?/EPA
United States
Environmental Protection
Agency
Prevention, Pesticides
and Toxic Substances
(7508P)
EPA738-R-08-012
Re registration
Eligibility Decision
(RED) Document for
Tetramethrin
Revised April 2010
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Reregistration Eligibility Decision (RED) for
Tetramethrin
Revised April 2010
ListB
Case No. 2660
Approved by: ffiy^Ho^-oi P
Richard P. Keigwin, Jr.
Director
Pesticide Re-evaluation Division
Date:
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TABLE OF CONTENTS
I. Introduction 1
II. Chemical Overview 2
A. Regulatory History 2
B. Chemical Identification 2
C. Use Profile 3
D. Estimated Usage of Pesticide 4
HI. Summary of Tetramethrin Risk Assessments 6
A. Human Health Risk Assessment 6
1. Toxicity of Tetramethrin 7
2. Carcinogenicity of Tetramethrin 10
3. Metabolites and Degradates 10
4. Dietary Exposure and Risk (Food and Water) 11
5. Residential Exposure and Risk 11
6. Aggregate Exposure and Risk 16
7. Occupational Exposure and Risk 16
8. Cumulative Exposure and Risk 18
9. Tetramethrin Human Incident Reports 19
B. Environmental Risk Assessment 20
1. Environmental Fate and Transport 20
2. Ecological Exposure and Risk 21
3. Adverse Ecological Incidents 24
4. Endangered Species Considerations 25
IV. Risk Management, Reregistration, and Tolerance Reassessment Decision 27
A. Determination of Reregistration Eligibility 27
B. Public Participation 27
C. Regulatory Position 27
1. Regulatory Rationale 27
2. Endocrine Disrupter Screening Program 29
3. Endangered Species 29
D. Labeling Requirements 30
V. What Registrants Need to Do 31
A. Manufacturing Use Products 31
1. Additional Generic Data Requirements 31
2. Labeling for Manufacturing-Use Products 31
B. End-Use Products 32
1. Additional Product-Specific Data Requirements 32
2. Labeling for End-Use Products 32
C. Labeling Changes Summary Table 34
Appendix A. Non-Food and Non-Feed Use Patterns Subject to the Reregistration of
Tetramethrin 52
Appendix B. Data Supporting Guideline Requirements for Tetramethrin 53
Appendix C. Technical Support Documents 56
Appendix D. Bibliography 57
Appendix E. Tetramethrin Acute Mammalian Toxicity Batching 64
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Glossary of Terms and Abbreviations
a.i. Active Ingredient
CFR Code of Federal Regulations
CSF Confidential Statement of Formula
DCI Data Call-In
DFR Dislodgeable Foliar Residue
DNT Developmental Neurotoxicity
EC Emulsifiable Concentrate Formulation
EEC Estimated Environmental Concentration
EPA Environmental Protection Agency
EUP End-Use Product
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FFDCA Federal Food, Drug, and Cosmetic Act
G Granular Formulation
GLN Guideline Number
HP High pressure
LC50 Median Lethal Concentration. A statistically derived concentration of a substance that can be expected
to cause death in 50% of test animals. It is usually expressed as the weight of substance per weight or
volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LD50 Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50% of
the test animals when administered by the route indicated (oral, dermal, inhalation). It is expressed as
a weight of substance per unit weight of animal, e.g., mg/kg.
LOG Level of Concern
LOAEL Lowest Observed Adverse Effect Level
LP Low pressure
mg/kg/day Milligram Per Kilogram Per Day
mg/L Milligrams Per Liter
MOE Margin of Exposure
MRID Master Record Identification (number). EPA's system of recording and tracking studies submitted.
MUP Manufacturing-Use Product
N/A Not Applicable
NDETF Non-Dietary Exposure Task Force
NLAA Not Likely to Adversely Affect
NR Not Required
NOAEL No Observed Adverse Effect Level
OPP EPA Office of Pesticide Programs
OPPTS EPA Office of Prevention, Pesticides and Toxic Substances
PCA Percent Crop Area
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
ppm Parts per Million
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RQ Risk Quotient
SF Safety Factor
SLC Single Layer Clothing
SLN Special Local Need (Registrations Under Section 24(c) of FIFRA)
TGAI Technical Grade Active Ingredient
USDA United States Department of Agriculture
UF Uncertainty Factor
UFdb Database Uncertainty Factor
IV
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TETRAMETHRIN TEAM MEMBERS
Office of Pesticide Programs:
Health Effects Risk Assessment
Becky Daiss
Marquea King
Abdallah Khasinawah
Matt Crowley
Susan Hummel
Ecological Fate and Effects Risk Assessment
William Eckel
Wanda Hall
Richard Lee
Ibrahim Abdel-Saheb
Dana Spatz
Biological and Economics Analysis Assessment
LaVerne Dobbins
Nikhil Mallampalli
Jihad Alsadek
Registration Division
Richard Gebken
Carmen Rodia
Risk Management
Jacqueline Guerry
Monica Wait
Neil Anderson
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Summary of Revisions to the Tetramethrin Reregistration Eligibility Decision
The Reregistration Eligibility Decision (RED) document for Tetramethrin was signed on
June 23, 2008, and is available on the Federal Docket Management System (FDMS), available at
http://www.regulations.gov (document # EPA-HQ-OPP-2008-0014-0019). Although a public
comment period did not follow the RED, the Agency did receive comments from the registrants
regarding the need for clarification and corrections in Appendix A, as well as clarification of
label statements in Table 12, Summary of Labeling Changes for Tetramethrin. Further, in the
2008 RED, the Agency assessed the indoor aerosol space spray scenario at a maximum
application rate of 0.25% active ingredient (a.i). To support indoor aerosol space spray products
up to 0.35% a.i., the registrants submitted a revised Cumulative and Aggregate Risk Evaluation
System (CARES®) assessment for this scenario and a short-term incidental oral benchmark dose
(BMD) analysis in order to revise the endpoint for incidental oral exposure. Finally, the
registrants requested the Agency review existing acute toxicological studies previously submitted
to the Agency in order to address data gaps identified in the 2008 RED document.
As a result of these post-RED discussions with the registrants and the review of existing
and new toxicity data, the Agency has revised the Tetramethrin RED, where appropriate, in order
to correct any errors, clarify the intent of its risk mitigation captured in Table 12, reflect the
revised occupational and residential risk assessments, and revise the acute toxicity data gaps and
data-call in requirements.
The major revisions to the human health risk assessment and data needs are as follows:
• The Agency reviewed the Guideline 870.2400 Primary Eye Irritation Testing (MRID#
41609611) submitted by Sumitomo Chemical Inc., and found the study to be acceptable.
Therefore, in Section III, Summary of Tetramethrin Risk Assessments, the acute toxicity
profile (Table 2) was revised to reflect this data requirement as fulfilled and tetramethrin
as a category III eye irritant.
• Additionally, the need for Guideline 870.2400 Primary Eye Irritation Testing was
removed from Section V, Additional Generic Data Requirements.
• The Agency determined the "Evaluation of Potential Human Health Risks Associated
with Residential Uses of Tetramethrin: Revised Supplemental - Short-term Oral
Benchmark Dose Analysis," (MRID# 47921601) submitted by the registrant on
November 30, 2009 to be acceptable. As a result, the short-term incidental oral endpoint
for use in the human health risk assessment was revised from 25 mg/kg/day to 61.1
mg/kg/day.
• The occupational handler inhalation risk assessment was revised to reflect the increased
rate of 0.35% for aerosol space sprays. The revised margin of exposure (MOE) of 9,000
is below the Agency's level of concern (LOG), and therefore, continues to be not of
concern to the Agency (MOEs > 1,000 are not of concern).
VI
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• The residential handler risk assessment was also revised to reflect the increased rate of
0.35% for aerosol space sprays. The revised MOE of 54,000 is below the Agency's
LOG, and therefore, continues to be not of concern to the Agency. The residential post-
application CARES assessment was also revised to reflect the revised short-term
incidental oral end-point and the increased use rate for the indoor aerosol space spray. In
the 2008 RED, the inhalation MOE for this scenario (using a use rate of 0.25% a.i.) was
not of concern (MOEs > 1,000) at the 99.88th percentile. In the revised CARES
assessment, this use scenario (with an application rate of 0.35% a.i. and revised incidental
oral endpoint) is not of concern at the 99.9 percentile (MOE = 1,131), and therefore, is
eligible for reregi strati on. The increased use rate of 0.35% is specified in Appendix A.
Section 5, What Registrants Need to Do., has been amended to require two additional
generic data requirements, Guideline 830.7050 UV / Visible Absorption and Guideline 870.7800
Immunotoxicity. Both are new studies which are now required for all pesticide active
ingredients. The Additional Product-Specific Data Requirements section has also been amended
to include efficacy data requirements for public health pests and companion animal studies for
tetramethrin products used on domestic animals. The determination of which efficacy studies
would be required for tetramethrin was still on-going at the time of publication of the June 2008
RED.
A number of revisions have also been made to the Summary of Labeling Changes for
Tetramethrin (Label Table), Table 12, for clarification and to reflect updates in labeling on
tetramethrin end-use products. Among the updates are the following:
• The Agency is requiring the following label statements to reduce the potential ecological
exposure of tetramethrin. While some of the label statements are additions to the Label
Table, others appeared in Table 12 of the June 28, 2008 Tetramethrin RED document;
however, they have been revised slightly to be consistent with other pyrethroid non-
agricultural outdoor product labeling.
o Incorporation of PR Notice 2008-1, "Environmental Hazard General Labeling
Statements on Outdoor Residential Use Products" on appropriate outdoor non-
agricultural end-use products.
o Products labeled for General Outdoor Surface and Space Sprays (except
outdoor fogging devices):
"All outdoor applications must be limited to spot or crack-and-crevice treatments
only, except for the following permitted uses:
• Treatment to soil or vegetation around structures;
• Applications to building foundations up to a maximum height of 3 feet.
Other than applications to building foundations, all outdoor applications to
impervious surfaces such as sidewalks, driveways, patios, porches and structural
surfaces (such as windows, doors, and eaves) are limited to spot treatments or
crack-and-crevice applications, only."
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o Products labeled for use around or near floor drains must contain the
following statement:
"Application is prohibited directly into sewers or drains, or to any area like a
gutter where drainage to sewers, storm drains, water bodies, or aquatic habitat can
occur. Do not allow the product to enter any drain during or after application."
o Products labeled for use in drains or sewers must contain the following
statement:
"Do not apply directly to sewers or drains, or to any area like a gutter where
drainage to sewers, storm drains, water bodies, or aquatic habitat can occur,
except as directed by this label."
• The Agency is also including the total release fogger (TRF) labeling requirements,
intended to improve residential safety, in the Label Table (Table 12). The label
requirements were sent to the pyrethrins and pyrethroid registrants in a letter dated March
23, 2010. EPA is requiring the following labeling changes on all TRF by September 30,
2011, except where manufacturers can satisfactorily explain to the Agency that an
alternative approach would be adequate to address the causes of bug bomb exposure
incidents:
o Bug bomb labels must be written in plain language with clear headings.
o The new labels must incorporate pictograms to illustrate the following list of
restrictions and directions for use:
• do not use multiple canisters in a room
• do not use in small confined areas
• turn off ignition sources
• remove or cover exposed food
• air out the room before entering
o Instructions to vacate upon use and air out upon return must be very prominent.
o Door hang-tags must be provided to inform others to stay out of treated areas.
• The following entry restriction label statements that appear in the "End-Use Products
Intended for Occupational Use (WPS and Non-WPS)" section of the Label Table (Table
12) have been added to the "End Use Products Primarily Used by
Consumers/Homeowners" section since they apply to applications made by both PCOs
and consumers.
o For products that do not contain directions for use that allow people to be
present during application:
"Do not enter or allow others to enter treated area until sprays have dried."
Vlll
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o For products that contain directions for use that allow people to be present
during application AND are labeled for use as a directed spray (does not
apply to products applied directly to domestic animals):
"Except when (insert application method or site that allows people to be present
during application), do not enter or allow others to enter treated area until sprays
have dried."
o For products that contain directions for use that allow people to be present
during application AND are labeled for use as a space spray:
"Except when (insert application method or site that allows people to be present
during application), do not enter or allow others to enter until vapors, mists, and
aerosols have dispersed, and the treated area has been thoroughly ventilated."
o For total release foggers labeled for indoor use:
"Wait at least two (2) hours after application, then open windows, vents and doors
for two more hours. If an odor is still detected additional ventilation is required."
A number of revisions have been made to Appendix A, Non-Food and Non-Feed Use
Patterns Subject to the Reregistration ofTetramethrin, to reflect the maximum use rates assessed
for aerosol space sprays. Furthermore, the Agency clarified Appendix A by including Outdoor
Jet Sprays (intended for wasp and hornet use) in its own row, with a maximum of 0.20% a.i. and
1 to 2 second bursts per application.
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Abstract
The Environmental Protection Agency (EPA or the Agency) has completed the human
health and environmental risk assessments for tetramethrin and is issuing its risk management
decision. Tetramethrin is not registered for use on food and has no U.S. tolerances associated
with its use; therefore, it is not subject to Food Quality Protection Act (FQPA). The risk
assessments, which are summarized below, are based on the review of the required database
supporting the use patterns of currently registered products and additional data provided by the
technical registrants, Valent BioSciences Corporation and Sumitomo Chemical Company, Ltd.
Tetramethrin is part of the pyrethroid class of pesticides and was first registered in 1968.
It is a broad spectrum, non-systemic, synthetic pyrethroid used to control flying and crawling
insects in a number of commercial, horticultural and residential applications. Commercial
applications include space, broadcast and crack-and-crevice treatment in a variety of
commercial, industrial, residential, and institutional sites. Horticultural applications include
foliar and fogger treatment on non-food plants. Residential uses include pest control in homes
and outdoor domestic structures, on gardens and direct application to cats, dogs and horses. The
registered uses of tetramethrin are not expected to adversely impact groundwater or surface
water; therefore, a drinking water assessment was not performed. There are no food uses of
tetramethrin or potential for dietary exposures, so no dietary risk assessment was conducted.
Therefore, the reregi strati on action considered only potential residential (inhalation and
incidental oral), occupational (inhalation only), and ecological risks. No endpoints were selected
for dermal exposure because no effects were observed at the limit dose in available acceptable
dermal toxicity studies.
For residential handler inhalation risk, calculated Margins of Exposure (MOEs) for all
scenarios assessed were below the Agency's Level of Concern (LOG) (MOEs > 1,000) and
therefore, are not of concern. For residential post-application inhalation and incidental oral risks,
the MOEs are all greater than the target MOE of 1,000 at the 99.9 percentile of the CARES
probabilistic risk assessment and are also not of concern.
Occupational handler and post-application inhalation exposures were assessed. All of
the MOEs are greater than the Agency's target occupational MOE of 1,000 without respirators,
and therefore, the inhalation risks are not of concern. The MOEs for the occupational post-
application scenarios assessed exceed the Agency's target MOE of 1,000 and are not of concern.
The Agency evaluated potential ecological risk from both indoor and outdoor uses of
tetramethrin. Although the Agency believes exposure to non-target organisms is unlikely,
tetramethrin is considered highly toxic to aquatic organisms. Therefore, the Agency is limiting
all outdoor uses to localized spot and crack and crevice treatments, with the exception of (1)
barrier, perimeter or band applications to soil or vegetation around structures; and (2) band
applications to building foundations, up to a maximum of 3 feet up the walls of the building.
Since outdoor uses will be limited to spot treatments, no additional mitigation measures for these
uses are required. Although these limitations will reduce exposure to tetramethrin, there could
be a potential for direct effects for Listed insects or indirect effects to plants if they have an
obligate relationship with a Listed insect pollinator.
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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. 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 EPA.
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 risks 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" criterion of FIFRA.
This document summarizes EPA's human health and ecological risk assessments and
reregistration eligibility decision (RED) for tetramethrin. The document consists of six sections.
Section I contains the regulatory framework for reregistration; Section II provides an overview
of the chemical and a profile of its use and usage; Section III gives an overview of the human
health and environmental effects risk assessments; Section IV presents the Agency's decision on
reregistration eligibility and risk management; and Section V summarizes the label changes
necessary to implement the risk mitigation measures outlined in Section IV. Finally, the
Appendices list related information, supporting documents, and studies evaluated for the
reregistration decision. The risk assessments for tetramethrin and all other supporting documents
are available in the Office of Pesticide Programs (OPP) public docket
(http://www.regulations.gov) under docket number EPA-HQ-OPP-2008-0014.
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II. Chemical Overview
A. Regulatory History
Tetramethrin was first registered in the United States in 1968. Current technical
registrants include Valent BioSciences Company and Sumitomo Chemical Corporation.
Tetramethrin is on reregi strati on List B; thus no Registration Standard was completed.
Currently, there are 58 end-use registrants and approximately 300 end-use products
containing tetramethrin, of which approximately 30 are manufacturing formulations.
Tetramethrin is not registered for direct application to agricultural crops and there are no food
tolerances for specific raw agricultural commodities. There are no proposed new uses by any of
the registrants for tetramethrin as part of this reregi strati on.
Prior to the reregi strati on of this active ingredient, the registrants have requested and the
Agency has approved a number of amendments to delete uses or certain registrations for
products containing tetramethrin. From 1996 through 2007, the registrants canceled all
greenhouse uses of tetramethrin and have also voluntarily canceled certain tetramethrin products.
These regulatory actions were published in the Federal Register for public comment and were
subsequently approved by the Agency.
B. Chemical Identification
TETRAMETHRIN:
Tetramethrin, [(1,3,4,5,6,7-hexahydro-l,3-dioxo-2H-isoindol-2-yl)methyl 2,2-dimethyl-
3-(2-methyl-l-propenyl)cyclopropanecarboxylate] is a mixture of four stereoisomers designated
as 1R - trans, 1R - cis, IS- trans, and 1S - cis in an approximate ratio of 4:1:4:1. The first two
isomers are the most insecticidally active, and a mixture of the two has been termed 'd-
tetramethrin' and has the trade name Neo-Pynamin Forte (Sumitomo). Neo-Pynamin Forte is not
registered in the U.S., but toxicity data on this material have been submitted to fulfill data
requirements for tetramethrin.
Common Name: Tetramethrin
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Chemical Name:
(1,3,4,5,6,7-hexahydro-l,3-dioxo-2H-isoindol-2-yl)methyl 2,2-
dimethyl-3-(2-methyl-l-propenyl)cyclopropanecarboxylate
Chemical Class:
Case Number:
Synthetic pyrethroid
2660
EPA Chemical (PC) Code: 069003
CAS Number: 7696-12-0
Empirical Formula: Ci9H25NO4
Technical Registrants:
Valent BioSciences Corporation
Sumitomo Chemical Company
Table 1. Physicochemical Properties of Technical Grade Tetramethrin.
Parameter
Melting point/range
Molecular Weight
Density
Water solubility
Solvent solubility
Vapor pressure
Dissociation constant, pKa
Octanol/water partition coefficient,
Log(Kow)
UV/visible absorption spectrum
Value
68 - 70 °C
331.4g/mol
1.1 specific gravity at 20 °C
1.83mg/Lat25°C
>2 g/100 mL in acetone, ethanol, methanol, hexane and n-octanol
0.944 mPa at 30 °C
Not available
logPow = 4.6at25°C
Not available
c.
