United States Prevention, Pesticides EPA 738-R-06-003
Environmental Protection and Toxic Substances June 2006
Agency (7508C)
Reregistration
Eligibility Decision for
Resmethrin
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REREGISTRATION ELIGIBILITY
DECISION
for
Resmethrin
List A
Case No. 0421
Approved by:
Debra Edwards, Ph.D.
Director, Special Review and
Reregistration Division
Date
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Table of Contents
Executive Summary 8
I. Introduction 15
I. Introduction 15
II. Chemical Overview 16
A. Regulatory History 16
B. Chemical Identification 17
C. Resmethrin Use Profile 17
III. Summary of Resmethrin Risk Assessments 19
A. Human Health Risk Assessment 19
1. Toxicity 19
2. Dietary Risk (Food + Water) 24
3. Acute Dietary Risk 24
4. Drinking Water Dietary Exposure and Risk 24
5. Chronic Non-Cancer Dietary Risk (Food + Water) 25
6. Cancer Dietary Risk (Food + Water) 27
7. Residential Risk 27
8. Residential Handler Risk 29
9. Residential Post-application Risk 30
10. Aggregate Risk 32
11. Cumulative Risk 34
12. Occupational Risk 34
a. Occupational Non-cancer Handler Summary 36
b. Occupational Cancer Handler Summary 36
c. Postapplication Occupational Risk 38
13. Human Incident Data 38
B. Environmental Risk Assessment 38
1. Environmental Fate and Transport 39
2. Ecological Risk 39
a. Risk to Aquatic Organisms 40
b. Risk to Terrestrial Organisms 45
3. Ecological Incidents 49
4. Endangered Species Concerns 49
IV. Risk Management, Reregistration, and Tolerance Reassessment Decision 51
A. Determination of Reregistration Eligibility and Tolerance Reassessment 51
B. Regulatory Position 51
1. Food Quality Protection Act Findings 51
2. Endocrine Disrupter Effects 52
3. Cumulative Risks 53
C. Tolerance Reassessment Summary 53
D. Regulatory Rationale 54
1. Human Health Risk 54
2. Environmental Risk 56
3. Ongoing Work on Pyrethoids 61
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V. What Registrants Need to Do 66
A. Manufacturing Use Products 66
1. Additional Generic Data Requirements 66
B. End-Use Products 67
1. Additional Product-Specific Data Requirements 67
2. Labeling for End-Use Products 67
Appendix A 81
Appendix B 83
Appendix C 93
Appendix D 95
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Resmethrin Reregistration Eligibility Decision Team
Office of Pesticide Programs
Biological and Economic Analysis Assessment
Alan Halvorson
Steve Jarboe
Timothy Kiely
Andrew Lee
Nikhil Mallampalli
Environmental Fate and Effects Risk Assessment
Michael Hoffman
Jean Holmes
Jose Melendez
Mah Shamim
Health Effects Risk Assessment
Rebecca Daiss
William Dykstra
Susan Hummel
David Jaquith
Ray Kent
Thurston Morton
Registration Support
Richard Gebken
Marion Johnson
Mark Suarez
Joseph Tavano
Risk Management
Katie Hall
Dirk Helder
Susan Jennings
Margaret Rice
Office of General Counsel
Erin Koch
United States Department of Agriculture
Teung Chin
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Glossary of Terms and Abbreviations
a.i. Active Ingredient
aPAD Acute Population Adjusted Dose
APHIS Animal and Plant Health Inspection Service
ARTF Agricultural Re-entry Task Force
BCF Bioconcentration Factor
CDC Centers for Disease Control
CDPR California Department of Pesticide Regulation
CFR Code of Federal Regulations
ChEI Cholinesterase Inhibition
CMBS Carbamate Market Basket Survey
cPAD Chronic Population Adjusted Dose
CSFII USDA Continuing Surveys for Food Intake by Individuals
CWS Community Water System
DCI Data Call-in
DEEM Dietary Exposure Evaluation Model
DL Double layer clothing {i.e., coveralls over SL}
DWLOC Drinking Water Level of Comparison
EC Emulsifiable Concentrate Formulation
EDSP Endocrine Disrupter Screening Program
EDSTAC Endocrine Disrupter Screening and Testing Advisory Committee
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an
environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
EXAMS Tier II Surface Water Computer Model
FDA Food and Drug Administration
FFDCA Federal Food, Drug, and Cosmetic Act
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FOB Functional Observation Battery
FQPA Food Quality Protection Act
FR Federal Register
GL With gloves
GPS Global Positioning System
HIARC Hazard Identification Assessment Review Committee
IDFS Incident Data System
IGR Insect Growth Regulator
IPM Integrated Pest Management
RED Reregistration Eligibility Decision
LADD Lifetime Average Daily Dose
LC50 Median Lethal Concentration. Statistically derived concentration of a substance expected
to cause death in 50% of test animals, usually expressed as the weight of substance per
weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LCO Lawn Care Operator
LD50 Median Lethal Dose. Statistically derived single dose causing death in 50% of the test
animals when administered by the route indicated (oral, dermal, inhalation), expressed as a
weight of substance per unit weight of animal, e.g., mg/kg.
LOAEC Lowest Observed Adverse Effect Concentration
LOAEL Lowest Observed Adverse Effect Level
LOG Level of Concern
LOEC Lowest Observed Effect Concentration
mg/kg/day Milligram Per Kilogram Per Day
MOE Margin of Exposure
MP Manufacturing-Use Product
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MRID Master Record Identification (number). EPA's system of recording and tracking studies
submitted.
MRL Maximum Residue Level
N/A Not Applicable
NASS National Agricultural Statistical Service
NAWQA USGS National Water Quality Assessment
NG No Gloves
NMFS National Marine Fisheries Service
NOAEC No Observed Adverse Effect Concentration
NOAEL No Observed Adverse Effect Level
NPIC National Pesticide Information Center
NR No respirator
OP Organophosphorus
OPP EPA Office of Pesticide Programs
ORETF Outdoor Residential Exposure Task Force
PAD Population Adjusted Dose
PCA Percent Crop Area
PDCI Product Specific Data Call-In
POP USDA Pesticide Data Program
PF10 Protections factor 10 respirator
PF5 Protection factor 5 respirator
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
PRZM Pesticide Root Zone Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RPA Reasonable and Prudent Alternatives
RPM Reasonable and Prudent Measures
RQ Risk Quotient
RTU (Ready-to-use)
RUP Restricted Use Pesticide
SCI-GROW Tier I Ground Water Computer Model
SF Safety Factor
SL Single layer clothing
SLN Special Local Need (Registrations Under Section 24(c) of FIFRA)
STORET Storage and Retrieval
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TRAC Tolerance Reassessment Advisory Committee
TTRS Transferable Turf Residues
UF Uncertainty Factor
USDA United States Department of Agriculture
USFWS United States Fish and Wildlife Service
USGS United States Geological Survey
WPS Worker Protection Standard
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Executive Summary
The Environmental Protection Agency (EPA or the Agency) has completed the
human health and environmental risk assessments for resmethrin and is issuing its risk
management decision and tolerance reassessment. There is currently one tolerance being
reassessed for resmethrin for use as an insecticide in food handling establishments and
storage areas. The revised risk assessments are based on the Agency's review of the
required data supporting the use patterns of currently registered resmethrin products and
additional information and comments received. After considering the risks identified in
the revised risk assessment, public comments, and mitigation suggestions from interested
parties, EPA developed its risk management decision for uses of resmethrin that pose
risks of concern. As a result, the Agency has determined that resmethrin-containing
products are eligible for reregistration provided that the risk mitigation measures outlined
in this document are adopted and labels are amended accordingly. The eligibility
decision is discussed fully in this document.
Resmethrin is a member of the pyrethroid class of pesticides and was first
registered in 1967. It is a broad spectrum, non-systemic, synthetic pyrethroid insecticide.
Resmethrin is registered for use as a wide area mosquito abatement insecticide, for use in
livestock and livestock housing, food item transportation, structures, buildings (including
food handling establishments), and for residential use to control flying and crawling
insects. Approximately 50,000 pounds of resmethrin are used annually, mostly for adult
mosquito control. Resmethrin is currently classified as a Restricted Use Pesticide for
wide area mosquito abatement.
Resmethrin is a member of the pyrethroid class of pesticides. Although all
pyrethroids alter nerve function by modifying the normal biochemistry and physiology of
nerve membrane sodium channels, EPA is not currently following a cumulative risk
approach based on a common mechanism of toxicity for the pyrethroids because there are
multiple types of sodium channels, and it is currently unknown whether all pyrethroids
have similar effects on all channels. In addition, the Agency does not have a clear
understanding of effects on key downstream neuronal function, e.g., nerve excitability,
nor do we understand how these key events interact to produce their compound-specific
patterns of neurotoxicity. There is ongoing research by both EPA's Office of Research
and Development and the pyrethroid registrants to evaluate the differential biochemical
and physiological actions of pyrethroids in mammals. This research is expected to be
completed by 2007. When the results of this research are available, the Agency will
make a determination of common mechanism of toxicity as a basis for assessing
cumulative risk. For information regarding EPA's procedures for cumulating effects
from substances found to have a common mechanism of toxicity, see EPA's website at
http ://www. epa. gov/pesticides/cumulative/.
Overall Risk Summary
The resmethrin human health risk assessment indicates low acute toxicity and no
acute dietary endpoint was identified in the studies reviewed by the Agency. The chronic
(non-cancer and cancer) dietary risks from food and drinking water sources are below the
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Agency's level of concern. Residential handler (non-cancer and cancer) risks are below
the Agency's level of concern. One residential post-application exposure scenario
slightly exceeds the Agency's level of concern (MOE=900), but this can be mitigated
with label language to reduce exposure.
All risk concerns for occupational handlers that mix, load, and/or apply
resmethrin can be mitigated with personal protective equipment (PPE).
Resmethrin poses acute risk to some aquatic species, with the most vulnerable
species being freshwater and estuarine/marine invertebrates. Terrestrial animals exposed
to resmethrin are below the Agency's level of concern; however, resmethrin does pose an
acute risk to non-target insects such as honeybees.
Dietary Risk
No acute dietary analysis was conducted for resmethrin because no acute oral
endpoint of concern attributable to a single exposure was established in dietary studies
reviewed by the Agency. Chronic (non-cancer) dietary risk from resmethrin is low and
below the Agency's level of concern. The chronic dietary assessment indicates no risks
of concern for the general population or any sub-population. Risk estimates are 2% of the
cPAD for the general population and 7% of the cPAD for children 1-2 years old, the most
highly exposed population sub-group. The drinking water exposure assessment for
resmethrin from both ground and surface water sources is also below the Agency's level
of concern.
Cancer dietary risk is below EPA's level of concern, as estimated lifetime cancer
risk for the general U.S. population is conservatively estimated at 1.6 xlO"6. The cancer
dietary assessment likely overestimates exposure from registered uses of resmethrin. The
only food use for resmethrin is in food handling establishments such as food processing
/handling plants, restaurants, commercial food item transportation, and food storage
facilities. The Agency conducted a conservative cancer risk estimate assuming that 10%
of food handling establishments are treated with resmethrin. This is likely an
overestimation of usage based on use data reviewed by the Agency. Additionally, for the
resmethrin cancer dietary assessment, the Agency assumed that the full limit of detection
(LOD) level was found for all non-residue detections in the Dietary Exposure Evaluation
Model (DEEM-FCID).
Resmethrin degrades rapidly when exposed to light (photolysis), however, when
not subject to photolysis, resmethrin tends to be more environmentally persistent.
Resmethrin has low mobility and has a high affinity to bind to soils/sediments and
organic carbon; therefore, it is not expected to leach to ground water. However, like
several other chemicals in its class, it can reach surface waters by spray drift or in run-off
events via erosion. Nonetheless, exposure from drinking water sources to resmethrin is
low. Acute, chronic, and cancer dietary risk from food and water are below the Agency's
level of concern.
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Residential Risk
Resmethrin has a wide variety of residential uses, including use on pets, indoor
and outdoor surfaces, garden crops, and residential outdoor mosquito control.
Resmethrin is also used in residential areas for wide area mosquito abatement programs
by Public Health Officials.
The Agency assessed residential handler and post-application exposure to
resmethrin. All residential handler non-cancer and cancer scenarios are below the
Agency's level of concern.
The post-application exposure assessment assumed individuals of varying ages
can potentially be exposed to resmethrin as a result of being in an area that has been
previously treated with resmethrin or have contact with treated companion animals. Most
non-cancer risks from post-application exposure to resmethrin range from 2400 to 8.5
million and are not of concern to the Agency. However, the non-cancer risk estimate for
a child exposed to an indoor aerosol space spray exceeds the Agency's level of concern
(MOE = 900). This exposure may occur when a child enters a room within 10 minutes
after a resmethrin indoor aerosol space spay application. This risk can be mitigated with
label instructions informing homeowners to keep all people and pets out of sprayed
rooms for 2 hours after application. Residential post-application cancer risk is below the
Agency's level of concern for all assessed scenarios.
Aggregate Risk
An acute aggregate assessment has not been conducted because no appropriate
endpoint attributable to a single exposure was identified in the resmethrin database. In
addition, the Agency did not conduct any non-cancer aggregate risk assessment (short-,
intermediate-, or long-term) because endpoints selected for the different routes of
exposure are not based on common toxic effects.
The aggregate cancer assessment combines lifetime estimated dietary and
residential risks. For resmethrin, aggregate dietary risk (food and drinking water) is 1.6x
10"6, and residential risk is Ix 10"6. The resulting aggregate risk estimate is 2.6x 10"6, and
thus does not exceed the Agency's level of concern. Each component of aggregate
exposure assessment (dietary, drinking water, and residential risk) is based on
conservative exposure scenarios which are greater than what people are likely to
experience. The probability of people experiencing all these high-end exposures together
and for the durations assessed by the Agency is unlikely. Nonetheless, the Agency is
requiring label changes and clarification on all homeowner product labels that will reduce
exposure.
Cumulative Risk
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Resmethrin is a member of the pyrethroid class of pesticides. Although all
pyrethroids alter nerve function by modifying the normal biochemistry and physiology of
nerve membrane sodium channels, EPA is not currently following a cumulative risk
approach based on a common mechanism of toxicity for the pyrethroids because there are
multiple types of sodium channels, and it is currently unknown whether all pyrethroids
have similar effects on all channels. In addition, the Agency does not have a clear
understanding of effects on key downstream neuronal function, e.g., nerve excitability,
nor do we understand how these key events interact to produce their compound-specific
patterns of neurotoxicity. There is ongoing research by both EPA's Office of Research
and Development and the pyrethroid registrants to evaluate the differential biochemical
and physiological actions of pyrethroids in mammals. This research is expected to be
completed by 2007. When the results of this research are available, the Agency will
make a determination of common mechanism of toxicity as a basis for assessing
cumulative risk. For information regarding EPA's procedures for cumulating effects
from substances found to have a common mechanism of toxicity, see EPA's website at
http ://www. epa. gov/pesticides/cumulative/.
FQP A Finding
EPA has determined with reasonable certainty that no harm to the general
population or any sub-population will result from exposure to resmethrin.
Occupational Risk
Occupational handler exposures were assessed with baseline attire or minimal
personal protective equipment. Non-cancer exposure and risk estimates indicate no
MOEs of concern (i.e., all MOEs are greater than 100) at the maximum use rate for all
occupational exposure scenarios assessed either at baseline or with the addition of
chemical-resistant gloves. Cancer exposure and risk estimates are also below EPA's
level of concern at the typical rate for all occupational exposure scenarios assessed when
appropriate PPE or engineering controls are considered.
Post-application exposures occur as a result of being in an environment that has
been previously treated with a pesticide. Occupational post-application scenarios were
not assessed because most worker re-entry exposure is considered unlikely, i.e.
resmethrin is not used on agricultural field crops, and worker re-entry exposures to treat
food handling establishments warehouses, and outdoor premises are not expected to
occur reoutinely for Pest Control Operators (PCOs). Also, there are few handler non-
cancer or cancer occupational scenarios of risk concern, and all handler scenarios are able
to be mitigated with minimal PPE. The only restricted-entry interval (REI) has been
established according to the Worker Protection Standard (WPS) for greenhouses at 12
hours for workers re-entering after treatment with resmethrin. For professional
applications to homes, food handling establishments or other buildings, no one will be
allowed to enter for 4 hours following an application and the area must be ventilated with
fresh air before anyone re-enters.
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Ecological Risk
EPA's screening level assessment for resmethrin indicates potential exceedences
of levels of concern (LOCs) for some classes of organisms. The scenario assessed for
ecological risk was wide area mosquito abatement sprays at maximum (0.007 Ib ai/acre)
and typical rates (0.0035 Ib ai/acre). The risk quotients, in general, are low (less than 7).
Freshwater and estuarine/marine invertebrates show the highest acute RQs of all taxa
(range from <0.05 to 6.5). The resmethrin screening level ecological risk assessment
shows no acute or chronic risk to endangered or non-endangered mammals, and shows
some risk to birds. Resmethrin does pose an acute risk to non-target insects such as
honeybees. No data were submitted to evaluate the risk of resmethrin exposure to non-
target terrestrial or aquatic plants; however, it is unlikely that resmethrin poses a
phytotoxic concern based on its neurotoxic mode of action.
Summary of Mitigation Measures
EPA has determined that the currently registered uses of resmethrin are eligible
for reregistration provided the mitigation measures outlined in this document are
implemented through label amendments. Mitigation measures include:
For Residential Exposure:
To reduce post-application exposure to adults and children:
• Resmethrin homeowner products applied as indoor aerosol space sprays must be
labeled to instruct users to keep all people and pets away from treated areas for 2
hours after application. Additionally, these products must be labeled to instruct the
user to ventilate the room for 20 minutes with fresh air before re-occupying the
treated area.
• Pest control operators (PCOs) applying indoor space sprays or fogs will be required
to inform clients that they may not re-enter the treated area for 4 hours after
application and that the client must ventilate the treated area before re-entering for 20
to 120 minutes depending on the size of the treated area.
• Manufacturing use labels must contain the following statements:
"Not for formulation into end use products for use in indoor metered spray systems."
"Not for formulation into end use products for use in outdoor misting systems."
For Occupational Exposure:
To reduce mixer, loader, handler and applicator exposure:
• All mixers, loaders, and applicators using liquid formulations of resmethrin are
required to wear gloves for dermal protection.
• Applicators using foggers in indoor spaces are required to wear a respirator for
protection against inhalation risk and coveralls over long pants and shirts for dermal
protection.
• Applicators using ready-to-use aerosol formulations are required to wear gloves for
dermal protection.
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• For products intended for wide area mosquito abatement programs, chemical-resistant
gloves are required for all mixers, loaders and handlers except applicators.
• The Agency incident report recommends appropriate protective respiratory equipment
for individuals who are likely to have substantial contact with resmethrin. Because
mosquito abatement handlers may be exposed to resmethrin on a regular basis,
enclosed cabs are required for ULV truck-mounted mosquito abatement spray
applications, and enclosed cockpits are required for ULV aerial mosquito abatement
spray applications.
• A 12-hour restricted entry interval (REI) is required for workers re-entering treated
greenhouses after resmethrin applications. In addition, the greenhouse must be
ventilated with fresh air prior to re-entry.
For Ecological Exposure:
To reduce ecological exposure:
• Products labeled for wide area mosquito abatement must state a maximum application
rate of 0.007 Ib ai/acre, and state a maximum yearly application limit of 0.2 Ib ai/acre.
• Release height requirement for rotary wing of no less than 75 feet above the ground
or canopy, for fixed wing of no less than 100 feet above the ground or canopy.
• Environmental hazard statements informing user of toxicity to fish, aquatic
invertebrates, and oysters/shrimp.
• Statement informing user of toxicity to bees visiting treated area.
Previously, resmethrin labels often did not specify label rates. The rates below will serve
as maximum application rates for registered resmethrin products.
• Products labeled for use on Livestock, Farm Animals, and Pets (Direct Application):
Product must contain 0.35% ai. or less.
• Products labeled for use in Outdoor Sites (Commercial, Recreational, Domestic
Outdoor Sites, Agricultural Structures, Agricultural Premises, and Agricultural
Equipment): 0.25 Ib ai per acre.
• Products labeled for use in Space Applications (Indoor Food
Handling/Processing/Eating Establishments; Commercial Structure Premises and
Equipment; Domestic Structure Premises and Equipment): 0.001 Ib ai per 1000 ft2.
• Products labeled for use in Surface Crack and Crevice Application (Indoor Food
Handling/Processing/Eating Establishments; Commercial Structure Premises and
Equipment; Domestic Structure Premises and Equipment): 0.242 Ib ai per 1000 ft2.
Stewardship Language
• To lessen potential risks to aquatic organisms from resmethrin use around the home,
the Agency is requiring directions for use on both professional and consumer-use
products for use in residential settings. These use directions include best
management and stewardship practices which are formulation specific and will serve
to reduce the potential run-off and drift that can occur from applications of these
products.
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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 EPA review of all
submitted data. 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" criteria of
FIFRA.
On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed
into law. This Act amends FIFRA to require reassessment of all tolerances in effect on
the day before it was enacted. In reassessing these tolerances, the Agency must consider,
among other things, aggregate risks from non-occupational sources of pesticide exposure,
whether there is increased susceptibility among infants and children, and the cumulative
effects of pesticides that have a common mechanism of toxicity. When the Agency
determines that aggregate risks are not of concern and concludes that there is a reasonable
certainty of no harm from aggregate exposure, the tolerances are considered reassessed.
EPA decided that, for those chemicals that have tolerances and are undergoing
reregistration, tolerance reassessment will be accomplished through the reregistration
process.
