?/EPA
United States Prevention, Pesticides EPA 739-R-08-005
Environmental Protection and Toxic Substances June 2008
Agency (751 OP)
Reregistration Eligibility Decision for
the Tributyltin Compounds:
Bis(tributyltin) oxide,
Tributyltin benzoate, and
Tributyltin maleate
(Case 2620)
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
CERTIFIED MAIL
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 tributyltin derivatives,
(bis)tributyltin oxide, tributyltin benzoate, and tributyltin maleate (collectively known as
"tributyltin" or "TBT"). Based on its review, EPA is now releasing its Reregi strati on Eligibility
Decision (RED) and risk management decision for tributyltin. The enclosed Reregi strati on
Eligibility Decision (RED) document was approved on June 30, 2008.
A Notice of Availability will be published in the Federal Register announcing the release
of the RED. The RED and supporting risk assessments for tributyltin are available to the public
on the U.S. Federal Government website www.regulations.gov. The docket is EPA-HQ-OPP-
2008-0171.
The tributyltin RED was developed through EPA's public participation process,
described in the Federal Register on September 10, 2004, which provides opportunities for
public involvement in the Agency's pesticide tolerance reassessment and reregi strati on
programs. Developed in partnership with USDA and with input from EPA's advisory
committees and others, the public participation process encourages robust public involvement
starting early and continuing throughout the pesticide risk assessment and risk mitigation
decision making process. The Agency tailors the public participation process 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. The
public participation process for the TBT RED provided for the consideration of public comment
on the preliminary risk assessments and ideas for risk mitigation. The Agency has now revised
the assessments based on substantive comments submitted during the public comment period, or
otherwise addressed such comments in a response to comments document. No comments were
submitted on ideas for risk mitigation, but the Agency has provided additional opportunity for
discussion with the registrants on risk mitigation measures proposed by the Agency.
Please note that the tributyltin risk assessments and the enclosed RED document concern
only this particular pesticide. This RED presents the Agency's conclusions on the dietary,
drinking water, occupational, residential and ecological risks posed by exposure to TBT alone.
This document also identifies both generic and product-specific data that the Agency intends to
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require via Data Call-In Notices (DCIs). The DCIs and instructions for responding will be sent
to registrants at a later date.
The Agency has determined that most tributyltin uses will be eligible for reregistration
provided that all the conditions identified in this document are satisfied. The Agency has
determined that some uses of tributyltin are not eligible for reregistration, based on a
consideration of the risks and benefits associated with those uses and the adequacy of the
database supporting them. Sections IV and V of this RED document explain the eligibility
decision for each use, and for those uses that are eligible, describe the necessary labeling
amendments and data requirements. Instructions for registrants on submitting the revised
labeling will accompany the product-specific DCI associated with this RED.
If you have questions on this document or the label changes relevant to this reregistration
decision, please contact the Chemical Review Manager, Jill Bloom, at (703) 308-8019. For
questions about product reregistration and/or the Product DCI that will follow this document,
please contact Marshall Swindell at (703) 308-6341.
Sincerely,
Sanders
Director, Antimicrobials Division
Enclosure
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REREGISTRATION ELIGIBILITY DECISION
for the Tributyltin Compounds:
Bis(tributyltin) oxide, Tributyltin benzoate, and Tributyltin maleate
List D--CASE 2620
Approved By:
Frank T. Sanders
Director, Antimicrobials Division
June 30, 2008
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TABLE OF CONTENTS
Tributyltin Reregistration Team i
Glossary of Terms and Abbreviations ii
Abstract iv
I. Introduction 1
II. Chemical Overview 2
A. Regulatory History 2
B. Chemical Identification 2
C. Chemical Structures 3
D. Use Profile 4
1. Type of Pesticide 4
2. Use Sites 4
III. Summary of Risk Assessments 7
A. Human Health Risk Assessment 7
1. Hazard profile 7
a) Acute toxicity 7
b) Endpoint selections; database uncertainty factor 8
c) FQPA considerations 10
d) Endocrine disruption 10
2. Incident reports 12
3. Dietary and drinking water risk summary 12
a) Residues in Food 12
b) Residues in drinking water 13
4. Occupational and residential risk assessment 13
a) Residential handler exposures 13
b) Residential post-application exposures 13
c) Residential risk characterization 14
5. Aggregate risk 15
6. Cumulative Exposure and Risk 16
7. Occupational Exposure and Risk 16
a) Occupational handler exposure scenarios 16
b) Occupational post-application exposure scenarios 17
c) Occupational risk characterization 17
B. Environmental Risk Assessment 18
1. Ecological toxicity for wildlife species 18
a) Acute and dietary toxicity to birds and mammals 19
b) Non-target insects - honeybees 19
c) Acute toxicity — freshwater fish 19
d) Acute toxicity — freshwater invertebrates 19
e) Estuarine and marine fish and invertebrates, acute toxicity 19
f) Chronic toxicity for aquatic organisms 19
2. Acute and chronic sediment toxicity 20
3. Aquatic plants 20
C. Environmental risk assessment criteria 20
D. Aquatic and Terrestrial Risk Characterization 21
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E. Endangered species considerations 23
IV. Reregistration Eligibility and Risk Management Decisions 23
A. Determination of reregi strati on eligibility 24
B. Public comments and responses 25
C. Regulatory Rationale 26
1. Human Health Risk Management 26
a) Dietary (food) and drinking water risk mitigation 26
b) Related issues; risks to domestic animals 28
c) Residential risk mitigation 28
Wood preservative handlers 28
d) Aggregate risk 29
e) Occupational risk mitigation—handlers 29
f) Occupational risk mitigation—post-application 33
2. Environmental risk management 34
a) Recirculating cooling towers 35
b) Wood preservatives 36
c) Disinfectant for farm premises 36
d) Oil field and petrochemical injection 37
e) Irrigation tubing 37
f) Antifouling for sonar domes and oceanographic instruments 37
3. Labeling requirements 37
4. Listed species considerations 38
5. General risk mitigation 38
V. What Registrants Need to Do 38
A. Manufacturing use products 40
1. Generic Data Requirements 40
2. Labeling for technical and manufacturing use products 42
B. End-use products 42
1. Product-specific data requirements 42
2. Labeling for end-use products 42
3. Label changes summary table 42
VI. APPENDICES 48
Appendix A. Table of Representative Use Patterns for TBTO, TBTB, TBTM 1
Appendix B. Generic Data and Studies Used for the Reregistration Decision 2
Appendix C. Technical Support Documents 1
Appendix D. Bibliography 1
Appendix E. Generic Data Call-In 1
Appendix F. Product Specific Data Call-In 1
Appendix G. Batching of TBT End-use Products 1
Appendix H. List of All Registrants Sent the Data Call-In 1
Appendix I. List of Available Forms 1
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Tributyltin Reregistration Team
Health Effects Risk Assessment
Cassi Walls, Ph.D.
Talia Lindheimer
Timothy Leighton
Michelle Centra
Jonathon Chen
Yung Yang, Ph.D.
Ecological Risk Assessment
William Erickson, Ph.D.
Environmental Fate Risk Assessment
James Breithaupt
Siroos Mostaghimi, Ph.D.
Registration Support
Marshall Swindell
Risk Management
Jill Bloom
Diane Isbell
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Glossary of Terms and Abbreviations
a.i., ai 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
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 Disrupter Screening Program
EDSTAC Endocrine Disrupter 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
LC50 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
LOG Level of Concern
LOEC Lowest Observed Effect Concentration
mg/kg/day Milligram Per Kilogram Per Day
MOE Margin of Exposure
MP Manufacturing-Use Product
11
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MRID Master Record Identification (number)~EPA's system of recording and tracking studies
submitted.
MRL Maximum Residue Level
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 Organophosphate
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
PDF USDA Pesticide Data Program
PF10 Protections 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
USDA United States Department of Agriculture
USFWS United States Fish and Wildlife Service
USGS United States Geological Survey
WP S 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 bis(tributyltin) oxide, tributyltin benzoate, and
tributyltin maleate (collectively, "tributyltin" or "TBT") and is issuing its risk management
decision. The risk assessments, which are summarized below, are based on review of registrant-
submitted data supporting the use patterns of currently registered products, citations from the
open literature, and additional information received through the public docket. The risk
assessments have been revised, as needed, according to information received since they were
first made available to the public in April 2008. After considering the risk assessments, available
information about alternatives to TBT for specific uses, public comments, and risk mitigation
options, the Agency developed its risk management decision for uses of tributyltin. As a result
of this review, EPA has determined that some uses of tributyltin are eligible for reregi strati on,
provided that the prescribed risk mitigation measures are adopted and labels are amended
accordingly, and required data are submitted. Other uses are not eligible for reregi strati on, based
on a combination of critical data gaps and unacceptable risks. The decision and the associated
risk mitigation measures are discussed fully in this document.
IV
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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.
This document presents the Agency's revised human health and ecological risk
assessments and the Reregistration Eligibility Decision (RED) for tributyltin. The tributyltin
case consists of three active ingredients: bis(tributyltin) oxide (PC code 083001), tributyltin
benzoate (083106), and tributyltin maleate (083118). There are currently 35 registered products
and two pending registrations containing these three active ingredients. There are no pesticide
inert uses for any of the three TBT compounds. The first pesticide product containing tributyltin
was registered in 1961.
The tributyltin compounds act as fungicides, disinfectants, microbiocides, and
microbiostats. They are used in water cooling towers, wood preservatives, hard surface
disinfectants for farm premises; as materials preservatives in textiles, carpet backing, sponges,
rope, fiberfill, foam, paper, and building materials (e.g., drywall, joint compound, grout); metal
working fluids; and petrochemical injection fluids.
Some of the labeled uses for the tributyltin-containing chemicals have the potential to
result in direct or indirect food exposures or other residential exposures that may impact children.
Based on published literature studies on the immunotoxicity of tributyltin oxide and uncertainties
surrounding the endpoint, the Agency believes that application of a database uncertainty factor is
warranted. A database uncertainty factor of 10X has been applied to the endpoint dose (BMDio =
0.03 mg/kg/day) selected for the residential exposure scenarios.
This document presents the Agency's decision regarding the reregistration eligibility of
the registered uses of tributyltin. It includes summary information derived from the more
detailed risk assessments that serve as support documents for the RED. The risk assessments are
not provided as attachments to this document, but are available in the Public Docket at
www.regulations.gov (Docket ID #EPA-HQ-OPP-2008-0171). To access these documents on
the electronic docket, go to www.regulations.gov. Select advanced docket search (right side of
page). For Docket ID, enter OPP-2008-0171 and then submit (bottom of page). Double-click on
the blue underlined Docket number for a listing of all the documents in that docket. Support
documents can also be obtained by request from the Office of Pesticide Programs Regulatory
Public Docket. The Docket Facility telephone number is (703) 305-5805.
1
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This document consists of six sections. Section I is the Introduction. Section II provides
a chemical overview, a profile of the use of the tributyltin compounds, and their regulatory
history. Section III gives a summary of the human health and environmental risk assessments
for tributyltin. Section IV presents the reregi strati on eligibility decision and describes the risk
management approach for TBT. Section V details the changes needed to product labels to
implement the risk mitigation measures outlined in Section IV, and the data required to support
the eligible uses of TBT. Finally, the Appendices list all use patterns eligible for reregi strati on,
bibliographic information, related documents and how to access them, and Data Call-In (DCI)
information.
II. Chemical Overview
A. Regulatory History
The tributyltin case consists of three compounds: bis(tributyltin) oxide (PC code
083001), tributyltin benzoate (083106), and tributyltin maleate (083118). There are no inert
uses of TBT in pesticides. Table I show the number of registrations associated with each active
ingredient.
Table 1. Number of Active and Pending Registrations for TBT AIs
Active ingredient
bis(tributyltin) oxide
tributyltin benzoate
tributyltin maleate
Manufacturing-use Products
4
0
0
End-use Products
28
2
1
Pending
1
0
1
The first pesticides containing tributyltin were registered in the 1960s, for use in
antifouling paints. Adverse ecological effects associated with TBT antifouling paints captured
global attention in the 1980s. In 2005, the Agency implemented the cancellation of last TBT
registration for ship hull antifouling. An international treaty prohibiting the use of TBT hull
coatings becomes effective in September 2008.
The three existing tributyltin active ingredients serve as fungicides, disinfectants,
microbiocides, and microbiostats in a number of commercial and residential applications. They
are used in water cooling towers, wood preservatives, hard surface disinfectants for farm
premises; as materials preservatives in textiles, carpet backing, sponges, rope, fiberfill, foam,
paper, and building materials (e.g., drywall, joint compound, grout); metal working fluids; and
petrochemical injection fluids.
B. Chemical Identification
Common Names: bis(tributyltin) oxide (TBTO)
tributyltin benzoate (TBTB)
tributyltin maleate (TBTM)
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Chemical Names:
CAS Registry Number:
Molecular Formula:
Highest % ai in EUP:
TB TO—hexabuty 1 di stannoxane
TB TB—stannane, (b enzoy 1 oxy)tributy 1 -
TBTM—stannane, tributyl(3-carboxyacryloyl)oxy
TB TO—56-35-9
TBTB—4342-36-3
TBTM-4027-18-3 ("mono" form; incorrectly cited by
some sources as 4275-57-1, which is the "bis" form)
TBTO-C24H54OSn2
TBTB-Ci9H32O2Sn
TBTM-Ci6H3oO4Sn
TBTO—29%
TBTB—45.5%
TBTM—25%
C. Chemical Structures
TBTO
TBTB
TBTM
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Table 2. Chemical Properties of TBT Compounds
Property
Molecular Weight
Boiling Point
Melting Point
Vapor Pressure @ 25 C,
mm Hg
Log Kow
Log Koc
Solubility in water, mg/L
Half-life in water
Half-life in air
TBTO
596.12
417 C
132C
7.8 x 10'06
3.84
7.57
0.0896
2.49 hrs
0.125 days
TBTB
411.18
390 C
128 C
1.34x 10'06
4.69
5.10
0.257
2. 172 hrs
0.241 days
TBTM
405.13
415 C
153 C
1.74x 10'07
3.79
2.99
4.086
343.5 days
25 hr
D.
