United States Prevention, Pesticides EPA OPP-2005-0293
Environmental Protection And Toxic Substances June 14, 2006
Agency (7508C)
Reregistration Eligibility
Decision for
Cypermethrin
(revised 01/14/08)
ListB
Case No. 2130
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TABLE OF CONTENTS
Cypermethrin Reregistration Eligibility Decision Team 5
Glossary of Terms and Abbreviations 6
Executive Summary 8
I. Introduction 14
II. Chemical Overview 15
A. Regulatory History 15
B. Chemical Identification 16
C. Use Profiles 17
III. Summary of Cypermethrin Risk Assessments 18
A. Human Health Risk Assessment 19
1. Toxicity 19
2. FQPA Safety Factor 21
3. Dermal Absorption 22
4. Dietary Exposure 22
a. Acute Dietary Exposure (food only) 22
b. Chronic Dietary Exposure (food only) 23
5. Drinking Water Exposure 23
6. Residential Exposure and Risk 23
a. Residential Handler Risk 24
b. Residential Post-application Risk 24
7. Aggregate Exposure and Risk (food, drinking water, and residential) 25
a. Acute Aggregate Risk (food and drinking water) 25
b. Short-term Aggregate Risk (food, drinking water, and residential) 26
c. Chronic Aggregate Risk (food and drinking water) 26
8. Occupational Exposure and Risk 26
a. Occupational Handler Risk 27
b. Occupational Post-application Risk 28
9. Human Incident Data 28
B. Environmental Risk Assessment 29
1. Environmental Fate and Transport 29
2. Ecological Risk 30
a. Risk to Aquatic Organisms 30
b. Risk to Terrestrial Organisms 37
c. Ecological Incidents 39
d. Endangered Species Concerns 39
IV. Risk Management, Reregistration, and Tolerance Reassessment Decision 41
A. Determination of Reregistration Eligibility and Tolerance Reassessment 41
B. Public Comments and Responses 41
C. Regulatory Position 42
1. Food Quality Protection Act Findings 42
2. Endocrine Disrupter Effects 43
3. Cumulative Risks 43
D. Tolerance Reassessment Summary 44
E. Regulatory Rationale 45
1. Human Health Risk Mitigation 46
2. Environmental Risk Mitigation 48
3. Benefits of Cypermethrin Use and Available Alternatives 56
V. What Registrants Need to Do 56
A. Manufacturing Use Products 57
1. Additional Generic Data Requirements 57
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2. Labeling Requirements 57
3. Spray Drift Management 57
B. End-Use Products 57
1. Additional Product-Specific Data Requirements 57
2. Labeling for End-Use Products 58
APPENDIX A. Uses of Cypermethrin Eligible for Reregistration 79
APPENDIX B. Table of Generic Data Requirements and Studies Used to Make the
Reregistration Decision for Cypermethrin 88
APPENDIX C: Technical Support Documents 93
APPENDIX D. Citations Considered to be Part of the Data Base Supporting the
Reregistration Eligibility Decision 95
APPENDIX E: Generic Data Call-In 112
APPENDIX F: Product Specific Data Call-In 113
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Cypermethrin Reregistration Eligibility Decision Team
Office of Pesticide Programs:
Environmental Fate and Effects Risk Assessment
Miachel Rexrode
Jose Luis Melendez
Health Effects Risk Assessment
William H. Donovan
Pamela M. Hurley
John Doherty
Seyed Tadayon
Biological and Economic Analysis Division
Alan Halvorson
Registration
George LaRocca
Risk Management
Yan Donovan
Veronique LaCapra
Dirk V. Helder
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Glossary of Terms and Abbreviations
AGDCI
ai
aPAD
AR
BCF
CFR
cPAD
CSF
CSFII
DCI
DEEM
DFR
DWLOC
EC
EDWC
EEC
EPA
EUP
FDA
FIFRA
FFDCA
FQPA
FOB
G
GENEEC
GLN
HAFT
IR
LC50
LD50
LOC
LOD
LOAEL
MATC
*§/§
Og/L
mg/kg/day
mg/L
MOE
MRID
MUP
NA
NAWQA
NPDES
NR
NOAEC
NOAEL
Agricultural Data Call-In
Active Ingredient
Acute Population Adjusted Dose
Anticipated Residue
Bioconcentration Factor
Code of Federal Regulations
Chronic Population Adjusted Dose
Confidential Statement of Formula
USDA Continuing Surveys for Food Intake by Individuals
Data Call-In
Dietary Exposure Evaluation Model
Dislodgeable Foliar Residue
Drinking Water Level of Comparison.
Emulsifiable Concentrate Formulation
Estimated Drinking Water Concentration
Estimated Environmental Concentration
Environmental Protection Agency
End-Use Product
Food and Drug Administration
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Food Quality Protection Act
Functional Observation Battery
Granular Formulation
Tier I Surface Water Computer Model
Guideline Number
Highest Average Field Trial
Index Reservoir
Median Lethal Concentration. A statistically derived concentration of a substance that
can be expected to cause death in 50% of test animals. It is usually expressed as the
weight of substance per weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
Median Lethal Dose. A statistically derived single dose that can be expected to cause
death in 50% of the test animals when administered by the route indicated (oral, dermal,
inhalation). It is expressed as a weight of substance per unit weight of animal, e.g.,
mg/kg.
Level of Concern
Limit of Detection
Lowest Observed Adverse Effect Level
Maximum Acceptable Toxicant Concentration
Micrograms Per Gram
Micrograms Per Liter
Milligram Per Kilogram Per Day
Milligrams Per Liter
Margin of Exposure
Master Record Identification (number). EPA's system of recording and tracking studies
submitted.
Manufacturing-Use Product
Not Applicable
USGS National Water Quality Assessment
National Pollutant Discharge Elimination System
Not Required
No Observed Adverse Effect Concentration
No Observed Adverse Effect Level
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OP
OPP
OPPTS
PAD
PCA
PDF
PHED
PHI
ppb
PPE
ppm
PRZM/EXAMS
Qi*
RAC
RED
REI
RfD
RQ
SCI-GROW
SAP
SF
SLC
SLN
TGAI
TRR
USDA
USGS
UF
UV
WPS
Organophosphate
EPA Office of Pesticide Programs
EPA Office of Prevention, Pesticides and Toxic Substances
Population Adjusted Dose
Percent Crop Area
USDA Pesticide Data Program
Pesticide Handler's Exposure Data
Preharvest Interval
Parts Per Billion
Personal Protective Equipment
Parts Per Million
Tier II Surface Water Computer Model
The Carcinogenic Potential of a Compound, Quantified by the EP A's Cancer Risk Model
Raw Agriculture Commodity
Reregistration Eligibility Decision
Restricted Entry Interval
Reference Dose
Risk Quotient
Tier I Ground Water Computer Model
Science Advisory Panel
Safety Factor
Single Layer Clothing
Special Local Need (Registrations Under Section 24(c) of FIFRA)
Technical Grade Active Ingredient
Total Radioactive Residue
United States Department of Agriculture
United States Geological Survey
Uncertainty Factor
Ultraviolet
Worker Protection Standard
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Executive Summary
This document presents EPA's decision regarding the reregi strati on eligibility of the registered
uses of cypermethrin. The Agency has conducted human health and ecological risk assessments
based on reviews of the database supporting use patterns of the currently registered cypermethrin
products. This document summarizes these risk assessments and describes the mitigation
measures needed to address the identified risks.
Cypermethrin is an insecticide used both in agricultural and non-agricultural settings. Total
cypermethrin use in the United States is approximately 1.0 million pounds of active ingredient
(a.i.) per year. Approximately 140,000 pounds a.i. are used in agricultural crops, mainly on
cotton (110,000 pounds), with minor uses on pecans and broccoli. Treatment of cattle and other
livestock accounts for approximately 1000 pounds a.i. per year. The great majority of
cypermethrin use occurs in non-agricultural settings, including a wide range of commercial,
industrial, and residential sites. Indoor pest control -mainly for control of ants, cockroaches, and
fleas - accounts for about 110,000 pounds a.i., while outdoor structural, perimeter, and turf uses
for control of subterranean termites and other insect pests accounts for nearly 750,000 pounds
a.i. In residential settings, cypermethrin can be applied both by professional applicators and by
residential users.
Cypermethrin was first registered in 1984 by FMC Corporation, who also subsequently
registered the isomer enriched zeta-cypermethrin in 1992. Current technical registrants for
cypermethrin included FMC, Syngenta, United Phosphorus International, and Valent
BioSciences. Data for the two active ingredients is considered interchangeable. Since zeta-
cypermethrin was registered after 1984, only cypermethrin is subject to reregi strati on.
Cypermethrin is on reregi strati on List B; thus no Registration Standard was completed. Data
call-ins (DCIs) for cypermethrin were issued in 1991 for basic toxicology and residue chemistry
data, and in 1995 for handler exposure and worker re-entry data. Cypermethrin is one of nine
synthetic pyrethroids registered on cotton, represented by the Pyrethroid Working Group (PWG),
that are considered to be conditionally registered pending the development and review of data
related to aquatic toxicity. EPA will make every effort to coordinate the implementation of its
reregi strati on eligibility decision provisions and labeling for cypermethrin with the ongoing
efforts of the PWG.
The Agency's human health effects and environmental fate risk assessment for cypermethrin
included the assessment for zeta-cypermethrin as well, since zeta-cypermethrin is an S-
enantiomer enriched formulation of cypermethrin, which is not distinguished from cypermethrin
by the analytical enforcement method, and the toxicological endpoints are the same for both
cypermethrin and zeta-cypermethrin.
Human Health Risk
Dietary Exposure (food only)
Refined acute (probabilistic) and chronic dietary exposure assessments were performed in order
to determine the dietary (food only) exposure and risk estimates which result from the use of
cypermethrin and zeta-cypermethrin in/on all registered crops. Actual residues from USDA PDF
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monitoring data (collected during 1994, 1996, 1999, and 2001), estimated percent crop treated
information, and processing factors, where available, were used. For acute exposure, the most
highly exposed population subgroup was children 1-2 years old at 6.1% of the aPAD at the
99.9th percentile. For chronic exposure, the most highly exposed population subgroup was
children 1-2 years old at 0.2% of the cPAD. Dietary exposures (both acute and chronic)
estimates are below the Agency's level of concern for the general U.S. population and all
population subgroups.
Drinking Water Exposure
The Estimated Drinking Water Concentrations (EDWCs) for cypermethrin were calculated using
PRZM/EXAMS model (Tier II), based on the highest seasonal application rate (0.6 Ib a.i./A on
cotton). The estimated acute drinking water concentration in surface water is 1.04 ppb, and the
estimated chronic drinking water concentration in surface water is 0.013 ppb. The SCI-GROW
model was used to generate the EDWC for groundwater. The groundwater EDWC for both
acute and chronic exposures is 0.0036 ppb.
Residential Exposure and Risk
Residential handler inhalation risks are below EPA's level of concern for all non-occupational
handler scenarios. No short-term dermal exposures or risks were assessed for residential
handlers since no dermal endpoints of concern were identified. EPA does not anticipate that
residential handlers would have intermediate- or long-term exposures to cypermethrin or zeta-
cypermethrin. Therefore, no intermediate- or long-term risks were assessed.
Residential /non-dietary post-application exposure to adults was assessed via the inhalation
route, since no effects were observed in the dermal exposure study. Exposure to toddlers was
assessed via the inhalation route, and via incidental oral exposure. All of these exposures are
considered short term. Although cypermethrin can be used indoors as termiticide, long term
exposure due to inhalation is considered negligible, since the vapor pressure for cypermethrin is
extremely low. Inhalation risks to both adults and toddlers were below the Agency's level of
concern. Individually, risks from hand to mouth exposure, object to mouth exposure, and
incidental soil ingestion were all below EPA's level of concern.
Aggregate risk
An acute aggregate risk assessment was conducted taking into account risk from food and
drinking water. EPA calculated the Drinking Water Levels of Comparison (DWLOC, which
represents the maximum allowable exposure from drinking water that would still fall below
EPA's level of concern) for all population subgroups. The acute DWLOC for the most highly
exposed population subgroup (children 1-2 years old) is 940 ppb, which is much higher than the
peak EDWC of 1.04 ppb in surface water and the maximum EDWC for ground water of 0.0036
ppb; therefore, acute aggregate risk estimates associated with exposure to cypermethrin residues
in food and water do not exceed EPA's level of concern.
Short-term aggregate exposure takes into account residential exposure plus average exposure
levels to food and water (considered to be a background exposure level). The calculated
DWLOC value for children 1-2 years old is 890 ppb and this level is higher than the surface and
ground water EDWCs of 0.013 and 0.0036 ppb.
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Chronic aggregate assessment only includes food and water since chronic exposure from
residential uses is negligible. The highest exposed population subgroup (children 1-2 years old)
has a DWLOC value of 600 ppb, which is greater than the average annual EDWCs of 0.013 ppb
for surface water and 0.0036 ppb for ground water. Therefore, chronic aggregate risk does not
exceed the Agency's level of concern.
Cumulative
Cypermethrin 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, available data shows that there are multiple types of sodium channels and that
these compounds may act on different isoforms of the sodium channel and with other ion
channels in producing their clinical signs. It is currently unknown whether the pyrethroids as a
class have similar effects on all channels or whether modifications of different types of sodium
channels would have a cumulative effect. Nor do we have a clear understanding of effects on
key downstream neuronal function e.g., nerve excitability, or how these key events interact to
produce their compound specific patterns of neurotoxicity. Without such understanding, there is
no basis to make a common mechanism of toxicity finding. Therefore, EPA is not currently
following a cumulative risk approach based on a common mechanism of toxicity for the
pyrethroids because the Agency has determined further study is needed regarding the
assumptions of dose additivity and common mechanism(s) of toxicity to appropriately identify a
group or subgroups for such an assessment. There is ongoing research by the EPA's Office of
Research and Development and pyrethroid registrants to evaluate the differential biochemical
and physiological actions of pyrethroids in mammals. The Agency anticipates the majority of
this research to be completed by 2007.
FQPA Safety Factor
The Agency determined that the FQPA safety factor should be IX since there are no residual
uncertainties for pre and/or post natal toxicity, and the dietary (food and drinking water) and
non-dietary exposure assessments will not underestimate the potential exposures for infants and
children. No database uncertainty factor is needed since the toxicity database is complete.
Occupational Risk
Short-term, intermediate-term, and long-term risks to occupational handlers are below the
Agency's level of concern with baseline attire (long sleeved shirt, long pants, shoes and socks),
as long as wettable powder formulations are packaged in water soluble bags, and chemical
resistant gloves are worn for hand-held application methods. Although risks could not be
calculated for the one granular product of cypermethrin, risks would be lower than for liquid
products which is below EPA's level of concern with baseline attire.
EPA did not assess occupational postapplication risks since no short- or intermediate-term
dermal endpoints were identified and long-term dermal exposures are not expected for any of the
registered use patterns. As per the Worker Protection Standard, a restricted-entry interval of 12
hours is required for agricultural uses.
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Ecological Risk
The Agency's Tier I screening-level (deterministic) risk assessment is focused on maximum uses
of cypermethrin on registered agricultural crops only, due to the difficulties of modeling and
quantifying urban uses. As with several other pyrethroids, the great majority of cypermethrin
use is non-agricultural. The non-agricultural applications of cypermethrin may result in
exposure to aquatic organisms following runoff and/or erosion. The Agency recognizes the
potential for aquatic toxicity from non-agricultural uses but was not able to quantify the risks due
to lack of available data and acceptable models.
Aquatic Risk (fish, invertebrates)
For freshwater fish, invertebrates, and estuarine/marine fish, invertebrates, technical grade
cypermethrin is very highly toxic on an acute basis. Cypermethrin formulations are also very
highly toxic, with LCso values that are similar to those reported for technical grade cypermethrin.
LOCs for acute risk (0.5) and acute endangered species risk (0.05) are exceeded for freshwater
and estuarine/marine invertebrates for all six crop scenarios considered in this assessment. The
highest acute RQs are observed for freshwater invertebrates, ranging from 49.4 to 558.3,
exceeding all acute LOCs.
LOCs for chronic risk (1) are exceeded for freshwater and estuarine/marine invertebrates. The
highest chronic RQs are observed for freshwater invertebrates, ranging from 57.6 to 325.4. All
chronic RQs for freshwater fish and estuarine/marine fish are less than the chronic LOG (1).
Terrestrial Risk (birds, mammals)
For birds, all acute (dose-based and dietary-based) RQs are below the acute risk LOG (0.5) and
the endangered species LOG (0.1) for all crop uses; chronic RQs are also below the LOG (1).
The Agency's screening level ecological risk assessment for endangered species results in the
determination that cypermethrin will have no direct acute or chronic effect on threatened and
endangered birds.
For mammals, acute (dose-based) RQs are below the acute risk LOG (0.5). The acute endangered
species LOG (0.1) is exceeded for 15g and 35g mammals feeding on short grass (dose-based
RQs 0.1-0.2) for all crop scenarios. Mammalian chronic RQs (dose-based) range from <0.1 to
9.3 (15g mammals feeding on short grass in cotton), exceeding the chronic LOG (1) for most
scenarios.
Plants
Toxicity data are not available for terrestrial plants; thus, risks associated with cypermethrin
exposure to terrestrial plants cannot be assessed. However, based on the cypermethrin mode of
action, phytotoxicity is not expected.
Non-target Insects
Cypermethrin exposure can present acute toxic risk to earthworms and to beneficial non-target
insects, such as honey bees. This risk concern is extended to listed insects also.
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Benefits and Alternatives
Usage data are sparse and generally do not distinguish between chemicals within the class. The
recent loss of chlorpyrifos and diazinon for residential pest control has resulted in a greater
reliance on pyrethrins and synthetic pyrethroids, as a class, among residential users. Most
pyrethroids have similar efficacy and cost. In the absence of any one pyrethroid, homeowners
and professional applicators would most likely simply substitute another pyrethroid insecticide.
Users might also substitute insecticides from other chemical classes (e.g. organophosphates,
carbamates, and neonicotinoids) and nonchemical control techniques (e.g. sanitation or
exclusion). Given the options for substitution, economic impacts of restricting any one chemical
would not likely be significant. The impact on risk of restricting any one chemical is uncertain
and might increase given the substitutes available.
Risk Management
Human health risk
To address the handler risks of concern, the following mitigation is required:
(1) All wettable powder products must be packaged in water soluble bags including agricultural
and residential (PCO/homeowner) products. Alternatively, replacing wettable powder products
with products formulated as dry flowables would also reduce risks below the Agency's level of
concern.
(2) Mixers/loaders/applicators using handheld equipment (all formulations) must wear chemical
resistant gloves, in addition to baseline attire (long sleeved shirt, long pants, shoes and socks).
Ecological Risk
To address the ecological risks of concern, the following mitigation is required:
For agricultural uses:
(1) Mitigation to address spray drift, including specifying minimum allowable droplet size and
buffer zones, maximum allowable wind speed and release height on product labels.
(2) Decreased application rates and increased application intervals.
(3) A constructed and maintained vegetative buffer.
For non-agricultural uses (residential, commercial and industrial), mitigation includes limiting
outdoor applications to impervious surfaces (such as sidewalks and driveways) to spot or crack
and crevice treatments, and adding best management practices to product labels to reduce
potential runoff to drains, sewers, or water bodies from outdoor nuisance pest and termite
applications.
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Reregistration Eligibility
The Agency has determined that cypermethrin is eligible for reregi strati on provided that the risk
mitigation measures outlined in this document are adopted and labels are amended accordingly.
In addition, where there are data gaps, data must be generated to confirm the reregi strati on
eligibility decision documented in this RED. EPA will continue to work with cypermethrin and
other pyrethroid registrants to better characterize aquatic risk from urban uses of the pyrethroids.
More data are needed to characterize ecological risk, especially risk from urban uses. EPA will
continue in registration review 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.
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I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988 to
accelerate the reregi strati on 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
reregi strati on of an active ingredient, as well as EPA review of all submitted data. Reregi strati on
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 reregi strati on, tolerance reassessment will be accomplished
through the reregi strati on process.
The Food Quality Protection Act (FQPA) requires that the Agency consider available
information concerning the cumulative effects of a particular pesticide's residues and other
substances that have a common mechanism of toxicity. The reason for consideration of other
substances is due to the possibility that low-level exposures to multiple chemical substances that
cause a common toxic effect by a common toxic mechanism could lead to the same adverse
health effect as would a higher level of exposure to any of the substances individually.
Cypermethrin 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, available data shows that there are multiple types of sodium channels and that
these compounds may act on different isoforms of the sodium channel and with other ion
channels in producing their clinical signs. It is currently unknown whether the pyrethroids as a
class have similar effects on all channels or whether modifications of different types of sodium
channels would have a cumulative effect. Nor do we have a clear understanding of effects on
key downstream neuronal function e.g., nerve excitability, or how these key events interact to
produce their compound specific patterns of neurotoxicity. Without such understanding, there is
no basis to make a common mechanism of toxicity finding. Therefore, EPA is not currently
following a cumulative risk approach based on a common mechanism of toxicity for the
pyrethroids because the Agency has determined further study is needed regarding the
assumptions of dose additivity and common mechanism(s) of toxicity to appropriately identify a
group or subgroups for such an assessment. There is ongoing research by the EPA's Office of
Research and Development and pyrethroid registrants to evaluate the differential biochemical
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and physiological actions of pyrethroids in mammals. The Agency anticipates the majority of
this research to be completed by 2007. When available, the Agency will consider this research
and make a determination of common mechanism as a basis for assessing cumulative risk. For
information regarding EPA's procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.
The Agency made its reregi strati on eligibility determination 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 cypermethrin are
eligible for reregi strati on provided the mitigation and labeling 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
reregi strati on 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 at www.regulations.gov under docket
number EPA-HQ-OPP-2005-0293.
II. Chemical Overview
A. Regulatory History
Cypermethrin was first conditionally registered in 1984 by FMC Corporation, who also
subsequently registered an isomer enriched zeta-cypermethrin in 1992. Current technical
registrants include FMC, Syngenta, United Phosphorus International, and Valent BioSciences.
Data for the two active ingredients is considered interchangeable. Since zeta-cypermethrin was
registered after 1984, only cypermethrin is subject to reregi strati on. Cypermethrin is on
reregi strati on List B; thus no Registration Standard was completed. Data Call-ins (DCIs) for
cypermethrin were issued in 1991 for basic toxicology and residue chemistry data, and in 1995
for handler exposure and worker re-entry data.
Cypermethrin is a synthetic pyrethroid insecticide. On June 14, 1984, the Agency conditionally
registered a technical grade product and two end-use formulations each to ICI (now known as
Syngenta Crop Protection) and FMC for use on cotton during the 1984 growing season. The
original conditional registration for cypermethrin was subsequently renewed on January 9, 1985,
and September 27, 1985. A conditional registration for cypermethrin use on pecans was issued
on April 24, 1986. The conditional registration for use on lettuce (head) was issued on March 15,
1988.
Cypermethrin is one of nine synthetic pyrethroids registered on cotton, represented by the
Pyrethroid Working Group (PWG), that are considered to be conditionally registered pending the
development and review of data related to aquatic toxicity. EPA will make every effort to
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coordinate the implementation of its reregi strati on eligibility decision provisions and labeling for
cypermethrin with the ongoing efforts of the PWG.
Due to the conditional status of the registration, tolerances were established for cypermethrin on
a temporary basis on cottonseed, pecans, lettuce, meat, fat, and meat byproducts of hogs, horses,
cattle, goats, sheep, and milk to cover residues expected to be present from use during the period
of conditional registration. On July 31, 1996, tolerances were established for brassica (head and
stem) and brassica (leafy). The conditional registrations for all cypermethrin uses were extended
several times to November 15, 1993, November 15, 1994, November 15, 1995, November 15,
1996 and November 15, 1997. At the time of FQPA, cypermethrin's tolerances had expiration
dates of 11/15/97. Agency policy was such that no temporary or time-limited tolerances were to
be included among the official baseline number of tolerances which the Agency had to reassess.