Use Profile
The following information on the currently registered uses includes an overview of use
sites and application methods. A detailed table of the uses of tetramethrin eligible for
reregi strati on is contained in Appendix A.
Type of Pesticide: Tetramethrin is a broad-spectrum, first-generation synthetic pyrethroid
insecticide. Pyrethroids are synthetic esters derived from naturally occurring pyrethrins
(insecticides derived from the extract of chrysanthemum flowers). Tetramethrin is a rapid
knockdown agent against flying and crawling insects. Tetramethrin may be co-formulated with
synergists (e.g., PBO and MGK-264), other active ingredients such as pyrethrins and other
pyrethroids (e.g., permethrin, allethrins, phenothrin, resmethrin, and cypermethrin), and growth
inhibitors (e.g., fenoxycarb) for greater effectiveness and to control a broader spectrum of insect
pests. These other active ingredients are more persistent than tetramethrin and provide residual
activity against insects not exposed initially.
Target Organisms: The primary target pests are flying and crawling insects such as wasps,
hornets, roaches, ants, fleas, and mosquitoes.
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Mode of Action: Tetramethrin is a type 1 pyrethroid (i.e., lacking a cyano group at the a carbon
position of the alcohol moiety). Type 1 pyrethroids act on axons in the peripheral and central
nervous system by interacting with sodium channels in mammals and/or insects. Tetramethrin is
a nerve cell membrane sodium channel modulator, which interferes with entrance of sodium ions
into the channel, leading to hyperactivity of the nervous system which can result in paralysis
and/or death.
Use Sites: Commercial applications include space sprays, broadcast surface treatments, and
crack and crevice treatments in a variety of industrial and institutional sites including: indoor
non-food areas; animal premises (not used for human consumption); and outdoors as localized
space and contact sprays on ornamental plants and perimeter treatments (sidewalks,
entranceways, outside surfaces of buildings, etc.).
Residential uses include: pest control in homes as a space spray, general surface spray, spot and
crack and crevice applications, on house plants, clothing and bedding, pet premises, and direct
applications to pets. Outdoors it is used as localized space and contact spray on ornamental
plants and perimeter treatments (sidewalks, decks, patios, outside surfaces of buildings, etc.).
Horticultural applications include foliar and fogger treatment on non-food plants. There are no
registered food use applications for tetramethrin.
Use Classification: Tetramethrin products are designated as general use. However, some end-
use products indicate they are for use by pest control operators (PCOs) only.
Formulation Types: Pressurized liquid, ready-to-use (RTU) liquids, emulsifiable concentrates,
and liquid concentrates.
Application Methods: Tetramethrin is applied by aerosol can, handheld sprayers, foggers, and
mechanical sprayers.
Application Rates: Tetramethrin application rates vary depending on the use pattern, indoor or
outdoor use, and consumer and professional or commercial operator use. Typical concentrations
of active ingredient (a.i.) in residential use products, including ready to use (RTU) (e.g., ant and
roach sprays, wasp and hornet sprays) and indoor and outdoor aerosols or aqueous sprays for
crawling and flying insects, range between 0.1 % and 0.35%. Indoor total release foggers are
typically around 0.54% a.i. Sprays designed for use on pets are typically 0.063% a.i.
Emulsifiable concentrate formulations are approximately 2.5% a.i. The maximum single
application rate to an outdoor site is 0.00002 Ib a.i./sq ft.
Application Timing: Tetramethrin is typically labeled for use "as needed."
D. Estimated Usage of Pesticide
Based on data provided to the Agency by the tetramethrin registrants, it appears that
tetramethrin usage has increased over the past few years. This is likely due to the fact that
pyrethroids are alternatives to several organophosphate pesticides, which are no longer registered
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for indoor residential areas. The Agency estimates annual usage of tetramethrin to be between
15,000 and 30,000 pounds (Ibs) a.i. However, tetramethrin use data is extremely limited and
difficult to interpret because tetramethrin products may be stored for periods of time and
produced only as inventory is exhausted. In addition, based on its localized use pattern and "use
as needed" directions, sales or production data does not accurately reflect usage.
Based on use information provided to the Agency by the tetramethrin registrants, the
majority of tetramethrin use is in residential outdoor spaces. It appears residential indoor use
sites and institutional and industrial sites make up a small percentage of tetramethrin use.
Further, tetramethrin is primarily used by residential consumers as opposed to PCOs. Sources
suggest that less than 1,000 Ibs a.i. are used annually by professional applicators.
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HI. Summary of Tetramethrin Risk Assessments
The following is a summary of EPA's revised human health and ecological risk
assessments for tetramethrin, as presented fully in the documents, Tetramethrin Risk Assessment
for Reregistration Eligibility Decision, dated June 18, 2008 and subsequent supplemental
assessments discussed below and the Revised Environmental Fate and Ecological Risk
Assessment for the Re-registration Eligibility Decision on Tetramethrin, dated February 5, 2008,
respectively. The purpose of this summary is to assist the reader by identifying key features and
findings of these risk assessments, and to help the reader better understand conclusions reached
in the assessments.
The human health and ecological risk assessment documents and supporting information
listed in Appendix C were used to reach the safety finding and regulatory decision for
tetramethrin. While the risk assessments and related addenda are not included in this document,
they are available from the OPP Public Docket, located at http://www.regulations.gov, under
docket number EPA-HQ-OPP-2008-0014.
Tetramethrin risk assessments rely in part on data from studies in which adult human
subjects were intentionally exposed to a pesticide to determine their dermal and inhalation
exposure. Many such studies, involving exposure to many different pesticides, comprise generic
pesticide exposure databases such as the Pesticide Handlers Exposure Database (PHED). EPA
has reviewed all the studies in these multi-pesticide generic exposure databases, and on the basis
of available evidence has found them to have been neither fundamentally unethical nor
significantly deficient relative to standards of ethical research conduct prevailing when they were
conducted. There is no regulatory barrier to continued reliance on these studies, and all
applicable requirements of EPA's Rule for the Protection of Human Subjects of Research (40
CFR Part 26) have been satisfied.
A. Human Health Risk Assessment
The human health risk assessment incorporates all sources of potential exposure, hazard,
and risks, including both residential and occupational applications. There are no registered food
uses for tetramethrin, and the majority of use is in consumer home products (indoor and outdoor
surface and space sprays). There are also commercial and horticultural uses for tetramethrin.
The Human Health Tetramethrin Risk Assessment for Registration Eligibility Decision
document was completed on June 18, 2008. Since the completion of the Human Health Risk
Assessment, the registrants requested the Agency review existing acute primary eye irritation data,
and also submitted a benchmark dose (BMD) analysis of the toxicity endpoint for incidental oral
exposures. The Agency's review of the BMD analysis, Tetramethrin: Benchmark Dose
Analysis of Toxicity Endpoint for Incidental Oral Exposure, dated January 6, 2010, found the
BMD analysis to be acceptable, and consequently, the short-term incidental oral end point was
revised. The Agency also revised the occupational and residential handler risk assessments, as
well as the residential post-application CARES portion of the Tetramethrin: Phase IVRevised
Occupational and Residential Exposure Assessment and Recommendations for the
Reregistration Eligibility Decision, dated June 13, 2008. Major revisions to the tetramethrin
human health risk assessment include the following:
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• The acute toxicity profile (Table 2) was revised to reflect the acute eye irritation
data requirement as fulfilled and tetramethrin as a category III eye irritant.
• The short-term incidental oral toxicity end point has been revised to 61.1
mg/kg/day based on the BMD analysis.
• Occupational and residential handler exposure and risks were revised from the
previous assessment to reflect use of the 0.35% tetramethrin aerosol space spray.
• Revision of the CARES portion of the Residential Exposure Assessment
considered the revised incidental oral endpoint and the use of the 0.35%
tetramethrin aerosol space spray.
For more information on the human health risk assessment, and the revisions to toxicity
and residential portions, see Tetramethrin Risk Assessment for Registration Eligibility Decision,
dated June 18, 2008; HED Review of Evaluation of Potential Human Health Risks Associated
with Residential Uses of Tetramethrin: Supplemental Assessment for Indoor Space Spray, dated
April 27, 2009; Tetramethrin: Benchmark Dose Analysis of Toxicity Endpoint for Incidental
Oral Exposure, dated January 6, 2010; and the HED Review of Evaluation of Potential Human
Health Risks Associated with Residential Uses of Tetramethrin: Revised Supplemental - Short-
Term Oral Benchmark Dose Analysis, dated February 25, 2010, which are available under docket
number EPA-HQ-OPP-2008-0014.
1. Toxicity of Tetramethrin
Toxicity assessments are designed to predict whether a pesticide could cause adverse health
effects in humans (including: short-term or acute effects, such as skin or eye damage; and lifetime or
chronic effects, such as cancer, developmental effects, or reproductive effects), and the level or dose at
which such effects might occur.
The toxicity database for tetramethrin contains acceptable acute toxicity, subchronic,
chronic, oncogenecity, and mutagenecity studies. However, the database lacks acceptable
developmental studies and acceptable acute neurotoxicity, subchronic neurotoxicity, and
developmental neurotoxicity (DNT) studies. Although developmental and neurotoxicity studies
are available, these studies are considered inadequate based on the use of
carboxymethylcellulose (CMC) as the dosing vehicle. CMC has been found to decrease the
absorption rate and thereby lessen the potency and toxicity of pyrethroid compounds. Concerns
regarding studies on pyrethroid compounds that used CMC as a vehicle are discussed in
published literature and further emphasized in a EPA report released in a July 18, 2007 draft
document, "Assessing Approaches for the Development of PBPK Models of Pyrethroid
Pesticides" prepared jointly by EPA's Office of Pesticide Programs and Office of Research and
Development. Therefore, new developmental toxicity, and acute, subchronic, and developmental
neurotoxicity studies utilizing an appropriate dosing vehicle are required to fully evaluate
potential risks from exposure to tetramethrin.
Since the tetramethrin database is currently incomplete with respect to data on
developmental and neurotoxicity studies, the Agency applied a ten-fold (lOx) database
uncertainty factor (UFDB) to account for this lack of data.
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a.
Acute Toxicity Profile
Tetramethrin is slightly toxic (Toxicity Category III or IV) by the oral and dermal routes
of exposure, and is a Category III eye irritant. However, in acute oral studies in mice with
technical tetramethrin and/or neopynamin forte, clinical signs sometimes included hyper-
excitability, muscular fibrillation, tremor, ataxia, limb paralysis, irregular respiration,
lacrimation, and salivation. These effects were also seen in acute percutaneous studies in rats.
As presented in Table 2, acceptable data on the acute inhalation toxicity, acute dermal irritation,
and skin sensitization for technical tetramethrin are unavailable. The Agency is requiring these
data.
Table 2. Acute Toxicity Profile - Tetramethrin (Neopynamin)
Guideline
No.
870.1100
870.1200
870.1200
870.1300
870.2400
870.2500
870.2600
Study Type
Acute oral [rat]*
Acute dermal [rat]
Acute dermal [rabbit]
Acute inhalation [rat]
Acute eye irritation [rabbit]
Acute dermal irritation [rabbit]
Skin sensitization [guinea pig]
MRID
42146405
00063574
42146405
40276101
~
41609611
—
-
Results
LD50 > 5,000 mg/kg
LD50> 5,000 mg/kg
LD50 > 2,000 mg/kg
~
~
—
-
Toxicity
Category
IV
IV
III
No data
III
No data
No data
Clinical signs of neurotoxicity (e.g., hyper-excitability, muscular fibrillation, tremor, ataxia etc.) were present at
2,500 and 5,000 mg/kg/day in acute oral studies in rodents.
b.
Toxicological Endpoints
The toxicological endpoints used in the human health risk assessment for tetramethrin are
listed in Table 3 below. There are no registered food uses for tetramethrin and dietary and
drinking water exposure to tetramethrin is not expected based on use patterns. Therefore, acute
and chronic reference doses are not required and were not selected for this assessment. Non-
cancer endpoints were selected for inhalation and incidental oral exposures only.
The short-term incidental oral endpoint was selected from a two-generation rat
reproduction study (MRID 00161842) with 1 litter per generation. The no observed adverse
effect level (NOAEL) is 50 mg/kg/day and the lowest observed adverse effect level (LOAEL) is
300 mg/kg/day based on decreased body weight and food consumption in both sexes of FO and
Fl parental animals and decreased pup body weight during lactation. A benchmark dose (BMD)
analysis was performed to determine the short-term incidental oral endpoint. A BMD is defined
as an exposure due to a dose of a substance associated with a specified low incidence of risk,
generally in the range of 1% to 10%, of a health effect; or the dose associated with a specified
measure or change of a biological effect. The selected toxicological endpoint of 61.1 mg/kg/day
was based on decreased offspring body weight on day 21 in the FO and Fl generations.
There are no dermal absorption studies available with tetramethrin. However, based on
available dermal absorption studies in pyrethrins/pyrethroid compounds, dermal absorption of
tetramethrin is expected to be very low (i.e., less than 2%). Tetramethrin was tested in a 21-day
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dermal toxicity study in rats (MRID 41995004) at doses of 0, 100, 300, or 1,000 mg/kg/day in
5/sex/dose Sprague-Dawley rats. There were no treatment-related systemic toxic effects and a
LOAEL was not established. No endpoints were selected for dermal exposure because no effects
were observed at the limit dose in available acceptable dermal toxicity studies.
The short and intermediate term inhalation exposure endpoint was selected based on two
90-day inhalation toxicity studies in rats conducted in 1991 (MRIDs 42012101 and 41995003).
The systemic toxicity NOAEL of 19.8/20.3 mg/m3 (3.5 mg/kg/day) was selected based on:
increased clinical signs (irregular respiration and bradypnea); decreased body weight gain;
changes in hematology, urinalysis, and blood chemistry; gross necropsy findings in liver;
hepatocellular hypertrophy; and hyaline droplets in kidney in both sexes at the LOAEL of 134
mg/m3 (23.5 mg/kg/day).
A combined uncertainty factor or margin of exposure (MOE) of 1,000 for residential and
occupational scenarios is based on the standard lOx for interspecies extrapolation and lOx for
intraspecies variation, plus an additional database uncertainty factor (UFDB) of lOx for the
absence of adequate neurotoxicity studies, since the nervous system is the target site for
tetramethrin. Based on the Agency's review of existing pyrethroid data, EPA has come to the
conclusion that the development neurotoxicity study (DNT) is not a particularly sensitive study
for comparing the sensitivity of young and adult animals to pyrethroids. EPA has recently
determined that, as an alternative to the generation and submission of a new DNT study,
pyrethroid registrants may instead choose to cite the six previously submitted DNT studies for
pyrethroid pesticides1. The Agency is also investigating the need for additional experimentation,
specific to the mode of action and pharmacokinetic characteristics of pyrethroids, to evaluate the
potential for increased susceptibility of young organisms. Therefore, the Agency is maintaining
the lOx database uncertainly factor to account for the outstanding neurotoxicity data gap. The
lOx database uncertainty factor is also applicable to workers because occupational exposures
may pose neurotoxic and developmental risk concerns. The uncertainty factors (UF) used to
account for interspecies extrapolation and intraspecies variability are also described in Table 3.
Table 3. Summary of Toxicological Doses and Endpoints for Tetramethrin for Use in Human Risk
Assessments
Exposure
Scenario
Acute and Chronic
Dietary
(general population)
Short-Term
Incidental Oral
(1 - 30 days)
Dose Used in Risk
Assessment, UF
Safety Factor and
Level of Concern
Study and Toxicological Effects
Acute and Chronic RfD's were not selected because there are no registered food uses
BMDL5 = 61.1
mg/kg/day
UFA=10
UFH = 10
UFDB = 10
Residential LOC for
MOE = 1,000
Occupational LOC for
MOE = N/A
2-Generation Reproduction (rats)
The NOAEL is 50 mg/kg/day and the
LOAEL is 300 mg/kg/day based on
decreased body weight and food
consumption in both sexes of FO and
Fl parental animals and decreased pup
body weight during lactation.
1 These conclusions and determinations were communicated to registrants of some pyrethroid active ingredients in a
letter from EPA dated September 4, 2009 (available from the public docket EPA-HQ-OPP-2008-03 31-0027).
Further details are also available from the website http://www.epa.gov/oppsrrdl/reevaluation/pyrethroids-
pyrethrins.html.
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Table 3. Summary of Toxicological Doses and Endpoints for Tetramethrin for Use in Human Risk
Assessments
Exposure
Scenario
Short-,
Intermediate- Term
Dermal
(1 - 30 days,
1-6 months)
Inhalation
Short-,
Intermediate-Term
(1 - 30 days, 1-6
months)
Cancer (oral,
dermal, inhalation)
Dose Used in Risk
Assessment, UF
Safety Factor and
Level of Concern
Study and Toxicological Effects
No risk is expected from this exposure scenario as no hazard was identified in a 21/28 day
dermal toxicity study conducted at the limit dose of 1,000 mg/kg/d.
Inhalation NOAEL =
19.8 mg/m3 (3.5
mg/kg/day (oral
equivalent)
UFA=10
UFH = 10
UFDB = 10
Residential LOC for
MOE = 1,000
Occupational LOC for
MOE = 1,000
90 Day Inhalation Toxicity (rats)
LOAEL = 134 rag/ m3 (23.5
mg/kg/day) based on f clinical signs,
absolute/relative kidney and liver
weights; J, body weight, changes in
hematology, urinalysis, hypertrophic
and gross liver necropsy findings, and
hyaline droplets in the kidney
Group C, possible human carcinogen based on evidence of benign testicular tumors in rats
and increased hepatocellular carcinomas in male mice at the HDT of 1 134 mg/kg/day. Based
on a recent review of the cancer data, HED has determined that tetramethrin would likely be
reclassified under EPA's 2005 Guidelines for Carcinogen Risk Assessment as "Suggestive
Evidence of Carcinogenic Potential."
UF = uncertainty factor (A= Animal/Interspecies, H= Human/Intraspecies, DB=Data Base)
NOAEL = no observed adverse effect level
LOAEL = lowest observed adverse effect level
MOE = margin of exposure
LOC = level of concern
N/A = Not Applicable
2. Carcinogenicity of Tetramethrin
The Agency concluded that, based on the available information, tetramethrin meets the
criteria for Group C, possible human carcinogen. Tetramethrin administered to Sprague-Dawley
rats was associated with a statistically significant dose-related increase in the incidence of
interstitial cell adenomas in the testes in mid- and high-dose males. These results were
reproducible in a second study in Sprague-Dawley rats and another study in Long-Evans rats.
This increase was outside the historical control range for Sprague-Dawley rats. No historical
control data were available on Long-Evans rats. Tetramethrin administration to BeCsFi mice did
not alter the spontaneous tumor profile for this strain of mice. Therefore, the Agency determined
that no chronic cancer risk assessment was necessary. The Agency based its decision on the fact
that this type of tumor (interstitial cell adenomas of the testes) is a benign tumor that does not
progress to a malignant tumor in rats; the tumors occurred at a later stage of the study; the
exposure started in utero; and the treatment did not cause reduction in latency.
3. Metabolites and Degradates
The Agency reviewed the metabolism of tetramethrin (MRTDs 42448901 and 42448902), and
concluded that for risk assessment, the parent compound, tetramethrin, is the only residue of
lexicological concern. For additional details, refer to the Tetramethrin Risk Assessment for
Registration Eligibility Decision., dated June 18, 2008.