Use Profile
Detailed information on TBT use sites and applications can be found in Appendix A.
1. Type of Pesticide
Fungicide, disinfectant, algicide, microbiocide, microbiostat.
2. Use Sites
Cooling towers
TBTO may be added to cooling tower water to prevent the build-up of biomass that can
interfere with the cooling function. TBTO may be used in industrial and commercial
recirculating cooling water towers, open recirculating cooling systems, air conditioning unit
cooling towers atop commercial buildings, and evaporative condensers. The biocide may be
added to cooling water with a metering pump or by drip-feed or open-pouring. Concentrations
of salts in the cooling water (which increase with time) dictate when water is discharged and
when new biocide is added. Cooling water additives containing TBT are labeled to show their
pesticide content.
Wood preservatives
TBTO is used to formulate paint, stains, and waterproofing to be applied to decks,
shingles, shakes, wood siding, fences, railings, floors, outdoor furniture, structural lumber,
beams, timber, sills, millwork, roofs, trim, clapboards, plywood, porches, and greenhouses.
These coatings serve as wood preservatives to discourage the growth of microorganisms that
cause degradation of the wood. Some product labels indicate that the TBTO biocides must not
be used in interior paints or coatings, based on earlier reports of adverse effects associated with
residential exposure to TBTO in interior paint and the absence of data to allow the Agency to
develop a quantitative risk assessment.
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Wood preservatives may be applied via brushes, rollers, mops, spray equipment, or
airless sprayers. Coatings containing TBTO are typically applied to exterior wood once every
several years. These coatings are labeled to show that they contain TBT.
Hard surface disinfectant for farm premises
One product containing TBTO is used in a number of farm settings. TBTO is used for
disinfecting housing for livestock, kennels, veterinary clinics, and animal laboratories and
breeding facilities. The product is also used in poultry houses, hatcheries, incubators, egg rooms,
egg trucks, and other farm vehicles, and on ventilation equipment, utensils, and ropes. It can
also be used to decontaminate tools and tack via immersion, and in boot baths. This product may
be applied to hard surfaces with a brush, wipe, or mop, or with a sprayer, hand-held fogger,
thermal fogger, or automated fogger. TBTO may be applied as frequently as once a day in
incubators with eggs present. Directions for use indicate that animals must be removed from the
premises prior to treatment and for up to two days after treatment, although use directions also
indicate that inter-depopulation treatments may be made to pens, hutches, etc. The disinfectant
is not rinsed or removed from treated surfaces, except for feeding and watering equipment that is
present during treatment. The disinfectant is labeled to show its TBTO content.
Materials preservatives in building materials
TBTO, TBTB, and TBTM are added to building materials to protect the materials
themselves from microbial degradation. These building materials include drywall, joint
compound, and medium density fiber board, and particulate board. TBT may also be used to
preserve building material adhesives and adhesives for other manufacturing uses, including
cardboard box production.
TBT additives are combined with these materials during the manufacturing process.
Materials treated with TBT preservatives are not labeled to show that they contain TBT.
Materials preservatives in textile, paper, and related uses
TBTO and TBTM are used by textile manufacturers in industrial settings to produce
fabrics that are resistant to growth and staining by microorganisms, particularly mildew. While
these products are "materials preservatives," the materials they are used to treat (such as fiberfill,
foam, rope, and paper) are being considered separately from materials preservatives used in
building materials.
Laundry and clothing treatments with TBT reportedly are not supported by any
formulator, but fabrics treated with TBT may be used for mattress pads and ticking, pillow
ticking, cushions for outdoor furniture, canvas and other fabrics for outdoor uses (e.g., tents,
tarps, awnings), and webbing (used with golf driving range protective netting, netting for
baseball batting cages, and tennis nets). Nylon rope may also be treated.
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In addition, TBT is used to protect sponges and sponge mop heads. Sponges typically are
sold in a damp state so they will remain absorbent until used, and treatment with TBT prevents
the growth of mold and mildew on the sponge in its original packaging.
TBT may also be used in rubber floor mats, carpet backing, fiberfill, polyurethane foam
used in furniture, and air filters for heaters and air conditioners. It is not used to treat carpet face
fibers.
Fabric may be treated with a coating (e.g., a polyvinyl coating) containing TBT.
Ingredients for the coating are cold-mixed and then applied to fabric or carpet backing with a
knife applicator: fabric is unwound from a feed roll onto a conveyor belt that passes the fabric
beneath a coating dispenser and then past a blade that distributes the coating evenly and presses
it into the weave. Fabrics may also be treated by an "exhaust" process in which fabric is soaked
in a liquid bath containing diluted TBT product and then dried. TBT applied in this manner is
dispersed throughout the fabric, rather than retained on the surface.
In the production of polyurethane foam, TBT is added to the other reactants in a "one
shot" process. Similarly, TBT is added with other components during the manufacture of rubber
and plastic. For fiberfill, TBT is co-applied with a silicone slip coating.
TBT products registered for use in paper bear labeling warning that such products may
not be used in paper for direct or indirect food contact.
Textiles, paper, and related materials treated with TBT products are not labeled to show
their TBT content.
Miscellaneous uses
TBT products also may be used in petrochemical injection applications, added to metal
working fluids, incorporated into irrigation tubing for non-agricultural applications, incorporated
into the rubber used to form sonar domes, and in antifoulant devices used in instruments
deployed for monitoring oceanographic conditions. TBT additives for metal working fluids and
petrochemical injection materials are labeled with their TBT content, as are the antifoulant
devices used in oceanographic instruments. TBT for metal working fluids and petrochemical
injection is added at the job site. Sonar domes are made from rubber impregnated with TBTO,
while the antifoulant devices for oceanographic instruments are packaged separately from the
conductivity sensors themselves and are installed without the opportunity for human contact.
Metal working and petrochemical injection fluids to which the TBT materials preservatives have
been added would not be labeled as containing TBT; neither would irrigation tubing or sonar
domes. Packaging for the oceanographic antifoulant devices shows the TBT content of the
devices.
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III. Summary of Risk Assessments
The purpose of this summary is to assist the reader by identifying the key features and
findings of the risk assessments and to help the reader better understand the Agency's
determination of reregi strati on eligibility. The human health and ecological risk assessment
documents and supporting information are listed in Appendix C. As indicated earlier, to access
these documents within the public docket, go to www.regulations.gov. Select advanced docket
search (right side of page). For Docket ID, enter OPP-2008-0171 and then submit (bottom of
page). Double-click on the blue underlined Docket number for a listing of all the documents in
that docket.
These documents also may be found in the OPP Public Docket which is located in Room
S-4400, One Potomac Yard, 2777 South Crystal Drive, Arlington, VA. The docket 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 TBT human health risk assessment is limited
to those studies incorporated into the PHED and similar databases, and 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. Hazard profile
A detailed toxicology assessment for the tributyltin containing compounds is available
from the docket. A summary of the key toxicological studies is presented in Appendix B.
a) Acute toxicity
Acute toxicity for the TBT containing-compounds is summarized in Table 3.
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Table 3. Acute Toxicity Profile for Tributyltin Compounds
Guideline Number
Study Type
MRID #(s)
Results
Toxicity
Category
Tributyltin Oxide
870.1100 Acute Oral - Rat
870.1100 Acute Oral - Rat
870.2600 Skin Sensitization-
Guinea pigs
00085004,
92172013
00085003,
92172004
00104789,
92172014
LD50 =180 mg/kg (males)
LDso =150 mg/kg (females)
LDso =170 mg/kg (combined)
LDso =193 mg/kg (males)
LDso =123 mg/kg (females)
LDso =160 mg/kg (combined)
Non-sensitizer
II
II
NA
Tributyltin Benzoate
870.1100
Acute Oral - rat
870. 1200 Acute Dermal - rat
870.2500 Primary Dermal
Irritation - rabbit
42415801
42415802
42415803
LDso =115 mg/kg (males)
LD50 =115 mg/kg (females)
LDso =115 mg/kg (combined)
LD50 > 2000 mg/kg
(combined)
Severe Irritation
II
III
I
Tributyltin Maleate
870.1100 Acute Oral - Rat
870.2600 Skin Sensitization -
Guinea pigs
43851201
44142303
LD50=224.7mg/kg
No-sensitizer; minimal irritation
in response to induction, no
increase in response to
challenge dose
II
NA
b) Endpoint selections; database uncertainty factor
The toxicological endpoints used for the human health risk assessment are identified in
Table 4. The uncertainty factor for studies in animals is 100 (10X for inter-species extrapolation,
10X for intra-species variation). Where exposures contributing to aggregate risk are likely, an
added database uncertainty factor of 10X is applied to the selected endpoint dose.
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Table 4. Endpoint Selection for Tributyltin Compounds
Exposure scenario
Dose; data base
uncertainty
Target Reference
Dose or MOE
Study and toxicological effects
Dietary Risk Assessment
Acute Dietary
Chronic Dietary
(all populations)
No appropriate endpoints were identified in the oral toxicity studies that represent a
single dose effect. An acute dietary risk assessment has not been conducted.
BMDio =
0.03 mg/kg/day
It is recommended
that 1 OX data base
uncertainty factor be
applied.
Chronic RfD (cRfD) =
0.00003 mg/kg/day
(A chronic dietary risk
assessment has not been
conducted because
dietary exposure data
are lacking. The
endpoint is provided for
future reference. )
Vosetal., (1990)1
NOAEL = 0.025 mg/kg/day
LOAEL = 0.25 mg/kg/day
immunotoxic effects
Non-Dietary Risk Assessments
Incidental Oral
Short-Term
(1-30 days) and
Intermediate-Term
(1-6 months)
Dermal
(all durations)
Inhalation
(all durations)
Dermal
Absorption
Carcinogenicity
BMDio =
0.03 mg/kg/day.
The 1 OX data base
uncertainty factor is
applied.
BMDio =
0.03 mg/kg/day.
The 10X database
uncertainty factor is
applied.
BMDio =
0.03 mg/kg/day.
The 10X database
uncertainty factor is
applied.
Target MOE = 1000
Target MOEs
occupational =100
residential 1000
Target MOEs
occupational 100
residential 1000
Vosetal., (1990)
NOAEL = 0.025 mg/kg/day
LOAEL = 0.25 mg/kg/day
immunotoxic effects
Vosetal., (1990)
NOAEL = 0.025 mg/kg/day
LOAEL = 0.25 mg/kg/day
immunotoxic effects
Vosetal., (1990)
NOAEL = 0.025 mg/kg/day
LOAEL = 0.25 mg/kg/day
immunotoxic effects
In the absence of a guideline dermal toxicity study or an acceptable dermal
absorption study, a 15% dermal absorption factor has been used (EPA/HED).
The carcinogenicity of tributyltin oxide has not been determined due to the high
spontaneous incidence of tumors in the test species, incidence variability in the
treated groups, and absence of a dose-effect relationship.
1 Vos et al., (1990) Immunotoxicity of bis (tri-n-butyltin) oxide in the rat: Effects on thymus-
dependent immunity and on nonspecific resistance following long-term exposure in young vs.
aged rats. Toxicol. Appl. Pharmacol. 105:144-155.
-------
The additional database uncertainty factor is applied to the selected endpoint dose from a
study reported in the open literature that suggests a potential for increased susceptibility in
children to non-dietary TBT exposures. The Vos et al. (1990) study has been identified by
several national and international entities as the basis of human health risk assessments for TBT.
The immunosuppressive effects observed by the study authors are critical effects associated with
a lower dose than the doses associated with other toxic effects, and suggest that weanling rats
may be more sensitive than (year-old) adult rats to TBTO in the diet. The data base uncertainty
factor is employed to address the unknowns in age-differentiated immune effects, and also to
account for uncertainty in the magnitude of endocrine effects and dietary residues of TBT and
degradates.
c) FQPA considerations
Under the Food Quality Protection Act (FQPA), P.L. 104-170, which was promulgated in
1996 as an amendment to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and
the Federal Food, Drug and Cosmetic Act (FFDCA), the Agency was directed to "ensure that
there is a reasonable certainty that no harm will result to infants and children" from aggregate
exposure to a pesticide chemical residue. The law further states that in the case of threshold
effects, for purposes of providing this reasonable certainty of no harm, "an additional tenfold
margin of safety for the pesticide chemical residue and other sources of exposure shall be applied
for infants and children to take into account potential pre- and post-natal toxicity and
completeness of the data with respect to exposure and toxicity to infants and children.
Notwithstanding such requirement for an additional margin of safety, the Administrator may use
a different margin of safety for the pesticide residue only if, on the basis of reliable data, such
margin will be safe for infants and children."
The Agency has concluded that labeled uses for the tributyltin could result in direct or
indirect food exposures and incidental exposures. As mentioned above, there is evidence in the
open literature suggesting that children may be more sensitive to TBT exposures than adults.
Other data from two developmental toxicity studies and one reproductive toxicity study with TBT
compounds show no evidence of increased sensitivity for fetuses or offspring. The Agency has
not at this time confirmed an increased sensitivity in young, so has not applied a special
sensitivity factor for the pre- and post-natal exposures. In addition to uncertainties about
differential sensitivity based on age, there is some uncertainty associated with the magnitude of
endocrine effects from human exposures to TBT, and in dietary exposures to TBT. As a result,
the Agency has applied a 10X data base uncertainty factor for exposures contributing to aggregate
risk.
d) Endocrine disruption
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 Disrupter Screening and Testing Advisory Committee
(EDSTAC), EPA determined that there was a scientific basis for including, as part of the
10
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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 Disrupter Screening
Program (EDSP). When the appropriate screening and/or testing protocols being considered
under the EDSP have been developed, tributyltin oxide, tributyltin maleate and tributyltin
benzoate may be subject to additional screening and/or testing to better characterize the known
effects related to endocrine disruption, reproductive anomalies in marine invertebrates and
thyroid effects in several other species.