These tolerances were considered revoked with an expiration date and were expected not to need
tolerance reassessment, nor need to be included in the tolerance reassessment baseline count.
On November 26, 1997, permanent tolerances were established for brassica (head and stem),
brassica (leafy), cattle (fat), cattle (mbyp), cattle (meat), cottonseed, goats (fat), goats (mbyp),
goats (meat), hogs (fat), hogs (mbyp), hogs (meat), horses (fat), horses (mbyp), horses (meat),
lettuce (head), milk, onions (bulb), pecans, sheep (fat), sheep (mbyp), and sheep (meat). Such
reassessments were not countable against the Agency's baseline number since they had not been
included within the Agency's original tolerance reassessment baseline. Upon cypermethrin RED
signature, no tolerance reassessments will be counted against the Agency's baseline number, nor
were any previously counted.
B. Chemical Identification
Cypermethrin has the following structure:
Cl H3C
CN
Physical/Chemical Properties
Empirical Formula:
Molecular Weight:
CAS Registry No.:
PC Code:
Melting Point:
Boiling Point:
Density:
Vapor Pressure:
Water Solubility:
416.3
52315-07-8
109702
60-80 degree C
216 degree C
1.204g/mLat25EC
3.1E-9 mm Hg at 20 degree C
7.6 ppb at 25 degree C
Log P (octanol-water): 6.60
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Cypermethrin is a combination of 8 stereoisomers with percentage compositions ranging from
11-14%, and very low volatility and water solubility. Zeta-cypermethrin is an enriched
enantiomer of cypermethrin consisting of the 4 stereo isomers with an "S" configuration at the
cyano bearing carbon at 24% each, and 4 insecticidally less active stereo isomers at a
concentration of 1% each. Since the analytical method does not distinguish cypermethrin from
zeta-cypermethrin, and the toxicological endpoints are the same, the Agency's human health risk
assessment and environmental fate assessment considered both cypermethrin and zeta-
cypermethrin.
C.
Use Profiles
Type of Pesticide:
Summary of Use:
Target Organisms:
Mode of Action:
Tolerances:
Use Classification:
Formulation Types:
Insecticide
Cypermethrin is registered for agricultural use as a foliar
application on food and feed crops including cotton, pecans,
peanuts, broccoli and other Brassicas, and sweet corn.
Cypermethrin can be applied to livestock in eartags, and to horses.
Cypermethrin is also registered for use on industrial, commercial,
and residential sites. It is registered for outdoor use as a soil
residual termiticide and to control insect pests such as ants in and
on structures, impervious surfaces (in perimeter and crack and
crevice treatments) and lawns. Cypermethrin can also be applied
indoors to control ants, cockroaches, fleas, and other insects.
Cypermethrin is registered for control of a wide range of pests.
It is likely that the toxic action of pyrethroids is primarily due to
their blocking action on some aspect of the synaptic function of the
nerve axon.
There are 23 cypermethrin tolerances established under 40 CFR
§180.418(a)(l) for pecans, bulb onions, cottonseed, head and stem
brassica, green onions, head lettuce, leafy brassica and for the
milk, fat, meat, and meat byproducts of cattle, goats, hogs, horses,
and sheep.
Agricultural products are restricted use. Residential, commercial,
and industrial products are general use (can be purchased and
applied by professional applicators or by residential applicators).
Cypermethrin is formulated as an emulsifiable concentrate (EC), a
soluble concentrate/liquid (SC/L), and a wettable powder (WP).
Cypermethrin is compatible with a number of insecticides and
fungicides, and has been formulated in products with two or more
active ingredients.
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Application Methods:
Application Rates:
Application Timing:
Usage of Cypermethrin:
Applications to agricultural crops can be made with aircraft,
chemigation, groundboom, and air blast equipment. Applications
at industrial, commercial, and residential sites can be made using
handheld equipment such as low-pressure handwand sprayers,
backpack sprayers, hose-end sprayers, handgun sprayers,
paintbrushes, and termiticide injectors, in addition to ready-to-use
(RTU) aerosol cans, indoor foggers, pump-trigger sprayers,
impregnated wipes and eartags.
The currently labeled maximum application rates for agricultural
uses range from 0.4 Ibs. a.i./acre to 3.4 Ibs. a.i./acre. The
minimum retreatment intervals range from 3-7 days and the pre-
harvest intervals (PHIs) range from 1 to 14 days. The maximum
application rate for non-agricultural uses is 0.44 Ibs ai/acre, for
applications to lawns and turf.
Cypermethrin agricultural products can be applied at various stages
of crop development.
Total Cypermethrin use is approximately 1.0 million pounds of
active ingredient (a.i.) per year. In agriculture, it is used mainly on
cotton (110,000 pounds a.i.) on about 13% of planted acres. Minor
use is also found in several other crops including pecans (6,000
pounds a.i.), peanuts, broccoli and sweet corn (1 to 2 thousand
pounds a.i each). Treatment of cattle and other livestock accounts
for approximately 1,000 pounds a.i. per year.
The great majority of Cypermethrin use occurs in non-agricultural
sites. Indoor pest control (mainly for ants, cockroaches, and fleas)
accounts for about 110,000 pounds a.i., while outdoor use for
subterranean termites and other insect pests accounts for nearly
750,000 pounds a.i. Of the non-agricultural use, approximately
300,000 pounds a.i. are applied by residential applicators, and
550,000 pounds a.i. by professional applicators.
III. Summary of Cypermethrin Risk Assessments
The purpose of this section is to highlight the key features and findings of the risk assessments in
order to help the reader better understand the risk management decisions reached by the Agency.
While the risk assessments and related addenda are not included in this document, they are
available in the OPP Public Docket http://www.regulations.gov.
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A.
Human Health Risk Assessment
The following is a summary of EPA's human health findings and conclusions for cypermethrin
as presented fully in the document, "Cypermethrin: Phase 4 HED Risk Assessment for the
Reregistration Eligibility Decision (RED). PC Code 109702; DP Barcode D293416. Dated 06-
APR-2006.
1. Toxicity
Technical grade cypermethrin has moderate acute toxicity via the dermal and inhalation routes
(Category III & IV), and is not a skin sensitizer. It is more toxic via the oral route (Category II).
Table 1: Acute Toxicity Profile
Guideline
No.
870.1000
870.1100
870.1200
870.2400
870.2500
870.2600
Study Type
Acute Oral - rat
Acute Dermal
Rat
Rabbit
Acute Inhalation - rat
Primary Eye Irritation
Primary Skin Irritation
Dermal Sensitization
MRID
00056800
00056800
00056800
42395702
00056800
00056800
00056800
40377701
Results
LD50 (M): 247 mg/kg (F): 309
mg/kg females
LD50 > 4920 mg/kg/day.
Abraded skin: LD50 > 2460
mg/kg.
LC50: % (not calculated but higher
than&)
LC50:&2.5(1.6-3.4)mg/L.
Slight redness of conjunctivae,
chemosis & discharge. Persisted
to day 7.
Slight to mild erythema on intact
& abraded skin. Reversed by 48
hours. Primary Irritation Index:
0.71
Not a sensitizer in Buehler assay.
Moderate sensitizer in
Magnusson Kligman
Maximization method.
Toxicity
Category
II
III
IV
III
IV
N/A
The toxicology database for cypermethrin is complete and there are no data gaps. The scientific
quality is relatively high and the toxicity profile of cypermethrin can be characterized for all
effects, including potential developmental, reproductive and neurotoxic effects. The data
provided no indication of increased susceptibility of rats or rabbits to in utero and/or postnatal
exposure.
Developmental and Reproductive Toxicity
Cypermethrin is not a developmental or reproductive toxicant. In prenatal developmental
toxicity studies in rats and rabbits, there was no evidence of developmental toxicity at the highest
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dose tested. In multi-generation reproduction studies in rats, offspring toxicity was observed at
the same treatment level which resulted in parental systemic toxicity. There did not appear to be
any increase in the severity of toxicity for the pups.
Neurotoxicity
Cypermethrin is a known neurotoxicant. It is a member of the pyrethroid class of insecticides,
which are known to induce clinical signs of neurotoxicity in mammals, but do not generally
induce neuropathologic lesions. For cypermethrin, neuromuscular effects (i.e. gait
abnormalities, tremors, reduced motor activity, changes in FOB parameters and convulsions)
occurred across species, sexes and routes of administration. These clinical signs occurred
following an acute exposure and appeared to be transient in nature. Effects occurred mainly in
oral studies in the dog and the rat, but similar signs were also observed in an inhalation study.
Effects were not observed in dermal studies in either rats (zeta-cypermethrin) or rabbits
(cypermethrin: nonabraded animals; abraded animals did exhibit decreases in activity).
Toxicological Endpoints
Table 2 contains endpoints selected for the dietary and residential assessments.
Table 2: Summary of Toxicological Doses and Endpoints for Use in Human Risk
Assessments
Exposure
Scenario
Acute Dietary
general
population
including infants
and children
Chronic Dietary
all populations
Short-Term
Incidental Oral (1
to 30 days)
Dose Used in Risk
Assessment, UF
NOAEL = 10
mg/kg/day
UF = 100
Acute RfD = 0.1
mg/kg/day
NOAEL= 6
mg/kg/day
UF = 100
Chronic RfD = 0.06
mg/kg/day
NOAEL=
10 mg/kg/day
FQPA SF and Level
of Concern for Risk
Assessment
FQPA SF = 1
aPAD = acute RfD
FQPA SF
= 0.1 mg/kg/day
FQPA SF = 1
~T> \T\
CrJ\L)
chronic RfD
FQPA SF
= 0.06 mg/kg/day
Residential LOC for
MOE = 100
Occupational LOC for
MOE = N/A
Study and Toxicological Effects
MRID 44962201: Acute neurotoxicity
study in the rat with zeta-
cypermethrin. LOAEL = 50
mg/kg/day based on clinical signs of
neurotoxicity and changes in the FOB.
MRID 44536801: Chronic feeding
study in the dog. LOAEL = 20.4
mg/kg/day based on clinical signs of
neurotoxicity and mortality in males,
and 18.1 mg/kg/day based on
decreased body weights and body
weight gains in females.
MRID 44962201: Acute neurotoxicity
study in the rat with zeta-
cypermethrin. LOAEL = 50
mg/kg/day based on clinical signs of
neurotoxicity and changes in the FOB
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Table 2: Summary of Toxicological Doses and Endpoints for Use in Human Risk
Assessments
Exposure
Scenario
Intermediate-Term
Incidental Oral (1 -
6 months)
Short- and
Intermediate-Term
Dermal (1 day to 6
months
Long-Term
Dermal (> 6
months)
Short- and
Intermediate-Term
Inhalation (1 day
to 6 months)
Long-Term
Inhalation (> 6
months)
Cancer (oral,
dermal, inhalation)
Dose Used in Risk
Assessment, UF
NOAEL= 5.0
mg/kg/day
None
OralNOAEL= 0.6
mg/kg/day
(dermal absorption
factor = 2.5%)
Inhalation NOAEL=
O.Olmga.i./L/day
(2.7 mg/kg/day)
Inhalation NOAEL=
0.01mga.i./L(2.7
mg/kg/day)
FQPA SF and Level
of Concern for Risk
Assessment
Residential LOC for
MOE = 100
Occupational LOC for
MOE = N/A
Residential LOC for
MOE = N/A
Occupational LOC for
MOE = N/A
Occupational LOC for
MOE = 100
Residential LOC for
MOE =
100
Occupational LOC for
MOE = 100
Occupational LOC for
MOE = 300 for the lack
of long-term study.
Route-to-route
estimation would result
in less protective
endpoint.
Study and Toxicological Effects
MRID 44962202: Subchronic
neurotoxicity study in the rat with
zeta-cypermethrin. LOAEL = 26.3
mg/kg/day based on decreased motor
activity, increased landing foot splay,
and decreased body weights, body
weight gains, and food consumption
MRID 45010401: No systemic effects
in 21 -day dermal study with zeta-
cypermethrin up to 1000 mg/kg/day
and no developmental concern. No
hazard identified to support
quantification of risk.
MRID 44536801: Chronic feeding
study in the dog. LOAEL = 20.4
mg/kg/day based on clinical signs of
neurotoxicity and mortality in males,
and 18.1 mg/kg/day based on
decreased body weights and body
weight gains in females.
MRID 43507101: 21 -day inhalation
study in the rat. LOAEL = 0.05
mg/L/day (13.5 mg/kg/day) based on
decrease in body weight and
salivation.
MRID 43507101: 21 -day inhalation
study in the rat. LOAEL = 0.05
mg/L/day (13.5 mg/kg/day) based on
decrease in body weight and
salivation.
Classification: Category C (possible human carcinogen). No quantification required.
UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no observed adverse effect level, LOAEL =
lowest observed adverse effect level, PAD = population adjusted dose (a = acute, c= chronic), RfD = reference dose,
MOE = margin of exposure, LOC = level of concern, N/A = not applicable.
2. FQPA Safety Factor
During the Agency's phase 3 reregi strati on process, an FQPA safety factor of lOx was retained
due to database uncertainty (the lack of DNT study). The DNT study has now been submitted,
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reviewed, and found to be acceptable. The Agency has determined that the FQPA safety factor
should be reduced to IX, since there are no residual uncertainties for pre- and/or post-natal
toxicity. In addition, EPA has concluded that there is no need to change any previously-selected
endpoints based on the submitted DNT, and that and the dietary (food and drinking water) and
non-dietary exposure assessments are protective of potential exposures to infants and children.
3. Dermal Absorption
A dermal absorption value of 2.5% has been estimated by comparing the maternal LOAEL of 25
mg/kg/day from the developmental study in the rat and the NOAEL (highest dose tested) of 1000
mg/kg/day from the 21-day dermal study in the rat (both conducted with zeta-cypermethrin).
Since there was no common endpoint because no systemic effects were observed in the 21-day
dermal study in the rat, this is considered to be a worst-case estimate.
4. Dietary Exposure
a. Acute Dietary Exposure (food only)
Zeta-cypermethrin is an S-enantiomer enriched formulation of cypermethrin. Since the
analytical method does not distinguish cypermethrin from zeta-cypermethrin, and the
toxicological endpoints are the same, the dietary and non-dietary (residential) aggregate risk
assessment included potential exposures from both chemicals. The residue of concern for
tolerance enforcement and risk assessment is the parent compound (cypermethrin) only. EPA
performed a refined (probabilistic) acute dietary assessment using PDF data, percent crop treated
information, and processing factors where appropriate. The assessment was conducted using the
Dietary Exposure Evaluation Model software with the Food Commodity Intake Database
(DEEM-FCID™, Version 1.3), which incorporates consumption data from USDA's Continuing
Surveys of Food Intakes by Individuals (CSFII), 1994-1996 and 1998.
Dietary risk assessment incorporates both exposure to and toxicity of a given pesticide. Dietary
risk is expressed as a percentage of a level of concern. The level of concern is the dose predicted
to result in no unreasonable adverse health effects to any human population subgroup, including
sensitive members of such population subgroups. This level of concern is referred to as the
population adjusted dose (PAD), which reflects the reference dose (RfD), either acute or chronic,
adjusted to account for the FQPA safety factor.
Estimated risks that are less than 100% of the PAD are below EPA's level of concern. The acute
PAD (aPAD) is the highest predicted dose to which a person could be exposed on any given day
with no adverse health effects expected. For cypermethrin, the acute risk estimates are below the
Agency's level of concern (100% of the aPAD) for the general U.S. population and all
population subgroups. The most highly exposed population subgroup was children 1-2 years old
at 6.1% of the aPAD at the 99.9th percentile of exposure.
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b. Chronic Dietary Exposure (food only)
A refined chronic dietary assessment was performed using PDF data, percent crop treated
information, and processing factors where appropriate. The assessment was conducted using
DEEM-FCID™, Version 1.3. The chronic PAD (cPAD) is the highest predicted dose to which a
person could be exposed over the course of a lifetime with no adverse health effects expected.
Chronic risk estimates for cypermethrin are below the Agency's level of concern (100% of the
cPAD) for the general U.S. population and all population subgroups. The most highly exposed
population subgroup was children 1-2 years old at 0.2% of the cPAD.
5. Drinking Water Exposure
(For a complete discussion, see the "Tier II Estimated Environmental Concentrations of
Cypermethrin for the Use in the Human Health Risk Assessment" dated 05/02/2005, and the
"Water Exposure/Risk, section 4.3 of the HED Chapter.)
Based on the available data, cypermethrin/zeta-cypermethrin is a moderately persistent chemical
that primarily degrades by photolysis in water and biodegradation. Cypermethrin is
hydrologically stable at neutral pH. Cypermethrin is more light stable than the first or second
generation pyrethroids like allethrin and resmethrin, but still undergoes photolysis in water, with
half-lives of about a month or more in distilled water. The rate of photolysis appears to be
enhanced in natural waters (which contain photosensitizing agents like humic and fulvic acids),
where it degrades with half-lives of a few days. It binds tightly to soil particles and is not likely
to move to groundwater. The Agency has determined that the residue of toxicological concern to
be included in drinking water assessment is the parent compound only.
The Estimated Drinking Water Concentrations (EDWCs) for cypermethrin were estimated using
PRZM/EXAMS, based on modeling six aerial applications to cotton in North Carolina at the
maximum application rate of 0.1 Ibs a.i./A (for a yearly maximum of 0.6 Ib a.i./A). According to
the label, the maximum application rate is 0.6 Ib a.i./A per season, so for certain crops like
lettuce which have several growing seasons in one year, exposures could be higher. The
exposure scenarios modeled assumed only one season per year. The estimated acute drinking
water concentration in surface water is 1.04 ppb, and the estimated chronic drinking water
concentration in surface water is 0.013 ppb (this value represents the mean over a 30-year
period). Various other scenarios were also assessed (CA, MS and TX cotton, CA onion, and CA
lettuce), but they consistently yielded lower EDWCs. The SCI-GROW model generated an
EDWC for groundwater based on a maximum application rate for cypermethrin of six
applications of 0.1 Ibs a.i./A (this rate is representative of both cotton and lettuce). The
groundwater EDWC for both acute and chronic exposures is 0.0036 ppb.
6. Residential Exposure and Risk
(For a complete discussion see, "Cypermethrin and Zeta-Cypermethrin: Revised Occupational
and Residential Exposure Assessment for the Reregi strati on Eligibility Decision Document",
dated April 5, 2006, DP barcode D293417).
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The general public can be exposed to cypermethrin when applying the pesticide for indoor and
outdoor residential pest control, or subsequent to applications made by residential applicators or
professional applicators. Non-cancer risk estimates are expressed as a margin of exposure
(MOE) which is a ratio of the dose from a toxicological study selected for risk assessment,
typically a NOAEL, to the predicted exposure. Estimated MOEs are compared to a level of
concern which reflects the dose selected for risk assessment and uncertainty factors (UFs)
applied to that dose. The standard UF is lOOx which includes lOx for interspecies extrapolation
(to account for differences between laboratory animals and humans) and lOx for intraspecies
variation (to account for differences between humans). Additional uncertainty or safety factors
may also be applied. In the case of cypermethrin, EPA's level of concern is an MOE of 100.
a. Residential Handler Risk
No short-term dermal exposures or risks were assessed for cypermethrin, since no dermal
endpoints of concern were identified. EPA does not anticipate that residential handlers would
have intermediate- or long-term exposures to cypermethrin or zeta-cypermethrin. Therefore, no
intermediate- or long-term risks were assessed.
EPA did assess short-term inhalation exposures and risks to residential handlers, for the
following scenarios:
• Mixing/Loading/Applying Liquid concentrates with Low Pressure Handwand
• Mixing/Loading/Applying Liquid concentrates with Wipes
• Applying Ready to Use Formulations with a Pump Sprayer (PHED aerosol can data)
• Applying Ready to Use Formulations with Aerosol Cans
• Applying Ready to Use Formulations with Fogger
• Applying Ready to Use Formulations with Wipes
Residential inhalation risks are below EPA's level of concern (i.e., MOE > 100) for all non-
occupational handler scenarios. All MOEs were greater than 16,000 which is below the
Agency's level of concern.
A granular product was registered on February 23, 2006 (EPA registration # 28293-367). This
product is for application to fire ant mounds on lawns and outside of homes. Similar products
are registered for liquid zeta-cypermethrin and for liquid and wettable powder cypermethrin
formulations. Due to lack of formulation-specific exposure data, no quantitative risk assessment
could be conducted for the cypermethrin granular formulation. However, the Agency believes
that the risk to residential handlers from exposure to this product will not exceed that for liquid
products, which is below the EPA's level of concern.
b. Residential Post-application Risk
Since no effects were observed in any dermal exposure study, non-dietary post-application
exposure to adults was assessed via the inhalation route only. Exposure to toddlers was assessed
via the inhalation route, and via incidental oral exposure. All of these exposures are considered
short term. Although cypermethrin can be used indoor as termiticide use, long term exposure
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due to inhalation is considered negligible, since the vapor pressure for cypermethrin is extremely
low. In general, post-application inhalation risks following outdoor applications are considered
negligible as well.
Post-application inhalation risks following indoor fogger applications were assessed using time-
weighted averages from a cyfluthrin room fogger air monitoring study. Post-application
inhalation risks following indoor aerosol spray applications to carpets were assessed using air
concentration estimates from the crack and crevice subset of PHED, and using a House Model to
estimate an emission rate.
Inhalation risks to both adults and toddlers were below the Agency's level of concern (i.e., MOE
> 100). All indoor inhalation MOEs for toddlers and adults were greater than 71,000 which is
below the Agency's level of concern.
Post-application risks to toddlers from incidental oral ingestion were assessed using a short-term
incidental oral endpoint (10 mg/kg/day). Incidental oral exposure to toddlers was assessed for
the following scenarios:
• Hand to mouth activity on turf
• Object to mouth activity on turf
• Incidental soil ingestion
• Hand to mouth activity from indoor surfaces following crack & crevice treatments
• Hand to mouth activity from indoor surfaces following broadcast fogger treatments
The results indicate that risks from short-term incidental oral exposures were below EPA's level
of concern for all indoor and outdoor scenarios, all MOEs were greater than 900.
7. Aggregate Exposure and Risk (food, drinking water, and residential)
In accordance with 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 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. Aggregate risk assessments for cypermethrin were
conducted as follows: acute and chronic aggregate assessments were conducted based on food
and water exposures, and short-term aggregate assessments were conducted based on food,
water, and residential exposures. No intermediate- or long-term aggregate risk assessments were
conducted because no intermediate- or long-term exposure scenarios are expected from
residential uses of cypermethrin.
a. Acute Aggregate Risk (food and drinking water)
In order to calculate aggregate risk from exposure to cypermethrin residues in food and drinking
water, EPA compared estimated cypermethrin concentrations in surface and groundwater (the
EDWCs presented in section III.A.4.) with Drinking Water Levels of Comparison (DWLOCs). A
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DWLOC is the portion of the PAD remaining after estimated dietary (food only) exposures have
been subtracted, and the remaining exposure has been converted to a concentration in ppb. This
concentration value, or DWLOC, represents the potential drinking water exposure that would
still fall below EPA's level of concern. As long as the maximum EDWCs for surface and ground
water are less than the DWLOC, aggregate risks from food and drinking water exposures are
below EPA's level of concern.
In the case of cypermethrin, the lowest acute DWLOC of 940 ppb for children 1-2 years old is
much higher than the peak EDWC of 1.04 ppb in surface water and 0.0036 ppb for ground water;
therefore, acute aggregate risk estimates associated with exposure to cypermethrin residues in
food and water do not exceed the Agency's level of concern.
b. Short-term Aggregate Risk (food, drinking water, and residential)
Short-term aggregate exposure takes into account residential exposure plus average exposure
levels to food and water (considered to be a background exposure level). Cypermethrin
residential uses constitute short-term exposure scenarios; endpoints have been selected for short-
term incidental oral and inhalation exposures, and the acceptable MOE for all short-term
exposures is 100. Since the toxicological effects through the inhalation exposure route are
similar to the toxicological effects from oral exposures, the short-term aggregate risk assessment
was conducted by adding the residential inhalation exposure, oral non-dietary exposure, and
average food and water exposure. The incidental oral residential exposure value selected for the
aggregate analysis was based on hand to mouth activity from indoor surfaces following crack
and crevice treatment, as this scenario resulted in the highest calculated exposure level, and is
therefore considered protective for all other exposure scenarios.