10
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4. Dietary Exposure and Risk (Food and Water)
Tetramethrin currently has no registered food uses and there are no tolerances for specific
raw agricultural commodities. Tetramethrin is not registered for direct application to agricultural
crops, livestock animals, or livestock premises, where livestock are used for food. Although
there are no registered food uses for tetramethrin, there are uses in the home where food may be
exposed (e.g., kitchens), but labels for these uses have restrictions to prevent / limit food
exposure such as, "In the home, all food-processing surfaces and utensils should be covered
during treatment or thoroughly washed before use. Cover exposed food." Therefore, dietary
exposure is not of concern.
The Agency did not conduct a quantitative drinking water assessment for tetramethrin,
given the limited extent of potential exposure and the chemical's environmental fate properties.
Tetramethrin is used by individual homeowners or industrial / commercial property owners, in
individual, isolated areas, and in small amounts as opposed to wide scale uses (i.e., for
agriculture or mosquito abatement by public authorities). Because tetramethrin products are not
expected to adversely impact groundwater or surface water (the sources of drinking water), a
quantitative drinking water assessment is not warranted.
5. Residential Exposure and Risk
Residential exposure assessments consider all potential non-occupational pesticide
exposure. Tetramethrin has a wide variety of residential uses, including use in/on indoor and
outdoor surfaces, and use on pets. Therefore, the Agency has determined that there is a potential
for exposure to tetramethrin in residential settings for homeowners who handle (mix, load, and
apply) products containing tetramethrin, as well as post-application exposure from entering
tetramethrin-treated areas. Non-occupational post-application exposures can result following use
of pesticides by homeowners themselves or following applications by professional pest control
operators in residential or non-residential settings.
Risk assessments have been completed for both residential handler (inhalation only) and
post-application scenarios (inhalation and incidental oral). Though dermal exposure is possible
and expected for residential handler and post-application scenarios of tetramethrin, the Agency
determined a dermal assessment was not necessary because no systemic effects were observed at
the limit dose in dermal toxicity studies in animals.
To estimate residential (inhalation and incidental oral) risks, the Agency calculates a
margin of exposure (MOE), which is the ratio of the toxicity endpoint (NOAEL or BMDL)
selected for risk assessment to the exposure value. The MOE is then compared to a level of
concern (LOG), which is the same value as the uncertainty factor (UF) applied to a particular
toxicity study. The standard UF is lOOx (lOx to account for interspecies extrapolation and lOx
for intraspecies variation). However, since the tetramethrin database is currently incomplete, the
Agency applied a ten fold (lOx) database uncertainty factor (UFDB) to account for this lack of
certain data; thus, for residential exposures to tetramethrin, MOEs greater than the target LOG of
1,000 are not of concern to the Agency. For detailed information on the residential risk
assessment, seethe Tetramethrin Risk Assessment for Registration Eligibility Decision., dated
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June 18, 2008; HED Review of Evaluation of Potential Human Health Risks Associated with
Residential Uses of Tetramethrin: Supplemental Assessment for Indoor Space Spray, dated April
27, 2009; and the HED Review of the Evaluation of Potential Human Health Risks Associated
with Residential Uses of Tetramethrin: Revised Supplemental Short-Term Oral Benchmark Dose
Analysis, dated February 25, 2010.
a.
Residential Handler Risks
The Agency determined that exposure to homeowners handling a tetramethrin product is
likely to occur via the inhalation route during the residential use of tetramethrin in a variety of
indoor and outdoor settings. The risk assessment considered three major residential exposure
scenarios, based on the types of equipment and techniques that can potentially be used to make
tetramethrin applications. While some tetramethrin products are packaged as RTU trigger
sprayer bottles, the handler risks calculated from aerosol can application are protective of risks
from trigger sprayer applications because the unit exposure values are lower for trigger sprayer
application. The Agency only considered short-term (1-30 days) inhalation exposure due to
infrequency of use associated with homeowner products and the non-persistence of tetramethrin.
Additionally, as discussed above, dermal exposures were not assessed, because no effects were
observed at the limit dose in available acceptable dermal toxicity studies. The following
scenarios were assessed:
• Mix / Load / Apply liquids with a backpack sprayer or low pressure hand wand.
• Aerosol can application
• Load / Apply liquids with a trigger-pump sprayer.
Pesticide handler exposure database (PHED) unit exposure values were used to assess
exposures, because chemical-specific monitoring data were not available. The following
assumptions were also used in estimating risks from residential handler exposure to tetramethrin:
• The body weight of an adult handler is 70 kg.
• The amount handled per day is based on formulation type:
o Aerosol can: One 16 ounce can is used per day.
o Trigger- pump Sprayer: 1 gallon of diluted solution per day.
o Low-pressure handwand sprayer: 5 gallons of diluted solution per day.
Table 4 summarizes the inhalation risk estimates for residential handlers of tetramethrin
products. All MOEs are well below the Agency's LOG (MOEs > 1,000 are not of concern), with
values ranging from 54,000 to 100,000.
Table 4. Residential Handler Risk Estimates from General Spray Applications
Exposure Scenario
M/L/A Liquids with
LP Hand-wand or
Backpack Sprayer
Aerosol Can
Application Rate
0.02 Ib a.i./gallon
solution
0.35% a.i.
Amount Sprayed per
Day
5 gallons
1 can (16 ozea)
Pound a.i.
handled per day
0.1
0.0025
Inhalation MOE
82,000
54,000
12
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Table 4. Residential Handler Risk Estimates from General Spray Applications
Application
L/A RTU with a
Trigger-pump
Sprayer
0.02 Ib a.i./gallon
solution
1 gallon
0.02
100,000
M/L/A = Mix / load / apply
LP = Low pressure
L/A = Load / apply
RTU = Ready-to-use
b. Residential Post-Application Risks
The Agency uses the term "post-application" to describe exposures to individuals that
occur as a result of being in an area that has been previously treated with a pesticide. Unlike
residential handler exposure, where the Agency assumed only adults will be handling and
applying tetramethrin products, individuals of varying ages can potentially be exposed when
reentering or performing activities in areas that have been previously treated. Tetramethrin can
also be used on pets, which can lead to exposure by contact with the treated animals.
Tetramethrin post-application incidental oral exposures may occur after applications are
made to residential areas resulting in residues on surfaces, such as carpets and vinyl flooring.
Post-application inhalation exposures are possible from residue concentrations in air following
applications such as space sprays and fogging applications. Post-application incidental oral
exposures were assessed for children only, and inhalation exposures were assessed for both
adults and children. Again, dermal exposures were not assessed, because no effects were
observed at the limit dose in available acceptable dermal toxicity studies. The following
scenarios were assessed:
• Inhalation exposure (adults and children) indoors:
o Space spray and total release fogger;
• Inhalation exposure (adults and children) outdoors:
o Handheld foggers and aerosols;
• Incidental oral ingestion (children only) of residues indoors:
o Total release aerosol fogger treatment,
o Aerosol and spray surface treatments,
o Aerosol and spray treatments to pets; and,
• Incidental oral ingestion (children only) of residues outdoors:
o Handheld fogger applications, and
o Aerosol surface treatments.
The Agency assessed the post-application exposure to tetramethrin using two approaches:
a deterministic approach and a probabilistic approach. A deterministic approach uses a point
estimate from a data set, e.g., a single maximum value or an average value, as an input variable
in the exposure model. This approach does not consider the range of potential exposures
incurred by members of a population and does not describe the potential or probability of
exposure to individuals within a population. Rather, the deterministic approach produces an
output value that represents the potential exposure or risk of a group; depending on how the
13
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estimate was generated, the output value may reflect a "central tendency," a "high-end," or an
"upper-bound." In contrast, a probabilistic approach uses the full range of available data and
produces a distribution of values as output, and is recognized as a refinement over the
deterministic assessment. More detail is provided below regarding the probabilistic risk
assessment.
i. Deterministic Risk Approach and Assessment
The February 5, 2008, Tetramethrin: Phase 1 Revised Occupational and Residential
Exposure Assessment and Recommendations for the Reregistration Eligibility Decision presented
results of the Agency's deterministic post-application risk assessment. Risks of concern were
identified for hand-to-mouth exposures following indoor aerosol can space spray treatments
(MOEs of 290 and 430 for children on carpet and vinyl, respectively), inhalation exposure
following indoor aerosol can treatments (MOE of 850 for children), and hand-to-mouth exposure
following indoor ready-to-use liquid spray treatments (MOEs of 570 and 840 for children on
carpet and vinyl, respectively). Because these risks of concern were identified using the
screening-level deterministic approach, a more refined probabilistic assessment was conducted
for the residential post-application exposure scenarios.
ii. Probabilistic Risk Approach and Assessment
In the Tetramethrin Risk Assessment for Registration Eligibility Decision, dated June 18,
2008, the Agency presents the results of the probabilistic exposure assessment, using the
Cumulative and Aggregate Risk Evaluation System (CARES® Version 3.0; http://cares.ilsi.org/),
a publicly available software program. Probabilistic exposure assessment is recognized as a
refinement over deterministic assessment because it allows users to identify percentiles of risk by
using inputs in the form of distributions rather than point estimates. In the HED Review of the
Evaluation of Potential Human Health Risks Associated with Residential Uses of Tetramethrin:
Revised Supplemental Short-Term Oral Benchmark Dose Analysis, dated February 25, 2010, the
CARES assessment was revised to reflect the revised short-term oral endpoint and the use rate of
0.35% a.i. for indoor aerosol applications.
a. Tetramethrin CARES Post-Application Risk Assessment
The Agency completed a CARES probabilistic residential exposure and risk assessment,
which verified the CARES assessment that was submitted by tetramethrin registrants Valent
BioSciences Corporation; Sumitomo Chemical Company, LTD; S. C. Johnson & Son, Inc.; and
McLaughlin Gormley King Company. CARES utilizes a reference population of 100,000
individuals selected from the 1990 U.S. Census. It is considered appropriate for use in exposure
analysis due to its similarity with the U.S. Census Public Use Micro Data Sample (PUMS), a
statistically representative dataset that contains data for statistical weights from sampled
individuals of the general U.S. population, provided by the U.S. Department of Commerce,
Bureau of the Census, Economics and Statistics Administration. Key sub-populations relevant to
exposure analysis within CARES include different races (e.g., white, black, Hispanic, etc.) and
different age groups (e.g., children 1-3 years old, male 20-54 years old, etc.) (Driver et al, 2008).
14
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CARES simulates daily (24-hour) exposures over the course of one calendar year for
each person in the specified sub-population based on user-specified routes of exposure (e.g.,
dietary, dermal, non-dietary ingestion), empirical data, and exposure algorithms. It can provide
cumulative exposures for more than one chemical, aggregate across exposure routes, and provide
results for different exposure patterns (e.g., acute or chronic exposures). Additionally, each input
(e.g., chemical residue, exposure duration, and mouthing behavior) is described and used as a
distribution in a Monte Carlo simulation to identify percentiles of risk and enable users to
conduct analyses to identify major exposure contributors.
The calculations and algorithms used to estimate exposure for the various scenarios and
routes are consistent with standard Agency practice for residential pesticide exposure
assessment. Risks of concern were not identified for residential handler scenarios in the
deterministic assessment; therefore, the CARES assessment considered only post-application
exposure routes. The tetramethrin exposure scenarios were assessed using standard EPA
algorithms for exposure estimation. Distributional inputs were included in the probabilistic
assessment where possible. The probabilistic assessment assumes post-application exposure
occurs on the "day of application," which is the most conservative assumption.
The tetramethrin CARES assessment calculated risk for adults (defined as males and
females 20 - 49 years old) and children (defined as males and females 1-2 years old). Though
older or younger children may be exposed to tetramethrin, the selection of 1 - 2 year olds is
appropriate since this age group exhibits the highest degree of mouthing behavior - a major route
of exposure for this assessment (Tulve et al., 2002). Combined male/female populations are also
appropriate since the toxicological endpoints used in the risk assessment are not gender specific.
The risk percentages generated by the CARES model correspond only to those individuals who
use tetramethrin as a pesticide (i.e., the population is "users only") and those that reside within
the home. The assessment does not characterize risk relative to the percentage of the population
that does not use tetramethrin.
Exposure factors used in the CARES assessment were determined based on consultation
between EPA and the tetramethrin registrants. Many of the non-tetramethrin-specific
distributional inputs are based on EPA's n-methyl Carbamate Revised Cumulative Risk
Assessment (NMCCRA), the most recent EPA publication using probabilistic methods and
distributional inputs for residential exposure assessment. For more information on the inputs and
distributions considered for the children's non-dietary ingestion exposure following use of 0.35%
tetramethrin aerosol space sprays, refer to the HED Review of "Evaluation of Potential Human
Health Risks Associated with Residential Uses of Tetramethrin: Revised Supplemental - Short-
term Oral Benchmark Dose Analysis, " dated February 25, 2010. For all other post-application
scenarios, refer to the Tetramethrin: Phase IVRevised Occupational and Residential Exposure
Assessment and Recommendations for the Reregistration Eligibility Decision, dated June 13,
2008, for more information on the inputs and distributions considered for the CARES
assessment.
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Table 5. CARES Residential Post-Application Assessment - Tetramethrin MOEs for Adults (20 - 49 years)
Percentile
100
99.9
99.8
99.7
99.6
99.5
Exposure Scenario and Route
Outdoor Treatment
Inhalation
1,690
2,051
2,117
2,150
2,188
2,215
Indoor Treatment (Spray)
Inhalation (Applicator)
37,336
47,342
48,848
48,848
48,848
48,848
Inhalation (Post-
application)
5,834
6,726
7,162
7,432
7,510
7,673
Table 6. CARES Residential Post-Application Assessment - Tetramethrin MOEs for Children (1-2 years)
Percentile
100
99.9
99.88
99.8
99.7
99.6
99.5
Exposure Scenario and Route
Outdoor Treatment
Ingestion
1,808
2,123
2,188
2,387
2,603
2,771
2,870
Inhalation
,034
,040
,042
,045
,045
,046
,048
Indoor Treatment
Fogger
Ingestion
3,351
5,347
5,487
6,085
6,952
7,951
8,475
Spray
Ingestion
754
1,131
1,247
1,455
n/a
n/a
n/a
Inhalation
3,007
3,113
3,130
3,160
3,221
3,246
3,285
Pet Care
Ingestion
3,725
5,135
5,207
5,770
6,131
6,482
6,719
n/a- The "Evaluation of Potential Human Health Risks Associated with Residential Uses of Tetramethrin: Revised Supplemental — Short-term
Oral Benchmark Dose Analysis" submitted by the registrant in November 2009 only provided MOEs down to the 99.8 percentile, which were all
below the Agency's LOC (MOE >1000).
As demonstrated in Tables 5 and 6, for the tetramethrin CARES probabilistic residential
exposure assessment, all MOEs were above 1,000 at the 99.9 percentile for all scenarios assessed
for both adults and children.
6. Aggregate Exposure and Risk
For tetramethrin, short term aggregate risk potentially involves adding exposure estimates
for incidental oral exposure and inhalation exposure pathways for young children. However,
exposures from incidental oral and inhalation pathways may not be aggregated for tetramethrin
because the toxicity endpoints for these exposure routes are not based on common toxic effects
(i.e., body weight changes are considered to be non-specific, and there are no common specific
target organ effects observed in the oral and inhalation toxicity studies.)
7. Occupational Exposure and Risk
The occupational risk assessment addresses risks to workers who may be exposed to
tetramethrin when mixing, loading, or applying a pesticide (i.e., handlers), and when entering
treated sites for routine tasks (post-application). Exposure for workers generally occurs via the
dermal or inhalation route. However, for tetramethrin, only inhalation exposures were calculated
since there were no treatment related systemic toxic effects at the highest dose tested in the 21
day dermal toxicity study. The target MOE is 1,000 for occupational exposures.
16
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Occupational exposure to tetramethrin was assessed using data from the Pesticide
Handler Exposure Database (PHED), and worker exposure and risk estimates are based on the
best data currently available to the Agency. In addition, standard default assumptions pertaining
to average body weight, work day, and area treated daily were used to calculate risk estimates.
Application rates used in this assessment are derived directly from current tetramethrin labels.
The occupational risk assessment is summarized here. For further detail, see the Tetramethrin
Risk Assessment for Registration Eligibility Decision, dated June 18, 2008, and HED Review of
Evaluation of Potential Human Health Risks Associated with Residential Uses of Tetramethrin:
Supplemental Assessment for Indoor Space Spray, dated April 27, 2009.
a. Occupational Handler Exposure and Risks
The term "handler" applies to individuals who mix, load, and apply the pesticide product.
Because most tetramethrin products are packaged in aerosol cans, most of the uses will involve
application only (i.e., there is no mixing or loading activities for aerosol cans). However, some
products are packaged as ready-to-use liquids or liquid concentrates, which are applied with
mechanical sprayers, compressed air sprayers or foggers (i.e., equipment and formulation that do
require mixing and loading activities). Based upon the currently registered product labels, the
Agency assessed the following occupational handler scenarios:
Pesticide Control Operator Scenarios
1. Mix/Load/Apply (M/L/A) liquids with a backpack sprayer or low pressure handwand
2. M/L/A liquids with handheld fogging equipment
3. Applying with an aerosol can
4. Load/Apply (L/A) liquids with a trigger-pump sprayer
Occupational handler exposure assessments are conducted by the Agency using different
levels of protection. The Agency typically evaluates all exposures with minimal protection and
then adds protective measures in a tiered approach to determine the level of protection necessary
to obtain appropriate MOEs. Dermal exposures were not assessed because no systemic effects
were observed at the limit dose in available acceptable dermal toxicity studies. Inhalation
exposures were assessed at the minimum level of protection, which is no respirator. Risk
estimates (i.e., MOEs) for the general surface and space sprays and handheld fogger handler
scenarios are summarized in Tables 7 and 8. All MOEs are above the target MOE of 1,000
(ranging from 9,000 to 50,000), and therefore, are not of concern.
Table 7. Short / Intermediate-term Inhalation MOEs for Occupational Handlers Applying General Surface
and Space Sprays
Exposure Scenario
M/L/A liquids with LP
hand-wand or backpack
sprayer
L/A liquids with Trigger-
pump Sprayer
Unit
ExposureA
(jig/lb a.i.)
30
123
Application
Rate8
0.02 Ib
a.i./gallon
solution
Amount
Sprayed
per Day
40 gallons0
2 gallons0
Ib a.i.
handled
per day
0.8
0.04
Inhalation
DoseE
(mg/kg/day)
0.00034
0.00007
Inhalation
MOEF
10,000
50,000
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Table 7. Short / Intermediate-term Inhalation MOEs for Occupational Handlers Applying General Surface
and Space Sprays
Exposure Scenario
Aerosol can application
Unit
ExposureA
(jig/lb a.i.)
1300
Application
Rate8
0.35% a.i.
Amount
Sprayed
per Day
6 cansD
Ib a.i.
handled
per day
0.015
Inhalation
DoseE
(mg/kg/day)
0.00039
Inhalation
MOEF
9,000
A. Unit Exposure values are from PHED.
B. Application rates are from labels 769-939 (0.02 Ib a.i./gallon solution) and 4822-513 (0.35%)
C. Based upon ExpoSAC Policy 9.
D. Screening level estimate based upon professional judgment.
E. Inhalation dose (mg/kg/day) = [unit exposure (ug/lb a.i.) * 0.001 mg/ g * Ib a.i. handled per day)] / Body weight
(70 kg).