In 1996, the White House's Office of Science and Technology Policy began coordinating
efforts across the Federal government to investigate and manage endocrine disrupting chemicals.
A report of that Office's National Science and Technology Council on those efforts, "The Health
and Ecological Effects of Endocrine Disrupting Chemicals," states that".. .many of the same
hormones and their receptors are present across species, genera, classes and even phyla
[suggesting] that effects reported in one species from exposure to endocrine disrupting chemicals
could have widespread biological implications."
(http://www.epa.gov/endocrine/frametext.html). It is on this basis that the Agency assumes that
endocrine disruption effects observed in other species indicate the potential for endocrine
disruption in humans.
The open literature includes many reports of endocrine effects associated with exposure
to TBT, including well-documented effects in marine species. Upon exposure to TBT in
antifouling paints, Nucella lapillus, a dogwhelk snail, has been shown to develop a pathological
condition termed "imposex," in which male reproductive organs (the penis and the vas deferens)
form in females of the species. The growth of the penis in a female dogwhelk blocks the oviduct,
ultimately preventing the release of ovules and ultimately resulting in her death. It has been
suggested that imposex can cause population reductions in affected species. TBT is the only
known inducer of imposex in the marine snails. Reports of the endocrine disrupting effects
of exposure to organotins also have been published for bivalves in the phylum Mollusca
(abalone) and mysids of the phylum Arthropoda. The open literature also contains reports of in
vitro endocrine effects on human enzymes involved in estrogen. As indicated previously, the
magnitude of such effects in humans is a source of database uncertainty.
The Agency has proposed priorities for screening pesticide active ingredients for
endocrine disruption, based primarily on the potential for human exposure rather than
documentation of potential endocrine effects. Exposures in four pathways were considered:
food, water, residential use, and occupational exposure. The organotin compounds are now
produced in relatively low quantities in the US, and were not selected for the initial screening
(Draft List of Initial Pesticide Active Ingredients and Pesticide Inerts to be Considered for
Screening under the Federal Food, Drug, and Cosmetic Act. 2007. 72FR 116, pp. 33486-33503,
which can be found at http://www.epa.gov/scipoly/oscpendo/pubs/draft_list_frn_061807.pdf).
11
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2. Incident reports
The following databases were consulted: Incident Data System of (EPA's) Office of
Pesticide Programs, Poison Control Centers, California Department of Pesticide Regulation, and
the National Pesticide Information Center. In addition, some incident reports associated with
TBT health hazards are published in the scientific literature. The incidents reported in these
databases are summarized here.
Primary systemic effects associated with the incidents recorded in these databases are
nausea, dizziness, headache, and sore throat. The primary dermal effects that have been reported
are rash, burning sensation, and itching.
Several incidents were reported for exposures to walls and joists treated with TBTO
wood preservatives. They occurred when TBTO was used in combination with other chemicals.
Exposures were associated with effects in residents and workers, including muscle weakness,
tremors, and numbness in the extremities, eye irritation, respiratory distress, poor coordination
and unsteadiness. Dermal exposure led to effects including rash, hives/welts, itching, blisters,
color alteration, eye irritation, headache, nausea, and dizziness. Inhalation of the chemical vapors
in one case resulted in chest pain and another resulted in seizures.
One incident was reported in which a woman was exposed to pillows treated with a
product containing tributyltin maleate. The exposure routes were dermal and ocular. The
woman developed swelling in her mouth, cheeks, neck, lips, and throat. She had difficulty
speaking. She also suffered irritation of the eyes and mouth, quivering of the jaws, and a lack of
concentration.
3. Dietary and drinking water risk summary
A more complete discussion of the dietary exposures considered for this RED is available
on the Docket in the dietary risk assessment, dated March 20, 2008. This document is available
in the Docket at www.regulations.gov (docket # EPA-HQ-2008-0171).
a) Residues in Food
TBT compounds are labeled for use in the following sites where a potential for food
contact may occur: water cooling systems for pasteurization/canneries, paper, and adhesives.
All of the TBT product labels for these use sites include specific prohibitions against the use of
treated materials for food contact uses or use otherwise include directions intended to minimize
indirect dietary exposures. The Agency believes that a dietary assessment is not warranted for
these uses.
TBTO is also used as a disinfectant in livestock operations. For some applications,
animals are removed prior to the treatment of the facilities, and the feeding equipment is rinsed
with water prior to reuse. The Agency typically assumes that such conditions result in negligible
residues. Product labels do not direct users to rinse or remove TBT solution or fogging residue
12
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from surfaces after treatment, except for feeding and watering equipment. For some
applications, animals are present when premises are treated. Eggs usually are present during
treatment of egg hatching and storage areas. The Agency typically assumes that incubating eggs
do not absorb pesticide residues on their shells. The registrant has indicated that the removal of
eggs to avoid deposition of residues during application is not feasible, and that premises may be
treated as frequently as once a day. No dietary residue data are available to assess potential
exposures resulting from any of these uses.
The Agency does not ordinarily require residue data for antimicrobial pesticides that are
used in animal premises, but because TBT residues are not physically removed from surfaces,
animals, or eggs in treated areas, and because TBT is very persistent in the environment and is
bioaccumulative, the Agency believes that it is possible for residues to remain in and on animals,
eggs, and animal premises long after a treatment has occurred, and to concentrate in animals via
incidental or dermal exposure. Consequently, there is a potential for human dietary exposure
associated with the livestock premises uses. These potential exposures cannot be quantified
without residue data.
b) Residues in drinking water
Discharges of treated cooling water, disposal of excess TBT solution from farm premises
treatments, and leaching of TBT from treated exterior building materials and irrigation tubing
may have potential to impact drinking water sources. A quantitative drinking water assessment
has not been conducted as an appropriate method for assessing exposure data is lacking.
4. Occupational and residential risk assessment
Details of the residential exposure assessment can be found in the occupational and
residential exposure assessment available on the Docket. This document is available at
www.regulations.gov (docket # EPA-HQ-2008-0171). The Agency selected representative
scenarios for residential exposures. These scenarios reflect high-end exposure estimates.
a) Residential handler exposures
Short-term inhalation and dermal exposures were assessed for applications of wood
preservatives on houses—exterior siding, decks, etc. Tributyltin vapor pressure is low;
inhalation exposures were assessed for aerosols only.
b) Residential post-application exposures
Post-application scenarios have been selected to represent high-end exposures and
include dermal exposure and/or incidental ingestion exposures from treated fabric. Bystander
inhalation of aerosols generated during painting is assumed to be less than exposures to the
applicator and was not assessed separately. Post-application exposures to vapors that result from
the wood preservative use are assumed to be negligible.
13
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The Agency has used available data to estimate exposures to treated clothing and
mattress covers. Two leaching studies for fabric treated with TBT were submitted to the Agency
during the public comment period on the risk assessments for the RED. A detailed discussion of
these studies is provided in the revised occupational and residential exposure assessment
available at www.regulations.gov (docket # EPA-HQ-2008-0171). The registrant believes that
the transfer of TBT from fabric to skin is much less that the default value of 100%. EPA has
reviewed both of the studies and has concluded that the submitted studies by themselves are not
adequate to support the use of the lower transfer rate. In particular, the second study does not
supply sufficient information for calculating the amount of TBTO transferred from fabric to skin;
the weight of the material is unknown and the 10 ppb concentration cannot be converted to
ug/cm2 of material. Risks were assessed for 100% and 5% transfer rates, to represent high- and
low-rates of transfer.
c)
Residential risk characterization
Data sources and methodologies utilized for both the handler and post-application
residential risk assessment include: the HED Residential Standard Operating Procedures (SOPs)
(USEPA, 1997a), the USEPA Exposure Factors Handbook (USEPA 1997b), Recommended
Revisions to the Residential SOPs (USEPA, 2001), and the Human and Environmental Risk
Assessment (HERA) Guidance Document (2003). The specific input parameters and
assumptions are discussed in the revised occupational and residential risk assessment available
from the Docket. Residential handler exposure and risk estimates are summarized below. The
target MOE for residential exposures is 1000, resulting from a 10X factor to account for species-
to-species variability, a 10X factor for within-species variability, and the 10X database
uncertainty factor described above.
Table 5. Residential handler MOEs for a
>plying paints and stains containing TBT
Exposure Scenario
Application Method
Staining/Painting
Application
Method
Paint brush
Airless sprayer
MOE
(Target MOE = 1000)
Inhalation
60
O
Dermal
<1
<1
Modeled exposures are much lower than the target MOE and are of concern.
For post-application exposures to treated fabric, the Agency calculated MOEs for a high
and low dermal transfer rate. The Agency also used transfer values from the first study
submitted by the registrant to estimate exposures.
14
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Table 6. Post-application MOEs for Toddlers and Adults Contacting Treated Textiles
Exposure Scenario
Percent residue transferred
from clothing to skin
Dermal MOE
(Target MOE = 1000)
Clothing, blankets
Toddler
Adult
100
5
100
5
<1
2
<1
3
Study #1 Application Rate (2.58% product by weight, product containing 1% TBTO)
Toddler
NA
35
Mattress covers
Children
Adults
100
5
100
5
<1
7
<1
11
Study #1 Application Rate (2.58% product by weight, product containing 1% TBTO)
Children
< 10 ppb
8
All the scenarios assessed yielded MOEs well below the target. Dermal transfer rates are
not relevant to potential incidental exposures to toddlers mouthing treated textiles. The Agency
estimates that the MOE for incidental oral exposure is 2, well below the target MOE of 1000.
5. Aggregate risk
In order for a pesticide registration to continue, it must be shown that the use does not
result in "unreasonable adverse effects on the environment." Section 2 (bb) of FIFRA defines
this term to include "a human dietary risk from residues that result from a use of a pesticide in or
on any food inconsistent with standard under section 408..." of FFDCA. As mandated by the
FQPA amendments to FIFRA and the Federal Food, Drug and Cosmetic Act (FFDCA), the
Agency must consider total potential aggregate exposure from food, drinking water and
residential sources of TBT. Aggregate exposure is the total exposure to a single chemical that
may occur from dietary (i.e., food and drinking water), residential, and other non-occupational
sources, and from plausible exposure routes (oral, dermal, and inhalation). Typically, aggregate
risk assessments are conducted for acute (1 day), short-term (1-30 days), intermediate-term (1-6
months) and chronic (6 months to lifetime) exposures.
The Office of Pesticide Programs has published guidance outlining the necessary steps to
performing aggregate exposure and risk assessments (General Principles for Performing
Aggregate Exposure and Risk Assessments, November 28, 2001; available at
http://www.epa.gov/pesticides/trac/science/aggregate.pdf ). Steps for deciding whether to
perform aggregate exposure and risk assessments are listed, which include: identification of
toxicological endpoints for each exposure route and duration; identification of potential
exposures for each pathway (food, water, and/or residential); reconciliation of durations and
pathways of exposure with durations and pathways of health effects; determination of which
15
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possible residential exposure scenarios are likely to occur together within a given time frame;
determination of magnitude and duration of exposure for all exposure combinations;
determination of the appropriate technique (deterministic or probabilistic) for exposure
assessment; and determination of the appropriate risk metric to estimate aggregate risk.
Risks are of concern for individual uses that contribute to TBT aggregate exposure,
therefore, the aggregate risks would be of a concern as well.
6. Cumulative Exposure and Risk
Section 408 of the FFDCA requires that the Agency must consider "available
information" concerning the cumulative effects of a particular pesticide's residues and "other
substances that have a common mechanism of toxicity" when making a determination about
unreasonable adverse effects for a pesticide.
Unlike other pesticides for which EPA has followed a cumulative risk approach based
on a common mechanism of toxicity, no common mechanism of toxicity finding relative to TBT
and any other substances has been made, and for the purposes of this RED, EPA has not assumed
that the TBT compounds have 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/.
7. Occupational Exposure and Risk
a) Occupational handler exposure scenarios
The Agency has assessed the exposures and risks for occupational workers who handle
TBT-containing products and who are exposed to TBT after application. A detailed discussion
of occupational risks can be found in the revised occupational and residential exposures
assessment posted to the TBT Docket (www.regulations.gov, docket # EPA-HQ-2008-0171).
Post-application exposures were assessed for machinists handling TBT-preserved metalworking
fluids and workers re-entering a hatchery after fogging with the TBT disinfectant.
Occupational handler exposures to TBT can occur during applications of materials
preservatives, applications to farm premises, cooling water towers, oilfield and petrochemical
injection systems, metalworking fluids, and when applying wood preservatives. Application of
materials preservatives refers to the scenario of a worker adding the TBT preservative to the
material being treated (joint compound, adhesives, paper, etc.) through either open pouring or a
metering pump. Open pouring is the transferring of antimicrobial product from a small container
to an open vat. Use of a metering pump involves transferring the antimicrobial product by
connecting a chemical metering pump from a tote or by gravity flow to be diluted for use.
These same processes are used for cooling towers, oilfield and petrochemical injection systems,
and metal working fluids. Workers may apply wood preservatives through several methods,
16
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including paint brushes and airless sprayers. Handlers of TBT products for farm premises
applications may apply the material by brush, mop, wipe, spray, or fogger (thermal, automated,
or otherwise).
