Document ID: EPA-HQ-OPP-2005-0293-0036
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2006-09-07T18:06:24Z

United States			Prevention, Pesticides		EPA  OPP-2005-0293	
Environmental Protection 		And Toxic Substances		June 14, 2006

			Agency				(7508C)

			_________________________________________________________________

  SEQ CHAPTER \h \r 1 Reregistration Eligibility    Decision for
Cypermethrin 

List B

Case No. 2130

  SEQ CHAPTER \h \r 1 

TABLE OF CONTENTS

  TOC \o "1-5" \h \z \u    HYPERLINK \l "_Toc142818366"  Cypermethrin
Reregistration Eligibility Decision Team	  PAGEREF _Toc142818366 \h  5  

  HYPERLINK \l "_Toc142818367"  Glossary of Terms and Abbreviations	 
PAGEREF _Toc142818367 \h  6  

  HYPERLINK \l "_Toc142818368"  Executive Summary	  PAGEREF
_Toc142818368 \h  8  

  HYPERLINK \l "_Toc142818369"  I.	Introduction	  PAGEREF _Toc142818369
\h  14  

  HYPERLINK \l "_Toc142818370"  II.	Chemical Overview	  PAGEREF
_Toc142818370 \h  15  

  HYPERLINK \l "_Toc142818371"  A.	Regulatory History	  PAGEREF
_Toc142818371 \h  15  

  HYPERLINK \l "_Toc142818372"  B.	Chemical Identification	  PAGEREF
_Toc142818372 \h  16  

  HYPERLINK \l "_Toc142818373"  C.	Use Profiles	  PAGEREF _Toc142818373
\h  17  

  HYPERLINK \l "_Toc142818374"  III.	Summary of Cypermethrin Risk
Assessments	  PAGEREF _Toc142818374 \h  18  

  HYPERLINK \l "_Toc142818375"  A.	Human Health Risk Assessment	 
PAGEREF _Toc142818375 \h  19  

  HYPERLINK \l "_Toc142818376"  1.	Toxicity	  PAGEREF _Toc142818376 \h 
19  

  HYPERLINK \l "_Toc142818377"  2.	FQPA Safety Factor	  PAGEREF
_Toc142818377 \h  21  

  HYPERLINK \l "_Toc142818378"  3.	Dermal Absorption	  PAGEREF
_Toc142818378 \h  22  

  HYPERLINK \l "_Toc142818379"  4.	Dietary Exposure	  PAGEREF
_Toc142818379 \h  22  

  HYPERLINK \l "_Toc142818380"  a.	Acute Dietary Exposure (food only)	 
PAGEREF _Toc142818380 \h  22  

  HYPERLINK \l "_Toc142818381"  b.	Chronic Dietary Exposure (food only)	
 PAGEREF _Toc142818381 \h  23  

  HYPERLINK \l "_Toc142818382"  5.	Drinking Water Exposure	  PAGEREF
_Toc142818382 \h  23  

  HYPERLINK \l "_Toc142818383"  6.	Residential Exposure and Risk	 
PAGEREF _Toc142818383 \h  23  

  HYPERLINK \l "_Toc142818384"  a.	Residential Handler Risk	  PAGEREF
_Toc142818384 \h  24  

  HYPERLINK \l "_Toc142818385"  b.	Residential Post-application Risk	 
PAGEREF _Toc142818385 \h  24  

  HYPERLINK \l "_Toc142818386"  7.	Aggregate Exposure and Risk (food,
drinking water, and residential)	  PAGEREF _Toc142818386 \h  25  

  HYPERLINK \l "_Toc142818387"  a.	Acute Aggregate Risk (food and
drinking water)	  PAGEREF _Toc142818387 \h  25  

  HYPERLINK \l "_Toc142818388"  b.	Short-term Aggregate Risk (food,
drinking water, and residential)	  PAGEREF _Toc142818388 \h  26  

  HYPERLINK \l "_Toc142818389"  c.	Chronic Aggregate Risk (food and
drinking water)	  PAGEREF _Toc142818389 \h  26  

  HYPERLINK \l "_Toc142818390"  8.	Occupational Exposure and Risk	 
PAGEREF _Toc142818390 \h  26  

  HYPERLINK \l "_Toc142818391"  a.	Occupational Handler Risk	  PAGEREF
_Toc142818391 \h  27  

  HYPERLINK \l "_Toc142818392"  b.	Occupational Post-application Risk	 
PAGEREF _Toc142818392 \h  28  

  HYPERLINK \l "_Toc142818393"  9.	Human Incident Data	  PAGEREF
_Toc142818393 \h  28  

  HYPERLINK \l "_Toc142818394"  B.	Environmental Risk Assessment	 
PAGEREF _Toc142818394 \h  29  

  HYPERLINK \l "_Toc142818395"  1.	Environmental Fate and Transport	 
PAGEREF _Toc142818395 \h  29  

  HYPERLINK \l "_Toc142818396"  2.	Ecological Risk	  PAGEREF
_Toc142818396 \h  30  

  HYPERLINK \l "_Toc142818397"  a.	Risk to Aquatic Organisms	  PAGEREF
_Toc142818397 \h  30  

  HYPERLINK \l "_Toc142818398"  b.	Risk to Terrestrial Organisms	 
PAGEREF _Toc142818398 \h  37  

  HYPERLINK \l "_Toc142818399"  c.	Ecological Incidents	  PAGEREF
_Toc142818399 \h  39  

  HYPERLINK \l "_Toc142818400"  d.	Endangered Species Concerns	  PAGEREF
_Toc142818400 \h  39  

  HYPERLINK \l "_Toc142818401"  IV.	Risk Management, Reregistration, and
Tolerance Reassessment Decision	  PAGEREF _Toc142818401 \h  41  

  HYPERLINK \l "_Toc142818402"  A.	Determination of Reregistration
Eligibility and Tolerance Reassessment	  PAGEREF _Toc142818402 \h  41  

  HYPERLINK \l "_Toc142818403"  B.	Public Comments and Responses	 
PAGEREF _Toc142818403 \h  41  

  HYPERLINK \l "_Toc142818404"  C.	Regulatory Position	  PAGEREF
_Toc142818404 \h  42  

  HYPERLINK \l "_Toc142818405"  1.	Food Quality Protection Act Findings	
 PAGEREF _Toc142818405 \h  42  

  HYPERLINK \l "_Toc142818406"  2.	Endocrine Disruptor Effects	  PAGEREF
_Toc142818406 \h  43  

  HYPERLINK \l "_Toc142818407"  3.	Cumulative Risks	  PAGEREF
_Toc142818407 \h  43  

  HYPERLINK \l "_Toc142818408"  D.	Tolerance Reassessment Summary	 
PAGEREF _Toc142818408 \h  44  

  HYPERLINK \l "_Toc142818409"  E.	Regulatory Rationale	  PAGEREF
_Toc142818409 \h  45  

  HYPERLINK \l "_Toc142818410"  1.	Human Health Risk Mitigation	 
PAGEREF _Toc142818410 \h  46  

  HYPERLINK \l "_Toc142818411"  2.	Environmental Risk Mitigation	 
PAGEREF _Toc142818411 \h  48  

  HYPERLINK \l "_Toc142818412"  3.	Benefits of Cypermethrin Use and
Available Alternatives	  PAGEREF _Toc142818412 \h  56  

  HYPERLINK \l "_Toc142818413"  V.	What Registrants Need to Do	  PAGEREF
_Toc142818413 \h  56  

  HYPERLINK \l "_Toc142818414"  A.	Manufacturing Use Products	  PAGEREF
_Toc142818414 \h  57  

  HYPERLINK \l "_Toc142818415"  1.	Additional Generic Data Requirements	
 PAGEREF _Toc142818415 \h  57  

  HYPERLINK \l "_Toc142818416"  2.	Labeling Requirements	  PAGEREF
_Toc142818416 \h  57  

  HYPERLINK \l "_Toc142818417"  3.	Spray Drift Management	  PAGEREF
_Toc142818417 \h  57  

  HYPERLINK \l "_Toc142818418"  B. 	End-Use Products	  PAGEREF
_Toc142818418 \h  57  

  HYPERLINK \l "_Toc142818419"  1.    Additional Product-Specific Data
Requirements	  PAGEREF _Toc142818419 \h  57  

  HYPERLINK \l "_Toc142818420"  2.    Labeling for End-Use Products	 
PAGEREF _Toc142818420 \h  58  

  HYPERLINK \l "_Toc142818421"  Appendix A. Uses of Cypermethrin
Eligible for Reregistration	  PAGEREF _Toc142818421 \h  77  

  HYPERLINK \l "_Toc142818422"  Appendix B.  Table of Generic Data
Requirements and Studies Used to Make the Reregistration Decision for
Cypermethrin	  PAGEREF _Toc142818422 \h  85  

  HYPERLINK \l "_Toc142818423"  APPENDIX C:  Technical Support Documents
  PAGEREF _Toc142818423 \h  91  

  HYPERLINK \l "_Toc142818424"  Appendix D. 	Citations Considered to be
Part of the Data Base Supporting the Reregistration Eligibility Decision
  PAGEREF _Toc142818424 \h  93  

  HYPERLINK \l "_Toc142818425"  APPENDIX E:  Generic Data Call-In	 
PAGEREF _Toc142818425 \h  113  

  HYPERLINK \l "_Toc142818426"  APPENDIX F:  Product Specific Data
Call-In	  PAGEREF _Toc142818426 \h  114  

 

Cypermethrin Reregistration Eligibility Decision Team

Office of Pesticide Programs:

Environmental Fate and Effects Risk Assessment

  SEQ CHAPTER \h \r 1 Miachel Rexrode

José Luis Meléndez

Health Effects Risk Assessment

  SEQ CHAPTER \h \r 1 William H. Donovan

Pamela M. Hurley

  SEQ CHAPTER \h \r 1 John Doherty

Seyed Tadayon

Biological and Economic Analysis Division

Alan Halvorson

Registration

George LaRocca

Risk Management

Yan Donovan

Véronique LaCapra

Dirk V. Helder

  SEQ CHAPTER \h \r 1 Glossary of Terms and Abbreviations  TC "Glossary
of Terms and Abbreviations" \f C \l "1"  

AGDCI		Agricultural Data Call-In

ai			Active Ingredient

aPAD			Acute Population Adjusted Dose

AR			Anticipated Residue

BCF			Bioconcentration Factor 

CFR			Code of Federal Regulations

cPAD			Chronic Population Adjusted Dose

CSF			Confidential Statement of Formula

CSFII			USDA Continuing Surveys for Food Intake by Individuals

DCI			Data Call-In

DEEM			Dietary Exposure Evaluation Model

DFR			Dislodgeable Foliar Residue

DWLOC		Drinking Water Level of Comparison.

