United States Prevention, Pesticides EPA 738-R-06-017
Environmental Protection and Toxic Substances December 2007
Agency(7508P)
Reregistration
Eligibility Decision
(RED) for Permethrin
Revised December 2007
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REREGISTRATION ELIGIBILITY DECISION
(RED)
For
Permethrin
CASE No. 2510
Revised December 2007
Approved by:
Steven Bradbury,
Director
Special Review and
Reregistration Division
Date:
/
11
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TABLE OF CONTENTS
Permethrin Reregistration Eligibility Decision Team v
Glossary of Terms and Abbreviations vi
Permethrin Reregistration Eligibility Decision viii
I. Introduction 1
II. Chemical Overview 2
A. Regulatory History 2
B. Chemical Identification - Permethrin 3
C. Use Profile 4
D. Estimated Usage of Permethrin 5
III. Summary of Permethrin Risk Assessments 7
A. Human Health Risk Assessment 8
1. Toxicity of Permethrin 8
a. Acute Toxicity Profile 9
b. FQPA Safety Factor Considerations 9
c. Toxicological Endpoints 10
2. Carcinogenicity of Permethrin 11
3. Metabolites and Degradates 12
4. Permethrin Endocrine Effects 12
5. Dietary Risk from Food and Drinking Water 12
a. Dietary (Food and Drinking Water) Exposure Assumptions 12
b. Population Adjusted Dose 13
c. Acute and Chronic Dietary (Food and Drinking Water) Risk 14
d. Cancer Dietary (Food and Drinking Water) Risk 14
6. Residential Exposure and Risk 15
a. Residential Handler Risks 16
b. Residential Post-Application Risks 18
7. Aggregate Risk 22
a. Acute Aggregate Risk 24
b. Short-Term Aggregate Risk 24
c. Intermediate-Term & Long-Term Aggregate Risk 26
d. Cancer Risk 26
e. Permethrin Pesticide and Pharmaceutical Use Co-Exposure Assessment 27
8. Occupational Exposure and Risk 28
a. Occupational Handler Exposure and Risk 29
b. Occupational Post-Application Exposure and Risk 35
c. Incident Reports 39
B. Environmental Fate and Effects Risk Assessment 40
1. Environmental Fate and Transport 40
2. Ecological Exposure and Risk 41
a. Terrestrial Organisms 42
b. Aquatic Organisms 45
c. Endangered Species 54
3. Ecological Incidents 56
IV. Risk Management, Reregistration, and Tolerance Reassessment 56
A. Determination of Reregistration Eligibility 56
in
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B. Public Comments and Responses 57
C. Regulatory Position 57
1. Food Quality Protection Act Findings 57
a. "Risk Cup" Determination 57
b. Determination of Safety to U.S. Population 57
c. Determination of Safety to Infants and Children 58
2. Endocrine Disrupter Effects 58
3. Cumulative Risks 58
4. Endangered Species 59
D. Tolerance Reassessment Summary 59
E. Regulatory Rationale 66
1. Human Health Risk Management 66
a. Dietary (Food and Drinking Water) Risk Mitigation 66
b. Residential Risk Mitigation 67
c. Aggregate Risk Mitigation 73
d. Occupational Risk Mitigation 74
2. Non-Target Organism (Ecological) Risk Management 80
a. Terrestrial Organisms 81
b. Aquatic Organisms 81
4. Significance of Permethrin to Users 89
5. Risk/Benefit Balancing Analysis 90
6. Summary of Mitigation Measures 92
7. Performance Measures 94
F. Other Labeling Requirements 95
1. Endangered Species Considerations 96
2. Spray Drift Management 96
V. What Registrant's Need to Do 96
A. Manufacturing-Use Products 96
1. Generic Data Requirements 97
2. Labeling for Manufacturing-Use Products 97
B. End-Use Products 97
1. Additional Product-Specific Data Requirements 97
2. Labeling for End-Use Products 98
C. Labeling Changes Summary Table 98
Table 38: Summary of Labeling Changes for Permethrin 99
Appendix A-l A-l
Appendix A-2 A-12
Appendix B B-l
Appendix C C-l
Appendix D D-l
IV
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Permethrin Reregistration Eligibility Decision Team
Office of Pesticide Programs
Biological and Economic Analysis Assessment
David Brassard
Tim Kiely
TJWyatt
Environmental Fate and Effects Risk Assessment
Jose Melendez
Mike Rexrode
Health Effects Risk Assessment
Samuel Ary
Sherrie Kinard
Bill Smith
Yung Yang
Registration Support
George LaRocca
Kevin Sweeney
Risk Management
Neil Anderson
Jacqueline Guerry
General Counsel
Angela Huskey
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Glossary of Terms and Abbreviations
ai Active Ingredient
aPAD Acute Population Adjusted Dose
APHIS Animal and Plant Health Inspection Service
ARTF Agricultural Re-entry Task Force
BCF Bioconcentration Factor
CDC Centers for Disease Control
CDPR California Department of Pesticide Regulation
CFR Code of Federal Regulations
ChEI Cholinesterase Inhibition
CMBS Carbamate Market Basket Survey
cPAD Chronic Population Adjusted Dose
CSFII USDA Continuing Surveys for Food Intake by Individuals
CWS Community Water System
DCI Data Call-in
DEEM Dietary Exposure Evaluation Model
DL Double layer clothing {i.e., coveralls over SL}
EC Emulsifiable Concentrate Formulation
EDSP Endocrine Disrupter Screening Program
EDSTAC Endocrine Disrupter Screening and Testing Advisory Committee
EEC Estimated Environmental Concentration. The estimated pesticide concentration in an
environment, such as a terrestrial ecosystem.
EP End-Use Product
EPA U.S. Environmental Protection Agency
EXAMS Tier II Surface Water Computer Model
FDA Food and Drug Administration
FFDCA Federal Food, Drug, and Cosmetic Act
FIFRA Federal Insecticide, Fungicide, and Rodenticide Act
FOB Functional Observation Battery
FQPA Food Quality Protection Act
FR Federal Register
GL With gloves
IDFS Incident Data System
IPM Integrated Pest Management
RED Reregistration Eligibility Decision
LADD Lifetime Average Daily Dose
LC50 Median Lethal Concentration. Statistically derived concentration of a substance expected
to cause death in 50% of test animals, usually expressed as the weight of substance per
weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
LCO Lawn Care Operator
LD50 Median Lethal Dose. Statistically derived single dose causing death in 50% of the test
animals when administered by the route indicated (oral, dermal, inhalation), expressed as a
weight of substance per unit weight of animal, e.g., mg/kg.
LOAEC Lowest Observed Adverse Effect Concentration
LOAEL Lowest Observed Adverse Effect Level
LOG Level of Concern
LOEC Lowest Observed Effect Concentration
mg/kg/day Milligram Per Kilogram Per Day
MOE Margin of Exposure
MP Manufacturing-Use Product
MRID Master Record Identification (number). EPA's system of recording and tracking studies
submitted.
MRL Maximum Residue Level
N/A Not Applicable
NASS National Agricultural Statistical Service
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NAWQA USGS National Water Quality Assessment
NG No Gloves
NMFS National Marine Fisheries Service
NOAEC No Observed Adverse Effect Concentration
NOAEL No Observed Adverse Effect Level
NPIC National Pesticide Information Center
NR No respirator
OP Organophosphorus
OPP EPA Office of Pesticide Programs
ORETF Outdoor Residential Exposure Task Force
PAD Population Adjusted Dose
PCA Percent Crop Area
PDCI Product Specific Data Call-In
POP USDA Pesticide Data Program
PF10 Protections factor 10 respirator
PF5 Protection factor 5 respirator
PHED Pesticide Handler's Exposure Data
PHI Preharvest Interval
ppb Parts Per Billion
PPE Personal Protective Equipment
PRZM Pesticide Root Zone Model
RBC Red Blood Cell
RED Reregistration Eligibility Decision
REI Restricted Entry Interval
RfD Reference Dose
RPA Reasonable and Prudent Alternatives
RQ Risk Quotient
RTU (Ready-to-use)
RUP Restricted Use Pesticide
SCI-GROW Tier I Ground Water Computer Model
SF Safety Factor
SL Single layer clothing
SLN Special Local Need (Registrations Under Section 24(c) of FIFRA)
TEP Typical End-Use Product
TGAI Technical Grade Active Ingredient
TTRS Transferable Turf Residues
UF Uncertainty Factor
USDA United States Department of Agriculture
USFWS United States Fish and Wildlife Service
USGS United States Geological Survey
WPS Worker Protection Standard
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Permethrin Reregistration Eligibility Decision
The Reregistration Eligibility Decision document for Permethrin was signed on
April 5, 2006. In accordance with the Agency's public participation process, a public
comment period for the RED was conducted. This comment period opened July 28, 2006
and closed September 28, 2006. The risk assessments, benefit assessments, and public
comments can be found on the Federal Docket Management System (FDMS), available
at http://www.regulations.gov (docket # EPA-HQ-OPP-2004-0385). The Agency has
reviewed the public comments submitted and has responded to those that related
specifically to the Permethrin RED. These responses are also available for viewing on
FDMS (docket # EPA-HQ-OPP-2004-0385). As a result of its review of the public
comments, as well as post-RED activities such as meeting with the registrants regarding
the development of mandatory label language for canine spot-on products and pre-
construction termiticide application, and meetings with the Pyrethroid Working Group to
revise spray drift language for agricultural products, the Agency has revised the
Permethrin RED, where appropriate. These revisions are listed below.
• In Section IV, Other Residential Uses To be Addressed in RED, in order to
address concerns regarding the residential use of outdoor pesticide misting
systems, the following was added, "In addition, the Agency has developed a
Outdoor Residential Misting System web-based fact sheet page aimed at helping
consumers decide if these systems are appropriate for their home, understand
safety precautions about using outdoor misting systems, find related information
on Integrated Pest Management, and understand the role of the US EPA and state
agencies in regulating misters
(http://www.epa.gov/pesticides/factsheets/misting_sy stems.htm)."
• In Section V, Additional Product-Specific Data Requirements, the Agency
included the following additional product-specific data requirements.
o The Agency determined it does not have efficacy data for permethrin products
registered for use in outdoor residential misting systems claiming to target
public health pests. Efficacy data for this use pattern will be required on the
product-specific data call-in (PDCI).
o The Agency is requiring a companion animal study (870.7200) for permethrin
products used on domestic animals. The study is to ensure that pesticide
formulations for the treatment of external pests on domestic animals have an
adequate margin of safety for the treated companion animal. In addition, data
from companion animal safety studies also serve as a basis for product
labeling. This data requirement will be included on the PDCI.
o The Agency is requiring efficacy data for permethrin impregnated clothing
applications claiming to target public health pests. This requirement will also
be included on the PDCI.
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A number of updates have also been made to the RED document, including the
Labeling Changes Summary Table, Table 38 (Label Table), for purposes of clarification.
Among the updates are the following:
• The incorrect maximum application rate for mushroom use was given in the
Permethrin RED Appendix A. Appendix A has been revised to reflect the correct
maximum application rate for mushroom, 2 -2.5 oz. per 30 oz water.
• For all wide area mosquito abatement products, the Agency received public
comments that the droplet sizes indicated in the RED for aerial applications
(Dv.05 <60 microns and Dv.09 <80 microns) were not feasible with current,
standard application equipment. The Agency revised the droplet size as follows:
o For aerial applications made at < 200 feet above ground elevation - Spray
equipment must be adjusted so that the volume median diameter product is
less than 60 microns (Dv 0.5 <60 um) and that 90% of the spray is
contained in droplets smaller than 100 microns (Dv 0.9 <100 microns);
and
o For aerial applications made at > 200 feet above ground elevation - Spray
equipment must be adjusted so that the volume median diameter product is
less than 70 microns (Dv 0.5 <70 um) and that 90% of the spray is
contained in droplets smaller than 145 microns (Dv 0.9 <145 microns).
• The Agency omitted a reference to the Residential Exposure Joint Venture
National Pesticide Use Survey data in the RED Bibliography, Appendix D. The
citation has been added in the Bibliography, Appendix D.
• The Agency determined the following data is not needed; they will not be
included on the Generic Data Call-In and have been deleted in the revised
Permethrin RED:
o 850.1735: Whole sediment acute toxicity for freshwater invertebrates
o 850.1740: Whole sediment acute toxicity for estuarine/marine
invertebrates
o 860.1200: Directions for Use
o 860.1340: Enforcement Analytical Method-Animals
• The Use Profile section of the RED has been revised to clarify that permethrin use
is only permitted in non-food/feed areas of food handling establishments. A
prohibitory statement has also been added to the label table.
The Whole sediment acute toxicity for freshwater invertebrates (850.1735) and
Whole sediment acute toxicity for estuarine/marine invertebrates (850.1740) studies are
considered unnecessary because the primary risk to estuarine/marine invertebrates has
been determined to be chronic, reproductive risk. These aspects will be addressed by the
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chronic studies that remain in the Generic Data Call-In: Chronic Freshwater Sediment
Testing and Chronic Estuarine/Marine Sediment Testing.
Existing data is sufficient so that the residue chemistry studies stipulated in the RED,
Directions for Use (860.1200) and Enforcement Analytical Method-Animals (860.1340)
are unnecessary.
Additionally, a permethrin dermal absorption study is being conducted by the
technical registrant to determine whether the 15% dermal absorption factor used in the
Permethrin RED was appropriate. This study is expected to be submitted to the Agency
for review in early 2008. The Agency will review the study and, if necessary, further
amend the Permethrin RED.
A number of updates have also been made to the Label Table based on public
comments and conversations with permethrin registrants and other external stakeholders
following the RED. This updated table is included with the revised RED. Among the
updates are the following:
• Revised spray drift and buffer zone language for agricultural products to reduce
permethrin off-target movement.
• Inclusion of pre-construction termiticide language for residential products.
• Mandatory precautionary statements for canine 45/65% concentrate spot-on
products.
• Additional directions for use for all products registered for outdoor use to reduce
permethrin off-target movement.
• Clarifying that permethrin use is only permitted in non-food/feed areas of food
handling establishments.
If you have questions on the Permethrin RED or any of the revisions listed above,
please contact the Chemical Review Manager, Jacqueline Guerry at (215) 814-2184. For
questions about product reregi strati on and/or the Product Data Call-In that will follow
this document, please contact Bonnie Adler at (703) 308-8523.
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Abstract
The Environmental Protection Agency (EPA or the Agency) has completed the
human health and environmental risk assessments for permethrin and is issuing its risk
management decision and tolerance reassessment. The risk assessments, which are
summarized below, are based on the review of the required target database supporting the
use patterns of currently registered products and additional information received through
the public docket. After considering the risks identified in the revised risk assessments,
comments received, and mitigation suggestions from interested parties, the Agency
developed its risk management decision for uses of permethrin that pose risks of concern.
As a result of this review, EPA has determined that permethrin-containing products are
eligible for reregi strati on, provided that risk mitigation measures are adopted and labels
are amended accordingly. That decision is discussed fully in this document.
Permethrin is part of the pyrethroid class of pesticides and was first registered in
1979. It is a broad spectrum, non-systemic, synthetic pyrethroid insecticide, and is
registered for use on numerous food/feed crops, livestock and livestock housing, modes
of transportation, structures, buildings, Public Health Mosquito abatement programs,
numerous indoor and outdoor residential spaces, pets, and clothing. Initial risk
assessments indicated some occupational and residential handler and post-application
risks of concern. Risk estimates were revised based on refinements to the assessments
and in some cases agreed to mitigation measures, and the Agency will be requiring
additional data for some exposure scenarios. Occupational risks have been mitigated
through personal protective equipment or engineering controls requirements on the
labels; residential risks to homeowners have been mitigated by discontinuing or
restricting certain application methods and reducing some application rates; and
ecological risks have been addressed through adding buffer zone requirements and
product stewardship statements to the labels, and amending use patterns for many uses.
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I. Introduction
The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988
to accelerate the reregistration of products with active ingredients registered prior to November
1, 1984. The amended Act calls for the development and submission of data to support the
reregistration of an active ingredient, as well as a review of all submitted data by the U.S.
Environmental Protection Agency (referred to as EPA or "the Agency"). Reregistration involves
a thorough review of the scientific database underlying a pesticide's registration. The purpose of
the Agency's review is to reassess the potential hazards arising from the currently registered uses
of the pesticide; to determine the need for additional data on health and environmental effects;
and to determine whether or not the pesticide meets the "no unreasonable adverse effects"
criteria of FIFRA.
On August 3, 1996, the Food Quality Protection Act (FQPA) was signed into law. This
Act amends FIFRA and the Federal Food, Drug, and Cosmetic Act (FFDCA) to require
reassessment of all existing tolerances for pesticides in food. FQPA also requires EPA to review
all tolerances in effect on August 2, 1996, by August 3, 2006. 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 of infants and children, and the
cumulative effects of pesticides with a common mechanism of toxicity. When a safety finding
has been made that aggregate risks are below the Agency's LOG and the Agency concludes that
there is a reasonable certainty of no harm from aggregate exposure, the tolerances are considered
reassessed. EPA decided that, for those chemicals that have tolerances and are undergoing
reregistration, tolerance reassessment will be accomplished through the reregistration process.
As mentioned above, FQPA requires EPA to consider available information concerning the
cumulative effects of a particular pesticide's residues and "other substances that have a common
mechanism of toxicity." Potential cumulative effects of chemicals with a common mechanism of
toxicity are considered because low-level exposures to multiple chemicals causing a common
toxic effect by a common mechanism could lead to the same adverse health effect as would a
higher level of exposure to any one of these individual chemicals. Permethrin is a member of the
pyrethroid class of pesticides. Although all pyrethroids alter nerve function by modifying the
normal biochemistry and physiology of nerve membrane sodium channels, EPA is not currently
following a cumulative risk approach based on a common mechanism of toxicity for the
pyrethroids. Although all pyrethroids interact with sodium channels, there are multiple types of
sodium channels and it is currently unknown whether they the pyrethroids have similar effects on
all channels. Nor do we have a clear understanding of effects on key downstream neuronal
function e.g., nerve excitability, nor do we understand how these key events interact to produce
their compound specific patterns of neurotoxicity. There is ongoing research by the EPA's
Office of Research and Development and pyrethroid registrants to evaluate the differential
biochemical and physiological actions of pyrethroids in mammals. This research is expected 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/.For additional
information regarding EPA's efforts to determine which chemicals have a common mechanism
of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements
released by EPA's Office of Pesticide Programs concerning common mechanism determinations
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and procedures for cumulating effects from substances found to have a common mechanism on
EPA's website at http://www.epa.gov/pesticides/cumulative/.
This document presents EPA's revised human health and ecological risk assessments, its
progress toward tolerance reassessment, and the reregi strati on eligibility decision for permethrin.
The document consists of six sections. Section I contains the regulatory framework for
reregistration/tolerance reassessment; Section II provides an overview of the chemical and a
profile of it's use and usage; Section III gives an overview of the human health and
environmental effects risk assessments; Section IV presents the Agency's decision on
reregi strati on eligibility and risk management; and Section V summarizes the label changes
necessary to implement the risk mitigation measures outlined in Section IV. Finally, the
Appendices list related information, supporting documents, and studies evaluated for the
reregi strati on decision. The revised risk assessments for permethrin and all other supporting
documents are available in the Office of Pesticide Programs (OPP) public docket
(http://www.regulations.gov.) under docket number EPA-HQ-OPP-2004-0385 and are available
on the Agency's web page at http://www.epa.gov/oppsrrdl/reregistration/permethrin/.
II. Chemical Overview
A. Regulatory History
Permethrin was first registered and tolerances established in the United States in 1979 for
use on cotton (April 29, 1979 44FR 24287). The registration was made conditional due to the
need for additional toxicology data to fully evaluate carcinogenicity and the need for additional
ecological effects data to fully evaluate aquatic risk. Laboratory studies indicated that
permethrin was highly toxic to fish and aquatic invertebrates and the use on cotton was classified
as Restricted Use pesticide (RUP). In making its decision to conditionally register the product,
EPA considered the beneficial role of this compound in cotton pest management, the reduction
of use of other cotton insecticides with known carcinogenic potentials, and the absence of
suitable and sufficient supplies of alternatives for control of resistant insect strains.
From 1979 to 1982, there was considerable scientific debate over the interpretation of the
carcinogenicity database, which considerably delayed the establishment of new crop tolerances
and non-food registrations. After additional toxicity data were reviewed, EPA concluded that
permethrin was a weak carcinogen. From 1982 to 1989, 55 + crop tolerances were approved for
a wide variety of crops, including vegetables (i.e., broccoli, celery, lettuce, potatoes, etc.), alfalfa,
pears, meat, milk and eggs. During this time, EPA regulated new crop uses on the basis of
average daily intake (ADI) and not by quantitative cancer risk assessment.
In 1985 a Data Call-In (DCI) for ecological effects data for permethrin was issued, which
include a full complement of ecological effects data. The additional data required were estuarine
mollusc acute tests, estuarine invertebrate life cycle and fish life cycle tests. After evaluation of
this data EPA concluded that the current RUP classification be maintained for all products for
wide area agricultural uses (except livestock and premises uses) and outdoor wide area non-crop
uses because of the possible adverse effects on aquatic organisms from spray drift and runoff.
In 1988 a comprehensive DCI was issued requiring additional residue chemistry,
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environmental fate and toxicological data. This DCI was issued so that data required by 40 CFR
Part 158 would be available to EPA for reregi strati on.
In 1990 EPA issued conditional registrations with product expiration dates for various
synthetic pyrethroids prescribed specifically for use on cotton. The reason for time-limited
tolerances/registrations was aquatic toxicity concerns. EPA required interim risk mitigation
measures, i.e. buffer zones around water, an education program to inform growers on reducing
off target spray deposition and additional data requirements. Since permethrin was registered for
use on cotton, it was subject to this conditions and product expiration dates. However in 1994
the producers of products containing permethrin for use on cotton requested voluntary
cancellation of this use and were no longer subject to the conditions of registration.
From 1994 thru 2000 permethrin was subject to specific DCIs requesting data to assess
agricultural and residential exposure, agricultural re-entry, and mosquito ULV products. In 2000
the Agency notified the producers of concentrated (40 - 65%) permethrin "Spot-On" products
for use on dogs of concerns about the potential misuse, of these products on cats. The Agency
was made aware of instances of consumers using these dog products accidentally on their pet
cats and/or not being aware of the danger of allowing cats to interact with newly treated dogs.
The producers of these products voluntarily agreed to make a number of label changes to reduce
this potential misuse such as adding in large bold type "Do Not Use On Cats" and the icon of a
cat in a circle with a slash through it and a statement indicating the cats which actively groom or
engage in physical contact with treated dogs may be at risk of harmful effect.
B.
Chemical Identification - Permethrin
Permethrin [(3-phenoxyphenyl)methyl 3-(2,2-dichloroethenyl)-2,2-dimethylcyclopropane
carboxylate] is a synthetic pyrethroid insecticide. Permethrin is a racemic mixture of the cis and
trans isomers. Permethrin is a colorless crystal to a pale yellow viscous liquid with a melting
point of 35EC and a boiling point of 220EC (0.05 mm Hg). Permethrin is soluble in water at less
than 1 ppm, and is miscible in most organic solvents except ethylene glycol. Permethrin is
soluble in acetone, ethanol, ether, and xylene.
Chemical Structure:
Common Name:
Chemical Name:
Chemical Family:
Permethrin
(3-phenoxyphenyl)methyl 3-(2,2-dichloroethenyl)-2,2-
dimethylcyclopropane carboxylate
Synthetic Pyrethroids
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Case Number:
2510
CAS Number:
PC Code:
Molecular Weight:
Empirical Formula:
Technical Registrants:
52645-53-1
109701
391.3
Bayer Environmental Science
Clark Mosquito Control
Control Solutions Incorporated
FMC Corporation
Gharda Chemicals LTD
LG Life Sciences LTD
McLaughlin Gormley King Company
Meghamani Organics Limited
Micro Flo Company
Syngenta Crop Protection, Incorporated
United Phosphorus, Incorporated
Valent BioSciences Corporation
C.
Use Profile
The following is information on the currently registered uses of permethrin,
including an overview of use sites and application methods. A detailed table of the uses
of permethrin eligible for reregi strati on is available in Appendix A.
Type of Pesticide:
Target Pests:
Mode of Action:
Use Sites:
Insecticide
Permethrin controls a broad spectrum of pests, including public
health pests such as mosquitoes.
Permethrin is a type I pyrethroid (i.e., it lacks a cyano group at the
a carbon position of the alcohol moiety) with the primary target
organ being the nervous system of insects which then causes
muscle spasms, paralysis and death.
Permethrin is registered for use on/in numerous food/feed crops, livestock
and livestock housing, modes of transportation, structures, buildings
(including the non-food/feed areas of food handling establishments),
Public Health Mosquito abatement programs, and numerous residential
use sites including use in outdoor and indoor spaces, pets, and clothing
(impregnated and ready to use formulations). Additionally, permethrin
has non-FIFRA pharmaceutical uses as a pediculicide for the treatment of
head lice and scabies. The Food and Drug Administration (FDA)
approves use of the pesticide-containing pharmaceutical under FFDCA.
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Use Classification:
Formulation Types:
Application Methods:
Application Rates:
Application Timing:
Permethrin is a restricted use pesticide for crop and wide area
applications (i.e. nurseries, sod farms) due to high toxicity to
aquatic organisms. It is a general use pesticide for residential and
industrial applications.
Permethrin formulations include emulsifiable concentrate, wettable
powders, dusts, granular, and ready-to-use formulations.
Permethrin application methods include broadcast or banded
application using ground or aerial application; handheld equipment
such as low and high pressure hand wand sprayers, handgun
sprayers, backpack sprayers, hose-end sprayer, paint brush,
foggers, and dip applications; automatic mister systems; and a
number of ready-to-use methods such as shaker and aerosol cans,
wipes, ear tags and flanges.
Permethrin application rates vary depending on the use pattern.
For most agriculture uses, maximum seasonal rates range from 0.1
to 0.4 pounds active ingredient per acre (Ib ai/A), and depending
on the crop, the maximum number of permethrin applications per
season can range from 1 to 8. The maximum application rate for
the public health use of permethrin is 0.018 Ib ai/A, however, the
typical application rate ranges from 0.0035 to 0.007 Ib ai/A, and
the number of applications depends on the need of the abatement
district. Application rates vary for residential use products
depending on indoor or outdoor use, and consumer or professional
or commercial operator use. The maximum residential application
rate is use on turf, 0.87 Ib ai/A.
Permethrin can be applied pre- or post-emergence, and most labels
suggest "as needed."
D. Estimated Usage of Permethrin
According to Agency data, approximately 2 million pounds of permethrin are applied
annually to agricultural, residential and public health uses sites. The majority of permethrin,
approximately 70%, is used in non-agricultural settings, whereas approximately 30% is used on
food/feed crops in agricultural settings. According to the Pyrethroid Issues and Reregi strati on
Task Force (PIRTF), approximately 1,450,000 pounds of permethrin active ingredient is used on
non-agricultural sites per year; 55% is applied by professionals, 41% is applied by homeowners
on residential areas, and 4% is applied on mosquito abatement areas.
The Agency's screening-level usage analysis (SLUA) of permethrin from 1998 to 2004
indicates that approximately 605,000 pounds of permethrin are used annually on agricultural use sites
in the United States. In terms of pounds applied, the greatest use is on corn (100,000 Ibs ai per year);
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however, annually this represents between <1 to 5 percent of corn acreage treated. In terms of percent
crop treated (%CT), the greatest use is on celery, pistachios, spinach, hazelnuts, and Brussels sprouts,
with on average, >50% crop treated. Table 1 summarizes the best estimates of permethrin usage
currently available to the Agency.
Table 1. Estimated Annual Permethrin Crop Usage Summary1
Crop
Alfalfa
Almonds
Apples
Apricots
Artichokes
Asparagus
Avocados
Beans, Green
Broccoli
Brussels Sprouts
Cabbage
Cantaloupe
Cauliflower
Celery
Cherries
Chicory
Collards
Corn
Cotton
Cucumbers
Eggplant
Garlic
Grapes
Greens, Turnips
Hazelnuts (Filberts)
Lettuce
Onions
Other Lettuces
Peaches
Pounds of Active
Ingredient Used on
Annual Basis
40,000
20,000
3,000
<500
1,000
2,000
1,000
1,000
3,000
<500
4,000
3,000
1,000
8,000
3,000
<500
<500
100,000
5,000
5,000
<500
1,000
1,000
<500
1,000
50,000
5,000
10,000
10,000
% Crop Treated
Average
<1
20
5
5
30
10
5
<1
15
50
15
10
15
65
10
ND*
5
<1
<1
10
5
15
<1
10
50
50
10
35
20
Maximum
<2.5
30
5
5
65
20
10
5
30
50
20
20
25
85
20
ND
5
5
<2.5
15
5
20
<2.5
10
70
70
20
35
25
-------
Crop
Pears
Peas, Green
Pecans
Peppers
Pistachios
Potatoes
Prunes & Plums
Pumpkins
Sorghum
Soybeans
Spinach
Squash
Strawberries
Sweet Corn
Swiss Chard (CA only)
Tobacco
Tomatoes
Walnuts
Watermelon
Pounds of Active
Ingredient Used on
Annual Basis
1,000
<500
<500
3,000
20,000
20,000
<500
4,000
2,000
20,000
9,000
3,000
<500
30,000
1,000
<500
8,000
5,000
5,000
% Crop Treated
Average
5
<1
<1
5
55
5
<1
15
<1
<1
50
10
<1
15
ND
<1
5
5
10
Maximum
10
<2.5.
<2.5
15
70
10
<2.5
20
<2.5
<2.5
70
15
<2.5
30
ND
<2.5
10
10
15
*ND - Not Determined
1 Based on EPA data from 1998-2004.
HI. Summary of Permethrin Risk Assessments
The following is a summary of EPA's revised human health and ecological risk
assessments for permethrin, as presented fully in the documents, Permethrin: Fifth Revision of
the HED Chapter of the Reregistration Eligibility Decision Document (RED), dated April 4,
2006, 2006, and The Agency Revised Risk Assessment for the Reregistration Eligibility Decision
on Permethrin After Public Comments, Phase III, dated April 5, 2006. The purpose of this
summary is to assist the reader by identifying the key features and findings of these risk
assessments, and to help the reader better understand the conclusions reached in the assessments.
The human health and ecological risk assessment documents and supporting information
listed in Appendix C were used to reach the safety finding and regulatory decision for permthrin.
While the risk assessments and related addenda are not included in this document, they are
-------
available from the OPP Public Docket EPA-HQ-OPP-2004-0385 and may also be accessed on
the Agency's website at http://www.regulations.gov. Hard copies of these documents may be
found in the OPP public docket under this same docket number.
A. Human Health Risk Assessment
The human health risk assessment incorporates potential exposure risks from all sources,
which include food, drinking water, residential (if applicable), and occupational scenarios.
Aggregate assessments combine food, drinking water, and any residential or other non-
occupational (if applicable) exposures to determine potential exposures to the U.S. population.
The Agency's human health assessment is protective of all U.S. populations, including infants
and young children.
The EPA released its preliminary risk assessments for permethrin for public comment on
August 31, 2005 for a 90-day public comment period (Phase 3 of the public participation
process). The preliminary risk assessments may be found in the OPP public docket at the
address given above and in EPA's electronic docket under docket number EPA-HQ-OPP-2004-
0385. In response to comments received and additional data submitted during Phase 3, the risk
assessments were updated and refined. The revised risk assessments may be found in the OPP
dockets under the same docket number identified above. Scenario specific revisions to the
human health risk assessment occurred based on exposure or usage data provided by the
registrants or PIRTF for several occupational and residential uses. Major revisions to the
permethrin human health risk assessment include the following:
• Revised drinking water concentrations provided in the Revised Tier IIEstimated
Drinking Water Concentrations ofPermethin, dated December 27, 2005, which is
also available in the public docket; and
• Inclusion of wash-off data for the impregnated clothing exposure scenarios
(residential and occupational), which assumes clothing is usable for up to 30
washes and that the first wash results in a 33% permethrin loss, the second wash
results in a 6% loss, washes 3 through 10 each result in a 3% loss, and washes 11
through 30 result in a total loss of 6.5% permethrin. For more detail, on the wash-
off assumptions refer to the Third Revision of the Occupational and Residential
Exposure Assessment for the Reregistration Eligibility Decision Document, dated
January 31,2006.
For more information on the permethrin revised human health risk assessment, see:
Permethrin: Fifth Revision of the HED Chapter of the Reregistration Eligibility Decision
Document (RED), dated April 4, 2006.
1. Toxicity of Permethrin
Toxicity assessments are designed to predict whether a pesticide could cause adverse health
effects in humans (including short-term or acute effects such as skin or eye damage, and lifetime or
chronic effects such as cancer, developmental effects, or reproductive effects), and the level or dose at
which such effects might occur. The Agency has reviewed all toxicity studies submitted for
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permethrin and has determined that the toxicological database is sufficient for each exposure scenario,
FQPA evaluation, and for important endpoints and dose-response evaluation. However, the Agency
is requiring a confirmatory developmental neurotoxicty study (DNT) for additional assurance as to the
dose-response in characterizing neurotoxic effects. For more details on the toxicity and
carcinogenicity of permethrin, see Permethrin: Fifth Revision of the HED Chapter of the
Reregistration Eligibility Decision Document (RED), dated April 4, 2006, which is available
under docket number EPA-HQ-OPP-2004-0385.
a. Acute Toxicity Profile
Permethrin is classified as category in for acute oral and acute dermal toxicity. No acceptable
data on acute inhalation toxicity for permethrin technical is available (Data Gap). Permethrin is
classified as category HI for eye irritation potential and category IV for dermal irritation potential.
Permethrin technical is not considered a skin sensitizer based on a weight-of-evidence evaluation of
available data.The acute toxicity profile for permethrin is summarized in Table 2 below.
Table 2. Acute Toxicity Profile for Permethrin
Guideline
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
Study Type
Acute Oral Toxicity in
Rats
Acute Dermal
Toxicity in Rabbits
Acute Inhalation
Toxicity in Rats
Primary Eye Irritation
in Rabbits
Primary Dermal
Irritation in Rabbits
Skin Sensitization in
Guinea Pigs
MRIDNo.
242899
242899
Data Gap
242899
242899
EPA Memo**
Results
LD50 =3580 mg/kg (M)
2280 mg/kg (F)
LD50 > 2000 mg/kg
Irritation 24-48 hrs.
All cleared by 72 hrs.
All irritation cleared by 48 hrs.
Non-sensitizer* * *
Toxicity
Category
III
III
ND*
III
IV
Not
Applicable
* ND: No Data
** EPA Memorandum, June 13,1995, "Permethrin: Review of a series 81-6 dermal sensitization study (guinea pig
maximization test) and a series 85-2 dermal penetration study."
* * * Based on a weight of evidence evaluation of other sensitization study data do not indicate that permethrin should be
regulated as a potential sensitizer.
b. FQPA Safety Factor Considerations
The Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by FQPA, directs the
Agency to use an additional ten fold (lOx) safety factor (SF) to account for potential pre- and postnatal
toxicity and completeness of the data with respect to exposure and toxicity to infants and children.
FQPA authorizes the Agency to modify the lOx FQPA SF only if reliable data demonstrate that the
resulting margin of safety would be safe for infants and children.
For permethrin, the database is adequate in terms of endpoint studies and dose response
information to characterize any potential for prenatal or postnatal risk for infants and children.
Developmental and reproductive toxicity studies demonstrated that there is no evidence (qualitatively
-------
or quantitatively) for increased susceptibility to infants and children following in utero and/or
pre/postnatal exposure to permethrin. Additionally, there is no evidence that permethrin induces any
endocrine disruption.
There is, however, concern for developmental neurotoxicity based on evidence of
neurotoxicity at high doses in a subchronic neurotoxicity study. The Agency is requiring a
confirmatory developmental neurotoxicity study (DNT) for further characterization of neurotoxic
effects. However, although a DNT is required, a dose-analysis with the existing reliable toxicity
data for permethrin, that included an evaluation of the acute and subchronic neurotoxicity studies
in addition to the 3-generation reproduction study, indicates that that the results of the DNT
would not have an impact on the risk assessment. Therefore, an FQPA database uncertainty
factor (UFDB) is not required for acute and chronic risk assessments or for residential (non-
dietary) exposures. The Agency has determined that, based on the existing exposure and toxicity
data for permethrin, the risk assessment, as conducted, indicates a reasonable certainty of no
harm to infants and children. In addition, the dietary food exposure assessment demonstrates
that acute and chronic exposures do not underestimate the risk and are not of concern, and the
residential exposure assessment is based on reliable data and is unlikely to underestimate
exposure and risk. Therefore, the FQPA SF is reduced to Ix.
c. Toxicological Endpoints
The toxicological endpoints used in the human health risk assessment for permethrin are listed
in Table 3 below. An estimated dermal absorption factor of 15% also is used in the risk assessment.
The dermal absorption factor of 15% was estimated by comparing the Lowest Observed Adverse
Effect Level (LOAEL) of the rat acute oral neurotoxicity study of 75 mg/kg/day and No Observed
Adverse Effect Level (NOAEL) of the rat 21-day dermal study (because no LOAEL was established)
of 500 mg/kg/day. The estimate is considered to be a conservative high-end estimate because the oral
dose represents a LOAEL rather than a NOAEL. The uncertainty factors (UF) and safety factors used
to account for interspecies extrapolation, intraspecies variability, and special susceptibility of infants
and children (FQPA SF) are also described in Table 3.
Table 3. Toxicology Endpoints for Permethrin
Exposure Scenario
Acute Dietary
(Females 13 to 49
years of age)
Dose, Uncertainty
Factors
Acute RfD= not applicable
FQPA Safety Factor and
Level of Concern
Study and Endpoint for Risk Assessment
Since there is no developmental or reproductive toxicity of concern for
permethrin, no appropriate endpoint or study was selected for the
female (13-49) subgroup. The selected dose/endpoint for general
population would provide adequate protection for females 13-49 years
old.
10
-------
Table 3. Toxicology Endpoints for Permethrin
Exposure Scenario
Dose, Uncertainty
Factors
FQPA Safety Factor and
Level of Concern
Study and Endpoint for Risk Assessment
Acute Dietary
(General
population
including infants
and children)
Oral NOAEL=25
mg/kg/day
UF=100X(10x
interspecies and lOx
intraspecies)
Acute RfD= 0.25
mg/kg/day
FQPA SF = IX
aPAD=Acute RfD
FQPA SF
aPAD= 0.25 mg/kg/day
Acute Neurotoxicity Study in Rats
LOAEL = 75 mg/kg/day based on
observations of clinical signs (i.e.
aggression, abnormal and/or decreased
movement) and increased body
temperature.
Chronic Dietary
(All populations)
OralNOAEL = 25
mg/kg/day
UF=100
Chronic RfD = 0.25
mg/kg/day
FQPA SF = IX
cPAD = Chronic RfD
FQPA SF
cPAD= 0.25 mg/kg/day
Short- and
Intermediate-Term
Incidental Oral
OralNOAEL = 25
mg/kg/day
UF=100
Residential LOC for
MOE =100
Short-,
Intermediate-, and
Long-Term Dermal
Dermal NOAEL = 500
mg/kg/day
UF=100
Residential LOC for
MOE =100
Occupational LOC for
MOE =100
21-Day Dermal Toxcitiy Study in Rats
LOAEL was not established.
Short-,
Intermediate-, and
Long-Term
Inhalation
Inhalation NOAEL = 0.042
mg/1 (converts to oral
equivalent of 11
mg/kg/day)
UF=100
Residential LOC for
MOE =100
Occupational LOC for
MOE =100
15-Day Inhalation Study in Rats
LOAEL = 0.583 mg/1 (converts to oral
equivalent of 154 mg/kg/day) based on
body tremors and hypersensitivity to
noise.
Cancer
(Oral, dermal,
inhalation)
Classification: "Likely to be Carcinogenic to Humans" with a Qi* (mg/kg/day)"1 = 9.6 x 10"3
(Dermal absorption rate=15% for dermal portion of the cancer equation)
UF = uncertainty factor, FQPA SF = FQPA safety factor, NO AEL = 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
2. Carcinogenicity of Permethrin
As described in Table 3 above, the Agency classified permethrin as "Likely to be
Carcinogenic to Humans" by the oral route. This classification was based on two reproducible
11
-------
benign tumor types (lung and liver) in the mouse, equivocal evidence of carcinogenicity in Long-
Evans rats, and supporting structural activity relationships (SAR) information. For the purpose
of risk characterization, a low dose extrapolation model (Qi*) was used. The Qi* is 9.6 x 10"3
(mg/kg/day)"1 and was derived from the female mouse lung (adenoma and/or carcinoma) tumors.
For more information, see the document Permethrin Report of the Cancer Assessment Review
Committee (ThirdEvaluation), dated October 23, 2002.
3. Metabolites and Degradates
The Agency reviewed the metabolism of permethrin, and concluded that for tolerance
expression and risk assessment, the parent (both cis- and /ram'-permethrin) is the only residue of
concern for both plants and livestock, and drinking water exposure. For additional details refer to
Permethrin: Fifth Revision of the HED Chapter of the Reregistration Eligibility Decision
Document (RED), Dated April 4, 2006.
4. Permethrin Endocrine Effects
The EPA is required under the FFDCA, as amended by FQPA, to develop a screening
program to determine whether certain substances (including pesticides active and other
ingredients) "may have an effect in humans similar to an effect produced by a naturally
occurring estrogen, or other such endocrine effects as the Administrator may designate." In the
available toxicity studies on permethrin, there was no lexicologically significant evidence of
endocrine disrupter effects. When additional appropriate screening and/or testing protocols
being considered under the Agency's Endocrine Screening Disruption Program have been
developed, permethin may be subject to further screening and/or testing to better characterize
effects related to endocrine disruption.
5. Dietary Risk from Food and Drinking Water
EPA conducted acute, chronic, and cancer dietary (food and drinking water) risk
assessments for permethrin 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 Survey of Food Intakes by Individuals (CSFII), 1994-1996 and
1998. The acute and chronic non-cancer and cancer dietary risk assessments were conducted for
all supported permethrin food uses. The estimated surface drinking water concentrations
(EDWCs) for permethrin were calculated using the Tier II Pesticide Root Zone Modeling
(PRZM) and Exposure Analysis Modelng System (EXAMS) and also includes the Index
Reservior (IR) and Percent Crop Area (PCA) factor requirements. The EDWCs from
groundwater sources of drinking water were derived from the Tier I model SCI-GROW. The
EDWCs were included in the DEEM-FCID analyses to estimate combined exposures from food
and drinking water.
a. Dietary (Food and Drinking Water) Exposure Assumptions
As stated above, the acute dietary (food) risk assessment for permethrin was conducted
using the DEEM-FCID™ computer model. Highly refined acute (probabilistic), chronic, and
12
-------
cancer dietary exposure assessments were conducted to estimate the dietary risks associated with
the reregi strati on of permethrin. Permethrin residue estimates used in these assessments include
cis- and /ram'-permethrin, calculated as total permethrin, along with the Agency's percent crop
treated data. The anticipated residue (AR) estimates are based primarily on the USDA Pesticide
Data Program (PDF) food sampling data. Processing data was also used on a number of crops if
available.
Drinking water exposure to pesticides can occur through surface and ground water
contamination. EPA considers both acute (one day) and chronic (lifetime) drinking water risks
and uses either modeling or monitoring data, if available and of sufficient quality, to estimate
those exposures. Permethrin is relatively persistent in the environment, and is stable to
hydrolysis and photolysis. The parent compound has a very low mobility and has a high affinity
to bind to soils/sediments and organic carbon; therefore, it is not expected to leach to
groundwater. However, like several other chemicals in its class, it can reach surface waters by
spray drift or in run-off events via erosion. Table 4 lists the EDWCs used to assess the exposure
to permethrin in drinking water from surface water and groundwater sources. Based on
screening-level model results, these values generally represent upper-bound estimates of the
concentration that might be found in surface water and groundwater sources of drinking water.
Because the surface water EDWCs from the screening-level PRZM-EXAMS model were higher
than those predicted from the SCI-GROW model for groundwater sources, the relevant EDWC
model value from surface water was used in the dietary exposure assessment conducted using the
DEEM-FCID model to be protective.
Table 4. Permethrin Surface Water and Groundwater EDWC
Drinking Water Source
Duration
EDWC (ppb)
*The surface water EDWCs are based on the Georgia onion use scenario - a maximum application rate of 0.285 Ib ai/A and 7
applications per year.
* *The groundwater EDWC is based on the California almond use scenario - a maximum application rate of 0.4 Ib ai/A/year and
5 applications per year.
For more detail on the calculation of the EDWCs, refer to the Second Revision Tier II
Estimated Drinking Water Concentrations of Permethrin, dated January 17, 2006 available in the
public docket.
b. Population Adjusted Dose
The dietary risk assessment incorporates both exposure and toxicity of a given pesticide.
For acute and chronic dietary assessments, the risk is expressed as a percentage of a level of
concern (i.e., the dose predicted to result in no unreasonable adverse health effects to any human
13
-------
sub-population, including sensitive members of such sub-populations). This level of concern is
referred to as the Population Adjusted Dose (PAD). Dietary risk is characterized in terms of the
PAD, which reflects the Reference Dose (RfD), either acute or chronic, that has been adjusted to
account for the FQPA SF. For permethrin, the FQPA SF is Ix.
Estimated dietary risks less than 100% of the PAD, either acute (aPAD) or chronic
(cPAD), are below the Agency's level of concern (LOG). The aPAD is the dose at which a
person could be exposed at any given day with no adverse health effects expected. The cPAD is
the dose at which an individual could be exposed over the course of a lifetime with no adverse
health effects expected. Risk estimates from permethrin in food and drinking water are
summarized in Table 5 below.
c. Acute and Chronic Dietary (Food and Drinking Water) Risk
Acute and chronic dietary risk estimates are provided for the general U.S. population and
various population subgroups, with the major emphasis placed on the exposure estimated for
infants and children. The Agency concluded that for all supported registered commodities, the
acute and chronic (non-cancer) dietary (food and drinking water) risk estimates do not exceed the
LOG (less than 100% of the aPAD and cPAD, respectively), with the highest exposed subgroup
being infants (<1 year old) at 16% of the aPAD and <1% of the cPAD. Table 5 below
summarizes the acute and chronic (non-cancer) risk estimates from dietary (combined food and
drinking water) exposure to permethrin.
Table 5. Permethrin Dietary (Food + Drinking Water) Exposure Analysis Using DEEM FCID.
Population Subgroup
U.S. Population
Infants (<1 year old)
Children 1-2 years
Acute
Exposure
(mg/kg/day)*
0.010971
0.039416
0.024494
% aPAD
99.9th Percentile
4
16
10
Chronic
Exposure
(mg/kg/day)*
0.000184
0.000432
0.000385
% cPAD
<1
<1
<1
*mg/kg/day = milligram per kilogram per day.
d. Cancer Dietary (Food and Drinking Water) Risk
The cancer dietary assessment was conducted for the general U.S. population. To
estimate cancer risk, the 70-year lifetime average daily exposure is multiplied by the cancer
potency factor (Qi*) to yield a unitless number that represents the excess number of cancers
potentially attributed to exposure to the pesticide over a lifetime. For the cancer dietary
assessment, risk estimates within the range of an increased cancer risk of one in a million (1 x
10"6) are generally below EPA's level of concern; however, the Agency generally considers risks
up to 3 x 10"6 to be within the negligible risk range and below the Agency's LOG. A Qi* is an
estimate of the upper bound on cancer risk.
14
-------
The estimated lifetime average daily exposure of the general U.S. population to
permethrin from food and drinking water is 0.000117 mg/kg/day. Applying the Qi* of 9.6 x 10
(mg/kg/day)"1 to the exposure value results in a combined cancer risk estimate of 1.1 x 10"6for
food and drinking water, which is considered to be within the negligible risk range of 1 x 10"6
and does not exceed the Agency's LOG. See Table 6 below for cancer dietary risk estimates.
-3
Table 6. Permethrin Cancer Dietary (Food + Drinking Water) Risk Estimates
Dietary Exposures Assessed
Food Alone
Drinking Water Alone
Food and Drinking Water Combined
Qi*
9.6 x ID'3
(mg/kg/day)"1
Cancer Risk Estimate
9.76 x 10"7
1.52X10'7
l.lxlO'6
6. Residential Exposure and Risk
Residential exposure assessments consider all potential non-occupational pesticide
exposure, other than exposure due to residues in foods or in drinking water. Permethrin has a
wide variety of residential uses, including use on pets, indoor and outdoor surfaces, turf and
garden crops, and use of clothing (ready to use formulations or impregnation). Permethrin is
also labeled as a mosquito adulticide, and can be used by Public Health Officials for mosquito
abatement and other mosquito control programs. It can also be used for mosquito and general
pest control in residential and commercial areas through outdoor automatic mister systems.
The Agency has determined that there is a potential for exposure to permethrin in
residential settings for homeowners who handle (mix, load, and apply) products containing
permethrin, as well as post-application exposure from entering permethrin-treated areas, such as
lawns, home gardens, or indoor areas. Risk assessments have been completed for both
residential handler and post-application scenarios.
To estimate residential non-cancer (dermal and inhalation) risks, the Agency calculates a
margin of exposure (MOE), which is the ratio of the NOAEL selected for risk assessment to the
exposure. This MOE is compared to a level of concern which is the same value as the
uncertainty factor (UF) applied to a particular toxicity study. The standard UF is lOOx (lOx to
account for interspecies extrapolation and lOx for intraspecies variation), plus any additional
FQPA SF retained due to concerns unique to the protection of infants and children. The FQPA
SF for permethrin is reduced tolx for reasons explained in section III.A.l.b.
To estimate the residential cancer risk, the lifetime average daily dose is calculated,
which assumes the homeowner will be exposed to permethrin in the same manner for 50 years
within a 70-year life span, and then multiplied by the Qi* value. Similarly, residential cancer
risk estimates within the range of an increased cancer risk of one in a million (1 x 10"6) are
generally below EPA's level of concern; however, the Agency generally considers risks up to 3 x
10"6 to be within the negligible risk range and below the Agency's LOG. The cancer risk
assessments also include the number of exposure events (handler and post-application) that could
15
-------
occur per year before the estimated cancer risk reached the Agency's level of concern.
a. Residential Handler Risks
The Agency determined that exposure to homeowners handling a permethrin product is
likely to occur via dermal (skin) and inhalation routes during the residential use of permethrin in
a variety of indoor and outdoor environments, including use on lawns, gardens, ornamentals,
indoor surfaces and spaces, and contact with pets. Permethrin is one of the most widely used
pesticide active ingredients, and has an extraordinary number of use patterns. The risk
assessment considered 25 major residential exposure scenarios, based on the types of equipment
and techniques that can potentially be used to make permethrin applications; such as various
handheld equipment, for example low pressure hand wand sprayers, backpack sprayers, hose-end
sprayer, paint brush, and dip applications; automatic outdoor mister systems; and a number of
ready-to-use (RTU) methods such as shaker and aerosol cans, wipes, ear tags and protective
flanges. The use patterns assessed are considered to be representative scenarios that are believed
to represent the vast majority of permethrin uses.
The Agency considered residential handler exposure scenarios to be short-term (1-30
days) only due to infrequency of use associated with homeowner products. According to the
data submitted by the Residential Exposure Joint Venture (REJV), which is a group of companies
that conducted a survey of homeowners to ascertain how consumer pesticide products are used
(e.g., rate, frequency, pests, etc), a permethrin product is used by homeowners on average 5
times a year. The residential risk assessment is also based on estimates of what and how much
homeowners would typically treat, such as the size of the lawn or garden, based on the Agency's
standard operating procedures for residential exposures and best professional judgment. For
more information on the daily volume handled and the area treated used in each residential
handler scenarios, refer to Permethrin: Third Revision of the Occupational and Residential
Exposure Assessment for the Reregistration Eligibility Decision Document., dated April 4, 2006.
