate), the handler personal protective equipment/engineering
control requirements set forth in this section must be compared to the
requirements on the current labeling and the more protective must be
retained. For guidance on which requirements are considered more
protective, see PR Notice 93-7.
(1) Minimum (Baseline) PPE/Engineering Control Requirements
EPA is requiring the following PPE based on the acute toxicity of
the methylene bis(thiocyanate) end-use products.
"Mixers, loaders, applicators and other handlers must wear:
— Long-sleeve shirt and long pants,
— Shoes plus socks."
If the end-use product is classified as toxicity category I or II for eye
irritation potential, add to the above list of PPE:
51
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— "Protective eyewear."
If the end-use product is classified as toxicity category I or II for acute
dermal toxicity or skin irritation potential, add to the above list of PPE:
— "Chemical-resistant apron, and chemical-resistant gloves*."
If the end-use product is classified as toxicity category I or II for acute
inhalation toxicity, a respirator requirement must be added. The type of
respirator must be specified in the statement and is based on the acute
toxicity category and the vapor pressure. EPA will assist registrants in
determining the appropriate type of respirator during the end-use product
phase of reregistration.
For the glove statement, use the statement established for methylene
bis(thiocyanate) through the instructions in Supplement Three of PR Notice
93-7. In addition, for concentrated methylene bis(thiocyanate) products, the
corrosiveness and penetration of methylene bis(thiocyanate) must be
considered. Appropriate chemical-resistant materials must be listed on the
product labeling.
(2) Other PPE/Engineering Control Requirements
In addition to the PPE specified above, the following specific PPE
requirements must be added to labels containing the following uses.
When labeling permits application as a dip, add the following:
"Handlers participating in hand-dip applications, including
introduction of materials to and removal from the dip and handling
materials still wet from the dip, must wear chemical-resistant full-
front aprons with attached full-sleeve gloves."
For liquid product formulations applied to cooling water systems of >4000
gallons the following engineering control restriction is required on product
labels.
"Do not apply by open pouring of liquid to cooling water systems;
a metering pump delivery system is required for this use and
application method."
(3) Placement in Labeling
The personal protective equipment requirements must be placed on
the end-use product labeling in the format and language specified above and
52
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must be placed in the "Hazards to Humans" section of the pesticide
labeling.
b. Other Application Restrictions
Other application restrictions for methylene bis(thiocyanate) product
labels are:
1. For all end-use products: "Do not apply this product in a
way that will contact workers or other persons."
"Follow manufacturer's instructions for cleaning/maintaining PPE.
If there are no such instructions for washables, use detergent and
hot water. Keep and wash PPE separately from other laundry."
2. When the labeling permits application as a spray, add the
following:
"All persons not directly participating in such spray applications in
enclosed or indoor areas must be excluded from the treatment site
and from an area extending at least 25 feet from the perimeter of
the treatment site until application is complete and sprays have
settled out of the air."
3. For liquid end-use products only: "Discard clothing or other
absorbent materials that have been drenched or heavily
contaminated with this product's concentrate. Do not reuse them."
c. User Safety Recommendations
Add the following user safety recommendations to labels of all
methylene bis(thiocyanate) end-use products:
"Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet."
"If pesticide gets inside clothing remove clothing immediately, wash
thoroughly, and put on clean clothing."
"Users should remove PPE immediately after handling this product. Wash
the outside of gloves before removing. As soon as possible, wash
thoroughly and change into clean clothing."
"This product may cause skin sensitization reactions in some
people."
53
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For Homeowner use products, add:
"Do not apply this product in a way that will contact any person or pet.
d. Effluent Discharge and Disposal Labeling Statements
See statement under Manufacturing Use Products, Section V.A.2.
e. 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).
C. Existing Stocks
Registrants may generally distribute and sell products bearing old labels/labeling
for 26 months from the date of the issuance of this 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 methylene
bis(thiocyanate) 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.
54
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VI. APPENDICES
55
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Report Run Date: 02/27/96 ) Time 13:01
PRD Report Date: 12/06/95
LUIS 2.22 - Page:
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
4444444444444444444444444444444,
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED
ADHESIVES, INDUSTRIAL
Industrial preservative treatment. During SC/L
manufacture. Not on label. Not
Applicable, Not applicable for this use
Preservative treatment, Not on label, Not SC/L
on label. Not Applicable, Not applicable
for this use
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/S
SC/S
SC/S
SC/L
W 7.5
W 7.5
W 10
W 20
W 200
W 9.8
W 14
W 14
W 6.7
AIR WASHER WATER SYSTEMS
Water treatment (recirculating system),
Continuous feed (initial), Not on label,
Not Applicable, Not applicable for this
use
SC/L
Use Group: INDOOR NON-FOOD
W 20 * NS NS NS
W 75 * NS NS
W 75 * NS NS
W 50 * NS NS
W 200 * NS NS
W 500 * NS NS
W 49 * NS NS
W 70 * NS NS
W 70 * NS NS
W 53 * NS NS
W 1000 * NS NS NS NS NS NS
Use Group: AQUATIC NON-FOOD INDUSTRIAL
W 6 * 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
A38, CIS,
C24
CIS, C24
CAH
C12, CIS
CAH
C22, CAH
C12, CIS
C12, CIS
CIS, C24
CIS, C24,
C92
C12, CIS
A08, C12,
CIS
SC/L
W 1.2
W 6 * NS NS
A08, CIS,
C24
56
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Report Run Date: 02/27/96
PRD Report Date: 12/06/95
) Time 13:01
LUIS 2.22 - Page:
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
4444444
Form(s)
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 Interv Entry
unless noted Max. /crop /year otherwise)/A] (days) Interv
otherwise) Dose cycle /crop /year [day(s)]
cycle
Geographic Limitations
Allowed Disallowed
Use
Limitations
Codes
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
AIR WASHER WATER SYSTEMS (con't)
Water treatment (recirculating system),
Continuous feed (subsequent), Not on
label, Not Applicable, Not applicable for
this use
SC/L
W .6
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
W 4.5 * NS NS NS NS NS NS
A08, C12,
CIS
SC/L
W 4.5 * NS NS
NS NS NS NS
A08, CIS,
C24
Water treatment (recirculating system),
Intermittent (slug)(initial), Not on
label, Not Applicable, Not applicable for
this use
SC/L
W 1.2
W 6 * NS NS
NS NS NS NS
A08, C12,
CIS
SC/L
W 6 * NS NS
NS NS NS NS
A08, CIS,
C24
Water treatment (recirculating system),
Intermittent (slug)(subsequent), Not on
label, Not Applicable, Not applicable for
this use
SC/L
W .6
W 4.5 * NS NS
NS NS NS NS
A08, C12,
CIS
SC/L
W 4.5 * NS NS
NS NS NS NS
A08, CIS,
C24
Water treatment, Initial, Not on label,
Not Applicable, Not applicable for this
use
SC/L
V 1
V 4 * NS NS
NS NS NS NS
A08, CIS,
C24
SC/L
W 4.2 * NS NS
NS NS NS NS
A08, CIS,
C24
SC/L
W 4.1 * NS NS
NS NS NS NS
A08, C22,
CAH
COATINGS, INDUSTRIAL
Additive treatment, Not on label, Not on SC/L
label, Not Applicable, Not applicable for
this use
Report Run Date: 02/27/96 ) Time 13:02
PRD Report Date: 12/06/95
W 500
Use Group: INDOOR NON-FOOD
W 9000 * NS NS NS
LUIS 2.22 - Page: 3
57
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APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Form(s) Min. Appl.
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr.
Geographic Limitations
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
less noted unless noted Max. /crop /year otherwise)/A] (days) Interv
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
Disallowed
Limitations
Codes
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
COATINGS, INDUSTRIAL (con't)
Industrial preservative treatment. During SC/L
manufacture. Not on label. Not
Applicable, Not applicable for this use
Industrial preservative treatment. Not on SC/L
label. Not on label. Not Applicable, Not
applicable for this use
Preservative treatment, Not on label, Not SC/L
on label. Not Applicable, Not applicable
for this use
SC/L
COMMERCIAL/INDUSTRIAL WATER COOLING SYSTEMS
Water related surface treatment. Not on SC/L
label. Paintbrush, Hard, Not applicable
for this use
Water related surface treatment. Not on SC/L
label. Sprayer, Hard, Not applicable for
this use
SC/L
SC/L
SC/L
SC/S
SC/S
SC/S
SC/L
W 10
W 200
W 500
W 9.8
W 14
W 14
W 500
W 6.7
W 50
V 500
V 500
Use Group: INDOOR NON-FOOD (con't)
W 75 * NS NS NS NS NS NS
W 50 * NS NS
W 5000 * NS NS
W 9000 * NS NS
W 49 * NS NS
W 70 * NS NS
W 70 * NS NS
W 9000 * NS NS
W 53 * 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
W 1000 * NS NS NS NS NS NS
Use Group: AQUATIC NON-FOOD INDUSTRIAL
V 700 * NS NS NS NS NS NS
V 700 * NS NS
NS NS NS NS
C12, CIS
C22, CAH
CIS, C24,
C92
C12, CIS
C12, CIS
CIS, C24
CIS, C24,
CAD
CIS, C24,
C92
C12, CIS
A08, CIS,
C22, C24
A08, CIS,
C22, C24
58
-------
Report Run Date: 02/27/96
PRD Report Date: 12/06/95
) Time 13:02
LUIS 2.22 - Page:
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
4444444
Form(s)
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 Interv Entry
unless noted Max. /crop /year otherwise)/A] (days) Interv
otherwise) Dose cycle /crop /year [day(s)]
cycle
Geographic Limitations
Allowed Disallowed
Use
Limitations
Codes
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
COMMERCIAL/INDUSTRIAL WATER COOLING SYSTEMS (con't)
Water related surface treatment, SC/L W 15
Shock/slug, Not on label, Hard, Not
applicable for this use
Water treatment (once-through system), SC/L W 1.2
Continuous feed (initial), Metering pump,
Not Applicable, Not applicable for this
use
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
W 15 * NS NS NS NS NS NS
W 4.4 * NS NS
NS NS NS NS
A08, CIS,
C22, C24
A08, C12,
CIS
Water treatment (once-through system),
Continuous feed (subsequent), Metering
pump, Not Applicable, Not applicable for
this use
SC/L
W 4.4 * NS NS
NS NS NS NS
A08, C12,
CIS
Water treatment (once-through system),
Intermittent (slug)(initial), Metering
pump, Not Applicable, Not applicable for
this use
SC/L
W 1.2
W 4.4 * NS NS
NS NS NS NS
A08, C12,
CIS
Water treatment (once-through system), SC/L
Intermittent (slug)(subsequent), Metering
pump, Not Applicable, Not applicable for
this use
W 4.4 * NS NS
NS NS NS NS
A08, C12,
CIS
Water treatment (recirculating system),
Continuous feed (initial), Not on label,
Not Applicable, Not applicable for this
use
SC/L
W .59
W 8.8 * NS NS
NS NS NS NS
A08, C12,
CIS
SC/L
W 3 * NS NS
NS NS NS NS
A08, C12,
CIS
SC/L W 1.2
W 6 * NS NS
NS NS NS NS
A08, C12,
CIS
SC/L W 1.2
W 6 * NS NS
NS NS NS NS
A08, CIS,
C24
Report Run Date: 02/27/96 ) Time 13:02
SC/L W 1.3
W 6.4 * NS NS NS NS NS NS
LUIS 2.22 - Page: 5
A08, CIS,
C24
59
-------
PRD Report Date: 12/06/95
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
444444444444444444
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
I))))))))))))))))))))))))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
COMMERCIAL/INDUSTRIAL WATER COOLING SYSTEMS (con't)
SC/L W 1.8
SC/L W 4.7
SC/L W 4.9
Water treatment (recirculating system), SC/L
label, Not Applicable, Not applicable for
this use
Water treatment (recirculating system),
Initial, Not on label, Not Applicable,
Not applicable for this use
V 1.2
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
W 6 * NS NS NS NS NS NS
W 10 * NS NS NS NS NS NS
W 11 * NS NS NS NS NS NS
V 4.7 * NS NS
NS
NS NS
NS
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
W .59
W .6
W .6
W .9
W 1.3
W 1.4
W 4.7
V 4.7
W .45
W .45
W .46
W
W
W
W
W
5
4
4
W
6
6
W
V
W
W
W
9
2
2
2
.9
.5
.5
3
.4
.7
10
.4
.8
.8
.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
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, C12, CIS
A08, CIS, C24
A08, CIS, C22,
C24
A08, CIS, C24
A08, C12, CIS
A08, C12, CIS
A08, CIS, C24
A08, C12, CIS
A08, CIS, C24
A08, C18,C22,
C24
A08, CIS, C24
CIS, C24
A08, C18,C24,
CAD
A08, C24, CAD
A08, C18,C24,
C92
SC/L
W .46
W 2.9 * NS NS
A08, C24, CAD
60
-------
Report Run Date: 02/27/96 ) Time 13:03 LUIS 2.22 - Page:
PRD Report Date: 12/06/95
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
4444444444444444444444444444444'
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
»)))))))))))))))))))))))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
)))))))))))))))))))))))
COMMERCIAL/INDUSTRIAL WATER COOLING SYSTEMS (con't)
SC/L W .48
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
W 3 * NS
SC/L
SC/L
W .49
W .66
W 3 * NS
W 4.1 * NS
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
Intermittent (slug) (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
W
W
W
W
W
W
V
W
W
W
W
W
W
W
.93
2
4.4
4.4
4.8
4.9
A.1
.47
.45
.49
.51
.59
.6
1.2
1.2
W 5
W
W 5
W 5
W 9
W 9
Vo
£
W 2
W
W 3
W 8
W
W
W
.7
12
.4
.5
.7
.7
.8
3
.1
.8
3
6
6
* 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
A08, CIS,
C24, CAD
A08, CIS,
C22, C24
A08, CIS,
C24, C92
A08, C24,CAD
A08, CIS,
C22, C24
A08, C22,C24
A08, C22,CAH
CIS, C24
A08, A1K4),
CIS, C24
A08, C12,
CIS
A08
A08, C12,C18
A08
A08, C12,C18
A08, C12,C18
A08, C12,C18
A08, C18,C24
61
-------
Report Run Date: 02/27/96 ) Time 13:03
PRD Report Date: 12/06/95
LUIS 2.22 - Page:
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
4444444444444444444444444444444'
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
»)))))))))))))))))))))))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
COMMERCIAL/INDUSTRIAL WATER COOLING SYSTEMS (con't)
SC/L W 1.3
SC/L W 1.8
SC/L W 2.4
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
W 6.4 * NS NS NS NS NS NS
W 6 * NS NS NS NS NS NS
W 4.8 * NS NS NS NS NS NS
Intermittent (slug) (subsequent) , Not on
label, Not Applicable, Not applicable for
this use
Shock/slug, Not on label
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
V .16
V 2.3
W .15
W .16
W .17
W .59
W .6
W .6
W .89
W .9
W 4.7
NA
NA
NA
