United States Prevention, Pesticides EPA739-R-05-003
Environmental Protection and Toxic Substances August 2006
A CD A Ag6nCy (751 OP)
SSftlTrX Reregistration Eligibility Decision
for 2-(Thiocyanomethylthio)-
benzothiazole (TCMTB)
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MATT,
Dear Registrant:
This is to inform you that the Environmental Protection Agency (hereafter referred to as
EPA or the Agency) has completed its review of the available data and public comments
received related to the preliminary risk assessments for the antimicrobial 2-
(thiocyanomethylthio) benzothiazole (TCMTB). The Reregistration Eligibility Decision (RED)
for TCMTB was approved on August 1, 2006. Public comments and additional data received
were considered in this decision.
Based on its review, EPA is now publishing its Reregistration Eligibility Decision (RED)
and risk management decision for TCMTB and its associated human health and environmental
risks. A Notice of Availability will be published in the Federal Register announcing the
publication of the RED.
The RED and supporting risk assessments for TCMTB are available to the public in
EPA's Pesticide Docket EPA-HQ-OPP-2006-0320 at: www.regulations.gov.
The TCMTB RED was developed through EPA's public participation process, published
in the Federal Register on September 10, 2004, which provides opportunities for public
involvement in the Agency's pesticide tolerance reassessment and reregistration programs. The
public participation process encourages robust public involvement starting early and continuing
throughout the pesticide risk assessment and risk mitigation decision making process. The
public participation process encompasses full, modified, and streamlined versions that enable the
Agency to tailor the level of review to the level of refinement of the risk assessments, as well as
to the amount of use, risk, public concern, and complexity associated with each pesticide. Using
the public participation process, EPA is attaining its strong commitment to both involve the
public and meet statutory deadlines.
Please note that the TCMTB risk assessment and the attached RED document concern
only this particular pesticide. This RED presents the Agency's conclusions on the dietary,
drinking water, occupational and ecological risks posed by exposure to TCMTB alone. This
document also contains both generic and product-specific data that the Agency intends to require
in Data Call-Ins (DCIs). Note that DCIs, with all pertinent instructions, will be sent to
registrants at a later date. Additionally, for product-specific DCIs, the first set of required
responses will be due 90 days from the receipt of the DCI letter. The second set of required
responses will be due eight months from the receipt of the DCI letter.
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As part of the RED, the Agency has determined that TCMTB will be eligible for
reregistration provided that all the conditions identified in this document are satisfied, including
implementation of the risk mitigation measure outlined in Section IV of the document. Sections
IV and V of this RED document describe the labeling amendments for end-use products and data
requirements necessary to implement this mitigation measure. Instructions for registrants on
submitting the revised labeling can be found in the set of instructions for product-specific data
that accompanies this document.
Should a registrant fail to implement any of the risk mitigation measures outlined in this
document, the Agency will continue to have concerns about the risks posed by TCMTB. Where
the Agency has identified any unreasonable adverse effect to human health and the environment,
the Agency may at any time initiate appropriate regulatory action to address this concern. At
that time, any affected person(s) may challenge the Agency's action.
If you have questions on this document or the label changes relevant to this reregistration
decision, please contact the Chemical Review Manager, K. Avivah Jakob, at (703) 305-1328.
For questions about product reregistration and/or the Product DCI that will follow this document,
please contact Marshall Swindell at (703)-308-6341.
Sincerely,
Frank T. Sanders
Director, Antimicrobials Division
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REREGISTRATION ELIGIBILITY
DECISION
for
2-(Thiocyanomethylthio) benzothiazole (TCMTB)
List B
CASE 2625
Approved By:
Frank T. Sanders
Director, Antimicrobials Division
August 1, 2006
Attachment
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Table of Contents
TCMTB Reregistration Team i
Glossary of Terms and Abbreviations ii
Abstract iv
I. Introduction 1
II. Chemical Overview 3
A. Regulatory History 3
B. Chemical Identification 3
C. Use Profile 4
III. Summary of TCMTB Risk Assessments 7
A. Human Health Risk Assessment 7
1. Toxicity of TCMTB 7
2. Metabolite Assessment 12
3. FQPA Safety Factor 13
4. Population Adjusted Dose (PAD) 14
a. Acute PAD 14
b. Chronic PAD 14
5. Dietary Exposure Assumptions 14
6. Dietary Risk Assessment 15
a. Dietary Risk from Food and Drinking Water 15
b. Dietary Risk from Drinking Water 17
7. Residential Risk Assessment 18
a. Residential Toxicity 18
b. Residential Handlers 20
i. Exposure Assessment 20
ii. Risk Assessment 21
c. Residential Post-Application 21
i. Exposure Assessment 21
ii. Risk Assessment 22
8. Aggregate Risk 23
a. Acute Aggregate Risk 24
b. Chronic Aggregate Risk 24
9. Occupational Risk 25
a. Occupational Toxicity 26
b. Occupational Handler Exposure 26
c. Occupational Handler Risk Summary 30
d. Occupational Post-application Risk Summary 34
9. Human Incident Data 37
B. Environmental Risk Assessment 38
1. Environmental Fate and Transport 38
a. Bioaccumulation in Aquatic Organisms 40
2. Ecological Risk 40
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a. Environmental Toxicity 40
b. Ecological Exposure and Risk 44
c. Risk to Listed Species 47
IV. Risk Management, Reregistration, and Tolerance Reassessment Decision... 49
A. Determination of Reregistration Eligibility 49
B. Public Comments and Responses 49
C. Regulatory Position 50
1. Food Quality Protection Act Findings 50
a. "Risk Cup" Determination 50
b. Determination of Safety to U.S. Population 50
c. Determination of Safety to Infants and Children 50
d. Endocrine Disruptor Effects 51
e. Cumulative Risks 52
2. Tolerance Summary 52
a. Currently Established Tolerances Under 40 CFR 52
180.288 & Tolerance Reassessment of TCMTB
b. Codex Harmonization 53
D. Regulatory Rationale 53
1. Human Health Risk Management 54
a. Dietary (Food) Risk Mitigation 54
b. Drinking Water Risk Mitigation 54
c. Residential Risk Mitigation 54
i. Handler Risk Mitigation 54
ii. Post-Application Risk Mitigation 54
d. Occupational Risk Mitigation 55
i. Handler Risk Mitigation 55
ii. Post-Application Risk Mitigation 56
2. Environmental Risk Management 56
3. Other Labeling Requirements 57
4. Listed Species Considerations 57
a. The Endangered Species Act 57
b. General Risk Mitigation 58
V. What Registrants Need to Do 60
A. Manufacturing-Use Products 62
1. Additional Generic Data Requirements 62
2. Labeling for Technical and Manufacturing Use Products 64
B. End-Use Products 64
1. Additional Product-Specific Data Requirements 64
2. Labeling for End-Use Products 64
a. Label Changes Summary Table 64
VI. Appendices 66
A. Table of Use Patterns for TCMTB 67
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B. Table of Generic Data Requirements and Studies Used to Make the 86
Reregistration Decision
C. Technical Support Documents 94
D. Bibliography Citations 96
E. Generic Data Call-In 108
F. Product Specific Data Call-In 109
G. Batching of End-Use Products 110
H. List of All Registrants Sent the Data Call-In Ill
I. List of Available Forms 112
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TCMTB Reregistration Team
Health Effects Risk Assessment
Deborah Smegal
Robert Quick
Siroos Mostaghimi
Jonathan Chen
Charles Smith
Samuel Ary
Timothy McMahon
Chris Jiang
Ecological Risk Assessment
Kathryn Montague
Environmental Fate Risk Assessment
Srinivas Gowda
James Lin
Risk Management
K. Avivah Jakob
Diane Isbell
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GLOSSARY OF TERMS AND ABBREVIATIONS
a.i. Active Ingredient
aPAD Acute Population Adjusted Dose
APHIS Animal and Plant Health Inspection Service
ARTF Agricultural Re-entry Task Force
BCF Bioconcentration Factor
CDC Centers for Disease Control
CDPR California Department of Pesticide Regulation
CFR Code of Federal Regulations
ChEI Cholinesterase Inhibition
CMBS Carbamate Market Basket Survey
cPAD Chronic Population Adjusted Dose
CSFII USDA Continuing Surveys for Food Intake by Individuals
CWS Community Water System
DCI Data Call-In
DEEM Dietary Exposure Evaluation Model
DL Double layer clothing {i.e., coveralls over SL}
DWLOC Drinking Water Level of Comparison
EC Emulsifiable Concentrate Formulation
EDSP Endocrine Disruptor Screening Program
ED STAC Endocrine Disruptor Screening and Testing Advisory Committee
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
EXAMS Tier II Surface Water Computer Model
FDA Food and Drug Administration
FFDCA Federal Food, Drug, and Cosmetic Act
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FOB Functional Observation Battery
FQPA Food Quality Protection Act
FR Federal Register
GL With gloves
GPS Global Positioning System
HIARC Hazard Identification Assessment Review Committee
IDFS Incident Data System
IGR Insect Growth Regulator
IPM Integrated Pest Management
RED Reregistration Eligibility Decision
LADD Lifetime Average Daily Dose
LC5o Median Lethal Concentration. Statistically derived concentration of a substance expected to cause
death in 50% of test animals, usually expressed as the weight of substance per weight or volume
of water, air or feed, e.g., mg/1, mg/kg or ppm.
LCO Lawn Care Operator
LD50 Median Lethal Dose. Statistically derived single dose causing death in 50% of the test animals
when administered by the route indicated (oral, dermal, inhalation), expressed as a weight of
substance per unit weight of animal, e.g., mg/kg.
LOAEC Lowest Observed Adverse Effect Concentration
LOAEL Lowest Observed Adverse Effect Level
LOC Level of Concern
LOEC Lowest Observed Effect Concentration
mg/kg/day Milligram Per Kilogram Per Day
MOE Margin of Exposure
MP Manufacturing-Use Product
MRID Master Record Identification (number). EPA's system of recording and tracking studies
submitted.
MRL Maximum Residue Level
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N/A
Not Applicable
NASS
National Agricultural Statistical Service
NAWQA
USGS National Water Quality Assessment
NG
No Gloves
NMFS
National Marine Fisheries Service
NOAEC
No Observed Adverse Effect Concentration
NOAEL
No Observed Adverse Effect Level
NPIC
National Pesticide Information Center
NR
No respirator
OP
Organophosphorus
OPP
EPA Office of Pesticide Programs
ORETF
Outdoor Residential Exposure Task Force
PAD
Population Adjusted Dose
PCA
Percent Crop Area
PDCI
Product Specific Data Call-In
PDP
USD A Pesticide Data Program
PF10
Protection factor 10 respirator
PF5
Protection factor 5 respirator
PHED
Pesticide Handler's Exposure Data
PHI
Pre-harvest Interval
PPb
Parts Per Billion
PPE
Personal Protective Equipment
PRZM
Pesticide Root Zone Model
RBC
Red Blood Cell
RED
Reregistration Eligibility Decision
REI
Restricted Entry Interval
RfD
Reference Dose
RPA
Reasonable and Prudent Alternatives
RPM
Reasonable and Prudent Measures
RQ
Risk Quotient
RTU
(Ready-to-use)
RUP
Restricted Use Pesticide
SCI-GROW
Tier I Ground Water Computer Model
SF
Safety Factor
SL
Single layer clothing
SLN
Special Local Need (Registrations Under Section 24C of FIFRA)
STORET
Storage and Retrieval
TEP
Typical End-Use Product
TGAI
Technical Grade Active Ingredient
TRAC
Tolerance Reassessment Advisory Committee
TTRS
Transferable Turf Residues
UF
Uncertainty Factor
USD A
United States Department of Agriculture
USFWS
United States Fish and Wildlife Service
USGS
United States Geological Survey
WPS
Worker Protection Standard
Ill
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ABSTRACT
The Environmental Protection Agency (EPA or the Agency) has completed the human
health and environmental risk assessments for 2-(thiocyanomethylthio) benzothiazole (TCMTB)
and is issuing its risk management decision and tolerance reassessment. The risk assessments,
which are summarized below, are based on the review of the required target database supporting
the use patterns of currently registered products and additional information received through the
public docket. After considering the risks identified in the revised risk assessments, comments
received, and mitigation suggestions from interested parties, the Agency developed its risk
management decision for uses of TCMTB that pose risks of concern. As a result of this review,
EPA has determined that TCMTB-containing products are eligible for reregistration, provided
that risk mitigation measures are adopted and labels are amended accordingly. That decision is
discussed fully in this document.
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I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988
to accelerate the reregistration of products with active ingredients registered prior to November
1, 1984 and amended again by the Pesticide Registration Improvement Act of 2003 to set time
frames for the issuance of Reregistration Eligibility Decisions. The amended Act calls for the
development and submission of data to support the reregistration of an active ingredient, as well
as a review of all submitted data by the U.S. Environmental Protection Agency (EPA or the
Agency). Reregistration involves a thorough review of the scientific database 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 or not the pesticide meets the
"no unreasonable adverse effects" criteria of FIFRA.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed into
law. This Act amends FIFRA to require tolerance reassessment. The Agency has decided that,
for those chemicals that have tolerances and are undergoing reregistration, the tolerance
reassessment will be initiated through this reregistration process. The Act also requires that by
2006, EPA must review all tolerances in effect on the day before the date of the enactment of the
FQPA. FQPA also amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require a
safety finding in tolerance reassessment based on factors including consideration of cumulative
effects of chemicals with a common mechanism of toxicity. This document presents the
Agency's revised human health and ecological risk assessments and the Reregistration Eligibility
Decision (RED) for 2-(thiocyanomethylthio) benzothiazole (TCMTB).
As an antimicrobial pesticide, TCMTB has several uses. TCMTB is used as a wood
preservative for antisapstain control, a microbiocide/microbiostat and bacteriocide/bacteriostat in
industrial processes and water systems (e.g., pulp and paper mill systems, sewage systems) and
in industrial/residential materials preservatives (e.g., pulp/paper products, leather products and
hides, paint, latex, carpet, textiles, wallpaper). TCMTB is also used as an agricultural pesticide
for seed treatment (e.g., barley, oats, rice, wheat, safflower, cotton and sugar beets).
The Agency has concluded that the FQPA Safety Factor for TCMTB should be removed
(equivalent to IX) based on: (1) the toxicology data base is complete with respect to assessing
the increased susceptibility to infants and children as required by FQPA for TCMTB; (2) there is
no concern for developmental neurotoxicity resulting from exposure to TCMTB in the rat and
rabbit prenatal developmental studies and 2-generation reproduction study; (3) there is no
evidence of increased susceptibility to the fetus following in utero exposure in the prenatal
developmental toxicity studies or to the offspring when adults are exposed in the two-generation
reproductive study; and (4) the risk assessment does not underestimate the potential exposure for
infants and children.
Risks summarized in this document are those that result only from the use of the active
ingredient, TCMTB. The Food Quality Protection Act (FQPA) requires that the Agency
consider available information concerning the cumulative effects of a particular pesticide's
residues and other substances that have a common mechanism of toxicity. The reason for
consideration of other substances is due to the possibility that low-level exposures to multiple
chemical substances that cause a common toxic effect by a common toxic mechanism could lead
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to the same adverse health effect that would occur at a higher level of exposure to any of the
substances individually. Unlike other pesticides for which EPA has followed a cumulative risk
approach based on a common mechanism of toxicity, EPA has not made a common mechanism
of toxicity finding for TCMTB and any other substances. TCMTB does not appear to produce a
toxic metabolite produced by other substances. For the purposes of this action, therefore, EPA
has not assumed that TCMTB has a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a common mechanism
of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements
released by EPA's Office of Pesticide Programs concerning common mechanism determinations
and procedures for cumulating effects from substances found to have a common mechanism on
EPA's website at http://www.epa.gov/pesticides/cumulative.
This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of TCMTB. In an effort to simplify the RED, the information presented
herein is summarized from more detailed information which can be found in the technical
supporting documents for TCMTB referenced in this RED. The revised risk assessments and
related addenda are not included in this document, but are available in the Public Docket at
http://www.regulations.gov (Docket ID #EPA-HQ-OPP-2006-0320).
This document consists of six sections. Section I is the introduction. Section II provides a
chemical overview, a profile of the use and usage of TCMTB and its regulatory history. Section
III, Summary of TCMTB Risk Assessments, gives an overview of the human health and
environmental assessments, based on the data available to the Agency. Section IV, Risk
Management, Reregistration, and Tolerance Reassessment Decision, presents the reregistration
eligibility and risk management decisions. Section V, What Registrants Need to Do, summarizes
the necessary label changes based on the risk mitigation measures outlined in Section IV.
Finally, the Appendices list all use patterns eligible for reregistration, bibliographic information,
related documents and how to access them, and Data Call-In (DCI) information.
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II. Chemical Overview
A. Regulatory History
TCMTB was first registered as an active ingredient by the United States Environmental
Protection Agency (EPA) on January 21, 1980. Currently, there are 27 products containing
TCMTB. TCMTB products are used in commercial/institutional premises and residential and
public access areas. As an antimicrobial pesticide, TCMTB is used largely as a materials
preservative (e.g., leather products and hides, pulp/paper products, latex, wallpaper, paints,
carpets). TCMTB is a slimicide regulated by the FDA (21 CFR 176.300) for controlling
bacteria, fungi and yeasts, which cause deterioration of paper and paperboard products.
TCMTB is also used as a fungicide for commercial and on-farm seed treatment. TCMTB
has 23 tolerances in the 40 CFR 180.288 for use as a fungicide on barley, sugar beets, cotton,
oats, rice, safflower and wheat. Seed treatment use of TCMTB are not being supported by the
technical registrant but are being supported by end-users.
B. Chemical Identification
Technical TCMTB
Figure 1. Molecular Structure of TCMTB
Common name:
TCMTB or TCMB
Chemical name: 2-(thiocyanomethylthio)benzothiazole
Chemical family: Thiazole
Empirical formula: C9H6N2S3
CAS Registry No.: 21564-17-0
Case number:
2625
OPP Chemical Code: 035603
Molecular weight: 238 g/mol
Other names:
2-(Benzothiazolythio)methyl thiocyanate, TCMTB, TCMB,
Busan 72
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Basic manufacturers:
Buckman Laboratories
Chemical properties: TCMTB is a vivid orange liquid with a strong sour and pungent
odor (like mineral oil). TCMTB is a liquid and, therefore, has no
melting point. It has a boiling point of 191°C, and
decomposition begins at 741.9 mm Hg. TCMTB has a log Kow of
3.23 at 20°C.
C. Use Profile
The following information is a description of the currently registered uses of TCMTB
products and an overview of use sites and application methods. A detailed table of the uses of
TCMTB eligible for reregistration is contained in Appendix A.
Type of Pesticide: Microbiocide/microbiostat, bacteriocide/bacteriostat, slimicide, fungicide,
algecide.
Summary of Use:
Materials Preservatives:
For use in industrial premises and residential & public access areas as a
materials preservative in leather processing liquors/extracts (preservative
incorporation), leather products and hides (preservative incorporation),
textiles/fibers/cordage (preservative/additive incorporation), paints,
sealants, emulsions/slurries/solutions, adhesives (preservative
incorporation), coatings (preservative incorporation), , metalworking
cutting fluids (preservative incorporation), oil recovery drill muds/packer
fluids (preservative incorporation), nonfood pulp/paper and paper products
(preservative/additive incorporation), wet-end/ industrial process
chemicals (preservative incorporation), caulking compounds, vinyl
wallpaper pastes, latex, dispersed colors, fuels (additive incorporation) and
paper/paperboard surface treatments.
Wood Preservative:
TCMTB is used to control sapstain and mold in commercial/industrial
premises and residential & public access areas on forest products
(seasoned, unseasoned, unpainted), lumber, poles/posts, timbers, wood
walls, wood (particleboard), wood shingles (roof), wood pressure
treatment, wood millwork, wood products, wood sashes, wet lap/sheet
pulp, wood surfaces, wood porches/decks, wood fences, wood
homes/houses, wood steps, window frames, wood doors, wood siding and
wood barns.
Industrial Processes and Water Systems:
For use in commercial and industrial water cooling tower systems, pulp
and paper mill systems, secondary oil recovery injection water, sewage
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systems, non-potable water storage tanks, fuel and oil storage tanks
bottom water, industrial disposal water, waste water systems, sewage
effluent water, storage tanks, metalworking cutting fluids and water-based
cutting fluid mixes.
Agricultural:
TCMTB is used as a fungicide for treating seeds (barley, oats, rice, wheat,
safflower, cotton and sugar beets) in commercial and on-farm settings.
Target Pests: Bacteria (unspecified); bacterial blight (xanthomonas); bacterial slime (of
paper mills, water systems); basal rot (fusarium); brown rot; bunt (smut)
(tilletia); covered kernel smut (sphacelotheca); covered smut (ustilago
kolleri/ ustilago); damping-off (fusarium/ pythium/ rhizoctonia/
thielviopsis), deterioration/spoilage bacteria; dry rot; dry rot fungi; false
loose smut (ustilago avenae/u. nigra); fungal decay/rot; fungal slime (of
paper mills/water systems); fungi (coatings/ leather/ metal working
coolants); fusarium blight; rot/ SPP; helminthosporium blight; mildew/
mold; rhizopus; rust (puccinia); sapstain; scab (head blight); seed and
seedling diseases/ decay/ rot/ fungi; slime forming bacteria; sulfate-
reducing bacteria.
Formulation Types: Liquid ready-to-use, soluble concentrate, emulsifiable liquid, suspended-
emulsion, formulation intermediate, wettable powder.
Method and Rates of Application:
Equipment for Antimicrobial Use:
TCMTB end use products are added during the manufacturing process of
treated articles and materials. Examples include: TCMTB being added
directly to pulp slurry by chemical metering pump; dipping/pressure
impregnation or brush/low pressure spraying of TCMTB for sapstain
control; TCMTB directly mixed into solution for leather preservation.
Equipment for Agricultural Use:
There are two primary methods for treating seeds: the batch system and
the continuous flow system. There are various pieces of equipment used
for on-nursery seed treatment such as drum mixers, other devices using
augers, cement mixers, hand cranked revolving drums, and gravity feed
systems. TCMTB treated seed can be planted with a wide range of
equipment.
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Application Rates: For details about specific use sites for TCMTB, refer to Appendix A.
• Dosage rates of 0.025-0.2% (250-2,000 ppm) TCMTB solution can be
used during various stages of leather processing.
• Application rates can range from 0.026 lbs ai/100 lbs seed to 0.093 lbs
ai/100 lbs of seed for seed treatment.
• Application rates can range from 5.6 to 44.0 kg antisapstain
product/100 L. of water for antisapstain treatment.
Use Classification: General use.
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III. Summary of TCMTB Risk Assessments
The purpose of this summary is to assist the reader by identifying the key features and
findings of these risk assessments and to help the reader better understand the conclusions
reached in the assessments. The human health and ecological risk assessment documents and
supporting information listed in Appendix C were used to formulate the safety finding and
regulatory decision for TCMTB. While the risk assessments and related addenda are not
included in this document, they are available from the OPP Public Docket EPA-HQ-OPP-2006-
0320, and may also be accessed from www.regulations.gov. Hard copies of these documents
may be found in the OPP public docket. The OPP public docket is located in Room S-4900, One
Potomac Yard, 2777 South Crystal Drive, Arlington, VA 22202, and is open Monday through
Friday, excluding Federal holidays, from 8:30 a.m. to 4:00 p.m.
The Agency's use of human studies in the TCMTB risk assessment is in accordance with
the Agency's Final Rule promulgated on January 26, 2006, related to Protections for Subjects in
Human Research, which is codified in 40 CFR Part 26.
A. Human Health Risk Assessment
1. Toxicity of TCMTB
A brief overview of the toxicity studies used for determining endpoints in the risk
assessment is outlined below in Table 1. Further details on the toxicity of TCMTB can be found
in the "Toxicology Disciplinary Chapter for the Reregistration Eligibility Decision (RED) Risk
Assessment," dated April 4, 2006; "2-(Thiocyanomethylthio) benzothiazole (TCMTB) Risk
Assessment for the Reregistration Eligibility Decision (RED) Document," dated August 1, 2006;
and "2-(Thiocyanomethylthio) benzothiazole (TCMTB)-Report of the Antimicrobials Division
Toxicity Endpoint Selection Committee (ADTC)," dated April 19, 2006. These documents are
available on the Agency's website in the EPA Docket at: http://www.regulations.gov (Docket ID
#EPA-HQ-OPP-2006-0320).
The Agency has reviewed all toxicity studies submitted for TCMTB and has determined
that the toxicological database is sufficient for reregistration. The studies have been submitted to
support guideline requirements.
Major features of the toxicology profile are presented below. TCMTB exhibits low acute
oral and dermal toxicity (toxicity category III). However, it is highly irritating to the eyes and
skin (toxicity category I and II, respectively) and is also considered to be highly toxic via the
inhalation route of exposure (toxicity category I). TCMTB is a dermal sensitizer.
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Table 1. Summary of Acute Toxicity Data for TCMTB
(¦iiiriclinc
No.
Siiulj Tj|H'
MRU) #(s>
Ki'sulls
Tuxk'il.t
CsiU'Siiin
Anile 1 o\icil\
870.1100
Acute oral toxicity
41583801
LD50 = 750 mg/kg (M+F); 80% ai
III
870.1200
Acute dermal toxicity
41515401
LD50 > 2000 mg/kg (M+F); 80% ai
III
870.1300
Acute inhalation toxicity
41640601
LC50=0.07 mg/L; 80% ai
I
870.2400
Acute eye irritation
Acc No.
111991
Diluted Busan 72 (60 % ai): Primary
Irritation Score (PIS)=2/110 (slight
conjunctival redness, no corneal
opacity); Undiluted Busan 72 (60% ai)
PIS=34/110 (blanched conjunctivae,
chemosis, corneal opacity not
reversible by day 7)
I
870.2500
Acute dermal irritation
41583701
Primary Irritation Index (PIS)=7.42
with severe erythema and edema
observed at 72 hours; 80% ai
II
870.2600
Skin sensitization
MRID
42349201
Acc No.
259676
Busan 74 (80% ai) caused delayed
contact hypersensitivity in guinea pigs
when induced and challenged by a 40%
w/v aqueous concentration of active
ingredient. Sensitizer.
Notes: LC = Lethal Concentration; LD = Lethal Dose; NA = Not Applicable
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The doses and toxicological endpoints selected for the dietary exposure scenarios are
summarized in Table 2 below:
Table 2. Dietary Toxicological Endpoints for TCMTB
l'l\|)OMII'C
Sccn.irio
Dose I sod in Risk
Assessment. 1 1
Special I QI'A SI-
iinri l.c\cl of
Concern lor Risk
Assessment
Sluclj iind Toxicolo^iciil I'.ITccIs
Acute Dietary
(all populations,
including infants and
children)
NOAEL= 25.1
mg/kg/day
83.55% ai purity
UF = 100
(lOx inter-species
extrapolation and
intra-species
variation)
FQPA SF = lx
Acute PAD = 0.25
mg TCMTB/kg/day
Developmental toxicity study in rats
(MRID 00154295, 92179009 (1985))
Maternal LOAEL = 76.5 mg
TCMTB/kg/day, based on clinical signs of
toxicity (ventral alopecia, rough coat,
dyspnea/wheezing, oral discharge,
diarrhea/loose stool, urine staining,
piloerection, and hunched gait).
Acute Dietary
(females 13-49)
An endpoint specific for females 13-49 was not identified because the Acute Dietary
endpoint for all populations is protective of developmental effects.
Chronic Dietary
(all populations)
LOAEL = 3.8
mg/kg/day
81.6% ai purity
UF = 300
(lOx inter-species
extrapolation and
intra-species
variation, 3x for use
of a LOAEL)
FQPA SF = lx
Chronic PAD = 0.01
mg ai/kg/day
Chronic toxicity study in dogs (MRID
41342201, 92179008 (1989))
LOAEL = 3.8 mg/kg/day (males), based
on decreased body weight gain, decreased
white cells, monocytes, and plasma ALT;
decreased uterine weight in females.
Carcinogenicity
The Agency concluded that TCMTB should be classified as Group C - possible human
carcinogen - and recommended that for the purpose of risk characterization, the Reference
Dose (RfD) approach should be used for quantitation of human risk. This was based on
statistically significant increases in tumors in both sexes of the Sprague-Dawley rat:
testicular interstitial cell adenomas in males and thyroid C-cell adenomas in females.
Notes: UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL = lowest
observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RiD = reference dose
(a) Note: an additional UF of 10X is used for route extrapolation from an oral endpoint to determine if a confirmatory inhalation
study is warranted. If results are below a MOE of 1,000, a confirmatory inhalation study may be required.