Resmethrin is a member of the pyrethroid class of pesticides. Although all
pyrethroids alter nerve function by modifying the normal biochemistry and physiology of
nerve membrane sodium channels, EPA is not currently following a cumulative risk
approach based on a common mechanism of toxicity for the pyrethroids because there are
multiple types of sodium channels, and it is currently unknown whether all pyrethroids
have similar effects on all channels. In addition, the Agency does not have a clear
understanding of effects on key downstream neuronal function, e.g., nerve excitability,
nor do we understand how these key events interact to produce their compound-specific
patterns of neurotoxicity. There is ongoing research by both EPA's Office of Research
and Development and the pyrethroid registrants to evaluate the differential biochemical
and physiological actions of pyrethroids in mammals. This research is expected to be
completed by 2007. When the results of this research are available, the Agency will
make a determination of common mechanism of toxicity as a basis for assessing
cumulative risk. For information regarding EPA's procedures for cumulating effects
from substances found to have a common mechanism of toxicity, see EPA's website at
http ://www. epa. gov/pesticides/cumulative/.
The Agency made its reregistration eligibility determination (RED) based on the
required data, the current guidelines for conducting acceptable studies to generate such
data, and published scientific literature. The Agency has found that currently registered
uses of resmethrin are eligible for reregistration provided the mitigation and labeling
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outlined in the RED are implemented. The document consists of six sections: Section I,
the introduction, contains the regulatory framework for reregistration/tolerance
reassessment; Section II provides an overview of the chemical, including 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 reregistration eligibility,
tolerance reassessment, and risk management decisions; Section V summarizes label
changes necessary to implement the risk mitigation measures outlined in Section IV; and
Section VI includes the appendices, related supporting documents and Data Call-In (DCI)
information. The revised risk assessment documents and related addenda are not included
in this document, but are available on the Agency's web page
http://www.epa.gov/pesticides, and in the Public Docket under docket number EPA-HQ-
OPP-2005-0284.
II. Chemical Overview
A. Regulatory History
Two chemicals are included in the resmethrin case, resmethrin and bioresmethrin,
as listed below in Table 1. Resmethrin was first registered in the U.S. in 1967.
Bioresmethrin was initially registered in the U.S. in 1973. Resmethrin and bioresmethrin
are in the same chemical case because of their similar chemical structures and use
patterns. The Registration Standard and associated data call-ins (DCIs) were issued for
these two chemicals in December of 1988. Resmethrin is classified as a General Use
Pesticide for all uses except for the ultra-low volume (ULV) mosquito control use. The
resmethrin ULV spray for mosquito control is classified as a Restricted Use Pesticide due
to acute aquatic organism toxicity.
Another DCI was issued for resmethrin in October 1995 that required a foliar
dissipation study and dermal and inhalation passive dosimetry exposure studies for
resmethrin and bioresmethrin. This RED reflects a reassessment of all the data reviewed
to date on resmethrin. As of October 28, 2005, registrants of all products containing
bioresmethrin have requested voluntary cancellation, and therefore products containing
bioresmethrin were not included in any risk assessments.
TABLE 1. Ingredients in Resmethrin Chemical Case (0421)
PC Code
097801
097802
Chemical Name
Resmethrin
Bioresmethrin
CAS Number
10453-86-8
28434-01-7
Status
Dietary and non-dietary uses being reregistered.
Since all bioresmethrin products have been
proposed for voluntary cancellation and no
bioresmethrin products are currently sold in the
U.S., bioresmethrin was not assessed. Because
it is expected that no registrations for
bioresmethrin will remain, bioresmethrin will
not be reregistered.
There are currently two manufacturing-use product registrants, Valent BioScience
and Bayer Environmental Science. Valent BioScience supports the household and
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commercial uses of resmethrin, and Bayer Environmental Science supports the mosquito
adulticide use.
B. Chemical Identification
TABLE 2. Resmethrin Nomenclature
PC Code 097801 Resmethrin
Chemical structure
Common name
Molecular Formula
Molecular Weight
IUPAC name
CAS name
CAS#
H3C 0, Q
V°^>
H3C/XCH3 ^0
"0
Resmethrin
C22H2603
338.45
5-benzyl-3-furylmethyl(1^5',3^5';1^5',3SR)-2,2-dimethyl-3-(2-methylprop-
1-enyl)- cyclopropanecarboxylate
or
5-benzyl-3 -furylmethyl ( 1^5)-c/5-/ran5-2,2-dimethyl-3 -(2-methylprop- 1 -
enyl)- cyclopropanecarboxylate
or
5 -benzyl-3 -furylmethyl (±)-c/5-/ran5-chrysanthemate
[5-(phenylmethyl)-3-furanyl]methyl 2,2-dimethyl-3 -(2 -methyl- 1-propenyl)-
cyclopropanecarboxylate
10453-86-8
C. Resmethrin Use Profile
Type of Pesticide:
Summary of Use:
Use sites:
Insecticide
Resmethrin is a synthetic Type I pyrethroid insecticide registered
for control of insects in residential, commercial and industrial
settings, and in animal living areas. Resmethrin is also registered
for use in food handling establishments and as a restricted use
pesticide when used in ULV spray to control adult mosquitoes in
the interest of public health.
Food uses include crack and crevice spray and enclosed space fog
in food handling establishments such as food processing/handling
plants, restaurants, commercial food item transportation, and food
storage facilities. There are no agricultural uses registered for
resmethrin.
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Non-food uses include animal kennel and sleeping quarters;
commercial warehouses; indoor and outdoor use in commercial,
institutional, and industrial premises; hospitals; indoor and outdoor
use in domestic dwellings; and application to ornamental plants.
Public health uses include wide area treatments for mosquito
control as an ultra-low volume (ULV) liquid spray.
Target Organisms: Resmethrin is used to control a broad spectrum of flying and
crawling insects.
Mode of Action:
Tolerances:
Resmethrin works by interacting with sodium channels in the
peripheral and central nervous system of target organisms.
There is currently one tolerance established for resmethrin under
40 CFR 180.525. The tolerance is established at 3.0 parts per
million (ppm) for use of resmethrin as an insecticide in food
handling and storage areas as a space spray, spot treatment, or
crack and crevice treatment.
The Agency is not proposing any new tolerances.
Use Classification: Commercial and residential use: General Use Pesticide
Formulations:
Public health mosquito abatement use: Restricted Use Pesticide
Resmethrin is formulated as ready-to-use pressurized liquid spray,
emulsifiable concentrate, and soluble concentrate.
Methods of Application:
Use rates:
Equipment: Applications are made with hand held
equipment such as ready-to-use spray containers, aerosol
cans, thermal fog generators, electric foggers, backpack
sprayers, and hand held sprayers. Applications are also
made with aircraft and ground equipment such as truck-
mounted sprayers.
Application Methods: Application methods include aerial
and truck-mounted ULV sprays, animal shampoos and
sprays, ready-to-use spray, and other sprays using hand-
held application equipment.
Maximum single application rates range from 0.007 pound active
ingredient per acre (Ib./a.i./A) for mosquito control to 0.25
Ib./a.i./A for outdoor commercial, recreational, and domestic sites,
and agricultural/farm structures. The maximum indoor crack and
crevice application rate is 0.242 lb./a,i./1000 feet squared (ft2), and
18
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the maximum enclosed area space application is 0.001 Ib./a.i./lOOO
ft3.
There are currently no limits on the number of applications per
year for any use site.
Application Timing: Resmethrin products used indoors may be applied at any time of
the year. Outdoor products are generally applied during warmer
months of the year when nuisance flying and crawling insects are
active. Resmethrin mosquito abatement products are applied when
adult mosquitoes are active or when mosquito borne diseases are a
concern.
Annual usage: An estimated 50,000 pounds of resmethrin are used annually. The
majority of resmethrin is used for adult mosquito control.
Resmethrin is also used by homeowners for indoor and outdoor
insect control, by pest control operators for insect control, by
industrial and commercial service personnel for crack and crevice
treatment, and for insect control on pets.
Technical registrants: Valent BioSciences and Bayer Environmental Science
III. Summary of Resmethrin Risk Assessments
The following is a summary of EPA's human health and environmental fate and
effects findings and conclusions for resmethrin as presented fully in the documents,
"Resmethrin HED Revised Risk Assessment for Reregistration Eligibility Document
(RED) PC Code 097801; DP Barcode No. 326088," revised per comments received
during the 60-day public comment period, dated February 23, 2006, and "EFED RED
Chapter for Resmethrin, Revision Phase 3; DP Barcode No. D326094;" revised per
comments received during the 60-day public comment period and dated March 8, 2006.
A. Human Health Risk Assessment
The Agency has conducted a human health risk assessment for resmethrin for the
purposes of making a reregistration eligibility decision. The Agency evaluated the
toxicology, product and residue chemistry, and occupational/residential exposure studies
and determined that the data are adequate to support a reregistration decision. Details of
the risk assessments and separate supporting disciplinary documents are available in the
electronic docket. A summary of the human health risk assessment findings and
conclusions are provided below.
1. Toxicity
(For a complete discussion, see Section 4.0 of the human health risk assessment.)
19
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The toxicological database for resmethrin is considered adequate to characterize
potential hazards and for FQPA determination. Resmethrin has low acute toxicity via the
oral, dermal, and inhalation routes of exposure. It is not an eye or skin irritant nor is it a
skin sensitizer. Table 3 below shows the acute toxicity profile for resmethrin.
Table 3. Acute Toxicity Profile - Resmethrin
Guideline
No.
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
Study Type
Acute oral [rat]
Acute dermal [rabbit]
Acute inhalation [rat]
Acute eye irritation [rabbit]
Acute dermal irritation [rabbit]
Skin sensitization [guinea pig]
MRID(s)
42076201
42076202
42153701
42076203
42076204
42153702
Results
LD50 = 6091mg/kg (m) 4639 mg/kg(l)
LD50>2000 mg/kg
LC50 = 5.28 mg/L
PIS = 2.3 at 1 hr. only
PIS = 0.0
Negative - Buehler
Toxicity
Category
III
III
IV
IV
IV
No
Subchronic and Chronic Effects
Liver toxicity is the most sensitive endpoint following resmethrin subchronic and
chronic exposure by the oral route. The liver effects include increased weight,
hepatocellular vacuolization and hypertrophy at higher doses, and increased enzymes. A
subchronic oral study in the rat demonstrated histopathological liver toxicity and a range-
finding study in the mouse showed increased hepatic vacuolization and liver enlargement.
A subchronic oral dog study revealed slightly increased liver weight that was not
associated with microscopic changes or clinical pathology. The chronic oral gavage dog
study showed decreased body weight gain and food consumption in both sexes, cataract
development in male dogs, and increased liver weight in both sexes of dogs. The two-
year oral study in mice indicates slight increases in mortality, and the two-year rat oral
toxicity study indicates slight decreases in body weight in females and anemia in males.
Evidence of Neurotoxicity
Resmethrin elicits adverse neurotoxic effects by interacting with sodium channels
in the peripheral and central nervous system of target organisms. Neurotoxic effects,
such as tremors, nasal discharge, blanching of the feet, and tear-shedding, were observed
in two non-guideline modified neurotoxicity screening batteries in rats.
Dermal and Inhalation Toxicity
No systemic effects were observed in a three-week dermal toxicity study in
rabbits. A subchronic rat inhalation study produced behavioral effects (sneezing, agitated
grooming), decrease in body weight for females, and decrease in glucose levels in males
at the lowest dose tested.
Developmental Toxicity
20
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In an oral rat developmental study, both maternal and developmental effects were
observed, including decreased maternal body weight and maternal food consumption and
delayed ossification and decreased fetal body weight in rat fetuses.
There are two rabbit developmental studies for resmethrin. In a 1979 rabbit
study, no maternal toxicity was observed at any dose level; however, developmental
toxicity was observed. Effects included increased incidence of fused sternebrae and extra
sternebrae. In the more recent (1991) rabbit developmental study, maternal toxicity
(decreased body weight gain) was observed at the low dose and developmental toxicity at
the high dose. The more recent rabbit developmental study replaces the older study.
Reproductive Toxicity
Two rat reproduction studies were used to determine the chronic dietary endpoint.
Reproductive effects, such as increased mortality, decreased survival in pups, decreased
pup birth weight and lactation weight, and increased incidence of stillborn pups, were
observed in a two-generation rat reproduction study. A three-generation rat reproduction
study is considered co-critical for the chronic dietary endpoint with effects of mortality
and decreased pup body weight.
FQPA Safety Factor
Resmethrin did not demonstrate qualitative or quantitative evidence of increased
susceptibility in the rat developmental study or the two-generation or three-generation rat
reproduction studies, and there is a low degree of concern for residual uncertainties for
pre- or postnatal susceptibility. In rat developmental and reproduction studies, maternal
or parental effects occurred at the same doses at which the fetal or offspring effects were
found to occur. Additionally, there was no increase in severity of the fetal or offspring
effects in comparison to the parental effects. In contrast, resmethrin did display increased
quantitative susceptibility in the 1979 rabbit developmental study since developmental
effects occurred in the absence of the maternal toxicity at the same dose level. The
endpoint selected is protective of developmental effects.
The 10X FQPA Safety Factor was retained in addition to the conventional
uncertainty factor of lOOx (lOx for interspecies variability and lOx for intraspecies
variability), due to database uncertainty (the absence of subchronic and developmental
neurotoxicity studies). The Agency is requiring a developmental neurotoxicity study at
this time for the following reasons: the toxicology data base for resmethrin lacks a
guideline acute and 13-week neurotoxicity study in rats; resmethrin is a member of the
class of synthetic pyrethroids, which are neurotoxic chemicals; and there is evidence of
quantitative increases in susceptibility in a rabbit developmental study.
Dermal Absorption
21
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A dermal absorption estimate of 2.0% was selected based in part on a recent
dermal absorption study for pyrethrins (2004) in humans that indicated 0.22% dermal
absorption. This study was further corroborated by other human dermal estimates with
cypermethrin showing dermal absorption of 0.3-1.8%. EPA's use of human dermal
absorption studies in the resmethrin risk assessment is in accordance with the Agency's
Final Rule promulgated on January 26, 2006, related to Protections for Subjects in
Human Research, which is codified in 40 CFR Part 26.
Carcinogenic Potential
(For more information on the classification of carcinogenic potential, see section
4.4.9 of the human health risk assessment.)
Resmethrin was classified as "Likely to be Carcinogenic to Humans" by the
Cancer Assessment Review Committee (CARC) of the Office of Pesticide Programs in
March 2005. This classification is based on increased incidences of benign and
malignant liver tumors in female rats and male mice. A low-dose extrapolation approach
was applied to the experimental animal data in order to estimate human cancer risk. The
unit risk, Q*i (mg/kg/day)"1 of resmethrin based upon male mouse liver combined
adenoma and/or carcinoma tumor rates is 5.621 x 10"2 in human equivalents.
Mutagenicity
Resmethrin is not mutagenic, as demonstrated in the Ames assay, in vitro
chromosome aberration assay in Chinese hamster ovary cells, and the unscheduled DNA
synthesis (UDS) assay in rat hepatocytes.
Endocrine Disruptor Effects
EPA is required under the FFDCA, as amended by FQPA, to develop a screening
program to determine whether certain substances (including all pesticide active and other
ingredients) "may have an effect in humans that is similar to an effect produced by a
naturally occurring estrogen, or other endocrine effects as the Administrator may
designate." Following recommendations of its Endocrine Disruptor Screening and
Testing Advisory Committee (EDSTAC), EPA determined that there was a scientific
basis for including, as part of the program, the androgen and thyroid hormone systems, in
addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation
that EPA include evaluations of potential effects in wildlife. For pesticides, EPA will use
FIFRA and, to the extent that effects in wildlife may help determine whether a substance
may have an effect in humans, FFDCA authority to require the wildlife evaluations. As
the science develops and resources allow, screening of additional hormone systems may
be added to the Endocrine Disruptor Screening Program (EDSP). In the available toxicity
studies for resmethrin submitted for registration purposes, there was no estrogen,
androgen, and/or thyroid mediated toxicity. When the appropriate screening and/or
testing protocols being considered under the EDSP have been developed, resmethrin may
be subject to additional screening and/or testing.
22
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A summary of the resmethrin studies reviewed for risk assessment are available in
section 4.0 of the human health risk assessment. A summary of the endpoints selected
for risk assessment is presented in Table 4 below.
Table 4. Summary of Toxicological Doses and Endpoints for Resmethrin for Use in Human Risk Assessments
Exposure
Scenario
Acute Dietary
(all population)
Chronic Dietary
(all populations)
(MRID)
Incidental Oral Short-,
Intermediate-Term
Dermal
Short-, Intermediate-, and
Long- Term
Inhalation
Short-, Intermediate-, and
Long- Term
Dose Used in Risk
Assessment, UF
FQPA SF* and Level
of Concern for Risk
Assessment
Study and Toxicological Effects
No endpoint of concern
Dose for risk
assessment = 35
mg/kg/day
UF = 1000
(10 for intraspecies
variation, 10 for
interspecies
extrapolation, and
FQPA 10 for
database
uncertainty)
Chronic RfD =
0.035 mg/kg/day
Maternal toxicity
NOAEL = 40
mg/kg/day
Oral Developmental
NOAEL = 30
mg/kg/day
(dermal absorption
rate = 2%)
Inhalation LOAEL
= 0.1mg/L(28.2
mg/kg/day)
FQPA SF = 10
cPAD = 0.035
mg/kg/day
[The FQPA safety
factor is retained due to
database uncertainty
and is included in the
calculation of the
RfD.]
Residential LOC for
MOE = 1000
[The FQPA safety
factor is retained due to
database uncertainty.]
Occupational LOC for
MOE = NA
Residential LOC for
MOE = 1000
[The FQPA safety
factor is retained due to
database uncertainty.]
Occupational LOC for
MOE = 100
Residential LOC for
MOE = 1000
[The FQPA safety
factor is retained due to
database uncertainty.]
Occupational LOC for
MOE = 100
2-Generation Reproduction Study - rat
Reproductive/Offspring LOAEL = 70.8
mg/kg/day based on decreased mating index in
males and females during the second Fl mating,
decreased viability index and decreased pup
weight in all generations at birth and during
lactation, and possible slight increase in
stillborn pups in the Fla and F2a generations. 3-
generation reproduction study is co-critical -
LOAEL = 47 mg/kg/day
Rat Developmental Toxicity Study
Maternal LOAEL = 80 mg/kg/day based on
reduced weight gain and reduced food
consumption during gestation
Oral Rabbit Developmental Toxicity Study
Developmental LOAEL = 100 mg/kg/day based
on increased incidence of skeletal variations and
a possible marginal increase in resorbed litters
in the absence of maternal toxicity
90-Day Inhalation Toxicity Study
Inhalation LOAEL = 0. 1 mg/L (28.2
mg/kg/day) based on clinical signs within the
first month, decreased glucose levels in males, a
decrease (-13%) in body weight gain during
weeks 1-4 and an increase in BUN (32%) at
week 12 in females.
23
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Table 4. Summary of Toxicological Doses and Endpoints for Resmethrin for Use in Human Risk Assessments
Exposure
Scenario
Cancer (oral, dermal,
inhalation)
Dose Used in Risk
Assessment, UF
FQPA SF* and Level
of Concern for Risk
Assessment
Study and Toxicological Effects
Classification: The CARC (4/13/05) classified resmethrin as "likely to be carcinogenic to
humans" and recommended a low-dose linear extrapolation Ql* for resmethrin. Oral Ql* =5.621
x 10~2 in human equivalents based upon male mouse liver combined adenoma and/or carcinoma
tumor rates
UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL
= lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c = chronic) RiD = reference dose,
MOE = margin of exposure, LOG = level of concern, NA = Not Applicable
2. Dietary Risk (Food + Water)
(For a complete discussion, see Section 6.0 of the human health risk assessment.)
Dietary risk assessment incorporates both exposure to and toxicity of a given
pesticide. The risk is expressed as a percentage of a maximum acceptable dose (i.e., the
dose which will result in no unreasonable adverse health effects). This dose is referred to
as the population adjusted dose (PAD). The PAD is equivalent to the Reference Dose
(RfD) divided by the FQPA Safety Factor. EPA is concerned when estimated dietary risk
exceeds 100% of the PAD.
3. Acute Dietary Risk
No acute dietary analysis was completed because no acute oral endpoint of
concern attributable to a single exposure was established in acute dietary studies.
4. Drinking Water Dietary Exposure and Risk
(For a complete discussion, see section 6.2 of the human health risk assessment)
Drinking water exposure to pesticides can occur through groundwater and surface
water contamination. EPA considers both acute (one day) and chronic (lifetime) drinking
water risks and uses either modeling or actual monitoring data, if available, to estimate
those risks. Modeling is carried out in tiers of increasing refinement, but is designed to
provide high-end estimates of exposure.
The drinking water assessment for resmethrin considers contribution from
resmethrin alone. Since no monitoring data were available for resmethrin, estimated
drinking water concentrations (EDWCs) were calculated from models. The EDWCs
were incorporated directly into the chronic and cancer aggregate dietary exposure
assessment. The EDWCs were based on application methods, rates, and use sites that
would likely yield the highest drinking water concentrations.
24
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The most important environmental route of dissipation for resmethrin is
photodegradation. The aqueous photolysis half-life for resmethrin is 22 minutes in
seawater and 47 minutes in distilled water. Resmethrin is generally slow to biodegrade in
the environment under aerobic and anaerobic conditions; half-lives are 198 days for
aerobic soil metabolism, 37 days for aerobic aquatic metabolism, and 682 days for
anaerobic soil metabolism. Hydrolysis occurs slowly at a range of pH values (half-life
>89 days at pHs 5-9). Resmethrin has relatively low mobility in soils and may be
expected to adsorb to suspended solids, organic matter, and sediment (Koc range 508-
3179). Like other pyrethroids, it appears to have a low potential to reach groundwaters,
but it may reach bodies of waters adjacent to the treated areas via runoff events
accompanies by erosion. Volatilization is not expected to be an important transport
process for resmethrin due to its low vapor pressure and Henry's Law constant.
Surface water - Tier II EDWCs were calculated using Pesticide Root Zone Model
(PRZM) v 3.12 beta and Exposure Analysis Modeling System (EXAMS) v 2.98.04.02.
As shown in Table 5 below, the Agency calculated a chronic EDWC in surface water of
0.13 ppb, based on the annual average surface water estimate using the PRZM Florida
turf scenario. Resmethrin is not used as a turf application, but this scenario was used to
conservatively estimate residues when resmethrin is used as a mosquito adulticide over
parks, golf courses, and other grassy areas without a canopy.