For materials preservatives, cooling towers, and oilfield and petrochemical injection
fluids, EPA expects that occupational exposures will be negligible or minimal for handling
tributyltin-containing products via closed loading, assuming that label-specified PPE (i.e., long
pants, long-sleeved shirts, protective eyewear, and chemical resistant gloves) are consistently
utilized.
b) Occupational post-application exposure scenarios
Occupational post-application exposures are believed to be minimal except for machinists
working with metal working fluids and workers reentering farm premises after TBT treatments.
Post-application exposures to machinists using metal working fluids with TBT additives are
considered to be long-term
c) Occupational risk characterization
Data sources and assumptions are fully discussed in the revised occupational and
residential risk assessment available from the Docket. Most occupational exposures are
considered to be short- and intermediate-term. .
Table 7. Risks for Occupational Handlers
Exposure Scenario
Method of Application
MOE (Target MOE = 100)
Inhalation
Dermal
Agricultural Premises and Equipment
Agri cultural/farm/
poultry structures/buildings
and equipment
Brush-on
Wipe
Mop
Spray
(hand held)
Spray
(mechanical)
Fogger (hand-held)
4500
360
1300
930
1300
2
47
(350 w/gloves)
57
300
22
420
<1
Material preservatives
Caulk (representing joint
compound, adhesives, etc.)
Metal working fluids
Open pour
Metering pump
Open pour
210
360
68
36
2
21
Industrial Processes and Water Systems
Paper
Cooling water
Open pour or metering pump
Closed loading systems are
expected to result in minimal
17
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Exposure Scenario
Oil fields and petrochemical
water injection systems
Method of Application
Open pour
Metering pump
MOE (Target MOE = 100)
Inhalation
Dermal
exposure.
3
3
Closed loading systems are
expected to result in minimal
exposure.
Wood preservatives
Painting/staining
(commercial)
Paint brush
Airless sprayer
24
<1
<1
<1
Occupational post-application exposures are assumed to be negligible except for the
machinist exposed to TBT-treated metalworking fluids and workers re-entering farm premises
after treatment. Dermal and inhalation MOEs for machinists are 3 and 36, respectively. It is not
considered feasible for a machinist to wear protective PPE due to the nature of the work.
Workers re-entering treated farm premises are considered to be adequately protected (i.e., MOE
at or above 100) after a restricted entry interval of 2 hours.
B.
Environmental Risk Assessment
Detailed information on environmental fate is presented in the environmental fate
assessment available at (www.regulations.gov, docket # EPA-HQ-2008-0171). A brief summary
is provided below. For purposes of this risk assessment, TBTO is the primary focus of the
environmental fate discussion.
TBTO is essentially stable to hydrolysis and photolysis in freshwater and saltwater.
Based on its low vapor pressure, it is not expected to volatilize from water. Biodegradation is
considered to be the major breakdown pathway of this chemical when it is present in either water
or sediments. Half-lives are in the range of several days to weeks in water and from several days
to more than a year in sediments (the open literature supports the longevity of TBT and
degradates, especially in the sediment.). The octanol/water partition coefficient is very high.
TBTO has a high tendency to bioconcentrate (e.g., concentrate in the tissues of species that may
ingest the chemical) and bioaccumulate (e.g., concentrate in the food chain).
1. Ecological toxicity for wildlife species
A detailed ecological hazard and environmental risk assessment for TBTO is available at
www.regulations.gov (docket # EPA-HQ-2008-0171). A summary of findings is presented
below. A quantitative ecological risk assessment has been conducted for TBTO wood
preservative applications. Data are not available for environmental exposures resulting from
other uses, but the Agency has highlighted those it believes have the potential to contaminate
drinking water and natural waters.
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a) Acute and dietary toxicity to birds and mammals
Acute oral and dietary studies indicate that technical-grade TBTO is moderately toxic to
birds if ingested. Based on these study results, an avian precautionary statement is not warranted
for the TBT product labels. The guidelines for avian acute-oral toxicity (OPPTS 850.2100) and
avian dietary toxicity OPPTS 850.2200) are satisfied. Mammalian acute toxicity data from
several studies indicate that TBT compounds are moderately toxic to small mammals on an
acute-oral basis.
b) Non-target insects - honeybees
No guideline data are available for TBTO. In the absence of data on residues in honey
and beeswax and acute toxicity of treated wood residues to bees, risks to honeybees cannot be
assessed. The Agency believes that precautionary labeling on the use of TBT wood
preservatives on wood used for beehive construction can be used to address these uncertainties.
c) Acute toxicity ~ freshwater fish
Two acute toxicity studies with the TGAI are required to establish the toxicity of TBTO
compounds to freshwater fish. The acute toxicity data characterize technical-grade TBTO as
being very highly toxic to freshwater fish. A precautionary statement is triggered for product
labels. The guideline for freshwater-fish acute toxicity (OPPTS 850.1075) is satisfied.
d) Acute toxicity ~ freshwater invertebrates
A study with the TGAI is required to establish the acute toxicity of TBT to freshwater
invertebrates. The preferred test species is the water flea, Daphnia magna. Results from two
guideline studies categorize technical-grade TBTO as being very highly acutely toxic to the
water flea. A precautionary statement is triggered for product labels. A study testing dibutyltin
dichloride categorizes this degradate as moderately toxic. The guideline requirement (OPPTS
850.1010) is satisfied.
e) Estuarine and marine fish and invertebrates, acute toxicity
Two guideline fish toxicity studies are available. The results of these studies indicate that
TBTO compounds are very highly toxic to estuarine/marine fish. The guideline for
estuarine/marine-fish acute toxicity (OPPTS 850.1075) is satisfied. Acute toxicity data are
available for a number of estuarine/marine invertebrate species, including the Eastern oyster
(Crassostrea virgmica), Pacific oyster (Crassostrea gigas), bay mussel (Mytilus edulis), fiddler
crab (Ucapugilator), pink shrimp (Penaeus duoramm), and grass shrimp (Palaemonetespugio).
The acute toxicity data indicate that TBT is very highly toxic to estuarine/marine invertebrates.
f) Chronic toxicity for aquatic organisms
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No guideline studies are available to assess chronic risks of TBT-containing compounds
to freshwater fish and invertebrates. However, EPA's (2003) Ambient Aquatic Life Water
Quality Criteria for Tributyltin (TBT) - Final presents chronic toxicity values for a 32-day early
life-stage study with the fathead minnow {Pimephalespromelas) and for two 21-day life-cycle
studies with Daphnia magna. NOEC values for adverse reproductive affects ranged from 0.1 to
0.19 jig ai/L across the three studies. Two guideline studies with the sheepshead minnow are
available to assess the chronic toxicity of TBTO to estuarine/marine fish. These studies fulfill the
guideline (850.1400) for a fish early life-stage (freshwater) study. No valid guideline studies are
available for aquatic invertebrates.
The open literature contains abundant information on the toxicity of TBT to aquatic
invertebrates including reports of shell deformation in oysters and reproductive aberrations in
certain marine snails (imposex). Research suggests that sensitive species may exhibit severe
toxic effects in water at TBT concentrations in the parts-per-trillion range. In addition, TBT has
been shown to bioaccumulate in the aquatic environment, and there are reports of toxicity in
marine mammals exposed in the natural environment, including suggestions of immunotoxic
effects. As mentioned previously, TBT is a known endocrine disrupter with documented effects
in wildlife. The bibliography for this RED includes several citations on the effects of TBT on
marine mammals.
2. Acute and chronic sediment toxicity
No guideline studies are available. Acute and chronic sediment toxicity data are needed
to support TBT uses with the potential for contaminating sediment, because pertinent
environmental fate data predict that residues will move into the aquatic environment and be
deposited and persist in sediments. The Kd >10 for acute and >50 for chronic, the log Kow >3,
the Koc > 1,000, and soil aerobic half-life has been reported as 127 days in laboratory testing.
3. Aquatic plants
No guideline studies have been submitted for TBT. Aquatic plant growth testing
(850.5400) with the TGAI or TEP is required for all pesticides that entail wood preservative
uses. The EPA (2003) Ambient Aquatic Life Water Quality Criteria for Tributyltin (TBT) - Final
provides some information indicating that phytotoxicity of TBTO to aquatic plants may be of
concern.
C. Environmental risk assessment criteria
Risk assessment and characterization integrate exposure and toxicity information to
evaluate the potential for adverse ecological effects to occur at concentrations of the pesticide
that may be found in natural waters. Risk quotients (RQs) are determined for each taxon or
ecological group by comparing exposure estimates (Estimated Environmental Concentrations,
EECs) to the available acute and chronic ecotoxicity values, where:
RQ = Exposure estimate (EEC) / Toxicity value
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RQs are compared to OPP's levels of concern (LOCs). Exceedance of an LOG indicates a
potential for acute or chronic adverse effects and identifies a need for regulatory action to
mitigate risk.
Table 8. Levels of Concern for Wildlife Subgroups
Presumption
Acute risk
Acute risk, listed species
Chronic risk
Aquatic Animals
0.5
0.05
1
Terrestrial
Animals
0.5
0.1
1
Plants
1
1
n/a
When available, toxicity measures or other appropriate information from non-guideline
studies or from the open literature also may be used to characterize risk.
OPP generally uses computer simulation models to estimate exposure of aquatic
organisms to an active ingredient. These models estimate EECs in surface waters using product-
label information (e.g., treatment site, application rate, application method,) and available
environmental-fate data to determine how fast the pesticide breaks down and its expected
movement in the environment. For some scenarios which the Agency believes may result in
environmental contamination with TBT, data and models are lacking to estimate environmental
concentrations, including farm premises uses, cooling tower discharges, disposal of metal
working fluids and petrochemical injection liquids after use, leaching from treated irrigation
tubing. The Agency is able to estimate environmental concentrations associated with TBTO-
containing wood preservatives. The model and results are summarized below and described in
more detail in the ecological risk chapter posted to the TBT Docket at www.regulations.gov
(docket # EPA-HQ-2008-0171).
D. Aquatic and Terrestrial Risk Characterization
EECs for the leaching of TBTO from treated wood into soil and surface waters were
calculated for six uses: transmission poles, fence posts, fences, deck posts, decks, and houses.
The methodology for this analysis is based on an environmental risk assessment previously
prepared by the Rohm and Haas (2006) for 4,5-dichloro-2-n-octyl-3(2H)-isothiazolone (DCOIT).
Soil concentrations and other input data are then used with EPA's Express model EXAMS-
PRZM Exposure Simulation Shell (version 1.03.02) to estimate concentrations in surface water.
Data compensation will need to be made for the use of Rohm and Haas' study.
TBT is expected to accrue in aquatic sediments, with half-lives from several days to
months or more (EPA 2003); thus, sediments may be a long-term source of exposure of aquatic
organisms. The risks associated with the presence of TBT in the sediment cannot be adequately
assessed without acute and chronic sediment-toxicity data. There is evidence in the open
literature that certain sediment concentrations can trigger severe effects in various aquatic
organisms, and the particulars of the various effects are discussed in more detail in the
supporting ecological hazard chapter.
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Potential risks to aquatic plants cannot be quantitatively assessed without the relevant
toxicity data.
Based on the values calculated for the ecological risks, acute risks to listed (i.e.,
endangered or threatened) fish and invertebrates are presumed to result from aquatic exposure to
TBTO resulting from wood preservative use. This presumption of risk necessitates a more
comprehensive risk assessment for listed species, but is not included in the current assessment
(see Endangered Species Considerations section). Although the Agency's calculated chronic
LOG is not exceeded for either fish or aquatic invertebrates, evidence exists that chronic
exposure may be a concern for some organisms. EPA considers TBT-containing compounds to
be a concern in the aquatic environment due in part to TBT's persistence and its link to imposex
and immunosupression in aquatic organisms. Through its authority under the Clean Water Act,
the Agency developed ambient water quality criteria for TBT-containing compounds (EPA
2003), based on a broad selection of published data. These criteria, in combination with
characteristics of local water bodies, are used by the States to establish permit limits under the
National Pollutant Discharge Elimination System.
TBT is moderately toxic to birds and mammals, and acute effects are possible if TBT-
contaminated food is eaten. Because TBT bioaccumulates in tissues of organisms, food sources
such as earthworms and fish could expose species of birds and mammals. At this time, the
Agency is unable to assess risks to birds and mammals that eat contaminated food.
The Agency conducted a quantitative assessment of the risks associated with the use of
TBT as a wood preservative. For other uses which may result in TBT releases in the aquatic
environment, risks are addressed in a qualitative manner. The following table shows only those
wood preservative uses with RQs which exceed LOCs.
Table 9. Acute Ecological Risks for the Wood Preservative Use of TBTO
Use
RQ
Acute LOCs
exceeded
Freshwater Invertebrates
House
0.05
listed species
Estuarine/Marine Invertebrates
House
Fence
Deck Post
Fence Post
Deck
0.45
0.32
0.20
0.12
0.09
listed species
listed species
listed species
listed species
listed species
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A more refined assessment should include analyses for direct and indirect exposures of
non-target organisms, and habitat effects.
E. Endangered species considerations
Section 7 of the Endangered Species Act (ESA), 16 U.S.C. Section 1536(a)(2), requires
that federal agencies consult with the National Marine Fisheries Service (NMFS) for marine and
anadromous listed species, or with the United States Fish and Wildlife Services (FWS) for listed
wildlife and freshwater organisms, if 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 is to "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 comply with subsection (a)(2) of the ESA, EPA's Office of Pesticide Programs has
established procedures to evaluate whether a proposed registration action may directly or
indirectly appreciably reduce 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). If any of the Listed Species LOG Criteria are exceeded for either direct or indirect
effects in the Agency's screening-level risk assessment, the Agency identifies any listed or
candidate species that may occur spatially and temporally in the footprint of the proposed use.