Developmental toxicity studies were available in both the rat and rabbit for TCMTB.
Rabbits appear to be more sensitive to the toxicity of TCMTB than rats. In rabbits, the maternal
NOAEL and LOAEL were significantly lower than those for rats. However, no developmental
effects were noted in the rabbit at the highest dose tested (32 mg ai/kg/day). In the rat, adverse
developmental effects including increased fetal and litter incidence of fused/wavy ribs,
9
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rudimentary cervical, thoracic and lumbar ribs and increased incidence of sternebrae and pelvic
girdle anomalies were noted at doses of 105 mg ai/kg/day, which was maternally toxic.
In a two-generation rat reproduction study, there were no treatment related effects noted
at the highest dose tested for parental toxicity or on reproductive parameters examined in this
study.
General Toxicity Observations
Following subchronic oral exposures to rodents, TCMTB caused increased incidence of
mild to severe stomach lesions characterized by inflammation, hyperplasia, necrosis, and
ulceration. TCMTB resulted in decreased body weight gains (78 to 84% of control), food
consumption (87-95% of control) and food efficiency. In a 21-day rat dermal toxicity study,
TCMTB produced dose-dependant dermal irritation in all dose groups beginning on treatment
days 3-4, which progressed to eschar formation. Rats in the mid and high dose group had ulcers,
hemorrhages and chronic dermatitis. Decreased body weight gain, food consumption, and
hematological (changes in hemoglobin, hematocrit, and segmented neutrophils) and clinical
chemistry changes (blood urea nitrogen, glucose, globulins, and elevated serum aspartate
aminotransferase (AST) were also noted. However, the clinical chemistry changes did not
correspond to any treatment-related findings in the liver or kidney.
The available toxicity data do no indicate neurotoxicity in the experimental animals
exposed to TCMTB by either oral or derma routes.
Dogs appear to be the most sensitive species to TCMTB toxicity following chronic
exposure. In the chronic dog toxicity study, adverse effects were noted at the lowest dose tested
of 3.8 mg/kg/day. Adverse effects included decreased body weight gain, hematological effects
(changes in white blood cells, monocytes), alterations in clinical chemistry parameters (plasma
ALT) and decreased uterine weight in females.
In the chronic rat toxicity/carcinogenicity study, no adverse effects were noted at the
highest dose tested of 20 mg/kg/day. However, there was a statistically significant increase in
the incidence of testicular interstitial cell adenomas in males of mid- and high-dose levels that
had a highly significant positive dose-related trend. Treatment was also associated with a
possible increased incidence of thyroid C-cell adenomas in females of the mid- and high-dose
levels, which had a highly significant positive dose-related trend, but did not attain a statistically
significant level in the pairwise comparison with concurrent controls.
In the chronic mouse toxicity/carcinogenicity study, decreased body weight gain was
noted in both sexes, while there was a statistically increased incidence of focal and diffuse
hyperplasia of duodenal mucosa in males. There was no evidence of carcinogenicity.
Dietary
The acute RfD of TCMTB is 0.25 mg/kg/day. The acute RfD was determined by using a
no-observed effect level (NOAEL) of 25.1 mg/kg/day for all populations based on clinical signs
10
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of toxicity in maternal rats in a rat developmental study (ventral alopecia, rough coat,
dyspnea/wheezing, oral discharge, diarrhea/loose stool, urine staining, piloerection, and hunched
gait). An uncertainty factor of 100 (10X for inter-species extrapolation, 10X for intra-species
variability) was applied to the NOAEL.
The chronic RfD is 0.013 mg/kg/day for all populations. The chronic RfD was
established by using a LOAEL of 3.8 mg/kg/day, which is based on a chronic dog study that
observed decreased body weight gain, decreased white cells, monocytes and plasma ALT and
decreased uterine weight in females. An uncertainty factor of 300 was applied (10X for inter-
species extrapolation and intra-species variation, and 3X for subchronic to chronic
extrapolation).
Incidental Oral
The NOAEL for the short- and intermediate-term incidental oral endpoint is 16
mg/kg/day, based on a rabbit developmental study. The target margin of exposure (MOE) is 100
(10X for inter-species extrapolation and intra-species variation).
Short-. Intermediate- and Long-term Dermal
The short-, intermediate- and long-term dermal NOAEL is 25 mg/kg/day, which is based
on a dermal toxicity study. The uncertainty factor, or "target" MOE, for TCMTB dermal
exposure is 100 for short- and intermediate-term durations and 300 for long-term durations (10X
for inter-species extrapolation and intra-species variation, and 3X for subchronic to chronic
extrapolation).
Short- and Intermediate-term Inhalation
The short- and intermediate-term inhalation endpoint is based on an oral rabbit
developmental toxicity study NOAEL of 16 mg/kg/day. The long-term inhalation endpoint is
LOAEL of 3.8 mg/kg/day, based on a chronic toxicity study in dogs. In the absence of route-
specific data, it was conservatively assumed that inhalation absorption is equivalent to oral
absorption (100%). The target MOE for TCMTB is 100 for short- and intermediate-term
durations and 300 for long-term durations (10X for inter-species extrapolation and intra-species
variation, 3X for subchronic to chronic extrapolation).
Carcinogenicity Classification
TCMTB has been classified as group C, possible human carcinogen. In the chronic
toxicity/carcinogenicity study in rats there was a statistically significant increase in the incidence
of testicular interstitial cell adenomas in males of mid (8 mg/kg/day) and high-dose (20
mg/kg/day) levels, that had a highly significant positive dose-related trend. Treatment was also
associated with a possible increased incidence of thyroid C-cell adenomas in females of the mid-
and high-dose levels, which had a highly significant positive dose-related trend, but did not attain
a statistically significant level in the pairwise comparison with concurrent controls. No historical
data were available for review.
11
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The Agency recommended that for the purpose of risk characterization the Reference
Dose (RfD) approach be used for quantifying the TCMTB cancer risk. The RfD approach is
considered to be protective of any carcinogenic effect (the chronic dietary endpoint is .01
mg/kg/day compared to .08 mg/kg/day). Further, the RfD approach was recommended because
there is no apparent compound-related increase in tumors in the mouse carcinogenicity study and
there is no apparent concern for mutagenicity.
Mutagenicity Potential
TCMTB was found to be negative for mutagenicity in the gene mutation assay with
bacteria and did not cause an increase in unscheduled DNA synthesis (UDS) in the rat
hepatocytes assay. TCMTB was also found to be negative for chromosomal aberrations in the in
vivo micronucleus assay in mice. Therefore, TCMTB is not mutagenic or genotoxic.
Endocrine Disruption Potential
EPA is required under the Federal Food Drug and Cosmetic Act (FFDCA), as amended
by FQPA, to develop a screening program to determine whether certain substances (including all
pesticide active and other ingredients) "may have an effect in humans that is similar to an effect
produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator
may designate." Following recommendations of its Endocrine Disruptor and Testing Advisory
Committee (EDSTAC), EPA determined that there was a scientific basis for including, as part of
the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone
system. EPA also adopted EDSTAC's recommendation that the Program include evaluations of
potential effects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that
effects in wildlife may help determine whether a substance may have an effect in humans,
FFDCA authority to require the wildlife evaluations. As the science develops and resources
allow, screening of additional hormone systems may be added to the Endocrine Disruptor
Screening Program (EDSP). When the appropriate screening and/or testing protocols being
considered under the Agency's Endocrine Disrupting Screening Program (EDSP) have been
developed, TCMTB may be subjected to additional screening and/or testing to better characterize
effects related to endocrine disruption.
2. Metabolite Assessment
TCMTB has several metabolites, including 2-mercaptobenzothiazole (2-MBT) and 2-
benzothiazolesulfonic acid (2-BTSA). The Agency's Risk Assessment Review Committee
(RARC) met and determined that the residue of concern for tolerance expression and risk
assessment is TCMTB in/on plants. 2-MBT and other TCMTB metabolites were not found at
significant levels to be considered residues of concern. The determination of the residues of
concern in plant commodities was based on tomato and melon metabolism studies and available
toxicity data. 2-BTSA was found at significant levels (62% in tomato fruit); however, it was
determined that it should be excluded as a residue of concern because it is expected to be less
toxic than the parent TCMTB. 2-BTSA does not contribute significantly to the chronic toxicity
of the parent. This decision is considered preliminary pending the results of confirmatory
metabolism data that are required to support the currently registered uses of TCMTB.
12
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For drinking water, the residues of concern included TCMTB and 2-MBT, based on an
available aerobic soil metabolism study (MRID 43532201). Although 2-MBT is distinctly less
toxic than the parent, it was conservatively included in the drinking water assessment because it
is a toxic metabolite of concern. All other metabolites were not found at significant levels; and
are not to be considered residues of concern.
A summary of the decisions concerning the residues of concern in plants and drinking
water are presented below in Table 3. For further information regarding the metabolism
assessment of TCMTB please refer to, 3.0 Metabolism Assessment in the "2-
(Thiocyanomethylthio) benzothiazole (TCMTB) Risk Assessment for the Reregistration
Eligibility Decision (RED) Document," dated August 1, 2006.
Table 3. Summary of TCMTB Residues to be Included in the Risk Assessment and
Tolerance Expression
Matrix
Residues Included in Risk
Assessment
Residues Included in
Tolerance Expression
Plants
Primary crop - barley, cotton,
oat, rice, safflower, sugar beet,
and wheat
TCMTB
TCMTB
Rotational crop
NA = not applicable
NA
Livestock
Ruminant
NA
NA
Poultry
NA
NA
Drinking water
TCMTB and 2-MBT
NA
NA= Not applicable
3. FQPA Safety Factor
The FQPA Safety Factor (as required by the Food Quality Protection Act of 1996) is
intended to provide an additional 10-fold safety factor (10X), to protect for special sensitivity in
infants and children to specific pesticide residues in food, drinking water, or residential
exposures, or to compensate for an incomplete database. The Agency has concluded that the
FQPA Safety Factor should be removed (i.e., reduced to IX) for TCMTB based on: (1) a
complete toxicology data base with respect to assessing the increased susceptibility to infants
and children as required by FQPA; (2) a lack of evidence that TCMTB will induce neurotoxic
effects; (3) no evidence of increased susceptibility to the fetus following in utero exposure in the
prenatal developmental toxicity studies; (4) no evidence of increased susceptibility to the
offspring when adults are exposed in the two-generation reproductive study; and (5) the risk
assessment does not underestimate the potential exposure for infants and children. Based on the
analysis of submitted developmental toxicity studies, the Agency determined that no special
FQPA Safety Factor was needed since there were no residual uncertainties for pre- and/or post-
natal toxicity.
13
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4. Population Adjusted Dose (PAD)
Dietary risk is characterized in terms of the Population Adjusted Dose (PAD), which
reflects the reference dose (RfD), either acute or chronic, that has been adjusted to account for
the FQPA Safety Factor (SF). This calculation is performed for each population subgroup. A
risk estimate that is less than 100% of the acute or chronic PAD is not of concern. The Agency
has conducted a dietary exposure and risk assessment for the use of TCMTB as a fungicide for
seed treatment as well as a slimicide and materials preservative in pulp and paper manufacturing.
a. Acute PAD
Acute dietary risk for TCMTB is assessed by comparing acute dietary exposure estimates
(in mg/kg/day) to the acute Population Adjusted Dose (aPAD). Acute dietary risk is expressed
as a percent of the aPAD. The aPAD is the acute reference dose (0.25 mg/kg/day) modified by
the FQPA safety factor. The TCMTB acute reference dose was derived from a developmental
toxicity study in rats in which a NOAEL (25 mg/kg/day) was determined. Acute dietary
exposure was estimated for all populations, including infants and children. The TCMTB aPAD
is 0.25 mg/kg/day based on a reference dose of 0.25 mg/kg/day and an FQPA safety factor of
IX.
b. Chronic PAD
Chronic dietary risk for TCMTB is assessed by comparing chronic dietary exposure
estimates (in mg/kg/day) to the chronic Population Adjusted Dose (cPAD). Chronic dietary risk
is expressed as a percent of the cPAD. The cPAD is the chronic reference dose (0.01 mg/kg/day)
modified by the FQPA safety factor. The cPAD was derived from a chronic toxicity study in
dogs in which the LOAEL (3.8 mg/kg/day) was determined. The TCMTB cPAD is 0.01
mg/kg/day based on a reference dose of 0.01 mg/kg/day, which incorporates the FQPA safety
factor (IX) for the overall U.S. population and all population subgroups.
5. Dietary Exposure Assumptions
Acute and chronic dietary exposure assessments were conducted for the use of TCMTB
as a fungicide for seed treatment as well as an antimicrobial pesticide for pulp and paper
products.
Seed Treatment Use
For the seed treatment use of TCMTB, conservative acute and chronic dietary exposure
assessments incorporated maximum theoretical concentration factors for all commodities,
existing tolerance level residues, and 100% crop treatment. These exposure assessments were
conducted using the Dietary Exposure Evaluation Model software with the Food Commodity
Intake Database (DEEM-FCID™, Version 2.03), which uses food consumption data from the
USDA's Continuing Surveys of Food Intakes by Individuals (CSFII) from 1994-1996 and 1998.
14
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Antimicrobial Use
The dietary risk assessment conducted for the antimicrobial use of TCMTB considered
only potential food exposures from the antimicrobial uses of TCMTB because this use is
expected to have minimal impact on drinking water exposure. In the absence of residue data, the
Agency estimated antimicrobial residue levels that may occur in food that contacts treated pulp
and paper products from the maximum application rates on TCMTB product labels. When
assessing the antimicrobial dietary risks of TCMTB the Agency used FDA's Center for Food
Safety & Applied Nutrition's (CFSAN) screening-level approach as presented in the
"Preparation of Food Contact Notifications and Food Additive Petitions for Food Contact
Substances: Chemistry Recommendations" dated April 2002. Using the maximum application
rates and US FDA's default assumptions, "worst-case" dietary concentration values were
calculated by the Agency. This model was used to determine the estimated daily intake (EDI).
In addition, the Agency estimated a total cumulative dietary intake of TCMTB that could
result from simultaneous exposure from the three antimicrobial uses that were assessed
(pulp/paper slimicide use; paper coating use; and paper adhesive preservative use).
6. Dietary Risk Assessment
The Agency conducted a dietary exposure/risk assessment for the use of TCMTB as a
fungicide for seed treatment as well as an antimicrobial pesticide in pulp and paper products.
Generally, a dietary risk estimate that is less than 100% of the acute or chronic PAD (aPAD or
cPAD) does not exceed the Agency's risk concerns. A summary of acute and chronic risk
estimates are shown in Tables 4 and 5.
a. Dietary Risk from Food and Drinking Water
Seed Treatment Use
The Agency has determined that the acute dietary risk estimates do not exceed the
Agency's level of concern (less then 100% of the aPAD) at the 95th exposure percentile for the
United States population (less than 1% of the aPAD) and all population subgroups. The highest
exposed population subgroup was children 3-5 years old at 2% of the aPAD.
The chronic dietary risk assessment concluded that for all supported agricultural uses of
TCMTB, the chronic risk estimates are below the Agency's level of concern (less than 100% of
the cPAD) for the general U.S. population (7% of the cPAD) and all population subgroups. The
highest exposed population subgroup was children 3-5 years old at 17% of the cPAD.
15
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Table 4. Seed Treatment Use Summary of Dietary Exposure and Risk for TCMTB Using
DEEM-FCID (Food and Water)
Pnpiilsilinn
Subgroup
Anile Dielsin i«)5"' Percentile)
Chronic Dielsin
Dielsin llxposure
(in;i/kii/(l;i\)
¦H. si PAD h
Dielsin l-lxposnre
(ni^/k^/d;i\)
ePAl)h
General U.S.
Population
0.002430
<1
0.000888
7
All Infants (< 1 year
old)
0.003256
1
0.000994
8
Children 1-2 years
old
0.004467
2
0.002054
16
Children 3-5 years
old 3
0.004581
2
0.002226
17
Children 6-12 years
old
0.003370
1
0.001625
13
Youth 13-19 years
old
0.002109
<1
0.000936
7
Adults 20-49 years
old
0.001547
<1
0.000680
5
Adults 50+ years old
0.001192
<1
0.000542
4
Females 13-49 years
old
0.001529
<1
0.000671
5
a The bolded values represent the highest exposed populations for each percentile.
b %PAD = dietary exposure (mg/kg/day) / aPAD or cPAD, where aPAD= 0.25 mg/kg/day (for all populations) and cPAD=0.013
mg/kg/day (for all populations)
Antimicrobial Use
TCMTB is used as a slimicide and paper coating preservative for controlling bacteria,
fungi and yeasts that cause deterioration of paper and paperboard products and used to preserve
paper-adhesive formulations.
The results of the acute dietary risk estimates for the antimicrobial use of TCMTB are
below the Agency's level of concern for all population subgroups (<1% of the aPAD for all use
sites). The highest dietary risk estimate was at 0.66% of the aPAD for infants and children. The
chronic dietary analysis indicates that all risk estimates are below the Agency's level of concern
for all population subgroups (<13% of cPAD for all use sites). The highest dietary risk estimate
was at 12.8%) of the cPAD, for combined exposure to infants and children.
16
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Table 5. Antimicrobial Use Summary of Dietary Exposure and Risk for TCMTB
Pnpiilsilinn
Subgroup
Anile Diclsin
Chronic Dii-lsin
Diclsin I'.xposurc
¦M, sil».\l) h
Dk'lsin I'.xposuiT
cPAl)h
Pulp I'apcr Sliimcidc
Adult Male
0.00024
0.096
0.00024
1.8
Adult Female (13-50
years old)
0.00028
0.11
0.00028
2.2
Infants/Children
0.00056
0.22
0.00056
4.3
Paper Coaling Preservative
Adult Male
0.00017
0.07
0.00017
1.31
Adult Female (13-50
years old)
0.0002
0.08
0.0002
1.54
Infants/Children
0.0004
0.16
0.0004
3.08
Paper Adhesive Preservative
Adult Male
0.00030
0.12
0.00030
2.3
Adult Female (13-50
years old)
0.00035
0.14
0.00035
2.7
Infants/Children
0.0007
0.28
0.0007
5.38
Cumulative
Adult Male
0.00071
0.29
0.00071
5.41
Adult Female (13-50
years old)
0.00083
0.33
0.00083
6.44
Infants/Children
0.0017
0.66
0.0017
12.8
a Acute and chronic exposure analysis based on body weights of 70kg, 60 kg, and 15 kg for adult males, females and children,
respectively.
b %PAD = dietary exposure (mg/kg/day) / aPAD or cPAD, where aPAD= 0.25 mg/kg/day (for all populations) and cPAD=0.013
mg/kg/day (for all populations)
b. Dietary Risk from Drinking Water
The Agency estimated drinking water exposures for the seed treatment use of TCMTB,
only. There are no antimicrobial uses associated with TCMTB that are expected to impact either
surface or groundwater resources.
The seed treatment drinking water estimates were incorporated directly into the dietary
risk assessment. Thus, the drinking water and food assessments are combined into the acute and
chronic dietary risk estimates where risk is shown as %PAD. The drinking water analysis was
17
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based on a derivation of estimated upper bound Tier I drinking water concentrations from
TCMTB seed treatment uses, which were based on the FQPA Index Reservoir Screening Tool
(FIRST). Both TCMTB and its' degradate, 2-MBT, were included in the drinking water
estimates. 2-MBT is distinctly less toxic than the parent; but was conservatively included in the
drinking water assessment because it is considered a toxic metabolite of concern.
A number of conservative assumptions related to runoff and leaching were utilized as
inputs including: a maximum application rate of 0.041 lb ai/acre, no potential degradation and
transformation reactions occur, no partitioning between the liquid phase and the solid phase
occurs, and that TCMTB does not sorb to the seed coat (only to the soil).
For surface drinking water, results from FIRST indicate that the peak (acute)
concentration of TCMTB and its' degradates is not likely to exceed 0.94 ug/L (ppb) and that the
average annual (chronic) concentration is not likely to exceed 0.67 ug/L (ppb). These drinking
water concentrations were used in the acute and chronic dietary risk assessment for the
agricultural uses of TCMTB as was discussed above.
For further details regarding the dietary risk assessment conducted for the seed treatment
use of TCMTB, refer to the "Drinking Water Assessment for the Use of the Fungicide of 2-
(Thiocyanomethylthio) benzothiazole (TCMTB) as a Seed Treatment on Cotton, Wheat, Barley,
Oats, Rice, Sugar Beets, and Safflower," dated January 31, 2006.
It should be noted that the Agency estimated higher concentrations for exposure to
aquatic animals resulting from the antisapstain use than were used in the drinking water
assessment. These levels were not considered appropriate for use in the drinking water
assessment due to the very conservative nature of the model used, that the model estimates
runoff concentrations and not water body concentrations, and the fact that the model does not
account for dilution.
7. Residential Risk Assessment
Residential exposure from TCMTB can occur from the antimicrobial uses of TCMTB.
The residential exposure assessment considers all potential pesticide exposure, other than
exposure due to residues in food and drinking water. Exposure may occur during and after
application methods including painting via brush/roller and airless sprayer. Each route of
exposure (oral, dermal, inhalation) is assessed, where appropriate, and risk is expressed as a
Margin of Exposure (MOE), which is the ratio of estimated exposure to an appropriate No
Observed Effect Level (NOAEL) dose. Based on the application methods, TCMTB has been
assessed for the residential mixing/loading/applicator (or "handler") exposure.
a. Residential Toxicity
The toxicological endpoints and associated uncertainty factors used for assessing the non-
dietary, residential and occupational risks for TCMTB are listed in Table 6.
18
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A MOE greater than or equal to 100 is considered adequately protective for the
residential exposure assessment for the dermal and inhalation routes of exposure. The MOE of
100 includes lOx for inter-species extrapolation, lOx for intra-species variation.
Table 6. Resident
ial and Occupational Toxicological Doses and Endpoints for TCMTB
r.\|)(isuiT
Scenario
Dose I sod in Risk
Asscssmcnl
Tar»cl MOr.s/l Is
1 QPA Salcl\
l-"aclor lor Risk
Assessment
Siiulj and Toxicological KITccls
Short-Term and
Intermediate-T erm
Incidental Oral (1-30
days; 30 days-
6months)
NOAEL= 16.2 mg
ai/kg/day
81% ai purity
(20 mg
T CMTB/kg/day)
MOE = 100 (ST and
IT)
(10X for inter-
species extrapolation
and intra-species
variation)
Developmental toxicity study in rabbits
(MRID 40075101, 40075102, 92179011,
(1986))
LOAEL = 32 mg ai/kg/day (40 mg
TCMTB/kg/day) based on decreased body
weight gain and food consumption in
maternal animals.
Short-Term,
Intermediate-T erm
and Long-Term
Dermal Exposure
NOAEL=25
mg/kg/day
82.33% ai purity
(20.6 mg ai/kg/day)
MOE = 100 (ST and
IT)
MOE = 300 (LT)
(10X for inter-
species extrapolation
and intra-species
variation, and 3X for
duration of exposure)
21-Day dermal toxicity study in rats (MRID
41655801)
LOAEL = 100 mg TCMTB/kg/day (82.3 mg
ai/kg/day) based on decreased body weight
gain, food consumption and hematological
and clinical chemistry changes
Short-Term and
Intermediate-T erm
Inhalation Exposure
NOAEL = 16.2 mg
ai/kg/day
81% ai purity (20 mg
T CMTB/kg/day)
Absorption = 100%
(inhalation and oral
equivalent)
MOE = 100 (ST and
IT)
(10X for inter-
species extrapolation
and intra-species
variation)
Developmental toxicity study in rabbits
(MRID 40075102)
LOAEL = 32 mg ai/kg/day (40 mg
TCMTB/kg/day) based on decreased body
weight gain and food consumption in
maternal animals.
Long-Term
Inhalation Exposure
LOAEL = 3.8
mg/kg/day
81.6% ai purity
Absorption = 100%
(inhalation and oral
equivalent)
MOE = 300 (a) (LT)
(10X for inter-
species extrapolation
and intra-species
variation and 3X for
use of a LOAEL)
Chronic toxicity study in dogs (MRID
41342201, 92179008 (1989))
LOAEL = 3.8 mg/kg/day (males) based on
decreased body weight gain, decreased white
cells, monocytes, and plasma ALT.
Decreased uterine weight in females.
19
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l'l\|)OSIIIV
Scen.irio
Dose I sod in Risk
Assessnu'iil
)
Tiirjyl MOr.s/l Is
1 QPA S;il'c(\
l-'iiclor lor Risk
Assessment
Siiulj ;iii(l Toxicolo^iciil EITccls
Short- and
Intermediate-T erm
Incidental Oral
(1-30 days; 30 days-6
months)
NOAEL=
16.2 mg ai/kg/day
81% ai purity
(20 mg
T CMTB/kg/day)
MOE = 100
(10X for inter-
species extrapolation
and intra-species
variation)
Developmental toxicity study in rabbits
(MRID 40075101, 40075102, 92179011
(1986))
LOAEL = 32 mg ai/kg/day (40 mg
TCMTB/kg/day), based on decreased body
weight gain and food consumption in
maternal animals.
Cancer
The Agency concluded that TCMTB should be classified as a "Group C- Possible Human
Carcinogen" and recommended that for the purpose of risk characterization, the Reference
Dose (RfD) approach should be used for quantitation of human risk. The chronic RfD is
protective of any potential carcinogenic effect. This decision was based on statistically
significant increases in tumors in both sexes of the Sprauge-Dawley rat (testicular interstitial
cell adenomas in males and thyroid C-cell adenomas in females).
Notes: LTF = uncertainty factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level,
LOC = level of concern, MOE = margin of exposure
(a) Note: An additional uncertainty factor (UF) of 10X is used for route extrapolation from an oral endpoint to determine if a
confirmatory inhalation study is warranted. If results are below a MOE of 1,000 a confirmatory inhalation study may be required.
b. Residential Handlers
i. Exposure Assessment
Residential exposure can occur through the application of TCMTB preserved paint via
airless sprayer or paintbrush. EPA selected high-end scenarios for each use site for the residential
handler exposure assessment. These scenarios are listed below:
Painting with an airless sprayer
Painting with a brush/roller
There was no chemical-specific exposure data to assess paint application with a brush
roller or airless sprayer. Therefore, dermal and inhalation exposures were assessed for these
scenarios using the Pesticide Handler Exposure Database (PHED, Version 1.1) and values were
found in the Residential Exposure SOPs (U.S. EPA, 1997a, 2001). The dermal and inhalation
exposures from these techniques have been normalized by the amount of active ingredient
handled and reported as unit exposures (UE), which are expressed as mg/lb of active ingredient
handled.
Maximum application rates, related use information and Agency standard values were
used to assess residential handler exposure. For example, it was conservatively assumed that a
resident applies 15 gallons of paint per day using an airless sprayer and 2 gallons of paint per day
using a brush/roller. The residential handler scenarios were assumed to be of short-term duration
(1-30 days).
20
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ii. Risk Assessment
Based on toxicological criteria and potential for exposure, the Agency has conducted
dermal and inhalation exposure assessments. A MOE greater than or equal to 100 is considered
adequately protective for the residential exposure assessment for the dermal and inhalation
routes of exposure. The MOE of 100 includes lOx for inter-species extrapolation, lOx for intra-
species variation.
All of the inhalation MOEs for residential handlers are above the target MOE of 100
and, therefore, are not of concern. For the residential handler dermal risk assessment, dermal
MOEs are below the target of 100 and, therefore, are of concern (MOE of 10 for airless
sprayer, MOE of 25 for paint brush). In addition, total dermal and inhalation risk estimates
were of concern primarily because of the dermal route of exposure. A summary of the
residential handler exposures and risks are presented on Table 7.