Ground water - Tier I EDWCs for ground water were calculated using the Screening
Concentration in Ground Water (SCI-GROW) model. The Agency calculated a chronic
EDWC in ground water of 0.016 ppb.
Monitoring Data - No monitoring data for resmethrin were found in searches of the
United States Geological Survey (USGS) National Water Quality Assessment Program
(NAWQA) database or the EPA Storage and Retrieval (STORET) database.
Results of a relatively limited monitoring study are available for resmethrin in Suffolk
County, New York, before and after mosquito spraying in 2002-2004. The maximum
concentration of resmethrin was 0.291 ppb. This concentration is in the range of values
predicted for the most conservative scenario.
Table 5. Estimated Drinking Water Concentrations (EDWCs) for Resmethrin
Duration of Exposure
Surface Water EDWCs
Ground Water EDWCs
Chronic
0.13 ppb
0.016 ppb
5. Chronic Non-Cancer Dietary Risk (Food + Water)
The chronic endpoint for all populations is based on a two-generation rat oral
study in which reproductive effects such as decreased survival in pups, decreased pup
birth weight and lactation weight, and increased incidence of stillborn pups, were
observed at the LOAEL of 70.8 mg/kg/day. The NOAEL was 35 mg/kg/day. A total
uncertainty factor of 1000X was applied for the chronic dietary assessment, incorporating
10X for interspecies extrapolation, 10X for intraspecies variability and a 10X FQPA
25
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safety factor for database uncertainty. The chronic population adjusted dose (cPAD) was
calculated to be 35 mg/kg/day divided by a safety factor of 1000 = 0.035 mg/kg/day.
Resmethrin residues may remain in or on food items, resulting from its use in
food handling areas and storage areas as a space treatment, spot application, or crack and
crevice treatment. Resmethrin is not applied to agricultural food crops so separate
tolerances for residues in or on specific plant or animal commodities do not exist. There
is only one tolerance established for resmethrin in 40 CFR 180.525 set at 3.0 ppm for
residues of resmethrin in or on food items resulting from its use in food handling and
storage areas. The chronic dietary exposure assessments for resmethrin were based on
data from a residue study conducted with a crack and crevice spray in food handling
establishments. Data pertaining to the nature and magnitude of resmethrin residue in or
on food items resulting from the currently registered use in food handling establishments
have been evaluated and deemed adequate by the Agency. The chronic dietary risk
assessments were conducted using the Dietary Exposure Evaluation Model (DEEM
FCID, Version 2.03).
Residue data from a study on the magnitude of the residues in foods from
application of resmethrin in food handling establishments as a crack and crevice
treatment was used for dietary analysis. Data on percent of food handling establishments
treated was conservatively estimated at 10% of all food handling establishments
nationwide based on registrant-submitted data. DEEM default processing factors were
used. An EDWC point estimate value for drinking water contribution to exposure was
used. The surface annual average EDWC was 0.13 ppb using a Tier 2 aquatic model
PRZM-EXAMS. The groundwater annual average EDWC was 0.016 ppb.
Estimated exposure to resmethrin from food and drinking water is below the
Agency's level of concern for all population subgroups at 2% of the cPAD for the U.S.
population and 7% of the cPAD for children 1-2 years old, which is the subgroup with
the highest estimated exposure.
Table 6. Resmethrin Chronic Dietary and Drinking Water Exposure Estimate and Percent of
Chronic PAD
Population Subgroup
General U.S. Population
Children 1-2 years old
cPAD (mg/kg/day)
0.035
0.035
Exposure (mg/kg/day)
0.000736
0.002463
% cPAD
2
7
The resmethrin dietary exposure assessment overestimates the use of resmethrin
due to several factors. The Agency assumes that 10% of food handling establishments
are treated with resmethrin. The Agency believes this is an overestimate of resmethrin
use in food handling establishments because, according to a proprietary survey of food
handling establishments, less than 10% of food handling establishments are expected to
be treated with resmethrin. A study on the magnitude of the residues in foods was used
for the resmethrin dietary assessment (MRID 41239901). In this study a single
application of a 0.25% ai ready-to-use resmethrin product was applied to representative
food handling establishments as a crack and crevice treatment. Of the 226 food samples
26
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analyzed, detectable residues of resmethrin (greater than 0.003 ppm) were found in or on
only 15 samples of food. An upper-bound residue of 0.38 ppm (the highest detect in a
non-tissue commodity) was used for all commodities in DEEM-FCID except meat,
poultry and eggs. For meat, poultry and eggs, 0.125 ppm was used since this was the
highest detect in a tissue commodity. Because the highest detected residue was assumed
for all commodities despite residues found in only 15 of 226 samples, these residue
estimates likely overestimate the resmethrin residues found on food commodities.
6. Cancer Dietary Risk (Food + Water)
The cancer dietary risk assessment was conducted using the Dietary Exposure
Evaluation Model (DEEM FCID, Version 2.03). The resmethrin dietary and drinking
water cancer risk assessment was slightly refined using residue data from a study on the
magnitude of the residues in foods from application of resmethrin to food handling
establishments as a crack and crevice treatment. In this study a single application of a
0.25% ai ready-to-use resmethrin product was applied to representative food handling
establishments as a crack and crevice treatment. A residue of 0.01 ppm , the average of
all detected residues in food in the study mentioned above, was used for all commodities
except water in the cancer dietary exposure analysis. An EDWC (residue level) of 0.13
ppb was used for water in the cancer dietary exposure analysis (for surface water analysis
the PRZM Florida turf scenario was used because it yields a high-end residue value).
The results of the cancer analysis indicate the estimated dietary and drinking water cancer
risk associated with the resmethrin uses do not exceed EPA's level of concern, as
estimated excess lifetime cancer risk for the general U.S. population was 1.6 x 10"6, as
shown in Table 7 below.
TABLE 7. Resmethrin Cancer Dietary and Drinking Water Exposure/Risk Estimate
Population Subgroup
General U.S. Population
Ql*
0.05621
Exposure (mg/kg/day)
0.000028
Cancer Risk
1.6xlO"6
The cancer dietary assessment overestimates the likely risks from use of
resmethrin. The only food use for resmethrin is use in food handling establishments such
as food processing/handling plants, restaurants, commercial food item transportation, and
food storage facilities. The cancer risk estimate assumes that 10% of all food handling
establishments are treated with resmethrin. The assumption is an overestimation of
exposure according to a proprietary survey food handling establishments use of
pesticides. Additionally, in the resmethrin cancer dietary assessment, the Agency
assumed that the full limit of detection (LOD) level was found for all non-residue
detections in the Dietary Exposure Evaluation Model (DEMM-FCID). In the past the
Agency has used 1A of the LOD value for all non-residue detections when calculating
dietary risk. In using the full LOD, the Agency has conservatively estimated dietary risk.
Additional data may allow refinement of this estimate. Cancer dietary and drinking water
risk from resmethrin is not of concern to the Agency.
7. Residential Risk
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(For a complete discussion, see section 7.0 of the human health risk assessment.)
Residential handlers can be exposed to a pesticide while mixing, loading, or
applying (handling) a pesticide, or after entering areas where the pesticide had previously
been applied by a professional applicator of public health official. Residential non-
cancer risks are measured by a margin of exposure (MOE), which determines how close
the residential exposure comes to a no observed adverse effect level (NOAEL) taken
from animal studies. For resmethrin residential exposures, a MOE of 1000 is considered
protective for inhalation, dermal, and incidental oral residential exposure and risk. The
MOE includes a lOx for interspecies extrapolation, a lOx for intraspecies variation, and a
lOx FQPA safety factor for database uncertainty due to missing toxicology studies.
The Agency calculates the residential risks with the assumption that the
residential handler wears shoes, socks, short-sleeved shirt, and shorts. For non-cancer
risk, both short- and intermediate-term exposures were assessed for residential handlers
and residential post-application exposures based on use and exposure patterns of
registered resmethrin products. Inhalation, dermal, and incidental ingestion were
considered to be the routes of exposure for citizens exposed to resmethrin. Maximum
labeled rates were used for the non-cancer residential handler and non-cancer residential
post-application risk assessments.
Residential cancer risks are estimated by calculating the probability that an
exposed person may develop cancer. Cancer risk estimates below Ix 10"6 are generally
below the Agency LOCs. However, given the many conservative assumptions in its low
dose, linear extrapolation cancer model, the Agency generally considers risks up to 3x
10"6 to be within the negligible risk range, and therefore below the level of concern. For
the residential space spray application exposure scenario, the Agency assumed that a
private citizen can be exposed to a pesticide throughout their lifetime (70 years) via non-
handler exposure, or 50 years for handler exposure (mixing, loading, or applying a
pesticide). The exposure frequency used for the resmethrin residential handler cancer
risk assessment was assumed to be 3 days per year at average or typical application rates
for resmethrin. Inhalation and dermal exposure were considered to be the routes of
exposure for the cancer risk assessment for residential handlers exposed to resmethrin.
The endpoints selected for residential uses of resmethrin for non-cancer and
cancer risk assessment are presented in Table 8 below.
Table 8. Summary of Toxicological Doses and Endpoints for Resmethrin for Use in the Residential and Occupational
Risk Assessments
Exposure
Scenario
Dose Used in Risk
Assessment
Level of Concern for
Risk Assessment
Study and Toxicological Effects
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Table 8. Summary of Toxicological Doses and Endpoints for Resmethrin for Use in the Residential and Occupational
Risk Assessments
Exposure
Scenario
Dose Used in Risk
Assessment
Level of Concern for
Risk Assessment
Study and Toxicological Effects
Incidental Oral Short-,
Intermediate-Term
Maternal toxicity
NOAEL = 40
mg/kg/day
Residential LOC for
MOE = 1000
(LOC for residential
exposures includes an
FQPA safety factor of
10 due to database
uncertainty)
Occupational = NA
Rat Developmental Toxicity Study
Maternal LOAEL = 80 mg/kg/day based on
reduced weight gain and reduced food
consumption during gestation
Dermal
Short-, Intermediate-, and
Long- Term
Oral Developmental
NOAEL = 30
mg/kg/day
(dermal absorption
rate = 2%)
Residential LOC for
MOE = 1000
(LOC for residential
exposures includes an
FQPA safety factor of
10 due to database
uncertainty)
Occupational LOC for
MOE = 100
Oral Rabbit Developmental Toxicity Study
Developmental LOAEL = 100 mg/kg/day based
on increased incidence of skeletal variations and
a possible marginal increase in resorbed litters
in the absence of maternal toxicity
Inhalation
Short-, Intermediate-, and
Long- Term
Inhalation LOAEL
= 0.1mg/L(28.2
mg/kg/day)
Residential LOC for
MOE = 1000
(LOC for residential
exposures includes an
FQPA safety factor of
10 due to database
uncertainty)
Occupational LOC for
MOE = 100
90-Day Inhalation Toxicity Study
Inhalation LOAEL = 0.1 mg/L (28.2
mg/kg/day) based on clinical signs within the
first month, decreased glucose levels in males, a
decrease (-13%) in body weight gain during
weeks 1-4 and an increase in BUN (32%) at
week 12 in females.
Cancer (oral, dermal,
inhalation)
Classification: The Agency classified resmethrin as "likely to be carcinogenic to humans" and
recommended a low-dose linear extrapolation of a Ql* for resmethrin. Oral Q* =5.621 x 10"2 in
human equivalents based upon male mouse liver combined adenoma and/or carcinoma tumor rates
NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, RiD = reference dose,
MOE = margin of exposure, LOC = level of concern, NA = Not Applicable
8. Residential Handler Risk
(For a complete discussion, see 7.2 of the human health risk assessment.)
The residential handler assessment considered both dermal and inhalation
exposures for adults applying resmethrin in outdoor areas with a hand held fogger and
low pressure hand wand, and in indoor areas applying resmethrin as an aerosol spray.
The exposure duration considered for non-cancer risk assessment was short- and
intermediate-term based on resmethrin use and exposure patterns. For cancer risk, the
Agency assumes that a residential handler is exposed to a pesticide for 50 years for
handler exposure (mixing, loading, or applying a pesticide). Application rates for all
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exposure scenarios assessed are based on information provided by a review of active
labels. For the non-cancer assessment, maximum labeled rates are used. For the cancer
assessment, typical or average rates are used in risk assessment. Data from the Pesticide
Handler Exposure Database (PFLED) or Occupational and Residential Exposure Task
Force (ORETF) data bases were used to assess residential handler exposures.
Residential Handler Exposure Scenarios
Mixing, loading, and applying liquid spray formulation by low-pressure handwand for
indoor surface spray and crack and crevice treatment application
Mixing, loading, and applying liquid formulation by fogger for general outdoor
application.
Residential Handler Non-Cancer Risk
All MOE estimates for residential handlers range from 2400 to 8.5 million and are
not of concern to the Agency. All residential handler risks are below the Agency's level
of concern (all MOEs are above 1000).
Residential Cancer Risk
Cancer risk estimates are within the acceptable range for residential handlers (i.e.,
less than 3x 10"6). The cancer estimates for residential handler exposure to resmethrin
range from Ix 10"6 to 2.4x 10"6.
9. Residential Post-application Risk
(For more information, see section 7.2 of the human health risk assessment.)
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. Resmethrin can be used in many areas that can be frequented by the general
population including residential areas (indoor and outdoor areas). As a result, individuals
can be exposed by entering these areas if they have been previously treated. Resmethrin
can also be used on companion animals, which can lead to exposure by contact with the
treated animals. Further, resmethrin is used in wide area mosquito abatement programs
as a mosquito adulticide. It can be applied to wide areas through ultra-low volume
(ULV) spraying, which can result in post-application exposure to the general population.
The residential post-application non-cancer risk assessment considered both
dermal and inhalation exposures on a short- and intermediate-term basis. Scenarios
assessed include adults and children exposed to an outdoor mosquito adulticide
application, adults and children re-entering treated lawns, and adults and children
exposed to an indoor space spray application. Other non-cancer exposures assessed
include incidental ingestion risks to toddlers reentering treated lawns, playing on vinyl
floor and carpet after indoor fogger treatment, and incidental ingestion and dermal risks
to toddlers playing with pets after the pets have been treated with a resmethrin spray
formulation. Application rates for all exposure scenarios assessed are based on active
labels. For non-cancer assessment, maximum labeled rates are used. Post application
30
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exposure estimates were developed using OPP standard operating procedures, Non-
Dietary Exposure Task Force Exposure (NDETF) data, Spray Drift Task Force Exposure
data, and Residential Exposure Joint Venture (REJV) data.
Residential Post-Application Exposure Scenarios
Inhalation exposure from application of mosquito adulticide from fixed wing aircraft
and/or helicopter
Inhalation exposure from application of mosquito adulticide from ULV truck-mounted
sprayer
Toddler incidental ingestion of residue from exposed turf grass via hand-to-mouth
activities
Toddler incidental ingestion of residue via object-to-mouth activity while on exposed turf
grass
Toddler incidental ingestion of soil from treated area
Toddler incidental ingestion of residues deposited on carpet via hand-to-mouth activities
after use of total release foggers
Toddler incidental ingestion of residues deposited on vinyl flooring via hand-to-mouth
activities after use of total release foggers
Toddler incidental ingestion of residues on pets via hand-to-mouth activities and dermal
exposure after pet treatment
Inhalation exposure by adult applicator handler scenarios during and after aerosol space
spray application; post-application inhalation exposure to aerosol spray by child
Dermal Exposure to adults and children reentering treated lawns
Post-Application Non-Cancer Risk
Most risk estimates for residential post-application risk range from 2400 to 8.5
million and are not of concern to the Agency. Most residential post-application risks are
below the Agency's level of concern (most MOEs are above 1000).
The non-cancer risk estimate for a child exposed to an indoor aerosol space spray
exceeds the Agency's level of concern (MOE = 900). This exposure may occur when a
child enters a room within 10 minutes after a resmethrin indoor aerosol space spray
application. This risk can be mitigated by label instructions that inform residents to keep
all people and pets out of sprayed rooms for 2 hours after application.
Post-Application Cancer Risk
Resmethrin is used to kill adult mosquitoes by exposing them directly to spray
containing resmethrin. Resmethrin is used by public health officials with federal, state,
county, or local governments; mosquito control districts; military officials in charge of
public health for military installations; or contractors or others employed by public health
agencies.
For cancer risk, the Agency assumes that a private citizen can be exposed to a
pesticide for 70 years. For the resmethrin residential post-application cancer risk
assessment, typical rates were used. Data from the Occupational and Residential
Exposure Task Force (ORETF) data bases were used to assess residential post-
31
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application exposures. Additionally, the registrants submitted Residential Exposure Joint
Venture (REJV) data to estimate resmethrin residential use frequency.
Two residential bystander post application cancer risk scenarios were assessed for
adults exposed to resmethrin when it is used as an ultra-low volume (ULV) mosquito
adulticide spray. (EPA did not assess cancer risk separately for children in residential
post-application scenarios because cancer risks are assessed assuming 70 years of
exposure; thus they are included in the adult cancer assessment.) The resmethrin risk
assessment estimates that an adult could be exposed to resmethrin when applied as an
aerial ULV mosquito adulticide spray up to 365 times a year for 70 years before the
Agency's cancer risk level of concern is exceeded. When resmethrin ULV mosquito
adulticide spray is applied through a truck-mounted sprayer, the Agency estimates that an
adult could be exposed up to 125 days a year for 70 years before exceeding the Agency's
cancer risk level of concern. Assumptions used in the residential post-application risk
assessment include an adult breathing rate is 1.0 meters cubed (m3) per hour and an
exposure duration is less than or equal to 20 minutes. Typical rates were used in the
residential post-application cancer risk assessment. In addition, for the truck mounted
ULV spray application, a dilution factor of 0.01 was applied to the airborne concentration
at the maximum application rate (i.e., 1% of product released was considered to be
available for exposure). EPA does not expect residential bystander exposures to
approach 125 days a year for 70 years, therefore residential bystander risk is not of
concern.
Table 9. Estimated Resmethrin Post-application Inhalation Cancer Risks -
Mosquito Adulticide and Estimated Number of Exposure Days Per Year at which
Cancer Risks are Not of Concern (Risk < IxlO"6 )
Exposed
Individual
Average
Application Rate
Ib ai/acre
Breathing Zone
Concentration
(mg/m3)
Lifetime
Average Daily
Dose
(mg/kg/day)
Number of Exposure
Days
Aerial Spray (Fixed Wing and Rotary Aircraft)
Adult
0.003
0.0015
0.00004
>365
Truck Mounted ULV Sprayer
Adult
0.003
0.0110
0.0003
125
10. Aggregate Risk
(For a complete discussion, see section 8.0 of the human health risk assessment.)
In accordance with the FQPA, the Agency must consider pesticide exposures and
risks from all potential sources. These usually include food, drinking water, and
residential exposures. In an aggregate assessment, exposures from relevant sources are
added together and compared to quantitative estimates of hazard (e.g., a NOAEL or
32
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PAD), or the risks themselves can be aggregated. When aggregating exposures and risks
from various sources, the Agency considers both the route and duration of exposure. For
this assessment, EPA aggregated exposures from resmethrin in food and water with
exposure from residential uses.
Acute Aggregate Risk
An acute aggregate risk assessment is not required, since no appropriate endpoint
attributable to a single exposure was identified in the resmethrin database.
Short-, Intermediate-, and Long-Term Aggregate Non-Cancer Risk
Aggregate non-cancer risk is normally estimated as the risk associated with
exposures through food and drinking water, as well as residential exposures through the
oral, dermal, and inhalation routes. An aggregate non-cancer risk assessment for
resmethrin was conducted only for food and water, however, because endpoints selected
for the residential routes of exposure are not based on common toxic effects. As
described earlier, aggregate non-cancer risk estimates for food and water do not exceed
the Agency's level of concern.
Aggregate Cancer Risk
The aggregate cancer assessment combines lifetime estimated dietary and
residential risks. For resmethrin, aggregate dietary risk (food and drinking water) is 1.6 x
10-6, and residential risk is Ix 10-6. The resulting aggregate risk estimate is 2.6x 10-6,
which falls generally within the range of acceptable risk to the Agency.
Table 10. Estimated Aggregate Cancer Risk from Dietary/Drinking Water and
Residential Exposures to Resmethrin
Dietary/Drinking water Risk
i.exitr6
Residential Exposure Risk*
ixitr6
Aggregate Cancer Risk
2.6xl(r6
*Estimated risk from indoor aerosol application assuming reentry 2 hrs after application
EPA has concluded that aggregate cancer risks are likely overestimates, based on
several factors. First, food risks are only somewhat refined. The cancer risk estimate
assumes that 10% of food handling establishments are treated with resmethrin. This
assumption is an overestimation of exposure according to a proprietary survey of
pesticides used in food handling establishments. Additionally, in the resmethrin cancer
dietary assessment, the Agency assumed that the full limit of detection (LOD) level was
found for all non-residue detections in the Dietary Exposure Evaluation Model (DEEM-
FCID). In the past the Agency has used 1A of the LOD value for all non-residue
detections when calculating dietary risk. In using the full LOD, the Agency has
conservatively estimated dietary risk, which results in high-end estimates of exposures to
residues in food. Second, drinking water exposure estimates were developed using the
Tier 2 model PRZM-EXAMS which also results in high-end estimates of potential
exposure to resmethrin. Finally, the residential exposure scenario which was aggregated
with the dietary risks is the one with the highest estimated exposure and risk (indoor
aerosol space spray) of all the residential scenarios assessed. For the indoor aerosol
space spray scenario, the Agency assumes that a residential handler performing an indoor
33
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aerosol space spray application does so three times a year for 50 years, and is additionally
exposed for 70 years to post-application residues. These are high-end exposure
assumptions. Additionally, given the relatively low usage of resmethrin (50,000 Ibs ai
per year) the probability of co-occurrence of these exposures is low.