Short-term aggregate risk does not exceed Agency's level of concern for any population
subgroup. The lowest DWLOC value of 890 ppb was calculated for children 1-2 years old and
this level is higher than the surface and ground water EDWCs of 0.013 and 0.0036 ppb,
respectively.
c. Chronic Aggregate Risk (food and drinking water)
Although cypermethrin can be used indoors as a termiticide, long term inhalation exposure is not
expected due to its very low vapour pressure (3.IE"9 mm Hg at 20 °C). Therefore, the chronic
aggregate assessment only includes food and water. Chronic dietary estimates of exposure from
food were taken from the dietary exposure model results described above. The calculated
DWLOCs for children 1-2 years old has the lowest chronic DWLOC value of 600 ppb, which is
greater than both the surface water (0.013 ppb) and ground water (0.0036 ppb) EDWCs;
therefore, chronic aggregate risk estimates do not exceed the Agency's level of concern.
8. Occupational Exposure and Risk
For a complete discussion, see section 7.0 of the "Cypermethrin: Phase 4 HED Risk Assessment
for the Reregistration Eligibility Decision (RED). PC Code 109702; DP Barcode D293416",
dated April 6, 2006. Also, see "Cypermethrin and Zeta-Cypermethrin: Revised Occupational
and Residential Exposure Assessment for the Reregistration Eligibility Decision Document",
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dated April 5, 2006, DP barcode D293417. Although the occupational risk assessment included
zeta-cypermethrin, only cypermethrin occupational assessment results are discussed here, since
this reregi strati on decision applies only to cypermethrin products.
Workers can be exposed to cypermethrin through mixing, loading, and applying the pesticide for
use on agricultural crops and livestock, and for use in indoor and outdoor industrial, commercial,
and residential settings.
a. Occupational Handler Risk
Short- and intermediate-term dermal risks were not assessed for occupational handlers, since no
short- or intermediate-term dermal endpoints were identified. Short and intermediate-term
inhalation risks to handlers when mixing, loading, and applying cypermethrin products were
assessed for the following agricultural and non-agricultural scenarios:
• Mixing and loading liquid and wettable powder formulations to support aerial,
chemigation, groundboom, and airblast applications to agricultural crops
• Applying sprays with aerial, groundboom, or airblast equipment to agricultural crops
• Flagging to support aerial applications
• Mixing, loading, and applying liquid formulations using a low pressure handwand
sprayer, a paint brush, a low pressure/high volume turf/handgun sprayer, or a
termiticide injector
• Mixing, loading, and applying wettable powder formulations using a low pressure
handwand sprayer, a paint brush, or a low pressure/high volume turf/handgun sprayer
• Mixing, loading, and applying wettable powder formulations packaged in water
soluble bags using a low pressure/high volume turf/handgun sprayer
• Applying Ready-to-Use eartags, trigger pump sprayers, wipes, aerosol cans, or
foggers
When data were available to assess risks, short- and intermediate-term inhalation risks to
occupational handlers are below the Agency's level of concern (i.e., MOE >100) at baseline
(long sleeved shirt, long pants, shoes and socks) for all formulations except the wettable powder.
For handlers mixing and loading to support aerial applications to cotton (a high acreage crop),
sodfarms, and agricultural uncultivated areas, fencerows and hedgerows, MOEs at baseline range
from 4 to 37. The addition of engineering controls (packaging wettable powders in water soluble
bags) reduces the risks to below EPA's level of concern for all scenarios. EPA has insufficient
data to assess exposures to pilots in open cockpits. Inhalation risks to pilots in enclosed cockpits
were below EPA's level of concern for all agricultural crop scenarios. No data are available to
assess inhalation risks during the application of impregnated eartags; however, the risks are
expected to be well below the inhalation risks (MOE=15,000) from applications using a ready-
to-use aerosol can (considered to represent a worst case exposure scenario).
A few occupational handler exposure scenarios may be considered long-term, including
applications to residential, commercial, and industrial turf by commercial lawn care operators
and applications in and around residential, commercial, and industrial premises by commercial
pest control operators. Since the toxicological endpoints of concern for long-term exposures are
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based on similar adverse effects, long-term dermal and inhalation risks must be combined for
occupational scenarios where long-term exposures are anticipated. The target MOEs for long-
term occupational workers are 100 for dermal risk and 300 inhalation risk. Since these MOEs
differ, an aggregate risk index (ARI) was used to assess combined long-term dermal and
inhalation risks to handlers. The target ARI is 1; therefore, ARIs of less than 1 indicate potential
risks of concern.
Long-term combined dermal and inhalation risks were assessed for the following
scenarios:
• Mixing, loading, and applying liquid and wettable powder formulations using a
low pressure handwand sprayer, a paint brush, or a low pressure/high volume
turf/handgun sprayer
• Mixing, loading, and applying wettable powder formulations packaged in water
soluble bags using a low pressure/high volume turf/handgun sprayer
Combined long-term dermal and inhalation risks are below EPA's level of concern for all
scenarios involving liquid formulations at baseline attire or with the addition of chemical-
resistant gloves to baseline attire. Combined long-term dermal and inhalation risks are below
EPA's level of concern for all scenarios involving wettable powder formulations at baseline
attire or with the addition of chemical-resistant gloves to baseline attire, except
mixing/loading/applying wettable powders with a low-pressure handwand sprayer. Although
data were not available to estimate the risks from mixing/loading and applying wettable powders
packaged in water soluble bags with a low-pressure handwand sprayer, the risks are expected to
be lower than for liquid products (below EPA's level of concern with the addition of chemical-
resistant gloves to baseline attire). A similar reduction in risk would be expected if wettable
powder products were reformulated into dry flowable formulations.
b. Occupational Post-application Risk
EPA did not assess occupational postapplication risks to agricultural workers following
treatments to agricultural crops, since no short- or intermediate-term dermal endpoints of
concern were identified and long-term dermal exposures are not expected for tasks involving any
of the registered crop use patterns.
EPA did not assess occupational postapplication exposures and risks following applications of
cypermethrin and zeta-cypermethrin to residential and commercial lawns, and in and around
industrial, commercial, and residential premises, since no short- or intermediate-term dermal
endpoints of concern were identified and long-term exposures are not expected for tasks
involving any of the registered use patterns.
9. Human Incident Data
(For a complete discussion, see "Review of Cypermethrin Incident Reports. DP Barcode
D293143, Chemical #109702", dated 08/26/2003.)
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Pyrethroids, like cypermethrin, have relatively low toxicity to humans. Skin and eye irritation,
nausea, vomiting, coughing and difficulty breathing were the most commonly reported
symptoms. As with other pyrethroids, burning or tingling sensations are often reported by
applicators (World Health Organization 1989). The occurrence of moderate and more serious
symptoms was generally more prevalent among those exposed to cypermethrin than those
exposed to other pesticides. Reports suggest that cypermethrin can cause asthma or asthma-like
symptoms in susceptible individuals. See Section IV for further discussion of incidents and
mitigation.
B. Environmental Risk Assessment
More detailed information can be found in the "Revised EFED Risk Assessment for the
Reregi strati on Eligibility Decision (RED) on Cypermethrin After 30-Day "Error Only"
Comment Period", DP Barcode: D293412, dated October 25, 2005 and the "Addendum to the
EFED RED Chapter for Cypermethrin", DP Barcode D293413, dated June 9, 2006.
The majority of cypermethrin use occurs in non-agricultural sites. Non-agricultural applications
of cypermethrin, such as perimeter treatments around buildings and applications to lawns, may
result in exposure to aquatic organisms from surface runoff and/or erosion. Even though
cypermethrin has a strong affinity to bind to soils and surfaces, residues at concentrations toxic
to aquatic organisms have been measured in streams that receive runoff from suburban
developments. A study recently conducted in an urban area of California found residues of
cypermethrin and other pyrethroids in urban streams adjacent to residential areas and suggested
that these areas are unlikely to be unique, particularly in dry regions where landscape irrigation
can dominate seasonal flow in some water bodies. The Agency recognizes the potential for
aquatic toxicity from non-agricultural uses. However, EPA was not able to assess the risks
associated with urban runoff due to limited monitoring data and lack of acceptable models. The
Agency's future plans to assess non-agricultural uses of cypermethrin and other pyrethroids are
discussed in Section IV.
The Agency's Tier I screening-level (deterministic) risk assessment is focused on registered
agricultural uses only. A summary of the Agency's environmental fate assessment is presented
below.
1. Environmental Fate and Transport
For the most part, the environmental fate data for cypermethrin were from studies on
cypermethrin; however, some studies were conducted on zeta-cypermethrin as well as other
isomers. Both cypermethrin and zeta-cypermethrin are expected to have similar fate in the
environment.
Cypermethrin is expected to bind strongly to organic carbon and have little mobility in soil (Koc
values ranged from 20,800 to 385,000 L/kg), and therefore it is not likely to leach into
groundwater. Due to its relatively low mobility, cypermethrin is most likely to reach adjacent
bodies of water via spray drift, through runoff events accompanied by soil erosion, or in runoff
from outdoor impervious surfaces. Cypermethrin is moderately persistent in the environment
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and degrades through a combination of biotic and abiotic mechanisms. In soil, under both
aerobic and anaerobic conditions, cypermethrin biodegrades relatively slowly, with half-lives on
the order of about 2 months. In contrast, degradation is enhanced in water, with aerobic and
anaerobic metabolism half-lives of 9 to 17 days. If released to surface water, cypermethrin
partitions to sediment, where it may degrade more slowly. In terrestrial field dissipation studies,
cypermethrin did not appear to persist in soil, where the major routes of degradation are
photolysis and aerobic biodegradation. Degradation of cypermethrin through photolysis appears
to be enhanced in natural waters which contain humic and fulvic acids. However, field studies
conducted on rice (with zeta-cypermethrin) show high persistence in aquatic sediments. If
cypermethrin is applied repeatedly, it is possible that the chemical can accumulate in the
sediment in ever larger amounts, with slow biodegradation. Cypermethrin bioaccumulates
moderately (488x) in fish.
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 cypermethrin 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 (LCso). 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
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).
Table 3. 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
a. Risk to Aquatic Organisms
i. Fish and Invertebrate Toxicity
The results of acute toxicity studies in fish, invertebrates, and benthic organisms show that
technical grade cypermethrin is very highly toxic on an acute basis. For freshwater fish and
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estuarine/marine fish, the lowest toxicity values reported were an LCso of 0.39 jig a.i./L
(rainbow trout), and an LCso of 0.95 jig a.i./L (sheepshead minnow), indicating that these
organisms all have a similar susceptibility to cypermethrin. For freshwater invertebrates the
lowest toxicity values reported were an LC50 of 0.0036 jig a.i./L (waterflea) and for
estuarine/marine invertebrates an LCso of 0.00475 jig ai/L (mysid shrimp), approximately 100
times lower than the toxicity values reported for fish. These results indicate that freshwater and
estuarine/marine invertebrates are substantially more sensitive than other types of aquatic
organisms to cypermethrin toxicity, and that they are expected to be at greatest risk for acute
effects (death).
The available experimental LCso value for benthic amphipods is expressed in terms of sediment
concentration of cypermethrin (LC50 = 3.6 jig a.i./kg sediment). To assess risk to benthic
organisms in terms of pore water, a surrogate benthic organism LCso value for pore water
(0.00257 jig a.i./L pore water) was derived using the sediment LCso value and the average Koc
value (141,700) for cypermethrin. In oysters, cypermethrin is categorized as highly toxic (370
|ig a.i./L).
Cypermethrin formulations are also very highly toxic, with LCso values that are similar to those
reported for technical grade cypermethrin.
Table 4. Cypermethrin (Technical Grade) Acute Toxicity Reference Values for Aquatic
Organisms.
Exposure
Scenario
Freshwater
Fish
Freshwater
Invertebrates
Benthic
Organisms
Species
rainbow
trout
amiphod
amphipod
Exposure
Duration
96 hours
48 hours
10 days
Toxicity
Reference
Value (jig
a.i./L)
LC50 = 0.39 jig
a.i./L
LC50 = 0.0036
Hg a.i./L
sediment value
(experimental
data):
a.i./kg
sediment
pore water
value (derived
data):
0.00257 (ig
a.i./L pore
water
Effects
Morbidity
Morbidity
Morbidity and
Growth
Reference
MRID 44546027
MRID 44423501
MRID 44074406
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Table 4. Cypermethrin (Technical Grade) Acute Toxicity Reference Values for Aquatic
Organisms.
Exposure
Scenario
Estuarine/
Marine Fish
Estuarine/
Marine
Invertebrates
Species
sheepshead
minnow
mysid
shrimp
Exposure
Duration
96 hours
96 hours
Toxicity
Reference
Value (jig
a.i./L)
LC50 = 0.95 ng
a.i./L
LC50 = 0.00475
(ig a.i./L
Effects
Morbidity
Morbidity
Reference
MRID 90075
Ace. No. 42444601
Chronic toxicity studies are available for freshwater fish and estuarine/marine invertebrates.
Results in freshwater fish show that neonate survival is adversely affected by cypermethrin
exposure (NOAEC = 0.14 jig a.i./L). For estuarine/marine invertebrates, chronic exposure to
cypermethrin produced adverse effects on reproductive (NOAEC = 0.0015 jig a.i./L) and growth
parameters (NOAEC = 0.000781 |ig a.i./L).
Table 5. Cypermethrin (Technical Grade) Chronic Toxicity Reference Values for
Aquatic Organisms.
Exposure
Scenario
Species
Exposure
Duration
Toxicity
Reference
Value (jig
a.i./L)
Effects
Reference
Freshwater
Fish
Freshwater
Invertebrates
Benthic
Organisms
Estuarine/Mar
ine Fish
fathead
minnow
30 days
NOAEC = 0.14
(ig a.i./L
LOAEC = 0.33
Ugai/L
Growth and
morbidity
MRID 89039
No adequate data submitted; to assess chronic risk to freshwater invertebrates,
surrogate NOAEC value of 0.00059 (ig a.i./L was derived based on the acute:chronic
ratio method using acute and chronic data for estuarine/marine invertebrates.
No chronic data submitted; to assess chronic risk to benthic organisms, surrogate
chronic NOAEC toxicity values for sediment of 0.59 (ig a.i./kg sediment and for
pore water of 0.00042 (ig a.i./L pore water were derived based on the acute:chronic
ratio method using acute and chronic data for estuarine/marine invertebrates.
No data submitted; to assess chronic risk to estuarine/marine fish, a surrogate
NOAEC value of 0.34 (ig a.i./L for sheepshead minnow was derived based on the
acute:chronic ratio method using acute and chronic data for freshwater fish, e
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Table 5. Cypermethrin (Technical Grade) Chronic Toxicity Reference Values for
Aquatic Organisms.
Exposure
Scenario
Estuarine/
Marine
Invertebrates
Species
mysid
shrimp
Exposure
Duration
28 days
Toxicity
Reference
Value (jig
a.i./L)
NOAEC =
0.000781 ng
a.i./L
LOAEC =
0.00197 |ig
ai/L
NOAEC =
0.0015 ugai/L
LOAEC =
0.0028 |ig ai/L
Effects
Weight of
females
reduced
Number of
offspring
reduced
Reference
MRID 42725301
ii. Fish and Invertebrate Exposure
For exposure to aquatic fish and invertebrates, EPA considers surface water only, since most
aquatic organisms are not found in ground water. Estimated environmental concentrations
(EECs) for cypermethrin calculated using the Tier IIPRZM/EXAMS models and employing
maximum application rates, indicate that cypermethrin preferentially partitions to the sediment.
Three crop usage scenarios, which constitute approximately 90% of cypermethrin's total crop
usage, were considered: cotton, lettuce, and pecans. Modeling produced the highest EECs for
cotton crops in North Carolina and Mississippi. A complete listing of EECs can be found in the
EFED risk assessment, dated October 25, 2005.
iii. Fish and Invertebrate Risk
To assess risks of cypermethrin to non-target aquatic animals (i.e., fish and invertebrates),
EPA uses the peak concentration to derive RQs for acute exposure and the 21-day average
concentration to derive RQs for chronic exposure. RQs are calculated as the concentration (peak
or average EEC) divided by the relevant endpoint (LC50 for acute risk, NOAEC for chronic risk).
Since results of acute toxicity studies in freshwater fish and invertebrates indicate that the major
cypermethrin degradate (3-phenoxy benzoic acid) is much less toxic than the parent compound,
EECs and RQs were derived only for the parent compound, not for total residue (parent plus
degradates). Acute risk quotient (RQ) values were calculated using the endpoint from the most
sensitive species tested within a taxonomic group.
Acute RQs for aquatic organisms are summarized in Table 6. The LOG for acute risk
(LOG 0.5) is exceeded for all aquatic organisms and modeled crop scenarios, except CA cotton
for freshwater invertebrates and estuarine/marine fish, and CA lettuce for estuarine/marine fish.
LOCs for acute endangered species risk (LOG 0.05) are exceeded for freshwater fish and
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invertebrates and estuarine/marine fish and invertebrates for all six crop scenarios assessed. The
highest acute RQs are observed for freshwater invertebrates, ranging from 49.4 (CA cotton) to
558.3 (NC cotton), exceeding all acute LOCs.
Table 6. Acute RQs for Freshwater Fish, Freshwater Invertebrates, Estuarine/Marine
Fish and Estuarine/Marine Invertebrates Exposed to Cypermethrin.
Crop Use
Cotton
Pecans
Lettuce
(Head)
PRZM/EXAMS
Scenario
California
Mississippi
North Carolina
Texas
Georgia
California
Freshwater
Fish
Acute RQ
0.5
3.3
5.2
1.3
2.4
0.7
Freshwater
Invertebrate
Acute RQ
49.4
355.6
558.3
136.9
264.7
80.6
Estuarine/Marine
Fish
Acute RQ
0.2
1.3
2.1
0.5
1.0
0.3
Estuarine/Marine
Invertebrate
Acute RQ
37
269
423
104
201
61
Chronic RQs for aquatic animals are summarized in Table 7. For freshwater invertebrates,
chronic RQs range from 57.6 to 325.4 and for estuarine/marine invertebrates, chronic RQs range
from 44 to 246 and, exceeding the chronic LOG (1). For freshwater fish and estuarine/marine
fish, all chronic RQs are below the chronic LOG.
Table 7. Chronic RQs for Freshwater Fish, Freshwater Invertebrates, Estuarine/Marine
Fish and Estuarine/Marine Invertebrates Exposed to Cypermethrin.
Crop Use
Cotton
Pecans
Lettuce
(Head)
PRZM/EXAMS
Scenario
California
Mississippi
North Carolina
Texas
Georgia
California
Freshwater
Fish
Chronic RQ
0.2
0.7
0.7
0.2
0.3
0.1
Freshwater
Invertebrate
Chronic RQ
93.2
318.6
325.4
101.7
145.8
57.6
Estuarine/Marine
Fish
Chronic RQ
0.1
0.3
0.3
0.1
0.1
0.1
Estuarine/Marine
Invertebrate
Chronic RQ
70
241
246
77
110
44
Sediment Exposure - Acute and Chronic Risk
Acute and chronic RQs have been derived for exposure of benthic organisms to sediments and
pore water (Table 10). All acute and chronic RQs for benthic organisms exceed the LOCs for
acute risk (LOG 0.5), acute endangered species risk (LOG 0.05) and chronic risk (LOG 1) for all
modeled crop uses. There are several uncertainties regarding both acute and chronic RQs. Due
to data gaps, acute RQs for pore water and chronic RQs for sediment and pore water were
derived from estimated toxicity values based on the acute sediment toxicity value. However,
there is considerable uncertainty surrounding the acute sediment toxicity value, since this value
was obtained from a study using a water-sediment system that was not at equilibrium (sediment
concentrations decreased throughout the exposure period).
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Table 8. Acute and Chronic RQs for Benthic Organisms Exposed to Cypermethrin.
Crop
Use
Cotton
Pecans
Lettuce
(Head)
PRZM/EXAM
S Scenario
California
Mississippi
North Carolina
Texas
Georgia
California
Sediment Acute
RQ
7
44
48
13
26
8
Pore Water
Acute RQ
2
11
12
3
7
2
Sediment
Chronic RQ
35
228
244
52
123
47
Pore Water
Chronic RQ
9
57
60
13
31
12
iv. Aquatic Plant Toxicity, Exposure and Risk
Toxicity data are not available for aquatic plants; thus, risks associated with cypermethrin
exposure to aquatic plants could not be assessed. However, based on cypermethrin's mode of
action, cypermethrin is not expected to be phytotoxic. In addition, the Agency is not aware of
any plant incidents involving exposure to cypermethrin.
v. Effect of Buffers on Spray Drift
The screening-level risk assessment indicates that peak EECs exceed acute levels-of-concern for all
aquatic taxa considered. The ecological risk assessment includes an evaluation of the relative contribution
of runoff and spray drift to the exposure simulated by PRZM/EXAMS. A hypothetical scenario was run
(for use on NC cotton) in which application of cypermethrin resulted in no spray drift. The resulting EEC
of 2.2 (ig a.i./L, which represented transport of cypermethrin to water via runoff and erosion alone, is high
enough to exceed the acute LOC for all aquatic taxa.
The effect of a 150-foot spray buffer on potential exposure from runoff and erosion cannot currently be
quantified. Presumably, the mass of cypermethrin that would be applied to that portion the field within
150 feet of a water body would be less than that applied to the rest of the crop, and would decline with
distance. However, the PRZM model is an edge-of-field model which cannot simulate an untreated area
between the field and the receiving water body.
The expected effect of a spray buffer on exposure through spray drift can be quantified using the
AgDRIFT model, which was developed using extensive field data collected by the Spray Drift Task
Force. This is important because while the EEC from PRZM/EXAMS used in the screening model
represents a 1-in-10-year exposure from combined runoff/erosion and spray drift, the output from
AgDRIFT can be made to represent the amount of exposure from spray drift that could occur any time a
pesticide is applied.
AgDRIFT modeling for cypermethrin indicates that the exposure from spray drift alone could be
sufficient to exceed levels of concern for aquatic organisms, and that implementation of a spray buffer
can reduce that exposure significantly. Using typical spray conditions (10 ft. release height, 10 mph wind,
and a fine-to-medium droplet size distribution [DSD]), the AgDRIFT model simulates a concentration of
0.73 (ig a.i./L in the standard pond from spray drift if no buffer zone is observed. Risk quotients
calculated with this EEC would exceed the acute LOCs of 0.5 for freshwater and estuarine/marine fish
and invertebrates.
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The table below shows the effect of spray buffers on the concentration of cypermethrin that AgDRIFT
simulates in the standard pond. These values reflect the typical spray conditions described above, and an
application rate of 0.1 Ib ai/acre:
Table 9. Effect of Various Buffers on EECs
Buffer (ft)
Concentration
(|ig a.i./L)
0
0.73
50
0.44
100
0.31
150
0.24
200
0.20
When a buffer of 150 feet is simulated, the resulting concentration of cypermethrin in the pond resulting
from drift alone is reduced by two-thirds. This is sufficient to reduce the EEC below the acute level-of-
concern of 0.5 for estuarine/marine fish (RQ = 0.24 (ig a.i./L/0.95 (ig a.i./L = 0.25). This reduction would
not reduce the risk quotients for drift alone below the acute LOG for freshwater fish (RQs of 0.61), but
the reduction in exposure could lead to lower levels of mortality, and perhaps be sufficiently protective
for less sensitive species. The toxicity reference values for freshwater and estuarine/marine invertebrates
(LC50 = 0.0036 and 0.0048 (ig a.i./L, respectively) are so low that even a two-third reduction in exposure
still results in RQs far above the LOC (RQ = 67 and 50, respectively).