EC			Emulsifiable Concentrate Formulation

EDWC			Estimated Drinking Water Concentration

EEC			Estimated Environmental Concentration

EPA			Environmental Protection Agency

EUP			End-Use Product

FDA			Food and Drug Administration

FIFRA			Federal Insecticide, Fungicide, and Rodenticide Act

FFDCA	Federal Food, Drug, and Cosmetic Act

FQPA			Food Quality Protection Act

FOB			Functional Observation Battery

G			Granular Formulation

GENEEC		Tier I Surface Water Computer Model

GLN			Guideline Number

HAFT			Highest Average Field Trial

IR			Index Reservoir

LC50			Median Lethal Concentration.  A statistically derived
concentration of a substance that can be expected to cause death in 50%
of test animals.  It is usually expressed as the weight of substance per
weight or volume of water, air or feed, e.g., mg/l, mg/kg or ppm.

LD50			Median Lethal Dose.  A statistically derived single dose that can
be expected to cause death in 50% of the test animals when administered
by the route indicated (oral, dermal, inhalation).  It is expressed as a
weight of substance per unit weight of animal, e.g., mg/kg.

LOC			Level of Concern

LOD			Limit of Detection 

LOAEL		Lowest Observed Adverse Effect Level

MATC			Maximum Acceptable Toxicant Concentration

g/g			Micrograms Per Gram

g/L			Micrograms Per Liter

mg/kg/day		Milligram Per Kilogram Per Day

mg/L			Milligrams Per Liter

MOE			Margin of Exposure 

MRID			Master Record Identification (number).  EPA's system of recording
and tracking studies submitted.

MUP			Manufacturing-Use Product

NA			Not Applicable

NAWQA		USGS National Water Quality Assessment

NPDES		National Pollutant Discharge Elimination System

NR			Not Required

NOAEC			No Observed Adverse Effect Concentration

NOAEL		No Observed Adverse Effect Level

OP			Organophosphate

OPP			EPA Office of Pesticide Programs

OPPTS			EPA Office of Prevention, Pesticides and Toxic Substances

PAD			Population Adjusted Dose

PCA			Percent Crop Area

PDP			USDA Pesticide Data Program

PHED			Pesticide Handler's Exposure Data 

PHI			Preharvest Interval

ppb			Parts Per Billion

PPE			Personal Protective Equipment

ppm			Parts Per Million

PRZM/EXAMS		Tier II Surface Water Computer Model  

Q1*			The Carcinogenic Potential of a Compound, Quantified by the EPA's
Cancer Risk Model

RAC			Raw Agriculture Commodity

RED			Reregistration Eligibility Decision

REI			Restricted Entry Interval

RfD			Reference Dose

RQ			Risk Quotient

SCI-GROW		Tier I Ground Water Computer Model

SAP			Science Advisory Panel

SF			Safety Factor

SLC			Single Layer Clothing

SLN			Special Local Need  (Registrations Under Section 24(c) of FIFRA)

TGAI			Technical Grade Active Ingredient

TRR			Total Radioactive Residue

USDA			United States Department of Agriculture

USGS			United States Geological Survey

UF			Uncertainty Factor

UV			Ultraviolet 

WPS			Worker Protection Standard

  SEQ CHAPTER \h \r 1  Executive Summary 

This document presents EPA’s decision regarding the reregistration
eligibility of the registered uses of cypermethrin.   The Agency has
conducted human health and ecological risk assessments based on reviews
of the database supporting use patterns of the currently registered
cypermethrin products.  This document summarizes these risk assessments
and describes the mitigation measures needed to address the identified
risks. 

Cypermethrin is an insecticide used both in agricultural and
non-agricultural settings.  Total cypermethrin use in the United States
is approximately 1.0 million pounds of active ingredient (a.i.) per
year.  Approximately 140,000 pounds a.i. are used in agricultural crops,
mainly on cotton (110,000 pounds), with minor uses on pecans, peanuts,
broccoli and sweet corn.  Treatment of cattle and other livestock
accounts for approximately 1000 pounds a.i. per year.  The great
majority of cypermethrin use occurs in non-agricultural settings,
including a wide range of commercial, industrial, and residential sites.
 Indoor pest control -mainly for control of ants, cockroaches, and fleas
- accounts for about 110,000 pounds a.i., while outdoor structural,
perimeter, and turf uses for control of subterranean termites and other
insect pests accounts for nearly 750,000 pounds a.i.  In residential
settings, cypermethrin can be applied both by professional applicators
and by residential users. 

Cypermethrin was first registered in 1984 by FMC Corporation, who also
subsequently registered the isomer enriched zeta-cypermethrin in 1992.
Current technical registrants for cypermethrin included FMC, Syngenta,
United Phosphorus International, and Valent BioSciences.  Data for the
two active ingredients is considered interchangeable. Since
zeta-cypermethrin was registered after 1984, only cypermethrin is
subject to reregistration.  Cypermethrin is on reregistration List B;
thus no Registration Standard was completed.  Data call-ins (DCIs) for
cypermethrin were issued in 1991 for basic toxicology and residue
chemistry data, and in 1995 for handler exposure and worker re-entry
data.  Cypermethrin is one of nine synthetic pyrethroids registered on
cotton, represented by the Pyrethroid Working Group (PWG), that are
considered to be conditionally registered pending the development and
review of data related to aquatic toxicity.  EPA will make every effort
to coordinate the implementation of its reregistration eligibility
decision provisions and labeling for cypermethrin with the ongoing
efforts of the PWG.

  SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1 The Agency’s human health
effects and environmental fate risk assessment for cypermethrin included
the assessment for zeta-cypermethrin as well, since zeta-cypermethrin is
an S-enantiomer enriched formulation of cypermethrin, which is not
distinguished from cypermethrin by the analytical enforcement method,
and the toxicological endpoints are the same for both cypermethrin and
zeta-cypermethrin.

Human Health Risk

Dietary Exposure (food only)

  SEQ CHAPTER \h \r 1 Refined acute (probabilistic) and chronic dietary
exposure assessments were performed in order to determine the dietary
(food only) exposure and risk estimates which result from the use of
cypermethrin and zeta-cypermethrin in/on all registered crops.    SEQ
CHAPTER \h \r 1 Actual residues from USDA PDP monitoring data (collected
during 1994, 1996, 1999, and 2001), estimated percent crop treated
information, and processing factors, where available, were used.  For
acute exposure,   SEQ CHAPTER \h \r 1 the most highly exposed population
subgroup was children 1-2 years old at 6.1% of the aPAD at the 99.9th
percentile.  For chronic exposure, the most highly exposed population
subgroup was children 1-2 years old at 0.2% of the cPAD.  Dietary
exposures (both acute and   SEQ CHAPTER \h \r 1 chronic) estimates are
below the Agency’s level of concern for the general U.S. population
and all population subgroups. 

		Drinking Water Exposure

The Estimated Drinking Water Concentrations (EDWCs)ervoir, cotton, not
brassicas?] te risks from food and drinking water  for cypermethrin were
calculated   SEQ CHAPTER \h \r 1 using PRZM/EXAMS model (Tier II ),
based on the highest seasonal application rate (0.6 lb a.i./A on
cotton). The estimated acute drinking water concentration in surface
water is 1.04 ppb, and the estimated chronic drinking water
concentration in surface water is 0.013 ppb.  The SCI-GROW model was
used to generate the EDWC for groundwater.  The groundwater EDWC for
both acute and chronic exposures is 0.0036 ppb.

		Residential Exposure and Risk

Residential handler inhalation risks are below EPA’s level of concern
for all non-occupational handler scenarios.  No short-term dermal
exposures or risks were assessed for residential handlers since no
dermal endpoints of concern were identified.  EPA does not anticipate
that residential handlers would have intermediate- or long-term
exposures to cypermethrin or zeta-cypermethrin.  Therefore, no
intermediate- or long-term risks were assessed.  

on-dietary post-application exposure to adults was assessed via the
inhalation route, since no effects were observed in the dermal exposure
study. Exposure to toddlers was assessed via the inhalation route, and
via incidental oral exposure.  All of these exposures are considered
short term.   Although cypermethrin can be used indoors as termiticide,
long term exposure due to inhalation is considered negligible, since the
vapor pressure for cypermethrin is extremely low.  Inhalation risks to
both adults and toddlers were below the Agency’s level of concern. 
Individually, risks from hand to mouth exposure, object to mouth
exposure, and incidental soil ingestion were all below EPA’s level of
concern.

Aggregate risk

An acute aggregate risk assessment was conducted taking into account
risk from food and drinking water.  EPA calculated the Drinking Water
Levels of Comparison (DWLOC, which represents the maximum allowable
exposure from drinking water that would still fall below EPA’s level
of concern) for all population subgroups.  The acute DWLOC for the most
highly exposed population subgroup (children 1-2 years old) is 940 ppb,
which is much higher than the peak EDWC of 1.04 ppb in surface water and
the maximum EDWC for ground water of 0.0036 ppb; therefore, acute
aggregate risk estimates associated with exposure to cypermethrin
residues in food and water do not exceed EPA’s level of concern.

Short-term aggregate exposure takes into account residential exposure
plus average exposure levels to food and water (considered to be a
background exposure level).    SEQ CHAPTER \h \r 1 The calculated DWLOC
value for children 1-2 years old is 890 ppb and this level is higher
than the surface and ground water EDWCs of 0.013 and 0.0036 ppb.

Chronic aggregate assessment only includes food and water since chronic
exposure from residential uses is negligible.  The highest exposed
population subgroup (children 1-2 years old) has a DWLOC value of 600
ppb, which is greater than the average annual EDWCs of 0.013 ppb for
surface water and 0.0036 ppb for ground water.   Therefore, chronic
aggregate risk does not exceed the Agency’s level of concern.

Cumulative 

Cypermethrin is a member of the pyrethroid class of pesticides. 
Although all pyrethroids alter nerve function by modifying the normal
biochemistry and physiology of nerve membrane sodium channels, available
data shows that there are multiple types of sodium channels and that
these compounds may act on different isoforms of the sodium channel and
with other ion channels in producing their clinical signs.  It is
currently unknown whether the pyrethroids as a class have similar
effects on all channels or whether modifications of different types of
sodium channels would have a cumulative effect.  Nor do we have a clear
understanding of effects on key downstream neuronal function e.g., nerve
excitability, or how these key events interact to produce their compound
specific patterns of neurotoxicity.  Without such understanding, there
is no basis to make a common mechanism of toxicity finding.  Therefore,
EPA is not currently following a cumulative risk approach based on a
common mechanism of toxicity for the pyrethroids because the Agency has
determined further study is needed regarding the assumptions of dose
additivity and common mechanism(s) of toxicity to appropriately identify
a group or subgroups for such an assessment.  There is ongoing research
by the EPA’s Office of Research and Development and pyrethroid
registrants to evaluate the differential biochemical and physiological
actions of pyrethroids in mammals.  The Agency anticipates the majority
of this research to be completed by 2007.  

FQPA Safety Factor

The Agency   SEQ CHAPTER \h \r 1 determined that the FQPA safety factor
should be 1X since there are no residual uncertainties for pre and/or
post natal toxicity, and   SEQ CHAPTER \h \r 1 the dietary (food and
drinking water) and non-dietary exposure assessments will not
underestimate the potential exposures for infants and children.   No
database uncertainty factor is needed since the toxicity database is
complete.