Table 7. Residential Handler Risk Summary (Short-Term Duration)
Exposure
Scenario
Use site
Dermal Dose
(mg/kg/day)a
Inhalation Dose
(mg/kg/day)b
Dermal
MOEc
Inhalation
MOE"
Total
Dermal
and
Inhalation
MOE
Airless Sprayer
Residential/
Household
Premises
2.54
0.0267
10
600
9.8
Paintbrush/
Roller
Residential/
Household
Premises
0.986
0.00122
25
13,000
25
a Dermal Dose (mg/kg/day) = [Unit dermal exposure (mg/lb ai) * Use rate (lb ai/lb product or lb ai/gal product) *
Amount handled per day (lb product/day)] / Body weight (kg)
b Inhalation Dose (mg/kg/day) = [Unite inhalation exposure (mg/lb ai) * Use rate (lb ai/lb product or lb ai/gal
product) * Amount handled per day (lb product/day) * inhalation absorption (1.0)] / Body Weight (kg)
c Dermal MOE = Dermal NOAEL (mg/kg/day) / Dermal Dose (mg/kg/day), where the NOAEL is 25 mg/kg/day
from the sub-chronic rat dermal toxicity study
d Inhalation MOE = Inhalation NOAEL (mg/kg/day) / Inhalation Dose (mg/kg/day), where the inhalation NOAEL of
16 mg/kg/day is from an oral rabbit developmental study. In absence of data, inhalation absorption is assumed to be
equivalent to oral absorptions.
c. Residential Post-application
i. Exposure Assessment
Residential post-application exposures result when adults and children come in contact
with TCMTB in areas where pesticide end-use products have recently been applied (e.g., treated
textiles/carpeting), or when children incidentally ingest the pesticide residues through mouthing
the treated end products/treated articles (i.e., hand-to-mouth or object-to-mouth contact). The
residential post-application scenarios considered in this assessment are from exposure to residues
on carpets that have been treated with TCMTB and wearing clothing that was treated with
TCMTB.
21
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There is the potential for dermal exposure to toddlers crawling on carpets preserved with
TCMTB. Short-term dermal risks to children have been identified, as the preservative is applied
only during the manufacturing of the carpet. In addition to dermal exposure, infants crawling on
treated floors will also be exposed to TCMTB via incidental oral exposure through hand-to-
mouth transfer. To calculate incidental ingestion exposure to TCMTB due to hand-to-mouth
transfer, the scenarios established in EPA's "Standard Operating Procedures (SOPs) for
Residential Exposure Assessments" were used.
The Agency evaluated the following three post-application scenarios, which are considered
to be representative of all possible residential exposure scenarios:
Contact with treated carpets by children (incidental oral and dermal exposure to
children);
Wearing treated textiles/leather products (dermal exposure to children and adults);
Mouthing treated textiles such as clothing/blankets/leather products (incidental
oral exposure to children).
For treated textiles/leather products, the Agency believes exposures are primarily short-
term because residents are assumed to be exposed to treated textiles with varying active
ingredients and that these textiles have not exclusively been treated with TCMTB. However, if
the products are used on a routine basis (i.e., once a week or impregnated into carpets as
materials preservative) and the active ingredient has a long indoor half-life, exposures may occur
over an intermediate-term (30 days-6 months). The Agency did not have residue dissipation data
or reliable use pattern data, including the frequency and duration use of antimicrobial products in
residential settings. Because of this lack of data, intermediate-term exposure was assessed to
provide an upper-bound estimate of exposure to treated textiles.
A number of conservative assumptions were used in assessing post-application risks
including maximum application rates from TCMTB product labels. In addition, quantities
handled/treated were estimated based on information form various resources, including the Draft
Standard Operating Procedures (SOPs) for Residential Exposure Assessments (USEPA 2000,
2001) and standard Agency residential SOP assumptions. Standard values were not available for
the textile and treated leather product uses. For these scenarios, it was assumed that either 100%
or 5% of TCMTB could transfer and be available for dermal contact.
ii. Risk Assessment
Based on toxicological criteria and potential for exposure, the Agency has conducted
dermal and incidental oral exposure assessments. A MOE greater than or equal to 100 is
considered adequately protective for the residential exposure assessment for the dermal,
incidental oral and inhalation routes of exposure. The MOE of 100 includes lOx for inter-
species extrapolation and lOx for intra-species variation.
The residential post-application risk assessment identifies short-term (1-30 days) and
intermediate-term (1-6 month) exposure doses based on the reported toxicology endpoints for
TCMTB. Because the toxicological endpoints are identical for short- and intermediate-term
22
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durations for both dermal and incidental oral exposures, the Agency calculated a total MOE for
children.
The short-term and intermediate-term MOEs for dermal contact with treated
clothing/leather products are of concern for both young children and adults (MOEs are less than
1, assuming a 100% transfer factor; MOEs are less than 10, assuming a 5% transfer factor). In
addition, the dermal MOE is of concern for young children crawling on treated carpets (MOE of
2). TCMTB is a dermal sensitizer and thus, there is a potential for adverse dermal allergic
reactions from direct skin contact of treated textiles.
The short- and intermediate-term MOEs for incidental oral ingestion of treated carpets by
children exceeds the Agency's level of concern (MOE of 4). In addition, the short-term oral
MOE for children mouthing treated textiles/leather products is also a risk of concern as the MOE
(MOE of 21) is below the target of 100.
As shown in Table 8, the total MOE for children who may contact TCMTB treated carpet
and treated clothing/leather products is less then 1 and, therefore, the total (oral and dermal
exposures combined) MOE for children is of concern.
Table 8 presents a summary of the short-term and intermediate-term residential post-
application exposures and risk estimates.
Table 8. Antimicrobial Short- and Intermediate-term Residential Post-application
Exposures and Risk Summary
Dose
moi:1'
Scenario
(m^/k»/(la>)
(Taipei MOI->HMD
Child
Ariull
Child
Ariull
Dermal Exposure
Treated carpets
15.6 mg/kg/day
NA
2
NA
Treated clothing/leather products
4.3 mg/kg/day
2.7mg/kg/day
5.8
9.1
(5% transfer)
(5% transfer)
(5% transfer)
(5 % transfer)
86 mg/kg/day
55 mg/kg/day
<1
<1
(100% transfer)
(100% transfer)
(100% transfer)
(100% transfer)
Incidental Oral Exposure
Treated carpets
3.81 mg/kg/day
NA
4.2
NA
Treated clothing/leather products
0.758 mg/kg/ day
NA
21
NA
TOTAL MOE RISK
NA
<1c
NA
ESTIMATE
NA= Not applicable
aDose calculations for each scenario above are outlined in the attached Occupational/Residential Assessment (memo from S. Mostaghimi,
February 2006).
b MOE= NOAEL (mg/kg/day) / PDR (mg/kg/day). Oral NOAEL is 16 mg/kg/day; dermal NOAEL is 25 mg/kg/day.
c Total MOE includes carpet (dermal and oral) and clothing (dermal and oral) exposures using the exposure estimates based on 5% residue
transfer.
8. Aggregate Risk Assessment
The Food Quality Protection Act amendments to the Federal Food, Drug, and Cosmetic
Act (FFDCA, Section 408(b)(2)(A)(ii)) require "that there is a reasonable certainty that no harm
will result from aggregate exposure to pesticide chemical residue, including all anticipated
23
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dietary exposures and other exposures for which there are reliable information." Aggregate
exposure typically includes exposures from food, drinking water, residential uses of a pesticide,
and other non-occupational sources of exposure.
The acute aggregate risk assessment is designed to provide estimates of risks likely to
result from exposures to the pesticide or pesticide residues in food, water, and from residential
(or other non-occupational) pesticide uses. As previously mentioned in section six of this
document, "Residential Risk Assessment," the antimicrobial residential uses evaluated for
TCMTB have risks of concern for residential handlers applying paint via airless sprayer or brush
roller; children playing on, or mouthing treated carpets; and, adults and children wearing treated
textiles/leather products. An aggregate assessment for short- and intermediate-term residential
exposures was not conducted, because risks of concern were previously identified for individual
residential exposure scenarios. An aggregate assessment would only reflect the identified
individual risks of concern and, therefore, was unnecessary. There are no long-term residential
exposure scenarios for TCMTB.
However, the Agency conducted both acute and chronic dietary aggregate assessments,
which considered food (antimicrobial and agricultural) and drinking water (agricultural only)
exposures, for the registered antimicrobial and agricultural uses.
In the case of TCMTB, a cancer aggregate assessment is not needed, as the chemical has
been classified by the Agency as having "Possible Human Carcinogen." Because an RfD
approach was used to evaluate chronic dietary risk and is considered protective of any cancer
risk concern, only the results of the chronic analysis are given.
a. Acute Aggregate Risk
The acute aggregate risk assessment considered the 95th percentile dietary exposure (food
and drinking water) from the agricultural seed treatment uses, as well as the acute dietary
exposure (food only) from the antimicrobial uses in pulp and paper. While it is standard to use
the chronic drinking water exposure estimate for acute aggregate risk assessments this was not
done in this case. Since the acute food and drinking water exposures were combined into a single
exposure estimate for the acute dietary assessment, this value was used in the aggregate
assessment. Using the acute drinking water estimate is a more conservative approach than the
standard method of conducting such an assessment. As shown in Table 9, the acute dietary
aggregate risk is 2.5% of the aPAD for children and less than 1.3% of the aPAD for adults.
These risk estimates are below the Agency's level of concern.
24
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Table 9. TCMTB Acute Aggregate Risk Estimates
l-lxposure Scenario
Dose"
% aPADh
Child
(IS kg)
Ariull
Child
(15 k»)
Ariull
Dieliin r.\|)OMiiv
\giiculluial Seal Tivaimcnt
(Food and Water)
0.004581
0.00243
1.8%
l"u
Antimicrobial Uses
Total Pulp/Paper/Adhesive
(Food)
0.0017
0.00083
0.66%
0.33
1 oliil Aiiiiivjiiik' Dose iiiul Risk
0.00628
0.00328
2.5%
<1.3%
NA= Not applicable
(a) Acute dietary exposure for females 13-50 years for antimicrobials uses.
(b) % aPAD = dietary exposure (mg/kg/day) / aPAD, where aPAD -= 0.25 mg/kg/day for all populations.
b. Chronic Aggregate Risk
The chronic aggregate risk assessment considered average dietary exposure (food and
drinking water) from the agricultural seed treatment uses of TCMTB, as well as dietary exposure
(food only) from the antimicrobial uses of TCMTB in pulp and paper. As shown in Table 10, the
chronic dietary aggregate risk estimate of TCMTB is 30% of the cPAD for children and is 13.4%
of the cPAD for adults. These risk estimates are below the Agency's level of concern.
Table 10. TCMTB Chronic Aggregate Risk Estimates
l-lxposure Scenario
Dose"
(nili/k;i/(l;i\)
% ePADh
Child
(15 k»)
Ariull
Child
(15 k»)
Ariull
Dielnn l-lxposure
Agricultural Seed treatment
(Food and Water)
0.002226
0.000888
17%
7%
Antimicrobial Uses
Total Pulp/Paper/Adhesive
(Food)
0.0017
0.00083
12.8%
6.44
l oliil A}»}»re}»«ile Dose iinri Risk
0.003926
0.001718
30%
13.4%
NA= Not applicable
(a) Chronic dietary exposure for females 13-50 years for antimicrobials uses.
(b) % cPAD = dietary exposure (mg/kg/day) / cPAD, where cPAD -= 0.013 mg/kg/day for all populations.
9. Occupational Risk
Workers can be exposed to a pesticide through mixing, loading, and/or applying a
pesticide, or re-entering treated sites. TCMTB is used as an antimicrobial pesticide (e.g.,
materials preservative, industrial processes and water systems, wood preservative and paint
application) and as a seed treatment. Potential occupational exposure can occur in various use
sites, which include commercial/industrial premises, industrial process and water systems, from
wood preservation, and from metal working fluid uses.
25
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Occupational handlers of TCMTB include handlers applying TCMTB treated paint via
airless sprayer or paint brush/roller; handlers pouring TCMTB liquid preservative for paint
preservation, textile preservation, drilling fluids, metal working fluids and small process water
systems; handlers pumping (metering) liquid preservative for metal working fluid, pulp and
paper and cooling water systems, paint and textiles preservation, and small process water
systems; and wood preservative handlers.
For the seed-treatment use of TCMTB, occupational handlers include workers in
agricultural seed treatment settings (commercial and on-farm settings) and workers handling
seed previously treated (post-application worker exposure).
a. Occupational Toxicity
The toxicological endpoints used in the occupational handler assessment of TCMTB can
be found in Table 6, "Residential and Occupational Toxicological Doses and Endpoints for
TCMTB", of this document.
b. Occupational Handler Exposure
Occupational risk for all potentially exposed populations is measured by a Margin of
Exposure (MOE), which determines how close the occupational exposure comes to a No
Observed Adverse Effect Level (NOAEL) from toxicological studies. Occupational risk is
assessed for exposure at the time of application (termed "handler" exposure). Application
parameters are generally defined by the physical nature of the formulation (e.g., formula and
packaging), by the equipment required to deliver the chemical to the use site and by the
application rate required to achieve an efficacious dose.
The Agency evaluated representative scenarios using maximum application rates as
recommended on TCMTB product labels. To assess handler risk, the Agency used surrogate unit
exposure data from both the proprietary Chemical Manufacturers Association (CMA)
Antimicrobial Exposure Study (USEPA, 1999) and the Pesticide Handlers Exposure Database
(PHED), (USEPA, 1998). The duration of exposure to TCMTB is expected to be short-term or
intermediate-term (1 day to 6 months) for most occupational scenarios. Wood preservation and
metal working fluid uses were assumed to be long-term exposure durations.
For more information on the assumptions and calculations of potential agricultural and
antimicrobial risks of TCMTB to workers, see the Occupational Exposure Assessment (Sections
9.0-9.2) in the "2-(Thiocyanomethylthio) benzothiazole (TCMTB) Risk Assessment for the
Reregistration Eligibility Decision (RED) Document," dated August 1, 2006, the antimicrobial
"Occupational and Residential Exposure Assessment for 2-(Thiocyanomethylthio) benzothiazole
TCMTB," dated April 19, 2006 and the "TCMTB [2-(Thiocyanomethylthio)benzothiazole]:
Third Revision of the Occupational and Residential Exposure Assessment for the Reregistration
Eligibility Decision Document" for the agricultural uses of TCMTB, dated July 27, 2006.
26
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Antimicrobial Use
Inhalation and dermal exposures to TCMTB (as an antimicrobial pesticide) were
addressed for occupational populations for both short- and intermediate-term durations. The
Agency used surrogate unit exposure data from the proprietary Chemical Manufacturers
Associated (CMA) antimicrobial exposure study (USEPA, 1999) and the Pesticide Handlers
Exposure Database (PHED) to assess handler risks (USEPA, 1998). MOEs for material
preservation of paints, textiles, adhesives and metalworking fluid were calculated using unit
exposure values from the cooling tower CMA data-set (USEPA, 1999) because exposure data
were not available for ungloved handlers. Handler exposures were assessed for the application of
TCMTB-preserved paint.
For the airless sprayer scenario, PHED dermal and inhalation unit exposure values for a
residential handler applying a pesticide using an airless sprayer were used. These unit un-gloved
exposure values (79 mg/lb a.i. for dermal and 0.83 mg/lb a.i. for inhalation) represent a handler
wearing short pants and a short sleeve shirt, with no gloves. It was assumed that 15 gallons (or
150 lb/day, assuming paint has a density of 10 lb/gal) of treated paint were to be used per day.
For the brush/roller scenario, PHED dermal and inhalation unit exposure values for a
residential handler applying a pesticide using an airless sprayer were used. These unit exposure
values (230 mg/lb a.i. for dermal and 0.284 mg/lb a.i. for inhalation) represent a handler wearing
short pants and a short sleeve shirt, with no gloves. It was assumed that for the brush/roller paint
applications 2 gallons (or 20 lb/day, assuming paint has a density of 10 lb/gal) of treated paint
were to be used per day.
The duration of exposure for most homeowner applications of paint is believed to be best
represented by the short-term duration (1 to 30 days). The reason that short term duration was
chosen to be assessed is because the different handler and post-application scenarios are assumed
to be episodic, not daily. In addition, homeowners are assumed to use different products with
varying activities, not exclusively TCMTB treated products.
The dermal and inhalation wood unit exposure values for wood preservation were based
on two replicates where the test subjects were wearing a single layer of clothing and chemical
resistant gloves. Surrogate unit exposures were taken from the CMA study (USEPA, 1999). The
quantity of the wood being treated was derived from other wood preservative estimates (USEPA,
2004) for the amount of wood slurry treated because no chemical specific data were available for
TCMTB. It was assumed that batches of wood slurry are treated in 10,000 gallon tanks and that
eight batches of wood slurry are treated per day (one per hour for an 8-hr work shift).
Additionally, it was assumed that each batch requires 3,000 gallons of preservatives and the
remainder volume of the tank consists of wood slurry (7,000 gallons of wood slurry per batch).
Wood chips have a density of approximately 380 kg/m3 (SIMetric, 2005) and, therefore, the total
amount of wood slurry treated per day would be 178,000 lbs (8 batches/day * 7,000
gallons/batch * 0.003785 m3/gallon * 380 kg/m3 * 2.2 lb/kg). The assumptions used for batch
sizes and the quantity of preservative needed are consistent with an assessment performed
previously by the EPA. For this assessment, an application rate of 0.003 TCMTB w/w was used.
27
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Based on the antimicrobial use patterns of TCMTB, the exposure scenarios in Table 11
were assessed:
Table 11. TCMTB Antimicrobial Occupational Handler Scenarios
C.iU'iion
Scenario
Commercial
Institutional
Premises
Airless sprayer and paint brush/roller may be used as methods of application for paint
application of TCMTB treated paint.
Materials
Preservative
Pouring or pumping TCMTB preservative into vats or tanks for preservation of
textiles/leather products, paints, adhesives and metal working fluid.
Industrial
Processes and
Water Systems
Occupational Handler Scenarios:
Metered pumping, pouring or liquid pumping TCMTB into vats or tanks for drilling fluids,
pulp and paper, and small process water systems/cooling towers.
Post-application Occupational Handler Scenarios:
Exposure can occur after the chemical has been incorporated into the cutting fluid and a
machinist is using/handling this treated end-product.
Wood Preservative
Occupational Handler Scenarios:
• Blender/spray operators are workers that add the wood preservative into a
blender/sprayer system for composite wood via closed-liquid pumping.
• Diptank Operators can be in reference to wood being lowered into the treating solution
through an automated process (i.e., elevator diptank, forklift diptank). This scenario can
also occur in a smaller scale treatment facility in which the worker can manually dip the
wood into the treatment solution.
• Chemical operators for a spray box system consist of chemical operators, chemical
assistants, chemical supervisors, and chemical captains. These individuals maintain a
chemical supply balance along with flushing and cleaning spray nozzles.
Post-application Occupational Handler Scenarios:
• Graders, positioned right after the spray box, grade dry lumber by hand (i.e. detect
faults). In the DDAC study, graders graded wet lumber; therefore, the exposures to
graders using TCMTB are worst-case scenarios.
• Millwrights repair all conveyer chains and general up-keep of the mill.
• Clean-up crews perform general cleaning duties at the mill.
• Trim saw operators operate the hula trim saw and consist of operators and strappers. In
the DDAC study, hula trim saw operators handled dry lumber.
• Construction workers install treated plywood, oriented strand board, medium density
fiberboard, and others.
Agricultural Seed Treatment Uses
EPA has assessed the exposure to handlers' mixing/loading/applying products containing
TCMTB. Inhalation and dermal exposure scenarios were addressed for occupational populations
for both short- and intermediate-term exposure durations. Occupational handler exposure
estimates were based on surrogate data from the "Health Effects Division Science Advisory
Committee on Exposure (HED ExpoSAC) SOP #15: Amount of Seed Treated or Planted per
28
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Day", which was completed on March 2, 2004. Generic protection factors (PFs) were used to
calculate exposures when data were not available. For example, an 80 percent protection factor
was assumed for the use of a respirator equipped with a quarter-face dust/mist filter. It was
assumed that on-farm treaters and planters are expected to have short-term exposure duration
(less than 30 days) for all seed crops. It was also assumed that personal protective equipment for
on-nursery and commercial mixer/loader/applicators and planter includes a single layer and
gloves. Personal protective equipment for commercial baggers and sewers includes baseline
attire only - no gloves. Personal protective equipment for performing multiple activities in a
commercial operation includes a single layer of clothing and gloves.
Exposure data used for the TCMTB seed treatment assessment are taken primarily from
the Agency's recently developed seed treatment standard operating procedure (SOPs for Seed
Treatment, 6/1/03). The seed treatment SOP contains representative scenarios for worker
exposure associated with seed treatment facilities and planting treated seed. These scenarios
were used to describe the various types of handler exposures that may occur from TCMTB.
Information from the current labels, use and usage information, toxicology data, and exposure
data were all key components in the development of the exposure scenarios. Exposure estimates
were taken from actual seed treatment studies and were based on exposure factors associated
with occupational handler scenarios (commercial seed treatment, on-nursery seed treatment,
planting of treated seed). Assessed application rates range from 0.026 lbs active ingredient/100
lbs of seed to 0.13 lbs active ingredient/100 lbs of seed.
Four categories of commercial seed treatment activities and two categories for on-nursery
activities were assessed and are shown in Table 12.
Tablel2. TCMTB Seed Treatment Occupational Handler Scenarios
C.iU'iion
Scenario
Agricultural Seed Treatment
Commercial Seed Treatment Scenarios:
(S-l) Loading and applying liquid formulations with commercial seed-treatment
equipment.
(S-2) Commercial sewer stitching bags of seed.
(S-3) Bagging and otherwise handling treated seeds with commercial equipment.
(S-4) Multiple commercial seed treatment activities.
On-Nursery Seed Treatment and Planting Post Application Scenarios:
(S-5) On-nursery loading/applying seed treatment.
(S-6) On-nursery loading/planting previously treated seeds.
29
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c. Occupational Handler Risk Summary
Antimicrobial Use
The occupational handler risk assessment, for the antimicrobial use of TCMTB,
included both inhalation and dermal exposure scenarios. The target MOE for short- and
intermediate term- inhalation and dermal exposures was 100. The target MOE for long-term
dermal and inhalation exposures was 300. All but two of the short- and intermediate-term dermal
and inhalation scenarios assessed were not of concern (MOEs greater than 100). The following
two dermal exposure scenarios indicate risks of concern even with the addition of chemical
resistant gloves:
• Paint Application: Airless Sprayer
(ST/IT Dermal MOE = 6.1 ungloved, MOE = 17 gloved)
• Paint Application: Paintbrush
(ST/IT Dermal MOE = 30 ungloved, MOE = 97 gloved)
Risks of concern were identified for six use scenarios (paint preservation liquid pour, paint
preservation liquid pump, textile preservation liquid pour, textile preservation liquid pump,
cutting fluid preservation liquid pour, pulp and paper liquid pump) at the baseline level of
evaluation (no PPE gloves). However, the dermal MOEs are greater than 100 with the addition
of PPE (gloves). Therefore, the use of PPE gloves eliminates all risks of concern for these six use
scenarios.
The total dermal and inhalation MOEs with added PPE (gloves) are not of concern for all
but two of the scenarios evaluated. The following scenarios have remaining total dermal and
inhalation MOEs that are less than 100 and are of concern:
• Paint Application: Airless Sprayer
(Total Dermal and Inhalation MOE = 16)
• Paint Application: Paintbrush
(Total Dermal and Inhalation MOE = 95)
For further information regarding the short- and intermediate-term risks associated with
occupational handlers, refer to Tables 13 and 14.
30
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Table 13. Antimicrobial Use Short- and Intermediate-Term Risks Associated with
Occupational Handlers
,. Vnnliiiilioii Oii;inlil\
I.MIOSIIIC McIIkmI o| ¦¦
M II \IC)I.
i 1 iir«*rl \l<>l IIMh
Vciiiiiio
V pplii-sil i«»n
Kiilc ( ii
Paintbrush
50 lb/day
30
97
5,300
Paint
Preservation
Liquid Pour
2,000 lb/day
1.2
430
11,000
414
Liquid Pump
10,000 lb/day
2(»
1900
19,000
1,727
Textiles/
Leather
Products
Liquid Pour
0.006 a.i.
weight
fraction
10,000 lb/day
1
220
5,400
211
Liquid Pump
(.4
4,600
46,000
4,182
Cutting Fluid
Liquid Pour
0.00125 a.i.
weight
fraction
2,502 lb/day
II
3,000
42,000
2,800
Liquid Pump
1,200
1,800
l.OOxlO5
1,768
Drilling
Fluids
Liquid Pour
0.00075 a.i.
weight
fraction
ST = 45.9 lb/day
ST =1000
ST = 380,000
ST = 9.40xl0"6
365,235
IT = 22.9 lb/day
IT = 2,000
IT = 7.60xl05
IT = 1.90x10'
730,769
Pulp and
Paper
Liquid Pump
1,000,000 lb/day
5
510
5,600
467
Small Process
Water
Systems/
Cooling
Tower
Liquid Pour
0.000009 a.i.
weight
fraction
90 lb/day
43,000
21,000
3.10xl06
20.858
Liquid Pump
180,000 lb/day
2,400
13,000
1.60xl05
12,023
ST = short-term; IT = intermediate-term
a Baseline Dermal: Long-sleeve shirt, long pants, no gloves,
b PPE Dermal with gloves: baseline dermal plus chemical-resistant gloves.
c MOE = NOAEL (mg/kg/day) / Absorbed Daily Dose [Where ST/IT NOAEL = 25 mg/kg/day for dermal and 16 mg/kg/day for inhalation].
Table 14 provides short- and intermediate-term doses and MOEs for workers adding
TCMTB preservative to wood slurry. When wearing single layer clothing and chemical resistant
gloves, all MOEs are above the target MOE of 100 for ST/IT dermal and inhalation and above
300 for LT dermal and inhalation exposures and, therefore, are not of concern.
31
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Table 14. Short-, Intermediate- and Long-term Risks Associated with Wood Preservative
Blender/Spray Operators
Drrniiil
I nit
K\po^iin*"
un» II) nil
Inhiiliiliuii
I nil
I \|)IIX|||I
¦ iiiaj III .ii¦
\pii.
Uillr
(IVsiiiion
:ii in
solution
1
N I II
I I
()iiii|)iilioiisil lliiinlli'i
4.03x10"' 0.00300 1.78x10' 0.0480 0.00307 520 5200 1200 478
ST = Short-term duration; IT = Intermediate-term duration; and LT = long-term.
a. Dermal unit exposure: Single layer clothing with chemical resistant gloves.
b. Inhalation unit exposure: Baseline.
c. The maximum application rate for the "immersion" application method is a solution containing 0.3% a.i.
d. Wood slurry treated = (8 batches/day * 7,000 gallons/batch * 0.003785 m3/gallon * 380 kg/m3 * 2.2 lb/kg)
e. Absorbed Daily Dose = unit exposure (mg/lb ai) x App Rate (fraction ai/day) x Quantity treated (lb/day) / BW (70 kg)
f. MOE = NOAEL (mg/kg/day)/ Daily dose [Where dermal ST/IT/LT NOAEL = 25 mg/kg/day, ST/IT inhalation NOAEL = 16 mg/kg/day,
and LT inhalation NOAEL = 3.8 mg/kg/day]. Target MOE is 100 for ST/IT dermal exposures and 300 for LT dermal and 100 for ST/IT
and 300 for LT inhalation exposures.
Agricultural Seed Treatment Uses
The occupational handler assessments were conducted using increasing levels of
protection. The Agency typically evaluates all exposures with minimal protection and then
considers additional protective measures using a tiered approach (going from minimal to
maximum levels of protection) in an attempt to obtain an adequate MOE. The lowest tier is
represented by the baseline clothing scenario (i.e., single layer clothing, socks and shoes),
followed by, if MOEs are of concern, increasing levels of risk mitigation such as personal
protective equipment (PPE) and engineering controls (EC).
The occupational handler risk assessment for the agricultural seed treatment use of
TCMTB included both inhalation and dermal exposures. The target MOE for both the inhalation
and dermal exposures was 100. Scenarios with an MOE less than 100 indicate a risk of concern.
The Agency evaluated occupational risks to workers that use TCMTB as a fungicide for treating
seeds in commercial and on-nursery/on-farm settings.
For commercial seed treatment, all individual dermal and inhalation MOEs met or
exceeded the target MOE of at the baseline level of mitigation (single layer of clothing with
gloves and no respirator). MOEs were above the target of 100 for the combined inhalation and
dermal exposure scenarios at the baseline level of mitigation (single layer of clothing with gloves
and no respirator). Please refer to Tables 15 and 16 for further details regarding the estimated
worker exposures and risks from commercial and on-nursery seed treatment.