V .94
V 4.7
W .9
W .98
W 1
W 5.9
W 4.5
W 4.5
W 1.8
W 3
W 10
uc
uc
uc
* 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
i o n
J.^ U
120
120
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
A08, CIS, C24
A08, C12, CIS
A08, C12
A08, C12, CIS
A08, CIS,
A08
A08, C12,
A08
A08, C12,
A08, C12,
A08, CIS,
A08, C12
A08, C12,
A08, CIS,
C24
CIS
CIS
CIS
C24
CIS
C24
C12, CIS
CIS, C22, C24
62
-------
Report Run Date: 02/27/96 ) Time 13:03
PRD Report Date: 12/06/95
LUIS 2.22 - Page:
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
444444444444444444
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
I))))))))))))))))))))))))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
COMMERCIAL/INDUSTRIAL WATER COOLING SYSTEMS (con't)
SC/L NA
SC/L NA
Water treatment (recirculating system), SC/L V 4.7
Shock/slug, Not on label, Not Applicable,
Not applicable for this use
Water treatment (recirculating system), SC/L V 2.3
Subsequent/maintenance, Not on label, Not
Applicable, Not applicable for this use
SC/L W .15
SC/L W .15
SC/L W .15
SC/L W .16
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
W .16
W .16
W .25
W .31
W .56
W .56
W .66
W 2.4
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
UC * NS NS NS NS 120 NS
UC * NS NS NS NS 120 NS
V 9.4 * NS NS NS NS NS NS
V 4.7 * NS NS NS NS NS NS
W .93 * NS NS NS NS NS NS
W .9 * NS NS NS
W .93 * NS NS NS
W .98 * NS NS NS
NS NS NS
NS NS NS
NS NS NS
Report Run Date: 02/27/96 ) Time 13:04
PRD Report Date: 12/06/95
W .97 * NS NS NS NS NS NS
W .98 * NS NS NS NS NS NS
W 1.3 * NS NS NS NS NS NS
W 1.9 * NS NS NS NS NS NS
W 2.7 * NS NS NS NS NS NS
W 2.7 * NS NS NS NS NS NS
W 3.9 * NS NS NS NS NS NS
W 4.9 * NS NS NS NS NS NS
LUIS 2.22 - Page: 9
CIS, C24,CAD
C24, CAD
A08, CIS,
C24
CIS, C24
A08,
C24,
CIS,
C24,
A08,
C22,
A08,
C24,
CIS,
CIS,
C24,
A08,
A08,
CIS,
A08,
CIS,
CIS,
C92
C24,CAD
CAD
CIS,
C24
CIS,
CAD
C22,C24
C24,C92
CAD
C22,C24
C22,CAH
C22,C24
A1K4) ,
C24
63
-------
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
4444444444444444444444444444444,
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
I))))))))))))))))))))))))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
COMMERCIAL/INDUSTRIAL WATER COOLING SYSTEMS (con't)
SC/L W 2.4
Wood surface treatment, Not on label, SC/L NA
Paintbrush
SC/L NA
SC/L NA
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
W 4.8 * NS NS NS NS NS NS
UC * NS NS NS NS NS NS
UC * NS NS NS NS NS NS
UC * NS NS NS NS NS NS
CIS, C24
C12, CIS
CIS, C22,
C24
SC/L NA
UC * NS NS
NS NS NS NS
CIS, C24,
C92
SC/L NA
UC * NS NS
NS NS NS NS
CIS, C24,
CAD
Wood surface treatment, Not on label,
Sprayer
SC/L
SC/L
SC/L
SC/L
NA
NA
NA
NA
UC * NS NS
UC * NS NS
UC * NS NS
UC * NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
C24, CAD
C12, CIS
CIS, C22,
C24
SC/L NA
UC * NS NS
NS NS NS NS
CIS, C24,
C92
SC/L
UC * NS NS
NS NS NS NS
CIS, C24,
CAD
SC/L NA
Wood surface treatment, Shock/slug, Not SC/L NA
on label
UC * NS NS
UC * NS NS
NS NS NS NS
NS NS 120 NS
C24, CAD
CIS, C24,
C92
SC/L
UC * NS NS
NS 120 NS
CIS, C24,
CAD
64
-------
EMULSIONS, RESIN/LATEX/POLYMER
Report Run Date: 02/27/96 ) Time 13:04
PRD Report Date: 12/06/95
Use Group: INDOOR NON-FOOD
LUIS 2.22 - Page: 10
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
4444444444444444444444444444444'
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
»)))))))))))))))))))))))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
EMULSIONS, RESIN/LATEX/POLYMER (con't)
Additive treatment, Not on label, Not on SC/L
label, Not Applicable, Not applicable for
this use
Industrial preservative treatment, During SC/L
manufacture, Not on label, Not
Applicable, Not applicable for this use
Use Group: INDOOR NON -FOOD (con't)
U 40 * NS NS NS NS NS NS
SC/L
SC/L
SC/L
SC/S
SC/S
SC/S
W 7.5
W 7.5
W 10
W 9.8
W 14
W 14
EVAPORATIVE CONDENSER WATER SYSTEMS
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
W 1.2
W 1.3
W 20 * NS NS
NS NS NS
W 75 *
W 75 *
W 50 *
W 49 *
W 70 *
W 70 *
Use Group:
W 8.8 *
W 3 *
W 6 *
W 6 *
W 6.4 *
W 6 *
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
AQUATIC
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
NON -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
A38, CIS,
C24
CIS, C24
CAH
C12, CIS
C12, CIS
C12, CIS
CIS, C24
A08, C12,
CIS
A08, C12,
CIS
A08, C12,
CIS
A08, CIS,
C24
A08, CIS,
C24
A08, C12,
CIS
65
-------
Report Run Date: 02/27/96 ) Time 13:04
PRD Report Date: 12/06/95
LUIS 2.22 - Page: 11
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Form(s) Min. Appl. Max. Appl. Soil Max. # 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
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
)))))))))))))))))))))))
EVAPORATIVE CONDENSER WATER SYSTEMS (con't)
SC/L
W 4.7
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
W 10 * NS NS NS NS NS NS
A08, CIS,
C24
SC/L
W 11 * NS NS
NS NS NS NS
A08, CIS,
C22, C24
Water treatment (recirculating system),
Continuous feed (subsequent), Not on
label, Not Applicable, Not applicable for
this use
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
Water treatment (recirculating system),
Intermittent (slug)(initial), Not on
label, Not Applicable, Not applicable for
this use
SC/L
W .59
W .6
W 1.3
W 4.7
W 5.9 * NS NS
NS NS NS NS
W 4.5 * NS NS
W 4.5 * NS NS
W 6.4 * NS NS
W 6.7 * NS NS
W 10 * NS NS
W 8.8 * 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
SC/L
W 3 * NS NS
A08, C12,
CIS
A08, C12,
CIS
A08, CIS,
C24
A08, CIS,
C24
A08, CIS,
C22, C24
A08, CIS,
C24
A08, C12,
CIS
A08, C12,
CIS
SC/L
W 1.2
W 6 * NS NS
A08, C12,
CIS
SC/L
SC/L
SC/L
Report Run Date: 02/27/96 ) Time 13:05
PRD Report Date: 12/06/95
W 1.2
W 1.3
W 1.8
W 6 * NS NS
W 6.4 * NS NS
NS
NS
W 6 * NS NS NS
LUIS 2.22 - Page: 12
NS NS
NS NS
NS NS
NS
NS
NS
A08, C18,C24
A08, C18,C24
A08, C12,C18
APPENDIX A REPORT
-------
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
SITE Application Type, Application
Timing, Application Equipment )
Form(s) Mln. Appl .
Rate (AI un-
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
less noted
otherwise)
Max. Appl . Soil Max. # Apps Max. Dose [ (AI Mln. Restr. Geographic Limitations Use
Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
(days) Interv Codes
unless noted Max. /crop /year otherwise) /A]
otherwise) Dose cycle
/crop
cycle
/year
[day(s)]
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
EVAPORATIVE CONDENSER WATER SYSTEMS (con't)
Water treatment (recirculating system) , SC/L
Intermittent (slug)(subsequent), Not on
label, Not Applicable, Not applicable for
this use
SC/L
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
W 5.9 * NS NS NS NS NS NS
W 4.5 * NS NS
NS NS NS NS
A08, C12,
CIS
A08, C12,
CIS
SC/L
W .6
W 4.5 * NS NS
NS NS NS NS
A08, CIS,
C24
SC/L
W 3 * NS NS
NS NS NS NS
A08, C12,
CIS
SC/L
W 4.7
W 10 * NS NS
NS NS NS NS
A08, CIS,
C24
Water treatment, Continuous feed SC/L
(subsequent), Not on label, Not
Applicable, Not applicable for this use
Water treatment, Initial, Not on label, SC/L
Not Applicable, Not applicable for this
use
V 4.7 * NS NS
V 9.4 * NS NS
NS NS NS NS
NS NS NS NS
A08, CIS,
C24
CIS, C24
Water treatment, Intermittent
(slug)(subsequent), Not on label, Not
Applicable, Not applicable for this use
SC/L
SC/L
Water treatment, Shock/slug, Not on SC/L
label, Not Applicable, Not applicable for
this use
W 4.8
V 2.3
W 9.7 * NS NS
V 4.7 * NS NS
V 9.4 * NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
CIS, C24
A08, CIS,
C24
A08, CIS,
C24
Water treatment, Subsequent/maintenance,
Not on label, Not Applicable, Not
applicable for this use
SC/L
SC/L
W 2.4
V 4.7 * NS NS
W 4.8 * NS NS
NS NS NS NS
NS NS NS NS
CIS, C24
CIS, C24
67
-------
Report Run Date: 02/27/96 ) Time 13:05
PRD Report Date: 12/06/95
LUIS 2.22 - Page: 13
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
4444444444444444444444444444444'
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
»)))))))))))))))))))))))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
FUELS/OIL STORAGE TANK BOTTOM WATER ADDITIVE
Additive treatment, Not on label, Not on SC/L
label, Not Applicable, Not applicable for
this use
Use Group: INDOOR NON-FOOD
V 4.7 * NS NS NS NS NS NS
Preservative treatment, Continuous feed
(initial), Not on label, Not Applicable,
Not applicable for this use
SC/L
SC/L
SC/L
Preservative treatment, Not on label, Not SC/L
on label, Not Applicable, Not applicable
for this use
V .47
V .47
V .47
V .47
V 4.7 * NS NS
V 5.2 * NS NS
V 5.2 * NS NS
V 4.7 * NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
C12, CIS
C22, C24
C22, CAH
CIS, C22,
C24
SC/L
V 4.7 * NS NS
NS NS NS NS
CIS, C24,
C92
SC/L
V .47
V 4.7 * NS NS
CIS, C24,
CAD
SC/L
SC/L
SC/L
V .47
V .47
V .62
V 5.2 * NS NS
V 4.7 * NS NS
V 6.2 * NS NS
NS
NS
NS
NS NS
NS NS
NS NS
NS
NS
NS
C22, C24
C24, CAD
CIS, C24,
C92
SC/L
SC/L
V .94
V 1.9
V 9.4 * NS NS NS NS NS NS
V 19 * NS NS NS NS NS NS
C24, CAD
CIS, C22,
C24
Preservative treatment, Shock/slug, Not
on label, Not Applicable, Not applicable
for this use
SC/L
SC/L
SC/L
Report Run Date: 02/27/96
PRD Report Date: 12/06/95
) Time 13:05
W 1
V .47
V 5
W 10 * NS NS NS
V 5.2 * NS NS NS
V 10 * NS NS NS
LUIS 2.22 - Page: 14
NS NS
NS NS
NS
NS
CIS, C24
C22, CAH
CIS, C24
-------
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
4444444444444444444444444444444,
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
I))))))))))))))))))))))))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
FUELS/OIL STORAGE TANK BOTTOM WATER ADDITIVE (con't)
SC/L W 5
Preservative treatment, SC/L V 2.5
Subsequent/maintenance, Not on label, Not
Applicable, Not applicable for this use
SC/L
Water treatment, Initial, Not on label,
Not Applicable, Not applicable for this
use
SC/L
W 2.5
V 2
Use Group: INDOOR NON-FOOD (con't)
W 10 * NS NS NS NS NS NS
V 5 * NS NS NS NS NS NS
W 5 * NS NS
V 2 * NS NS
NS NS NS NS
NS NS NS NS
CAH
CIS, C24
CAH
C12
Water treatment, Subsequent/maintenance, SC/L
Not on label, Not Applicable, Not
applicable for this use
VI * NS NS
NS NS NS NS
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
W .6
Use Group: AQUATIC NON-FOOD INDUSTRIAL
W 8.8 * NS NS NS NS NS NS
W 3 * NS NS
NS NS NS NS
A08, C12,
CIS
A08, C12,
CIS
SC/L
W 6 * NS NS
NS NS NS NS
A08, C12,
CIS
SC/L
W 1.2
W 6 * NS NS
NS NS NS NS
A08, CIS,
C24
SC/L
W 6 * NS NS
NS NS NS NS
A08, C12,
CIS
Water treatment (recirculating system),
Continuous feed (subsequent), Not on
label, Not Applicable, Not applicable for
this use
SC/L
SC/L
Report Run Date: 02/27/96 ) Time 13:06
PRO Report Date: 12/06/95
W .59
W .6
APPENDIX A REPORT
W 5.9 * NS NS
NS NS NS NS
W 4.5 * NS NS NS NS NS NS
LUIS 2.22 - Page: 15
A08, C12,
CIS
A08, C12,
CIS
69
-------
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
HEAT EXCHANGER WATER SYSTEMS (con't)
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. 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
W
W
W
W
W
W
W
W
W
W
W
V
.6
.9
.59
.6
1.2
1.2
1.8
.59
.6
.6
.9
4.7
SC/L
Water treatment, Subsequent/maintenance, SC/L
Not on label, Not Applicable, Not
applicable for this use
W 4.8
V 2.3
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
W 4.5 * NS NS NS NS NS NS
W 3 * NS NS NS NS NS NS
W 8.8 * NS NS NS NS NS NS
W 3 * NS NS
W 6 * NS NS
W 6 * NS NS
W 6 * NS NS
W 5.9 * NS NS
W 4.5 * NS NS
W 4.5 * NS NS
W 3 * NS NS
V 9.4 * NS NS
W 9.7 * NS NS
V 4.7 * 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, CIS, C24
A08, C12, CIS
A08, C12, CIS
A08, C12, CIS
A08, C12, CIS
A08, CIS, C24
A08, C12, CIS
A08, C12, CIS
A08, C12, CIS
A08, CIS, C24
A08, C12, CIS
CIS, C24
CIS, C24
CIS, C24
70
-------
Report Run Date: 02/27/96
PRD Report Date: 12/06/95
) Time 13:06
LUIS 2.22 - Page: 16
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
4444444
Form(s)
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 Interv Entry
unless noted Max. /crop /year otherwise)/A] (days) Interv
otherwise) Dose cycle /crop /year [day(s)]
cycle
Geographic Limitations
Allowed Disallowed
Use
Limitations
Codes
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
HEAT EXCHANGER WATER SYSTEMS (con't)
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
SC/L
SC/L
SC/L
W 2.4
W 5.9
W 2.9
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
W 4.8 * NS NS NS NS NS NS
Use Group: AQUATIC NON-FOOD INDUSTRIAL
W 18 * NS NS NS NS NS NS
W 8.8 * NS NS
NS NS NS NS
CIS, C24
A08, A1K8),
C12, CIS
A08, C12,
CIS
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
W .6
W 1.2
W 1.8
Use Group: AQUATIC NON-FOOD INDUSTRIAL
W 3 * NS NS NS NS NS NS
W 6 * NS NS
W 6 * NS NS
NS NS NS NS
NS NS NS NS
A08, C12,
CIS
CIS, C24
A08, C12,
CIS
Water treatment (recirculating system),
Continuous feed (subsequent), Not on
label, Not Applicable, Not applicable for
this use
SC/L
SC/L
SC/L
W .6
W .6
W .9
W 1.8 * NS NS
W 4.5 * NS NS
W 3 * NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
A08, C12,
CIS
CIS, C24
A08, C12,
CIS
Water treatment (recirculating system),
Intermittent (slug)(initial), Not on
label, Not Applicable, Not applicable for
this use
SC/L
W .6
W 3 * NS NS
NS NS NS NS
A08, C12,
CIS
71
-------
Report Run Date: 02/27/96 ) Time 13:06
PRD Report Date: 12/06/95
LUIS 2.22 - Page: 17
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
4444444444444444444444444444444'
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
»)))))))))))))))))))))))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
INDUSTRIAL SCRUBBING SYSTEM (con't)
SC/L W 1.2
SC/L W 1.8
Water treatment (recirculating system), SC/L W .6
label, Not Applicable, Not applicable for
this use
SC/L W .6
SC/L W .9
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
W 6 * NS NS NS NS NS NS
W 6 * NS NS NS NS NS NS
W 1.8 * NS NS NS NS NS NS
W 4.5 * NS NS
W 3 * NS NS
NS NS NS
NS NS NS
NS
NS
CIS, C24
A08, C12, CIS
A08, C12, CIS
CIS, C24
A08, C12, CIS
INDUSTRIAL WASTE DISPOSAL SYSTEMS
Water treatment, Continuous feed
(initial), Not on label, Not Applicable,
Not applicable for this use
SC/L
SC/L
Use Group: AQUATIC NON-FOOD INDUSTRIAL
W 14 * NS NS NS NS NS
W 11 * NS NS
NS NS NS NS
A08, C12,
CIS, C24
A08, C12,
CIS, C24
Water treatment, Continuous feed
(subsequent), Not on label, Not
Applicable, Not applicable for this use
SC/L
SC/L
SC/L
W 1.4
W 14 * NS NS
W 7 * NS NS
W 3.6 * NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
A08, CIS,
C22, C24
A08, CIS,
C22, C24
A08, C12,
CIS, C24
Water treatment, Intermittent
(slug)(initial), Not on label, Not
Applicable, Not applicable for this use
SC/L
SC/L
SC/L
Report Run Date: 02/27/96
PRD Report Date: 12/06/95
) Time 13:06
W .57
W 1.4
W 10 * NS NS
W 14 * NS NS
W 11 * NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
LUIS 2.22 - Page: 18
A08, C12,
CIS, C24
A08, A28(8),
C12, CIS, C24
A08, A27(4),
A28(8), C12,
CIS, C24
-------
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
Form(s) Min. Appl.
Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr.
Geographic Limitations
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed
less noted unless noted Max. /crop /year otherwise)/A] (days) Interv
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
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
SC/L
SC/L
SC/L
W 1.4
W .43
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
W 14 * NS NS NS NS NS NS
W 5 * NS NS
W 10 * NS NS
NS NS NS NS
NS NS NS NS
A08, A27(4),
28(8) ,C18,
C22, C24
A08, C12,
CIS, C24
A08, C12,
CIS, C24
SC/L
W 1.4
W 7 * NS NS
NS NS NS NS
A08, CIS,
C22, C24
LEATHER PROCESSING LIQUORS
Additive treatment, Not on label, Not on SC/L V 5000
label, Not Applicable, Not applicable for
this use
SC/L V 20000
Preservative treatment, Not on label, Not SC/L W 25
on label, Not Applicable, Not applicable
for this use
SC/L W 25
SC/L W 50
Use Group: INDOOR NON-FOOD
V 5000 * NS NS NS
V 20000 * NS NS
W 249 * NS NS
W 249 * NS NS
W 249 * NS NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
CIS, C24,
CAD
CIS, C22,
C24
CIS, C24
CIS, C24,
C92
LEATHER/LEATHER PRODUCTS
Fresh hide treatment, Not on label, Not
on label, Not Applicable, Not applicable
for this use
SC/L
W 3
Use Group: INDOOR NON-FOOD
W 20 * NS NS NS NS NS NS
C22, CAH
Hides and skins treatment, Not on label,
Not on label, Not Applicable, Not
applicable for this use
SC/L
W 20
W 200 * NS NS
NS NS NS NS
CIS, C24
73
-------
Report Run Date: 02/27/96 ) Time 13:07
PRD Report Date: 12/06/95
LUIS 2.22 - Page:
19
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
4444444444444444444444444444444'
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
LEATHER/LEATHER PRODUCTS (con't)
SC/L
SC/L
W 30
W 30
Use Group: INDOOR NON-FOOD (con't)
W 200 * NS NS NS NS NS NS
W 199 * NS NS NS NS NS NS
CIS, C24,
C92
SC/L
W 30
W 198 * NS NS
NS NS NS
CIS, C24,
CAD
SC/L W 50
Preservative treatment, Not on label, Not SC/L W 25
on label, Not Applicable, Not applicable
for this use
SC/L W 40
SC/L W 50
SC/L W 50
W 299 * NS NS NS
W 200 * NS NS NS
W 269 * NS NS NS
W 249 * NS NS NS
W 248 * NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
C22, CAH
CIS, C24
CIS, C24,
C92
CIS, C24,
CAD
METALWORKING CUTTING FLUIDS
Preservative treatment, Not on label, Not SC/L
on label, Not Applicable, Not applicable
for this use
SC/L
Preservative treatment, Shock/slug, Not
on label, Not Applicable, Not applicable
for this use
SC/L
V 15
W 10
V 10
Use Group: INDOOR NON-FOOD
V 15 * NS NS NS
W 1000 * NS NS NS
V 40 * NS NS NS
NS NS NS
NS NS NS
NS NS NS
CIS, C24
C12, CIS
CIS, C24
Water treatment, Not on label, Metering
pump, Not Applicable, Not applicable for
this use
SC/L
W 46
W 459 * NS NS
NS NS NS
Water treatment, Not on label, Not on SC/L
label, Not Applicable, Not applicable for
this use
W 46
W 459 * NS NS
NS NS NS
74
-------
Report Run Date: 02/27/96 ) Time 13:07
PRD Report Date: 12/06/95
LUIS 2.22 - Page:
20
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
4444444444444444444444444444444'
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
»)))))))))))))))))))))))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
METALWORKING CUTTING FLUIDS (con't)
Water treatment, Shock/slug, Not on SC/L
label, Not Applicable, Not applicable for
this use
V 10
Use Group: INDOOR NON-FOOD (con't)
V 40 * NS NS NS NS NS NS
CIS, C24
SC/L
OIL RECOVERY DRILLING MUDS/PACKER FLUIDS
Additive treatment, Not on label, Not on SC/L
label, Not Applicable, Not applicable for
this use
W 10
W 50
W 41 * NS NS NS NS NS NS
Use Group: AQUATIC NON-FOOD INDUSTRIAL
W 250 * NS NS NS NS NS NS
C22, CAH
SC/L W 50
Make-up fluids treatment, Initial, Not on SC/L V 477
label, Not Applicable, Not applicable for
this use
W 250 * NS NS
V 477 * NS NS
NS NS NS NS
NS NS NS NS
C12, CIS
CIS, C24
Make-up fluids treatment, Not on label,
Not on label, Not Applicable, Not
applicable for this use
SC/L
Preservative treatment, Not on label, Not SC/L
on label, Not Applicable, Not applicable
for this use
SC/L
V 456
V 6.5
V 456 * NS NS
V 65 * NS NS
V 67 * NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
CIS, C22,
C24
C12, CIS,
C24
C12, CIS,
C24
SC/L
V 7.3
V 72 * NS NS
CIS, C22,
C24
SC/L
SC/L
SC/L
W 10
W 50
W 50
W 1000 * NS NS NS NS NS NS
W 250 * NS NS NS NS NS NS
W 250 * NS NS NS NS NS NS
C12, CIS
CIS, C22,
C24
SC/L
Report Run Date: 02/27/96 ) Time 13:07
W 50
W 250 * NS NS NS
LUIS 2.22 - Page: 21
CIS, C24,
C92
75
-------
PRD Report Date: 12/06/95
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
Form(s) Min. Appl. Max. Appl. Soil Max. # 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
OIL RECOVERY DRILLING MUDS/PACKER FLUIDS (con't)
SC/L W 50
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
W 250 * NS NS NS NS NS NS
CIS, C24,
CAD
SC/L
SC/L
SC/L
SC/L
W 50
W 50
W 50
W 70
W 280 * NS NS
W 280 * NS NS
W 250 * NS NS
W 330 * NS NS
NS
NS
NS
NS
NS NS
NS NS
NS NS
NS NS
NS
NS
NS
NS
C22, C24
C22, CAH
C24, CAD
CIS, C24,
C92
SC/L
SC/L
W 100
W 200
W 500 * NS NS
W 1000 * NS NS
NS NS NS NS
NS NS NS NS
C24, CAD
CIS, C22,
C24
Additive treatment, Not on label, Not on SC/L W 50
label, Not Applicable, Not applicable for
this use
SC/L W 50
Make-up fluids treatment, Initial, Not on SC/L V 477
label, Not Applicable, Not applicable for
this use
Use Group: TERRESTRIAL NON-FOOD CROP
W 250 * NS NS NS NS NS NS
W 250 * NS NS
V 477 * NS NS
NS NS NS NS
NS NS NS NS
C12, CIS
CIS, C24
Make-up fluids treatment, Not on label,
Not on label, Not Applicable, Not
applicable for this use
SC/L
Preservative treatment, Not on label, Not SC/L
on label, Not Applicable, Not applicable
for this use
SC/L
V 456
V 6.5
V 456 * NS NS
V 65 * NS NS
V 67 * NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
CIS, C22,
C24
C12, CIS,
C24
C12, CIS,
C24
SC/L
Report Run Date: 02/27/96 ) Time 13:08
PRD Report Date: 12/06/95
V 7.3
APPENDIX A REPORT
V 72 * NS NS NS NS NS NS
LUIS 2.22 - Page: 22
CIS, C22, C24
76
-------
Case 2415[Methylene bis (thiocyanate) ] Chemical 068102 [Methylenebis (thiocyanate) ]
4444444444444444444444444444444,
SITE Application Type, Application Form(s) Min. Appl . Max. Appl . Soil Max. # Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise) /A] (days) Interv Codes
otherwise) otherwise) Dose cycle /crop /year [day (s) ]
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
)))))))))))))))))))))))
OIL RECOVERY DRILLING MUDS/PACKER FLUIDS (con't)
SC/L
SC/L
SC/L
SC/L
SC/L
PAINTS (IN-CAN)
Preservative treatment, Not on label, Not SC/L
on label, Not Applicable, Not applicable
for this use
PAPER/PAPER PRODUCTS
Industrial preservative treatment, During SC/L
manufacture, Not on label, Not
Applicable, Not applicable for this use
SC/S
SC/S
Report Run Date: 02/27/96 ) Time 13:08
PRO Report Date: 12/06/95
W 10
W 50
W 50
W 50
W 10
W 9.8
W 14
Use Group: TERRESTRIAL NON-FOOD CROP (con't)
W 1000 * NS NS NS NS NS NS
W 250 * NS NS NS NS NS NS
W 250 * NS NS NS NS NS NS
W 250 * NS
W 250 * NS
Use Group: INDOOR NON-FOOD
W 1000 * NS NS NS
Use Group: INDOOR NON-FOOD
W 50 * NS NS NS
W 49 * NS NS NS
W 70 * NS NS NS
LUIS 2.22 - Page: 23
NS NS NS
NS NS NS
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
W
W
W
W
W
W
50
50
50
70
100
200
W
W
W
W
W
W
280
280
250
330
500
1000
* 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
C12, CIS
CIS, C22,
C24
CIS, C24,
C92
CIS, C24,
CAD
C22, C24
C22, CAH
C24, CAD
CIS, C24,
C92
C24, CAD
CIS, C22,
C24
C12, CIS
C12, CIS
A, C12, CIS
C12, CIS
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
77
-------
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted
less noted unless noted Max. /crop /year otherwise) /A]
otherwise) otherwise) Dose cycle /crop /year
cycle
Interv Entry Allowed
(days) Interv
[day(s)]
Disallowed
Use
Limitations
Codes
PAPER/PAPER PRODUCTS (con't)
Preservative treatment, Not on label,
Applicator rolls, Not Applicable, Not
applicable for this use
SC/S
SC/L
Preservative treatment, Not on label, Not SC/L
on label
W 14
W 25
Use Group: INDOOR NON-FOOD (con't)
W 70 * NS NS NS NS NS NS
W 200 * NS NS NS NS NS NS
UC * NS NS
CIS, C24
NS NS NS NS
Preservative treatment, Not on label, Not SC/L
on label, Not Applicable, Not applicable
for this use
W 25
W 75 * NS NS
NS NS NS NS
Preservative treatment, Not on label,
Sprayer, Not Applicable, Not applicable
for this use
SC/L
W 25
W 200 * NS NS
NS NS NS NS
Wood chip treatment, Not on label,
Sprayer, Not Applicable, Not applicable
for this use
SC/L
W 25
W 100 * NS NS
NS NS NS NS
PASTEURIZER/WARMER/CANNERY COOLING WATER SYSTEMS
Water treatment (recirculating system), SC/L W .59
Continuous feed (initial), Not on label,
Not Applicable, Not applicable for this
use
SC/L W .6
Use Group: INDOOR NON-FOOD
W 8.8 * NS NS NS NS NS NS
W 3 * NS NS
NS NS NS NS
A08, C12,
CIS
A08, C12,
CIS
SC/L
W 1.2
W 6 * NS NS
NS NS NS NS
A08, C12,
CIS
SC/L
SC/L
W 1.2
W 1.8
W 6 * NS NS
W 6 * NS NS
NS NS NS NS
NS NS NS NS
CIS, C24
A08, C12,
CIS
78
-------
Report Run Date: 02/27/96 ) Time 13:08
PRD Report Date: 12/06/95
LUIS 2.22 - Page:
24
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
4444444444444444444444444444444,
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
I))))))))))))))))))))))))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
PASTEURIZER/WARMER/CANNERY COOLING WATER SYSTEMS (con't)
Water treatment (recirculating system), SC/L W .59
Continuous feed (subsequent), Not on
label, Not Applicable, Not applicable for
this use
SC/L
W .6
Use Group: INDOOR NON-FOOD (con't)
W 5.9 * NS NS NS NS NS NS
W 4.5 * NS NS
NS NS NS NS
A08, C12,
CIS
A08, C12,
CIS
SC/L
SC/L
W .6
W .9
W 4.5 * NS NS
W 3 * NS NS
NS NS NS NS
NS NS NS NS
CIS, C24
A08, C12,
CIS
Water treatment (recirculating system),
Intermittent (slug)(initial), Not on
label, Not Applicable, Not applicable for
this use
SC/L
SC/L
W .59
W .6
W 8.8 * NS NS
W 3 * NS NS
NS NS NS NS
NS NS NS NS
A08, C12,
CIS
A08, C12,
CIS
SC/L
W 1.2
W 6 * NS NS
NS NS NS NS
A08, C12,
CIS
SC/L
SC/L
W 1.2
W 1.8
W 6 * NS NS
W 6 * NS NS
NS NS NS NS
NS NS NS NS
CIS, C24
A08, C12,
CIS
Water treatment (recirculating system),
Intermittent (slug)(subsequent), Not on
label, Not Applicable, Not applicable for
this use
SC/L
SC/L
W .59
W .6
W 5.9 * NS NS
W 4.5 * NS NS
NS NS NS NS
NS NS NS NS
A08, C12,
CIS
A08, C12,
CIS
SC/L
SC/L
W .6
W .9
W 4.5 * NS NS
W 3 * NS NS
NS NS NS NS
NS NS NS NS
CIS, C24
A08, C12,
CIS
79
-------
Report Run Date: 02/27/96 ) Time 13:09
PRD Report Date: 12/06/95
LUIS 2.22 - Page:
25
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
4444444444444444444444444444444,
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
I))))))))))))))))))))))))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
PASTEURIZER/WARMER/CANNERY COOLING WATER SYSTEMS (con't)
Water treatment, Continuous feed SC/L W 2.1
(initial), Not on label, Not Applicable,
Not applicable for this use
SC/L
SC/L
W 3
W 3.2
Use Group: INDOOR NON-FOOD (con't)
W 4.2 * NS NS NS NS NS NS
W 4.5 * NS NS
W 6.4 * NS NS
NS NS NS NS
NS NS NS NS
A08, CIS,
C24
CIS, C24
A08, C22,
C24
SC/L
W 3.2
W 6.5 * NS NS
NS NS NS NS
A08, C22,
CAH
Water treatment, Continuous feed
(subsequent), Not on label, Not
Applicable, Not applicable for this use
SC/L
SC/L
SC/L
SC/L
W 3.2
W 1
W 1.5
W 1.6
W 4.8 * NS NS
W 3.1 * NS NS
W 1.5 * NS NS
W 3.2 * NS NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
CIS, C24
A08, CIS,
C24
CIS, C24
A08, C22,
C24
SC/L
W 1.6
W 3.2 * NS NS
NS NS NS NS
A08, C22,
CAH
Water treatment, Intermittent
(slug)(initial), Not on label, Not
Applicable, Not applicable for this use
SC/L
SC/L
SC/L
SC/L
W 1.6
W 2.1
W 3
W 3.2
W 1.6 * NS NS
W 4.2 * NS NS
W 4.5 * NS NS
W 6.4 * NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
CIS, C24
A08, CIS,
C24
CIS, C24
A08, C22,
C24
SC/L
W 3.2
W 6.5 * NS NS
NS NS NS NS
A08, C22,
CAH
SC/L
W 3.2
W 4.8 * NS NS
NS NS NS NS
CIS, C24
80
-------
Report Run Date: 02/27/96 ) Time 13:09
PRD Report Date: 12/06/95
LUIS 2.22 - Page:
26
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
4444444444444444444444444444444'
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
»)))))))))))))))))))))))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
PASTEURIZER/WARMER/CANNERY COOLING WATER SYSTEMS (con't)
Water treatment, Intermittent SC/L W 1
(slug)(subsequent), Not on label, Not
Applicable, Not applicable for this use
SC/L
SC/L
SC/L
W 1.5
W 1.6
W 1.6
Use Group: INDOOR NON-FOOD (con't)
W 3.1 * NS NS NS NS NS NS
W 1.5 * NS NS
W 3.2 * NS NS
W 3.2 * NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
A08, CIS,
C24
CIS, C24
A08, C22,
C24
A08, C22,
CAH
Water treatment, Not on label, Not on
label, Not Applicable, Not applicable for
this use