Non-cancer (dermal and inhalation) risks for homeowners handling permethrin products
are below the Agency's LOG. The combined (dermal and inhalation) MOEs for all scenarios
assessed are greater than 100 (ranging from 690 to 22 million) and are, therefore, not tabulated in
this document, but are available in the document referenced above. For residential handler
cancer risks, the Agency considered the REJV homeowner use pattern information discussed
above, that homeowners use pesticide products on an average of 5 times a year, to assess whether
homeowner use scenarios were above the Agency's LOG. Handler scenarios that result in a
cancer risk estimate of <3 x 10"6, which the Agency considers to be within the negligible cancer
risk range, at 5 or more exposure events a year, are below the Agency's LOG and are similarly
not tabulated in this document. All assessed residential handler cancer risk estimates are below
the Agency's LOG at >5 exposure events per year, except for the eight use site scenarios listed in
Table 7.
Table 7: Residential Cancer Handler Risk Estimates
Exposure Scenario
Use Site
Application
Rate
Area Treated
Daily or Amount
Applied per Day
# of Events per
Year to Reach
3 x lO'6 LOC
Mixing/Loading/Applying
16
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Table 7: Residential Cancer Handler Risk Estimates
Exposure Scenario
Emulsifiable Concentrates
(EC) with Low Pressure
Handwand
EC with a Hose-End Sprayer
EC via Sponge
Granulars via Belly Grinder
Use Site
Outdoor surfaces
Ornamentals: outdoor trees
Perimeter treatment:
outdoor wood surfaces
Ornamentals: outdoor tress
Stored lumber, wood piles
Ornamentals: outdoor
Horses
Turf
Application
Rate
0.46 Ib
ai/gallon
0.043 Ib
ai/gallon
0.4 Ib
ai/gallon
0.043 Ib
ai/gallon
0.04 Ib
ai/gallon
0.02 Ib
ai/gallon
0.005 Ib
ai/gallon
0.65 Ib ai/acre
Area Treated
Daily or Amount
Applied per Day
5 gallons
5 gallons
5 gallons
100 gallons
100 gallons
100 gallons
2 animals
0.5 acres
# of Events per
Year to Reach
3 x 10"6 LOC
o
J
o
J
o
J
<1
<1
3
2
2
For the complete residential handler assessment and risk estimates refer to the
Permethrin: Third Revision of the Occupational Residential Exposure Assessment for the
Reregistration Eligibility Decision Document., dated April 4, 2006. Additionally, refer to
Permethrin: Comparing Cancer Target Levels of Concern (1 x Iff6 vs 3 x 10~6), dated April 4,
2006, for refined residential cancer risk estimates.
The area treated daily used in the risk assessment for each scenario was based on the
Agency's standard operating procedures for each application method. Additionally, the
residential cancer risk assessment assumes a homeowner would be using a permethrin product in
the manner assessed for 50 years of a 70-year lifetime. For most of these scenarios, the Agency
does not believe they are feasible or likely to occur based on the frequency of application,
amount of product handled, and the application method paired with the use patterns assessed
above. For example, the Agency did not think it was likely that a homeowner would be applying
5 gallons of finished spray to outdoor surfaces, ornamentals, and perimeter treatments with a low
pressure handwand more than three times a year, which would be a total of 15 gallons a year on
these use sites. Further, the Agency does not believe it is likely that a homeowner would use a
belly grinder to treat 0.5 acres of turf more than twice a year. Low pressure handwands and belly
grinder are not conducive to handling a large amount of product (liquid or granular respectively)
or treating a large area. The equipment would require multiple refills and would be labor
intensive. Finally, the Agency does not believe a homeowner will be applying 100 gallons of
finished spray in a day, as assumed above in the mixing/loading/applying EC formulated
products with a hose-end sprayer scenario. Therefore, these scenarios are considered not to be of
concern to the Agency. The Agency does not believe these scenarios are likely to occur in a
year, and are highly unlikely to occur multiple times per year over 50 years.
The only handler scenario listed in Table 7 that the Agency considers to be of cancer risk
concern is mixing/loading/applying the EC formulation via sponge to horses. The Agency
believes that this use pattern is likely to occur as assessed. However, because the Agency lacked
exposure data for this specific use pattern, data from a Chemical Manufacturers Association
17
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(CMA) Antimicrobial Exposure Assessment Study was used to assess exposure to individuals
who used wipes to apply antimicrobial pesticides. This study was judged to be the best available
surrogate for this exposure scenario. While the wipe data from this study provides the best
available information on handler exposure to sponge scenarios, there are some uncertainties
associated with the data used, such as: good laboratory practices were not closely followed,
extraction efficiencies were below the minimum level suggested in the guidelines, calibration of
the air monitoring equipment resulted in much of the data being less than detection, and the
limited number of replicates (the guidelines recommend 15 replicates). Therefore, although this
scenario results in a risk estimate above the Agency's LOG, there are a number of uncertainties
that may be addressed with better quality data.
b. Residential Post-Application Risks
The Agency refers to the term "post-application" to describe exposures to individuals that
occur as a result of being in an environment that has been previously treated with a pesticide.
Permethrin can be used in many areas that can be frequented by the general population including
residential areas (indoor and outdoor areas). As a result, individuals can be exposed by entering
these areas if they have been previously treated. Permethrin can also be used on companion
animals, which can lead to exposure by contact with the treated animals. Further, permethrin is
used in Public Health Abatement Programs as a mosquito adulticide, where it can be applied to
wide areas through ultra-low volume (ULV) spraying, which can result in post-application
exposure to the general population.
Permethrin is also used to treat clothing (ready to use formulations and impregnation),
which can lead to exposure during use of the clothing. The Agency is aware that there are a
variety of commercial application/impregnation methods currently being used to produce
permethrin treated clothing, and that some of the new more technologically advanced
application/impregnation methods will result in less exposure to individuals wearing this
clothing. However, the Agency used the best available data collected from clothing treated with
older and less technologically advanced application/impregnation methods when assessing post-
application exposure to permethrin impregnated clothing. The Agency recently received a pilot
exposure study based on a newer technologically advanced impregnation method currently being
used by one permethrin registrant. This study is currently being reviewed by the Agency to
determine the scientific viability and applicability of the study. However, based on a cursory
review, the Agency has found that the "pilot study" (as it is referred to by the registrant) includes
a very limited number of biomonitoring and patch replicates. Assuming a full review deems the
study scientifically viable and applicable, it would appear that this pilot, product-specific
exposure study suggests no risks in excess of those from the conservative assessment discussed
above. Therefore, the Agency believes that the current assessment results in conservative and
protective estimates of exposure and risk to permethrin impregnated clothing produced by any
currently used application/impregnation method.
Unlike residential handler exposure, where the EPA assumed only adults will be handling
and applying permethrin products, individuals of varying ages can potentially be exposed to
permethrin when reentering or performing activities in areas that have been previously treated,
wear permethrin treated-clothing, or have contact with treated companion animals. The
18
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residential populations that were considered in the risk assessment include:
• Residential adults engaged in:
o Mowing or exercising on a treated lawn,
o Working in a treated garden,
o Outdoor activities after a mosquito abatement public health ULV
application (truck fogger and aerial spray),
o Outdoor activities after the use of an outdoor residential mister system,
o Playing/exercising on treated indoor surfaces, such as carpets and hard
floors,
o Pet contact activities, and
o Wearing permethrin treated clothing.
• Residential youth (representative age 10-12) engaged in:
o Working in a treated garden, and
o Wearing permethrin treated clothing.
• Residential toddlers (3 years) engaged in:
o Playing on a treated lawn,
o Outdoor activities after a mosquito abatement public health ULV
application (truck fogger and aerial spray),
o Outdoor activities after the use of an outdoor residential mister system,
o Wearing permethrin treated clothing,
o Pet contact activities, and
o Playing/exercising on treated indoor surfaces, such as carpets and hard
floors.
Post-application exposures to permethrin for adults are most likely through the skin and
inhalation routes (mosquito abatement scenarios), whereas children may also receive oral
exposures from mouthing behaviors (i.e., hand-to-mouth, object-to-mouth, and soil ingestion).
Non-Cancer Risks
The non-cancer risks (dermal and inhalation) from post-application exposure to
permethrin, for the scenarios listed above, including wearing impregnated clothing, are below the
Agency's LOG for residential adults and youth (MOEs ranged from 120 to 500 billion) for adults
and 3,700 to 48,000 for youth), and are, therefore, not tabulated in this document, but are
available in Permethrin: Third Revision of the Occupational and Residential Exposure
Assessment for the Reregistration Eligibility Decision Document, dated April 4, 2006.
Additionally, most of the toddler risk estimates are also below the Agency's LOG (MOEs
ranging from 140 to 250 billion); however, the incidental oral and dermal toddler post-
application risk estimates for the indoor surface spray (carpet) scenario are of concern to the
Agency (MOEs <100) and are listed in Table 8 below.
Table 8: Toddler Risk Estimates for Post-application Exposure to Permethrin
Exposure Scenario
Route of
Exposure
Application Rate
MOE on day of application
19
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Table 8: Toddler Risk Estimates for Post-application Exposure to Permethrin
Exposure Scenario
Hand to mouth activities on indoor
surfaces - Spray (carpet)
Indoor Surfaces (high contact
activities)- Spray (carpet)
Route of
Exposure
Oral
Dermal
Application Rate
0.0001 Ib ai/sq. ft.
0.0001 Ib ai/sq. ft.
MOE on day of application
37
69
Both scenarios in Table 8 assume a 1% concentration of permethrin in a directed spray, a
rate only used by professional applicators. Further, table 8 does not include aerosol sprays,
which were assessed separately in the risk assessment referenced above, and are result in risk
below the Agency's LOG (MOEs for oral and dermal exposure are 8,500 and 16,000,
respectively).
The Agency also combines risk values from separate post-application exposure scenarios,
when it is likely that they can occur simultaneously based on the use pattern and the behavior
associated with the exposed population. The non-cancer risk estimates for toddlers were
combined since toddlers are the most sensitive population assessed, and are presented in Table 9
below.
Table 9: Permethrin Post-application Residential Scenarios for Combined Non-cancer Risk Estimates
Post-application Exposure Scenario
Toddler
Toddler
Toddler
Toddler
Toddler
Toddler
(0.87 Ib ai/A)
Indoor Carpet -
Aerosols
Indoor Carpet -
Fogger
Pet - Shampoo
Pet- Dusts
Impregnated Clothing:
Long Sleeves/Long
Pants
Dermal
Hand to Mouth
Object to Mouth
Incidental Soil
Ingestion
Dermal
Hand to Mouth
Dermal
Hand to Mouth
Dermal
Hand to Mouth
Dermal
Hand to Mouth
Dermal
Object to Mouth
Margins of Exposure (MOEs)
(UF=100)
Individual
Exposure
12,000
15,000
250,000
570,000
8,500
16,000
410
770
12,000
360
1,600
1,300
2,700
24,000
Combined (Total)
Exposure
6,400
5,600
270
350
720
2,400
The combined MOEs for the individual turf spray, indoor carpet-aerosol, indoor carpet-
fogger, pet dust, pet shampoo, and impregnated clothing scenarios are all greater than 100, and
therefore, do not exceed the Agency's LOG.
Cancer Risks
Similar to the residential handler cancer risk assessment, the post-application risk
assessment includes the number of exposure events that could occur per year before the cancer
20
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risk reached the negligible risk range (<3 x 10"6) and assumes the same exposure occurring over
a period of 50 years of a 70-year lifetime. Moreover, for indoor post-application exposure to
toddlers, the Agency assumed 8 hours of exposure for carpet sprays, and 4 hours for vinyl
flooring. Additionally, the post-application risk assessment assumed exposure to permethrin
residues the same day the area was treated (i.e., day 0 residue), which are considered reasonably
conservative assumptions, considering indoor residues are removed over time through cleaning
and other indoor activities. Therefore, for example, 5 days of post-application exposure to day 0
residue, would assume 5 treatment event per year. Since the Agency assumed a residential
handler would be applying a pesticide on average 5 times per year, the same assumption was
used for post-application risk assessment, except for the impregnated clothing scenario. In
general, the post-application risk estimates that reached the <3 x 10"6 negligible risk range after 5
or more exposure events per year (over a period of 50 years of a 70-year lifetime) are considered
to be below the Agency's LOG.
The same residential adult scenarios that were assessed for the non-cancer risk estimates
were also assessed for the cancer risk estimates. All outdoor and pet contact scenarios assessed
are below the Agency's LOG and are, therefore, not tabulated in this document. The number of
exposure events per year (over a period of 50 years of a 70-year lifetime) to reach the cancer
negligible risk level for these outdoor and pet contact scenarios are all > 5 (ranging from 18 to
365 days). However, two indoor scenarios are of concern to the Agency, and are presented in
Table 10 below.
Table 10: Summary of Permethrin Post-application Residential Cancer Risks of Concern
Exposure Scenario
Indoor Surfaces (high Contact
Activities) - Spray
Indoor Surfaces (high contact
activities)- Fogger
Route of
Exposure
Dermal
Dermal
Application Rate
0.000 llbai/sq. ft.
0.0023 Ib ai/s6 oz
fogger
# of Events/Year to
Reach LOC
<1
2
For the impregnated clothing scenario, the Agency estimated the number of days an
article of clothing would typically be worn within a year's time. Unlike the other post-
application scenarios, that considered each post-application exposure event to be day 0 residues,
the Agency considered wash-off data to determine the potential exposure that would occur after
each consecutive wear and wash of the garment. The Agency believes that consumers will
primarily use permethrin treated clothing recreationally (i.e., weekends, outdoor activities,
sporting events), as well as seasonally when mosquitoes are most active. Therefore, it is likely
individuals will wear permethrin impregnated clothing more than 5 times per year, but highly
unlikely that a consumer will wear a treated shirt 151 times per year, or treated pants and a long
sleeve shirt 92 times per year, as presented in Table 11 below. Furthermore, the cancer risk
assessment assumes that the consumer will wear the combination of permethrin treated clothing
stated in Table 11 below each year for 50 years. Therefore, based on the use pattern discussed
above, the cancer risk estimates for wearing impregnated clothing are below the Agency's LOC.
Table 11: Summary of Permethrin Post-application Impregnated Clothing Cancer Risks for Adults
Exposure Scenario
Impregnated Clothing: Long Sleeve
Route of
Exposure
Dermal
Application Rate
0.125 mgai/cm2
# of Days/Year to Reach
LOC
151
21
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Table 11: Summary of Permethrin Post-application Impregnated Clothing Cancer Risks for Adults
Shirt
Impregnated Clothing: Long Sleeve
Shirt/Long Pants
Dermal
0.125mgai/cm2
92
Permthrin is also used in outdoor residential misting systems. The Agency assessed the
potential risks to both adults and toddlers exposed to permethrin during applications via outdoor
residential misting systems. The MOE for adults by inhalation route is 160,000, and the MOE
for toddlers is 69,000. The non-cancer risk estimates are below the Agency's LOG (MOE>100).
Further, it took 365 exposure events to reach the Agency's cancer LOG. The Agency does not
believe an individual will be exposed to permethrin from an outdoor residential misting system
application daily for 50 years. Therefore, the cancer risk estimate is below the Agency's LOG.
For the entire homeowner post-application assessment and risk estimates, refer to
Permethrin: Third Revision of the Occupational Residential Exposure Assessment for the
Reregistration Eligibility Decision Document, dated April 4, 2006. Additionally, refer to
Permethrin: Comparing Cancer Target Levels of Concern (1 x Iff6 vs 3 x J0~6), dated April 4,
2006, for refined residential cancer risk estimates.
7. Aggregate Risk
The FQPA amendments to the Federal Food, Drug, and Cosmetic Act (FFDCA, Section
408(b)(2)(A)(ii)) require "that there is a reasonable certainty that no harm will result from
aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures
and other exposures for which there is reliable information." Aggregate exposure will typically
include exposures from food, drinking water, residential uses of a pesticide, and other non-
occupational sources of exposure.
In accordance with the FQPA, the Agency must consider and aggregate pesticide
exposures and risks from three major sources or pathways: food, drinking water and, if
applicable, residential or other non-occupational exposures. For permethrin, the Agency
conducted a refined aggregate risk assessment that combines exposures across all pathways. The
Agency included acute, chronic and cancer EDWCs directly in the dietary exposure assessments
to calculate aggregate dietary (food + drinking water) risk. This was accomplished by using the
relevant screening-level PRZM-EXAMS model value as a residue for drinking water (all
sources) in the dietary exposure assessment conducted using the DEEM-FCID™ model.
The short-term residential and other non-occupational exposure assessments consider all
potential pesticide exposure, other than exposure due to residues in food and/or in drinking
water. Each route of exposure (i.e., oral, dermal, inhalation) is assessed. Risk estimates from all
relevant pathways (i.e., food, drinking water, and residential or non-occupational) for permethrin
from all sources were calculated to assess aggregate risks. When aggregating exposure and risk
from various sources, both the route and duration of exposure are considered. Exposure to
multiple sources that are expected to co-occur are also considered in the aggregate risk estimate.
In this case, preliminary results from the REJV survey were used to further refine the aggregate
assessment. Again, the REJV survey is a 12-month longitudinal survey that examined pesticide
use in a residential environment. The data evaluated by the Agency in this analysis were
22
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information collected in 2001 and 2002.
The following scenarios were aggregated:
o Acute: food + drinking water
o Short-term
o Food + drinking water + (lawn care and post-application vegetable garden)
o Food + drinking water + (U.S. Population: handler lawn care and post-
application indoor surface spray on carpet)
o Food + drinking water + (U.S. population: handler lawn care and post-application
vegetable garden)
o Food + drinking water + (Females 13-49: handler lawn care and post-application
indoor surface spray on carpet)
o Food + drinking water + (Females 13-49: handler lawn care and post-application
indoor surface spray on carpet)
o Food + drinking water + (Toddler: post-application lawn and post-application
indoor surface spray on carpet)
o Food + drinking water + (Toddler: post-application lawn and post-application
indoor surface spray on vinyl)
o Food + drinking water + (Toddler: post-application lawn and post-application pet
shampoo)
o Long-term (chronic): food + drinking water
o Cancer
o Food + drinking water + (U.S. Population: handler lawn care and post-
application vegetable garden)
o Food + drinking water + (U.S. Population: handler lawn care and post-
application indoor surface spray on carpet)
A technical registrant submitted an aggregate assessment for permethrin conducted with
CARES (Cumulative and Aggregate Risk Evaluation System), a software program which
performs single chemical, aggregate, and cumulative (multichemical) exposure and risk
assessments. In the submission, exposures through food, drinking water, and residential
pathways were assessed. The Agency reviewed and evaluated the CARES submission with
respect to the internal guidelines and standard operating procedures for submission of
probabilistic assessments. The Agency's review particularly focused on the residential pathways
of exposure as these exposures were the main driver in the Agency's non-cancer deterministic
aggregate assessment. Overall, the Agency concluded that the assessment submitted selected
reasonable input parameters to estimate exposure to permethrin from the food and residential
pathways. However, the CARES assessment does not reflect the revised EDWC developed in
the Second Revision Tier II Estimated Drinking Water Concentrations of Permethrin, dated
January 19, 2006, and instead relied on the EDWC developed from the State of Maine potato
scenario in Tier II Estimated Drinking Water Concentrations of Permethrin, dated July 16, 2004.
Both documents are available in the public docket. The CARES assessment only considered
acute aggregate and short-term aggregate risks, and not cancer aggregate risks, and is discussed
in more detail in the Acute Aggregate Risk and Short-Term Aggregate Risk sections below.
23
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a. Acute Aggregate Risk
The acute aggregate risk estimate includes the contribution of risk from dietary (food +
drinking water sources) only. Acute aggregate risk estimates from exposures to food and
drinking water, associated with the use of permethrin, do not exceed the Agency's level of
concern (<100% aPAD). The estimated acute dietary risk for the general U.S. population is 4%
of the aPAD, and 16% of the aPAD for infants, the highest exposed population subgroup (see
Table 5).
The CARES assessment reported dietary (food only) exposures (on a mg/kg per capita
basis) and MOEs corresponding to the 99.9 percentile for both children 1-2 and adults 20-49.
For children 1-2 years old, the CARES assessment reported food only exposures at the 99.9th
percentile of 0.0269 mg/kg (equivalent to an MOE of 929). For adults 20-49, the food only
exposures at the 99.9th percentile were 0.0107 mg/kg (equivalent to an MOE of 2,332). The
CARES assessment also reported drinking water exposures (on a mg/kg per capita basis) and
MOEs corresponding to the 99.9 percentile for both children 1-2 and adults 20-49. For children
1-2 years old, the drinking water exposures at the 99.9th percentile were 0.000749 mg/kg
(equivalent to an MOE of 33,391). For adults 20-49, the CARES assessment reported drinking
water exposures at the 99.9th percentile of 0.000447 mg/kg (equivalent to an MOE of 55,932).
Again, these results do not reflect the results presented in the Second Revision Tier II Estimated
Drinking Water Concentrations of Permethrin, dated January 19, 2006.
b. Short-Term Aggregate Risk
Aggregate short-term (1-30 days) risk estimates include the contribution of risk from
chronic dietary sources (food + drinking water) and short-term residential sources. There are a
number of exposure scenarios that could be aggregated. According to the preliminary results of
the REJV survey, uses on lawns and on indoor crack and crevice sites account for the most use in
the residential market place. For this assessment, the Agency used the REJV survey to
determine the likelihood of a co-occurrent application scenario.
For adult aggregate short-term risk, chronic food and drinking water exposures for the
U.S general population and for females 13-49 years of age were combined with residential
handler and post-application exposures. Residential handler dermal and inhalation exposures for
mixing/loading/applying EC formulated products with a low pressure handwand to lawns were
combined with post-application exposures (dermal) for vegetable gardens. Residential handler
dermal and inhalation exposures for mixing/loading/applying EC formulated products with a low
pressure handwand to lawns were also combined with post-application exposures (dermal) for
indoor carpet surface sprays.
To assess short-term aggregate risks for toddlers, chronic food and drinking water
exposures for children 1-2 years of age were added to three separate combinations of post-
application residential exposure scenarios that are likely to occur for toddlers, based on the REJV
survey. These scenarios include 1) hand-to-mouth activity and dermal contact to lawns and
indoor carpets; 2) hand-to-mouth activity and dermal contact to lawns and indoor vinyl floor
sprays; and 3) hand-to-mouth activity and dermal contact to lawns and pets.
24
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Table 12 summarizes the short-term aggregate risks to the general U.S. population, adult
females (13-49), and toddlers. With the exception of post-application exposure of toddlers to
treated lawns and indoor surfaces (carpets), the combined residues of permethrin from food,
drinking water, and other potential residential exposures do not result in short-term aggregate
risks of concern to population subgroups (MOEs >100).
Table 12: Estimated Short-Term Aggregate Risk for Permethrin [Dietary (food + drinking water) and
Residential Exposures]
Population
U.S Pop
Adult
Female
(13-49)
Toddler
(1-2)
Residential Scenarios
Included in the
Aggregate
Lawn care, Postapp
Vegetable
Lawn Care, Postapp
Indoor Surface Spray
on Carpet
Lawn care, Postapp
Vegetable
Lawn Care, Postapp
Indoor Surface Spray
on Carpet
Post-App Lawn
Care, Post-App
Indoor Surface Spray
on Carpet
Post-App Lawn care,
Post-App Indoor
surface Spray on
Vinyl
Post-App Lawn
Care, Post-App Pet
Shampoo
Short-Term Exposure
EPA's
Aggregate
LOC
100
100
100
100
100
MOE
food +
water
210,000
220,000
88,000
88,000
88,000
MOE
incid.
oral
NA
NA
37
150
350
MOE
dermal
4,200
120
4,200
120
69
440
6,000
MOE
inhalation
1,000,000
1,000,000
1,000,000
1,000,000
NA
NA
NA
Aggregate MOE
(dietary and
residential)
4,100
120
4,100
120
24
110
330
The aggregate assessment considers the highest exposure, by route, from each scenario
included. For example, for the aggregate assessment for toddlers, this considers post-application
exposure from treated lawns and indoor surface sprays, the highest exposures result from the
indoor surface sprays on carpet and vinyl. Therefore, the exposures from the indoor surface
sprays are driving the aggregate risk estimates. For a detailed discussion of the short-term
aggregate risk assessment and the REJV co-occurrence matrix, please refer to Permethrin. Fifth
Revision of the HED Chapter of the Reregistration Eligibility Decision Document, dated April 4,
2006.
The CARES assessment estimated residential exposures (on a mg/kg per capita basis) and
MOEs corresponding to the 99.9th percentile for both children 1-2 and adults 20-49 based on the
11 residential scenarios reported in the REJV survey data, including indoor and outdoor use. For
more detail on the input parameters used in the residential CARES assessment, refer to
Permethrin: Review ofValentBioSciences Corporation's CARES Aggregate Submission entitled
"Preliminary Evaluation of Potential Aggregate Human Health Risks Associated with
Agricultural and Consumer Uses of Permethrin"., dated June 21, 2005, which is available in the
25
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public docket.
The residential portion of the CARES assessment relied extensively upon the data from
the REJV survey. Based on the information collected under the REJV and the scenarios used in
the Agency's human health risk assessment, the CARES assessment included 15 residential uses
[including lawn care operator/pest control operator (LCO/PCO) applications] for permethrin
including lawn and vegetable garden care, wasp and hornet control, indoor crack and crevice
treatments, termite treatments, pet care, indoor and outdoor fogger, indoor flying insect
knockdown aerosols, impregnated clothing, indoor carpet aerosols, and public health mosquito
control. The Agency verified that these scenarios are of most interest with respect to high-end
exposures and most relevant for inclusion in the residential portion of an aggregate probabilistic
risk assessment.
For children 1-2 years old, the CARES assessment reported exposures at the 99.9th
percentile of 0.801 mg/kg (equivalent to an MOE of 624). For adults 20-49, the CARES
assessment reported exposures at the 99.9th percentile of 0.337 mg/kg (equivalent to an MOE of
1484). These estimates are expressed on aper capita basis, i.e., all individuals (or all exposure-
days) are considered and not just those individuals (or exposure days) on which an actual
application occurs. This is a fundamental difference between the residential assessment
calculations performed by the EPA in its assessment, in accordance with the Agency's standard
operating procedures, and those performed in the CARES submission. The residential exposure
estimates calculated by the Agency reflect exposure estimates to a user on the day of application,
whereas those represented in the CARES assessment apply to all individuals (i.e., whether they
are users or not, and on all days, and whether permethrin was used or not). The two methods of
expressing risk cannot be considered directly comparable, but should rather be seen as two
alternate ways in which exposures can be viewed. The Agency's short-term aggregate
assessment is more conservative and is, therefore, relied upon in this document.
c. Intermediate-Term & Long-Term Aggregate Risk
All residential/recreational exposures are expected to be short-term (1-30 days) in
duration. Therefore, no intermediate-term (1-6 months) aggregate risk was assessed. Moreover,
because labeled uses indicate no long-term (>6 months) or chronic residential or other non-
occupational exposures, chronic aggregate risk estimates include exposures from food and
drinking water sources only. As indicated in Table 5, chronic aggregate risk, associated with the
use of permethrin, do not exceed the Agency's level of concern for the U.S. population and all
population subgroups (all populations were less than 1% of the cPAD).
d. Cancer Risk
Cancer food and drinking water exposures for the U.S. general population were combined
with residential handler and post-application exposures similar to the short-term aggregate risk
assessment. Residential handler dermal and inhalation exposures for mixing/loading/applying
EC formulated products with a low pressure handwand to lawns were combined, by exposure
route, with post-application exposures (dermal) for vegetable gardens. Residential handler
dermal and inhalation exposures for mixing/loading/applying EC formulated products with a low
26
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pressure handwand to lawns was also combined, by exposure route with post-application
exposures (dermal) for indoor carpet surface sprays.
Table 13 summarizes the cancer aggregate risk estimates associated with the use of
permethrin. With the exception of exposure to indoor carpet sprays, the Agency can conclude
that combined exposures to residues of permethrin from food, drinking water, and other potential
residential use scenarios are within the negligible risk range of <3 x 10"6 and do not result in
cancer aggregate risks of concern.
Table 13: Estimated Permethrin Cancer Aggregate Risk
Population
U.S. Pop
Residential Scenarios
Included in Aggregate
Lawn Care, Postapp
Vegetable
Lawn Care, Postapp Indoor
Surface Spray on Carpet
Cancer Risk from
Dietary
l.lxlO'6
Cancer Risk from
Residential
4.3 x ID'7
1.4xl(r5
Aggregate Cancer
Risk (Dietary and
Residential)
1.5 x ID'6
1.5 x ID'5
Similar to the short-term aggregate risk assessment, the aggregate cancer assessment
considers the highest exposure from each scenario included. For a detailed discussion of the
aggregate cancer risk assessment and the REJV co-occurrence matrix, please refer to Permethrin.
Fifth Revision of the HED Chapter of the Reregistration Eligibility Decision Document, dated
April 4, 2006.
e. Permethrin Pesticide and Pharmaceutical Use Co-Exposure
Assessment
As indicated above, in determining the risk to human health, the Agency examines more
than just dietary exposures. Section 408 of FFDCA requires EPA to consider potential sources
of exposure to a pesticide in addition to the dietary sources expected to result from a pesticide
use subject to the tolerance. In order to determine whether to maintain a pesticide tolerance,
EPA must "determine that there is a reasonable certainty of no harm. . . ." Under FFDCA
section 505, the Federal Drug Administration reviews human drugs for safety and effectiveness
and may approve a drug notwithstanding the possibility that some patients may experience
adverse side effects. EPA does not believe that, for purposes of the section 408 dietary risk
assessment, it is compelled to treat a pharmaceutical patient the same as a non-patient, or to
assume that combined exposures to pesticide and pharmaceutical residues that lead to a
physiological effect in the patient constitutes "harm" under the meaning of section 408 of the
FFDCA
Rather, EPA believes the appropriate way to consider the pharmaceutical use of
permethrin in its risk assessment is to examine the impact that the additional non-occupational
pesticide exposures would have to a pharmaceutical patient exposed to a related (or, in some
cases, the same) compound. Where the additional pesticide exposure has not more than a
minimal impact on the pharmaceutical patient, EPA could make a reasonable certainty of no
harm finding for the pesticide tolerances of that compound under section 408 of the FFDCA. If
the potential impact on the pharmaceutical user as a result of co-exposure from pesticide use is
more than minimal, then EPA and FDA could discuss appropriate measures to reduce exposure
27
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from one or both sources. The Agency provided its findings with respect to permethrin to FDA
in a letter dated August 10, 2005, which is available on the public docket (EPA-HQ-OPP-2004-
0385).
The exposure estimates used in the determination of permethrin pharmaceutical and
pesticide co-exposure assessment, attachments A and B to the August 10, 2005 letter referenced
above, reflect the external dermal dose of permethrin a patient treated with a pharmaceutical
permethrin product would receive in a reasonable worst-case scenario. EPA's pesticide exposure
assessment has taken into consideration the appropriate population, exposure route, and exposure
duration for comparison with exposure to the pharmaceutical use of permethrin. Using the
permethrin 1% and 5% registered pharmaceutical labels, EPA estimated exposure from a typical
treatment of both products, and compared those to the potential exposure an individual would
receive from the pesticide uses of permethrin. Because the permethrin 1% and 5% creams are
used over a 10 minute period and an 8 - 14 hour period, respectively, EPA considers the
pharmaceutical use as a short-term exposure. To estimate combined pesticide exposure for a
short-term scenario, EPA integrated average dietary exposure estimates (food + drinking water)
with one of the non-occupational exposure scenarios (i.e. post-application to permethrin treated
residential lawns). EPA chose the treated residential lawn exposure scenario because this
application is a reasonable high-end scenario, and the REJV survey data showed this use to be
among the most frequent exposure scenarios.
EPA estimates that the permethrin exposure a patient is expected to receive from a typical
single application of Nix (1%) and Elimite (5%) creams, respectively, is 450 to 2300 times
greater than the combined exposure from the dietary and other non-occupational sources of
permethrin. FDA has reviewed these estimates and determined that pesticide exposure in
patients receiving treatment with a pharmaceutical permethrin drug product would fall within the
expected range of exposure following treatment with permethrin drug product alone, and would
not present an increased safety risk.
8. Occupational Exposure and Risk
Workers can be exposed to a pesticide through mixing, loading, and/or applying the
pesticide, or re-entering a treated site. For dermal and inhalation exposures, worker risk is
estimated by a Margin of Exposure (MOE) which determines how close the occupational
exposure comes to the No Observed Adverse Effect Level (NOAEL) selected from animal
studies. Please see Table 3 for the toxicological endpoints used in the permethrin occupational
assessment. The risk assessment for short-term (1-30 days) and intermediate-term (1-6 months)
occupational exposures are similar because the toxicity endpoints (NOAELs) are numerically the
same, and the target MOE of 100 is the same for both durations. Based on the registered use
patterns of permethrin, long-term (> 6 months) handler exposure is not expected to occur for
permethrin. The dermal and inhalation risks were combined for all scenarios assessed because
the adverse effects for the dermal and inhalation routes of exposure were the same
(neurotoxicity). Since permethrin is currently classified as a "likely to be carcinogenic to
humans," the Agency assessed both cancer and non-cancer risks for occupational handlers and
post-application workers. A dermal absorption factor of 15% was used for the dermal
component of the cancer equation for the cancer risk assessment.
28
-------
For permethrin, MOEs that are greater than 100 and cancer risks within the range of an
increased cancer risk of 1 x 10"6 generally do not exceed the Agency's level of concern.
However, when occupational MOEs are less than 100 or occupational cancer risks exceed 1 x
10"6, EPA strives to reduce worker cancer risks through the use of personal protective equipment
and engineering controls. The Agency generally considers occupational cancer risks within the
range of 1 to 3 x 10"6 (approximately 1-3 in 1 million persons) or less to be negligible, but will
consider risks as high as 1 x 10"4 (1 in 10,000 persons) when all mitigation measures that are
practical and feasible have been applied and when there are critical pest management needs
associated with the use of the pesticide.
a. Occupational Handler Exposure and Risk
Exposure to permethrin by pesticide handlers (mixers, loaders, applicators and flaggers)
is likely during the use of permethrin based on the type of equipment and techniques that can
potentially be used. Thirty-nine occupational exposure scenarios were assessed based on
registered labels, equipment, and techniques that could be used for permethrin applicators. Due
to the scope of the various permethrin occupational uses (there are over 900 registered
permethrin products), it would be difficult to assess each individual exposure scenario.
Therefore, the following selected scenarios are representative of the worse-case exposure
scenarios to represent the major ways permethrin can be handled in the occupational
environment. The scenario numbers correspond to the non-cancer and cancer risk estimate tables
presented in the Permethrin: Third Revision of the Occupation and Residential Exposure
Assessment for the Reregistration Eligibility Decision Document, dated April 4, 2006. Scenarios
denoted with a "*" could not be evaluated quantitatively because applicable unit exposure data
are not available; however, the Agency believes other assessed scenarios are protective of these
specific, and specialized, uses.
Mixer/Loaders:
la Liquids for Aerial Applications;
Ib Liquids for Groundboom Applications;
Ic Liquids for Airblast Applications;
1 d Liquids for Truck Mounted ULV Applications;
le Liquids for Dip Applications;
If Liquids for Residential Mister Systems;
2a Wettable Powder for Aerial Applications;
2b Wettable Powder for Groundboom Applications;
2c Wettable Powder for Airblast Applications;
2d Dusts for Mechanical Duster Applications (using PHED WP mixer/loader data);
2e Dusts for Dust Bag Applications (using PHED WP mixer/loader data);
3a Granulars for Aerial Applications;
3b Granulars for Tractor Drawn Spreader Applications
Applicators:
4 Aerial Applications (Sprays);
5 Groundboom Applications;
29
-------
6 Airblast Applications;
7 Truck Mounted ULV Applications;
8 Dip Applications*;
9 Aerial Applications;
10 Tractor Drawn Spreader Applications (Granulars);
11 Mechanical Duster Applications*;
12 Dust Bag Applications*;
Flaggers:
13 Flagging for Aerial-Sprays;
14 Flagging for Aerial-Granulars;
Mixing/Loading/Applicators:
15 Liquid: Low Pressure Handwand Sprayer:
16 Liquid: Handgun Sprayer;
17 Liquids: High Pressure Handwand Sprayer;
18 Liquid: Termite Injector;
19 Liquid: Foam Applicator Equipment (using ORETF low pressure handwand
data);
20 Liquid: Watering Can (using ORETF residential hose end sprayer data);
21 Liquid: Backpack ULV Sprayer (using ORETF low pressure handwand data);
22 Liquid: Paint Brush;
23 Liquid: Cold Fogger*;
24 Wettable Powder: Low Pressure Handwand Sprayer;
25 Wettable Powder: Handgun Sprayer;
26 Wettable Powder: High Pressure Handwand Sprayers*;
27 Water Soluable Bag: Handgun Sprayer;
28 Wettable Powder: Cold Fogger*;
29 Dusts: Shaker Cans;
30 Liquid: Fogger/Mister Generator*;
31 RTU: Liquid: Pour On Applications (using PHED mixing/loading liquid data);
32 RTU: Ear Tag Applications*;
33 RTU: Hand Applications (Shampoos)*;
34 RTU: Wipe Applications*;
35 RTU: Trigger Pump Sprayer Applications;
36 RTU: Aerosol Cans;
37 RTU: Fogger (using PHED aerosol can data);
38 RTU: Protective Flanges*;
39 RTU: Vapor Recovery Systems Tubes*.
The level of personal protective equipment (PPE) varies on the numerous permethrin
labels. Some labels only require the minimum level of PPE, while others require additional PPE,
such as chemical-resistant gloves, respirators, etc., depending on the labeled handler activity.
Therefore, the Agency considered the following levels of PPE or engineering controls in the
occupational non-cancer and cancer exposure assessments:
30
-------
• Baseline, or long-sleeve shirt, long pants, no gloves, and no respirator. (Baseline)
• Baseline plus chemical-resistant gloves, and no respirator. (PPE-G-NR)
Coveralls worn over long-sleeve shirt and long pants, chemical-resistant gloves, and
no respirator. (PPE-G-DL-NR)
• Baseline plus chemical-resistant gloves and an 80% PF (quarter-face dust/mist)
respirator. (PPE-G-80%R)
Coveralls worn over long-sleeve shirt and long pants, chemical-resistant gloves, and
an 80% PF (quarter-face dust/mist) respirator. (PPE-G-DL-80%R)
• Engineering Controls, or closed mixing/loading system, enclosed cab, or enclosed
cockpit. (EC)
No chemical-specific information was available for permethrin handler exposure
assessments. Therefore, the Agency used the Pesticide Handler Exposure Database (PFLED,
Version 1.1, 1998) data, as well as acceptable surrogate exposure data, to calculate unit exposure
values to estimate occupational handler exposures to permethrin for each scenario assessed.
For each of the 39 handler scenarios above, the Agency considered numerous crops or
target use sites with various application rates and area treated daily to reflect the way in which
permethrin can be applied (approximately 200 various use patterns were assessed). Additionally,
due to the broad spectrum use of permethrin, the Agency believes that occupational exposure can
occur over a single day or up to a week's time for many use-patterns, and intermittent exposure
over several weeks are also anticipated. Therefore, the non-cancer risk assessment considers
both short- (1-30 days) and intermediate-term (1-6 months) exposure to permethrin, and dermal
and inhalation exposures are combined.
Non-Cancer Risks
The majority of the non-cancer risk estimates were below the Agency's level of concern,
MOEs ranged from 120 to 200 million, when baseline PPE and chemical-resistant gloves were
applied and are, therefore, not tabulated in this document; however, six of the approximately 200
use patterns assessed required additional PPE before the risk estimates were below the Agency's
LOG and are listed in Table 14. The number next to each scenario corresponds to the handler
scenarios listed above, and the non-cancer risk estimate tables and calculations in the
Permethrin: Third Revision of the Occupation and Residential Exposure Assessment for the
Reregistration Eligibility Decision Document, dated April 4, 2006, which is available in the
public docket.
Table 14. Summary of Permethrin Non-Cancer Handler Risk Estimates Requiring PPE greater than Baseline and
Gloves
Exposure Scenario
Crop or Use
Max.
Application
Rate
Max.
Area
Treated
Daily
Base-
line
PPE-
G-NR
PPE-
G-DL-
NR
PPE-
G-
80%R
PPE-
G-DL-
80%R
EC
Mixer/Loader (M/L)
ML Wettable Powder
(WP) for Aerial
Corn: Sweet (FL
only)
0.25 Ib ai/A
1200 acres
21
55
56
650
840
ND
-------
Table 14. Summary of Permethrin Non-Cancer Handler Risk Estimates Requiring PPE greater than Baseline and
Gloves
Exposure Scenario
Crop or Use
Max.
Application
Rate
Max.
Area
Treated
Daily
Base-
line
PPE-
G-NR
PPE-
G-DL-
NR
PPE-
G-
80%R
PPE-
G-DL-
80%R
EC
Mixer/Loader (M/L)
Application (2a)
Loading Dusts via
Mechanical Duster
(2d)
Alfalfa, corn (field,
pop, seed, sweet),
corn: field
(preplant), range
grasses, soybeans
Animal: poultry
0.2 Ib ai/A
0.0025 Ib
ai/animal
1200 acres
100000
animals
26
25
69
66
70
67
820
780
1100
1000
ND
ND
Mixer/Loader/Applicator (M/L/ A)
ML/A WP via Low
Pressure Handwand
(24)
ML/A Emulsifiable
Concentrates via Cold
Fogger(23)
Conifer: field grown
Mushroom Houses
Indoor Spaces
0.2 Ib ai/gal
0.0078 Ib ai/
sqft
0.00036 Ib
ai/cu ft
40 gal
40000 sq
ft
(8000 sq ft
per house)
200000 cu
ft
ND
ND
ND
75
ND
35000*
78
4000*
ND
500
ND
ND
680
ND
ND
NF
ND
ND
Four of the scenarios, wettable powder and dust formulations, in Table 14 require
baseline PPE with chemical-resistant gloves and respirator (PPE-G-80%R) to be worn by
workers before the estimated MOEs are >100 and are, therefore, below the Agency's LOG at this
level of PPE. The two emulsifiable concentration scenarios with a ULV cold fogger applicator
are below the Agency's LOG with double layer PPE.
Cancer Risks
The occupational handler cancer risk assessment considered the same use patterns
(approximately 200) for each handler activity listed above. Based on EPA information, it is
assumed that all handlers (small, medium, and large scale growers, as well as commercial
applicators) would handle permethrin approximately 10 days per year. In addition, a 35-year
career and a 70-year life span were considered in the cancer risk estimate calculations. PPE and
engineering controls were also evaluated in the assessment.
The estimated cancer risks for the majority of grower scenarios are also within the
negligible risk range (<3 x 10"6) or less with baseline PPE and gloves and were, therefore, below
the Agency's LOG and not tabulated in this document. However, 45 of the approximately 200
use patterns assessed results in risk in the 10"5 to 10"6 range at this level of PPE, and either
require additional PPE before the cancer risk estimates are below the negligible risk range of <3
x 10"6, have no data available to estimate risk ,or further mitigation measures are not feasible.
Table 15 below presents the predicted cancer risk estimates for these scenarios at the baseline
PPE and gloves, and lists the required level of PPE at which the cancer risk estimate reaches the
32
-------
negligible risk range. The handler scenarios are grouped by formulation, and, again, the number
next to each scenario corresponds with handler scenarios listed in the section above.
Table 15: Permethrin Occupational Handler Cancer Risk Estimates Between 10"4 and 10"6
Exposure Scenario
Use Site
Application
Rate
Area Treated
Daily or
Amount
Applied per
Day
Baseline PPE
& Gloves
PPE to Reach
LOC
Wettable Powders
Mixing/loading Wettable
Powder for Aerial
Applications (2a)
Mixing/loading Wettable
Powder for Groundboom
(2b)
Mixing/loading/applying
Wettable Powder with Low
Pressure Handwand (24)
Mixing/loader/applying
Wettable Powder with a
Handgun Sprayer (25)
Mixing/loading/applying
Water Soluable Bags with
Handgun Sprayer (27)
Mixing/loader/applying
Wettable Powder with a High
Pressure Handwand (26)
Pine seed orchard
almonds, apples, filberts, pears
(dormant & pre-bloom combo),
pistachios, walnuts
artichokes, garlic, nectarines, onion:
dry: bulb, peaches
Corn: sweet (FL only)
Corn: sweet (FL only)
alfalfa, corn (pop, field, seed, sweet),
com: field (preplant), range grasses,
soybeans
Cabbage, Chinese cabbage, com (pop,
seed, sweet), cucurbits, eggplant, leafy
vegetables, peppers: bell, potatoes,
tomatoes, tomatillos
asparagus, broccoli, Brussels sprouts,
cauliflower, Chinese broccoli, collards
com: sweet (FL only)
alfalfa, corn (pop, field, seed, sweet),
com: field (preplant), range grasses,
soybeans
Conifers (field grown)
confier (field grown)
rose: field grown
Chrysanthemum
rose: greenhouse, ornamental nursery
stock (non-bearing)
rose: field grown
Chrysanthemum
rose: greenhouse
1.21bai/A
0.4 Ib ai/A
0.3 Ib ai/A
0.25 Ib ai/A
0.25 Ib ai/A
0.2 Ib ai/A
0.2 Ib ai/A
0.1 Ibai/A
0.25 Ib ai/A
0.2 Ib ai/A
0.2 Ib
ai/gallon
0.2 Ib
ai/gallon
0.02 Ib
ai/gallon
0.005 Ib
ai/gallon
0.002 Ib
ai/gallon
0.02 Ib
ai/gallon
0.005 Ib
ai/gallon
0.002 Ib
ai/gallon
100 acres
350 acres
350 acres
1200 acres
350 acres
1200 acres
350 acres
350 acres
200 acres
200 acres
40 gallons
40 gallons
40 gallons
1000 gallons
1000 gallons
1000 gallons
1000 gallons
1000 gallons
l.SOxlO'5
l.SOxlO'5
1.30xlO'5
3.80xlO'5
LlOxlO'5
S.lOxlO'5
9.00X10'6
4.50X10'6
6.40X10'6
S.lxlO'6
3.60xlO'5
6.40xlO'5
6.40xlO'6
4.10X10'6
4.10xlO'5
ND
ND
ND
EC
EC
EC
EC
EC
EC
EC
PPE-G-80%R
PPE-G-DL-
80%R
PPE-G-80%R
PPE-G-DL
PPE-G-DL
PPE-G-DL
PPE-G-DL
PPE-G-DL
ND
ND
ND
33
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Table 15: Permethrin Occupational Handler Cancer Risk Estimates Between 10"4 and 10"6
Exposure Scenario
Mixing/loader/applying
Wettable Powder with via
Cold Fogger (28)
Use Site
mushroom houses
Indoor surfaces
Application
Rate
0.0078 Ib ai/
sqft
0.00036 Ib
ai/cu ft
Area Treated
Daily or
Amount
Applied per
Day
40000 sq ft
(8000 sq ft per
house)
200000 cu ft
Baseline PPE
& Gloves
1.2xlO'6
2.8xlO'7
PPE to Reach
LOC
PPE-G-DL
PPE-G-DL
Emulsiflable Concentrate (EC)
Applying EC via dip (8)
Mixing/loading/applying EC
with a handgun sprayer (16)
Mixing/loading/applying EC
with low pressure handwand
(15)
Mixing/loading/applying EC
with a high pressure
handwand (17)
Mixing/loading/applying EC
Liquids via Fogger/Mist
Generator (30)
Mixing/loading/applying EC
with an injector (18)
animal: livestock (beef and dairy
cattle), horses, swine
animal: dogs
Military battle dress
Conifers (field grown)
perimeter treatment
ornamental: outdoor
Termites
rose: field grown
agricultural premises
Chry santhemum
animal: poultry
Animal premises
indoor spaces
Termites
0.0023 Ib
ai/animal
0.005 Ib
ai/dog
0.000001 lib
ai/cm2 of
fabric
0.2 Ib
ai/gallon
0.08 Ib
ai/gallon
0.046 Ib
ai/gallon
33.2 Ib
ai/1000 linear
feet
0.02 Ib
ai/gallon
0.012 Ib
ai/gallon
0.005 Ib
ai/gallon
0.00027 Ib
ai/animal
0.012 Ib
ai/1000 sqft.
0.00036 Ib
ai/lOOOcuft.
0.08 Ib
ai/gallon
400 animals
10 gallons
1000 gallons
500 gallons
1000 gallons
1000 linear
feet
1000 gallons
1000 gallons
1000 gallons
4000 gallons
1000 sqft
lOOOcuft
2000 gallons
ND
ND
ND
2.80xlO'5
5.5xlO'6
6.30X10'6
5.90X10'6
1.90X10'5
l.lOxlO'5
4.60x1 0'6
2.50xlO'5
ND
ND
1.70X10'5
ND
ND
ND
NF
PPE-G-DL
PPE-G-DL-
80%R
PPE-G-DL-
90%R
PPE-G-DL
PPE-G-DL
PPE-G-DL
PPE-G-DL
ND
ND
PPE-G-DL
Dust Formulation
Applying Dusts via
Mechanical Duster (11)
Applying Dusts via Dust Bag
(12)
animal : dairy and beef cattle, horses
animal : poultry
animal: swine
animal : dairy and beef cattle, horses
0.000031 Ib
ai/animal
0.0025 Ib
ai/animal
.00016 Ib
ai/animal
0.000031 Ib
ai/animal
400 animals
100,000
animals
400 animals
400 animals
ND
ND
ND
ND
ND
ND
ND
ND
34
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Table 15: Permethrin Occupational Handler Cancer Risk Estimates Between 10"4 and 10"6
Exposure Scenario
Loading Dusts via
Mechanical Duster (2d) -
using PHED data for WP
Applying ready to use
formulations via RTU Ear
Tag (32)
Applying RTU formulations
via hands (3 3)
Applying RTU formulations
via wipes (34)
Applying RTU formulations
via Protective Flanges (38)
Applying RTU Vapor
Recovery Systems (39)
Use Site
animal: swine
animal: poultry
Animal
animal: dogs
animal: dogs, horses
Ants
Engines
Application
Rate
.00016 Ib
ai/animal
0.0025 Ib
ai/animal
0.0044 Ib ai/2
ear tags
0.0062 Ib
ai/animal
0.0062 Ib
ai/animal
ND
0.000189 Ib
ai/tube
Area Treated
Daily or
Amount
Applied per
Day
400 animals
100000
animals
400 cattle (2
tags/cattle)
8 animals
8 animals
ND
ND
Baseline PPE
& Gloves
ND
3. 20x1 0'5
ND
ND
ND
ND
ND
PPE to Reach
LOG
ND
NF
ND
ND
ND
ND
ND
ND= No Data
NF= Not feasible to reach 10" range with highest level of PPE.