32
-------
Table 15. Estimated Worker Exposure and Risk from Commercial Seed Treatment
('nip
l'.\|io<>iir('
^(ciiiirio
V |>|>l it-nl ion
Kill i-
illi ni 1IHI
lb)"
AiiimiiiiI
1 llllllllcll
pel Dm
ill) :ii (l;i\ i1'
*>horl iiml liilcrinciliiilc 11-i'in l\i«U 1-liiiLili-
1 r\cl MlMili»:ili<>ii'
Dcriniil
MOI.
i 1 iiriirl
MOI. 1 IHI |
Inliiiliilioii
\l< >1'. ( 1 iir«rl
MOI. 1 <101
1 oliil MOI. 1
(T;ir»i-I
MOI. IMII)
Barley, Oat, Rice,
Wheat Seeds
Loader/Applicator
0.026
187
410
18,000
400
SL, G+NR
Sewer
1,500
26,000
1,400
SL + NR
Bagger
1,000
37,000
970
SL + NR
Multiple
Activities
220
3,700
210
SL, G+NR
Cotton Seeds
Loader/Applicator
0.13
208
370
16,000
360
SL, G+NR
Sewer
1,400
23,000
1,300
SL + NR
Bagger
920
34,000
900
SL + NR
Multiple
Activities
200
3,400
190
SL, G+NR
Safflower Seeds
Loader/Applicator
0.041
294
260
11,000
250
SL, G+NR
Sewer
960
17,000
910
SL + NR
Bagger
650
24,000
630
SL + NR
Multiple
Activities
140
2,400
130
SL, G+NR
Sugar Beet Seeds
Loader/Applicator
0.041
36
2,100
91,000
2,100
SL, G+NR
Sewer
7,800
130,000
7,400
SL + NR
Bagger
5,300
190,000
5,200
SL + NR
Multiple
Activities
1,200
19,000
1,100
SL, G+NR
ND = No Data; NF = Not Feasible; NR=No respirator
a Application rates are the maximum application rates determined from EPA registered labels for TCMTB
b Amount handled per day calculated from the maximum application rate and the lbs of seed treated or planted/day and: for barley, rice,
safflower, and wheat seed - 718000 lb/day; for cotton seed - 160000 lb/day; and sugar beet seed - 88000 lb/day.
c Baseline Dermal: Long-sleeve shirt, long pants, no gloves.
Baseline Inhalation: no respirator.
SL, G = Single layer w/gloves is baseline attire plus chemical-resistant gloves.
DL, G = Double layer w/gloves is coveralls worn over long-sleeve shirt and long pants, plus
Table 16. Estimated Worker Exposure and Risk from On-nursery Seed Treatment
I nil Exposures
Short- and Intermediate-term MOEs
. \cres
treated
day
App
Amount
Handled
per da\1'
(lb'
ai day)
Baseline
Personal Protective
Equipment
Engineering
Controls
Baseline
Personal Protective
Equipment
Crop
Rale
(lb ai
100 \bf
Dermal1
(nig lb
Inhalation'1
( glbai)
Dermal
(nig lb
ai)
Inhalation
(ug lb ai)
Dermal'1
(nig lb
ai)
Inhalation1
(ug lb ai)
Inhalation
Dermal
Inhalation
ai)
SI. w
glovesc
80° n R1
90° o R"
SI.w
gloves
80° o R
90°.. R
LOADING/APPLYING LIQUID SEED TREATMENTS
Cotton
125
0.051
0.64
ND>
ND = No Data
D On-nursery seed treatment with liquid formulations is generally done with automated equipment, essentially miniature versions of
commercial treaters.
33
-------
d. Occupational Post-application Risk Summary
Occupational post-application exposures may occur from both antimicrobial and
agricultural use scenarios. Occupational handlers may be exposed to TCMTB by handling
treated wood; handling metal working/cutting fluids; and loading/planting previously treated
seeds.
Antimicrobial Use
TCMTB is used in products that are intended to preserve wood through non-pressure
treatment methods. It can be applied as a sapstain control to freshly-cut wood, incorporated into
particle board, or used to treat wood chips. When used as a sapstain control, the product may be
dipped, sprayed, or impregnated into the wood via pressure treatment (up to 0.3% a.i. solution).
When used in particle board, the pesticide is incorporated into the resin or binding agent (0.3%
a.i., based on dry weight of wood). As very little chemical specific data were available regarding
typical exposures to TCMTB as a wood preservative, surrogate data were used to estimate
exposure risks. The blender/spray operator position was assessed using CMA unit exposure data
and the remaining handler and post-application positions were assessed using data from a DDAC
study (Bestari et al., 1999).
Post-application exposures to chemical operators, graders, millwrights, trim saw
operators, and clean-up crews were assessed using surrogate data from the DDAC study (Bestari
et al., 1999). The DDAC study examined individuals' exposure to DDAC while working with
antisapstains and performing routine tasks at 11 sawmills/planar mills in Canada. Dermal and
inhalation exposure monitoring data were gathered for each job function of interest using
dosimeters and personal sampling tubes. Dosimeters and personal air sampling tubes were
analyzed for DDAC. Exposure data for individuals performing the same job functions were
averaged together to determine job specific averages. Monitoring was conducted using 2 trim
saw workers, 13 grader workers, 11 chemical operators, 3 millwrights, and 6 clean-up staff.
Exposures to diptank operators were also assessed using surrogate data from the DDAC
study (Bestari et al., 1999). The diptank scenario assessment was conducted differently than for
the other job functions because the concentration of DDAC in the diptank solution was provided.
The exposure data for diptank operators wearing gloves were converted into unit exposures in
terms of mg a.i. for each 1% of concentration of the product. Dermal and inhalation unit
exposures were 2.99 and 0.046 mg/1% solution, respectively. The air concentrations presented in
the DDAC study were converted to unit exposures using an inhalation rate of 1.0 m3/hr (light
activity) and a sample duration of 8 hrs/day.
There are no risks of concern for the short-, intermediate- or long-term occupational
handler dermal and inhalation wood preservative exposure scenarios (ST/IT dermal and
inhalation MOEs > 100; LT dermal and inhalation MOEs > 300). The combined dermal and
inhalation scenarios also met or exceeded the target MOE of 100 when handlers were wearing
short sleeve shirts, cotton work trousers, and cotton glove dosimeter gloves under chemical
resistant gloves and, therefore, are not of concern.
34
-------
Table 17. Short-, Intermediate- and Long-Term Exposures and Risk for Occupational
Handlers for Wood Preservative Use
|-'.\|H>s|||V Sccllill io1
(IIIIIIiIhT i ri s,
\IOIVi liiriiil MOI. IIHMiirM 1 1. 1 li
Di-mnil
liiliiiliiliiin
IOI \\ MOI.
iilcrniiil mill iiiliiiliiliniii
M II 1 1
M II
1 1
M II
1 1
Blender/Spray Operator (b)
520
5,200
1,200
478
364
Chemical Operator (n=l 1)
48,000
l.lOxlO7
2.50xl06
47,790
47,095
Grader (n=13)
1.50xl05
l.OOxlO7
2.40xl06
147,783
141,176
Trim Saw (n=2)
3.40xl05
4.90xl06
1.20xl06
317,940
264,935
Millwright (n=3)
36,000
5.20xl06
1.20xl06
35,752
34,951
Clean-Up (n=6)
8,400
4.90xl05
1.20xl05
8,258
7,850
Diptank Operator
1,900
8.10xl04
19,000
1,856
1,727
ST = Short-term duration; IT = Intermediate-term duration; and LT = long-term
a. Unless specified, the exposure scenario represents a worker wearing short sleeve shirts, cotton work trousers, and cotton glove
dosimeter gloves under chemical resistant gloves. Volunteers were grouped according to tasks they conducted at the mill.
b. Single layer clothing with chemical resistant
c MOE = NOAEL (mg/kg/day)/ Daily dose [Where ST/IT/LT dermal NOAEL = 25 mg/kg/day, ST/IT NOAEL for inhalation is 16
mg/kg/day and LT NOAEL for inhalation is 3.8 mg/kg/day]. Target MOE is 100 for ST/IT dermal and inhalation exposures, 300 for
LT dermal and inhalation exposure.
Not enough data exists to estimate the amount of exposure associated with construction
workers who install treated wood. In particular, values for the transfer coefficient associated with
a construction worker handling the wood could not be determined. It is believed that the
construction worker using a trim saw will have larger dermal and inhalation exposures than the
installer, due to the amount of sawdust generated and the greater amount of hand contact that
would be necessary to handle the wood when using a saw compared to installing the wood.
Because the dermal and inhalation MOE's are well above the target of 100 for trim saw
operators and handler exposure is expected to be greater for trim saw operation, risks of concern
are not anticipated for construction workers installing treated wood.
Occupational workers may also be exposed to TCMTB when handling previously treate
metal working/cutting fluids. For the metal working/cutting fluids scenario, dermal exposure
estimates were derived using the two-hand immersion model from ChemSTEER. A screening
level intermediate- and long-term inhalation exposure estimate for treated metal working fluids
was developed using the OSHA Permissible Exposure Limit (PEL) for oil mist. Post-application
dermal and inhalation exposure occurs after the chemical has been incorporated into the metal
working fluid and a machinist is using/handling this treated end-product. It was assumed that a
machinist is exposed to the metal working fluid 8 hours a day, for 5 days a week and that the
body weight of an adult is 70 kg (US EPA1997).
For the metal working fluid scenario, all combined dermal and inhalation scenarios met or
exceeded the target MOE of 100 and, therefore, are not of concern. However, there are human
incident data related to the occupational handler post-application use of TCMTB as an
antimicrobial product. This and other data indicate dermal irritation from exposure to TCMTB
and that TCMTB is a dermal sensitizer (toxicity category I for eye irritation and toxicity category
II for dermal irritation).
35
-------
Table 18. Short-, Intermediate and Long-Term Risks Associated with Post-application
Exposure to Metal Working Fluids Treated with TCMTB (Machinist)
l)cnn;il 1 ii pill ^
liilisiliilion Inpiiis
\IC)I.
1 l:ir»rl MOI. Illinois 1 1 1. .1
l()l \i MOI.
iilcrniiil mill
inliiiliil i< i
(cm")
M II 1 1
M II
1,1
M II
1,1
0.00125
840
1.75
1
5
1
8
950
22000
5300
910
806
Absorbed Dermal Daily Dose (mg/kg/day) = [fraction a.i. in treated fluid * hand surface area* film thickness (mg/cm )* Frequency
(event/day)] / Body weight (70 kg).
Absorbed Inhalation Daily Dose (mg/kg/day) = fraction a.i. in treated fluid * OSHA PEL (mg/m3) * Inhalation rate (m3/hr) * exposure
duration (hr/day) / body weight (70 kg)
Dermal MOE = NOAEL (mg/kg/day) / Absorbed Daily Dose (mg/kg/day) [Where: ST/IT/LT dermal NOAEL = 25 mg/kg/day].
Inhalation MOE = NOAEL (mg/kg/day) / Absorbed Daily Dose (mg/kg/day) [Where: ST/IT inhalation NOAEL = 16 mg/kg/day and
LT Inhalation NOAEL = 3.8 mg/kg/day].
Agricultural Seed Treatment Use
For the agricultural seed treatment use, the post-application occupational risk assessment
considered exposure to TCMTB from entering nurseries after plants had been treated. On-
nursery seed treatment scenarios were assessed for loading/planting previously treated seeds.
Dermal and inhalation exposures were evaluated in the post-application worker
assessment. For the on-nursery seed treatment scenarios, individual dermal and inhalation MOEs
are all greater than the target of 100 without the use of PPE, and thus are not of concern. The
combined dermal and inhalation on-nursery seed treatment MOEs are also all above the target of
100 with PPE, single layer baseline attire and chemical-resistant gloves. Table 19 list the worker
risk estimates for the post-application on-nursery seed treatment.
36
-------
Table 19. Estimated Worker Exposure and Risk from On-Nursery Seed Treatment (Post-
application)
( l'M|l
Acres
llVilll'll
llil\
V|>|> Kiilc
ill) ;ii
IIMI llii'1
ViiiiiiiiiI
1 lillllllcll |lrl
»1; l \''
illi ni ilu\ i
*>lnirl iiml liilrrinciliiilr U-l'lll Ui-li l\-lilll;ili-
liiliiiliiliiin
MOI.
i 1 iir
-------
For TCMTB, dermal, inhalation, ocular and oral exposures were reported. Most of the
incidents reported were irritation type reactions. The primary routes of exposure for these
incidents were dermal and inhalation; though oral ingestion incidents were reported. The most
common symptoms reported for each exposure route are as follows:
• Dermal exposure: skin irritation/burning, rash, itching, skin
discoloration/redness and blistering.
• Inhalation exposure: respiratory irritation/burning, irritation to
mouth/throat/nose, coughing/chocking, shortness of breath and
sore throat.
• Ocular exposure: eye irritation/burning, eye pain and swelling of
eyes.
• Ingestion/oral exposure: irritation to mouth/throat/nose, abdominal
pain, kidney failure, hypothermia and loss of consciousness.
In addition, a cross-sectional study was conducted to observe the health effects associated
with the use of TCMTB in the British Columbia sawmill industry (Teschke, 1992). Workers in
five costal sawmills were asked to complete a self-administered questionnaire about symptoms
they experienced after fungicide exposure and about injuries commonly reported in sawmills.
The reported symptoms related to TCMTB consistently included dry skin around the eyes,
blood-stained mucus from the nose, nose bleed, peeling skin, burning or itching skin, and skin
redness or rash.
B. Environmental Risk Assessment
A summary of the Agency's environmental risk assessment is presented below. TCMTB
has several registered use sites that could result in environmental exposures. Indoor uses were
not assessed as the Agency does not anticipate exposure, given the current use patterns of
TCMTB. The following risk characterization is intended to describe the magnitude of the
estimated environmental risks for TCMTB use sites and any associated uncertainties.
For a detailed discussion of all aspects of the environmental risk assessment, refer to the
Environmental Risk Assessment (Section 10.1) in the "2-(Thiocyanomethylthio) benzothiazole
(TCMTB) Risk Assessment for the Reregistration Eligibility Decision (RED) Document," dated
August 1, 2006; the "2-(Thiocyanomethylthio) benzothiazole (TCMTB) Ecological Hazard and
Environmental Risk Assessment Chapter-Revised," dated August 1, 2006; and the
"Environmental Fate Assessment of 2-(Thiocyanomethylthio) benzothiazole (TCMTB) for the
Reregistration Eligibility Decision (RED) Document," dated March 30, 2006.
1. Environmental Fate and Transport
The environmental fate assessment for TCMTB was based on guideline data required by
the Agency for an environmental fate assessment. These studies were submitted by the technical
registrant. However, not all of these studies fulfill guideline requirements. For additional
38
-------
information, please refer to the "Environmental Fate Assessment of 2-(Thiocyanomethylthio)
benzothiazole (TCMTB) for the Reregistration Eligibility Decision (RED) Document," dated
March 30, 2006. Several metabolites are formed during the biotic degradation of TCMTB,
including 2-benzothiazolesulfonic acid (BTSA) and 2-mercaptobenzothiazole (2-MBT). BTSA
is not of toxicological concern because it has negligible toxicity and is completely excreted. 2-
MBT is generally less toxic than parent TCMTB; therefore, the environmental risk assessment
was conducted for TCMTB only. Please note that although the environmental assessment does
not include 2-MBT for the reasons stated above, 2-MBT was included in the drinking water
assessment as a conservative approach to conducting the assessment.
An assessment of the submitted guideline studies indicates the hydrolysis of TCMTB to
be pH dependent. TCMTB is hydrolytically stable under abiotic and buffered conditions at pH 5
and slowly degrades at pH 7. Under more alkaline conditions, hydrolysis proceeds more rapidly
with a calculated half-life ranging from 1.8 to 2.1 days. Photolytically, TCMTB degrades in pH
5 buffered aqueous solutions with a calculated half-life of 1.5 hours. Based on its degradation in
the environment, TCMTB is not likely to pose a concern for surface water run-off
Aquatic metabolism under aerobic and anaerobic conditions, as well as aerobic soil
metabolism, are major routes of dissipation for TCMTB. TCMTB's calculated degradation half-
life in flooded lake sediment is 6.9 days; however, the apparent half-life occurs between 2 and 4
days. Similarly, TCMTB shows a tendency of degrading anaerobically in flooded sediment
within 2.7 days. Under aerobic conditions in sandy loam soil, a representative agricultural soil,
TCMTB degrades with a calculated half-life of 1.4 days. Because of the biodegradation in water
and soils, TCMTB is not likely to contaminate surface and ground waters.
TCMTB's tendency to bind with agricultural soils varies according to soil type. TCMTB
is mobile-very mobile in various soils; however, because of its tendency to biodegrade in water
and soils, TCMTB is not likely to contaminate surface and ground waters. TCMTB is very
mobile in clay loam, sand, and sandy loam soil, and mobile in clay and silt loam soil. KdS are 3.5
for clay loam soil, 0.99 for sand soil, 9.9 for sandy loam soil, 22.1 for clay soil, and 62.7 for silt
loam soil. There may be a water/sediment partitioning issue and an acute adverse impact on
benthic organisms. However, TCMTB degrades fairly rapidly in freshwater and soils and the
impacts may be short-lived.
Additional information on the aqueous availability of TCMTB from treated wood,
indicates that the use of TCMTB as a wood preservative may result in minimal releases to the
environment. Nevertheless, the Agency conducted modeling to estimate TCMTB concentrations
in surface water from the antisapstain use. Based on conservative assumptions, the Agency
estimated runoff concentrations that range from 8.5 to 32.7 ppb.
39
-------
a. Bioaccumulation in Aquatic Organisms
Bioconcentration testing was conducted for TCMTB. Results from this study conducted
with fish indicate that the bioaccumulation potential of TCMTB is minimal and, therefore, not of
concern to the Agency.
2. Ecological Risk
The Agency's ecological risk assessment compares toxicity endpoints from ecological
toxicity studies to estimated environmental concentrations based on environmental fate
characteristics and pesticide use data. A summary of the submitted data is provided below.
a. Environmental Toxicity
Available data indicate that TCMTB is slightly toxicity to birds on an acute oral basis and
subacute dietary basis. Because birds are not expected to come into contact with TCMTB on a
chronic basis, avian reproduction studies were not required for TCMTB.
Based on the results of mammalian studies conducted to meet human toxicity data
requirements, TCMTB exhibits low acute oral and dermal toxicity (toxicity category III);
however, it is highly irritating to the eyes and skin (toxicity category I and II, respectively).
TCMTB is also considered to be highly toxic via the inhalation route of exposure (toxicity
category I). TCMTB is a dermal sensitizer.
On an acute basis, TCMTB is very highly toxic to freshwater fish, freshwater
invertebrates, estuarine/marine fish, and estuarine/marine invertebrates. TCMTB is generally
more toxic then its' degradate, 2-MBT, and therefore, only TCMTB was evaluated in the risk
assessment. Published literature reports (MRID# 424053-01) indicate that TCMTB may cause
sublethal effects in fish, which could result in an increase in predation and a decreased ability to
survive. These studies demonstrate that exposure to TCMTB at levels of 8-10 ppb cause gill
damage and behavioral changes, which can severely reduce the ability of fish to survive in the
wild (Chew., Proceedings of the Seventeenth Annual Aquatic Toxicity Workshop Vol. 1). The
toxicity values used in the TCMTB ecological risk assessment (8.7 Mg/L) are comparable to the
levels described in the published literature where sublethal effects occur. Therefore, the TCMTB
risk assessment is protective of these sublethal effects.
A summary of submitted acute ecological toxicity data for TCMTB and 2-MBT along
with, avian sub-acute dietary toxicity data, chronic freshwater fish toxicity data and aquatic plant
toxicity data for TCMTB are provided in Tables 20, 21, 22 and 23, respectively.
40
-------
Table 20. Acute Ecological Toxicity for TCMTB and 2-MBT
Speck's
(lu'inical
;icli\c
iniimlicnl
(
2150
mg/kg
NOEL
< 1000
mg/kg
Practically
non-toxic
Some evidence
of dose-related
abnormalities
upon gross
necropsy
(friable livers,
resorbed eggs,
fluid-filled sacs
in abdomen)
MRID:
42267101
(Pedersen end
Helsten 1992a)/
Acceptable
Mammals
Laboratory rat
(Rattus norvegicus)
TCMTB
80% ai
LD50=750
mg/kg
Moderately
toxic
41583801/
Acceptable
I rcshwakT l isli
Rainbow trout
Oncorhynchusmykiss)
TCMTB
90%
96hr static
LC50 =
55.2 ug/L
(ppb)
Very
highly
toxic
None reported
TN 2437
(USEPA 1980)/
Supplemental
TCMTB
80.4%
96hr flow
through
LC50 =
20.91 ug/L
(ppb)
Very
highly
toxic
NOEC = 8.7
Ug/L (ppb) due
to mortality and
lethargy and
loss of
equilibrium in
surviving fish at
higher levels
41818101
(Machado
1991b)/
Acceptable
TCMTB
75%
96hr static
LC50 =
29 ug/L
(ppb)
Very
highly
toxic
Loss of
equilibrium and
lying on sides
observed
ACC+0916 24
(Knott and
Woodard 1968b)/
Supplemental
Bluegill sunfish
(Lepomis
macrochirus)
TCMTB
90%
96hr static
LC50 =
32 ug/L
(ppb)
Very
highly
toxic
None reported
TN 2432
(USEPA 1979)/
Supplemental
TCMTB
80.4%
96hr flow
through
LC50 =
8.7 ug/L
Very
highly
toxic
NOEC =
5.1 ug/L (ppb)
due to signs of
toxicity at
41804201
(Machado
1991a)/
Acceptable
41
-------
Speck's
Chemical
acli\c
iniimlicnl
(ai)
I'liulpninl
Toxicity
Calefion
(ic;All
Oilier I'.ITccls
Nolccl
Rcl'crcncc/Sialiis
(ppb)
higher levels
TCMTB
75%
96hr static
LC50 =
47 ug/L
(ppb)
Very
highly
toxic
Loss of
equilibrium and
lying on sides
observed
ACC#091624
(Knott and
Woodard 1968b)/
Supplemental
Rainbow trout
Oncorhynchus
mykiss)
2-MBT
98.2%
96 hr
static
LC50 =
730 ug/L
(ppb)
Very
highly
toxic
NOEC = 310
Ug/L (ppb) due
to mortality at
higher treatment
levels
42232201
(Collins 1992)/
Acceptable
Freshwater Invertebrates
Waterflea
(Daphnia magna)
TCMTB
90%.
48-hr. static
EC50 = 23
ug/L (ppb)
Very
highly
toxic
TN 2427
(USEPA 1979)/
Supplemental
TCMTB
80.4%
48-hr. flow
through
EC50 = 22
ug/L (ppb);
NOEC =
8.7 ug/L
(ppb)
Very
highly
toxic
41838201
(McNamara
1991)/
Acceptable
2-MBT
100%
48-hr. static
ec50 =
2,900 ug/L
(ppb)
Moderately
toxic
42226001
(Collins 1992b)/
Acceptable
Estuarine/Marinc Fish
Sheepshead
minnow
(Cyprinodon
variegates)
TCMTB
80%
96 hr. static
LC50 = 60
ug/L (ppb)
Very
highly
toxic
40363601
(Suprenant
1986a)/
Acceptable
I'.sliiarinc/Marinc ln\crlcl>ralcs
Quahog clam
(Mercenaria
mercenaria)
TCMTB
80%
48-hr. static
EC50= 13.9
ug/L (ppb);
NOEC < 13
ug/L (ppb)
Very
highly
toxic
40363603
(Suprenant 1986)
/
Acceptable
Mysid
(Americamysis
bahia, formerly
Mysidopsis bahia)
TCMTB
80%
96-hour
static
LC50=
20.3 ug/L
(PPb);
NOEC <
7.8 ug/L
(PPb)
Very
highly
toxic
40363602
(Suprenant 1987)
/
Acceptable
42
-------
Table 21. Avian Sub-acute Dietary
oxicity of TCMTB and 2-MBT
Tesl Tj pe
(Chcmiciil
iind "" 10000
ppm
"practically
non-toxic"
Feed
consumption and
10% mortality at
5,000 and 10,000
ppm
Accession #009869
(Booden, 1974)/
Acceptable
TCMTB
(75 % a.i.)
Bobwhite
quail (Colinus
virginianus)
Mortality
LC50 >
10000 ppm
"Practically
non-toxic"
Huddling and
depression at
levels > 1000
ppm
Accession #091624
(Knott and Woodard,
1968a)/Supplemental
TCMTB
(80% a.i.)
Mallard duck
(Anas
platyrhynchos)
Mortality
8-day LC50
>4496 ppm
"Slightly
toxic"
NOEC < 450
ppm based on
reduction in body
weight gain and
food
consumption
415956-01 (Longet
al., 1990/Acceptable
TCMTB
(80% a.i.)
Bobwhite
quail (Colinus
virginianus)
Mortality
8-day LC50
>4496 ppm
"Slightly
toxic"
NOEC = 450
ppm, based on
reduction of
average body
weight gain at
higher levels
415956-02 (Longet
al., 1990/Acceptable
2-MBT
(98.22%
a.i.)
Bobwhite
quail (Colinus
virginianus
Mortality
8-day LC50
>3387 ppm
"Slightly
toxic"
NOEC = 3387
ppm - no signs
of toxicity at any
level
424285-0 l(Pedersen
and Helsten,
1992b)/Acceptable
Table 22. Freshwater Fish Chronic Toxicity of TCMTB
Siuclj Tjpc
Species
l.ndpoinl
Nor.c
}» ii.i./l
i.or.c
Si ii.i./l
MRU)#
(reference )/S|;i(iis
Freshwater fish
Early life-stage
toxicity (72-
4a/850.1300)
(83.78% a.i.)
Rainbow trout
(Oncorhynchus
mykiss)
Reproduction,
post-hatch
survival,
growth
0.34 ppb based
on growth and
egg
hatchability
0.56 ppb based on
growth
425959-01
(Rhodes,
1992)/Acceptable
43
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Table 23. TCMTB Aquatic Plant Toxicity
Tcsl
Species/"'" ;i.i.
Knripninl
Toxicity
\ ()!¦:< Vol her
elTcels noted
MRU)
(reference)
Sliilns
Aquatic
Vascular Plant
Acute Toxicity,
Tier II (dose-
response), 123-
2/850.4400
Duckweed
(Lemna
gibba)/83.5%
a.i.
Frond growth
14-day static
renewal EC50
= 0.43 (0.29 -
0.65) mg/L
(ppm)
0.15 mg/L
(ppm)
442009-01
(Thompson
and
Swigert,
1996)
Acceptable
b. Ecological Exposure and Risk
The Agency has evaluated the outdoor uses of TCMTB being considered for
reregistration. Environmental exposure modeling was conducted for both the agricultural and
antimicrobial uses of TCMTB.
Terrestrial Organisms
Modeling was performed to address the exposure and risk to birds and mammals
consuming seeds treated with TCMTB using the Terrestrial Residue Exposure Model (TREX)
(http://www.epa.gov/oppefedl/models/terrestrian for the treatment on safflower, which has the
highest application rate of 0.041 lb ai/A. The Agency determined that acute risk to birds and
mammals from consuming TCMTB-treated seeds are below the Agency's level of concern
(LOC). The following Risk Quotients (RQs) for acute and chronic avian exposure to TCMTB
treated seeds were calculated:
Avian Acute: 0.02 as (mg ai/kg/day)/LD50
Avian Chronic: Not required
The avian RQ was calculated with no toxicity scaling factor. Scaling factors are used when it is
likely that a pesticide will be proportionally more toxic to smaller organisms than larger ones.
TREX recommended a default scaling factor of 1.15, based on Mineaue et al. (1996). This
scaling factor was developed based on 37 conventional pesticides, most of which are
cholinesterase inhibitors. There is no information available indicating that such an adjustment is
necessary or appropriate for TCMTB. The following Risk Quotients (RQs) for acute and chronic
mammalian exposure to TCMTB treated seeds were calculated:
Mammalian Acute: 0.05 as (mg ai/kg/day)/LD50,
0.02 as (mg ai/ft2)/(LD50*BW)
Mammalian Chronic: 0.53 as (mg/kg seed)/reproduction NOAEC
All of the agricultural use RQs are below any LOCs for avian and mammalian acute risk and
mammalian chronic risk. Avian chronic data are not available or required for the currently
registered uses of TCMTB, therefore chronic avian risk was not assessed.
Terrestrial risks from the wood preservative uses of TCMTB were not addressed due to a
lack of available models to estimate terrestrial exposure from antisapstain treatments. The
44
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Agency conducted environmental exposure modeling for the antisapstain wood preservation use.
Runoff concentrations of TCMTB were estimated for facilities that treat wood with antisapstain
chemicals. The concentrations were estimated using an approach developed to determine runoff
concentrations of pesticides from antisapstain facilities in British Columbia, Canada (Krahn and
Strub, 1990).
Predictions of leaching behavior (as would be observed in a study following the Krahn
and Strub (1990) protocol) were made based on the chemical properties of TCMTB and a
number of assumptions.