Occupational Risk

Short-term, intermediate-term, and long-term risks to occupational
handlers are below the Agency’s level of concern with baseline attire
(long sleeved shirt, long pants, shoes and socks), as long as wettable
powder formulations are packaged in water soluble bags, and chemical
resistant gloves are worn for hand-held application methods. Although
risks could not be calculated for the one granular product of
cypermethrin, risks would be lower than for liquid products which is
below EPA’s level of concern with baseline attire.

EPA did not assess occupational postapplication risks since no short- or
intermediate-term dermal endpoints were identified and long-term dermal
exposures are not expected for any of the registered use patterns.   
SEQ CHAPTER \h \r 1  As per the Worker Protection Standard, a
restricted-entry interval of 12 hours is required for agricultural uses.

Ecological Risk

The Agency’s Tier I screening-level (deterministic) risk assessment is
focused on maximum uses of cypermethrin on registered agricultural crops
only, due to the   SEQ CHAPTER \h \r 1 difficulties of modeling and
quantifying urban uses.  As with several other pyrethroids, the great
majority of cypermethrin use is non-agricultural.  The non-agricultural
applications of cypermethrin may result in exposure to aquatic organisms
following runoff and/or erosion.  The Agency recognizes the potential
for aquatic toxicity from non-agricultural uses but was not able to
quantify the risks due to lack of available data and acceptable models. 

Aquatic Risk (fish, invertebrates)

For freshwater fish, invertebrates, and estuarine/marine fish,
invertebrates, technical grade cypermethrin is very highly toxic on an
acute basis.  Cypermethrin formulations are also very highly toxic, with
LC50 values that are similar to those reported for technical grade
cypermethrin.  LOCs for acute risk (0.5) and acute endangered species
risk (0.05) are exceeded for freshwater and estuarine/marine
invertebrates for all six crop scenarios considered in this assessment. 
The highest acute RQs are observed for freshwater invertebrates, ranging
from 49.4 to 558.3, exceeding all acute LOCs.  

LOCs for chronic risk (1) are exceeded for freshwater and
estuarine/marine invertebrates.  The highest chronic RQs are observed
for freshwater invertebrates, ranging from 57.6 to 325.4.  All chronic
RQs for freshwater fish and estuarine/marine fish are less than the
chronic LOC (1).

Terrestrial Risk (birds, mammals)

  SEQ CHAPTER \h \r 1 For birds, all acute (dose-based and
dietary-based) RQs are below the acute risk LOC (0.5) and the endangered
species LOC (0.1) for all crop uses; chronic RQs are also below the LOC
(1).  The Agency’s screening level ecological risk assessment for
endangered species results in the determination that cypermethrin will
have no direct acute or chronic effect on threatened and endangered
birds.  

For mammals, acute (dose-based) RQs are below the acute risk LOC (0.5).
The acute endangered species LOC (0.1) is exceeded for 15g and 35g
mammals feeding on short grass (dose-based RQs 0.1-0.2) for all crop
scenarios. Mammalian chronic RQs (dose-based) range from <0.1 to 9.3
(15g mammals feeding on short grass in cotton), exceeding the chronic
LOC (1) for most scenarios.

Plants

  SEQ CHAPTER \h \r 1 Toxicity data are not available for terrestrial
plants; thus, risks associated with cypermethrin exposure to terrestrial
plants cannot be assessed.  However, based on the cypermethrin mode of
action, phytotoxicity is not expected.

Non-target Insects

  SEQ CHAPTER \h \r 1 Cypermethrin exposure can present acute toxic risk
to earthworms and to beneficial non-target insects, such as honey bees.
This risk concern is extended to listed insects also.

Benefits and Alternatives

Usage data are sparse and generally do not distinguish between chemicals
within the class.  The recent loss of chlorpyrifos and diazinon for
residential pest control has resulted in a greater reliance on
pyrethrins and synthetic pyrethroids, as a class, among residential
users.  Most pyrethroids have similar efficacy and cost.  In the absence
of any one pyrethroid, homeowners and professional applicators would
most likely simply substitute another pyrethroid insecticide.  Users
might also substitute insecticides from other chemical classes (e.g.
organophosphates, carbamates, and neonicotinoids) and nonchemical
control techniques (e.g. sanitation or exclusion).  Given the options
for substitution, economic impacts of restricting any one chemical would
not likely be significant.  The impact on risk of restricting any one
chemical is uncertain and might increase given the substitutes
available.

Risk Management

Human health risk

  SEQ CHAPTER \h \r 1 To address the handler risks of concern, the
following mitigation is required:

(1) All wettable powder products must be packaged in water soluble bags
including agricultural and residential (PCO/homeowner) products.
Alternatively, replacing wettable powder products with products
formulated as dry flowables would also reduce risks below the Agency’s
level of concern.

(2) Mixers/loaders/applicators using handheld equipment (all
formulations) must wear chemical resistant gloves, in addition to
baseline attire (long sleeved shirt, long pants, shoes and socks).

Ecological Risk

To address the ecological risks of concern, the following mitigation is
required:

For agricultural uses:

(1) Mitigation to address spray drift, including specifying minimum
allowable droplet size and buffer zones, maximum allowable wind speed
and release height on product labels.

(2) Decreased application rates and increased application intervals.

(3) A constructed and maintained vegetative buffer.

For non-agricultural uses (residential, commercial and industrial),
mitigation includes limiting outdoor applications to impervious surfaces
(such as sidewalks and driveways) to spot or crack and crevice
treatments, and adding best management practices to product labels to
reduce potential runoff to drains, sewers, or water bodies from outdoor
nuisance pest and termite applications.

Reregistration Eligibility

  SEQ CHAPTER \h \r 1 The Agency has determined that cypermethrin is
eligible for reregistration provided that the risk mitigation measures
outlined in this document are adopted and labels are amended
accordingly.  In addition, where there are data gaps, data must be
generated to confirm the reregistration eligibility decision documented
in this RED.  EPA will continue to work with cypermethrin and other
pyrethroid registrants to better characterize aquatic risk from urban
uses of the pyrethroids.  More data are needed to characterize
ecological risk, especially risk from urban uses. EPA will continue in
registration review to ensure the periodic review of all pesticides to
make sure they continue to meet current scientific and regulatory
requirements, with the goal of reviewing each pesticide every fifteen
years.  The pyethroids are tentatively scheduled for re-evaluation under
the proposed Registration Review program in 2010.

  SEQ CHAPTER \h \r 1  Introduction

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended in 1988 to accelerate the reregistration of products with active
ingredients registered prior to November 1, 1984.  The amended Act calls
for the development and submission of data to support the reregistration
of an active ingredient, as well as EPA review of all submitted data. 
Reregistration involves a thorough review of the scientific database
underlying a pesticide's registration.  The purpose of the Agency's
review is to reassess the potential risks arising from the currently
registered uses of the pesticide, to determine the need for additional
data on health and environmental effects, and to determine whether or
not the pesticide meets the "no unreasonable adverse effects" criteria
of FIFRA.

On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was
signed into law.  This Act amends FIFRA to require reassessment of all
tolerances in effect on the day before it was enacted.  In reassessing
these tolerances, the Agency must consider, among other things,
aggregate risks from non-occupational sources of pesticide exposure,
whether there is increased susceptibility among infants and children,
and the cumulative effects of pesticides that have a common mechanism of
toxicity.  When the Agency determines that aggregate risks are not of
concern and concludes that there is a reasonable certainty of no harm
from aggregate exposure, the tolerances are considered reassessed.  EPA
decided that, for those chemicals that have tolerances and are
undergoing reregistration, tolerance reassessment will be accomplished
through the reregistration process.

The Food Quality Protection Act (FQPA) requires that the Agency consider
available information concerning the cumulative effects of a particular
pesticide’s residues and other substances that have a common mechanism
of toxicity.  The reason for consideration of other substances is due to
the possibility that low-level exposures to multiple chemical substances
that cause a common toxic effect by a common toxic mechanism could lead
to the same adverse health effect as would a higher level of exposure to
any of the substances individually. Cypermethrin is a member of the
pyrethroid class of pesticides.  Although all pyrethroids alter nerve
function by modifying the normal biochemistry and physiology of nerve
membrane sodium channels, available data shows that there are multiple
types of sodium channels and that these compounds may act on different
isoforms of the sodium channel and with other ion channels in producing
their clinical signs.  It is currently unknown whether the pyrethroids
as a class have similar effects on all channels or whether modifications
of different types of sodium channels would have a cumulative effect. 
Nor do we have a clear understanding of effects on key downstream
neuronal function e.g., nerve excitability, or how these key events
interact to produce their compound specific patterns of neurotoxicity. 
Without such understanding, there is no basis to make a common mechanism
of toxicity finding.  Therefore, EPA is not currently following a
cumulative risk approach based on a common mechanism of toxicity for the
pyrethroids because the Agency has determined further study is needed
regarding the assumptions of dose additivity and common mechanism(s) of
toxicity to appropriately identify a group or subgroups for such an
assessment.  There is ongoing research by the EPA’s Office of Research
and Development and pyrethroid registrants to evaluate the differential
biochemical and physiological actions of pyrethroids in mammals.  The
Agency anticipates the majority of this research to be completed by
2007.  When available, the Agency will consider this research and make a
determination of common mechanism as a basis for assessing cumulative
risk.  For information regarding EPA’s procedures for cumulating
effects from substances found to have a common mechanism on EPA’s
website at     HYPERLINK "http://www.epa.gov/pesticides/cumulative/." 
http://www.epa.gov/pesticides/cumulative/.   

The Agency made its reregistration eligibility determination based on
the required data, the current guidelines for conducting acceptable
studies to generate such data, and published scientific literature.  The
Agency has found that currently registered uses of cypermethrin are
eligible for reregistration provided the mitigation and labeling
outlined in the RED are implemented.  The document consists of six
sections:  Section I, the introduction, contains the regulatory
framework for reregistration/tolerance reassessment; Section II provides
an overview of the chemical, including a profile of its use and usage;
Section III gives an overview of the human health and environmental
effects risk assessments; Section IV presents the Agency’s
reregistration eligibility, tolerance reassessment, and risk management
decisions; Section V summarizes label changes necessary to implement the
risk mitigation measures outlined in Section IV; and Section VI includes
the appendices, related supporting documents and Data Call-In (DCI)
information.  The revised risk assessment documents and related addenda
are not included in this document, but are available on the Agency’s
web page   HYPERLINK "http://www.epa.gov/pesticides" 
http://www.epa.gov/pesticides , and in the Public Docket at   HYPERLINK
"http://www.regulations.gov"  www.regulations.gov  under docket number
EPA-HQ-OPP-2005-0293.

Chemical Overview

Regulatory History

Cypermethrin was first conditionally registered in 1984 by FMC
Corporation, who also subsequently registered an isomer enriched
zeta-cypermethrin in 1992. Current technical registrants include FMC,
Syngenta, United Phosphorus International, and Valent BioSciences.  Data
for the two active ingredients is considered interchangeable. Since
zeta-cypermethrin was registered after 1984, only cypermethrin is
subject to reregistration.  Cypermethrin is on reregistration List B;
thus no Registration Standard was completed.  Data Call-ins (DCIs) for
cypermethrin were issued in 1991 for basic toxicology and residue
chemistry data, and in 1995 for handler exposure and worker re-entry
data.  