F. MOE = NOAEL (3.5 mg/kg/day) / Dose
Table 8. Inhalation MOEs for Occupational Handlers Applying Sprays using Handheld Fogging Equipment
Application Rate
(Ib a.i./ft3)A
0.00000001
(mg/m3)8
0.218
Inhalation
Exposure0
(mg/day)
0.0174
Inhalation DoseD
(mg/kg/day)
0.00025
Inhalation
MOEE
14,000
C.
D.
E.
A. Based on EPA Reg. No. 73049-432: 1 fluid ounce of 0.10% RTU solution per 600 square feet at an
approximate spray height of 8 feet. [1 fl.oz./600 ft2] * [1 gallon/128 fl.oz.] * [8.35 Ib soln/gallon] * [0.1% a.i.] /
8 ft = 0.0000000 llba.i./ft3
B. Application rate (mg/m3) = 0.00000001 Ib a.i./ft3 * [454000 mg/lb] * [35 ft3/m3] = 0.218 mg/m3
Inhalation Exposure (mg/day) = [Application Rate (mg/m3) * Breathing Rate (1 m3/hr) * Exposure Time (8
hours/day)] / Outdoor Dilution Factor (100)
Inhalation Dose (mg/kg/day) = Inhalation Exposure (mg/day) / Body Weight (70 kg)
MOE = NOAEL/Dose where the NOAEL is 3.5 mg/kg/day.
b. Occupational Post-Application Exposure and Risk
The Agency uses the term "post-application" to describe exposures to individuals that
occur as a result of being in an environment that has been previously treated with a pesticide
(also referred to as re-entry exposure). The Agency did not conduct a post-application risk
assessment for tetramethrin for occupational exposures. Although dermal exposure is possible
and expected, no occupational post-application assessment was conducted because no systemic
effects were observed at the limit dose in available acceptable dermal toxicity studies in animals.
Additionally, inhalation post-application exposures were not assessed because tetramethrin is
applied in areas where prolonged occupational presence in areas with low ventilation following
application (e.g., following greenhouse applications) is not expected.
8. Cumulative Exposure and Risk
Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish,
modify, or revoke a tolerance, the Agency consider "available information" concerning the
cumulative effects of a particular pesticide's residues and "other substances that have a common
mechanism of toxicity."
Tetramethrin is a member of the pyrethroid class of insecticides. This class also includes
permethrin, cypermethrin, cyfluthrin, fluvalinate, bifenthrin, fenpropathrin, and lambda-
cyhalothrin, among others. EPA developed a draft science policy document on the proposed
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common mechanism of toxicity for naturally-occurring pyrethrins and synthetic pyrethroids
(Proposed common mechanism grouping for the pyrethrins and pyrethroids, draft, May 19, 2009;
http://www.regulations.gov/search/Regs/home.html#documentDetail?R=09000064809a62df).
This document was supported by the FIFRA Scientific Advisory Panel (SAP) and EPA will
finalize the policy document on the pyrethroid common mechanism of toxicity taking into
account the SAP comments. Pesticides with a common mechanism of toxicity are subject to
cumulative risk assessment under the FQPA. Research is on-going by EPA's Office of Research
and Development (ORD) to make improvements to the Stochastic Human Exposure and Dose
Simulation (SHEDS) probabilistic exposure model which are important for the cumulative risk
assessment. EPA ORD is also developing physiologically-based pharmacokinetic models for
several pyrethroids. The status of both of these research modeling efforts will be reviewed by
the FIFRA SAP in July, 2010. For information regarding EPA's efforts to evaluate the risk to
pyrethroids, see http://www.epa.gov/oppsrrdl/reevaluation/pyrethroids-pyrethrins.html.
9. Tetramethrin Human Incident Reports
The OPP Incident Data System (IDS) and Poison Control Centers (PCC) databases were
consulted for poisoning incident data on the active ingredient tetramethrin. Reports submitted to
the IDS and PCC typically represent anecdotal reports or allegations only; therefore, no
conclusions can be drawn implicating tetramethrin as a cause of any of the reported health
effects unless supported by results from other data sources or unless the individual incidents are
well documented.
There were approximately 98 reported incidents in the IDS database over the five year
period from 2002 to 2007 (for which the incident report was conducted) for products containing
tetramethrin. Since there are no pesticide products for which tetramethrin is the sole active
ingredient, reported incidents cannot be solely attributed to exposure to tetramethrin. The
incidents are classified as mild to moderate human incidents (less than 1% involved major
effects). The majority (approximately 85%) of incidents with documented health effects
reported either no effects or mild effects resulting from tetramethrin-related exposures. The
majority of the symptoms included respiratory irritation, shortness of breath, blisters, welts,
hives, dizziness, rashes, coughing, and eye irritation, which are similar to that of other pyrethroid
compounds. The PCC incidents involved a wide range of effects including cardiovascular,
gastrointestinal, respiratory, dermal, and ocular effects.
The Agency believes the number of reported incidents is small in relation to the estimated
usage of tetramethrin, which is approximately 15,000 to 30,000 pounds per year. Tetramethrin
applications are primarily residential localized or spot treatments via aerosol or RTU sprays on
an "as needed" basis (residential exposures accounted for 98% of the reported cases involving
tetramethrin); therefore, given this broad spectrum residential use pattern, the Agency estimates
the number of applications per year could range in the hundreds of thousands or greater.
In conclusion, the incident report does not garner greater concern for the active ingredient
tetramethrin solely. Furthermore, in a recent review of the pyrethroid class of chemicals and
aggravated dermal and asthmatic reactions, titled "A Review of the Relationship between
Pyrethrins, Pyrethroid Exposure and Asthma and Allergies, " dated September 18, 2009, the
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Agency concluded, based on the weight of the evidence, there is not a clear relationship between
pyrethrins/pyrethroid exposure and asthma and allergies. Therefore, the Agency is not requiring
additional warnings or label statements specific to asthmatics on pyrethroids and pyrethrins end-
use product labels at this time. For more information on this review, please refer to
http://www.epa.gov/oppsrrdl/reevaluation/pyrethrins-pyrethroids-asthma-allergy-9-18-09.pdf.
B. Environmental Risk Assessment
Tetramethrin is used in residential and industrial/commercial areas in relatively small
quantities through aerosols, foggers, and space sprays. On a nationwide basis, tetramethrin use is
relatively limited. It is not used on a wide scale, such as agriculture or in mosquito abatement by
public authorities. The use pattern is, therefore, in individual, isolated areas, and again, in small
amounts. Tetramethrin also decomposes rapidly by photolysis and hydrolysis. The localized use
pattern of tetramethrin, combined with the low total pounds used on a national basis, and rapid
degradation due to photolysis and hydrolysis, make it highly unlikely that non-target organisms
will be exposed at harmful levels. Non-target organism exposure is most likely to result from
outdoor uses, such as spraying wasp or hornet nests under the eaves of houses, and backyard
foggers for flying insects. Further, because of the very rapid photolytic decomposition of
tetramethrin, only those organisms present at the time of spraying are likely to be exposed and
are at risk of acute effects.
The standard models (GENEEC, PRZM-EXAMS, T-REX, Terrplant) used to calculate
and quantify risks to terrestrial and aquatic organisms do not fit with the localized use patterns of
tetramethrin. As a result, tetramethrin's ecological risk assessment did not follow the standard
methodology and the acute risks will be characterized qualitatively rather than quantitatively. A
summary of the Agency's environmental fate and effects risk assessment is presented below.
For detailed discussion of all aspects of the environmental risk assessment, please see the
February 5, 2008 Revised Environmental Fate and Ecological Risk Assessment Chapter in
Support of Phase I of the Re-registration Eligibility Decision on Tetramethrin, which is available
under docket number EPA-HQ-OPP-2008-0014.
1. Environmental Fate and Transport
Tetramethrin is not a persistent pyrethroid in the environment. It may be co-formulated
with synergists, other active ingredients such as pyrethrins and pyrethroids, and growth
inhibitors. These other ingredients are more persistent than tetramethrin and provide residual
activity against insects not initially exposed. Tetramethrin decomposes rapidly by photolysis and
hydrolysis in shallow, non-turbid water. Photolysis in air is expected to be rapid (half-life 30
minutes) based on reaction with ozone. Tetramethrin is more susceptible to hydrolysis at pH 7
and 9 than pH 5. The half-lives were 15.9 - 19.7 days (pH 5), 0.89 - 1.06 days (pH 7), and
0.009 - 0.014 days (pH 9). Tetramethrin is slightly mobile in soil (Koc value range from 1,249-
2,939), has a vapor pressure of 7.1x10-6 mm Hg, water solubility of 1.83 mg/L, and an estimated
Henry's law constant of 1.7x10-6 atm-m3/mol-l.
At least nine degradates were detected in a column leaching study, and in an aerobic soil
metabolism study, seven degradates were identified including one (acid-NPY) that retains the
20
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entire ester structure and possibly the mode of action of the parent tetramethrin. However, it too
is subject to rapid hydrolysis, and therefore, exposure to acid-NPY is unlikely. In two acceptable
field dissipation studies, tetramethrin dissipated from the upper 15 cm of soil with a DT50 (time
to 50% degradation) of 3 hours in a California study, and less than one hour in a Florida study.
No toxicity data are available for tetramethrin degradates.
Indoor uses of tetramethrin are not expected to result in significant exposure pathways to
terrestrial and aquatic ecosystem as they are confined indoors, and tetramethrin rapidly degrades
in hours. While there are numerous outdoor uses, these applications are limited to spot
treatments in localized areas and, again, the degradation of tetramethrin to non-toxic degradates
is rapid. There is potential for tetramethrin residues to be transported to aquatic systems from
use in drainage systems, but only in acidic water where hydrolysis is slower. However, the
Agency believes exposure is unlikely because product labels prohibit direct application to water.
2. Ecological Exposure and Risk
The possible exposure mechanisms considered following tetramethrin applications were
runoff, spray drift, and direct spray. Only direct spray is considered to be a completed exposure
pathway, since tetramethrin is too non-persistent to be transported via runoff, and it is not used in
sufficient quantities for spray drift to be of concern. As stated above, neither indoor nor outdoor
uses of tetramethrin are expected to result in significant exposure pathways to terrestrial and
aquatic ecosystems since they are limited and tetramethrin degrades rapidly. Given that
degradation of tetramethrin to non-toxic degradates is rapid, the primary risk will be acute
exposure to tetramethrin at the time of application and a brief period thereafter.
Acute toxicity data from studies submitted by pesticide registrants along with the
available open literature were used to evaluate the potential direct effects of tetramethrin aquatic
and terrestrial organisms. This includes toxicity data on the technical grade active ingredient,
degradates, and formulated products when available. The open literature studies are indentified
through EPA's ECOTOX database (https://cfpub.epa.gov/ecotox/X which employs a literature
search engine for locating chemical toxicity data for aquatic life, terrestrial plants, and wildlife.
The evaluation of both sources of data can also provide insight into the direct and indirect effects
of tetramethrin on biotic communities from loss of species that are sensitive to the chemical and
from changes in structure and functional characteristics of affected communities.
a. Terrestrial Organisms
No terrestrial modeling was conducted for tetramethrin because exposure of non-target
organisms to harmful levels is unlikely based on the localized use patterns, low total pounds used
on a national basis, and rapid degradation due to photolysis and hydrolysis. Instead, the Agency
conducted a qualitative assessment using submitted studies and review of the literature.
The Agency developed an effects characterization, which describes the potential effects a
pesticide can produce in a terrestrial organism, and is based on registrant-submitted studies that
describe acute effects toxicity information for various terrestrial animals. Table 9 summarizes
21
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the specific measurement endpoint value selected to evaluate risks for tetramethrin to mammals
and birds.
Table 9. Summary of Specific Measurement Endpoint Values Selected to Evaluate Risk for the Associated
Terrestrial Animal Assessment Endpoints
Assessment
Ends
Survival and
Reproduction
of Birds,
Reptiles and
Amphibians
Survival and
Reproduction
of Terrestrial
Mammals
Survival of
Terrestrial
Invertebrates
and Beneficial
Insects
Acute
Measurement
Endpoint
(most
sensitive)
Acute oral
toxicity
Acute dietary
toxicity
Acute oral
toxicity, LD50
Dermal
toxicity, LD50
Inhalation
toxicity, LC50
Reproduction
NOAEL
Contact LD50
(ug/bee)
Foliar residue
toxicity (honey
bee)
Selected Measurement Endpoint Values and Source
Species
Bobwhite
quail
Bobwhite
quail and
Mallard
duck
Rat
Rat
Rat
Rat
Honey bee
(Apis
mellifera)
Honey bee
(Apis
mellifera)
Study
Duration
Single oral
dose
8 days
Single oral
dose
Not
available
Not
available
Two-
generation
48 hours
24 hours
post
treatment
Toxicity
Value
LD50 >2250
mg/kg-bw
LC50 >5620
mg/kg/-diet
LD50 >5000
mg/kg-bw
LD50 >5000
mg/kg-bw
LC50 >1.18
mg/L
25
mg/kg/day
LD50 0.155
ug/bee
< 3 hours
post
treatment
Most Sensitive
Endpoint
(MRID)
Mortality*
(416096-04/
Acceptable)
Mortality*
(416096-05,
416096-06/
Acceptable)
Mortality*
(00063 574/
Acceptable)
Mortality*
(00063 574/
Acceptable)
Mortality*
(421464-017
Acceptable)
Mortality*
(1618427
Acceptable)
Mortality
(416096-137
Acceptable)
Mortality
(419408-017
Acceptable)
Acute
Toxicity
Classification
Practically
non-toxic
Practically
non-toxic
Highly Toxic
*None observed at the highest dose
Birds and Mammals
Non-target terrestrial animals are not likely to be subject to mortality from the use of
tetramethrin because it is practically non-toxic to birds and mammals on an acute exposure basis.
The limitation of outdoor applications to spot treatments and the non-persistent nature of
tetramethrin make it unlikely that exposure sufficient to cause the chronic effects seen in
laboratory studies would occur in the field. The Agency's conceptual model for assessing risk to
terrestrial animals assumes that the animals derive the entirety of their diet from treated feed
items. The use of tetramethrin as a spot treatment in residential and/or commercial settings is
unlikely to result in extensive treatment of potential feed items. In addition, although chronic
toxicity studies are not designed to determine how long an exposure is necessary to cause
adverse chronic effects, the quick degradation of tetramethrin would reduce the amount of time
that toxic residues are available for potential dietary exposure.
22
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Given that tetramethrin is an insecticide, it is considered highly toxic to invertebrates,
including beneficial insects, such as honey bees, on an acute contact exposure basis. Non-target
invertebrates present at the time of spraying and shortly thereafter are considered to be at risk of
acute effects.
Terrestrial Plants
Toxicity data are not available for terrestrial plants. Therefore, the potential for risk to
terrestrial plants from exposure to tetramethrin cannot be assessed, and remains an uncertainty.
The Agency believes there is a low likelihood of exposure to non-target terrestrial plants because
outdoor applications are limited to spot treatments, and therefore, is not requiring additional
toxicity data at this time. The Agency, however, may reevaluate the need for this data during
registration review, which is scheduled to being in 2012.
b. Aquatic Organisms
No aquatic exposure modeling was conducted for tetramethrin because exposure of non-
target organisms to harmful levels is unlikely based on the localized use patterns, low total
pounds used on a national basis, and rapid degradation due to photolysis and hydrolysis. Also,
the aquatic exposure models assume that the chemical is applied to a ten-acre watershed draining
to a one-acre pond, which is unlikely for current use scenarios for tetramethrin. Instead, the
Agency conducted a qualitative assessment using submitted studies and review of the literature.
The Agency developed an effects characterization, which describes the potential effects a
pesticide can produce in an aquatic organism, and is based on registrant-submitted studies that
describe acute effects for various aquatic animals. Table 10 summarizes the toxic effects and
reference values used to assess risks for tetramethrin to aquatic organisms.
Table 10. Summary of Specific Measurement Endpoint Values Selected to Evaluate Risk for the Associated
Terrestrial Animal Assessment Endpoints
Assessment
Ends
Survival and
Reproduction
of Freshwater
Vertebrates
(fishes, etc.)
Survival and
Reproduction
of Freshwater
Invertebrates
Acute
Measurement
Endpoint
(most
sensitive)
Freshwater
fish or
amphibian
LC50
Freshwater
invertebrates
Selected Measurement Endpoint Values and Source
Species
Rainbow
trout
(Oncorhyn
chus
mykiss)
Water flea
(Daphnia
magna)
Study
Duration
96hrLC50
48hrEC50
flow-
through
Toxicity
Value
3.7ppb
45 ppb
Most Sensitive
Endpoint
(MRID)
Mortality
(416096-087
Acceptable)
Immobilization and
mortality
(416096-097
Supplemental)
Acute
Toxicity
Classification
Very Highly
Toxic
Very Highly
Toxic
Freshwater and Estuarine/Marine Fish and Invertebrates
The acute toxicity of tetramethrin was tested in two species of freshwater fish (rainbow
trout and bluegill sunfish) and one freshwater invertebrate. Based on submitted studies,
23
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tetramethrin is classified as very highly toxic to fish and invertebrates on an acute exposure
basis. No chronic toxicity data were available for freshwater fish or invertebrates. However,
the limitation of outdoor applications to spot treatments and the non-persistent nature of
tetramethrin make it unlikely that exposure sufficient to cause the chronic effects would occur.
The use of tetramethrin as a spot treatment in residential and/or commercial settings is unlikely
to result in spray drift or run-off activities that would lead to exposure to non-target aquatic
organisms. In addition, although chronic toxicity studies are not designed to determine how
long an exposure is necessary to cause adverse chronic effects, the quick degradation of
tetramethrin would reduce the amount of time that toxic residues are available for potential
dietary exposure.
Additionally, no acute or chronic toxicity data were available for estuarine/marine fish or
invertebrates. The Agency is not requesting this toxicity data for estuarine/marine fish or
invertebrates because the outdoor uses of tetramethrin should not pose an acute risk to aquatic
animals (fish, aquatic-phase amphibians, and invertebrates) since exposure levels are not
expected to reach thresholds where adverse effects would be likely for such uses. Additionally,
based on the rapid photolytic and hydrolytic degradation of tetramethrin, and its demonstrated
rapid dissipation in field studies, the exposure duration is not expected to be sufficient to cause
reproductive effects. There are potential acute risks to non-target aquatic organisms from direct
application to drainage systems, but only in acidic waters where hydrolysis is slower. This
remains an uncertainly in the risk assessment; however, the Agency believes exposure is unlikely
because product labels prohibit direct application to water.
Aquatic Plants
Toxicity data are lacking for vascular and nonvascular aquatic plants. However,
tetramethrin is not expected to reach water bodies in sufficient concentrations to induce
phytotoxic effects in aquatic plants. Runoff exposure is not expected due to very short
photolysis, hydrolysis, and field dissipation half-lives. Spray drift exposure is expected to be
minimal based on use patterns and label restrictions. Therefore, the Agency is not requiring
additional toxicity data at this time. The Agency, however, may reevaluate the need for this data
during registration review, which is scheduled to being in 2012.
c. Data Gaps
As stated above, the Agency does not have chronic toxicity data for either terrestrial or
aquatic organisms, acute or chronic toxicity data for terrestrial or aquatic plants, nor acute
toxicity data for are estuarine/marine animals. Although these data are guideline requirements,
the available effects data, non-persistent nature of tetramethrin, and low potential for
environmental exposure indicate this data would not affect the outcome of the risk assessment.