Krahn and Strub (1990) assume that leachate entering the storm drain is diluted with
extra runoff water at a 1:15 ratio. This is based on measurements of runoff in storm drains at
facilities using antisapstain chemicals in British Columbia. Use of the ratios 1:6 and 1:23 were
also suggested by Krahn and Strub (1990) to determine a "general industry wide" predicted
runoff concentration. These values were used in this assessment. The estimated leachate
concentration (0.196 ppm) was used in conjunction with these dilution factors to estimate runoff
concentrations.
Table 24. Estimated Runoff Concentrations for TCMTB from Antisapstain Use
Piii'iiiiKMcr
Dilution l-'iiclor
l'.sliin;ilc(l KiiiioIT ( oniTiili'iilion
(ppm)'"
High-end dilution
23.0
0.00852
Typical dilution
15.0
0.0131
Low-end dilution
6.00
0.0327
Estimated Runoff Concentration = Estimated Leachate Concentration (0.196 ppm) / Dilution Factor.
Aquatic Organisms
To develop risk quotients (RQs), the estimated environmental concentrations (EECs)
determined by modeling were compared to the most sensitive endpoint for each taxa. For seed
treatment, no levels of concern (LOCs) were exceeded. The seed treatment use of TCMTB poses
minimal risk to aquatic organisms and, therefore, is below the Agency's level of concern.
The Agency has also conducted environmental exposure modeling for the antisapstain
wood preservative use. Based on the Tier I screening model used for the antisapstain use, there
are risks of concern to aquatic organisms. Acute LOCs were exceeded for all taxa except aquatic
plants. Chronic LOCs for fish were also exceeded. However, chronic risk to invertebrates could
not be addressed due to lack of chronic invertebrate toxicity data. Additional information
regarding the TCMTB ecological assessment can be found in the "2-(Thiocyanomethylthio)
benzothiazole (TCMTB) Risk Assessment for the Reregistration Eligibility Decision (RED)
Document," dated August 1, 2006; and the "2-(Thiocyanomethylthio) benzothiazole (TCMTB)
Ecological Hazard and Environmental Risk Assessment Chapter-Revised," dated August 1,
2006.
Please refer to Table 25 for a comprehensive list of the identified aquatic organism risk
quotients for the seed treatment and antimicrobial uses of TCMTB.
45
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Table 25. Aquatic Organism Risk Quotients for Seed Treatment and Antisapstain Uses of
TCMTB
i ii\ii/r.ii(i|)(iini
Seed IIVillllKMII
i:i.(
Seed 1 iviilmonl
HQ
Anlisiipsliiin
r.i:<
Low dilution
lliiili (liliilion
A ill isiipsliiin UQ
Freshwater fish Acute 8.7
0.28 ppb
0.03
32.7 ppb
3.76
Hg/L
8.5 ppb
0.98
Freshwater Invertebrates
0.28 ppb
0.01
32.7 ppb
1.49
Acute 22 |ig/L
8.5 ppb
0.39
Marine/Estuarine Fish Acute
0.28 ppb
0.00
32.7 ppb
0.54
60ng/L
8.5 ppb
0.14
Marine/Estuarine Bivalve
0.28 ppb
0.02
32.7 ppb
2.35
Acute 13.9|ig/L
8.5 ppb
0.61
Marine/Estuarine Invertebrate
0.28 ppb
0.01
32.7 ppb
1.61
Acute 20.3 |ig/L
8.5 ppb
0.42
Green Algae Acute EC50 430
0.28 ppb
0.00
32.7 ppb
0.08
Hg/L
8.5 ppb
0.02
Green Algae NOEC 150|ig/L
0.28 ppb
0.00
32.7 ppb
8.5 ppb
0.22
0.06
Fish Chronic 0.34|ig/L
0.12 ppb
0.35
13.1 ppb
8.5 ppb
38.53
25.00
Invertebrate Chronic - DATA
0.20 ppb
13.1 ppb
GAP
Plants
A single aquatic plant study was submitted for TCMTB, the results of which are
summarized in Table 23. Results indicate that TCMTB exposure impairs growth of aquatic
vascular plants at levels greater than 0.15 ppm (150 ppb). Further data are required to support the
antimicrobial and agricultural uses of TCMTB.
Non-target Insects (Honeybee)
Honeybees could potentially be exposed to pesticide residues if treated wood is used to
construct hives or hive components. These residues may be toxic to the bees or result in residues
in honey or other hive products intended for human use/consumption. Therefore, a special
honeybee study is required for all wood preservative uses unless a statement prohibiting the use
of treated wood in hive construction is added to the label such as, "Wood treated with TCMTB
shall not be used in the construction of beehives." This study is a combination of Guidelines
171-4 and 850.3030 (see information regarding residue data requirements for uses in beehives in
the residue chemistry section of 40 CFR part 158). Numbers of bees used in this study and
methods for collection/introduction of bees into hives, feeding, and observations for toxicity and
mortality should be consistent with those described in OPPTS Guideline 850.3030, "Honey Bee
Toxicity of Residues on Foliage." The toxicity portion of this study is in lieu of the honeybee
contact LD50 test.
46
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c. Risk to Listed Species
Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2), requires all
federal agencies to consult with the National Marine Fisheries Service (NMFS) for marine and
anadromous listed species, or the United States Fish and Wildlife Services (FWS) for listed
wildlife and freshwater organisms, if they are proposing an "action" that may affect listed species
or their designated habitat. Each federal agency is required under the Act to insure that any
action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a
listed species or result in the destruction or adverse modification of designated critical habitat.
To jeopardize the continued existence of a listed species means "to engage in an action that
reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both
the survival and recovery of a listed species in the wild by reducing the reproduction, numbers,
or distribution of the species" (50 C.F.R. § 402.02).
To facilitate compliance with the requirements of the Endangered Species Act subsection
(a)(2) the Environmental Protection Agency, Office of Pesticide Programs has established
procedures to evaluate whether a proposed registration action may directly or indirectly reduce
appreciably the likelihood of both the survival and recovery of a listed species in the wild by
reducing the reproduction, numbers, or distribution of any listed species (U.S. EPA 2004). After
the Agency's screening-level risk assessment is performed, if any of the Agency's Listed Species
LOC Criteria are exceeded for either direct or indirect effects, a determination is made to identify
if any listed or candidate species may co-occur in the area of the proposed pesticide use. If
determined that listed or candidate species may be present in the proposed use areas, further
biological assessment is undertaken. The extent to which listed species may be at risk then
determines the need for the development of a more comprehensive consultation package as
required by the Endangered Species Act.
For certain use categories, the Agency assumes there will be minimal environmental
exposure, and only a minimal toxicity data set is required (Overview of the Ecological Risk
Assessment Process in the Office of Pesticide Programs U.S. Environmental Protection Agency -
Endangered and Threatened Species Effects Determinations, 1/23/04, Appendix A, Section IIB,
pg.81). Chemicals in these categories therefore do not undergo a full screening-level risk
assessment, and are considered to fall under a no effect determination. The active ingredient
uses of TCMTB, with the exception of the seed treatment and antisapstain wood preservation
uses, fall into this category. Using Tier I screening modeling to assess potential exposure from
seed treatment risks to Listed Species were not identified. Using Tier I screening modeling to
assess potential exposure from antisapstain wood preservation uses of TCMTB, risks to Listed
Species are indicated. Since the model is only intended as a screening-level model, and, as such,
has inherent uncertainties and limitations which may result in inaccurate exposure estimations,
further refinement of the model is recommended before any regulatory action is taken regarding
the antisapstain uses of TCMTB. Additionally, impacts from the antisapstain use could
potentially be mitigated with precautions to prevent leaching and runoff when wood is stored
outdoors (see General Risk Mitigation, below). Due to these circumstances, the Agency defers
making a determination for the antisapstain uses of TCMTB until additional data and modeling
47
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refinements are available. At that time, the environmental exposure assessment of the
antisapstain use of TCMTB will be revised, and the risks to Listed Species will be reconsidered.
48
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IV. Risk Management, Reregistration, and Tolerance Reassessment Decision
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether or not 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 TCMTB as an active ingredient. The Agency has completed its review of
these generic data and has determined that the data are sufficient to support reregistration of all
supported products containing TCMTB.
The Agency has completed its assessment of the dietary, occupational, drinking water,
and ecological risks associated with the use of pesticide products containing the active ingredient
TCMTB. Based on a review of these data and on public comments on the Agency's assessments
for the active ingredient TCMTB, the Agency has sufficient information on the human health
and ecological effects of TCMTB to make decisions as part of the tolerance reassessment process
under FFDCA and reregistration process under FIFRA, as amended by FQPA. The Agency has
determined that TCMTB-containing products are eligible for reregistration provided that: (i)
current data gaps and confirmatory data needs are addressed; (ii) the risk mitigation measure
outlined in this document is adopted; and (iii) label amendments are made to reflect this measure.
Label changes are described in Section V. Appendix A summarizes the uses of TCMTB that are
eligible for reregistration. Appendix B identifies the generic data requirements that the Agency
reviewed as part of its determination of reregistration eligibility of TCMTB and lists the
submitted studies that the Agency found acceptable. Data gaps are identified as generic data
requirements that have not been satisfied with acceptable data.
Based on its evaluation of TCMTB, the Agency has determined that TCMTB products,
unless labeled and used as specified in this document, would present risks inconsistent with
FIFRA. Accordingly, should a registrant fail to implement the risk mitigation measure identified
in this document, the Agency may take regulatory action to address the risk concerns from the
use of TCMTB. If all changes outlined in this document are incorporated into the product labels,
then all current risks for TCMTB will be substantially mitigated for the purposes of this
determination. Once an Endangered Species assessment is completed, further changes to these
registrations may be necessary as explained in Section III of this document.
B. Public Comments and Responses
Through the Agency's public participation process, the EPA worked with stakeholders
and the public to reach the regulatory decision for TCMTB. EPA released its preliminary risk
assessment for TCMTB for public comment on April 26, 2006. The Agency received no
comments during the 60-day public comment period on the TCMTB risk assessment and
supporting science documents, which closed on June 26, 2006.
49
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C. Regulatory Position
1. Food Quality Protection Act Findings
a. "Risk Cup" Determination
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated
with TCMTB use. The Agency has determined that, if the mitigation described in this document
is adopted and labels are amended, human health risks as a result of exposures to TCMTB are
within acceptable levels. In other words, EPA has concluded that the tolerances for TCMTB
meet FQPA safety standards. In reaching this determination, EPA has considered the available
information on the special sensitivity of infants and children, as well as exposures to TCMTB
from all possible sources.
b. Determination of Safety to U.S. Population
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated
with TCMTB. The Agency has determined that the tolerances for TCMTB, with amendments
and changes specified in this document, meet the safety standards under the FQPA amendments
to section 408(b)(2)(D) of the FFDCA, and that there is a reasonable certainty no harm will
result to the general population or any subgroup from the use of TCMTB. In reaching this
conclusion, the Agency has considered all available information on the toxicity, use practices
and exposure scenarios, and the environmental behavior of TCMTB.
Dietary risk assessments were conducted for adults and children, with the highest risks
(children at 2% aPAD for seed treatment use and children at 0.66% aPAD for antimicrobial use;
children at 17% of cPAD for seed treatment use and children at 12.8% cPAD) being below the
Agency's level of concern.
The Agency conducted acute and chronic aggregate assessments that considered food and
drinking water exposures from the registered agricultural and antimicrobial uses of TCMTB. The
residential uses of TCMTB were not included in the aggregate assessment because all of the
residential uses evaluated have risks of concern (MOEs <100). Thus, the short- and
intermediate-term aggregate assessment that included the residential uses would also show risks
of concern.
The subpopulation with the greatest risk for both the acute and chronic aggregate risk
assessments was children (2.5% of aPAD for children and 40% of cPAD for children). These
risk estimates are below the Agency's level of concern.
c. Determination of Safety to Infants and Children
EPA has determined that the currently registered uses of TCMTB, with changes as
specified in this document, meet the safety standards under the FQPA amendments to section
408(b)(2)(C) of the FFDCA, that there is a reasonable certainty of no harm for infants and
children. The safety determination for infants and children considers factors of the toxicity, use
50
-------
practices, and environmental behavior noted above for the general population, but also takes into
account the possibility of increased susceptibility to the toxic effects of TCMTB residues in this
population subgroup.
No Special FQPA Safety Factor is necessary to protect the safety of infants and children.
In determining whether or not infants and children are particularly susceptible to toxic effects
from TCMTB residues, the Agency considered the completeness of the database for
developmental and reproductive effects, the nature of the effects observed, and other
information. The FQPA Safety Factor has been removed (i.e., reduced to IX) for TCMTB based
on: (1) the toxicology database is complete with respect to assessing the increased susceptibility
to infants and children as required by FQPA; (2) there is no concern for developmental
neurotoxicity resulting from exposure to TCMTB in the rat and rabbit prenatal developmental
studies and the 2-generation reproduction study; (3) there is no evidence of increased
susceptibility to the fetus following in utero exposure in the prenatal developmental toxicity
studies or to the offspring when adults are exposed in the two-generation reproductive study; and
(4) the risk assessment does not underestimate the potential exposure for infants and children.
d. Endocrine Disruptor Effects
EPA is required under the FFDCA, as amended by FQPA, to develop a screening
program to determine whether certain substances (including all pesticide active and other
ingredients) "may have an effect in humans that is similar to an effect produced by a naturally
occurring estrogen, or other endocrine effects as the Administrator may designate." Following
recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee
(EDSTAC), EPA determined that there was a scientific basis for including, as part of the
program, the androgen and thyroid hormone systems, in addition to the estrogen hormone
system. EPA also adopted EDSTAC's recommendation that EPA include evaluations of
potential effects in wildlife. For pesticides, EPA will use FIFRA and, to the extent that effects in
wildlife may help determine whether a substance may have an effect in humans, FFDCA
authority to require the wildlife evaluations. As the science develops and resources allow,
screening of additional hormone systems may be added to the Endocrine Disruptor Screening
Program (EDSP).
In the chronic rat toxicity/carcinogenicity study, TCMTB was associated with thyroid C-
cell adenomas. Although these results were not seen as statistically significant, they may
indicate an association with endocrine disruption. When the appropriate screening and/or testing
protocols being considered under the EDSP have been developed, TCMTB may be subject to
additional screening and/or testing to better characterize effects related to endocrine disruption.
e. Cumulative Risks
Risks summarized in this document are those that result only from the use of TCMTB.
The Food Quality Protection Act (FQPA) requires that the Agency consider "available
information" concerning the cumulative effects of a particular pesticide's residues and "other
substances that have a common mechanism of toxicity." The reason for consideration of other
substances is due to the possibility that low-level exposures to multiple chemical substances that
cause a common toxic effect by a common toxic mechanism could lead to the same adverse
health effect as would a higher level of exposure to any of the substances individually. Unlike
51
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other pesticides for which EPA has followed a cumulative risk approach based on a common
mechanism of toxicity, EPA has not made a common mechanism of toxicity finding for TCMTB.
For information regarding EPA's efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy
statements released by EPA's Office of Pesticide Programs concerning common mechanism
determinations and procedures for cumulating effects from substances found to have a common
mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.
2. Tolerance Summary
Tolerances for residues in/on plant livestock commodities have been established under 40
CFR §180.288. The permanent tolerances for residues in/on plant commodities are established at
the limit of quantitation (LOQ) of 0.1 ppm (N) and are expressed in term of residues of TCMTB
per se [(2-benzothiazolylthio)methyl thiocyanate].
Confirmatory metabolism data conducted with wheat, cotton, and sugar beet are
necessary to determine the nature of residues in plants. Depending on the results from the
confirmatory metabolism studies, additional guideline requirements may be requested for:
livestock metabolism; storage stability; and magnitude of the residue studies on livestock,
processed crop commodities, and magnitude of residue studies for rotational crops. A summary
of the TCMTB tolerance reassessment is presented below in Table 26.
a. Currently Established Tolerances Under 40 CFR 180.288 &
Tolerance Reassessment of TCMTB
Tolerances for barley hay and cotton gin byproducts must be proposed. The "N"
designation, denoting "negligible" residues, must be deleted from 40 CFR §180.288. Use of
TCMTB on sorghum and corn are no longer supported and, therefore, must be revoked under 40
CFR §180.288.
52
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Table 26. Established Tolerances and Tolerance Reassessment Summary Table for
TCMTB
Ciirrenl
Tolerance
Tolerance
Reassessment
( ommcnl/|Correct Commodity
IKTinilionl
Tolerances l-lslahlishcd I ndcr 40 ( I'K §180.288:
Barley, grain
0.1 (N1)
TBD2
Barley, straw
0.1 (N)
TBD
Beet, sugar, roots
0.1 (N)
TBD
Beet, sugar, tops
0.1 (N)
TBD
Corn, grain
0.1 (N)
Revoke
The registrants do not intend to support
use of TCMTB on corn.
Corn, forage
0.1 (N)
Revoke
The registrants do not intend to support
use of TCMTB on corn.
Corn, stover
0.1 (N)
Revoke
The registrants do not intend to support
use of TCMTB on corn.
Cotton, forage
0.1 (N)
Revoke
No longer considered a significant
livestock feed item.
Cotton, undelinted seed
0.1 (N)
TBD
Oat, forage
0.1 (N)
TBD
Oat, grain
0.1 (N)
TBD
Oat, hay
0.1 (N)
TBD
Oat, straw
0.1 (N)
TBD
Rice, grain
0.1 (N)
TBD
Rice, straw
0.1(N)
TBD
Safflower, seed
0.1 (N)
TBD
Sorghum, grain, forage
0.1 (N)
Revoke
The registrants do not intend to support
use of TCMTB on sorghum.
Sorghum, grain, grain
0.1 (N)
Revoke
The registrants do not intend to support
use of TCMTB on sorghum.
Sorghum, grain, stover
0.1 (N)
Revoke
The registrants do not intend to support
use of TCMTB on sorghum.
Wheat, forage
0.1 (N)
TBD
Wheat, grain
0.1 (N)
TBD
Wheat, hay
0.1 (N)
TBD
Wheat, straw
0.1 (N)
TBD
Tolerances To Be Proposed Under 40 CFR §180.288:
Barley, hay
None established
TBD
Cotton, gin byproducts
None established
TBD
1. N = Negligible. The "N" designation must be removed from all tolerances.
2. TBD = To be determined. Tolerances cannot be determined at this time because additional data are required.
b. Codex of Harmonization
There are no codex maximum residue limits (MRLs) for TCMTB; therefore, no questions
of compatibility with U.S. tolerances exist.
D. Regulatory Rationale
The Agency has determined that TCMTB is eligible for reregistration provided that
additional required data confirm this decision, the risk mitigation measures outlined in this
document are adopted, and label amendments are made to reflect these measures.
53
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The following is a summary of the rationale for managing risks associated with the uses
of TCMTB. Where labeling revisions are warranted, specific language is set forth in the
summary tables of Section V of this document.
1. Human Health Risk Management
a. Dietary (Food) Risk Mitigation
The acute and chronic dietary risks from TCMTB residues on food, estimated using
conservative measures are below the Agency's level of concern for the seed treatment and
antimicrobial uses. Therefore, no mitigation measures are necessary at this time. Additional
confirmatory metabolism data are required to verify that 2-MBT and other TCMTB metabolites
are not residues of concern in plant commodities.
b. Drinking Water Risk Mitigation
The Agency estimated drinking water exposure for the seed treatment use of TCMTB
only, as no antimicrobial uses are expected to impact surface or groundwater resources. The
drinking water concentrations did not result in risk of concern. Therefore, no mitigation
measures are necessary at this time.
c. Residential Risk Mitigation
i. Handler Risk Mitigation
Residential handler risks were assessed for the application of TCMTB-preserved paint
via airless sprayer and paint brush/roller (antimicrobial uses) to determine dermal and inhalation
exposure. Short-term dermal risks of concern were identified for paint applicators using both
airless sprayer and paint brush/roller scenarios (ST Dermal MOE of 10 for airless sprayer
applications and ST Dermal MOE of 25 for paintbrush applications). The inhalation MOEs were
above the target MOE of 300; however, the total dermal and inhalation MOEs for both
application scenarios were under the target MOE of 100 and, thus, are risks of concern.
Because of remaining residential exposure concerns, the registrants for TCMTB have
agreed to conduct a dermal exposure study for paint applicators that would allow the Agency to
assess the risks associated with these uses. However, this study will not be completed in time for
inclusion in this RED. Until acceptable exposure data are submitted, the Agency has determined
that the residential use of TCMTB as a materials preservative in paints is ineligible for
reregistration and this use must be deleted. The registrant has agreed that once the data has been
determined to be acceptable, and if it is established that the risks are not of concern, the
registrants can request that this use be reinstated.
ii. Post-Application Risk Mitigation
For the residential post-application assessment, high-end residential exposures were
assessed for treated carpets (dermal and incidental oral exposure to children) and treated
54
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clothing/leather products (dermal exposure to adults/children and incidental oral exposure to
children). The short- and intermediate- term MOEs for dermal contact with treated
clothing/leather products were of concern for both young children and adults (MOEs < 1
assuming 100% transfer factor; MOEs <10 assuming 5% transfer factor). In addition, the short-
term MOEs for dermal and incidental oral contact with treated carpet were less then the target of
100 for children (ST dermal MOE of 2, ST oral MOE of 4).
To address these risks all TCMTB textile preservative uses, with the exception of the
leather preservative use, must be deleted. In addition, the registrant has agreed to conduct a study
on TCMTB-treated leather products to determine how much TCMTB would transfer onto skin
through normal wear. This study, which is confirmatory data, is expected to further refine the
risk assessment for the leather preservative use.
As a result of the cancellation of the textile use, the Agency has determined that all
dermal and oral risks of concern pertaining to children will be eliminated. The rationale for this
decision is that children are not likely to come into oral contact through mouthing of treated
leather products. In addition, children are not likely to wear TCMTB-treated leather products.
Therefore, there are no remaining risks of concern for residential exposure of TCMTB-treated
leather products to children.
Preliminary data was submitted by the technical registrant, Buckman Laboratories, to the
Agency regarding leaching of TCMTB from treated leather. This data estimated the amount of
TCMTB that would transfer to the skin during normal wear of leather products. A preliminary
review of this data was used to characterize risks associated with wearing treated leather and
suggests that dermal risks from wearing these products well exceeds the target MOE of 100 for
adults and, thus, is not of concern. Confirmatory leather leaching data is required to support these
findings.
d. Occupational Risk Mitigation
i. Handler Risk Mitigation
Seed Treatment Use
For commercial seed treatment, all dermal and inhalation MOEs met or exceeded the
required uncertainty factor of 100 with baseline levels of PPE. Therefore, no mitigation is
required.
Antimicrobial Use
Dermal risks of concern were identified for six individual use scenarios (paint
preservation liquid pour, paint preservation liquid pump, textile preservation liquid pour, textile
preservation liquid pump, cutting fluid preservation liquid pour, pulp and paper liquid pump) at
the baseline level of evaluation (no PPE gloves). To mitigate the risks for occupational handlers
of material preservation for adhesives, pulp and paper and metalworking, these workers must
wear chemical resistant gloves while handling TCMTB products. The use of chemical resistant
55
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gloves eliminates the dermal risks of concern (MOEs are well above 100 with the addition of
gloves). Paint and textile uses, with the exception of leather, must be deleted based on residential
risk concerns.
Short-term and intermediate-term dermal risks of concern were identified for
occupational paint applicators with the use of an airless sprayer and paintbrush/roller. These
risks remained a concern, even with addition of PPE (gloves). Because of remaining risk
concerns associated with this use, the technical registrant for TCMTB has agreed to conduct a
study that would allow the Agency to assess the risks associated with these uses. However, this
study will not be completed in time for inclusion in this RED. Until acceptable exposure data are
submitted, the Agency has determined that the occupational use of TCMTB in commercial and
institutional premises for paint application is ineligible for reregistration and paint uses must be
deleted. Once the data has been determined to be acceptable, and if it is established that the risks
are not of concern, the registrants can request that this use be reinstated.
Dermal risks of concern were identified for occupational handlers of textiles and carpets
being treated with TCMTB. To mitigate these risks all textile uses of TCMTB must be deleted,
with the exception of leather. To mitigate the dermal risks for handlers during the manufacturing
of leather products, pulp and paper products, and handling of metal cutting fluid, workers must
wear gloves. The estimates for these risks are well over the target of 100 and are not of concern
with the use of gloves.
The short-, intermediate- and long-term risks for occupational handlers who apply
TCMTB to wood for non-pressure treatment were assessed. All of these risks were above the
target MOEs of 100 (short- and intermediate-term) and 300 (long-term), and are not of concern.
ii. Post-Application Risk Mitigation
For the occupational post-application risk assessment of the seed treatment and
antimicrobial uses of TCMTB, there are no risks of concern. Therefore, mitigation measures are
not necessary at this time.
2. Environmental Risk Management
Seed Treatment Use
The Agency considers the seed treatment use of TCMTB assessed in this RED to be
unlikely to result in any appreciable exposure to terrestrial or aquatic organisms. Therefore no
environmental risk mitigation is required for the agricultural use of TCMTB at this time.
Antimicrobial Use
For the antisapstain use of TCMTB, the Agency used a Tier I screening model to estimate
exposures that could result from this use. The worst case ecological concern for the TCMTB
antisapstain use is for chronic risk to fish with RQs ranging from 25 - 39.
The estimated environmental concentrations (EECs) exceed chronic levels of concern (LOCs). It
should be noted that this model has inherent assumptions and uncertainties that may result in
over or under estimation of exposure levels. Additional information, including, specific leaching
56
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data from TCMTB used as an antisapstain wood preservative would result in more accurate risk
estimations. Therefore, the Agency is requesting an aerobic soil metabolism, anaerobic soil
metabolism, and aerobic aquatic metabolism studies. Such data may remove uncertainties and
may result in more accurate exposure estimations
In addition, the following language must be placed on all antisapstain products to
decrease leaching risks:
"Treated lumber must be stored under cover, indoors, or at least 100 feet from
any pond, lake, stream, wetland, or river to prevent possible runoff of the
product into the waterway. Treated lumber stored within 100 feet of a pond,
lake, steam, or river must be either covered with plastic or surrounded by a
berm to prevent surface water runoff into the nearby waterway. If a berm or
curb is used around the site, it should consist of impermeable material (clay,
asphalt, concrete) and be of sufficient height to prevent runoff during heavy
rainfall events."
Registrants are responsible for amending all TCMTB wood preservative product labels to
incorporate the required label language, which will help mitigate ecological risks of concern.
To address exposure to non-target insects, a special honeybee study is required for all
wood preservative uses unless a statement prohibiting the use of treated wood in hive
construction is added to the label such as, "Wood treated with TCMTB shall not be used in the
construction of beehives." This study is a combination of Guidelines 171-4 and 850.3030 (see
information regarding residue data requirements for uses in beehives in the residue chemistry
section of 40 CFR part 158). Numbers of bees used in this study and methods for
collection/introduction of bees into hives, feeding, and observations for toxicity and mortality
should be consistent with those described in OPPTS Guideline 850.3030, "Honey Bee Toxicity
of Residues on Foliage." The toxicity portion of this study is in lieu of the honeybee contact
LD50 test.
3. Other Labeling Requirements
In order to be eligible for reregistration, various use and safety information will be
included in the labeling of all end-use products containing TCMTB. For the specific labeling
statements and a list of outstanding data, refer to Section V of this RED document.
4. Listed Species Considerations
a. The Endangered Species Act
Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2), requires all
federal agencies to consult with the National Marine Fisheries Service (NMFS) for marine and
anadromous listed species, or the United States Fish and Wildlife Services (FWS) for listed
wildlife and freshwater organisms, if they are proposing an "action" that may affect listed species
or their designated habitat. Each federal agency is required under the Act to insure that any
57
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action they authorize, fund, or carry out is not likely to jeopardize the continued existence of a
listed species or result in the destruction or adverse modification of designated critical habitat.
To jeopardize the continued existence of a listed species means "to engage in an action that
reasonably would be expected, directly or indirectly, to reduce appreciably the likelihood of both
the survival and recovery of a listed species in the wild by reducing the reproduction, numbers,
or distribution of the species." 50 C.F.R. § 402.02.
To facilitate compliance with the requirements of the Endangered Species Act subsection
(a)(2) the Environmental Protection Agency, Office of Pesticide Programs has established
procedures to evaluate whether a proposed registration action may directly or indirectly reduce
appreciably the likelihood of both the survival and recovery of a listed species in the wild by
reducing the reproduction, numbers, or distribution of any listed species (U.S. EPA 2004). After
the Agency's screening-level risk assessment is performed, if any of the Agency's Listed Species
LOC Criteria are exceeded for either direct or indirect effects, a determination is made to identify
if any listed or candidate species may co-occur in the area of the proposed pesticide use. If
determined that listed or candidate species may be present in the proposed use areas, further
biological assessment is undertaken. The extent to which listed species may be at risk then
determines the need for the development of a more comprehensive consultation package as
required by the Endangered Species Act.