None of the occupational handler scenarios assessed in Table 15, for which there is
available exposure data, have non-cancer MOEs <100 or cancer risks estimates greater than 1 x
10"4 at some level of PPE. Further, most cancer risk estimates are less than 1 x 10"6 with some
level of PPE. However, there are several occupational scenarios that the Agency was unable to
assess due to lack of data. The Agency believes that other scenarios assessed are appropriate
surrogates for some of these uses. In other cases, where the use is specialized and/or the Agency
does not believe other scenarios assessed are an appropriate surrogate for the use, the Agency
will require additional data.
b. Occupational Post-Application Exposure and Risk
The Agency uses the term "post-application" to describe exposures to individuals that
occur as a result of being in an environment that has been previously treated with a pesticide
(also referred to as reentry exposure). There are distinct job functions or tasks related to the
kinds of activities that occur in previously treated areas. Job requirements (e.g., the kinds of jobs
to cultivate a crop), the nature of the crop or target that was treated, and the degradation of
residues in the environment can cause exposure levels to differ over time. Each factor has been
considered in this assessment. Additionally, the EPA considered post-application risks for both
agricultural scenarios and impregnated clothing scenarios.
i. Agricultural Scenarios
To assess post-application exposures and risks, the Agency estimates the amount of
contact with a treated surface a worker likely would have while doing a specific post-application
task or activity, such as hand harvesting, conducting scouting activities, crop maintenance tasks
35
-------
(e.g., irrigating, hoeing and weeding), and turf maintenance. To determine the amount of post-
application exposure for each crop and post-application activity, the EPA used dislodgeable
foliar residue (DFR) and turf transferable residue (TTR) data in the post-application risk
assessment. The Agency's standard transfer coefficients were also used to assess worker reentry
exposures. EPA has received permethrin-specific post-application DFR data on cotton and
peaches, as well as TTR data from treated turf. DFR data do not cover all crops treated with
permethrin; therefore, the existing DFR data were extrapolated to the remaining crops by
considering the effects of application method, crop type, and climate.
Post-application exposures are calculated by multiplying the DFR or TTR concentrations
and transfer coefficients factors by an 8 hour work day. Exposures are then normalized by body
weight and adjusted for dermal absorption (if necessary) to calculate absorbed doses. Risk
estimates were then calculated. Post-application risks diminish over time because permethrin
residues eventually dissipate in the environment. As a result, risk values were calculated over
time based on the specified retreatment interval and the changing residue levels over that time.
Permethrin labels specify retreatment intervals as needed or 7 days, except for conifers grown for
seed where the retreatment interval is 28 days. The risk assessment assumed the average foliar
residue between 1 to 7 days for all crop scenarios, except conifer seed cone harvesting, which
assumed an average foliar residue value between 1 to 28 days.
The use of personal protective equipment or other types of equipment to reduce
exposures for post-application workers is not considered a viable alternative for the regulatory
process. This is described in some detail in EPA's Worker Protection Standard (40CFR170).
However, the Restricted-Entry Interval (REI) is an approach to reduce the risks. The REI is the
required time period following a pesticide application during which entry into the treated area is
restricted. The REI on current permethrin labels is 12 hours.
EPA assessed the post-application exposure to permethrin to both hired hand and migrant
agricultural workers. The Agency assumed growers and hired hands would perform post-
application activities 10 days per year and migrant workers would perform post-application
activities 30 days per year. Inhalation exposures are thought to be negligible in outdoor post-
application scenarios, because of the low vapor pressure and due to the infinite dilution expected
outdoors. As such, inhalation post-application exposures are not considered in this assessment.
The Agency assessed 20 post-application crop scenarios, with various post-application activities
or tasks associated with each crop scenario.
For short- and intermediate-term post-application exposure, the target MOE is 100. For
all agricultural post-application scenarios assessed, the non-cancer risks do not exceed the level
of concern (MOEs > 100) on the day of application, approximately 12 hours following
application. The MOEs range from 1,900 to 130,000 and are, therefore, not tabulated in this
document. A summary of the results for each post-application crop/activity combination
considered is detailed in the Permethrin: Third Revision of the Occupation and Residential
Exposure Assessment for the Reregistration Eligibility Decision Document, dated April 4, 2006.
As stated in the section above, the Agency generally considers occupational cancer risks
within the range of 1 to 3 x 10"6 (approximately 1-3 in 1 million persons) or less to be negligible,
36
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but will consider risks as high as 1 x 10"4 (1 in 10,000 persons) when all mitigation measures that
are practical and feasible have been applied and when there are critical pest management needs
associated with the use of the pesticide. Most of the post-application cancer risk estimated for
both hired hands and commercial/migratory farm workers are in the 10"5 to 10"7 range. The
highest risk estimates, in the 10"4 range, are for conifer seed cone harvesting and thinning of
certain fruit trees. Table 16 below summarizes the post-application scenarios for migratory
workers that result in cancer risk estimates between 10"4 and 10"6. These present the worst case
cancer risk estimates since the Agency assumed migratory workers are exposed to post-
application residues of permethrin for 30 days per year for 35 years.
Table 16: Permethrin Occupational Post-Application Cancer Risk Estimates for Migrant Workers Between 10" and
106
Crop
conifer seed orchard
apples, pears
almonds, filberts, pistachios, walnuts
cherries: sweet and sour, nectarines,
peaches
avocados, conifer (field grown-
christmas trees), papayas
ornamentals
alfalfa, soybeans
corn
curbits
onions: dry bulb, garlic
potatoes
Activity
seed cone harvesting
thinning
hand-weeding, irrigation, scouting
hand-harvesting, hand-pruning,
propping, training
hand-weeding, irrigation, scouting
thinning
hand-harvesting, hand-pruning
hand-weeding, irrigation, scouting
thinning
hand-pruning
hand-weeding, scouting
hand-prunning
hand-harvesting
irrigating, scouting (full development)
detasseling, hand-harvesting
hand-harvesting, hand-pruning
irrigating, scouting
hand-harvesting
hand-weeding, irrigating, scouting,
thinning (min development)
hand-harvesting
Cancer Risk Estimate
(30 days/yr for 35 yr)
i.90xicr4
9.60xl(r5
4. 80x1 0'5
4.80xl(r5
3.20xl(r5
7.20x1 0'5
3.50xlO'5
2.40x1 0'5
4.80xlO'5
2.40xlO'5
1.60xlQ-5
6.40X10'6
9.10xlO'6
5.40X10'6
6.20xlO'5
9.10X10"6
5. 40x1 0'6
1.20xlO'5
8.20X10'6
9.10X10'6
37
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Table 16: Permethrin Occupational Post-Application Cancer Risk Estimates for Migrant Workers Between 10"4 and
106
Crop
turnips
cabbage
broccoli, Brussels sprouts, cauliflower,
Chinese broccoli
collards
Chinese cabbage, leafy vegetables
artichokes
cut flowers
Activity
hand-weeding, irrigating, scouting,
thinning (full development)
hand-harvesting
hand-harvesting, hand-pruning,
irrigating
scouting
hand-weeding
hand-harvesting, hand-pruning,
irrigating
scouting
hand-weeding
hand-harvesting
hand-harvesting
irrigating, scouting, thinning (all at
medium development)
hand-harvesting, hand-pruning
cut roses
Cancer Risk Estimate
(30 days/yr for 35 yr)
5. 40x1 0'6
4.50X10'6
1.80xl(T5
i.soxicr5
7.20x1 0'6
9.10X10'6
7.20x1 (T6
3. 60x1 0'6
4.50xlO'6
Q.lOxlO'6
5. 40x1 0'6
5. 40x1 0'6
1.40xlO'5
ii. Impregnated Clothing Scenarios
The Agency considered two different types of occupational post-application exposures to
permethrin treated clothing: military personnel who wear battle dress impregnated with
permethrin on a daily basis (i.e., approximately 250 days/year) and factory workers who work
with fabric or clothing after impregnation during making of garments or packaging of clothing
on a work-day basis (i.e., 250 days/year).
Since both post-application occupational exposures are more than 180 days per year, the
duration of exposure considered for this non-cancer assessment is long-term. The cancer
assessment assumed that these populations would be exposed to permethrin from post-
application activities involving impregnated clothing 250 days per year. These assumptions are
conservative in nature and were selected based on best professional judgment. Inhalation
exposures are thought to be negligible for post-application scenarios involving exposure to
permethrin-impregnated clothing, and as such, inhalation post-application exposures are not
considered in this assessment.
When assessing post-application exposures to impregnated clothing, EPA used the latest
approaches to estimate the post-application exposures. The data required for estimating post-
38
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application potential doses include the clothing residue concentration (assumed to be equivalent
to the application rate on a mass per area basis, as determined from the label), surface area of the
skin that is in contact with the fabric, the transfer factor, and the body weight. EPA estimated
exposures to permethrin-impregnated clothing by considering exposure frequency and duration,
as well as degree of contact.
Dermal exposures to military personnel are based on the clothing contact surface area of
adults exposed to permethrin-impregnated clothing (0.85 m2). This number is based on the
assumption that military personnel wear briefs and undershirts underneath the battle dress and,
therefore, the surface area of arms and legs (but not the torso) for an adult are used. Dermal
exposures to garment workers are based on the contact surface area of adults exposed to
permethrin impregnated clothing in a factory after the impregnation process (0.22 m2). This
number is based on the hands and forearms of an adult garment worker.
For the cancer assessment, risks were calculated for wearing impregnated military
clothing calculated to have an average exposure level of 0.038 mg permethrin/cm2. This average
was calculated by assuming the uniform is usable for up to 30 washes and that the first wash
results in a 33% permethrin loss, the second wash results in a 6% permethrin loss, washes 3
through 10 each result in a 3% permethrin loss, and washes 11 through 30 result in a total loss of
6.5% permethrin (MRID 457519-02). It was also assumed that each individual would wear a
uniform for 7 days before a washing event took place to take into account military personnel
being in the field for extended periods of time. Further, the exposure durations for military
personnel and garment workers were assumed to 10 and 35 years, respectively.
All non-cancer post-application exposure scenarios for permethrin-impregnated clothing
do not exceed the Agency's level of concern. The MOEs are 6,700 and 26,000 for military
personnel and garment workers, respectively. Further, all of the post-application cancer risk
estimates for both populations are in the 10"6 range. The cancer risk estimates are 3.2 x 10"6 and
9.5 x 10"6 for military personnel and garment workers, respectively.
c. Incident Reports
The Agency evaluated reports of human permethrin poisonings and adverse reactions
associated with its use from the following sources: OPP Incident Data System (IDS); Poison
Control Center Data; California Pesticide Illness Surveillance Program; National Pesticide
Information Center (NPIC); the National Institute of Occupational Safety and Health; and
scientific literature. Review of these data sources concluded that it is likely that most poisonings
from permethrin resulted from misuse or inadvertent exposures. The large majority of cases
resulted in minor effects to the skin (primarily rash, irritation, itching), eyes (redness, pain,
burning), headache, dizziness, nausea, vomiting, and shortness of breath or difficulty breathing.
Loss of consciousness appears to occur only in cases of ingestion involving 700 mg/kg body
weight or more. Persons handling permethrin directly are the most likely to experience
symptoms. Permethrin does not appear to pose significant risks from exposure to residues or
drift, based upon a relatively small number of documented cases.
39
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Compared to other pesticides, permethrin is much less likely to result in serious or
persistent medical outcome/condition. Even ingestion of suicidal or potentially lethal doses can
be resolved within a few days with medical treatment. The only death reported was due to
pneumonitis, and was likely due to xylene solvent rather then permethrin. Although it is a
relatively safe product, it can aggravate asthma or lead to asthma like symptoms.
The EPA performed a review of animal incidents reported between April 1, 1998 to
March 31, 2002. For permethrin containing products, there were 18,343 incidents involving
domestic animals. The products were either used directly on the animals or for other uses, such
as household ant or roach killer. There have also been severe adverse reactions, including
deaths, in cats exposed directly to concentrated permethrin products or secondarily exposed to
treated dogs. As such, the registrants voluntarily included a warning statement on permethrin
concentrated spot-on products indicating they are highly toxic to cats.
B. Environmental Fate and Effects Risk Assessment
A summary of the Agency's environmental fate and effects risk assessment is presented
below. For detailed discussion of all aspects of the environmental risk assessment, please see the
Agency Revised Risk Assessment for the Reregistration Eligibility Decision on Permethrin After
Public Comments, Phase III, dated April 5, 2006, which is available on the internet and in the public
docket. This risk assessment was refined and updated to incorporate comments and additional
studies submitted by the registrant. Major changes to the risk assessment include the following:
• Consideration of 150 and 25 foot buffer zone for aerial and ground agricultural
applications consistent with the buffer zones required for all pyrethroids;
• Clarification of agricultural use patterns, such as typical application rates and
number of applications;
• Revisions to the public health use parameters based on the provisions of the PR
Notice 2005-1, which aims to standardize the use of public health use pesticides.
• Modification to the down-the-drain residential assessment to include revised
production numbers of permethrin used in pharmaceuticals provided by the US
Food and Drug Administration (FDA).
1. Environmental Fate and Transport
Permethrin is a persistent pyrethroid in the environment, and was immobile in several
soils tested, both sterile and viable (Koc >5000). It is also slow to hydrolyze and biodegrade. It
is relatively stable to hydrolysis at pHs ranging from 3 to 7 when stored in the dark at 25°C. At
pH 9, permethrin degraded very slowly with a half-life of 125-350 days. The half-life reported
for permethrin in an anaerobic aquatic study ranged from 113 days to 175 days, which indicates
that the degradation in soil and water is slower as the oxygen levels are reduced. The relatively
low water solubility and hydrophobic nature of permethrin leads to strong soil adsorption and a
tendency to partition to sediment in aquatic systems. The high octanol/water partition coefficient
suggests that permethrin will bioconcentrate in aquatic organisms. Permethrin has a vapor
pressure of 2.15xlO"8 mm Hg, water solubility of 0.0055 mg/L, and an estimated Henry's law
constant of 1.4xlO"6 atm-mVmol. Based upon its Henry's law constant and vapor pressure,
40
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permethrin is expected to have a relatively low potential for volatilization from soil and water
surfaces. Permethrin's potential for volatilization is also reduced significantly because it adsorbs
strongly to soils and suspended solids or sediment in the water column.
Based on laboratory and field studies that were submitted to the Agency, permethrin has
very low mobility, is moderately persistent and has a high affinity to bind to soils/sediments and
organic carbon. This compound binds readily to particulate matter and organic carbon in a lake
or stream, thus possibly reducing its bioavailability in this medium after 48 hours. However, as
the particulate-bound permethrin settles out of the water column and onto the benthos, there is an
increase in permethrin sediment concentrations that could result in toxic exposure to benthic and
epibenthic aquatic organisms (e.g., early life stage of many invertebrates and fish, as well as
crabs and shrimp).
Additionally, like several other chemicals in its class, permethrin can reach surface
waters by spray drift or in runoff events via erosion. However, as opposed to many other
synthethic pyrethroids, permethrin labels currently do not have a required buffer zone to protect
bodies of water against spray drift. In addition to drift and runoff from agricultural areas,
permethrin residues can also be transported to aquatic systems via release of water from
wastewater treatment plants. The Agency assessed the occurrence of permethrin residues being
found in wastewater as a result of laundering permethrin treated clothing and the disposal
wastewater from of other household uses (e.g., pet shampoo and pharmaceutical shampoo
rinsate).
2. Ecological Exposure and Risk
To estimate potential ecological risk, EPA integrates the results of exposure and
ecotoxicity studies using the risk quotient method. Risk quotients (RQs) are calculated by
dividing acute and chronic estimated environmental concentrations (EECs), based on
environmental fate characteristics and pesticide use data, by ecotoxicity values for various
wildlife and plant species. RQs are then compared to levels of concern (LOCs), and when the
RQ exceeds the level of concern for a particular category, the Agency presumes a risk of concern
to that category. In general, the higher the RQ, the greater the potential risk (see Table 17 below
for the Agency's LOCs). Risk characterization provides further information on potential adverse
effects and the possible impact of those effects by considering the fate of the chemical and its
degradates in the environment, organisms potentially at risk, and the nature of the effects
observed. To the extent feasible, the Agency seeks to reduce environmental concentrations in an
effort to reduce the potential for adverse effects to non-target organisms.
Table 17. EPA's Levels of Concern (LOCs) and Risk Presumptions
If a calculated RQ is greater than the LOG presented, then the Agency presumes
that...
Acute Risk . . .there is potential for acute risk; regulatory action may be warranted in
addition to restricted use classification
Acute Restricted Use . . .there is potential for acute risk, but may be mitigated through
restricted use classification
LOC
terrestrial
animals
0.5
0.2
LOC
aquatic
animals
0.5
0.1
LOC
plants
1.0
NA
41
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Table 17. EPA's Levels of Concern (LOCs) and Risk Presumptions
If a calculated RQ is greater than the LOG presented, then the Agency presumes
that...
Acute Endangered Species ...endangered species may be adversely affected
Chronic Risk . . .there is potential for chronic risk
LOC
terrestrial
animals
0.1
1
LOC
aquatic
animals
0.05
1
LOC
plants
1.0
NA
For permethrin, the Agency modeled EECs for six crop scenarios, which are listed in Table 18
below. The scenarios were selected to represent a variety of crops among the major uses, and a
variety of sites in the U. S.
Table 18: Input parameters for permethrin used in PRZM/EXAMS
Crop
Alfalfa
Corn
Potatoes
Sweet Corn
Apples
Tomatoes
Modeled Location
California
North Dakota
Maine
Oregon
Pennsylvania
Florida
Max. App. Rate* (Ib ai/A)
[Typical App. Rate**]
0.2 [0.1]
0.2 [0.8]
0.2 [0.11]
0.2 [0.15]
0.3 [0.13]
0.2 [0.13]
Maximum # of Apps.*
[Typical #**]
5[1]
3[1]
8[1]
6 [2]
2[1]
6 [7]
*The maximum application rates and number of applications were derived from currently registered labels.
**The data for the typical application rates and number of applications are from EPA and USD A National
Agricultural Statistics Service (NASS) databases for the years 2002-2004, and reflect the annual number of
applications, and maximum annual application rate for the selected crops for the US. The annual averages are
straight averages. The National Potato Council provided typical use information, which was corroborated by the
Agency and used in the assessment.
a. Terrestrial Organisms
Birds and Mammals
The Agency terrestrial exposure model (ELL-FATE, Version 1.4, dated April 7, 2004)
was used to estimate exposures and risks to avian and mammalian species. Input values on avian
and mammalian toxicity, as well as chemical application and foliar dissipation half-time data, are
required to run the model. The model provides estimates of both exposure concentrations and
RQs. Specifically, the model provides estimates of concentrations (maximum and average) of
chemical residues on the surface of different types of foliage that may be sources of exposure to
avian, mammalian, reptilian, or terrestrial phase amphibian receptors. The surface residue
concentration (ppm) is estimated by multiplying the application rate (pounds active ingredient
per acre) by a value specific to each food item.
ELL-FATE was run for permethrin for use on potato crops using the inputs provided in
Table 19 below. In the absence of foliar dissipation half-life data for permethrin the Agency's
42
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default half-life value of 35 days because the Agency did not have half-life data for the crops
used in the assessment.
Table 19: Input Parameters for Permethrin Used in ELL-FATE.
Parameter
Application rate (Ibs ai/A)
Foliar half -life (days)
Retreatment interval (days)
Maximum applications per year
Value
0.2
35
4
8
Effects characterization describes the potential effects a pesticide can produce in a
terrestrial organism, and is based on registrant-submitted studies that describe acute and chronic
effects toxicity information for various terrestrial animals. Table 20 summarizes the toxicity
effects and reference values used to assess risks for permethrin to mammals and birds.
Table 20. Toxicity Reference Values for Mammals and Birds for Permethrin.
Exposure
Scenario
Species
Exposure Duration
Toxicity
Reference Value
Toxicity Category/
Effect
Mammals
Acute
Chronic
Rat
Rat
Single dose
Developmental
Toxicity
LD50 = 8,900 mg/kg /day
NOAEC = 1,000 ppm (50
mg/kg/day)
LOAEC =3,000 ppm
(150 mg/kg/day)
Practically non-toxic
Decreased mean fetal
bodyweight
Birds
Acute
Chronic
Mallard duck
Mallard duck
5 -day dietary
Reproduction study
LC50 > 10,000 ppm
NOAEC = 500 ppm
Practically non-toxic
Slight decrease in egg
production
As presented in Table 21 below, avian acute RQs are below the acute, restricted use, and
endangered species LOCs and the chronic RQs are below the chronic LOG at registered
maximum application rates for permethrin for all forage items.
Table 21. Acute and Chronic Risk Quotients for Birds Exposed to Permethrin
Food Item
Short grass
Tall grass
Maximum EEC (ppm)
295.8
135.6
Bird
Acute RQs
0.03
0.01
Bird
Chronic RQs
0.59
0.27
43
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Table 21. Acute and Chronic Risk Quotients for Birds Exposed to Permethrin
Food Item
Broadleaf plants
small insects
Fruits, pods,
large insects, seeds
Maximum EEC (ppm)
166.4
18.5
Bird
Acute RQs
0.02
<0.01
Bird
Chronic RQs
0.33
0.04
Table 22 below presents the acute RQs for small mammalian species that forage on plants
and insects containing permethrin residues. All acute RQs were below the acute LOG for each
environmental scenario and therefore not of concern.
Table 22. Acute Risk Quotients for Terrestrial Mammals Exposed to Permethrin
Food Item
Short grass
Tall grass
Broadleaf plants
small insects
Fruits, pods,
large insects, seeds
Maximum EEC
(ppm)
295.8
135.6
166.4
18.5
Mammal Acute RQs
by Body Weight
15g
35 g
1000 g
Chronic RQs for mammals were calculated using the results of a developmental toxicity study
performed with rats. Dose based RQs based on the Maine Potatoe scenario, which is the most
conservative of the crop scenarios assessed, range from 0.02 to 2.57. This study was conducted via
oral gavage and represents a more intense dosing regime than that of the 3-generation rat
reproduction studies (dietary exposure) which the Agency typically relies on to estimate chronic
effects and risk to mammals. Therefore, given the questionable toxicological response and the
intense dosing regime, it should be noted that this NOAEC represents a conservative estimate of
toxicity and its use may result in the overestimation of chronic risk to mammals. Thus, the
results are not tabulated in this document. The Agency is not requiring additional data at this
time. For more details, refer to the Addendum to Revised Draft EFED RED Chapter for
Permethrin, dated April 5, 2006.
Non-Target Insects
EPA currently does not estimate RQs for terrestrial non-target insects. However, permethrin
toxicity data show that the compound is highly toxic to honeybees, as well as beneficial insects.
A hazard assessment shows that permethrin exposure can result in acute toxicity to honeybees
and is considered to be highly toxic on both a contact and an oral basis (contact LD50 = 0.13
ug/bee; oral LDso = 0.024 ug/bee). Permethrin was also found to be highly toxic to honeybees
exposed to foliage that had been sprayed with a permethrin formulation. Several field studies
were submitted that showed the effects of permethrin formulations on non-target insects. These
studies show that applications of formulations of permethrin are likely to reduce the numbers and
possibly eliminate populations of beneficial insects.
44
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Non-Target Plants
Toxicity data are not available for terrestrial plants. Therefore, the potential for risk to
terrestrial plants from exposure to permethrin cannot be assessed, and remains an uncertainty.
However, any toxicity to plants would occur for reasons other than permethrin's insecticidal
mode of action, because permethrin works in insects as a neural toxin. Unlike insects, plants do
not have neural networks that could be affected.
b. Aquatic Organisms
i. Agricultural Use of Permethrin
Freshwater and Estuarine/Marine Fish and Invertebrates
To assess potential risks to aquatic animals, the Agency considers predicted EECs in surface
water using the Tier II model PRZM/EXAMS. Unlike the drinking water assessment described in the
human health risk assessment section of this document, the exposure values used in the ecological risk
assessment do not include the Index Reservoir (TR) and Percent Cropped Area (PCA) factor
refinements. These factors represent a drinking water reservoir, not the variety of aquatic habitats
relevant to a risk assessment for aquatic animals, such as ponds adjacent to treated fields. Therefore,
the EEC values used to assess potential exposure and risk to aquatic animals are not the same as those
used to assess exposure and risk to humans from pesticides in drinking water.
Peak EECs were compared to acute toxicity endpoints to derive acute RQs. The highest
EECs were observed for the Maine potatoes scenario followed by Pennsylvania apples. These
results are summarized in The Agency Revised Risk Assessment for the Reregistration Eligibility
Decision on Permethrin After Public Comments, Phase III, dated April 5, 2006.
Effects characterization describes the potential effects a pesticide can produce in an
aquatic organism, and is based on registrant-submitted studies that describe acute and chronic
effects toxicity information for various aquatic animals. Table 23 summarizes the toxicity
effects and reference values used to assess risks for permethrin to aquatic organisms.
Table 23. Permethrin Toxicity Reference Values for Aquatic Organisms
Exposure Scenario
Species
Exposure
Duration
Toxicity Reference Value
(Ppb)
Toxicity Category/
Effect
Freshwater Fish
Acute
Chronic
Bluegill sunfish
Fathead minnow
96 hours
Full life cycle
LC50 =0.79 ppb
NOAEC = 0.30 ppb
LOAEC = 0.41 ppb
Very highly toxic
Reduced survival
Freshwater Invertebrates
Acute
Hexagenia
bilineuta
48 hours
EC50 = 0.1 ppb
Very highly toxic
45
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Table 23. Permethrin Toxicity Reference Values for Aquatic Organisms
Exposure Scenario
Chronic
Species
Daphnia magna
Exposure
Duration
Life cycle
Toxicity Reference Value
(ppb)
NOAEC = 0.039 ppb
LOAEC = 0.084 ppb
Toxicity Category/
Effect
Reproduction and growth
Estuarine/Marine Fish
Acute
Chronic
Atlantic silverside
Sheepshead
minnow
96 hours
28 day early life
stage
LC50 = 2.2 ppb
NOAEC 0.83 ppb1
LOAEC 10 ppb
Very highly toxic
Reduced survival
Estuarine/Marine Invertebrates
Acute
Chronic
Mysid shrimp
Mysid shrimp
96 hours
30 day life cycle
LC50 = 0.019 ppb
NOAEC = 0.011 ppb
LOAEC = 0.024 ppb
Very highly toxic
Mortality
As noted in Table 18, the Agency considered the maximum labeled application rate, as
well as the typical use scenario in order to evaluate the potential for permethrin to cause acute
and chronic toxic risk to fish and aquatic invertebrates (freshwater and estuarine/marine). As
presented in Table 34, at the maximum application rates, most acute RQs for both freshwater and
estuarine/marine fish and invertebrates exceed the Agency's acute LOG (0.5), and all exceed the
Agency's endangered species LOG (0.05).
Table 24. Acute Risk Quotients for Aquatic Organisms Exposed to Permethrin (no buffer zone; Maximum
application rate and number of applications)
Crop Scenario
California
Alfalfa
Maine Potatoes
North Dakota
Corn
Oregon Sweet
Corn
Pennsylvania
Apples
Florida
Tomatoes
PeakEECs
(ppb)
.54
5.32
0.55
0.96
1.83
1.11
Freshwater RQs
Fish
96 hr. LC50=
0.79 ppb
0.68
6.73
0.7
1.22
2.32
1.41
Invertebrates
96hr.EC50 = 0.10
ppb
5.4
53.2
5.5
9.6
18.3
11.1
Estuarine/Marine RQs
Fish
96 hr. LC50 =
2.2 ppb
0.25
2.42
0.25
0.44
0.83
0.50
Invertebrates
EC50 =
0.0 19 ppb
28.4
280.0
29.0
50.5
96.3
58.4
As presented in Table 25, at the maximum application rates, RQs for both freshwater and
estuarine/marine invertebrates exceed the Agency's chronic LOG (1.0). The RQs for freshwater and
estuarine/marine fish exceed the chronic LOG only for the Maine potato scenario.
46
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Table 25. Chronic Risk Quotients for Aquatic Organisms Exposed to Permethrin [no buffer zone; Maximum
application rate and number of applications)
Crop Scenario
California
Alfalfa
Maine Potatoes
North Dakota
Corn
Oregon Sweet
Corn
Pennsylvania
Apples
Florida
Tomatoes
21-d/60-d
EECs
(ppb)
0.1/0.09
1.3/1.0
0.16/0.11
0.35/0.24
0.29/0.24
0.24/0.18
Freshwater RQs
Fish
NOAEC=
0.30 ppb
0.3
3.4
0.4
0.8
0.8
0.6
Invertebrates
NOAEC=
0.039 ppb
2.6
33.9
4.1
9.0
7.4
6.2
Estuarine/Marine RQs
Fish
NOAEC =
0.83 ppb
0.1
1.23
0.1
0.3
0.3
0.2
Invertebrates
NOAEC =
0.0 11 ppb
9.1
120
14.6
31.8
26.4
21.8
If typical application rates and numbers of applications are considered, all resulting RQs are
reduced from the maximum rate and are listed in Table 26. However, the resulting freshwater and
estuarine/marine invertebrate RQs still exceed the acute and endangered species LOCs for all crops
simulated. All of the freshwater and estuarine/marine fish RQs exceed the endangered species LOG,
and most exceed the acute LOG.
Table 26. Acute Risk Quotients for Aquatic Organisms Exposed to Permethrin (no buffer zone; typical application
rate and number of applications)
Crop Scenario
California
Alfalfa
Maine Potatoes
North Dakota
Corn
Oregon Sweet
Corn
Pennsylvania
Apples
Florida
Tomatoes
Peak EECs
(ppb)
0.24
0.61
0.20
0.43
0.38
0.74
Freshwater RQs
Fish
96 hr. LC50=
0.79 ppb
0.30
0.77
0.25
0.54
0.48
0.93
Invertebrates
96hr.EC50 = 0.10
ppb
2.4
6.1
2.0
4.3
3.8
7.4
Estuarine/Marine RQs
Fish
96 hr. LC50 =
2.2 ppb
0.11
0.28
0.09
0.20
0.17
0.34
Invertebrates
EC50 =
0.0 19 ppb
12.6
32.1
10.5
22.6
20.0
39.0
For typical use scenarios, RQs for both freshwater and estuarine/marine invertebrates exceed
the Agency's chronic LOG (1.0) in most cases, and are presented in Table 27. The RQs for freshwater
and estuarine/marine fish calculated for typical use scenarios do not exceed the chronic LOG.
47
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Table 27. Chronic Risk Quotients for Aquatic Organisms Exposed to Permethrin [no buffer zone; typical
application rate and number of applications)
Crop Scenario
California
Alfalfa
Maine Potatoes
North Dakota
Corn
Oregon Sweet
Corn
Pennsylvania
Apples
Florida
Tomatoes
21-d/60-d
EECs
(ppb)
0.1/0.09
1.3/1.0
0.16/0.11
0.35/0.24
0.29/0.24
0.24/0.18
Freshwater RQs
Fish
NOAEC=
0.30 ppb
0.03
0.3
0.03
0.23
0.17
0.43
Invertebrates
NOAEC=
0.039 ppb
0.5
3.1
0.5
2.3
1.5
4.4
Estuarine/Marine RQs
Fish
NOAEC =
0.83 ppb
0.01
0.1
0.01
0.08
0.06
0.16
Invertebrates
NOAEC =
0.0 11 ppb
1.8
10.9
1.8
8.2
5.5
15.5
Effect of Spray Buffers
In addition to considering typical application rates and numbers of applications, the
Agency considered buffer zones proposed by the registrant of 150 ft for aerial applications that
do not involve Ultra Low Volume (ULV) and 25 feet for ground applications. The effects of
spray drift and the use of buffer zones in reducing exposure to bodies of water adjacent to treated
areas were investigated using the AgDRIFT model.
Table 28 and 29 below present the acute and chronic RQs to aquatic organisms, respectively,
exposed to permethrin at the maximum labeled application rates, and with a 150 foot buffer zone for
aerial applications, and 25 feet for ground application (PA Apples).
Table 28. Acute Risk Quotients for Aquatic Organisms Exposed to Permethrin (Buffer Zone 150 ft, 25 ft for PA
apples; Maximum application rate and number of applications)
Crop Scenario
California
Alfalfa
Maine Potatoes
North Dakota
Corn
Oregon Sweet
Corn
Pennsylvania
Apples
Florida
Tomatoes
Peak EECs
(ppb)
0.42
5.27
0.43
0.83
1.83
1.00
Freshwater RQs
Fish
96 hr. LC50=
0.79 ppb
0.53
6.67
0.54
1.05
2.32
1.27
Invertebrates
96hr.EC50 = 0.10
ppb
4.20
52.70
4.30
8.30
18.30
10.00
Estuarine/Marine RQs
Fish
96 hr. LC50 =
2.2 ppb
0.19
2.40
0.20
0.38
0.83
0.45
Invertebrates
EC50 =
0.0 19 ppb
22.11
277.37
22.63
43.68
96.32
52.63
At the maximum application rates, most acute RQs for both freshwater and estuarine/marine
fish, invertebrates, and sediment organisms exceed the Agency's acute LOG (0.5), and all exceed the
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Agency's acute LOG for restricted use risk (0.1) and endangered species (0.05).
Table 29. Chronic Risk Quotients for Aquatic Organisms Exposed to Permethrin [Buffer Zone 150 ft, 25 ft. for PA
apples; Maximum application rate and number of applications)
Crop Scenario
California
Alfalfa
Maine Potatoes
North Dakota
Corn
Oregon Sweet
Corn
Pennsylvania
Apples
Florida
Tomatoes
21-d/60-d
EECs
(ppb)
0.08/0.07
1.28/0.98
0.13/0.09
0.29/0.20
0.28/0.24
0.20/0.15
Freshwater RQs
Fish
NOAEC=
0.30 ppb
0.23
3.27
0.30
0.67
0.80
0.50
Invertebrates
NOAEC=
0.039 ppb
2.05
32.82
3.33
7.44
7.18
5.13
Estuarine/Marine RQs
Fish
NOAEC =
0.83 ppb
0.08
1.18
0.11
0.24
0.24
0.18
Invertebrates
NOAEC =
0.0 11 ppb
7.27
116.36
11.82
26.36
25.45
18.18
In contrast to the acute risk estimate, most of the freshwater and estuarine/marine chronic risks
to fish are below the Agency's chronic LOG (1). However, the chronic RQs for freshwater and
estuarine/marine invertebrates and sediment organisms exceed the LOG (1) in all scenarios.
The effect of a spray buffer on potential exposure may be underestimated by the risk quotients
shown above. AgDrift was used to evaluate the effect of spray buffers on the amount of permethrin
reaching the standard pond via spray drift. However, the PRZM model is an edge-of-field model
which cannot simulate an untreated area between the field and the receiving water body. Therefore,
the RQs for the scenario with the 150-foot buffer reflect the same amount of loading from
runoff/erosion as the RQs with no buffer at all. Presumably, the mass of permethrin that would be
applied to that portion the field within an untreated spray buffer zone would be less than that applied
to the rest of the crop, and would decline with distance, but the resulting reduction in the loading from
runoff and erosion cannot currently be quantified.
All of the risk quotients reflect the same predicted reduction in spray drift for any particular
spray buffer, but different contributions from runoff/erosion. 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 typical drift fractions calculated by AgDrift used for the buffer-
analysis RQs above represent the amount of exposure from spray drift that could occur any time a
pesticide is applied. Therefore, while the buffer may not reduce exposure below LOCs when
permethrin exposure from spray drift coincides with heavy rain events, it will reduce exposure from
spray drift even when runoff does not occur. Comparison of the results from PRZM/EXAMS runs in
the risk assessment performed with varying amounts of spray drift with those from the hypothetical
"no drift" scenario suggests that exposure from drift alone might be enough to exceed some acute
aquatic LOCs.
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Risk to Sediment Dwelling Organisms
The ecological risk assessment also considers the potential for risk to epibenthic and sediment-
dwelling invertebrates from exposure to permethrin in sediment pore water. The risk assessment
estimates pore water exposure to sediment organisms through the use of equilibrium-partitioning
predicted porewater concentrations of permethrin normalized to the organic carbon (OC) in
sediment. Since aquatic invertebrates living in the water column are no less sensitive to toxic
compounds than those invertebrates living in the benthos, and toxicity data were not available for
sediment-dwelling invertebrates, the assessment uses standard water-column toxicity values with
the model-generated porewater exposure values for RQ calculations. As presented in Table 30,
the resulting RQs indicate a potential for acute and chronic risk to epibenthic and sediment-
dwelling invertebrates from exposure to permethrin in sediment pore water, based on maximum
application rates and no buffer zone restrictions.
Table 30. Acute and Chronic Risk Quotients for Aquatic Organisms Exposed to Permethrin in Sediment Pore
Water [no buffer zone; Maximum application rate and number of applications)
Crop Scenario
California
Alfalfa
Maine Potatoes
North Dakota
Corn
Oregon Sweet
Corn
Pennsylvania
Apples
Florida
Tomatoes
Acute/Chronic
pore water
EECs
(ppb)
0.05/0.05
0.56/0.55
0.05/0.05
0.12/0.12
0.12/0.12
0.08/0.07
Acute RQs
Freshwater
Invertebrates
EC50 =
0.1 ppb
0.5
5.6
0.5
12.0
12.0
0.80
Estuarine/Marine
ECso =
0.019 ug/L
2.6
29.5
2.6
6.3
6.3
4.2
Chronic RQs
Freshwater
Invertebrates
NOEC =
0.039 ppb
1.3
14.1
1.3
3.1
3.1
1.8
Estuarine/Marine
Invertebrates
NOEC =
0.0 11 ug/L
4.6
50
4.6
10.9
10.9
6.4
Non-Target Plants
Toxicity data are not available for aquatic plants. Therefore, the potential for risk to
aquatic plants from exposure to permethrin cannot be assessed, and remains an uncertainty.
However, any toxicity to plants would occur for reasons other than permethrin's insecticidal
mode of action, because permethrin works in insects as a neural toxin. Unlike insects, plants do
not have neural networks that could be affected.
a. Public Health Use of Permethrin
Permethrin is registered as a mosquito adulticide for use in Public Health Abatement
Programs. Permethrin used in mosquito abatement programs to control adult mosquitoes in
residential and recreational areas can lead to potential exposure to various types of water bodies. The
Agency conducted aquatic exposure modeling for mosquito abatement to consider the risk to aquatic
organisms from this use of permethrin.
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Mosquito adulticides are more efficacious if they come into contact with insects in flight. For
that reason, mosquito abatement using permethrin (as well as other mosquito adulticides) is typically
applied via aerial spray methods with very fine mists to prevent immediate deposition of the pesticide.
Therefore, the modeling approach for this type of use included calculations of spray drift using the
Agricultural Disperal (AGDISP) model. This model estimates the deposition of the pesticide to the
treatment area and deposition assessment to the adjacent bodies of water (i.e. standard pond).
Most input parameters are standard for AGDISP; however, some are variable. For example,
the temperature and relative humidity were selected to be similar to those conditions where
mosquitoes grow, a wind speed of 10 miles per hour was selected, a low evaporation rate was
assumed, and the volatile fraction was very small. The current permethrin labels vary in their
specificity of application parameters (i.e. boom height, droplet size, application rate, and number of
applications). Therefore, the Agency relied upon the guidelines and recommendations in the
Pesticide Registration (PR) Notice 2005-1, which presents Agency guidance for pesticide
products intended for wide-application to control adult mosquitoes. The specific label
statements and label organization principles recommended in the Notice are intended to improve
existing labels by clarifying language conveying environmental hazards posed by the products,
as well as specific use direction and instructions to the applicators. The Agency also considered
public comments submitted to the Agency by the American Mosquito Control Association
(AMCA) during Phase 3 of the public process for reregistering pesticides.
Most labels specify a maximum boom height of 300 feet; however, most do not specify a
minimum boom height. The Agency initially assumed a minimum boom height of 25 feet. However,
following receipt of comments from the AMCA that most applications do not take place lower than
100 and 75 feet for fixed wing and helicopters, respectively, the Agency also assessed minimum
boom heights of 75 and 100 feet. The current and proposed labels provide a range of droplet size
ranging from 20 to 50 ug; however, the proposed labels recently submitted to the Agency in response
to PR-2005-1 propose a droplet size of 60 ug. Larger droplets are expected to result in higher
deposition and potential exposure in the spray area, but lower deposition outside the spray area. In
order to be conservative in its assessment, the Agency considered the two larger sized droplets, 50 ug
and 60 ug, in the risk assessment. Based on the Agency's assessment there was little difference in risk
to aquatic organisms between 50 ug and 60 ug.
Currently, the maximum application rate registered for aerial application is 0.021 Ib ai/A;
however, according to the AMCA and technical registrant, this is rate is hardly used. The "high-end"
application rate used in mosquito abatement programs is 0.007 Ib ai/A, and the "typical" application
rate is 0.0035 Ib ai/A. The Agency assessed both the proposed high-end and typical application rates
in the risk assessment. Further, most permethrin labels do not specify the number of applications and
application timing. The Agency assumed 26 applications per site per season in the risk assessment
based on use data provided for another mosquito adulticide.
Finally, the current permethrin mosquito adulticide labels maintain a 100-foot buffer zone
between the treated area and any body of water. However, according to PR-2005-1 the buffer zone
may not be warranted, because it was added to labels out of concern for aquatic toxicity that might
result due to runoff from agricultural sites, and not as a result of risks associated with the significantly
lower concentration of the active ingredient involved in ULV mosquito control applications. Further,
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the PR Notice contends that protecting human health from mosquito-borne diseases with pesticides
now available often involves some degree of ecological risks, and that a buffer zone may require
leaving potentially infested areas untreated. Therefore, to determine the extent of the ecological risk,
and the need for a buffer zone on permethrin mosquito adulticide labels, the Agency considered a
zero, 100, and 150 foot buffer zone in its assessment.
The Agency assessed a number of scenarios with different variables, such as boom height and
application rate, with the various buffer zones (zero, 100 ft, and 150 ft). Based on the risk estimates,
the Agency concluded for the public health use of permethrin, a buffer zone does not serve to reduce
the potential risk to aquatic organisms. Further, a zero foot buffer zone and a minimum boom of 100
ft results in over a 50% reduction in acute and chronic exposure to aquatic fish and invertebrates as
compared to a 75 ft. boom height. Additionally, as stated above, there was little difference in risk to
aquatic organisms between 50 ug and 60 ug. For more detail on the various scenarios assessed, refer
to The Agency Revised Risk Assessment for the Reregistration Eligibility Decision on Permethrin
After Public Comments, Phase III, dated April 5, 2006, available on the internet and in the public
docket.
Based on the conclusions above, the tables below are provided to present the acute and
chronic RQs to freshwater and estuarine/marine fish and invertebrates with a zero foot buffer, a boom
height of 100 feet, and a droplet size of 50 ug. Table 31 presents the RQs when the high-end
application rate is used, and Table 32 presents to RQs when the typical application rate is used.
Table 31. Comparison of the Freshwater and Estuarine/Marine Acute and Chronic RQs for Fish and Invertebrates (Application
rate 0.007 Ib ai/A, boom height 100 feet, Buffer Zone 0 ft., Droplet size 50 ug)
Depth of
Water
6.6 feet
Fish
Freshwater
Acute
0.07
Chronic
0.10
Estuarine/Marine
Acute
0.03
Chronic
<0.00
Invertebrates
Freshwater
Acute
1.46
Chronic
0.76
Estuarine/Marine
Acute
3.00
Chronic
2.73
The reduction in application rate to the typical rate of 0.0035 Ib ai/A can further result in a
reduction in potential permethrin exposure to freshwater and estuarine/marine fish and invertebrates.
The RQs associated with this rate at a boom height of 100 feet and zero buffer zone do not exceed the
Agency's acute and chronic LOG for all fish and the chronic LOG for freshwater invertebrates.
However, although a reduction in rate reduced the overall risk to invertebrates, RQs exceed the acute
LOG both freshwater and estuarine/marine invertebrates and the chronic LOG is exceeded for
estuarine/marine invertebrates. See Table 32 below for more details.
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Table 32. Comparison of the Freshwater and Estuarine/Marine Acute and Chronic RQs for Fish and
Invertebrates (Application rate 0.0035 Ib ai/A, boom height 100 feet, Buffer Zone 0 ft., Droplet size 50 ug)
Depth of
Water
6.6 feet
Fish
Freshwater
Acute
0.03
Chronic
0.05
Estuarine/Marine
Acute
0.01
Chronic
<0.00
Invertebrates
Freshwater
Acute
0.71
Chronic
0.38
Estuarine/Marine
Acute
1.47
Chronic
1.36
b. Down-the-Drain Assessment
As part of its aquatic exposure assessment, the Agency also assessed the ecological impact of
permethrin released into domestic wastewater, and eventually into Publicly Owned Treatment Works
(POTWs). The Agency relied on the Office of Pollution Prevention and Toxics (OPPT) consumer
exposure model, Exposure and Fate Assessment Screening Tool (E-FAST). The Down-the-Drain
module of E-FAST is specifically designed to address all sources of permethrin that could potentially
be disposed to domestic wastewater from a down-the-drain application. This model provides
screening-level estimate of chemical residues in surface water that may result from household uses
and the disposal of consumer products into wastewater. The model uses input parameters that include
annual production volume of the pesticide and takes into account the fraction of the chemical removed
during wastewater treatment. The assumptions of the model state that in a given year, the entire
production volume of permethrin is parceled out on a daily per capita basis to the entire US population
and converted to a mass release per capita. This mass is diluted into the average daily volume of
wastewater released per person per day to arrive at an estimated concentration of target permethrin in
wastewater prior to entering a treatment facility. The concentration of permethrin in untreated
wastewater is then reduced by the fraction removed during the wastewater treatment process before
release into a river or stream. The remaining chemical is discharged into surface water, where it is
assumed that it is instantaneously diluted, with no further removal. A stream Dilution Factor is the
volume of the receiving stream flow divided by the volume of the wastewater released from the
POTW. The resulting EEC values are then used to assess potential ecological risks resulting from this
exposure scenario.
The Agency included permethrin pesticide products (pre-treated clothing and pets products),
as well as permethrin pediculicide pharmaceutical products, both over the counter (OTC) and
prescription, in the down-the-drain assessment. Production volume of permethrin for these specific
uses was based on unpublished market data, from the U.S. Food and Drug Administration, the
technical registrants, and by Agency sources. A total of approximately 252,000 kg ai of permethrin
are used per year for pet products, products to treat clothes, impregnated clothing, and OTC and
prescribed drugs.
Information on the degree of removal of permethrin from wastewater at POTWs is limited.
Agency data shows the removal of permethrin in pretreatment systems employing granular activated
carbon and resin adsorption to be 52, 75 and 94%. For permethrin, granular carbon and resin
adsorption is considered the best available technology economically achievable. Although the values
of removal varied widely, the Agency considers this the best available data and relied on it for the
down-the-drain assessment.
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Table 33 summarizes the risk estimates for aquatic organisms' exposure to permethrin
from surface waters containing permethrin after varying levels of removal at POTWs. Acute and
chronic RQs were below the LOCs at the three removal levels for freshwater and
estuarine/marine fish. However, aquatic invertebrates appear to be at acute risk from exposure to
surface waters containing permethrin from wastewater. Acute RQs exceeded some LOCs for
freshwater and estuarine/marine invertebrates at most treatment levels of removal. Additionally,
chronic RQs were below the LOG for all aquatic invertebrates. See Table 33 below.
Table 33. Estimated risks to aquatic organisms from permethrin consumer products released into domestic wastewater after
different levels of removal a POTWs
Level of
Removal
52%
75%
94%
Fish
Freshwater
Acute
0.06
0.03
0.01
Chronic
0.01
0.01
0.01
Estuarine/Marine
Acute
0.02
0.01
O.OO
Chronic
O.01
O.01
O.01
Invertebrates
Freshwater
Acute
0.44
0.23
0.06
Chronic
0.09
0.05
0.01
Estuarine/Marine
Acute
2.33
1.21
1.29
Chronic
0.09
0.16
0.04
iii. Other Non-Agricultural Use
The other non-agricultural applications of permethrin that include perimeter treatments in and
around buildings, lawn care, outdoor surfaces, etc., may result in exposure to aquatic organisms in
adjacent water bodies because of irrigation that can result in runoff and/or erosion. Even though
permethrin has a strong affinity to bind to soils and surfaces, residue monitoring in non-agricultural
areas, such as in certain areas of California, have shown that residues toxic to aquatic organisms are
occurring in aquatic areas that receive runoff from suburban developments. A recent monitoring
study conducted in an urban area of California found residues of permethrin and other pyrethroids in
adjacent water bodies from these residential areas and suggested that these areas are unlikely to be
unique with similar profiles occurring in other suburban areas, particularly in dry regions where
landscape irrigation can dominate seasonal flow in some water bodies. The Agency recognizes the
potential of aquatic toxicity from non-agricultural uses, but was not able to assess the risks associated
with these uses at this time due to lack of available data. The Agency's plan to consider aquatic
exposure from non-agricultural uses of permethrin is further discussed in Section IV.
c. Endangered Species
Based on a screening-level assessment, permethrin will have no direct acute or chronic
effect on listed terrestrial mammal, avian, and plants species, or aquatic plants species. The
screening level assessment, however, indicates there is a potential concern for direct effects to a
variety of aquatic organisms, should exposure actually occur at the modeled level. These are as
follows:
• Freshwater Fish and Aquatic-phase Amphibians- The acute endangered LOG (RQ
>0.05) for direct effects were exceeded for all maximum application rates for
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corn, sweet corn, potatoes, alfalfa, orchards, tomatoes, and mosquito abatement
modeled scenarios. Estimated concentrations in surface water due to waste water
containing permethrin were also used to calculate RQ values and show acute
endangered species LOG exceedance. Potential chronic exposure for fish was
limited to the corn modeled scenario. (In the ecological risk assessment for
permethrin, freshwater fish toxicity data are used as surrogates for aquatic-phase
amphibians).
• Freshwater Invertebrates- The acute and chronic LOG was exceeded for the
maximum application rate for all crops relative to aquatic macroinvertebrate
exposure. Permethrin is expected to reach surface water concentrations high
enough to exceed the acute endangered LOG (acute RQ > 0.05) for aquatic
invertebrates.
• Estuarine/Marine Fish- The acute endangered LOG (acute RQ >0.05) is exceed
for all maximum application rates. The Agency also calculated estimated
concentrations of permethrin in surface water due to waste water and noted the
potential for acute endangered species exceedances. However, maximum
application rates only showed that the potential for chronic exposure to fish was
limited to the corn modeled scenario.
• Estuarine/Marine Invertebrates- The endangered species acute LOG and chronic
LOG is exceeded for all modeled use sites and maximum label rates. However,
currently there are no listed estuarine/marine invertebrates.
Although a hazard assessment shows that permethrin exposure can result in acute toxicity
to honey bees and is considered to be highly toxic on both a contact and an oral basis (contact
LDso = 0.13 ug/bee; oral LDso = 0.024 ug/bee), an assessment method for estimating the risk to
bees is not yet available; therefore, we cannot preclude the possibility of potential effects to
listed insect species. Additionally, the Agency currently does not have toxicity data to quantify
risks for permethrin at the screening-level for terrestrial and aquatic plants and, therefore, can not
preclude potential direct effects to plants. However, a review of permethrin's mode of action
(neural toxin) suggests that direct toxicity to plants should not be an issue of concern. Finally,
the agency cannot preclude the potential for indirect effects to listed species that may be
dependent upon taxa that experience direct effects from the use of permethrin. These findings
are based solely on EPA's screening-level assessment and do not constitute "may affect"
findings under the Endangered Species Act (ESA) for any listed species. Rather, this assessment
serves as a screen to determine the need for any species specific assessments that will evaluate
whether exposure may be at levels that could cause harm to specific listed species and their
critical habitat. That assessment refines the screening-level assessment to take into account the
geographic area of pesticide use in relation to the listed species, the habits and habitat
requirements of the listed species, etc. If the Agency's specific assessments result in the need to
modify use of the pesticide in specific geographic 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.