No additional environmental fate studies are needed to complete this assessment.
3. Adverse Ecological Incidents
A search of the EIIS (Environmental Incident Information System) database for
ecological incidents (run on Dec. 2, 2005) identified no ecological incidents involving
24
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tetramethrin. The number of documented incidents in EIIS is believed to be a very small fraction
of total mortality caused by pesticides for a variety of reasons. An absence of reports does not
necessarily equate to an absence of incidents given the nature of the incident reporting.
4. Endangered Species Considerations
Table 11 provides a matrix that depicts the potential for direct and indirect effects to
listed species resulting from the use of tetramethrin. No direct or indirect effects to endangered
species are expected, except the potential for direct effects for Listed insects or indirect effects to
plants if they have an obligate relationship with a Listed insect pollinator.
Table 11. Listed Species Associated With Direct or Indirect Effects Due to Applications of Tetramethrin for
all Outdoor Uses
Listed Taxon
Terrestrial and semi-aquatic plants - monocots
Terrestrial and semi-aquatic plants - dicots
Insects
Birds
Terrestrial phase amphibians
Reptiles
Mammals
Aquatic vascular plants
Freshwater fish
Aquatic phase amphibians
Freshwater crustaceans
Mollusks
Marine/estuarine fish
Marine/estuarine crustaceans
Direct Effects
None (1)
None (1)
Yes (acute)
None (3)
None (3)
None (3)
None (5)
None (1)
None (6)
None (6)
None (6)
None (6)
None (6)
None (6)
Indirect Effects
Possible (2)
Possible (2)
None
None (4)
None (4)
None (4)
None (4)
None
None (4)
None (4)
None (4)
None (4)
None (4)
None (4)
(1) Direct effects to plants are not anticipated based on lack of incident reports, registration on ornamental plants,
and no identified mechanism of toxicity.
(2) Indirect Effects on plants are possible if they have an obligate relationship with a Listed insect pollinator.
(3) Direct Effects are considered unlikely due to low toxicity to birds and low exposure.
(4) Indirect effects via loss of prey base (insects and invertebrates) not likely due to low magnitude of effect.
(5) Direct effects are considered unlikely due to low toxicity to mammals and low exposure.
(6) Direct Effects are not anticipated due to low exposure, despite high toxicity to freshwater fish and invertebrates.
Specific levels of concern could not be evaluated for the supported use of tetramethrin
because risk quotients (RQs) were not calculated in this assessment. However, acute risks from
tetramethrin's outdoor uses to listed aquatic species are not expected due to low application
rates, the localized and spatially fragmented use patterns, and rapid dissipation of the chemical
stressor due to photolysis and hydrolysis.
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In terrestrial environments, vertebrates such as mammals, birds, reptiles and amphibians
are not expected to be at risk because tetramethrin is practically non-toxic to birds and mammals,
and because of the localized and fragmented use patterns. Insects, if directly exposed, are at risk
of mortality.
The potential for chronic risk to any listed animal cannot be dismissed at this time
because of a lack of available data. However, tetramethrin is not expected to persist long enough
to lead to chronic exposure.
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IV. Risk Management, Reregistration, and Tolerance Reassessment Decision
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether or not products containing the active
ingredient are eligible for reregi strati on. The Agency has previously identified and required the
submission of the generic (i.e., active ingredient-specific) data required to support reregi strati on
of products containing the active ingredient tetramethrin. The Agency has completed its review
of these generic data, and has determined that the data are sufficient to support reregi strati on of
all products containing tetramethrin.
The Agency has completed its assessment of the human health and ecological risks
associated with the use of pesticide products containing the tetramethrin. The Agency has
determined that tetramethrin-containing products are eligible for reregi strati on provided that
label amendments are made as outlined in Chapter V. Appendix A summarizes the uses of the
tetramethrin that are eligible for reregi strati on. Appendix B identifies the generic data
requirements that the Agency reviewed as part of its determination of reregistration eligibility of
tetramethrin, and lists the submitted studies that the Agency found acceptable.
Based on its evaluation of tetramethrin, the Agency has determined that products
containing tetramethrin, unless labeled and used as specified in this document, would present
risks inconsistent with FIFRA. Accordingly, should a registrant fail to implement any of the
label changes identified in this document, the Agency may take regulatory action to address the
risk concerns from the use of tetramethrin. If all changes outlined in this document are
incorporated into the product labels, then all current risks for tetramethrin will be adequately
mitigated for the purposes of this determination under FIFRA.
B. Public Participation
Through the Agency's public participation process, EPA worked with stakeholders and
the public to reach the regulatory decisions for tetramethrin. EPA released the tetramethrin
preliminary risk assessments for public comment on February 27, 2008, for a 60-day public comment
period (Phase 3 of the public participation process). During the public comment period on the risk
assessments, which closed on April 28, 2008, the Agency received comments from: the
registrant McLaughlin, Gormley, King Company; the California Regional Water Quality Control
Board, S.F. Bay Region; the California Stormwater Quality Association (CASQA); California
Tri-TAC; as well as from private citizens. These comments in their entirety, responses to the
comments, as well as the preliminary and revised risk assessments, are available in the public
docket (OPP-2008-0014) at http:www.regulations.gov.
C. Regulatory Position
1. Regulatory Rationale
27
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The Agency has determined that products containing tetramethrin are eligible for
reregi strati on provided that specified label amendments are made. The following is a summary
of the rationale for managing risks associated with the use of tetramethrin. Where labelling
revisions are warranted, specific language is set forth in the summary table of Section V.
Maximum application rates eligible for reregi strati on are set forth in Appendix A.
a. Human Health Risk Management
There are no human health risks of concern for tetramethrin, and therefore, no risk
mitigation is necessary. The personal protective equipment (PPE) for all occupational handlers
is baseline (long-sleeve shirt, long pants, and shoes plus socks), and the re-entry interval (REI) is
12 hours.
b. Ecological Risk Management
The Agency evaluated potential ecological risk from both indoor and outdoor uses of
tetramethrin. However, although the Agency believes exposure to non-target organisms is
unlikely, tetramethrin is considered highly toxic to aquatic organisms. Therefore, the Agency is
requiring the following label statements to reduce the potential exposure of tetramethrin to
aquatic organisms as stipulated in the Label Table, Table 12. Because outdoor uses will be
limited to localized spot treatments, no additional mitigation measures, beyond those specified
below, are required.
• Incorporation of PR Notice 2008-1, "Environmental Hazard General Labeling Statements
on Outdoor Residential Use Products" on appropriate outdoor non-agricultural end-use
products.
• Products labeled for General Outdoor Surface and Space Sprays (except outdoor fogging
devices):
"All outdoor applications must be limited to spot or crack-and-crevice treatments only,
except for the following permitted uses:
• Treatment to soil or vegetation around structures;
• Applications to building foundations up to a maximum height of 3 feet.
Other than applications to building foundations, all outdoor applications to impervious
surfaces such as sidewalks, driveways, patios, porches and structural surfaces (such as
windows, doors, and eaves) are limited to spot treatments or crack-and-crevice
applications, only."
• Products labeled for use around or near floor drains must contain the following statement:
"Application is prohibited directly into sewers or drains, or to any area like a gutter
where drainage to sewers, storm drains, water bodies, or aquatic habitat can occur. Do
not allow the product to enter any drain during or after application."
• Products labeled for use in drains or sewers must contain the following statement:
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"Do not apply directly to sewers or drains, or to any area like a gutter where drainage to
sewers, storm drains, water bodies, or aquatic habitat can occur, except as directed by this
label."
2. Endocrine Disrupter Screening Program
As required under FFDCA section 408(p), EPA has developed the Endocrine Disrupter
Screening Program (EDSP) to determine whether certain substances (including pesticide active
and other ingredients) may have an effect in humans or wildlife similar to an effect produced by
a "naturally occurring estrogen, or other such endocrine effects as the Administrator may
designate." The EDSP employs a two-tiered approach to making the statutorily required
determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a
chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal
systems. Chemicals that go through Tier 1 screening and are found to have the potential to
interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA
will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2
testing is designed to identify any adverse endocrine related effects caused by the substance, and
establish a quantitative relationship between the dose and the E, A, or T effect.
Between October 2009 and February 2010, EPA issued test orders/data call-ins for the
first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert
ingredients. This list of chemicals was selected based on the potential for human exposure
through pathways such as food and water, residential activity, and certain post-application
agricultural scenarios. This list should not be construed as a list of known or likely endocrine
disrupter s.
Tetramethrin is not among the group of 58 pesticide active ingredients on the initial list to
be screened under the EDSP. Under FFDCA sec. 408(p) the Agency must screen all pesticide
chemicals. Accordingly, EPA anticipates issuing future EDSP orders/data call-ins for all
registration review cases, including those for which EPA has already opened a registration
review docket for a pesticide active ingredient. The tetramethrin registration review docket is
currently scheduled to open in 2012.
For further information on the status of the EDSP, the policies and procedures, the list of
67 chemicals, the test guidelines and the Tier 1 screening battery, please visit our website:
http://www.epa.gov/endo/.
3. Endangered Species
The Endangered Species Act required federal agencies to ensure that their actions are not
likely to jeopardize listed species or adversely modify designated critical habitat. The Agency
has developed the Endangered Species Protection Program to identify pesticides whose use may
cause adverse impacts on federally listed endangered and threatened species, and to implement
mitigation measures that address these impacts. To assess the potential of registered pesticide
uses that may affect any particular species, EPA puts basic toxicity and exposure data developed
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for the REDs into context for individual listed species and considers ecological parameters,
pesticide use information, the geographic relationship between specific pesticide uses and
species locations and biological requirements and behavioral aspects of the particular species.
When conducted, these analyses take into consideration any regulatory changes recommended in
this RED being implemented at that time. A determination that there is a likelihood of potential
effects to a listed species may result in limitations on the use of the pesticide, other measures to
mitigate any potential effects, and/or consultations with the Fish and Wildlife Service or National
Marine Fisheries Service, as necessary. If the Agency determines use of tetramethrin "may
affect" listed species or their designated critical habitat, EPA will employ the provisions in the
Services regulations (50 CFR Part 402).
No direct or indirect effects to endangered species are expected due to tetramethrin
applications, except the potential for direct effects for Listed insects or indirect effects to plants if
they have an obligate relationship with a Listed insect pollinator. The ecological assessment that
EPA conducted for this RED does not, in itself, constitute a determination as to whether specific
species or critical habitat may be harmed by the pesticide. Rather, this assessment serves as a
screen to determine the need for any species specific assessment that will evaluate whether
exposure may be at levels that could cause harm to specific listed species and their critical
habitat. That assessment refines the screening-level assessment to take into account the
geographic area of pesticide use in relation to the listed species, the habits and habitat
requirements of the listed species, etc. If the Agency's specific assessments for tetramethrin
result in the need to modify use of the pesticide, any geographically specific changes to the
pesticide's registration will be implemented through the process described in the Agency's
Federal Register Notice (54 FR 27984) regarding implementation of the Endangered Species
Protection Program.
D. Labeling Requirements
In order to be eligible for reregi strati on, various use and safety information will be
included in the labeling of all end-use products containing tetramethrin. For the specific labeling
statements, refer to Section V of this RED document.
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V. What Registrants Need to Do
The Agency has determined that products containing tetramethrin are eligible for
reregi strati on provided that the required label amendments are made. The Agency intends to
issue Data Call-In Notices (DCIs) requiring product-specific data. Generally, registrants will
have 90 days from receipt of a DCI to complete and submit response forms or request time
extension and/or waiver requests with a full written justification. For product-specific data, the
registrant will have eight months to submit data. Additionally, below are the label amendments
that the Agency intends to require for tetramethrin to be eligible for reregi strati on.
A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregi strati on of tetramethrin for currently registered
uses has been reviewed and determined to be substantially complete. However, a few data gaps
remain, and these are listed below.
Product Chemistry
All product chemistry data requirements will be required for the technical grade active ingredient
(see Appendix B).
Toxicology
830.7050 UV / Visible Absorption
870.1300 Acute Inhalation
870.2500 Acute Dermal Irritation
870.2600 Skin Sensitization
870.3700a Developmental Toxicity (rodent)
870.6200a Acute Neurotoxi city
870.6200b Sub chronic Neurotoxi city study
870.6300 Developmental Neurotoxicity study2
870.7800 Immunotoxicity
2. Labeling for Manufacturing-Use Products
Based on the Agency's review of existing pyrethroid data, EPA has come to the conclusion that the DNT is
not a particularly sensitive study for comparing the sensitivity of young and adult animals to pyrethroids. EPA
has recently determined that, as an alternative to the generation and submission of a new DNT study, pyrethroid
registrants may instead choose to cite the six previously submitted DNT studies for pyrethroid pesticides. The
Agency is also investigating the need for additional experimentation, specific to the mode of action and
pharmacokinetic characteristics of pyrethroids, to evaluate the potential for increased susceptibility of young
organisms. These conclusions and determinations were communicated to registrants of some pyrethroid active
ingredients in a letter from EPA dated September 4, 2009 (available from the public docket EPA-HQ-OPP-
2008-0331-0027). Further details are also available from the website
http://www.epa.gov/oppsrrdl/reevaluation/pYrethroids-PYrethrins.html.
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To ensure compliance with FIFRA, manufacturing-use product (MUP) labeling should be
revised to comply with all current EPA regulations, PR Notices, and applicable policies. The
MUP labeling should bear the label statements contained in Table 12.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific
data regarding the pesticide after a determination of eligibility has been made. The registrant
must review previous data submissions to ensure that they meet current EPA acceptance criteria,
and if not, commit to conduct new studies. If a registrant believes that previously submitted data
meet current testing standards, then the study MRID numbers should be cited according to the
instructions in the Requirement Status and Registrant's Response Form provided for each
product. The Agency intends to issue a separate product-specific data call-in (PDCI), outlining
specific data requirements. For any questions regarding the PDCI, please contact Karen Jones at
(703) 308-8047.
In addition to the standard product-specific data requirements, efficacy data for all
applications that target public health pests must be submitted. Additional information on the
efficacy data can be found in the Series 810 Product Performance Test Guidelines on the
Agency's website (http://www.epa.gov/opptsfrs/publications/OPPTS Harmonized/
810_Product_Performance_Test_Guidelines/index. html).
Efficacy Data
810.3000 General considerations for efficacy of invertebrate control agents
810.3100 Soil treatments for imported fire ants
810.3200 Livestock, poultry, fur- and woo-bearing animal treatment
810.3300 Treatments to control pests of humans and pets
810.3400 Mosquito, black fly, and biting midge (sand fly) treatments
810.3500 Premises treatments
SS Special study for arthropods
The Agency is also requiring a companion animal study (870.7200) for tetramethrin
products used on domestic animals. The study is to ensure that pesticide formulations for the
treatment of external pests on domestic animals have an adequate margin of safety for the treated
companion animal. In addition, data from companion animal safety studies also serve as a basis
for product labeling.
870.7200 Companion animal study
2. Labeling for End-Use Products
To be eligible for reregi strati on, labeling changes are necessary to implement measures
outlined in Section IV above. Specific language to incorporate these changes is specified in
Table 12. Generally, conditions for the distribution and sale of products bearing old
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labels/labeling will be established when the label changes are approved. However, specific
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.
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C. Labeling Changes Summary Table
In order to be eligible for reregi strati on, amend all product labels to comply with the following table. Table 12 describes how
language on the labels should be amended.
Table 12. Summary of Labeling Changes for Tetramethrin
Description
Amended Labeling Language
Placement on Label
Manufacturing Use Products
Maximum application rates eligible for reregistration are set forth in Appendix A.
For Manufacturing Use Products that
will be formulated into total release
fogger end-use products that contain
directions for use indoors
If information is available that justifies a duration longer than 2 hours
for the waiting period before beginning ventilation following an
application or a duration longer than 2 hours as the length of the
ventilation period, submit that information to the Agency.
Directions for use
For all Manufacturing Use Products
"Only for formulation into an insecticide for the following use(s) [fill
blank only with those uses that are being supported by MP registrant]."
Directions for use
One of these statements may be added
to a label to allow reformulation of the
product for a specific use or all
additional uses supported by a
formulator or user group
"This product may be used to formulate products for specific use(s) not
listed on the MP label if the formulator, user group, or grower has
complied with U.S. EPA submission requirements regarding support of
suchuse(s)."
"This product may be used to formulate products for any additional use(s)
not listed on the MP label if the formulator, user group, or grower has
complied with U.S. EPA submission requirements regarding support of
suchuse(s)."
Directions for Use
Environmental Hazards Statements
"ENVIRONMENTAL HAZARDS"
"This pesticide is highly toxic to aquatic organisms, including fish and
aquatic invertebrates. 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
Eliminations System (NPDES) permit and the permitting authority has
been notified in writing prior to discharge. Do not discharge effluent
containing this product to sewer systems without previously notifying the
local sewage treatment plant authority. For guidance, contact your State
Precautionary Statements:
Environmental Hazards
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Table 12. Summary of Labeling Changes for Tetramethrin
Description
Amended Labeling Language
Water Board or Regional Office of the Environmental Protection Agency."
Placement on Label
End-Use Products Intended for Occupational Use (WPS and Non-WPS)
Maximum application rates eligible for reregistration are set forth in Appendix A.
PPE Requirements for Ready To Use
(RTU) Formulations (RTU Liquids and
Pressurized Liquids)
PPE Requirements for Liquid
Concentrates including Emulsifiable
Concentrates
User Safety Requirements
User Safety Recommendations
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are [registrant
inserts correct material(s)]." For more options, follow the instructions for
category [insert A, B, C, D, E, F, G or H] on the chemical-resistance
category selection chart.
"Applicators and other handlers must wear:
> Long-sleeve shirt and long pants, and
> Shoes plus socks."
"Personal Protective Equipment (PPE)"
"Some materials that are chemical-resistant to this product are [registrant
inserts correct material(s)]." For more options, follow the instructions for
category [insert A, B, C, D, E, F, G or H] on the chemical-resistance
category selection chart.
"Mixers, Loaders, Applicators and other handlers must wear:
> Long-sleeve shirt and long pants, and
> Shoes plus socks."
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no
such instructions for washables exist, use detergent and hot water. Keep
and wash PPE separately from other laundry."
"User Safety Recommendations"
"Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet."
"Users should remove clothing/ PPE immediately if pesticide gets inside,
Immediately following/below
Precautionary Statements: Hazards
to Humans and Domestic Animals
Immediately following/below
Precautionary Statements: Hazards
to Humans and Domestic Animals
Precautionary Statements: Hazards
to Humans and Domestic Animals
immediately following the PPE
requirements
Precautionary Statements under:
Hazards to Humans and Domestic
Animals
(Must be placed in a box.)
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Table 12. Summary of Labeling Changes for Tetramethrin
Description
Amended Labeling Language
Placement on Label
then wash thoroughly and put on clean clothing."
"Users should remove PPE immediately after handling this product. Wash
the outside of gloves before removing. As soon as possible, wash
thoroughly and change into clean clothing."
Environmental Hazards Statements for
Outdoor Aerosols and Foggers
AND
Outdoor Products Registered Only for
Commercial Use Sites (eg. golf-
courses).