Further biological assessment is undertaken to refine the risk. The extent to which any species
may be at risk determines the need to develop a more comprehensive consultation package as
required by the ESA. The comprehensive assessment has not been conducted at this time for the
TBT compounds.
IV. Reregistration Eligibility and Risk Management Decisions
The Agency typically assesses tolerances for pesticides as part of the reregistration
decision. At this time, there are no existing tolerances for TBT or metabolites and no data to
indicate if residues are present in food commodities as a result of the use of TBT. No tolerance
assessment has been conducted at this time.
TBT is highly bioaccumulative and very persistent in the environment. The Agency does
not ordinarily require residue data for antimicrobial pesticides that are used in farm premises.
The Agency believes that the persistence and bioaccumulative potential of TBT could result in
residues of TBT in animals and eggs inhabiting, incubating, or held in areas that have been
treated. Residues deposited in the treated area may remain long after a treatment has occurred,
and may concentrate in animals via incidental or dermal exposure. Based on the use of the farm
premises disinfectant and the environmental fate characteristics of TBT, the Agency has
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determined that TBT residue data are required to support the use of TBTO on farm premises;
these data, once reviewed, could indicate a need for the establishment of tolerances.
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 a pesticide
active ingredient are eligible for reregistration. The Agency has previously identified and
required the submission of the generic (i.e., active ingredient-specific) data to support
reregistration of products containing TBT compounds. The Agency has completed its review of
these generic data and has determined that the data are sufficient to support reregistration of
some uses of TBT. Other uses are lacking data the Agency has determined are necessary for the
support of TBT reregistration. These studies are identified in Section V of this document.
Based on available data, the Agency has completed its assessment of the residential,
occupational, and ecological risks associated with the use of pesticide products containing TBT
active ingredients. The Agency has determined that some TBT uses are eligible for
reregistration with the following caveats: 1) all risk mitigation measures described in this
document must be implemented, 2) current data gaps and confirmatory data must be addressed,
and 3) label amendments must be made as described in Section V.
Some uses of TBT are not eligible for reregistration. For some products with uses not
eligible for reregistration, registrants have requested termination of the subject uses or
cancellation of the subject registrations. At a minimum, if the Agency were to consider the
registration of these uses of TBT in the future, uses identified as ineligible would be subject to
additional data requirements not included in the data gaps identified in Section V.
The following table shows which uses are eligible for reregistration and which are not.
The reregistration eligibility decisions are explained under "Regulatory Rationale" below.
Table 10. Eligibility of Uses of TBT for Reregistration
Eligible for Reregistration
Not Eligible/
Request for Voluntary Cancellation
Farm premises
livestock premises
kennels
veterinary clinics
animal laboratories
breeding facilities
hatcheries
egg rooms
incubators, setters
inter-depopulation treatments
tack
equipment with direct animal
contact
tools
immersion treatments
boot bath
Eligibility dependent on labeling that prohibits application when animals or eggs are present, application via hand-
held fogger (thermal or otherwise)
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Eligible for Reregistration
egg trucks
Not Eligible/
Request for Voluntary Cancellation
Wood preservatives
all uses
Materials preservatives in building materials
dry wall, joint compound
fiber board, particulate board
adhesives
Materials
preservatives in textiles and related materials
fiberfill, foam3
carpet backing
air filters
rubber mats
canvas/other fabrics for tarps,
tents, awnings
webbing for nets in sport applications
paper
clothing, including hosiery
mattress covers, pillow covers, ticking
sponges, mop heads
laundry treatments
canvas/other fabrics for cushions, hammocks
rope
textiles with potential for direct dermal contact
Cooling water
iiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiii)
iiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiii)
all uses
Metal working fluids
all uses
Petrochemical injection
iiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiii)
iiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiii)
all uses
Irrigation tubing for non-agricultural applications
iiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiii)
all uses
Antifouling
sonar domes
antifoulant devices in oceanographic
conductivity sensors
previously cancelled: ships, boats,
crab/lobster/bass pots
The Agency has determined that some TBT products, labeled and used according to label
directions, may present risks inconsistent with FIFRA. Accordingly, should a registrant fail to
implement the risk mitigation measures, make the label changes identified in this document, and
submit confirmatory data, the Agency may take regulatory action to address the risk concerns
from the uses of these TBT registrations. If the registrants comply in entirety with all
requirements outlined in this document for products otherwise eligible for reregi strati on, then,
for the purposes of this determination, no risks of concern will exist for the registered uses of
TBT. When the endangered species assessment for TBT is completed, further changes to TBT
registrations may be necessary.
B. Public comments and responses
Except if used in mattress covers
4 Request for use termination pending
5 Eligibility dependent on labeling that prohibits use in paper for direct or indirect food contact
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Through the Agency's public participation process, EPA has solicited input from
stakeholders (including the general public) for consideration in formulating the regulatory
decision for TBT. EPA released its preliminary risk assessment of the TBT compounds for
public comment on April 2, 2008. The Agency received just one comment (from a registrant)
during the 60-day public comment period, which closed on June 2, 2008. This comment
included observations on the Agency's human health risk endpoint selection, leaching of TBT
from treated sponges, and transfer of TBT from treated textiles to human skin. The comments
have been addressed through revisions to the risk assessments or in a separate "response to
comments" document that is posted to the TBT docket along with other supporting information
at www.regulations.gov (Docket ID #EPA-HQ-OPP-2008-0171).
C. Regulatory Rationale
The Agency has determined that some uses of TBT are eligible for reregi strati on, with
several caveats and conditions. For those uses that are eligible, risk mitigation measures and
label changes must be implemented as outlined in this document, and required data must be
submitted. Requirements for revised label language are set forth in Table 12 in Section V of this
document.
Eligibility decisions for the different uses of TBT are all influenced by an overarching
concern associated with the environmental fate characteristics of TBT. In particular, TBT
compounds are very persistent in the environment and have a high potential for bioaccumulation.
These characteristics increase opportunities for exposure to TBT in the environment and the food
chain.
The environmental persistence of TBT increases opportunities for human and wildlife
exposures because organisms are exposed to TBT residues for a long time after the pesticide is
introduced into the environment. Aquatic organisms remain in contact with contaminated water
or sediment, or may ingest food items contaminated with TBT residues, long after the initial
contamination occurs. Because TBT is bioaccumulative and lipophilic, TBT may concentrate in
the food chain, so that species at the top of the food chain, like predator species and man, may be
exposed to concentrations above what is present in individual food sources, water, or sediment.
Another overarching concern affects decision-making for TBT. Research findings
indicating that TBT is an endocrine disrupter in a number of species represent a toxicological
impact that EPA's current risk assessment methodologies cannot account for quantitatively. The
Agency is working to understand the scope of endocrine effects associated with pesticides and
the relationship between endocrine effects in wildlife and effects in humans. For the time being,
the Agency is assuming that exposures that result in adverse endocrine effects in animals have
the potential to cause adverse endocrine effects in humans.
1. Human Health Risk Management
a) Dietary (food) and drinking water risk mitigation
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The Agency was unable to conduct a quantitative food or water dietary exposure
assessment for TBT because empirical exposure data are lacking. However, TBT is highly toxic,
so that even very small exposures may be associated with unacceptable risks. Instead of a
quantitative exposure assessment, the Agency considered the fate and toxicological
characteristics of the TBT compounds, the nature of potential dietary exposures, and the type of
data that would facilitate a quantitative dietary assessment. The Agency has concluded that there
is a potential for dietary exposures of concern associated with the use of TBT disinfectants on
farm premises.
In order to address the potential for harmful dietary exposures associated with the farm
premises uses, the Agency is prescribing the following risk mitigation measures:
• Animals must be removed from premises (e.g., livestock housing and breeding facilities)
prior to treatment of premises and surfaces within these premises with TBT. Animals
must not be returned to premises for at least 48 hours following the conclusion of
treatment. As required by current labeling, feeding and watering bowls and equipment
must be removed prior to treatment, or washed with soap and water after treatment and
before reuse.
• The use of TBT in egg handling facilities and vehicles (hatcheries, egg rooms, incubators,
egg trucks, etc.) when eggs are present is prohibited. The registrant has not provided data
showing that repeated and frequent applications of TBT do not result in transfer of
residues in eggs through the shell or in hatched chicks. Labels allow that eggs may be
treated daily before hatching, and because TBT is both persistent and bioaccumulative,
the Agency is concerned that TBT could concentrate in the eggs and enter the food
supply in chickens raised from treated eggs, posing a risk of dietary exposure. Several
products containing other active ingredients are registered for similar uses, including
some registered to the registrant holding the TBT farm premises product. The Agency
has concluded that only a small percentage of egg producers use the TBT product,
suggesting that effective alternatives are available and preferred by many producers.
• Treatment of tack (halters, etc.) with TBT is prohibited. Animals may have constant,
direct contact with tack; there is potential for TBT transfer from treated tack to livestock
that may be used to produce meat and milk, or companion animals. By the same
reasoning, treatment of other equipment or tools that come into direct contact with
livestock is prohibited.
Other risk mitigation measures for the farm premises use are explained in the sections on
occupational handler and post-application exposures below. If the risk mitigation measures and
revised labeling are implemented, and if related data needs are satisfied, the use of TBT on farm
premises is eligible for reregi strati on. The Agency is requiring data on residues of TBT and
metabolites in meat, milk, and eggs in support of the use of TBT on farm premises, as noted in
SectionVofthisRED.
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Although the Agency believes there are a number of TBT use sites with potential for
contaminating water sources and underlying sediments, data and appropriate models are lacking
to conduct a drinking water risk assessment for TBT. (The same use sites have the potential to
pose risks of concern to wildlife. These other uses and the rationale for the associated
reregi strati on eligibility decisions are discussed below under Environmental Risk Management
below. Per the Agency's concern about TBT residues in both drinking water and wildlife
habitat, these uses are not eligible for reregi strati on.)
b) Related issues; risks to domestic animals
The same TBT product registered for use on farm premises is also registered for use in
animal housing facilities in non-farm situations (e.g., kennels, veterinary clinics, and breeding
facilities). Although the treatment of such facilities is not expected to result in dietary exposures,
the Agency believes it is prudent to apply similar risk mitigation measures to these use sites,
based on concerns about dermal exposures to companion animal veterinarians, veterinary
technicians, laboratory workers, and owners and handlers of domestic animals. The risks
associated with these exposures cannot be quantified, but potential risks can be mitigated via the
same measures applied to the farm premises uses. Therefore, the risk mitigation measures of
farm premises will apply to non-farm animal premises. Other risk mitigation measures for this
use are explained in the sections on occupational handler and post-application exposures below.
The use of TBT in animal housing facilities in non-farm situations will be eligible for
reregi strati on if all appropriate risk mitigation measures and labeling revisions are implemented.
c) Residential risk mitigation
Wood preservative handlers
Short-term residential handler risks were estimated for people who apply wood
preservatives to outdoor construction and building components. The target MOE for these
applications is 1000. Risks were estimated for application by brush and airless sprayer. Both
dermal and inhalation MOEs were much lower than the target—ranging from <1 to 60. These
MOEs represent application of 2 gallons (by brush) and 15 gallons (by airless sprayer). It is not
feasible to reduce residential handler risks by requiring personal protective equipment or
engineering controls.
Other measures, such as reductions in the percentage of active ingredient in TBT
products, would have to effect a reduction of exposure by a factor on the order of 1000 (to
increase the MOE of <1 to the target MOE) in order to provide adequate protection. An
application rate of this magnitude would likely result in an inefficacious product. It is unlikely
that even a combination of measures would reduce the risks to residential handlers adequately.
There currently are no data available to refine the assessment, and the Agency believes that any
such data would be unlikely to yield MOEs of 1000 or more. Because of the very low MOEs,
the lack of feasible mitigation options, and the absence of data which do or could be expected to
yield adequately protective refined MOEs, the Agency has determined that TBT products used
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for wood preservation on homes, buildings, building components, and outdoor furniture are not
eligible for reregistration. Additional discussion of the risks and mitigation for this use are
explained in the sections on occupational risk mitigation and environmental risk management
below.
Post-application residential risk mitigation; textiles and related uses
Residential post-application risks were estimated for dermal exposures to clothing and
mattress covers treated with TBT; incidental oral exposure for toddlers mouthing treated fabric
was also estimated. In all cases, MOEs were well below the target MOE of 1000. It is not likely
that application rate reductions or refined estimates for fabric to skin transfer or dermal
absorption would be adequate to increase these MOEs by a factor of 100 or more to the target
MOE.
Although there are no data for use in quantifying residential post-application exposures
from the use of treated sponges and mop heads, the Agency is concerned about exposure to
dishes, counters, floors, and other residential surfaces washed with treated sponges or mops.
Data are also lacking for exposures associated with fiberfill or foam in upholstered
furniture, carpet backing (not face fibers), treated air filters, rubber mats, canvas and other
fabrics for outdoor applications (such as tarps, awnings, and tents), and webbing (used with golf
driving range protective netting, netting for baseball batting cages, and tennis nets), but the
Agency believes that these uses would result in negligible or no post-application residential
exposure.
Based on the risk assessment and the assumptions cited above, and in the absence of
relevant data, the Agency has determined that the uses of TBT on textiles and related materials
that have the potential for prolonged dermal exposure or incidental oral exposure (e.g., clothing,
mattress and pillow covers and ticking, sponges, mop heads, canvas or other fabrics for furniture
cushions and hammocks) are not eligible for reregistration. The uses of TBT in textiles and
related materials that are not associated with prolonged human exposure (e.g., paper, fiberfill or
foam in upholstered furniture (but not for mattress pads); carpet backing; air filters; rubber mats;
canvas and other fabrics for tarps, awnings, and tents; and webbing used for golf course/driving
range protective netting, netting for baseball batting cages, and tennis nets) are eligible for
reregistration. Labeling is required to prohibit the use of paper containing TBT for direct and
indirect food contact.