SC/L
SC/L
W 1.6
W 4.9
W 1.6 * NS NS
W 9.7 * NS NS
NS NS NS NS
NS NS NS NS
CIS, C24
CIS, C24
PULP/PAPER MILL WATER SYSTEMS
Water treatment, Continuous feed
(initial), Chemical pump, Not Applicable,
Not applicable for this use
Water treatment, Continuous feed
(initial), Metering pump, Not Applicable,
Not applicable for this use
Water treatment, 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
W 5.2
W .9
W 2.5
UC
W 1.2
W 3
Use Group: AQUATIC NON-FOOD INDUSTRIAL
W 10 * NS NS NS NS NS NS
W 9 * NS NS
W 50 * NS NS
UC * NS NS
W 4.5 * NS NS
W 24 * NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
CIS, C24
CAH
C22, CAH
CIS, C24
C12, CIS
A08, C12,
CIS
SC/L
W 5.6
W 13 * NS NS
NS NS NS NS
CIS, C24
81
-------
Report Run Date: 02/27/96 ) Time 13:09
PRD Report Date: 12/06/95
LUIS 2.22 - Page: 27
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
4444444444444444444444444444444,
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
I))))))))))))))))))))))))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
PULP/PAPER MILL WATER SYSTEMS (con't)
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
Water treatment. Continuous feed
(subsequent), Chemical pump. Not
Applicable, Not applicable for this use
Water treatment. Continuous feed
(subsequent), Not on label. Not
Applicable, Not applicable for this use
SC/L
SC/L
SC/L
SC/S
SC/S
SC/S
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/S
SC/S
SC/S
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
6.7
6.8
7.1
.84
1.2
4.2
5.2
.6
.6
2.5
6.7
6.8
.59
.84
.84
W 27
W 14
W 14
W 8.4
W 15
W 34
W 10
W 9
W 1.8
W 50
W 27
W 14
W 12
W 6.3
W 4.2
* 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
CIS, C24
A08, CIS, C24
A08, CIS,
C22, C24
A08, C12, CIS
A08, C12, CIS
A08, CIS, C24
CIS, C24
A08, C12,
CIS
C12, CIS
CAH
CIS, C24
A08, CIS, C24
A08, C12, CIS
A08, C12, CIS
A08, CIS, C24
Water treatment, Intermittent
(slug)(initial), Metering pump, Not
Applicable, Not applicable for this use
SC/L
W 9 * NS NS
CAH
82
-------
Report Run Date: 02/27/96 ) Time 13:10
PRD Report Date: 12/06/95
LUIS 2.22 - Page:
28
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
Form(s) Min. Appl. Max. Appl. Soil Max. # 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
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
SC/L
SC/L
SC/L
W 2.5
W 1.2
W 3
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
W 50 * NS NS NS NS NS NS
W 6 * NS NS NS NS NS NS
W 24 * NS NS
NS
NS NS
NS
C22, CAH
C12, CIS
A08,
CIS
C12,
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/S
SC/S
SC/S
SC/L
SC/L
W 6.2
W 6.7
W 8.4
W 12
W 12
W 12
W 1.2
W .6
W 1.5
W
W
W
W
W
W
W 8
W
W
25 * NS NS
27 * NS NS
17 * NS NS
18 * NS NS
17 * NS NS
17 * NS NS
.4 * NS NS
15 * NS NS
34 * NS NS
W 3 * NS NS
W
12 * 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
CIS,
CIS,
CIS,
A08,
CIS,
A08,
CIS,
A08,
C24
A08,
CIS
A08,
CIS
A08,
C24
C24
C24
C24
A1K2),
C22,C24
A1K2),
C24
CIS,
C12,
C12,
CIS,
C12, CIS
A08, C12,
CIS
SC/L
SC/L
W 2.5
W 6.7
W 50 * NS NS
W 27 * NS NS
NS NS NS NS
NS NS NS NS
CAH
CIS, C24
83
-------
Report Run Date: 02/27/96 ) Time 13:10
PRD Report Date: 12/06/95
LUIS 2.22 - Page:
29
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
4444444444444444444444444444444,
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
I))))))))))))))))))))))))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
PULP/PAPER MILL WATER SYSTEMS (con't)
SC/L W 12
SC/S W .59
SC/S W .84
SC/S W 2.1
Water treatment, Not on label, Drip-feed SC/L W 25
device, Not Applicable, Not applicable
for this use
Water treatment, Not on label, Not on SC/L W 5
label, Not Applicable, Not applicable for
this use
SC/L W 5
SC/L
SC/L W 5
SC/L
SC/L W 33
SC/S
Water treatment, Shock/slug, Metering SC/L W 9
pump, Not Applicable, Not applicable for
this use
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
W 17 * NS NS NS NS NS NS
W 12 * NS NS
W 6.3 * NS NS
W 17 * NS NS
W 100 * NS NS
W 25 * NS NS
W 25 * NS NS
W 25 * NS NS
W 25 * NS NS
W 33 * NS NS
W 100 * NS NS
W 70 * 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
NS NS NS NS
NS NS NS NS
NS NS NS NS
A08, A1K2),
CIS, C24
A08, C12, CIS
A08, C12, CIS
A08, CIS, C24
C12, CIS
CIS, C22,
C24
CIS, C24,
C92
CIS, C24,
CAD
CIS, C24,
C92
CIS, C24,
C92
A08, CIS,
C24
REVERSE OSMOSIS WATER SYSTEM
Use Group: INDOOR NON-FOOD
84
-------
Report Run Date: 02/27/96
PRD Report Date: 12/06/95
) Time 13:10
LUIS 2.22 - Page:
30
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
4444444
Form(s)
SITE Application Type, Application
Timing, Application Equipment )
Surface Type (Antimicrobial only) & Effica-
cy Influencing Factor (Antimicrobial only)
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [ (AI Min. Restr.
Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry
less noted unless noted Max. /crop /year otherwise)/A] (days) Interv
otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
Geographic Limitations
Allowed Disallowed
Use
Limitations
Codes
REVERSE OSMOSIS WATER SYSTEM (con't)
Water treatment, Continuous feed
(initial), Not on label, Not Applicable,
Not applicable for this use
SC/L
Use Group: INDOOR NON-FOOD (con't)
W .45 * NS NS NS NS NS NS
A27(l),
A28(3),
CIS,
C24, CAD
SC/L
W .023
W .5 * NS
A27(l),
A28(3),
C24, CAD
SC/L
W .025
W .49 * NS
A27(l),
A28(3),
CIS, C22,
C24
Water treatment, Not on label, Not on SC/L
label, Not Applicable, Not applicable for
this use
SC/L
W .49
W 4.5 * NS NS
W 4.9 * NS NS
NS NS NS NS
NS NS NS NS
CIS, C24,
CAD
CIS, C22,
C24
SC/L
SECONDARY OIL RECOVERY INJECTION WATER
Water treatment (recirculating system),
Intermittent (slug)(initial), Not on
label, Not Applicable, Not applicable for
this use
SC/L
W 5 * NS NS NS NS NS NS
Use Group: AQUATIC NON-FOOD INDUSTRIAL
W 78 * NS NS NS NS NS NS
C24, CAD
CIS, C24
Water treatment (recirculating system), SC/L
Shock/slug, Not on label, Not Applicable,
Not applicable for this use
Water treatment (recirculating system), SC/L
Subsequent/maintenance, Not on label, Not
Applicable, Not applicable for this use
Water treatment, Continuous feed
(initial), Metering pump, Not Applicable,
Not applicable for this use
SC/L
W 78
W 52
V .47
W 78 * NS NS
W 52 * NS NS
V 3.1 * NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
CIS, C24
CIS, C24
CIS, C24
85
-------
Report Run Date: 02/27/96 ) Time 13:11
PRD Report Date: 12/06/95
LUIS 2.22 - Page: 31
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
4444444444444444444444444444444'
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
»)))))))))))))))))))))))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
>n't)
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
SC/L
Use Group: AQUATIC NON- FOOD INDUSTRIAL
V
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
.94
.48
.48
2.9
2.9
2.9
3
3
3.1
3.2
3.2
3.3
4.3
6
13
.43
V 3
W 3
W 3
W 9
W 9
W 9
W
W
W
W
W
W
W
W
W
W
.1
.2
.2
.7
.7
.7
10
10
10
11
11
11
14
20
43
14
* 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
(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
(initial), Not on label, Not Applicable,
Not applicable for this use
SC/L
SC/L
W 1.4
W 11 * NS NS
W 7.1 * NS NS
C12, CIS
C22, C24
C22, CAH
CIS, C24, CAD
C24, CAD
CIS, C24, C92
C24, CAD
CIS, C24, CAD
C12, CIS
CIS, C22, C24
CIS, C24, C92
C24, CAD
CIS, C22, C24
A08, C12,
CIS, C24
A08, C12,
CIS, C24
A08, CIS,
C22, C24
-------
Report Run Date: 02/27/96 ) Time 13:11
PRD Report Date: 12/06/95
LUIS 2.22 - Page:
32
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
4444444444444444444444444444444'
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
»)))))))))))))))))))))))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
SECONDARY OIL RECOVERY INJECTION WATER (con't)
Water treatment, Continuous feed
(subsequent), Metering pump, Not
Applicable, Not applicable for this use
SC/L
V .16
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
V 1 * NS NS NS NS NS NS
Water treatment, Continuous feed
(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
SC/L
V
W
W
W
W
W
W
W
W
W
W
W
W
W
W
W
.94
.16
.16
2.9
2.9
2.9
3
3
3.1
3.2
3.2
3.3
4.3
6
13
.42
V 1.6
W 1
W 1
W 9.7
W 9.7
W 9.7
W 10
W 10
W 10
W 11
W 11
W 11
W 14
W 20
W 43
W 7
* 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
NS
NS
NS
NS
NS
NS
CIS, C24
C12, CIS
C22, C24
C22, CAH
CIS, C24,
CAD
C24, CAD
CIS, C24,
C92
C24, CAD
CIS, C24,
CAD
C12, CIS
CIS, C22, C24
CIS, C24, C92
C24, CAD
CIS, C22, C24
A08, CIS,
C22, C24
87
-------
Report Run Date: 02/27/96 ) Time 13:11
PRD Report Date: 12/06/95
LUIS 2.22 - Page: 33
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
4444444444444444444444444444444'
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
»)))))))))))))))))))))))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
SECONDARY OIL RECOVERY INJECTION WATER (con't)
SC/L
SC/L
W .43
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
W 3.6 * NS NS NS NS NS NS
W 10 * NS NS
NS NS NS NS
A08, C12,
CIS, C24
A08, C12,
CIS, C24
SC/L
Water treatment, Initial, Not on label, SC/L
Not Applicable, Not applicable for this
use
W .71
W 5.7 * NS NS
W 82 * NS NS
NS NS NS NS
NS NS NS NS
A08, CIS,
C22, C24
CIS, C22,C24
Water treatment, Intermittent SC/L V .47
Applicable, Not applicable for this use
SC/L V .94
SC/L W .48
SC/L W .48
V 3.1 * NS NS
V 3.1 * NS NS
W 3.2 * NS NS
W 3.2 * NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
A27(4),A28(8) ,
CIS, C24
C12, CIS
A27(4),A28(8),
C22, C24
A27(4),A28(8),
C22, CAH
SC/L
SC/L
SC/L
SC/L
W .48
W 2.9
W 2.9
W 2.9
W 3.2 * NS NS
W 9.7 * NS NS
W 9.7 * NS NS
W 9.7 * NS NS
NS
NS
NS
NS NS NS
NS NS NS
NS NS NS
C22, C24
A27(4),A28(8),
CIS, C24, CAD
A27(4),A28(8),
C24, CAD
SC/L
W 10 * NS
A27(4) ,A28(8) ,
C24, CAD
SC/L
W 3
W 10 * NS
CIS, C24, C92
-------
Report Run Date: 02/27/96 ) Time 13:12
PRD Report Date: 12/06/95
LUIS 2.22 - Page:
34
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
4444444444444444444444444444444,
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
cycle
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
)))))))))))))))))))))))
SECONDARY OIL RECOVERY INJECTION WATER (con't)
SC/L
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
W 10 * NS NS NS NS NS NS
A27 (4) ,A28(8) ,
CIS, C24, CAD
SC/L
SC/L
SC/L
SC/L
W 3.2
W 3.2
W 3.3
W 6
W 11 * NS NS
W 11 * NS NS
W 11 * NS NS
W 20 * NS NS
NS
NS
NS
NS NS NS
NS NS NS
NS NS NS
A27(4),A28(8),
CIS, C22, C24
C12, CIS
A27 (4) ,A28(8) ,
C24, CAD
Water treatment, Intermittent
(slug)(initial), Not on label, Not
Applicable, Not applicable for this use
Water treatment, Intermittent
(slug)(subsequent), Metering pump, Not
Applicable, Not applicable for this use
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
W 13
V .94
W .48
W 43 * NS NS
W 14 * NS NS
W 11 * NS NS
W 7.1 * NS NS
V 3.1 * NS NS
V 3.1 * NS NS
W 3.2 * 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
A27(4),A28(8),
CIS, C22, C24
A08, A27(4),
A28(8), C12,
CIS, C24
A08, A27(4),
A28(8), C12,
CIS, C24
A08, A27(4),
A28(8), CIS,
C22, C24
A27(4),A28(8),
CIS, C24
C12, CIS
A27 (4) ,A28(8) ,
C22, C24
SC/L
A27 (4) ,A28(8) ,
C22, CAH
89
-------
Report Run Date: 02/27/96 ) Time 13:12
PRD Report Date: 12/06/95
LUIS 2.22 - Page: 35
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
4444444444444444444444444444444,
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
I))))))))))))))))))))))))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
SECONDARY OIL RECOVERY INJECTION WATER (con't)
SC/L W .48
SC/L W 2.9
SC/L W 2.9
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
W 3.2 * NS NS NS NS NS NS
W 9.7 * NS NS NS NS NS NS
W 9.7 * NS NS NS NS NS NS
C22, C24
A27(4),A28(8),
CIS, C24, CAD
SC/L
SC/L
W 2.9
W 9.7 * NS NS
W 10 * NS NS
NS NS NS NS
NS NS NS NS
A27(4),A28(8),
C24, CAD
A27 (4) ,A28(8) ,
CIS, C24, C92
SC/L
SC/L
W 3
W 10 * NS NS
W 10 * NS NS
NS NS NS NS
NS NS NS NS
A27(4),A28(8),
C24, CAD
A27(4) ,A28(8) ,
CIS, C24, CAD
SC/L
SC/L
SC/L
SC/L
W 3.2
W 3.2
W 3.3
W 6
W 11 * NS NS
W 11 * NS NS
W 11 * NS NS
W 20 * NS NS
NS
NS
NS
NS NS NS
NS NS NS
NS NS NS
A27(4),A28(8),
CIS, C22, C24
C12, CIS
A27 (4) ,A28(8) ,
C24, CAD
Water treatment, Intermittent
(slug)(subsequent), Not on label, Not
Applicable, Not applicable for this use
SC/L
SC/L
SC/L
W 13
W .57
W 43 * NS NS
W 5 * NS NS
W 10 * NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
A27(4),A28(8),
CIS, C22, C24
A08, C12,
CIS, C24
A08, C12,
CIS, C24
90
-------
Report Run Date: 02/27/96 ) Time 13:12
PRD Report Date: 12/06/95
LUIS 2.22 - Page:
36
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
4444444444444444444444444444444'
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