11. Cumulative Risk
Resmethrin is a member of the pyrethroid class of pesticides. Although all
pyrethroids alter nerve function by modifying the normal biochemistry and physiology of
nerve membrane sodium channels, EPA is not currently following a cumulative risk
approach based on a common mechanism of toxicity for the pyrethroids because there are
multiple types of sodium channels, and it is currently unknown whether all pyrethroids
have similar effects on all channels. In addition, the Agency does not have a clear
understanding of effects on key downstream neuronal function, e.g., nerve excitability,
nor do we understand how these key events interact to produce their compound-specific
patterns of neurotoxicity. There is ongoing research by both EPA's Office of Research
and Development and the pyrethroid registrants to evaluate the differential biochemical
and physiological actions of pyrethroids in mammals. This research is expected to be
completed by 2007. When the results of this research are available, the Agency will
make a determination of common mechanism of toxicity as a basis for assessing
cumulative risk. For information regarding EPA's procedures for cumulating effects
from substances found to have a common mechanism of toxicity, see EPA's website at
http ://www. epa. gov/pesticides/cumulative/.
12. Occupational Risk
(For a complete discussion, see section 10.0 of the human health risk assessment.)
Workers can be exposed to a pesticide while mixing, loading, or applying a
pesticide, or re-entering a treated site. Handler non-cancer risks are measured by a
margin of exposure (MOE), which determines how close the occupational exposure
comes to a NOAEL taken from animal studies. For resmethrin non-cancer risk, an MOE
greater than or equal to 100 has been determined to be adequately protective for short-
term (1 to 30 days), intermediate-term (1 to 6 months) and long-term (greater than 6
months) exposures and risk.
Handler cancer risks are estimated by calculating the probability that an exposed
handler may develop cancer. For agricultural workers, the Agency will typically seek to
reduce the individual risks to be greatest extent feasible, preferably to 10"6 or less. The
Agency seeks to reduce risks between 10"6 and 10"4 to the greatest extent feasible,
through requiring additional protective clothing or equipment or changes in application
methods, taking benefits into account. For cancer risk estimates, the Agency typically
assumes that handler exposure duration to a pesticide is 240 days a year for 35 years.
Typical application rates were used in the occupational cancer risk assessment.
Inhalation and dermal were considered to be the routes of exposure for the handler cancer
risk assessment.
34
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Occupational Toxicity
The following table lists the endpoints used for the occupational risk assessment
for resmethrin.
Table 11. Summary of Toxicological Doses and Endpoints for resmethrin for Use in
Human Risk Assessments
Exposure
Scenario
Dermal
Short-,
Intermediate-,
and Long- Term
Inhalation
Short-,
Intermediate-,
and Long- Term
Cancer (oral,
dermal,
inhalation)
Dose Used in
Risk
Assessment
Oral
Developmental
NOAEL = 30
mg/kg/day
(dermal
absorption rate =
2%)
Inhalation
LOAEL = 0.1
mg/L (28.2
mg/kg/day)
Special FQPA SF*
and Level of
Concern for Risk
Assessment
Occupational LOG
for MOE = 100
Occupational LOC
for MOE = 100
Study and Toxicological Effects
Oral Rabbit Developmental Toxicity
Study
Developmental LOAEL = 100
mg/kg/day based on increased
incidence of skeletal variations and a
possible marginal increase in
resorbed litters in the absence of
maternal toxicity
90-Day Inhalation Toxicity Study
Inhalation LOAEL = 0. 1 mg/L (28.2
mg/kg/day) based on clinical signs
within the first month, decreased
glucose levels in males, a decrease (-
13%) in body weight gain during
weeks 1-4 and an increase in BUN
(32%) at week 12 in females.
Classification: The Agency (4/13/05) classified resmethrin as "likely to be
carcinogenic to humans" and recommended a low-dose linear extrapolation of a
Ql* for resmethrin. Oral Q* =5.621 x 10"2 in human equivalents based upon male
mouse liver combined adenoma and/or carcinoma tumor rates
UF = uncertainty factor, FQPA SF = Special FQPA safety factor, NOAEL = no observed adverse effect
level, LOAEL = lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c =
chronic) RfD = reference dose, MOE = margin of exposure, LOC = level of concern, NA = Not Applicable
Occupational Handler Exposure
The Agency initially calculates the handler risks using baseline work clothing
(e.g., long sleeve shirt and long pants), no gloves, and no respirator. If there is a concern
at this level, the Agency considers the use of protective measures (e.g., personal
protective equipment and engineering controls) to lower the exposure. Personal
protective equipment (PPE) can include an additional layer of clothing, chemical-
resistant gloves, and a respirator. Common examples of engineering controls include
enclosed cabs, closed loading systems, and water-soluble packaging.
Occupational handlers of resmethrin include mixers, loaders, or applicators in
indoor and outdoor environments. EPA assessed risk scenarios for pesticide control
operator handlers, wide area mosquito abatement, and direct application to pets and some
farm animals.
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Pesticide Control Operator Handler Scenarios
Mixing, loading, and applying liquids with a high pressure hand wand sprayer in a non-
food greenhouse
Mixing, loading and applying liquids with a low pressure hand wand sprayer in a non-
food greenhouse
Mixing, loading and applying liquids with a fogger in a greenhouse
Mixing, loading and applying liquids with a fogger in outdoor sites
Mixing, loading and applying liquids with a low pressure hand wand for indoor crack
and crevice treatment
Mixing, loading and applying liquids with a low pressure hand wand in food
handling/processing/eating establishments and warehouses for crack and crevice
treatment
Mixing, loading and applying liquids with a low pressure hand wand in grain storage
facilities.
Mosquito Abatement Scenarios
Mixing, loading liquid for aerial application
Mixing, loading liquid for ULV truck-mounted spray application
Mixing, loading, and applying liquids for truck-mounted ULV ground spray
Mixing, loading, and applying liquids with a low pressure hand wand application.
Direct Application to Pets and Farm Animals
Spray application.
Exposure analyses were performed using PHED, ORETF data, or the National
Pest Management Association (NPMA) Survey.
a. Occupational Non-cancer Handler Summary
Occupational handler exposures were assessed with baseline or minimal personal
protective equipment. Non-cancer exposure and risk estimates indicate no MOEs of
concern (i.e., all MOEs are greater than 100) at the maximum use rate for all occupational
exposure scenarios assessed either at baseline or considering the use of chemical-resistant
gloves.
When workers apply resmethrin with a low pressure handwand with no PPE, the
MOE is calculated to be 90. When gloves are added for this scenario, the MOE is
calculated to be 20,000 and is not of concern.
b. Occupational Cancer Handler Summary
The cancer risk estimates for pesticide control operators and mosquito abatement
personnel are presented in Table 12 below.
TABLE 12. Estimated Resmethrin Exposure & Cancer Risk Estimate for Pesticide Control Operator &
Mosquito Abatement
36
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Exp Scenario
Dermal
Unit
Exposure
(mg/lb ai)
Inhalation
Unit
Exposure
(ug/lb ai)
Use
Site
Typical
Application
Rate
Daily Area
Treated
Or Amount
Handled
Cancer
Risk
Baseline
Cancer
Risk
Dermal
PPE
(Baseline
+ Gloves)
Greenhouse - Non Food Mix/Load/Apply Liquid Formulation
High Pressure
Handwand
Low Pressure
Handwand
Handheld Fogger
2.5
100
14
120
30
190
Greenhouse
Greenhouse
Greenhouse
0.001 Ib/aigal
0.001 Ib/ai gal
0.001 Ib/ai gal
1000 gal/day
40 gal/day
10 gal/day
4.E-05
l.E-03
4.E-05
NA
4.E-06
NA
Outdoor Sites Mix/Load/Apply Liquid Formulation
Handheld Fogger
14
190
Patio/Yards/
Recreational
Areas
0.05 Ib ai/acre
2 acre/day
l.E-05
NA
Indoor Homes/Buildings Mix/Load/Apply Liquid Formulation
Low Pressure
Handwand
100
30
Contact
Spray/Crack
& Crevice
0.02
lbs/1000 ft2
1 building/day
avg area- 1600
ft2
2.E-05
NA
Indoor Food Handling/Processing/Eating Establishments/Non-Food Warehouses Mix/Load/Apply Liquid
Formulation
Low Pressure
Handwand Sprayer
100
30
Contact
Spray/Crack
& Crevice
0.02
lbs/1000 ft2
1 facility/ per day
10000ft2/
facility
l.E-04
NA
Indoor Grain Storage Units Mix/Load/Apply Liquid Formulation
Low Pressure
Handwand
100
30
Contact
Spray/Crack
& Crevice
0.02
lbs/1000 ft2
1 bin/day
1000 ft2 /bin
l.E-05
NA
Mosquito Abatement Mix/Load Liquid Formulation
ULV Truck Mounted
Spray (Open Cab)
ULV Aerial
2.9
2.9
1.2
1.2
Adulticide
Adulticide
0.003 Ib
ai/acre
0.003 Ib
ai/acre
3000 acre/day
7500 acre/day
l.E-04
4.E-04
NA
l.E-05
Mosquito Abatement Apply Liquid Formulation
ULV Truck Mounted
Spray (Open Cab)
0.36
4.5
Adulticide
0.003 Ib
ai/acre
3000 acre/day
3.E-05
NA
Mosquito Abatement Mix/Load/Apply Liquid Formulation
Low Pressure
Handwand
100
30
Adulticide
0.003 Ib
ai/acre
2 acre/day
3.E-06
NA
Pet Groomer and Veterinarian Apply Aerosol
Aerosol
190
1300
Pet Spray
0.003 Ib ai per
16 oz can
1 pet/day
'/2 can spray/pet
2.E-06
NA
In use scenarios where cancer risk estimates exceeded 10"4, the Agency is
requiring personal protective equipment (gloves) to reduce exposure. For most other
scenarios, estimated cancer risks are between 10"6 and 10"4. However, because the
exposure inputs to these estimates are conservative and likely overestimate actual
exposure, no additional mitigation will be required at this time. For pest control operator
and mosquito abatement scenarios, assuming full day, long-term application for each
application method may significantly overestimate total exposure. Based on usage data
37
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of likely resmethrin containing pesticides presented in a National Pest Management
Association survey, this assumption would result in significant overestimate of exposure
for PCOs. Similarly, assuming continuous usage of resmethrin containing pesticides for
mosquito abatement applications would also significantly overestimate total exposure
based on personal communication with mosquito control district officials regarding
current usage of these products. Further, based on current usage, the assumption for
cancer risk assessment that workers are exposed for 240 days per year for 35 years should
be considered highly conservative. Default assumptions regarding acres treated per day
for aerial and truck mounted ULV sprayer applications for mosquito abatement should
also be considered conservative based on resmethrin specific information provided by the
registrant. The agency used default assumptions of 7500 acres per day for aerial
applications and 3000 acres per day for ULV applications. The registrant cites
information from the American Mosquito Control Association that typically, no more
than 4000 acres per day are treated by aerial application and no more than 400 acres per
day are treated by truck-mounted ULV spray applications.
c. Postapplication Occupational Risk
Post-application exposures occur as a result of being in an environment that has
been previously treated with a pesticide. Occupational post-application scenarios were
not assessed because worker re-entry exposure is considered unlikely in most situations,
i.e. resmethrin is not used on agricultural field crops, and worker re-entry exposures to
treated food handling establishments, warehouses, greenhouses, and outdoor premises are
not expected to occur routinely for Pest Control Operators (PCOs).
The only restricted-entry interval (REI) currently established under the WPS is for
greenhouses. The REI will be maintained at 12 hours for workers re-entering a
greenhouse after treatment with resmethrin.
13. Human Incident Data
In evaluating incidents to humans, the Agency reviewed reports from five sources
including the OPP Incident Data System (IDS), Poison Control Centers (PCC), California
Department of Pesticide Regulation (CDPR), National Pesticide Information Center
(NPIC), and National Institute of Occupational Safety and Health's Sentinel Event
Notification System for Occupational Risks (NIOSH SENSOR). The majority of cases
involved systemic and respiratory effects, such as headache, nausea, coughing, dizziness,
and shortness of breath. The Agency incident report recommends appropriate protective
respiratory equipment for individuals who are likely to have substantial inhalation
exposure to resmethrin. See Chapter IV for a description of measures to address this
concern.
B. Environmental Risk Assessment
A summary of the Agency's environmental risk assessment for resmethrin is
presented below. More detailed information associated with the environmental risk from
38
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the use of resmethrin can be found in the "EFED RED Chapter for Resmethrin, Revision
Phase 3; DP Barcode No. D326094;" revised per comments received during the phase 3
60-day public comment period and dated March 8, 2006.
1. Environmental Fate and Transport
The environmental fate database is sufficient to characterize the environmental
exposure associated with resmethrin use. However, EPA intends to issue a DCI as part of
this RED to require submission of additional data for resmethrin to address areas of
uncertainty. These data are expected to confirm the conclusions of this environmental
risk assessment.
EPA expects all the isomers of resmethrin to have similar environmental fate
characteristics. The most important route of dissipation for resmethrin is photolysis. The
aqueous photolysis half-life for resmethrin is very short (22 minutes in seawater and 47
minutes in distilled water). No data were submitted regarding the potential for resmethrin
to undergo photodegradation on soil surfaces; however, current labels recommend that
resmethrin be applied in the early morning or in the evening to prevent photodegradation,
which indicates that resmethrin may be subject to relatively rapid photodegradation in the
terrestrial environment.
Other than when subjected to photolysis, resmethrin is generally slow to degrade.
The aerobic soil metabolism half-life is 198 days, the aerobic aquatic metabolism half-
life is 37 days, and resmethrin is relatively stable to anaerobic soil metabolism.
Hydrolysis occurs slowly at a range of pH values. In hydrolysis studies, the resmethrin
half-life is greater than 89 days at pH values 5 to 9.
2. Ecological Risk
The Agency's ecological risk assessment compares toxicity endpoints from
ecological toxicity studies to estimated environmental concentrations (EECs) based on
environmental fate characteristics and pesticide use data. To evaluate the potential risk to
non-target organisms from the use of resmethrin products, the Agency calculates a Risk
Quotient (RQ), which is the ratio of the EEC to the most sensitive toxicity endpoint
values, such as the median lethal dose (LD50) or the median lethal concentration (LC50).
These RQ values are then compared to the Agency's levels of concern (LOCs), which
indicate whether a pesticide, when used as directed, has the potential to cause adverse
effects to non-target organisms. When the RQ exceeds the LOG for a particular category,
the Agency presumes a risk of concern. These risks of concern may be addressed by
further refinements of the risk assessment or mitigation measures. Use, toxicity, fate, and
exposure are considered when characterizing the risk, as well as the levels of certainty
and uncertainty in the assessment. EPA further characterizes ecological risk based on
any reported incidents to non-target terrestrial or aquatic organisms in the field (e.g., fish
or bird kills).
39
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Table 13. EPA's Levels of Concern and Associated Risk Presumptions
Risk Presumption
Acute Risk - there is potential for acute risk
Acute Endangered Species - endangered species
may be adversely affected
Chronic Risk - there is potential for chronic risk
LOC
Terrestrial
Animals
0.5
0.1
1
LOC
Aquatic
Animals
0.5
0.05
1
LOC
Plants
1
1
N/A
Restricted Use
Resmethrin products used for wide area mosquito abatement are classified as
Restricted Use due to aquatic toxicity. All applicators for wide area mosquito abatement
must be certified applicators trained in pesticide application or be under the direct
supervision of someone who has been trained in pesticide application.
a. Risk to Aquatic Organisms
i. Fish and Invertebrate Exposures and Toxicity
For exposure to aquatic fish and invertebrates, EPA considers surface water only,
since most aquatic organisms are not found in ground water. The aquatic exposure
assessment is based on the Tier II models Pesticide Root Zone Model (PRZM) which
simulates fate and transport on the agricultural field, while the water body is simulated
with Exposure Analysis Modeling System (EXAMS). Simulations are run for multiple
years based on the thirty years of daily values generated during the simulation.
Wide Area Mosquito Abatement
The default values of application efficiency (95%) and spray drift (5%), currently
used for applications to agricultural crops, are not appropriate for applications for a
mosquito adulticide like resmethrin. Instead, to calculate the level of drift from this type
of application, the Agency used the Agricultural Dispersal model (AGDISP) version
8.07. AGDISP provides a better estimate of spray drift for ULV applications. AGDISP
estimates for resmethrin ULV spray include an application efficiency of 40% and a spray
drift value of 60.0%.
PRZM/EXAMS modeling of resmethrin was done for use on turf to simulate
mosquito abatement scenarios. The registrant-defined maximum application rate,
maximum number of applications per year, and minimum application interval were
modeled to represent an upper-end of exposure potential. Scenarios were assessed for
aerial and ground applications. Simulations are run for multiple (usually 30) years and
the reported EECs represent the values that are expected once every ten years based on
the thirty years of daily values generated during the simulation.
40
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The maximum application rate for resmethrin is 0.007 Ib ai/A. Resmethrin
registrants have defined the maximum number of applications per year to be 50, however,
limitations in PRZM/EXAMS prevented modeling more than 26 applications per year.
The estimate of 26 applications per year is closer to the registrant-reported typical
number of applications per year. An application frequency of twice per week (every 3 or
4 days) was modeled. Aquatic estimated environmental concentrations (EECs) generated
for this assessment may underestimate actual environmental exposure to resmethrin since
more than 26 applications may be applied per year. Table 14 and 15 below show the
water column and pore water EECs.
When typical rates were modeled (0.0035 Ib ai/A, 3-day application interval, 26
applications per year), the resulting EECs were approximately one-half the values
observed for the maximum application rate. This applies for the peak, 21-day, and 60-
day EECs. A complete listing of EECs, including those used for resmethrin RQ
calculations included in this summary, can be found in the risk tables in the resmethrin
ecological risk assessment.
Table 14. Water column EECs (ppb or |lg/L) ecological risk assessment for ponds of various
depths based on resmethrin use on turf (using maximum application rate of 0.007 Ib ai/acre).
Application
Interval
3 days
Time-point
for EEC
Peak Value
21 Day Value
60 Day Value
Average Pond Depth
6.6 ft. = 2 m.
0.777
0.575
0.547
Table 15. Pore water EECs (ppb or |lg/L) ecological risk assessment for ponds of various
based on resmethrin use on turf (using typical application rate of 0.007 Ib ai/acre).
Application
Interval
3 days
Time-point
for EEC
Peak Value
21 Day Value
60 Day Value
depths
Average Pond Depth
6.6 ft. = 2 m.
0.347
0.338
0.309
"Down-the-Drain"
To address potential resmethrin release to domestic wastewater treatment through
indoor household use, EPA used the Exposure and Fate Assessment Screening Tool (E-
FAST). The "down-the-drain" module of E-FAST is designed to address sources of
resmethrin that could potentially be disposed in wastewater. The acute surface water
EEC for resmethrin is 1.15x 10"4 ppb. The 60-day EEC for resmethrin is 8.9x 10"6 ppb.
41
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(For more information, see section III.B.2.b. of the EFED assessment)
Aquatic Toxicity
The acute fish and invertebrate toxicity data, outlined in table 16 below, indicate
that resmethrin is very highly toxic to freshwater fish and invertebrates and to
estuarine/marine fish and invertebrates.
Table 16. Summary of Acute Aquatic Toxicity Data for Resmethrin
Toxicity Study
Freshwater Fish
(96-hour)
Freshwater
Invertebrate (48-
hour)
Estuarine /
Marine Fish
Estuarine /
Marine
Invertebrates
Estuarine /
Marine Mollusks
Test Species
Rainbow trout
Oncorhynchus
mykiss
(TGAI)
Water flea
Daphnia magna
(TGAI)
Sheepshead
minnow
Cyprinodon
variegates
(TGAI)
Pink shrimp
Penaeus
duorarum
(TGAI)
LC50 or EC50
(ppb)
0.28
3.10
11
1.30
Toxicity
Category
Very highly
toxic
Very highly
toxic
Very highly
toxic
Very highly
toxic
MRID/Accession
No.
40098001
40991210
40991218
40991217
No Data
Both freshwater fish and estuarine/marine fish early life-stage chronic toxicity
tests were used to evaluate the chronic toxicity of resmethrin. Results from the
freshwater fish early life-stage toxicity test indicated at the No Observed Adverse Effect
Concentration (NOAEC) of 0.32 ppb and an associated Lowest Observed Adverse Effect
Concentration (LOAEC) of 0.59 ppb. The basis of these effect levels was an observed
decrease in larval survival of resmethrin-exposed fish. An estuarine/marine early fish
life-stage study was used to evaluate the toxicity of resmethrin to estuarine/marine fish.
The most sensitive endpoint was juvenile survival with a NOAEC of 1.9 ppb and a
LOAEC of 4.1 ppb. There were no chronic freshwater invertebrate or estuarine/marine
invertebrate toxicity data available for this assessment.
Table 17. Summary of Chronic Aquatic Toxicity Data for Resmethrin
Toxicity Study
Freshwater Fish
Early Life-Stage
Test Species
Rainbow trout
Oncorhynchus
mykiss
NOAEC /
LOAEC (ppb)
0.32/0.59
Effects at
LOAEC
Larval survival
MRID/Accession
No.
40991223
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Estuarine /
Marine Fish
Early Life-Stage
(TGAI)
Sheepshead
minnow
Cyprinodon
variegates
(TGAI)
1.90/4.05
Juvenile survival
43858304
ii. Fish and Invertebrate Risk
Risks presented in this section are estimates offish and invertebrate risk that may
occur due to the wide area mosquito abatement use of resmethrin, or from exposure
modeled for the "down the drain" scenario.
Freshwater Fish
The acute risk level of concern (LOG) (0.5) and acute endangered species LOG
(0.05) are exceeded for freshwater fish exposed to resmethrin. The RQ range is from
2.78 for the technical product and 1.73 for the formulated product. The LOG for chronic
risk (1) is exceeded only for freshwater fish at 1.71 for the 3-day modeled interval.
Estuarine/Marine Fish
The acute risk LOG (0.5) is not exceeded in acute risk estimates for
estuarine/marine fish. The endangered species acute risk LOG (0.05) is exceeded for
estuarine/marine fish exposed to formulated resmethrin (RQ 0.48) and estuarine/marine
fish exposed to technical resmethrin (RQ = 0.07). Chronic risks of concern (1) associated
with estuarine/marine fish exposed to resmethrin are not likely based on the RQs
calculated which range (highest RQ = 0.29).