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3. Ecological Incidents
The incident reports reported to the Agency since 1994 support the conclusions of the
risk assessment that exposure to permethrin has a low acute toxicity to terrestrial animal and
plants, but is highly toxic to aquatic species and beneficial insects. According to the Ecological
Incident Data System (BIDS), terrestrial risks from exposure to permethrin appear to be low.
Three incidents resulting in seven bird kills and one dog incapacitation have been reported. Six
occurrences of damage to plants have been reported, the largest reported damage occurring on
142 acres of soybeans in Wisconsin. The majority of incidents (21) reported are fish kills,
ranging from 50 to 3000. Finally, three beneficial insect, bees and butterflies, kills were also
reported.
Incidents entered into EIIS are usually categorized into one of several certainty levels:
highly probable, probable, possible, unlikely, or unrelated. Additionally, incidents entered into
the EIIS are also categorized as to use/misuse. Unless specifically confirmed by a state or
federal agency to be misuse, or there was very clear misuse, such as intentional baiting to kill
wildlife, incidents would not typically be considered misuse. The permethrin incidents data
available in the EIIS is inconclusive of the probability and if the incidents were a result of misuse
or registered use.
IV. Risk Management, Reregistration, and Tolerance Reassessment
A. Determination of Reregistration Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of
relevant data concerning an active ingredient, whether or not products containing the active
ingredient are eligible for reregi strati on. The Agency has previously identified and required the
submission of the generic (i.e., active ingredient-specific) data required to support reregi strati on
of products containing permethrin as an active ingredient. The Agency has completed its review
of these generic data, and has determined that the data are sufficient to support reregi strati on of
all products containing permethrin.
The Agency has completed its assessment of the dietary, occupational, residential, and
ecological risk associated with the use of pesticide products containing the active ingredient
permethrin. Based on a review of these data and on public comments on the Agency's
assessments for the active ingredient permethrin, the Agency has sufficient information on the
human health and ecological effects 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 permethrin-containing products are eligible for reregi strati on
provided that: (i) the risk mitigation measures outlined in this document are adopted and (ii)
label amendments are made to reflect these measures. Label changes are described in Section V.
Appendix A summarizes the uses of permethrin 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 of permethrin, and lists the submitted studies that the Agency found
acceptable. Data gaps are identified as generic data requirements that have not been satisfied
with acceptable data.
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Based on its evaluation of permethrin, the Agency has determined that permethrin
products, unless labeled and used as specified in this document, would present risks inconsistent
with FIFRA. Accordingly, should a registrant fail to implement any of the risk mitigation
measures identified in this document, the Agency may take regulatory action to address the risk
concerns from the use of permethrin. If all changes outlined in this document are incorporated
into the product labels, then all current risks for permethrin will be adequately mitigated for the
purposes of this determination under FIFRA. Once an Endangered Species assessment is
completed, further changes to these registrations may be necessary as explained in Section III.
B.2.c. of this document.
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 permethrin. EPA released its permethrin
preliminary risk assessments for public comment on August 31, 2005, for a 60-day public comment
period (Phase 3 of the public participation process). During the public comment period on the risk
assessments, which closed on October 31, 2005, the Agency received comments from the
technical registrants, the PIRTF, stakeholder groups, such as the American Mosquito Control
Association, the American Mushroom Institute, and the National Association of Clean Water
Agencies, State and Local government entities in California, California Water Boards, Publicly
Owned Treatment Works, Mosquito and Vector Control Districts, and several private citizens.
These comments in their entirety, responses to the comments, as well as the preliminary and
revised risk assessments, are available in the public docket (OPP-2004-0385) at the address
given above and in the EPA's electronic docket at http:www.regulations.gov.
C. Regulatory Position
1. Food Quality Protection Act Findings
a. "Risk Cup" Determination
As part of the FQPA tolerance reassessment process, EPA assessed the risks associated
with this pesticide. The Agency has determined that, if the mitigation described in this document
is adopted and labels are amended, human health risks as a result of exposures to permethrin are
within acceptable levels. In other words, EPA has concluded that the tolerances for permethrin
meet FQPA safety standards. In reaching this determination, EPA has considered the available
information on the special sensitivity of infants and children, as well as exposures to permethrin
from all possible sources.
b. Determination of Safety to U.S. Population
The Agency has determined that the established tolerances for permethrin, 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, and that there is a reasonable
certainty no harm will result to the general population or any subgroup from the use of
permethrin. In reaching this conclusion, the Agency has considered all available information on
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the toxicity, use practices and exposure scenarios, and the environmental behavior of permethrin.
As discussed in Section III, the acute, chronic, and cancer dietary (food and drinking water) risks
from permethrin are below the Agency's acute and chronic LOG.
c. Determination of Safety to Infants and Children
EPA has determined that the established tolerances for permethrin, 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 permethrin residues in this population subgroup.
In determining whether or not infants and children are particularly susceptible to toxic
effects from exposure to residues of permethrin, the Agency considered the completeness of the
hazard database for developmental and reproductive effects, the nature of the effects observed,
and other information. On the basis of this information, the FQPA SF has been reduced to IX
for permethrin. The rationale for the decisions on the FQPA SF can be found in Section III and
the following document: Permethrin: Fifth Revision of the HED Chapter of the Reregistration
Eligibility Decision Document (RED), dated April 4, 2006.
2. Endocrine Disrupter Effects
EPA is required under the FFDCA, as amended by FQPA, to develop a screening
program to determine whether certain substances (including all pesticide active and other
ingredients) "may have an effect in humans that is similar to an effect produced by a naturally
occurring estrogen, or other such endocrine effects as the Administrator may designate. "
Following the recommendations of its Endocrine Disrupter Screening and Testing Advisory
Committee (EDSTAC), EPA determined that there were scientific bases for including, as part of
the program, androgen and thyroid hormone systems, in addition to the estrogen hormone
system. EPA also adopted EDSTAC's recommendation that the Program include evaluations of
potential effects in wildlife. In the available toxicity studies on permethrin, there was no
significant toxicological evidence of endocrine disrupter effects. When the appropriate
screening and/or testing protocols being considered under the Agency's Endocrine Disrupter
Screening Program (EDSP) have been developed and vetted, permethrin may be subjected to
additional screening and/or testing to better characterize effects related to endocrine disruption.
3. Cumulative Risks
Permethrin is a member of the pyrethroid class of pesticides. Although all pyrethroids
alter nerve function by modifying the normal biochemistry and physiology of nerve membrane
sodium channels, EPA is not currently following a cumulative risk approach based on a common
mechanism of toxicity for the pyrethroids. Although all pyrethroids interact with sodium
channels, there are multiple types of sodium channels and it is currently unknown whether they
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the pyrethroids have similar effects on all channels. Nor do we have a clear understanding of
effects on key downstream neuronal function e.g., nerve excitability, nor do we understand how
these key events interact to produce their compound specific patterns of neurotoxicity. There is
ongoing research by the EPA's Office of Research and Development and pyrethroid registrants
to evaluate the differential biochemical and physiological actions of pyrethroids in mammals.
This research is expected 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.
4. Endangered Species
The Endangered Species Act required federal agencies to ensure that their actions are not
likely to jeopardize listed species or adversely modify designated critical habitat. The Agency
has developed the Endangered Species Protection Program to identify pesticides whose use may
cause adverse impacts on federally listed endangered and threatened species, and to implement
mitigation measures that address these impacts. To assess the potential of registered pesticide
uses that may affect any particular species, EPA puts basic toxicity and exposure data developed
for the REDs into context for individual listed species and considers ecological parameters,
pesticide use information, the geographic relationship between specific pesticide uses and
species locations and biological requirements and behavioral aspects of the particular species.
When conducted, these analyses take into consideration any regulatory changes recommended in
this RED being implemented at that time. A determination that there is a likelihood of potential
effects to a listed species may result in limitations on the use of the pesticide, other measures to
mitigate any potential effects, and/or consultations with the Fish and Wildlife Service or National
Marine Fisheries Service, as necessary. If the Agency determines use of permethrin "may
affect" listed species or their designated critical habitat, EPA will employ the provisions in the
Services regulations (50 CFR Part 402).
The ecological assessment that EPA conducted for this RED does not, in itself, constitute
a determination as to whether specific species or critical habitat may be harmed by the pesticide.
Rather, this assessment serves as a screen to determine the need for any species specific
assessment that will evaluate whether exposure may be at levels that could cause harm to
specific listed species and their critical habitat. That assessment refines the screening-level
assessment to take into account the geographic area of pesticide use in relation to the listed
species, the habits and habitat requirements of the listed species, etc. If the Agency's specific
assessments for permethrin result in the need to modify use of the pesticide, any geographically
specific changes to the pesticide's registration will be implemented through the process
described in the Agency's Federal Register Notice (54 FR 27984) regarding implementation of
the Endangered Species Protection Program. Until that species specific analysis is completed,
the risk mitigation measures being implemented through this RED will help to reduce the
likelihood that endangered and threatened species may be exposed to permethrin at levels of
concern.
D. Tolerance Reassessment Summary
Tolerances for residues of permethrin in/on plant RACs are currently expressed in terms
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of permethrin and the sum of its metabolites, DCVA and MPBA [40 CFR §180.378 (b), and (d)].
Tolerances for residues of permethrin in/on cottonseed expired on November 15, 1997.
Tolerances for permethrin residues in/on animal RACs are currently expressed in terms of
permethrin and the sum of its metabolites, DCVA, MPBA, and 3-PBA [40 CFR §180.378 (c)].
The Codex Alimentarius Commission, Canada, and Mexico have established maximum
residue limits (MRLs) for permethrin residues in/on various plant and animal commodities. U.S.
tolerances are not currently compatible with Codex, Canadian, and Mexican MRLs, because the
U.S. tolerance expression includes the parent permethrin and its DCVA and MPBA metabolites
(also 3-PBA in animal commodities). The Agency concluded that for purposes of tolerance
assessment, the regulated residues of permethrin would include only the cis- and trans-isomers
of permethrin. Accordingly, the tolerance definition for permethrin should be amended to
include only isomers of the parent, permethrin. In addition, the tolerances currently listed under
40 CFR §180.378 (b) and (c) for plant and animal commodities should be reassigned to
§180.378(a) under general tolerances. Once the U.S. tolerance definition is amended, it will be
compatible with the Codex, Canadian, and Mexican MRL definitions.
Table 34 summarizes the reassessment of the permethrin tolerances. 40 CFR must be
reorganized to reflect the tolerance reassessment values in the table below. The tolerances listed
in 40 CFR must be reorganized in order to: (i) incorporate the recommendations made by the
Agency concerning the permethrin residues of concern that need to be regulated for plant and
animal commodities; (ii) include tolerances that are needed to cover permethrin residues of
concern in/on the raw agricultural commodities and processed commodities of rotational crops;
and (iii) conform with the requirements of FQPA.
Table 34. Tolerance Reassessment Summary for Permethrin.
Commodity
Current
Tolerance
(ppm)
Range of Residues
(ppm) 1
Tolerance
Reassessment
(ppm)
Comment/Correct Commodity
Definition
Tolerances listed under 40 CFR §180.378 (b):
Alfalfa, fresh2
Alfalfa, hay 2
Almond
Almond, hulls
Apple
Artichoke, globe
25.0
55.0
0.05
20.0
0.05
10.0
0.11bai/A(ODAT):
2.1-15.2
0.2 Ib ai/A (14 DAT):
0.51-12.6
0. lib ai/A (0 DAT):
0.7-44.5
0.2 Ib ai/A (14 DAT)
<1.0-31.4
0.01-0.05
0.043-18.1
O.02 (2x)
0.28-4.00
20.0
45.0
0.05
20.0
Reassign
5.0
Residue data support lower
tolerances.
Residue data support
establishing a 0.05 ppm
tolerance on pome fruits.
Concomitant with establishing
a 0.05 ppm tolerance on fruit,
pome, group 11, the tolerance
on apples should be deleted.
Residue data support a lower
tolerance.
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Table 34. Tolerance Reassessment Summary for Permethrin.
Commodity
Asparagus
Avocado
Broccoli
Brussels sprouts
Cabbage
Cauliflower
Celery
Cherry
Corn, forage
Corn, grain
Corn, stover
Corn, sweet, kernel
plus cob with husks
removed
Eggplant
Filbert
Garlic
Current
Tolerance
(ppm)
1.0
1.0
1.0
1.0
6.0
1.0
5.0
3.0
60.0
0.05
60.0
0.1
1.0
0.05
0.1
Range of Residues
(ppm) 1
0.11-1.24
0.10-0.80
0.03-1.76
(0.8-1.2x)
0.04-1.0
(0.9-1.4x)
0.01-18.5
0.05-0.32
0.47-4.02
0.47-3.94
0.21-42.6
(lx-1.3x)
O.01-0.02
field corn: 0.02-16.97
sweet corn: 1.40-27.1
O.01-0.08
0.008-0.26
0.02
no data
Tolerance
Reassessment
(ppm)
2.0
1.0
2.0
1.0
TBD3
0.50
1.0
Reassign
4.0
50.0
0.05
30.0
0.10
0.50
0.05
0.10
Comment/Correc/ Commodity
Definition
Residue data indicate that a
higher tolerance is required.
Residue data indicate that a
higher tolerance is required.
The majority of the available
data reflect Ix the maximum
seasonal rate, but only 0.5x the
maximum single use rate,
therefore EPA is requiring
additional cabbage field trial
data (860.1500) to determine
the appropriate tolerance level.
Residue data support a lower
tolerance.
The tolerance should be deleted
once a tolerance is established
for Leaf petioles, subgroup 4B.
Residue data indicate that a
higher tolerance is required.
Residue data support a lower
tolerance. Separate tolerances
should be established for Com,
field, forage and Corn, sweet,
forage each at 50 ppm.
Separate tolerances should be
established for Corn, field,
grain and Corn, pop, grain
each at 0.05 ppm.
Residue data support a lower
tolerance. Higher residues on
sweet corn fodder reflect the
shorter PHI for sweet corn (1
day) than field or pop corn (30
days) Separate tolerances
should be established for Corn,
field, stover and Corn, sweet,
stover, and Corn, pop, stover
each at 30 ppm.
Residue data support a lower
tolerance.
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Table 34. Tolerance Reassessment Summary for Permethrin.
Commodity
Grass, range
Horseradish
Kiwifruit
Leafy Vegetables
(except Brassica)
Lettuce, head
Mushroom
Onion, dry bulb
Peach
Pear
Pepper, bell
Pistachio
Potato
Soybean
Spinach
Current
Tolerance
(ppm)
15.0
1.0
2.0
20.0
20.0
6.0
0.1
5.0
3.0
1.0
0.1
0.05
0.05
20.0
Range of Residues
(ppm) 1
1.79, 2.13 4
0.01-0.48
no data
Celery: O.01-1.0
Head Lettuce: 0.01-16.8
Leaf lettuce: 4. 98-10.7
Spinach: 9.04-18.2
0.17-10.7
O.02-4.9
0.01-0.09
(1.2x, ODAT)
0.20-0.92
#0.02
(lx-2x)
0.10-0.47
O.008-0.093
O.01-0.04
0.01-0.05
9.04-18.2
Tolerance
Reassessment
(ppm)
TBD
Reassign
0.50
Revoke
TBD
Reassign
5.0
0.10
1.0
Reassign
0.50
0.10
0.05
0.05
20.0
Comment/Correc/ Commodity
Definition
Residue data are required. This
tolerance should also be listed
with other tolerances having
regional restrictions.
Residue data support a lower
tolerance.
No registered uses.
No data are available
supporting the use on leaf
lettuce. Depending on the
results from the requested leaf
lettuce field trials, a tolerance
on Leafy greens, subgroup 4A
may be appropriate. The
available celery field trial data
will support a separate
tolerance on Leaf petioles,
subgroup 4B.
If supported by the requested
leaf lettuce data, the separate
tolerance for head lettuce
should be deleted and a
tolerance should be established
for Leafy greens, subgroup 4 A.
Residue data support a lower
tolerance.
Residue data support a lower
tolerance with a 14-day PHI.
Residue data support
establishing a 0.05 ppm
tolerance on pome fruits.
Concomitant with establishing
a 0.05 ppm tolerance on Fruit,
pome, group 11, and the
separate tolerance on pears
should be deleted.
Residue data support a lower
tolerance.
Soybean, seed.
If supported by the requested
leaf lettuce data, the separate
tolerance for head lettuce
should be deleted and a
tolerance should be established
for Leafy greens, subgroup 4 A.
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Table 34. Tolerance Reassessment Summary for Permethrin.
Commodity
Tomato
Vegetable,
curcurbit, group 9
Watercress
Current
Tolerance
(ppm)
2.0
3.0
5.0
Range of Residues
(ppm) 1
0.08-1.3
(0.7x-1.8x)
Cucumbers: O.036-0.52
Melons: O.01-1.2
Squash: 0.11-1.27
<6.4-15.5
Tolerance
Reassessment
(ppm)
TBD
1.50
Revoke
Comment/Correct Commodity
Definition
The majority of the available
data reflect 0.5x the maximum
single use rate. Only limited
data (6 samples) are available
supporting the current use rate.
New tomato field trial data are
required.
Current use pattern and residue
data support a lower tolerance.
No registered uses.
Tolerances currently listed under 40 CFR §180.378 (c):
Cattle, fat
Cattle, meat
Cattle, meat
byproducts
Egg
Goat, fat
Goat, meat
Goat, meat
byproducts
Hog, fat
Hog, meat
Hog, meat
byproducts
Horse, fat
Horse, meat
Horse, meat
byproducts
Milk, fat
Poultry, fat
Poultry, meat
Poultry, meat
byproducts
Sheep, fat
Sheep, meat
Sheep, meat
byproducts
3.0
0.25
2.0
1.0
3.0
0.25
2.0
3.0
0.25
3.0
3.0
0.25
2.0
6.25
0.15
0.05
0.25
3.0
0.25
2.0
0.88 5
0.064
0.048
0.023
0.88
0.064
0.048
0.01
0.01
O.01
0.88
0.064
0.048
0.088 whole milk
-2.20 milk, fat
0.11
0.01
0.01
0.88
0.064
0.048
1.50
0.10
0.10
0.10
1.50
0.10
0.10
0.05
0.05
0.05
1.50
0.10
0.10
3.0
0.15
0.05
0.05
1.50
0.10
0.10
Residue data support lower
tolerances. Eggs were lowered
to only 0.1 ppm to harmonize
with the Codex MRL.
Residue data support lower
tolerances.
Residue data support lower
tolerances.
Residue data support a lower
tolerance.
Residue data support lower
tolerances.
Residue data support a lower
tolerance. Milk fat (reflecting
0.0.88 ppm in whole milk)
Maximum excepted residue in
poultry meat and fat were
estimated using data from the
oral poultry metabolism study.
Residue data support a lower
tolerance.
Residue data support a lower
tolerance.
Residue data support lower
tolerances.
Tolerances currently listed under 40 CFR §180.378 (d):
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Table 34. Tolerance Reassessment Summary for Permethrin.
Commodity
Collards
Papaya
Turnip, greens
Turnip, roots
Current
Tolerance
(ppm)
20.0
1.0
20.0
1.0
Range of Residues
(ppm) 1
1.48-11.27
0.610-0.697
0.30-8.25
0.02-0.12
Tolerance
Reassessment
(ppm)
15.0
1.0
10.0
0.20
Comment/Correct Commodity
Definition
Residue data support a lower
tolerance
Residue data support a lower
tolerance.
Residue data support a lower
tolerance.
Tolerances needed under 40 CFR §180.378(a):
grain, aspirated
fractions
None
0.386 6
0.50
Residue data from a corn grain
processing study indicate that a
tolerance is required on
aspirated grain fractions.
Unless otherwise indicated, the reported range of residues for permethrin are from commodities treated at Ix the
maximum specified use rate and harvested at the minimum specified PHI. Rates other than Ix are reported in
parentheses.
2 Residue ranges reflect residues in/on forage and hay harvested at a 0-day PHI following applications up to 0.1 Ib ai/A or
at a 14 day PHI for applications at 0.2 Ib ai/A.
3 TBD = To be determined. Tolerance level cannot be determined at this time because additional data are required.
4 Results for the two samples of rangeland grass were originally reported on a dry weight basis (3.33, 4.42 ppm), but have
been converted to a fresh weight basis.
For animal commodities, the residues are the estimated maximum residues for the Ix MTDB using data from the feeding
studies or metabolism studies.
6 Calculated residue value bases on 19.3x concentration factor in aspirated grain fractions from com and HAFT residues of
0.02 ppm from field corn grain.
a. Tolerances Listed Under 40 CFR §180.378(a)
The temporary tolerance for residues of permethrin in/on cottonseed expired on
November 15, 1997, and therefore 40 CFR §180.378(a) should be removed.
b. Tolerances Listed Under 40 CFR §180.378(b)
The tolerance expression and tolerances in 40 CFR §180.378(b) should be recodified as
40 CFR §180.378(a)(l). Based on available residue data, the existing tolerances are adequate on
almond, almond hulls, apple, avocado, Brussels sprouts, corn grain, filbert, garlic, dry bulb
onion, pistachio, potato, soybean seeds, spinach and walnuts. Tolerances can be lowered for
residues in/on alfalfa fresh and hay, artichoke (globe), cauliflower, celery, corn forage, stover
and sweet, cucurbit vegetables, eggplant, horseradish, mushroom, peach, pear, and pepper (bell);
the recommended tolerances are listed in Table 34. Tolerances for permethrin should be
increased to 2.0 ppm in/on asparagus and broccoli and to 4.0 ppm in/on cherry.
Tolerances on kiwifruit and watercress should be revoked as there are no registered uses
for permethrin on these commodities, and these tolerances are no longer needed.
Additional residue data are required to support the existing tolerances on cabbage, grass
(rangeland), tomato, and leafy vegetables (excluding Brassica). The existing residue data on
cabbage are incomplete, but indicate that the current 6 ppm tolerance may be too low. The
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existing residue data on tomatoes are also incomplete, but indicate that the current 2.0 ppm
tolerance is likely to be adequate. The available rangeland grass data indicate that the current 15
ppm tolerance may be too high. In addition, the tolerance for grass (rangeland) should be
reassigned to §180.378 (d), as this is a regionally restricted use.
The current crop group tolerance for leafy vegetables (excluding Brassica) is supported
by adequate field trial data on celery, head lettuce, and spinach. However, no residue data are
available on the representative commodity leaf lettuce, which is likely to incur the highest
residues based its growth habit and the current use pattern. Although incomplete, the available
data indicate that separate tolerances should be established for the leafy greens (4A) and leaf
petiole (4B) subgroups of the leafy vegetable crop group, as residues in/on celery are
substantially lower than on head lettuce and spinach. The existing celery data would support a
general tolerance of 1.0 ppm for the Vegetable, leaf petiole, subgroup 4B. Once the requested
leaf lettuce data are available, a separate tolerance should be established for the Vegetable, leafy
greens, subgroup 4A.
The apple and pear field trial data also indicate that a single tolerance of 0.05 ppm would
be appropriate for Fruit, pome, group 11. Concomitant with establishing this crop group
tolerance, the separate tolerances of apple and pear should be removed.
c. Tolerances Listed Under 40 CFR §180.378(c)
The tolerance expression and tolerances in 40 CFR §180.378(c) should be recodified as
40 CFR §180.378(a)(2). Part 180.378(b) should be established for Section 18 emergency
exemptions as is current Agency practice, and reserved. Sufficient data are available to ascertain
the adequacy of the established tolerances on animal commodities provided that adequate data
depicting the stability of permethrin in frozen animal matrices are submitted.
Data from the ruminant and poultry feeding studies were used as the basis for reassessing
tolerances. Based upon residue data from feeding studies and studies involving direct
applications to livestock and their housing, dietary exposure to permethrin residues is the route
that results in the highest potential residues in animal commodities. As feeding studies are not
available for swine, the ruminant feeding studies were used to reassess tolerances for hogs.
For tolerances on commodities of cattle, goats, horses, and sheep, the available data
indicate that the tolerances for fat, meat, meat byproducts, and milk fat should be lowered to 1.50
ppm, 0.10, 0.10 ppm, and 3.0, respectively. The tolerance for fat of hogs, hog meat and meat
byproducts can be lowered to 0.05 ppm.
For poultry commodities, the 0.15 ppm tolerance for fat is adequate. Tolerances for
poultry meat and meat byproducts should be lowered to 0.05 ppm, and the tolerance for eggs
should be lowered to 0.10 ppm.
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d. Tolerances Listed Under 40 CFR §180.378(d)
The tolerance expression and tolerances in 40 CFR §180.378(d) should be recodified as
40 CFR §180.378(c) for regional registrations as is current Agency practice. Part 180.378(d)
should be established for indirect or inadvertent residues, as is current Agency practice, and
reserved. Sufficient data are available to ascertain the adequacy of the established tolerances
with regional registration for papayas and turnip roots and tops. The current 1.0 ppm tolerance
in/on papaya is adequate and the available turnip data indicate that tolerances for turnip roots and
tops can be lowered to 0.20 and 10.0 ppm, respectively.
Additional data are required on collards before the tolerance level can be determined, but
the currently available data would support lowering the tolerance to 15.0 ppm.
e. New Tolerances Needed Under 40 CFR §180.378(a)(l)
The available corn grain processing study indicates that a tolerance is required on
aspirated grain fractions (grain dust). Based on the HAFT residues for field corn grain of 0.02
ppm and the observed processing factor of 19.3x for grain dust, the maximum expected residues
in corn grain dust would be 0.386 ppm. These data would support establishing at tolerance of
0.50 ppm for residues of permethrin in grain, aspirated fractions.
As indicate above, the available celery, apple and pear field trial data support establishing
crop group tolerances for the leaf petiole vegetables subgroup 4B and the pome fruits group 11.
E. Regulatory Rationale
The following is a summary of the rationale for mitigation measures necessary for
managing risks associated with the use of permethrin for permethrin products to be eligible for
reregi strati on. Where labelling revisions are warranted, specific language is set forth in the
summary table of Section V.
1. Human Health Risk Management
a. Dietary (Food and Drinking Water) Risk Mitigation
Acute dietary (food and drinking water) risk is below the Agency's level of concern;
acute dietary risk estimates are 4% of the aPAD for the general U.S. population, and 16% for
infants, the subgroup most exposed. Additionally, the chronic dietary (food and drinking water)
risk is below the Agency's level of concern; risk estimated are <1% cPAD for the general U.S.
population and all population subgroups. The estimated cancer dietary (food and drinking water)
risk, 1.1 x 10"6, is within the negligible risk range of up to 3 x 10"6, and is also below the
Agency's LOG. No mitigation is required to address dietary risks.
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b. Residential Risk Mitigation
A dermal absorption factor was used for the dermal part of the cancer equation for
residential. The Agency calculated the dermal absorption factor from an oral to dermal toxicity
ratio (oral exposures LOAEL of 75/dermal NOAEL of 500), and concluded 15% is appropriate
for the dermal part of the cancer equation for cancer risk assessment.
The permethrin registrants and the PIRTF believe that 15% is still a highly conservative
factor, and requested that the Agency employ a weight-of-the-evidence approach to determine
the human dermal absorption factor for permethrin from existing peer-reviewed published
studies and registrant-submitted data which, in this view, supports a 2-5% dermal absorption
factor. The Agency previously concluded that the dermal penetration study submitted by the
registrants to support a 2-5% dermal absorption factor does not satisfy the basic criteria for an in
vivo survival primate study, and therefore, was determined to be scientifically unacceptable.
Further, the Agency contends that after consideration of other data available for permethrin, a
weight-of-evidence approach was utilized to reduce the dermal absorption factor to 15%. Again,
this value is considered to be a conservative high-end estimate because the oral dose represents a
LOAEL rather than a NOAEL.
Although the Agency recognizes that the 15% dermal absorption factor used for
residential risk assessment is a conservative high-end factor, without an additional guideline
dermal absorption study, the Agency does not have the confidence to further reduce the dermal
absorption factor. However, if a guideline dermal absorption study were voluntarily submitted,
the Agency would review the data and consider the results with the risk assessments and risk
mitigation measures for this RED.
i. Residential Handler
The Agency assessed the potential non-cancer (dermal and inhalation) and cancer risks to
homeowners handling (mixing, loading, and applying) permethrin products in residential settings
(indoor and outdoor). All handler scenarios assessed were below the Agency's non-cancer LOG
(MOEs >100). However, the Agency is concerned with the potential cancer risks associated with
exposure a homeowner could receive when mixing, loading, and applying emulsifiable
concentrate (EC) formulation of permethrin to horses via sponge (see Table 7).
Mitigation for Sponge Application of EC formulation
This scenario reached the Agency's cancer LOG (<3 x 10"6) after 2 exposure events (2
days) per year. Current registered labels recommend this application for use on horses, foals,
dogs, cats and kittens to treat numerous pests, such as face flies, stable flies, deer flies, fleas,
ticks, mosquitoes, gnats, mites, chiggers, and lice. Additionally, the labels recommend for initial
treatment to apply to the animal daily, and as the infestation subsides, reapply every 2-3 days as
needed. Given the broad range of target pests, coupled with the re-treatment instructions, the
Agency believes an individual using a permethrin product for this purpose will be exposed more
than 2 times per year.
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To determine the potential exposure a homeowner could receive for this scenario, the
Agency relied on Chemical Manufacturers Association antimicrobial wipe exposure data, which
is the best available data for the sponge application scenario. However, as stated in Section III,
the Agency has concerns regarding the quality of the data and believes exposure data specific to
this scenario would be more reliable, and potentially result in a reduced risk estimate. However,
neither the technical registrants nor any member of the PIRTF have volunteered to conduct
exposure data to support this application method.
Therefore, to mitigate the risks associated with this use, the registrants have agreed to
discontinue the use of sponge application for products applied as a liquid, and amend their
respective labels appropriately (see Section V, Table 35). Other application methods are
available for this use, such as RTU wipes, RTU pour-on, and RTU trigger pump sprays. The
Agency assessed these alternative application methods in the residential handler risk assessment
and both non-cancer and cancer risk estimates for all scenarios were below the Agency's non-
cancer and cancer LOCs, respectively.
ii. Residential Post-Application
The non-cancer dermal, inhalation and oral risks from post-application exposure to
permethrin are below the Agency's LOG for residential adults and youth aged children (MOEs
ranged from 120 to 500 billion). Additionally, most of the toddler non-cancer risk estimates are
also below the Agency's LOG (MOEs ranged from 140 to 250 billion); however, the incidental
oral and dermal risk estimates for toddlers exposed to post-application of permethrin on carpets
by directed surface sprays were above the Agency's non-cancer LOG (MOEs <100). The MOEs
are 37 and 69 for oral and dermal exposures respectively.
Additionally, all post-application outdoor and pet contact activities were below the
Agency's cancer LOG. Based on the REJV survey data, a typical homeowner uses permethrin
products approximately 5 times per year. The number of exposure events per year for these
scenarios to reach the Agency's cancer LOG ranged from 18 to 365 days. However, two indoor
scenarios assessed were of concern to the Agency; 1) post-application exposure treated with
permethrin products by directed carpet sprays (broadcast and crack and crevice) and 2) total
release foggers. These scenarios reached the Agency's cancer LOG in <1 and 2 events per year,
respectively. Moreover, the Agency assumed 8 hours of exposure for carpet sprays, and 4 hours
for vinyl flooring. Additionally, the post-application risk assessment assumed exposure to
permethrin residues the same day the area was treated (i.e., day 0 residue), which are considered
reasonably conservative assumptions, considering indoor residues are removed over time
through cleaning and other indoor activities.
To address the non-cancer and cancer risks associated with these post-application
scenarios, the following mitigation measures are to be implemented.
Mitigation for Indoor Directed Surface Sprays:
The permethrin registrants and PIRTF members suggested that 1% ai was a high-end
concentration, and a large majority of indoor products for either PCO or consumer use contains
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0.5% ai or less. The Agency's Standard Operating Procedure, which is based on a number of
2
indoor deposition studies, identifies the ISR for 0.5% broadcast sprays as 15 ug/cm , and 7.5
2
ug/cm for crack and crevice treatment. The Agency calculated comparison cancer risk
estimates for 0.5% ai broadcast products using a 15% dermal absorption factor. As a result,
these products also reached the Agency's cancer LOG in <1 event/year. Additionally, the 0.5%
crack and crevice sprays reached the Agency's cancer LOG in approximately 2 events/year.
Based on these comparison risk assessments, a reduced application rate would not mitigate the
cancer risks of concern.
The registrants also pointed to the conservative dermal absorption factor used in the
cancer risk assessment. To determine if a reduced dermal absorption factor would significantly
reduce the risks, the Agency calculated potential risk estimates using a hypothetical 10% and 5%
dermal absorption factor for 0.5% ai concentrated products. The Agency determined that for
both broadcast and crack and crevice applications, neither a 10% nor a 5% reduced dermal
absorption factor would significantly increase the number of exposure events to a level that
would be below the Agency's cancer LOG. However, if a guideline dermal absorption study was
voluntarily submitted, which supported a dermal absorption factor less than 5%, the Agency may
consider the results following this RED determination.
According to the PIRTF, the majority of RTU sprays contain 0.5% ai permethrin or less.
Therefore, the Agency assessed a 0.5% ai spray, based on a pyrethrin and piperonyl butoxide
deposition study following the use of an aerosol spray submitted by the Non-Dietary Exposure
Task Force, with an ISR of 0.21 ug/cm2. The Agency believes aerosol sprays and trigger pump
sprays will result in similar deposition. These application methods are used on indoor surfaces,
but unlike the indoor broadcast and crack and crevice applications used by PCOs, they are
mostly consumer products used more as spot treatments, thus, the deposition is considerably less
than the directed sprays intended to treat larger areas. Both the non-cancer and cancer risk
estimates for application of aerosol sprays on indoor surfaces (hard and carpet) were below the
Agency's LOG. For carpet and vinyl floors, the post-application MOEs for toddlers, the most
sensitive sub-population, are 8,500 and 35,000 (oral route) and 16,000 and 84,000 (dermal
route), respectively. Also, for the US general population, the number of events per year it takes
the cancer LOG to reach the negligible risk range are 57 and 114, respectively, which is
significantly greater than the average number of times per year permethrin products are used in
the home in this manner, according to the REJV survey.
Therefore, in order to mitigate the non-cancer and cancer risks, the registrants have
agreed to discontinue all directed spray application methods (i.e., low pressure handwands, ULV
cold foggers, and backpack sprayers) for use on indoor surfaces, and amend their respective
labels as appropriate (see Section V, Table 38). RTU consumer sprays, such as aerosol and
trigger pump sprays, will be the only application methods for use on indoor surfaces. Based on
its risk assessment, the Agency is limiting RTU sprays to concentrations of 0.5% ai or less.
However, the Agency acknowledges that there are specialized sprays with higher concentrations,
up to 3% ai, which are intended to be injected directly into cracks and crevices and behind walls
or spaces, and therefore, result in little to no potential exposure. The Agency will consider these
products if the registrants for these products are able to provide justification or data to the
Agency which demonstrate that little to no exposure will occur due to the specialized use of the
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product. The registrants have agreed to limit use of all aerosol sprays with a concentration of no
more than 0.5% ai of permethrin, and amend their respective labels as appropriate (see Section
V, Table 38).
Mitigation for Indoor Total Release Foggers
The Agency assessed a 0.58% ai concentrated indoor total release fogger (TRF) with a
maximum application rate of 0.0023 Ib ai/6 oz fogger, which is labeled to treat 6000 cubic feet
(ft3) or less. A permethrin specific deposition study was available to the Agency, which
determined the ISR for a 0.5% ai concentrated 6 oz TRF to be 4.8 ug/cm2 when treating a space
approximately 2000 ft3. Therefore, the Agency used an ISR of 4.8 ug/cm2 in both its non-cancer
and cancer risk assessments.
The non-cancer risk estimates on both hard surfaces and carpets were below the
Agency's LOG for both adults and toddlers. However, the cancer risk estimate for total release
foggers reached the Agency's cancer LOG in 2 exposure events/year for carpet, and 5 exposure
events/year for vinyl surfaces. This estimate assumes that an individual is exposed to permethrin
residues the day of treatment, and is engaged in high contact activities, such as exercising or
playing, for 8 hours on carpet and 4 hours on vinyl. According to the registrants, a single
permethrin active ingredient fogger loses efficacy below approximately 0.48% ai. However,
there are combination products registered that contain permethrin with other chemicals, often
other pyrethroids, and a synergist, such as PBO. These combination products contain
approximately 0.25% of permethrin or less. The Agency calculated the potential cancer risk
estimate from a TRF with a 0.25% ai concentration (ISR of 2.4 ug/cm2). The risk estimates
reached the Agency's LOG after 5 exposure events and 33 exposure events for carpet and vinyl
surfaces, respectively. According to the REJV survey data, a typical homeowner will use a TRF
approximately 3 times per year. Therefore, the Agency believes the use of permethrin TRF
products with 0.25% ai concentration or less are below the Agency's LOG, and are eligible for
reregi strati on.
In order to mitigate the cancer risks associated with this use, the registrants have agreed
to limit all TRF products to no more than 0.25% ai permethrin. The Agency will consider
products with higher concentrations if the registrants of the products can provide justification or
data to the Agency which demonstrates that an equivalent ISR of 2.4 ug/cm2, or less, will result
in a room size of 2000 ft3 or less.
Further, unlike the indoor surface sprays, a reduced dermal absorption factor does
significantly decrease the risk associated with post-application exposure to a 0.5% ai
concentrated permethrin TRF. Using a hypothetical 10% dermal absorption factor, the risk
estimates reach the Agency's LOG in 4 and 8 exposure events for carpet and vinyl, respectively;
and using a hypothetical 5% dermal absorption factor, the risk estimates reach the Agency's
LOG in 8 and 16 exposure events, respectively. As stated in the discussion of the dermal
absorption study above, the Agency may consider the results of a guideline dermal absorption
study, which is proposed to be voluntarily conducted and submitted by the registrants, following
this RED determination.
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iii. Other Residential Uses To be Addressed in RED
Outdoor Residential Misting Systems
As stated in Section III, the Agency considered post-application exposure to adults and
toddlers who are exposed to permethrin from an outdoor residential misting system pesticide
application. These systems are fairly new to the pesticide market, and vary in their system
design. Based on outreach to the permethrin registrants and review of labels currently registered
for use in these systems, the Agency used the following assumptions in the permethrin risk
assessment:
• The breathing rates utilized were:
o adult breathing rate for moderate activity is 1.6 m3/hour, and
o toddler breathing rate for light activity is 0.8 m3/hour.
• Cubic feet treated is based on the assumption that nozzles are placed at 10 feet from the
ground (e.g., on eaves) creating a ceiling of 10 feet in height;
• The emission is to be treated as an "instant release" scenario where all active ingredient is
assumed to be released in the air immediately (this is assumed to represent a conservative
approach); and
• It was assumed that in an individual (toddler or adult) was exposed to one nozzle that
released 1.5 fl. oz. in a one minute period of time.
As stated in section III, based on these assumptions, the Agency has no risk concerns
associated with post-application exposure to permethrin from outdoor residential misting
systems. However, the Agency recognizes that due to the variation in the systems' design and
the way in which the systems are installed, these assumptions may not be inclusive of all systems
available in the market. However, the Agency did not receive any comments on the assumptions
used in the permethrin risk assessment during the Phase 3 public comment period.
Statutory Requirements
Further, the distribution or sale, and use of pesticides in outdoor residential misting
systems are subject to several statutory requirements. At this time, permethrin, pyrethrins, and
piperonyl butoxide (PBO) appear to be the only chemicals used in outdoor residential misting
systems; however, it is possible that other pesticides registered for residential outdoor use-might
also be used in a similar systems. Section 2(ee)(3) of FIFRA permits the use of any application
methods that are not prohibited by the pesticide's labeling; however, the application must only
be to target sites specified by the labeling and at no more than the maximum dosage rates
specified by the labeling. Since most pesticide labels do not explicitly prohibit use in outdoor
residential misting systems, other chemicals that target similar pests could be used in these
misting systems. The Agency is not aware of other pesticides being used in outdoor residential
misting systems, and therefore, has not assessed the potential risks to homeowners associated
with use of pesticides in these systems from pesticides other than permethrin, pyrethrins, and
PBO.
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All permethrin, pyrethrins, and PBO registrants that do not support outdoor residential
misting systems use for their products, will be expected to amend their Manufacturing Use
Product label to state the following, "This product must not be formulated into an end use
product for use in outdoor misting systems." Additionally, all registrants of permethrin,
pyrethrins, and PBO wettable powder or EC formulated EPs, with outdoor residential use, will
be expected to include a statement prohibiting use in an outdoor residential misting system or
include separate and specific instructions for use in outdoor residential misting systems,
including the maximum application rate per day, use directions, and restrictions specified in
Section V, Table 38. Although this action will only address permethrin, pyrethrins, and PBO
products, the Agency plans to issue broader guidance pertaining to use of outdoor misting
systems, and the pesticides which can be used in these systems, as part of its on-going effort to
standardize the way in which these systems are used.
Finally, in accordance with FIFRA Section 2(e)(l) and (gg), leaving unapplied pesticide
at a use site constitutes the distribution or sale of a pesticide. In order to be in compliance with
FIFRA, companies which sell, install, and service outdoor residential misting systems must
ensure that one of the following transactions occur when providing these services:
• the unopened registered pesticide is distributed or sold to the use site owner prior to
mixing and loading into the equipment; or
• the diluted registered pesticide is distributed or sold as a custom blend in accordance with
EPA's custom blending policies at 3.4 and 7.1 of the Enforcement Policy Compendium;
or
• the diluted pesticide is registered and is distributed or sold to the use site owner prior to
loading into the equipment.
Although the Agency's post-application assessment for adult and toddler exposure to
permethrin via outdoor residential misting systems indicates exposures below the Agency's
LOG, several issues, in addition to those discussed above, have been raised to the Agency
through State FIFRA Issues Research and Evaluation Group issue papers, stakeholder forums
and comments, and other sources regarding the use of these systems. These issues include, but
are not limited to, the potential for inadvertent exposure and risks to residents, misuse of the
systems and pesticide products, offsite drift and potential exposure to non-target organisms, and
resistance issues. The Agency is aware of a cooperative effort lead by the National Pest
Management Association involving state and industry stakeholders, and pest management
professionals to standardize these systems and address the issues raised above, and intends to
continue to address these on-going issues through continued involvement and discussions with
the States, industry and stakeholder groups. In addition, the Agency has developed a Outdoor
Residential Misting System web-based fact sheet page aimed at helping consumers decide if
these systems are appropriate for their home, understand safety precautions about using outdoor
misting systems, find related information on Integrated Pest Management, and understand the
role of the US EPA and state agencies in regulating misters
(htt|3j//wwwj;]3j^^ Finally, the Agency is
requiring efficacy data be submitted for all products registered for use in outdoor residential
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misting systems claiming to target public health pests. Refer to the product-specific data call-in
PDCI) for more detail regarding the required data.
The Agency provided a 60-day comment period after the publication of the RED to
solicit feedback on the assumptions used in the permethrin risk assessment, the required label
language in Section V, Table 38, and the statutory requirements addressed above.
Permethrin Impregnated Fabrics
The Agency has approved methods for impregnating fabric with permethrin when
treating bulk fabric (prior to being cut and constructed) and treating the finished fabric (after
being cut and constructed into an article of clothing, tents, netting, etc.). The issue has been
raised to the Agency that several different finishing processes i.e., pre-washing, dying,
permanent press etc. can occur, before a fabric is finished which may compromise the efficacy of
the permethrin treatment.
Further, the labeling of current impregnated fabric products claim to retain a level of
permethrin that is efficacious up to 25 washings. The Agency has received comment that
depending on the manufacturing method, the claims may not be accurate and that the product
may lose efficacy in less than 25 washings.
To address these uncertainties, the Agency is requiring product specific efficacy data for
all permethrin impregnated fabric products, and wash-off data to support the efficacy claims.
Refer to the PDCI for more detail regarding the required data.
c. Aggregate Risk Mitigation
Acute Aggregate Risk
For permethrin, the acute aggregate risk estimates are the same as those presented in the
acute dietary (combined food and drinking water) risk section of this document. Since acute
aggregate risks are below the Agency's LOG, no mitigation is necessary.
Short-Term Aggregate
This section describes the aggregate (combined) risk from food, drinking water, and
short-term residential exposures, as well as risk refinements and the mitigation measures that
need to be implemented to manage risks of concern. As noted above in Section III of this
document, short-term aggregate risks for the U.S. general population and adult females were
below the Agency's LOG. However, the short-term aggregate risk for toddlers exceeded the
Agency's LOG for one scenario, with an aggregate MOE of 24, due to the incidental oral and
dermal risks associated with post-application exposure to indoor carpets treated with directed
sprays (see Table 12). In order to mitigate these risks, the registrants agreed to discontinue use
of directed spray applications on indoor surfaces. As a result, aerosol cans will be the only
remaining application method. This measure reduces the toddler non-cancer incidental oral and
dermal exposures, thus increasing the MOEs to 8,500 and 16,000, respectively. Provided these
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mitigation measures are implemented, the short-term aggregate risks are below the Agency's
LOG and no further mitigation measures are necessary. Moreover, the Agency believes it is still
appropriate to include this post-application scenario in the short-term aggregate risk assessment
because, according to the preliminary results of the REJV survey, permethrin use on lawns and
on indoor crack and crevice sites account for the most use in the residential market place, and are
likely to co-occur. Thus, Table 35 summarizes the short-term aggregate scenarios that
previously were of concern and the new risk results based on mitigation measures detailed
above.
Table 35: Short-Term Aggregate Risk with Mitigation
Population
Toddler
Short-Term Scenario
Previous Short-Term Aggregate MOE
[Food, Drinking Water and Residential (Lawn
Care and Indoor Surface Spray on Carpet)]
24
Revised Short-Term Aggregate MOE
[Food, Drinking Water and Residential (Lawn
Care and Indoor Aerosol Spray on Carpet)]
4709
Cancer Risk
Similar to the short-term aggregate risk assessment, the indoor surface spray application
was the risk driver for the cancer aggregate risk scenario that was above the Agency's level of
concern. With implementation of the same risk mitigation measures to address the short-term
aggregate risks of concern, the cancer risk estimate on the first day of application for aerosol
sprays to treat indoor carpets is 5.7 x 10"8, and takes 18 exposure events per year to reach the
Agency's LOG. Table 36 summarizes the cancer aggregate scenario that was previously of
concern and the new risk results based on mitigation measures detailed above.
Table 36: Cancer Aggregate Risk with Mitigation
Population
U.S. Pop
Short-Term Scenarios
Previous Short-Term Aggregate Cancer Risk
[Food, Drinking Water and Residential (Lawn
Care and Indoor Surface Spray on Carpet)]
1.5 x 10'5
Revised Short-Term Aggregate Cancer Risk
[Food, Drinking Water and Residential (Lawn
Care and Indoor Aerosol Spray on Carpet)]
l.lxlO'8
d. Occupational Risk Mitigation
It is the Agency's policy to mitigate occupational risk to the greatest extent practical and
feasible. Occupational exposure assessments are completed by the Agency considering the use
of baseline PPE, and, if warranted, for handlers, increasing levels of PPE and engineering
controls in order to estimate the potential impact on exposure and risk. The target MOE for
permethrin is 100, based on information provided in Section III of this document. For
occupational cancer risks, estimates within the negligible risk range of up to 3 x 10"6 do not
exceed the Agency's level of concern. When occupational MOEs are estimated to be less than
100 or occupational cancer risk estimates exceed the general range of <3 x 10"6, EPA strives to
reduce worker risks through the use of PPE and engineering controls or other mitigation
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measures. The Agency generally considers occupational cancer risks in the general range of 1 x
10"6 or less to be negligible, but may accept risks as high as 1 x 10"4 when all mitigation
measures that are feasible and practical have been applied, particularly when there are critical
pest management needs associated with the use of the pesticide.
Mitigation measures may include reducing application rates, adding PPE to end-product
labels, requiring the use of engineering controls, and other measures. Levels of PPE considered,
as described in Tables 14 and 15, and applicable to the proposed mitigation are described below:
• Baseline, or long-sleeve shirt, long pants, no gloves, and no respirator. (Baseline)
• Baseline plus chemical-resistant gloves, and no respirator.
Coveralls worn over long-sleeve shirt and long pants, chemical-resistant gloves, and
no respirator.
• Baseline plus chemical-resistant gloves and an 80% PF (quarter-face dust/mist)
respirator.
Coveralls worn over long-sleeve shirt and long pants, chemical-resistant gloves, and
an 80% PF (quarter-face dust/mist) respirator.
• Engineering Controls, or closed mixing/loading system, enclosed cab, or enclosed
cockpit.
A wide range of factors are considered in making risk management decisions for worker
risks. These factors include, in addition to the estimated MOEs and cancer risk estimates,
incident data, the nature and severity of adverse effects observed in the animal studies,
uncertainties in the risk assessment, alternative registered pesticides, the importance of the
chemical in integrated pest management (IPM) programs, and other factors.
Similar to the residential cancer risk assessment, a dermal absorption factor of 15% was
used for the dermal part of the cancer equation for the occupational cancer risk assessment. As
discussed above, the registrant may voluntarily conduct a guideline dermal absorption study to
refine this estimate; however, unlike for some residential exposure scenarios, a reduced dermal
absorption factor is not expected to significantly affect the risk mitigation for any of the
occupational risks discussed below.
i. Handler Risk Mitigation
As stated in Section III, most of the non-cancer and cancer risk calculations for
occupational handlers were below the Agency's LOG when handlers wore baseline PPE and
gloves. However, as summarized in Tables 14 and 15, some handler scenarios required
additional PPE to be below the Agency's non-cancer and cancer LOCs, respectively. Therefore,
specific mitigation measures and additional data needs are necessary to address these risk
concerns. Following the implementation of the formulation specific and activity specific risk
mitigation measures, handler risks will no longer be of concern to the Agency. The registrants
have agreed to the following mitigation:
Mixing, Loading and Applying Emulsifiable Concentrate (EC) and Granular Formulations
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All non-cancer risk estimates are below the Agency's LOG for workers handling the
granular formulation of permethrin (MOEs >1700) with baseline PPE and gloves. Additionally,
all cancer risk estimates were <1.2 x 10"6 with the same level of PPE, which is within the
negligible risk range of <3 x 10"6 and not of risk concern.
For all handlers scenarios of the liquid (EC) formulations, except for those which utilize
handheld equipment (i.e., handwands, handgun sprayers, backpack sprayer, etc.), all non-cancer
risk estimates are below the Agency's LOG (MOEs >1500) with baseline PPE and chemical-
resistant gloves, and all cancer risk estimates were <2.6 x 10"6 with the same level of PPE, which
is also within the negligible risk range of 1 x 10"6 and not of risk concern. For handlers of the EC
formulation with handheld equipment, all non-cancer risk estimates are below the Agency's
LOG (MOEs >160) with baseline PPE and chemical-resistant gloves, and all cancer risk
estimates were <2.8 x 10"5 with the same level of PPE. Since additional PPE (i.e., double-layer
clothing, respirator, etc.) beyond baseline PPE and gloves will only marginally reduce the cancer
risk estimates, and instead may cause additional heat related stress to workers, the Agency has
determined additional PPE will be an undo burden and is not required. Therefore, products
containing the EC or granular formulations of permethrin are eligible for reregi strati on provided
the following PPE is required on the labels: baseline PPE and chemical-resistant gloves.