"ENVIRONMENTAL HAZARDS"
"This pesticide is extremely toxic to aquatic organisms, including fish and
aquatic invertebrates. Do not apply directly to water, or to areas where
surface water is present, or to inter-tidal areas below the mean high water
mark. Do not contaminate water when cleaning equipment or disposing of
equipment washwater or rinsate."
"This product is highly toxic to bees exposed to direct treatment on
blooming crops or weeds. Do not apply this product or allow it to drift to
blooming crops or weeds while bees are actively visiting the area."
Precautionary Statements: Hazards to
Humans and Domestic Animals
Environmental Hazard Statements on
Liquid Concentrate consumer outdoor
products (e.g., liquids mixed with water
by the user for a tank sprayer or hose-
end attachment)
"This pesticide is extremely toxic to aquatic organisms, including fish and
invertebrates.
To protect the environment, do not allow pesticide to enter or run off into
storm drains, drainage ditches, gutters or surface waters. Applying this
product in calm weather when rain is not predicted for the next 24 hours
will help to ensure that wind or rain does not blow or wash pesticide off
the treatment area. Rinsing application equipment over the treated area
will help avoid run off to water bodies or drainage systems.
This pesticide is highly toxic to bees exposed to direct treatment on
blooming crops or weeds. Do not apply this product or allow it to drift to
blooming crops or weeds while bees are actively visiting the treatment
area."
Environmental Hazard Statement
Environmental Hazard Statements on
Liquid Ready-to-Use (except aerosols
and foggers) consumer outdoor
products
"This pesticide is extremely toxic to aquatic organisms, including fish and
invertebrates.
To protect the environment, do not allow pesticide to enter or run off into
storm drains, drainage ditches, gutters or surface waters. Applying this
Environmental Hazard Statement
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Table 12. Summary of Labeling Changes for Tetramethrin
Description
Amended Labeling Language
Placement on Label
product in calm weather when rain is not predicted for the next 24 hours
will help to ensure that wind or rain does not blow or wash pesticide off
the treatment area.
This pesticide is highly toxic to bees exposed to direct treatment on
blooming crops or weeds. Do not apply this product or allow it to drift to
blooming crops or weeds while bees are actively visiting the treatment
area."
Environmental Hazards Statements for
Products Labeled for Indoor Uses Only
"ENVIRONMENTAL HAZARDS"
"This pesticide is extremely toxic to aquatic organisms, including fish and
aquatic invertebrates. Do not contaminate water when disposing of
equipment, washwater, or rinsate. See Directions for Use for additional
precautions and requirements."
For indoor commercial, industrial or institutional products packaged
in containers equal to or greater than 5 gallons or 50 Ibs add the
following statement:
"Do not discharge effluent containing this product into lakes, streams,
ponds, estuaries, oceans, or other waters unless in accordance with the
requirements of a National Pollution Discharge Elimination System
(NPDES) permit and the permitting authority has been notified in writing
prior to discharge. Do not discharge effluent containing this product to
sewer systems without previously notifying the local sewage treatment
plant authority. For guidance contact your State Water Board or Regional
Office of the EPA."
Precautionary Statements: Hazards to
Humans and Domestic Animals
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Table 12. Summary of Labeling Changes for Tetramethrin
Description
Amended Labeling Language
Placement on Label
Environmental Hazards Statements for
Products Labeled for Both Indoor and
Outdoor Uses Only
"ENVIRONMENTAL HAZARDS for TERRESTRIAL
APPLICATIONS"
Refer to appropriate consumer outdoor environmental hazard statements
above.
"ENVIRONMENTAL HAZARDS for INDOOR USE"
"This pesticide is extremely toxic to aquatic organisms, including fish and
aquatic invertebrates. Do not contaminate water when disposing of
equipment, washwater, or rinsate. See Directions for Use for additional
precautions and requirements."
For indoor commercial, industrial or institutional products packaged
in containers equal to or greater than 5 gallons or 50 Ibs add the
following statement:
"Do not discharge effluent containing this product into lakes, streams,
ponds, estuaries, oceans, or other waters unless in accordance with the
requirements of a National Pollution Discharge Elimination System
(NPDES) permit and the permitting authority has been notified in writing
prior to discharge. Do not discharge effluent containing this product to
sewer systems without previously notifying the local sewage treatment
plant authority. For guidance contact your State Water Board or Regional
Office of the EPA."
Precautionary Statements: Hazards to
Humans and Domestic Animals
"Do not enter or allow worker entry into treated areas during the restricted
entry interval (REI) of 12 hours."
Restricted-Entry Interval for Products
with Directions for use within the
scope of the Worker Protection
Standard for Agricultural Pesticides
(WPS)
For Products Subject to WPS as
required by Supplement 3 of PR Notice
93-7
Directions for Use, in the
Agricultural Use Requirements Box
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Table 12. Summary of Labeling Changes for Tetramethrin
Description
Amended Labeling Language
Placement on Label
Early Entry Personal Protective
Equipment
For Products Subject to WPS as
required by Supplement 3 of PR Notice
93-7
"PPE required for early entry to treated areas that is permitted under the
Worker Protection Standard and that involves contact with anything that
has been treated, such as plants, soil, or water is coveralls, shoes and
socks, and waterproof gloves."
Directions for Use, in Agricultural
Use Requirements Box
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."
"Do not apply when food is present."
"Do not use in food areas of food handling establishments, restaurants, or
other areas where food is commercially prepared or processed. Do not use
in serving areas while food is exposed or facility is in operation. Serving
areas are areas where prepared foods are served, such as dining rooms, but
excluding areas where foods may be prepared or held. In the home, all
food processing surfaces and utensils should be covered during treatment
or thoroughly washed before use. Exposed food should be covered or
removed."
Place in the Directions for Use
directly above the Agricultural Use
Box
Entry Restrictions for NonWPS Uses
For products that do not contain directions for use that allow people
to be present during application:
"Do not enter or allow others to enter treated area until sprays have dried."
For products that contain directions for use that allow people to be
present during application AND are labeled for use as a directed spray
(does not apply to products applied directly to domestic animals):
"Except when (insert application method or site that allows people to be
present during application), do not enter or allow others to enter treated
area until sprays have dried."
For products that contain directions for use that allow people to be
present during application AND are labeled for use as a space spray:
If no WPS uses on the product label,
place the appropriate statement in the
Directions for Use Under General
Precautions and Restrictions. If the
product also contains WPS uses, then
create a Non-Agricultural Use
Requirements box as directed in PR
Notice 93-7 and place the appropriate
statement inside that box.
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Table 12. Summary of Labeling Changes for Tetramethrin
Description
Amended Labeling Language
Placement on Label
"Except when (insert application method or site that allows people to be
present during application), do not enter or allow others to enter until
vapors, mists, and aerosols have dispersed, and the treated area has been
thoroughly ventilated."
For total release foggers (TRF) labeled for indoor use (see additional
requirements in TRF section below):
"Wait at least two (2) hours after application, then open windows, vents
and doors for two more hours. If an odor is still detected additional
ventilation is required."
General Application Restrictions for all
products that do not contain directions
for use in drains or sewers
Products labeled for use around or near floor drains must contain the
following statement.
"Application is prohibited directly into sewers or drains, or to any area
like a gutter where drainage to sewers, storm drains, water bodies, or
aquatic habitat can occur. Do not allow the product to enter any drain
during or after application."
Directions for Use
General Application Restrictions for all
products that contain directions for use
in drains or sewers
"Do not apply directly to sewers or drains, or to any area like a gutter
where drainage to sewers, storm drains, water bodies, or aquatic habitat
can occur, except as directed by this label."
Directions for Use
General Application Restrictions for
Total Release Foggers (TRF) labeled
for indoor use
Note to registrants: The following labeling was sent to pyrethrins and
pyrethroid registrants on March 23, 2010. The following label
statements are required to appear on TRF EUPs, except where
manufacturers can satisfactorily explain to the Agency that an
alternative approach would be adequate to address the causes of bug
bomb exposure incidents.
Use simple terms to express the volume of space treated in terms of
linear dimensions, with an assumed ceiling height, rather than in terms
of cubic feet. Update the current statements to follow this model in the
Directions for Use:
Example: "One canister of fogger will treat a room up to x feet
by y feet with an 8 foot ceiling."
Directions for Use
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Table 12. Summary of Labeling Changes for Tetramethrin
Description
Amended Labeling Language
Placement on Label
All current restrictions and requirements regarding the size of the
treated area remain unchanged.
At a minimum include pictograms, where applicable, to illustrate the
following list of restrictions and directions for use:
• do not use multiple canisters in a room
• do not use in small confined areas
• turn off ignition sources
• remove or cover exposed food
• air out the room before entering
Include the following directions that prohibit use in closed, confined
spaces:
• "Do not use in small, enclosed spaces such as closets, cabinets or
under counters or tables. Use of a fogger in an enclosed space
may cause the product to explode, resulting in injury to people or
damage to property."
Include prominent headings using different font size or style (e.g., bold) in
the directions, such as:
• To Use This Product Correctly [before the standard language
about small spaces and ignition sources]
• Before you fog [cover food, remove pets, etc]
• To Start Fogging [how to set up and activate]
• Airing Out [how long]
Include the following phrase in a prominent place in the directions and in
boldface type:
• "Vacate the treated house, individual apartment unit, or other
structure immediately"
In addition to the standard Precautionary Statements, add the following
language to the Precautionary Statements section of the label:
• "Breathing spray mist may be harmful."
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Table 12. Summary of Labeling Changes for Tetramethrin
Description
Amended Labeling Language
Placement on Label
Include the following statement in bold font in the Directions for Use:
• "Does not control bed bugs"
Include the phrase "Do Not Re-enter for X Hours" in a prominent place in
the directions and in boldface type. Include a clock face pictogram shading
the entry restriction immediately above or below this direction.
Example:
Provide door knob hang tags at the point-of-sale with a space for
customers to write-in when the entry restricted time has expired.
• For example, the text on the hang tag could state: "Do not enter
until [space for time] on [space for date]."
Add the following statement to tell others of the treatment:
• "Fill out and place hang-tag on the door to the treated area to alert
family and others with access to the treated area not to enter for X
hours."
Include label statements in both English and Spanish on all indoor total
release fogger product labels. Verify that the Spanish language text is a
true and accurate translation of the English text and submit verification
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Table 12. Summary of Labeling Changes for Tetramethrin
Description
Amended Labeling Language
Placement on Label
statement to EPA. Include both language versions of the labeling on the
product container.
Note: EPA is working to develop more general guidance for non-English
pesticide labeling. If companies are interested in substituting a different
language on product labels, in place of Spanish, please submit a rationale
for such substitution along with the alternate label language.
Additional Application Restrictions For
Outdoor Residential Use
Products labeled for General Outdoor Surface and Space Sprays
(except outdoor fogging devices):
"All outdoor applications must be limited to spot or crack-and-crevice
treatments only, except for the following permitted uses:
(1) Treatment to soil or vegetation around structures;
(2) Applications to building foundations, up to a maximum height of 3
feet.
Other than applications to building foundations, all outdoor applications to
impervious surfaces such as sidewalks, driveways, patios, porches and
structural surfaces (such as windows, doors, and eaves) are limited to spot
and crack-and-crevice applications, only."
Note to registrant: If the end use product does not contain directions for
use consistent with the exceptions above the exceptions may be eliminated
from the label.
Requirements for Granular Formulations labeled or intended for
outdoor residential uses:
"Apply this product directly to the lawn or garden area. Water treated area
as directed on this label. Do not water to the point of run-off."
"Do not make applications during rain."
Requirements for Liquid, Dust, and Ready to Use Formulations
products labeled or intended for outdoor residential uses:
Directions for Use under General
Precautions and Restrictions
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Table 12. Summary of Labeling Changes for Tetramethrin
Description
Amended Labeling Language
"Do not water the treated area to the point of run-off."
"Do not make applications during rain."
Placement on Label
End Use Products Primarily Used by Consumers/Homeowners
Maximum application rates eligible for reregistration are set forth in Appendix A.
Environmental Hazards Statements for
Outdoor Aerosols (including TRF)
AND
Outdoor Products Registered Only for
Commercial Use Sites (eg. golf-
courses).
Environmental Hazard Statements on
Liquid Concentrate consumer outdoor
products (e.g., liquids mixed with water
by the user for a tank sprayer or hose-
end attachment)
Environmental Hazard Statements on
Liquid Ready -to-Use (except aerosols,
including TRF) consumer outdoor
products
"ENVIRONMENTAL HAZARDS"
"This pesticide is extremely toxic to aquatic organisms, including fish and
aquatic invertebrates. Do not apply directly to water, or to areas where
surface water is present, or to inter-tidal areas below the mean high water
mark. Do not contaminate water when cleaning equipment or disposing of
equipment washwater or rinsate."
"This product is highly toxic to bees exposed to direct treatment on
blooming crops or weeds. Do not apply this product or allow it to drift to
blooming crops or weeds while bees are actively visiting the area."
"This pesticide is extremely toxic to aquatic organisms, including fish and
invertebrates. To protect the environment, do not allow pesticide to enter
or run off into storm drains, drainage ditches, gutters or surface waters.
Applying this product in calm weather when rain is not predicted for the
next 24 hours will help to ensure that wind or rain does not blow or wash
pesticide off the treatment area. Rinsing application equipment over the
treated area will help avoid run off to water bodies or drainage systems.
This pesticide is highly toxic to bees exposed to direct treatment on
blooming crops or weeds. Do not apply this product or allow it to drift to
blooming crops or weeds while bees are actively visiting the treatment
area."
"This pesticide is extremely toxic to aquatic organisms, including fish and
invertebrates. To protect the environment, do not allow pesticide to enter
or run off into storm drains, drainage ditches, gutters or surface waters.
Applying this product in calm weather when rain is not predicted for the
Precautionary Statements: Hazards to
Humans and Domestic Animals
Environmental Hazard Statement
Environmental Hazard Statement
44
-------
Table 12. Summary of Labeling Changes for Tetramethrin
Description
Amended Labeling Language
Placement on Label
next 24 hours will help to ensure that wind or rain does not blow or wash
pesticide off the treatment area.
This pesticide is highly toxic to bees exposed to direct treatment on
blooming crops or weeds. Do not apply this product or allow it to drift to
blooming crops or weeds while bees are actively visiting the treatment
area."
Environmental Hazards Statements for
Products Labeled for Indoor Uses Only
"ENVIRONMENTAL HAZARDS"
"This pesticide is extremely toxic to aquatic organisms, including fish and
aquatic invertebrates. Do not contaminate water when disposing of
equipment, washwater, or rinsate. See Directions for Use for additional
precautions and requirements."
For indoor commercial, industrial or institutional products packaged
in containers equal to or greater than 5 gallons or 50 Ibs add the
following statement:
"Do not discharge effluent containing this product into lakes, streams,
ponds, estuaries, oceans, or other waters unless in accordance with the
requirements of a National Pollution Discharge Elimination System
(NPDES) permit and the permitting authority has been notified in writing
prior to discharge. Do not discharge effluent containing this product to
sewer systems without previously notifying the local sewage treatment
plant authority. For guidance contact your State Water Board or Regional
Office of the EPA."
Precautionary Statements: Hazards to
Humans and Domestic Animals
Environmental Hazards Statements for
Products Labeled for Both Indoor and
Outdoor Uses Only
"ENVIRONMENTAL HAZARDS for TERRESTRIAL
APPLICATIONS"
Refer to appropriate consumer outdoor environmental hazard statements
above.
"ENVIRONMENTAL HAZARDS for INDOOR USE"
"This pesticide is extremely toxic to aquatic organisms, including fish and
Precautionary Statements: Hazards to
Humans and Domestic Animals
45
-------
Table 12. Summary of Labeling Changes for Tetramethrin
Description
Amended Labeling Language
Placement on Label
aquatic invertebrates. Do not contaminate water when disposing of
equipment, washwater, or rinsate. See Directions for Use for additional
precautions and requirements."
For indoor commercial, industrial or institutional products packaged
in containers equal to or greater than 5 gallons or 50 Ibs add the
following statement:
"Do not discharge effluent containing this product into lakes, streams,
ponds, estuaries, oceans, or other waters unless in accordance with the
requirements of a National Pollution Discharge Elimination System
(NPDES) permit and the permitting authority has been notified in writing
prior to discharge. Do not discharge effluent containing this product to
sewer systems without previously notifying the local sewage treatment
plant authority. For guidance contact your State Water Board or Regional
Office of the EPA."
Entry Restrictions for Non-WPS Uses
For products that do not contain directions for use that allow people
to be present during application:
"Do not enter or allow others to enter treated area until sprays have dried."
For products that contain directions for use that allow people to be
present during application AND are labeled for use as a directed spray
(does not apply to products applied directly to domestic animals):
"Except when (insert application method or site that allows people to be
present during application), do not enter or allow others to enter treated
area until sprays have dried."
For products that contain directions for use that allow people to be
present during application AND are labeled for use as a space spray:
"Except when (insert application method or site that allows people to be
present during application), do not enter or allow others to enter until
If no WPS uses on the product label,
place the appropriate statement in the
Directions for Use Under General
Precautions and Restrictions. If the
product also contains WPS uses, then
create a Non-Agricultural Use
Requirements box as directed in PR
Notice 93-7 and place the appropriate
statement inside that box.
46
-------
Table 12. Summary of Labeling Changes for Tetramethrin
Description
Amended Labeling Language
Placement on Label
vapors, mists, and aerosols have dispersed, and the treated area has been
thoroughly ventilated."
For total release foggers labeled for indoor use (see additional
requirements in TRF section below):
"Wait at least two (2) hours after application, then open windows, vents
and doors for two more hours. If an odor is still detected additional
ventilation is required."
General Application Restrictions
"Do not apply this product in a way that will contact adults, children, or
pets, either directly or through drift."
Place at the beginning of the
Direction for Use
General Application Restrictions for all
products that do not contain directions
for use in drains or sewers
Products labeled for use around or near floor drains must contain the
following statement.
"Application is prohibited directly into sewers or drains, or to any area
like a gutter where drainage to sewers, storm drains, water bodies, or
aquatic habitat can occur. Do not allow the product to enter any drain
during or after application."
Directions for Use
General Application Restrictions for all
products that contain directions for use
in drains or sewers
"Do not apply directly to sewers or drains, or to any area like a gutter
where drainage to sewers, storm drains, water bodies, or aquatic habitat
can occur, except as directed by this label."
Directions for Use
Additional Application Restrictions For
Outdoor Residential Use
Products labeled for General Outdoor Surface and Space Sprays
(except outdoor fogging devices:
"All outdoor applications must be limited to spot or crack-and-crevice
treatments only, except for the following permitted uses:
(1) Treatment to soil or vegetation around structures; and,
(2) Applications to building foundations, up to a maximum height of 3
feet.
Other than applications to building foundations, all outdoor applications to
impervious surfaces such as sidewalks, driveways, patios, porches and
structural surfaces (such as windows, doors, and eaves) are limited to spot
and crack-and-crevice applications, only."
Note to registrant: If the end use product does not contain directions for
use consistent with the exceptions above the exceptions may be eliminated
Directions for Use under General
Precautions and Restrictions
47
-------
Table 12. Summary of Labeling Changes for Tetramethrin
Description
Amended Labeling Language
Placement on Label
from the label.