»)))))))))))))))))))))))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
SECONDARY OIL RECOVERY INJECTION WATER (con't)
SC/L
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
W 5.7 * NS NS NS NS NS NS
A08, CIS,
C22, C24
Water treatment, Shock/slug, Metering
pump, Not Applicable, Not applicable for
this use
Water treatment, Subsequent/maintenance,
Not on label, Not Applicable, Not
applicable for this use
SC/L
SC/L
SC/L
W 1.4
W 7 * NS NS
W 14 * NS NS
W 55 * NS NS
NS NS NS NS
NS NS NS NS
NS NS NS NS
A08, CIS,
C22, C24
A27(4),
A28(8), CIS
C24, C92
CIS, C22,
C24
SEWAGE SYSTEMS
Water treatment (recirculating system),
Continuous feed (initial), Not on label,
Not Applicable, Not applicable for this
use
SC/L
SC/L
W .6
Use Group: AQUATIC NON-FOOD INDUSTRIAL
W 8.8 * NS NS NS NS NS NS
W 3 * NS NS
NS NS NS NS
A08, C12,
CIS
A08, C12,
CIS
SC/L
SC/L
W 1.2
W 1.8
W 6 * NS NS
W 6 * NS NS
NS NS NS NS
NS NS NS NS
CIS, C24
A08, C12,
CIS
Water treatment (recirculating system),
Continuous feed (subsequent), Not on
label, Not Applicable, Not applicable for
this use
SC/L
W .59
W 5.9 * NS NS
NS NS NS NS
A08, C12,
CIS
SC/L
W .6
W 1.8 * NS NS
NS NS NS NS
A08, C12,
CIS
SC/L
SC/L
W .6
W .9
W 4.5 * NS NS
W 3 * NS NS
NS NS NS NS
NS NS NS NS
CIS, C24
A08, C12,
CIS
91
-------
Report Run Date: 02/27/96 ) Time 13:13
PRD Report Date: 12/06/95
LUIS 2.22 - Page: 37
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
4444444444444444444444444444444'
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
»)))))))))))))))))))))))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
SEWAGE SYSTEMS (con't)
Water treatment (recirculating system),
Intermittent (slug)(initial), Not on
label, Not Applicable, Not applicable for
this use
SC/L
SC/L
W .59
W .6
Use Group: AQUATIC NON-FOOD INDUSTRIAL (con't)
W 8.8 * NS NS NS NS NS NS
W 3 * NS NS
NS NS NS NS
A08, C12,
CIS
A08, C12,
CIS
SC/L
SC/L
W 1.2
W 1.8
W 6 * NS NS
W 6 * NS NS
NS NS NS NS
NS NS NS NS
CIS, C24
A08, C12,
CIS
Water treatment (recirculating system),
Intermittent (slug)(subsequent), Not on
label, Not Applicable, Not applicable for
this use
SC/L
SC/L
W .59
W .6
W 5.9 * NS NS
W 1.8 * NS NS
NS NS NS NS
NS NS NS NS
A08, C12,
CIS
A08, C12,
CIS
SC/L
SC/L
W .6
W .9
W 4.5 * NS NS
W 3 * NS NS
NS NS NS NS
NS NS NS NS
CIS, C24
A08, C12,
CIS
Water treatment, Initial, Not on label,
Not Applicable, Not applicable for this
use
SC/L
V 4.7
V 9.4 * NS NS
NS NS NS NS
CIS, C24
Water treatment, Subsequent/maintenance,
Not on label, Not Applicable, Not
applicable for this use
SC/L
V 2.3
V 4.7 * NS NS
NS NS NS NS
CIS, C24
SPECIALITY INDUSTRIAL PRODUCTS
Industrial preservative treatment, During SC/L W 7.5
manufacture, Not on label, Not
Applicable, Not applicable for this use
SC/L W 7.5
Use Group: INDOOR NON-FOOD
W 20 * NS NS NS NS NS NS
W 75 * NS NS
NS NS NS NS
ASS, CIS,
C24
CIS, C24
92
-------
Report Run Date: 02/27/96 ) Time 13:13
PRD Report Date: 12/06/95
LUIS 2.22 - Page:
38
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
4444444444444444444444444444444,
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
I))))))))))))))))))))))))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
SPECIALITY INDUSTRIAL PRODUCTS (con't)
SC/L W 7.5
SC/L W 200
Preservative treatment, Not on label, Not SC/L V 15
on label, Not Applicable, Not applicable
for this use
SC/L W 6.7
WET-END ADDITIVES/INDUSTRIAL PROCESSING CHEMICALS
Additive treatment, Not on label, Not on SC/L
label, Not Applicable, Not applicable for
this use
W 5
Industrial preservative treatment, During SC/L W 7.5
manufacture, Not on label, Not
Applicable, Not applicable for this use
SC/L W 10
SC/S W 9.8
SC/S W 14
SC/S W 14
Preservative treatment, Not on label, Not SC/L W 6.7
on label, Not Applicable, Not applicable
for this use
SC/L W 200
WOOD PROTECTION TREATMENT TO BUILDINGS/PRODUCTS INDOOR
Use Group: INDOOR NON-FOOD (con't)
W 75 * NS NS NS NS NS NS
W 2000 * NS NS NS NS NS NS
V 15 * NS NS NS NS NS NS
W 53 * NS NS
NS
Use Group: INDOOR NON-FOOD
W 40 * NS NS NS
W 75 * NS NS NS
W 500 * NS NS NS
Use Group: INDOOR RESIDENTIAL
NS NS
W
W
W
W
W
50
49
70
70
53
* 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
CAH
C22, CAH
CIS, C24
CIS, C24,
C92
C12, CIS
C12, CIS
C12, CIS
CIS, C24
CIS, C24,
C92
C22, CAH
93
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Report Run Date: 02/27/96 ) Time 13:13
PRD Report Date: 12/06/95
LUIS 2.22 - Page:
39
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
4444444444444444444444444444444'
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
»)))))))))))))))))))))))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
WOOD PROTECTION TREATMENT TO BUILDINGS/PRODUCTS INDOOR (con't)
Nonsoil contact nonfumigation, Not on RTU NA
label, Not on label
WOOD PROTECTION TREATMENT TO BUILDINGS/PRODUCTS OUTDOOR
Brush-on, Not on label, Brush RTU NA
Dip treatment, Not on label, Not on label RTU
Nonsoil contact nonfumigation, Not on RTU
label, Brush
NA
Use Group: INDOOR RESIDENTIAL (con't)
.05491 Ib IK * NS NS NS NS NS
sq.ft
Use Group: OUTDOOR RESIDENTIAL
.4333 Ib IK * NS NS NS NS NS
sq.ft
.4333 Ib IK * NS NS
sq.ft
UC * NS NS
NS NS NS
NS NS NS
C65
C24, C93
Nonsoil contact nonfumigation, Not on
label, Not applicable
Nonsoil contact nonfumigation, Not on
label, Roller
Nonsoil contact nonfumigation, Not on
label, Sprayer
Nonsoil contact nonfumigation, Not on
label, Sprinkler can
RTU
SC/L
RTU
SC/L
RTU
SC/L
SC/L
NA
NA
NA
NA
.05491 Ib IK * NS NS
sq.ft
UC * NS NS
UC * NS NS
UC * NS NS
UC * NS NS
.05491 Ib IK * NS NS
sq.ft
UC * NS NS
UC * NS NS
NS NS NS
NS NS NS
NS NS NS
NS
NS
NS NS
NS NS
NS
NS
NS
NS
C24, C93
C24, C93
94
-------
Report Run Date: 02/27/96 ) Time 13:13
PRD Report Date: 12/06/95
LUIS 2.22 - Page: 40
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
444444444444444444444444444444444444444444444444444444444444444444444444
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [(AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
I))))))))))))))))))))))))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
WOOD PROTECTION TREATMENT TO BUILDINGS/PRODUCTS OUTDOOR (con't)
Nonsoil contact nonfumigation, Not on RTU NA
label, Tank
Soil contact nonfumigation, Not on label, SC/L NA
Brush
Use Group: OUTDOOR RESIDENTIAL (con't)
UC * NS NS NS NS NS
UC * NS NS
NS NS NS NS
C24, C93
Soil contact nonfumigation, Not on label, SC/L NA
Roller
UC * NS NS
NS NS NS
Soil contact nonfumigation, Not on label, SC/L NA
Sprayer
Soil contact nonfumigation, Not on label, SC/L NA
Sprinkler can
Spray, Not on label, Sprayer
RTU NA
Surface treatment, Not on label, Roller RTU NA
Surface treatment, When needed, Brush RTU NA
UC * NS NS
UC * NS NS
.4333 Ib IK * NS NS
sq.ft
.4333 Ib IK * NS NS
sq.ft
UC * NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
NS NS NS
C65
C24, C65,
C93, CAL,
CSK, CSL
RTU NA
Surface treatment, When needed, Roller RTU NA
.1436 Ib IK * NS NS
sq.ft
UC * NS NS
NS NS NS
NS NS NS
C93, CAL
C24, C65,
C93, CAL,
CSK, CSL
RTU NA
WOOD PROTECTION TREATMENT TO FOREST PRODUCTS (SEASONED)
Dip treatment, When needed, Dip tank SC/L NA
.1436 Ib IK * NS
sq.ft
NS NS NS
Use Group: TERRESTRIAL NON-FOOD CROP
UC * NS NS NS NS NS
C93, CAL
CIS, C24
95
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Report Run Date: 02/27/96 ) Time 13:13
PRD Report Date: 12/06/95
LUIS 2.22 - Page: 41
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
4444444444444444444444444444444'
SITE Application Type, Application Form(s) Min. Appl. Max. Appl. Soil Max. # Apps Max. Dose [ (AI Min. Restr. Geographic Limitations Use
Timing, Application Equipment ) Rate (AI un- Rate (AI Tex. @ Max. Rate unless noted Interv Entry Allowed Disallowed Limitations
Surface Type (Antimicrobial only) & Effica- less noted unless noted Max. /crop /year otherwise)/A] (days) Interv Codes
cy Influencing Factor (Antimicrobial only) otherwise) otherwise) Dose cycle /crop /year [day(s)]
»)))))))))))))))))))))))))))))))))))))))))))))))))))))
USES ELIGIBLE FOR REREGISTRATION
NON-FOOD/NON-FEED (con't)
WOOD PROTECTION TREATMENT TO FOREST PRODUCTS (SEASONED) (con't)
Nonsoil contact nonfumigation, Not on RTU NA
label, Brush
Nonsoil contact nonfumigation, Not on RTU NA
label, Sprayer
Soil contact nonfumigation, Not on label, SC/L NA
Brush
Use Group: TERRESTRIAL NON-FOOD CROP (con't)
.05491 Ib IK * NS NS NS NS NS NS
sq.ft
.05491 Ib IK * NS NS
sq.ft
UC * NS NS
NS NS NS NS
NS NS NS NS
Soil contact nonfumigation, Not on label, SC/L NA
Roller
UC * NS NS
NS NS NS NS
Soil contact nonfumigation, Not on label, SC/L NA
Sprayer
Soil contact nonfumigation, Not on label, SC/L NA
Tank
UC * NS NS
UC * NS NS
NS NS NS NS
NS NS NS NS
WOOD PROTECTION TREATMENT TO FOREST PRODUCTS (UNSEASONED)
Dip treatment, Not on label, Tank SC/L NA
SC/L NA
Use Group: TERRESTRIAL NON-FOOD CROP
UC * NS NS NS NS NS NS
UC * NS NS NS NS NS NS
CIS, C24,
C92
SC/L
NA
UC * NS NS
NS NS NS NS
CIS, C24,
CAD
Dip treatment, When needed, Dip tank
Spray, Not on label, Sprayer
SC/L
SC/L
SC/L
NA
NA
NA
UC
UC
UC
*
*
*
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
NS
CIS, C24
CIS, C24,
C92
SC/L
UC * NS NS
CIS, C24,
CAD
96
-------
Report Run Date: 02/27/96 ) Time 13:13 LUIS 2.22 - Page: 42
PRD Report Date: 12/06/95
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
444444
LEGEND
444444
Sort: Uses Eligible or Ineligible for Re-registration, Food/Feed or Non-Food/Non-Feed Uses, Alpha Site Name, Use Group Name, Alpha Application Type/Timing/Equipment
Description, Formulation, Maximum Application Rate Unit/Area Quantity, Minimum Application Rate, Maximum Number of Applications at Maximum Rate, Maximum Dose per Crop
Cycle or per Year, Minimum Interval Between Applications (Days), Restricted Entry Interval (Days), Allowed/Disallowed Geographical Areas, Use Limitations Codes.
HEADER ABBREVIATIONS
Min. Appl. Rate (AI unless : Minimum dose for a single application to a single site. System calculated. Microbial claims only.
noted otherwise)
Max. Appl. Rate (AI unless : Maximum dose for a single application to a single site. System calculated.
noted otherwise)
Soil Tex. Max. Dose : Maximum dose for a single application to a single site as related to soil texture (Herbicide claims only).
Max. # Apps @ Max. Rate : Maximum number of Applications at Maximum Dosage Rate. Example: "4 applications per year" is expressed as "4/1 yr"; "4 applications
per 3 years" is expressed as "4/3 yr"
Max. Dose [(AI unless : Maximum dose applied to a site over a single crop cycle or year. System calculated.
noted otherwise)/A]
Min. Interv (days) : Minimum Interval between Applications (days)
Restr. Entry Interv (days) : Restricted Entry Interval (days)
PRD Report Date : LUIS contains all products that were active or suspended (and that were available from OPP Document Center) as of this date. Some
products registered after this date may have data included in this report, but LUIS does not guarantee that all products registered
after this date have data that has been captured.
SOIL TEXTURE FOR MAX APP. RATE
* : Non-specific
C : Coarse
M : Medium
F : Fine
O : Others
FORMULATION CODES
RTU : LIQUID-READY TO USE
SC/L : SOLUBLE CONCENTRATE/LIQUID
SC/S : SOLUBLE CONCENTRATE/SOLID
ABBREVIATIONS
AN : As Needed
NA : Not Applicable
NS : Not Specified (on label)
UC : Unconverted due to lack of data (on label), or with one of following units: bag, bait, bait block, bait pack, bait station, bait station(s), block,
briquet, briquets, bursts, cake, can, canister, capsule, cartridges, coil, collar, container, dispenser, drop, eartag, grains, lure, pack, packet,
packets, pad, part, parts, pellets, piece, pieces, pill, pumps, sec, sec burst, sheet, spike, stake, stick, strip, tab, tablet, tablets, tag, tape,
towelette, tray, unit, --
APPLICATION RATE
DCNC
No Calc
W
V
U
cwt
nnE-xx
Dosage Can Not be Calculated
No Calculation can be made
PPM calculated by weight
PPM Calculated by volume
Unknown whether PPM is given by weight or by volume
Hundred Weight
nn times (10 power -xx); for instance, "1.234E-04" is equivalent to
'.0001234°
97
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PRD Report Date: 12/06/95
) Time 13:13
LUIS 2.22 - Page: 43
APPENDIX A REPORT
Case 2415[Methylene bis(thiocyanate)] Chemical 068102[Methylenebis(thiocyanate)]
14444444444444444444'
USE LIMITATIONS CODES
A :
A08 Preclean claim.
All hour(s) contact time.
A27 hour(s) contact time (minimum).
A28 hour(s) contact time (maximum).
A38 This product is not cleared for use in defearners and/or coatings that may come in contact with food.
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 (POTW).