Freshwater Invertebrates
The acute risk LOG (0.5) and endangered species LOG (0.05) is exceeded for
resmethrin formulated products. The RQ range for freshwater invertebrates acutely
exposed to resmethrin in formulated products is 2.81 to 6.48. The endangered species
LOG (0.05) is slightly exceeded for freshwater invertebrates exposed to technical
resmethrin (RQ range = 0.25 to 0.11) No chronic freshwater invertebrate data were
submitted for resmethrin. Chronic data from a similar pesticide, the pyrethrins, show
reproductive effects in freshwater invertebrates with a NO AEG value of 0.86 ppb, which
indicates that there may be potential for chronic reproductive effects to aquatic
invertebrates exposed to resmethrin.
Estuarine/Marine Invertebrates
The acute risk LOG (0.5) and endangered species LOG (0.05) is exceeded for
some estuarine/marine invertebrates exposed to technical resmethrin. The RQ range for
acute risk to estuarine/marine invertebrates is 0.25 to 0.58. RQs for estuarine/marine
invertebrates exposed to formulated resmethrin range from 1.47 to 3.38, which indicates
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potential acute risk and acute endangered species risk to estuarine/marine invertebrates.
Chronic data from a similar pesticide, the pyrethrins, show reproductive effects in
freshwater invertebrates with a NOAEC value of 0.86 ppb, which indicates that there
may be potential for chronic reproductive effects to aquatic invertebrates exposed to
resmethrin.
Freshwater Benthic Organisms
RQs for freshwater benthic organisms were calculated from water column studies
in the absence of sediment toxicity data for resmethrin. The acute risk LOG (0.5) was not
exceeded for freshwater benthic organisms; however the acute endangered species LOG
was exceeded for freshwater benthic organisms in water (RQs = 0.11). No chronic
freshwater or estuarine/marine benthic organism data were submitted to the Agency.
However, based on the potential for chronic risk to freshwater fish due to exposure to
technical resmethrin, chronic invertebrate data from other synthetic pyrethroids, and the
affinity of resmethrin to partition to sediment, there may be potential for resmethrin to
cause chronic effects in benthic organisms.
Estuarine/Marine Benthic Organisms
RQs for estuarine/marine benthic organisms were calculated from water column
studies in the absence of sediment toxicity data for resmethrin. These risk estimates do
not exceed the acute risk LOG (0.5) for estuarine/marine benthic organisms exposed to
technical resmethrin. However, the acute endangered species LOG (0.05 is exceeded for
estuarine/marine benthic organisms in water 1 foot, 1 meter, and 2 meters deep (RQs
range from 0.05 to 0.26). No chronic freshwater or estuarine/marine benthic organism
data were submitted to the Agency. However, based on the potential for chronic risk to
freshwater fish due to exposure to technical resmethrin, chronic invertebrate data from
other synthetic pyrethroids, and the affinity of resmethrin to partition to sediment, there
may be potential for resmethrin to cause chronic effects in benthic organisms.
"Down-the-Drain " Risk to Aquatic Organisms
Acute and chronic RQs for freshwater and estuarine fish and invertebrates are
below 0 and are therefore below the Agency's level of concern for acute risk (0.5) and
chronic risk (1.0).
iii. Non-target Aquatic Plants Exposure, Toxicity, and
Risk
No data were submitted to evaluate the risk of resmethrin exposure to non-target
aquatic plants. However, the Agency has determined that resmethrin will have no effect
on listed plants. Because of its neural toxic mode of action, resmethrin poses no
phytotoxic concern. Also, no incident reports have reliably linked resmethrin or any
other synthetic pyrethroid to phytotoxic effects despite the fact that pyrethroids are often
applied on or near agricultural crops.
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b. Risk to Terrestrial Organisms
Risks presented in this section are estimates of avian and mammalian risk that
may occur due to the wide area mosquito abatement use of resmethrin. No other
resmethrin uses were assessed for ecological risk because most uses are used indoors
only, or used on a limited basis outdoors by residential handlers.
i. Birds and Mammals Exposure and Toxicity
The Agency assessed exposure to terrestrial organisms by first predicting the
amount of resmethrin residues found on animal food items and then using information on
typical food consumption by various species of birds and mammals to determine the
amount of pesticide consumed. The amount of residues on animal feed items is based on
the Fletcher nomogram, which is a model developed by Hoerger and Kenaga (1972) and
modified by Fletcher (1994), and the current maximum application rates for resmethrin.
Estimated exposure concentrations for terrestrial receptors were determined using
the standard screening-level exposure model, Terrestrial Residue Exposure model
(TREX) version 1.1, which is a simulation model that, in addition to incorporating the
nomogram relationship, also includes pesticide degradation in the estimation of EECs.
TREX considers exposure only in the area where resmethrin is applied. In general, the
underlying assumption is that most, if not all, of the applied pesticide will settle in the use
area. However, because resmethrin is used as a mosquito adulticide and when applied is
intended to drift, the Agency considered that 40% of resmethrin settles within the area
treated and 60% drifts away from the treated area. Resmethrin is applied as a ULV spray
from aerial and truck-mounted sprayers.
EPA's estimates of resmethrin residues on various wild animal food items are
summarized in table 18. EPA used these EECs and standard food consumption values to
estimate dietary exposure levels to birds and mammals for resmethrin. Exposure
modeling was done for the mosquito adulticide use with maximum and typical rates,
application frequencies, and number of applications per year.
Table 18. Residue EECs on Avian and Mammalian Food Items
Scenario
Mosquito
Adulticide
Application
Rate Ib a.i./A
Max rate:
0.007
Number
Applications /
Interval
(days)
50/3
25/3
Range of EECs Based on Mean
Residues for:
1) Short grass;
2) Tall grass;
3) Broadleaf plants/small insects;
4) Fruits, pods, seeds, and large
insects
(ppm)
0.8 (fruits, etc.) - 9.8 (short grass)
0.6 (fruits, etc.) - 8.0 (short grass)
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Typical rate:
0.0035
50/4
25/4
25/3
25/4
0.6 (fruits, etc.) - 7.6 (short grass)
0.5 (fruits, etc.) - 6.7 (short grass)
0.3 (fruits, etc.) - 3.9 (short grass)
0.3 (fruits, etc.) - 3.4 (short grass)
The acute toxicity of resmethrin to mammals was evaluated using the common
laboratory rat to calculate an LD50 of 4639 mg a.i./kg. This classifies resmethrin as
practically non-toxic to mammals on an acute basis. Chronic studies in the rat show that
the endpoints most sensitive to resmethrin exposure are reproductive endpoints such as
decreases in female body weight gain during gestation, no weight gain during lactation,
decreased pup weight in all generations and slight increases in stillborn pups.
Avian acute toxicity was measured using the red-winged blackbird to calculate an
LD50 value of 75 mg ai/kg body weight, which classifies resmethrin as moderately toxic
to birds on an acute basis. A subacute dietary study was performed with bobwhite quail
to determine an LC50 for resmethrin. The subacute dietary study with bobwhite quail
showed an LC50 of greater than 5000 ppm. This categorizes resmethrin as practically
non-toxic to avian species on a subacute dietary basis. Chronic studies in the mallard
duck show that the endpoint most sensitive to resmethrin is increased incidence of early
embryonic deaths in the 60 ppm treatment group. The NOAEC in the chronic mallard
study was 12 ppm. Table 19 below presents the acute and chronic toxicity data for
terrestrial organisms exposed to resmethrin.
Table 19. Summary of Acute and Chronic Toxicity Data for Terrestrial Organisms Exposed to Resmethrin
Species
Bird
Mammal
Red-winged
blackbird
Agelaius
phoeniceus
Bobwhite
quail
Colinus
virginianus
Mallard
duck
Anas
platyrhychos
Laboratory
rat
Rattus
norvegicus
Acute Toxicity
LD50
(mg/kg)
75
4639
Acute Oral
Toxicity
(MRID)
Moderately
toxic
(Acc.#
43653)
Practically
non-toxic
(42076201)
LC50
(ppm ai)
>5000
ppmai
>5000
ppmai
Subacute
Dietary
Toxicity
(MRID)
Practically
non-toxic
(41653601)
Practically
non-toxic
(41653602)
Chronic Toxicity
NOAEC/LOAEC
(ppm) (MRID)
60.0/300.0
(41465002)
12.0/60.0
(41465001)
34.8/70.8
(43189101)
Affected
Endpoints
Decrease of
adult male
body weight
Decrease in
hatchling body
weight,
increase in
embryonic
death
decrease in
female body
weight gain
during
gestation, no
weight gain
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Insect
Honey bee
Apis
mellifera
0.063 ug
a^ee
Highly toxic
(VAORES01)
during
lactation,
decreased pup
weight in all
generations
11.
Birds and Mammals Risk
Risk quotients were calculated for both birds and mammals using the dose-based
and dietary-based toxicity values. Generally dose-based RQs are higher than those
calculated using the dietary-based values because the dose-based RQs are calculated with
the assumption that birds or mammals will experience a very short-term high intensity
exposure from the pesticide. The dietary-based approach assumes that animals in the
field are consuming food at a rate similar to that of confined laboratory animals despite
the fact that energy content in food items differs between the field and the laboratory.
There are benefits and uncertainties by considering both methods which are outlined in
more detail in the environmental fate and effects chapter for resmethrin. RQs calculated
using both methods are included in the discussion below.
In addition, in order to bound the estimates of RQs, mean Kenega residue values
were calculated along with upper-bound values. Log-normal distributions were
generated that describe residues levels on the various food items. The analysis
demonstrates that Kenega values range from about 62-87 percent of the possible
resmethrin residues values, indicating that 12 to 38 percent of the higher-end food item
residue estimates are not captured in estimating exposure by using the mean Kenega
values. For the upper-bound Kenega residue estimates, about 3-13 percent of the upper-
end residue estimates were not captured. Using the mean Kenega residue values for
calculating RQs would not protect birds and mammals that consume food items that have
residues on the higher end of the residue distribution.
A range of RQs was calculated using dose and dietary-based toxicity values and
mean or upper-bound Kenega residue values. A summary of the high- and low-end RQs
are outlined in the following tables; for a complete list of calculated RQs, refer to Section
4.A.2 of the environmental fate and effects assessment for resmethrin.
Birds
Using dose-based (LD50 = 75 mg/kg-bw for red-winged blackbird) toxicity
values acute endangered species level of concern was (0.1) exceeded for 20g and lOOg
birds that feed on short grass (RQ range = 0.13 to 0.17) when the maximum application
rate was used. Using the dietary-based toxicity values (LC50 greater than 5000 mg ai/kg
diet for mallard duck), no LOCs are exceeded for any scenario. The acute dietary RQs
are listed in table 20 below.
Table 20. Dose-based acute RQs for birds (red-winged blackbird) exposed to resmethrin
based on mean residues, maximum application rate (0.007 Ib ai/acre), maximum number of
47
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applications (50), and minimum application interval (3 days)
Number of
applications/
Application
interval
50/3
Body
Weight
20
100
1000
Short Grass
Tall Grass
Broadleaf
Plants /
Small
Insects
Fruits/Pods/
Seeds/Large
Insects
Avian Acute Risk Quotients
0.17 l
0.13 l
0.04
0.07
0.06
0.02
0.09
0.07
0.2
0.01
0.01
0.003
Dietary-based acute RQs for birds (mallard duck) exposed to resmethrin based on mean
residues, maximum application rate (0.007 Ib ai/acre), maximum number of applications
(50), and minimum application interval (3 days)
50/3
0.002
0.001
0.001
0.0002
1 RQ exceeds LOG for acute endangered species (>0. 1)
Chronic RQs are calculated using mean Kenaga residue values and a chronic
NOAEC (12 mg ai/kg diet) from the dietary study in mallard duck. LOCs are not
exceeded for birds that consume short grass, tall grass, and broadleaf plants/small insects
when maximum application rates are used. See table 21 below for a summary of RQs.
Table 21. Dietary-based chronic RQs for birds exposed to resmethrin based on mean
residue levels, maximum application rate (0.007 Ib ai/acre), maximum number of
applications (50), and minimum application interval (3 days).
Number of
applications/
Application
interval
50/3
Short Grass
0.82
Tall Grass
0.35
Broadleaf
Plants / Small
Insects
0.43
Fruits/Pods/
Seeds/Large
Insects
0.07
Mammals
Acute mammalian risks were calculated using the acute oral LD50 of 4639 mg
ai/kg body weight from a rat study, and chronic mammalian risks were calculated using a
chronic NOAEL of 34.8 mg ai/kg body weight in rats. Chronic RQs were calculated
using upper-bound Kenaga residue values and dose-based toxicity values. All acute RQs
are below the LOCs for acute risk and acute endangered species risk. All chronic RQs
are below the LOCs for chronic risk. Therefore, resmethrin is not likely to pose an acute
or chronic risk to mammals.
iii. Non-Target Terrestrial Plant Toxicity, Exposure,
and Risk
No data were submitted to evaluate the risk of resmethrin exposure to non-target
terrestrial plants. However, the Agency has determined that resmethrin will have no
effect on listed plants. Because of its neural toxic mode of action, resmethrin poses no
phytotoxic concern. Also, no incident reports have reliably linked resmethrin or any
other synthetic pyrethroid to phytotoxic effects despite the fact that pyrethroids are often
applied on or near agricultural crops.
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iv. Non-Target Insect Risk
Currently, the Agency does not estimate RQs for terrestrial non-target insects.
However, based on a single contact study in honey bees, technical resmethrin is classified
as highly toxic on an acute contact basis to non-target terrestrial insects (LD50 = 0.063
ug/ai per bee). Concern for acute toxicity to non-target insects is high when they are
exposed directly to resmethrin. A label statement addressing this concern is required for
all resmethrin occupational outdoor use products and wide area mosquito abatement
products.
3. Ecological Incidents
A total of three incidents involving aquatic resmethrin exposure have been
reported to EPA involving aquatic organisms allegedly exposed to resmethrin via spray
drift. The organisms exposed in these incidents include blue claw crabs, goldfish, fish
(general), and shrimp (general). Since no information regarding application rate, residue
analysis, or time of event relative to application was provided, the strength of these
incidents as an additional line of evidence is uncertain.
A total of four incidents involving terrestrial resmethrin exposure have been
reported to EPA. The organisms exposed in these incidents include bees, ornamental
plants, and corn. No information regarding application rate, residue analysis, or time of
event relative to application was provided for any of these terrestrial incidents. In
addition, the neurotoxic mode of action of resmethrin does not cause concern for
phytotoxic effects. The strength of these incidents involving exposure of terrestrial plants
as evidence of phytotoxic effects is highly uncertain.
4. Endangered Species Concerns
The Agency's screening level risk assessment indicates that uses of resmethrin
will have no direct acute or chronic effects on aquatic or terrestrial plants. The Agency
has determined that resmethrin will have no effect on listed terrestrial or aquatic plants.
There are potential indirect effects to any listed species dependent on a species that is
affected by the use of resmethrin. For the screening level assessment, potential risks to
reptiles and terrestrial phase amphibians are estimated based on risks to birds; and
potential risks to aquatic phase amphibians are estimated based on risks to freshwater
fish. Because the screening level assessment shows potential risks for both birds and
freshwater fish, the potential risks to reptiles, terrestrial phase amphibians, and aquatic
phase amphibians cannot be precluded based on the screening level assessment.
A preliminary analysis of the co-occurrence of listed species and proposed re-
registration of resmethrin uses was conducted using the Agency's LOCATES database.
In general, for all labeled uses of resmethrin there is at least one, and usually more, listed
species that may potentially occur in or near a use area. This preliminary analysis
49
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indicates that there is a potential for resmethrin use to overlap with listed species and that
a more refined assessment is warranted.
The Endangered Species Act requires 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 endangered and threatened species,
and to implement mitigation measures, as appropriate, that address these impacts. In
general, to assess the potential of registered pesticide uses that may affect any particular
species, EPA uses basic toxicity and exposure data developed for the REDs and considers
it in relation to individual species and their locations by evaluating important ecological
parameters, pesticide use information, geographic relationship between specific pesticide
uses and species locations, and biological requirements and behavioral aspects of the
particular species, as part of a refined species-specific analysis. When conducted, this
species-specific analysis will take into consideration any regulatory changes
recommended in this RED that have been implemented at that time. A determination that
there is a likelihood of potential impact to a listed species or its critical habitat may result
in limitations on the use of resmethrin, other measures to mitigate any potential impace,
or consultations with the Fish and Wildlife Service and/or the National Marine Fisheries
Service as necessary.
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 resmethrin. Rather, this assessment serves as a screen to determine the need for any
species specific assessments 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 resmethrin result in the need
to modify use of the pesticide, EPA will employ the provisions in the Services
regulations (50 CFR Part 402). Until that species-specific analysis is completed, the risk
mitigation measures being implemented through this RED will reduce the likelihood that
endangered and threatened species may be exposed to resmethrin at levels of concern.
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IV. Risk Management, Reregistration, and Tolerance Reassessment Decision
A. Determination of Reregistration Eligibility and Tolerance Reassessment
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission
of relevant data concerning an active ingredient, whether or not products containing the
active ingredient are eligible for reregistration. The Agency has previously identified and
required the submission of the generic data to support reregistration of products
containing resmethrin. The Agency has determined that the data are sufficient to support
reregistration of resmethrin.
The Agency has completed its assessment of the dietary, occupational and
ecological risk associated with the use of resmethrin apart from a species specific
Endangered Species assessment as discussed above. Based on this assessment, the
Agency has sufficient information on resmethrin to make decisions as part of the
tolerance reassessment process under FFDCA and reregistration process under FIFRA, as
amended by FQPA. The Agency has determined that resmethrin-containing products are
eligible for reregistration provided that label amendments are made as outlined in this
RED. Appendix A summarizes the uses of resmethrin that are eligible for reregistration.
Appendix B identifies the generic data that the Agency reviewed as part of its
determination of reregistration eligibility, and lists the submitted studies that the Agency
found acceptable.
Based on its evaluation of resmethrin, the Agency has determined that resmethrin
products, unless labeled and used as specified in this document, would present risks
inconsistent with FIFRA and FQPA. Accordingly, should a registrant fail to implement
any of the reregistration requirements identified in this document, the Agency may take
regulatory action to address the risk concerns from the use of resmethrin. If all changes
outlined in this document are incorporated into the product labels, then all current risks
for resmethrin will be adequately mitigated for the purposes of this determination. Once
an Endangered Species assessment is completed, further changes to these registrations
may be necessary as explained under "Endangered Species Concerns" above.
B. Regulatory Position
1. Food Quality Protection Act Findings
a. "Risk Cup" Determination
As part of the FQPA tolerance reassessment process, EPA assessed the risks
associated with resmethrin. EPA has determined that risk from dietary (food + water)
exposure is within its own "risk cup." An aggregate assessment was conducted for
resmethrin for exposures through dietary (food + water) and residential (indoor and
outdoor) pathways. The Agency has determined that the human health risks from these
combined exposures are within acceptable levels. In other words, EPA has concluded
that the tolerances for resmethrin meet FQPA safety standards. In reaching this
51
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determination, EPA has considered the available information on the special sensitivity of
infants and children, as well as aggregate exposure from food, drinking water, and
residential sources.
b. Determination of Safety to U.S. Population
The Agency has determined that the established tolerance for resmethrin, with
amendments and changes as specified in this document, meets the safety standards under
the FQPA amendments to section 408(b)(2)(D) of the FFDCA, as amended by FQPA,
and that there is a reasonable certainty no harm will result to the general population or
any major identifiable subgroup from the use of resmethrin. In reaching this conclusion,
the Agency has considered all available information on the toxicity, use practices, and the
environmental behavior of resmethrin. As discussed in Section III, aggregate short-,
intermediate-, and long-term risks from food, drinking water, and residential exposures
are below the Agency's LOG.
c. Determination of Safety to Infants and Children
EPA has determined that the established tolerance for resmethrin, with
amendments and changes as specified in this document, meets the safety standards under
the FQPA amendments to section 408(b)(2)(C) of the FFDCA, and that there is a
reasonable certainty of no harm for infants and children. The safety determination for
infants and children considers factors on the toxicity, use practices and environmental
behavior noted above for the general population, but also takes into account the
possibility of increased dietary exposure due to the specific consumption patterns of
infants and children, as well as the possibility of increased susceptibility to the toxic
effects of resmethrin residues in this population subgroup. In determining whether or not
infants and children are particularly susceptible to toxic effects from exposure to residues
of resmethrin, the Agency considered the completeness of the hazard database for
developmental and reproductive effects, the nature of the effects observed, and other
information. The FQPA Safety Factor has been retained at 10X. There are no residual
uncertainties for pre- and/or post- natal toxicity, exposure is not underestimated, and
there is no evidence of increased susceptibility. However, an FQPA safety factor due to
database uncertainty is retained at lOXto account for lack of a developmental
neurotoxicity study.
2. Endocrine Disrupter Effects
EPA is required under the FFDCA, as amended by FQPA, to develop a screening
program to determine whether certain substances (including all pesticide active and other
ingredients) "may have an effect in humans that is similar to an effect produced by a
naturally occurring estrogen, or other endocrine effects as the Administrator may
designate." Following recommendations of its Endocrine Disrupter Screening and
Testing Advisory Committee (EDSTAC), EPA determined that there was a scientific
basis for including, as part of the program, the androgen and thyroid hormone systems, in
addition to the estrogen hormone system. EPA also adopted EDSTAC's recommendation
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that EPA include evaluations of potential effects in wildlife. For pesticides, EPA will use
FIFRA and, to the extent that effects in wildlife may help determine whether a substance
may have an effect in humans, FFDCA authority to require the wildlife evaluations. As
the science develops and resources allow, screening of additional hormone systems may
be added to the Endocrine Disrupter Screening Program (EDSP). In the available
toxicity studies on resmethrin submitted for registration purposes, there was no estrogen,
androgen, and/or thyroid mediated toxicity. When the appropriate screening and/or
testing protocols being considered under the EDSP have been developed, resmethrin may
be subject to additional screening and/or testing.