  SEQ CHAPTER \h \r 1 Cypermethrin is a synthetic pyrethroid
insecticide. On June 14, 1984, the Agency conditionally registered a
technical grade product and two end-use formulations each to ICI (now
known as Syngenta Crop Protection) and FMC for use on cotton during the
1984 growing season. The original conditional registration for
cypermethrin was subsequently renewed on January 9, 1985, and September
27, 1985.  A conditional registration for cypermethrin use on pecans was
issued on April 24, 1986. The conditional registration for use on
lettuce (head) was issued on March 15, 1988.

Cypermethrin is one of nine synthetic pyrethroids registered on cotton,
represented by the Pyrethroid Working Group (PWG), that are considered
to be conditionally registered pending the development and review of
data related to aquatic toxicity.  EPA will make every effort to
coordinate the implementation of its reregistration eligibility decision
provisions and labeling for cypermethrin with the ongoing efforts of the
PWG.

Due to the conditional status of the registration, tolerances were
established for cypermethrin on a temporary basis on cottonseed, pecans,
lettuce, meat, fat, and meat byproducts of hogs, horses, cattle, goats,
sheep, and milk to cover residues expected to be present from use during
the period of conditional registration.  On July 31, 1996, tolerances
were established for brassica (head and stem) and brassica (leafy).  The
conditional registrations for all cypermethrin uses were extended
several times to November 15, 1993, November 15, 1994, November 15,
1995, November 15, 1996 and November 15, 1997.  At the time of FQPA,
cypermethrin's tolerances had expiration dates of 11/15/97.  Agency
policy was such that no temporary or time-limited tolerances were to be
included among the official baseline number of tolerances which the
Agency had to reassess.  These tolerances were considered revoked with
an expiration date and were expected not to need tolerance reassessment,
nor need to be included in the tolerance reassessment baseline count.

 

On November 26, 1997, permanent tolerances were established for brassica
(head and stem), brassica (leafy), cattle (fat), cattle (mbyp), cattle
(meat), cottonseed, goats (fat), goats (mbyp), goats (meat), hogs (fat),
hogs (mbyp), hogs (meat), horses (fat), horses (mbyp), horses (meat),
lettuce (head), milk, onions (bulb), pecans, sheep (fat), sheep (mbyp),
and sheep (meat).  Such reassessments were not countable against the
Agency's baseline number since they had not been included within the
Agency's original tolerance reassessment baseline.  Upon cypermethrin
RED signature, no tolerance reassessments will be counted against the
Agency's baseline number, nor were any previously counted.

Chemical Identification

Cypermethrin has the following structure:

 

Physical/Chemical Properties  tc "Physical/Chemical Properties " \l 2 

Empirical Formula:	C22H19Cl2 NO3

Molecular Weight:	416.3

CAS Registry No.:	52315-07-8

PC Code:		109702

Melting Point: 	60-80 degree C

Boiling Point: 		216 degree C

Density: 		1.204 g/mL at 25C

Vapor Pressure: 	3.1E-9 mm Hg at 20 degree C

Water Solubility: 	7.6 ppb at 25 degree C

Log P (octanol-water): 6.60

Cypermethrin is a combination of 8 stereoisomers with percentage
compositions ranging from 11-14%, and very low volatility and water
solubility.    SEQ CHAPTER \h \r 1 Zeta-cypermethrin is an enriched
enantiomer of cypermethrin consisting of the 4 stereo isomers with an
“S” configuration at the cyano bearing carbon at 24% each, and 4
insecticidally less active stereo isomers at a concentration of 1% each.
 Since the analytical method does not distinguish cypermethrin from
zeta-cypermethrin, and the toxicological endpoints are the same, the
Agency’s human health risk assessment and environmental fate
assessment considered both cypermethrin and zeta-cypermethrin.  

Use Profiles

Type of Pesticide:		  SEQ CHAPTER \h \r 1 Insecticide

Summary of Use:	  SEQ CHAPTER \h \r 1 Cypermethrin   SEQ CHAPTER \h \r 1
is registered for agricultural use as a foliar application on food and
feed crops including cotton, pecans, peanuts, broccoli and other
Brassicas, and sweet corn.  Cypermethrin can be applied to livestock in
eartags, and to horses.  Cypermethrin is also registered for use on
industrial, commercial, and residential sites.  It is registered for
outdoor use as a soil residual termiticide and to control insect pests
such as ants in and on structures, impervious surfaces (in perimeter and
crack and crevice treatments) and lawns.  Cypermethrin can also be
applied indoors to control ants, cockroaches, fleas, and other insects.

Target Organisms:		Cypermethrin is registered for control of a wide
range of pests.

Mode of Action:		  SEQ CHAPTER \h \r 1 It is likely that the toxic
action of pyrethroids is primarily due to their blocking action on some
aspect of the synaptic function of the nerve axon.  

Tolerances:			  SEQ CHAPTER \h \r 1 There are 23 cypermethrin tolerances
established under 40 CFR §180.418(a)(1) for pecans, bulb onions,
cottonseed, head and stem brassica, green onions, head lettuce, leafy
brassica and for the milk, fat, meat, and meat byproducts of cattle,
goats, hogs, horses, and sheep.  

Use Classification:		Agricultural products are restricted use. 
Residential, commercial, and industrial products are general use (can be
purchased and applied by professional applicators or by residential
applicators).

Formulation Types:	  SEQ CHAPTER \h \r 1  	Cypermethrin is formulated as
an emulsifiable concentrate (EC), a soluble concentrate/liquid (SC/L),
and a wettable powder (WP).  Cypermethrin is compatible with a number of
insecticides and fungicides, and has been formulated in products with
two or more active ingredients. 

Application Methods: 		  SEQ CHAPTER \h \r 1 Applications to
agricultural crops can be made with aircraft, chemigation, groundboom,
and air blast equipment.  Applications at industrial, commercial, and
residential sites can be made using handheld equipment such as
low-pressure handwand sprayers, backpack sprayers, hose-end sprayers,
handgun sprayers, paintbrushes, and termiticide injectors, in addition
to ready-to-use (RTU) aerosol cans, indoor foggers, pump-trigger
sprayers, impregnated wipes and eartags.  

Application Rates:   		The currently labeled maximum application rates
for agricultural uses range from 0.4 lbs. a.i./acre to 3.4 lbs.
a.i./acre.  The minimum retreatment intervals range from 3-7 days and
the pre-harvest intervals (PHIs) range from 1 to 14 days. The maximum
application rate for non-agricultural uses is 0.44 lbs ai/acre, for
applications to lawns and turf.

Application Timing: 		Cypermethrin agricultural products can be applied
at various stages of crop development.

Usage of Cypermethrin:  	Total cypermethrin use is approximately 1.0
million pounds of active ingredient (a.i.) per year.  In agriculture, it
is used mainly on cotton (110,000 pounds a.i.) on about 13% of planted
acres.  Minor use is also found in several other crops including pecans
(6,000 pounds a.i.), peanuts, broccoli and sweet corn (1 to 2 thousand
pounds a.i each).  Treatment of cattle and other livestock accounts for
approximately 1,000 pounds a.i. per year.

The great majority of cypermethrin use occurs in non-agricultural sites.
 Indoor pest control (mainly for ants, cockroaches, and fleas) accounts
for about 110,000 pounds a.i., while outdoor use for subterranean
termites and other insect pests accounts for nearly 750,000 pounds a.i.
Of the non-agricultural use, approximately 300,000 pounds a.i. are
applied by residential applicators, and 550,000 pounds a.i. by
professional applicators.

Summary of Cypermethrin Risk Assessments

  SEQ CHAPTER \h \r 1 The purpose of this section is to highlight the
key features and findings of the risk assessments in order to help the
reader better understand the risk management decisions reached by the
Agency.  While the risk assessments and related addenda are not included
in this document, they are available in the OPP Public Docket 
http://www.regulations.gov.

Human Health Risk Assessment

The following is a summary of EPA’s human health findings and
conclusions for cypermethrin as presented fully in the document, “ 
SEQ CHAPTER \h \r 1 Cypermethrin:    SEQ CHAPTER \h \r 1 Phase 4 HED
Risk Assessment for the Reregistration Eligibility Decision (RED).  PC
Code 109702; DP Barcode D293416.  Dated   SEQ CHAPTER \h \r 1
06-APR-2006.

Toxicity

Technical grade cypermethrin has moderate acute toxicity via the dermal
and inhalation routes (Category III & IV), and is not a skin sensitizer.
 It is more toxic via the oral route (Category II).  

  SEQ CHAPTER \h \r 1 Table 1:  Acute Toxicity Profile 

Guideline No.	Study Type	MRID	Results	Toxicity Category

  SEQ CHAPTER \h \r 1 870.1000	  SEQ CHAPTER \h \r 1 Acute Oral - rat	 
SEQ CHAPTER \h \r 1 00056800	  SEQ CHAPTER \h \r 1 LD50 (M): 247 mg/kg
(F): 309 mg/kg females	II

870.1100	  SEQ CHAPTER \h \r 1 Acute Dermal

Rat

Rabbit	  SEQ CHAPTER \h \r 1 00056800

00056800	  SEQ CHAPTER \h \r 1 LD50 > 4920 mg/kg/day.  

 (not calculated but higher than )

LC50:  2.5 (1.6-3.4) mg/L.  	IV

870.2400	  SEQ CHAPTER \h \r 1 Primary Eye Irritation	  SEQ CHAPTER \h
\r 1 00056800	  SEQ CHAPTER \h \r 1 Slight redness of conjunctivae,
chemosis & discharge. Persisted to day 7.	III

870.2500	  SEQ CHAPTER \h \r 1 Primary Skin Irritation	  SEQ CHAPTER \h
\r 1 00056800	  SEQ CHAPTER \h \r 1 Slight to mild erythema on intact &
abraded skin. Reversed by 48 hours. Primary Irritation Index: 0.71	IV

870.2600	  SEQ CHAPTER \h \r 1 Dermal Sensitization	  SEQ CHAPTER \h \r
1 00056800  40377701	  SEQ CHAPTER \h \r 1 Not a sensitizer in Buehler
assay.  Moderate sensitizer in  Magnusson Kligman Maximization method.  
N/A

  SEQ CHAPTER \h \r 1 The toxicology database for cypermethrin is
complete and there are no data gaps.  The scientific quality is
relatively high and the toxicity profile of cypermethrin can be
characterized for all effects, including potential developmental,
reproductive and neurotoxic effects.  The data provided no indication of
increased susceptibility of rats or rabbits to in utero and/or postnatal
exposure.

Developmental and Reproductive Toxicity

Cypermethrin is not a developmental or reproductive toxicant.    SEQ
CHAPTER \h \r 1 In prenatal developmental toxicity studies in rats and
rabbits, there was no evidence of developmental toxicity at the highest
dose tested.  In multi-generation reproduction studies in rats,
offspring toxicity was observed at the same treatment level which
resulted in parental systemic toxicity.  There did not appear to be any
increase in the severity of toxicity for the pups.