C22 Do not apply in marine and/or estuarine oil fields.
C24 Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans, or public water. (NPDES license restriction)
C65 Do not use on wood intended for food, feed or potable water contact surfaces.
C92 For terrestrial uses, do not apply directly to water or to areas where surface water is present or to intertidal areas below the mean high water mark.
C93 Do not apply directly to water.
CAD Do not apply directly to water or wetlands.
CAH Do not discharge into lakes, streams, ponds, or public water unless in accordance with NPDES Permit.
CAL Do not contaminate water, food or feed.
CSK Do not use on wood which will come in contact with food.
CSL Do not use on interior wood.
* NUMBER IN PARENTHESES REPRESENTS THE NUMBER OF TIME UNITS (HOURS,DAYS, ETC.) DESCRIBED IN THE LIMITATION.
98
-------
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active ingredients
within the case methylene bis(thiocyanate) covered by this Reregistration Eligibility Decision Document. It
contains generic data requirements that apply to methylene bis(thiocyanate) 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
0 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.
99
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Methylene bis(thiocyanate
REQUIREMENT
USE PATTERN
CITATION(S)
PRODUCT CHEMISTRY
61-1 Chemical Identity
61-2A Start. Mat. & Mnfg. Process
61-2B Formation of Impurities
62-1 Preliminary Analysis
62-2 Certification of limits
62-3 Analytical Method
63-2 Color
63-3 Physical State
63-4 Odor
63-5 Melting Point
63-7 Density
63-8 Solubility
63-9 Vapor Pressure
63-10 Dissociation Constant
63-11 Octanol/Water Partition
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
ALL
MRID 41648001,
MRID 41607701,
MRID 41607701,
MRID 41607702,
MRID 41607702,
MRID 41607702
41607701, 41611902,
41611901, 40518601
42739201, 41648001,
41611901, 40518601
42739202, 41648001,
41611901, 40518601
41648001, 41648002,
41611902, 40518602
41648001, 41648002,
41611902, 40518602
41648001, 41648002,
41611902, 40518602
MRID 41648003
MRID 41648003
43328601
MRID 41648003
MRID 41648003
43328601, 41648003
MRID 41648003
MRID 41648003
MRID 41648003
100
-------
Data Supporting Guideline Requirements for the Reregistration of Methylene bis(thiocyanate
REQUIREMENT
USE PATTERN
CITATION(S)
63-12 PH
63-13 Stability
ECOLOGICAL EFFECTS
71-1A Acute Avian Oral - Quail/Duck
71-2A Avian Dietary - Quail
71-2B Avian Dietary - Duck
71-3 Wild Mammal Toxicity
72-1A Fish Toxicity Bluegill
72-1C Fish Toxicity Rainbow Trout
72-2A Invertebrate Toxicity
72-3A Estuarine/Marine Toxicity - Fish
72-3B Estuarine/Marine Toxicity - Mollusk
72-3C Estuarine/Marine Toxicity - Shrimp
72-4B Life Cycle Invertebrate
TOXICOLOGY
81-1
81-2
81-3
81-4
81-5
81-6
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
ALL
ALL
FM
FM
FM
FM
FM
FM
FM
FM
FM
FM
FM
FM
FM
FM
FM
FM
FM
FM
MRID 41648003
43328601, 41648003
MRIDs 150232, 150231
MRID 150233
MRID 150232
MRID 41592901
MRID 40518608
MRID 40518609
MRID 40518601
MRID 42513402
MRID 42441601
MRID 42513401
MRID 42517001
MRID 41592901
MRID 42873101
MRID 41201601
WAIVED
MRID 43699601
MRID 159567
101
-------
Data Supporting Guideline Requirements for the Reregistration of Methylene bis(thiocyanate
REQUIREMENT USE PATTERN
82-1A
82-2
82-4
83-1A
83-1B
83-2A
83-2B
83-3A
83-3B
83-4
84-2A
84-2B
84-4
85-1
90-Day Feeding - Rodent
21 -Day Dermal - Rat
90-Day Inhalation - Rat
Chronic Feeding Toxicity - Rodent
Chronic Feeding Toxicity -
Non-Rodent
Oncogenicity - Rat
Oncogenicity - Mouse
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
Gene Mutation (Ames Test)
Structural Chromosomal Aberration
Other Genotoxic Effects
General Metabolism
FM
FM
FM
FM
FM
FM
FM
FM
FM
FM
FM
FM
FM
FM
CITATION(S)
MRID 43420001
MRID 41111901
REQUIRED
MRID 42777601
MRID 41463201
MRID 42777601
MRID 42777301
MRID 41171901
MRID 41171902
MRID 42028601
MRID 41003701
MRID 41503801
MRIDs 41503802, 151926, 41003703
MRID 41088501, 41774501
OCCUPATIONAL/RESIDENTIAL EXPOSURE
133-3
133-4
231
232
Dermal Passive Dosimetry Exposure
Inhalation Passive Dosimetry
Exposure
Dermal Exposure at Outdoor Sites
Respiratory Exposure at Outdoor
FM
FM
FM
FM
REQUIRED
REQUIRED
REQUIRED
REQUIRED
Sites
102
-------
Data Supporting Guideline Requirements for the Reregistration of Methylene bis(thiocyanate
REQUIREMENT USE PATTERN CITATION(S)
233
234
Dermal Exposure at Indoor Sites
Respiratory Exposure at Indoor
Sites
FM
FM
ENVIRONMENTAL FATE
161-1 Hydrolysis
168-1-ss Aquaeous Availability
168-2-ss Photodegradation - On Wood
FM
FM
FM
REQUIRED
REQUIRED
MRID 43092101
MRID 43545601
MRID 43511101
103
-------
104
-------
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.
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."
105
-------
(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.
106
-------
BIBLIOGRAPHY
MRID
CITATION
00150231 Roberts, N,; Fairley, C. (1985) The Acute Oral Toxicity (LD50) of MET to the Mallard Duck:
A&W 453BT/85116. Unpublished study prepared by Huntingdon Research Center pic. 20 p.
00150232 Roberts, N.; Fairley, C. (1985) The Subacute Dietary Toxicity (LC50) of MET to the Mallard
Duck: Report No. A&W 454BT/85699. Unpublished study prepared by Huntingdon Research
Center. 40 p.
00150233 Roberts, N.; Fairley, C. (1985) The Subacute Dietary Toxicity (LC50) of MET to the
Bobwhite Quail: Report No. A&W 455BT/85721. Unpublished study prepared by Huntingdon
Research Center. 22 p.
00150234 Anderson, A.; Dawe, I.; Bourne, N.; et al. (1985) Analysis of Methylene Bisthiocyanate
(MET) in Avian Diet: Study No. A&W 455BT. Unpublished study prepared by Huntingdon
Research Centre. 30 p.
00151926 Collier, T. (1981) Micronucleus Study in the Mouse with Methylene bis thiocyanate:
Experiment Number 119/8103. Unpublished study prepared by Safepharm Labs., Ltd. 23 p.
40518601 Frances, J. (1988) Product Identity: Methylene bis thiocyanate. Unpublished study prepared
by Dead Sea Bromide Co. 14 p.
40518602 Frances, J. (1988) Analysis and Certification of Product Ingredients: Methylene bis
thiocyanate. Unpublished study prepared by Dead Sea Bromide Co. 22 p.
40518608 Surprenant, D.; Nicholson, R. (1986) Acute Toxicity of Methylene bis thiocyanate to Bluegill
(Lepomis macrochirus): Study No. 11192-1185-6101-100. Unpublished study prepared by
Springborn Bionomics, Inc. 16 p.
40518609 Surprenant, D.; Nicholson, R. (1986) Acute Toxicity of Methylene bis thiocyanate to
Rainbow Trout (Salmo gairdneri): Study No. 11192-1185-6101-103. Unpublished study
prepared by Springborn Bionomics, Inc. 16 p.
41003701 Lawlor, T.; Wagner, V. (1988) Salmonell/Mammalian-Microsome Plate Incorporation
Mutagenicty Assay (Ames Test) with a Confirmatory Assay: Methylene Bis (thiocyanate) Lot
No. 70846-M: Study No. T8013.501014. Unpublished study prepared by Microbiological
Associates, Inc. 61 p.
41003703 Curren, R, (1988) Unscheduled DNA Synthesis in Rat Primary Hepatocytes: Methylene
Bis (thiocyanate): Study No. T8013.380. Unpublished study prepared by Microbiological
Associates, Inc. 26 p.
41088501 Brown, L; Cameron, B.; Mutch, P.; et al. (1988) The Metabolism of Methylene Bis
107
-------
MRID
BIBLIOGRAPHY
CITATION
(Thiocyanate) in the Rat: IRI Project No. 137336. Unpublished study prepared by Inveresk
Research International. 106 p.
41111901 Kenwood, S. (1989) 21-Day Dermal Toxicity Study with Methelene bis(thiocyanate) in Rats:
Project ID HLA 6142-109. Unpublished study prepared by Hazleton Laboratories America,
Inc. 177 p.
41171901 Hoberman, A. (1989) Developmental Toxicity (Embryo/Fetal Toxicity and Teratogenic
Potential) Study of Methylene Bis (Thiocyanate) Administered Orally Via Gavage to Crl:CD
(SD)BR Presumed Rats: Project ID: 1419-001. Unpublished study prepared by Argus
Research Laboratories, Inc. 281 p.
41171902 Hoberman, A. (1989) Developmental Toxicity (Embryo/Fetal Toxicity and Teratogenic
Potential) Study of Methylene Bis (Thiocyanate) Administered Orally (Stomach Tube) to New
Zealand White Rabbits: Project ID: 1419-002. Unpublished study prepared by Argus
Research Laboratories, Inc. 354 p.
41201601 Hoffman, G. (1989) An Acute Inhalation Toxicity Study of Methylene Bis Thiocyanate in the
Rat: Project No. 87-8005. Unpublished study prepared by Bio/dynamics, Inc. 101 p.
41463201 Goburdhun, R.; Greenough, R.; Howroyd, P. (1989) Methylene Bis (Thiocyanate) (MTC): 52
Week Oral Toxicity Study in Dogs: IRI Project I.D.637445: Report No. 5892. Unpublished
study prepared by Research International. 204 p.
41503801 Holmstrom, L. (1989) MET: Chromosomal Aberrations Assay with Chinese Hamster Ovary
Cells in vitro: Lab Project Number: 4976. Unpublished study prepared by Inveresk Research
International. 41 p.
41503802 Cattanach, P. (1989) Methylene Bis Thiocyanate (MET): Mouse Lymphoma Mutation Assay:
Lab Project Number: 4947
41592901 Glaza, S. (1990) Acute Oral Toxicity Study of Methylene Bis(thiocyanate) in Rats: Lab
Project Number: HLA 00301639. Unpublished Study Prepared by Hazleton Laboratories
America, Inc. 43 p.
41607701 Harrison, E. (1990) Product Chemistry: Description of Beginning Materials and
Manufacturing Process for Albright & Wilson Methyl bis (thiocyanate): Supplement to.
Unpublished study prepared by Albright & Wilson Ltd. 38 p.
41607702 Harrison, E. (1990) Product Chemistry: Certification of Ingredient Limits for Albright &
Wilson Methylene bis (thiocyanate): Supplement to: Lab Project Number: 9577-F.
Unpublished study prepared by Albright & Wilson Ltd. 8 p.
108
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BIBLIOGRAPHY
MRID
CITATION
41611901 Helmhout, S.; Little, R. (1990) Product Chemistry for Methylene (bis)thiocyanate
[Manufacturing Process]. Unpublished study prepared by Buckman Laboratories
International, Inc. 26 p.
41611902 Helmhout, S.; Little, R. (1990) Product Chemistry for Methylene (bis)thiocyanate [Certified
Limits]. Unpublished study prepared by Buckman Laboratories International, Inc. 7 p.
41648001 Haggerty, W. (1990) Product Chemistry for Methylene bis(thiocyanate): Product Identity,
Manufacturing Process and Discussion of Impurities: Lab Project Number: 9577-F.
Unpublished study prepared by Midwest Research Institute. 14 p.
41648002 Sieman, L. (1900) Product Chemistry for Methylene bis(thiocyanate): Preliminary Analysis,
Certification of Limits and Analytical Methods to Verify Certified Limits: Lab Project
Number: 9577-F. Unpublished study prepared by Midwest Research Institute. 46 p.
41648003 Sieman, L. (1990) Product Chemistry for Methylene bis(thiocyanate): Physical and Chemical
Characteristics: Lab Project Number 9577-F. Unpublished study prepared by Midwest
Research Institute. 31 p.
41774501 Sipes, L; Carter, D.; Roby, M. (1991) Estimation of Cyanide as a Metabolite of Methylene
Dithiocyanate CH2(SCN)2 in Blood of Male Fischer 344 Rats: Lab Project Number:
NOl-ES-3-137336. Unpublished study prepared by Buckman Laboratories International, Inc.
20 p.
42028601 Wilson, J.; Barton, S. (1990) Methylene Bis (Thiocyanate) (MTC): Two Generation
Reproduction Study in Rats: Lab Project Number: 436385. Unpublished study prepared by
Inveresk Research International. 135 p.
42440400 Buckman Laboratories International, Inc. (1992) Submission of toxicity data in support of
FIFRA 6(a) (2) requirements for Methylene bis(thiocyanate). Transmittal of 1 study.
42440401 Watson, C. (1992) Letter Sent to EPA, dated August 12, 1992, preliminary and unaudited
data from a daphnia 21-day life cycle study: Methylene bis(thiocyanate). Prepared by
Buckman Labs. 6 p.
42513400 Buckman Laboratories Inc., (1992) Submittal of acute toxicity data in support of Methylene
Bis(thiocyanate) reregistration data call-in. Transmittal of 2 studies.
42513401 Machado, M. (1992) Methylene Bis (Thiocyanate)-Acute Toxicity to Mysid Shrimp
(Mysidopsis bahia) Under Flow-Through Conditions: Lab Project Number: 92-8-4373:
995.0492.6144.515. Unpublished study prepared by Springborn Laboratories Inc. 67 p.
42513402 Machado, M. (1992) Methylene Bis (Thiocyanate)—Acute Toxicity to Sheepshead Minnow
(Cyprinadon variegatus) Under Flow-Through Conditions: Lab Project Number: 92-8-4386:
109
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BIBLIOGRAPHY
MRID
CITATION
995.0492.6145.505. Unpublished study prepared by Springborn Laboratories Inc. 70 p.
42517000 Methylene Bis(thiocyanate) Task Force (1992) Submission of aquatic toxicity data under
FIFRA 6(a)2 to support reregistration of Methylene Bis(thiocyanate). Transmittal of 1 study.
42517001 Putt, A. (1992) Methylene Bis(thiocyanate): The Chronic Toxicity to Daphnia magna under
Flow-through Conditions: Final Report: Lab Project Number: 995.0492.6148.130: 92-8-4375.
Unpublished study prepared by Springborn Labs, Inc. 108 p.
42518601 Watson, C. (1992) Letter Sent to OPP, USEPA dated Oct. 15, 1992: Preliminary and
Unaudited Data from an Early Life-stage Study with Rainbow Trout. 7 p.
42541601 Dionne, E. (1992) Methylene Bis(thiocyanate): Acute Toxicity to Eastern Oyster (Crassostrea
virginica) under Flow-through Conditions: Final Report: Lab Project Number:
995.0492.6146.504: 92-10-4443. Unpublished study prepared by Springborn Labs, Inc. 64 p.
42603301 Bettencourt, M. (1992) Methylene Bis(Thiocyanate)—The Toxicity to Rainbow Trout
(Oncorhynchus mykiss) during an Early Life-stage Exposure: Final Report: Lab Project
Number: 92-10-4466: 995.0492.6147.121. Unpublished study prepared by Springborn
Laboratories, Inc. 96 p.
42739201 Lamirsa Laboratorios Miret S. A. (1993) Product Chemistry: Detailed Description of
Beginning Materials and Manufacturing Process for Vedexil-DM/K: A Supplement: Lab
Project Number: LAMIRSA-1993-1. Unpublished study. 12 p.