Requirements for Granular Formulations labeled or intended for
outdoor residential uses:
"Apply this product directly to the lawn or garden area. Water treated area
as directed on this label. Do not water to the point of run-off."
"Do not make applications during rain."
Requirements for Liquid, Dust, and Ready to Use Formulations
products labeled or intended for outdoor residential uses:
"Do not water the treated area to the point of run-off."
"Do not make applications during rain."
Application Restrictions for End Use
Products containing directions for
indoor use
"Do not apply when food is present. Exposed food should be covered or
removed. All food preparation surfaces and utensils should be covered
during treatment or thoroughly washed before use."
Directions for use, within the
application restrictions area
General Application Restrictions for
Total Release Foggers (TRF) labeled
for indoor use
Note to registrants: The following labeling was sent to pyrethrins and
pyrethroid registrants on March 23, 2010. The following label
statements are required to appear on TRF EUPs, except where
manufacturers can satisfactorily explain to the Agency that an
alternative approach would be adequate to address the causes of bug
bomb exposure incidents.
Use simple terms to express the volume of space treated in terms of
linear dimensions, with an assumed ceiling height, rather than in terms
of cubic feet. Update the current statements to follow this model in the
Directions for Use:
Example: "One canister of fogger will treat a room up to x feet
by y feet with an 8 foot ceiling."
All current restrictions and requirements regarding the size of the
Directions for Use
48
-------
Table 12. Summary of Labeling Changes for Tetramethrin
Description
Amended Labeling Language
Placement on Label
treated area remain unchanged.
At a minimum include pictograms, where applicable, to illustrate the
following list of restrictions and directions for use:
• do not use multiple canisters in a room
• do not use in small confined areas
• turn off ignition sources
• remove or cover exposed food
• air out the room before entering
Include the following directions that prohibit use in closed, confined
spaces:
• "Do not use in small, enclosed spaces such as closets, cabinets or
under counters or tables. Use of a fogger in an enclosed space
may cause the product to explode, resulting in injury to people or
damage to property."
Include prominent headings using different font size or style (e.g., bold) in
the directions, such as:
• To Use This Product Correctly [before the standard language
about small spaces and ignition sources]
• Before you fog [cover food, remove pets, etc]
• To Start Fogging [how to set up and activate]
• Airing Out [how long]
Include the following phrase in a prominent place in the directions and in
boldface type:
• "Vacate the treated house, individual apartment unit, or other
structure immediately"
In addition to the standard Precautionary Statements, add the following
language to the Precautionary Statements section of the label:
• "Breathing spray mist may be harmful."
49
-------
Table 12. Summary of Labeling Changes for Tetramethrin
Description
Amended Labeling Language
Placement on Label
Include the following statement in bold font in the Directions for Use:
• "Does not control bed bugs"
Include the phrase "Do Not Re-enter for X Hours" in a prominent place in
the directions and in boldface type. Include a clock face pictogram shading
the entry restriction immediately above or below this direction.
Example:
Provide door knob hang tags at the point-of-sale with a space for
customers to write-in when the entry restricted time has expired.
• For example, the text on the hang tag could state: "Do not enter
until [space for time] on [space for date]."
Add the following statement to tell others of the treatment:
• "Fill out and place hang-tag on the door to the treated area to alert
family and others with access to the treated area not to enter for X
hours."
Include label statements in both English and Spanish on all indoor total
release fogger product labels. Verify that the Spanish language text is a
true and accurate translation of the English text and submit verification
statement to EPA. Include both language versions of the labeling on the
50
-------
Table 12. Summary of Labeling Changes for Tetramethrin
Description
Amended Labeling Language
Placement on Label
product container.
Note: EPA is working to develop more general guidance for non-English
pesticide labeling. If companies are interested in substituting a different
language on product labels, in place of Spanish, please submit a rationale
for such substitution along with the alternate label language.
51
-------
Appendix A. Non-Food and Non-Feed Use Patterns Subject to the Reregistration of Tetramethrin
Use Profile
(Application Method)
General IndoorA and Outdoor SprayB
(Trigger Pump Sprays, Low Pressure Hand Wand,
Back Pack Sprayer)
Aerosol Cans (Indoor & Outdoor Spray)
Indoor Total Release FoggerA
Animal Treatment
(Aerosol Can)
Outdoor Jet Sprays (intended for wasp and
hornet use only)
Outdoor Fogging Devices80
Maximum Application Rate
% Active
Ingredient (% a.i.)
0.20
0.35
0.54
0.063
0.20
0.10
Volume-based
0.02 Ib ai/gal
solution
0.035 Ib ai/gal
solution
n/a
n/a
1-2 sec burst
n/a
Area-based
0.00002 Ib ai/ft2
0.000035 Ib ai/ft2
n/a
n/a
n/a
0.000000 lib ai/ft2
Space-based
0.000002 Ib ai/ft3
0.0000035 Ib ai/ft3
6 oz can / 4,600 ft3
n/a
n/a
1.25E-081b ai/ft3
A Use sites include but are not limited to: commercial, industrial, institutional, and residential locations; agricultural structures and equipment;
eating establishments; animal kennels and sleeping quarters; empty greenhouses; hospitals.
B Use sites include but are not limited to: commercial, industrial, institutional, and residential locations; compost piles; ornamental plants; patios;
paths.
c Excludes RTU fogging devices.
52
-------
Appendix B. Data Supporting Guideline Requirements for Tetramethrin
Data Supporting Guideline Requirements for the Reregistration of Tetramethrin
Guideline
Number
Study Description
Citation(s)
PRODUCT CHEMISTRY
830.1550
830.1600
830.1620
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
830.6313
830.7000
830.7050
830.7200
830.7220
830.7300
830.7370
830.7550
830.7570
830.7840
830.7860
830.7950
Product Identity and Composition
Description of Materials Used
Description of Production Process
Discussion of Formation of Impurities
Preliminary Analysis
Certified Limits
Enforcement Analytical Method
Color
Physical State
Odor
Stability
pH
UV/Visible Absorption
Melting Point
Boiling Point
Density
Dissociation Constant
Octanol / Water Partition Coefficient
Solubility
Vapor Pressure
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
Required
ECOLOGICAL EFFECTS
850.1010
850.1025
850.1035
850.1045
850.1055
850.1075
850.1300
850.1350
850.1400
850.1500
850.1710
Aquatic Invertebrate Acute
Oyster Acute Toxicity Test
Mysid Acute Toxicity Test
Penaeid Acute Toxicity Test
Bivalve Acute Toxicity Test
Fish Acute Toxicity
Freshwater
Estuarine / Marine
Aquatic Invertebrate Life Cycle (Freshwater)
Aquatic Invertebrate Life Cycle (Marine)
Fish Early Life-Stage (Freshwater and
Marine)
Fish Full Life-Cycle (Freshwater and
Marine)
Oyster BCF
41609609
Data gap
Data gap
Data gap
Data gap
41609608,41609607
Data gap
Data gap
Data gap
Data gap
Data gap
Data gap
53
-------
Data Supporting Guideline Requirements for the Reregistration of Tetramethrin
Guideline
Number
850.1730
850.1850
850.2100
850.2200
850.2300
850.2400
850.3020
850.3030
850.3040
850.4100
850.4150
850.4400
850.4500
850.4550
Study Description
Fish BCF
Aquatic Food Chain Transfer
Avian Acute Oral Toxicity
Avian Subacute Dietary Toxicity
Avian Reproduction Toxicity
Wild Mammal Toxicity
Honey Bee Acute Contact Toxicity
Residues on Foliage Honeybee Toxicity
Honeybee Feeding Toxicity Test
Seedling Emergence and Growth
Vegetative Vigor
Aquatic Plant Growth
Algal Plant Toxicity
Algal Plant Toxicity
Citation(s)
Data gap
Data gap
41609604
41609605,41609606
Data gap
00063574, 00161842
41609613
41940801
Data gap
Data gap
Data gap
Data gap
Data gap
Data gap
TOXICOLOGY
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
870.3100
870.3150
870.3200
870.3465
870.3700
870.3800
870.4100
870.4200
870.4300
870.5265
870.5385
870.5550
870.6200
(a)
(b)
Acute Oral Toxicity
Acute Dermal Toxicity
Acute Inhalation Toxicity
Acute Eye Irritation
Acute Dermal Irritation
Skin Sensitization
90-Day Oral Toxicity in Rodents
90-Day Oral Toxicity in Non-rodents
21/28 -Day Dermal Toxicity
90-Day Inhalation Toxicity
Prenatal Developmental Toxicity
Reproduction and Fertility Effects, 2-
Generation Reproduction
Chronic Toxicity
Carcinogenicity
Combined Chronic Toxicity /Carcinogenicity
Gene Mutation (Ames assay)
Bone Marrow Chromosomal Aberration Test
Unscheduled DNA Synthesis in mammalian
cells in culture
42146405
00063574,40276101
Required
41609611
Required
Required
42146404
42146403,41698902
41995004
42012101,41995003
Required
42189202, 41995005, 00114369, 00114370
00114371, 00137656, 00137658, 00161842
41723301, 40009401, 40280401,
00156488, 40007501, 41723302,
42189301,44083501
41723301, 40009401, 40280401,
00156488, 40007501, 41723302
00158951, 40276301, 44096001
40276001,40275801
40275901, 42414401, 42414402, 42414403
40778401,40275801
Neurotoxicity Screening battery
Acute Neurotoxicity
Subchronic Neurotoxicity
Required
42601501, 42601502, 43152701
Required
54
-------
Data Supporting Guideline Requirements for the Reregistration of Tetramethrin
Guideline
Number
870.6300
870.7485
Study Description
Developmental Neurotoxicity Study
Metabolism and Pharmacokinetics
Special Study - motor activity in male and
female mice post-natally exposed by
inhalation
Citation(s)
Required
42448901,42448902
44222801
ENVIRONMENTAL FATE
835.1230
835.1410
835.2120
835.2240
835.2370
835.2410
835.4100
835.4200
835.4300
835.4400
835.6100
835.6200
835.6400
835.7100
835.8100
Leaching and Adsorption / Desorption
Laboratory Volatility
Hydrolysis
Photodegradation in Water
Photodegradation in Air
Photodegradation on Soil
Aerobic Soil Metabolism
Anaerobic Soil Metabolism
Aerobic Aquatic Metabolism
Anaerobic Aquatic Metabolism
Terrestrial Field Dissipation
Aquatic (Sediment) Dissipation
Combination and Tank Mixes Dissipation
Ground Water Monitoring
Field Volatility
41995007,42212901
Data gap
41995006
00164634,43773401
Data gap
Data gap
42563301
Data gap
Data gap
Data gap
42622401,42622402
Data gap
Data gap
Data gap
Data gap
55
-------
Appendix C. Technical Support Documents
Additional documentation in support of the Tetramethrin RED is maintained in the OPP
Regulatory Public Docket, located in Room S-4400 One Potomac Yard (South Building), 2777
S. Crystal Drive, Arlington, VA. It is open Monday through Friday, excluding legal holidays,
from 8:30 a.m. to 4:00 p.m. All documents may be viewed in the OPP Docket room or viewed
and/or downloaded via the Internet at http://www.regulations.gov. The Agency's documents in
support of this RED include the following:
1. Daiss, B. Tetramethrin Health Effects Division's Risk Assessment for Reregi strati on
Eligibility Decision. June 18,2008.
2. Crowley, M. Tetramethrin: Phase IV Revised Occupational and Residential Exposure
Assessment and Recommendations for the Reregi strati on Eligibility Decision. June 13,
2008.
3. Eckel, W. et al. Revised Environmental Fate and Ecological Risk Assessment for the Re-
registration Eligibility Decision on Tetramethrin. February 5, 2008.
4. Abdel-Saheb, I. Revised Drinking Water Assessment for Tetramethrin Use as a Rapid
Knockdown Agent Against Flying and Crawling Insects. February 5, 2008.
5. Crowley, M. HED Review of "Evaluation of Potential Human Health Risks Associated
with Residential Uses of Tetramethrin: Supplemental Assessment for Indoor Space
Spray" (EPA MRID 47713101). April 27, 2009.
6. Daiss, B. Tetramethrin: Benchmark Dose Analysis of Toxicity Endpoint for Incidental
Oral Exposure. January 6, 2010.
7. Crowley, M. HED Review of "Evaluation of Potential Human Health Risks Associated
with Residential Uses of Tetramethrin: Revised Supplemental - Short-Term Oral
Benchmark Dose Analysis" (EPA MRID 47921601). February 25, 2010.
56
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Appendix D. Bibliography
In addition to the studies listed in Appendix B, this bibliography contains additional
citations considered to be part of the database supporting the reregi strati on decision for
Tetramethrin.
In addition to the MRID study references listed in Appendix B, this bibliography contains the
expanded study citations as well as additional literature considered to be part of the database
supporting the reregi strati on decision for Tetramethrin.
MRID
Citation Reference
63574
Miyamoto, J.; Kadota, T.; Kohda, H. (1977) Acute Oral and Dermal Toxicities of
Neopynamin in Mice and Rats. (Unpublished study received Apr 21, 1978 under
10308-1; prepared by Sumitomo Chemi- cal Co., Ltd., Japan, submitted by
Sumitomo Chemical Co., Ltd., Baltimore, Md.; CDL:233835-A)
114369
Sato, T.; Narama, K. (1982) Reproduction Test of Neopynamin: Part 2. Teratology
Study in Rats: Doc. Code IT-01-0076. (Transla- tion; unpublished study received Sep
20, 1982 under 10308-1; prepared by Sumitomo Chemical Co., Ltd., Japan,
submitted by Sumitomo Chemical Co., Ltd., Baltimore, MD; CDL:248342-B)
114370
Sato, T.; Narama, K. (1982) Reproduction Test of Neopynamin: Part 3. Teratology
Study in Rabbits: Doc. Code IT-01-0077. (Transla- tion; unpublished study received
Sep 20, 1982 under 10308-1; prepared by Sumitomo Chemical Co., Ltd., Japan,
submitted by Sumitomo Chemical Co., Ltd., Baltimore, MD; CDL:248342-C)
114371
Sato, T.; Tagawa, G.; Narama, K. (1982) Reproduction Test of Neo- pynamin: Part
4. Perinatal and Postnatal Study in Rats: Doc. Code IT-01-0078. (Translation;
unpublished study received Sep 20, 1982 under 10308-1; prepared by Sumitomo
Chemical Co., Ltd., Japan, submitted by Sumitomo Chemical Co., Ltd., Balti- more,
MD; CDL:248342-D)
131413
Gabriel, K. (1981) Guinea Pig Contact Dermal Irritation/Sensitization—Buehler
Method: TL-2252: Project No. 81-2354A. (Unpublished study received Sep 19,
1983 under 1021-1492; prepared by Biosearch, Inc., submitted by McLaughlin
Gormley King Co., Minneapolis, MN; CDL:251313-E)
137656
Hazleton Laboratories America, Inc. (1980) One-generation Reproduc- tion Study--
Rats: Neo-Pynamin: Individual Animal Data: Project No. 343-106; IT-01-0081.
(Unpublished study received Apr 30, 1982 under 10308-1; submitted by Sumitomo
Chemical Co., Ltd., Baltimore, MD; CDL:247530-A)
137658
Rutter, H. (1974) One-generation Reproduction Study—Rats: Neo-Pyn- amin: Project
No. 343-106; IT-41-0042. Final rept. (Unpub- lished study received Apr 30, 1982
under 10308-1; prepared by Hazleton Laboratories, Inc., submitted by Sumitomo
Chemical Co., Ltd., Baltimore, MD; CDL:247530-C)
156488
Pence, D. (1986) Chronic Toxicity Study in Rats: Neopynamin Technical:
Addendum to Final Report: Project No. 343-117. Unpublished study prepared by
Hazleton Laboratories America, Inc. 575 p.
158951
Cox, R. (1986) Combined Chronic Toxicity and Oncogenicity Study in Mice:
Neopynamin: Final Report: Project No. 343-136. Unpublish- ed study prepared by
Hazleton Laboratories America, Inc. 4980 p.
57
-------
MRID
Citation Reference
161842 Pence, D.; Wolfe, G.; Kulwich, B. (1986) Two-generation Reproduction Study in
Rats: Neopynamin Forte: Final Report: Project No. 343-147. Unpublished study
prepared by Hazleton Labo- ratories America, Inc. 418 p. _
164634 Chen, Y.; Casida, J. (1970) Photodecomposition of pyrethrin I, allethrin, phthalthrin,
and dimethrin modifications in the acid moiety. Pyrethum Post 10(3):7-16. _
40007501 Cox, R. (1986) Chronic Toxicity Study in Rats, Neopynamin Techni- cal: Addendum
III to Final Report: Hazleton Project No. 343-1 17. Unpublished study prepared by
Hazleton Laboratories America, Inc. 7 p. _
40009401 Cox, R. (1986) Two-year Dietary Administration in the Rat: Neo Pynamin:
Addendum 1: Final Report: Project No.: 343-107. Unpub- lished study prepared by
Hazleton Laboratories America, Inc. 831 p. _
40275701 Suzuki, H.; Miyamoto, J. (1975) Mutagenicity of Some Synthetic Pyrethroids in
Bacterial Test System: Laboratory Project ID: ET-50-0024. Unpublished study
prepared by Sumitomo Chemical Co., Ltd. 14 p. _
40275801
Ding, C.; Yu, Y.; Zhang, J.; et al. (1985) Genotoxicity of tetramethrin in mammalian
cells and salmonella typhimuriam. Journal of the Zhejiang Univ. of Medicine
40275901 Kogiso, S.; Kara, M.; Yoshitake, A.; et al. (1986) In vivo Chromo- somal Aberration
Test of Neopynamin in Mouse Bone Marrow Cells: Laboratory Project ID: IT-60-
0197. Unpublished study prepared by Sumitomo Chemical Co., Ltd. 12 p. _
40276001 Kogiso, S.; Yamada, F.; Kara, M.; et al. (1987) Reverse Mutation Test of
Neopynamin in Salmonella typhimurium and Escherichia coli: Lab Project No. : IT-
70-0205. Unpublished study prepared by Sumitomo Chemical Co., Ltd. 18 p. _
40276101 Suzuki, T.; Sako, H.; Okuno, Y.; et al. (1987) Acute Dermal Toxicity of
Neopynamin in Rabbits: Lab Project No.: IT-70-0207. Unpublished study prepared
by Takarazuka Research Center. 17 p. _
40276301 Cox, R. (1987) Combined Chronic Toxicity and Oncogenicity Study in Mice:
Neopynamin Technical: Amendment to Final Report (IT-71- 0210). Unpublished
study prepared by Hazleton Laboratories America, Inc. 1487 p. _
40280401 Cox, R.; Jones, S. (1987) Historical Control Data for Liver Adenoma Incidence
among Mice, and Supporting Information: Hazleton Product No. 343-107.
Unpublished study prepared by Hazleton Laboratories America, Inc. 53 p. _
40778401 Kogiso, S. (1988) In vitro Unscheduled DNA Synthesis (UDS) Assay of
Neopynamine in Rat Hepatocytes: Study No. 1280. Unpublished study prepared by
Sumitomo Chemical Co., Ltd. 54 p. _
41054701 Knarr, R.D. (1988) Exposure of Applicators to Propoxur During Trigger-Pump Spray
Application of a Liquid Product. Unpublished study prepared by Mobay
Corporation. 195 p. _
41609604 Culotta, J. et al. (1990) Neo-Pynamin: An Acute Oral Toxicity Study with the
Bobwhite: (IW-0 1-0008): Final Report: Lab Project Number: IW/01/0008.