3. Cumulative Risks
Resmethrin is a member of the pyrethroid class of pesticides. Although all
pyrethroids alter nerve function by modifying the normal biochemistry and physiology of
nerve membrane sodium channels, EPA is not currently following a cumulative risk
approach based on a common mechanism of toxicity for the pyrethroids. Although all
pyrethroids because there are multiple types of sodium channels, and it is currently
unknown whether all pyrethroids have similar effects on all channels. In addition, the
Agency does not have a clear understanding of effects on key downstream neuronal
function, e.g., nerve excitability, nor do we understand how these key events interact to
produce their compound-specific patterns of neurotoxicity. There is ongoing research by
both EPA's Office of Research and Development and the pyrethroid registrants to
evaluate the differential biochemical and physiological actions of pyrethroids in
mammals. This research is expected to be completed by 2007. When the results of this
research are available, the Agency will make a determination of common mechanism of
toxicity as a basis for assessing cumulative risk. For information regarding EPA's
procedures for cumulating effects from substances found to have a common mechanism
of toxicity, see EPA's website at http ://www. epa. gov/pesticides/cumulative/.
C. Tolerance Reassessment Summary
Table 23. Tolerance Reassessment Summary for Resmethrin (40 CFR §180.525)
Commodity
Food items
Current
Tolerance
(ppm)
3.0
Range of
Residues
(ppm)
<0.003-0.377 '
Tolerance
Reassessment
(ppm)
To be
determined
Commenty/Correc^ Commodity
Definition]
Additional information/data are
required to upgrade the existing study
supporting the use of resmethrin as a
crack and crevice treatment, and new
studies are required supporting space
treatment uses in food and feed
handling establishments.
Resmethrin residues in/on representative food commodities following crack and crevice treatment to
representative types of food handling establishments.
There are no dietary or aggregate risk concerns associated with the current
tolerance and EPA considers it reassessed at the current tolerance level. However,
additional data are necessary to confirm this tolerance level is appropriate for resmethrin.
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There are currently no Codex or Canadian MRLs for resmethrin.
D. Regulatory Rationale
The Agency has determined that resmethrin is eligible for reregistration provided
that the risk mitigation measures and label amendments specified in the RED are
implemented. The following is a summary of the rationale for managing risks associated
with the use of resmethrin.
1. Human Health Risk
a. Dietary (Food + Drinking Water) Risk
Non-Cancer Dietary Risk
There are no resmethrin non-cancer dietary (food + drinking water) risks that
exceed the Agency's level of concern. This assessment is protective of the general U.S.
population and all population subgroups, including infants and children. Therefore, no
mitigation is necessary for these scenarios.
Cancer Dietary Risk
A slightly refined cancer dietary risk assessment was conducted for all supported
resmethrin food uses. When both detections and non-detections are included in the
resmethrin cancer dietary analysis, and the percentage of food handling establishment
treated is conservatively estimated to be 10%, dietary and drinking water risks are not of
concern to the Agency (lifetime dietary cancer risk for the general U.S. population is 1.6
x 10"6). Food risks are only slightly refined, which results in high-end estimates of
exposures to residues in food. Additionally, the LOD was used as the residue value for
all non-detections in a crack and crevice residue study with resmethrin. This also is an
overestimation of exposure. Drinking water exposure estimates were developed using the
tier 2 model PRZM-EXAMs, which also results in high-end estimates of potential
exposure to resmethrin. No mitigation is necessary for this scenario.
b. Residential Risk
Non-Cancer Residential Risk
Most estimates for residential risk are below EPA's level of concern. All
residential risks are below the Agency's level of concern (MOEs are above 1000), except
for post-application risk for a child exposed to indoor aerosol space sprays.
The non-cancer post-application inhalation risk estimate for a child exposed to an
indoor aerosol space spray exceeds the Agency's level of concern with an MOE of 900.
For the non-cancer post-application inhalation risk estimate, the Agency assumed that
one 16 oz spray can containing 0.2% ai was used per application. This exposure may
occur when a child enters a room within 10 minutes after a resmethrin indoor aerosol
space spray application. Potential risk is below the Agency's level of concern if a child
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waits 2 hours before entering a room where resmethrin has been applied as an indoor
aerosol space spray. In order to mitigate this inhalation risk, resmethrin products applied
as indoor aerosol space sprays must be labeled to instruct users to keep all people and
pets out of sprayed rooms for 2 hours after application. When residents stay out of
sprayed rooms for 2 hours, the post-application MOE for a child is 3500 which is below
the Agency's level of concern for residential exposure. No additional mitigation is
needed for this scenario.
Cancer Residential Risk
There are no residential cancer risks of concern when resmethrin is handled by
residents or applied to residential areas. Residential handler risk, bystander risk, and
residential post-application risk are below the Agency's level of concern for all scenarios.
Additionally, the residential handler scenario with the highest exposure and risk (indoor
aerosol space spray) was assumed to occur three times a year for 70 years. No mitigation
is necessary for these scenarios.
c. Aggregate (Food + Drinking Water + Residential) Risk
Non-Cancer Aggregate Risk
Non-cancer residential risks cannot be aggregated with the resmethrin non-cancer
assessment for food and drinking water because the toxicity endpoints for residential
dietary, incidental oral, dermal, and inhalation exposures are not based on common
effects. Therefore, no non-cancer aggregate risk assessment was conducted for
resmethrin, other than the previously described aggregate assessment of food and
drinking water.
Cancer Aggregate Risk
For the cancer aggregate risk analysis, a slightly refined dietary assessment was
combined with the residential cancer risk scenario with the highest exposure and risk
(residential indoor aerosol spray application). The slightly refined dietary assessment
risk estimate was 1.6 x 10"6, and the residential indoor aerosol spray application risk
estimate was 1.0 x 10"6 when residents wait 2 hours before re-entering the space that was
sprayed. The residential exposure scenario which was aggregated with dietary risks is the
one with the highest estimated exposure and risk (indoor aerosol space spray) of all the
residential scenarios assessed. EPA believes the estimated risks for each pathway of
exposure (food, drinking water, and residential) are greater than what people are likely to
experience, and the probability of people experiencing all these high-end exposures
together over the course of a lifetime is low. When these scenarios are combined, the
aggregate cancer risk estimate is 2.6 x 10"6, which is within an acceptable range.
Because the residential indoor aerosol spray application risk estimate is dependant
upon residents not entering sprayed spaces for 2 hours after application, a statement must
be placed on aerosol space spray residential labels indicating that residents must not enter
fogged spaces for 2 hours after application. A ventilation requirement will also be
required on labels indicating that residents must ventilate the sprayed space for 10
minutes with fresh air before occupying the room. Similar label requirements must also
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be placed on labels of products used by pest control operators (PCOs) that they must
inform residents to not enter sprayed spaces for 4 hours and ventilate for 20-120 minutes
depending on the size of the treated area before occupying the sprayed space. No
additional mitigation is necessary for these scenarios.
d. Occupational Risk
Non-Cancer Occupational Risk
Concerns for workers mixing, loading, and applying the liquid formulations of
resmethrin can be mitigated with PPE. All mixers, loaders, and appliers using liquid
formulations of resmethrin are required to wear gloves for dermal protection. In addition,
workers using foggers in indoor spaces are required to wear respirators for protection
against potential inhalation risk and coveralls for protection against potential dermal risk.
All applicators and other handlers using ready-to-use aerosol formulations will be
required to wear gloves. For products intended only for wide area mosquito abatement
programs, chemical-resistant gloves are required for all handlers except applicators.
Cancer Occupational Risk
There are some concerns for workers when mixing, loading, and applying the
liquid formulations of resmethrin. All mixers, loaders, and appliers using liquid
formulations of resmethrin are required to wear gloves for dermal protection. In addition,
workers using foggers in indoor spaces are required to wear respirators for protection
against potential inhalation risk and coveralls for protection against potential dermal risk.
All applicators and other handlers using ready-to-use aerosol formulations will be
required to wear gloves. For products intended only for wide area mosquito abatement
programs, chemical-resistant gloves are required for all handlers except applicators.
Exposure Reduction
The Agency incident report recommends appropriate respiratory protective
equipment for individuals who are likely to have substantial contact with resmethrin.
Because mosquito abatement handlers may be exposed to resmethrin on a regular basis,
enclosed cabs are required for ULV truck-mounted mosquito abatement spray
applications, and enclosed cockpits are required for ULV aerial mosquito abatement
spray applications. Additionally, as mentioned above, workers using foggers in indoor
spaces must wear respirators for protection from inhalation risk and coveralls for
protection from dermal risk.
A 12-hour REI is required for workers re-entering treated greenhouses after
resmethrin applications. In addition, workers who enter a resmethrin-treated greenhouse
before the REI has expired must wear coveralls over long-sleeve shirt and long pants,
chemical-resistant gloves made of any waterproof material, and shoes plus socks.
2. Environmental Risk
The Agency has conducted a screening-level ecological risk assessment for the
mosquito control use of resmethrin based on application of resmethrin to Florida turf.
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Based on the available data, the Agency has identified potential acute and chronic risks of
concern to freshwater fish, potential acute risks estuarine/marine fish, acute risks and
potential chronic risks to freshwater and estuarine/marine invertebrates, and freshwater
and estuarine/marine benthic organisms. Available data show potential acute and chronic
risks to birds when a dose-based study is used. When a dietary-based study is used, acute
and chronic risks to birds are considered not likely. There are no acute or chronic effects
to mammals, aquatic plants, or terrestrial plants exposed to resmethrin when it is applied
as a wide area mosquito abatement spray as modeled in the environmental fate and
effects assessment.
While there are slight estimated exceedances of the LOCs for some terrestrial and
aquatic species, based on its use pattern and usage information the ecological risks
associated with resmethrin are expected to be limited. Resmethrin is used for wide area
ULV mosquito abatement, in and around homes, commercial establishments, industrial
areas, and food handling establishments to treat flying and crawling insects, and by pet
groomers, veterinarians, and citizens for insect control on livestock and pets. Resmethrin
use is estimated at 50,000 Ibs per year, with over half of those pounds applied per year
used for mosquito control.
Release-height restrictions on resmethrin aerial mosquitocide applications will
reduce wildlife exposure. RQs were estimated with a 25 foot aerial boom height. The
resmethrin registrants have agreed to nozzle heights of no less than 100 feet above
ground or canopy for fixed wing applicators and no less than 75 feet above ground or
canopy for rotary wing applicators. The higher release heights will reduce wildlife
exposure to resmethrin.
The registrants for resmethrin have also agreed to set new application rates for
resmethrin. Previously, resmethrin labels had often not specified application rates. The
rates listed below will serve as maximum application rates for reregistered resmethrin
products.
Products labeled for use on Livestock, Farm Animals, and Pets (Direct Application):
Product must contain 0.35% ai. or less.
Products labeled for use in Outdoor Sites (Commercial, Recreational, Domestic Outdoor
Sites, Agricultural Structures, Agricultural Premises, and Agricultural Equipment): 0.25
Ib ai per acre.
Products labeled for use in Space Applications (Indoor Food Handling/Processing/Eating
Establishments; Commercial Structure Premises and Equipment; Domestic Structure
Premises and Equipment): 0.001 Ib ai per 1000 ft2.
Products labeled for use in Surface Crack and Crevice Application (Indoor Food
Handling/Processing/Eating Establishments; Commercial Structure Premises and
Equipment; Domestic Structure Premises and Equipment): 0.242 Ib ai per 1000 ft2.
Additionally, wide area mosquito control products must contain the following
requirements:
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• Products labeled for wide area mosquito abatement must state a maximum application
rate of 0.007 Ib ai/acre, and state a maximum yearly application limit of 0.2 Ib ai/acre.
• Release height requirement for rotary wing of no less than 75 feet above the ground
or canopy, for fixed wing of no less than 100 feet above the ground or canopy.
• Must contain environmental hazard statements informing user of toxicity to fish,
aquatic invertebrates, and oysters/shrimp.
• Must contain a statement informing user of toxicity to bees visiting treated area.
• Must be in compliance with EPA PR Notice 2005-1.
Stewardship Language
The Agency cannot currently fully assess the potential risks to aquatic organisms
from resmethrin use around the home. Therefore to lessen potential risks the Agency is
seeking to reduce the drift and run-off of resmethrin into aquatic habits through explicit
directions for use on both professional and consumer-use products for use in residential
settings. These use directions include best management and stewardship practices which
are formulation specific, and will serve to reduce the potential run-off and drift that can
occur from applications of these products. Label statements implementing these
measures are listed in the Label Changes Summary Table in Section V of this RED
document.
a. Fish and Aquatic Invertebrate Risk
The following summary of ecological concerns does not reflect all of the
mitigation measures mentioned above. Thus, the actual exposure to resmethrin will be
less for all non-target species than current estimates reflect.
Acute and Chronic Freshwater and Estuarine'/Marine Fish
For freshwater fish, the highest acute RQ value is 2.8 for freshwater fish in water
2 meters deep. This exceeds the acute risk LOG of 0.5 and the acute endangered species
LOG of 0.05 and is of concern. The RQ decreases in shallow water because resmethrin is
broken down through aqueous photolysis, and more light is available in shallow water.
The RQ value for chronic risk to freshwater fish is 1.7 for fish exposed to the TGAI in a
water body 2 meters deep at a 3 day application interval. This exceeds the chronic risk
LOG of 1. When a release height of 75 feet for aerial applications is considered, the RQs
for freshwater fish decrease to an acute RQ of 0.75 and a chronic RQ of 0.51. Thus,
when the release height of 75 feet is considered, the acute risk level is still of concern, but
the freshwater chronic risk level is no longer of concern.
For estuarine/marine fish, the RQ value does not exceed the acute risk LOG (0.5).
However, the acute endangered species LOG (0.05) is exceeded for estuarine/marine fish
(estimated value of 0.48 for formulated resmethrin). When a release height of 75 feet for
aerial applications is considered, the acute RQ decreases to 0.13, which is still above the
acute endangered species LOG. Chronic risks of concern for estuarine/marine fish are
not likely (RQs range from 0.02 to 0.29, therefore less than the chronic LOG of 1).
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Acute and Chronic Freshwater andEstuarine/Marine Invertebrates
For freshwater invertebrates, the acute RQ value exceeds the acute risk LOG (0.5)
and acute endangered species LOG (0.05) for resmethrin formulated products with an
estimated RQ value of 6.5. When a release height of 75 feet is considered for aerial
applications, the acute RQ decreases to 1.74, which is still above the acute risk and acute
endangered species LOCs. Chronic resmethrin exposure to freshwater invertebrate data
was not available, but chronic data from a similar pesticide, the pyrethrins, shows
reproductive effects in freshwater invertebrates with a NOAEC value of 0.86 ppb. This
may indicate potential chronic risk for freshwater invertebrates exposed to resmethrin.
For estuarine/marine invertebrates, the maximum acute RQ value exceeds the
acute risk LOG (0.5) and acute endangered species LOG (0.05) at 3.4 when
estuarine/marine invertebrates are exposed to formulated resmethrin. When a release
height of 75 feet is considered for aerial applications, the acute RQ decreases to 0.91,
which is a level that still exceeds the acute risk and acute endangered species LOCs.
Chronic resmethrin exposure to esturarine/marine invertebrates data was not available,
but chronic data from a similar pesticide, the pyrethrins, shows reproductive effects in
freshwater invertebrates with a NOAEC value of 0.86 ppb. This may indicate potential
chronic risk for estuarine/marine invertebrates exposed to resmethrin.
Acute and Chronic Freshwater and Estuarine/Marine Benthic Organisms
RQs for freshwater benthic organisms were calculated from water column studies
in the absence of sediment toxicity data for resmethrin. The maximum acute RQ value
does not exceed the acute risk LOG (0.5) at 0.11 for technical resmethrin, however this
level does exceed the acute endangered species LOG of 0.05. Registrants have agreed to
a release height of 75 for aerial mosquito applications. When this is taken into account
for aerial applications, the RQ decreases to 0.03, which is below the acute endangered
species LOG of 0.05. Therefore, acute risk is not likely to be of concern for freshwater
benthic organisms exposed to resmethrin. No chronic freshwater or estuarine/marine
benthic organism data were submitted to the Agency. However, based on the potential
for chronic risk to freshwater fish due to exposure to technical resmethrin, chronic
invertebrate data from other synthetic pyrethroids, and the affinity of resmethrin to
partition to sediment, there is potential for resmethrin to cause chronic effects in benthic
organisms.
RQs for estuarine/marine benthic organisms were calculated from water column
studies in the absence of sediment toxicity data for resmethrin. The maximum acute RQ
value does not exceed the acute risk LOG (0.5) at 0.26 for technical resmethrin.
However, the acute RQ does exceed the acute endangered species LOG 0.05. When a
release height of 75 feet is considered for aerial applications, the acute RQ decreases to
0.08, which is still slightly above the acute endangered species level of concern. No
chronic freshwater or estuarine/marine benthic organism data were submitted to the
Agency. However, based on the potential for chronic risk to freshwater fish due to
exposure to technical resmethrin, chronic invertebrate data from other synthetic
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pyrethroids, and the affinity of resmethrin to partition to sediment, there is potential for
resmethrin to cause chronic effects in benthic organisms.
Aquatic Plants
No aquatic vascular or non-vascular data plant data were submitted for
resmethrin. However, the Agency has determined that resmethrin will have no effect on
listed plants. It is unlikely that resmethrin poses a phytotoxic concern based on its
neurotoxic mode of action, lack of toxic effects when plants are exposed to other
pyrethroids, and lack of ecological incident reports for plants.
"Down-the-Drain " Assessment
Acute and chronic RQs for freshwater and estuarine fish and invertebrates are
below 0 and are therefore below the Agency's level of concern for acute risk (0.5) and
chronic risk (1.0). Therefore, no mitigation is necessary at this time to address
resmethrin risk to aquatic organisms around wastewater plant releases.
b. Avian Risk
Terrestrial Birds
When mean residues are considered, the acute use LOG (0.5) is not exceeded for
birds that feed on short grass, tall grass, and broadleaf plants/small insects when RQs are
calculated with a dose-based red-winged blackbird study. The acute endangered species
LOG of 0.1 is exceeded for 20g and lOOg birds feed on short grass. The chronic LOG (1)
is not exceeded for birds feeding on short grass, tall grass, and broadleaf plants/small
insects when the dose-based study is used. The highest chronic RQ considering mean
residues is 0.8.
When avian RQs are calculated with dietary-based toxicity values, no LOCs are
exceeded for any acute or chronic scenario.
c. Mammalian Risk
Terrestrial Mammals
All acute and chronic RQs are below the respective acute and chronic LOCs for
mammalian risk. Therefore, resmethrin is not likely to pose an acute or chronic risk to
mammals.
d. Terrestrial Plant Risk
No terrestrial plant data were submitted to the Agency for resmethrin. However,
the Agency has determined that resmethrin will have no effect on listed plants. It is
unlikely that resmethrin poses a phytotoxic concern based on its neurotoxic mode of
action, lack of toxic effects when plants are exposed to other pyrethroids, and lack of
ecological incident reports for plants.
e. Non-Target Insect Risk
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Currently, the Agency does not estimate RQs for terrestrial non-target insects.
However, based on a single study in honey bees, technical resmethrin is classified as
highly toxic on an acute contact basis to non-target terrestrial insects (LD50 = 0.063 ug/ai
per bee). Label statements addressing bee risk are required for all resmethrin
occupational and wide area mosquito abatement products used outdoors.
3. Ongoing Work on Pyrethoids
One of the risk assessment goals of the Office of Pesticide Programs (OPP) is to
estimate pesticide exposure through all significant routes of exposure from both
agricultural and non-crop uses. However, the ecological risk assessments for most
pyrethroid insecticides focus predominantly on the agricultural uses for these
insecticides, because pesticide transport models are available to estimate potential aquatic
exposure. Based on laboratory toxicity tests with terrestrial and aquatic animals, aquatic
exposure would be more likely to cause adverse effects in the environment.
However, sales data indicate that non-crop uses of the pyrethroids comprise a
much larger fraction of total use than agricultural uses. The use of pyrethroids in urban
and suburban settings has increased since the phase-out of these uses of the
organophosphate insecticides diazinon and chlorpyrifos. Sales data indicate that the
majority of urban use of pyrethroids is for structural pest control, such as for control of
termites or ants. Other outdoor non-crop uses include landscape maintenance, and
homeowner lawn and garden use. Indoor uses include insect control, and treatment of
pets and clothing.
The Agency uses a "down-the-drain" model to perform a screening-level aquatic
risk assessment for indoor uses of pesticides. In these simulations, waste water
containing pesticide residue flows into a building drain and passes through a sanitary
sewer and publicly owned treatment works (POTW) before being discharged to surface
water. However, no analogous exposure model has been developed to allow a similar
screening-level assessment for pesticides applied in an outdoor urban setting. As a result,
the Agency has had to take a qualitative approach to characterize the potential aquatic
risk from urban and suburban use of pyrethroids.
For outdoor urban uses, it is assumed that runoff water from rain and/or lawn
watering may transport pesticides to storm sewers and then directly to surface water.
Conceptually, a greater contribution to pyrethroid loading to surface water bodies would
be expected from application to impervious surfaces such as walkways, driveways or the
sides of buildings, than to lawns or bare ground, because of the pyrethroids' strong
affinity to bind to organic carbon in soils. However, the Agency is unaware of any model
which can simulate the different application methods for urban use and the physical
representation of the urban landscape, storm sewer and receiving water configuration.
There are models available which can be calibrated to simulate sites and
pesticides for which extensive flow and pollutant data have been collected in advance.
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The HSPF/NPSM model, for instance, which is included in the Office of Water's
BASINS shell, has been used to calibrate stream flow and copper pesticide use data to
simulate loading of these pesticides consistent with concentrations measured in surface
water monitoring. Risk assessors with the California Department of Environmental
Protection confirmed in conversations with the Agency that they also have used
watershed models to calibrate to previously collected flow and pesticide monitoring data,
but that they did not know of any models capable of predicting concentrations of
pyrethroids that might occur because of outdoor urban uses.
Development of a screening model which could simulate the fate and transport of
pesticides applied in an urban setting would require a large body of data which is
currently unavailable. For instance, an urban landscape cannot be simulated as easily as
an agricultural field. The PRZM model simulates runoff from an agricultural field using
readily available data describing surface soil characteristics and laboratory data detailing
the persistence and mobility of pesticides in these soils. The agricultural field simulated
is homogenously planted to a single crop, and soil and water are transported from the
field to a receiving water body with dimensions consistent with USDA farm-pond
construction guidelines.