	

Neurotoxicity 

  SEQ CHAPTER \h \r 1 Cypermethrin is a known neurotoxicant.  It is a
member of the pyrethroid class of insecticides, which are known to
induce clinical signs of neurotoxicity in mammals, but do not generally
induce neuropathologic lesions.  For cypermethrin, neuromuscular effects
(i.e. gait abnormalities, tremors, reduced motor activity, changes in
FOB parameters and convulsions) occurred across species, sexes and
routes of administration.  These clinical signs occurred following an
acute exposure and appeared to be transient in nature. Effects occurred
mainly in oral studies in the dog and the rat, but similar signs were
also observed in an inhalation study.  Effects were not observed in
dermal studies in either rats (zeta-cypermethrin) or rabbits
(cypermethrin: nonabraded animals; abraded animals did exhibit decreases
in activity).

Toxicological Endpoints

	Table 2 contains endpoints selected for the dietary and residential
assessments.  

  SEQ CHAPTER \h \r 1 				

Table 2:  Summary of Toxicological Doses and Endpoints for Use in Human
Risk Assessments

Exposure

Scenario	Dose Used in Risk Assessment, UF 	FQPA SF and Level of Concern
for Risk Assessment	Study and Toxicological Effects

Acute Dietary

general population including infants and children	NOAEL = 10 mg/kg/day

UF = 100

Acute RfD = 0.1 mg/kg/day

	FQPA SF = 1 

aPAD = acute RfD

              FQPA SF

= 0.1 mg/kg/day	MRID 44962201: Acute neurotoxicity study in the rat with
zeta-cypermethrin.  LOAEL = 50 mg/kg/day based on clinical signs of
neurotoxicity and changes in the FOB.

Chronic Dietary

all populations	NOAEL= 6 mg/kg/day

UF = 100

Chronic RfD = 0.06 mg/kg/day	FQPA SF = 1

cPAD =  

chronic RfD

 FQPA SF

= 0.06 mg/kg/day	MRID 44536801: Chronic feeding study in the dog.  LOAEL
= 20.4 mg/kg/day based on clinical signs of neurotoxicity and mortality
in males, and 18.1 mg/kg/day based on decreased body weights and body
weight gains in females.

Short-Term Incidental Oral (1 to 30 days)	NOAEL= 

10 mg/kg/day	Residential LOC for MOE = 100

Occupational LOC for MOE = N/A	MRID 44962201: Acute neurotoxicity study
in the rat with zeta-cypermethrin.  LOAEL = 50 mg/kg/day based on 
clinical signs of neurotoxicity and changes in the FOB

Intermediate-Term

Incidental Oral (1 - 6 months)	NOAEL= 5.0 mg/kg/day	Residential LOC for
MOE = 100

Occupational LOC for MOE = N/A	MRID 44962202: Subchronic neurotoxicity
study in the rat with zeta-cypermethrin.  LOAEL = 26.3 mg/kg/day based
on decreased motor activity, increased landing foot splay, and decreased
body weights, body weight gains, and food consumption

Short- and Intermediate-Term Dermal (1 day to 6 months	None	Residential
LOC for MOE = N/A 

Occupational LOC for MOE = N/A 	MRID 45010401: No systemic effects in
21-day dermal study with zeta-cypermethrin up to 1000 mg/kg/day and no
developmental concern.  No hazard identified to support quantification
of risk.

Long-Term Dermal (> 6 months)	Oral NOAEL=  0.6 mg/kg/day 

(dermal absorption factor = 2.5%)	Occupational LOC for MOE = 100	MRID
44536801: Chronic feeding study in the dog.  LOAEL = 20.4 mg/kg/day
based on clinical signs of neurotoxicity and mortality in males, and
18.1 mg/kg/day based on decreased body weights and body weight gains in
females.

Short- and Intermediate-Term Inhalation (1 day to 6 months)	Inhalation
NOAEL= 0.01 mg a.i./L/day (2.7 mg/kg/day)	Residential LOC for MOE =

100

Occupational LOC for MOE = 100	MRID 43507101: 21-day inhalation study in
the rat.  LOAEL = 0.05 mg/L/day (13.5 mg/kg/day) based on decrease in
body weight and salivation.

Long-Term Inhalation (> 6 months)	Inhalation NOAEL= 0.01 mg a.i./L (2.7
mg/kg/day)	Occupational LOC for MOE = 300 for the lack of long-term
study.  Route-to-route estimation would result in less protective
endpoint.	MRID 43507101: 21-day inhalation study in the rat.  LOAEL =
0.05 mg/L/day (13.5 mg/kg/day) based on decrease in body weight and
salivation.

Cancer (oral, dermal, inhalation)	Classification: Category C (possible
human carcinogen).  No quantification required.

UF = uncertainty factor, FQPA SF = FQPA safety factor, NOAEL = no
observed adverse effect level, LOAEL = lowest observed adverse effect
level, PAD = population adjusted dose (a = acute, c= chronic), RfD =
reference dose, MOE = margin of exposure, LOC = level of concern, N/A =
not applicable.

FQPA Safety Factor

During the Agency’s phase 3 reregistration process, an FQPA safety
factor of 10x was retained due to database uncertainty (the lack of DNT
study).  The DNT study has now been submitted, reviewed, and found to be
acceptable. The Agency has   SEQ CHAPTER \h \r 1 determined that the
FQPA safety factor should be reduced to 1X, since there are no residual
uncertainties for pre- and/or post-natal toxicity.  In addition, EPA has
concluded that there is no need to change any previously-selected
endpoints based on the submitted DNT, and that and   SEQ CHAPTER \h \r 1
the dietary (food and drinking water) and non-dietary exposure
assessments are protective of potential exposures to infants and
children.

Dermal Absorption

  SEQ CHAPTER \h \r 1 A dermal absorption value of 2.5% has been
estimated by comparing the maternal LOAEL of 25 mg/kg/day from the
developmental study in the rat and the NOAEL (highest dose tested) of
1000 mg/kg/day from the 21-day dermal study in the rat (both conducted
with zeta-cypermethrin).  Since there was no common endpoint because no
systemic effects were observed in the 21-day dermal study in the rat,
this is considered to be a worst-case estimate.

Dietary Exposure

Acute Dietary Exposure (food only)

  SEQ CHAPTER \h \r 1    SEQ CHAPTER \h \r 1 Zeta-cypermethrin is an
S-enantiomer enriched formulation of cypermethrin.  Since the analytical
method does not distinguish cypermethrin from zeta-cypermethrin, and the
toxicological endpoints are the same, the dietary and non-dietary
(residential) aggregate risk assessment included potential exposures
from both chemicals.    SEQ CHAPTER \h \r 1 The residue of concern for
tolerance enforcement and risk assessment is the parent compound
(cypermethrin) only.    SEQ CHAPTER \h \r 1 EPA performed a refined
(probabilistic) acute dietary assessment using PDP data, percent crop
treated information, and processing factors where appropriate.  The
assessment was conducted using the Dietary Exposure Evaluation Model
software with the Food Commodity Intake Database (DEEM-FCID™, Version
1.3), which incorporates consumption data from USDA’s Continuing
Surveys of Food Intakes by Individuals (CSFII), 1994-1996 and 1998.  

Dietary risk assessment incorporates both exposure to and toxicity of a
given pesticide.  Dietary risk is expressed as a percentage of a level
of concern.  The level of concern is the dose predicted to result in no
unreasonable adverse health effects to any human population subgroup,
including sensitive members of such population subgroups.  This level of
concern is referred to as the population adjusted dose (PAD), which
reflects the reference dose (RfD), either acute or chronic, adjusted to
account for the FQPA safety factor.

Estimated risks that are less than 100% of the PAD are below EPA’s
level of concern.  The acute PAD (aPAD) is the highest predicted dose to
which a person could be exposed on any given day with no adverse health
effects expected.  For cypermethrin, the   SEQ CHAPTER \h \r 1 acute
risk estimates are below the Agency’s level of concern (100% of the
aPAD) for the general U.S. population and all population subgroups.  The
most highly exposed population subgroup was children 1-2 years old at
6.1% of the aPAD at the 99.9th percentile of exposure. 

Chronic Dietary Exposure (food only)

  SEQ CHAPTER \h \r 1 

onducted using DEEM-FCID™, Version 1.3.  The chronic PAD (cPAD) is the
highest predicted dose to which a person could be exposed over the
course of a lifetime with no adverse health effects expected.  Chronic
risk estimates for cypermethrin are below the Agency’s level of
concern (100% of the cPAD) for the general U.S. population and all
population subgroups. The most highly exposed population subgroup was
children 1-2 years old at 0.2% of the cPAD. 

  SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1 

Drinking Water Exposure

(For a complete discussion, see the “  SEQ CHAPTER \h \r 1 Tier II
Estimated Environmental Concentrations of Cypermethrin for the Use in
the Human Health Risk Assessment” dated 05/02/2005, and the “  SEQ
CHAPTER \h \r 1 Water Exposure/Risk, section 4.3 of the HED Chapter.)

  SEQ CHAPTER \h \r 1 Based on the available data,
cypermethrin/zeta-cypermethrin is a moderately persistent chemical that
primarily degrades by photolysis in water and biodegradation. 
Cypermethrin is hydrologically stable at neutral pH.    SEQ CHAPTER \h
\r 1 Cypermethrin is more light stable than the first or second
generation pyrethroids like allethrin and resmethrin, but still
undergoes photolysis in water, with half-lives of about a month or more
in distilled water.  The rate of photolysis appears to be enhanced in
natural waters (which contain photosensitizing agents like humic and
fulvic acids), where it degrades with half-lives of a few days.  It
binds tightly to soil particles and is not likely to move to
groundwater.  The Agency has determined that the residue of
toxicological concern to be included in drinking water assessment is the
parent compound only.

The Estimated Drinking Water Concentrations (EDWCs)ervoir, cotton, not
brassicas?] te risks from food and drinking water  for cypermethrin were
estimated   SEQ CHAPTER \h \r 1 using PRZM/EXAMS, based on modeling six
aerial applications to cotton in North Carolina at the maximum
application rate of 0.1 lbs a.i./A (for a yearly maximum of 0.6 lb
a.i./A).   SEQ CHAPTER \h \r 1 According to the label, the maximum
application rate is 0.6 lb a.i./A per season, so for certain crops like
lettuce which have several growing seasons in one year, exposures could
be higher.  The exposure scenarios modeled assumed only one season per
year.  The estimated acute drinking water concentration in surface water
is 1.04 ppb, and the estimated chronic drinking water concentration in
surface water is 0.013 ppb (this value represents the mean over a
30-year period).  Various other scenarios were also assessed (CA, MS and
TX cotton, CA onion, and CA lettuce), but they consistently yielded
lower EDWCs. The SCI-GROW model generated an EDWC for groundwater based
on a maximum application rate for cypermethrin of six applications of
0.1 lbs a.i./A (this rate is representative of both cotton and lettuce).
The groundwater EDWC for both acute and chronic exposures is 0.0036 ppb.