Other risk mitigation measures for these uses are explained in the section on occupational
handler mitigation below.
d) Aggregate risk
Aggregate risks were not estimated because risks associated with some individual
contributors to post-application residential risk exceed levels of concern.
e) Occupational risk mitigation—handlers
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Occupational handler exposures may be associated with commercial application of TBT
wood preservatives, adding TBT products to cooling water, applying TBT disinfectant in farm
and animal premises, manufacturing treated materials such as textiles and building materials,
using TBT in oil field and petrochemical water injection systems and metalworking fluids.
Cooling towers
TBT is currently registered for use in commercial and industrial recirculating cooling
towers. For handlers adding TBT products to cooling tower water, data are not available to
estimate exposures for open-pour or metering-pump applications. The Agency's practice for
handler risk mitigation for this use pattern is to take into account both the volatility of the
pesticide and its toxicity. In the case of TBT, volatility is not a big concern, but the toxicity of
TBT suggests occupational exposures will pose risks. The Agency does not always require the
closed loading systems for antimicrobial pesticides, but in the case of TBT, given its toxicity, the
Agency believes that a closed loading system with a dry coupling (i.e., a system in which the
TBT additive can be withdrawn from the product container via a dry coupling and fed into the
cooling system without opportunity for human contact with the additive) is needed. The Agency
is also believes that long pants, long-sleeved shirts, protective eyewear, and chemical resistant
gloves are needed to protect handlers. The combination of these measures is expected to reduce
handler exposures adequately.
Risk management for this use also is discussed in the section on Environmental Risk
Management below. Per that discussion, this use is not eligible for reregistration.
Wood preservatives
Inhalation and dermal short- and intermediate-term risks for commercial applicators
of paints and stains containing TBT were well below the target MOE, for applications both by
paint brush and airless sprayer. These risk estimates are consistent with what has been estimated
for residential applicators; the MOEs are the same or lower. Because of the very low MOEs and
the lack of feasible mitigation options, the Agency has determined that TBT products used for
wood preservation on homes, buildings, building components, and outdoor furniture are not
eligible for reregistration. Additional discussion of the risk management for this use is provided
in the section on environmental risk management below.
Disinfectant for Farm Premises
Exposures for workers who apply TBT hard surface disinfectants in farm and related
animal husbandry situations were assessed for several methods of application: brush-on, wipe,
mop, hand held and mechanical sprayers, and hand-held foggers. The product also is applied via
thermal foggers and automated foggers. The following methods are associated with dermal risk
estimates below the target MOE of 100: wipe, hand-held spray, and hand-held fogger.
Information was available on the effect of gloves on exposures for brush-on applications only;
the use of gloves increased the MOE for this application method to a level above the target
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MOE. Based on a comparison of with and without glove dermal risk estimates for the brush-on
method, it seems likely that risk estimates for both the wipe and hand-held spray methods would
be increased above the target MOE if handlers wore gloves. For inhalation exposures, all
methods are associated with MOE estimates above the target except for hand-held foggers.
Information is not available for estimating the impact of PPE on inhalation exposure.
The registrant has provided information on the size of various poultry facilities that
indicates the size of incubators, setters, and egg rooms is much less than the volumes the Agency
assessed for handler exposures in poultry facilities. It is not clear that the size of individual
incubators, etc. alone is representative of handler exposures because numerous incubators, etc.
may be treated by one individual during a work day. It is anticipated that the use of an
automated fogger, with appropriate precautions, would not pose inhalation risks of concern for
handlers.
The Agency has not quantified occupational handler exposure for immersion treatments
of tack, tools, and equipment with TBT, or boot baths. No data are available to assess these
exposures or to assess the impact of PPE on those exposures, but the Agency believes that they
represent areas of concern.
The Agency has concluded that the handler risks associated with the disinfectant use are
likely to be above the target MOE for the following application methods, if PPE includes
chemical-resistant gloves: brush-on, wipe, mop, hand-held sprayers, and mechanical sprayers.
Data will be required on the impact of gloves on handler risks for the wipe and hand-held sprayer
application methods. The application of TBT on farm premises via a hand-held fogger (thermal
or otherwise) is prohibited. Additional discussion of the risks and potential mitigation measures
associated with this use is provided in the sections on dietary risk mitigation (above), and post-
application occupational risk mitigation and environmental risk management (below).
Materials preservatives in building materials
For the manufacture of treated building materials, the Agency assessed exposures to
workers who add the TBT product to building materials during the production process. The
exposures were modeled on the use of TBT in the caulk manufacturing process, in which a
formulation of TBT is added with the other ingredients of caulk to be mixed together prior to
finishing and packaging. The scenario was assessed for handlers adding TBT by pouring from
an open container and by automated dispensing via a metering pump system. Data were
available for evaluating the impact of gloves on handler risk. The target MOE is 100. Inhalation
MOEs were well above the margin of exposure, but dermal MOEs were estimated at 36 for
open-pouring and 2 for the metered pump. Systems using metered pumps typically handle
greater volumes of biocide than systems in which handlers open-pour the biocide by hand.
Although data are lacking to calculate the impact of engineering controls on handler
exposure to TBT products added during the manufacture of building materials, the Agency
believes that the margin of exposure can be adequately increased through use of a closed loading
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system that uses a dry coupling, along with wearing long pants, long-sleeved shirts, protective
eyewear, and chemical resistant gloves.
The use of TBT in caulk and related materials is permitted by product labels, but it is now
our understanding that TBT is no longer used in caulk production. The use of TBT in building
materials appears to be limited to joint compound, drywall, adhesives, medium density fiber
board, and particulate board. We have been informed that TBT is also used in the manufacture
of grout, although grout is not specifically listed on products labels as an acceptable use site. If
registrant support for this use can be confirmed, the registrant may request that grout be added to
the use sites via a request for an amendment to the registration, as long as all pertinent risk
mitigation measures are implemented. The Agency is requiring that TBT products for use in
producing these materials, and any as-yet-unidentified but legal uses in building materials
production, must be added to such materials via a closed loading system with dry coupling and
the PPE discussed above.
TBT also is used as a preservative for industrial adhesives that may be used in assembly
of cardboard boxes. The Agency is not able to assess quantitatively the risks to manufacturing
handlers who add TBT products to adhesives for use in cardboard boxes because there are no
available exposure data specific to the corresponding scenario. Also, as in the case of the
building materials discussed directly above, data are lacking to calculate the impact of
engineering controls on the potential exposures of handlers adding TBT products during the
adhesives production process. Drawing a parallel between these exposures and the exposures of
workers adding TBT to building materials, the Agency is requiring that handlers of TBT
additives for incorporation into all adhesives use closed loading systems with dry coupling, and
wear long pants, long-sleeved shirts, protective eyewear, and chemical resistant gloves.
Materials preservatives in textiles, paper, and related uses
The Agency did not assess exposures specifically for handlers involved in the treatment
of textiles and related materials with TBT, but has used estimated exposures for handlers
involved in the production of treated building materials to understand the potential risks (see
above). For this use of TBT, the Agency found that the inhalation MOEs for both open-pour and
metered pump applications were well above the target margin of exposure of 100 while dermal
MOEs fell well below the target.
The Agency believes that handler risks for textile treatment, paper production, and related
use sites can be adequately addressed through use of a closed loading system with a dry coupling
device, and long pants, long-sleeved shirts, protective eyewear, and chemical resistant gloves.
Post-application residential risk mitigation for these uses is discussed above.
Oil field and petrochemical water injection systems
The Agency assessed exposures to workers who add the TBT product to water injection
systems, either via an open-pouring process or a metering pump, while wearing gloves. Risks
were quantified for the open-pour option only. The target MOE is 100. The inhalation and
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dermal MOEs (both 3) fell well below the target; workers adding TBT via a metering pump
system were estimated to be exposed to higher volumes of TBT solution and so the MOEs would
be expected to be even lower. The Agency believes that handler risks for adding TBT into these
water injection systems could be addressed through use of a closed loading system with a dry
coupling device, along with wearing long pants, long-sleeved shirts, protective eyewear, and
chemical resistant gloves.
Additional discussion of the risks and potential mitigation measures associated with this
use is provided in the section on environmental risk management (below). Per that discussion,
this use is not eligible for reregi strati on.
Metal working fluids
The Agency assessed exposure for workers adding TBT to metal working fluids via
open-pouring. The target MOE is 100, and the Agency estimates that dermal risks are associated
with an MOE of 21, while the inhalation MOE is estimated at 68. Risks were not quantified for
other means of application such as the use of metering pumps, although it is anticipated that
larger volumes of TBT products would be added in circumstances where automated equipment is
used, so that exposures are potentially greater for this equipment than when the product is added
by pouring. The Agency believes that handler risks for adding TBT to metal working fluids
could be addressed through use of a closed loading system with a dry coupling device, along
with wearing long pants, long-sleeved shirts, protective eyewear, and chemical resistant gloves.
Additional discussion of the risks and mitigation potential for this use is provided in the
section on post-application occupational risk mitigation (below). Per that discussion, this use is
not eligible for reregi strati on.
f) Occupational risk mitigation—post-application
Occupational post-application exposures are assumed to be negligible except for workers
reentering farm premises where TBT disinfectants have been applied by fogging and machinists
using TBT-treated metalworking fluids.
Disinfectant for Farm Premises
The Agency has estimated exposures for workers reentering poultry buildings after
fogging treatments for various periods after the completion of treatment. The TBT farm premises
product label states that after a fogging treatment, the treated area should be well-ventilated and
not entered until 1 to 4 hours after fogging. If the building must be entered, the label states
individuals entering the building must wear a self-contained respirator approved by
NIOSH/MSHA, goggles, long sleeves and long pants. Exposures have been estimated for a
person entering the building 1, 2, and 4 hours after fogging. Reentry at 1 hour after fogging is
associated with an inhalation MOE of 17, well below the target MOE of 100. After two hours,
the MOE is estimated to have increased to 900. The Agency is requiring that the label indicate a
mandatory reentry interval of (no less than) two hours.
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Tools and equipment present during premises treatments and tack and tools treated via
immersion with TBT may transfer TBT to human skin. Because of the potential for worker
exposure, the immersion application is prohibited. Labels will require that tools and instruments
be removed from premises prior to treatment or washed with soap and water after treatment and
before re-use.
Additional discussion of the risks and mitigation potential for this use is provided in the
sections above on dietary risk mitigation, risks to domestic animals, and occupational handler
risk mitigation (above), and on environmental risk management (below).
Metal working fluids
Dermal and inhalation exposure to TBT occur after the chemical has been incorporated
into the metalworking fluid and a machinist is using a TBT treated end-product. MOEs
calculated for dermal and inhalation risks are 3 and 36, respectively, well below the target MOE
of 100. Because feasible means of reducing exposure to metal workers are limited, e.g.,
machinists cannot work effectively while wearing gloves and are not reasonably expected to do
so, the Agency has concluded that the use of TBT in metal working fluids is not eligible for
reregi strati on.
Discussion of other risks associated with this use is provided in the section on
occupational handler risk mitigation (above).
2. Environmental risk management
The Agency has assessed the ecological risks associated with the use of TBT wood
preservatives on houses, parts of houses, and architectural structures. For other uses, risks have
not been quantitatively assessed, primarily because data are not available to characterize
environmental exposures, but these uncertainties and insights gained from the published
literature have led to Agency concerns about uses that might potentially contribute to
environmental concentrations of TBT and its degradates.
Historically, TBT derivatives such at TBTO have been used in the formulation of
antifouling paints. TBT antifouling paints are very efficacious, because TBT is extremely toxic
to fouling organisms that attach to ship hulls (e.g., slime-producing bacteria, algae, tubeworms,
barnacles) and it can be formulated into paint systems that slough off spent layers as the ship
moves through the water, exposing fresh toxin and providing a long service life.
Unfortunately, the same toxicity that makes TBT such an efficacious antifoulant
represents toxicity to nontarget aquatic organisms. Marine organisms including oysters
important to the seafood industry and marine snails have demonstrated serious developmental
and reproductive effects at concentrations of TBT in the parts-per-trillion range. In addition,
TBT is very persistent in the aquatic environment, particularly in the sediment, or benthos, where
many types of aquatic animals live and feed. TBT bioaccumulates in exposed organisms, and
has been shown to concentrate in the bodies of predator species including marine mammals. It
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has also been detected in seafood for human consumption. TBT is a known endocrine disrupter
that has been shown to affect the endocrine systems of a range of species. Data are lacking for
sediment toxicity, and for calculation of risk quotients for honeybees and aquatic plants. Limited
non-guideline data indicate that TBT is highly phytotoxic to some algae and diatoms.
Because of its ecological effects and widespread manifestations of ecological risk, the
global community has developed an international treaty prohibiting the use of TBT antifouling
systems. The prohibition will become effective in September 2008.
In the US, the last TBT-based antifouling hull paint registration was cancelled in 2005. It
remains legal to produce and sell TBT antifouling systems for two applications. TBT is
incorporated into rubber for the formation of sonar domes used in US Navy vessels. This
application is considered to be critical for naval operations and releases a much smaller amount
of TBT into the aquatic environment than did the antifouling hull coatings. TBT is also used in
antifoulant devices within oceanographic instruments deployed by government researchers to
monitor global ocean conditions (i.e., conductivity sensors). The total amount of TBT present in
the instruments is very small, and the use is considered to be critical by government research
organizations such as the National Oceanographic and Atmospheric Administration.