The use of a spray buffer would reduce exposure under conditions other than the typical conditions
described above, but conditions more conducive to spray drift could result in unacceptable exposure from
drift alone regardless of the buffer. For instance, if the wind speed (10 mph) and release height (10 ft) are
kept the same as above, but a very fine-to-fine DSD is simulated instead of a fine-to-medium DSD, much
greater exposure to cypermethrin could result.
Table 10. Effect of Various Buffers Using Fine-to-Fine Droplets on EECs
Buffer (ft)
Concentration
(|ig a.i./L)
0
1.7
50
1.2
100
0.96
150
0.8
200
0.68
The resulting amount of spray drift would lead to more than three times the exposure at 150 feet
than if the fine-to-medium DSD were used, and the resulting EECs would still exceed the LOC
for all aquatic taxa.
In summary, a 150-foot no-spray buffer can result in significant reductions in exposure and risk
to aquatic organisms, provided that application occurs under typical conditions and the DSD
used for application is not too fine. Such exposure from spray drift alone can be expected any
time cypermethrin is applied, regardless of whether a significant runoff/erosion event happens
soon after.
vi. Risk to Aquatic Organisms from Non-Agricultural Uses
In addition to these potential acute and chronic risks from agricultural uses, aquatic organisms
may be exposed to cypermethrin from non-agricultural uses, as well. The Agency has received
and considered the results of a published study that measured pyrethroid residues in stream
sediments adjacent to an urban subdivision in California. The study found toxic residue levels of
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cypermethrin and other pyrethroids in stream sediments that receive runoff from the subdivisions
via storm drains and summer over-irrigation of landscapes and lawns (Weston, etal., 2005).
Although bifenthrin was the major pyrethroid found, cypermethrin concentrations were also of
toxic significance to aquatic invertebrates. Weston's work is significant because it documents the
presence of pyrethroids in the sediments of creeks near residential areas. Since most of the use
of cypermethrin is in non-agricultural settings, urban uses pose additional risks to aquatic
systems that the Agency cannot quantitatively assess at this time. EPA currently is evaluating
appropriate modeling approaches to assess risks from urban runoff (see Chapter IV for further
discussion).
b. Risk to Terrestrial Organisms
i. Bird and Mammal Toxicity
Results of acute toxicity studies on birds suggest that cypermethrin is practically non-toxic to
slightly toxic to avian species (LDso >2,000 mg a.i./kg body weight; LCso > 2,634 mg a.i./kg
diet) on an acute basis. Chronic avian studies showed no adverse effects at 50 mg a.i./kg diet (the
highest dose tested), but the study was incomplete because a LOAEC was not determined
Mammalian data suggest that cypermethrin is moderately toxic (LDso = 247 mg/kg body weight)
on an acute basis. A chronic study in rats showed adverse effects (decreased body weight and
body weight gain) in adults and offspring (NOAEC = 5.0 mg a.i./kg/ body weight/day; 100 mg
a.i./kg diet).
Table 11. Cypermethrin Toxicity Reference Values for Terrestrial Organisms.
Exposure
Scenario
Species
Exposure
Duration
Toxicity Reference Value
Reference
Mammals
Acute
(Dose-based)
Chronic
(Dietary-based
and
Dose-based)
rat
rat
single oral dose
3 generation
reproduction
study
LD50 (M): 247 mg/kg/ body wt
NOAEL (toxicity to parents
and offspring) = 5.0 mg/kg/day
LOAEC = (toxicity to parents
and offspring) = 25 mg/kg/day
MRID 00056800
MRID 00090040
Birds
Acute
(Dose-based)
Acute
(Dietary-based)
bobwhite quail
mallard duck
single oral dose
5 -day dietary
LD50 >2,000 mg a.i./kg body
wt
LC50 >2,634 mg a.i./kg diet
MRID 44546024
MRID 00090071
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Table 11. Cypermethrin Toxicity Reference Values for Terrestrial Organisms.
Exposure
Scenario
Chronic
(Dietary-based)
Species
mallard duck
and
bobwhite quail
Exposure
Duration
Avian
reproduction
Toxicity Reference Value
NOAEC >50 mg a.i./kg diet
Reference
MRID 42322902
MRID 42322901
ii. Bird and Mammal Exposure
The Agency assessed exposure to terrestrial organisms by first predicting the amount of
cypermethrin 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 cypermethrin.
Estimated exposure concentrations for terrestrial receptors were determined using the standard
screening-level exposure model, TREX (v.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 cypermethrin is applied. The
underlying assumption is that most, if not all, of the applied pesticide will settle in the use area.
However, depending on weather conditions and type of application, spray drift of pesticides may
occur, increasing the likelihood of wildlife exposure outside the use area. Since cypermethrin is
applied via spray methods, spray drift is likely to occur and in some cases could be a significant
source of exposure.
Four crop usage scenarios were assessed: cotton, pecans, lettuce, and canola. Cypermethrin
maximum dose-based EECs ranged from 1.2-122 mg/kg body weight for birds, and 0.1-102
mg/kg body weight for mammals.
in.
Bird and Mammal Risk
For birds, all acute, dose-based and dietary based RQs are below the LOG for acute risk (LOG
0.5) and endangered species (LOG 0.1) for all crop uses. However, the acute endangered species
LOG (0.1) is exceeded for 15g and 35g mammals feeding on short grass (dose-based RQs 0.1-
0.2) for all crop scenarios, and for 15g mammals feeding on broadleaf plants/small insects in
cotton (RQ = 0.11).
Chronic, dietary-based RQs for birds are all below the LOG for chronic risk (LOG 1). It was not
possible to calculate a chronic dose-based RQ for birds because there were no acceptable dose-
based toxicity values for birds available. For mammals, chronic, dose-based RQs range from
<0.1 to 9.3 (15g mammals feeding on short grass in cotton), exceeding the chronic LOG (1) for
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most scenarios. The chronic dietary-based RQ (1.1) exceeded the chronic LOG (1) for mammals
feeding on short grass in cotton.
iv. Non-target Insect Toxicity, Exposure and Risk
Results of available toxicity studies indicate that cypermethrin is highly toxic to honey bees
(LDso = 0.023 - 0.56 ug/bee) and very toxic to earthworms (LC50 = 26.09 ug/cm2) on an acute
contact basis. Thus, honey bees and other non-target terrestrial invertebrates (e.g. beneficial
insects and listed insects) are expected to be at risk for acute effects (lethality). No RQ values
for non-target insects were derived; however, risks can be assessed qualitatively. Cypermethrin
toxicity data show that it is very highly toxic to honey bees and is considered to be highly toxic
on both a contact and an oral basis. Cypermethrin was also found to be highly toxic to honey
bees exposed to foliage that had been sprayed with a cypermethrin formulation (Cymbush 3E).
In addition, cypermethrin has also been shown to be highly toxic to earthworms. Based on these
results, acute risks to non-target insects and terrestrial invertebrates are anticipated for the uses
considered in this assessment.
v. Terrestrial Plants
As for aquatic plants, toxicity data are not available for terrestrial plants and risks could not be
assessed. Cypermethrin is not expected to be phytotoxic based on its mode of action, and no
incidents involving terrestrial plants have been reported to the Agency.
c. Ecological Incidents
A total of 10 aquatic incidents involving cypermethrin exposure have been reported to EPA and
tracked by Ecological Incident Information System (EIIS). All incidents were categorized
according to the Certainty Index as follows: possible (3 reports); probable (3 reports); and highly
probable (4 reports). Although in about half of these aquatic incidents the source of
cypermethrin was not reported, several fish kills were attributed to termiticide use of
cypermethrin.
A total of five incidents involving terrestrial organisms (birds, goats, dog) were noted. The
incident involving birds (5000 sparrows) was attributed to birds eating insects that had been
killed from cypermethrin use the previous night on an eggplant crop.
d. Endangered Species Concerns
The Agency's screening level ecological risk assessment for endangered species results in the
determination that cypermethrin will have no direct acute effects on threatened and endangered
birds. However, potential indirect effects to any species dependent upon a species that
experiences effects cannot be precluded from use of cypermethrin. These findings are based
solely on EPA's screening level assessment and do not constitute "may effect" findings under the
Endangered Species Act.
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For birds, all acute RQs are below the endangered species LOG (0.1) for all crop uses. The
Agency's acute endangered species LOG for birds was not exceeded in the screening level
assessment, but one incident involving acute effects on birds was reported.
For mammals, the acute endangered species LOG (0.1) is exceeded for 15g and 35g mammals
feeding on short grass (dose-based RQs 0.1-0.2) for all crop scenarios and aquatic organisms
(LOG = 0.05) were exceeded. The maximum calculated acute RQs for all organisms resulted
from modeling cypermethrin use on North Carolina cotton; the maximum screening level acute
RQs which exceed acute LOCs are shown in Table 12, below.
Table 12. Maximum acute RQs in screening level assessment.
Organism Maximum Acute RQ
Mammals 0.2
Freshwater fi sh 5.2
Freshwater invertebrates 558.3
Estuarine/marine fish 2.1
Estuarine/marine invertbrates 423
Benthic organisms (sediment 48
exposure)
Benthic organisms (pore water 12
exposure)
The Agency's screening level assessment results in the determination that cypermethrin will
have no direct chronic effects on birds (all RQs are less than the chronic LOG of 1.0). However,
the chronic LOG is exceeded for mammals, freshwater and estuarine/marine invertebrates, and
benthic organisms. The maximum calculated chronic RQs for all organisms resulted from
modeling cypermethrin use on North Carolina cotton; the maximum screening level chronic RQs
which exceed the chronic LOG are shown in Table 13, below.
Table 13. Maximum chronic RQs in screening level assessment.
Organism Maximum Chronic RQ
Mammals (dose-based risk) 9.3
Freshwater invertebrates 325.4
Estuarine/marine invertbrates 246
Benthic organisms (sediment 244
exposure)
Benthic organisms (pore water 60
exposure)
No data were submitted to evaluate the risk of cypermethrin exposure to non-target terrestrial
plants. However, the agency has determined that cypermethrin will have no effect on listed
plants. Also, no incident reports have reliably linked cypermethrin or any other synthetic
pyrethroid to phytoxic effects despite the fact that pyrethroids are often applied on or near
agricultural crops.
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All of these findings are based solely on EPA's screening level assessment and do not constitute
"may effect" findings under the Endangered Species Act. 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 species specific assessments result in the
need to modify use of the pesticide in specific geogrpahic areas, those changes to the pesticide's
registration will take through the process described in the Agency's Federal Register Notice (54
FR 27984) regarding implementation of the Endangered Species Protection Program.
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 reregi strati on. The Agency has previously identified and required the submission of
the generic data to support reregi strati on of products containing cypermethrin and has
determined that the data are sufficient to support reregi strati on.
The Agency has completed its assessment of the dietary, residential, occupational and ecological
risk associated with the use of cypermethrin. Based on this assessment the Agency has sufficient
information to make decisions as part of the tolerance reassessment process under FFDCA and
reregi strati on process under FIFRA, as amended by FQPA. The Agency has determined that
cypermethrin containing products are eligible for reregi strati on provided that label amendments
are made as outlined in this RED. Appendix A summarizes the uses of cypermethrin that are
eligible for reregi strati on. Appendix B identifies the generic data requirements that the Agency
reviewed as part of its determination of reregi strati on eligibility, and lists the submitted studies
that the Agency found acceptable.
Based on its evaluation of cypermethrin, the Agency has determined that cypermethrin 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 reregi strati on
requirements identified in this document, the Agency may take regulatory action to address the
risk concerns from the use of cypermethrin. If all changes outlined in this document are
incorporated into the product labels, then all current risks for cypermethrin 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. Public Comments and Responses
Through the Agency's public participation process, EPA worked with stakeholders and the
public to reach the regulatory decisions for cypermethrin. EPA released its cypermethrin
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preliminary risk assessments for public comment on December 28, 2005, for a 60-day public
comment period (Phase 3 of the public participation process). During the public comment
period, the Agency received comments from the technical registrants, the California water
quality control boards, the California Stormwater Quality Association, and other stakeholders.
These comments in their entirety, responses to the comments, as well as the preliminary and
revised risk assessments, are available in the public docket (EPA-HQ-OPP-2005-0293) at
http://www.regulations.gov.
C. Regulatory Position
1. Food Quality Protection Act Findings
a. "Risk Cup" Determination
Even though cypermethrin tolerances are not included in EPA's baseline tolerance reassessment
counts, EPA assessed the risks associated with cypermethrin. EPA has concluded that the
tolerances for cypermethrin meet FQPA safety standards. In reaching this determination, EPA
has considered the available information on the special sensitivity of infants and children, as well
as aggregate exposure from food and residential sources.
b. Determination of Safety to U.S. Population
The Agency has determined that the established tolerances for cypermethrin, with amendments
and changes as specified in this document, meet 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 subgroup from the use
of cypermethrin. In reaching this conclusion, the Agency has considered all available
information on the toxicity, use practices, and the environmental behavior of cypermethrin. As
discussed in Section III, aggregate acute, 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 tolerances for cypermethrin, with amendments and
changes as specified in this document, meet the safety standards under the FQPA amendments to
section 408(b)(2)(C) of the FFDCA, that there is a reasonable certainty of no harm for infants
and children. The safety determination for infants and children considers factors 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 cypermethrin residues in this population subgroup.
In determining whether or not infants and children are particularly susceptible to toxic effects
from exposure to residues of cypermethrin, the Agency considered the completeness of the
hazard database for developmental and reproductive effects including a developmental neurotox
study, the nature of the effects observed, and other information. The FQPA Safety Factor has
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been reduced to IX, because there are no residual uncertainties for pre- and/or post-natal
toxicity, exposure is not underestimated, and there is no evidence of increased susceptibility.
2. Endocrine Disrupter Effects
The available database provides no evidence that cypermethrin induces endocrine disruption.
EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to
determine whether certain substances (including all pesticide active and other ingredients) "may
have an effect in humans that is similar to an effect produced by a naturally occurring estrogen,
or other endocrine effects as the Administrator may designate." Following recommendations of
its Endocrine Disrupter Screening and Testing Advisory Committee (EDSTAC), EPA
determined that there was a scientific basis for including, as part of the program, the androgen
and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted
EDSTAC's recommendation that EPA include evaluations of potential effects in wildlife. For
pesticides, EPA will use FIFRA and, to the extent that effects in wildlife may help determine
whether a substance may have an effect in humans, FFDCA authority to require the wildlife
evaluations. As the science develops and resources allow, screening of additional hormone
systems may be added to the Endocrine Disrupter Screening Program (EDSP). In the available
toxicity studies on cypermethrin 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, cypermethrin may be subject
to additional screening and/or testing.
3. Cumulative Risks
Cypermethrin 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, available data shows that there are multiple types of sodium channels and that
these compounds may act on different isoforms of the sodium channel and with other ion
channels in producing their clinical signs. It is currently unknown whether the pyrethroids as a
class have similar effects on all channels or whether modifications of different types of sodium
channels would have a cumulative effect. Nor do we have a clear understanding of effects on
key downstream neuronal function e.g., nerve excitability, or how these key events interact to
produce their compound specific patterns of neurotoxicity. Without such understanding, there is
no basis to make a common mechanism of toxicity finding. Therefore, EPA is not currently
following a cumulative risk approach based on a common mechanism of toxicity for the
pyrethroids because the Agency has determined further study is needed regarding the
assumptions of dose additivity and common mechanism(s) of toxicity to appropriately identify a
group or subgroups for such an assessment. There is ongoing research by the EPA's Office of
Research and Development and pyrethroid registrants to evaluate the differential biochemical
and physiological actions of pyrethroids in mammals. The Agency anticipates the majority of
this research to be completed by 2007. When available, the Agency will consider this research
and make a determination of common mechanism as a basis for assessing cumulative risk. For
information regarding EPA's procedures for cumulating effects from substances found to have a
common mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.
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D. Tolerance Reassessment Summary
The Codex Alimentarius Commission has established several maximum residue limits (MRLs)
for cypermethrin residues in/on various plant and livestock commodities. The Codex and U.S.
tolerances are in harmony with respect to MRL/tolerance expression. Both regulate the parent
compound, cypermethrin.
Special efforts to increase harmony between recommended US tolerance levels and Codex
MRLs were made for the following commodities: 1) poultry, meat (0.05 ppm instead of no
tolerance), and 2) meat of cattle, goat, sheep, and horse (0.20 instead of 0.05 ppm). The
following conclusions can be made regarding efforts to harmonize the U.S. tolerances with the
Codex MRLs with respect to MRL/tolerance level: (i) compatibility between the U.S. tolerances
and Codex MRLs exists for bulb onions; meat byproducts; poultry, meat; and meat of cattle,
goat, sheep, and horse; and (ii) incompatibility of the U.S. tolerances and Codex MRLs remains
for Brassica vegetables, cottonseed, lettuce, and milk, because of differences in good agricultural
practices and determination of secondary residue levels in livestock commodities. No questions
of compatibility exist with respect to commodities where Codex MRLs have been established but
U.S. tolerances do not exist, or vice versa.
A summary of cypermethrin tolerance reassessments is presented in Table 14.
Table 14, Tolerance Reassessment Summary for Cypermethrin.
Commodity
Current
Tolerance
(ppm)
Tolerance
Reassessment
(ppm)
Comment/Correct Commodity
Definition
Tolerances listed under 40 CFR 180.418(a)(l):
Brassica, head and stem
Brassica, leafy
Cattle, fat
Cattle, meat
Cattle, mbyp
Cottonseed
Goats, fat
Goats, meat
Goats, mbyp
Hogs, fat
Hogs, meat
Hogs, mbyp
Horses, fat
2.0
14.0
0.05
0.05
0.05
0.5
0.05
0.05
0.05
0.05
0.05
0.05
0.05
2.0
14.0
1.0
0.20
0.05
0.50
1.0
0.20
0.05
0.10
0.05
—
1.0
[Brassica, head and stem, subgroup]
[Brassica, leafy greens, subgroup]
Harmonize with Codex MRL
[Cattle, meat byproducts]
[Cotton, undelinted seed]
[Goat, fat]
[Goat, meat] Harmonize with Codex MRL
[Goat, meat byproducts]
[Hog, fat]
[Hog, meat]
Residue data support removal of tolerance.
[Horse, fat]
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Table 14, Tolerance Reassessment Summary for Cypermethrin.
Commodity
Horses, meat
Horses, mbyp
Lettuce, head
Milk
Onions, bulb
Onions, green
Pecans
Sheep, fat
Sheep, meat
Sheep, mbyp
Current
Tolerance
(ppm)
0.05
0.05
10.0
0.05
0.1
6.0
0.05
0.05
0.05
0.05
Tolerance
Reassessment
(Ppm)
0.20
0.05
4.0
2.5
0.10
6.0
0.05
1.0
0.20
0.05
Comment/Correct Commodity
Definition
[Horse, meat] Harmonize with Codex
MRL
[Horse, meat byproducts]
Residue data support reduction of
tolerance.
[Milk, fat (reflecting 0.10 in whole milk)]
[Onion, bulb]
Residue data support a tolerance level of
3.0 ppm for zeta-cypermethrin//(9«/o»,
green]
Harmonizes with Codex MRL
[Sheep, meat byproducts]
Tolerances That Need To Be Proposed under 40 CFR 180.418(a)(l):
Cotton gin byproducts
Egg
Poultry, fat
Poultry, meat
-
-
-
-
11
0.05
0.05
0.05
Harmonizes with Codex MRL
Tolerances That Need To Be Changed under 40 CFR 180.418(a)(2):
Hog, fat
Hog, meat
Hog, meat byproducts
Lettuce, head
Poultry, meat byproducts
1.0
0.2
0.05
10.00
0.05
0.10
0.05
None
None
None
Updated dietary burden supports lower
tolerance level.
Updated dietary burden supports lower
tolerance level.
Updated dietary burden eliminates need for
tolerance.
Covered by Vegetable, leafy, except
Brassica, group 04.
Updated dietary burden eliminates need for
tolerance.
E. Regulatory Rationale
The Agency has determined that cypermethrin is eligible for reregi strati on provided that the risk
mitigation measures and label amendments specified in this RED are implemented. The
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following is a summary of the rationale for managing risks associated with the use of
cypermethrin.
1. Human Health Risk Mitigation
a. Dietary, drinking water, residential, and aggregate risk
mitigation
Cypermethrin dietary (food + drinking water), residential, and aggregate risks were below the
Agency's level of concern. Moreover, the risk assessments are protective of the general U.S.
population and all population subgroups, including infants and young children. Therefore, no
mitigation is necessary for these scenarios.
b. Worker risk mitigation
i. Handler risk mitigation
A number of application scenarios involving aerial, ground, or handheld equipment result in
risks above EPA's level of concern (MOE < 100 or ARI < 1). The following mitigation measures
are necessary to address occupational risks that exceed the Agency's level of concern:
Mixing, loading and applying liquid formulations
For motorized ground and aerial equipment, risks are below EPA's level of concern at baseline
and therefore, no mitigation is needed. For handheld application equipment, risks are below the
level of concern with the addition of chemical resistant gloves.
• For liquid formulations, chemical-resistant gloves are required for all hand-held
application methods.
Mixing, loading and applying wettable powder formulations
• For wettable powder formulations, all products must be repackaged in water soluble bags.
• For wettable powder formulations, chemical-resistant gloves are required for all hand-
held application methods.
One registrant with a wettable powder product for use in industrial, commercial, and residential
settings has requested to reformulate their product into a dry flowable or prill formulation, rather
than repackaging it into water soluble bags. Although risks can not be calculated due to lack of
exposure data for dry flowables, EPA is confident that the risks to mixer, loader, and applicators
of dry flowables products would be lower than those for liquid products, and thus below the
Agency's level of concern with the addition of chemical resistant gloves.
• For dry-flowable or prill formulations, chemical-resistant gloves are required for all
hand-held application methods.
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Additional mitigation for aerial applications
• Closed cockpits are required.
• Human flagging is prohibited.
The human health assessment estimated risks to mixers, loaders and applicators making
groundboom and aerial applications to sod farms at 0.74 Ibs a.i./A. Application to sod farms is
allowed through two Special Local Need registrations (FL SLN 890033, and CA SLN 840214).
The Florida SLN allows application to Anheuser Busch sod farms using a soil injection rig only.
The registrant (Syngenta) has been unable to verify whether or not this SLN is still in use and is
not opposed to canceling it, since it is still tied to a former registrant's product and has never
been updated to reflect the change of product ownership. In any case, EPA does not anticipate
risks of concern to human health (or aquatic organisms) from this soil injection use on sod farms.
The California SLN allows both groundboom and aerial application to sod farms. The registrant
(FMC) has no record of this SLN and does not think it is currently active.
• Withdraw FL SLN 890033 and CA SLN 840214, for use on sod farms
Mixing, loading and applying granular formulations
In February 2006, a granular product was registered for use on lawns and outside of homes to kill
fire ants (application to fire ant mounds). Although no data were available to assess the risks of
this use for cypermthrin, the Agency believes that the risks from this granular cypermethrin
product will not exceed those for liquid products, which are below EPA's level of concern for
this scenario. No mitigation is needed for this use.
Applying ready-to-use (RTU) formulations
No risks exceeded EPA's level of concern, and no mitigation is needed.
ii. Post-application risk mitigation
Agricultural uses
EPA did not assess occupational postapplication risks to agricultural workers following
treatments to agricultural crops, since no short- or intermediate-term dermal endpoints of
concern were identified and long-term dermal exposures are not expected for tasks involving any
of the registered crop use patterns.
• As per the Worker Protection Standard, a restricted-entry interval of 12 hours is required
for agricultural uses.
Non-agricultural (industrial, commercial, and residential) uses
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EPA did not assess occupational post-application exposures and risks following applications to
residential and commercial lawns, and in and around industrial, commercial, and residential
premises, since no short- or intermediate-term dermal endpoints of concern were identified and
long-term exposures are not expected for tasks involving any of the registered use patterns.
• No new mitigation is required, but existing precautionary label statements and use
directions intended to be protective of human health must be retained (see label table in
Section V. for examples).
iii. Additional recommendations based on incident reports
Based on documented incident reports involving cypermethrin, skin and eye protection is
recommended for agricultural handlers making broadcast applications. Bystanders should vacate
indoor areas receiving treatment and the area should be appropriately ventilated afterwards
before persons reenter the premises. Further study is needed to determine whether labels should
advise of potential allergy or asthma-like problems among sensitive individuals.