For certain use categories, the Agency assumes there will be minimal environmental
exposure, and only a minimal toxicity data set is required (Overview of the Ecological Risk
Assessment Process in the Office of Pesticide Programs U.S. Environmental Protection Agency -
Endangered and Threatened Species Effects Determinations, 1/23/04, Appendix A, Section IIB,
pg.81). Chemicals in these categories therefore do not undergo a full screening-level risk
assessment, and are considered to fall under a no effect determination. The active ingredient
uses of TCMTB, with the exception of the seed treatment and antisapstain wood preservation
uses, fall into this category. Using Tier I screening modeling to assess potential exposure from
seed treatment risks to Listed Species were not identified. Using Tier I screening modeling to
assess potential exposure from antisapstain wood preservation uses of TCMTB, risks to Listed
Species are indicated. Since the model is only intended as a screening-level model, and, as such,
has inherent uncertainties and limitations which may result in inaccurate exposure estimations,
further refinement of the model is recommended before any regulatory action is taken regarding
the antisapstain uses of TCMTB. Additionally, impacts from the antisapstain use could
potentially be mitigated with precautions to prevent leaching and runoff when wood is stored
outdoors (see General Risk Mitigation, below). Due to these circumstances, the Agency defers
making a determination for the antisapstain uses of TCMTB until additional data and modeling
refinements are available. At that time, the environmental exposure assessment of the
antisapstain use of TCMTB will be revised, and the risks to Listed Species will be reconsidered.
b. General Risk Mitigation
TCMTB end-use products (EPs) may also contain other registered pesticides. Although
the Agency is not proposing any mitigation measures for products containing TCMTB specific to
federally listed species, the Agency needs to address potential risks from other end-use products.
Therefore, the Agency requires that users adopt all listed species risk mitigation measures for all
active ingredients in the product. If a product contains multiple active ingredients with
58
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conflicting listed species risk mitigation measures, the more stringent measure(s) should be
adopted.
59
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V.
What Registrants Need to Do
The Agency has determined that TCMTB is eligible for reregistration provided that: (i)
additional data that the Agency intends to require confirm this decision; (ii) the risk mitigation
measure outlined in this document is adopted; and (iii) label amendments are made to reflect this
measure. To implement the risk mitigation measure, the registrants must amend their product
labeling to incorporate the label statement set forth in the Label Changes Summary Table in
Section B below (Table 24). The additional data requirements that the Agency intends to obtain
will include, among other things, submission of the following:
For TCMTB technical grade active ingredient products, the registrant needs to submit the
following items:
Within 90 days from receipt of the generic data call-in (DCI):
1. Completed response forms to the generic DCI (i.e., DCI response form and
requirements status and registrant's response form); and
2. Submit any time extension and/or waiver requests with a full written justification.
Within the time limit specified in the generic DCI:
1. Cite any existing generic data which address data requirements or submit new generic
data responding to the DCI.
Please contact K. Avivah Jakob at (703) 305-1328 with questions regarding generic
reregistration.
By US mail:
Document Processing Desk
K. Avivah Jakob
Office of Pesticide Programs
(751OP)
U.S. Environmental Protection Agency
1200 Pennsylvania Ave., NW
Washington, DC 20460-0001
By express or courier service:
Document Processing Desk
K. Avivah Jakob
Office of Pesticide Programs
(751OP)
U.S. Environmental Protection Agency
One Potomac Yard, Room S-4900
2777 South Crystal Drive
Arlington, VA 22202
60
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For end-use products containing the active ingredient TCMTB. the registrant needs to submit the
following items for each product.
Within 90 days from the receipt of the product-specific data call-in (PDCI):
1. Completed response forms to the PDCI (i.e., PDCI response form and requirements
status and registrant's response form); and
2. Submit any time extension or waiver requests with a full written justification.
Within eight months from the receipt of the PDCI:
1. Two copies of the confidential statement of formula (EPA Form 8570-4);
2. A completed original application for reregistration (EPA Form 8570-1). Indicate on
the form that it is an "application for reregistration";
3. Five copies of the draft label incorporating all label amendments outlined in Table 23
of this document;
4. A completed form certifying compliance with data compensation requirements (EPA
Form 8570-34);
5. If applicable, a completed form certifying compliance with cost share offer
requirements (EPA Form 8570-32); and
6. The product-specific data responding to the PDCI.
Please contact Marshall Swindell at (703) 308-6341 with questions regarding product
reregistration and/or the PDCI. All materials submitted in response to the PDCI should be
addressed as follows:
By US mail: By express or courier service:
Document Processing Desk Document Processing Desk
Marshal Swindell Marshal Swindell
Office of Pesticide Programs (751 OP) Office of Pesticide Programs (751 OP)
U.S. Environmental Protection Agency U.S. Environmental Protection Agency
1200 Pennsylvania Ave., NW Room S-4900, One Potomac Yard
Washington, DC 20460-0001 2777 South Crystal Drive
Arlington, VA 22202
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A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic database supporting the reregistration of TCMTB has been reviewed and
determined to be substantially complete. However, the following additional data requirements
have been identified by the Agency as confirmatory data requirements and are included in the
generic data call in (DCI) for this RED.
Data must be submitted indicating whether the use of TCMTB, as an antimicrobial
materials preservative, in pulp and papermaking will result in residues of 2-MBT in paper. The
registrant must also provide information regarding the level of 2-MBT that will occur in paper.
Application rates (ranges) on all TCMTB paper coating use labels must be identified/clarified.
The risk assessment noted deficiencies in the surrogate inhalation exposure data available
from the Chemical Manufacturers Association (CMA) data base. Therefore, the Agency is
requiring confirmatory data to support the uses assessed with the CMA exposure data within this
risk assessment. The risk assessment also noted that many of the use parameters (e.g., amount
handled and duration of use) were base on professional judgments. Therefore, descriptions of
human activities associated with the uses assessed are required as confirmatory.
The requested environmental fate and ecological studies outline in Table 24 are data gaps
for the seed treatment and/or wood preservative uses of TCMTB.
Table 24. Data Requirements for TC
MTB
(.uidcliiK' Sludj Niimo
Now OI'P I S C.uidoline
Number
Old (iuidoliiK* Number
Anaerobic soil metabolism
835.4200
162-2
Terrestrial field dissipation
835.6100
164-1
Aquatic Field Study
835.6200
164-2
Aquatic Invertebrate Life-Cycle Study
850.1400
72-4b
Life Cycle Fish Study
850.1500
72-5
Terrestrial Plant Toxicity, Tier I (seedling
emergence)
850.4100
122-la
Seedling emergence, Tier II
850.4225
123-1
Vegetative vigor with Rice, Tier II
850.4250
123-1
Aquatic Plant Growth, Tier II
850.5400
123-2
Plant Metabolism
860.1300
171-4a
Residue Analytical Methods- Plant
Commodities
860.1340
171-4c
Storage Stability Data-Plant Commodities
860.1380
171-4e
Processed Food/Feed- Barley
860.1520
171-41
Processed Food/Feed- Beet, Sugar
860.1520
171-41
Processed Food/Feed- Cotton
860.1520
171-41
Processed Food/Feed- Oat
860.1520
171-41
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Processed Food/Feed- Rice
860.1520
171-41
Processed Food/Feed-Safflower
860.1520
171-41
Processed Food/Feed- Wheat
860.1520
171-41
Proposed Tolerances
860.1550
171-6
Submittal of Analytical Reference Standards
860.1650
171-13
Dermal Indoor Exposure
875.1200
233
Inhalation Indoor Exposure
875.1400
234
Description of Human Activity
875.2800
133-1
Leather Leaching Data
Special Study
Special Study
Residues in honey/beeswax and toxicity of
treated wood residues to bees
No Guideline
No Guideline
Rescned ( onl'irm;i(or\ l);il;i Kc(|iiiivnionls lor Kciv^isli'iilion
Terrestrial Plant Toxicity, Tier II (seedling
emergence)
850.4225
123-1
Livestock Metabolism
860.1300
171-4b
Residue Analytical Methods- Livestock
Commodities
860.1340
171-4d
Multi-residue Methods
860.1360
171-4m
Storage Stability Data-Processed
Commodities
860.1380
171-4e
Storage Stability Data- Livestock
Commodities
860.1380
171-4e
Meat, Milk, Poultry, and Eggs
860.1480
17 l-4i
Crop Field Trials-Beat, Sugar, Tops (Root
and Tuber Vegetables Group)
860.1500
171-4k
Crop Field Trials-Beet, Sugar, Tops (Leaves
of Root and Tuber Vegetables Group)
860.1500
171-4k
Crop Field Trials-Barley, Grain (Cereal
Grains Group)
860.1500
171-4k
Crop Field Trials-Oat, Grain (Cereal Grains
Group)
860.1500
171-4k
Crop Field Trials-Rice, Grain (Cereal Grains
Group)
860.1500
171-4k
Crop Field Trials-Wheat, Grain and
Aspirated Grain Fractions (Cereal Grains
Group)
860.1500
171-4k
Crop Field Trials-Barley, Hay and Straw
(Fodder, Forage, Hay and Straw of Cereal
Grains Group)
860.1500
171-4k
Crop Field Trials-Oat, Forage, Hay and
Straw (Fodder, Forage, Hay and Straw of
Cereal Grains Group)
860.1500
171-4k
Crop Field Trials-Rice, Straw (Fodder,
Forage, Hay and Straw of Cereal Grains
Group)
860.1500
171-4k
63
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Crop Field Trials-Wheat, Forage, Hay, and
Straw (Fodder, Forage, Hay and Straw of
Cereal Grains Group)
860.1500
171-4k
Crop Field Trials-Cotton, Undelinted Seed
and Gin Byproducts (Miscellaneous
Commodities)
860.1500
171-4k
Confined Rotational Crops
860.1850
165-1
Field Rotational Crops
860.1900
165-2
2. Labeling for Technical and Manufacturing Use Products
To ensure compliance with FIFRA, technical and manufacturing-use product (MP)
labeling should be revised to comply with all current EPA regulations, PR Notices and
applicable policies. The Technical and MP labeling should bear the labeling contained in Table
25, Label Changes Summary Table.
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 Registrant
must review previous data submissions to ensure that they meet current EPA acceptance criteria
and if not, commit to conduct new studies. If a registrant believes that previously submitted data
meet current testing standards, then the study MRID numbers should be cited according to the
instructions in the Requirement Status and Registrants Response Form provided for each
product. A product-specific data call-in will be issued at a later date.
2. Labeling for End-Use Products
Labeling changes are necessary to implement measures outlined in Section IV above.
Specific language to incorporate these changes is specified in Table 25, Label Changes Summary
Table.
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 document.
Persons other than the registrant may generally distribute or sell such products for 52 months
from the approval of labels reflecting the mitigation described in 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.
a. Label Changes Summary Table
In order to be eligible for reregistration, all product labels must be amended to
incorporate the risk mitigation measure outlined in Section IV of the TCMTB RED. The
following table describes how language on the labels should be amended.
64
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Table 25. Labeling Changes Summary Table
Description
Amended l.iihclin^ luniiuniic
I'litcenienl on l.iihel
Environmental Hazards
Statements Required by the
RED and Agency Label Policies
"This product is toxic to fish, aquatic invertebrates, oysters and shrimp. 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 Pollution 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."
Precautionary
Statements
I ikI I so Products Intended lor Occupulionsil I sc
PPE Requirements
"Wear chemical resistant gloves while handling concentrate."
Immediately
following/below
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
For all antisapstain end-use
products
"Treated lumber must be stored under cover, indoors, or at least 100 feet from any pond, lake,
stream, wetland, or river to prevent possible runoff of the product into the waterway. Treated
lumber stored within 100 feet of a pond, lake, steam, or river must be either covered with
plastic or surrounded by a berm to prevent surface water runoff into the nearby waterway. If a
berm or curb is used around the site, it should consist of impermeable material (clay, asphalt,
concrete) and be of sufficient height to prevent runoff during heavy rainfall events."
This language is to be
included in the
Environmental Hazards
section of the label.
Directions l-'or I se
Use Cancellation
All TCMTB textile materials preservative/additive incorporation uses are cancelled and must
be deleted from current product labels, with the exception use on leather. Examples of
cancelled textiles are carpets, fibers and cordage.
Use Cancellation
All TCMTB paint preservation/application uses are cancelled and must be deleted from all
product labels.
65
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VI. APPENDICES
66
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Appendix A. Table of Use Patterns for TCMTB
Use Site
Formulation/
EPA No.
Method of
Application
Application Rate/ No.
of applications
Use Limitations
Materials preservatives
Leather
Soluble
Concentrate
1448-55
1448-81
1448-377
1448-412
Add to pickling liquor
or tanning liquor at the
start of the tanning
process or to the rinse
water in a post tanning
refloat
The dosage level used will
depend on storage conditions
and the length of protection
required.
A dosage rate of 0.025-0.3%
(250-2,000 ppm) can be used.
A satisfactory dilution of 1
part solution to 5 parts water
can be prepared.
Per TCMTB RED mitigation, occupational handlers of
antimicrobial materials preservative products must wear
PPE chemical resistant gloves while handling
concentrate.
Per TCMTB RED mitigation, all TCMTB labels must state
the following:
"This product is toxic to fish, aquatic invertebrates, oysters
and shrimp. 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 Pollution 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."
67
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Use Site
Formulation/
EPA No.
Method of
Application
Application Rate/ No.
of applications
Use Limitations
Leather
1448-386
1448-102
1448-100
1448-376
1448-408
1.5 to 12.0 lbs per 1,000 lbs of
white weight stock.
Per TCMTB RED mitigation, occupational handlers of
antimicrobial materials preservative products must wear
PPE chemical resistant gloves while handling concentrate.
Per TCMTB RED mitigation, all TCMTB labels must state
the following:
"This product is toxic to fish, aquatic invertebrates, oysters
and shrimp. 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 Pollution 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."
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Use Site
Formulation/
EPA No.
Method of
Application
Application Rate/ No.
of applications
Use Limitations
Particle Board
Soluble
concentrate
1448-55
1448-81
1448-99
1448-100
1448-377
Mix with resin or
binding agent
0.1 to 3% based on the dry
weight of the wood.
Per TCMTB RED mitigation, occupational handlers of
antimicrobial materials preservative products must wear
PPE chemical resistant gloves while handling concentrate.
Per TCMTB RED mitigation, all TCMTB labels must state
the following:
"This product is toxic to fish, aquatic invertebrates, oysters
and shrimp. 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 Pollution 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."
1448-386
0.6 to 6.0% based on the dry
weight of the wood.
Per TCMTB RED mitigation, occupational handlers of
antimicrobial materials preservative products must wear
PPE chemical resistant gloves while handling concentrate.
Per TCMTB RED mitigation, all TCMTB labels must state
the following:
"This product is toxic to fish, aquatic invertebrates, oysters
and shrimp. 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 Pollution 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."
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Use Site
Formulation/
EPA No.
Method of
Application
Application Rate/ No.
of applications
Use Limitations
Coatings, caulking-
sealants, & wall
cover adhesives,
pigment slurries,
non food adhesives
Soluble
concentrate
1448-45
1448-55
1448-81
1448-99
1448-100
1448-102
1448-376
1448-377
44392-11
Incorporation (mixing)
0.5 to 36% based on the total
formulation weight.
For solvent based
formulations use
combinations of aromatic and
aliphatic solvents.
Per TCMTB RED mitigation, occupational handlers of
TCMTB antimicrobial materials preservative products
must wear PPE chemical resistant gloves while handling
concentrate.
Per TCMTB RED mitigation, all TCMTB paint
preservation/application uses are cancelled and must be
deleted from all product labels.
Per TCMTB RED mitigation, all TCMTB labels must state
the following:
"This product is toxic to fish, aquatic invertebrates, oysters
and shrimp. 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 Pollution 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."
Textiles
Soluble
concentrate
1448-55
Impregnate
Apply solution to an emulsion
of convenient concentration of
1-5% impregnate into the
fabric using conventional
padding or sizing equipment
Per TCMTB RED mitigation, all TCMTB textile materials
preservative/additive incorporation uses are cancelled and
must be deleted from current product labels, with the
exception of use on leather. Examples of cancelled textiles
are carpets, fibers and cordage.
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Use Site
Formulation/
EPA No.
Method of
Application
Application Rate/ No.
of applications
Use Limitations
Crude and refined
oils
Soluble
concentrate
1448-81
1448-99
1448-100
1448-102
1448-147
1448-148
1448-171
1448-172
1448-376
1448-386
1448-377
44392-11
Incorporation
Chemical should be added to
the oil as it is being
transferred from the shipping
container to the storage tank
at a rate of 0.6 to 32 11 oz per
1,000 gal of oil.
Per TCMTB RED mitigation, occupational handlers of
antimicrobial materials preservative products must wear
PPE chemical resistant gloves while handling concentrate.
Per TCMTB RED mitigation, all TCMTB labels must state
the following:
"This product is toxic to fish, aquatic invertebrates, oysters
and shrimp. 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 Pollution 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."
Hides and skins
Soluble
concentrate
1448-55
1448-81
1448-99
1448-102
1448-376
1448-377
1448-408
1448-412
None stated
The solution should be used at
a level of 0.003% to 0.02%
(30 to 200ppm) based on the
weight of the green fleshed
hides or skins and saturated
brine solution.
Per TCMTB RED mitigation, occupational handlers of
antimicrobial materials preservative products must wear
PPE chemical resistant gloves while handling concentrate.
Per TCMTB RED mitigation, all TCMTB labels must state
the following:
"This product is toxic to fish, aquatic invertebrates, oysters
and shrimp. 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 Pollution 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."
71
-------
Use Site
Formulation/
EPA No.
Method of
Application
Application Rate/ No.
of applications
Use Limitations
Fuels
Soluble
concentrate
1448-102
1448-148
1448-147
1448-171
1448-172
44392-11
Incorporation
125 to 25 fl oz per 100 gallons
of fuel.
-or-
3.0 to 6.0 fl oz per 1,000 gal
of fuel.
Per TCMTB RED mitigation, occupational handlers of
antimicrobial materials preservative products must wear
PPE chemical resistant gloves while handling concentrate.
Per TCMTB RED mitigation, all TCMTB labels must state
the following:
"This product is toxic to fish, aquatic invertebrates, oysters
and shrimp. 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 Pollution 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."
72
-------
Use Site
Formulation/
EPA No.
Method of
Application
Application Rate/ No.
of applications
Use Limitations
Bacteriostatic paper
Soluble
concentrate
1448-81
1448-377
None stated
Dosage: 0. 5% to 9.0%
weight/weight of product and
added at the size press or
similar application.
The bacteriostatic paper and paperboard applications are
not to be used in the manufacture of food contact paper,
paper coatings or paperboard.
Per TCMTB RED mitigation, occupational handlers of
antimicrobial materials preservative products must wear
PPE chemical resistant gloves while handling concentrate.
Per TCMTB RED mitigation, all TCMTB labels must state
the following:
"This product is toxic to fish, aquatic invertebrates, oysters
and shrimp. 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 Pollution 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."
73
-------
Use Site
Formulation/
EPA No.
Method of
Application
Application Rate/ No.
of applications
Use Limitations
Industrial processes and water systems
Pulp mills
Soluble
concentrate
1448-45
1448-55
1448-81
1448-99
1448-100
1448-102
1448-376
1448-383
1448-377
1448-386
Spray
Applicator rolls
0.5 to 12.0 lb per ton of oven
dry wood (50 to 400 ppm).
It can be applied through a
water shower located in the
pneumatic conveyor carrying
chips from the chipper to the
storage pile.
To control bacteria and fungal
growth on paper and paper
board machines add to the
white water or stock 0.1 to
12.0 lb/ton of dry paper.
To make mold resistant paper
or paperboard use at 0.05 to
0.61b/1000 sq ft.
For coated paper or board, the
solution is incorporated in the
coating mix prior to
application.
For uncoated paper or board,
the solution is dispersed in
water, surface sizing solution,
or other solvent and applied to
the surface to be protected by
means of applicator roller.
For mulch paper 1.5 to 51b/ton
air dry paper.
Per TCMTB RED mitigation, all TCMTB labels must state
the following:
"This product is toxic to fish, aquatic invertebrates, oysters
and shrimp. 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 Pollution 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."
74
-------
Use Site
Formulation/
EPA No.
Method of
Application
Application Rate/ No.
of applications
Use Limitations
Cooling Water
Soluble
concentrate
1448-55
1448-81
1448-147
1448-148
1448-149
1448-150
1448-377
Fill, Flush
Initial dose:
0.6 to 3.7 fl oz per 1,000
gallons of water in the system.
Subsequent dose:
0.2 to 1.2 fl oz per 1,000
gallons should be made every
1 to 5 days.
Per TCMTB RED mitigation, all TCMTB labels must state
the following:
"This product is toxic to fish, aquatic invertebrates, oysters
and shrimp. 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 Pollution 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."
1448-100
1448-152
1448-153
1448-386
1448-408
Fill, Flush
3.6 to 22.2 fl oz. per 1,000
gallons of water.
Per TCMTB RED mitigation, all TCMTB labels must state
the following:
"This product is toxic to fish, aquatic invertebrates, oysters
and shrimp. 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 Pollution 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."
75
-------
Use Site
Formulation/
EPA No.
Method of
Application
Application Rate/ No.
of applications
Use Limitations
Cooling Water
1448-99
1448-102
1448-151
1448-171
1448-172
1448-244
1448-376
1448-383
44392-11
1.3 to 14.8 fl oz per 1,000
gallons of water.
Per TCMTB RED mitigation, all TCMTB labels must state
the following:
"This product is toxic to fish, aquatic invertebrates, oysters
and shrimp. 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 Pollution 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."
Drilling Fluids
Soluble
concentrate
1448-55
1448-81
1448-99
1448-100
1448-102
1448-147
1448-148
1448-149
1448-150
1448-151
1448-152
1448-153
1448-171
1448-172
1448-376
1448-383
1448-386
1448-377
1448-408
44392-11
Incorporation in the
drilling fluid.
0.05% to 1.5 % based on the
total wet weight of the fluid.
Per TCMTB RED mitigation, all TCMTB labels must state
the following:
"This product is toxic to fish, aquatic invertebrates, oysters
and shrimp. 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 Pollution 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."
76
-------
Use Site
Formulation/
EPA No.
Method of
Application
Application Rate/ No.
of applications
Use Limitations
Petroleum
Soluble
Continuous feed method
0.2 to 6.3 fl oz per 100 gallons
Secondary Recovery
concentrate
of
1448-55
Intermittent feed
Water.
1448-81
1448-99
Slug feed
0.65 to 10 fl oz per 1,000
1448-100
gallons of water 4 to 8 hrs per
1448-102
day.
1448-147
1448-148
1.3 to 13.0 fl oz per 1,000
1448-149
gallons of water every 1 to 7
1448-150
days,
1448-151
1448-152
15.6 to 52.0 fl oz per 1000
1448-153
gallons of water every 1 to 7
1448-171
days.
1448-172
1448-376
1448-383
1448-386
1448-377
1448-244
44392-11
77
-------
Use Site
Formulation/
EPA No.
Method of
Application
Application Rate/ No.
of applications
Use Limitations
Cutting fluids
Soluble
concentrate
1448-55
1448-99
1448-100
1448-149
1448-150
1448-151
1448-152
1448-153
1448-386
1448-265
1448-244
Incorporation
Solution should be added to
diluted cutting fluid at a rate
that will provide 150 to 1,500
ppm.
To prevent fungal growth,
concentrations of 1,000 to
7,500ppm are necessary.
Per TCMTB RED mitigation, all TCMTB labels must state
the following:
"This product is toxic to fish, aquatic invertebrates, oysters
and shrimp. 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 Pollution 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."
Waste water
treatment systems
Soluble
concentrate
1448-55
None stated
The quantity of solution
required varies with the
degree of fouling.
It should be added at a rate
that will provide 10 to 30 ppm
of the waste water.
Per TCMTB RED mitigation, all TCMTB labels must state
the following:
"This product is toxic to fish, aquatic invertebrates, oysters
and shrimp. 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 Pollution 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."
78
-------
Use Site
Formulation/
EPA No.
Method of
Application
Application Rate/ No.
of applications
Use Limitations
Wood Preservatives
Sapstain Control
1448-55
1448-81
Dipping/ Pressure
Impregnation
0.5 to 8 gal of product (10%
TCMB) per 100 gal of water.
Treatment should be made within 24 hrs of cutting or
sawing.
Per RED mitigation, the following language must appear
on all products with an antisapstain use:
"Treated lumber must be stored under cover, indoors, or at
least 100 feet from any pond, lake, stream, wetland, or
river to prevent possible runoff of the product into the
waterway. Treated lumber stored within 100 feet of a
pond, lake, steam, or river must be either covered with
plastic or surrounded by a berm to prevent surface water
runoff into the nearby waterway. If a berm or curb is used
around the site, it should consist of impermeable material
(clay, asphalt, concrete) and be of sufficient height to
prevent runoff during heavy rainfall events."
Per TCMTB RED mitigation, all TCMTB labels must state
the following:
"This product is toxic to fish, aquatic invertebrates, oysters
and shrimp. 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 Pollution 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."
79
-------
Use Site
Formulation/
EPA No.
Method of
Application
Application Rate/ No.
of applications
Use Limitations
Sapstain Control
1448-102
Dipping/ Pressure
Impregnation
5.6 kg to 44.0 kg of product
(5% TCMB) per 100 liters of
water.
Treatment should be made within 24 hrs of cutting or
sawing.
Per RED mitigation, the following language must appear
on all products with an antisapstain use:
"Treated lumber must be stored under cover, indoors, or at
least 100 feet from any pond, lake, stream, wetland, or
river to prevent possible runoff of the product into the
waterway. Treated lumber stored within 100 feet of a
pond, lake, steam, or river must be either covered with
plastic or surrounded by a berm to prevent surface water
runoff into the nearby waterway. If a berm or curb is used
around the site, it should consist of impermeable material
(clay, asphalt, concrete) and be of sufficient height to
prevent runoff during heavy rainfall events."
Per TCMTB RED mitigation, all TCMTB labels must state
the following:
"This product is toxic to fish, aquatic invertebrates, oysters
and shrimp. 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 Pollution 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."
80
-------
Use Site
Formulation/
EPA No.
Method of
Application
Application Rate/ No.
of applications
Use Limitations
Sapstain Control
1448-100
1448-99
Dipping/ Pressure
Impregnation
1.5 to 48 gal of product (5 to
10% TCMB) per 100 gal of
water.
Treatment should be made within 24 hrs of cutting or
sawing.
Per RED mitigation, the following language must appear
on all products with an antisapstain use:
"Treated lumber must be stored under cover, indoors, or at
least 100 feet from any pond, lake, stream, wetland, or
river to prevent possible runoff of the product into the
waterway. Treated lumber stored within 100 feet of a
pond, lake, steam, or river must be either covered with
plastic or surrounded by a berm to prevent surface water
runoff into the nearby waterway. If a berm or curb is used
around the site, it should consist of impermeable material
(clay, asphalt, concrete) and be of sufficient height to
prevent runoff during heavy rainfall events."
Per TCMTB RED mitigation, all TCMTB labels must state
the following:
"This product is toxic to fish, aquatic invertebrates, oysters
and shrimp. 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 Pollution 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."
81
-------
Use Site
Formulation/
EPA No.
Method of
Application
Application Rate/ No.
of applications
Use Limitations
Vertical Wood
Surfaces, roofs and
sidewalls
56156-1
Brush or low pressure
sprayer
Sidewalls - first coat: 100 sq.
ft. per gallon, second coat 200
sq ft. per gallon
Roofs - 75 to 150 sq. ft. per
gallon depending on porosity
of surface.
VOC Content limit: less than
500 grams per liter or 4.6 lbs.
per gallon
Do not apply this product in a way that will contact
workers or other persons.
Per TCMTB RED mitigation, all TCMTB labels must state
the following:
"This product is toxic to fish, aquatic invertebrates, oysters
and shrimp. 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 Pollution 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."
Cooling Tower
Wood
1448-55
1448-81
Brush or periodic shock
dose
Brush: 0.5 to 0.7% of product
in water onto surface,
(provides 0.6 to 0.8 lbs per
1000 sq. ft. of wood surface)
Shock Dose: 1.25 lb of
product per 1000 gallons of
water. Bleedoff should be
stopped for 4 to 6 hrs after
treatment. Repeat shock
treatment every four months.