Other uses of TBT also have the potential to contaminate natural waters. In the case of
the wood preservatives, the Agency is able to estimate environmental concentrations for
particular applications. In the case of the use in cooling towers, immersion treatments on farm
premises, petrochemical injection systems, and irrigation tubing for non-agricultural
applications, data or models do not exist to allow the quantification of environmental exposures,
but other evidence points to the need for risk mitigation or the use pattern suggests that aquatic
contamination is possible. The remaining antifouling uses of TBT are also discussed in this
section.
a) Recirculating cooling towers
Cooling towers are designed to recirculate cooling water for a period of time before salts
and debris in the cooling water necessitate the discharge of water and replacement with fresh
water and biocidal additives. It is the Agency's understanding that most of the discharge is
directed to municipal water treatment facilities. Evidence from California strongly suggests that
the discharge of cooling water containing TBT biocide can result in levels of TBT in treated
water that are higher than risk- and site-specific discharge permit levels.
The use of TBT in cooling tower water is prohibited in nine California counties around
the San Francisco Bay (Alameda, Contra Costa, Marin, Napa, San Francisco, San Mateo, Santa
Clara, Solano, and Sonoma), based on the exceedance of discharge standards for the Bay, as
reported by the California Department of Pesticide Regulation
(http://www.cdpr.ca.gov/docs/legbills/calcode/040301.htm). In 1994, the Palo Alto Regional
Water Quality Control Plant calculated that the equivalent of one gallon of 2% TBT solution
discharged into the sewer system and treated with other wastewater would contaminate over
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2 billion gallons of effluent at concentrations exceeding the 5 ppt discharge limit
(http://www.city.palo-alto.ca.us/civica/filebank/blobdload.asp?BlobID=2469). The City of Palo
Alto concluded that even very small discharges from one or two cooling towers could place the
city in violation of its discharge permit.
The problem in the San Francisco Bay suggests that even moderate use of TBT in cooling
towers can pose permit problems and a threat to nearby water bodies. It also suggests that water
treatment facilities are not effective in removing TBT from the water, and the Agency is not
aware of any information to the contrary. The Agency has not attempted to draw conclusions
about drinking water exposure and risks from this information, but since TBT causes adverse
effects in non-target organisms at extremely low concentrations, the Agency believes there is a
potential for ecological risks of concern associated with the cooling tower use.
Both the California Department of Pesticide Regulation and the City of Palo Alto have
reported that effective alternatives to TBT cooling water additives are available at comparable
prices (http://www.city.palo-alto.ca.us/civica/filebank/blobdload.asp?BlobID=2469) and
(http://www.cdpr.ca.gov/docs/emon/pubs/ehapreps/eh9507.pdf), and the Agency has estimated
that TBT represents less than 3% cooling water biocide usage annually in the US. In the absence
of additional information, these findings strongly suggest that the benefits associated with TBT
cooling water additives are limited.
For purposes of this reregi strati on eligibility decision, the Agency has concluded that the
risks associated with the cooling tower use of TBT are unacceptable, and that this use of TBT is
not eligible for reregistration. Discussion of other risks associated with this use is provided in
the section on occupational handler risk mitigation (above).
b) Wood preservatives
The Agency calculated risk quotients for the leaching into the water column of TBT from
various wood preservative-treated use sites (from highest estimated environmental concentration
to lowest): whole house, fences, deck posts, fence posts, decks, and transmission poles. Based
on registrant-submitted toxicity data for test species, the Agency concluded that the acute risk
LOG is equaled or exceeded for listed (e.g., endangered and threatened) freshwater and
estuarine/marine invertebrates exposed in the water column. In addition, the published literature
indicates that marine species exhibit adverse chronic effects from TBT in concentrations at or
below those estimated for the same wood preservative scenarios.
The Agency has determined that the wood preservative uses of TBT are not eligible for
reregistration. Discussion of other risks associated with this use is provided in the sections on
residential and occupational handler risk mitigation (above).
c) Disinfectant for farm premises
The registrant reports that excess solution from immersion treatments with TBT is
typically discharged on-site or to municipal wastewater facilities. Information was not available
36
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specifically for disposal of used/excess boot bath solution, but the registrant has noted that this
use is a very small portion of TBT use on farm premises. Based on our previously noted
assumption about the inability of municipal wastewater facilities to remove or adequately reduce
the concentration of TBT in wastewater, the Agency believes that excess solution may
potentially contaminate farm premises, drinking water, and aquatic habitats. Based on these
conclusions and the presumed low benefits of the boot bath application of TBT, the Agency
believes that the environmental risks outweigh the benefits for the farm premises immersion and
boot bath uses, as related to disposal of excess treatment solution. Discussion of other risk
concerns associated with the immersion treatment and boot bath use is provided in the sections
on occupational handler and occupational post-application risk mitigation (above).
d) Oil field and petrochemical injection
The Agency believes that fluids used for these purposes may reenter groundwater and
surface waters after use. Environmental concentrations in water and drinking water exposures
cannot be estimated, and means of precluding environmental contamination are not apparent.
This use is not eligible for reregi strati on.
e) Irrigation tubing
The Agency believes that irrigation water from treated tubing may contain TBT residues
that may enter groundwater and surface waters. Although such tubing is not used in agricultural
settings, there is a potential for environmental exposures in water and drinking water exposures.
This use is not eligible for reregi strati on.
f) Antifouling for sonar domes and oceanographic instruments
The Agency has recently completed a lengthy review of TBT used in antifouling systems,
which culminated with the cancellation of all uses of TBT in antifouling systems used on boat
and ship hulls and underwater drive units. During the course of that review, the Agency
determined that the use of TBT in sonar domes is critical for U.S. military readiness. The
Agency also determined that there were exceptional benefits associated with the use of TBT
devices used to protect conductivity sensors in oceanographic research instruments. In addition,
the quantity of TBT used in these instruments is very small. Because of the favorable benefits
situation for these two uses and the very small volumes used in research instruments, the Agency
has determined that these uses are eligible for reregi strati on. It is not anticipated that
occupational risk mitigation for sonar dome production that parallels measures required for other
materials preservatives will preclude the use of TBT in this critical application.
3. Labeling requirements
In order to be eligible for reregi strati on, various use and safety information will be
included in the labeling of all manufacturing use products containing TBT. For the specific
labeling statements and a list of outstanding data, refer to Section V of this RED document.
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4. Listed species considerations
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
LOG 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.
5. General risk mitigation
TBT end-use products (EPs) may also contain other registered pesticide active
ingredients. The Agency has determined that the use of TBT in wood preservatives is not
eligible for reregi strati on, in part because of potential risks to federally listed species. The same
determination has not been made for other uses of TBT. According to published schedules for
reregi strati on (http://www.epa.gov/oppsrrdl/reregi strati on/decision_schedule.htm) and
registration review (http://www.epa.gov/oppsrrdl/registration review/schedule summary.pdf:
schedule dated 11/07, will be updated periodically), the Agency will be evaluating other
pesticides, some with end-use products that also contain a TBT active ingredient. The Agency
requires that registrants adopt all listed species risk mitigation measures for all active ingredients
in the product. If a product contains multiple active ingredients with conflicting listed species
risk mitigation measures, the more stringent measure(s) will be adopted.
V. What Registrants Need to Do
The Agency has determined that TBT is eligible for reregi strati on provided that: 1)
additional data that the Agency intends to require confirm this decision is submitted; 2) required
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label amendments are made; and 3) all other risk mitigation measures identified in this document
are adopted. Required labeling amendments and the required risk mitigation measures to be
implemented via revised labeling are set forth in the Label Changes Summary Table below
(Table 13). TBT data requirements the Agency intends to impose will include the elements
listed below in Table 12.
Registrants of TBT products will be required respond to these data requirements within
90 days of receipt of the generic data call-in (DCI) to be issued subsequent to the release of the
RED by submitting:
1. completed response forms to the generic DCI (i.e., DCI response form and
requirements status and registrant's response form); and
2. any time extension and/or waiver requests with a full written justification.
Furthermore, within the time limit specified in the generic DCI, the registrants must cite
any existing generic data which address data requirements or submit new generic data
responding to the DCI.
Please contact Jill Bloom at (703) 308-8019 or bloom.jill@epa.gov with questions regarding
generic reregi strati on. Mail delivery addresses:
By US mail: By express or courier service:
Document Processing Desk Document Processing Desk
Jill Bloom Jill Bloom
Office of Pesticide Programs (7508P) Office of Pesticide Programs (7508P)
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
For end-use products containing the active ingredients TBT, registrants must 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. 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);
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2. a completed original application for reregi strati on (EPA Form 8570-1). Indicate on
the form that it is an "application for reregi strati on";
3. five copies of the draft label incorporating all label amendments outlined in Table 13
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
reregi strati on and/or the PDCI. All materials submitted in response to the PDCI must be
addressed as follows:
By US mail:
Document Processing Desk
Marshall Swindell
Office of Pesticide Programs (751 OP)
U.S. Environmental Protection Agency
1200 Pennsylvania Ave., NW
Washington, DC 20460-0001
By express or courier service:
Document Processing Desk
Marshall Swindell
Office of Pesticide Programs (751 OP)
U.S. Environmental Protection Agency
Room S-4900, One Potomac Yard
2777 South Crystal Drive
Arlington, VA 22202
A. Manufacturing use products
1. Generic Data Requirements
The generic database supporting the reregi strati on of TBT has been reviewed and
reregi strati on eligibility decisions have been made for the various uses of TBT. The following
data requirements have been identified by the Agency as needed to facilitate a refined
assessment of TBT and to determine if any adjustments need to be made to the TBT
registrations. In some cases, data gaps are cited for the support of uses deemed not eligible for
reregi strati on. These data would be the kind of data EPA would require if a reconsideration of
the eligibility decisions for specific uses appeared to be warranted. Such data submissions are
likely to be evaluated as a part of the registration review project, although the Agency has not
yet scheduled the assessment of TBT active ingredients that will take place under registration
review. Pesticides in registration review generally undergo reassessment on a 15-year cycle.
A generic data call-in (DCI) will be issued at a later date for the TBT active ingredients.
Table 11 provides a summary of data gaps, but distinctions are not made for the three different
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TBT compounds. The generic DCI will detail and confirm the data required to be submitted
for each active ingredient.
Table 11. Data Requirements for Reregistration of Tributyltin Oxide, Tributyltin
Benzoate, and Tributyltin Maleate
Guideline
Number
171-4 & 850.3020
850.1735
850.1740
No Guideline
850.5400
850.4400
850.4225
850.4250
860.1300, .1340,
.1380, and. 1480
870.1200
870.1300
870.2400
870.2500
870.2600
870.3250
870.3700
870.5100 to .5915
875.1200, .1600
875.1400
875.1700, .2700
875.2800
Study Title
Honey /beeswax residues and acute toxicity of treated materials to
bees
Whole sediment: acute freshwater invertebrates
Whole sediment: acute marine invertebrates
Whole sediment: chronic invertebrates
Freshwater diatom; TGAI or EP
Marine diatom; TGAI or EP
Blue-green cyanobacteria; TGAI or EP
Freshwater green alga; TGAI or EP
Freshwater floating macrophyte duckweed; TGAI or EP
Freshwater rooted macrophyte rice seedling emergence; EP
Freshwater rooted macrophyte rice vegetative vigor; EP
Residues in meat, milk, and eggs
Acute Dermal - Rabbit
Acute Inhalation - Rat
Primary Eye Irritation - Rabbit
Primary Dermal Irritation - Rabbit
Dermal Sensitization
90-day Dermal Toxicity - Rodent
Developmental Toxicity - rodent
Mutagenicity
Dermal Indoor Exposure (inc. impact of chemical resistant gloves)
Indoor Inhalation Monitoring
Product Use Information (handler, post-application)
Description of Human Activity (post-application)
Appendix B to this RED shows the data requirements that will be imposed for each active
ingredient based on specific use sites.
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2. Labeling for technical and manufacturing use products
To ensure compliance with FIFRA, technical and manufacturing-use product (MP)
labeling must be revised to comply with all current EPA regulations, PR Notices and applicable
policies. According to the timeline for label changes, technical and MUP labeling must bear the
language shown in Table 12, Label Changes Table.
B. End-use products
1. Product-specific data requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific
data for a 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, outlining the required data for each product or set of
products, will be sent to registrants 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 13, Label Changes Table.
Registrants may generally distribute and sell products bearing old labels/labeling for 26
months from the date of the issuance of this Reregi strati on Eligibility Decision 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.
3. Label changes summary table
In order to be eligible for reregi strati on, all product labels must be amended to
incorporate the risk mitigation measures outlined in Section IV of the TBT RED. The following
table describes how language on the labels should be amended.
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Table 12. Labeling Changes Summary Table for Products Containing TBT
for Manufacturing Use Products containing TBT
Description
Amended Labeling Language
Placement on Label
For all
manufacturing-use
products
"This product may be formulated into products for the following uses only:
farm and animal premises when animals and eggs have been removed
(livestock housing, kennels, veterinary clinics, animal laboratories, breeding
facilities, hatcheries, egg rooms, egg trucks, incubators, and setters, but not
tack, tools, equipment, or boot baths), fiberfill, polyurethane foam (except in
mattress covers), carpet backing, air filters, rubber mats, canvas and other
textiles with outdoor applications (tarps, tents, and awnings, but not furniture
components or hammocks), webbing for nets in sports applications (golf
courses/driving ranges, batting cages, tennis nets), paper (except in paper with
direct or indirect food contact), adhesives, particulate board, medium density
fiberboard, dry wall, grout, joint compound, sonar domes, and in antifoulant
devices within oceanographic instruments (conductivity sensors)."
"Not for formulating wood preservatives, paints, or stains; cooling
tower/cooling water treatments; antifouling paints for ships, boats, fish nets, or
crab, bass, or lobster pots; oilfield and petrochemical injection fluids; or metal
working fluids. Not for use in manufacturing irrigation tubing."