2. Environmental Risk Mitigation
The Agency has conducted a screening-level ecological and environmental risk assessment for
the registered agricultural uses of cypermethrin. Based on the available data, the Agency has
identified potential acute risks of concern to freshwater and estuarine/marine invertebrates and
fish, benthic organisms, mammals, earthworms, and non-target insects, and potential chronic
risks of concern to freshwater and estuarine/marine invertebrates, benthic organisms, and
mammals.
Risk from non-agricultural uses of cypermethrin could not be quantitatively assessed at this time,
but is expected based on the risks from agricultural uses, the high proportion of use of
cypermethrin in outdoor non-agricultural areas (e.g. for nuisance pest control around structures
and on lawns, and as a pre-construction termiticide), and the limited existing data showing the
presence of cypermethrin in California urban creeks at concentrations toxic to benthic
invertebrates. Mitigation to address the ecological risks from agricultural and non-agricultural
cypermethrin applications is described below.
a. Mitigation to Address Risks to Non-Target Organisms from
Agricultural Uses
To address ecological risks from agricultural uses of cypermethrin, the following mitigation
measures are required:
Decrease total yearly application rates, and increase re-treatment intervals
The maximum rate per application will be maintained at 0.1 Ibs a.i./A for all crops. However, the
following changes will be made to reduce the frequency of application and total pounds applied
per year:
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For cotton:
• Limit the total amount of product applied to 0.4 Ibs ai/A/year (reduced from 0.6 Ibs
ai/A/year).
• Increase the minimum re-treatment interval to 5 days (increased from 3 days).
For pecans:
• Limit the total amount of product applied to 0.5 Ibs ai/A/year (reduced from 0.6 Ibs
ai/A/year).
• Establish a minimum re-treatment interval of 7 days.
For head lettuce, head and stem brassicas (such as broccoli), and bulb vegetables (such as
onions):
• Limit the total amount of product applied to 0.6 Ibs ai/A/year.
• Establish a minimum re-treatment interval of 7 days.
For leafy brassicas (such as canola):
• Limit the total amount of product applied to 0.4 Ibs ai/A/year.
• Establish a minimum re-treatment interval of 7 days.
Prohibit high-rate, high-ecological-impact use sites
• Remove the use sites: agricultural uncultivated areas, fencerows, and hedgerows
(application rate of 3.4 Ibs ai/A) from product labels, and prohibit use on these sites
• Prohibit use on rights-of-way
• Prohibit use on sod farms
Require the following mitigation to reduce spray drift from agricultural applications
EPA understands the history of spray drift language development with the Pyrethroid Working
Group (PWG), and the desire of registrants to maintain a level playing field among the
pyrethroids with respect to spray drift restrictions. Since the current spray drift labeling for
pyrethroids is over ten years old, EPA would like to update it as described below and in chapter
5 of this RED, and have all PWG pyrethroid products adopt these restrictions by early 2007.
EPA is willing to meet with the PWG to discuss any issues concerning these spray drift label
statements, and welcomes comments from other stakeholders during the 60-day post-RED
comment period.
• For groundboom and aerial applications, use medium or coarser spray nozzles
• For motorized ground or aerial applications, apply only when the wind velocity is 3 to 10
mph for all crops other than cotton; for cotton, apply only when the wind velocity is 3 to
15 mph
• Do not make ground or aerial applications during temperature inversions
• For airblast applications to tree crops, direct spray into the canopy, and turn off outward
pointing nozzles at row ends and when spraying outer two rows
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• For groundboom, chemigation, or airblast applications, do not apply within 25 feet of
water bodies or aquatic habitat
• For aerial applications, do not apply within 150 feet of water bodies or aquatic habitat;
increase this no spray buffer zone to 450 feet when making an ultra low volume (ULV)
application
• For aerial applications, do not release spray at a height greater than 10 feet above the
ground or crop canopy, when spraying within 1000 feet of water bodies or aquatic habitat
See Section V and the label table for required spray drift label statements.
Require the following mitigation to reduce run-off from agricultural fields
• Construct and maintain a 10-foot-wide vegetative filter strip of grass or other permanent
vegetation between the field edge and any water body or aquatic habitat (USDA, NRCS.
2000. Conservation Buffers to Reduce Pesticide Losses. Natural Resources Conservation
Service. Fort Worth, Texas.)
c. Mitigation to Address Risks to Non-Target Organisms from Non-
Agricultural Uses
Estimating risk from non-agricultural uses of pyrethroids
The Office of Pesticide Programs (OPP) strives to estimate pesticide exposure through all
significant routes of exposure from both agricultural and non-crop uses. However, the ecological
risk assessments for 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 cypermethrin 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 nuisance
insect control, and termite applications.
For pyrethroids with relevant indoor uses (not including cypermethrin), the Agency uses a
"down-the-drain" model to perform a screening-level aquatic risk assessment. 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, like cypermethrin.
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.
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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. 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.
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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 (another pyrethroid currently
undergoing reregi strati on) 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
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; fram'-permethrin was detected in 0.8% of
bed sediment samples.
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 cypermethrin and permethrin), as well
as for other insecticides. 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
reregi strati on 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 reregi strati on 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 reregi strati on is that only
three pyrethroid insecticides are required to be reviewed for reregi strati on in accordance 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
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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 pyrethroids undergoing reregi strati on, 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 Tennessee, 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 has
performed some toxicity studies identified by the Agency as data gaps, such as sediment
invertebrate toxicity tests and those studies are in review.
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Interim mitigation required for reregi strati on
Until the Agency can perform a quantitative risk assessment for the non-agricultural uses of
cypermethrin, the Agency believes that certain interim mitigation measures are warranted. These
mitigation measures are intended to reduce the runoff and drainage to storm sewers, surface
water, and aquatic habitats associated with the current industrial, commercial, and residential
uses of cypermethrin, and to address potential risks to aquatic organisms from these existing use
patterns. These mitigation measures should also help to reduce off-site exposure and risk to
terrestrial organisms.
To reduce runoff and drift to water bodies, and to address potential ecological risks from non-
agricultural (industrial, commercial, and residential) uses of cypermethrin, the following
mitigation measures are required:
For products with indoor and/or outdoor nuisance pest control uses (other than termiticides)
• Limit all outdoor non-termite applications to spot and crack-and-crevice applications,
only, except for the following barrier, perimeter, band or broadcast spray applications,
which are permitted:
(1) Barrier, perimeter or band applications to soil or vegetation around structures;
(2) Broadcast applications to vegetated residential or commercial landscapes,
including lawns and turf;
(3) Band applications to building foundations, up to a maximum height of 3 feet.
Other than number (3), above, all outdoor non-termite applications to impervious
surfaces such as sidewalks, driveways, patios, porches and structural surfaces (such as
windows, doors, and eaves) are limited to spot and crack-and-crevice applications, only.
• Reduce the maximum broadcast application rate for residential, commercial, and
industrial lawns to 0.44 Ibs ai/A (0.0101 Ibs ai/1000 ft2) for all formulations. (Maximum
rate was 0.74 Ibs ai/A).
• For outdoor uses, do not apply within 10 feet of storm drains. Do not apply within 25 feet
of rivers, fish ponds, lakes, streams, reservoirs, marshes, estuaries, bays, or oceans.
• Prohibit application directly into drains, or to any area where drainage to storm sewers,
water bodies, or aquatic habitat can occur. When making an application around or near a
floor drain, limit the application to a spot treatment and do not allow the product to enter
the drain during or after the application. The use site "Application around or near floor
drains" should be listed separately from other indoor use sites on the label, with these
restrictions.
• Broadcast applications to exterior surfaces of boats are prohibited. Applications to
exterior surfaces of boats are limited to spot treatments, only. Use inside boats, ships, and
other vessels is permitted. Do not allow product to drain or wash off into water bodies or
aquatic habitat. The use site "Application in and on boats" should be listed separately
from other use sites on the label, with these restrictions.
• Cover any water inhabited by fish (such as aquariums and ornamental fish ponds) during
treatment, and turn aquarium systems off.
• Remove birds and other pets. Do not allow pets to enter treated areas or contact treated
surfaces until sprays have dried.
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• Do not apply when windy (sustained wind speeds or gusts above 10 mph).
• After application, do not over-water the treated area to the point of runoff. Do not apply
when raining or when rain is expected within 8 hours.
• Rinse application equipment over lawn or garden area only. Do not allow rinse water to
flow into drains (including storm drains), street gutters, sewers, drainage ditches, water
bodies, or aquatic habitat.
Comments were received concerning use of cypermethrin in "swimming pool water systems."
Application to swimming pool water systems, or to swimming pools in general, is not a labeled
use of cypermethrin. Cypermethrin may be applied as a broadcast treatment to lawns and other
vegetated areas around swimming pools, or as a spot or crack-and-crevice treatment to
impermeable surfaces (such as tiled walkways) around pools.
A granular product was registered on February 23, 2006 (EPA registration # 28293-367). This
product is for application to fire ant mounds on lawns and outside of homes. EPA does not
believe that this product, when used according to label directions (very limited, targeted use),
presents a risk of concern to non-target organisms.
For pre-construction subterranean termite control
During the phase 3 comment period for cypermethrin, EPA received comments from California
water regulatory agencies concerning the potential for runoff and aquatic risk from pre-
construction (non-injected) termite applications. Commenters also submitted label statements
for this use. After receiving input from the Association of Structural Pest Control Regulatory
Officials (ASPCRO), EPA developed the proposed label statements listed below. EPA would
like to invite further stakeholder input on these statements during the post-RED comment period
for cypermethrin.
(1) If concrete slabs cannot be poured over the treated soil on the day of application, the treated
soil must be covered with a waterproof covering (such as polyethylene sheeting).
(2) Do not treat soil that is water-saturated or frozen. Do not treat when raining or when rain is
expected within 8 hours. All treated areas must covered (with a waterproof covering) before
it starts to rain. If a waterproof cover is used, storm water runoff must be diverted around the
treatment area to prevent water from contacting or collecting in the treatment area.
(3) Do not apply within 10 feet of storm drains. Do not apply within 25 feet of rivers, fish ponds,
lakes, streams, reservoirs, marshes, estuaries, bays, or oceans.
(4) Do not make on-grade applications when sustained wind speeds or gusts are above 10 mph.
c. Endangered Species
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
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mitigation measures that address these impacts. The Endangered Species Act (ESA) requires
federal agencies to ensure that their actions are not likely to jeopardize listed species or adversely
modify designated critical habitat. To analyze 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 are being implemented at that time.
Following this future species-specific analysis, 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
cypermethrin, other measures to mitigate any potential impact, or consultations with the Fish and
Wildlife Service or the National Marine Fisheries Service as necessary. If the Agency determines
use of cypermethrin "may affect" listed species or their designated critical habitat, EPA will
employ the provisions in the Services regulations (50 CFRPart 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 cypermethrin at
levels of concern. EPA is not requiring specific cypermethrin label language at the present time
relative to threatened and endangered species. If, in the future, specific measures are necessary
for the protection of listed species, the Agency will implement them through the Endangered
Species Protection Program.
3. Benefits of Cypermethrin Use and Available Alternatives
Pyrethrin and synthetic pyrethroids, including cypermethrin, cyfluthrin, deltamethrin,
esfenvalerate, lambda cyhalothrin, permethrin, resmethrin, sumithrin, tetramethrin, and
tralomethrin, are available to control a wide variety of nuisance, lawn and garden plant,
structural, and public health arthropod pests. Pyrethroids may be applied inside residential areas
as a crack and crevice, area, or spot spray. They may also be applied in areas adjacent to or
surrounding residential areas as a perimeter treatment to prevent the movement of pests into
houses and as a spot and yard treatment. Usage data are sparse and generally do not distinguish
between chemicals within the class or differentiate the amounts used on various residential sites.
The recent loss of chlorpyrifos and diazinon for residential pest control has resulted in a greater
reliance on pyrethrins and synthetic pyrethroids, as a class, among residential users. Most
pyrethroids have similar efficacy and cost. In the absence of any one pyrethroid, homeowners
and professional applicators would most likely simply substitute another pyrethroid insecticide.
Users might also substitute insecticides from other chemical classes (e.g. organophosphates,
carbamates, and neonicotinoids) and nonchemical control techniques (e.g. sanitation or
exclusion). Given the options for substitution, the economic impacts of restricting any one
chemical would not likely be significant; also, the impact on risk of restricting any one
pyrethroid is uncertain and might increase given the substitute available.
V. What Registrants Need to Do
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The Agency has determined that cypermethrin is eligible for reregi strati on 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 16). 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 reregi strati on of cypermethrin for currently
registered uses has been reviewed and determined to be substantially complete. However, the
data listed below are necessary to confirm the reregi strati on eligibility decision documented in
this RED.
Table 15. Guideline Requirements for Cypermethrin
Data Requirement
Life-Cycle Aquatic Invertebrate, Freshwater:
Old Guideline
Number
72-4 (b)
New OPPTS
Guideline No.
850.1350
Additional Residue Chemistry Clarifications
Other needed label changes pertain to the following: 1) minimum retreatment intervals, 2)
minimum aerial application volumes, and 3) impractical cotton forage grazing/feeding
restrictions.
2. Labeling Requirements
To ensure compliance with FIFRA, manufacturing use product (MUP) labeling should be
revised to comply with all current EPA regulations, PR Notices, and applicable policies. The
MUP labeling should bear the labeling contained in Table 16.
3. Spray Drift Management
The Agency has been working closely with stakeholders to develop improved approaches
for mitigating risks to human health and the environment from pesticide spray and dust drift. As
part of the reregi strati on process, the EPA will continue to work with all interested parties on this
important issue.
B. End-Use Products
1. Additional Product-Specific Data Requirements
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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. For any questions regarding the PDCI, please contact Jane Mitchell
at (703) 308-8061.
2. Labeling for End-Use Products
To be eligible for reregi strati on, labeling changes are necessary to implement measures outlined
in Section IV above. Specific language to incorporate these changes is specified in table 16.
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.
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Labeling Changes Summary Table 16
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 16: Summary of Labeling Changes for Cypermethrin
Description
Amended Labeling Language
Placement on Label
For all Manufacturing
Use Products
"Only for formulation into an insecticide for the following use(s) [fill blank only
with those uses that are being supported by MP registrant]."
"This product must not be formulated into end-use products that contain
directions for use on sod farms, agricultural uncultivated areas, fencerows,
hedgerows, or rights-of-way. These use sites must be removed from all end-use
product labels and any special need registration must be canceled.
"This product must not be formulated into wettable powder end use formulations
unless they are packaged in water soluble bags."
"This product must not be formulated into end-use products that contain
directions for use on both agricultural crops and for other uses, such as in and
around residential, commercial and industrial sites or on farm animals. This
product may only be formulated into end-use products that with directions for
use for agricultural crop (WPS) uses only, or end-use products with directions
for use for non-agricultural-crop (Non-WPS) uses only."
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
"This pesticide is toxic to fish and aquatic invertebrates. Do not discharge
effluent containing this product into lakes, streams, ponds, estuaries, oceans, or
other waters unless in accordance with the requirements of a National Pollutant
Discharge Elimination System (NPDES) permit and the permitting authority has
Precautionary Statement
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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."
'End Use Products for WPS (agricultural) use ONLY
Restricted Use Pesticide
required for all products.
"RESTRICTED USE PESTICIDE Due to Toxicity to fish and aquatic
invertebrates or retail sale to and use only by certified applicators or persons
under the direct supervision and only for those uses covered by the certified
applicator's certification."
Front Panel and Directions for Use
Handler PPE
Requirements Established
by the RED1 for Wettable
Powder Formulations
packaged into water
soluble bags.
Note: Wettable powder
formulations must be
packaged in Water
Soluble Bags to be
eligible for
Reregistration. As an
alternative, a dry flowable
formulation may be
developed.
"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."
"Mixers, loaders, applicators, and other handlers must wear:
> Long-sleeve shirt and long pants,
> Shoes plus socks, and
>In addition to the above, handlers using hand-held equipment must also wear
chemical-resistant gloves."
"See engineering controls for additional requirements."
Precautionary Statements under Hazards to Humans
and Domestic Animals
Handler PPE
Requirements Established
by the RED1 for Liquid
Concentrate and Dry
Flowable formulations.
"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."
"Mixers, loaders, applicators, and other handlers must wear the following:
> Long-sleeve shirt and long pants,
Precautionary Statement under Hazards to Humans
and Domestic Animals
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> Shoes and socks and
>In addition to the above, handlers using hand-held equipment must also wear
chemical-resistant gloves."
"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.
If the product is a concentrate and pesticide handlers are required to wear
coveralls, use the following statement in addition to the statement above.
"Discard clothing and other absorbent materials that have been drenched or
heavily contaminated with this product's concentrate. Do not reuse them."
Precautionary Statements under: Hazards to Humans
and Domestic Animals immediately following PPE
Requirements
Engineering controls for
Wettable Powder
Formulations, formulated
into water soluble bags.
Note: Wettable powder
formulations must be
packaged in Water
Soluble Bags to be
eligible for
Reregistration. As an
alternative, a dry flowable
formulation may be
developed.
"Engineering controls"
"Water-soluble packets when used correctly qualify as a closed mixing/loading
system under the Worker Protection Standard for Agricultural Pesticides [40
CFR 170.240(d)(4)]. Mixers and loaders using water-soluble packets must:
-wear the personal protective equipment required in the PPE section of this
labeling for mixers and loaders, and
-be provided, must have immediately available for use, and must wear in an
emergency, such as a broken package, spill, or equipment breakdown a NIOSH-
approved respirator 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.
"Pilots must use an enclosed cockpit that meets the requirements listed in the
Worker Protection Standard (WPS) for agricultural pesticides [40 CFR
170.240(d)(6)]."
"Human flagging is prohibited. Flagging to support aerial application is limited
Precautionary Statements under Hazards to Humans
and Domestic Animals Immediately following the
User Safety Requirements
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to use of the Global Positioning System (GPS) or mechanical flaggers."
Engineering controls for
Liquids and Dry
Flowables
"Engineering controls"
"Pilots must use an enclosed cockpit that meet the requirements listed in the
Worker Protection Standard (WPS) for agricultural pesticides [40 CFR
170.240(d)(6)]."
"Human flagging is prohibited. Flagging to support aerial application is limited
to use of the Global Positioning System (GPS) or mechanical flaggers."
Precautionary Statements: Hazards to Humans and
Domestic Animals Immediately following the User
Safety Requirements
User Safety
Recommendations
"USER SAFETY RECOMMENDATIONS"
"Users should wash hands with plenty of soap and water 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."
Immediately following Engineering Controls
(Must be placed in a box.)
Environmental Hazards
"This pesticide is toxic to fish, aquatic invertebrates, oysters and shrimp. Do not
apply directly to water, or to areas where surface water is present or to intertidal
areas below the mean water mark. Do not apply when weather conditions favor
drift from treated areas. Drift and runoff from treated areas may be hazardous to
aquatic organisms in neighboring areas. Do not contaminate water when
disposing of equipment wash waters."
"This pesticide is highly toxic to bees exposed to direct treatment on blooming
crops or weeds. Do not apply this product or allow it to drift to blooming crops
or weeds while bees are actively visiting the treatment area."
Precautionary Statements immediately following the
User Safety Recommendations
Restricted-Entry Interval
for products with
directions for use within
scope of the Worker
Protection Standard for
Agricultural Pesticides
"Do not enter or allow worker entry into treated areas during the restricted entry
interval (REI) of 12 hours."
Place in the Direction for Use, In Agricultural Use
Requirements Box
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(WPS)
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."
Place in the Directions for Use In Agricultural Use
Requirements box, immediately following the REI
General Application
Restrictions
"Do not apply this product in a way that will contact workers or other persons,
either directly or through drift. Only protected handlers may be in the area during
application."
Place in the Directions for Use directly above the
Agricultural Use Box.
Buffer Zone
Requirements
"BUFFER ZONES"
"Vegetative Buffer Strip
Construct and maintain a minimum 10-foot-wide vegetative filter strip of grass
or other permanent vegetation between the field edge and down gradient aquatic
habitat (such as, but not limited to, lakes; reservoirs; rivers; permanent streams;
marshes or natural ponds; estuaries; and commercial fish farm ponds)."
"Only apply products containing (name ofpyrethroid) onto fields where a
maintained vegetative buffer strip of at least 10 feet exists between the field and
down gradient aquatic habitat."
"For guidance, refer to the following publication for information on constructing
and maintaining effective buffers:
Conservation Buffers to Reduce Pesticide Losses. Natural Resources
Conservation Services. USD A, NRCS. 2000. Fort Worth, Texas. 21 pp.
http://www.in.csusda/v/technical/agronom/newconbuf.pdF'
"Buffer Zone for Ground Application (groundboom, overhead chemigation,
or airblast)
Do not apply within 25 feet of aquatic habitats (such as, but not limited to, lakes,
reservoirs, rivers, streams, marshes, ponds, estuaries, and commercial fish
ponds)."
"Buffer Zone for ULV Aerial Application
Do not apply within 450 feet of aquatic habitats (such as, but not limited to,
Place in Directions for Use under the heading
"BUFFER ZONES"
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lakes, reservoirs, rivers, streams, marshes, ponds, estuaries, and commercial fish
ponds)."
"Buffer Zone for Non-ULV Aerial Application
Do not apply within 150 feet of aquatic habitats (such as, but not limited to,
lakes, reservoirs, rivers, streams, marshes, ponds, estuaries, and commercial fish
ponds)."
Spray Drift
"Spray Drift Requirements"
"Wind Direction and Speed"
"Only apply this product if the wind direction favors on-target deposition."
"Do not apply when the wind velocity exceeds 15 mph."
"Temperature Inversion"
"Do not make aerial or ground applications into temperature inversions."
"Inversions are characterized by stable air and increasing temperatures with
height above the ground. Mist or fog may indicate the presence of an inversion
in humid areas. The applicator may detect the presence of an inversion by
producing smoke and observing a smoke layer near the ground surface."
Droplet Size
"Use only Medium or coarser spray nozzles (for ground and non-ULV aerial
application) according to ASAE (S572) definition for standard nozzles. In
conditions of low humidity and high temperatures, applicators should use a
coarser droplet size".
Additional Requirements for Ground Applications
"Wind speed must be measured adjacent to the application site on the upwind
side, immediately prior to application."
"For ground boom applications, apply using a nozzle height of no more than 4
feet above the ground or crop canopy."
Directions for Use under Spray Drift Requirements
Page 64 of 113
-------
"For airblast applications, turn off outward pointing nozzles at row ends and
when spraying the outer two rows. To minimize spray loss over the top in
orchard applications, spray must be directed into the canopy."
Additional Requirements for Aerial Applications
"The spray boom should be mounted on the aircraft as to minimize drift caused
by wingtip or rotor vortices. The minimum practical boom length should be
used and must not exceed 75% of the wing span or 80% rotor diameter."
"Flight speed and nozzle orientation must be considered in determining droplet
size."
"Spray must be released at the lowest height consistent with pest control and
flight safety. Do not release spray at a height greater than 10 feet above the crop
canopy unless a greater height is required for aircraft safety."
"When applications are made with a cross-wind, the swath will be displaced
downwind. The applicator must compensate for this displacement at the
downwind edge of the application area by adjusting the path of the aircraft
upwind."
Other Application
Restrictions (Risk
Mitigation)
(Note: The maximum
application rate and
maximum seasonal rates
specified in this table
must be listed as pounds
or gallons of formulated
product per acre, not just
as pounds active
ingredient)
Any directions for use on sod farms, agricultural uncultivated areas, fencerows,
hedgerows, and rights-of-way must be removed from all product labels. Special
Local Need registrations with these uses must be cancelled.
Products must be amended to reflect the following maximum application
rates (a.i./A), minimum re-treatment intervals and maximum annual
application rates
Cotton:
Maximum single application rate of 0.1 Ibs a.i./A
Minimum re-treatment interval of 5 days
Maximum annual application rate of 0.4 Ibs a.i./A/year
"Do not make more than 10 synthetic pyrethroid applications (of one product or
combinations of products) to cotton in one growing season."