Mixing, Loading, and Applying Wettable Powder (WP) Formulations
The non-cancer and cancer risk estimates for workers handling WP in the scenarios
identified Table 14 and 15, respectively, require additional risk mitigation measures in order for
scenarios with the WP formulation to be below the Agency's LOG. The Agency determined that
engineering controls (i.e., water soluble packages) significantly reduce the non-cancer and cancer
risks associated with mixing and loading activities (all MOEs >100; MOEs range from 5700 to
420000, and cancer risk estimates are less than 1 x 10"6). Additionally, the Agency believes that
the reduced exposure to mixers/loaders/applicators as a result of the engineering controls does
not require additional PPE, and thus, baseline and chemical-resistant gloves are protective.
Therefore, in order to be eligible for registration, the following mitigation measures are required:
1) wettable powder formulations must be packaged in water soluble bags (see Table 38 for PPE
requirements for engineering control), and 2) all mixers and loaders plus applicators using
handheld equipment applicators must wear baseline PPE and chemical-resistant gloves (except
RTUs and products applied as fogs or dips, see below). An apron will also be required for
handlers exposed to the concentrate and applicators applying liquid via dip application to
animals as specified below.
Mixing, Loading and Applying Dry Flowables
Although permethrin is not currently manufactured into a dry flowable formulation, one
technical registrant stated the company would prefer to change over all its WP products to dry
flowable products, instead of packaging the WP products in water soluble bags as required for
reregi strati on. Because there are no current registrations of permethrin products formulated as
dry flowables, an assessment was not conducted to evaluate worker risks associated with the use
of these products. However, available information on the units of exposure for both dermal and
inhalation routes indicate that they are significantly less for dry flowable formulations than for
liquid formulations. As a result, the Agency believes the level of PPE required for mixing,
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loading, and applying liquid (EC) formulation products of permethrin will be protective for
workers handling dry flowables. Therefore, baseline PPE and chemical-resistant gloves would
be required for mixing, loading, and applying dry flowable formulation products, if
manufactured.
Mixing, Loading, and Applying Dusts
The non-cancer and cancer risk estimates for workers handling dusts in the scenarios
identified Table 14 and 15, respectively, require additional risk mitigation measures in order for
scenarios with the dust formulation, for which there is available data, to be below the Agency's
LOG. The non-cancer risk estimate for loading the dust formulation into a mechanical duster
(poultry use based on the assumption that 100,000 animals are treated each day) requires
baseline PPE, chemical-resistant gloves and a PF5 respirator to be below the Agency's non-
cancer LOG (MOE=780). The cancer risk for this scenario is 1.6 x 10"5 with this level of PPE;
however, additional PPE only marginally decreases the risk estimate. For example, with the
maximum PPE feasible for this scenario (i.e., double layers, gloves, and a PF10 respirator), the
cancer risk estimate is decreased to only 1.1 x 10"5. In addition, the assumption that 100,000
animals are treated daily is a high-end estimate and is likely not to be generally performed.
Considering the high-end assumption used to estimate the handler risks for this particular
scenario, and the fact that additional PPE beyond baseline PPE, gloves, and a PF5 respirator will
not measurably reduce exposure, and instead may cause additional heat related stress to the
worker, the Agency has determined additional PPE to be an undo burden and is not required for
loaders. Additionally, all other loading scenario assessed for the dust formulation resulted in
MOEs > 3 million, and cancer risk estimates <4.1 x 10"9 with the same level of PPE. Therefore,
the Agency believes baseline PPE, chemical-resistant gloves, and a PF5 respirator is protective
of both non-cancer and cancer risks for all scenarios, and is required for loaders handling the
dust formulation.
The Agency did not have exposure data to assess the potential exposure to workers
applying the dust formulation via shaker can, mechanical duster, or dust bag. Dust applications
are made to livestock animals, dogs, and cats. The Agency believes little to no exposure to
applicators will occur with the mechanical duster and dust bag application methods because
applications are not made manually. Although applications via shaker can are made manually to
either a single animal (dog or cat) or to a smaller number of livestock animals, the shaker can is
rarely used in an occupational environment. Therefore, the Agency believes the PPE protective
of non-cancer and cancer risks for loaders will also be protective for applicators. Thus, dust
formulations are eligible for reregi strati on provided baseline PPE, chemical-resistant gloves, and
a PF5 respirator are required for all handler activities, and the Agency will not be requiring
additional data.
Applying RTU Products
Although there is no available data to assess potential occupational risks associated with
the application of RTU permethrin products, such as RTU wipes, ear tags, animal shampoos and
spot-ons, and protective flanges, etc., the Agency believes there will be little to no exposure to
handlers and that any potential exposure will be adequately reduced by the use of gloves, since
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handler scenarios for agricultural uses, which involve much higher volumes of product, are
adequately protected with the same level of PPE. Therefore, in order for RTU permethrin
products to be eligible for reregi strati on, baseline PPE and chemical-resistant gloves are
required, and the Agency will not be requiring additional data.
Applying Liquids via Dip
Exposure data is not available to assess the potential risks associated with applying liquid
products via dip applications. Currently, the dip application method is registered to treat military
battle dress (MBD), as well as to treat livestock animals, dogs, and cats. Permethrin is used by
the U.S. Department of Defence to treat MBD while in the field. The dip is provided to the
servicemen and women in a RTU package with plastic gloves provided. Based on this use
scenario, the Agency believes little to no exposure will occur to the individual treating his/her
MBDs with a RTU dip, and that baseline PPE and chemical-resistant gloves, the PPE required
for all liquid formulations, will be adequately protective.
Further, the Agency believes little exposure will occur with dip applications to livestock
animals. The animals move through the dip relatively unaided, and are primarily handled prior
to entering the dip and afterwards. Individuals treating smaller animals, such as dogs or cats, via
dip will possibly receive more exposure since they will most likely be lifting the animal in and
out of the dip. The Agency believes that based on the non-cancer and cancer risk estimates for
occupational handlers using the liquid formulation of permethrin for agricultural crop uses,
which involve much higher volume of product, baseline PPE and chemical-resistant gloves will
be adequately protective for all dip applications as well. However, to reduce additional exposure
that may result from potential splashing of the product onto the individual during the dip
application, the Agency is additionally requiring chemical-resistant aprons to be worn for animal
use.
Applying Liquids via Handheld Cold Foggers and Fog/Mist Generators
A cold fogger is a handheld ULV application method that is used to treat a number of
indoor spaces, such as mushroom houses, animal premises, and warehouses. The Agency does
not have permethrin specific data for this application method; however, the exposures for the
hand held ULV fogger application were based on surrogate data from a pulse fogger application
in a greenhouse (Nigg, 1987). The exposure data used in the risk assessment to estimate the
potential risk to occupational handlers using ULV cold fogger application equipment reflect the
dermal and respiratory exposure from the use of hand held backpack foggers in a greenhouse.
The applicators in this study were wearing chemical resistant protective clothing (Tyvek
coveralls) over long sleeve shirt and long pants, gloves, boots, and goggles. Although this study
is the best available data to use as surrogate data for the ULV cold fogger application method,
the Agency believes there are uncertainties with this data because the study only has three usable
replicates.
The workers in this study were wearing chemical resistant protective clothing (Tyvek
coveralls); generally the Agency does not require workers to wear Tyvek coveralls because of
concerns over potential heat stress related injuries. Therefore, the Agency believes that double
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layer PPE (coveralls over long pants and long sleeved shirt with socks and shoes) with gloves
will be protective because the dermal exposure an individual will receive from using a cold
fogger is likely equivalent to the dermal exposure he/she will receive when applying a liquid-
based spray of permethrin via any high pressure handheld application method.
Fog/mist generators are registered for use in similar indoor areas. However, they are not
handheld; instead, soon after the product is released the worker leaves the space. Therefore, the
Agency believes the potential exposure a worker will receive from application of permethrin via
a fog/mist generator is less than a handheld cold fogger. Thus, the level of PPE required for cold
fogger applications will be adequately protective for fog/mist generator applications.
The Agency has determined that permethrin products that are applied with cold foggers
and fog/mist generators on indoor areas are eligible for reregi strati on given the following PPE is
required: double layer PPE, and gloves. However, confirmatory dosimetry data for cold fogger
applications indoors is required. Given that the Agency believes the potential exposure from a
cold fogger will be greater than the potential exposure from a fog/mist generator, the outcome of
the dosimetry data for cold foggers will be protective of the fog/mist generator use and,
therefore, additional exposure data for fog/mist generators is not required.
Applying Liquid Formulations via High Pressure Handwand in Mushroom Houses
The Agency previously assessed the use of high pressure handwands in mushroom
houses in the Updated Revised Occupational and Residential Exposure Assessment for the
Reregistration Eligibility Decision Document., dated June 29, 2005. The cancer risk estimates for
handlers that mix/load/apply liquids via high pressure handwand in mushroom houses was above
the Agency's LOG, 1.3 x 10-4, assuming the highest level of PPE possible, which is coveralls
worn over long-sleeve shirt and long-pants, chemical-resistant gloves, and a 90% respirator.
Engineering controls are not feasible with this use scenario.
The American Mushroom Institute (AMI) provided the Agency with information
regarding permethrin use in mushroom houses during phase 3, the public comment phase.
According to the AMI, they could find no grower that uses high pressure handwands to apply
permethrin in mushroom houses. Instead, ULV cold foggers and fog/mist generators are the
typical and preferred application methods.
In response to Phase 3 comments, the Agency removed this scenario from the current
revised occupational risk assessment. In order to ensure that high pressure handwands are not
used in mushroom houses, the registrants have agreed to amend their wettable powder and EC
formulation products labeled for use in mushroom houses to specify that high pressure
handwands are prohibited. See Section IV, Table 38 for amended label language.
Aerial Applications - Liquid and Granular Formulations
For aerial applications of permethrin liquid or granular formulations, 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)].
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ii. Post-Application Worker Risk Mitigation
For workers re-entering treated fields to conduct post-application activities, such as
irrigation and hand weeding, all non-cancer risk estimates are below the Agency's LOG (MOEs
range from 570 to 200,000) at a 12 hour restricted-entry interval (REI). Additionally, most
cancer risk estimates are in the 10"5 to 10"7 range, except for migrant workers engaging in conifer
cone seed harvesting and thinning activities in certain tree orchards 30 days per year. The
predicted cancer risk for these scenarios is in the 10"4 range. Although the Agency typically tries
to mitigate all cancer risk estimates to be less than 1 x 10"6, the Agency does not believe that
extending REI is practical for permethrin because, according to Agency use and usage data, most
applications of permethrin on agricultural crops coincide with post-application activities, such as
trimming, pruning, or harvesting. Moreover, available dislodgeable foliar residue data indicate
that permethrin residues on foliage degrade slowly, requiring the REI to be several weeks in
order for cancer risk estimates to be below the LOG.
However, according to Agency data, permethrin is primarily used during the post-harvest
and dormant season apple and pear production, which indicated little chance for repeated and
prolonged exposure to residues. Only about 10-12% of treated acres, on average, are treated
during the period between bloom and harvest. Further, only about 5% of pome fruit acreage are
treated with permethrin annually. Together, these data suggest that it is unlikely that workers
would be annually exposed to permethrin residues for 30 days in commercial orchards (such as
migrant workers) or 10 days in small orchards (such as self-employed producers). Production
practices in tart cherry imply that exposure concerns are also unlikely. Further, very low and
sporadic treatments make it unlikely that frequent exposure would occur in the following crops:
hazelnut, walnut, avocado, alfalfa, potato, soybean, and turnip and collard greens.
The Agency also anticipates post-application exposure from conifer cone seed harvesting
to be low. According to the U.S. Forest Service, the last application of permethrin each season is
usually made at least 30 days prior to cone harvest. Additionally, it is highly improbable that a
cone picker would be exposed to permethrin for 30 days in a year because permethrin is not
typically used as a final application in very few orchards, and it would be very unusual for
migrant pickers to work on two or three permethrin treated orchards sequentially. Considering
the use pattern of permethrin on conifer cone seeds, and characterization of the cone seed
harvesting, the Agency reassessed the cancer risk estimate with an REI of 30 days. A 30 day
REI reduces the cancer risk to the 10"5 range. The registrants have agreed to amend their labels
to reflect this mitigation.
In addition, the registrants have agreed to reduce maximum application rates and number
of applications per year or season to help reduce potential post-application risks to workers. The
specific use pattern reductions are listed in Table 37. Based on these measures, and the
impracticality to extend the REI, the Agency intends to maintain the current 12 hour REI for all
crop uses, except for conifer cone seed harvesting, which will require a 30 day REI.
2. Non-Target Organism (Ecological) Risk Management
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a. Terrestrial Organisms
Birds and Mammals
EPA's screening-level risk assessment, based on maximum application rates, for both
aerial and ground application scenarios for permethrin, suggests no acute risks of concern for
birds and mammals. The highest acute RQ is approximately 0.03 for birds feeding on short grass
and 0.04 for the smallest mammals feeding on short grass (see Tables 21 and 22). Chronic RQs
for mammals were calculated using the results of a developmental toxicity study performed with rats.
Dose based RQs based on the Maine Potatoe scenario, which is the most conservative of the crop
scenarios assessed, range from 0.02 to 2.57. This study was conducted via oral gavage and
represents a more intense dosing regime than that of the 3-generation rat reproduction studies
(dietary exposure) which the Agency typically relies on to estimate chronic effects and risk to
mammals. Therefore, given the questionable toxicological response and the intense dosing
regime, it should be noted that this NOAEC represents a conservative estimate of toxicity and its
use may result in the overestimation of chronic risk to mammals. Thus, the results are not
tabulated in this document. The Agency is not requiring additional data at this time.
Non-Target Insects
Available toxicity data shows that permethrin is highly toxic to honeybees, as well as
beneficial insects on both a contact and oral basis. Further, permethrin was also found to be
highly toxic to honeybees exposed to foliage that had been sprayed with a permethrin
formulation. Therefore, a precautionary statement is required on permethrin product labels to
limit the exposure to honeybees and other beneficial insects during applications of permethrin.
Plants
Although the Agency does not have plant toxicity data to assess risks associated with
permethrin exposure to terrestrial plants, permethrin's mode of action for controlling insect pests
would not be expected to be a mode of action that would harm plants because it is a neurotoxin.
The Agency is not requiring plant toxicity data at this time.
b. Aquatic Organisms
i. Agricultural Uses
Freshwater and Estuarine Fish, Invertebrates, and Sediment Organisms
EPA's screening-level risk assessment for permethrin, based on maximum rates and both
aerial and ground application scenarios, suggests it is highly toxic to both freshwater and
estuarine aquatic organisms. The acute LOG (0.5) was exceeded for most scenarios modeled for
freshwater and estuarine fish, invertebrates, and sediment organisms. The screening-level risk
assessment also shows the potential for chronic risks to both freshwater and estuarine
invertebrates and sediment organisms. The chronic LOG (1) was exceeded for all scenarios.
However, the risk assessment also suggests that chronic risks to freshwater and estuarine fish are
less likely to occur. The chronic LOG was only exceeded in the Maine Potatoes scenario, which
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assumes a maximum application rate of 0.2 Ib ai/A, applied 8 times per year. According to
comments received by the National Potatoes Council, permethrin is applied only once or twice
per year on potatoes due to treat for Colorado Potato Beetles. Use is limited by the need to rotate
products due to the potential for resistance development. Based on this information, the Agency
believes chronic risk to fish is below the Agency's LOG.
In order to reduce the exposure of permethrin to aquatic organisms, the registrants have
agreed to impose a 150 foot buffer zone for aerial applications, and a 25 foot buffer zone for
ground applications. The screening-level risk assessment suggests that the use of a buffer zone
will decrease the EEC by approximately 20%, and reduce both the acute and chronic risks to
freshwater and estuarine aquatic organisms. Further, the acute and chronic RQs are reduced
further when typical application rates and number of applications are considered. Typical
application rates and number of applications, which are based on Agency use data, reduce acute
RQs by over half for all freshwater and estuarine/marine fish, invertebrate, and sediment
organisms, and can result in even greater reduction of chronic RQs.
The registrants have also proposed a number of reductions in single and seasonal
maximum application rates, as well as number of applications. In many cases, the registrants
reduced the seasonal maximum application rate by half, and in all cases specified a minimum
retreatment interval. Although the Agency did not revise its risk estimated based on this
mitigation, the Agency believes these reductions will serve to further reduce the risks to aquatic
organisms. Table 37 lists the amended use patterns for permethrin on agricultural labels.
Table 37. Amended Agricultural Use Patterns
Crop
Alfalfa
Almonds
Hazelnuts
Pistachios
Walnuts
Apples
Pears
Cherries
Peaches/Nectarines
Artichokes
Asparagus
Avocados
Broccoli
Brussels Sprouts
Cabbage
Current Labels
Max. Rate
per
application
(Ib ai/A)
0.2
0.4
0.4
0.4
0.4
0.4
0.4
0.2
0.3
0.3
0.1
0.2
0.2
0.2
0.2
Minimum
retreatment
interval
(days)
14
3
As needed
As needed
As needed
As needed
As needed
As needed
7
As needed
As needed
7
As needed
As needed
5
Seasonal
Maximum
Appication
Rate (Ib
ai/A)
0.2 per
cutting
2
1.6
1.6
1.6
0.6
0.8
1.2
1.5
1.5
0.4
1.2
0.8
0.8
1
Mitigation Per the RED
New
Maximum
rate per
application
(Ib ai/A)
0.2
0.25
0.25
0.3
0.25
0.25
0.25
(0.4
dormant
only)
0.2
0.25
0.3
0.1
0.2
0.2
0.1
0.2
New
Minimum
retreatment
interval
(days)
30
10
10
10
10
10
10
10
10
10
7
7
5
5
5
New
Seasonal
Maximum
Appication
Rate (Ib
ai/A)
0.2 per
cutting
0.75
0.75
0.9
0.75
0.5
0.65
0.6
0.75
0.9
0.4
0.8
0.8
0.4
0.4 (0.8 in
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Table 37. Amended Agricultural Use Patterns
Crop
Cauliflower
Cantaloupes
Cucumbers
Pumpkins
Squash (summer,
winter)
Watermelon
Eggplant
Peppers, bell
Tomatoes
Celery
Lettuce
Spinach
Collards
Greens, Turnip
Corn, Field
Sweet Corn
Garlic
Onions
Horseradish
Papaya
Potatoes
Soybeans
Current Labels
Max. Rate
per
application
(Ib ai/A)
0.2
0.2
0.2
0.2
0.2
0.2
0.21
0.2
0.2
0.2
0.2
0.2
0.2
0.2
0.2
0.25
0.3
0.3
0.21
0.4
0.2
0.2
Minimum
retreatment
interval
(days)
As needed
7
As needed
As needed
As needed
As needed
3
As needed
5
As needed
3
As needed
As needed
As needed
6
3
As needed
As needed
As needed
7
As needed
As needed
Seasonal
Maximum
Appication
Rate (Ib
ai/A)
0.8
1.6
1.6
1.6
1.6
1.6
2
1.6
1.2
2
2
2
0.8 (0.4 in
SC, GA,
FL, WA)
0.8 (0.4 in
SC, GA,
FL, WA)
0.6
1.2
2
2
0.6
1.2
1.6
0.4
Mitigation Per the RED
New
Maximum
rate per
application
(Ib ai/A)
0.1
0.2
0.2
0.2
0.2
0.2
0.15
0.2
0.2
0.2
0.2
0.2
0.15
0.15
0.15
0.2
0.2
0.3
0.15
0.15
0.2
0.2
New
Minimum
retreatment
interval
(days)
5
7
7
7
7
7
7
5
7
7
7
3
3
3
7
3
10
7
10
10
10
10
New
Seasonal
Maximum
Appication
Rate (Ib
ai/A)
HI)
0.4 (0.6 in
HI)
0.8 (1.2 in
HI)
1.2
1.2
1.2
1.2
0.6 (1.0 in
HI)
0.8
0.6 (0.8 in
HI)
1.0 (1.2 in
HI)
0.8 (1.2 in
HI)
0.6
0.45
0.45
0.45
0.8
0.8
1.0
0.45
0.75
0.8
0.4
11.
Public Health Uses
The Agency has conducted a screening-level ecological risk assessment for the mosquito
control use of permethrin based on aerial applications of permethrin to Florida turf. Based on the
available data, the Agency has identified potential acute risks of concern to freshwater and
estuarine/marine invertebrates, and potential chronic risks of concern for estuarine/marine
invertebrates. While there is a slight estimated exceedence of the endangered species LOG (0.5)
for freshwater fish at the high-end application rate of 0.007 Ib ai/A (RQ=0.07), the Agency
expects risks of concern to be limited based on the following: 1) aerial release (boom) heights
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typically occur at height much higher than assessed, which will further reduce the risks, and 2)
there are no risks of concern associated with this use for freshwater fish at the typical application
rate (0.0035 Ib ai/A).
Although the acute RQs for freshwater and estuarine invertebrates exceed the restricted
use LOG (RQ > 0.1), the Agency believes that the use restrictions specified in the guidelines and
recommendations of PR-2005-1 will serve to reduce overall risk to aquatic organisms and,
therefore, it is not necessary to classify permethrin as a restricted use product for wide area
mosquito abatement applications. Additionally, the Agency believes that the typical application
practices of mosquito abatement districts, as stated in comments received by the American
Mosquito Control Association, such as application rate, number of applications, and release
height, etc. employed by public health abatement districts result in a reduced risk to aquatic
organisms as compared to the maximum rate and number of applications, and minimum release
height assessed in the risk assessment.
Further, in order to reduce the acute and chronic risks to invertebrate organisms, the
registrants have agreed to the following mitigation measures for products labeled for wide area
mosquito abatement:
• Reduce maximum daily application rate to 0.007 Ib ai/A, and a maximum yearly
application of 0.18 Ib ai/A;
• Require minimum boom height of 100 feet for fixed wing, and 75 feet for helicopter
applications;
• For aerial applications made at < 200 feet above ground elevation - Spray equipment
must be adjusted so that the volume median diameter product is less than 60 microns
(Dv 0.5 <60 um) and that 90% of the spray is contained in droplets smaller than 100
microns (Dv 0.9 <100 microns);
• For aerial applications made at > 200 feet above ground elevation - Spray equipment
must be adjusted so that the volume median diameter product is less than 70 microns
(Dv 0.5 <70 um) and that 90% of the spray is contained in droplets smaller than 145
microns (Dv 0.9 <145 microns), and
• Specify a droplet size Dv. <30 microns for ground applications.
Finally, the screening-level ecological risk assessment also determined that the use of a
buffer zone during wide area applications of permethrin for mosquito abatement did not serve to
reduce the risk to aquatic invertebrates. Therefore, in accordance with PR-2005-1, a 100 foot
buffer zone is no longer required for wide area mosquito applications. However, permethrin is
also registered as an adult mosquito adulticide for ground barrier treatments. Unlike wide area
applications where the permethrin application is intended to stay adrift in the air, and targeted
flying mosquitoes, barrier treatments are intended to treat the foliage and target resting
mosquitoes. Therefore, the 100 foot buffer zone requirement will still apply to mosquito
adulticide barrier applications of permethrin.
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Plants
As stated above, although the Agency does not have plant toxicity data to assess risks
associated with permethrin exposure to aquatic plants, permethrin's mode of action for
controlling insect pests would not be expected to be a mode of action that would harm plants
because it is a neurotoxin. The Agency is not requiring plant toxicity data at the time.
iii. Other Non-Agricultural Uses
One of the risk assessment goals of the Office of Pesticide Programs (OPP) is to estimate
pesticide exposure through all significant routes of exposure from both agricultural and non-crop
uses. However, the ecological risk assessments for pyrethroid insecticides focus predominantly
on the agricultural uses for these insecticides, because pesticide transport models are available to
estimate potential aquatic exposure. Based on laboratory toxicity tests with terrestrial and
aquatic animals, aquatic exposure would be more likely to cause adverse effects in the
environment.
However, sales data indicate that non-crop uses of the pyrethroids comprise a much
larger fraction of total use than agricultural uses. The use of pyrethroids in urban and suburban
settings has increased since the phase-out of these uses of the organophosphate insecticides
diazinon and chlorpyrifos. Sales data indicate that the majority of urban use of pyrethroids is for
structural pest control, such as for control of termites or ants. Other outdoor non-crop uses
include landscape maintenance, and homeowner lawn and garden use. Indoor uses include insect
control, and treatment of pets and clothing.
The Agency uses a "down-the-drain" model to perform a screening-level aquatic risk
assessment for indoor uses of pesticides. In these simulations, waste water containing pesticide
residue flows into a building drain and passes through a sanitary sewer and publicly owned
treatment works (POTW) before being discharged to surface water. However, no analogous
exposure model has been developed to allow a similar screening-level assessment for pesticides
applied in an outdoor urban setting. As a result, the Agency has had to take a qualitative
approach to characterize the potential aquatic risk from urban and suburban use of pyrethroids.
For outdoor urban uses, it is assumed that runoff water from rain and/or lawn watering
may transport pesticides to storm sewers and then directly to surface water. Conceptually, a
greater contribution to pyrethroid loading to surface water bodies would be expected from
application to impervious surfaces such as walkways, driveways or the sides of buildings, than to
lawns or bare ground, because of the pyrethroids' strong affinity to bind to organic carbon in
soils. However, the Agency is unaware of any model which can simulate the different
application methods for urban use and the physical representation of the urban landscape, storm
sewer and receiving water configuration.
There are models available which can be calibrated to simulate sites and pesticides for
which extensive flow and pollutant data have been collected in advance. 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
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consistent with concentrations measured in surface water monitoring. Risk assessors with the
California Department of Environmental Protection confirmed in conversations with the Agency
that they also have used watershed models to calibrate to previously collected flow and pesticide
monitoring data, but that they did not know of any models capable of predicting concentrations
of pyrethroids that might occur because of outdoor urban uses.
Development of a screening model which could simulate the fate and transport of
pesticides applied in an urban setting would require a large body of data which is currently
unavailable. For instance, an urban landscape cannot be simulated as easily as an agricultural
field. The PRZM model simulates runoff from an agricultural field using readily available data
describing surface soil characteristics and laboratory data detailing the persistence and mobility
of pesticides in these soils. The agricultural field simulated is homogenously planted to a single
crop, and soil and water are transported from the field to a receiving water body with dimensions
consistent with USDA farm-pond construction guidelines.
By contrast, an urban landscape or suburban housing development consists of impervious
surfaces such as streets and sidewalks, and pervious surfaces such as lawns and parkland. One
could expect much greater mobility for pesticides applied to impervious surfaces, but laboratory
soil metabolism studies may not provide an accurate measure of the persistence of pesticides on
these surfaces. The path runoff water and eroded sediment might take is less obvious for an
urban setting than an agricultural field. First, an urban landscape cannot be considered
homogeneous, as the proportion of impervious and pervious surfaces varies for different
locations. In addition, the flow path of runoff water and sediment is not necessarily a direct path
over land, but can pass below ground through storm sewer networks, or be directed or slowed by
pumping stations or temporary holding ponds.
Finally, the timing and magnitude of urban uses is less well defined for urban uses than
agricultural uses. While agricultural uses would occur within a predictable window during the
growing season, the need for urban uses could occur at different times each year, and might
occur at different times within the same watershed. In addition, since records of how and to
what extent pyrethroids are applied by homeowners are less well defined than for professional
applications, it is harder to estimate the total load to model.
Pyrethroid monitoring data
The Agency considers surface water monitoring data in addition to modeling results
when they are available. However, surface water monitoring for pyrethroids has been limited,
perhaps because the pyrethroids would more likely be associated with aquatic sediment than the
water column. The USGS NAWQA program included permethrin as the only pyrethroid among
its pesticide analyses, 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;
^raw5-permethrin was detected in 0.8% of bed sediment samples.
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More recently, researchers from the University of California-Berkeley have published
studies which reported transport of pyrethroids to stream bed sediment as a result of urban uses.
In 2004, Weston, et al. collected sediment from creeks draining a residential area in Rosedale,
California. The sediments were analyzed for 7 pyrethroids (including permethrin and
cypermethrin, which are currently in the reregi strati on process), 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
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.
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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 is currently performing specific toxicity studies identified by the Agency as data gaps,
such as sediment invertebrate toxicity tests.
Data Needs
The Agency will be issuing a generic data call-in for all registered pyrethroids after the
permethrin RED to be used to assess pyrethroids as a group in Registration Review.
Stewardship Language
While the Agency cannot currently assess the potential risks to aquatic organisms from
non-agricultural uses of permethrin, the Agency is still seeking to reduce the potential drift and
run-off of permethrin into aquatic habits through explicit directions for use on both professional
and consumer use products for use in residential settings. These use directions include best
management and stewardship practices which are formulation specific, and will serve reduce the
potential run-off and drift that can occur from applications of these products. Label statements
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implementing these measures are listed in the "direction for use" section of the label table (Table
38) in Section V of this RED document.
4. Significance of Permethrin to Users
Non-Agricultural Use
According to data provided by the PIRTF, over 70% of permethin, approximately 1.5
million pounds, is used on non-agricultural settings. Of this amount applied in residential
settings: 55% is applied by professionals; 41% is applied by the homeowners; and 4% is used in
mosquito abatement districts.
Permethrin is used to control a wide variety of pests in and around residential structures.
Although permthrin is heavily relied upon by both pest management professionals (PMPs) and
homeowners, and over a million pounds is used on residential areas per year, there are a number
of available alternatives registered for similar indoor and outdoor use sites. The recent loss of
chlorpyrifos and diazinon for residential pest control has resulted in a greater reliance on
permethrin and the pyrethroids among residential users. Based on Agency data, in the absence
of permethrin, homeowners and PMPs would most likely substitute other pyrethroid insecticides
for use in or around home, such as cyfluthrin, cypermethrin, deltamethrin, esfenvalerate, lambda
cyhalothrin, pyrethrins, resmethrin, sumithrin, tetramethrin, and tralomethrin. Permethrin users
may also substitute insecticides from other chemical classes, such as malathion, carbaryl, and
imidicloprid, as well as a non-chemical methods.
Permethrin is the only pesticide registered to pre-treat fabric. The U.S. Department of
Defense uses permethrin as part of its vector control efforts; pre-treated military battle dress
(MBD) are made available to servicemen and woman, as well as RTU packages for treatment of
MBDs in the field. Comments received by the Armed Forces Pest Management Board strongly
support the use of permethrin as a clothing repellent, due to that fact that medical preventive
countermeasures (i.e., vaccines) do not exist for many arthropod-borne diseases, such as West
Nile Virus, which once acquired can cause permanent disability or death. Therefore, the
AFPMB believes permethrin treated fabrics serve as a viable method to control or help prevent
the transmission of these diseases.
Given its efficacy at controlling public health pests, permethrin is the most widely used
mosquito adulticide in the U.S. and is used to treat 9 to 10 million acres annually (out of 32-39
million acres treated with a mosquito adulticide). Permethrin's widespread use can be attributed
to its low cost, high efficacy, low incidence of pest resistance, and broad labeling. Alternatives
to permethrin for adult mosquito control include resmethrin, sumithrin, pyrethrins, malathion,
and naled. Permethrin alternatives are comparably priced and are likely to be as effective as
permethrin in many situations, but are not likely to universally substitute for all permethrin uses
because of labeling constraints or resistance concerns. The Agency believes that the loss of
permethrin would adversely affect the ability of mosquito abatement professionals to control
mosquitoes in some situation, such as agricultural-urban interface and areas with known
resistance to alternatives.
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Agricultural Uses
Based on Agency data, approximately 600,000 pounds of permethrin is used to treat a
variety of crops, such as pome and stone fruit, nut crops, other tree crops (avocado, papaya,
conifer), seed cone, ornamentals and cut flowers, field crops, dry bulb crops, greens, and cole
crops. According to comments received from various growers, the broad spectrum of pests that
permethrin targets makes its use highly beneficial since the agricultural industry has been losing
a number of insecticides, and the newer insecticides replacing them have chemistries that target
specific insects and are narrow in their spectrum. Further, USDA has established limits on how
many insect parts can be present in finished product, and according to growers, many other
alternatives have labeled pre-harvest intervals (PHIs) that are too long to accommodate the
narrow harvest window required to comply with these standards. Permethrin has a 1 day PHI,
which allows for effective pest control near harvest of registered crops.
Further, based on Agency data and analysis, permethrin is considered to be of high
benefit to the following crops because it is applied to 30% or more of the growing crop:
almonds, artichokes, Brussels sprouts, celery, lettuce, other lettuces, pistachios, and sweet corn.
Although permethrin is applied to less than 1% of the soybeans, alfalfa, and corn (field), and
maybe considered of low benefit, because approximately 20,000, 40,000, and 100,000 pounds
are applied to each crop, respectively, per year, it constitutes a significant amount of use.
In general, the Agency believes that fourth generation pyrethroids (i.e., bifenthrin,
lambda-cyhalothrin, cypermethrin, cyfluthrin, deltamethrin, esfenvalerate, fenpropathrin,
flucythrinate, fluvalinate, prallethrin, tau-fluvalinate, tefluthrin, tralomethrin, and zeta-
cypermethrin) are as effective as permethrin and would be acceptable alternatives as long as they
are registered and used on the crops in question. The fourth generation pyrethroids generally
control the same pests and have a longer period of residual effectiveness than permethrin.
However, these pyrethroids are also assumed to pose a greater ecological risk to aquatic
organisms given their persistence in the environment. The Agency has not assessed the
comparative ecological toxicity of all registered pyrethroids as part of reregi strati on, however, it
intends to assess pyrethroids as a group in Registration Review, as discussed in section
IV.E.2.b.iii above.
5. Risk/Benefit Balancing Analysis
The Agency has determined that permethrin-containing products are eligible for
reregi strati on, provided that risk mitigation measures are adopted and labels are amended
accordingly. On the human health side, residential risks to homeowners that exceeded the
Agency's level of concern have been mitigated completely by discontinuing or restricting certain
application methods and reducing some application rates, and occupational risks have been
mitigated through personal protective equipment or engineering controls requirements on the
labels.
The remaining risks are found on the ecological side. Ecological risks can occur as a
result of agricultural use, use of permethrin as a mosquito adulticide, and residential uses,
including uses in and around homes. Although data suggest that permethrin is practically non-
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toxic to small mammals and avian species on an acute basis, it has a toxic effect on beneficial
insects. The Agency is proposing to limit this effect by requiring precautionary labeling on
permethrin product labels to limit the exposure to honey bees and other beneficial insects during
applications of permethrin. Data also suggest that permethrin is highly toxic to both freshwater
and estuarine aquatic organisms. As a result, the Agency is imposing a number of restrictions on
agricultural uses (e.g., spray drift buffer zones and reductions in single and seasonal maximum
application rates, as well as increased retreatment intervals), which will reduce both the acute
and chronic risks to freshwater and estuarine aquatic organisms. The Agency is also imposing a
number of requirements on permethrin's use as a mosquito adulticide (e.g., reduction in the
maximum application rate, restrictions on number of applications, mandatory boom heights, and
specific droplet sizes), which the Agency believes will reduce acute and chronic risks to aquatic
invertebrates.
There are a number of reasons why the Agency has concluded that the risk/benefit
balance tips in favor of finding permethrin eligible for reregi strati on despite the ecological risks.
With respect to the ecological risks, the Agency has reduced those risks by imposing various
conditions that should reduce exposure of aquatic species to permethrin. With respect to the
benefits, as described above in the section entitled Significance of Use, permethrin offers
substantial benefits to users. In the agricultural area, permethrin provides a high benefit to the
agricultural industry because of its broad label and 1 day PHI. According to comments received
from various growers, the broad spectrum of pests that permethrin targets makes its use highly
beneficial since the agricultural industry has been losing a number of insecticides, and the newer
insecticides replacing them have chemistries that target specific insects and are narrow in their
spectrum. Further, permethrin has a 1 day pre-harvest interval, which allows for effective pest
control near harvest of registered crops. Also alternatives to permethrin, such as the fourth
generation pyrethroids, may pose a greater risk to aquatic organisms because of their persistence
in the environment.
For the public health use, permethrin is the most widely used mosquito adulticide in the
United States because of its low cost, high efficacy, and low incidence of pest resistance.
Although permethrin alternatives are comparably priced and are likely to be as effective as
permethrin in many situations, they are not likely to universally substitute for all permethrin uses
because of labeling constraints or resistance concerns. The Agency believes that the loss of
permethrin would adversely affect the ability of mosquito abatement professionals to control
mosquitoes in some situation, such as agricultural-urban interface and areas with known
resistance to alternatives. With regard to the treatment of fabrics, permethrin is the only
pesticide registered to pre-treat fabrics, which the AFPMB strongly supports as a method of
preventing many diseases that might afflict military personnel in the field. On other uses, such
as residential uses, where there may be a potential for ecological effects due to urban runoff, the
Agency intends to identify steps which can be taken to allow a greater understanding of potential
ecological risk from urban uses of pyrethroid as a whole during Registration Review.
Given the significance of the use of permethrin and the mitigated nature of the risks of
permethrin, the Agency believes, on balance, that the benefits of permethrin outweigh the risks.
Therefore, permethrin-containing products are eligible for reregi strati on, provided that risk
mitigation measures are adopted and labels are amended accordingly.
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6. Summary of Mitigation Measures
The following mitigation measures are necessary for permethrin to be eligible for
reregi strati on.
Dietary Risk
No label changes are necessary for these risks.
Residential Risk
• Discontinue use of sponge application method for formulations applied as liquids.
RTU products, such as wipes and trigger pump sprays will still be available for this
use pattern.
• Discontinue use of all directed broadcast and crack and crevice sprays (i.e., low
pressure handwand, backpack sprayer, cold fogger) on all residential indoor surfaces,
except for aerosol sprays.
o Limit concentration of RTU consumer sprays to 0.5% ai of permethrin.
The Agency will consider products with higher concentrations if the
registrants for these products are able to provide justification or data to the
Agency which demonstrate that little to no exposure will occur due to the
specialized use of the product.
• Limit all total release fogger formulation to 0.25% ai of permethrin.
o The Agency will consider products with higher concentrations if the
registrants are able to provide justification or data that an equivalent
indoor surface residue of 2.4 ug/cm2, or less, will result in a room size of
2000 ft3 or less.
• Amend all liquid and wettable powder products registered for outdoor residential use
to either prohibit use in outdoor residential misting systems, or provide specific use
directions.
• Efficacy data for all finished pre-treated permethrin products, and wash-off data to
support efficacy claims is required.
Occupational Risk
Handler
• Require wettable powder formulations to be packed in water soluble packaging.
• Require all aerial applications to be in closed cab aircraft.
• Discontinue the use of high pressure handwands in mushroom houses.
• Add PPE requirement to labels as follows:
o Wettable Powders- baseline PPE and chemical-resistant gloves for mixers,
loaders, and applicators.
o Emulsifiable Concentrations- baseline PPE and chemical-resistant gloves for
mixers, loader, and applicators. Additional chemical-resistant apron is
required for applicators performing animal dip applications.
o Dry Flowables- baseline PPE and chemical-resistant gloves.
o Dust- Double layer, chemical-resistant gloves, and a PF5 respirator for loaders
and applicators.
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o RTU Formulations- Baseline PPE and chemical-resistant gloves.
o Applicators of liquids via cold foggers and fog mister/generators.
• Require applicators to wear DL, chemical-resistant gloves, and PF10
respirator.
Post-Application
• Increase REI for conifer cone seed harvesting to 30 days.
• Amend agricultural labels to include new use pattern (rate reductions, seasonal
maximum reductions, and minimum retreatment interval) identified for the selected
crop uses specified in Table 37 above.
Ecological Risks
Include standard pyrethroid specific spray drift language, including a 25 foot buffer
zone for ground applications, 100-foot for aerial application, and 450 foot for ULV
applications.
Amend agricultural labels to include new use pattern (rate reductions, seasonal
maximum reductions, and minimum retreatment interval) identified for the selected
crop uses specified in Table 37 above.
Include the following statement in the environmental hazard section of the end use
products, as specified in Table 38 below:
o 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.
For all wide area mosquito abatement products:
o Reduce daily maximum application rate to 0.007 Ib ai/A, and a maximum
yearly application rate of 0.18 Ib ai/A;
o Remove 100 foot buffer zone restriction;
o For aerial applications made at < 200 feet above ground elevation - Spray
equipment must be adjusted so that the volume median diameter product is
less than 60 microns (Dv 0.5 <60 um) and that 90% of the spray is contained
in droplets smaller than 100 microns (Dv 0.9 <100 microns); and
o For aerial applications made at > 200 feet above ground elevation - Spray
equipment must be adjusted so that the volume median diameter product is
less than 70 microns (Dv 0.5 <70 um) and that 90% of the spray is contained
in droplets smaller than 145 microns (Dv 0.9 <145 microns), and
o Specify a droplet size <30 microns for ground applications.
Include the following label language in the directions for use section of all products
registered for outdoor use.
Products labeled for use on and around buildings and other structures:
"For Band applications to and around buildings foundations, band up to a maximum
of 10 feet away from the building and up to a maximum of 3 feet up the walls of the
building."
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Products labeled for preconstruction termiticide applications:
"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.
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 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."
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."
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 applicator
over treated area only."
7. Performance Measures
As stated in the EPA's Strategic Plan, the Agency's objectives are to protect human
health and the environment from pesticide exposures. The mitigation resulting from chemical
reviews contributes to the Agency's ability to meet its strategic targets by reducing pesticide
exposure in people's diet, in and around the home, in occupational settings, to non-target species
and to water resources. Because of the tremendous difficulty and costs associated with
measuring the direct effects of the work accomplished in OPP, the Agency continues its
development of indicators and measures to help evaluate the program's effect on human health
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and the environment.
For permethrin, there were no estimated dietary (food and drinking water) risks of
concern. Therefore, no mitigation measures were required to reduce potential permethrin
exposure in people's diets. However, risks of concern were identified from various applications
of permethrin products in an around homes. Specifically, handler and/or post-application risks
of concern were identified for indoor broadcast, and crack and crevice surface spray applications;
indoor foggers; and sponge application of EC formulated products on animals. With
implementation of the required mitigation measures, the Agency expects that potential exposure
to permethrin residues by individuals in the home will be reduced.
For occupational handler risks, the Agency is requiring specific levels of PPE or
engineering controls on product labels, depending upon the formulation being used. Most
products will include baseline PPE with chemical-resistant gloves, which are likely most
commonly being used by workers in the field. In cases where respirators are being additionally
required, such as for use of dust formulation or cold foggers, it is likely that most handlers are
already using a respirator for these particular uses. Therefore, in these cases, the protective
measures being required on the labels will likely not result in measurable reductions in handler
exposures or reports of worker incidents. However, for wettable powder formulations, the
Agency is requiring that engineering controls (i.e., water soluble packaging) be utilized to reduce
exposures to handlers. Some registrants indicated that they may transfer these products to dry
flowable formulations, which result in relatively low unit exposures to workers. Thus, these
measures may result in possible reductions in worker exposures and incidents.
In addition, the permethrin registrants have agreed to reduce application amounts and/or
extend re-treatment intervals for many uses. These changes are stipulated in Table 38. While
many of these changes likely reflect actual current use patterns by most users, because of the
extensive number of agricultural uses and associated number of products available, the Agency
believes that these measures to specify use patterns will limit the number of over-use events, and
thus contribute to reducing exposure to workers and the environment.
To address ecological risks, the Agency is requiring spray drift restrictions, such as buffer
zones, droplet size, application height, and other requirements. These measures are expected to
reduce the amount of exposure to aquatic habitats. In addition, for all wide area mosquito
abatement products, a maximum application rate and other similar requirement are being
specified. Finally, as stated above, the Agency intends to assess pyrethroids as a class in
Registration Review, and in particular, water quality issues resulting from use in urban settings.
In order to being to reduce potential spray drift and run-off of permethrin products used by
consumers in a residential outdoor setting, the registrants have agreed to include stewardship
language in the directions for use section of all products registered for outdoor use in residential
areas.
F. Other Labeling Requirements
To be eligible for reregi strati on, various use and safety information will be included in
the labeling of all end-use products containing permethrin. For the specific labeling statements
and a list of outstanding data, refer to Section V of this RED document.
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1. Endangered Species Considerations
At this time, the Agency is not requiring label changes specific to the protection of listed
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. While RQs
exceeded the Agency's endangered species LOG for several taxa, these results were based on a
screening-level assessment and do not constitute "may affect" findings under the Endangered
Species Act. As explained earlier, after a species-specific assessment is conducted, a
determination that there is a likelihood of potential effects to a listed species may result in
limitations on the use of the pesticide, other measures to mitigate any potential effects, or
consultations with the Fish and Wildlife Service or National Marine Fisheries Service as
appropriate. 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 permethrin at levels of concern.
2. 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, EPA will continue to work with all interested parties on this
important issue.
From its assessment of permethrin, as summarized in this document, the Agency
concludes that certain drift mitigation measures are needed to address the risks from off-target
drift for permethrin, including a requirement for medium to coarse droplet size. Label statements
implementing these measures are listed in the "spray drift management" section of the label table
(Table 38) in Section V of this RED document. In the future, permethrin product labels may
need to be revised to include additional or different drift label statements.
V. What Registrants Need to Do
The Agency has determined that permethrin is eligible for reregi strati on provided that the
risk mitigation measures outlined in this document are adopted and label amendments are made
to reflect these measures. To implement the risk mitigation measures, the registrants will be
required to amend their product labeling to incorporate the label statements set forth in the Label
Summary Table in Section C below. In the near future, the Agency intends to issue Data Call-In
(DCI) Notices requiring label amendments, product-specific data and additional generic
(technical grade) data. Generally, registrants will have 90 days from receipt of a DCI to
complete and submit response forms or request time extension and/or waiver requests with a full
written justification. For product-specific data, the registrant will have eight months to submit
data and amended labels. For generic data, due dates can vary depending on the specific studies
being required. Below are tables of additional generic data and label amendments that the
Agency intends to require for permethrin to be eligible for reregi strati on.
A. Manufacturing-Use Products
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1. Generic Data Requirements
The generic data base supporting the reregi strati on of permethrin has been reviewed and
determined to be substantially complete. However, the Agency has identified data necessary to
confirm the reregi strati on eligibility decision for permethrin. These studies are listed below and
will be included in the generic DCI for this RED, which the Agency intends to issue at a future
date.
Toxicology:
870.6300 Developmental Neurotoxicity Study
870.1300 Acute Inhalation Toxicity Study
Residue Chemistry:
860.1380 Storage Stability
860.1500 Magnitude of the Residue in Crop Plants [collards, cabbage, grass and forage, leaf
lettuce, peach, pear, sobean (forage, seed), and tomato]
Occupational Exposure
875.1200 Dermal Exposure Indoors (ULV Cold Fogger)
875.1400 Inhalation Exposure Indoors (ULV Cold Fogger)
Environmental Toxicology
EPA/600/R-99/064 (ORD Study Method) Chronic Freshwater Sediment Testing
EPA/600/RO1/020 (ORD Study Method) Chronic Estuarine/Marine Sediment Testing
2. Labeling for Manufacturing-Use Products
To ensure compliance with FIFRA, manufacturing-use product (MP) labeling should be
revised to comply with all current EPA regulations, PR Notices, and applicable policies. The
MP labeling should bear the labeling contained in Table 38.
B. End-Use Products
1. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific
data regarding the pesticide after a determination of eligibility has been made. Registrants 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 product-specific data requirements.
As discussed earlier, the Agency does not have adequate efficacy studies on pre-treated
fabrics to support the efficacy claims of finished products. To address this uncertainty, the
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Agency is requiring efficacy data for all finished pre-treated permethrin products, and wash-off
data to support the efficacy claims. In addition, efficacy data must be submitted, including data
for outdoor residential misting systems. Additional information on the efficacy data can be found
in the Series 810 Product Performance Test Guidelines on the Agency's website. Finally,
permethrin is registered for use on domestic animals. In addition to ensuring a product is
efficacious to protect animals from fleas and ticks, the Agency must ensure that pesticide
formulations for the treatment of external pests on domestic animals have an adequate margin of
safety for the companion animal. Data from companion animal safety studies also serve as a
basis for product labeling. This data requirement (870.7200) will also be included in the PDCI.
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 38. 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.
C. Labeling Changes Summary Table
For permethrin to be eligible for reregi strati on, all permethrin labels must be amended to
incorporate the risk mitigation measures outlined in Section IV. Table 38 describes specific
label amendments. This table has been amended from the table included in the Permethrin RED
which was signed on April 6, 2006.
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Table 38: Summary of Labeling Changes for Permethrin
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]."
Formulation into Wettable Powder:
"Not for formulation into Wettable Powder formulations unless they are packaged
in water soluble bags."
Outdoor Residential Misting Systems:
If Registrants are not supporting outdoor residential misting systems use for their
products, the following statement must appear on the MUP label of all liquid or
wettable powder products:
"Not for formulation into an end use product for use in outdoor residential
misting systems"
Formulation into Ready to Use Products labeled or intended for use on
residential indoor surfaces:
Ready to Use consumer spray products labeled for use on indoor surfaces
(broadcast, spot, and crack and crevice) at residential sites must be formulated to
contain no more than 0.5% of permethrin active ingredient.
Note to Registrant: The Agency will consider specialized sprays with higher
concentrations, up to 3% ai, which are intended to be injected directly into cracks
and crevices and behind walls or spaces if the registrants of the products can
provide justification or data to the Agency which demonstrates that the
specialized use will result in little to no exposure. In addition, these products
must state the following "Not for broadcast use."
Formulation into products intended for use in Total Release Foggers
(residential indoor use):
Directions for Use
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Table 38: Summary of Labeling Changes for Permethrin
"Total release foggers labeled for indoor use at residential sites must be
formulated to contain no more than 0.25% permethrin active ingredient."
Note to Registrant: The Agency will consider products with higher
concentrations if the registrants of the products can provide justification or data to
the Agency which demonstrates that an equivalent ISR of 2.4 ug/cm2, or less, will
results in a room size of 2000 ft3 or less.
Formulations into products intended for impregnated fabric applications:
"Do not exceed an application rate equivalent to 1.25 grams of a.i. per square
meter of fabric."
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 extremely toxic to aquatic organisms, including fish and
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 been notified in writing prior to discharge.
Do not discharge effluent containing this product to sewer systems without
previously notifying the local sewage treatment plant authority. For guidance,
contact your State Water Board or Regional Office of the EPA."
Precautionary Statements
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Description
Amended Labeling Language
Placement on Label
End Use Products Primarily Intended for WPS and Occupational Use (includes commercial pest control operators)
Restricted Use Pesticide
(For all products used for
wide area outdoor
broadcast application
including agricultural
crops, golf courses,
nurseries, and sod farms)
"RESTRICTED USE PESTICIDE Due to Toxicity to Fish and Aquatic
Organisms. For 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."
Top front panel of label
PPE Requirements
Established by the RED1
For Wettable Powder,
Liquid, and Dry Flowable
Concentrates (Dry
Flowables not registered
at this time, but may be
registered in the future.)
Note: If the use of ULV
foggers or fog or mist
generators is not
permitted or not feasible
for the end-use product,
the statement requiring
special PPE and
respirators for those uses
may be omitted.
"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."
"Applicators using ULV cold foggers or fog/mist generators in indoor spaces
must wear:
> Coveralls over long-sleeved shirt and long pants,
> Chemical-resistant gloves,
> Chemical resistant footwear plus socks, and
> Chemical-resistant headgear, if overhead exposure."
"Applicators using ULV cold foggers and/or fog/mist generators in outdoor
spaces must wear:
> Long-sleeve shirt and long pants,
> Shoes plus socks, and
> Chemical-resistant gloves."
Note to Registrant: If cold fogger and/or fog/mist generator use is prohibited on
the label, the above PPE for these uses may be omitted.