Per TCMTB RED mitigation, all TCMTB labels must state
the following:
"This product is toxic to fish, aquatic invertebrates, oysters
and shrimp. 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 Pollution 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."
82
-------
Use Site
Formulation/
EPA No.
Method of
Application
Application Rate/ No.
of applications
Use Limitations
Cooling Tower
Wood
1448-302
Brash or periodic shock
dose
Brash: 2.0 to 2.8% of product
in water onto surface,
(provides 2.4 to 3.2 lbs per
1000 sq. ft. of wood surface)
Shock Dose: 5.0 lb of product
per 1000 gallons of water.
Bleedoff should be stopped
for 4 to 6 hrs after treatment.
Repeat shock treatment every
four months.
Per TCMTB RED mitigation, all TCMTB labels must state
the following:
"This product is toxic to fish, aquatic invertebrates, oysters
and shrimp. 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 Pollution 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."
1488-100
Brash or periodic shock
dose
Brash: 3.0 to 4.2% of product
in water onto surface,
(provides 3.6 to 4.8 lbs per
1000 sq. ft. of wood surface)
Shock Dose: 7.5 lb of product
per 1000 gallons of water.
Bleedoff should be stopped
for 4 to 6 hrs after treatment.
Repeat shock treatment every
four months.
Per TCMTB RED mitigation, all TCMTB labels must state
the following:
"This product is toxic to fish, aquatic invertebrates, oysters
and shrimp. 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 Pollution 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."
83
-------
Use Site
Formulation/
EPA No.
Method of
Application
Application Rate/ No.
of applications
Use Limitations
Seed Treatment
Barley Seed, Oat
Seed, Rice Seed,
Wheat Seed
Liquid-
Concentrate
2935-389
Commercial treater
Maximum application rate:
0.026 lbs ai/100 lbs of seed
Per TCMTB RED mitigation, all TCMTB labels must state
the following:
"This product is toxic to fish, aquatic invertebrates, oysters
and shrimp. 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 Pollution 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."
Cotton
Liquid-
Concentrate
264-965
264-983
2935-413
2935-389
Commercial treater
On-farm treater
Maximum application rate
(commercial treater):
0.13 lbs ai/100 lbs of seed
Maximum application rate
(on-farm treater):
0.051 lbs ai/100 lbs of seed
Per TCMTB RED mitigation, all TCMTB labels must state
the following:
"This product is toxic to fish, aquatic invertebrates, oysters
and shrimp. 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 Pollution 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."
84
-------
Use Site
Formulation/
EPA No.
Method of
Application
Application Rate/ No.
of applications
Use Limitations
Safflower Seed,
Sugar beet Seed
Liquid-
Concentrate
2935-389
Commercial treater
Maximum application rate:
0.041 lbs ai/100 lbs of seed
Per TCMTB RED mitigation, all TCMTB labels must state
the following:
"This product is toxic to fish, aquatic invertebrates, oysters
and shrimp. 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 Pollution 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."
85
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Appendix B. Table of Generic Data Requirements and Studies Used to Make the Reregistration Decision
Guide to Appendix B
Appendix B contains listing of data requirements which support the reregistration for active ingredients within case
#2625(TCMTB) covered by this RED. It contains generic data requirements that apply to TCMTB in all products, including data
requirements for which a "typical formulation" is the test substance.
The data table is organized in the following formats:
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 Guidance, which are
available from the National technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.
2. Use Pattern (Column 4). This column indicates the use patterns for which the data requirements apply. The following
letter designations are used for the given use patterns.
(1) Agricultural premises and equipment
(2) Food handling/ storage establishments' premises and equipment
(3) Commercial, institutional and industrial premises and equipment
(4) Residential and public access premises
(5) Medical premises and equipment
(6) Human water systems
(7) Materials preservatives
(8) Industrial processes and water systems
(9) Antifouling coatings
(10) Wood preservatives
(11) Swimming pools
(12) Aquatic areas
3. Bibliographic Citation (Column 5). If the Agency has acceptable data in its files, this column list the identify 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.
86
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DATA REQUIREMENT
CITATION(S)
New Guideline
Number
Old Guideline
Number
Study Title
Use Pattern
IVI RID Number
PRODUCT CHEMISTRY
830.1550
61-1
Product Identity and Composition
1,3, 4, 7,8,10
41612001
830.1600
830.1620
830.1650
61-2a
Starting Materials and Manufacturing Process
1,3, 4, 7,8,10
41612001
830.1670
61-2b
Formation of Impurities
1,3, 4, 7,8,10
41612001
830.1700
62-1
Preliminary Analysis
1,3, 4, 7,8,10
41612002
830.1750
62-2
Certification of Limits
1,3, 4, 7,8,10
41612002
830.1800
62-3
Analytical Method
1,3, 4, 7,8,10
41612002
830.6302
63-2
Color
1,3, 4, 7,8,10
41612003
830.6303
63-3
Physical State
1,3, 4, 7,8,10
41612003
830.6304
63-4
Odor
1,3, 4, 7,8,10
41612003
830.7220
63-6
Boiling Point
1,3, 4, 7,8,10
41612003,42407401
830.7300
63-7
Density
1,3, 4, 7,8,10
41612003
830.7840
830.7860
63-8
Solubility
1,3, 4, 7,8,10
42059701, 41612003
830.7950
63-9
Vapor Pressure
1,3, 4, 7,8,10
41612003,42059701
830.7550
830.7560
830.7570
63-11
Partition Coefficient (Octanol/Water)
1,3, 4, 7,8,10
4232450,4205970, 41612003
830.7000
63-12
PH
1,3, 4, 7,8,10
41612003
830.6313
63-13
Stability
1,3, 4, 7,8,10
41612003
830.6314
63-14
Oxidizing/Reducing Action
1,3, 4, 7,8,10
41612003
830.6315
63-15
Flammability
1,3, 4, 7,8,10
41612003
87
-------
DATA Ul-:yi 1 KIM I N I
( 11 A l lON(S)
Now (iuiriclinc
Number
Old (iuirii'linc
Number
Smd> Tille
I so Piiiimi
MKII) Number
830.6316
63-16
Explodability
1,3, 4, 7,8,10
41612003
830.6317
63-17
Storage Stability
1,3, 4, 7,8,10
41612003
830.7100
63-18
Viscosity
1,3, 4, 7,8,10
41612003
830.6319
63-19
Miscibility
1,3, 4, 7,8,10
41612003
830.6320
63-20
Corrosion Characteristics
1,3, 4, 7,8,10
41612003
830.6321
63-21
Dielectric breakdown voltage
1,3, 4, 7,8,10
41612003
ECOLOGICAL EFFECTS
850.2100
71-la
Avian Acute Oral Toxicity Test Quail/Duck
1,3, 4, 7,8,10
41780901
850.2100
71-lb
Avian Acute Oral Toxicity Test Quail/Duck TEP
1,3, 4, 7,8,10
41780901
850.2200
71-2a
Avian Acute Dietary Toxicity Quail
1,3, 4, 7,8,10
41595602, 42428501
850.2200
71-2b
Avian Dietary Toxicity Duck
1,3, 4, 7,8,10
41595601
850.1075
72-la
Fish Acute Toxicity - Freshwater Bluegill
1,3, 4, 7,8,10
41804201
850.1075
72-lc
Fish Toxicity Rainbow Trout
1,3, 4, 7,8,10
41818101
850.1010
72-2a
Acute Aquatic Invertebrate Toxicity
1,3, 4, 7,8,10
41838201, 42226001
850.1075
72-3a
Acute Estuarine/Marine Toxicity - Fish
1,3, 4, 7,8,10
40363601
850.1025
72-3b
Acute Estuarine/Marine Toxicity - Invertebrate (Mollusk)
1,3, 4, 7,8,10
40363603
72-3c
Estuarine/Marine Toxicity - Invertebrate (Shrimp)
1,3, 4, 7,8,10
40363602
850.1300
72-4a
Fish Early Life-Stage Testing
1,3, 4, 7,8,10
425929-01
850.1400
72-4b
Aquatic Invertebrate Life-Cycle
1,3, 4, 7,8,10
Data Gap
850.1500
72-5
Life Cycle Fish
1,3, 4, 7,8,10
Data Gap
850.1710
72-6
Aquatic Org. Accumulation
1,3, 4, 7,8,10
42418501,46705201, 42453201
88
-------
DATA Ul-:yi 1 KIM I N I
( 11 A l lON(S)
Now (iuiriclinc
Number
Old (iuirii'linc
Number
Siiulj Tille
I so Piiiimi
MKII) Number
850.4100
122-la
Terrestrial Plant Toxicity, Tier I (seeding emergence)
1,3, 4, 7,8,10
Data Gap
850.4400
123-2
Aquatic Vascular Plant Toxicity, Tier II
1,3, 4, 7,8,10
442009-01
850.5400
123-2
Aquatic Plant Growth, Tier II
1,3, 4, 7,8,10
Data Gap
850.4225
123-1
Seedling Emergence- Tier II
1,3, 4, 7,8,10
Data Gap
850.4250
123-1
Vegetative Vigor with Rice- Tier II
1,3, 4, 7,8,10
Data Gap
875.2100
132-la
Foliar Residue Dissipation - not an eco requirement, check with
fate/residue chem
1,3, 4, 7,8,10
Waived
None
None
Honey Bee Wood Preservative Residues Test
1,3, 4, 7,8,10
Data Gap (Unless label statement
prohibiting use for beehive construction
is added)
TOXICOLOGY
870.1100
81-1
Acute Oral - Rat
1,3, 4, 7,8,10
41583801
870.1200
81-2
Acute Dermal - Rabbit
1,3, 4, 7,8,10
41515401
870.1300
81-3
Acute Inhalation - Rat
1,3, 4, 7,8,10
40419301,41640601
870.2400
81-4
Primary Eye Irritation - Rabbit
1,3, 4, 7,8,10
Acc. No. 111991
870.2500
81-5
Primary Dermal Irritation - Rabbit
1,3, 4, 7,8,10
41583701
870.2600
81-6
Dermal Sensitization
1,3, 4, 7,8,10
42349201, Acc No. 259676
870.3100
82-la
90-Day Feeding-Rodent
1,3, 4, 7,8,10
41342201
82-lb
90-Day Feeding-Non-Rodent
1,3, 4, 7,8,10
41342201
870.3200
82-2
21/28-Day Dermal Toxicity - Rat/Rabbit
1,3, 4, 7,8,10
41655801
870.3465
82-4
90-Day Inhalation Toxicity
1,3, 4, 7,8,10
Reserved
870.3700
83-3
Developmental Toxicity
1,3, 4, 7,8,10
00154295, Accession no. 260491,
40075102
89
-------
DATA Ul-:yi 1 KIM I N I
( 11 A l lON(S)
Now (iuiriclinc
Number
Old (iuirii'linc
Number
Sluclj Tillc
I so Piiiimi
MRU) Number
870.3800
83-4
Reproduction and Fertility Effects - 2 Generation Repro Rat
1,3, 4, 7,8,10
41471401
870.4100
83-la
Chronic Feeding Toxicity - Rodent
1,3, 4, 7,8,10
41342201
83-lb
Chronic Feeding Toxicity - Non-Rodent
1,3, 4, 7,8,10
41342201
870.4200
83-2a
Oncogenicity - Rat
1,3, 4, 7,8,10
42383001
83-2b
Oncogenicity - Mouse
1,3, 4, 7,8,10
42383001
870.3700a
83-3a
Teratogenicity- Rat
1,3, 4, 7,8,10
00154295, accession no. 260491
870.3700b
83-3b
T eratogenicity-Rabbit
1,3, 4, 7,8,10
40075102
870.4300
83-5
Combined Chronic Toxicity/Carcinogenicity in Rats
1,3, 4, 7,8,10
42116301,41529701, 41570301
870.5100
84-2
Mutagenicity study- Gene mutation
1,3, 4, 7,8,10
41386101
870.5395
84-2
Mutagenicity—Mammalian erythrocyte micronucleus
1,3, 4, 7,8,10
00165520
870.5550
84-4
Rat Primary Hepatocyte Unscheduled DNA Synthesis Assay
1,3, 4, 7,8,10
00165518
870.7485
85-1
General Metabolism
1,3, 4, 7,8,10
40884801 (upgradeable)
The study does not fulfill the complete
requirements for a metabolism study, as
incomplete identification of metabolites and
the purity of TCMTB was not reported.
Only a single low does and a single high
does were tested, a repeated does is
required.
OCCUPATIONAL/RESIDENTIAL EXPOSURE
875.2800
133-1
Description of Human Activity
1,3, 4, 7,8,10
Data Gap
875.2400
875.2900
133-3
Dermal Passive Dosimetry
1,3, 4, 7,8,10
Waived
875.1200
875.1600
233
Dermal Indoor Exposure
1,3, 4, 7,8,10
Data Gap
90
-------
DATA Ul-:yi 1 KIM I N I
( 11 A l lON(S)
Now (iuiriclinc
Number
Old (iuirii'linc
Number
Sluclj Tillc
I so Piiiimi
MRU) Number
875.1400
875.1600
234
Inhalation Indoor Exposure
1,3, 4, 7,8,10
Data Gap
ENVIRONMENTAL FATE
835.2120
161-1
Hydrolysis
1,3, 4, 7,8,10
Upgradeable
42386101,43437601
835.2240
161-2
Photodegradation-water
1,3, 4, 7,8,10
42630901
835.2410
161-3
Photodegradation-soil
1,3, 4, 7,8,10
41515701
835.4100
162-1
Aerobic Soil Metabolism
1,3, 4, 7,8,10
Upgradeable
435322-01
835.4200
162-2
Anaerobic Soil Metabolism
1,3, 4, 7,8,10
Data Gap
835.4400
162-3
Anaerobic Aquatic Metabolism
1,3, 4, 7,8,10
428154-01
835.4300
162-4
Aerobic Aquatic Metabolism
1,3, 4, 7,8,10
Upgradeable
425086-01
835.1240
163-1
Leach/Adsorption/Desorption
1,3, 4, 7,8,10
426314-01
835.1240
163-1
Soil Column Leaching
1,3, 4, 7,8,10
Data Gap
835.6100
164-1
Terrestrial Field Dissipation
1,3, 4, 7,8,10
Data Gap
835.6200
164-2
Aquatic Field Study
1,3, 4, 7,8,10
Data Gap
850.1730
165-4
Accumulation Studies in Fish
1,3, 4, 7,8,10
424185-01, 424932-01, 467052-01
RESIDUE CHEMISTRY
860.1100
171-2
Chemical Identity
1,3, 4, 7,8,10
41612001
860.1300
171-4
Plant Metabolism
1,3, 4, 7,8,10
Data Gap
860.1300
171-4
Livestock Metabolism
1,3, 4, 7,8,10
Reserved
860.1340
171-4
Residue Analytical Methods- Plant Commodities
1,3, 4, 7,8,10
Data Gap
91
-------
DATA Ul-:yi 1 KIM I N I
( 11 A l K)N(S)
Now (iuiriclinc
Number
Old (iuirii'linc
Number
Smd> Tille
I so Piiiimi
MKII) Number
860.1340
171-4
Residue Analytical Method- Livestock
1,3, 4, 7,8,10
Reserved
860.1360
171-4
Multi-residue Methods
1,3, 4, 7,8,10
Reserved
860.1380
171-4
Storage Stability Data-Plant Commodities
1,3, 4, 7,8,10
Data Gap
860.1380
171-4
Storage Stability Data- Processed Commodities
1,3, 4, 7,8,10
Reserved
860.1380
171-4
Storage Stability Data- Livestock Commodities
1,3, 4, 7,8,10
Reserved
860.1480
17 l-4i
Meat/Milk/Poultry/Egg
1,3, 4, 7,8,10
Reserved
860.1500
171-4k
Crop Field Trials-Beat, Sugar, Tops (Root and Tuber
Vegetables Group)
1,3, 4, 7,8,10
Reserved
860.1500
171-4k
Crop Field Trials-Beet, Sugar, Tops (Leaves of Root and Tuber
Vegetables Group)
1,3, 4, 7,8,10
Reserved
860.1500
171-4k
Crop Field Trials-Barley, Grain (Cereal Grains Group)
1,3, 4, 7,8,10
Reserved
860.1500
171-4k
Crop Field Trials-Oat, Grain (Cereal Grains Group)
1,3, 4, 7,8,10
Reserved
860.1500
171-4k
Crop Field Trials-Rice, Grain (Cereal Grains Group)
1,3, 4, 7,8,10
Reserved
860.1500
171-4k
Crop Field Trials-Wheat, Grain and Aspirated Grain Fractions
(Cereal Grains Group)
1,3, 4, 7,8,10
Reserved
860.1500
171-4k
Crop Field Trials-Barley, Hay and Straw (Fodder, Forage, Hay
and Straw of Cereal Grains Group)
1,3, 4, 7,8,10
Reserved
860.1500
171-4k
Crop Field Trials-Oat, Forage, Hay and Straw (Fodder, Forage,
Hay and Straw of Cereal Grains Group)
1,3, 4, 7,8,10
Reserved
860.1500
171-4k
Crop Field Trials-Rice, Straw (Fodder, Forage, Hay and Straw
of Cereal Grains Group)
1,3, 4, 7,8,10
Reserved
860.1500
171-4k
Crop Field Trials-Wheat, Forage, Hay, and Straw (Fodder,
Forage, Hay and Straw of Cereal Grains Group)
1,3, 4, 7,8,10
Reserved
860.1500
171-4k
Crop Field Trials-Cotton, Undelinted Seed and Gin Byproducts
(Miscellaneous Commodities)
1,3, 4, 7,8,10
Reserved
860.1520
171-41
Processed Food/Feed- Barley
1,3, 4, 7,8,10
Data Gap
860.1520
171-41
Processed Food/Feed- Beet, Sugar
1,3, 4, 7,8,10
Data Gap
860.1520
171-41
Processed Food/Feed- Cotton
1,3, 4, 7,8,10
Data Gap
92
-------
DATA Ul-:yi 1 KIM I N I
( 11 A l lON(S)
Now (iuiriclinc
Number
Old (iuirii'linc
Number
Siiulj Tillc
I so Piiiimi
MRU) Number
860.1520
171-41
Processed Food/Feed- Oat
1,3, 4, 7,8,10
Data Gap
860.1520
171-41
Processed Food/Feed- Rice
1,3, 4, 7,8,10
Data Gap
860.1520
171-41
Processed Food/Feed-Safflower
1,3, 4, 7,8,10
Data Gap
860.1520
171-41
Processed Food/Feed- Wheat
1,3, 4, 7,8,10
Data Gap
860.1550
171-6
Proposed Tolerances
1,3, 4, 7,8,10
Data Gap
860.1650
171-13
Submittal of Analytical Reference Standards
1,3, 4, 7,8,10
Data Gap
860.1850
165-1
Confined Rotational Crops
1,3, 4, 7,8,10
Reserved
860.1900
165-2
Field Rotational Crops
1,3, 4, 7,8,10
Reserved
OTHER DATA REQUIREMENTS
Special Study
Special Study
Leather Leaching Study
1,3, 4, 7,8,10
Data Gap
93
-------
Appendix C. Technical Support Documents
Additional documentation in support of this RED is maintained in the OPP docket,
located in Room S-4400, One Potomac Yard, 2777 South Crystal Drive, Arlington, VA, and is
open Monday through Friday, excluding legal holidays, from 8:30 am to 4 pm.
The docket initially contained the April 19, 2006 preliminary risk assessment and the
related documents. EPA then considered comments on these risk assessments (which are posted
to the e-docket) and revised the risk assessments. The revised risk assessments will be posted in
the docket at the same time as the RED.
All documents, in hard copy form, may be viewed in the OPP docket room or
downloaded or viewed via the Internet at the following site:
http://www.regulations.gov
These documents include:
• 2-(Thiocyanomethylthio) benzothiazole (TCMTB) Risk Assessment (Phase 3 of 4-Phase
Process); Notice of Availability, 4/26/2006
Preliminary Risk Assessment and Supporting Science Documents:
• 2-(Thiocyanomethylthio)benzothiazole (TCMTB) Preliminary Risk Assessment for the
Reregistration Eligibility Decision (RED) Document, 04/19/2006.
• TCMTB. Acute and Chronic Dietary Exposure Assessments for the Reregistration
Eligibility Decision (RED) Document, 02/28/2006. Samuel Ary.
• TCMTB. Summary of Analytical Chemistry and Residue Data for the Reregistration
Eligibility Decision (RED) Document, 2/28/2006. Samuel Ary.
• Incident Reports Associated with 2-(Thiocyanomethylthio)benzothiazole (TCMTB),
04/18/2006. Jonathan Chen.
• Environmental Fate Assessment of 2-(Thiocyanomethylthio)benzothiazole (TCMTB) for
the Reregistration Eligibility Decision (RED) Document, 03/30/2006. Srinivas Gowda.
• Product Chemistry Science Chapter for 2-(Benzpthiazolylthio)methly thiocyanate,
03/31/2006. Chris Jiang.
• Drinking Water Assessment for the Use of the Fungicide of 2-
(Thiocyanomethylthio)benzothiazole (TCMTB) as a Seed Treatment on Cotton, Wheat,
Barley, Oats, Rice, Sugar Beets, and Safflower, 07/31/2006. James Lin.
• Aquatic Exposure Assessment for the Use of the Fungicide of 2-
(Thiocyanomethylthio)benzothiazole (TCMTB) as a Seed Treatment on Cotton, Wheat,
Barley, Oats, Rice, Sugar Beets, and Safflower, 02/16/2006. James Lin
• 2-(Thiocyanomethylthio)benzothiazole (TCMTB)- Report of the Antimicrobials Division
Toxicity Endpoint Selection Committee (ADTC), 04/19/2006. Timothy F. McMahon.
• 2-(Thiocyanomethylthio) benzothiazole (TCMTB) Ecological Hazard and Environmental
Risk Characterization and Environmental Modeling Chapters for the Reregistration
Eligibility Decision (RED) Document (D322613), Edited per Phase I Error Correction
94
-------
Comments and Revised ESA Language, 04/06/2006. Kathryn Montague.
• TCMTB [2-(Thiocyanomethylthio)benzothiazole]: First Revision of the Occupational
and Residential Exposure Assessment for the Reregistration Eligibility Decision
Document. 04/06/2006, Charles Smith.
• Toxicology Disciplinary Chapter for the Reregistration Eligibility Decision (RED) Risk
Assessment, 04/04/2006. Deborah Smegal.
• Occupational and Residential Exposure Assessment for 2-
(Thiocyanomethylthio)benzothiazole TCMTB, 04/18/2006. Siroos Mostaghimi.
Revised Risk Assessment and Supporting Science Documents (RED Supporting Documents):
• 2-(Thiocyanomethylthio) benzothiazole (TCMTB) Risk Assessment for the
Reregistration Eligibility Decision (RED) Document, 08/01/2006.
• 2-(Thiocyanomethylthio) benzothiazole (TCMTB) Ecological Hazard and Environmental
Risk Assessment Chapter-Revised, 08/01/2006. Kathryn Montague
• TCMTB [2-(Thiocyanomethylthio) benzothiazole]: Second Revision of the Occupational
and Residential Exposure Assessment for the Reregistration Eligibility Decision
Document, 07/27/2006. Charles Smith
95
-------
Appendix D. Citations Considered to be Part of the Data Base Supporting the
Reregistration Decision (Bibliography)
1. MRID Studies
MRU)# Citation
00004239 Wilbur-Ellis Company (1979) Residue Data Summary. Unpublished study
including letter dated Oct 16, 1978 from J.H. Stoner to Dave T. Schulteis,
received Feb 6, 1979 under 2935-413; pre-pared in cooperation with
Stoner Laboratories; CDL:237334-A
00004241 Wilbur-Ellis Company (1979) Results of Tests on the Amount of Resi- due
Remaining, Including a Description of the Analytical Method: Nu-Flow
ND. Unpublished study received Feb 6, 1979 under 2935-413;
CDL:237335-B.
00046073 Buckman Laboratories, Incorporated (1975) Analytical Procedures and Results of
Residue Analyses: Busan 30. Undated method. Unpublished study
received Nov 12, 1976 under 7F1885; CDL: 095601-D.
00078556 Buckman Laboratories, Incorporated (1972) Analytical Procedures and Results of
Residue Analyses: Busan 30. Includes undated methods entitled:
Analyses of 2-(thiocyanomethylthio)benzothiazole in soil; Regulatory
method of analysis. Unpublished study re- ceived Mar 26, 1975 under
4F1613; CDL:095525-F.
00112618 Buckman Laboratories, Inc. (1970) Results of Tests on the Amount of Residue
Remaining, Including a Description of the Analytical Method: 2-
(Thiocyanomethylthio)benzothiazole. Compilation; unpublished study
received on unknown date under 0F0954; CDL: 091624-K.
00117874 Buckman Laboratories, Inc. (1967) Study: TCMTB Residues in Selected Grains).
(Compilation; unpublished study received Sep 28, 1972 under 2F1264;
CDL:091795-A.
00124027 Buckman Laboratories, Inc. (19??) Analysis of Grains for Thioben- zothiazole-
Containing Residues. Unpublished study received Oct 20, 1972 under
2F1264; CDL:094858-A.
00136342 Buckman Laboratories, Inc. (19??) Analysis of Grains for Thioben- zothiazole-
Containing Residues. Unpublished study received on unknown date under
2F1264; CDL:097967-A.
96
-------
mrid#
Citation
00138078 Buckman Laboratories, Inc. (1975) Residue Data: Busan 30: Sugar Cane.
Unpublished study received Nov 12, 1976 under 7F1885; CDL:097566-B.
00154295 Goad P. T., et al. 1985. Teratogenicity study of TCMTB in rats. HED Doc no.
005769.
165518 Bonner, G. (1986) Evaluation of Other Genotoxic Effects TCMTB (EPA Reg.
No.: 1448-29): In the Rat Primary Hepatocyte Unscheduled DNA
Synthesis Assay: HBC Project No. 20991. Unpublished study prepared by
Hazleton Biotechnologies Company. 21 p.
165520 Bonner, G. (1986) Evaluation for Structural Chromosomal Aberration of TCMTB
(EPA Reg. No.: 1448-29): Clastogenic Evaluation in the in vivo Mouse
Micronucleus Assay: HBC Project No. 20996. Unpublished study
prepared by Hazleton Biotechnologies Co. 23 p.
009869 Booden, R.M. 1974. Avian Dietary LC50, Mallard Duck, Report #4043620.
Unpublished data, conducted by Warf Institute for Buckman Laboratories,
Memphis, TN.
091624 Knott, W.B., and G. Woodard. 1968a. Busan 72 - Safety Evaluation on
Bobwhite Quail. Unpublished data, conducted by Woodard Research
Corp., for Buckman Laboratories, Inc., Memphis, TN.
091624 Knott, W.B., and G. Woodard. 1968b. Busan 72 - Safety Evaluation on Bluegill
Sunfish and Rainbow Trout. Unpublished data, conducted by Woodard
Research Corp., for Buckman Laboratories, Inc., Memphis, TN
400751-01 Adam, C. P. 1986. TCMTB—A teratology study in rabbits.
400751-02 Adam, C. P. 1986. TCMTB—A teratology study in rabbits.
403636-01 Surprenant, D.C. 1986a. Acute Toxicity of TCMTB to the Sheepshead Minnow,
Cyprinodon variegatus. Unpublished data, conducted by Springborn
Bionomics, Inc., for Buckman Laboratories, Inc., Memphis, TN
403363-02 Surprenant, D.C. 1987. Acute Toxicity of TCMTB to Mysid Shrimp {Mysidopsis
bahia). Unpublished data, conducted by Springborn Bionomics, Inc., for
Buckman Laboratories, Inc., Memphis, TN.
97
-------
mrid#
Citation
403636-03
404193-01
Surprenant, D.C. 1986b. Acute Toxicity of TCMTB to Embryo-Larvae of the
Quahog Clam {Mercenaria mercenaria). Unpublished data, conducted by
Springborn Bionomics, Inc., for Buckman Laboratories, Inc., Memphis,
TN.
Buckman Laboratories, Inc. (1987) Submission of Toxicity Data on TCMTB in
support of EPA Reg. No. 1448-29. Transmittal of 1 study.
408848-01 Cameron, B.D. Scott, G. 1987. The Metabolism of 2-
(Thiocyanomethylthio)benzothiazole (TCMTB) in the rat. Buckman
Laboratories, Inc., Memphis TN. Inveresk Research International Ltd.,
Scotland
413422-01 Goburdhun, R., and Greenough, R.J. 1989. 2-
(Thiocyanomethylthio)benzothiazole (TCMTB): 52-Week dietary toxicity
study in dogs.