Directions for Use
Environmental
Hazards Statement
"This pesticide is toxic to fish and aquatic invertebrates. Do not contaminate
water when disposing of equipment washwaters. Do not discharge effluent
containing this product into lakes, streams, ponds, estuaries, oceans, or other
waters unless in accordance with the requirements of a National Pollutant
Discharge Elimination System (NPDES) permit and the permitting authorities
are 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
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for End-Use Products containing TBT
Description
Amended Labeling Language
Placement on Label
For all end-use
products
containing TBTO,
TBTB, or TBTM
Allowable use sites for an end-use product are one or more of the following:
farm and animal premises when animals and eggs have been removed
(livestock housing, kennels, veterinary clinics, animal laboratories, breeding
facilities, hatcheries, egg rooms, egg trucks, incubators, and setters but not tack,
tools, equipment, or boot baths), fiberfill, polyurethane foam (except in
mattress covers), carpet backing, air filters, rubber mats, canvas and other
textiles with outdoor applications (tarps, tents, and awnings, but not furniture
components or hammocks), webbing for nets in sports applications (golf
courses/driving ranges, batting cages, tennis nets), paper (except in paper with
direct or indirect food contact), adhesives, particulate board, medium density
fiberboard, dry wall, grout, joint compound, sonar domes, and in antifoulant
devices within oceanographic instruments (conductivity sensors)."
The registrant must list the allowable use site(s) on the product label. The
registrant must not label a product containing TBT with any of the following
uses: wood preservatives, paints, or stains; cooling tower/cooling water
treatments; oilfield and petrochemical injection fluids; metal working fluids;
antifouling paints for use on ships, boats, fish nets, or crab, bass, or lobster
pots; or irrigation tubing."
Directions for Use
Environmental
Hazards Statement
"This pesticide is toxic to fish and aquatic invertebrates. Do not contaminate
water when disposing of equipment washwaters. Do not discharge effluent
containing this product into lakes, streams, ponds, estuaries, oceans, or other
waters unless in accordance with the requirements of a National Pollutant
Discharge Elimination System (NPDES) permit and the permitting authorities
are 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
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for End-Use Products containing TBT
Description
Amended Labeling Language
Placement on Label
Personal
Protective
Equipment (for all
use sites except
antifouling devices
in conductivity
sensors for
oceanographic
instruments)
"Handlers must wear long sleeve shirts, long pants, socks, shoes, protective
eyewear, and chemical resistant gloves. Materials that are chemically resistant
to this product include [registrant must provide examples of chemical resistant
materials here]."
Precautionary Statements:
Hazards to Humans and
Domestic Animals
User Safety
Requirements
"Follow manufacturer's instructions for cleaning/maintaining Personal
Protective Equipment. If no such instructions for washables exist, use
detergent and hot water. Keep and wash Personal Protective Equipment
separately from other laundry."
"Discard clothing and other absorbent materials that have been drenched or
heavily contaminated with this product's concentrate. Do not reuse them."
Precautionary Statements:
Hazards to Humans and
Domestic Animals
immediately following the
Personal Protective
Equipment requirements
Engineering
controls (for all
use sites except
farm and animal
premises
treatments and
antifouling devices
in conductivity
sensors for
oceanographic
instruments)
"Handlers must use closed loading systems with dry coupling for introducing
this material into treatment and manufacturing systems."
Immediately following User
Safety Requirements
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for End-Use Products containing TBT
Description
Amended Labeling Language
Placement on Label
User Safety
Recommendations
"User Safety Recommendations"
"Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet."
"Users should remove clothing/ Personal Protective Equipment immediately if
pesticide gets inside. Then wash thoroughly and put on clean clothing."
"Users should remove Personal Protective Equipment immediately after
handling this product."
"Wash the outside of gloves before removing. As soon as possible, wash
thoroughly and change into clean clothing."
Precautionary Statements:
Hazards to Humans and
Domestic Animals
immediately following
Engineering Controls
General
Application
Restrictions
"Do not apply this product in a way that will contact workers or other persons,
either directly or through drift. Only protected handlers may be in the area
during application."
Directions for Use
Entry restrictions
for products with
directions for use
on farm and
animal premises
"Do not re-enter treated area for at least 2 hours after treatment is complete."
Directions for Use
Site-Specific
Directions for Use
End-use product labels must be amended to contain directions for use only on
the allowed use sites. All other use sites and the corresponding directions for
use must be removed from end-use product labels.
"Do not use materials containing TBT for underwater uses on wood, textiles, or
rope."
Directions for Use
associated with the specific
use site
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for End-Use Products containing TBT
Description
Amended Labeling Language
Placement on Label
Site-Specific
Directions for
Use: Farm/animal
premises uses
"Animals and eggs must be removed from premises prior to treatment of
premises and surfaces within premises. Animals must not be returned to
premises for at least 48 hours following the conclusion of treatment. Remove
all feeding and watering bowls and containers prior to treatment, or wash with
soap and water after treatment and before re-use."
"Do not use as immersion treatment. Do not treat tack or tools or other
equipment that come into direct contact with animals; remove from premises
prior to treatment or wash with soap and water after treatment and prior to re-
use."
"Do not use in boot baths or otherwise on footwear."
"Application is prohibited via hand-held foggers, thermal or otherwise.
Applications may only be applied via brush, wipe, mop, hand-held and
mechanical sprayers, or automated foggers when handlers are wearing required
personal protective equipment."
Directions for Use
associated with the specific
use-site
Site-Specific
Directions for
Use: Treatment of
textiles and related
materials
"Do not use on clothing, mattress and pillow covers and ticking, sponges, mop
heads, upholstery fabric, covers of furniture cushions or parts of furniture
which contact human skin during normal use, hammocks, or materials that will
be used to make these items, or as a laundry treatment. Do not use on textiles
for applications with potential for direct contact with human skin. Do not use
on rope."
Directions for Use
associated with the specific
use-site
47
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VI. APPENDICES
48
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Appendix A. Table of Representative Use Patterns for TBTO, TBTB, TBTM
Table of Representative Use Patterns for TBT Compounds
Use Site
Formulation
Method of
Application
Application Rate/ No. of
applicationsa
Use Limitations
Materials Preservative
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Appendix B. Generic Data and Studies Used for the Reregistration Decision
Guide to Appendix B
Appendix B contains listing of data requirements which support the reregi strati on for active ingredients within case #4122
(organic esters of phosphoric acid) covered by this RED. It contains generic data requirements that apply to organic esters of
phosphoric acid 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 establishment 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
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.
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DATA REQUIREMENT
New
Guideline
Number
Old
Guideline
Number
Study Title
Use
Pattern
CITATION(S)
MRID Number
PRODUCT CHEMISTRY
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
830.7200
830.7220
830.7300
830.7840
830.7860
830.7950
830.7370
61-1
61-2a
61-2b
62-1
62-2
62-3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
Product Identity and Composition
Starting Materials and Manufacturing Process
Formation of Impurities
Preliminary Analysis
Certification of Limits
Analytical Method
Color
Physical State
Odor
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant in Water
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DATA REQUIREMENT
New
Guideline
Number
830.7550
830.7560
830.7570
830.7000
830.6313
830.6314
830.6315
830.6316
830.6317
830.7100
830.6319
830.6320
830.6321
Old
Guideline
Number
63-11
63-12
63-13
63-14
63-15
63-16
63-17
63-18
63-19
63-20
63-21
Study Title
Partition Coefficient (Octanol/Water)
PH
Stability
Oxidizing/Reducing Action
Flammability
Explodability
Storage Stability
Viscosity
Miscibility
Corrosion Characteristics
Dielectric breakdown voltage
Use
Pattern
CITATION(S)
MRID Number
ECOLOGICAL EFFECTS
850.2100
850.1075
850.1075
850.1010
71-1
72-1
72-1
72-2
Avian Acute Oral Toxicity Test
Acute Freshwater Fish (bluegill)
Acute Freshwater Fish (rainbow trout)
Acute Freshwater Invertebrate (daphnia magna)
TOXICOLOGY
870.1100
81-1
Acute Oral - Rat
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DATA REQUIREMENT
New
Guideline
Number
870.1200
870.1300
Old
Guideline
Number
81-2
81-3
Study Title
Acute Dermal - Rabbit
Acute Inhalation - Rat
Use
Pattern
CITATION(S)
MRID Number
870.2400
81-4
Primary Eye Irritation - Rabbit
870.2500
870.2600
870.3100
870.3200
870.3250
870.3465
870.3700a
870.3700
870.3800
870.4100
870.4200
870.4300
81-5
81-6
82-la
82-2
82-3
82-4
83-3a
83-3b
83-4
83-la
83-lb
83-2a
83 -2b
83-5
Primary Dermal Irritation - Rabbit
Dermal Sensitization
90-Day Feeding-Rodent
21/28-Day Dermal Toxicity - Rat
90-day Dermal Toxicity - Rodent
90-Day Inhalation - Rat
Developmental Toxicity - rodent
Teratogenicity - Rabbit
Reproduction and Fertility Effects - 2 Generation
Repro
Chronic Feeding Toxicity - Rodent
Chronic Feeding Toxicity - Non-Rodent (dog)
Oncogenicity - Rat
Oncogenicity - Mouse
Combined Chronic Toxicity/Carcinogenicity
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DATA REQUIREMENT
New
Guideline
Number
870.5100
870.5300
870.5265
870.5385
870.5395
870.5450
870.5900
870.7485
870.7600
Old
Guideline
Number
84-2
84-2a
84-2b
84-2
84-2
85-1
85-2
Study Title
Bacterial reverse mutation test
In Vitro mammalian cell gene mutation test
Gene Mutation - ames
Structural Chromosome Aberration
In Vivo mammalian micronucleus test /Mammalian
erythrocyte micronucleus test
Rodent dominant lethal assay
Mammalian cytogenetics (sister chromatid
exchange)- hamster
General Metabolism
Dermal Absorption
Use
Pattern
CITATION(S)
MRID Number
OCCUPATIONAL/RESIDENTIAL EXPOSURE
875.2300
875.1200
875.1400
133-3
233
234
Indoor Surface Residue Dissipation (Dermal Residue
Transfer Studies for Textiles/Clothing,
Mattress/Mattress Ticking and Carpet
Shampoo/Cleaner)
Dermal Indoor Exposure
Inhalation Indoor Exposure
-------
DATA REQUIREMENT
New
Guideline
Number
875.1600
875.1700
875.2700
875.2800
875.2900
Old
Guideline
Number
133-1
134
Study Title
Applicator Exposure Monitoring Data Reporting
Product Use Information
Description of Human Activity
Data Reporting and Calculations
Use
Pattern
CITATION(S)
MRID Number
ENVIRONMENTAL FATE
835.2120
161-1
Hydrolysis
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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 Federal holidays, from 8:30 a.m. to 4:00 p.m.
The docket initially contained the April 19, 2006 preliminary risk assessment and the
related supporting science documents. EPA then considered comments on the risk assessment
and revised the risk assessment and supporting chapters as necessary. The revised risk
assessment 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:
• Preliminary Risk Assessment; Notice of Availability, /08.
Preliminary Risk Assessment and Supporting Science Documents (RED Supporting
Documents):
Revised Risk Assessment and Revised Supporting Science Documents (RED Supporting
Documents):
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Appendix D. Bibliography
Bibliography
MRID # Citations
Other Supporting Documents
Web References
HERA. 2003. Human and Environmental Risk Assessment, Guidance Document Methodology,
April 22, 2002 (http://www.heraproiect.com/files/Guidancedocument.pdf).
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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 RED
for a list of studies that the Agency plans to require.
-------
Appendix F. Product Specific Data Call-In
The Agency intends to issue a Product Specific Data Call-In at a later date.
-------
Appendix G. Batching of TBT End-use Products
The Agency will complete the batching for acute toxicity data requirements for reregi strati on at a
later date.
-------
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.
-------
Appendix I. List of Available Forms
Pesticide Registration Forms are available at the following EPA internet site:
http://www.epa.gov/opprd001/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 atwilliams.nicole@epamail.epa.gov.
The following Agency Pesticide Registration Forms are currently available via the
internet at the following locations:
Document
Number
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
Document Name
Application for Pesticide
Registration/ Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of
Distribution of a Registered Pesticide
Product
Application for an Experimental Use
Permit
Application for/Notification of State
Registration of a Pesticide To Meet a
Special Local Need
Formulator's Exemption Statement
URL
http://www.epa.sov/opprd001/forms/8570-
l.pdf
http://www.epa.sov/opprd001/forms/8570-
4.pdf
http://www.epa.sov/opprd001/forms/8570-
5.pdf
http://www.epa.sov/opprd001/forms/8570-
17.pdf
http://www.epa.sov/opprd001/forms/8570-
25.pdf
http://www.epa.sov/opprd001/forms/8570-
27.pdf
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Document
Number
8570-28
8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
Document Name
Certification of Compliance with Data
Gap Procedures
Pesticide Registration Maintenance Fee
Filing
Certification of Attempt to Enter into an
Agreement with other Registrants for
Development of Data
Certification with Respect to Citations of
Data (in PR Notice 98-5)
Data Matrix (in PR Notice 98-5)
Summary of the Physical/Chemical
Properties (in PR Notice 98-1)
Self-Certification Statement for the
Physical/Chemical Properties (in PR
Notice 98-1)
URL
http://www.epa.sov/opprd001/forms/8570-
28.pdf
http://www.epa.sov/opprd001/forms/8570-
30.pdf
http://www.epa.sov/opprd001/forms/8570-
32.pdf
http://www.epa.sov/opppmsdl/PR Notices
/Dr98-5.odf
http://www.epa.sov/opppmsdl/PR Notices
/pr98-5.pdf
http://www.epa.sov/opppmsdl/PR Notices
/or98-l.odf
http://www.epa.sov/opppmsdl/PR Notices
7pr98-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/opppmsdl/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
1
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d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
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
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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. orst. 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
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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