"All other mixers, loaders, applicators, and other handlers must wear:
> Long-sleeve shirt and long pants,
Immediately following/below
Precautionary Statements: Hazards to
Humans and Domestic Animals
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Description
Amended Labeling Language
Placement on Label
> Shoes plus socks,
> Chemical-resistant gloves for all handlers except for applicators using
motorized ground equipment, pilots, and flaggers,
> Chemical-resistant apron for mixers/loaders, persons cleaning equipment, and
persons exposed to the concentrate and for handlers performing animal dip
applications."
"See engineering controls for additional requirements."
Instruction to Registrant: Drop the "N" type prefilter from the respirator
statement, if the pesticide product contains, or is used with, oil.
PPE Requirements
Established by the RED1
For Granular
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."
"All loaders , applicators, and other handlers must wear:
> Long-sleeve shirt and long pants,
> Shoes plus socks, and
> Chemical-resistant gloves for all handlers except for applicators using
motorized ground equipment, pilots, and flaggers."
"See engineering controls for more requirements."
Immediately following/below
Precautionary Statements: Hazards to
Humans and Domestic Animals
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Description
Amended Labeling Language
Placement on Label
PPE Requirements
Established by the RED1
For Dust
Formulations
Note: if application with
aerial or motorized
ground equipment is not
feasible with the labeled
uses, the prohibition
statement may be
eliminated.
"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."
"Loaders, applicators, and other handlers must wear:
> Long-sleeve shirt and long pants,
> Shoes plus socks,
> Chemical-resistant gloves, and
> 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."
"Application with aerial or motorized ground equipment is prohibited."
Immediately following/below
Precautionary Statements: 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.
Discard clothing and other absorbent materials that have been drenched (except as
required by directions for use) or heavily contaminated with this product=s
concentrate. Do not reuse them."
Precautionary Statements: Hazards to
Humans and Domestic Animals
immediately below PPE requirements
Engineering controls for
Wettable Powder
Formulations
Note if aerial application
is not permitted or not
feasible for the end-use
product, the engineering
control statements
referring to pilots may be
omitted.
"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 and must have immediately available for use in an emergency, such
as a broken package, spill, or equipment breakdown chemical resistant footwear
and dust/mist respirators.
Pilots must use an enclosed cockpit that meets the requirements listed in the
Precautionary Statements: Hazards to
Humans and Domestic Animals
immediately below User Safety
Requirements
103
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Description
Amended Labeling Language
Placement on Label
Worker Protection Standard (WPS) for agricultural pesticides [40 CFR
170.240(d)(6)1"
Engineering controls for
Liquids, Dry Flowable,
and Granular
Formulations
Note if aerial application
is not permitted or not
feasible for the end-use
product, the engineering
control statements
referring to pilots may be
omitted.
"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)]."
Precautionary Statements: Hazards to
Humans and Domestic Animals
immediately below PPE requirements
Precautionary statement
for all permethrin canine
spot on products (i.e.
45/65% permethrin
concentrations spot-on
products for dogs)
Note to registrant:
All cat warning labels will be placed within a shaded box within the
Precautionary Statements on the label. The coloring of the box and text will be
such to provide a contrasting color to other label text. The shaded box must
contain the following.
"DO NOT USE ON CATS. May be toxic or potentially fatal if applied to or
ingested by cats. Accidental application to cats and/or grooming a recently
treated dog may result in tremors and/or uncoordinated muscle movements. If
this occurs, immediate veterinary care should be provided."
Each label must include at least one cat slash icon. This icon may be in the
shaded box or in other areas on the label.
Each individual tube must be labeled with the "DO NOT USE ON CATS'
statement or cat slash icon.
Include the following statement prominently on the front panel of product
Precautionary Statements
104
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Description
Amended Labeling Language
Placement on Label
packaging (in bold), "DO NOT USE ON CATS''
Environmental Hazards
(For Products with any
Outdoor Use, except wide
area mosquito adulticide
application)
"This pesticide is extremely toxic to aquatic organisms, including fish and
invertebrates. 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."
"Under some conditions, it may also have a potential for transport into surface
water in runoff (primarily adsorbed to suspended soil particles), for several
months or more after application. These include poorly draining or wet soils with
readily visible slopes toward adjacent surface waters, frequently flooded areas,
and areas overlying extremely shallow groundwater, areas with in-field canals or
ditches that drain to surface water, areas not separated from adjacent surface
waters with vegetated filter strips, and areas over-lying tile drainage systems that
drain to surface 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."
For commercial, industrial, and institutional use products packaged in
containers equal or greater than 5 gallons or 50 pounds, add the following
statement:
"Do not discharge effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or other waters unless in accordance with the requirements of a
National Pollutant Discharge Elimination System (NPDES) permit and the
permitting authority has been notified in writing prior to discharge. Do not
discharge effluent containing this product to sewer systems without previously
notifying the local sewage treatment plant authority. For guidance contact your
State Water Board or Regional Office of the EPA."
Precautionary Statements immediately
following the User Safety
Recommendations
105
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Description
Amended Labeling Language
Placement on Label
Environmental
Hazards Statements for
products labeled solely
for use as a wide area
mosquito adulticide:
(PR Notice 2005-1
recommends separating
labels intended for wide
area mosquito adulticide
applications.)
"ENVIRONMENTAL HAZARDS"
"This pesticide is extremely toxic to aquatic organisms, including fish and
invertebrates. Runoff from treated areas or deposition of spray droplets into a
body of water may be hazardous to fish and aquatic invertebrates."
"Before making the first application in a season, it is advisable to consult with the
state or tribal agency with primary responsibility for pesticide regulation to
determine if other regulatory requirements exist."
"Do not apply over bodies of water (lakes, rivers, permanent streams, natural
ponds, commercial fish ponds, swamps, marshes or estuaries), except when
necessary to target areas where adult mosquitoes are present, and weather
conditions will facilitate movement of applied material away from the water in
order to minimize incidental deposition into the water body. Do not contaminate
bodies of water when disposing of equipment rinsate or washwaters."
Precautionary Statements under
Environmental Hazards
Environmental
Hazards Statements for
products labeled as a
wide area mosquito
adulticide and is labeled
for other outdoor uses as
well:
(PR Notice 2005-1
recommends separating
labels intended for wide
area mosquito
adulticiding applications.)
"ENVIRONMENTAL HAZARDS for TERRESTRIAL APPLICATIONS"
"This pesticide is extremely toxic to aquatic organisms, including fish and
invertebrates. This product may contaminate water through drift of spray in wind
or via runoff events. Use care when applying in areas adjacent to any body of
water. Do not apply when weather conditions favor drift from target area."
"Except as specified in the directions for use, do not apply directly to water, to
areas where surface water is present or to intertidal areas below the mean high
water mark. Do not contaminate water when disposing of equipment wash-waters
or rinsate."
"ENVIRONMENTAL HAZARDS for WIDE AREA MOSQUITO
ADULTICIDE APPLICATIONS"
"This pesticide is extremely toxic to aquatic organisms, including fish and
invertebrates. Runoff from treated areas or deposition of spray droplets into a
body of water may be hazardous to fish and aquatic invertebrates."
Precautionary Statements under
Environmental Hazards
106
-------
Description
Amended Labeling Language
Placement on Label
"When applying as a wide area mosquito adulticide, before making the first
application in a season, it is advisable to consult with the state or tribal agency
with primary responsibility for pesticide regulation to determine if other
regulatory requirements exist."
"When applying as a wide area mosquito adulticide, do not apply over bodies of
water (lakes, rivers, permanent streams, natural ponds, commercial fish ponds,
swamps, marshes or estuaries), except when necessary to target areas where adult
mosquitoes are present, and weather conditions will facilitate movement of
applied material away from the water in order to minimize incidental deposition
into the water body."
Environmental Hazards
(For Products labeled
only for Indoor Use
including ready to use
impregnated materials
(e.g. products used on
domestic animals like flea
collars and ear tags)
No Environmental Hazard Statement is required.
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
(WPS)
Note: If use on conifer
cone seeds is not on the
label, the above
prohibition statement may
be omitted.
"Do not enter or allow worker entry into treated areas during the restricted entry
interval (RET) of 12 hours."
"PROHIBITION - Harvesting of conifer seed cones is prohibited within 30 days
of application."
Directions for Use, Agricultural Use
Requirements Box
107
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Description
Amended Labeling Language
Placement on Label
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"
Direction for Use
Agricultural Use Requirements box
Entry Restrictions for
products having non-
WPS uses applied as
spray
Note: This excludes
products labeled for use
when people are present
(e.g. outdoor residential
misting systems, fabric
treatments and pet
applications)
Entry Restriction for products applied as a surface spray (does not apply to
products applied directly to domestic animals):
"Do not enter or allow others to enter until sprays have dried."
Entry Restriction for products applied as a space spray or fog:
"Do not enter or allow others to enter until vapors, mists, and aerosols have
dispersed, and the treated area has been thoroughly ventilated."
Entry Restrictions for
products having non-
WPS uses applied as
granular or dusts
"Do not enter or allow others to enter until dusts have settled."
For products with use instructions requiring watering in after application:
"Do not enter or allow others to enter the treated area until dusts have settled. If
soil incorporation is required after the application, do not enter or allow others to
enter the treated area (except those persons involved in the incorporation) until the
incorporation is complete. If the incorporation is accomplished by watering-in, do
not enter or allow others to enter the treated area until the surface is dry after the
watering-in."
Entry Restrictions for
products labeled solely
No entry restrictions are required. See below under "Use Restrictions" for further
If no WPS uses on the product label, place
the appropriate statement in the Directions
for Use Under General Precautions and
Restrictions. If the product also contains
WPS uses, then create a Non-Agricultural
Use Requirements box as directed in PR
Notice 93-7 and place the appropriate
statement inside that box.
108
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Description
Amended Labeling Language
Placement on Label
for use when people are
present (e.g. fabric
treatments, livestock, and
pet applications)
requirements.
Entry Restrictions for
products labeled for use
when people are present
(e.g. fabric treatments,
livestock, and pet
applications) and for use
on other sites as a
directed or space spray.
Products labeled for use as a directed spray (does not apply to products
applied directly to domestic animals):
"Except when (insert application method or site that allows people to be present),
do not enter or allow others to enter treated area until sprays have dried."
Products labeled for use as a space spray:
"Except when (insert application method or site that allows people to be present),
do not enter or allow others to enter until vapors, mists, and aerosols have
dispersed, and the treated area has been thoroughly ventilated."
Note to Registrant: An example is as follows: Except when applying to pets or
livestock, do not enter or allow others to enter until sprays have dried.
General Application
Restrictions for products
with WPS or non-WPS
uses on the label
Note: This excludes
products that contain any
directions for when
people are permitted to be
present in the treated area
(e.g. wide-area mosquito
adulticide applications,
fabric treatments, and
applications to livestock
"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 Direction for Use.
109
-------
Description
Amended Labeling Language
Placement on Label
and pets)
General Application
Restrictions for products
with WPS and non-WPS
uses on the label AND
are labeled for use when
people may be present
(e.g. . wide-area mosquito
adulticide applications,
fabric treatments, and
applications to livestock
and pets)
"Except when" (insert application method or site that allows people to be present)
"do not apply this product in a way that will contact workers or other persons,
either directly or through drift."
"Except when" (insert application method or site that allows people to be present)
"only protected handlers may be in the area during application."
"Do not breathe dusts, vapors, or spray mist."
For applications to food/feed handling and service areas:
"Do not apply when food is present."
"Do not use in food areas of food handling establishments, restaurants, or other
areas where food is commercially prepared or processed. Do not use in serving
areas while food is exposed or facility is in operation. Serving areas are areas
where prepared foods are served, such as dining rooms, but excluding areas where
foods may be prepared or held. In the home, all food processing surfaces and
utensils should be covered during treatment or thoroughly washed before use.
Exposed food should be covered or removed."
Place in the Direction for Use.
General Application
Restrictions for products
solely labeled for use
when people may be
present (e.g. wide-area
mosquito adulticide
applications, fabric
treatments, and
applications to livestock
and pets)
No general application restrictions are required. See below under "Use
Restrictions" for further requirements.
Place in the Direction for Use.
Other Application
Products labeled for use in mushroom houses:
Directions for Use
110
-------
Description
Amended Labeling Language
Placement on Label
Restrictions (Risk
Mitigation)
"Use of high pressure hand wand prohibited in mushroom houses."
Products formulated as dusts:
"Use of handheld power duster equipment is prohibited."
Products labeled for or intended to be applied by sponge application:
Application instruction for sponge application must be removed from the label,
and the following statement must be added: "This product may not be applied by
sponge application."
Products labeled for or intended for use as directed surface sprays for use on
residential indoor surfaces (excludes Ready to Use products and Total
Release Foggers):
Application instruction for directed surface sprays (such as low pressure hand
wand, backpack sprayer, and ULV cold fogger) to indoor surfaces at residential
sites must be removed from the label, and the following statement must be added:
"Do not apply as a broadcast, crack and crevice, or spot treatment to indoor
surfaces at residential sites, including nurseries, day care centers, schools,
hospitals, and nursing homes."
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 hour. If an odor is still detected additional ventilation is required."
Note to registrant- If you have any information that justifies a change in the
duration after application (2 hours), submit the information to the Agency.
Ill
-------
Description
Amended Labeling Language
Placement on Label
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."
Additional Application
Restrictions For Outdoor
Use
Products labeled for use on and around buildings and other structures:
"For Band applications to and around buildings foundations, band up to a
maximum of 10 feet away from the building and up to a maximum of 3 feet up
the walls of the building."
Products labeled for preconstruction termiticide applications:
"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."
"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 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."
112
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Description
Use-Specific Application
Rate and Related
Restrictions
(Note: The maximum
application rate and
maximum seasonal rates
specified in this table
product per acre/square
ft/ppm/cubic feet etc not
just as pounds active
ingredient)
Amended Labeling Language
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."
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."
Amend all agricultural use product labels with the following crops to reflect
the following maximum application rate, retreatment intervals, and seasonal
maximum application rates:
Crop
Alfalfa
Almonds
Hazelnuts
Pistachios
Walnuts
Apples
Pears
Maximum rate
per application
(lb ai/A)
0.2
0.25
0.25
0.3
0.25
0.25
0.25
(0.4 dormant only)
Retreatment
interval
(Days)
30
10
10
10
10
10
10
Seasonal
Maximum
Application
Rate (lb ai/A)
0.2 per cutting
0.75
0.75
0.9
0.75
0.5
0.65
Placement on Label
Directions for Use under Application
Instructions
113
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Description
Use-Specific Application
Restrictions for all liquid
and wettable powder
Amended Labeling Language
Cherries
Peaches/
Nectarines
Artichokes
Asparagus
Avocados
Broccoli
Brussels Sprouts
Cabbage
Cauliflower
Cantaloupes
Cucumbers
Pumpkins
Squash (summer,
winter)
Watermelon
Eggplant
Peppers, bell
Tomatoes
Celery
Lettuce
Spinach
Collards
Greens, Turnip
Corn, Field
Sweet Corn
Garlic
Onions
Horseradish
Papaya
Potatoes
Soybeans
0.2
0.25
0.3
0.1
0.2
0.2
0.1
0.2
0.1
0.2
0.2
0.2
0.2
0.2
0.15
0.2
0.2
0.2
0.2
0.2
0.15
0.15
0.15
0.2
0.2
0.3
0.15
0.15
0.2
0.2
10
10
10
7
7
5
5
5
5
7
7
7
7
7
7
5
7
7
7
3
3
3
7
3
10
7
10
10
10
10
0.6
0.75
0.9
0.4
0.8
0.8
0.4
0.4 (0.8 in HI)
0.4 (0.6 in HI)
0.8 (1.2 in HI)
1.2
1.2
1.2
1.2
0.6 (1.0 in HI)
0.8
0.6 (0.8 in HI)
1.0 (1.2 in HI)
0.8 (1.2 in HI)
0.6
0.45
0.45
0.45
0.8
0.8
1.0
0.45
0.75
0.8
0.4
Products not labeled or intended for use in outdoor residential misting
systems must contain the following statement:
Placement on Label
Directions for Use under General
Precautions and Restrictions and/or
Application Instructions
114
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Description
Amended Labeling Language
Placement on Label
labels
(Outdoor residential
misting system
requirement)
Note to registrant: also
express this application
rate as pounds or gallons
of end-use product
formulation.
"Not for use in outdoor residential misting systems."
Products labeled or intended for use in outdoor residential misting systems
must contain the following statements:
"Directions for use in outdoor residential misting systems:
When using this product installers and service technicians must comply with the
license, certification, or registration requirements of the state(s), tribe(s), or local
authority(ies) where they are installed."
"Do not apply this pesticide when people, pets, and/or food are present."
"Do not use in an evaporative cooling system."
"Direct nozzles to spray towards the target area and away from swimming pools,
water bodies, or eating and cooking areas."
"Do not set nozzles to direct mist near outside air condition systems or other
home air intakes."
"If used in a system with a reservoir tank for the end use dilution, the system
reservoir tank must be locked. Securely attach the end use pesticide label and a
dilution statement to the system reservoir tank in a weather protected area or
plastic sleeve. The dilution statement must be phrased as follows: this container
holds parts [product name] to parts water"
"If used in a direct injection system, the pesticide container must be locked.
Securely attach the end use label to the pesticide container in a weather protected
area or plastic sleeve." (These instructions not applicable to wettable powder
products).
"If the system works on an automatic timer, set the timing for application when
people, pets, and/or food are unlikely to be present."
115
-------
Description
Amended Labeling Language
Placement on Label
"If the system works when a person operates a remote activation device, then
application of this pesticide when people, pets, and/or food are present is
prohibited."
"Contact the system manufacture for guidance or assistance to ensure compliance
with the following requirement:
This product may only be used in systems that have been calibrated to apply no
more than the maximum application rate of 0.25 grams per 1000 cubic feet per
day."
Products with use
instructions for use as a
wide area mosquito
adulticide
(PR Notice 2005-1
recommends that separate
registrations be issued for
products with these use
patterns.)
Amend label instruction to reflect the following:
• Recommendations and requirements specified in Pesticide Registration
Notice 2005-1;
• Remove 100 foot buffer zone use restriction from the product label; and
• Maximum application rate 0.007 Ib ai/A.
In addition, labels must be amended to include the following statements:
"Do not retreat site more than once in 3 days. Do not exceed 25 applications at
0.007 pounds of permethrin per acre or 0.18 pounds of permethrin per acre in any
given season. More frequent treatments may be made to prevent or control a
threat to public and/or animal health determined by a state, tribal or local health or
vector control agency on the basis of documented evidence of disease causing
agents in vector mosquitoes or the occurrence of mosquito-borne diseases in
animal or human populations, or if specifically approved by the state or tribe
during a natural disaster recovery effort."
"Apply when wind speed is greater than 1 mph."
"Do not apply by fixed wing aircraft at a height less than 100 feet, or by
helicopter at a height less than 75 feet unless specifically approved by the state or
tribe based on public health needs."
Directions for Use under General
Precautions and Restrictions and/or
Application Instructions
116
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Description
Buffer Zone
Requirements
Amended Labeling Language
"Aerial Application made at <200 above ground elevation:
Spray equipment must be adjusted so that the volume median diameter product is
less than 60 microns (Dv 0.5 < 60 um) and that 90% of the spray is contained in
droplets smaller than 100 microns (Dv 0.9 < 100 microns). The effects of flight
speed and, for non-rotary nozzles, nozzle angle on the droplet size spectrum must
be considered. Directions from the equipment manufacturer or vendor, pesticide
registrant or a test facility using a wind tunnel and laser-based measurement
instrument must be used to adjust equipment to produce acceptable droplet size
spectra. Application equipment must be tested at least annually to confirm that
pressure at the nozzle and nozzle flow rate(s) are properly calibrated."
"Aerial Application made at >200 above ground elevation:
Spray equipment must be adjusted so that the volume median diameter product is
less than 70 microns (Dv 0.5 < 70 um) and that 90% of the spray is contained in
droplets smaller than 145 microns (Dv 0.9 < 145 microns). The effects of flight
speed and, for non-rotary nozzles, nozzle angle on the droplet size spectrum must
be considered. Directions from the equipment manufacturer or vendor, pesticide
registrant or a test facility using a wind tunnel and laser-based measurement
instrument must be used to adjust equipment to produce acceptable droplet size
spectra. Application equipment must be tested at least annually to confirm that
pressure at the nozzle and nozzle flow rate(s) are properly calibrated."
"Ground-based application:
Spray equipment must be adjusted so that the volume median diameter is less than
30 microns (Dv 0.5 < 30 um) and that 90% of the spray is contained in droplets
smaller than 50 microns (Dv 0.9 < 50 um). Directions from the equipment
manufacturer or vendor, pesticide registrant or a test facility using a laxer-based
measurement instrument must be used to adjust equipment to produce acceptable
droplet size spectra. Application equipment must be tested at least annually to
confirm that pressure at the nozzle and nozzle flow rate(s) are properly
calibrated."
BUFFER ZONES
Placement on Label
Directions for Use under General
Precautions and Restrictions and/or
117
-------
Description
Amended Labeling Language
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 permethrin 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.
hUp://www.in.csusda/v/tcchnical/asronom/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,
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 Requirements
Wind Direction and Speed
Placement on Label
Application Instructions
Directions for Use under Spray Drift
Requirements.
118
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Description
Amended Labeling Language
Placement on Label
"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."
"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
119
-------
Description
Amended Labeling Language
Placement on Label
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."
End Use Products Primarily Intended for Residential Use
Environmental Hazard
Statements
For products that have outdoor uses:
"This pesticide is extremely toxic to aquatic organisms, including fish and
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 precautions and requirements."
Precautionary Statements
Precautionary statement
for all permethrin canine
spot on products (i.e.
45/65% permethrin
concentrations spot-on
products for dogs)
Note to registrant:
All cat warning labels will be placed within a shaded box within the
Precautionary Statements on the label. The coloring of the box and text will be
such to provide a contrasting color to other label text. The shaded box must
contain the following.
"DO NOT USE ON CATS. May be toxic or potentially fatal if applied to or
ingested by cats. Accidental application to cats and/or grooming a recently
treated dog may result in tremors and/or uncoordinated muscle movements. If
this occurs, immediate veterinary care should be provided."
Precautionary Statement
120
-------
Description
Amended Labeling Language
Placement on Label
Each label must include at least one cat slash icon. This icon may be in the
shaded box or in other areas on the label.
Each individual tube must be labeled with the "DO NOT USE ON CATS"
statement or cat slash icon.
Include the following statement prominently on the front panel of product
packaging (in bold), "DO NOT USE ON CATS"
Entry Restrictions for
products labeled solely
for use when people are
present (e.g. fabric
treatments, livestock, and
pet applications)
No entry restrictions are required. See below under "Use Restrictions" for further
requirements.
Directions for use under General
Precautions and Restrictions
Entry Restrictions for
products labeled for use
when people are present
(e.g. fabric treatments,
livestock, and pet
applications) and for use
on other sites as a
directed or space spray.
Products labeled for use as a directed spray (does not apply to products
applied directly to domestic animals):
"Except when (insert application method or site that allows people to be present),
do not enter or allow others to enter treated area until sprays have dried."
Products labeled for use as a space spray:
"Except when (insert application method or site that allows people to be present),
do not enter or allow others to enter until vapors, mists, and aerosols have
dispersed, and the treated area has been thoroughly ventilated."
Note to Registrant: An example is as follows: Except when applying to pets or
livestock, do not enter or allow others to enter until sprays have dried.
General Application
Restrictions for products
No general application restrictions are required. See below under "Use
Restrictions" for further requirements.
Place in the Direction for Use.
121
-------
Description
Amended Labeling Language
Placement on Label
solely labeled for use
when people may be
present (e.g. misting
systems, fabric treatments
and pet applications)
Additional Application
Restrictions For Outdoor
Residential Use
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 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."
Products labeled for or intended to be applied by sponge application:
Application instruction for sponge application must be removed from the label,
and the following statement must be added: "This product may not be applied by
sponge application."
Directions for Use under General
Precautions and Restrictions
122
-------
Description
Amended Labeling Language
Placement on Label
Additional Application
Restrictions For Indoor
Residential Use
Products labeled for or intended for use as directed surface sprays for use on
residential indoor surfaces (excludes Ready to Use products and Total
Release Foggers:
Application instruction for directed surface sprays (such as low pressure hand
wand, backpack sprayer, and ULV cold fogger) to indoor surfaces at residential
sites must be removed from the label, and the following statement must be added:
"Do not apply as a broadcast, crack and crevice, or spot treatment to indoor
surfaces at residential sites, including nurseries, day care centers, schools,
hospitals, and nursing homes."
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 hour. If an odor is still detected additional ventilation is required."
Note to registrant- If you have any information that justifies a change in the
duration after application (2 hours), submit the information to the Agency.
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."
Directions for Use under General
Precautions and Restrictions
123
-------
Description
Amended Labeling Language
Placement on Label
Additional Application
Restrictions For Either
Indoor and Outdoor
Residential Use
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."
Use-Specific Application
Restrictions for all liquid
and wettable powder
labels
(Outdoor residential
misting system
requirement)
Note to registrant: also
express this application
rate as pounds or gallons
of end-use product
formulation.
Products not labeled or intended for use in outdoor residential misting
systems must contain the following statement:
"Not for use in outdoor residential misting systems."
Products labeled or intended for use in outdoor residential misting systems
must contain the following statements:
"Directions for use in outdoor residential misting systems:"
"When using this product installers and service technicians must comply with the
license, certification, or registration requirements of the state(s), tribe(s), or local
authority(ies) where they are installed."
"Do not apply this pesticide when people, pets, and/or food are present."
"Do not use in an evaporative cooling system."
"Direct nozzles to spray towards the target area and away from swimming pools,
water bodies, or eating and cooking areas."
"Do not set nozzles to direct mist near outside air condition systems or other
Directions for Use under General
Precautions and Restrictions and/or
Application Instructions
124
-------
Description
Amended Labeling Language
Placement on Label
home air intakes."
"If used in a system with a reservoir tank for the end use dilution, the system
reservoir tank must be locked. Securely attach the end use pesticide label and a
dilution statement to the system reservoir tank in a weather protected area or
plastic sleeve. The dilution statement must be phrased as follows: this container
holds parts [product name] to parts water"
"If used in a direct injection system, the pesticide container must be locked.
Securely attach the end use label to the pesticide container in a weather protected
area or plastic sleeve." (These instructions not applicable to wettable powder
products).
"If the system works on an automatic timer, set the timing for application when
people, pets, and/or food are unlikely to be present."
"If the system works when a person operates a remote activation device, then
application of this pesticide when people, pets, and/or food are present is
prohibited."
"Contact the system manufacture for guidance or assistance to ensure compliance
with the following requirement:
This product may only be used in systems that have been calibrated to apply no
more than the maximum application rate of 0.25 grams per 1000 cubic feet per
day."
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.
125
-------
Appendix A-l
Food and Feed Use Patterns Subject for Reregistration of Permethrin
Site
Application Type
Application Timing
Application Equipment
Formulation
Max. Single
Application Rate
(ai)
Max. #
Apps.
Minimum
Retreatment
Interval (Days)
Use Limitations
Food/Feed Crop Uses
Alfalfa (including alfalfa grown for seed)
Postemergence broadcast
Ground and aerial equipment
EC
WP
0.2 Ib/A
1 per
cutting
Not Specified
(NS)
A 0-day PHI is specified following applications at #0.1
Ib/A, and a 14-day PHI is specified following
applications at >0.1 Ib/A.
Do not exceed 0.2 Ib ai/A/cutting.
Apply in a minimum of 2 and 10 gal/A using aerial or
ground equipment, respectively.
Alfalfa (grown for seed)
Postemergence broadcast
Ground and aerial equipment
EC
0.2 Ib/A
NS
NS
SLN No. AZ850006: Apply in a minimum of 5 and 10
gal/A using aerial or ground equipment, respectively.
SLNNo. CA820081: Apply in a minimum of 10 gal/A
using aerial equipment.
Do not feed treated hay or straw. Do not use seed for
feed or food.
Almonds
Foliar and soil broadcast
applications
Ground and aerial equipment
Foliar and soil broadcast
applications
Ground equipment
EC
G
EC
0.4 Ib/A
5
NS
A 7-day PHI is specified.
Apply no more than 2 Ib ai/A/season with no more than
0.8 Ib ai/A applied during hull split.
Apply in a minimum of 15 gal/A using aerial or ground
equipment.
Do not graze livestock in treated areas or feed cover
crops from treated areas to livestock.
A 7-day PHI is specified.
Apply no more than 2 Ib ai/A/season.
Apply in a minimum of 25 gal/A using ground equipment
only.
Do not graze livestock in treated areas or feed cover
crops from treated areas to livestock.
A-l
-------
Site
Application Type
Application Timing
Application Equipment
Formulation
Max. Single
Application Rate
(ai)
Max. #
Apps.
Minimum
Retreatment
Interval (Days)
Use Limitations
Apples
Broadcast foliar application
Ground equipment
EC
WP
0.25 Ib ai/A
2
10
Do not apply more than 0.5 Ib ai/A/season.
Do not apply after petal fall.
Apply in a minimum of 25 gal/A using ground
equipment.
Do not graze livestock in treated areas or feed cover
crops from treated areas to livestock.
Artichoke
Broadcast foliar application
Ground and aerial equipment
Broadcast foliar application
Ground equipment
Foliar application
Aerial equipment
EC
WP
EC
WP
EC
0.3 Ib/A
3
NS
10
NS
A 0-day PHI is specified.
Do not apply more than 0.9 Ib ai/A/season.
Apply in a minimum of 2 and 10 gal/A using aerial or
ground equipment, respectively.
A 0-day PHI is specified.
Do not apply more than 1.5 Ib ai/A/season.
Apply in a minimum of 10 gal/A using ground equipment
only.
No PHI is specified.
Apply in a minimum of 10 gal/A
Asparagus
Broadcast postemergence
application
Ground equipment
EC
WP
0.1 Ib/A
4
7
A 1-day PHI is specified.
Do not apply more than 0.4 Ib ai/A/season.
A minimum application volume of 10 gal/A is specified.
Avocados
Broadcast foliar application
Ground equipment
EC
WP
0.2 Ib/A
4
7
A 7-day PHI is specified.
Do not apply more than 0.8 Ib ai/A/season or make more
than 6 applications/season.
Apply in a minimum of 25 gal/A.
Do not graze livestock in treated areas or feed cover
crops from treated areas to livestock.
Broccoli, Chinese broccoli
A-2
-------
Site
Application Type
Application Timing
Application Equipment
Broadcast foliar application
Ground and aerial equipment
Formulation
EC
WP
Max. Single
Application Rate
(ai)
0.2 Ib/A
Max. #
Apps.
5
Minimum
Retreatment
Interval (Days)
4
Use Limitations
A 1-day PHI is specified.
Do not apply more than 0.8 Ib ai/A/season.
Labels specify minimum application volumes of 2 or 10
gal/A using aerial or ground equipment, respectively.
Brussel sprouts
Broadcast foliar application
Ground and aerial equipment
EC
WP
0.1 Ib/A
4
5
A 1-day PHI is specified.
Do not apply more than 0.4 Ib ai/A/season.
Labels specify minimum application volumes of 2 or 10
gal/A using aerial or ground equipment, respectively.
Cabbage and Chinese cabbage (tight-heading varieties only)
Broadcast foliar application
Ground and aerial equipment
EC
WP
0.2 Ib/A
2
(4 in HI)
5
A 1-day PHI is specified.
Do not apply more that 0.4 (0.8 in HI) Ib ai/A/season.
Labels specify minimum application volumes of 2 and 10
gal/A using aerial or ground equipment, respectively.
Cantaloupe
Broadcast foliar application
Ground and aerial equipment
EC
WP
0.2 Ib/A
4
(6 in HI)
7
A 0-day PHI is specified.
Do not apply more than 0.8 (1 .2 in HI) Ib ai/A/season.
Apply in a minimum of 4 or 5 gal/A using aerial
equipment and 20 gal/A using ground equipment.
Cauliflower
Broadcast foliar application
Ground and aerial equipment
EC
WP
0.1 Ib/A
4
(6 in HI)
5
A 1-day PHI is specified.
Do not apply more than 0.4 (0.6 in HI) Ib ai/A/season.
Labels specify minimum application volumes of 2 and 10
gal/A using aerial or ground equipment, respectively.
Celery
Broadcast foliar application
Ground and aerial equipment
EC
WP
0.2 Ib/A
5
(6 in HI)
7
A 1-day PHI is specified.
Do not apply more than 1 .0 (1 .2 in HI) Ib ai/A/season.
Apply in a minimum of 2 and 10 gal/A using aerial or
ground equipment, respectively.
Cherry
A-2
-------
Site
Application Type
Application Timing
Application Equipment
Broadcast foliar application
Ground equipment
Collards (only in AR, AZ, GA, IL, NC,
Broadcast foliar application
Ground equipment
Broadcast foliar application
Ground and aerial equipment
Corn, field and pop
Broadcast or banded
preemergence application and
broadcast foliar applications
Ground and aerial equipment
Corn, sweet
Formulation
EC
WP
OK, SC, and TX)
EC
WP
EC
EC
WP
G
Max. Single
Application Rate
(ai)
0.2 Ib/A
0.151b/A
0.151b/A
Max. #
Apps.
3
3
3
Minimum
Retreatment
Interval (Days)
10
3
7
Use Limitations
A 3-day PHI is specified.
Do not apply more than 0.6 Ib ai/A/season.
Do not graze livestock in treated areas or feed cover
crops from treated areas to livestock.
Apply in a minimum of 25 gal/A.
A 1-day PHI is specified.
The maximum seasonal use rate is specified as 0.45 Ib
ai/A.
Apply in a minimum of 10 gal/A.
For use only in AR, IN, and TN.
A 1-day PHI is specified.
Do not apply more than 0.45 Ib ai/A/season.
Apply in a minimum of 1 or 10 gal/A using aerial and
ground equipment, respectively.
Apply preemergence from 5 days prior to planting up to
emergence.
A 0-day PHI is specified for forage, and a 30-day PHI is
specified for grain and fodder (stover).
Do not apply more than 0.45 Ib ai/A/season.
Apply in a minimum of 2 and 10 gal/A using aerial and
ground equipment, respectively.
A-4
-------
Site
Application Type
Application Timing
Application Equipment
Broadcast preemergence and
foliar applications
Ground and aerial equipment
Formulation
EC
WP
G
Max. Single
Application Rate
(ai)
0.2 Ib/A
Max. #
Apps.
4
Minimum
Retreatment
Interval (Days)
3
Use Limitations
A 1-day PHI is specified.
Do not apply more than 0.8 Ib ai/A/season
Apply in a minimum of 2 and 10 gal/A using aerial or
ground equipment, respectively.
Cucurbit vegetables (except cantaloupes)
Broadcast foliar application
Ground and aerial equipment
EC
WP
0.2 Ib/A
6
7
A 0-day PHI is specified.
Do not apply more than 1.2 Ib ai/A/season.
Apply in a minimum of 4 or 5 gal/A using aerial
equipment and 20 gal/A using ground equipment.
Eggplant
Broadcast foliar application
Ground or aerial equipment
EC
WP
0.151b/A
4
(except HI
see use
limitation)
7
A 3-day PHI is specified.
Do not apply more than 0.6 (1 .0 in HI) Ib ai/A/season.
Apply in a minimum of 2 and 10 gal/A using aerial or
ground equipment, respectively.
Filberts
Broadcast foliar application
Ground and aerial equipment
EC
WP
0.4 Ib/A
4
NS
A 14-day PHI is specified.
Do not apply more than 1.6 Ib ai/A/season.
Labels specify minimum application volumes of 10 gal/A
using ground equipment and 25 or 50 gal/A using aerial
equipment.
Do not graze livestock in treated areas or feed cover
crops from treated orchards to livestock.
Garlic
A-5
-------
Site
Application Type
Application Timing
Application Equipment
Broadcast foliar application
Ground or aerial equipment
Formulation
EC
WP
Max. Single
Application Rate
(ai)
0.2 Ib/A
Max. #
Apps.
4
Minimum
Retreatment
Interval (Days)
10
Use Limitations
A 1-day PHI is specified.
Do not apply more than 0.8 Ib ai/A/season.
Apply in a minimum of 5 or 6 gal/A using aerial
equipment, and 20 gal/A using ground equipment.
Grass, rangeland (NM only)
Broadcast application
Ground and aerial equipment
EC
WP
0.01 Ib/A
1
NA
Do not apply more than once per year.
Cattle may be present during application.
Do not harvest or feed hay to livestock.
The Label 100-985 has no regional restriction.
Apply in a minimum of 2 or 10 gal/A using aerial and
ground equipment, respectively.
SLN No. NM840005 specifies a minimum volume of 1
qt/A for aerial application.
SLN No. NM840006 specifies a minimum volume for
aerial application of 1 qt/A of vegetable oil or 1 gal/A of
water.
Horseradish
Preplant dip
Broadcast foliar application
Ground equipment
EC
EC
WP
0.83 lb/100 gal
(0.1%ai solution)
0.151b/A
1
3
NA
10
Soak sets for 30 minutes and air-dry prior to planting.
A 30-day PHI is specified.
Do not apply more than 0.45 Ib ai/A/season.
Apply in a minimum of 20 gal/A using ground
equipment.
Leafy Vegetables (except Brassica, Celery, Lettuce, and Spinach)
Broadcast foliar application
Ground and aerial equipment
EC
WP
0.2 Ib/A
10
3
A 1-day PHI is specified.
Do not apply more than 2 Ib ai/A/season.
Apply in a minimum of 2 and 10 gal/A using aerial or
ground equipment, respectively.
Lettuce
Broadcast foliar application
Ground and aerial equipment
EC
WP
0.2 Ib/A
4
(6 in HI)
7
A 1-day PHI is specified.
Do not apply more than 0.8 (1 .2 in HI) Ib ai/A/season.
Apply in a minimum of 2 and 10 gal/A using aerial or
ground equipment, respectively.
A-6
-------
Mushrooms (mushroom houses and adjacent premise areas)
Fogging or aerosol application
prior to filling house, during cool-
down, during spawning, up to
pinning, and between breaks.
Surface application until runoff to
walls and ceilings prior to filling
house, during cool-down, during
spawning, up to pinning, and
between breaks.
EC
D
WP
2.5 oz. per 30 oz water
0.14oz/gal
(0.34oz/l,000ft2)
30 per crop
of 5 breaks
1
A 3-day PHI is specified.
Do not use when mushrooms are present.
Do not make more than 20 applications prior to pinning
of first break; more than 2 applications between each
break; and no more than a total of 30 applications per
crop of 5 breaks.
Onions (dry bulb only)
Broadcast foliar application
Ground or aerial equipment
EC
WP
0.3 Ib/A
l.Olbai
seasonal
max.
7
A 1-day PHI is specified.
Do not apply more than 1.0 Ib ai/A/season.
Apply in a minimum of 5 or 6 gal/A using aerial
equipment, and 20 gal/A using ground equipment.
Papayas (FL only)
Broadcast foliar application
Ground Equipment
EC
WP
0.151b/A
5
10
A 7-day PHI is specified.
Do not make more than 5 applications per season, or
apply more than 0.15 Ib ai/A/season.
Apply in a minimum of 25 gal/A.
Do not graze livestock in treated areas or feed cover
crops from treated areas to livestock.
Peaches/Nectarines
Broadcast foliar application
Ground and aerial equipment
EC
WP
0.25 Ib/A
3
10
A 14-day PHI is specified.
Do not apply more than 0.75 Ib ai/A/season.
Apply in a minimum of 10 and 25 gal/A using aerial or
ground equipment, respectively.
Do not graze livestock in treated areas or feed cover
crops from treated areas to livestock.
Pears
A-7
-------
Dormant through delayed dormant
(prebloom) applications
Ground and aerial equipment
EC
WP
0.25 Ib/A
(0.4 Ib/A for dormant
only)
0.65 Ib/A
seasonal
max.
10
Do not apply more than 0.65 Ib ai/A/season.
Dormant applications of EC formulations may include 2-
8 gal of spray oil/acre.
Apply in a minimum of 10 and 25 gal/A using aerial or
ground equipment, respectively.
Do not graze livestock in treated area or feed livestock
cover corps from treated areas.
Peppers, bell
Broadcast foliar application
Ground and aerial equipment
EC
WP
0.2 Ib/A
4
5
A 3-day PHI is specified.
Do not apply more than 0.8 Ib ai/A/season.
Apply in a minimum of 2 and 10 gal/A using aerial or
ground equipment, respectively.
Pistachios
Broadcast foliar application prior
to 10% hull split
Ground and aerial equipment
EC
WP
G
0.4 Ib/A
2or4
NS
A 0-day PHI is specified.
The maximum seasonal rate is 1.6 Ib ai/A on FMC labels
and 0.8 Ib ai/A on all other labels.
Do not apply after 10% hull split.
Apply in a minimum of 10 and 25 gal/A using aerial or
ground equipment, respectively.
Do not graze livestock in treated areas or feed cover
crops from treated areas to livestock.
The label for the 1 .5% G allows aerial applications, but
prohibits use on pistachios grown in CA.
Potatoes
Broadcast foliar application
Ground and aerial equipment
EC
WP
0.2 Ib/A
4
10
A 14-day PHI is specified.
Do not apply more than 0.8 Ib ai/A/season.
Apply in a minimum of 2 and 10 gal/A using aerial and
ground equipment, respectively.
Potatoes (for greenhouse grown seed potatoes or transplants)
Foliar application
Handsprayers
EC
0.03 oz/gal
9
NS
Only for use in CA.
A maximum of 9 applications per crop is specified.
The use of treated potatoes for human or livestock
consumption is prohibited.
Soybeans
A-8
-------
Broadcast foliar application
Ground and aerial equipment
EC
WP
EC
0.2 Ib/A
0.1 Ib/A
2
2
10
10
10
A 60-day PHI is specified.
Do not apply more than 0.4 Ib ai/A/season.
Do not graze or feed soybean forage or hay.
Apply in a minimum of 2 and 10 gal/A using aerial and
ground equipment, respectively. Applications may be
made in vegetable oil at a minimum of 1 qt oil/A.
For use only in AR, FL, LA, MS, OK, and TX.
A 40-day PFfl is specified.
Do not apply more 2 time per season.
Do not graze or feed soybean forage.
Apply in a minimum of 1 and 5 gal/A using aerial and
ground equipment, respectively.
Applications can include vegetable oil at 1 qt/A.
For use only in AL, GA, MS, SC, and TX.
A 60-day PFfl is specified.
Do not apply more than 2 times per season.
Do not graze or feed soybean forage.
GA830007 specifies minimum application volumes of 1
and 5 gal/A using aerial and ground equipment,
respectively; the other SLNs do not specify application
volumes.
Applications can include vegetable oil at 1 qt/A.
Spinach
Broadcast foliar application
Ground and aerial equipment
EC
WP
0.2 Ib/A
3
3
A 1-day PFfl is specified.
Do not apply more than 0.6 Ib ai/A/season.
Apply in a minimum of 2 and 10 gal/A using aerial or
ground equipment, respectively.
Tomatoes
Broadcast foliar application
Ground and aerial equipment
EC
WP
0.2 Ib/A
6
NS
FMC labels include use on tomatillos
A 0-day PFfl is specified.
Do not apply more than 1.2 Ib ai/A/season.
Do not apply as a banded application.
Do not apply to tomato varieties which produce mature
fruit <1 inch in diameter.
Apply in a minimum of 2 and 10 gal/A using ground or
aerial equipment, respectively.
Turnips (only in FL, GA, IL, IN, OK, SC, TX, and WA)
A-9
-------
Broadcast foliar application
Ground equipment
Broadcast foliar application
Ground and aerial equipment
EC
WP
EC
0.151b/A
0.1 Ib/A
3
8
3
NS
A 1-day PHI is specified.
Do not apply more than 0.45 Ib ai/A/season.
Apply in a minimum of 10 gal/A.
For use only in AR, IN, and TN.
A 1-day PHI is specified.
Do not apply more than 0.45 Ib ai/A/season.
Apply in a minimum of 1 or 10 gal/A using ground and
aerial equipment, respectively.
Do not graze treated areas or feed crop refuse to
livestock.
Walnut
Broadcast foliar application
Ground and aerial equipment
EC
WP
0.25 Ib/A
3
10
A 1-day PHI is specified.
Do not apply more than 0.45 Ib ai/A/season.
Apply in a minimum of 10 or 20 gal/A using aerial
equipment and 25 gal/A using ground equipment.
Do not graze livestock in treated areas or feed cover
crops from treated areas to livestock.
Seed Treatments
Seed Treatments (commercial seed treaters only)
Seed Treatment by commercial
seed treaters
EC
WP
0.5 oz/100 Ib seed
1
NA
For application to seeds of the following crops: broccoli,
Brussel sprouts, cabbage, cauliflower, celery, corn (all
types), cucurbits, eggplant, leafy vegetables (except
Brassica), peppers (Bell), soybean, and tomato.
Not for use on agricultural establishments in seed
treatment equipment at or immediately before planting.
Do not use treated seed for food, feed, or processing.
Livestock Uses
Livestock Housing and Premises (dairies, barns, feedlots, stables, poultry houses, swine and livestock houses)
Surface application to building
walls and ceilings
EC
WP
0.17oz/1000ft2
NS
1-2 weeks
Do not treat manure or litter.
Do not apply directly to livestock or poultry.
Dairy and Beef Cattle, Goats, and Sheep
Dilute whole body spray
Concentrated Mid-line and ear
spray
Self oiler
EC
0.05% a.i. solution at 1-2
qt/animal
(.907 mg ai/animal)
0.5% a.i. solution at
-6 fl oz/animal
(.212 mg/animal)
0.125%aiinoil
NS
NS
NA
10
NS
NA
No PSI is specified
A-10
-------
Poultry
Whole body spray
EC
0.33% a.i. solution at 1
gal/1 00 birds
(.120mgai/bird)
NS
NS
Swine
Whole body spray or dip
EC
0.05% a.i. solution at 1-2
qt/animal
(.907 mg ai/animal)
NS
14
A 5 day PSI is specified
Horses
Spot application to back, face,
legs, tail, and ears
Whole body wash/dip
EC
0.63% ai solution at 2 fl.
oz/animal
(.354 mg ai/animal)
0.063% ai solution
NS
NS
NS
NS
A-ll
-------
Appendix A-2
Non-Food and Non-Feed Use Patterns Subject for Reregistration of Permethrin
Site
AGRICULTURAL
UNCULTIVATED AREAS
AGRICULTURAL/FARM
PREMISES
ALFALFA
ANIMAL KENNELS/SLEEPING
QUARTERS (COMMERCIAL)
AUTOMOBILES- TAXIS -
LIMOUSINES - RECREATIONAL
VEHICLES - & TIRES
Form
Code
EC
WP
WP
EC
EC*RTU
PRL
SC/L
SC/L*
RTU
SC/L*
RTU
PRL
Max.App
Rate/App
0.2125
0.0523
0.0801
0.1212
0.2
0.1067
0.0801
0.04
6.18E-04
0.4604
0.008
Unit
(ai)
Ib/A
Ib/lK
sq.ft
Ib/moun
d
bag/1 K
sq.ft
Ib/A
Ib/A
Ib/moun
d
lb/1 gal
Ib/lK
cu.ft
Ib/lK
sq.ft
Ib/lK
sq.ft
NS
0.0974
2.72E-
04
0.0457
0.0366
0.0974
0.0098
Ib/A
Ib/lK cu.ft
Ib/lK sq.ft
lb/1 gal
Ib/A
Ib/lK sq.ft
NS
Use Pattern/Limitations
Remove or carefully protect food products and
food packaging.
Do not treat animals under 12 weeks of age.
14 day MRI.
12hourREI
12hourREI.
Remove animals prior to treatment.
Remove feed and water prior to treatment.
Do not apply to plant foliage.
For use only in New Mexico (SLN
Registration)
Remove animals prior to treatment.
Remove feed and water prior to treatment.
Do not apply to plant foliage.
14 day MRI.
For use only in New Mexico (SLN
Registration
Remove animals prior to treatment.
Remove feed and water prior to treatment.
Do not apply to plant foliage.
Do not treat animals under 12 weeks of age.
Remove or carefully protect food products and
food packaging.
Cover feed and water prior to treatment.
Do not allow children or pets on treated areas
until surfaces are dry.
14 day MRI.
Cover feed and water prior to treatment.
Do not allow children or pets on treated areas
until surfaces are dry.
A-12
-------
Site
BATHROOM PREMISES/HARD
SURFACES
BATHROOM PREMISES/HARD
SURFACES
CADAVERS AND CASKETS
CATS (ADULTS/KITTENS)
CATTLE FEEDLOTS
CHRISTMAS TREE
PLANTATIONS
CHRISTMAS TREE
PLANTATIONS
COMMERCIAL
STORAGES/WAREHOUSES
PREMISES
Form
Code
EC
PRL
PRL
D
EC
PRL
RTU
SC/L
EC
WP
EC
SC/L
Max.App Unit
Rate/App (ai)
0.7805
Ib/lK sq.ft
NS
NS
1.56E-
04
0.0039
Ib/Animal
lb/1 gal
NS
1
0.0175
1.047
0.02
0.2
0.7805
0.0366
2.72E-
04
0.0457
sec Ib body
wt(L)
lb/1 gal
Ib/A
Ib/tree
Ib/A
Ib/lK sq.ft
lb/1 gal
Ib/lK cu.ft
Ib/lK sq.ft
Use Pattern/Limitations
Remove food and animals from premises prior
to treatment. Remove or carefully protect
food products and food packaging.
Remove animals prior to treatment.
Do not allow children or pets on treated areas
until surfaces are dry.
Remove or carefully protect food products and
food packaging.
Remove animals prior to treatment.
Do not allow children or pets on treated areas
until surfaces are dry.
14 day MRI.
Do not allow children or pets on treated areas
until surfaces are dry.
Do not treat animals under 12 weeks of age.
14 day MRI.
Do not treat animals under 30 weeks of age.
90 day MRI.
Do not treat animal under three months of age.
14 day MRI.
Retreat as needed.
Remove animals prior to treatment.
Retreat as needed.
Do not allow children or pets on treated areas
until surfaces are dry.
Disallowed in CA.
5 day MRI.
12hourREI.
Do not allow children or pets on treated areas
until surfaces are dry.
5 day MRI.
12hourREI.
Disallowed in CA.
5 day MRI.
12hourREI.
Remove food and animals from premises prior
to treatment.
Remove or carefully protect food products and
food packaging.
Remove animals prior to treatment.
Do not allow children or pets on treated areas
until surfaces are dry.
A-13
-------
Site
COMMERCIAL
TRANSPORTATION FACILITIES-
NONFEED/NONFOOD
COMMERCIAL/INDUSTRIAL
LAWNS
COMMERCIAL/INSTITUTIONAL
/INDUSTRIAL PREMISES/EQUIP.
(INDOOR)
COMMERCIAL/INSTITUTIONAL
/INDUSTRIAL
PREMISES/EQUIPMENT
(OUTDOOR)
Form
Code
PRL
EC
SC/L
PRL
EC
EC
SC/L*
RTU
SC/L
PRL
FM
SC/L
EC
Max.App Unit
Rate/App (ai)
NS
0.4604
0.08
2.72E-
04
0.0457
0.0366
Ib/lK sq.ft
lb/1 gal
Ib/lK cu.ft
Ib/lK sq.ft
lb/1 gal
NS
2.47E-
04
0.4604
0.08
0.0974
0.0974
2.72E-
04
0.0457
0.0366
Ib/lK sq.ft
Ib/lK sq.ft
lb/1 gal
Ib/A
Ib/A
Ib/lK cu.ft
Ib/lK sq.ft
lb/1 gal
NS
1.75
0.0175
0.85
0.7805
0.1561
0.04
fl.oz (L)
lb/1 gal
Ib/A
Ib/lK sq.ft
Ib/mound
lb/1 gal
Use Pattern/Limitations
Remove animals prior to treatment.