By contrast, an urban landscape or suburban housing development consists of
impervious surfaces such as streets and sidewalks, and pervious surfaces such as lawns
and parkland. One could expect much greater mobility for pesticides applied to
impervious surfaces, but laboratory soil metabolism studies may not provide an accurate
measure of the persistence of pesticides on these surfaces. The path runoff water and
eroded sediment might take is less obvious for an urban setting than an agricultural field.
First, an urban landscape cannot be considered homogeneous, as the proportion of
impervious and pervious surfaces varies for different locations. In addition, the flow path
of runoff water and sediment is not necessarily a direct path over land, but can pass
below ground through storm sewer networks, or be directed or slowed by pumping
stations or temporary holding ponds.
Finally, the timing and magnitude of urban uses is less well defined for urban uses
than agricultural uses. While agricultural uses would occur within a predictable window
during the growing season, the need for urban uses could occur at different times each
year, and might occur at different times within the same watershed. In addition, since
records of how and to what extent pyrethroids are applied by homeowners are less well
defined than for professional applications, it is harder to estimate the total load to model.
Pyrethroid monitoring data
The Agency considers surface water monitoring data in addition to modeling
results when they are available. However, surface water monitoring for pyrethroids has
been limited, perhaps because the pyrethroids would more likely be associated with
aquatic sediment than the water column. The USGS NAWQA program included
permethrin as the only pyrethroid among its pesticide analytes, and detected it in 0.15%
of 1185 agricultural stream samples from 78 sample locations. Permethrin was not
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detected in 803 urban stream samples taken from 33 sample locations. The NAWQA
program also analyzed for c/'s-permethrin in bed sediments, and had similar detection
rates in between the agricultural (1.5%) and urban (1.0%) land use sites; trans-permethrin
was detected in 0.8% of bed sediment samples. Resmethrin was not detected in the
USGS NAWQA survey.
More recently, researchers from the University of California-Berkeley have
published studies which reported transport of pyrethroids to stream bed sediment as a
result of urban uses. In 2004, Weston, et al. collected sediment from creeks draining a
residential area in Rosedale, California. The sediments were analyzed for 7 pyrethroids
(including permethrin and cypermethrin, which are currently in the reregistration
process), as well as for other insecticides. The sediments were not analyzed for
resmethrin. All of the pyrethroids were detected in the bed sediment from at least one
sampling location. The researchers exposed the aquatic amphipod Hyalella azteca to the
21 sediment samples they collected; pesticide concentrations in 9 of these samples was
sufficient to cause 90% mortality in the amphipods after a 10-day exposure. The
concentrations of pyrethroids detected in the sediments were above the level expected to
cause 50% mortality in H. azteca, suggesting that the pyrethroids were responsible for the
observed toxicity.
In a subsequent study, Weston, et al. collected samples from 15 urban creeks in
California and 12 in Tennessee. Toxicity to H. azteca was observed at least once with
sediments taken from 12 of the 15 California sampling sites. In most cases, the toxicity
could be accounted for by the concentrations of pyrethroids detected in the sediment.
Pyrethroids were rarely detected in the Tennessee sediment samples, and exposure to the
Tennessee sediments did not prove to be toxic to H. azteca.
Future steps
The results of the Weston, et al. studies has led a number of organizations, such as
the California State Water Resources Control Board (SWRCB) to submit comments to
the Agency during the reregistration process of several pyrethroid insecticides, calling for
mitigation measures to prevent pyrethroid surface-water contamination. However, the
lack of knowledge which makes it difficult to develop an urban pesticide transport model
also makes it difficult to identify meaningful mitigation at this time. The Agency has
developed some initial mitigation options during the reregistration process, and intends to
identify steps which can be taken to allow a greater understanding of potential ecological
risk from urban pyrethroid uses.
One reason that broad mitigation measures cannot be adopted during
reregistration is that only three pyrethroid insecticides are required to be reviewed for
reregistration in accoradance with FQPA. If use restrictions were placed on one of these
three pesticides, one of the other pyrethroids would likely replace it for that use. It is
important, as some commenters have suggested, to perform a risk assessment for all of
the pyrethroids at the same time. The Weston papers indicated that the sediments which
proved toxic to the tested aquatic invertebrate were contaminated not only with the
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pyrethroids undergoing reregistration, but also other pyrethroids such as bifenthrin and
lambda-cyhalothrin.
The next opportunity to assess the pyrethroids as a group will occur during the
Registration Review program, for which the Agency issued a proposed rule in July 2005
and plans to issue the final rule and implement the program in 2006. The purpose of
Registration Review is to ensure the periodic review of all pesticides to make sure they
continue to meet current scientific and regulatory requirements, with the goal of
reviewing each pesticide every fifteen years. The pyethroids are tentatively scheduled for
re-evaluation under the proposed Registration Review program in 2010.
A number of steps are planned for the intervening years which should improve the
Agency's ability to assess the level of aquatic exposure to pyrethroids from urban use.
One step is to better identify what conditions in an urban setting might lead to greater
vulnerability to transport to urban water bodies. Although the Weston papers reported
sediment toxicity from samples from California but not Tennesse, the authors could only
speculate what differences in use or geography made an area more vulnerable to exposure
than the other.
Further investigation into the dominant urban uses and application practices of
pyrethroids around the country would help provide a clearer picture of relative
vulnerability. The SWRCB commented that structural pest control is likely a major
source of pyrethroids in urban runoff, and suggested best management practices (BMP).
The Pyrethroid Working Group (PWG) indicated that irrigation of lawns in areas of
California with little rainfall during the application season could be a major contributor,
and has contacted organizations such as Responsible Industry for a Sound Environment
(RISE) and the Coalition for Urban/Residential Environmental Stewardship (CURES) to
develop BMPs as part of their product stewardship plan. As further sediment monitoring
studies are published describing parts of the country with different weather and pest
pressures, more detailed usage data will make it easier to correlate the causes of
pyrethroid use practices.
The Agency will also continue in its efforts to develop a screening-level model
for urban pesticide uses. Advances in the resolution of GIS databases may allow better
representation of the impervious and pervious portions of a typical urban landscape. As
it becomes clearer which uses are most likely to lead to transport of pyrethroids to surface
water, the conceptual model of how urban transport should be simulated will be more
focused.
Finally, the Agency will evaluate available published literature and call-in data to
resolve data gaps to ensure a robust comparison of the potential ecological risk of all the
pyrethroids during Registration Review. Toxicity data cited by several commenters from
published literature are included in the Agency's ECOTOX database. The Agency will
evaluate the quality of studies to identify those to be included in the risk assessments
during Registration Review. The PWG is currently performing specific toxicity studies
identified by the Agency as data gaps, such as sediment invertebrate toxicity tests.
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V. What Registrants Need to Do
The Agency has determined that resmethrin is eligible for reregistration provided
that the mitigation measures and label changes identified in this RED are implemented.
Registrants will need to amend their product labeling to incorporate the label statements
set forth in the Label Changes Summary Table (table XX). The Agency intends to issue
Data Call- Ins (DCIs) requiring generic and product specific data. Generally, the
registrant will have 90 days from receipt of a DCI to complete and submit response forms
or request time extensions and/or waivers with a full written justification. For product-
specific data, the registrant will have eight months to submit data and amended labels.
A. Manufacturing Use Products
1. Additional Generic Data Requirements
The generic data base supporting the reregistration of resmethrin for currently
registered uses has been reviewed and determined to be substantially complete. However,
the data listed below are necessary to confirm the reregistration eligibility decision
documented in this RED.
Table 24. Guideline Requirements for Resmethrin
Data Requirement
Old Guideline
No.
New OPPTS
Guideline No.
Environmental Fate and Ecological Effects Data Requirements
Photodegradation of parent and degradates in soil
(Photodegradation in Soil of Resmethrin)
Aquatic invertebrate life cycle (freshwater and
estuarine/marine invertebrates)
Acute sediment testing (freshwater and estuarine/marine)
(Freshwater held in reserve)
Chronic sediment testing (freshwater and estuarine/marine)
Avian reproduction test (with bobwhite quail)
Fish early life-stage toxicity test (freshwater and
estuarine/marine)
Fish acute toxicity test (freshwater and marine)
Aquatic invertebrate acute toxicity test, freshwater
daphnids
Mysid acute toxicity test
Bivalve acute toxicity test (embryo larval)
Oyster acute toxicity test (shell deposition)
161-3
72-4
74-1
EPA/600/R-
99/064
EPA/600/RO 1/020
71-4
72-4
72-1
72-3
72-2
72-3
72-3
72-3
835.2410
850.1350
850.1300
850.1735
850.1740
850.2300
850.1400
850.1075
850.1010
850.1035
850.1055
850.1025
Human Health Effects Data Requirements
90-Day neurotoxicity screening battery
870.6200b
66
-------
Developmental neurotoxicity study
Nature of the residue - plants
Multiresidue Method
Storage Stability Data
Magnitude of the Residue - food handling - food items
Magnitude of the Residue - meat, milk, poultry, eggs
83-6
171-4
171-4
171-4
171-4
171-4
870.6300
860.1300
860.1360
860.1380
860.1460
860.1480
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-
specific data regarding the pesticide after a determination of eligibility has been made.
The registrant must review previous data submissions to ensure that they meet current
EPA acceptance criteria and if not, commit to conduct new studies. If a registrant
believes that previously submitted data meet current testing standards, then the study
MRID numbers should be cited according to the instructions in the Requirement Status
and Registrants Response Form provided for each product. The Agency intends to issue
a separate product-specific data call-in (PDCI) outlining specific data requirements.
2. Labeling for End-Use Products
To be eligible for reregistration, labeling changes are necessary to implement
measures outlined in Section IV above. Specific language to incorporate these changes is
specified in Table 25. Generally, conditions for the distribution and sale of products
bearing old 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.
67
-------
68
-------
Labeling Changes Summary Table
In order to be eligible for reregistration, amend all product labels to incorporate the risk mitigation measures outlined in Section IV.
The following table describes how language on the labels should be amended.
Table 25: Summary of Labeling Changes for Resmethrin
Description
Manufacturing Use Products
Placement on Label
Formulation instructions
required on 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]."
"Not for formulation into end use products for use in indoor metered spray systems."
"Not for formulation into end use products for use in outdoor misting systems."
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 such use(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 such use(s)."
Directions for Use
Environmental Hazards
Statements Required by the
RED and Agency Label
Policies
"Environmental Hazards
This product is toxic to fish, aquatic invertebrates, and oysters/shrimp. Do not discharge
effluent containing this product into lakes, streams, ponds, estuaries, oceans, or other waters
unless in accordance with the requirements of a National Pollution Discharge Elimination
System (NPDES) permit and the permitting authority has been notified in writing prior to
discharge. Do not discharge effluent containing this product to sewer systems without
previously notifying the local sewage treatment plant authority. For guidance contact your
State Water Board or Regional Office of the EPA."
Precautionary Statements
-------
End Use Products Intended for Occupational Use
Excludes Products Intended for Use in Wide Area Mosquito Abatement Programs (See below requirements)
PPE Requirements Established
by the RED1
for Liquid Formulations
(excludes formulations applied
via ready-to-use aerosols)
"Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are" (registrant inserts correct
chemical-resistant material). If you want more options, follow the instructions for category
[registrant inserts A,B,C,D,E,F,G,or H] on an EPA chemical-resistance category selection
chart.
All mixers, loaders, applicators, and other handlers must wear:
- long sleeved shirt and long pants,
- socks plus shoes, and
- chemical resistant gloves.
Applicators using handheld fog equipment must wear:
- coveralls over long sleeved shirt and long pants,
- chemical-resistant gloves,
- chemical-resistant footwear plus socks,
- chemical-resistant headgear, if overhead exposure,
- chemical-resistant apron when mixing, loading, and cleaning equipment or spills, and
- A NIOSH-approved respriator with
- a dust/mist filter with MSHA/NIOSH approval number prefix TC-21C or
- any N* R, P, or He filter."
instruction to Registrant: Drop the "N" type prefilter from the respirator statement, if the
pesticide product contains, or is used with, oil.
Immediately following/below
Precautionary Statements:
Hazards to Humans and Domestic
Animals
PPE Requirements Established
by the RED1
for Ready-to-use Aerosol
Products
"Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are" (registrant inserts correct
chemical-resistant material). If you want more options, follow the instructions for category
[registrant inserts A,B,C,D,E,F,G,or H] on an EPA chemical-resistance category selection
chart.
All applicators and other handlers must wear:
- long sleeved shirt, long pants, and
- socks plus shoes, and
Immediately following/below
Precautionary Statements:
Hazards to Humans and Domestic
Animals
-------
- chemical-resistant gloves."
User Safety Requirements
"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."
Precautionary Statements:
Hazards to Humans and Domestic
Animals immediately following
the PPE requirements
User Safety Recommendations
"User Safety Recommendations
Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the
toilet.
Users should remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly
and put on clean clothing.
Users should remove PPE immediately after handling this product. Wash the outside of gloves
before removing. As soon as possible, wash thoroughly and change into clean clothing."
Precautionary Statements under:
Hazards to Humans and Domestic
Animals immediately following
Engineering Controls
(Must be placed in a box.)
Environmental Hazards for All
Products that have outdoor use
sites
Note: Products with indoor
uses only see below
"Environmental Hazards
This pesticide is toxic to fish, aquatic invertebrates, and oysters/shrimp. Do not apply directly
to water, or to areas where surface water is present or to intertidal areas below the mean high
water mark. Do not contaminate water when disposing of equipment washwater or rinsate.
Drift and runoff may be hazardous to aquatic organisms in water adjacent to treated areas.
This product may contaminate water through runoff. This product has a potential for runoff for
several days after application. Poorly draining soils and soils with shallow water tables are
more prone to produce runoff that contains this product. A level, well maintained vegetative
buffer strip between areas to which this product is applied and surface water features such as
ponds, steams, and springs will reduce the potential for contamination of water from rainfall-
runoff. Runoff of this product will be reduced by avoiding applications when rainfall is
forecasted to occur within 48 hours. Sound erosion control practices will reduce this product's
contribution to surface water contamination."
Precautionary Statements
immediately following the User
Safety Recommendations
Environmental Hazards for
products that only contain
indoor use sites
Note to registrant:
Products labeled solely for indoor use except as noted below may omit the Environmental
Hazards statements. Such products must have the following statement in the Directions for
Use:
Precautionary Statements
immediately following the User
Safety Recommendations
-------
Environmental Hazards for
Indoor Use Products packaged
in containers equal to or greater
than 5 gallons or 50 Ibs
"For indoor use only."
"This pesticide is toxic to fish, aquatic invertebrates, and oysters/shrimp. Do not discharge
effluent containing this product into lakes, streams, ponds, estuaries, oceans, or other waters
unless in accordance with the requirements of a National Pollution Discharge Elimination
System (NPDES) permit and the permitting authority has been notified in writing prior to
discharge. Do not discharge effluent containing this product to sewer systems without
previously notifying the local sewage treatment plant authority. For guidance contact your
State Water Board or Regional Office of the EPA."
Precautionary Statements
Restricted-Entry Interval for
products with directions for use
within the scope of the Worker
Protection Standard for
Agricultural Pesticides (WPS)
"Do not enter or allow worker entry into treated areas during the restricted entry interval (REI)
of 12 hours."
Directions for Use, Under
Agricultural Use Requirements
Box
Entry Restrictions for all
products with indoor use sites
AND directions for use outside
the scope of the WPS.
For products applied as crack and crevice and surface sprays:
"Do not enter or allow other people (or pets) to enter the treated area until sprays have dried."
For products applied as space sprays or fogs:
"Close doors, windows and shut off all ventilation equipment before application. Leave the
treated area. Post signs on entrances stating that the area has been treated with resmethrin and
that it is to remain closed for at least 4 hours after application. Do not re-enter and do not allow
anyone else to re-enter the site for 4 hours. Ventilate thoroughly before anyone is allowed to
re-enter.
- Ventilate thoroughly for 20 minutes for treatment of less than 10,000 cubic feet of space.
- Ventilate thoroughly for 60 minutes for treatment of less than 50,000 cubic feet of space.
- Ventilate thoroughly for 120 minutes for treatment of greater than 50,000 cubic feet of
space."
If no WPS uses on the product,
place the appropriate statement
in the Directions for Use Under
General Precautions and
Restrictions If the product also
contains WPS uses, then create a
NonAgricultural Use
Requirements box as directed in
PR Notice 93-7 and place the
appropriate statement inside that
box.
Early Entry Personal Protective
Equipment for products with
directions for use within the
scope of the WPS
"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 plus socks
- chemical-resistant gloves made of any waterproof material."
Directions for Use Inside the
Agricultural Use Requirements
Box
General Application
"Do not apply this product in a way that will contact workers or other persons, either directly or
Place in the Direction for Use
-------
Restrictions
Use-Specific Application
Restrictions
through drift. Only protected handlers may be in the area during application."
Labeling required on all products:
"Do not use in indoor metered spray systems."
"Do not use in automatic misting systems."
Note: Registrants must amend the label to include the maximum allowable application rate and
maximum allowable rate per year must be listed as pounds or gallons of formulated products
per acre or 1000 ft2, not just as pounds active ingredient per acre or 1000 ft2.
Products labeled for use on Livestock, Farm Animals, and Pets (Direct Application):
"Do not apply with product containing more than 0.35% ai."
Products labeled for use in Outdoor Sites (Commercial, Recreational, Domestic Outdoor Sites,
Agricultural Structures, Agricultural Premises, and Agricultural Equipment):
"Do not apply more than 0.25 Ib ai per acre."
OR
For ready-to-use products, registrants must amend their labels to specify use rates that result in
no more than 0.25 Ib ai per acre.
Products labeled for use in Space Applications (Greenhouses; Indoor Food
Handlins/Processins/Eatins Establishments; Commercial Structure Premises and Equipment;
Domestic Structure Premises and Equipment):
"Do not apply more than 0.001 Ib ai per 1000 ft2."
OR
For ready-to-use products, registrants must amend their labels to specify use rates that result in
no more than 0.001 Ib ai per 1000 ft2
Products labeled for use in Surface Crack and Crevice Application (Greenhouses; Indoor Food
Handlins/Processins/Eatins Establishments; Commercial Structure Premises and Equipment;
directly above the Agricultural
Use Box.
Directions for Use
-------
Domestic Structure Premises and Equipment):
"Do not apply more than 0.242 Ib ai per 1000 ft2."
OR
For ready-to-use products, registrants must amend their labels to specify use rates that result in
no more than 0.242 Ib ai per 1000 ft2
Products labeled for indoor use sites:
"Remove pets, birds, and cover aquariums and turn off air pumps before application.
In food processing operations, homes, or any other location where food is prepared or served,
do not apply this product while food is exposed or being processed. Cover or remove all
exposed food, packaging material, and food contact surfaces. Do not apply directly to food,
packaging material, or any food contact surfaces.
Remove or cover dishes, utensils, food processing equipment and food preparation surfaces
before use of this product. All food processing surfaces and equipment in the treatment area
must be covered or washed with an effective cleaning compound followed by a potable water
rinse after use of this product."
For End-Use Products Intended for Wide Area Mosquito Abatement Programs Only
Restricted Use Pesticide
"Restricted Use Pesticide. Due to Acute Fish Toxicity. For retail sale to and use only by
certified applicators or persons under their direct supervision and only for those uses covered
by the certified applicator's certification. Direct supervision for this product is defined as the
certified applicator being physically present during mixing, loading, equipment repair and
equipment cleaning. Certified applicators must ensure that all persons involved in these
activities under their direct supervision are informed of the precautionary statements."
Top front panel
PPE Requirements Established
by the RED1
"Personal Protective Equipment (PPE)
Some materials that are chemical-resistant to this product are" (registrant inserts correct
chemical-resistant material). If you want more options, follow the instructions for category
[registrant inserts A,B, C,D,E,F, G, or H] on an EPA chemical-resistance category selection
chart.
Immediately following^elow
Precautionary Statements:
Hazards to Humans and Domestic
Animals
-------
All mixers, loaders, applicators, and other handlers must wear:
- long sleeved shirt and long pants,
- socks plus shoes, and
- chemical-resistant gloves for all handlers except applicators.
See engineering controls for additional requirements."
User Safety Requirements
"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."
Precautionary Statements:
Hazards to Humans and Domestic
Animals immediately following
the PPE requirements
Engineering Controls
Engineering Controls:
"Applicators using ground mechanical application equipment must use an enclosed cab that has
a nonporous barrier that totally surrounds the occupants and prevents contact with pesticides
outside the cab. Must be provided and have immediately available for use upon exiting the cab
chemical-resistant gloves."
"Pilots must use an enclosed cockpit. The cockpit must have a nonporous barrier that totally
surrounds the occupants and prevents contact with pesticides outside the cab. Pilots must wear
the PPE specified in this label for applicators."
Precautionary Statements:
Hazards to Humans and Domestic
Animals (Immediately following
PPE and User Safety
Requirements.)
User Safety Recommendations
"User Safety Recommendations
Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the
toilet.
Users should remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly
and put on clean clothing.
Users should remove PPE immediately after handling this product. Wash the outside of gloves
before removing. As soon as possible, wash thoroughly and change into clean clothing."
Precautionary Statements under:
Hazards to Humans and Domestic
Animals immediately following
Engineering Controls
(Must be placed in a box.)
-------
Environmental Hazards
"This pesticide is toxic to aquatic organisms, including fish, crustaceans, and oysters. Runoff
from treated areas or deposition of spray droplets into a body of water may be hazardous to
fish, crustaceans, and oysters."
"Do not apply when bees are visiting the treatment area, except when applications are made to
prevent or control a threat to public and/or animal health determined by a state, tribal, or local
health or vector control agency on the basis of documented evidence of disease causing agents
in vector mosquitoes or the occurrence of mosquito-borne disease in animal or human
populations, or if specifically approved by the state or tribe during a natural disaster recovery
effort."