Residential Exposure and Risk

(For a complete discussion see, “  SEQ CHAPTER \h \r 1   SEQ CHAPTER
\h \r 1 Cypermethrin and Zeta-Cypermethrin: Revised Occupational and
Residential Exposure Assessment for the Reregistration Eligibility
Decision Document”, dated April 5  SEQ CHAPTER \h \r 1 , 2006, DP
barcode   SEQ CHAPTER \h \r 1 D293417).

The general public can be exposed to cypermethrin when applying the
pesticide for indoor and outdoor residential pest control, or subsequent
to applications made by residential applicators or professional
applicators.  Non-cancer risk estimates are expressed as a margin of
exposure (MOE) which is a ratio of the dose from a toxicological study
selected for risk assessment, typically a NOAEL, to the predicted
exposure.  Estimated MOEs are compared to a level of concern which
reflects the dose selected for risk assessment and uncertainty factors
(UFs) applied to that dose.  The standard UF is 100x which includes 10x
for interspecies extrapolation (to account for differences between
laboratory animals and humans) and 10x for intraspecies variation (to
account for differences between humans).  Additional uncertainty or
safety factors may also be applied.  In the case of cypermethrin,
EPA’s level of concern is an MOE of 100.

Residential Handler Risk

No short-term dermal exposures or risks were assessed for cypermethrin,
since no dermal endpoints of concern were identified.  EPA does not
anticipate that residential handlers would have intermediate- or
long-term exposures to cypermethrin or zeta-cypermethrin.  Therefore, no
intermediate- or long-term risks were assessed.

EPA did assess short-term inhalation exposures and risks to residential
handlers, for the following scenarios:

Mixing/Loading/Applying Liquid concentrates with Low Pressure Handwand

Mixing/Loading/Applying Liquid concentrates with Wipes

Applying Ready to Use Formulations with a Pump Sprayer (PHED aerosol can
data)

Applying  Ready to Use Formulations with Aerosol Cans

Applying  Ready to Use Formulations with Fogger

Applying  Ready to Use Formulations with Wipes

Residential inhalation risks are below EPA’s level of concern (i.e.,
MOE > 100) for all non-occupational handler scenarios. All MOEs were
greater than 16,000 which is below the Agency’s level of concern. 

  SEQ CHAPTER \h \r 1 A granular product was registered on February 23,
2006 (EPA registration # 28293-367).  This product is for application to
fire ant mounds on lawns and outside of homes.  Similar products are
registered for liquid zeta-cypermethrin and for liquid and wettable
powder cypermethrin formulations.  Due to lack of formulation-specific
exposure data, no quantitative risk assessment could be conducted for
the cypermethrin granular formulation.  However, the Agency believes
that the risk to residential handlers from exposure to this product will
not exceed that for liquid products, which is below the EPA’s level of
concern.

Residential Post-application Risk

on-dietary post-application exposure to adults was assessed via the
inhalation route only. Exposure to toddlers was assessed via the
inhalation route, and via incidental oral exposure.  All of these
exposures are considered short term.  Although cypermethrin can be used
indoor as termiticide use, long term exposure due to inhalation is
considered negligible, since the vapor pressure for cypermethrin is
extremely low.  In general, post-application inhalation risks following
outdoor applications are considered negligible as well.

Post-application inhalation risks following indoor fogger applications
were assessed using time-weighted averages from a cyfluthrin room fogger
air monitoring study.  Post-application inhalation risks following
indoor aerosol spray applications to carpets were assessed using air
concentration estimates from the crack and crevice subset of PHED, and
using a House Model to estimate an emission rate. 

Inhalation risks to both adults and toddlers were below the Agency’s
level of concern (i.e., MOE > 100). All indoor inhalation MOEs for
toddlers and adults were greater than 71,000 which is below the
Agency’s level of concern.

Post-application risks to toddlers from incidental oral ingestion were
assessed using a short-term incidental oral endpoint (10 mg/kg/day). 
Incidental oral exposure to toddlers was assessed for the following
scenarios: 

Hand to mouth activity on turf

Object to mouth activity on turf

Incidental soil ingestion

Hand to mouth activity from indoor surfaces following crack & crevice
treatments

Hand to mouth activity from indoor surfaces following broadcast fogger
treatments

The results indicate that risks from short-term incidental oral
exposures were below EPA’s level of concern for all indoor and outdoor
scenarios, all MOEs were greater than 900.

Aggregate Exposure and Risk (food, drinking water, and residential)

  SEQ CHAPTER \h \r 1 In accordance with FQPA, the Agency must consider
pesticide exposures and risks from all potential sources.  These usually
include food, drinking water, and residential exposures.  In an
aggregate assessment, exposures from relevant sources are added together
and compared to quantitative estimates of hazard (e.g., a NOAEL or PAD),
or the risks themselves can be aggregated.  When aggregating exposures
and risks from various sources, the Agency considers both the route and
duration of exposure.    SEQ CHAPTER \h \r 1 Aggregate risk assessments
for cypermethrin were conducted as follows: acute and chronic aggregate
assessments were conducted based on food and water exposures, and
short-term aggregate assessments were conducted based on food, water,
and residential exposures.  No intermediate- or long-term aggregate risk
assessments were conducted because no intermediate- or long-term
exposure scenarios are expected from residential uses of cypermethrin.

Acute Aggregate Risk (food and drinking water)

In order to calculate aggregate risk from exposure to cypermethrin
residues in food and drinking water, EPA compared estimated cypermethrin
concentrations in surface and groundwater (the EDWCs presented in
section III.A.4.) with Drinking Water Levels of Comparison (DWLOCs). A
DWLOC is the portion of the PAD remaining after estimated dietary (food
only) exposures have been subtracted, and the remaining exposure has
been converted to a concentration in ppb. This concentration value, or
DWLOC, represents the potential drinking water exposure that would still
fall below EPA’s level of concern.  As long as the maximum EDWCs for
surface and ground water are less than the DWLOC, aggregate risks from
food and drinking water exposures are below EPA’s level of concern.

In the case of cypermethrin,   SEQ CHAPTER \h \r 1 the lowest acute
DWLOC of 940 ppb for children 1-2 years old is much higher than the peak
EDWC of 1.04 ppb in surface water and 0.0036 ppb for ground water;
therefore, acute aggregate risk estimates associated with exposure to
cypermethrin residues in food and water do not exceed the Agency’s
level of concern.

Short-term Aggregate Risk (food, drinking water, and residential)

Short-term aggregate exposure takes into account residential exposure
plus average exposure levels to food and water (considered to be a
background exposure level).  Cypermethrin   residential uses constitute
short-term exposure scenarios; endpoints have been selected for
short-term incidental oral and inhalation exposures, and the acceptable
MOE for all short-term exposures is 100.  Since the toxicological
effects through the inhalation exposure route are similar to the
toxicological effects from oral exposures, the short-term aggregate risk
assessment was conducted by adding the residential inhalation exposure,
oral non-dietary exposure, and average food and water exposure.  The
incidental oral residential exposure value selected for the aggregate
analysis was based on hand to mouth activity from indoor surfaces
following crack and crevice treatment, as this scenario resulted in the
highest calculated exposure level, and is therefore considered
protective for all other exposure scenarios.  

						

  SEQ CHAPTER \h \r 1 Short-term aggregate risk does not exceed
Agency’s level of concern for any population subgroup.  The lowest
DWLOC value of 890 ppb was calculated for children 1-2 years old and
this level is higher than the surface and ground water EDWCs of 0.013
and 0.0036 ppb, respectively.  

Chronic Aggregate Risk (food and drinking water)

Although cypermethrin can be used indoors as a termiticide, long term
inhalation exposure is not expected due to its very low vapour pressure
(3.1E-9 mm Hg at 20 0C).  Therefore, the   SEQ CHAPTER \h \r 1 chronic
aggregate assessment only includes food and water.  Chronic dietary
estimates of exposure from food were taken from the dietary exposure
model results described above.  The calculated DWLOCs for children 1-2
years old has the lowest chronic DWLOC value of 600 ppb, which is
greater than both the surface water (0.013 ppb) and ground water (0.0036
ppb) EDWCs; therefore, chronic aggregate risk estimates do not exceed
the Agency’s level of concern.

  SEQ CHAPTER \h \r 1 Occupational Exposure and Risk

For a complete discussion, see section 7.0 of the “  SEQ CHAPTER \h \r
1 Cypermethrin:  Phase 4 HED Risk Assessment for the Reregistration
Eligibility Decision (RED).  PC Code 109702; DP Barcode D293416”,
dated April 6, 2006.  Also, see “  SEQ CHAPTER \h \r 1   SEQ CHAPTER
\h \r 1 Cypermethrin and Zeta-Cypermethrin: Revised Occupational and
Residential Exposure Assessment for the Reregistration Eligibility
Decision Document”, dated April 5  SEQ CHAPTER \h \r 1 , 2006, DP
barcode   SEQ CHAPTER \h \r 1 D293417.  Although the occupational risk
assessment included zeta-cypermethrin, only cypermethrin occupational
assessment results are discussed here, since this reregistration
decision applies only to cypermethrin products.

	

Workers can be exposed to cypermethrin through mixing, loading, and
applying the pesticide for use on agricultural crops and livestock, and
for use in indoor and outdoor industrial, commercial, and residential
settings. 

- - if this is not the case,

  SEQ CHAPTER \h \r 1 Occupational Handler Risk

Short- and intermediate-term dermal risks were not assessed for
occupational handlers, since no short- or intermediate-term dermal
endpoints were identified.  Short and intermediate-term inhalation risks
to handlers when mixing, loading, and applying cypermethrin products
were assessed for the following agricultural and non-agricultural
scenarios:

Mixing and loading liquid and wettable powder formulations to support
aerial, chemigation, groundboom, and airblast applications to
agricultural crops

Applying sprays with aerial, groundboom, or airblast equipment to
agricultural crops

Flagging to support aerial applications

Mixing, loading, and applying liquid formulations using a low pressure
handwand sprayer, a paint brush, a low pressure/high volume turf/handgun
sprayer, or a termiticide injector

Mixing, loading, and applying wettable powder formulations using a low
pressure handwand sprayer, a paint brush, or a low pressure/high volume
turf/handgun sprayer

Mixing, loading, and applying wettable powder formulations packaged in
water soluble bags using a low pressure/high volume turf/handgun sprayer

Applying Ready-to-Use eartags, trigger pump sprayers, wipes, aerosol
cans, or foggers

When data were available to assess risks, short- and intermediate-term
inhalation risks to occupational handlers are below the Agency’s level
of concern (i.e., MOE >100) at baseline (long sleeved shirt, long pants,
shoes and socks) for all formulations except the wettable powder. For  
SEQ CHAPTER \h \r 1 handlers mixing and loading to support aerial
applications to cotton (a high acreage crop), sodfarms, and agricultural
uncultivated areas, fencerows and hedgerows, MOEs at baseline range from
4 to 37.  The addition of engineering controls (packaging wettable
powders in water soluble bags) reduces the risks to below EPA’s level
of concern for all scenarios.  EPA has insufficient data to assess
exposures to pilots in open cockpits. Inhalation risks to pilots in
enclosed cockpits were below EPA’s level of concern for all
agricultural crop scenarios.  No data are available to assess inhalation
risks during the application of impregnated eartags; however, the risks
are expected to be well below the inhalation risks (MOE=15,000) from
applications using a ready-to-use aerosol can (considered to represent a
worst case exposure scenario).