14 day MRI.
Remove food and animals from premises prior
to treatment.
Remove or carefully protect food products and
food packaging.
Remove animals prior to treatment.
Do not allow children or pets on treated areas
until surfaces are dry.
Remove food and animals from premises prior
to treatment. Remove or carefully protect
food products and food packaging.
Remove animals prior to treatment.
Do not allow children or pets on treated areas
until surfaces are dry.
14 day MRI.
Do not allow children or pets on treated areas
until surfaces are dry.
12 hours REI.
Remove food and animals from premises prior
to treatment.
Remove or carefully protect food products and
food packaging.
Remove animals prior to treatment.
Do not allow children or pets on treated areas
until surfaces are dry.
Remove or carefully protect food products and
food packaging.
Remove animals prior to treatment.
Do not allow children or pets on treated areas
until surfaces are dry.
14 day MRI.
Remove food and animals from premises prior
to treatment.
Remove or carefully protect food products and
food packaging.
Remove animals prior to treatment.
Do not allow children or pets on treated areas
until surfaces are dry.
12 hour REI.
A-14
-------
Site
CONIFERS (SEED ORCHARD)
DOGS/CANINES
(ADULTS/PUPPIES)
DRAINAGE SYSTEMS
EATING ESTABLISHMENTS
EATING ESTABLISHMENTS
NON-FOOD AREAS (NONFOOD
CONTACT)
FOREST TREES (SOFTWOODS -
CONIFERS)
Form
Code
EC
D
EC
PRL
RTU
SC/L
EC
EC
SC/L
SC/L*
RTU
EC
SC/L
SC/L
SC/L
PRL
WP
EC
Max.App Unit
Rate/App (ai)
0.016
7.81E-
06
0.0067
0.1727
0.1068
8
8
0.0438
0.4604
0.1992
0.0974
0.0974
0.7805
2.72E-
04
0.0457
0.0366
Ib IK trees
Ib/Animal
Ib/Animal
lb/1 gal
lb/20 gal
sec Ib body
wt(L)
sec Ib body
wt(L)
lb/12.5 gal
Ib/lK sq.ft
Ib/minute
Ib/A
Ib/A
Ib/lK sq.ft
Ib/lK cu.ft
Ib/lK sq.ft
lb/1 gal
NS
0.2
1.047
0.02
Ib/A
Ib/A
Ib/tree
Use Pattern/Limitations
For use in Florida and Texas (SLN
Registrations)
1 application per crop cycle or year.
Do not treat animals under 12 weeks of age.
14 day MRI.
Do not treat animals under 26 weeks of age.
90 day MRI.
Do not treat animals under 3 months of age.
14 day MRI.
Remove or carefully protect food products and
food packaging.
Do not treat animals under 12 weeks of age.
14 day MRI.
Do not treat animals less than 4 weeks of age.
Remove or carefully protect food products and
food packaging.
Remove or carefully protect food products and
food packaging.
Remove food and animals from premises prior
to treatment.
Remove or carefully protect food products and
food packaging.
Do not allow children or pets on trated areas
until surfaces have dried.
Remove food and animals from premises prior
to treatment.
Remove or carefully protect food products and
food packaging.
Do not allow children or pets on trated areas
until surfaces have dried.
14 day MRI.
5 day MRI.
12hourREI.
30 day REI for Conifer Cone Seed Harvesting
only.
A-15
-------
Site
GOLF COURSE TURF
GREENHOUSE-EMPTY
HORSES
(SHOW/RACE/SPECIAL/PONIES)
HOSPITALS/MEDICAL
INSTITUTIONS PREMISES
(HUMAN/VETERINARY)
Form
Code
EC
SC/L
SC/L*
RTU
EC
D
RTU
SC/L
SC/L*
RTU
WP
EC
EC
EC*RTU
SC/L
Max.App Unit
Rate/App (ai)
0.016
0.1992
0.0974
0.0175
0.0974
0.7805
2
6.52E-
04
0.0366
0.0098
0.1212
0.0455
7.69E-
04
0.1068
0.0021
0.0268
0.1727
6.18E-
04
0.4604
0.08
0.0488
2.72E-
04
0.0457
0.0366
Ib/lK trees
Ib/minute
Ib/A
lb/1 gal
Ib/A
Ib/lK sq.ft
oz/animal
Ib/Animal
lb/1 gal
Ib/lK sq.ft
bag IK sq.ft
Ib/lK sq.ft
Ib/lK cu.ft
Ib/lK sq.ft
Ib/Animal
Ib/unit
lb/1 gal
Ib/lK cu.ft
Ib/lK sq.ft
lb/1 gal
Ib/lK sq.ft
Ib/lK cu.ft
Ib/lK sq.ft
lb/1 gal
Use Pattern/Limitations
For use only in Alabama, Arkansas, Georgia,
Lousianna, North Carolina, South Carolina,
Tennassee, Texas, and Virginia (SLN
Registrations).
1 day MRI.
12hourREI.
30 day REI for Conifer Cone Seed Harvesting
only.
Remove food and animals from premises prior
to treatment.
Do not allow children or pets on trated areas
until surfaces have dried.
Do not treat more than once every three days.
1 day MRI.
14 day MRI.
12 hour REI
For use only in New Mexico (SLN
Registration).
14 day MRI.
5 days preslaughter interval.
Do not treat animals under 12 weeks of age.
For use only in New Mexico (SLN
Registration).
Remove food and animals from premises prior
to treatment.
Remove or carefully protect food products and
food packaging.
Remove feed and water prior to treatment.
Remove food and animals from premises prior
to treatment.
Remove feed or carefully protect food
products and food packaging.
Do not allow children or pets on treated areas
until surfaces have dried.
A-16
-------
Site
HOUSEHOLD/DOMESTIC
DWELLINGS CONTENTS
HOUSEHOLD/DOMESTIC
DWELLINGS INDOOR
PREMISES
HOUSEHOLD/DOMESTIC
DWELLINGS OUTDOOR
PREMISES
Form
Code
SC/L*
RTU
PRL
EC
RTU
PRL
EC
RTU
SC/L
PRL
EC
RTU
RTU
Max.App Unit
Rate/App (ai)
0.0098
Ib/lK sq.ft
NS
0.7805
Ib/lK sq.ft
NS
NS
0.7805
Ib/lK sq.ft
NS
2.72E-
04
0.0457
0.0366
Ib/lK cu.ft
Ib/lK sq.ft
lb/1 gal
NS
0.7805
0.0076
0.042
0.1561
0.04
1
0.2422
Ib/lK sq.ft
Ib linear ft
Ibmin
Ib/mound
lb/1 gal
part(L)
Ib/A
NS
0.1
Ib/A
Use Pattern/Limitations
Remove food and animals from premises prior
to treatment.
Do not allow children or pets on treated areas
until surfaces have dried.
14 day MRI.
Remove food and animals from premises prior
to treatment.
Remove feed or carefully protect food
products and food packaging.
Do not allow children or pets on treated areas
until surfaces have dried.
Do not allow children or pets on treated areas
until surfaces have dried.
Do not enter treated areas without protective
clothing until spray has dried.
14 day MRI.
Remove food and animals from premises prior
to treatment.
Remove feed or carefully protect food
products and food packaging.
Do not allow children or pets on treated areas
until surfaces have dried.
Do not allow children or pets on treated areas
until surfaces have dried.
Do not enter treated areas without protective
clothing until spray has dried.
14 day MRI.
Remove food and animals from premises prior
to treatment.
Remove feed or carefully protect food
products and food packaging.
Do not allow children or pets on treated areas
until surfaces have dried.
Remove food and animals from premises prior
to treatment.
Remove feed or carefully protect food
products and food packaging.
Do not allow children or pets on treated areas
until surfaces have dried.
Disallowed in FL.
Remove food and animals from premises prior
A-17
-------
Site
HUMAN BEDDING/MATTRESSES
HUMAN CAMPING EQUIPMENT
HUMAN CLOTHING (INSECT
AND MOLD/MILDEW CONTROL)
MEAT PROCESSING PLANT
PREMISES (NONFOOD
CONTACT)
MEAT PROCESSING PLANT
PREMISES (NONFOOD
CONTACT)
MORGUES/MORTUARIES/AUTO
PSY/EMBALMING ROOM
PREMISES
MUSHROOM HOUSES-EMPTY
PREMISES/EQUIPMENT
Form
Code
G
RTU
SC/L
SC/L*
RTU
EC
RTU
PRL
PRL
RTU
EC
EC*RTU
SC/L
SC/L
SC/L
SC/L*
RTU
PRL
D
FM/S
Max.App Unit
Rate/App (ai)
1.56E-
04
0.005
0.0038
0.0554
5.57E-
05
0.0974
0.0175
0.0974
0.4604
gal mound
Ib/lK sq.ft
Tsp ant hill
Ib/lK sq.ft
Ibft
Ib/A
lb/1 gal
Ib/A
Ib/lK sq.ft
NS
NS
NS
60
sec (L)
NS
0.0035
0.0488
2.72E-
04
0.0457
0.0366
0.0098
Ib/lK sq.ft
Ib/lK sq.ft
Ib/lK cu.ft
Ib/lK sq.ft
lb/1 gal
Ib/lK sq.ft
NS
0.0017
2.18E-
04
Ib/lK cu.ft
gal IK cu.ft
Use Pattern/Limitations
to treatment.
Remove feed or carefully protect food
products and food packaging.
Do not allow children or pets on treated areas
until surfaces have dried.
Remove or carefully protect food products and
food packaging.
Remove animals prior to treatment.
Do not allow children or pets on treated areas
until surfaces are dry.
Do not enter treated areas without protective
clothing until sprays have dried.
14 day MRI.
Do not enter treated areas without protective
clothing until sprays have dried.
14 day MRI.
14 day MRI.
For use only in New Mexico (SLN
Registration).
Remove animals prior to treatment.
Cover feed and water prior to treatment.
14 day MRI.
Remove animals prior to treatment.
Do not allow children or pets on treated areas
until surfaces are dry.
120 MRI.
3 day PHI.
1 day MRI.
24 hour REI.
Maximum of 30 applications per crop cycle.
A-18
-------
Site
NONAGRICULTURAL AREAS
(PUBLIC HEALTH USE)
NONAGRICULTURAL OUTDOOR
BUILDINGS/STRUCTURES
NONAGRICULTURAL RIGHTS-
OF-
WAY/FENCEROWS/HEDGEROW
S
NONAGRICULTURAL RIGHTS-
OF-
WAY/FENCEROWS/HEDGEROW
S
NONAGRICULTURAL RIGHTS-
OF-
WAY/FENCEROWS/HEDGEROW
S
NONAGRICULTURAL RIGHTS-
OF-
WAY/FENCEROWS/HEDGEROW
S
NONAGRICULTURAL
UNCULTIVATED AREAS/SOILS
ORNAMENTAL AND/OR SHADE
TREES
Form
Code
EC
WP
SC/L
SC/L*
RTU
EC
SC/L
SC/L*
RTU
EC
EC
RTU
D
WP
EC
EC
Max.App Unit
Rate/App (ai)
0.0019
0.375
0.0057
0.0455
0.0974
0.0974
0.85
0.04
0.7805
0.1561
0.0974
0.0974
0.85
0.04
0.7805
0.1561
0.85
0.3951
0.0801
0.04
0.0316
0.0053
Ib/lK cu.ft
Ib/A
gal IK sq.ft
Ib/lK sq.ft
Ib/A
Ib/A
Ib/A
lb/1 gal
Ib/lK sq.ft
Ib/mound
Ib/A
Ib/A
Ib/A
lb/1 gal
Ib/lK sq.ft
Ib/mound
Ib/A
Ib/lK sq.ft
Ib/mound
lb/1 gal
Ibmin
Ib/A
NS
0.0195
0.2
0.2
0.2
0.7805
lb/10 gal
lb/1 00 gal
Ib/A
Ib/A
Ib/lK sq.ft
Use Pattern/Limitations
12hourREI.
Maximum of 30 application per crop cycle.
3 day PHI.
12hourREI.
Maximum of 30 application per crop cycle.
Do not allow children or pets in treated area
until sprays have dried.
12hourREI.
Remove food and animals from premises prior
to treatment.
Remove or carefully protect food products and
packaging.
Do not allow children or pets in treated area
until surfaces are dry.
Do not allow children or pets in treated area
until surfaces are dry.
12 hours REI.
Remove food and animals from premises prior
to treatment.
Remove animals prior to treatment.
Do not allow children or pets in treated area
until surfaces are dry.
Do not allow children or pets in treated area
until surfaces are dry.
12 hours REI.
Disallowed in Florida.
Do not apply through any type of irrigation
system.
12 hour REI.
Disallowed in California.
12 hour REI.
See below.
A-19
-------
Site
ORNAMENTAL HERBACEOUS
PLANTS
ORNAMENTAL LAWNS AND
TURF
ORNAMENTAL
NONFLOWERING PLANTS
Form
Code
EC
PRL
RTU
WP
EC
PRL
RTU
EC
G
EC
Max.App Unit
Rate/App (ai)
0.0319
0.1992
0.1561
4.28
0.08
0.02
4.28
Ib lin. ft/ft
depth
Ib minute
Ib/mound
Ib/tree
lb/1 gal
lb/10 gal
lb/1 00 gal
NS
NS
0.0195
0.5
0.2
0.2
0.7805
0.1992
0.1561
0.0355
0.02
0.5
lb/10 gal
lb/1 00 gal
Ib/A
Ib/A
Ib/lK sq.ft
Ib minute
Ib/mound
lb/1 gal
lb/10 gal
lb/1 00 gal
NS
0.7805
0.0319
0.1561
0.08
1.56E-
04
0.0075
0.0038
0.2
Ib/lK sq.ft
Ib lin. ft/ft
depth
Ib/mound
lb/1 gal
gal mound
Ib/lK sq.ft
Tsp ant hill
Ib/A
Use Pattern/Limitations
Remove food and animals from premises prior
to treatment.
Remove animals prior to treatment.
Do not allow children or pets in treated area
until surfaces are dry.
Do not apply through any type of irrigation
system.
Disallowed in California.
12hourREI.
7 day MRI.
For use in California and Florida.
12hourREI.
For use only in Florida.
Disallowed in California.
Do not allow children or pets in treated area
until surfaces are dry.
12hourREI.
Remove food and animals from premises prior
to treatment. Remove animals prior to
treatment.
Do not allow children or pets in treated area
until surfaces are dry.
Remove food and animals from premises prior
to treatment. Remove animals prior to
treatment.
Do not allow children or pets in treated area
until surfaces are dry.
For use in Florida.
Disallowed in California.
Do not allow chilren or pets in treated area
until surfaces are dry.
12hourREI.
A-20
-------
Site
ORNAMENTAL WOODY SHRUBS
AND VINES
PATHS/PATIOS
PET LIVING/SLEEPING
QUARTERS
Form
Code
RTU
WP
PRL
PRL
RTU
EC
WP
EC
RTU
D
EC
PRL
RTU
Max.App Unit
Rate/App (ai)
0.2
0.7805
0.1992
0.1561
0.0355
0.02
lb/100 gal
Ib/lK sq.ft
Ib/minute
Ib/mound
lb/1 gal
lb/10 gal
NS
0.1
0.2
0.0195
Ib/A
lb/100 gal
lb/10 gal
NS
NS
0.7805
0.0319
0.1992
0.1561
0.08
0.02
0.25
0.2
0.5
0.2
0.0195
0.0523
2.72E-
05
1
5.57E-
05
Ib/lK sq.ft
Ib lin. ft/ft
depth
Ib minute
Ib/mound
lb/1 gal
lb/10 gal
Ib/A
lb/100 gal
Ib/A
lb/100 gal
lb/10 gal
Ib/lK sq.ft
Ib linear ft
part(L)
Ibft
NS
0.7805
Ib/lK sq.ft
NS
NS
Use Pattern/Limitations
12hourREI.
Remove food and animals from premises prior
to treatment. Remove animals prior to
treatment.
Do not allow children or pets in treated area
until surfaces are dry.
12hourREI.
Do not apply through any type of irrigation
system.
Remove food and animals from premises prior
to treatment.
Remove animals prior to treatment.
Do not allow children or pets in treated area
until surfaces are dry.
Disallowed in California.
Do not allow children or pets in treated area
until surfaces are dry.
Disallowed in California.
12hourREI.
Do not apply through any type of irrigation
system.
Remove food and animals from premises prior
to treatment.
Remove animals prior to treatment.
Do not allow children or pets in treated area
until surfaces are dry.
Remove food and animals from premises prior
to treatment.
Remove animals prior to treatment.
Do not allow children or pets in treated area
until surfaces are dry.
A-21
-------
PINE (FOREST/SHELTERBELT)
PINE (SEED ORCHARD)
POME FRUITS
POULTRY PROCESSING PLANT
PREMISES (NONFOOD
CONTACT)
RECREATION AREA LAWNS
RECREATIONAL AREAS
REFUSE/SOLID WASTE
CONTAINERS (GARBAGE CANS)
REFUSE/SOLID WASTE SITES
(INDOOR)
REFUSE/SOLID WASTE SITES
(OUTDOOR)
REFUSE/SOLID WASTE SITES
(OUTDOOR)
REFUSE/SOLID WASTE SITES
(OUTDOOR)
EC
EC
WP
WP
EC
EC*RTU
EC
EC
RTU
SC/L
SC/L*
RTU
PRL
EC
EC
EC
EC
1.047
0.02
1.05
0.02
1.6
1.6
0.2
3.27E-
04
0.0139
0.0488
2.47E-
04
0.7805
0.1953
0.1561
1
2.422
0.1341
0.1
Ib/A
Ib/tree
Ib/A
Ib/tree
Ib/A
Ib/tree
lb/100 gal
Ib/lK cu.ft
Ib/lK sq.ft
Ib/lK sq.ft
Ib/lK sq.ft
Ib/lK sq.ft
Ibmin
Ib/mound
part(L)
Ib/A
Ib minute
Ib/A
NS
0.0077
0.0422
0.0464
0.0974
0.0175
0.0011
0.0974
0.1406
Ib/A
Ibmin
Ib minute
Ib/A
lb/1 gal
part A
Ib/A
Ib minute
NS
0.7805
0.85
0.3951
0.04
Ib/lK sq.ft
Ib/A
Ib/lK sq.ft
lb/1 gal
Do not allow children or pets in treated area
until surfaces are dry.
12 hours REI.
Do not allow children or pets in treated area
until surfaces are dry.
12 hours REI.
Maximum of 6 applications per crop cycle.
28 day MRI.
12 hour REI.
Maximum of 6 applications per crop cycle.
12 hour REI.
For use only in New Mexico (SLN
Registration). 14
day MRI.
Do not allow children or pets in treated area
until surfaces are dry.
12 hour REI.
Remove food and aminals from premises prior
to treatment. Remove or carefully
protect food products and food packaging.
Do not allow children or pets in treated area
until surfaces are dry.
Disallowed in Florida.
Do not allow children or pets in treated area
until surfaces are dry.
For use only in Utah (SLN Registration).
Remove food and aminals from premises prior
to treatment. Remove or carefully
protect food products and food packaging.
Do not allow children or pets in treated area
until surfaces are dry.
12 hour REI.
A-22
-------
RESIDENTIAL LAWNS
SHEEP
SPECIALIZED ANIMALS
URBAN AREAS
WIDE AREA/GENERAL
OUTDOOR TREATMENT
(PUBLIC HEALTH USE)
EC
EC
EC
EC
EC
SC/L*
RTU
SC/L*
RTU
SC/L
EC
PRL
SC/L
SC/L*
RTU
EC
EC*RTU
RTU
SC/L
SC/L*
RTU
EC
EC*RTU
RTU
SC/L
SC/L*
RTU
2.47E-
04
6.18E-
04
0.0021
1.65E-
04
0.1068
0.0098
0.0017
0.0089
0.1992
Ib/lK sq.ft
Ib/lK cu.ft
Ib/Animal
Ibear
lb/10 gal
Ib/lK sq.ft
Ib/Animal
lb/1 gal
Ib minute
NS
0.0974
0.0175
0.0974
2.422
0.1953
0.1992
Ib/A
lb/1 gal
Ib/A
Ib/A
Ibmin
Ib minute
NS
0.1341
0.1
0.0077
0.0422
0.0464
0.0974
0.0175
0.0011
0.0974
0.1406
2.422
0.1953
1
0.1
0.1341
0.0077
0.0422
0.0464
0.0011
0.0234
0.1406
Ib minute
Ib/A
Ib/A
Ibmin
Ib minute
Ib/A
lb/1 gal
part A
Ib/A
Ib minute
Ib/A
Ibmin
part(L)
Ib/A
Ib minute
Ib/A
Ibmin
Ib minute
part A
Ib/A
Ib minute
Do not allow children or pets in treated area
until surfaces are dry.
14 day MRI.
Do not treat animals under 12 weeks of age.
1 day MRI.
14 day MRI.
Disallowed in Florida.
For use only in Utah (SLN Registration).
UT-a FL-d
Disallowed in Florida.
Disallowed in Florida.
For use only in Utah (SLN Registration).
For use only in Utah (SLN Registration).
A-23
-------
WOOD PRESSURE TREATMENT
TO FOREST PRODUCTS
WOOD PROTECTION
TREATMENT TO
BUILDINGS/PRODUCTS INDOOR
WOOD PROTECTION
TREATMENT TO
BUILDINGS/PRODUCTS
OUTDOOR
WOOD PROTECTION
TREATMENT TO FOREST
PRODUCTS (SEASONED)
WOOD PROTECTION
TREATMENT TO FOREST
PRODUCTS (UNSEASONED)
EC
EC
EC
EC
EC
3.2
0.7805
0.1
0.0319
0.08
0.0324
0.0081
3.2
0.0379
3.2
0.7805
0.1561
3.2
lb/40 gal
Ib/lK sq.ft
Ib/lK sq.ft
Ib lin. ft/ft
depth
lb/1 gal
Ib linear ft
Ib sq.ft
fl.oz (L)
lb/1 gal
Ib/A
Ib/lK sq.ft
Ib/mound
lb/40 gal
12hourREI.
Remove food and animals from premises prior
to treatment.
Do not allow children or pets on treated areas
until surface has dried.
Remove food and animals from premises prior
to treatment.
Do not allow children or pets on treated areas
until surface has dried.
For use only in Mississippi (SLN
Registration).
Do not allow children or pets on treated areas
until surface has dried.
Do not allow children or pets on treated areas
until surface has dried.
Remove food or animals from premises prior
to treatment.
Do not allow children or pets on treated areas
until surface has dried.
NS- The use rate is not specified because product is labeled as a spot treatment.
A-24
-------
Appendix B
GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregi strati on for active
ingredients within the case 2510 covered by this Reregi strati on Eligibility Decision Document.
It contains generic data requirements that apply to 2510 in all products, including data
requirements for which a "typical formulation" is the test substance.
The data table is organized in the following format:
1. Data Requirement (Column 1). The data requirements are listed in the order in which
they appear in 40 CFR Part 158. The reference numbers accompanying each test refer to the test
protocols set in the Pesticide Assessment Guidelines, which are available from the National
Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.
2. Use Pattern (Column 2). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food
J Forestry
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable data in its files, this
column lists the identifying number of each study. This normally is the Master Record
Identification (MRID) number, but may be a "GS" number if no MRID number has been
assigned. Refer to the Bibliography appendix for a complete citation of the study.
B-l
-------
Data Supporting FIFRA Guideline Requirements for the Reregistration of Permethrin
Guideline Requirement
Guideline Number
New
Old
Study Title
MRID Citation
PRODUCT CHEMISTRY
830.1550
830.1600
830.1620
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
830.7050
830.7200
830.7220
830.7300
830.7840
830.7860
830.7950
830.7370
830.7550
61-1
6 1-2 A
61-2B
62-1
62 2
62 3
63-2
63-3
63-4
63-5
63-6
63-7
63-8
63-9
63-10
63-11
Chemical Identity & Composition
Starting Material & Manufacturing Process
Formation of Impurities
Preliminary Analysis
Certification of limits
Enforcement Analytical Method
Color
Physical State
Odor
UV/Visible Absorption
Melting Point
Boiling Point
Density
Solubility
Vapor Pressure
Dissociation Constant
Octanol/Water Partition Coefficient
44994001, 44707101, 44841201, 40955301
44994001, 40943601, 44707101, 44841201, 40955301
44994001, 40943601, 44707101, 44841201, 40955301
44812001, 41136401, 44707101, 44841201, 41150901
44994001, 41136401, 44707101, 44841201, 41150901, 40955301
44812001, 41136401, 44707101, 44841201, 41150901
44994002, 42377601, 44707201, 44841202, 42109801
44994002, 42377601, 44707201, 44841202, 42109801
44994002, 42377601, 44707201, 44841202, 42109801
44994002, 44707201, 44841202
44994002, 42377601, 44707201, 42109801, 42802701
42377601, 44707201, 44841202, 42109801, 42802701
44994002, 42377601, 44707201, 44841202, 42109801
44994002, 45095801, 42109801, 44707201, 44841202
45095801, 42109801, 44707201, 44841202
45095801,44841202
44994002, 42109801, 43651601, 44707201, 44841202, 42109801
B-l
-------
Guideline Requirement
Guideline Number
New
830.7000
830.6313
850.1735
850.1735
850.1740
850.1740
850.2100
850.2200
850.2200
850.2300
850.2300
850.1075
850.1075
850.1075
850.1010
850.1010
Old
63-12
63-13
Study Title
EH
Stability
MRID Citation
44994002, 43164801, 44707201, 44841202, 42109801
44994002, 42377601, 43651601, 44707201, 44841202, 42109801, 42802701
ECOLOGICAL EFFECTS
73-1
73-1
74-1
74-1
71-1
7 1-2 A
71-2B
71 4A
71 4B
72-1A
72-1B
72-1D
72-2A
72-2B
72-3A
72-3B
Whole sediment: acute freshwater
invertebrates
Whole sediment: acute marine invertebrates
Whole sediment: chronic freshwater
invertebrates
Whole sediment: chronic marine
invertebrates
Avian Acute Oral Toxicitv - Quail
Avian Dietary Toxicitv - Quail
Avian Dietary Toxicitv - Duck
Avian Reproduction - Quail
Avian Reproduction - Duck
Fish Toxicitv Bluegill
Fish Toxicitv Sheepshead Minnow
Fish Toxicitv Rainbow Trout- TEP
Acute Aquatic Invertebrate Toxicitv
Invertebrate Toxicitv- TEP
Acute Estuarine/Marine Tox Fish (Active)
Acute Estuarine/Marine Mollusk (Active)
Data Gap
Data Gap
Data Gap
Data Gap
41888402
41888403
41888401
42322902
42322902
40098001
42277001
43740601
40098001,00110690
42277004, 43740602, 42584002
40228401
00042140
B-2
-------
Guideline Requirement
Guideline Number
New
None
None
None
850.1400
850.1500
850.3020
Old
72-3 C
72-3D
72-3E
72-3F
72-4A
72-4B
72-5
141-1
141-2
Study Title
Acute Estuarine/Marine Shrimp (Active)
Estuarine/Marine Toxicitv Fish - TEP
Estuarine/Marine Toxicitv Mollusk - TEP
Estuarine/Marine Toxicitv Shrimp - TEP
Fish Earlv Life Stase
Life Cycle Aquatic Invertebrate
Fish Lifecvcle Toxicitv
Honey Bee, acute contact
Honey Bee Residue on Foliage
MRID Citation
40228401
43394601
42723301
00110661
Hansenetal., 1983
43745701,41315701
00110666
42674501
42009301
TOXICOLOGY
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
870.6200
870.3100
870.3150
870.3200
81-1
81-2
81-3
81-4
81-5
81-6
81-8-SS
82-1A
82-1B
82-2
Acute Oral Toxicitv -Rat
Acute Dermal Toxicitv -Rabbit/Rat
Acute inhalation toxicitv
Primary Eye Irritation-Rabbit
Primary Skin Irritation
Dermal Sensitization
Acute Neurotoxicitv Study - Rat
90-Day Feeding - Rodent
90-Day Feeding - Non-rodent (Dog)
21-Dav Dermal - Rabbit/Rat
242899
242899
Data Gap
242899
242899
EPA Memorandum, June 13, 1995, "Permethrin: Review of a series 81-6
dermal sensitization study (guinea pig maximization test) and a series 85-2
dermal penetration study."
43046301,45657401
92142123
92142123
41143801,42653301
B-3
-------
Guideline Requirement
Guideline Number
New
870.4100
870.4100
870.4200
870.4200
870.3700
870.3700
870.3800
870.5100
870.5395
870.5550
870.7485
870.7485
870.6200
870.6300
870.7600
Old
83-1A
83-1B
83 -2 A
83-2B
83-3A
83-3B
83-4
84-2
84-2
84-2
85-1
85-1
82-7
83-6
85-3
Study Title
Chronic Feeding Toxicitv - Rodent
Chronic Feeding Toxicitv -
Non-Rodent
Oncogenicitv - Rat
Oncogenicitv - Mouse
Developmental Toxicitv - Rat
Developmental Toxicitv - Rabbit
2-Generation Reproduction - Rat
Gene Mutation
In Vivo Mammalian Cvtogenetics Tests:
Erythrocvte Micronucleus Assay
Other Genotoxic Effects
General Metabolism - Rat
General Metabolism - Dog
Subchronic Neurotoxicitv Screening Battery
Developmental Neurotoxicitv Study
Dermal Absorption in Rats
MRID Citation
92142123
00129600
See 870.4100 (a)
00102110, 92142032, 00062806, 92142033
40943603
92142091, 40943602, 92142036
00102108, 00120271, 92142092, 92142037
41031107
42723302
40943604
00089006, 00054719, 92142041, 92142042, 00102185, 00065903
0054721, 00042160
40766807
Data Gap
43169001
OCCUPATIONAL/RESIDENTIAL EXPOSURE
B-4
-------
Guideline Requirement
Guideline Number
New
875.1100
875.1200
875.1200
875.1400
875.2100
875.2200
875.2400
875.2500
875.2500
None
None
Old
231
232
233
234
132-1A
132-1B
133-3
133-4
133-4
231
232
Study Title
Dermal Exposure - Outdoor
Inhalation Exposure - Outdoor
Dermal Exposure- Indoor
Inhalation Exposure- Indoor
Foliar Residue Dissipation
Soil Residue Dissipation
Dermal Passive Dosimetry Exposure
Inhalation Passive Dosimetry Exposure
Inhalation Passive Dosimetry Exposure
Estimation of Dermal Exposure at Outdoor
Sites
Estimation of Inhalation Exposure at
Outdoor Sites
MRID Citation
ORETF Data
PHEDv. 1.1 Data
See Appendix D for Chemical Specific Studies
ENVIRONMENTAL FATE
835.2120
835.2240
835.2410
835.4100
835.4200
835.4400
835.4300
835.1240
161-1
161-2
161-3
162-1
162-2
162-3
162-4
163-1
Hydrolysis
Photodegradation - Water
Photodegradation - Soil
Aerobic Soil Metabolism
Anaerobic Soil Metabolism
Anaerobic Aquatic Metabolism
Aerobic Aquatic Metabolism
Leaching/Adsorption/Desorption
102043, 112936
40242801
40190101
41970602,42410002
41970601
43982001
43938201
41868001, 45170102, 43424901, 42196701
B-5
-------
Guideline Requirement
Guideline Number
New
835.6100
835.1200
None
Old
164-1
164.2
165-4
Study Title
Terrestrial Field Dissipation
Aquatic Field Dissipation
Bioaccumulation in Fish
MRID Citation
42359101
44030501,44157101
41300401, 41300402, 41300403
RESIDUE CHEMISTRY
860.1200
860.1300
860.1300
860.1340
860.1340
860.1380
860.1480
860.1850
860.1900
171-3
171-4A
171-4B
171-4C
171-4D
171-4E
171-4J
Directions for Use
Nature of Residue - Plants
Nature of Residue - Livestock
Residue Analytical Method - Plants
Residue Analytical Method - Animals
Storage Stability Data
Magnitude of Residues -
Meat/Milk/Poultry/Egg
Confined Accumulation in Rotational Crops
Field Accumulation in Rotational Crops
00025919, 00025920, 00094393, 00094394, 43307801, 92142094, 9214209
42196702,42196703, 42410001, 42503201, 43458801, 43458802,
43505201, 43713301, 43713302, 43713303, 43713304, 43962801,
44196101, 44196102, 44417803
00043877, 00054724, 00072582, 00160394, 40404002, 40446403,
40446404, 40556804, 41641001, 42137202, 43364705, 44428204
00064675, 00064678, 00070916, 43962801, 44196103, 44417801,
44417802
00102107, 00110622, 00137902, 00165525, 41560202, 42919201,
43494701, 43505201, 44135001
00054723, 00064674, 00064676, 00064679, 00064680, 00064682, 00064683,
00064684, 00064685, 00064686, 00070914, 00070915, 00070917, 00079385,
00079386, 00079387, 00110624, 41560201
43174401
44428201, 44428202, 44428203
Cron Field Trials - Root and Tuber Vegetable Group
-------
Guideline Requirement
Guideline Number
New
860.1500
860.1500
860.1500
Old
171-4K
171-4K
171-4K
Study Title
Crop field trial- horseradish
Crop field trial- potatoes
Crop field trial- turnip roots
MRID Citation
00035517,41565404
00025985, 00025986, 00081578, 00081579, 43343102, 44162601
00155947, 41575901
Crop Field Trials - Leafv Vegetables (Except Brassica) Group
860.1500
860.1500
860.1500
860.1500
860.1500
171-4K
171-4K
171-4K
171-4K
171-4K
Crop field trial- cabbage
Crop field trial- celery
Crop field trial- lettuce, leaf
Crop field trial- spinach
Crop field trial- turnip greens
00034779, 00080054, 00080055, 00080057, 00080058 00110693, 00156265,
41065802
00025921, 00081628, 00102082, 00139530, 43350501
00034780, 00034781, 00110622, 00139530, 00140140, 00156265, 42322904
00150293, 41065808, 42431401, 42979901, 43350502
00155947,41575901
OOD Field Trials - Bulb Vegetables
860.1500
171-4K
Crop field trial- onions
40404001
Cron Field Trials - Brassica (Cole) Leafv Vegetables
860.1500
860.1500
860.1500
860.1500
171-4K
171-4K
171-4K
171-4K
Crop field trial- broccoli
Crop field trial- Brussels Sprouts
Crop field trial- cauliflower
Crop field trial- collards
00034774, 00034778, 00080054, 41065802, 43903501
00034775, 00080054
00034776, 00080054, 41065802
0015029, 00155947, 41575901
Crop Field Trials -Legume Vegetables (Succulent or Dry)
860.1500
171-4K
Crop field trial- soybeans
00026542 00026548 00057091 00110622 00135413 00137902 00144855
00155947 00165525 43364704
Crop Field Trials -Fruiting Vegetables
860.1500
171-4K
Crop field trial- eggplant
00129296,41565403
B-7
-------
Guideline Requirement
Guideline Number
New
860.1500
860.1500
Old
171-4K
171-4K
Study Title
Crop field trial- pepper
Crop field trial- tomato
MRID Citation
00129296, 41565403, 43494701
00026543, 00026546, 00034785, 00110622, 00140140, 41404301, 42322903
Crop Field Trials - Cucurbit Vegetables
860.1500
171-4K
Crop field trial- vegetable, cucurbit group
00126691, 00151251, 00155167, 40556801, 40556802, 40556803, 41565402,
41565405,44182701, 44182702
Crop Field Trials - Pome Fruits
860.1500
860.1500
171-4K
171-4K
Crop field trial- apple
Crop field trial- pear
4283810
00042620, 00042621, 00083972, 42322905
Cron Field Trials - Stone Fruit
860.1500
860.1500
171-4K
171-4K
Crop field trial- cherry
Crop field trial- peach
41065803,44135001
00118504,43348101
Crop Field Trials - Trees Nuts
860.1500
860.1500
860.1500
860.1500
171-4K
171-4K
171-4K
171-4K
Crop field trial- almond
Crop field trial- almond, hull
Crop field trial- filbert
Crop field trial- walnut
00100520, 00110564, 42322903, 43938801
00100520, 00110564, 42322903, 43938801
00142263
00072833, 42322906
Cron Field Trials - Cereal Grains
860.1500
860.1500
171-4K
171-4K
Crop field trial- Corn (field and pop)
Corn, sweet (kernel plus cob with husks
removed)
00069651, 00069652, 00088973, 41065804, 43149501, 43364701, 43364702
00034777, 00034778, 41052402, 43350503
Cron Field Trials - Forase, Fodder, and Straw of Cereal Grains
860.1500
171-4K
Corn (Forage and Fodder)
00069651, 00069652, 00080047, 43149501, 43350503, 43364701,43364702
-------
Guideline Requirement
Guideline Number
New
Old
Study Title
MRID Citation
Crop Field Trials - Grass, Forase, Fodder, and Hay
860.1500
171-4K
Crop field trial- grass range
00128728,41565406
Cron Field Trials - Non-Grass Animal Feed Group
860.1500
860.1500
171-4K
171-4K
Crop field trial- alfalfa, fresh
Crop field trial- alfalfa, hay
00025992, 00026551, 00026552, 00047632, 00047634, 00047635, 00151832,
40072401, 42909001, 43343101
00047634, 00047635, 00151832, 40072401, 42909001, 43343101
Crop Field Trials - Misc. Commodities
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
860.1500
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
171-4K
Crop field trial- artichoke
Crop field trial- asparagus
Crop field trial- avocado
Crop field trial- cottonseed
Crop field trial- mushroom
Crop field trial- papaya
Crop field trial- pistachios
Crop field trial- watercress
00145266,42137201
40446401,40446402
00144307, 41565401, 44229501
00043877, 00043879, 00043883, 00054888, 00057091, 00064451, 00093708,
00102107, 00109336, 00110610, 00110622, 00110634, 00137902, 00151832,
00155947
00165524
00144307, 41565401, 44453101
00133293, 41065805, 41641002
00145971
Processed Food/Feed Studies
860.1520
860.1520
860.1520
860.1520
171-41
171-41
171-41
171-41
Processed foods/feed - apple
Processed foods/feed - corn
Processed foods/feed - cottonseed
Processed foods/feed - Potato
42824702
42860601, 42910101, 43374601
00044517
42824701
B-9
-------
Guideline Requirement
Guideline Number
New
860.1520
860.1520
Old
171-41
171-41
Study Title
Processed foods/feed - soybean
Processed foods/feed- tomato
MRID Citation
00070912,43364703
41404301
B-10
-------
Appendix C
TECHNICAL SUPPORT DOCUMENTS
Additional documentation in support of this RED is maintained in the OPP docket,
located in Room S-4400, One Potomac Yard (South Building), 1777 S. Crystal Drive, Arlington,
VA. It is open Monday through Friday, excluding legal holidays, from 8:30 am to 4 pm.
The preliminary risk assessments for permethrin are available in the public docket and in
e-dockets under docket number OPP-2004-0385. This contains risk assessments and related
documents as of August 2005. During the comment period, the registrant submitted additional
data for permethrin. EPA reviewed these data and incorporated them into the revised risk
assessments for permethrin. These revised risk assessments form the basis of the regulatory
decision described in this RED. These risk assessment and related documents are available
under docket number OPP-2004-0385.
Technical support documents for the Permethrin RED include the following:
Human Health Risk Assessment Documents;
1. Permethrin. Fifth Revision of the HED Chapter of the Reregistration Eligibility
Decision Document (RED), dated April 4, 2006;
2. Permethrin. Second Revised Acute, Chronic, and Cancer Dietary Exposure
Assessments for the Reregistration Eligibility Decision (RED) Document, dated
February 1, 2006;
3. Permethrin. Revised Residue Chemistry Chapter of the Reregistration Eligibility
Decision, dated March 17, 2005;
4. Permethrin. Third Revision of the Occupational and Residential Exposure
Assessment for the Reregistration Eligibility Decision Document, dated April 4,
2006;
5. Permethrin: Toxicology Discipline Chapter for the Reregistration Eligibility
Decision Document (RED), dated December 16, 2003;
6. Permethrin. Product Chemistry Chapter for the Reregistration Eligibility Decision
(RED) Document, dated June 4, 2004.
Environmental Fate and Effects Documents;
1. The Agency Revised Risk Assessment for the Reregistration Eligibility Decision on
Permethrin After Public Comments, Phase III, dated April 5, 2006;
2. Addendum to the EFED Red Chapter for Permethrin, dated April 5, 2006;
3. Second Revision Tier II Estimated Drinking Water Concentrations of Permethrin,
dated January 17,2006.
And the following documents on use and usage, and biological and economic analysis;
1. BEAD Review of American Mosquito Control Association Comments and
Alternative Analysis Regarding the User of Permethrin for Adult Mosquito
C-l
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Control and Indoor; Outdoor Residential Uses, dated March 14, 2006;
2. Qualitative Information about the Role ofPermethrin in Select Uses to Inform
Risk-Benefit Decision, dated March 01, 2006.
C-2
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Appendix D
Bibliography
MRID Citation Reference
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Cabbage: M-4130. (Unpublished study received Mar 7, 1980 under 10182-18; prepared by
FM1978 under 275-18; Mar 7, 1980 under 10182-18; prepared by FMC, submitted by ICI
Americas, Inc., Wilmington, Del.; CDL:099273-F)
00025920 Capps; T.M.; Munger, D.M.; Reynolds, J.L.; et al. (1979) Isolation and Structure Elucidation
of FMC 33297 Metabolites in Cabbage: M 4331. (Unpublished study received Mar 7, 1980
under 10182 18; prepared by FMC, submitted by ICI Americas, Inc., Wilmington,Del.;
CDL:099273 G)
00025921 Ussary, J.P. (1979) Permethrin Metabolite Residues on Celery: Report Series TMU0439/B.
Including method dated Nov 1978. (Unpublished study received Mar 7, 1980 under 10182 18;
submitted by ICI Americas, Inc., Wilmington, Del.; CDL:099273 H)
00025922 Hillhouse, T.L.; Daniel, I; Sexson, G.D.; et al. (1979) Permethrin Metabolite Residues on
Soybeans: Report Series TMU0449/B. (Unpublished study received Mar 7, 1980 under 10182
18; submitted by ICI Americas, Inc., Wilmington, Del.; CDL:099273 I)
00025985 Ussary, J.P.; Whiteman, C.R.; Sexson, G.D.; et al. (1979) Permethrin Residues on Potatoes:
Report Series TMU0451/B. (Unpublished study received Feb 18, 1979 under 10182 18;
submitted by ICI Americas, Inc., Wilmington, Del.; CDL:099148 H)
00025986 Ussary, J.P.; Ekeh, M.K.; Whiteman, C.R. (1979) Permethrin Metabolite Residues on
Potatoes: Report Series TMU0458/B. (Unpublished study received Dec 18, 1979 under 10182
18; submitted by ICI Americas, Inc., Wilmington, Del.; CDL:099148 I)
00025992 Ussary, J.P.; Haulsee, R.E.; Wilson, D.; et al. (1979) Permethrin Metabolite Residues on
Alfalfa: Report Series TMU0462/B. (Unpublished study received Dec 18, 1979 under
10182-18; submitted by ICI Americas, Inc., Wilmington, Del.; CDL:099152-C)
00026542 Ussary, J.P.; Haulsee, R.E.; Harrison, S.; et al. (1978) Permethrin Residues from Aerial
Applications to Soybeans: Report Series TMU0454/B. (Unpublished study received Dec 18,
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00026543 Ussary, J.P.; Haulsee, R.E.; Whiteman, C.R.; et al. (1978) Permethrin Residues on Tomatoes:
Report Series TMU0435/B. Rev. (Unpublished study received Dec 18, 1979 under 10182 EX
6; submitted by ICI Americas, Inc., Wilmington, Del.; CDL:099145 C)
00026546 Ussary, J.P.; Haulsee, R.E.; Gouger, R.J.; et al. (1978) Permethrin Metabolite Residues on
Tomatoes: Report Series TMU0441/B. (Unpublished study received Dec 18, 1979 under
10182-EX-6; submitted by ICI Americas, Inc., Wilmington, Del.; CDL:099145 F)
00026548 Ussary, J.P.; Haulsee, R.E.; Hillhouse, T.L.; et al. (1978) Permethrin Metabolite Residues on
Soybeans: Report Series TMU0449/ B. (Unpublished study received Dec 18, 1979 under
10182 EX 6; submitted by ICI Americas, Inc., Wilmington, Del.; CDL:099145 H)
D-l
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MRID Citation Reference
00026551 Ussary, J.P.; Anderson, K.; Cammack, M.W.; et al. (1978) Permethrin Residues on Alfalfa:
TMU0388/B. (Unpublished study received Dec 18, 1979 under 10182 EX 6; submitted by ICI
Americas, Inc., Wilmington, Del.; CDL:099145 M)
00026552 Ussary, J.P.; Haulsee, R.E.; Anderson, K.; et al. (1978) Permethrin Metabolite Residues on
Alfalfa: Report Series TMU0462/B. (Unpublished study received Dec 18, 1979 under 10182
EX 6; submitted by ICI Americas, Inc., Wilmington, Del.; CDL:099145 N)
00034774 ICI Americas, Incorporated (1978) Residues in Broccoli. (Unpublished study received Dec
18, 1979 under 10182 EX 6; CDL: 099144 B)
00034775 MCI Americas, Incorporated (1977) Residues in Brussels Sprouts. (Unpublished study
received Dec 18, 1979 under 10182 EX 6; CDL: 099144 C)
00034776 ICI Americas, Incorporated (1977) Residues in Cauliflower. (Unpublished study received
Dec 18, 1979 under 10182 EX 6; CDL: 099144 D)
00034777 ICI Americas, Incorporated (1978) Residues in Sweet Corn. (Unpublished study received
Dec 18, 1979 under 10182-EX-6; CDL:099144 E)
00034778 ICI Americas, Incorporated (19??) Permethrin Metabolite Residues. (Unpublished study
received Dec 18, 1979 under 10182-EX-6; CDL:099144 F)
00034779 ICI Americas, Incorporated (1978) Residues in Cabbage. (Unpublished study received Dec
18, 1979 under 10182-EX-6; CDL:099144-G)
00034780 ICI Americas, Incorporated (1978) Residues in Lettuce. (Unpublished study received Dec 18,
1979 under 10182-EX-6; CDL:099144 H)
00034781 ICI Americas, Incorporated (19??) Permethrin Metabolite Residues. (Unpublished study
received Dec 18, 1979 under 10182-EX-6; CDL:099144 I)
00034785 ICI Americas, Incorporated (19??) Permethrin Metabolism Residues in Celery, Tomatoes and
Soybeans. (Unpublished study received Dec 18, 1979 under 10182 EX 6; CDL:099144 M)
00035517 Felsot, A.; Wilson, I; Eastman, C. (1979) Summary: [Ambush]. Includes method dated Dec
11, 1979 entitled Permethrin Residues in Horseradish: Analytical Methods and Results.
(Unpublished study received Jun 17, 1980 under 10182 18; prepared in cooperation with
Illinois, Natural History Survey, Pesticide Residue Laboratory, submitted by ICI Americas,
Inc., Wilmington,Del.; CDL:099463 A)
00042140 Thompson, R.S.; Hill, R.W.; Cornish, S.K. (1977) Investigation of the Acute Toxicity of PP
557 to the Pacific Oyster (Crassostrea gigas?): BL/B/1796. Includes undated method entitled:
The determination of low levels of PP 557 in seawater samples from bioassay tests.
(Unpublished study received Aug 22, 1977 under 10182-EX-3; prepared by Imperial
Chemical Industries, Ltd., submitted by ICI America, Inc., Wilmington, Del.; CDL: 096325-
AC)
D-2
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MRID Citation Reference
00042160 Bratt, H.; Slade, M. (1977) Permethrin: Tissue Retention in the Dog: Report No. CTL/P/353.
(Unpublished study received Aug 22, 1977 under 101823; prepared by Imperial Chemical
Industries, Ltd., submitted by ICI Americas, Inc., Wilmington, Del.; CDL: 096330_O)
00042620 Fujie, G.H.; Hidalgo Gato, E.; Johnson, M.; et al. (1980) Determination of Permethrin
Residues on Pears (Pre bloom Applications): RAN 0005. (Unpublished study received Sep
24, 1980 under 279 3014; submitted by FMC Corp., Philadelphia, Pa.; CDL:099655 B)
00042621 Fujie, G.H. (1980) Determination of Permethrin, Dichlorovinyl acid and m Phenoxybenzyl
alcohol Residues in/on Pears (Pre bloom Applications): RAN 0008. (Unpublished study
received Sep 24, 1980 under 279 3014; prepared by Analytical Bio Chemistry Laboratories,
Inc., submitted by FMC Corp., Philadelphia, Pa.; CDL:099655 C)
00043877 Ussary, J.P. (1976) A Gas Liquid Chromatographic Method for the De termination of
Permethrin in Oily Crops: Report Series TMUO199/ 76A. (Unpublished study received Aug
22, 76A. (Unpublished study received Aug 22, 1977 under 10182 EX 3; submitted by ICI
Americas, Inc., Wilmington, Del.; CDL:096337 D)
00043879 Ussary, J.P. (1977) Stability of Permethrin Residues in Cottonseed Samples Stored at 20-C:
Report Series TMU0275/B. (Unpublished study received Aug 22, 1977 under 10182 EX 3;
submitted by ICI Americas, Inc., Wilmington, DE.; CDL:096337 F)
00043883 Ussary, J.P.; Koubek; Kramer, J.A., Jr.; et al. (1977) Permethrin Residues in Cottonseed:
Report Series TMUO195/76B. (Unpublished study including report series TMUO196/76B,
TMUO197/76B, TMUO210/76B..., received Aug 29, 1977 under 10182 EX 3; submitted by
ICI Americas, Inc., Wilmington, Del.; CDL:096337 J)
00044517 Fujie, G.H. (1976) Letter sent to Route List dated Jun 7, 1976: Determination of parent FMC
33297 residues in cottonseed and cottonseed by products from a cottonseed processing study:
W 0105. (Unpublished study received 1976 under 6G1769; submitted by FMC Corp.,
Middleport, N.Y.; CDL:095536 E)
00047632 FMC Corporation (1980) Results of Tests for the Amount of Residue Remaining and a
Description of the Analytical Methods: [Pounce 3.2EC]. (Unpublished study received Jul 11,
1980 under 2793014; CDL:099528 A)
00047634 Fujie, G.H.; Eames, M.A.; Grana, B.; et al. (1980) Determination of Permethrin Residues On
Alfalfa: W 0247. (Unpublished study received Jul 11, 1980 under 279 3014; submitted by
FMC Corp., Philadelphia, Pa.; CDL:099528 C)
00047635 Nelsen, T.R.; Burt, J.E.; Carlin, J.L.; et al. (1980) Determination of Dichlorovinyl acid and M
Phenoxybenzyl alcohol Residues in/on Green Alfalfa and Alfalfa Hay: M 4457. (Unpublished
study received Jul 11, 1980 under 279 3014; submitted by FMC Corp., Philadelphia, Pa.;
CDL:099528 D)
00054719 Mills, I.H.; Mullane, M. (1976) PP557: Absorption and Excretion in the Rat: Report No.
CTL/P/228. (Unpublished study received Aug 22, 1977 under 10182-EX-3; submitted by ICI
Americas, Inc., Wilmington, Del.; CDL:096334D)
D-3
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MRID Citation Reference
00054721 Mills, I.H.; Slade, M. (1977) PP557: Absorption, Distribution and Excretion in the Dog:
Report No. CTL/P/285. Includes undated methods entitled: Measurement of radioactivity and
Extraction, clean-up and chromatography. (Unpublished study received Dec 5, 1977 under
10182EX3; prepared by Imperial Chemical Industries, Ltd., submitted by ICI Americas, Inc.,
Wilmington, Del.; CDL: 096334F)
00054723 Edwards, M.J.; Iswaran, T.J. (1977) Permethrin: Residue Transfer and Toxicology Study with
Cows Fed Treated Grass Nuts: Report Series TMJ 1519 B. Includes undated method entitled:
Analysis of feed, milk and tissues for residues of Permethrin. (Unpublished study received
Aug 22, 1977 under 10182 EX 3; prepared by Imperial Chemical Industries, Ltd., submitted
by ICI Americas, Inc., Wilmington, Del.; CDL:096334 J)
00054724 Imperial Chemical Industries, Limited (1977) Determination of Residues of Permethrin
(PP557) in Fruit and Vegetable Crops. Method no. 29/1 dated Jul 1, 1977. (Unpublished
study received Aug 22, 1977 under 10182 EX 3; submitted by ICI Americas, Inc.,
Wilmington, Del.; CDL:096334 K)
00054888 ICI Americas, Incorporated (1977) Cottonseed Residue Studies. (Compilation; unpublished
study received Mar 23, 1977 under 10182 EX 3; CDL:096909 E)
00057091 FMC Corporation (1975) Summary: [33297 Technical]. Summary of studies 226419 B
through 226419 AA. (Unpublished study received on unknown date under 279 EX 60;
CDL:226419A)
00062806 FMC Corporation (1980) Analysis of Physical Observations: Bio/dynamics Project 76_1695;
FMC Study No. ACT 115.35. (Compilation; unpublished study received Dec 5, 1980 under
unknown admin, no.; CDL:243863_A)
00064451 ICI Americas, Incorporated (1976) Cottonseed Residue Studies. Summary of study 229220 F.
(Unpublished study received Mar 28, 1977 under 10182 EX 3; CDL:229220 E)
00064674 Edwards, M.J.; Iswaran, T.J. (1977) Permethrin: Residue Transfer and Toxicology Study with
Cows Fed Treated Grass Nuts: Report Series TMJ 1519 B. (Unpublished study received Nov
3, 1980 under CO 80/19; prepared by Imperial Chemical Industries Ltd., England, submitted
by state of Colorado for ICI Americas, Inc.,Wilmington, Del.; CDL:243664 G)
00064675 Imperial Chemical Industries Limited (1977) Determination of Residues of Permethrin
(PP557) in Milk and Animal Tissues. Residue analytical method no. PPRAM 31 dated Jul 1,
1977. (Unpublished study received Nov 3, 1980 under CO 80/19; submitted by state of
Colorado for ICI Americas, Inc., Wilmington, Del.; CDL:243664 I)
00064676 Edwards, M.J.; Swaine, H. (1977) Permethrin: Incorporation of Permethrin in the Diet of
Laying Hens. Part II: Residues in Eggs and Tissues: Report Series TMJ 1520 B.