413861-01 Lawlor, T.; Respess, C. (1990) Mutagenicity Test on TCMTB in the
Salmonella/Mammalian-microsome Reverse Mutation Assay (Ames Test)
with Confirmatory Assay: Final Report: Lab Project I.D.: 110277-0-401R.
Unpublished study prepared by Hazleton Labora- tories America, Inc.32p.
414714-01 Hazelden, K., PI. and Wilson, J.A. 1988. TCMTB-Two generation reproduction
study in rats. HED Doc 010607
415154-01 Hazleton-Institut Francais de Toxicologie (1990) TCMTB Technical Grade:
Acute Dermal Median Lethal Dose: Lab Project Number: 410211. 48 p.
415157-01 Saxena, A. (1987) Artificial Sunlight Photodegradation of TCMTB in a Buffered
Aqueous Solution: Lab Project Number: HLA 6015-335. Unpublished
study prepared by Hazleton Laboratories America, Inc. 86 p.
415297-01 Everett, D. J. et al. 1989. 104-Week dietary toxicity/carcinogenicity study n rats
with 52-week interim kill.
415703-01 Everett, D. J. et al. 1989. 104-Week dietary toxicity/carcinogenicity study n rats
with 52-week interim kill.
415837-01 Rush, R. (1990) Primary Skin Irritation Study in Rabbits with TCMTB -80 (...):
Lab Project Number: 3138.61. Unpublished study pre- pared by
Springborn Laboratories, Inc. 20 p.
98
-------
MRU)# Citation
415838-01 Rush, R. (1990) Acute Oral Toxicity Study in Rats with TCMTB-80 (.. .): Lab
Project Number: 3138.59. Unpublished study prepared by Springborn
Laboratories, Inc. 63 p.
415956-01 Long, R.D., C.P. Driscoll, K.A. Hoxter, and G.J. Smith. 1990. TCMTB: A
Dietary LC50 Study with the Mallard. Unpublished data, conducted by
Wildlife International, Ltd., for Buckman Laboratories, Inc., Memphis,
TN.
415956-02 Long, R.D., C.P. Driscoll, K.A. Hoxter, and G.J. Smith. 1990. TCMTB: A
Dietary LC50 Study with the Northern Bobwhite. Unpublished data,
conducted by Wildlife International, Ltd., for Buckman Laboratories,
Inc., Memphis, TN.
416120-01 Fues, R.; Conaway, L.; Bowles, D. (1990) Product Chemistry for TCMTB:
Product Identity; Manufacturing Process; Discussion of Impurities).
Unpublished study prepared by Buckman Laboratories International, Inc.
55 p.
416120-02 Fues, R.; Conaway, L.; Bowles, D. (1990) Product Chemistry for TCMTB:
Preliminary Analysis; Certified Limits; Enforcement Ana- lytical
Techniques): Lab Project Number: 101-01. Unpublished study prepared by
Buckman Laboratories International, Inc. 51 p.
416120-03 Bowles, D. (1990) Product Chemistry for TCMTB: (Physical/Chemical
Properties). Unpublished study prepared by Buckman Laboratories
International, Inc. 89 p.
416558-01 Siglin, J. (1990) 21-Day Dermal Toxicity Study in Rats with TCMTB- 80: Final
Report: Lab Project Number: 3138.53. Unpublished stu- dy prepared by
Springborn Laboratories, Inc. 274 p.
417809-01 Campbell, S. 1991. TCMTB: An Acute Oral Toxicity Study with the Northern
Bobwhite." Unpublished data, conducted by Wildlife International, Ltd.,
for Buckman Laboratories, Memphis, TN
418042-01 Machado, M. W. 1991a. TCMTB - Acute Toxicity to Bluegill Sunfish (Lepomis
macrochirus) under Flow-through Conditions. Unpublished data,
conducted by Springborn Laboratories, Inc., for Buckman Laboratories,
Inc., Memphis, TN.
99
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Citation
418181-01 Machado, M. W. 1991b. TCMTB - Acute Toxicity to Rainbow Trout
{Oncorhynchus mykiss) Under Flow-Through Conditions. Unpublished
data, conducted by Springborn Laboratories, Inc., for Buckman
Laboratories, Inc., Memphis, TN
418382-01 McNamara, P.C. 1991. TCMTB - Acute Toxicity to Daphnids {Daphnia magna)
Under Flow- Through Conditions. Unpublished data, conducted by
Springborn Laboratories, Inc, for Buckman Laboratories, Inc., Memphis,
TN.
420597-01 Watson, C. (1991) Product Chemistry for TCMTB. Unpublished study prepared
by Buckman Labs International, Inc. 37 p.
4211653-01 Everett, D. J. et al. 1989. 104-Week dietary toxicity/carcinogenicity study n rats
with 52-week interim kill.
422260-01 Collins, M.K. 1992b. 2-Mercaptobenzothiazole (ROKON) - Acute Toxicity to
Daphnids (Daphnia magna) Under Static Conditions. Unpublished data,
conducted by Springborn Laboratories, Inc., for R.T. Vanderbilt Ct., Inc.,
Norwalk, CT.
422322-01 Collins, M.K. 1992a. 2-Mercaptobenzothiazole (ROKON) - Acute Toxicity to
Rainbow Trout (Oncorhynchus mykiss) Under Static Conditions.
Unpublished data, conducted by Springborn Laboratories, Inc., for R.T.
Vanderbilt Ct., Inc., Norwalk, CT
422671-01 Pedersen, C.A., and B.R. Helsten. 1992a. 2-Mercaptobenzothiazole (ROKON):
14-day Acute Oral LD50 Study in Bobwhite Quail. Unpublished data,
conducted by Bio-Life Associates, Ltd., for RT. Vanderbilt Co., Inc.,
Norwalk, CT.
423245-01 Whetzel, J. (1992) Determination of the Octanol/Water Partition Coefficient of
TCMTB: Lab Project Number: 94/91-BUC.24. Un- published study
prepared by Twin City Testing Corp. 30 p.
423492-01 Karcher, R.; Siglin, J.; Becci, P. (1986) Delayed Contact Hypersensitivity Study
in Guinea Pigs with HPMTS: Lab Project Number: 3138.7. Unpublished
study prepared by Springborn Institute for Bioresearch, Inc. 55 p.
423768-01 Raub, M.; Valle, H. (1992) Uptake and Translocation of carbon 14| Busan 30A
Used in Seed Treatment: Combustion Analysis Phase: Lab Project
Number: 39601. Unpublished study prepared by ABC Labs, Inc. 34 p.
100
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MRU)# Citation
423833-01 Everett, D.J., et al. 1990. 2-(Thiocyanomethylthio)benzothiazole-104-Week
423861-01 Fathulla, R.N. 1992. Hydrolysis of 14C-TCMTB in Aqueous Buffer Solutions.
Unpublished data. Conducted by Hazleton Wisconsin, Inc. for Buckman
Laboratories International, Inc.
424074-01 Whetzel, J. (1992) Determination of the Boiling Point of TCMTB: Supp.|: Lab
Project Number: 1002-001. Unpublished study prepared by Twin City
Testing Corp. 19 p.
424185-01 Blasberg, J.W., S.L. Hicks and L.S. Stuerman. 1992. Uptake, Depuration, and
Bioconcentration of 14C-TCMTB by Bluegill Sunfish Lepomis
macrochirus. Unpublished data. Conducted by ABC Laboratories, Inc.
for Buckman Laboratories International, Inc.
424285-01 Pedersen, C.A., and B.R. Helsten. 1992b. 2-Mercaptobenziothiazol (ROKON):
8-Day Acute Dietary LC50 Study in Bobwhite Quail. Unpublished data,
conducted by Bio-Life Associates, Ltd., for RT. Vanderbilt Co., Norwalk,
CT.
424932-01 Falb, L. And Stewart, R.C. 1992. Metabolism of [14C]TCMTB in Water and Fish
Tissue. Unpublished data. Conducted by ABC Laboratories, Inc. for
Buckman Laboratories International, Inc.
425086-01 Fathulla, R.N. 1992. Aerobic Aquatic Metabolism of TCMTB. Unpublished
data. Conducted by Hazleton Wisconsin, Inc. for Buckman Laboratories
International, Inc.
425929-01 Rhodes, J.E. 1992. Early Life-Stage Toxicity of 2-
(Thiocyanomethylthio)benzothiazole (TCMTB) to the Rainbow Trout
Under Flow-Through Conditions. Unpublished data, conducted b ABC
Laboratories, Inc., for Buckman Laboratories International, Inc.,
Memphis, TN.
426309-01 Fathulla, R.N. 1993. Artificial Sunlight Photodegradation of 14C-TCMTB in an
Aqueous Buffer Solution. Unpublished data. Conducted by Hazleton
Wisconsin, Inc. for Buckman Laboratories International, Inc.
426314-01 Fathulla, R.N. 1992. The Adsorption and Desorption of 14C-TCMTB on
Representative Agricultural Soils. Unpublished data. Conducted by
Hazleton Wisconsin, Inc. for Buckman Laboratories International, Inc.
101
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Citation
428154-01 Fathuella, R.N. 1993. Anaerobic Aquatic Metabolism of 14C-TCMTB.
Unpublished data. Conducted by Hazleton Wisconsin, Inc. for Buckman
Laboratories International, Inc.
43112801 Atkinson, C., et al. 1987. 2-(Thiocyanomethylthio)benzothiazole (TCMTB). 13-
Week dietary dose range finding study in rats.
431472-01 Raub, M. (1994) Uptake and Translocation of (carbon 14)-Busan 30A Used in
Seed Treatment: Addendum Report: Lab Project Number: 39601 A.
Unpublished study prepared by ABC Labs., Inc. 13 p.
434376-01 Lowrie, C. 1994. Hydrolysis of (cyano-(14C))-TCMTB in Aqueous Buffer
Solution. Unpublished data. Conducted by Hazleton Wisconsin, Inc. for
Buckman Laboratories International, Inc.
435322-01 Fathulla, R.N. 1994. Aerobic Soil Metabolism of 14C-TCMTB. Unpublished
data. Conducted by Hazleton Wisconsin, Inc. for Buckman Laboratories
International, Inc.
441198-02 Duguet J.S. and V. Dartigues. 1988. Evaluating Possibilities of Leaching of
Deltamethrin and TCMB (Insecticide and Fungicide for Protecting Wood)
by Rain Water or by Soaking in Water. Unpublished data. Conducted by
IRG Secretariat, Sweden for AgrEvo Environmental Health.
442009-01 Thompson, S.G., and J.P. Swigert. 1996. TCMTB: A 14-Day Static-Renewal
Toxicity Test with Duckweed (Lemna gibba). Unpublished data,
conducted by Wildlife International, Ltd., for Buckman Laboratories
International, Inc., Memphis, TN.
445013-01 Singer, G. (1998) Nature of the Residue from (carbon 14)-TCMTB in/on
Tomatoes after Soil-Drench Applications: Final Report: Lab Project
Number: AA960317: XBL96101. Unpublished study prepared by
American Agricultural Services, Inc. and XenoBiotic Labs. 26 p.
445013-02 Singer, G. (1998) Nature of the Residue from (carbon 14)-TCMTB in/on Melons
after Soil-Drench Applications: Final Report: Lab Project Number:
AA960318: XBL96101. Unpublished study prepared by American
Agricultural Services, Inc. and XenoBiotic Labs. 26 p.
102
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MRU)# Citation
446541-01 Singer, G. (1998) Nature of the Residue from (carbon-14)-TCMTB in/on Melons
after Soil-Drench Applications: Final Report: Lab Project Number:
AA960318: XBL96101: AA960318.NC. Unpublished study prepared by
American Agricultural Services, Inc. and XenoBiotic Laboratories. 268 p.
446541-02 Singer, G. (1998) Nature of the Residue from (carbon-14)-TCMTB in/on
Tomatoes after Soil-Drench Applications: Final Report: Lab Project
Number: XBL96101: AA960317. Unpublished study prepared by
American Agricultural Services, Inc. and XenoBiotic Laboratories. 257 p.
455243-04 Bestari KT, Macey K, Soloman KR, Tower N. 1999. Measurement and
Assessment of Dermal and Inhalation Exposures to Didecyl Dimethyl
Ammonium Chloride (DDAC) Used in the Protection of Cut Lumber
(Phase III).
467052-01 Blasberg, J.W., S.L. Hicks and L.S. Stuerman. 1992. Uptake, Depuration, and
Bioconcentration of 14C-TCMTB by Bluegill Sunfish Lepomis
macrochirus. Unpublished data. Conducted by ABC Laboratories, Inc.
for Buckman Laboratories International, Inc. Supplemental Information in
Response to Chris Jiang's DERs for Bioaccumulation Study of TCMTB
MRID Nos. 424185-01 & 424932-01.
467110-01 Byrne, A. and D.R. Minchin. (1989) Leaching of TCMTB from Packaged
Lumber. Prepared for Buckman Laboratories of Canada by Forintex
Canada Corporation, Western Region, 6620 N.W. Marine Drive,
Vancouver, B.C. V6T 1X2. Contract No. 17-86-K-409.
467111-01 Beck, Maureen; Hartmann, FE; May, JH; Reid, TC. 1996. Leachability Study....
(leaching of TCMTB from wood blocks). Buckman Laboratories, Inc.,
Memphis, TN. Control no. 452779.dietary carcinogenicity study in mice.
HEDDoc. 010332.
92179008 Goburdhun, R., and Greenough, R.J. 1989. 2-
(Thiocyanomethylthio)benzothiazole (TCMTB): 52-Week dietary toxicity
study in dogs.
92179009 Goad P. T., et al. 1985. Teratogenicity study of TCMTB in rats. HED Doc no.
005769.
92179011 Adam, C. P. 1986. TCMTB—A teratology study in rabbits.
103
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mrid#
Citation
92179011 Hazelden, K., PI. and Wilson, J. A. 1988. TCMTB-Two generation reproduction
study in rats. HED Doc 010607
92179026 Rao, G., No. 1980. 90-Day subchronic oral toxicity study of TCMTB in rats
2. Open Literature
Chew, G.L., G.M. Kruzynski, and I.K. Birtwell. Behavioral assessment of exposure of
juvenile Chinook salmon (Oncorhynchus tshawtscha) to sublethal doses of a toxicant. In
Proceedings of the Seventeenth Annual Aquatic Toxicity Workshop, Nov. 5-7, 1990,
Vancouver, BC, Vol. 1. (edited by P. Chapman, F. Bishay, E. Power, K. Hall, L. Harding,
D. Mcleay, M. Nassichuk and W. Knapp). Canadian Technical report of Fisheries and
Aquatic Sciences, No. 1774 (vol 1).
Freeman, N , Jimenez M, Reed KJ,Gurunathan S, Edwards RD, Roy A, Adgate JL, Pellizzari
ED, Quackenboss J, Sexton K, Lioy PJ, 2001. Quantitative analysis of chilren's
microactivity patterns: The Minnesota Children's Pesticide Exposure Study. Journal of
Exposure Analysis and Environmental Epidemiology. 11(6): 501-509.
HERA, 2005. Human and Environmental Risk Assessment, Guidance Document Methodology,
February 2005 (http://www.heraproject.com).
The Multi-Chamber Concentration and Exposure Model (MCCEM) Model Version 1.2.
Prepared for the US EPA Office of Pollution Prevention and Toxics. Prepared by Versar,
Inc. and Wilkes Technologies, LLC.
Karickhoff SW, DS Brown, TA Scott, 1979. Sorption of Hydrophobic Pollutants on Natural
Sediments. Water Resources. 13:241-248.
Krahn P and Strub R, 1990. Standard Leaching Test for Antisapstain Chemicals: Regional
Program Report 90-10. Environment Canada, Conservation and Protection, Pacific and
Yukon Region North Vancouver, BC.
Kruzynski, G.M., and I.K. Birtwell. 1990. Some Respiratory Responses of Juvenile Pacific
Salmon to the Antisapstain Chemical TCMTB. Proceedings of the Seventeenth Annual
Aquatic Toxicity Workshop. Nov. 5-7. 1990. Vancouver. BC. Vol. 1. (edited by P.
Chapman, F. Bishay, E. Power, K. Hall, L. Harding, D. Mcleay, M. Nassichuk and W.
Knapp). Canadian Technical report of Fisheries and Aquatic Sciences, No. 1774 (vol 1).
Kruzynski, G.M., I.K. Birtwell, G.L. Chew, G.E. Piercey,and S. Spohn. 1990. An approach to
testing for ecological relevance using behavioral toxicology. Proceedings of the
Seventeenth Annual Aquatic Toxicity Workshop. Nov. 5-7. 1990. Vancouver. BC. Vol.
L. (edited by P. Chapman, F. Bishay, E. Power, K. Hall, L. Harding, D. Mcleay, M.
104
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Nassichuk and W. Knapp). Canadian Technical report of Fisheries and Aquatic Sciences,
No. 1774 (vol 1).
Manninen, A., Auriola S, Vartiainen M., Leisivuori J., Turunen, T., Pasanen M. 1996.
Determination of urinary 2-mercaptobenzothiazole (2-MBT), the main metabolite of 2-(
thiocyanomethylthio)benzothiazole (TCMTB) in humans and rats.
Mineau, P., B.T. Collins, and A. Baril. 1996. On the Use of Scaling Factors to Improve
Interspecies Extrapolation of Acute Toxicity in Birds. Regul Toxicol Pharmacol 24; 24-
29.
USDA's Continuing Surveys of Food Intakes by Individuals (CSFII), 1994-1996 and 1998.
3. Website References
Aschacher G and Gruendlinger R, 2000. Methods to evaluate the ecotoxicological risks of anti-
sapstain preservatives. Holzforschung, Austria Research and Development,
www. holzforschung. at/english/img_eng/ascha200. pdf
Addinsoft, 2004. XLSTAT v7.5. http://www.xlstat.com
Do It Yourself, 2005. What You Need to Know When Carpet Shopping.
http://doitvourself.com/carpet/carpetshopping. htm. (September 2005).
FIRST (version 1.0; Aug. 1, 2001) Screening Model.
http://www.epa.gov/oppefedl/models/water/
Terrestrial Residue Exposure Model (TREX). (http://www.epa.gov/oppefed 1 /models/terrestrial).
Tier 1 models: GENEEC (version 2.0; Aug. 1, 2001) and SCI-GROW (version 2.3;
Nov. 4, 2003) screening models, http://www.epa.gov/oppefedl/models/water/.
USEPA. 2000. Information on Assessing Exposure from Pesticides, "A User's Guide."
http://www.epa.gov/fedrgstr/EPA-PEST/2000/Julv/Dav-12/6Q61.pdf
USEPA. 2004. PBT Profiler: Assessing Chemicals in the Absence of Data, vl.203.
http://www.pbtprofiler.net/default.asp. (January 2006).
4. Internal Documents and Models
USEPA. 1979. TN 2432. Biological Report of Analysis, 90+ TCMTB, sample MB618.
Unpublished data, performed by US EPA Terrestrial and Aquatic Biology Laboratory.
USEPA. 1979. TN 2427. Biological Report of Analysis, 90+ TCMTB, sample MB618.
105
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Unpublished data, performed by US EPA Terrestrial and Aquatic Biology Laboratory.
USEPA. 1980. TN 2437. Biological Report of Analysis, 90+ TCMTB, sample MB618.
Unpublished data, performed by US EPA Terrestrial and Aquatic Biology Laboratory.
USEPA. 1997. Exposure Factors Handbook. Volume I-II. Office of Research and
Development. Washington, D.C. EPA/600/P-95/002Fa. August 1997.
USEPA. 1998. PHED Surrogate Exposure Guide. Estimates of Worker Exposure from the
Pesticide Handler Exposure Database Version 1.1. Washington, DC: U.S.
Environmental Protection Agency.
USEPA. 1999. Evaluation of Chemical Manufacturers Association Antimicrobial Exposure
Assessment Study (Amended on 8 December 1992). Memorandum from Siroos
Mostaghimi, PH.D., USEPA to Julie Fairfax, USEPA. Dated November, 4 1999. DP
Barcode D247642.
USEPA. 2000. Residential SOPs. EPA Office of Pesticide Programs Human Health Effects
Division. Dated April 5, 2000.
USEPA. 2000. Information on Assessing Exposure from Pesticides, "A User's Guide."
http://www.epa.gov/fedrgstr/EPA-PEST/2000/Julv/Dav-12/6Q61.pdf
USEPA. 2001. HED Science Advisory Council for Exposure. Policy Update, November 12.
Recommended Revisions to the Standard Operating Procedures (SOPs) for Residential
Exposure Assessment, February 22, 2001.
USEPA, March 2, 2004. Health Effects Division Science Advisory Committee on Exposure
(HED ExpoSAC) SOP #15: "Amount of Seed Treated or Planted per Day."
USEPA. 2004. WLM recommendation regarding chemical generalization. Memorandum to
Siroos Mostaghimi, from Lee R. December 15, 2004.
USEPA. 2004. Overview of the Ecological Risk Assessment Process in the Office of Pesticide
Programs U.S. Environmental Protection Agency - Endangered and Threatened Species
Effects Determinations, January 23, 2004.
USEPA, 2004. Wood Leaching Model: Chemical Concentration Screening Tool, vl.0.
USEPA/OPPT/AD, developed by Versar, Inc.
USEPA. 2004. PBT Profiler: Assessing Chemicals in the Absence of Data, vl.203.
http://www.pbtprofiler.net/default.asp. (January 2006).
USEPA. 2006. 2-(thiocyano methyl ethylthio) benzothaizole (TCMTB)- report of the
106
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Antimicrobials Division Toxicity Endpoint Selection Committee (ADTC). Memorandum
from Timothy McMahon to Deborah Smegal. April 4, 2006.
USEPA. 2006. Office of Pesticide Programs internal memorandum, "Aquatic Exposure
Assessment for the Use of the Fungicide of 2-(Thiocyanomethylthio)benzothiazole
(TCMTB) as a Seed Treatment on Cotton, Wheat, Barley, Oats, Rice, Sugar Beets, and
Safflower," February 16, 2006.
USEPA. 1/11/2006. Deschamp, P,"Report of the RARC."
Dietary Exposure Evaluation Model Software with the Food Commodity Intake Database
(DEEM-FCID™, Version 2.03).
FDA Center for Food Safety & Applied Nutrition's (CFSAN), 4/2002. "Preparation of Food
Contact Notifications and Food Additive Petitions for Food Contact Substances:
Chemistry Recommendations."
FIRST (version 1.0; Aug. 1, 2001) Screening Model.
http://www.epa.gov/oppefedl/models/water/.
Terrestrial Residue Exposure Model (TREX) (http://www.epa.gov/oppefedl/models/terrestrian.
Tier 1 models: GENEEC (version 2.0; Aug. 1, 2001) and SCI-GROW (version 2.3;
Nov. 4, 2003) screening models, http://www.epa.gov/oppefedl/models/water/.
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Appendix E. Generic Data Call-In
The Agency intends to issue a Generic Data Call-In at a later date. See Chapter V of the
TCMTB RED for a list of studies that the Agency plans to require.
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Appendix F. Product Specific Data Call-In
The Agency intends to issue a Product Specific Data Call-In at a later date.
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Appendix G. Batching of TCMTB Products for Meeting Acute Toxicity Data
Requirements for Reregistration
The Agency will complete the batching for TCMTB at a later date.
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Appendix H. List of All Registrants Sent the Data Call-In
A list of registrants sent the data call-in will be posted at a later date.
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Appendix I. List of Available Related Documents and Electronically Available Forms
Pesticide Registration Forms are available at the following EPA internet site:
http ://www. epa. gov/ opprdOO 1 /forms/.
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions
1. Print out and complete the forms. (Note: Form numbers that are bolded can be
filled out on your computer then printed.)
2. The completed form(s) should be submitted in hardcopy in accord with the
existing policy.
3. Mail the forms, along with any additional documents necessary to comply with
EPA regulations covering your request, to the address below for the Document
Processing Desk.
DO NOT fax or e-mail any form containing 'Confidential Business Information' or
'Sensitive Information.'
If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-
5551 or by e-mail at williams.nicole@epamail.epa.gov.
The following Agency Pesticide Registration Forms are currently available via the
internet at the following locations:
8570-1
Application for Pesticide Registration/Amendment
http://www.era.gov/opprd001/forms/8570-l.pdf
8570-4
Confidential Statement of Formula
http://www.epa. gov/opprdOO l/forms/8570-4.pdf
8570-5
Notice of Supplemental Registration of Distribution of
a Registered Pesticide Product
http://www.epa. gov/opprdOO l/forms/8570-5.pdf
8570-17
Application for an Experimental Use Permit
http://www.epa.gov/opprd001/forms/8570-17.pdf
8570-25
Application for/Notification of State Registration of a
Pesticide To Meet a Special Local Need
http://www.epa.gov/opprd001/forms/8570-25.pdf
8570-27
Formulator's Exemption Statement
http://www.epa. gov/opprdOO l/forms/8570-27.pdf
8570-28
Certification of Compliance with Data Gap Procedures
http://www.epa. gov/opprdOO l/forms/8570-28.pdf
8570-30
Pesticide Registration Maintenance Fee Filing
http://www.epa. gov/opprdOO l/forms/8570-30.pdf
8570-32
Certification of Attempt to Enter into an Agreement
with other Registrants for Development of Data
http://www.epa. gov/opprdOO l/forms/8570-32.pdf
8570-34
Certification with Respect to Citations of Data (in PR
Notice 98-5)
http://www.epa.gov/opppmsdl/PR Notices/pr98-
5.pdf
8570-35
Data Matrix (in PR Notice 98-5)
http://www.epa.gov/opppmsdl/PR Notices/pr98-
5.pdf
8570-36
Summary of the Physical/Chemical Properties (in PR
Notice 98-1)
http://www.epa.gov/opppmsdl/PR Notices/pr98-
l.pdf
8570-37
Self-Certification Statement for the Physical/Chemical
Properties (in PR Notice 98-1)
http://www.epa.gov/opppmsdl/PR Notices/pr98-
l.pdf
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Pesticide Registration Kit
www.epa.gov/pesticides/registrationkit/.
Dear Registrant:
For your convenience, we have assembled an online registration kit that contains the
following pertinent forms and information needed to register a pesticide product with the U.S.
Environmental Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal
Food, Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality
Protection Act (FQPA) of 1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program—Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through
Irrigation Systems (Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f. 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation
Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This
document is in PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsd 1/PR Notices.
3. Pesticide Product Registration Application Forms (These forms are in PDF format
and will require the Acrobat reader.)
a. EPA Form No. 8570-1, Application for Pesticide
Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
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4. General Pesticide Information (Some of these forms are in PDF format and will
require the Acrobat reader.)
a. Registration Division Personnel Contact List
b. Biopesticides and Pollution Prevention Division (BPPD) Contacts
c. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data
Requirements (PDF format)
e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF
format)
f. 40 CFR Part 158, Data Requirements for Registration (PDF format)
g. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27,
1985)
Before submitting your application for registration, you may wish to consult some
additional sources of information. These include:
1. The Office of Pesticide Programs' Web Site
2. The booklet "General Information on Applying for Registration of Pesticides in
the United States", PB92-221811, available through the National Technical
Information Service (NTIS) at the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000. Please note that EPA is currently in
the process of updating this booklet to reflect the changes in the registration program resulting
from the passage of the FQPA and the reorganization of the Office of Pesticide Programs. We
anticipate that this publication will become available during the Fall of 1998.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue
University's Center for Environmental and Regulatory Information Systems. This
service does charge a fee for subscriptions and custom searches. You can contact
NPIRS by telephone at (765) 494-6614 or through their Web site.
4. The National Pesticide Telecommunications Network (NPTN) can provide
information on active ingredients, uses, toxicology, and chemistry of pesticides.
You can contact NPTN by telephone at (800) 858-7378 or through their Web site:
ace. or st. edu/info/nptn.
The Agency will return a notice of receipt of an application for registration or amended
registration, experimental use permit, or amendment to a petition if the applicant or petitioner
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encloses with his submission a stamped, self-addressed postcard. The postcard must contain the
following entries to be completed by OPP:
Date of receipt
EPA identifying number
Product Manager assignment
Other identifying information may be included by the applicant to link the
acknowledgment of receipt to the specific application submitted. EPA will stamp the date of
receipt and provide the EPA identifying File Symbol or petition number for the new submission.
The identifying number should be used whenever you contact the Agency concerning an
application for registration, experimental use permit, or tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly coded and
assigned to your company, please include a list of all synonyms, common and trade names,
company experimental codes, and other names which identify the chemical (including "blind"
codes used when a sample was submitted for testing by commercial or academic facilities).
Please provide a CAS number if one has been assigned.
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