A few occupational handler exposure scenarios may be considered
long-term, including applications to residential, commercial, and
industrial turf by commercial lawn care operators and applications in
and around residential, commercial, and industrial premises by
commercial pest control operators.  Since the toxicological endpoints of
concern for long-term exposures are based on similar adverse effects,
long-term dermal and inhalation risks must be combined  for occupational
scenarios where long-term exposures are anticipated. The target MOEs for
long-term occupational workers are 100 for dermal risk and 300
inhalation risk.  Since these MOEs differ, an aggregate risk index (ARI)
was used to assess combined long-term dermal and inhalation risks to
handlers.  The target ARI is 1; therefore, ARIs of less than 1 indicate
potential risks of concern.

Long-term combined dermal and inhalation risks were assessed for the
following scenarios:

Mixing, loading, and applying liquid and wettable powder formulations
using a low pressure handwand sprayer, a paint brush, or a low
pressure/high volume turf/handgun sprayer

Mixing, loading, and applying wettable powder formulations packaged in
water soluble bags using a low pressure/high volume turf/handgun sprayer

Combined long-term dermal and inhalation risks are below EPA’s level
of concern for all scenarios involving liquid formulations at baseline
attire or with the addition of chemical-resistant gloves to baseline
attire.  Combined long-term dermal and inhalation risks are below
EPA’s level of concern for all scenarios involving wettable powder
formulations at baseline attire or with the addition of
chemical-resistant gloves to baseline attire, except
mixing/loading/applying wettable powders with a low-pressure handwand
sprayer. Although data were not available to estimate the risks from
mixing/loading and applying wettable powders packaged in water soluble
bags with a low-pressure handwand sprayer, the risks are expected to be
lower than for liquid products (below EPA’s level of concern with the
addition of chemical-resistant gloves to baseline attire).  A similar
reduction in risk would be expected if wettable powder products were
reformulated into dry flowable formulations.

b.	  SEQ CHAPTER \h \r 1 Occupational Post-application Risk

 

EPA did not assess occupational postapplication risks to agricultural
workers following treatments to agricultural crops, since no short- or
intermediate-term dermal endpoints of concern were identified and
long-term dermal exposures are not expected for tasks involving any of
the registered crop use patterns.

EPA did not assess occupational postapplication exposures and risks
following applications of cypermethrin and zeta-cypermethrin to
residential and commercial lawns, and in and around industrial,
commercial, and residential premises, since no short- or
intermediate-term dermal endpoints of concern were identified and
long-term exposures are not expected for tasks involving any of the
registered use patterns.

Human Incident Data

(For a complete discussion, see “  SEQ CHAPTER \h \r 1   SEQ CHAPTER
\h \r 1 Review of Cypermethrin Incident Reports.  DP Barcode D293143,
Chemical #109702”, dated 08/26/2003.)

  SEQ CHAPTER \h \r 1 Pyrethroids, like cypermethrin, have relatively
low toxicity to humans. Skin and eye irritation, nausea, vomiting,
coughing and difficulty breathing were the most commonly reported
symptoms. As with other pyrethroids, burning or tingling sensations are
often reported by applicators (World Health Organization 1989). The
occurrence of moderate and more serious symptoms was generally more
prevalent among those exposed to cypermethrin than those exposed to
other pesticides. Reports suggest that cypermethrin can cause asthma or
asthma-like symptoms in susceptible individuals. See Section IV for
further discussion of incidents and mitigation.

  SEQ CHAPTER \h \r 1 Environmental Risk Assessment

More detailed information can be found in the “  SEQ CHAPTER \h \r 1
Revised EFED Risk Assessment for the Reregistration Eligibility Decision
(RED) on Cypermethrin After 30-Day “Error Only” Comment Period”,  
SEQ CHAPTER \h \r 1 DP Barcode: D293412, dated   SEQ CHAPTER \h \r 1
October 25, 2005 and the “Addendum to the EFED RED Chapter for
Cypermethrin”, DP Barcode D293413, dated June 9, 2006.

The majority of cypermethrin use occurs in non-agricultural sites. 
Non-agricultural applications of cypermethrin, such as perimeter
treatments around buildings and applications to lawns, may result in
exposure to aquatic organisms from surface runoff and/or erosion.  Even
though cypermethrin has a strong affinity to bind to soils and surfaces,
residues at concentrations toxic to aquatic organisms have been measured
in streams that receive runoff from suburban developments.  A study
recently conducted in an urban area of California found residues of
cypermethrin and other pyrethroids in urban streams adjacent to
residential areas and suggested that these areas are unlikely to be
unique, particularly in dry regions where landscape irrigation can
dominate seasonal flow in some water bodies.  The Agency recognizes the
potential for aquatic toxicity from non-agricultural uses. However, EPA
was not able to assess the risks associated with urban runoff due to
limited monitoring data and lack of acceptable models.  The Agency’s
future plans to assess non-agricultural uses of cypermethrin and other
pyrethroids are discussed in Section IV.

The Agency’s Tier I screening-level (deterministic) risk assessment is
focused on registered agricultural uses only.  A summary of the
Agency’s environmental fate assessment is presented below.  

Environmental Fate and Transport

For the most part,   SEQ CHAPTER \h \r 1 the environmental fate data for
cypermethrin were from studies on cypermethrin; however, some studies
were conducted on zeta-cypermethrin as well as other isomers.  Both
cypermethrin and zeta-cypermethrin are expected to have similar fate in
the environment.  

  SEQ CHAPTER \h \r 1 Cypermethrin is expected to bind strongly to
organic carbon and have little mobility in soil (KOC values ranged from
20,800 to 385,000 L/kg), and therefore it is not likely to leach into
groundwater.    SEQ CHAPTER \h \r 1 Due to its relatively low mobility,
cypermethrin is most likely to reach adjacent bodies of water via spray
drift, through runoff events accompanied by soil erosion, or in runoff
from outdoor impervious surfaces.  Cypermethrin is moderately persistent
in the environment and degrades through a combination of biotic and
abiotic mechanisms.  In soil,   SEQ CHAPTER \h \r 1 under both aerobic
and anaerobic conditions, cypermethrin biodegrades relatively slowly,
with half-lives on the order of about 2 months.  In contrast,
degradation is enhanced in water, with aerobic and anaerobic metabolism
half-lives of 9 to 17 days.  If released to surface water, cypermethrin
partitions to sediment, where it may degrade more slowly.  In
terrestrial field dissipation studies, cypermethrin did not appear to
persist in soil, where the major routes of degradation are photolysis
and aerobic biodegradation. Degradation of cypermethrin through
photolysis appears to be enhanced in natural waters which contain humic
and fulvic acids.   SEQ CHAPTER \h \r 1 However, field studies conducted
on rice (with zeta-cypermethrin) show high persistence in aquatic
sediments.  If cypermethrin is applied repeatedly, it is possible that
the chemical can accumulate in the sediment in ever larger amounts, with
slow biodegradation. Cypermethrin bioaccumulates moderately (488x) in
fish.

Ecological Risk

  SEQ CHAPTER \h \r 1 The Agency’s ecological risk assessment compares
toxicity endpoints from ecological toxicity studies to estimated
environmental concentrations (EECs) based on environmental fate
characteristics and pesticide use data.  To evaluate the potential risk
to non-target organisms from the use of cypermethrin products, the
Agency calculates a Risk Quotient (RQ), which is the ratio of the EEC to
the most sensitive toxicity endpoint values, such as the median lethal
dose (LD50) or the median lethal concentration (LC50).  These RQ values
are then compared to the Agency’s levels of concern (LOCs), which
indicate whether a pesticide, when used as directed, has the potential
to cause adverse effects to non-target organisms.  When the RQ exceeds
the LOC for a particular category, the Agency presumes a risk of
concern.  These risks of concern may be addressed by further refinements
of the risk assessment or mitigation measures.  Use, toxicity, fate, and
exposure are considered when characterizing the risk, as well as the
levels of uncertainty in the assessment.  EPA further characterizes
ecological risk based on any reported incidents to non-target
terrestrial or aquatic organisms in the field (e.g., fish or bird
kills).

  SEQ CHAPTER \h \r 1 Table 3.  EPA’s Levels of Concern and Associated
Risk Presumptions

Risk Presumption	LOC

Terrestrial Animals	LOC 

Aquatic Animals	LOC Plants

Acute Risk - there is potential for acute risk	0.5	0.5	1

Acute Endangered Species - endangered species may be adversely affected
0.1	0.05	1

Chronic Risk - there is potential for chronic risk	1	1	N/A

Risk to Aquatic Organisms

Fish and Invertebrate Toxicity

The   SEQ CHAPTER \h \r 1 results of acute toxicity studies in fish,
invertebrates, and benthic organisms show that technical grade
cypermethrin is very highly toxic on an acute basis.  For freshwater
fish and estuarine/marine fish, the lowest toxicity values reported were
an LC50 of 0.39 µg a.i./L  (rainbow trout), and an LC50 of 0.95 µg
a.i./L (sheepshead minnow), indicating that these organisms all have a
similar susceptibility to cypermethrin. For freshwater invertebrates the
lowest toxicity values reported were an LC50 of 0.0036 µg a.i./L
(waterflea) and for estuarine/marine invertebrates an LC50 of 0.00475
µg ai/L (mysid shrimp), approximately 100 times lower than the toxicity
values reported for fish. These results indicate that freshwater and
estuarine/marine invertebrates are substantially more sensitive than
other types of aquatic organisms to cypermethrin toxicity, and that they
are expected to be at greatest risk for acute effects (death). 

  SEQ CHAPTER \h \r 1 The available experimental LC50 value for benthic
amphipods is expressed in terms of sediment concentration of
cypermethrin (LC50 = 3.6 µg a.i./kg sediment).  To assess risk to
benthic organisms in terms of pore water, a surrogate benthic organism
LC50 value for pore water (0.00257 µg a.i./L pore water) was derived
using the sediment LC50 value and the average Koc value (141,700) for
cypermethrin.  In oysters, cypermethrin is categorized as highly toxic
(370 µg a.i./L).

g of active ingredient/L) for Aquatic Organisms " \f D  .