(Unpublished study received Nov 3, 1980 under CO 80/19; prepared by Imperial Chemical
Industries Ltd., England, submitted by state of Colorado for ICI Americas, Inc., Wilmington,
Del.; CDL:243664 J)
D-4
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MRID Citation Reference
00064678 Imperial Chemical Industries Limited (1977) Determination of Residues of Permethrin (PP
557) in Eggs. Residue analytical method no. PPRAM 37 dated Jun 28, 1977. (Unpublished
study received Nov 3, 1980 under CO 80/19; submitted by state of Colorado for ICI
Americas, Inc., Wilmington, Del.; CDL:243664 M)
00064679 Bewick, D.W.; Leahey, J.P.; Saunders, R. (1977) Permethrin: Absorption in Pigs after Dermal
Treatment: Report Series TMJ 1448B. (Unpublished study received Nov 3, 1980 under CO
80/19; prepared by Imperial Chemical Industries Ltd., England, submitted by state of
Colorado for ICI Americas, Inc., Wilmington, Del.; CDL:243664 O)
00064680 Leahey, J.P.; Bewick, D.W.; Gatehouse, D.M.; et al. (1977) Permethrin: Absorption in
Chickens after Dermal and Oral Treatments: Report Series TMJ 1481B. (Unpublished study
received Nov 3, 1980 under CO 80/19; prepared by Imperial Chemical Industries Ltd.,
England, submitted by state of Colorado for ICI Americas, Inc., Wilmington, Del.;
CDL:243664 P)
00064682 Ussary, J.P.; Braithwaite, G.B. (1979) Ectiban Insecticide: Residue Monitoring under Section
18 Program for Fly Control in Caged Layer Poultry Houses 1979: Report Series TMU0476/B.
(Unpublished study received Nov 3, 1980 under CO 80/19; submitted by state of Colorado for
ICI Americas, Inc., Wilmington, Del.; CDL:243664 S)
00064683 Ussary, IP.; Braithwaite, G.B.; Fitzpatrick, R.D.; et al. (1980) Residues of Permethrin and 3
Phenoxybenzyl Alcohol in Tissues and Eggs from Ectiban® Treated Chickens (Trial No.
35NC79 003): Report Series TMU0492/B. Includes undated provisional method entitled: Gas
liquid chromatographic determination of permethrin, free and conjugated 3 phenoxybenzyl
alcohol in animal tissues and eggs. (Unpublished study received Nov 3, 1980 under CO
80/19; submitted by state of Colorado for ICI Americas, Inc., Wilmington, Del.; CDL:243664-
U)
00064684 Ussary, J.P.; Braithwaite, G.B.; Fitzpatrick, R.D.; et al. (1980) Residues of Permethrin and 3
Phenoxybenzyl Alcohol in Tissues from Ectiban® Treated Swine (Trial No. 35NC79 002):
Report Series TMU0491/B. Includes undated provisional method entitled: Gas liquid
chromatographic determination of permethrin, free and conjugated 3 phenoxybenzyl alcohol
in animal tissues and eggs. (Unpublished study received Nov 3, 1980 under CO 80/19;
submitted by state of Colorado for ICI Americas, Inc., Wilmington, Del.; CDL:243664-V)
00064685 Ussary, J.P.; Braithwaite, G.B.; Fitzpatrick, R.D.; et al. (1980) Residues of Permethrin and 3
Phenoxybenzyl Alcohol in Cow Tissues (Trial No. 35N79 001): Report Series TMU0493/B.
Includes undated provisional method entitled: Gas liquid chromatographic determination of
permethrin, free and conjugated 3 phenoxybenzyl alcohol in animal tissues and eggs.
(Unpublished study received Nov 3, 1980 under CO 80/19; submitted by state of Colorado for
ICI Americas, Inc., Wilmington, Del.; CDL:243664-V)
D-5
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MRID Citation Reference
00064686 Ussary, J.P.; Braithwaite, G.B.; Fitzpatrick, R.; et al. (1980) Residues of Permethrin and
Permethrin Metabolites in Milk from EctibanA(R) Treated Cows (Trial No. 35N79 001):
Report Series TMU0490/B. Includes undated methods entitled: Determination of residues of
permethrin and its metabolites in whole milk by electron capture gas chromatography and
Determination of 3 phenoxybenzoic acid and cis trans dichlorovinyl acid; Derivatization using
pentafluorobenzyl bromide, (unpublished study received Nov 3, 1980 under CO 80/19;
submitted by state of Colorado for ICI Americas, Inc., Wilmington, Del.; CDL:243664-X)
00065903 Gaughan, L.C.; Unai, T.; Casida, J.E. (1976) Permethrin Metabolism in Rats. (Unpublished
study, including submitter summary, received Jan 3, 1978 under 279-3013; prepared by Univ.
of California Berkeley, Div. of Entomology & Parasitology, submitted by FMC Corp.,
Philadelphia, Pa.; CDL:096692B)
00069651 Tilka, M.A.; Hidalgo Gate, E.; Johnson, M.A.; et al. (1980) Determination of Permethrin
Residues in Field Corn Forage, Fodder and Grain: RAN 0004. (Unpublished study received
Feb 19, 1981 under 279 3014; submitted by FMC Corp., Philadelphia, Pa.; CDL:099922 B)
00069652 Nelsen, T.R.; Burt, J.E.; Lover, G.E.; et al. (1980) Determination of Dichlorovinyl Acid and
M Phenoxybenzyl Alcohol Residues in/on Field Corn, Forage, Fodder, and Grain: M 4525.
(Unpublished study received Feb 19, 1981 under 279 3014; submitted by FMC Corp.,
Philadelphia, Pa.; CDL:099922 C)
00070912 Ussary, J.P.; Pearson, F.J.; Koubek, K.G. (1981) Permethrin Residues in Process Fractions
from Laboratory Fortified Soybeans: Report No. TMU0604/B. (Unpublished study received
Apr 7, 1981 under 10182 18; submitted by ICI Americas, Inc., Wilmington, Del.;
CDL:099977 F)
00070914 Swaine, H.; Francis, P.O.; Rippington, D.; et al. (1980) Permethrin: Residue Levels of the
Major Metabolites of the Insecticide in the Milk and Tissues of Cows Fed on a Treated Diet:
Report No. RJ 0124B. Includes undated method entitled: Multiresidue analytical method for
the determination of residues of metabolites of permethrin in milk and animal tissues.
(Unpublished study received Apr 7, 1981 under 10182 18; prepared by Imperial Chemical
Industries, Ltd., England, Submitted by ICI Americas, Inc., Wilmington, Del.; CDL:099976-
B)
00070915 Swaine, H.; Sapiets, A. (1981) Permethrin: Residue Transfer Study with Dairy Cows Fed on a
Diet Containing the Insecticide at 150 Mg Kg-1: Report No. RJ 0188B. (Unpublished study
received Apr 7, 1981 under 10182 18; prepared by Imperial Chemical Industries, Ltd.,
England, submitted by ICI Americas, Inc., Wilmington, Del.; CDL:099976 C)
00070916 Sapiets, A.; Swaine, H. (1981) Determination of Residues of the Major Metabolites of
Permethrin and Cypermethrin in Products of Animal Origin. Method PPRAM 48 dated Mar
1981. (Unpublished study received Apr 7, 1981 under 10182 18; prepared by Imperial
Chemical Industries, Ltd., England, submitted by ICI Americas,Inc., Wilmington, Del.;
CDL:099976 D)
D-6
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MRID Citation Reference
00070917 Swaine, H.; Francis, P.O.; Rippington, D.; et al. (1980) Permethrin: Incorporation of
Permethrin in the Diet of Laying Hens: Part III Metabolite Residues in Eggs and Tissues:
Residue Data Report RD/557/27. (Unpublished study received Apr 7, 1981 under 10182 18;
prepared by Imperial Chemical Industries, Ltd., England, submitted by ICI Americas, Inc.,
Wilmington, Del.; CDL: 099976 E)
00071952 Glaister, J.R.; Pratt, I.; Richards, D. (1977) Effects of High Dietary Levels of PP557 on
Clinical Behaviour and Structure of Sciatic Nerves in the Rat: A Combined Report of Two
Studies: Report No. CTL/P/317. (Unpublished study received Jan 27, 1978 under 1018218;
prepared by Imperial Chemical Industries, Ltd., England, submitted by ICI Americas, Inc.,
Wilmington, Del.; CDL: 096768B)
00072582 Imperial Chemical Industries, Limited (1976) Determination of Residues of Permethrin
(PP557) in Fruit and Vegetable Crops. Method PPRAM 29 dated Feb 13, 1976.
(Unpublished study received May 7, 1981 under 1E2515; submitted by ICI Americas, Inc.,
Wilmington, Del.; CDL:070069 E)
00079385 Ussary, J.P.; Braithwaite, G.B.; Pearson, F.J.; et al. (1981) Permethrin and Permethrin
Metabolite Residues in Cow Tissues Trial No. 35NC79 001: Report Series TMU0656/O 81/5;
submitted by Trial No. 35NC79 001: Report Series TMU0656/B. (Unpublished study
received Aug 27, 1981 under 1F2564; submitted by ICI Americas, Inc., Wilmington, Del.;
CDL:070264 D)
00079386 Ussary, J.P.; Braithwaite, G.B.; Fitzpatrick, R.D.; et al. (1981) Permethrin and Permethrin
Metabolite Residues in Swine Tissues Trial No. 35NC79 002: Report Series TMU0655/B.
(Unpublished study received Aug 27, 1981 under 1F2564; submitted by ICI Americas, Inc.,
Wilmington, Del.; CDL:070264 E)
00079387 Ussary, J.P.; Braithwaite, G.B.; Kramer, J.A.; et al. (1981) Residues of Permethrin and
Permethrin Metabolites in Milk from Ectiban® treated Cows (Trial No. 35NC79 001): Report
Series TMU0653/B. Final rept. (Unpublished study received Aug 27, 1981 under 1F2564;
submitted by ICI Americas, Inc., Wilmington, Del.; CDL:070264 F)
00080047 Ussary, J.P.; Fitzpatrick, R.D.; Beguhn, M.A.; et al. (1981) Permethrin and Permethrin
Metabolite Residues on Corn Fodder: Report Series TMU0628/B. (Unpublished study
received Aug 20, 1981 under 10182 18; submitted by ICI Americas, Inc., Wilmington, Del.;
CDL:070217B)
00080054 Fujie, G.H.; Grana, B.; Casida, M.E.; et al. (1976) Determination of Parent FMC 33297
Residues in/on Cabbage, Brussels Sprouts, Broccoli, and Cauliflower: Analytical Report W
0125. (Unpublished study received Aug 25, 1981 under 1F2562; submitted by FMC Corp.,
Philadelphia, Pa.; CDL:070232 B)
00080055 Stearns, J.W.; Topolewski, T.V.; Grana, B.; et al. (1980) Determination of Permethrin
Residues on Cabbage: RAN-0015. (Unpublished study received Aug 25, 1981 under 1F2562;
submitted by FMC Corp., Philadelphia, Pa.; CDL:070232-\C)
D-7
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MRID Citation Reference
00080057 Nelsen, T.R.; Burt, J.E.; Carlin, J.L.; et al. (1980) Determination of Dichlorovinyl Acid and M
Phenoxybenzyl Alcohol Residues in/on Cabbage: M 4512. (Unpublished study received Aug
25, 1981 under 1F2562; submitted by FMC Corp., Philadelphia, Pa.; CDL:070232 E)
00080058 Nelsen, T.R.; Burt, J.E.; Siedlecki, A.J.; et al. (1980) Determination of Dichlorovinyl Acid
and M Phenoxybenzyl Alcohol Residues in/on Cabbage: M 4591. (Unpublished study
received Aug 25, 1981 under 1F2562; submitted by FMC Corp., Philadelphia, Pa.;
CDL:070232 F)
00081578 Ussary, J.P.; Crain, L.; Harkins, J.T.; et al. (1980) Permethrin Residues on Potatoes: Report
Series TMU0532/B. (Unpublished study received Aug 11, 1981 under 10182 18; submitted
by ICI Americas, Inc., Wilmington, Del.; CDL:070286 A)
00081579 Ussary, J.P.; Fitzpatrick, R.D.; Furqueron, T.C.; et al. (1981) Permethrin and Permethrin
Metabolites on Potatoes: Report Series TMU0630/B. (Unpublished study received Aug 11,
1981 under 10182 18; submitted by ICI Americas, Inc., Wilmington, Del.; CDL:070286 B)
00081628 ICI Americas, Incorporated (1981) Permethrin Residues in Celery. (Compilation; unpublished
study received Aug 11, 1981 under 10182 18; CDL:070287 A)
00083972 Interregional Research Project Number 4 (1980) Summary of Residue Chemistry Data:
[Permethrin]. (Compilation; unpublished study, including published data, received Sep 28,
1981 under 1E2580; CDL:070369A)
00088973 ICI Americas, Incorporated (1980) Residues: [Permethrin]. (Compilation; unpublished study
received Dec 30, 1981 under 10182 18; CDL:070568 E)
00089006 Bratt, H.; Mills, I.H.; Slade, M. (1977) Permethrin: Tissue Retention in the Rat: Report No.
CTL/P/352. (Unpublished study received Dec 30, 1981 under 1018264; prepared by Imperial
Chemical Industries, Ltd., England, submitted by ICI Americas, Inc., Wilmington, Del.;
CDL:070565\G)
00093708 FMC Corporation (1981) Crop Residues: [Pounce 3.2 EC]. (Compilation; unpublished study,
including RAN 0011 and RAN 0017, received Jan 15, 1982 under 279 3014; CDL: received
Jan 15, 1982 under 279 3014; CDL:246593 A)
00094393 Capps, T.M.; Reynolds, J.L.; Selim, S.; et al. (1979) Metabolism of Permethrin in/on Soybean
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00094394 Capps, T.M.; Munger, D.M.; Reynolds, J.L.; et al. (1979) Translocation of Permethrin in
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00096713 Alexander, D.J.; Clark, G.C.; Jackson, G.C.; et al. (1980) Permethrin Technical: Inhalation
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59200; prepared by Huntingdon Research Centre, England, submitted by Burroughs
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D-8
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1982 under 59_200; prepared by Wellcome Foundation, Ltd., England, submitted by
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00100520 Stearns, J.W.; Hidalgo Gate, E.; Fung, R.; et al. (1981) Determination of Permethrin,
Dichlorovinyl Acid and Metaphenoxybenzyl Alcohol Residues in Almond Meats, Shells and
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00102107 ICI Americas, Inc. (19??) Stability of Permethrin Residues in Samples of Cottonseed Process
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00102110 Hart, D.; Banham, P.; Glaister, J.; et al. (1977) PP557: Whole Life Feeding Study in Mice:
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00102185 Bewick, D.; Leahey, J. (1978) Permethrin: The Analysis of the Permethrin Metabolite 3-(2,2-
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Single Oral Dose of 14C_Permethrin: Report Series RJ0019B. (Unpublished study received
May 23, 1978 under 1018218; prepared by Imperial Chemical Industries, Ltd., Eng.,
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00110564 ICI Americas, Inc. (1982) Ambush Insecticide (Containing Permethrin): Residue Chemistry.
(Compilation; unpublished study received Aug 19, 1982 under 10182 18; CDL:248182 A)
00110610 ICI Americas, Inc. (1976) Ambush Pyrethroid Insecticide: [Residue on Cotton].
(Compilation; unpublished study received Dec 1, 1976 under 10182 EX 3; CDL:095628 A)
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D-9
-------
MRID Citation Reference
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00110634 FMC Corp. (1976) Results of the Amount of Residues Remaining and Description of
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date under 279 EX 60; CDL: 226420 A)
00110661 Heitmuller, T. (1975) Acute Toxicity of FMC 33297 3.2 EC to Eastern Oysters (Crassostrea
virginica), Pink Shrimp (Penaeus duorarum), and Fiddler Crabs (Uca pugilator): (Submitter)
NCT 620.61. (Unpublished study received Jan 3, 1978 under 279-3013; prepared by
Bionomics, EG & G, Inc., submitted by FMC Corp., Philadelphia, PA; CDL:096699-G)
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andBluegill (Lepomis macrochirus): Submitter NCT 162.74. (Unpublished study received Jan
3, 1978 under 279-3013; prepared by EG & G, Bionomics, submitted by FMC Corp.,
Philadelphia, PA; CDL:096699-Q)
00110690 ICI United States, Inc. (1976) Ectiban Pyrethroid Insecticide 25% Wettable Powder
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00110693 ICI Americas, Inc. (1978) Ambush Pyrethroid Insecticide (Containing Permethrin): Petition
for Tolerance for Permethrin on Cabbage and Lettuce: Section D Residue Chemistry.
(Compilation; unpublished study received Mar 30, 1979 under 10182 18; CDL: 098040 A)
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00120271 Hodge, M.; Banham, P.; Glaister, J.; et al. (1977) PP557: 3 Gener_ ation Reproduction Study
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00126691 Interregional Research Project No. 4 (1982) The Results of Tests on the Amount of
Permethrin Residues Remaining in or on Pumpkins, Including a Description of the Analytical
Method Used. (Compilation; unpublished study received Mar 28, 1983 under 10182 18;
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D-10
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MRID Citation Reference
00128728 Interregional Research Project No. 4 (1980) The Results of Tests of the Amount of Permethrin
Residues Remaining in or on Range grass, Including a Description of the Analytical Method
Used.(Compilation; unpublished study received Jun 16, 1983 under 3E2911; CDL:071700 A)
00129296 Interregional Research Project No. 4 (1983) The Results of Tests on the Amount of
Permethrin Residues Remaining in or on Eggplant and Peppers Including a Description of the
Analytical Method Used. (Compilation; unpublished study received May 17, 1983 under
3E2892; CDL:071608 A)
00129600 Kalinowski, A.; Banham, P.; Chart, I.; et al. (1982) Permethrin: One Year Oral Dosing Study
in Dogs: Report No. CTL/P/647. (Unpublished study received Jul 28, 1983 under 1018218;
prepared by Imperial Chemical Industries PLC, Eng., submitted by ICI Americas, Inc.,
Wilmington, DE; CDL:250845A)
00133293 ICI Americas, Inc. (1983) Ambush Insecticide (Containing Permethrin). (Compilation;
unpublished study received Nov 22, 1983 under 10182 18; CDL:072147 A)
0013 5413 FMC Corp. (1979) Results of Tests for the Amount of Residue Remaining and a Description
of the Analytical Methods: [Pounce 3.2 EC]. (Compilation; unpublished study received Apr
12, 1979 under 279 3014; CDL:098202 A)
00137902 FMC Corp. (1977) Results of the Amount of Permethrin Residues Remaining and Description
of Analytical Methods. (Compilation; unpublished study received Jan 3, 1978 under 279
3013; CDL:096701 A)
00140140 FMC Corp. (1979) Results of Tests for the Amount of Residue Remaining and a Description
of the Analytical Methods: [Pounce]. (Compilation; unpublished study received Jul 31, 1979
under 279 3014; CDL:098899 A)
00142263 FMC Corp. (1984) Results of Tests for the Amount of Residues Remaining and a Description
of the Analytical Methods. Unpublished compilation. 37 p.
00144307 Interregional Research Project No. 4 (1983) The Results of Tests on the Amount of
Permethrin Residues Remaining in or on Avocados and Papayas Including a Description of
the Analytical Method Used. Unpublished compilation. 105 p.
00144855 Markle, J. (1984) Determination of Permethrin, Dichlorovinyl Acid and m Phenoxybenzyl
Alcohol in/on 40 Day PHI Soybeans: RAN 0125. Unpublished study prepared by FMC
Corporation. 29 p.
00145266 ICI Americas, Inc. (1984) Ambush Insecticide (Containing Permethrin): Residue Chemistry:
(Artichoke Buds). Unpublished compilation. 61 p.
00145971 Interregional Research Project No. 4 (1983) The Results of Tests on the Amount of
Permethrin Residues Remaining in or on Watercress. Unpublished compilation. 29 p.
00150293 ICI Americas Inc. (1984) Residue Chemistry with Ambush Insecticide Containing Permethrin
. Unpublished compilation. 105 p.
D-ll
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MRID Citation Reference
00151251 Interregional Research Project No.4 (1984) The Results of Tests on the Amount of Permethrin
Residues Remaining in or on Cantaloupes. Unpublished compilation. 92 p.
00151832 FMC Corp. (1984) Results of Tests for the Amount of Residues Remaining and a Description
of the Analytical Methods: Pounce. Unpublished compilation. 94 p.
00155167 Fitzpatrick, R. (1985) Permethrin and Permethrin Metabolite Residues on Pumpkins: Report
Series TMU1691/B. Unpublished study prepared by ICI Americas Inc. 28 p.
00155947 Interregional Research Project No. 4 (1985) The Results of Tests on the Amount of
Permethrin Residues Remaining in or on Collards, Mustard and Turnip Including a
Description of the Analytical Method Used. Unpublished compilation. 192 p.
00156265 ICI Americas Inc. (1980) Permethrin Residues on Lettuce and Cabbage . Unpublished
compilation. 173 p.
00160394 ICI Americas Inc. (1984) (Response to EPA's Comments on Analysis of Permethrin on Leafy
Vegetables: Includes Analytical Methods and Residue Data in Sweet Corn). Unpublished
compilation. 93 p.
00165524 Markle, J. (1982) Determination of Permethrin, Dichlorovinyl Acid and Metaphenoxybenzyl
Alcohol Residues in Mushrooms: Pounce Insecticide: RAN 0047. Unpublished study
prepared by FMC Agricultural Chemical Group, Richmond. 30 p.
00165525 Nelsen, T. (1982) Cold Storage Stability of Dichlorovinyl Acid and M Phenoxybenzyl
Alcohol Residues in/on Green Alfalfa, Alfalfa Hay, and Lettuce: Pounce Insecticide: M 4838.
Unpublished study prepared by FMC Agricultural Chemical Group, Middleport. 22 p.
40072401 Rabenold, J. (1986) Permethrin & Metabolites Magnitude of Residue in Alfalfa: Final Report
#34688/FMC Corp 138ALFR03. Unpublished study prepared by Analytical Bio Chemistry
Laboratories. 94 p.
40190101 Brown, P.M., and J.P. Leahy (1987) Permethrin: Photolysis on a soil surface. Labroratory
Project ID: RJ0581B. Prepared and submitted by ICI Americas Inc., Wilmington, DE.
40404001 Stearns, J. (1987) Determination of Permethrin, Dichlorovinyl Acid and m Phenoxybenzyl
Alcohol Residues in/on Onion Bulbs: Study No. 1380NIR02. Unpublished study prepared by
FMC Corp. 87 p.
40404002 Stearns, J. (1987) Methodology for the Determination of Permethrin, Dichlorovinyl Acid and
m Phenoxybenzyl Alcohol Residues in/on Onion Bulbs: Study No. 1380NIR02. Unpublished
study prepared by FMC Corp. 35 p.
40446401 Armentrout, T.; Koch, D. (1987) Pounce Insecticide Magnitude of the Residue of Permethrin
in/on Asparagus: Laboratory Project ID 35803. Unpublished study performed by Analytical
Bio Chemistry Laboratories. 33 p.
D-12
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MRID Citation Reference
40446402 Rizzi, L. (1987) Pounce Insecticide Magnitude of the Residue of Dichlorovinyl Acid and m
Phenoxybenzyl Alcohol in/on Asparagus: Study No. 138ASPR01. Unpublished study
prepared by FMC Corporation. 37 p.
40446403 Armentrout, T.; Koch, D. (1987) Pounce Insecticide Analytical Method for the Determination
of Permethrin in/on Asparagus: Report No. 35803 M. Unpublished study prepared by
Analytical Bio Chemistry Laboratories. 19 p.
40446404 Rizzi, L. (1987) Pounce Insecticide Analytical Method for the Determination of
Dichlorovinyl Acid and m Phenoxybenzyl Alcohol in/on Asparagus: Study No. 138ASPR01.
Unpublished study prepared by FMC Corporation. 28 p.
40556801 Armentrout, T.; Koch, D. (1987) Permethrin and Its Major Metabolites Magnitude of the
Residue in Cucumbers: Study No. 138CURR01. Unpublished study prepared by Analytical
Bio Chemistry Laboratories. 47 p.
40556802 Armentrout, T.; Koch, D. (1987) Permethrin and Its Major Metabolites Magnitude of the
Residue in Melons: Study No. 138CURR01. Unpublished study prepared by Analytical Bio
Chemistry Laboratories. 49 p.
40556803 Armentrout, T.; Koch, D. (1987) Permethrin and Its Major Metabolites Magnitude of the
Residue in Squash: Study No. 138CURR01. Unpublished study prepared by Analytical Bio
Chemistry Laboratories. 47 p.
40556804 Armentrout, T.; Koch, D. (1987) Permethrin, Dichlorovinyl Acid and m Phenoxybenzyl
Alcohol Methodology for Cucurbits: Study No. 138CURR01. Unpublished study prepared by
Analytical Bio-Chemistry Laboratories. 46 p.
40766807 Snodgrass, H. (1986) Neurotoxicity in Rats Following Subchronic Ingestion of Permethrin
TreatedFood: Proj. ID 7551035187. Unpublished study prepared by US Army Environmental
Hygiene Agency.
40943601 Wilks, K.; Eitelman, S. (1988) Permethrin Technical: [Product Chemistry]: ICI No.
TMR0006C. Unpublished study prepared Western Research Center. 104 p.
40943603 Hodge, M. (1988) Permethrin: Teratogenicity Study in the Rat: Laboratory Project ID:
CTL/P/2269. Unpublished study prepared by ICI Central Toxicology Laboratory.
40943604 Truemann, R. (1988) Permethrin: Assessment for the Induction of Unscheduled DNA
Synthesis in Primary Rat Hepatocyte Cultures: Laboratory Project ID: CTL/P/1888.
Unpublished study prepared by Imperial Chemical Industries PLC.
40955301 Halfon, M. (1988) Permethrin: Product Identity and Disclosure of Ingredients: Description of
Starting Materials and Manufacturing Process: Discussion on the Formation of Impurities.
Unpublished study prepared by FMC Corp. 75 p.
41031107 Callander, R. (1989) Permethrin: An Evaluation in the Salmonella Mutation Assay: Report
No. CTL/P/2423: CTL Study No. YV2410. Unpublished study prepared by ICI Central
Toxicology Laboratory.
D-13
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MRID Citation Reference
41054701 Knarr, R. (1988) Exposure of Applicators to Propoxur During Trigger Pum Spray Application
of a Liquid Product: 99100.
41054701 Knarr, R. (1988) Exposure of Applicators to Propoxur During Trigger Pum Spray Application
of a Liquid Product: 99100.
41065802 Leppert, B. (1985) Determination of Permethrin, Dichlorovinyl Acid and m Phenoxy benzyl
Alcohol Residues on Broccoli, Cauliflower and Cabbage Treated with Pounce 3.2 EC
Insecticide: Proj. ID RAN 0162. Unpublished study prepared by FMC Corp. 64 p.
41065803 Leppert, B. (1985) Determination of Permethrin, Dichlorovinyl Acid and m Phenoxy benzyl
Alcohol Residues on Cherries Treated with Pounce 3.2 EC Insecticide: Proj. ID RAN 0145.
Unpublished study prepared by FMC Corp. 38 p.
41065804 Leppert, B. (1985) Determination of Permethrin, Dichlorovinyl Acid and m Phenoxy benzyl
Alcohol Residues in Field Corn Treated with Pounce 3.2 EC Insecticide at the Brown Silk
Stage at a 10X Rate: Proj. ID RAN 0150. Unpublished study prepared by FMC Corp. 31 p.
41065805 Stearns, J. (1983) Determination of Permethrin Residues in/on Pistachio Nuts: Proj. ID RAN
0073. Unpublished study prepared by FMC Corp. 16 p.
41065808 Leppert, B. (1985) Determination of Permethrin, Dichlorovinyl Acid and m Phenoxy benzyl
Alcohol Residues in Spinach Treated Aerially with Pounce 3.2 EC Insecticide: Proj. ID RAN
0159. Unpublished study prepared by FMC Corp. 29 p.
41136401 Kahn, B. (1989). Analyisis and Certification of Product Ingredients in Permethrin Insecticides:
Rept. No. WRC 89-57. Unpublished study prepared by ICI Americas Inc. 132 p.
41143801 Citation: Milburn, G. (1989) Permethrin: 21 Day Dermal Study inRats: Report No.
CTL/P/2445: Study No. LR0533. Unpublished study prepared by ICI Central Toxicology
Laboratory.
41150901 Halfon, M. (1989) Analysis and Certification of Product Ingredients: Permethrin. Unpublished
Compilation prepared by FMC Corp. 31 p.
41300401 Burgess, D. (1989) Uptake, Depuration and Bioconcentration of 14C-Permethrin by Bluegill
Sunfish (Lepomis macrochirus). Laboratory Report #PC-0117. Unpublished study performed
by Analytical Bio-Chemistry Laboratories, Inc., Columbia, MO, and submitted by FMC
Corporation, Princeton, NJ.
41300402 Tullman, R. (1989) Accumulation Studies: Lavboratory Studies of Pesticide Accumulation in
Fish: Acid (Cycloprophyl)-14C-Permethrin in the Bluegill Sunfish. Laboratory Report
#138E5489E1-1. Unpublished study performed and submitted by FMC Corporation,
Princeton, NJ.
41300403 Singer, S. (1989) Accumulation Studies: Laboratory Studies of Pestcide Accumulation in
Fish: 14C-Alcohol (Phenyl)-Labled Permethrin in the Bluegill Sunfish. Laboratory Report
#138E5489El-2. Unpublished study performed and submitted by FMC Corporation,
Princeton, NJ.
D-14
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MRID Citation Reference
41404301 Francis, P. (1990) Ambush (Permethrin) Magnitude of the Residue Study on Processed
Tomato Products: Lab Project ID 0557 89 PR 01. Unpublished study prepared by ICI
Americas, Inc. 129 p.
41560201 Sapiets, A.; Swaine, H.; Hayward, G.; et al. (1982) Permethrin: Residue Transfer Study with
Laying Hens Fed on a Diet Containing Insecticide: Lab Project Number: PP557BB01.
Unpublished study prepared by ICI Agrochemicals. 115 p.
41560202 Swaine, H.; Rippington, D.; Ward, R. (1978) Permethrin: Storage Stability of Residues in
Deep Frozen Apple and Cabbage: Lab Project Number: M5117B. Unpublished study prepared
by ICI Agrochemicals. 19 p
41565401 Choban, R. (1984) Permethrin: Magnitude of the Residue In or On Avocados and Papayas:
Lab Project Number: IR 4/1727,1729: PP4E31 46. Unpublished study prepared by Univ. of
Florida in cooperation with USD A ARS. lip.
41565402 Choban, R. (1984) Permethrin: Magnitude of the Residue In or On Cantaloupe: Summary ...:
Lab Project Number: IR 4 71730: PP 5E 3225. Unpublished study prepared by USDA ARS.
lip.
41565403 Choban, R. (1983) Permethrin: Magnitude of the Residue In or On Egg plant and Bell
Peppers: Summary ...: Lab Project Number: IR4/1259, 1357: PP 3E2892:. Unpublished
study prepared by Rutgers Univ. in coop, with USDA ARS and ICI Americas, Biological
Research Ctr. 12 p.
41565404 Choban, R. (1981) Permethrin: Magnitude of the Residue In or On Horseradish: Reformat of
MRID'S 3551718 and 9460910: Lab Project Number: IR 4/3684: PP OE2377. Unpublished
study prepared by ICI Americas Inc., Biological Research Ctr. and Illinois Natural History
Survey. 51 p.
41565405 Choban, R. (1982) Permethrin: Magnitude of the Residue In or On Pumpkin: Summary . . .:
Lab Project Number: IR 4/1732: PP 3E2861. Unpublished study prepared by ICI Americas.
12 p
41565406 Choban, R. (1980) Permethrin: Magnitude of the Residue In or On Range Grass: Summary ...:
Lab Project Number: IR 4/2323: PP 3E2911. Unpublished study prepared by ICI ARS. 11 p.
3E2911. Unpublished study prepared by ICI Americas Inc. 10 p.
41575901 Choban, R. (1984) Permethrin: Magnitude of the Residue in or on Collards and Turnips: Lab
Project Number: IR 4 PR NO. 941. Unpublished study prepared by Yakima Agricultural
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41641001 Leppert, B. (1990) Methodology for the Determination of Permethrin, Dichlorovinyl Acid and
m Phenoxybenzyl Alcohol Residues in/on Pistachios: Lab Project Number: 138PIS87R1.
Unpublished study Prepared by FMC Corp. 38 p.
41641002 Leppert, B. (1990) Pounce Insecticide Magnitude of the Residue of Permethrin,
Dichlorovinyl Acid and m Phenoxybenzyl Alcohol in/on Pistachios: Lab Project Number:
138PIS87R1. Unpublished study prepared by FMC Corp. 43 p.
D-15
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MRID Citation Reference
41868001 Davis, M.L. (1991) Sorption/Desorption of 14C-Permethrin on Soils by thr Batch Equilibrium
mMethod. Study performed by Battelle Memorial Institute. Columbus, OH, and submitted by
FMC Corporation, Princeton, NJ.
41970601 Hawkins, D., et al. (1991) The Metabolism of 14C-Permethrin in Sandy Loam Soil Under
Anaerobic Conditions. Laboratory Report No. HRC/ISN 236/91107. Unpublished study
performed and submitted by ICI Agrochemicals, Huntingdon Research Center, Ltd.
Huntingdon, England.
41970602 Hawkins, D., et al. (1991) The Effects of Application Rates and Soil Moisture Content on the
Rater of Degradation of 14C-Permethrin. Laboratory Report No. HRC/ISN 247/91296.
Unpublished study performed and submitted by ICI Agrochemicals, Inc., Huntingdon
Research Center, Huntingdon, England.
42109801 Alvarez M. (1989) Permethrin: Physical Properties: Lab Project No. 138AF88113.
Unpublished study prepared by FMC Corp. 50 p.
42009301 Lynn, S.; Hoxter, K. (1991) Permethrin Wettable Powder-Ambush 25 W: A Foliage Residue
Toxicity Study with the Honey Bee: Lab Project Number: WIL 123-165. Unpublished study
prepared by Wildlife International Ltd. 28 p.
42137201 Leppert, B. (1991) Pounce 3.2 EC Insecticide-Magnitude of the Residue on Artichoke from
Field Trials Using Aerial Applications : Lab Project Number: 138ART91R1. Unpublished
study prepared by FMC Corp. 77 p.
42137202 Leppert, B. (1991) Pounce Insecticide: Residue Analytical Methods for the Determination of
the Residues of Permethrin and Its Metabolites on Artichokes: Lab Project Number:
138ART91R1. Unpublished study prepared by FMC Corp. 46 p.
42196701 Cranor, W. (1991) Leaching Characteristics of Soil Incorporated Permethrin Following
Aerobics Aging. Laboratory Report #39227. Performed by ABC Laboratories, Inc.,
Columbia, MO. Submitted by FMCCorporation, Princeton, NJ.
42196702 Leahey, I; et al. (1977) Permethrin: Absorption in Chickens after Dermal and Oral
Treatments. Unpublished study prepared by ICI Agrochemicals. 33 p.
42196703 Leahey, I; Cameron, ?.; et al. (1978) Permethrin: Residues in Cows after Dermal
Applications. Unpublished study prepared by ICI Agrochemicals. 32 p.
42322904 ICI Americas; FMC Corp. (1992) Permethrin: Residues in Lettuce: Addenda to MRID
92142116. Unpublished study. 7 p.
42322905 ICI Americas; FMC Corp. (1992) Permethrin: Residues in Pears: Addenda to MRID
92142117. Unpublished study. 3 p.
42322906 ICI Americas; FMC Corp. (1992) Permethrin: Residues in Walnuts: Addenda to MRID
072833. Unpublished study. 25 p.
D-16
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MRID Citation Reference
42359109 Becker, J.M. (1992) Pounce 3.2 EC Insecticide - Terrestrial Field Dissipation. Vol 3 of 8.
FMC Study#138E4191Rl. Performed and submitted by FMC Corporation, Princeton, NJ.
42377601 Wollweton, C.; Husband, R. (1992) Permethrin: Physico-Chemical Study on Technical Grade
Active Ingredient: Lab Project Number: PJ114IB: 92JH3. Unpublished study prepared by
ICI Agrochemicals; Jealott's Hill, UK. 17 p.
42410001 Hawkins, D.; Kirkpatrick, D.; Shaw, D. (1992) The Metabolism of [carbon 14] Permethrin in
the Goat: Lab Project Number: HRC/ISN 248/920216. Unpublished study prepared HRC/ISN
248/920216. Unpublished study prepared by Huntingdon Research Centre, Ltd. 97 p.
42410002 Hawkins, D.R., et al (1992) The Aerobic Soil Metabolism of 14C-Permethrin. Laboratory
Report No. HRC/ISN 251/911499. Unpublished study performed by ICI Agrochemicals,
Huntingdon research Center, Huntingdon, England.
42431401 Dansbury, L. (1992) US EPA/OPP dated July 31, 1992 from Linda Dansbury [FMC] with
Attachments 1 and 2 of preliminary data on residues of Permethrin in spinach. Unpublished
study prepared by Rhone Poulenc Ag. Co. 4 p.
42503201 Hawkins, D.; Kirkpatrick, D.; Shaw, D.; et al. (1992) The Metabolism of [Carbon 14]
Permethrin in the Hen: Lab Project Number: HRC/ISN 272/920435. Unpublished study
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42653301 Citation: Milburn, G. (1989) Permethrin: 21 Day Dermal Study in Rats: Individual Animal
Data Supplement: An Addendum: Lab Project Number: CTL/P/2445: LR0533. Unpublished
study prepared by Zeneca Central Toxicology Lab.
42723302 Fox, D.; Mackay, J. (1993) Permethrin: An Evaluation in the Mouse Micronucleus Test: Lab
Project Number: CTL/P/3934. Unpublished study prepared by Zeneca, Ltd.
42802701 Alvarez, A. (1993) Response to Questions Raised by EPA Regarding MRID 42109801:
Permethrin Product Chedmistry: Lab Project Nos. P-2822: 138AF93248. Unpublished study
prepared by FMC Corp. 36 p.
42824701 Francis, P.; Grant, C. (1993) Permethrin (ICIA0557): Residue Processing Study Following
the Application of AMBUSH to Potatoes: Lab Project Number: PERM-92-PR-02: RR
93-026B. Unpublished study prepared by Zeneca, Inc. and Wm. J. Englar & Associates, Inc.
81 p.
42824702 Francis, P.; Grant, C. (1993) Permethrin (ICIA0557): Residue Processing Study for AMBUSH
on Apples: Lab Project Number: PERM 92 PR 01: RR 93 023B. Unpublished study prepared
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42838101 Francis, P. (1993) Permethrin (ICIA0557): Residue Levels in Apples from Trials Carried Out
in the USA During 1992: Lab Project Number: PERM 92 MR 04: PERM 92 MR 05: RR 93
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D-17
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MRID Citation Reference
42860601 Munoz, W. (1993) Magnitude of the Residues of Permethrin, Dichlorovinyl Acid and meta
Phenoxybenzyl Alcohol in/on Sweet Corn Processed Products (Cannery Waste) Treated with
Pounce 3.2EC Insecticide: Lab Project Number: RAN 0247. Unpublished study prepared by
FMC Corporation. 116 p.
42909001 Francis, P. (1993) Permethrin (ICIA0557): Residue Levels in Alfalfa Forage, Hay and Meal
from Trials Carried Out in the USA During 1992: Lab Project Number: RR 93 071B: PERM
92 MR 01: PERM 92 MR 02. Unpublished study prepared by ZENECA Ag Products. 117 p.
42910101 Hebert, V.; Starner, K. (1993) Magnitude of the Residue of Permethrin, Dichlorovinyl Acid
and Meta phenoxybenzyl Alcohol Residues in/on Field Corn Grain Treated with Pounce 3.2
EC Insecticide at Exaggerated Label Rates: Lab Project Number: 138COF92R2: RAN 0246.
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42919201 Eckstein, C. (1993) Part III: Final Report on Storage Stability of Pyrethroid Metabolites
(PP890, 3 PB acid, 3 PBalcohol, andDCVA) in Raw Agricultural Commodities (36 Month
Interval): Lab Project Number: PYRE 89 SS 01. Unpublished study prepared by Western
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42933701 Freeman, C. (1993) Permethrin Technical: Subchronic Neurotoxicity Screen in Rats: Lab
Project Number: A923647. Unpublished study prepared by FMC Corp.
42979901 Lepert, B. (1993) Magnitude of the Residues of Permethrin, Dichlorovinyl Acid and meta
Phenoxybenzyl Alcohol in/on Spinach Treated with Ten Applications of Pounce 3.2 EC
Treated with Ten Applications of Pounce 3.2 EC Insecticide of Pounce 25 WP Insecticide at
0.2 Ib Active Ingredient per Acre per Application: Lab Project Number: 138SPI92R1: RA
0240. Unpublished study prepared by FMC Corp. 165 p.
43046301 Freeman, C. (1993) Permethrin Technical: Acute Neurotoxicity Screen in Rats: Lab Project
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43088401 Biehn, W. (1994) Permethrin in/on Raspberry (Amendment IR 4 Petition 8E 3675, MRID
40782901, EPA 28 NOV 88 Response Letter): Lab Project Number: IR 4 PR NO. 2564:
2564.91 CAR 02: 89:CAR:005. Unpublished study prepared by IR 4 Western Region
Analytical Lab.; Washington State Univ., Research & Extension Unit; N. Willamette Research
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43149501 Munoz, W. (1994) Magnitude of the Residue of Permethrin, Dichlorovinyl Acid and Meta
Phenoxybenzyl Alcohol Residues in/on Field Corn Treated with Pounce 3.2 EC Insecticide:
Lab Project Number: 138COF93R2: RAN 0255. Unpublished study prepared by FMC Corp.
120 p.
43164801 Goodman, M. (1993) Permethrin - pH: Lab Project Number: APP-020: RR-93-051B.
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D-18
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MRID Citation Reference
43173801 Groome, J.M., et. Al. (1992) Permanone lOECSpray Drift Study. Study performed by
Wellcome Foundation LTD., Berkhamsted, United Kingdom, and Fairfield America Co.,
Frenchtown, NJ.
43174401 Schanne, C. (1993) Confined Rotational Crop Study in the Greenhouse with (carbon 14)
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43307801 Flueckiger, J. (1994) Plant Metabolism Study in Field Grown Sweet Corn with (Carbon 14)
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43343101 Eckstein, C. (1994) Permethrin (ICIA0557): Magnitude of the Residue Study on Alfalfa Seed
and Seed Screenings After Treatment of Alfalfa with AMBUSH or AMBUSH 25 W from
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107B: 16 ID 92 121. Unpublished study prepared by Zeneca Ag Products. 65 p.
43343102 Francis, P. (1994) Permethrin (ICIA0557): Magnitude of the Residue Study on Potatoes After
Treatment with AMBUSH or AMBUSH 25W from Trials Carried out in the USA During
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43348101 Robbins, J. (1994) Permethrin (ICIA0557): Magnitude of the Residue Study on Peaches After
Treatment with AMBUSH and AMBUSH 25W from Trials Carried out in the USA During
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43350501 Hebert, V. (1994) Magnitude of the Residues of Permethrin, Dichlorovinyl Acid and m
Phenoxybenzyl Alcohol in/on Celery Treated with Ten Applications of with Pounce 3.2 EC
Insecticide or Pounce 25 WP Insecticide at 0.2 Ib Active Ingredient per Acre per Application:
Lab Project Number: 138CEL92R1: RAN/0258. Unpublished study prepared by FMC
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43350502 Jang, D. (1994) Magnitude of the Residues of Permethrin, Dichlorovinyl Acid and m
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Insecticide at 0.2 Ib Active Ingredient per Acre per Application: Lab Project Number:
138SPI93R1. Unpublished study prepared by FMC Corp. 149 p.
43350503 Brooks, M. (1994) Magnitude of the Residues of Permethrin, Dichlorovinyl Acid and m
Phenoxybenzyl Alcohol in/on Sweet Corn Ears, Husks and Stalks Treated with Pounce 1.5
Ears, Husks and Stalks Treated with Pounce 1.5 G and 3.2 EC Insecticides: Lab Project
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43364701 Jang, D. (1994) Magnitude of the Residue of Permethrin, Dichlorovinyl Acid and m
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Lab Project Number: 138COF92R3: RAN 0256. Unpublished study prepared by FMC Corp.
188 p.
D-19
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MRID Citation Reference
43364702 Jang, D. (1994) Magnitude of the Residue of Permethrin, Dichlorovinyl Acid and meta
Phenoxybenzyl Alcohol Residues in/on Field Corn Treated with Pounce 1.5 G and/or 3.2 EC
Insecticide: Lab Project Number: 138COF93R1: RAN 0257. Unpublished study prepared by
FMCCorp. 163 p.
43364703 Stearns, J. (1994) Magnitude of the Residue of Permethrin, Dichlorovinyl Acid and meta
Phenoxybenzyl Alcohol Residues in/on Soybean Seeds (Dry) and Processed Products Treated
with Pounce 3.2 EC Insecticide at 60 Day PHI: Lab Project Number: 138SOY92R4: RAN
0261. Unpublished study prepared by FMC Corp. 116 p.
43364704 Stearns, J. (1994) Magnitude of the Residue of Permethrin, Dichlorovinyl Acid and meta
Phenoxybenzyl Alcohol Residues in/on Soybean Seeds (Dry) Treated with Pounce 3.2 EC
Insecticide at 60 Day PHI: Lab Project Number: 138SOY92R2: RAN 0262. Unpublished
study prepared by FMC Corp. 88 p.
43364705 Stearns, J. (1994) Analytical Methods for the Determination of Permethrin, Dichlorovinyl
Acid and meta Phenoxybenzyl Alcohol Residues in/on Soybeans and its Processed and/or 3.2
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138SOY92R2: 138SOY92R3. Unpublished study prepared by FMC Corp. 72 p.
43374601 Castro, T. (1993) Magnitude of the Residue of Permethrin, Dichlorovinyl Acid and m
Phenoxybenzyl Alcohol Residues in/on Field Corn Grain and Processed Products (Wet and
Dry Mill Products) Treated with Pounce 3.2 EC Insecticide at Exaggerated Label Rates: Lab
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43424901 Gravelle, W.D. (1994) Adsorption/Desorption of UC-tmns-DCVA on Four Soils. Study
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43458801 Baker, P.; Dighton, M.; Elsom, L. et al. (1994) The Dermal Metabolism of (carbon 14)
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43494701 Samoil, K. (1994) Magnitude of Residue: Permethrin on Pepper (Bell): Lab Project Number:
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43505201 Kirkpatrick, D. (1994) Addendum to MRID 42410001, (carbon 14) Permethrin Metabolism in
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D-20
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MRID Citation Reference
43713301 Baker, P.; Cameron, D.; Dighton, M; et al. (1995) Fate of (Carbon 14) Permethrin When
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43713302 Dighton, M.; Elsom, L.; Hawkins, D. (1995) The Metabolite Profiles in Tissues, Eggs and
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43713303 Baker, P.; Cameron, D.; Dighton, M.; et al. (1995) Fate of (Carbon 14) Permethrin When
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43713304 Dighton, M.; Elsom, L.; Hawkins, D. (1995) The Metabolite Profiles in Tissues, Milk and
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43755701 Belcher, T. & Schuster, L. (1995) Dissipation of Dislodgeable Foliar Residues of Permethrin
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43755701 Belcher, T. & Luster, S. (1995) Dissipation of Dislodgeable Foliar Residues of Permethrin
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43903501 Francis, P.; Grant, C. (1996) Permethrin (ICIA0557): Magnitude of the Residue Study on
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43938201 Robinson, R.A., and J.E. Ryan (1996) Aerobic Aquatic Metabolism of [14]C-Permethrin.
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43938801 Curry, K. (1992) Phase 3 Reformat of MRIDs 00110564 and 100520: AMBUSH and
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43962801 Skidmore, M. (1996) Permethrin: Supplemental Information on MRID Nos. 42410001 and
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D-21
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MRID Citation Reference
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44157101 Michael W.H. November 5, 1996. Addendum to Aquatic Field Dissipation of Permethrin in
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44196103 Earl, V. (1996) Radiovalidation of the Residue Analytical Method for the Analysis of 3
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D-22
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44518501 Merricks, D. (1998) Carbaryl Mixer/Loader/Applicator Exposure Study During Application of
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44658401 Mester, T. (1998) Dermal Exposure and Inhalation Exposure to Carbaryl by Commercial Pet
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D-24
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D-25
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