Place in the Directions for Use
Page 65 of 113
-------
Pecans:
Maximum single application rate of 0.1 Ibs a.i./A
Minimum re-treatment interval of 7 days
Maximum annual application rate of 0.5 Ibs a.i./A/year
Head and Stem Brassica and Head Lettuce:
Maximum application rate of 0.1 Ibs a.i./A
Minimum re-treatment interval of 7 days
Maximum seasonal application rate of 0.6 Ibs a.i./A
Leafy Brassica:
Maximum application rate of 0.1 Ibs a.i./A
Minimum re-treatment interval of 7 days
Maximum seasonal application rate of 0.4 Ibs a.i./A
Bulb Vegetables:
Maximum application rate of 0.1 Ibs a.i./A
Minimum re-treatment interval of 7 days
Maximum seasonal application rate of 0.5 Ibs a.i./A
'•".".".".".".' ''End Use Products'Prrmarilf Intended for Occupational Use* (JIon-Agrioultural)''
Handler PPE
Requirements Handler
PPE Requirements
Established by the RED1
for Wettable Powder
Formulations packaged
into water soluble bags.
Note: Wettable powder
formulations must be
packaged in Water
Soluble Bags to be eligible
"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."
"Mixers, loaders, applicators, and other handlers must wear:
> Long-sleeve shirt and long pants,
> Shoes plus socks,
> Chemical resistant gloves for mixers loaders and applicators using handheld
equipment."
Precautionary Statements under Hazards to Humans
and Domestic Animals
66 of 113
-------
for Reregistration. As an
alternative, a dry flowable
formulation may be
developed
"See engineering controls for additional requirements."
Handler PPE
Requirements Established
by the RED1 for Liquid
Concentrate, Granular and
Dry Flowable
formulations
"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."
"Mixers, loaders, applicators, and other handlers must wear the following:
> Long-sleeve shirt and long pants,
> Shoes and socks,
> Chemical resistant gloves for mixers loaders and applicators using handheld
equipment."
Precautionary Statements under Hazards to Humans
and Domestic Animals
Handler PPE
Requirements Established
by the RED1 for Ready-
To-Use Products (total
release foggers, aerosols,
pump sprays, wipes, ear
tags)
"Personal Protective Equipment (PPE)"
"Handlers must wear:
> Long-sleeve shirt and long pants,
> Shoes plus socks."
Precautionary Statements under Hazards to Humans
and Domestic Animals
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.
If the product is a concentrate and pesticide handlers are required to wear
coveralls, use the following statement in addition to the statement above.
Discard clothing and other absorbent materials that have been drenched or
heavily contaminated with this product's concentrate. Do not reuse them."
Precautionary Statements under: Hazards to Humans
and Domestic Animals immediately following PPE
Requirements
Engineering controls for
Wettable Powder
Formulations, formulated
into water soluble bags.
"Engineering controls"
"Mixers and loaders using water-soluble packets must:
-wear the personal protective equipment required in the PPE section of this
labeling for mixers and loaders, and
Precautionary Statements: Hazards to Humans and
Domestic Animals Immediately following the User
Safety Requirements
Page 67 of 113
-------
Note: Wettable powder
formulations must be
packaged in Water
Soluble Bags to be eligible
for Reregistration. As an
alternative, a dry flowable
formulation may be
developed.
-be provided and must have immediately available for use in an emergency,
such as a broken package, spill, or equipment breakdown a NIOSH-approved
respirator 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.
User Safety
Recommendations
"USER SAFETY RECOMMENDATIONS"
"Users should wash hands with plenty of soap and water 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."
Immediately following Engineering Controls
(Must be placed in a box.)
Environmental Hazard
Statements for products
that have outdoor uses
"This product is extremely toxic to fish and aquatic invertebrates. 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
requirements."
Precautionary Statements under Environmental
Hazards immediately following the User Safety
Recommendations
Entry Restrictions for
products applied as a Total
Release Fogger Products
and Space Sprays
Total release foggers labeled for indoor use must contain the following
entry restriction:
"Wait two (2) hours after application, then open windows, vents and doors for
two hours. If an odor is still detected additional ventilation is required."
Directions for Use
General Application
Restrictions
Products applied as a spray:
"Do not apply this product in a way that will contact any person, pet, either
directly or through drift. Keep people and pets out of the area during
application. Exit area immediately and remain outside the treated area until
sprays have dried."
Directions for Use
Page 68 of 113
-------
Total Release Fogger Products:
"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. Exit area immediately and remain outside the treated area until the
area is thoroughly ventilated and until aerosols, vapors, and/or mists have
dispersed."
Products applied dry (granulars):
"Do not apply this product in a way that will contact any person, pet, either
directly or through drift. Keep people and pets out of the area during
application. Exit area immediately and remain outside the treated area until
dusts have settled."
Application Restrictions
for End-Use Products
labeled for use or that can
be used for outdoor
applications (other than
termiticide use)
"Restrictions for Outdoor Uses"
"All outdoor applications must be limited to spot or crack-and-crevice
treatments only, except for the following permitted uses:
• Treatments to soil or vegetation around structures;
• Applications to lawns, turf, and other vegetation;
• Applications to building foundations up to a maximum height of 3 feet
• Broadcast application to building foundations
All outdoor applications to impervious surfaces such as sidewalks, driveways,
patios, porches and structural surfaces (such as windows, doors, and eaves) are
limited to spot treatments or crack-and-crevice applications, only."
Products labeled for use around or near floor drains. |
"Do not apply directly into sewers or drains, or to any area like a gutter where
drainage to storm sewers, water bodies, or aquatic habitat can occur. Do not
allow the product to enter any drain during or after application."
Requirements for Granular Formulations labeled or intended for outdoor
residential uses:
"Do not apply directly to or near water, storm drains, gutters, sewers, or
drainage ditches. Do not apply when windy. Apply this product directly to
your lawn or garden, and sweep any product landing on the driveway, sidewalk,
gutter, or street, back onto the treated area. Do not water the treated area to the
point of run-off or apply when raining or when rain is expected that day."
Directions for Use under General Precautions and
Restrictions
69 of 113
-------
Requirements for Liquid, Dust, and Ready to Use Formulations products
labeled or intended for outdoor residential uses:
"Do not apply directly to or near water, storm drains, gutters, sewers, or
drainage ditches. Do not apply when windy. Do not water the treated area(s) to
the point of run-off or apply when raining or when rain is expected that day.
Rinse application equipment over treated area only."
Application Restrictions
for end-use products
labeled for or that can be
used on residential lawns
or turfgrass at commercial
or industrial sites.
(Note: The maximum
application rates specified
must be listed as pounds
or gallons of formulated
product per acre or per
square feet, not just as
pounds active ingredient)
"Applications to Lawns and Other Turfgrass Sites"
Labels must be amended to reflect the following maximum application rate on
lawns and other turfgrass of 0.44 Ibs a.i./A (0.0101 Ibs ai/1000 ft2).
Directions for Use under the heading: Applications to
Lawns and Other Turfgrass Sites
Page 70 of 113
-------
Application Restrictions
for end-use products
labeled for or that can be
used near or around
swimming pools
"Applications Around Swimming Pools"
"Do not apply directly to swimming pools or swimming pool systems"
"This product may be applied as a broadcast treatment to lawns and other
vegetated areas around swimming pools, or as a spot treatment or crack-and-
crevice treatment to impermeable surfaces (such as tiled walkways) around
pools."
Directions for Use under the heading: Applications
Around Swimming Pools
Application Restrictions
for end-use products
labeled for or that can be
used in or on boats
"Applications In and On Boats"
The use site "Application in and on boats" should be listed separately from
other use sites on the label, along with these restrictions.
"Do not apply to boat surfaces which contact water. "Broadcast applications to
exterior surfaces of boats are prohibited. Spot treatments may be made to
exterior surfaces that do not contact water.".
"Use inside boats, ships, and other vessels is permitted. Do not allow product to
drain or wash off into water bodies or other aquatic habitat."
Directions for Use under the heading: Applications
In and on Boats
Application Restrictions
for all end-use products
labeled for or that can be
used near or around
aircraft
"Applications Near or Around Aircraft"
"Do not apply to aircraft cabins."
Directions for Use under the heading: Applications
Near or Around Aircraft
Page 71 of 113
-------
Application Restrictions
for ALL end-use products
labeled for outdoor termite
control
"Termite Control"
"All leaks resulting in the deposition of termiticide in locations other than those
prescribed on this label must be cleaned up prior to leaving the application site.
Do not allow people or pets to contact contaminated areas or to reoccupy the
contaminated area until the clean up is completed."
"Use anti-backflow equipment or procedures to prevent siphonage of pesticide
back into water supplies."
"Care should be taken that the treatment solution is not introduced into the
gravel and/or pipe drainage system which may be located on the exterior of the
foundation in close proximity to the footing of the structure."
"Do not treat soil that is water-saturated or frozen."
"Do not treat when raining."
"Do not allow treatment to runoff from the target area."
"Do not apply within 10 feet of storm drains. Do not apply within 25 feet of
aquatic habitats (such as, but not limited to, lakes; reservoirs; rivers; permanent
streams; marshes or natural ponds; estuaries; and commercial fish farm ponds)."
"Do not make on-grade applications when sustained wind speeds are above 10
mph (at application site) at nozzle end height."
Directions for Use under the heading: "Termite
Control"
Application Restrictions
for all end-use products
labeled for indoor termite
control
"All leaks resulting in the deposition of termiticide in locations other than those
prescribed on this label must be cleaned up prior to leaving the application site.
Do not allow people or pets to contact contaminated areas or to reoccupy the
contaminated area until the clean up is completed."
"Use anti-backflow equipment or procedures to prevent siphonage of
pesticide back into water supplies."
Directions for Use under the heading: "Termite
Control"
Application Restrictions
for end-use products
labeled for subterranean
termite control
"Products Labeled for Subterranean Termite Control"
"Do not treat soil beneath structures that contain wells or cisterns."
"Whenever possible, make termite control applications near the structure
Directions for Use under the heading: "Products
Labeled for Subterranean Termite Control"
Page 72 of 113
-------
foundation using soil injections."
Application Restrictions
for end-use products
labeled for preconstruction
termite control
"Products Labeled for Preconstruction Applications for Termite Control"
"The applicator must insure the treatment site is covered. The applicator can
cover the soil him/herself or notify the contractor on the site that: 1) if the
concrete slab cannot be poured over the treated soil within 24 hours of
application the treated soil should be covered with a waterproof covering (such
as polyethylene sheeting), and 2) that the contractor should cover the treated soil
if precipitation occurs before the concrete slab is poured."
"Whenever possible, make termite control applications near the structure
foundation using soil injection."
Directions for Use under the heading: "Products
Labeled for Preconstruction Applications for Termite
Control"
Application Restrictions
for end-use products
labeled for or that can be
used indoors for uses other
than termite control.
"Restrictions For Indoor Uses"
"Do not use water-based sprays in conduits, motor housings, junction boxes,
switch boxes, or other electrical equipment because of possible shock hazard."
"During any indoor surface application, do not allow dripping or runoff to
occur. During any application to ceilings of a structure, cover surface below
with plastic shielding or similar material."
"Do not apply this product in any room being used as a living, eating, or
recovery area by patients, the elderly, or the infirm when they are in the room.'
"Do not apply to classrooms when in use."
"Do not apply to areas of institutions (including libraries, sport facilities, etc.)
when occupants are present in the immediate treatment area."
"Do not use as a space spray"
"Use only in well-ventilated areas."
"Do not use concentrate or emulsion in fogging equipment." (Non RTU
Directions for Use under the heading: "Restrictions
For Indoor Uses"
Page 73 of 113
-------
Formulations only)
"Do not use in food areas of food handling establishments, restaurants, or other
areas where food is commercially prepared or processed. Do not use in serving
areas while food is exposed or facility is in operation. Serving areas are areas
where prepared foods are served, such as dining rooms, but excluding areas
where foods may be prepared or held. In the home, all food processing surfaces
and utensils should be covered during treatment or thoroughly washed before
use. Exposed food should be covered or removed."
"Do not use in warehouses while raw agricultural commodities for food or feed,
and/or raw or cured tobacco are being stored."
"Do not use in greenhouses where crops for food or feed are grown."
Pet Restrictions
"Do not apply to pets. Remove birds and other pets before application. Cover
any water inhabited by fish (such as aquariums and ornamental fish ponds)
during treatment, and turn aquarium systems off."
End ,Us6Products Primarily IntfindM for Can'sumef 'Residential Use' ••••••••••••••••••••••••••••••••••••••••••
Environmental Hazard
Statements, except for
impregnated ready-to-use
products, such as ear tags
or animal wipes
"This product is extremely toxic to fish and aquatic invertebrates. Do not apply
directly to or near water. Do not contaminate water when disposing of
equipment, washwater, or rinsate. See Directions for Use for additional
requirements."
Precautionary Statements under Environmental
Hazards
Homeowner User Safety
Recommendations
Statements
"User Safety Recommendations"
"Users should wash hands with plenty of soap and water before eating, drinking,
chewing gum, using tobacco, or using the toilet."
"Users should remove clothing immediately if pesticide gets inside. Then wash
thoroughly and put on clean clothing."
Precautionary Statements under: Hazards to Humans
and Domestic Animals
Entry Restrictions for
Products Applied as a
"Do not allow adults, children or pets to enter the treated area or contact treated
surfaces until sprays have dried."
Directions for Use Under General Precautions and
Restrictions.
Page 74 of 113
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Spray
Entry Restrictions for
Total Release Fogger
Products and Space
Sprays
"Wait two (2) hours after application, then open windows, vents and doors for
two hours. If an odor is still detected additional ventilation is required."
Directions for use under General Precautions and
Restrictions
Entry Restrictions for end-
use products applied dry
(granulars)
"Do not allow adults, children, or pets to enter the treated area or contact treated
surfaces until dusts have settled."
Directions for use under General Precautions and
Restrictions
General Application
Restrictions
Products applied as a spray:
"Do not apply this product in a way that will contact any person, pet, either
directly or through drift. Keep people and pets out of the area during
application. Exit area immediately and remain outside the treated area until
sprays have dried."
Total Release Fogger Products:
"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. Exit area immediately and remain outside the treated area until the
area is thoroughly ventilated and until aerosols, vapors, and/or mists have
dispersed."
Products applied dry (granulars):
"Do not apply this product in a way that will contact any person, pet, either
directly or through drift. Keep people and pets out of the area during
application. Exit area immediately and remain outside the treated area until
dusts have settled."
Place in the Direction for Use
Application Restrictions
for End-Use Products
labeled for use or that can
be used for outdoor
applications
Products labeled for use around or near floor drains. Products labeled for
use in drains or sewers are excluded from this label requirement:
"Do not apply directly into sewers or drains, or to any area like a gutter where
drainage to storm sewers, water bodies, or aquatic habitat can occur. Do not
allow the product to enter any drain during or after application."
Requirements for Granular Formulations labeled or intended for outdoor
residential uses:
"Do not apply directly to or near water, storm drains, gutters, sewers, or
Directions for use under the heading: "Application to
Outdoor Sites"
Page 75 of 113
-------
drainage ditches. Do not apply when windy. Apply this product directly to your
lawn or garden, and sweep any product landing on the driveway, sidewalk,
gutter, or street, back onto the treated area. Do not water the treated area to the
point of run-off or apply when raining or when rain is expected that day."
Requirements for Liquid, Dust, and Ready to Use Formulations products
labeled or intended for outdoor residential uses:
"Do not apply directly to or near water, storm drains, gutters, sewers, or
drainage ditches. Do not apply when windy. Do not water the treated area(s) to
the point of run-off or apply when raining or when rain is expected that day.
Rinse application equipment over treated area only."
Application Restrictions
for end-use products
labeled for or that can be
used on lawns, gardens,
ornamentals, or other
residential landscape sites
(Note: The maximum
application rates specified
must be listed as pounds
or gallons of formulated
product per acre or per
square feet, not just as
pounds active ingredient)
"Applications to Lawns, Gardens, Ornamentals, and Other Landscape
Sites"
Labels must be amended to reflect the following maximum application rate of
0.44 Ibs ai/A (0.0101 Ibs ai/1000 ft2). Rates must be expressed as fluid ounces
or Ibs of formulated product.
Directions for Use under the heading: "Applications
to Lawns, Gardens, Ornamentals, and Other
Landscape Sites"
Application Restrictions
for end-use products
labeled for or that can be
used near or around
swimming pools
"Applications Around Swimming Pools"
"Do not apply directly to swimming pools or swimming pool systems"
"This product may be applied as a broadcast treatment to lawns and other
vegetated areas around swimming pools, or as a spot treatment or crack-and-
crevice treatment to impermeable surfaces (such as tiled walkways) around
pools."
Directions for Use under the heading: "Applications
Around Swimming Pools"
Application Restrictions
for end-use products
"Applications Around or Near Floor Drains"
Directions for Use under the heading: "Applications
Around or Near Floor Drains"
Page 76 of 113
-------
labeled for or that can be
used near or around floor
drains
"Do not apply directly into floor drains, or to any area where drainage to storm
sewers, water bodies, or other aquatic habitats can occur."
"When making an application around or near a floor drain, limit the application
to a spot treatment and do not allow the product to enter the drain during or after
the application."
Application Restrictions
for end-use products
labeled for or that can be
used in or on boats
"Applications In and On Boats"
The use site "Application in and on boats" should be listed separately from other
use sites on the label, along with these restrictions.
"Do not apply to boat surfaces which contact water. Broadcast applications to
exterior surfaces of boats are prohibited. Spot treatments may be made to
exterior surfaces that do not contact water.."
"Use inside boats, ships, and other vessels is permitted. Do not allow product to
drain or wash off into water."
Directions for Use under the heading: "Applications
In and on Boats"
Application Restrictions
for End-Use Products
labeled for use or that can
be used for indoor
applications
"Restrictions For Indoor Uses"
"Do not use water-based sprays in conduits, motor housings, junction boxes,
switch boxes, or other electrical equipment because of possible shock hazard."
"During any indoor surface application, do not allow dripping or runoff to occur.
During any application to ceilings of a structure, cover surface below with
plastic shielding or similar material."
"Do not use as a space spray."
"Use only in well-ventilated areas."
"Do not use in greenhouses where plants are grown for food."
"Do not use water-based sprays in conduits, motor housings, junction boxes,
switch boxes, or other electrical equipment because of possible shock hazard."
"During any indoor surface application, do not allow dripping or runoff to
occur. During any application to ceilings of a structure, cover surface below
with plastic shielding or similar material."
Directions for use under the heading: "Application to
Indoor Sites"
Page 77 of 113
-------
"Do not apply this product in any room being used as a living, eating, or
recovery area by patients, the elderly, or the infirm when they are in the room."
Pet Restrictions
"Do not apply to pets. Remove birds and other pets before application. Cover
any water inhabited by fish (such as aquariums and ornamental fish ponds)
during treatment, and turn aquarium systems off."
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.
Page 78 of 113
-------
APPENDIX A. Uses of Cypermethrin Eligible for Reregistration
Page 79 of 113
-------
Appendix A: Agricultural Uses of Cypermethrin Eligible for Reregistration
Site
Application Type
Application
Timing
Application
Equipment
Maximu
m Single
Appl.
Rate (ai)
Maximum
Preharvest
Interval (PHI)
(Days)
Minimum
Reentry
Interval (REI)
Max. Yearly
Application
Rate
(ai).
Minimum
Retreatment
Interval
/T~\0,rc\
(Jjays)
Use Limitations :
Maximum Application Rates for Registered Cypermethrin Agricultural Crop Uses
Cotton
Foliar broadcast
application
Ground, sprinkler
irrigation,
or aerial
equipment
Pecans
Foliar broadcast
application
Pre-shuck split
Ground
equipment
0. lib/A
0. lib/A
14 days
21 days
12
12
0.4 Ibs
a.i./A/year
0.5 Ibs
a.i./A/year
5 days
7
Applications may be made in water or refined vegetable oil.
When using water, applications may be made in a minimum
of 5 gal of finished spray /A using ground equipment or 1
gal of finished spray /A using aerial equipment. One quart
of emulsified oil (minimum) may be substituted for one
quart of water in aerial applications. When using oil,
applications may be made in a minimum of 1 qt/A in the
finished spray. Applications may be made alone or as a
tank mix with other products approved for use on cotton.
The grazing or feeding of cotton forage is prohibited.
Do not make more than 10 synthetic pyrethroid applications
(of one product or combinations of products) to cotton in
one growing season.
Ground applications may be made to the point of drip; 100
gal/A for smaller trees and 200 to 300 gal/A for larger trees.
The grazing of livestock in treated orchards or cutting of
treated cover crops for feed is prohibited.
Page 80 of 113
-------
Head and stem
Brassica. and
Leafy Brassica
Greens sub
groups
Foliar broadcast
application
Ground or aerial
equipment
Head lettuce and
Onion. bulb&
green (including
garlic and
shallots')
subgroups
Foliar broadcast
application
Ground or aerial
equipment
Ornamental
Plants
Groundboom
airblast, handgun
Low pressure
handwand
sprayer
Top Soil Potting
Soil
Handgun
0. lib/A
0. lib/A
3.41b
ai/A
0.008 Ib
ai/gal
3.41b
ai/A
Iday
5 days
NA
NA
NA
12
12
NA
NA
NA
0.6 Ibs
a.i./A/year
0.6 Ibs
a.i./A/year
NA
0.4 Ibs a.i./A
0.4 Ibs a.i./A
7
7
NA
NA
NA
Applications may be made in a minimum of 15 gal/A using
ground equipment or 5 gal/A using aerial equipment.
Applications may be made in a minimum of 15 gal/A using
ground equipment or 5 gal/A using aerial equipment.
Do not allow children or pets to contact treated surfaces
until sprays have dried.
Do not allow children or pets to contact treated surfaces
until sprays have dried.
Maximum Application Rates for Registered Cypermethrin uses in Food-Handling Establishments
Spot or
crack/crevice
application
Brush or spray
0.2%
NA
NA
NA
NA
Application is allowed in non-food areas of food-handling
establishments (other than private residences) in which food
is held, processed, prepared or served.
Page 81 of 113
-------
equipment
Spot or
crack/crevice
application
Brash or spray
equipment
0.1%
NA
NA
NA
NA
Use in food areas of food handling establishments,
restaurants or other areas where food is commercially
prepared is prohibited. The label prohibits use in serving
areas while food is exposed or facility is in operation. The
label specifies that in the home all food processing surfaces
and utensils should be covered during treatment or
thoroughly washed before use; exposed food should be
covered or removed.
Application in warehouses where raw or cured tobacco is
stored, or while raw agricultural commodities for food or
feed are being stored is prohibited. Applications may be
repeated as necessary.
Applications may be repeated as necessary.
Do not allow children or pets to contact treated surfaces
until sprays have dried.
Page 82 of 113
-------
Appendix A: Non-Agricultural Registered Uses of Cypermethrin
Site
Application Type
Application Timing
Application Equipment
Maximum Single
Appl. Rate (ai)
Entry Prohibition
Use Limitations :
Maximum Application Rates for Registered Cypermethrin Occupational (not Agricultural Crop) Uses
Maximum Application Rates for Registered Cypermethrin uses in Food-Handling Establishments
Spot or crack/crevice
application
Brash or spray
equipment
Spot or crack/crevice
application
Brash or spray
equipment
0.2%
0.1%
Do not allow children or pets in
treated area until surfaces are
dry.
Application is allowed in non-food areas of food-handling establishments
(other than private residences) in which food is held, processed, prepared or
served.
Use in food areas of food handling establishments, restaurants or other areas
where food is commercially prepared is prohibited. The label prohibits use
in serving areas while food is exposed or facility is in operation. The label
specifies that in the home all food processing surfaces and utensils should
be covered during treatment or thoroughly washed before use; exposed food
should be covered or removed.
Application in warehouses where raw or cured tobacco is stored, or while
raw agricultural commodities for food or feed are being stored is prohibited.