Unpublished study prepared by Sumitomo Chemical Company. 17 p. _
41609605 Long, R. ; Hoxter, K. ; Smith, G. (1990) Neo-Pynamin: A Dietary LC50 Study with
the Northern Bobwhite: Lab Project Number: 166/133. Unpublished study prepared
by Sumitomo Chemical Company. 54 p. _
58
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MRID
Citation Reference
41609606 Long, R. ; Hoxter, K. ; Smith, G. (1990) Neo-Pynamin: A Dietary LC50 Study with
the Mallard: Lab Project Number: 166/134. Unpublished study prepared by
Sumitomo Chemical Company. 54 p.
41609607 Bowman, J. (1990) Acute Flow-through Toxicity of Neo-Pynamin to Bluegill:
(Lepomis-macrochirus): Lab Project Number: IW/01/0010. Unpublished study
prepared by Analytical Bio-Chemistry Labora- tories, Inc. 188 p.
41609608 Bowman, J. ; Gormley, M. (1990) Acute Flow-Through Toxicity of Neo- Pynamin to
Rainbow Trout (Oncorhynchus mykiss): Lab Project Number: IW/01/0011.
Unpublished study prepared by Analytical Bio-Chemistry Laboratories, Inc., 189 p.
41609609 Burgess, D. (1990) Acute Flow-through Toxicity of Neo-Pynamin to Daphnia
magna: Lab Project Number: IW/01/0009. Unpublished Study Prepared by
Analytical Bio-Chemistry Laboratories, Inc., 176 p.
41609611 Nakanishi, T. (1990) Primary Eye and Skin Irritation Tests with Neo-Pynamin in
Rabbits: Lab Project Number: IT/00/0217. Unpublished study prepared by
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Aberrations In vivo in Mouse Bone Marrow Cells: Final Report: Lab Project
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Number: 2557: IM-20-0016. Unpublished study prepared by Sumitomo Chemical
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(Carbon 14)-(lRS)-trans-Tetramethrin: Lab Project Number: SOI90001.
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Effects of Orally Administered Neo-Pynamin on Behavior and Neuromorphology in
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Pynamin) Applied for Control of Insects in Plants (California Field Study): Lab
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Pynamin) Applied for Control of Insects in Plants (Florida Field Study): Lab Project
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and dimethrin: Modifications in the acid moiety. J. Agr. Food Chem. 17(2):208-215.
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Report: Lab Project Number: CHV 343-249: IT-0276: 343-249. Unpublished study
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Report: Lab Project Number: HWA 343-242: IT-51-0272: 343-242. Unpublished
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Measurements in Male and Female Mice Postnatally Exposed to Tetramethrin by
Inhalation (Including Measuremenets of Muscarinic Acetylcholine Receptors in the
Brain): Lab Project Number: IT-0277: T3059027: 25749. Unpublished study
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(TCVP) from the Fur of Dogs Following the Application of an Insecticide Powder,
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prepared by Hartz Mountain Corp. 137 p.
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National Pesticide Use Survey - Design, Implementation, Analysis Methods and
Results. Project Number: 03/REJV/12M/002. Unpublished study prepared by NFO
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Deposition Measurements for Pyrethrins & Piperonyl Butoxide Following Use of a
Total Release Indoor Fogger.
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Residues from Vinyl and Carpet Flooring Treated with a Fogger Formulation to DSS
Wetted Hands Following a Single Hand Press.
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Deposition of Pyrethrin and Piperonyl Butoxide Following the Use of an Aerosol
Spray.
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Piperonyl Butoxide Following Use of a Total Release Indoor Fogger.
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Residues from Vinyl and Carpet Flooring Treated with a Fogger Formulation to DSS
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63
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Appendix E. Tetramethrin Acute Mammalian Toxicity Batching
>r <*.
I UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
T
WASHINGTON, D.C. 20460
OFFICE OF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
December 3, 2008
MEMORANDUM
SUBJECT: Tetramethrin [PC Codes 069003], Acute Mammalian Toxicity Batching
Appendix for Tetramethrin RED Document.
FROM: Marianne Lewis, Biologist [sign. M.Lewis 12/3/08]
Product Reregi strati on Branch
Special Review and Reregi strati on Division (7508P)
TO: Monica Wait, CRM
Reregi strati on Branch III
Special Review and Reregi strati on Division (7508P)
Attached is the batching appendix for Tetramethrin. Please let me know if you have any
questions regarding this document.
64
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EPA'S BATCHING OF TETRAMETHRIN PRODUCTS FOR MEETING ACUTE TOXICITY
DATA REQUIREMENTS FOR REREGISTRATION
In an effort to reduce the time, resources and number of animals needed to fulfill the
acute toxicity data requirements for reregi strati on of products containing TETRAMETHRIN as
the active ingredient, the Agency has batched products which can be considered similar for
purposes of acute toxicity. Factors considered in the sorting process include each product's active
and inert ingredients (identity, percent composition and biological activity), type of formulation
(e.g., emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g.,
signal word, use classification, precautionary labeling, etc.). Note that the Agency is not
describing batched products as "substantially similar" since some products within a batch may
not be considered chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described in
the preceding paragraph. Notwith-standing the batching process, the Agency reserves the right to
require, at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or
cite a single battery of six acute toxicological studies to represent all the products within that
batch. It is the registrants' option to participate in the process with all other registrants, only some
of the other registrants, or only their own products within a batch, or to generate all the required
acute toxicological studies for each of their own products. If a registrant chooses to generate the
data for a batch, he/she must use one of the products within the batch as the test material. If a
registrant chooses to rely upon previously submitted acute toxicity data, he/she may do so
provided that the data base is complete and valid by today's standards (see acceptance criteria
attached), the formulation tested is considered by EPA to be similar for acute toxicity, and the
formulation has not been significantly altered since submission and acceptance of the acute
toxicity data. Regardless of whether new data is generated or existing data is referenced,
registrants must clearly identify the test material by EPA Registration Number. If more than one
confidential statement of formula (CSF) exists for a product, the registrant must indicate the
formulation actually tested by identifying the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow
the directions given in the Data Call-In Notice and its attachments appended to the RED. The
DCI Notice contains two response forms which are to be completed and submitted to the Agency
within 90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant
will meet the data requirements for each product. The second form, "Requirements Status and
Registrant's Response," lists the product specific data required for each product, including the
standard six acute toxicity tests. A registrant who wishes to participate in a batch must decide
whether he/she will provide the data or depend on someone else to do so. If a registrant supplies
the data to support a batch of products, he/she must select one of the following options:
Developing Data (Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing
Study (Option 5) or Citing an Existing Study (Option 6). If a registrant depends on another's
data, he/she must choose among: Cost Sharing (Option 2), Offers to Cost Share (Option 3) or
Citing an Existing Study (Option 6). If a registrant does not want to participate in a batch, the
choices are Options 1, 4, 5 or 6. However, a registrant should know that choosing not to
65
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participate in a batch does not preclude other registrants in the batch from citing his/her studies
and offering to cost share (Option 3) those studies.
Many products containing TETRAMETHRIN have been previously batched in the PBO,
Pyrethrins, & MGK 264 REDs. If a TETRAMETHRIN product registration number cannot be
found in the following tables, please refer to the batching appendices for PBO, Pyrethrins, &
MGK 264. One hundred and thirty eight products have been found which contain
TETRAMETHRIN as the active ingredient, and have not been previously batched in the PBO,
Pyrethrins, & MGK 264 REDs. These products have been placed into seventeen batches and a
No Batch group in accordance with the active and inert ingredients and type of formulation.
Batching Instructions:
No Batch: Each product in this Batch should generate their own data.
NOTE: The technical acute toxicity values included in this document are for informational
purposes only. The data supporting these values may or may not meet the current acceptance
criteria.
Batch 1
EPA Reg. No.
10308-1
73049-145
73049-258
Percentage Active Ingredient
95.0
95.0
100.0
Batch 2
EPA Reg. No.
270-356
1021-177
2517-76
9444-165
28293-215
Percentage Active Ingredient
Tetramethrin: 0.400
Phenothrin: 0.300
Pyriproxyfen: 0.015
Tetramethrin: 0.400
Phenothrin: 0.300
Pyriproxyfen: 0.015
Tetramethrin: 0.400
Phenothrin: 0.300
Pyriproxyfen: 0.015
Tetramethrin: 0.400
Phenothrin: 0.300
Pyriproxyfen: 0.015
Tetramethrin: 0.400
Phenothrin: 0.300
Pyriproxyfen: 0.015
Batch 3
EPA Reg. No.
192-196
Percentage Active Ingredient
Tetramethrin: 0.400
Phenothrin: 0.300
66
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1021-1622
2724-663
40849-55
68543-23
Pyriproxyfen: 0.015
Tetramethrin: 0.400
Phenothrin: 0.300
Pyriproxyfen: 0.015
Tetramethrin: 0.400
Phenothrin: 0.300
Pyriproxyfen: 0.015
Tetramethrin: 0.400
Phenothrin: 0.300
Pyriproxyfen: 0.015
Tetramethrin: 0.400
Phenothrin: 0.300
Pyriproxyfen: 0.015
Batch 4
EPA Reg. No.
4822-436
9688-254
Percentage Active Ingredient
Tetramethrin: 0.50
Cypermethrin: 0.15
Tetramethrin: 0.10
Cypermethrin: 0.60
Batch 5
EPA Reg. No.
769-584
9444-145
Percentage Active Ingredient
Tetramethrin: 0.20
Esfenvalerate: 0.10
Tetramethrin: 0.20
Esfenvalerate: 0.10
Batch 6
EPA Reg. No.
1021-1715
8848-83
Percentage Active Ingredient
Tetramethrin: 0.20
Permethrin: 0.20
Tetramethrin: 0.20
Permethrin: 0.20
Batch 7
EPA Reg. No.
73049-313
73049-314
73049-328
Percentage Active Ingredient
Tetramethrin: 0.20
Permethrin: 0.50
Tetramethrin: 0.10
Permethrin: 0.25
Tetramethrin: 0.20
Permethrin: 0.50
Batch 8
EPA Reg. No.
Percentage Active Ingredient
67
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73049-436
73049-437
Tetramethrin: 0.10
Permethrin: 0.10
Tetramethrin: 0.20
Permethrin: 0.20
Batch 9
EPA Reg. No.
2724-533
8845-67
Percentage Active Ingredient
Tetramethrin: 0.40
Permethrin: 0.30
Tetramethrin: 0.40
Permethrin: 0.30
Batch 10
EPA Reg. No.
192-153
239-2535
2724-541
2724-547
8845-84
46515-21
46515-30
Percentage Active Ingredient
Tetramethrin: 0.286
Permethrin: 0.572
Tetramethrin: 0.050
Permethrin: 0.100
Tetramethrin: 0.050
Permethrin: 0.100
Tetramethrin: 0.050
Permethrin: 0.100
Tetramethrin: 0.050
Permethrin: 0.100
Tetramethrin: 0.029
Permethrin: 0.057
Tetramethrin: 0.029
Permethrin: 0.057
Tetramethrin: 0.40
Permethrin: 0.30
Batch 1 1
EPA Reg. No.
4822-271
4822-423
4822-533
Percentage Active Ingredient
Tetramethrin: 0.200
Permethrin: 0.200
Tetramethrin: 0.119
Permethrin: 0.124
Tetramethrin: 0.200
Permethrin: 0.200
Batch 12
EPA Reg. No.
1021-1780
1021-1806
Percentage Active Ingredient
Tetramethrin: 0.20
Phenothrin: 0.20
Tetramethrin: 0.15
Permethrin: 0.15
68
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Batch 13
EPA Reg. No.
478-101
498-160
8845-68
46813-10
Percentage Active Ingredient
Tetramethrin: 0.20
Phenothrin: 0.20
Tetramethrin: 0.20
Phenothrin: 0.20
Tetramethrin: 0.20
Phenothrin: 0.20
Tetramethrin: 0.20
Phenothrin: 0.20
Batch 14
EPA Reg. No.
1021-1775
1021-1808
2724-540
2724-542
2724-543
8845-83
Percentage Active Ingredient
Tetramethrin: 0.2000
Phenothrin: 0.2000
Tetramethrin: 0.2000
Phenothrin: 0.2000
Tetramethrin: 0.0500
Phenothrin: 0.1000
Tetramethrin: 0.0286
Phenothrin: 0.0572
Tetramethrin: 0.05
Phenothrin: 0.10
Tetramethrin: 0.05
Phenothrin: 0.10
Batch 15
EPA Reg. No.
2724-536
5887-118
Percentage Active Ingredient
Tetramethrin: 0.2
Phenothrin: 0.4
Tetramethrin: 0.2
Phenothrin: 0.4
Batch 16
EPA Reg. No.
192-184
498-156
506-140
1021-1649
3862-127
Percentage Active Ingredient
Tetramethrin: 0.200
Phenothrin: 0.125
Tetramethrin: 0.200
Phenothrin: 0.125
Tetramethrin: 0.200
Phenothrin: 0.125
Tetramethrin: 0.200
Phenothrin: 0.125
Tetramethrin: 0.200
Phenothrin: 0.125
69
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4313-87
5887-158
7405-71
7754-44
9444-181
10806-105
11623-38
40849-52
44446-54
46515-44
55809-3
68543-8
Tetramethrin: 0.200
Phenothrin: 0.125
Tetramethrin: 0.200
Phenothrin: 0.125
Tetramethrin: 0.200
Phenothrin: 0.125
Tetramethrin: 0.200
Phenothrin: 0.125
Tetramethrin: 0.200
Phenothrin: 0.125
Tetramethrin: 0.200
Phenothrin: 0.125
Tetramethrin: 0.200
Phenothrin: 0.125
Tetramethrin: 0.200
Phenothrin: 0.125
Tetramethrin: 0.200
Phenothrin: 0.125
Tetramethrin: 0.200
Phenothrin: 0.125
Tetramethrin: 0.200
Phenothrin: 0.125
Tetramethrin: 0.200
Phenothrin: 0.125
Batch 17
EPA Reg. No.
192-189
239-2523
239-2524
239-2525
478-93
498-114
499-355
506-157
706-83
769-609
Percentage Active Ingredient
Tetramethrin: 0.20
Phenothrin: 0.20
Tetramethrin: 0.05
Phenothrin: 0.10
Tetramethrin: 0.20
Phenothrin: 0.20
Tetramethrin: 0.25
Phenothrin: 0.15
Tetramethrin: 0.25
Phenothrin: 0.15
Tetramethrin: 0.20
Phenothrin: 0.19
Tetramethrin: 0.40
Phenothrin: 0.30
Tetramethrin: 0.20
Phenothrin: 0.20
Tetramethrin: 0.20
Phenothrin: 0.20
Tetramethrin: 0.25
70
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1021-1587
1021-1588
1021-1667
1021-1862
2724-529
2724-530
2724-537
2724-545
2724-597
2724-604
2724-615
2915-59
5887-123
5887-159
7056-99
8845-63
8848-38
8848-42
9688-54
10088-116
10806-41
10807-61
10807-182
Phenothrin: 0.15
Tetramethrin: 0.25
Phenothrin: 0.15
Tetramethrin: 0.20
Phenothrin: 0.20
Tetramethrin: 0.20
Phenothrin: 0.20
Tetramethrin: 0.10
Phenothrin: 0.10
Tetramethrin: 0.25
Phenothrin: 0.20
Tetramethrin: 0.25
Phenothrin: 0.15
Tetramethrin: 0.20
Phenothrin: 0.20
Tetramethrin: 0.20
Phenothrin: 0.20
Tetramethrin: 0.25
Phenothrin: 0.15
Tetramethrin: 0.20
Phenothrin: 0.20
Tetramethrin: 0.20
Phenothrin: 0.40
Tetramethrin: 0.20
Phenothrin: 0.20
Tetramethrin: 0.20
Phenothrin: 0.19
Tetramethrin: 0.25
Phenothrin: 0.15
Tetramethrin: 0.25
Phenothrin: 0.15
Tetramethrin: 0.25
Phenothrin: 0.15
Tetramethrin: 0.20
Phenothrin: 0.20
Tetramethrin: 0.40
Phenothrin: 0.30
Tetramethrin: 0.20
Phenothrin: 0.40
Tetramethrin: 0.25
Phenothrin: 0.15
Tetramethrin: 0.25
Phenothrin: 0.14
Tetramethrin: 0.20
Phenothrin: 0.20
Tetramethrin: 0.25
71
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11623-11
11715-82
28293-160
40849-4
40859-46
46515-40
46515-43
64240-23
Phenothrin: 0.15
Tetramethrin: 0.20
Phenothrin: 0.20
Tetramethrin: 0.20
Phenothrin: 0.20
Tetramethrin: 0.40
Phenothrin: 0.30
Tetramethrin: 0.20
Phenothrin: 0.20
Tetramethrin: 0.20
Phenothrin: 0.40
Tetramethrin: 0.25
Phenothrin: 0.15
Tetramethrin: 0.20
Phenothrin: 0.20
Tetramethrin: 0.25
Phenothrin: 0.15
No Batch
EPA Reg. No.
478-126
706-109
769-931
769-938
769-939
1021-1384
1021-1386
1021-1387
1021-1437
1021-1505
1021-1613
1021-1640
1021-1652
1021-1659
Percentage Active Ingredient
Tetramethrin: 0.2
Permethrin: 0.4
Tetramethrin: 0.200
Phenothrin: 0.125
Tetramethrin: 0.25
Phenothrin: 0.15
Tetramethrin: 0.284
Resmethrin: 0.120
Tetramethrin: 2.84
Resmethrin: 2.96
80.0
Tetramethrin: 8.9
Phenothrin: 8.9
Tetramethrin: 12.5
Phenothrin: 7.5
Tetramethrin: 8.0
Phenothrin: 16.0
Tetramethrin: 12.30
Phenothrin: 9.23
Tetramethrin: 0.20
Esfenvalerate: 0.03
Tetramethrin: 10.00
Phenothrin: 6.26
Tetramethrin: 10.01
Esfenvalerate: 1.57
Tetramethrin: 8.89
72
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1021-1856
2724-538
2724-599
4822-513
4822-514
7056-185
10807-191
73049-233
73049-255
73049-260
73049-262
73049-264
73049-265
73049-315
73049-434
Permethrin: 8.90
Tetramethrin: 0.05
Cypermethrin: 0.05
Tetramethrin: 12.0
Phenothrin: 3.83
Tetramethrin: 0.40
Phenothrin: 0.23
Butoxypolypropylene gly col : 5 1 . 92
Tetramethrin: 0.35
Permethrin: 0.10
Allethrin: 0.10
Tetramethrin: 0.3
Permethrin: 0.1
Tetramethrin: 0.2
Permethrin: 0.2
Tetramethrin: 0.2
Esfenvalerate: 0.1
Tetramethrin: 25.0
Resmethrin: 10.6
Tetramethrin: 0.250
Resmethrin: 0.106
Tetramethrin: 26.64
Resmethrin: 5.85
Tetramethrin: 0.25
Resmethrin: 0.25
Tetramethrin: 16.67
Resmethrin: 7.06
Tetramethrin: 20.84
Resmethrin: 20.84
Tetramethrin: 16.0
Resmethrin: 40.0
Tetramethrin: 10.0
Permethrin: 10.0
73
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