42739202 Lamirsa Laboratorios Miret S. A. (1993) Product Chemistry: Elaboration on Discussion of
Formation of Impurities for Vedexil-DM/K: A Supplement: Lab Project Number:
LAMIRSA-1993-2. Unpublished study. 15 p.
42771201 Vinings Industries, Inc. (1993) Raw Materials Specifications: Quality Control Data for
AM A-10: Supporting Information. 4 p.
42777301 Atkinson, C.; Inglis, R.; Hudson, P.; et al. (1991) Methylene Bis (Thiocyanate) 78 Week
Oral Gavage Carcinogenicity Study in Mice: Lab Project Number: 437085: 7814.
Unpublished study prepared by Inveresk Research International. 602 p.
42777601 Atkinson, C.; Inglis, R.; Hudson, P.; et al. (1993) Methylene Bis (Thiocyanate): 104 Week
Oral by Gavage Carcinogenicity Study in Rats with 52 Week Interim Kill: Lab Project
Number: 437090: 7917. Unpublished study prepared by Inveresk Research International.
1138 p.
42873101 Gingrich, S.; Morrison, R.; O'Hara, G. (1993) Methylene Bis(thiocyanate): Acute Dermal
Toxicity Study in Male and Female Rats: Lab Project Number: 93P-001: 93R-001.
Unpublished study prepared by Rohm and Haas Co. 15 p.
110
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MRID
BIBLIOGRAPHY
CITATION
43092101 Cohen, S. (1994) Methylene Bis(thiocyanate) (MET): Hydrolysis of MET in Buffered
Aqueous Solutions: Final Report: Lab Project Number: ME 9200145. Unpublished study
prepared by Pittsburgh Environmental Research Laboratory, Inc. 102 p.
43328601 Siemann, L. (1994) Methylene Bis(thiocyanate) Product Chemistry Series 63-Physical and
Chemical Characteristics: Lab Project Number: 3758-F: BUCKMAN/3758. Unpublished
study prepared by Midwest Research Institute. 33 p.
43420001 Burka, L. (1993) NTP Technical Report on Toxicity Studies of Methylene Bis(thiocyanate)
Administered by Gavage to F344/N Rats and B6C3F1 Mice: NIH Publication 94-3381.
Prepared by National Toxicology Program. Toxicity Report Series No. 32. U.S. Public
Health Service, National Inst. of Health. 79 p.
43511101 Misra, B. (1995) Methylene Bis(thiocyanate) (MET): Photodegradation of MET on Wood
Surface under Artificial Sunlight Irradiation: Final Report: Lab Project Number:
ME/9400158. Unpublished study prepared by Pittsburgh Environmental Research
Laboratory, Inc. 110 p.
43545601 Donnelly, C. (1995) The Leaching of Methylene Bis(thiocyanate) (MET) from Treated Wood:
Final Report: Lab Project Number: ME 9400159. Unpublished study prepared by Pittsburgh
Environmental Research Lab, Inc. 133 p.
43699601 Procopio, K.; Hamilton, J. (1992) Methylene Bis(Thiocyanate): Skin Irritation Study in
Rabbits: Final Report: Lab Project Number: 92P-042: 92R-042. Unpublished study prepared
by Rohm and Haas Co. 18 p.
Ill
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, B.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
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your product(s) subject to this Notice will be subject to suspension. We have provided a list of
all of your products subject to this Notice in Attachment 2, Data Call-In Response Form, as
well as a list of all registrants who were sent this Notice (Attachment 6).
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide
and Rodenticide Act as amended (FIFRA), 7 U.S.C. section 136a(c)(2)(B). Collection of this
information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-
0107 and 2070-0057 (expiration date 03-31-99).
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.
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II-B. SCHEDULE FOR SUBMISSION OF DATA
You are required to submit the data or otherwise satisfy the data requirements specified in
Attachment 3, Requirements Status and Registrant's Response Form, within the time frames
provided.
II-C. TESTING PROTOCOL
All studies required under this Notice must be conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established.
These EPA Guidelines are available from the National Technical Information Service
(NTIS), Attn: Order Desk, 5285 Port Royal Road, Springfield, Va 22161 (tel: 703-487-4650).
Protocols approved by the Organization for Economic Cooperation and Development
(OECD) are also acceptable if the OECD-recommended test standards conform to those specified
in the Pesticide Data Requirements regulation (40 CFR § 158.70). When using the OECD
protocols, they should be modified as appropriate so that the data generated by the study will
satisfy the requirements of 40 CFR § 158. Normally, the Agency will not extend deadlines for
complying with data requirements when the studies were not conducted in accordance with
acceptable standards. The OECD protocols are available from OECD, 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
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The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this notice or ©
request a data waiver (s).
A discussion of how to respond if you chose the Voluntary Cancellation option is
presented below. A discussion of the various options available for satisfying the product specific
data requirements of this Notice is contained in Section III-C. A discussion of options relating to
requests for data waivers is contained in Section III-D.
There are two forms that accompany this Notice of which, depending upon your response,
one or both must be used in your response to the Agency. These forms are the Data-Call-in
Response Form, and the Requirements Status and Registrant's Response Form, Attachment 2 and
Attachment 3. The Data Call-in Response Form must be submitted as part of every response to
this Notice. In addition, one copy of the Requirements Status and Registrant's Response Form
must be submitted for each product listed on the Data Call-In Response Form unless the voluntary
cancellation option is selected or unless the product is identical to another (refer to the instructions
for completing the Data Call-In Response Form in Attachment 2). Please note that the company's
authorized representative is required to sign the first page of the Data Call-In Response Form and
Requirements Status and Registrant's Response Form (if this form is required) and initial any
subsequent pages. The forms contain separate detailed instructions on the response options. Do
not alter the printed material. If you have questions or need assistance in preparing your
response, call or write the contact person(s) identified in Attachment 1.
1. Voluntary Cancellation - You may avoid the requirements of this Notice by requesting
voluntary cancellation of your product(s) containing the active ingredient that is the subject of this
Notice. If you wish to voluntarily cancel your product, you must submit a completed Data Call-In
Response Form, indicating your election of this option. Voluntary cancellation is item number 5
on the Data Call-In Response Form. If you choose this option, this is the only form that you are
required to complete.
If you chose to voluntarily cancel your product, further sale and distribution of your
product after the effective date of cancellation must be in accordance with the Existing Stocks
provisions of this Notice which are contained in Section IV-C.
2. Satisfying the Product Specific Data Requirements of this Notice There are various
options available to satisfy the product specific data requirements of this Notice. These options
are discussed in Section III-C of this Notice and comprise options 1 through 6 on the
Requirements Status and Registrant's Response Form and item numbers 7a and 7b on the Data
Call-in Response Form. Deletion of a use(s) and the low volume/minor use option are not valid
options for fulfilling product specific data requirements.
3. Request for Product Specific Data Waivers. Waivers for product specific data are
discussed in Section III-D of this Notice and are covered by option 7 on the Requirements Status
and Registrant's Response Form. If you choose one of these options, you must submit both forms
as well as any other information/data pertaining to the option chosen to address the data
requirement.
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III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTICE
If you acknowledge on the Data Call-In Response Form that you agree to satisfy the
product specific data requirements (i.e. you select item number 7a or 7b), then you must select
one of the six options on the Requirements Status and Registrant's Response Form related to data
production for each data requirement. Your option selection should be entered under item
number 9, "Registrant Response." The six options related to data production are the first six
options discussed under item 9 in the instructions for completing the Requirements Status and
Registrant's Response Form. These six options are listed immediately below with information in
parentheses to guide registrants to additional instructions provided in this Section. The options
are:
(1) I will generate and submit data within the specified time frame (Developing Data)
(2) I have entered into an agreement with one or more registrants to develop data
jointly (Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradable (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
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considered if it is submitted at or after the lapse of the subject deadline.
Option 2, Agreement to Share in Cost to Develop Data — Registrants may only choose
this option for acute toxicity data and certain efficacy data and only if EPA has indicated in the
attached data tables that your product and at least one other product are similar for purposes of
depending on the same data. If this is the case, data may be generated for just one of the products
in the group. The registration number of the product for which data will be submitted must be
noted in the agreement to cost share by the registrant selecting this option. If you choose to enter
into an agreement to share in the cost of producing the required data but will not be submitting
the data yourself, you must provide the name of the registrant who will be submitting the data.
You must also provide EPA with documentary evidence that an agreement has been formed. Such
evidence may be your letter offering to join in an agreement and the other registrant's acceptance
of your offer, or a written statement by the parties that an agreement exists. The agreement to
produce the data need not specify all of the terms of the final arrangement between the parties or
the mechanism to resolve the terms. Section 3(c)(2)(B) provides that if the parties cannot resolve
the terms of the agreement they may resolve their differences through binding arbitration.
Option 3, Offer to Share in the Cost of Data Development — This option only applies to
acute toxicity and certain efficacy data as described in option 2 above. If you have made an offer
to pay in an attempt to enter into an agreement or amend an existing agreement to meet the
requirements of this Notice and have been unsuccessful, you may request EPA (by selecting this
option) to exercise its discretion not to suspend your registration(s), although you do not comply
with the data submission requirements of this Notice. EPA has determined that as a general
policy, absent other relevant considerations, it will not suspend the registration of a product of a
registrant who has in good faith sought and continues to seek to enter into a joint data
development/cost sharing program, but the other registrant(s) developing the data has refused to
accept your offer. To qualify for this option, you must submit documentation to the Agency
proving that you have made an offer to another registrant (who has an obligation to submit data)
to share in the burden of developing that data. You must also submit to the Agency a completed
EPA Form 8570-32, Certification of Offer to Cost Share in the Development of Data, Attachment
7. In addition, you must demonstrate that the other registrant to whom the offer was made has
not accepted your offer to enter into a cost sharing agreement by including a copy of your offer
and proof of the other registrant's receipt of that offer (such as a certified mail receipt). Your
offer must, in addition to anything else, offer to share in the burden of producing the data upon
terms to be agreed or failing agreement to be bound by binding arbitration as provided by FIFRA
section 3(c)(2)(B)(iii) and must not qualify this offer. The other registrant must also inform EPA
of its election of an option to develop and submit the data required by this Notice by submitting a
Data Call-In Response Form and a Requirements Status and Registrant's Response Form
committing to develop and submit the data required by this Notice.
In order for you to avoid suspension under this option, you may not withdraw your offer
to share in the burdens of developing the data. In addition, the other registrant must fulfill its
commitment to develop and submit the data as required by this Notice. If the other registrant fails
to develop the data or for some other reason is subject to suspension, your registration as well as
that of the other registrant will normally be subject to initiation of suspension proceedings, unless
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.
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Option 4, Submitting an Existing Study — If you choose to submit an existing study in
response to this Notice, you must determine that the study satisfies the requirements imposed by
this Notice. You may only submit a study that has not been previously submitted to the Agency
or previously cited by anyone. Existing studies are studies which predate issuance of this Notice.
Do not use this option if you are submitting data to upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the
required date of submission. The Agency may determine at any time that a study is not valid and
needs to be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data
and specimens from the study are available for audit and review and you must
identify where they are available. This must be done in accordance with the
requirements of the Good Laboratory Practice (GLP) regulation, 40 CFR Part 160.
As stated in 40 CFR 160.3(j) " 'raw data' means any laboratory worksheets,
records, memoranda, notes, or exact copies thereof, that are the result of original
observations and activities of a study and are necessary for the reconstruction and
evaluation of the report of that study. In the event that exact transcripts of raw
data have been prepared (e.g., tapes which have been transcribed verbatim, dated,
and verified accurate by signature), the exact copy or exact transcript may be
substituted for the original source as raw data. 'Raw data' may include
photographs, microfilm or microfiche copies, computer printouts, magnetic media,
including dictated observations, and recorded data from automated instruments."
The term "specimens", according to 40 CFR 160.3(k), means "any material
derived from a test system for examination or analysis."
b. Health and safety studies completed after May 1984 must also contain all GLP-
required quality assurance and quality control information, pursuant to the
requirements of 40 CFR Part 160. Registrants must also certify at the time of
submitting the existing study that such GLP information is available for post-May
1984 studies by including an appropriate statement on or attached to the study
signed by an authorized official or representative of the registrant.
c. You must certify that each study fulfills the acceptance criteria for the Guideline
relevant to the study provided in the FIFRA Accelerated Reregistration Phase 3
Technical Guidance and that the study has been conducted according to the
Pesticide Assessment Guidelines (PAG) or meets the purpose of the PAG (both
available from NTIS). A study not conducted according to the PAG may be
submitted to the Agency for consideration if the registrant believes that the study
clearly meets the purpose of the PAG. The registrant is referred to 40 CFR 158.70
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
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are met by the study, clearly articulate the rationale why you believe the study
meets the purpose of the PAG, including copies of any supporting information or
data. It has been the Agency's experience that studies completed prior to January
1970 rarely satisfied the purpose of the PAG and that necessary raw data are
usually not available for such studies.
If you submit an existing study, you must certify that the study meets all requirements of
the criteria outlined above.
If you know of a study pertaining to any requirement in this Notice which does not meet
the criteria outlined above but does contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study. If such study is in the Agency's files, you
need only cite it along with the notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5.
Option 5, Upgrading a Study — If a study has been classified as partially acceptable and
upgradable, 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 upgradable studies will normally be classified as supplemental. However, it is
important to note that not all studies classified as supplemental are upgradable. 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
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the study has been reviewed by the Agency, you must provide the Agency's classification of the
study.
If you are citing a study of which you are not the original data submitter, you must submit
a completed copy of EPA Form 8570-31, Certification with Respect to Data Compensation
Requirements.
Registrants who select one of the above 6 options must meet all of the requirements
described in the instructions for completing the Data Call-in Response Form and the Requirements
Status and Registrant's Response Form, as appropriate.
III-D REQUESTS FOR DATA WAIVERS
If you request a waiver for product specific data because you believe it is
inappropriate, you must attach a complete justification for the request, including technical
reasons, data and references to relevant EPA regulations, guidelines or policies. (Note: any
supplemental data must be submitted in the format required by PR Notice 86-5). This will be the
only opportunity to state the reasons or provide information in support of your request. If the
Agency approves your waiver request, you will not be required to supply the data pursuant to
section 3(c)(2)(B) of FIFRA. If the Agency denies your waiver request, you must choose an
option for meeting the data requirements of this Notice within 30 days of the receipt of the
Agency's decision. You must indicate and submit the option chosen on the Requirements Status
and Registrant's Response Form. Product specific data requirements for product chemistry, acute
toxicity and efficacy (where appropriate) are required for all products and the Agency would grant
a waiver only under extraordinary circumstances. You should also be aware that submitting a
waiver request will not automatically extend the due date for the study in question. Waiver
requests submitted without adequate supporting rationale will be denied and the original due date
will remain in force.
IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due to
failure by a registrant to comply with the requirements of this Data Call-In Notice, pursuant to
FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent to
Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of this
Notice.
2. Failure to submit on the required schedule an acceptable proposed or final protocol
when such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a study
as required by this Notice.
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4. Failure to submit on the required schedule acceptable data as required by this
Notice.
5. Failure to take a required action or submit adequate information pertaining to any
option chosen to address the data requirements (e.g., any required action or
information pertaining to submission or citation of existing studies or offers,
arrangements, or arbitration on the sharing of costs or the formation of Task
Forces, failure to comply with the terms of an agreement or arbitration concerning
joint data development or failure to comply with any terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of submitted
studies, as required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost of
developing data and provided proof of the registrant's receipt of such offer or
failure of a registrant on whom you rely for a generic data exemption either to:
a. inform EPA of intent to develop and submit the data required by this Notice
on a Data Call-in Response Form and a Requirements Status and
Registrant's Response Form;
b. fulfill the commitment to develop and submit the data as required by this
Notice; or
c. otherwise take appropriate steps to meet the requirements stated in this
Notice, unless you commit to submit and do submit the required data in the
specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required time) is
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds
for suspension include, but are not limited to, failure to meet any of the following:
1. EPA requirements specified in the Data Call-In Notice or other documents incorporated
by reference (including, as applicable, EPA Pesticide Assessment Guidelines, Data
Reporting Guidelines, and GeneTox Health Effects Test Guidelines) regarding the design,
conduct, and reporting of required studies. Such requirements include, but are not limited
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.