Applications may be repeated as necessary.
Applications may be repeated as necessary.
Non-termite application
Page 83 of 113
-------
Site
Application Type
Application Timing
Application Equipment
Maximum Single
Appl. Rate (ai)
Entry Prohibition
Use Limitations
Residential,
Commercial and
Industrial Lawns
0.44 Ib ai/A
(liquid
concentrate)
Do not allow adults, children or
pets to enter the treated area or
contact treated surfaces until
sprays have dried.
0.282 Ib ai
/cup/mound
(granules)
Do not allow adults, children, or
pets to enter the treated area or
contact treated surfaces until
dusts have settled.
Exit area immediately and
remain outside the treated area
until dusts have settled.
Do not apply when windy (sustained wind speeds or gusts above 10 mph).
Do not allow applications to contact water inhabited by fish, such as
aquariums and ornamental fish ponds that are located in/near structures
being treated. Cover any water inhabited by fish during treatment, and turn
aquarium systems off.
Do not apply this product in a way that will contact any person, pet, either
directly or through drift. Keep people and pets out of the area during
application.
Indoor and outdoor
surfaces at
residential,
commercial and
industrial sites,
animal premises
0.0014 Ib ai/fogger
(broadcast)
Do not remain in treated area.
Exit area immediately and
remain outside the treated area
until aerosols, vapors, and mists
have dispersed and the treated
area has been thoroughly
ventilated.
0.005 Ib ai/16 oz
can
.0171bai/gallon
(crack & crevice)
Do not allow adults, children or
pets to enter the treated area or
contact treated surfaces until
sprays have dried.
Do not use in greenhouses where crops for food or feed are grown.
During any indoor surface application, do not allow dripping or runoff to
occur. During any application to ceilings of a structure, cover surface below
with plastic shielding or similar material.
Do not apply this product in a way that will contact any person, pet, either
directly or through drift. Keep people and pets out of the area during
application.
Do not apply when windy (sustained wind speeds or gusts above 10 mph).
0.282 Ib ai
/cup/mound
(granules)
Do not allow adults, children, or
pets to enter the treated area or
contact treated surfaces until
Page 84 of 113
-------
Site
Application Type
Application Timing
Application Equipment
Maximum Single
Appl. Rate (ai)
Entry Prohibition
dusts have settled.
Exit area immediately and
remain outside the treated area
until dusts have settled.
Use Limitations :
Termite Applications
To soil and sides of
buildings near to
ground, building
perimeters, masonry
voids, and standing
wood in uninhabited
areas
Termites applications
to preconstruction
lumber and logs, and
to soil under
firewood
Termite Applications to
standing wood in
uninhabited areas at
residential, commercial
and industrial sites
Termites: trees,
utility poles,
fenceposts, building
voids
05 Ib ai/gallon
0.041 Ib ai/gallon
0.008 Ib ai/gallon
0.05 Ib ai/gallon
Do not remain in treated area.
Exit area immediately and
remain outside the treated area
until aerosols, vapors, and mists
have dispersed and the treated
area has been thoroughly
ventilated.
All leaks resulting in the
deposition of termiticide in
locations other than those
prescribed on this label must be
cleaned up prior to leaving the
application site. Do not allow
people or pets to contact
contaminated areas or to
reoccupy the contaminated area
of the structure until the clean
up is completed.
Do not apply this product in a way that will contact people or pets, either
directly or through drift.
Care must be taken to avoid runoff. Do not treat soil that is water-saturated
or frozen. Do not treat when raining or when rain is expected within 8
hours.
Livestock
1 MA (~^f\\Tf*r -pf*f*r\ on/1 iirot^i* r\mr\r t/~\ trv^otmi^nt
Page 85 of 113
-------
Site
Application Type
Application Timing
Application Equipment
Cattle
Horses
Maximum Single
Appl. Rate (ai)
0.003 Ib ai/2 ear
tags
0.017 Ib ai/gallon
0.0004 llbai/wipe
Entry Prohibition
Use Limitations :
Maximum Application Rates for Registered Cypermethrin Residential Uses
Indoor Spaces
Indoor surfaces
Horses
0.0014 Ib ai/
fogger
0.005 Ib ai/sixteen
ounce can
0.017 Ib ai/gallon
Do not allow adults, children, or
pets to enter the treated area,
until vapors, mists, and aerosols
have dispersed, and the treated
area has been thoroughly
ventilated.
Keep people and pets out of the
area during application.
Do not allow adults, children or
pets to enter the treated area or
contact treated surfaces until
sprays have dried.
NA
Do not apply this product in a way that will contact any person, pet, either
directly or through drift.
Do not apply to pets.
Do not use as a space spray.
Use only in well-ventilated areas.
Do not use concentrate or emulsion in fogging equipment.
During any indoor surface application, do not allow dripping or runoff to
occur. During any application to ceilings of a structure, cover surface below
with plastic shielding or similar material.
Remove food and animals from premises prior to treatment.
Cover feed and water prior to treatment
Page 86 of 113
-------
Site
Application Type
Application Timing
Application Equipment
Maximum Single
Appl. Rate (ai)
Entry Prohibition
Use Limitations
0.000411bai/wipe
Page 87 of 113
-------
APPENDIX B. Table of Generic Data Requirements and Studies Used to Make the
Reregistration Decision for Cypermethrin
Page 88 of 113
-------
Appendix B. Table of Generic Data Requirements and Studies Used to Make the
Reregistration Decision for Cypermethrin
GUIDE TO APPENDIX B
Appendix B contains a listing of data requirements which support the reregi strati on for
active ingredients within the pyrethrins case covered by this RED. It contains generic data
requirements that apply pyrethrins in all products, including data requirements for which a
"typical formulation" is the test substance.
The data table is organized in the following formats:
1. Data requirement (Column 1). The data requirements are listed in the order in which they
appear in 40 CFR 158. The reference numbers accompanying each test refer to the test
protocols set in the Pesticide Assessment Guidance, which is 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 is no MRID number has been assigned. Refer to
the Bibliography appendix for a complete citation of the study.
Data Requirement | Use | Citations
Page 89 of 113
-------
New
Guideline
Number
Old
Guideline
Number
Description
PRODUCT CHEMISTRY
830.1550
830.1700
830.1700
830.1750
830.1800
830.6302
830.6302
830.6317
830.7050
830.7370
830.7550
61-1
61-3
62-1
62-2
62-3
61-2
63-0
63-17
None
63-10
63-11
Product Identity and Composition
Discussion of Formation of
Impurities
Preliminary Analysis
Certification of Limits
Analytical Method
Description of Beginning Materials
and Manufacturing Process
Reports of Multiple phys/chem
Characteristics
Storage stability
UV/Visible Absorption
Dissociation Constants in Water
Partition coefficient, shake flask
method
All
All
All
All
All
All
All
All
All
All
All
86966, 97866, 97869, 133028,
161909, 40513301, 41887001,
45462101
81566, 42068501, 40513301,
41887001, 45462101
46775902, 42043801, 41887002,
45462101, 45850201,
90032, 97865, 97868, 41887002,
45462101, 46775902
46775902, 42043801, 161909,
45462101
81566, 90032, 97865, 97868,
102991, 115281, 133028, 161909,
40513301,41887001,
42068501,45462101, 42854301,
41887003, 102991, 133028,
161909,40513301,42868201,
42868202, 45474201,
133028, 161909,45474201
46775902
42650601
161909
ECOLOGICAL EFFECTS
850.1010
850.1075
850.1400
850.1850
850.2100
850.2200
850.2300
875.2400
875.2500
72-2
72-1
72-4
72-6
71-1
71-2
71-4
133-3
133-4
Acute Toxicity to Freshwater
Invertebrates
Acute Toxicity to Freshwater Fish
Fish Early Life Stage/Aquatic
Invertebrate Life Cycle Study
Aquatic org. accumulation
Avian Single Dose Oral Toxicity
Avian Dietary Toxicity
Avian Reproduction
Dermal passive dosimetry expo
Inhal. passive dosimetry expo
All
All
All
All
All
All
All
All
All
43293501, 44423501, 90071,
90072,44546025, 41068004,
62793,41968210,43293501,
44074401, 44074402, 44074406,
44546031, 44546032, 152737,
90075
62792, 65812, 88948, 41968208,
41968209, 44546028, 44546029,
65813, 88947, 88948, 89037,
89038, 41068004, 41068003,
89039, 44546027, 65813,
44546030,
DATA GAP, 155770, 42725301,
44546035, 45121822, 155772,
42868203
44546024, 90070
90072,90071,44546025,
44546026
90074, 42322902, 42322901
44459801, 44518501
44459801,44518501
TOXICOLOGY
None
850.1045
82-7
72-3
Subchronic Neurotoxicity
Panaeid Acute Toxicity Test
All
A, B, D
44962202,43152002,
90075 , 89049, 90075, 41968211,
90 of 113
-------
Data Requirement
New
Guideline
Number
850.1735
850.3020
870.1100
870.1200
870.1300
870.1400
870.2400
870.2500
870.2600
870.3150
870.3200
870.3465
870.3700
870.3800
870.3800
870.4200
870.6200
870.7485
Old
Guideline
Number
(NONE)
141-1
81-1
81-2
81-3
83-1
81-4
81-5
81-6
82-1
82-2
82-4
83-3
84-2
83-4
83-2
81-8
85-1
Description
Whole Sediment Acute Toxicity
Testing with Freshwater Invertebrates
(Chironomus tentans)
Honey bee acute contact LD50
Acute Oral Toxicity - Rat
Acute Dermal Toxicity - Rabbit/Rat
Acute Inhalation Toxicity - Rat
Chronic Toxicity
Primary Eye Irritation - Rabbit
Primary Skin Irritation
Dermal Sensitization
Subchronic Oral Toxicity: 90-Day
Study
21 -Day Dermal - Rabbit/Rat
90-day inhal.-rat
Teratogenicity ~ 2 Species
Interaction with Gonadal DNA
2-Generation Reproduction - Rat
Oncogenicity
Acute neurotoxicity screen study in
rats
General Metabolism
Use
Patterns
A,B,D
A,B,D
All
All
All
All
All
All
All
A,B,D
A,B,D
A,B,D
A,B,D
All
A,B,D
All
All
A,B,D
Citations
41968212, 42444601, 44546033,
44546034, 44561210
DATA GAP
44544208
56800, 40377701
56800,40377701
42395702
44536801, 112909, 112910,
42068503, 92027037,
56800,40377701
56800,40377701
56800, 40377701
112929,56802,41776101,
44527002, 92027034
90035, 45010401
43507101,90040,112912
56805,41776102,43776301,
43776302
90036, 90037, 90038, 126834,
92027042, 92027062, 92027043,
90039,41599801,
56804, 112912, 42068504, 90040,
41968204, 92027040, 112912,
112910, 112911,92027038
44962201,43152001,
41551102,41551103,41551104
ENVIRONMENTAL FATE
835.6200
164-2
Aquatic Field Dissipation
A,B,D
44876107
RESIDUE CHEMISTRY
835.1240
835.2120
835.2240
835.2410
835.4100
835.4200
835.4300
835.4400
835.6100
850.1730
860.1300
860.1300
163-1
161-1
161-2
161-3
162-1
162-2
162-4
162-3
164-1
165-4
171-4A1
171-4 A2
Leaching/Adsorption/Desorption
Hydrolysis
Photodegradation - Water
Photodegradation - Soil
Aerobic Soil Metabolism
Anaerobic Soil Metabolism
Aerobic Aquatic Metabolism
Anaerobic Aquatic Metabolism
Terrestrial Field Dissipation
Accumulation in Fish
Characterization of Total Terminal
Residue
Nature of the Residue in Plants
A,B,D
A,B,D
A,B,D
A,B,D
A,B,D
A,B,D
A,B,D
A,B,D
A,B,D
A,B,D
All
A,B,D
42129003, 42129002
42620501
42395701
42129001
42156601
42156602
45920801
44876105
42459601
42868203
42169901, 42169903
125658, 42876301, 43775101,
43421301
Page 91 of 113
-------
Data Requirement
New
Guideline
Number
860.1300
860.1340
860.1340
860.1380
860.1500
860.1520
860.1540
Old
Guideline
Number
171-4 A3
171-4C
171-4C
171-4K
171-4L
171-5
Description
Nature of the Residue in Livestock
Residue Analytical Method - Plants
Residue Analytical Method -
Livestock
Storage Stability Data
Crop field trials
Magnitude of Residue in Processed
Food/Feed
Reduction of residues
Use
Patterns
A,B,D
A,B,D
A,B,D
A,B,D
A,B,D
All
Citations
89014, 42410001, 43278001,
41899802
00090027 0009002800125658
00127892 40880202
00081571 4327800343775103
43775104 4377510543775106
43775107 43775108
92027056 421770011 43578201
43578202 43775 109 43775 1 10
PP#7F3498 43516001 00125658
00145249
43578203 43009701 43578204
43578205 43009702 43578206
0013167000067376 00081574
00081575 0009002700090046
00127892 00132000 00132828
40880202 43172001
00067377 00090028 00090050
00132828 43270201
43278002 43278001
OTHER
Non-
guideline
Study
Non-
guideline
Study
Non-
guideline
Study
Non-
guideline
Study
Non-
guideline
Study
Non-
guideline
Study
Non-
guideline
Study
Non-
guideline
Study
Non-
guideline
Study
Non-
guideline
Study
Data Waiver Rationale
Legal and regulatory documents
Complete primary report ~
experimental research
Opinion or commentary from
interested groups
Transmittal documents
All
All
A,B,D
All
All
46775903
130888
46775906, 131455,46538902,
46670401, 46670402, 46670403,
43261603, 70562, 41054701,
89047
46775901,
44972201, 41390200, 41892600,
43578200, 43841300
CBRS No. 9592, DP Barcode D175749, 5/20/92, W. Anthony.
Page 92 of 113
-------
APPENDIX C: Technical Support Documents
Page 93 of 113
-------
APPENDIX C: Technical Support Documents
Additional documentation in support of this RED is maintained in the OPP docket EPA-HQ-
OPP-200X-OXXX. This docket may be accessed in the OPP docket room located at Room S-
4900, One Potomac Yard, 2777 S. Crystal Drive, Arlington, VA. It is open Monday through
Friday, excluding Federal holidays, from 8:30 a.m. to 4:00 p.m. All documents may be viewed
in the OPP docket room or downloaded or viewed via the Internet at the following site:
http://www.regulations.gov.
Page 94 of 113
-------
APPENDIX D. Citations Considered to be Part of the Data Base Supporting the
Reregistration Eligibility Decision
Page 95 of 113
-------
Appendix D. Citations Considered to be Part of the Data Base Supporting the
Reregistration Eligibility Decision
MRID Citation Reference
56800 Henderson, C.; Oliver, G.A.; Smith, I.K.; et al. (1980) Cypermethrin (PP383): Acute Toxicity and Local
Irritation: Report No. CTL/P/537. (Unpublished study received Dec 29, 1980 under 10182-EX-19;
prepared by Imperial Chemical Industries, Ltd., United Kingdom, submitted by ICI Americas, Inc.,
Wilmington, Del.; CDL:099855-B)
56802 Glaister, J.R.; Gore, C.W.; Marsat, G.J.; et al. (1980) PP383: 90 Day Feeding Study in Rats: Report No.
CTL/P/327. Rev. (Unpublished study received Dec 29, 1980 under 10182-EX-19; prepared by Imperial
Chemical Industries, Ltd., United Kingdom, submitted by ICI Americas, Inc., Wilmington, Del.;
CDL:099855-D)
56804 Tesh, J.M.; Tesh, S. A.; Davies, W. (1978) WL 43467: Effects upon the Progress and Outcome of
Pregnancy in the Rat: LSR Report No. 78/SHL2/364. (Unpublished study received Dec 29, 1980 under
10182-EX-19; prepared by Life Science Research, England, submitted by ICI Americas, Inc.,
Wilmington, Del.; CDL:099855-F)
56805 Dix, K.M.; Van derPauw, C.L.; Whitaker, I; et al. (1978) Toxicity of WL 43467: Teratological Studies
in Rabbits Given WL 43467 Orally: Group Research Report TLGR.0010.78. (Unpublished study
received Dec 29, 1980 under 10182-EX-19; prepared by Shell Research, Ltd., England, submitted by ICI
Americas, Inc., Wilmington, Del.; CDL:099855-G)
62792 Hill, R.W.; Maddock, E.G.; Harland, B.J. (1980) Determination of the Acute Toxicity of Cypermethrin
(PP 383) to Rainbow Trout (Salmo gairdneri): BL/B/2006. (Unpublished study received Dec 5, 1980
under 279-EX-86; prepared by Imperial Chemical Industries, Ltd., England, submitted by FMC Corp.,
Philadelphia, Pa.; CDL:243861-AF)
62793 Edwards, P.I; Brown, S.M.; Sapiets, A.S. (1980) Cypermethrin (PP383): Toxicity of Technical and
Formulated Material to First Instar Daphnia magna: Report Series RJ 0110B. (Unpublished study
received Dec 5, 1980 under 279-EX-86; prepared by Imperial Chemical Industries, Ltd., England,
submitted by FMC Corp., Philadelphia, Pa.; CDL:243861-AG)
65812 Hill, R.W.; Maddock, E.G.; Harland, B.J. (1980) Determination of the Acute Toxicity of Cypermethrin
(PP 383) to Bluegill Sunfish (Lepomis macrochirus): BL/B/2011. (Unpublished study received Dec 29,
1980 under 10182-EX-19; prepared by Imperial Chemical Industries, Ltd., England, submitted by ICI
Americas, Inc., Wilmington, Del.; CDL:244017-D)
65813 Hill, R.W.; Maddock, E.G.; Harland, B.J. (1980) Determination of the Acute Toxicity of GFU 061, a
36% w/v Formulation of Cypermethrin to Rainbow Trout (Salmo gairdneri): BL/B/2016. (Unpublished
study received Dec 29, 1980 under 10182-EX-19; prepared by Imperial Chemical Industries, Ltd.,
England, submitted by ICI Americas, Inc., Wilmington, Del.; CDL:244017-E)
67376 Ussary, J.P.; Daniel, J.T.; Harkins, J.T.; et al. (1980) Cypermeth- rin Residues on Cottonseed: Report
Series TMU0507/B. (Unpublished study received Dec 29, 1980 under 10182-EX-19; prepared in
cooperation with Analytical Biochemistry Laboratories, Inc., submitted by ICI Americas, Inc.,
Wilmington, Del.; CDL:099856-F)
67377 Ussary, J.P.; Watkins, S.D.; Pearson, F.J. (1980) Cypermethrin Residues in Cottonseed Processed
Fractions: Report No. TMU0518/ B. Rev. Includes undated method entitled: Gas liquid chromatographic
method for the determination of Cypermethrin in oily crops and their process fractions (provisional
method). (Unpublished study received Dec 29, 1980 under 10182-EX-19; prepared in cooperation with
Texas A & M Univ., Oil Seed Products Labora- tory, Food Protein Research and Development Center,
submitted by ICI Americas, Inc., Wilmington, Del.; CDL:099856-G)
81566 Eitelman, S.J.; Cheplen, J.M. (1981) Characterization of Typical Cypermethrin Technical Manufactured
: 96 of 113
-------
MRID Citation Reference
by ICI Americas Inc.: Report Series TMU0557/C. (Unpublished study received Sep 10, 1981 under
10182-EX-19; submitted by ICI Americas, Inc., Wilmington, Del.; CDL:070289-B)
81571 Sapiets, A.; Swaine, H. (1981) The Determination of Residues of Cypermethrin in Products of Animal
Origin, a GLC Method Using Internal Standardisation. Residue analytical method no. 56 dated Jun 17,
1981. (Unpublished study received Sep 10, 1981 under 10182-EX-19; prepared by Imperial Chemical
Industries Ltd., England, submitted by ICI Americas, Inc., Wilmington, Del.; CDL:070288-E)
81574 Ussary, J.P.; Fitzpatrick, R.D.; Johnson, G.A.; et al. (1981) Freezer Storage Stability of Cypermethrin
Residues on Cottonseed: Report Series TMU0661/B. (Unpublished study received Sep 10, 1981 under
10182-EX-19; submitted by ICI Americas, Inc., Wilmington, Del.; CDL:070288-H)
81575 Ussary, J.P.; Albritton, J.; Feese, H.D.; et al. (1981) Cypermethrin Residues on Cottonseed: Report
Series TMU0662/B. (Unpublished study received Sep 10, 1981 under 10182-EX-19; submitted by ICI
Americas, Inc., Wilmington, Del.; CDL:070288-I)
86966 ICI Americas, Incorporated (1981) Confidential Statement of Formula: Cymbush 3E. (Unpublished
study received Nov 5, 1981 under 10182-EX-25; CDL:246211-A)
88947 Hill, R.W.; Maddock, E.G.; Comber, M.H.I. (1981) Cypermethrin: Determination of the Acute Toxicity
of Formulation GFU 070 to Rainbow Trout (Salmo gairdneri)'. BL/B/2093. (Unpublished study received
Dec 30, 1981 under 10182-64; prepared by Imperial Chemical Industries, Ltd., submitted by ICI
Americas, Inc., Wilmington, Del.; CDL:070558-C)
88948 Hill, E.W.; Maddock, E.G.; Comber, M.H.I. (1981) Cypermethrin. Determination of the Acute Toxicity
of Formulation GFU 070 to Bluegill Sunfish (Lepomis macrochirus): BL/B/2099. (Unpublished study
received Dec 30, 1981 under 10182-64; prepared by Imperial Chemical Industries, Ltd., submitted by
ICI Americas, Inc., Wilmington, Del.; CDL:070558-D)
89014 Hutson, D.H.; Croucher, A.; Stoyden, G.; et al. (1980) The Metabolic Fate of Cypermethrin in the Cow:
Elimination and Residues Derived fromA14IC-Benzyl Label: TLGR.80.121. (Unpublished study
received Dec 30, 1981 under 10182-64; prepared by Shell Research, Ltd., England, submitted by ICI
Americas, Inc., Wil- mington, Del.; CDL:070565-P)
89037 Hill, R.W.; Young, B.E.; Comber, M.H.I. (1981) Determination of the Acute Toxicity of 3-Phenoxy
Benzoic Acid to Rainbow Trout (Salmo gairdneri): Brixham Report No. Bl/B/2038. (Unpublished study
received Dec 30, 1981 under 10182-64; prepared by Imperial Chemical Industries, Ltd., England,
submitted by ICI Americas, Inc., Wilmington, Del.; CDL:070562-B)
89038 Hill, R.W.; Young, B.E.; Comber, M.H.I. (1981) Determination of the Acute Toxicity of 3-Phenoxy
Benzoic Acid to Bluegill Sunfish (Lepomis macrochirus)'. Brixham Report No. BL/B/2086. (Un-
published study received Dec 30, 1981 under 10182-64; prepared by Imperial Chemical Industries, Ltd.,
England, submitted by ICI Americas, Inc., Wilmington, Del.; CDL:070562-C)
89039 Jaber, M.J.; Hawk, R.E. (1981) The Toxicity of Cypermethrin to Fat- head Minnow (Pimephales
promelas) Embryos and Larvae: Report Series TMUE0007/B. (Unpublished study received Dec 30,
1981 under 10182-64; submitted by ICI Americas, Inc., Wilmington, Del.; CDL:070562-D)
89047 Edwards, P.J.; Hamer, M.J.; Bull, J.M.; et al. (1981) Cypermethrin: 21 Day Daphnia magna Life Cycle
Study: Report Series RJ 0177B. (Unpublished study received Dec 30, 1981 under 10182-64; prepared by
Imperial Chemical Industries, Ltd., submitted by ICI Americas, Inc., Wilmington, Del.; CDL:070562-
M)
89049 Jaber, M.J.; Hawk, R.E. (1981) The Acute Toxicity of Cypermethrin to Eastern Oysters (Crassostrea
virginica): Report Series TMUE0009/B. (Unpublished study received Dec 30, 1981 under 10182-64;
submitted by ICI Americas, Inc., Wilmington, Del.; CDL:070562-O)
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90027 Stearns, J.W.; Hidalgo-Gato, E.; Fung, R.; et al. (1981) Determination of Cypermethrin Residues in
Ginned Cottonseed: RAN-0025. Method dated Apr 22, 1981. (Unpublished study received Dec 17, 1981
under 279-EX-88; submitted by FMC Corp., Phialadelphia, Pa.; CDL:070541-G)
90028 Stearns, J.W.; Fung, R.; Markle, J.C.; et al. (1981) Determination of Cypermethrin Residues in
Cottonseed Processing Products: RAN- 0027. Method dated May 14, 1981. (Unpublished study received
Dec 17, 1981 under 279-EX-88; submitted by FMC Corp., Philadelphia, Pa.; CDL:070541-H)
90032 ICI Americas, Incorporated (19??) Manufacturing Process. (Unpub- lished study received Dec 30, 1981
under 10182-64; CDL:070563-D)
90035 Henderson, C.; Parkinson, G.R.; Smith, I.K. (1981) Cypermethrin Technical: Subacute Dermal Toxicity
Study in Rabbits: Report No. CTL/P/588. (Unpublished study received Dec 30, 1981 under 10182-64;
prepared by Imperial Chemical Industries, Ltd., England, submitted by ICI Americas, Inc., Wilmington,
Del.; CDL:070564-C)
90036 Brooks, T.M.; Dean, B.J.; Gonzalez, L.P.; et al. (1980) Toxicity Studies with Agricultural Chemicals:
Mutagenicity Studies with Ripcord in Microorganisms in vitro and in the Host-mediated Assay: Group
Research Report TLGR.80.059. (Unpublished study received Dec 30, 1981 under 10182-64; prepared by
Shell Research, Ltd., England, submitted by ICI Americas, Inc., Wilmington, Del.; CDL:070564-D)
90037 Trueman, R.W.; Longstaff, E. (1981) An Examination of Cypermethrin for Potential Mutagenicity
Using the Salmonella/Micmsome Reverse Mutation Assay: Report No. CTL/P/595. (Unpublished study
received Dec 30, 1981 under 10182-64; prepared by Imperial Chemical Industries, Ltd., England,
submitted by ICI Americas, Inc., Wilmington, Del.; CDL:070564-E)
90038 Dean, B.J.; Thorpe, E.; Stevenson, D.E. (1980) Toxicity Studies with WL 43467: Chromosome Studies
on Bone Marrow Cells of Chinese Hamsters after Two Daily Oral Doses of WL 43467: Group Research
Report TLGR.0136.77. (Unpublished study received Dec 30, 1981 under 10182-64; prepared by Shell
Research, Ltd., England, submitted by ICI Americas, Inc., Wilmington, Del.; CDL:070564-F)
90039 Dean, B.J.; Van der Pauw, C.L.; Butterworth, S.T.G.; et al. (1980) Toxicity Studies with WL 43467:
Dominant Lethal Assay in Male Mice after Single Oral Doses of WL 43467: Group Research Report
TLGR.0042.77. (Unpublished study received Dec 30, 1981 under 10182-64; prepared by Shell
Toxicology Laboratory, England, submitted by ICI Americas, Inc., Wilmington, Del.; CDL:070564-G)
90040 Hend, R.W.; Hendy, R.; Fleming, D.J. (1972?) Toxicity Studies on the Insecticide WL 43467: A Three
Generation Reproduction Study in Rats: Group Research Report TLGR.0188.78. (Unpublished study
received Dec 30, 1981 under 10182-64; prepared by Shell Research, Ltd., England, submitted by ICI
Americas, Inc., Wil- mington, Del.; CDL:070564-H)
90046 Ussary, J.P.; Fitzpatrick, R.D.; Albritton, J.; et al. (1981) Cypermethrin Residues on Cottonseed: Report
Series TMU0662/B. (Unpublished study received Dec 30, 1981 under 10182-64; sub- mittedby ICI
Americas, Inc., Wilmington, Del.; CDL:070566-D)
90050 Ussary, J.P.; Pearson, F.J.; Fitzpatrick, R.D.; et al. (1981) Cypermethrin Residues in Cottonseed Process
Fractions: Report Series TMU0667/B. (Unpublished study received Dec 30, 1981 under 10182-64;
submitted by ICI Americas, Inc., Wilmington, Del.; CDL:070566-J)
90064 Woods, T.M.; Bewick, D.W.; Leahey, J.P. (1980) Cypermethrin: Rota- tional Crop Study: Report Series
RJ 0161B; 4D 5/2. (Unpublished study received Dec 30, 1981 under 10182-64; prepared by Imperial
Chemical Industries, Ltd., England, submitted by ICI Americas, Inc., Wilmington, Del.; CDL:070560-
Q)
90070 Roberts, N.L.; Fairley, C. (1980) The Acute Oral Toxicity (LDI50) of Cypermethrin to the Mallard
Duck: ICI 302/80305; CTL/8/994. (Unpublished study received Dec 30, 1981 under 10182-64; pre-
pared by Huntington Research Centre, England, submitted by ICI Americas, Inc., Wilmington, Del.;
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90071 Roberts, N.L.; Fairley, C.; Woodhouse, R.N. (1980) The Subacute Dietary Toxicity (LCI50A) of
Cypermethrin to the Mallard Duck: ICI 330/WL/80812; 55 l(a)/3. (Unpublished study received Dec 30,
1981 under 10182-64; prepared by Hungtindon Research Centre, England, submitted by ICI Americas,
Inc., Wilmington, Del.; CDL: 070561-C)
90072 Roberts, N.L.; Fairley, C.; Woodhouse, R.N. (1981) The Subacute Dietary Toxicity (LCI50A) of
Cypermethrin to the Bobwhite Quail: ICI 331 WL/80811; 5E.l(a)/4. (Unpublished study received Dec
30, 1981 under 10182-64; prepared by Huntingdon Research Centre, England, submitted by ICI
Americas, Inc., Wilmington, Del.; CDL: 070561-D)
90074 Roberts, N.L.; Fairley, C.; Chanter, D.O.; et al. (1981) The Effect of Dietary Inclusion of Cypermethrin
on Reproduction in the Bobwhite Quail: ICI 342/81341; CTL/C/1105. (Unpublished study received Dec
30, 1981 under 10182-64; prepared by Huntingdon Research Centre, England, submitted by ICI
Americas, Inc., Wilmington, Del.; CDL:070561-F)
90075 Jaber, M.J.; Hawk, R.E. (1981) The Acute Toxicity of Cypermethrin to Sheepshead Minnows
(Cyprinodon variegatus): Report Series TMUE0002/B. (Unpublished study received Dec 30, 1981 under
10182-64; submitted by ICI Americas, Inc., Wilmington, Del.; CDL:079561-G)
97865 ICI Americas, Incorporated (19??) Composition and Manufacturing Process of Cymbush (R)
Insecticide. (Unpublished study received Dec 30, 1981 under 10182-64; CDL:070556-F)
97866 ICI Americas, Incorporated (1981) Confidential Statement of Formula: Cymbush 3E. (Unpublished
study received Dec 30, 1981 under 10182-64; CDL:070556-G)