"Before making the first application in a season, it is advisable to consult with the state or tribal
agency with primary responsibility for pesticide regulation to determine if other regulatory
requirements exist."
"Do not apply over bodies of water (lakes, rivers, permanent streams, natural ponds,
commercial fish ponds, swamps, marshes or estuaries), except when necessary to target areas
where adult mosquitoes are present, and weather conditions will facilitate movement of applied
material away from the water in order to minimize incidental deposition into the water body.
Do not contaminate bodies of water when disposing of equipment rinsate or washwaters."
Precautionary Statements
immediately following the User
Safety Recommendations
Application Restrictions
"Do not apply more than 0.007 Ib ai/acre per application."
"Do not apply more than 0.2 Ib ai/acre per year in any treated area. More frequent treatments
may be made to prevent or control a threat to public and/or animal health determined by a state,
tribal, or local health or vector control agency on the basis of documented evidence of disease
causing agents in vector mosquitoes or the occurrence of mosquito-borne disease in animal or
human populations, or if specifically approved by the state or tribe during a natural disaster
recovery effort."
"Products must comply with EPA PR Notice 2005-1."
Directions for Use
Spray Drift Label Language for
ALL Products Intended for
SPRAY DRIFT MANAGEMENT
Directions for Use under General
Precautions and Restrictions
-------
ULV Mosquito Abatement
Programs Only
"A variety of factors including weather conditions (e.g., wind direction, wind speed,
temperature, relative humidity) and method of application (e.g., ground, aerial, airblast,
chemigation) can influence pesticide drift. The applicator must evaluate all factors and make
appropriate adjustments when applying this product."
WIND SPEED:
"Do not apply when wind speed is 0 mph."
DROPLET SIZE:
"Ground-based application:
Spray equipment must be adjusted so that the volume median diameter is less than microns (Dv
0.5 < 8-30 um) and that 90% of the spray is contained in droplets smaller than microns (Dv 0.9
< 50 um). Directions from the equipment manufacturer or vendor, pesticide registrant or a test
facility using a laxer-based measurement instrument must be used to adjust equipment to
produce acceptable droplet size spectra. Application equipment must be tested at least annually
to confirm that pressure at the nozzle and nozzle flow rate(s) are properly calibrated."
"Aerial Application:
Spray equipment must be adjusted so that the volume median diameter produced is less than
microns (Dv 0.5 < 60 um) and that 90% of the spray is contained in droplets smaller than
microns (Dv 0.9 < 80 um). The effects of flight speed, and for non-rotary nozzles, nozzle angle
on the droplet size spectrum must be considered. Directions from the equipment manufacturer
or vendor, pesticide registrant or a test facility using a wind tunnel and laser-based
measurement instrument must be used to adjust equipment to produce acceptable droplet size
spectra.
EQUIPMENT CALIBRATION:
Application equipment must be tested at least annually to confirm that pressure at the nozzle
and nozzle flow rate(s) are properly calibrated."
RELEASE HEIGHT:
Fixed wing:
"Apply using a nozzle height of no less than 100 feet above the ground or canopy."
-------
Rotary wing:
"Apply using a nozzle height of no less than 75 feet above the ground or canopy."
BOOM LENGTH:
"The boom length must not exceed 75% of the wingspan or 90% of the rotor blade diameter."
End Use Products Intended for Residential Use
Application Restrictions
"Do not apply this product in a way that will contact any person or pet, either directly or
through drift. Keep people and pets out of the area during application."
Directions for Use under
General Precautions and
Restrictions
Entry Restrictions
For products applied as crack and crevice and surface sprays:
"Do not enter or allow other people (or pets) to enter the treated area until sprays have dried."
For products applied as space sprays or fogs:
"Close doors, windows and shut off all ventilation equipment before application. Leave treated
area closed for at least 2 hours after application. Do not remain in treated area(s). Ventilate
thoroughly for 20 minutes with fresh air before re-occupying treated area(s)."
Directions for use under General
Precautions and Restrictions
Environmental Hazards
For products that have outdoor uses:
"This product is extremely toxic to fish, aquatic invertebrates, and oysters/shrimp. Do not
apply directly to or near water. Drift and run-off may be hazardous to fish in water adjacent to
treated areas. Do not contaminate water when disposing of equipment, washwater, or rinsate.
See Directions for Use for additional precautions and requirements."
Precautionary Statements
immediately following the User
Safety Recommendations
Use-Specific Application
Restrictions
Labeling required on all products applied as sprays:
"Do not use in indoor metered spray systems."
"Do not use in automatic misting systems."
APPLICATION RATE RESTRICTIONS:
Directions for Use
-------
Products containing greater than 0.35% ai must not be labeled for use on pets.
Note: Registrants must amend the label to reflect the below maximum allowable application
rate per year. The rate must be listed as pounds or gallons of formulated product per acre or
1000 ft2, not just as pounds active ingredient per acre or 1000 ft2. For ready-to-use products,
registrants must amend their labels to specify use rates that will result in the below maximum
application rates.
Products labeled for use in Outdoor Sites (Backyard, patios, and ornamentals):
Maximum application rate 0.25 Ib ai per acre.
Products labeled for Space Application (domestic dwellings'):
Maximum application rate 0.001 Ib ai per 1000 ft2.
"Do not use more than 3 times a year."
Products labeled for Surface Crack and Crevice Application (domestic dwellings'):
Maximum application rate 0.242 Ib ai per 1000 ft2.
OTHER RESTRICTIONS:
Products labeled for use in indoor use sites:
"Remove pets, birds, and cover aquariums and turn off air pumps before application."
"In homes or any other location where food is prepared or served, do not apply this product
while food is exposed or being processed. Cover or remove all exposed food and food contact
surfaces. Do not apply directly to food, packaging material, or any food contact surfaces."
"Remove or cover dishes, utensils, food processing equipment and food preparation surfaces
before use of this product. All food processing surfaces and equipment in the treatment area
should be covered or washed with an effective cleaning compound followed by a potable water
rinse after use of this product."
Products labeled for use in outdoor use sites except for Ready to Use Formulations:
-------
"Do not apply directly to or near water, storm drains, or drainage ditches. Do not apply when
windy. To prevent product run-off, do not over water the treated area(s) or apply when heavy
rain is expected. Rinse application equipment over lawn or garden area only."
Ready to use products labeled for outdoor use sites:
"Do not apply directly to or near water, storm drains, or drainage ditches. Do not apply when
windy. To prevent product run-off, do not over water the treated area(s) or apply when heavy
rain is expected."
1 PPE that is established on the basis of Acute Toxicity of the end-use product must be compared to the active ingredient PPE in this document. The more
protective PPE must be placed in the product labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7.
-------
Appendix A
Use Patterns Subject for Reregistration of Resmethrin
Site
DIRECT APPLICATION TO
LIVESTOCK, FARM ANIMALS,
AND PETS
OUTDOOR USE SITES
(COMMERCIAL, RECREATIONAL,
DOMESTIC OUTDOOR SITES,
AGRICULTURAL STRUCTURES,
AGRICULTURAL PREMISES, AND
AGRICULTURAL EQUIPMENT)
SPACE APPLICATIONS
(GREENHOUSES; INDOOR FOOD
HANDLING/PROCESSING/
EATING ESTABLISHMENTS;
COMMERCIAL STRUCTURE
PREMISES AND EQUIPMENT;
DOMESTIC STRUCTURE
PREMISES AND EQUIPMENT)
SURFACE CRACK AND
CREVICE APPLICATION
(GREENHOUSES; INDOOR FOOD
HANDLING/PROCESSING/
EATING ESTABLISHMENTS;
COMMERCIAL STRUCTURE
PREMISES AND EQUIPMENT;
DOMESTIC STRUCTURE
PREMISES AND EQUIPMENT)
Form
Code
RTU
EC,
PRL,
RTU,
SC/L
EC,
PRL,
RTU
EC,
PRL,
RTU
Max.App
Rate/App
0.35%
0.25
0.001
0.242
Unit
(ai)
N/A
Ib/acre
lb/1 000ft2
lb/1 000ft2
Use Pattern/Limitations
For ready-to-use products, registrants must
amend their labels to specify use rates that
result in no more than 0.25 Ib ai per acre.
For ready-to-use products, registrants must
amend their labels to specify use rates that
result in no more than 0.001 Ib ai per
1000ft2.
For ready-to-use products, registrants must
amend their labels to specify use rates that
result in no more than 0.242 Ib ai per
1000ft2.
81
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Site
END-USE PRODUCTS INTENDED
FOR WIDE AREA MOSQUITO
ABATEMENT PROGRAMS
Form
Code
EC,
EC*RTU
Max.App
Rate/App
0.007
Unit
(ai)
Ib/acre
Use Pattern/Limitations
"Restricted Use Pesticide. Due to Acute
Fish Toxicity. For retail sale to and use
only by certified applicators or persons
under their direct supervision and only for
those uses covered by the certified
applicator's certification. Direct
supervision for this product is defined as the
certified applicator being physically present
during mixing, loading, equipment repair
and equipment cleaning. Certified
applicators must ensure that all persons
involved in these activities under their
direct supervision are informed of the
precautionary statements."
"Do not apply more than 0.007 Ib ai/acre
per application."
"Do not apply more than 0.2 Ib ai/acre per
year in any treated area. More frequent
treatments may be made to prevent or
control a threat to public and/or animal
health determined by a state, tribal, or local
health or vector control agency on the basis
of documented evidence of disease causing
agents in vector mosquitoes or the
occurrence of mosquito-borne disease in
animal or human populations, or if
specifically approved by the state or tribe
during a natural disaster recovery effort."
"Products must comply with EPA PR
Notice 2005-1."
82
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Appendix B
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for
active ingredients within the case 2510 covered by this Reregistration Eligibility Decision
Document. It contains generic data requirements that apply to 2510 in all products,
including data requirements for which a "typical formulation" is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in
which they appear in 40 CFR Part 158. The reference numbers accompanying each test
refer to the test protocols set in the Pesticide Assessment Guidelines, which are available
from the National Technical Information Service, 5285 Port Royal Road, Springfield, VA
22161 (703)487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the
data requirements apply. The following letter designations are used for the given use
patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its
files, this column lists the identifying number of each study. This normally is the Master
Record Identification (MRID) number, but may be a "GS" number if no MRID number
has been assigned. Refer to the Bibliography appendix for a complete citation of the
study.
83
-------
APPENDIX B
Data Supporting Guideline Requirements for the Reregistration of Resmethrin
REQUIREMENT
USE
PATTERN
CITATION(S)
PRODUCT CHEMISTRY
New
Guideline
Number
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
830.1800
830.6302
Old
Guideline
Number
61-1
61-2A
61-2B
62-1
62-2
62-3
63-2
Product Identity and Composition
Start. Mat. & Mnfg. Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Analytical Method
Color
All
All
All
All
All
All
All
42085701,43184901
42085701,43184901,43392201,43090801
42085701,43184901,4309081
42085702
42085702, 43184901,43090802
43241602,42085703,
43259801,43184901,43435701,
-------
Data Supporting Guideline Requirements for the Reregistration of Resmethrin
REQUIREMENT
830.6303
830.6304
830.6314
830.6315
830.6316
830.6317
830.6319
830.6320
830.7100
830.7200
830.7300
63-3
63-4
63-14
63-15
63-16
63-17
63-19
63-20
63-18
63-5
63-7
Physical State
Odor
Oxidation/reduction: chemical
incompatability
Flammability
Explodability
Storage Stability
Miscibility
Corrosion Characteristics
Viscosity
Melting Point
Density
USE
PATTERN
All
All
All
All
CITATION(S)
43330101,43090803
43241602, 42085703, 43259801,
43184901,43435701, 43330101, 43090803
43241602, 42085703, 43259801, 43184901,
43435701, 43330101,43090803
43241602, 42085703, 43259801, 43184901,
43435701, 43330101, 43090803
43241602, 43259801, 43184901, 43435701,
43330101,43090803
43241602, 42085703, 43259801, 43184901,
43435701, 43330101, 43090803
42085703,43184901,43993701,43993601,43090
803, 40766101
43241602, 43259801,43184901, 43435701,
43330101,43090803
42085703, 43259801, 43184901, 43993701,
43993601,43090803
43241602,43259801, 43184901, 43435701,
43330101,43090803
42085703
43241602,42085703,43259801,
-------
Data Supporting Guideline Requirements for the Reregistration of Resmethrin
REQUIREMENT
830.7840
830.7860
830.7950
830.7370
830.7550
830.7000
830.6313
850.2100
850.2200
850.2200
850.1075
850.1075
850.1010
None
63-8
63-9
63-10
63-11
63-12
63-13
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition Coefficient
pH
Stability
USE
PATTERN
All
All
All
All
All
All
CITATION(S)
43184901,43435701, 43330101
42085703
42085703
42085703,42143701
43241602, 42085703, 43184901, 43435701,
43330101,43090803
42085703
ECOLOGICAL EFFECTS
71-1A
71-2A
71-2B
72-1A
72-1C
72-2
72-3A
Avian Acute Oral Toxicity - Quail
Avian Dietary Toxicity - Quail
Avian Dietary Toxicity - Duck
Fish Acute Toxicity Bluegill
Fish Acute Toxicity Rainbow Trout
Invertebrate Toxicity
Estuarine/Marine Toxicity - Fish
ABCIKM
ABCIKM
ABCK
ABCK
ABCIKM
ABCIKM
ABCK
-------
Data Supporting Guideline Requirements for the Reregistration of Resmethrin
REQUIREMENT
None
None
850.4225
850.4250
850.4400
72-3C
72-4B
122-2
123-1A
123-1B
123-2B
Estuarine/Marine Toxicity - Shrimp
Estuarine/Marine Invertebrate Life
Cycle
Aquatic plant growth
Seed germ/seedling emergence
Vegetative vigor
Aquatic Plant Growth, Tier 2
USE
PATTERN
ABCK
ABCK
ABCK
ABCK
ABCK
CITATION(S)
TOXICOLOGY
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
870.3100
870.3200
870.3465
81-1
81-2
81-3
81-4
81-5
81-6
82-1A
82-2
82-4
Acute Oral Toxicity-Rat
Acute Dermal Toxicity-Rabbit
Acute Inhalation Toxicity-Rat
Primary Eye Irritation-Rabbit
Primary Skin Irritation
Dermal Sensitization
90-Day Feeding - Rodent
21-Day Dermal - Rabbit/Rat
90-Day Inhalation
ABCIKM
ABCIKM
ABCIKM
ABCIKM
ABCIKM
ABCIKM
ABCIKM
ABCHIK
42076201
42076202
42153701
42076203
42076204
42153702
43338601,43838101
42066901
00158476
-------
Data Supporting Guideline Requirements for the Reregistration of Resmethrin
REQUIREMENT
870.4100
870.4100
870.4200
870.4200
870.4300
870.3700
870.3700
870.3800
870.3800
870.5140
870.5265
870.5375
870.5550
870.6200
870.6200
83-1A
83-1B
83-2A
83-2B
83-5
83-3A
83-3B
83-4A
83-4B
84-2A
84-2B
84-2
82-7A
82-7B
Chronic Feeding Toxicity - Rodent
Chronic Feeding Toxicity - Non-
Rodent
Oncogenicity - Rat
Oncogenicity - Mouse
Chronic/Oncogenicity
Developmental Toxicity - Rat
Developmental Toxicity- Non Rodent
2-Generation Reproduction - Rat
Reproduction
Gene Mutation (Ames Test)
Structural Chromosomal Aberration
Acute Neurotox. Screening Battery
(rat)
90 Day Neuro. Screening Battery (rat)
USE
PATTERN
ABCIKM
ABCIKM
ABCIKM
ABCIKM
ABCIKM
ABCIKM
ABCIKM
ABCIKM
CITATION(S)
00157961,43601601
43062601
0083319
43052101
00041402,00085870,00108628,43271701,
43601601,00041402,00108828
00028453,
46582601,00029002
43189101,
00081276, 124308
41068010
41068011,
00025552,00025553,00025554
-------
Data Supporting Guideline Requirements for the Reregistration of Resmethrin
REQUIREMENT
None
870.7485
870.7600
84-4
85-1
85-3
Other Genotoxic Effects
General Metabolism
Dermal Penetration
USE
PATTERN
ABCIKM
ABCIKM
CITATION(S)
42133801,42136101
46382501
OCCUPATIONAL/RESIDENTIAL EXPOSURE
875.2100
132-1A
Foliar
Residue
Dissipation
ABCIK
ENVIRONMENTAL FATE
835.2120
835.2240
835.2410
835.4100
835.4400
835.1240
161-1
161-2
161-3
161-4
162-1
162-2
162-3
162-4
163-1
163-2
163-3
Hydrolysis
Photodegradation - Water
Photodegradation - Soil
Aerobic Soil Metabolism
Anaerobic soil Metabolism
Anaerobic Aquatic Metabolism
Aerobic Aquatic Metabolism
Leaching/Adsorption/Desorption
ABCIK
ABCK
ABC
ABCIK
ABC
ABCIK
470077046
00153059,
41913601,41913601
42298401
42043003
-------
Data Supporting Guideline Requirements for the Reregistration of Resmethrin
REQUIREMENT
835.6100
164-1
164-2
164-3
165-4
165-5
166-1
166-2
201-1
202-1
Terrestrial Field Dissipation
USE
PATTERN
ABCK
CITATION(S)
RESIDUE CHEMISTRY
860.1300
860.1300
860.1340
860.1340
860.1360
860.1380
171-4A
171-4B
171-4C
171-4D
171-4M
171-4E
Nature of Residue - Plants
Nature of Residue - Livestock
Residue Analytical Method -
Plants/Animals
Residue Analytical Method- Animal
Multiresidue Method
Storage Stability
ABK
AB
ABK
ABK
-------
Data Supporting Guideline Requirements for the Reregistration of Resmethrin
REQUIREMENT
860.1480
860.1500
171-4J
171-4K
Magnitude of Residues -
Meat/Milk/Poultry /Egg
Crop Field Trials
(Potatoes)
USE
PATTERN
ABK
ABK
CITATION(S)
OTHER
860.1850
810.1900
840.1200
165-1
165-2
202-1
Confined Accumulation in Rotational
Field Accumulation in Rotational
Drift field evaluation
ABC
ABC
a- TGAI is a solid at room temperature.
b- Data used to support carbendazim.
c- Additional data is needed. The registrant has proposed two HPLC/UV methods for enforcing tolerances of thiophenate-methyl in
plant (Method BR-93-28) and animal (Method KP-100-04) commodities. Prior to validation by the Agency, the method should be
radiovalidated using samples from animal and plant metabolism studies.
d- Multiresidue method (MRM) recovery data are required for thiophenate-methyl and MBC through FDA protocols A through G.
e- Data are required depicting the frozen storage stability of thiophenate-methyl and MBC in representative raw and processed plant
commodities held in frozen storage for up to five years.
f- Additional field trial in CA is required (see residue chemistry chapter).
g- Data are required depicting residues of thiophenate-methyl and MBC in/on green onions harvested at the minimum interval
following a broadcast application at planting of thiophenate-methyl (WP/WDG/FIC) at 1.4 Ib ai/A. A minimum of three field trials
should be conducted; two in Region 10 and one in Region 6.
h- If the registrant intends to support a use on dry peas and lentils, additional residue data for dried peas need to be submitted.
-------
i- To support this group crop tolerance, the registrant has submitted representative field trials for the following representative crops:
cucumbers, melon, pumpkin and squash.
j- The available residue data are inadequate because of deficiencies in analytical method.
N/A not applicable.
-------
Appendix C
TECHNICAL SUPPORT DOCUMENTS
Additional documentation in support of this RED is maintained in the OPP
docket, located in Room S-4400, One Potomac Yard (South Building), 1777 S. Crystal
Drive, Arlington, VA. It is open Monday through Friday, excluding legal holidays, from
8:30 am to 4 pm.
The preliminary risk assessments for permethrin are available in the public docket
and in e-dockets under docket number OPP-2004-0385. This contains risk assessments
and related documents as of August 2005. During the comment period, the registrant
submitted additional data for permethrin. EPA reviewed these data and incorporated
them into the revised risk assessments for permethrin. These revised risk assessments
form the basis of the regulatory decision described in this RED. These risk assessment
and related documents are available under docket number OPP-2004-0385.
Technical support documents for the Permethrin RED include the following:
Human Health Risk Assessment Documents;
1. Resmethrin HED Revised Risk Assessment for Reregistration Eligibility
Document (RED) PC Code 097801; DP Barcode 326088, dated February 23,
2006.
2. Resmethrin: Response to Public Comments on the HED Risk Assessment for
Resmethrin RED Chapter; PC Code 097801; DP Barcode 291445, dated
February 23, 2006.
3. Resmethrin and Bioresmethrin. Revised Product and Residue Chemistry
Considerations for Reregistration Eligibility Decisions, dated February 16,
2006.
4. Revised Occupational and Residential Exposure Assessment and
Recommendations for the Reregistration Eligibility Decision (RED) for
Resmethrin, dated February 23, 2006.
5. Resmethrin Revised Chronic and Cancer Dietary Exposure Assessments for
the Reregistration Eligibility Decision PC Code 097801 DP Barcode 326090,
dated February 22, 2006.
Environmental Fate and Effects Documents;
1. EFED RED Chapter for Resmethrin, Revision Phase 3, dated March 8, 2006.
2. Response to Comments of the Phase 3 Period for the Revised Draft EFED
RED Chapter for Resmethrin, dated March 8, 2006.
3. Revised Tier II Estimated Drinking Water Concentrations for Resmethrin,
dated February 13,2006.
4. Preliminary Environmental Fate and Effects Division Risk Assessment
Chapter for the Reregistration Eligibility Decision (RED) Document for:
Resmethrin, dated March 8, 2006.
93
-------
5. Appendicies to the EFED Risk Assessment Chapter for the RED Document
for Resmethrin, dated March 8, 2006
94
-------
Appendix D
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MRID
Citation Reference
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43338601
42066901
00025552
00025553
00025554
00157961
43062601
42133801
42136101
42076201
42076202
42153701
42076203
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97
-------
MRID
43090801
43090802
43090803
43241602
43184901
43259801
43330101
43392201
43435701
43993601
43993701
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