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2. EPA requirements regarding the submission of protocols, including the incorporation
of any changes required by the Agency following review.
3. EPA requirements regarding the reporting of data, including the manner of reporting,
the completeness of results, and the adequacy of any required supporting (or raw) data,
including, but not limited to, requirements referenced or included in this Notice or
contained in PR 86-5. All studies must be submitted in the form of a final report; a
preliminary report will not be considered to fulfill the submission requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR 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 canceled 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.
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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.
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, 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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METHYLENE BIS(THIOCYANATE) DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing methylene bis(thiocyanate).
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 methylene
bis(thiocyanate). 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 methylene bis(thiocyanate) 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 methylene
bis(thiocyanate) are contained in the Requirements Status and Registrant's Response, Attachment 3.
The Agency has concluded that additional data on methylene bis(thiocyanate) 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 methylene bis(thiocyanate)
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 Karen Jones at (703) 308-8047.
All responses to this Notice for the Product Specific data requirements should be submitted
to:
Karen Jones
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: methylene bis(thiocyanate)
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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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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, SubpartC.
Item 5. The study title associated with the guideline reference number is identified.
Item 6. The use pattern(s) of the pesticide associated with the product specific requirements
is (are) identified. For most product specific data requirements, all use patterns are
covered by the data requirements. In the case of efficacy data, the required studies
only pertain to products which have the use sites and/or pests indicated.
Item 7. The substance to be tested is identified by EPA. For product specific data, the
product as formulated for sale and distribution is the test substance, except in rare
cases.
Item 8. The due date for submission of each study is identified. It is normally based on 8
months after issuance of the Reregistration Eligibility Document unless EPA
determines that a longer time period is necessary.
Item 9. Enter only one of the following response codes for each data requirement to show
how you intend to comply with the data requirements listed in this table. Fuller
descriptions of each option are contained in the Data Call-In Notice.
1. I will generate and submit data by the specified due date (Developing Data). By
indicating that I have chosen this option, I certify that I will comply with all the
requirements pertaining to the conditions for submittal of this study as outlined in the
Data Call-In Notice. By the specified due date, I will also submit: (1) a completed
"Certification With Respect To Data Compensation Requirements" form (EPA
Form 8570-29) and (2) two completed and signed copies of the Confidential
Statement of Formula (EPA Form 8570-4).
2. I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing). I am submitting a copy of this agreement. I understand that this
option is available only for acute toxicity or certain efficacy data and only if EPA
indicates in an attachment to this Notice that my product is similar enough to another
product to qualify for this option. I certify that another party in the agreement is
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committing to submit or provide the required data; if the required study is not
submitted on time, my product may be subject to suspension. By the specified due
date, I will also submit: (1) a completed "Certification With Respect To Data
Compensation Requirements" form (EPA Form 8570-29) and (2) two completed
and signed copies of the Confidential Statement of Formula (EPA Form 8570-4).
3. I have made offers to share in the cost to develop data (Offers to Cost Share). I
understand that this option is available only for acute toxicity or certain efficacy data
and only if EPA indicates in an attachment to this Data Call-in Notice that my product
is similar enough to another product to qualify for this option. I am submitting
evidence that I have made an offer to another registrant (who has an obligation to
submit data) to share in the cost of that data. I am also submitting a completed
"Certification of Offer to Cost Share in the Development Data" form. I am
including a copy of my offer and proof of the other registrant's receipt of that offer.
I am identifying the party which is committing to submit or provide the required data;
if the required study is not submitted on time, my product may be subject to
suspension. I understand that other terms under Option 3 in the Data Call-in Notice
(Section III-C.l.) apply as well. By the specified due date, I will also submit: (1) a
completed "Certification With Respect To Data Compensation Requirements"
form (EPA Form 8570-29) and (2) two completed and signed copies of the
Confidential Statement of Formula (EPA Form 8570-4).
4. By the specified due date, I will submit an existing study that has not been submitted
previously to the Agency by anyone (Submitting an Existing Study). I certify that
this study will meet all the requirements for submittal of existing data outlined in
Option 4 in the Data Call-In Notice (Section III-C.l.) and will meet the attached
acceptance criteria (for acute toxicity and product chemistry data). I will attach the
needed supporting information along with this response. I also certify that I have
determined that this study will fill the data requirement for which I have indicated this
choice. By the specified due date, I will also submit a completed "Certification With
Respect To Data Compensation Requirements" form (EPA Form 8570-29) to
show what data compensation option I have chosen. By the specified due date, I will
also submit: (1) a completed "Certification With Respect To Data Compensation
Requirements" form (EPA Form 8570-29) and (2) two completed and signed copies
of the Confidential Statement of Formula (EPA Form 8570-4).
5. By the specified due date, I will submit or cite data to upgrade a study classified by
the Agency as partially acceptable and upgradable (Upgrading a Study). I will
submit evidence of the Agency's review indicating that the study may be upgraded
and what information is required to do so. I will provide the MRID or Accession
number of the study at the due date. I understand that the conditions for this option
outlined Option 5 in the Data Call-In Notice (Section III-C.l.) apply. By the
specified due date, I will also submit: (1) a completed "Certification With Respect
To Data Compensation Requirements" form (EPA Form 8570-29) and (2) two
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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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EPA'S BATCHING OF METHYLENE BIS(THIOCYANATE); PRODUCTS FOR MEETING
ACUTE TOXICITY DATA REQUIREMENTS FOR REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the acute
toxicity data requirements for reregistration of products containing MBTC as the active ingredient,
the Agency has batched products which can be considered similar for purposes of acute toxicity.
Factors considered in the sorting process include each product's active and inert ingredients (identity,
percent composition and biological activity), type of formulation (e.g., emulsifiable concentrate,
aerosol, wettable powder, granular, etc.), and labeling (e.g., signal word, use classification,
precautionary labeling, etc.). Note that the Agency is not describing batched products as
"substantially similar" since some products within a batch may not be considered chemically similar
or have identical use patterns.
Using available information, batching has been accomplished by the process described in the
preceding paragraph. Not-withstanding the batching process, the Agency reserves the right to
require, at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or cite
a single battery of six acute toxicological studies to represent all the products within that batch. It
is the registrants' option to participate in the process with all other registrants, only some of the other
registrants, or only their own products within a batch, or to generate all the required acute
toxicological studies for each of their own products. If a registrant chooses to generate the data for
a batch, he/she must use one of the products within the batch as the test material. If a registrant
chooses to rely upon previously submitted acute toxicity data, he/she may do so provided that the
data base is complete and valid by today's standards (see acceptance criteria attached), the
formulation tested is considered by EPA to be similar for acute toxicity, and the formulation has not
been significantly altered since submission and acceptance of the acute toxicity data. Regardless of
whether new data are generated or existing data are referenced, registrants must clearly identify the
test material by EPA Registration Number. If more than one confidential statement of formula (CSF)
exists for a product, the registrant must indicate the formulation actually tested by identifying the
corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow the
directions given in the Data Call-In Notice and its attachments appended to the RED. The DCI
Notice contains two response forms which are to be completed and submitted to the Agency within
90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant will meet
the data requirements for each product. The second form, "Requirements Status and Registrant's
Response," lists the product specific data required for each product, including the standard six acute
toxicity tests. A registrant who wishes to participate in a batch must decide whether he/she will
provide the data or depend on someone else to do so. If a registrant supplies the data to support a
batch of products, he/she 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,
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a registrant should know that choosing not to participate in a batch does not preclude other registrants
in the batch from citing his/her studies and offering to cost share (Option 3) those studies.
Sixty two active products were found which contain MBTC as an active ingredient. One
product, 10445-92, will not be batched because of insufficient CSF. The remaining products have
been placed into 3 Tables in accordance with the active and inert ingredients, type of formulation and
current labeling.
TABLE I
Batch 1 Active Ingredients of Methylene bis(thiocyanate)
TABLE II
Batch 1 Methylene bis(thiocyanate) and Bis (trichloromethyl) Sulfone
Batch 2 Methylene bis(thiocyanate) and beta-Bromo-beta-Nitrostyrene
Batch 3 Methylene bis(thiocyanate) and dodecyl guanidine HC1
Batch 4 Methylene bis(thiocyanate) and 2-(Thiocyanomethylthio) benzothiazole
Batch 5 Methylene bis(thiocyanate) and chlorothalonil
TABLE III
Batch 1 Methylene bis(thiocyanate) at low concentrations of Methylene
bis(thiocyanate) and solvents, and surfactants.
TABLE I
Batch 1 consists of Active Ingredients (AIs) or concentrations of Methylene bis(thiocyanate).
Data are available to identify the toxicity of these products. Products containing data reviews are
identified with an asterisk (*). They are summarized below:
Data Required Toxicity Category Classification
Acute Oral (§81-1) II A
Acute Dermal (81-2) III A
Eye Irr. (§81-4) I A
Dermal Irr. (§81-5) I A
Dermal Sens. (§81-6) Sens. A
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EPA Reg#
1448-80*
8622-42*
9386-12
33766-1*
64715-1*
67869-17
%AI
99.0
98.5
100.0
99.0
99.0
100.0
Formulation Type
G
G
G
G
G
G
Table II
Batch 1 consists of products containing bistrichloromethyl sulfone (BisTCMS). No data are
available for these products.
Batch 1
EPA Reg J
45017-27
68329-11
68329-15
%MBTS/%AI
5.0/49.6
5.0/17.4
5.0/20.4
Formulation Type
EC
EC
EC
Batch 2 consists of products containing 2-(thiocyano-methylthio) benzothiazole (TCMBT).
Data are available to identify the toxicity of these products. Products containing data reviews
are identified with an asterisk (*). They are summarized below:
Data
Required
Acute Oral (§81-1)
Acute Dermal (81-2)
Eye Irr. (§81-4)
Dermal Irr. (§81-5)
Dermal Sens. (§81-6)
Toxicity
Category
II
II
I
I
Sens.
Classification
A
A
A
A
A
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Batch 2
EPA Reg. %
458-31
577-548
1448-81*
1448-101
1448-102*
1448-179
1448-344
7053-30
10445-92
56156-1
%MBTS/%AI
1096/10%
0.5%/0.5%
10%/10%
5%/5%
2.5%/2.5%
5%/5%
10%/5%
10%/5%
10.4%/12.8%
0.5%/0.5%
Formulation Type
EC
WdPr
EC
EC
EC
EC
EC
EC
EC
WdPr
Batch 3 consists of products containing beta-bromo-beta nitrostyrene (BNS).
Data are available to identify the toxicity of these products. Products containing data reviews
are identified with an asterisk (*). They are summarized below:
Data
Required
Eye Irr. (§81-4)
Toxicity
Category
Classification
I
A
Batch 3
EPA Reg J
3876-90
3876-127*
45017-25
68329-13
%MBTS/%AI
5%/17.4%
5%/36.8%
5%/36.8%
5%/36.8%
Formulation Type
EC
EC
EC
EC
Batch 4 consists of products containing dodecyl guanidine HC1 (DGH).
Data are available to identify the toxicity of these products. Products containing data reviews
are identified with an asterisk (*). They are summarized below:
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Data
Required
Acute Oral (§81-1)
Acute Dermal (81-2)
Acute Inhal. (81-3)
Eye Irr. (§81-4)
Dermal Irr. (§81-5)
Dermal Sens. (§81-6)
Toxicity
Category
II
III
II
I
III
Sens.
Batch 4
Classification
A
A
A
A
A
V
EPA Reg J
3876-121*
34571-13
45017-28
68329-10
%MBTS/%AI
596/10%
5%/10%
5%//10%
5%/10%
Formulation Type
EC
EC
EC
EC
Batch 5 consists of products containing chlorothalonil (CTN).
Data are available to identify the toxicity of these products. Products containing data reviews
are identified with an asterisk (*). They are summarized below:
Data
Required
Acute Oral (§81-1)
Acute Dermal (81-2)
Acute Inhal. (81-3)
Eye Irr. (§81-4)
Dermal Irr. (§81-5)
Dermal Sens. (§81-6)
Toxicity
Category
III
III
II
I
II
Sens
Batch 5
Classification
A
A
A
A
A
A
EPA Reg J
50534-208*
%MBTS/%AI
14.7%/14.5%
Formulation Type
EC
Table III
Batch 1 consists of products containing low levels of Methylene bis(thiocyanate) (10% or
less). Data are available to identify the toxicity of these products. Products containing data reviews
are identified with an asterisk (*). They are summarized below:
141
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Data Toxicity
Required Category
Acute Oral (§81-1) III
Acute Dermal (81-2) III
Acute Inhal. (81-3) II
Eye Irr. (§81-4) I
Dermal Irr. (§81-5) I
Dermal Sens. (§81-6) Sens.
Batchl
Classification
A
A
A
A
A
A
EPA Reg, #
1409-58
1448-34
1448-94*
1448-147*
1448-171
1448-172*
1448-178*
1448-249
1448-357
1448-358
1448-359
1448-360
1706-112
1757-42
3876-61
4654-14
4654-16
6832-139
7053-31
9386-4*
9386-26
9386-31
10445-61
10445-60
33677-4*
38635-5
%AI
0.2
10.0
5.0
10.0
2.5
2.5
5.0
2.5
10.0
10.0
10.0
10.0
10.0
10.0
5.0
10.0
9.5
5.90
2.5
10.0
10.0
10.0
10.0
10.2
10.0
10.0
Formulation Type
WdPr
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
EC
142
-------
44392-11
45017-13
45017-19
45017-28
47091-12
56473-2
55710-2
68329-10
2.5
7.1
7.0
5.0
12.0
1.0
2.5
5.0
EC
EC
EC
EC
EC
EC
EC
EC
The remaining product is unbatched due to insufficient CSF:
EPA RegJ
10445-92
%A.I.
7.1
Type of Formulation
GR
Abbreviations:
A = Acceptable
EC = Emulsifiable Concentrate
GR = Granular
WdPr = Wood Preservative
143
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Attachment 5. List of Registrants Sent This Data Call-In Notice
144
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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.
145
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146
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00
147
-------
148
-------
United States Environmental Protection Agency
Washington, B.C. 20460
Certification of Offer to Cost
Share in the Development of Data
Form Approved
OMB No. 2070-0106,
2070-0057
Approval Expires
3-31-99
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
Company Number
Product Name
EPA Reg. No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
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 firms 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 obselete
149
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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
3-31-99
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 reregistration under the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA) that is an exclusive use study, I am the original data submitter, or I have obtained the written permission of the original
data submitter to cite that study.
2. That for each study cited in support of registration or reregistration under FIFRA that is NOT an exclusive use study, I am the
original data submitter, or I have obtained the written permission of the original data submitter, or I have notified in writing the
company(ies) that submitted data I have cited and have offered to: (a) Pay compensation for those data in accordance with sections
3(c)(1 )(F) and 3(c)(2)(D) of FIFRA; and (b) Commence negotiation to determine which data are subject to the compensation
requirement of FIFRA and the amount of compensation due, if any. The companies I have notified are. (check one)
[ ] The companies who have submitted the studies listed on the back of this form or attached sheets, or indicated on the attached
"Requirements Status and Registrants' Response Form,"
3. That I have previously complied with section 3(c)(1)(F) of FIFRA for the studies I have cited in support of registration or
reregistration under FIFRA.
Signature
Date
Name and Title (Please Type or Print)
GENERAL OFFER TO PAY: I hereby offer and agree to pay compensation to other persons, with regard to the registration or
reregistration of my products, to the extent required by FIFRA section 3(c)(1)(F) and 3(c)(2)(D).
Signature
Date
Name and Title (Please Type or Print)
EPA Form 8570-31 (4-96)
150
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The following is a list of available documents for methylene bis(thiocyanate) that my 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 by using ftp on FTP.EPA.GOV, or using WWW (World Wide
Web) on WWW.EPA.GOV.
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 methylene bis(thiocyanate).
The following documents are part of the Administrative Record for methylene
bis(thiocyanate) 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
151
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152
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