97868 ICI Americas, Incorporated (19??) Cypermethrin: Composition and Manufacturing Process.
(Unpublished study received Dec 30, 1981 under 10182-64; CDL:070557-D)
97869 ICI Americas, Incorporated (1981) Confidential Statement of Formula: Cymbush 2E (JF 6670).
(Unpublished study received Dec 30, 1981 under 10182-64; CDL:070557-E)
98000 Ussary, J.P.; Barnes, J.W.; Harkins, J.T.; et al. (1981) Cypermethrin Field Crop Rotation Study:
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102991 ICI Americas, Inc. (1980?) Cypermethrin: Chemical Study. (Compilation; unpublished study received
May 20, 1982 under 10182- 68; CDL:247563-A)
112909 Ishmael, I; Kalinowski, A.; Banham, P.; et al. (1982) Cypermethrin: One Year Oral Dosing Study in
Dogs: Report No. CTL/ P/703. (Unpublished study received Sep 1, 1982 under 2F2623; prepared by
Imperial Chemical Industries PLC, Eng., submitted by ICI Americas, Inc., Wilmington, DE;
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112910 Milburn, G.; Forbes, D.; Banham, P.; et al. (1982) Cypermethrin: 2 Year Feeding Study in Rats: Report
No. CTL/P/669. (Unpublished study received Sep 1, 1982 under 2F2623; prepared by Imperial Chemical
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112911 Lindsay, S.; Banham, P.; Chart, I.; et al. (1982) Cypermethrin: Lifetime Feeding Study in Mice: Report
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112912 Milburn, G.; Banham, P.; Birtley, R.; et al. (1982) Cypermethrin: Three Generation Reproduction Study
in the Rat: Report No. CTL/ P/683. (Unpublished study received Sep 1, 1982 under 2F2623; prepared by
Imperial Chemical Industries PLC, Eng., submitted by ICI Americas, Inc., Wilmington, DE;
CDL:071074-A; 071075)
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112929 Buckwell, A.; Butterworth, S.; Stevenson, D. (1977) Toxicity Studies on the Pyrethroid Insecticide WL
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115281 FMC Corp. (1982) Product Chemistry: Ammo Technical and Ammo 2.SEC Formulation. (Compilation;
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125658 FMC Corp. (1982) Results of Tests for the Amount of Residue Remaining and a Description of the
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126834 Suzuki, H.; Miyamoto, J. (1977) Studies on Mutagenicity of Some Pyrethroids on Salmonella Strains in
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127892 ICI Americas, Inc. (1983) Residues of Cypermethrin in or on Cottonseed, in the Meat, Fat and Meat
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130888 US EPA (1982) Administrative Record of the Registration Standard for Terbacil. (Unpublished File)
131455 Scott, R.; Chester, G.; Hart, T.; et al. (1983) Fluazifopbutyl: A Spray Trial To Assess Operator Exposure
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132828 ICI Americas, Inc. (1983) Residues: Cymbush Insecticide. (Compilation; unpublished study received
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145249 Stearns, J. (1984) Determination of Cyperamide and m-Phenoxybenzaldehyde Residues in/on Lettuce
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152737 Getty, C.; Wilkinson, W.; Swaine, H.; et al. (1983) Cypermethrin: Effects of Multiple Low Rate
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40880202 Fitzpatrick, R. (1981) A Gas-Liquid Chromatographic Method for the Determination of Cypermethrin
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42395701 Estigoy, L.; Ruzo, L.; Shepler, K. (1992) Photodegradation of carbon 14-acid and carbon 14-alcohol
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247/248W: 247/248W-1: 191E1290E1. Unpublished study prepared by Pharmacology and Toxicology
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42395702 Mount, E. (1992) Cypermethrin Technical: Acute Inhalation Toxicity Study in Rats: Lab Project
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42444601 Ward, T.; Boeri, R.; Palmieri, M. (1992) Acute Toxicity of FMC 56701 Technical and Cypermethrin
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42459601 Leppert, B. (1992) Ammo 2.5 EC Insecticide-Terrestrial Field Dissipation: Lab Project Number:
191E4191E1: RAN-0239. Unpublished study prepared by FMC Corporation. 182 p.
42620501 Clifton, J. (1992) Environmental Fate Studies: Hydrolysis Studies of Cypermethrin in Aqueous Buffered
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42854301 Wilks, K. (1993) Description of Beginning Materials and Manufacturing Process and Discussion of the
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43009701 Kim, I. (1993) Magnitude of the Residue of Cypermethrin, Dichlorovinyl Acid, m-Phenoxybonzoic
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43009702 Starner, K. (1993) Magnitude of the Residue of Cypermethrin, Dichlorovinyl Acid, and m-
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Insecticide Followed by Five Foliar Applications of Ammo 2.5 EC: Lab Project Number: RAN-0253:
191COT93R1. Unpublished study prepared by FMC Corp. 79 p.
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43278001 Nagel, W. (1994) Magnitude of the Residue of Cypermethrin and its Metabolites in/on Poultry Tissues
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43278002 Chen, A. (1994) Magnitude of the Residue of Cypermethrin and its Acid Metabolites in/on Meat, Meat
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43278003 Chen, A. (1994) Residue Analytical Method for the Determination of Cypermethrin and its Acid
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43293501 Wheat, J.; Evans, J. (1994) Zetacypermethrin Technical and Cypermethrin Technical: Comparative
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43328401 Stearns, J. (1993) Ammo 2.5 EC Insecticide—Magnitude of the Residues on Alfalfa: Determination of
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43421301 George, M. (1994) Cypermethrin (Ammo) Insecticide: Nature of the Residue: Metabolism of
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43507101 Parr Dobrzanski, R. (1994) Cypermethrin: 21 Day Sub-acute Inhalation Toxicity Study in the Rat: Lab
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43578200 FMC Corp. (1995) Submission of Residue Data in Support of Tolerance Petition for Cypermethrin on
Brassica Crops. Transmittal of 6 Studies.
43578201 Akbari, Z. (1995) Ammo Insecticide-Cold Storage Stability of Cypermethrin in/on Broccoli and
Mustard Greens: Lab Project Number: 191CSS92R3: RAN-0266. Unpublished study prepared by FMC
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43578202 Starner, K. (1993) Ammo Insecticide-Storage Stability of the Residues of Cypermethrin, Dichlorovinyl
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43578203 Hebert, V. (1994) Ammo Insecticide-Magnitude of the Residue of Cypermethrin, Dichlorovinyl Acid,
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43578204 Noon, P. (1994) Magnitude of the Residues of zeta-Cypermethrin (Proposed Common Name),
Dichlorovinyl Acid and meta-Phenoxybenzoic Acid in/on Broccoli Treated with Six Applications of
Fury 1.5 EW Insecticide at 0.05 Pounds Active Ingredient per Acre per Application with a 1 Day Pre-
harvest Interval: Lab Project Number: 194BRO93R1: RAN-0047: 70.004. Unpublished study prepared
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43578205 Noon, P. (1994) Magnitude of the Residues of zeta-Cypermethrin (Proposed Common Name),
Dichlorovinyl Acid and meta-Phenoxybenzoic Acid in/on Cabbage Treated with Six Applications of
Fury 1.5 EW Insecticide at 0.05 Pounds Active Ingredient per Acre per Application with a 1 Day Pre-
harvest Interval: Lab Project Number: 194CAB93R1: RAN-0045: 70.003. Unpublished study prepared
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43578206 Noon, P. (1994) Magnitude of the Residues of zeta-Cypermethrin (Proposed Common Name),
Dichlorovinyl Acid and meta-Phenoxybenzoic Acid in/on Mustard Greens Treated with Four
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a 1 Day Pre-harvest Interval: Lab Project Number: 194MUS93R1: RAN-0046: 70.005. Unpublished
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43775102 Jang, D. (1995) Magnitude of the Residues of Cypermethrin, Dichlorovinyl Acid and m-
Pagel06ofll3
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MRID Citation Reference
Phenoxybenzoic Acid in/on Sorghum Forage, Fodder, Grain and Aspirated Grain Fractions Treated with
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43775103 Nagel, W. (1994) Residue Analytical Method for the Determination of Cypermethrin and its Acid
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43775104 Nagel, W. (1995) Radiovalidation of Residue Methodology for Cypermethrin and its Major Metabolites
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43775105 Griffin, P.; Perez, R. (1995) Independent Method Validation of FMC Analytical Method Report P-
2901M "Residue Analytical Method for the Determination of Cypermethrin and its Acid Metabolites
in/on Cow Milk, Meat, and Meat By-Products": Final Report: Lab Project Number: 191MVL94R3:
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43775106 Griffin, P. (1995) Independent Method Validation of FMC Analytical Method Report P-2901M:
"Residue Analytical Method for the Determination of Cypermethrin and its Acid Metabolites in/on Cow
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43775107 Perez, R.; Griffin, P. (1995) Independent Method Validation of FMC Analytical Method Report P-
2901M "Residue Analytical Method for the Determination of Cypermethrin and its Acid Metabolites
in/on Cow Milk, Meat, and Meat By-Products": Final Report: Lab Project Number: 191MVL94R2:
ADPEN-911-94-0610: PC-0222. Unpublished study prepared by ADPENLabs, Inc. 32 p.
43775108 Griffin, P.; Perez, R. (1995) Independent Method Validation of FMC Analytical Method Report P-
2925M "Residue Analytical Method for the Determination of Cypermethrin and its Acid Metabolites
in/on Poultry Eggs Matrices": Final Report: Lab Project Number: 191MVL94R4: ADPEN-911-94-0712:
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43775109 Barrett, G. (1994) Storage Stability of Cypermethrin, cis/trans Dichlorovinyl Acids and m-
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43775110 Barrett, G.; Pearsall, J. (1995) Storage Stability of Cypermethrin, cis/trans Dichlorovinyl Acids and m-
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43776301 Freeman, C. (1994) Cypermethrin Technical: Pilot Oral Teratology Study in Rabbits: Lab Project
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43776302 Freeman, C. (1994) Cypermethrin Technical: Oral Teratology Study in Rabbits: Lab Project Number:
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43841300 FMC Corp. (1995) Submission of Residue Chemistry Data in Support of the Petition for Tolerance for
Cypermethrin on Sweet Corn. Transmittal of 2 Studies.
43841301 Leppert, B. (1993) Magnitude of the Residues of Cypermethrin, Dichlorovinyl Acid and meta-
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0.1 Lb Active Ingredient per Acre Per Application: Revised Report: Lab Project Number: 191COS90R1:
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43841302 Munoz, W. (1993) Methodology forthe Determination of the Magnitude of the Residues of
Cypermethrin, Dichlorovinyl Acid and meta-Phenoxybenzoic Acid in/on Sweet Corn: Revised Report:
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Dichlorovinyl Acid and meta-Phenoxybenzoic Acid in/on Alfalfa Forage and Hay from Alfalfa Treated
with Fury 1.5 EC Insecticide or Fury 1.5 EW Insecticide, Once per Cutting for Three Consecutive
Cuttings, at 0.05 Pounds Active Ingredient per Acre per Application with 3 Day Pre-Harvest Interval:
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43899402 Goehre, K. (1995) Magnitude of the Residues of Ammo 2.5 EC Insecticide in/on Alfalfa for Seed:
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44074401 Rapley, J.; Hamer, M. (1996) Cypermethrin: Toxicity to Chironomus riparius andHyalella azteca'. Lab
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44074402 Gentle, W.; Goggin, U.; Rapley, J.; et al. (1996) Cypermethrin: Toxicity to Chironomus tentans in
Sediment-Water Systems: Lab Project Number: RC0001: 96JH007. Unpublished study prepared by
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44074406 Farrelly, E.; Gentle, W.; Goggin, U.; et al. (1996) Cypermethrin: Toxicity to Hyalella azteca in
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44423501 Hamer, M. (1997) Cypermethrin: Acute Toxicity of Short-Term Exposures to Hyalella Azteca: Lab
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44459801 Merricks, D. (1997) Carbaryl Mixer/Loader/Applicator Exposure Study During Application of RP-2
Liquid (21%), Sevin Ready to Use Insect Spray or Sevin 10 Dust to Home Garden Vegetables: Lab
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44518501 Merricks, D. (1998) Carbaryl Mixer/Loader/Applicator Exposure Study During Application of RP-2
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44527002 Daly, I. (1994) A Subchronic (3-month) Oral Toxicity Study of FMC 30980 Technical in the Dog Via
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44536801 Daly, I. (1995) A Chronic (12-Month) Oral Toxicity Study of FMC 30980 Technical in the Dog via
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44544208 Halsall, N. (1998) Betacypermethrin 10 EC: Acute Toxicity to Honey Bees (Apis mellifera): Lab Project
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44546025 Johnson, A. (1998) Dietary (LC50) to the Mallard Duck: Betacypermethrin: Lab Project Number: PWT
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44546027 Sousa, J. (1998) (Carbon 14)-Cypermethrin~Acute Toxicity to Rainbow Trout (Oncorhynchus mykiss)
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44546029 Sousa, J. (1998) (Carbon 14)(Beta)-Cypermethrin~Acute Toxicity to Bluegill Sunfish (Lepomis
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44546031 Putt, A. (1998) (Carbon 14)(Beta)Cypermethrin~Acute Toxicity to Daphnids (Daphnia magna) Under
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44546032 Putt, A. (1998) Cypermethrin Technical—Acute Toxicity to Daphnids (Daphnia magna) Under Flow-
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44546033 Dionne, E. (1998) Cypermethrin Technical-Acute Toxicity to Sheepshead Minnow (Cyprinodon
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44546034 Sousa, J. (1998) (Carbon 14)(Beta)-Cypermethrin~Chronic Toxicity to Sheepshead Minnow
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44972201 Klonne, D. (1999) Integrated Report for Evaluation of Potential Exposures to Homeowners and
Professional Lawn Care Operators Mixing, Loading, and Applying Granular and Liquid Pesticides to
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46775906 Class, T. (2003) Zeta-Cypermethrin and Its Degradates: UV-VIS Absorption Spectra. Project Number:
P/B/661/G. Unpublished study prepared by PTRL Europe Gmbh. 38 p.
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MRID
Citation Reference
92027034 Barber, J. (1990) ICI Americas Inc. Phase 3 Summary of MRID 00056802. Cypermethrin (PP383): 90
Day Feeding Study in Rats: CTL ReportNo.: CTL/P/327; CTL Study No.: PR0044.: 10 p.
92027034 Barber, J. (1990) ICI Americas Inc. Phase 3 Summary of MRID 00056802. Cypermethrin (PP383): 90
Day Feeding Study in Rats: CTL ReportNo.: CTL/P/327; CTL Study No.: PR0044.: 10 p.
92027037 Guttmann, E. (1990) ICI Americas Inc. Phase 3 Summary of MRID 00112909. Cypermethrin: One Year
Oral Dosing Study in Dogs: CTL Report No.: CTL/P/703; CTL Study No.: PD0398.: 8 p.
92027038 Barber, J. (1990) ICI Americas Inc. Phase 3 Summary of MRID 00112911 and Related MRIDs
00133338, 00163497. Cypermethrin: Lifetime Feeding Study in Mice: CTL Report Nos.: CTL/P/687,
CTL/P/687A, CTL/P/1614; CTL Study No.: PM0366.: 8 p.
92027040 Guttmann, E. (1990) ICI Americas Inc. Phase 3 Summary of MRID 00112912. Cypermethrin: Three
Generation Reproduction Study in the Rat: CTL ReportNo.: CTL/P/683; CTL Study No.: RR0143.: 9 p.
92027042 Callander, R. (1990) ICI Americas Inc. Phase 3 Summary of MRID 00090037. An Examination of
Cypermethrin for Potential Mutagenicity Using the Salmonella/Microsome Reverse Mutation Assay:
CTL ReportNo.: CTL/P/595; CTL Study Nos.: YV0017, YV0026, YV0199. Prepared by ICI Central
Toxicology Laboratory. 7 p.
92027043 Mackay, J. (1990) ICI Americas Inc. Phase 3 Summary of MRID 00090038. Toxicity Studies with WL
43467: Chromosome Studies on Bone Marrow Cells of Chinese Hamsters after Two Daily Oral Doses of
WL 43467: ReportNo.: TLGR.0136.77; Study No.: 1110; CTL ReportNo.: CT1/C/1052. Prepared by
Shell Research Ltd. 6 p.
92027056 Leung, L. (1990) ICI Americas Inc. Phase 3 Summary of MRID 00071380. Cypermethrin (FMC
30980)-Storage Stability.: 9 p.
92027062 Trueman, R. (1990) ICI Americas Inc. Phase 3 Reformat of MRID 00090037. An Examination of
Cypermethrin for Potential Mutagenicity Using the Salmonella/Microsome Reverse Mutation Assay:
CTL ReportNo.: CTL/P/595; CTL Study Nos.: YV0017, YV0199, YV0026. Prepared by ICI Central
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APPENDIX E: Generic Data Call-In
Note that a Data Call-In (DCI), with all pertinent instructions, will be sent to the registrants.
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APPENDIX F: Product Specific Data Call-In
Note that a Data Call-In (DCI), with all pertinent instructions, will be sent to the registrants.
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