Exposure Scenario	Species 	Exposure Duration	Toxicity Reference Value
(µg a.i./L)	Effects	Reference

Freshwater Fish	rainbow trout	96 hours	LC50 = 0.39 µg a.i./L	Morbidity
MRID 44546027

Freshwater Invertebrates	amiphod	48 hours	LC50 = 0.0036 µg a.i./L
Morbidity	MRID 44423501

Benthic Organisms	amphipod	10 days	sediment value (experimental data): 

LC50 = 3.6 µg a.i./kg sediment

pore water value (derived data):

LC50 =  0.00257 µg a.i./L pore water	Morbidity and Growth	MRID 44074406

Estuarine/

Marine Fish	sheepshead minnow	96 hours	LC50 = 0.95 µg a.i./L	Morbidity
MRID 90075

Estuarine/

Marine Invertebrates	mysid shrimp	96 hours   	LC50 = 0.00475 µg a.i./L
Morbidity	Acc. No. 42444601

  SEQ CHAPTER \h \r 1 Chronic toxicity studies are available for
freshwater fish and estuarine/marine invertebrates.  Results in
freshwater fish show that neonate survival is adversely affected by
cypermethrin exposure (NOAEC = 0.14 µg a.i./L). For estuarine/marine
invertebrates, chronic exposure to cypermethrin produced adverse effects
on reproductive (NOAEC = 0.0015 µg a.i./L) and growth parameters (NOAEC
= 0.000781 µg a.i./L).

Table 5.  Cypermethrin (Technical Grade) Chronic Toxicity Reference
Values for Aquatic Organisms tc "Table 12.  Cypermethrin Toxicity
Reference Values (TRVs) (g of active ingredient/L) for Aquatic
Organisms " \f D  .

Exposure Scenario	Species 	Exposure Duration	Toxicity Reference Value
(µg a.i./L)	Effects	Reference

Freshwater Fish	fathead minnow	30 days	NOAEC = 0.14 µg a.i./L

LOAEC = 0.33 µg ai/L	Growth and morbidity	MRID 89039

Freshwater Invertebrates	No adequate data submitted; to assess chronic
risk to freshwater invertebrates,  surrogate NOAEC value of  0.00059 µg
a.i./L was derived based on the acute:chronic ratio method using acute
and chronic data for estuarine/marine invertebrates.  

Benthic Organisms	No chronic data submitted; to assess chronic risk to
benthic organisms, surrogate chronic NOAEC toxicity values for sediment
of  0.59 µg a.i./kg sediment  and for pore water of 0.00042 µg a.i./L
pore water  were derived based on the acute:chronic ratio method using
acute and chronic data for estuarine/marine invertebrates.

Estuarine/Marine Fish	No data submitted; to assess chronic risk to
estuarine/marine fish, a surrogate NOAEC value of 0.34 µg a.i./L for
sheepshead minnow was derived based on the acute:chronic ratio method
using acute and chronic data for freshwater fish.  e	

Estuarine/

Marine Invertebrates	mysid shrimp	28 days  	NOAEC = 0.000781 µg a.i./L

LOAEC = 0.00197 µg ai/L

NOAEC = 0.0015 µg ai/L

LOAEC = 0.0028 µg ai/L	Weight of females reduced

Number of offspring reduced	MRID 42725301

Fish and Invertebrate Exposure 

For exposure to aquatic fish and invertebrates, EPA considers surface
water only, since most aquatic organisms are not found in ground water. 
  SEQ CHAPTER \h \r 1 Estimated environmental concentrations (EECs) for
cypermethrin calculated using the Tier II PRZM/EXAMS models and
employing maximum application rates, indicate that cypermethrin
preferentially partitions to the sediment.  Three crop usage scenarios,
which constitute approximately 90% of cypermethrin’s total crop usage,
were considered: cotton, lettuce, and pecans.  Modeling produced the
highest EECs for cotton crops in North Carolina and Mississippi.    SEQ
CHAPTER \h \r 1 A complete listing of EECs can be found in the EFED risk
assessment, dated October 25, 2005.

  SEQ CHAPTER \h \r 1 Fish and Invertebrate Risk 

  SEQ CHAPTER \h \r 1 To assess risks of cypermethrin to non-target
aquatic animals (i.e., fish and invertebrates), EPA uses the peak
concentration to derive RQs for acute exposure and the 21-day average
concentration to derive RQs for chronic exposure.  RQs are calculated as
the concentration (peak or average EEC) divided by the relevant endpoint
(LC50 for acute risk, NOAEC for chronic risk).  Since results of acute
toxicity studies in freshwater fish and invertebrates indicate that the
major cypermethrin degradate (3-phenoxy benzoic acid) is much less toxic
than the parent compound, EECs and RQs were derived only for the parent
compound, not for total residue (parent plus degradates).  Acute risk
quotient (RQ) values were calculated using the endpoint from the most
sensitive species tested within a taxonomic group.

	

  SEQ CHAPTER \h \r 1 Acute RQs for aquatic organisms are summarized in
Table 6. The LOC for acute risk (LOC 0.5) is exceeded for all aquatic
organisms and modeled crop scenarios, except CA cotton for freshwater
invertebrates and estuarine/marine fish, and CA lettuce for
estuarine/marine fish. LOCs for acute endangered species risk (LOC 0.05)
are exceeded for freshwater fish and invertebrates and estuarine/marine
fish and invertebrates for all six crop scenarios assessed. The highest
acute RQs are observed for freshwater invertebrates, ranging from 49.4
(CA cotton) to 558.3 (NC cotton), exceeding all acute LOCs.

Table 6.  Acute RQs for Freshwater Fish, Freshwater Invertebrates,
Estuarine/Marine Fish and Estuarine/Marine Invertebrates Exposed to
Cypermethrin. tc "Table 14.  Acute RQs for Freshwater Fish, Freshwater
Invertebrates, Estuarine/Marine Fish and Estuarine/Marine Invertebrates
Exposed to Cypermethrin " \f D  

Crop Use

	PRZM/EXAMS Scenario	Freshwater Fish 

Acute RQ	Freshwater Invertebrate 

Acute RQ	Estuarine/Marine

Fish

Acute RQ	Estuarine/Marine

Invertebrate

Acute RQ

Cotton	California	0.5	49.4	0.2	37

	Mississippi	3.3	355.6	1.3	269

	North Carolina	5.2	558.3	2.1	423

	Texas	1.3	136.9	0.5	104

Pecans	Georgia	2.4	264.7	1.0	201

Lettuce (Head)	California	0.7	80.6	0.3	61

Chronic RQs for aquatic animals are summarized in Table 7.  For
freshwater invertebrates, chronic RQs range from 57.6 to 325.4 and for
estuarine/marine invertebrates, chronic RQs range from 44 to 246 and,
exceeding the chronic LOC (1).  For freshwater fish and estuarine/marine
fish, all chronic RQs are below the chronic LOC.

Table 7.  Chronic RQs for Freshwater Fish, Freshwater Invertebrates,
Estuarine/Marine Fish and Estuarine/Marine Invertebrates Exposed to
Cypermethrin. tc "Table 15.  Chronic RQs for Freshwater Fish, Freshwater
Invertebrates, Estuarine/Marine Fish and Estuarine/Marine Invertebrates
Exposed to Cypermethrin " \f D  

Crop Use

	PRZM/EXAMS Scenario	Freshwater Fish 

Chronic RQ	Freshwater Invertebrate 

Chronic RQ	Estuarine/Marine

Fish

Chronic RQ	Estuarine/Marine

Invertebrate

Chronic RQ

Cotton	California	0.2	93.2	0.1	70

	Mississippi	0.7	318.6	0.3	241

	North Carolina	0.7	325.4	0.3	246

	Texas	0.2	101.7	0.1	77

Pecans	Georgia	0.3	145.8	0.1	110

Lettuce (Head)	California	0.1	57.6	0.1	44

Sediment Exposure - Acute and Chronic Risk  tc "b.         Sediment
Exposure - Acute and Chronic Risk " \l 4 

Acute and chronic RQs have been derived for exposure of benthic
organisms to sediments and pore water (Table 10).  All acute and chronic
RQs for benthic organisms exceed the LOCs for acute risk (LOC 0.5),
acute endangered species risk (LOC 0.05) and chronic risk (LOC 1) for
all modeled crop uses. There are several uncertainties regarding both
acute and chronic RQs.  Due to data gaps, acute RQs for pore water and
chronic RQs for sediment and pore water were derived from estimated
toxicity values based on the acute sediment toxicity value.  However,
there is considerable uncertainty surrounding the acute sediment
toxicity value, since this value was obtained from a study using a
water-sediment system that was not at equilibrium (sediment
concentrations decreased throughout the exposure period).  SEQ CHAPTER
\h \r 1 

Table 8.  Acute and Chronic RQs for Benthic Organisms Exposed to
Cypermethrin tc "Table 16.  Acute and Chronic RQs for Benthic Organisms
Exposed to Cypermethrin " \f D  . 

Crop Use

	PRZM/EXAMS Scenario	Sediment Acute RQ 	Pore Water Acute RQ 	Sediment 

Chronic RQ 	Pore Water 

Chronic RQ

Cotton	California	7	2	35	9

	Mississippi	44	11	228	57

	North Carolina	48	12	244	60

	Texas	13	3	52	13

Pecans	Georgia	26	7	123	31

Lettuce (Head)	California	8	2	47	12

iv.	  SEQ CHAPTER \h \r 1 Aquatic Plant Toxicity, Exposure and Risk

  SEQ CHAPTER \h \r 1 Toxicity data are not available for aquatic
plants; thus, risks associated with cypermethrin exposure to aquatic
plants could not be assessed. However, based on cypermethrin’s mode of
action, cypermethrin is not expected to be phytotoxic.  In addition, the
Agency is not aware of any plant incidents involving exposure to
cypermethrin.

v.	Effect of Buffers on Spray Drift

The screening-level risk assessment indicates that peak EECs exceed
acute levels-of-concern for all aquatic taxa considered. The ecological
risk assessment includes an evaluation of the relative contribution of
runoff and spray drift to the exposure simulated by PRZM/EXAMS. A
hypothetical scenario was run (for use on NC cotton) in which
application of cypermethrin resulted in no spray drift. The resulting
EEC of 2.2 µg a.i./L, which represented transport of cypermethrin to
water via runoff and erosion alone, is high enough to exceed the acute
LOC for all aquatic taxa.

The effect of a 150-foot spray buffer on potential exposure from runoff
and erosion cannot currently be quantified. Presumably, the mass of
cypermethrin that would be applied to that portion the field within 150
feet of a water body would be less than that applied to the rest of the
crop, and would decline with distance. However, the PRZM model is an
edge-of-field model which cannot simulate an untreated area between the
field and the receiving water body.

The expected effect of a spray buffer on exposure through spray drift
can be quantified using the AgDRIFT model, which was developed using
extensive field data collected by the Spray Drift Task Force. This is
important because while the EEC from PRZM/EXAMS used in the screening
model represents a 1-in-10-year exposure from combined runoff/erosion
and spray drift, the output from AgDRIFT can be made to represent the
amount of exposure from spray drift that could occur any time a
pesticide is applied. 

AgDRIFT modeling for cypermethrin indicates that the exposure from spray
drift alone could be sufficient to exceed levels of concern for aquatic
organisms, and that implementation of a spray buffer can reduce that
exposure significantly. Using typical spray conditions (10 ft. release
height, 10 mph wind, and a fine-to-medium droplet size distribution
[DSD]), the AgDRIFT model simulates a concentration of 0.73 µg a.i./L
in the standard pond from spray drift if no buffer zone is observed.
Risk quotients calculated with this EEC would exceed the acute LOCs of
0.5 for freshwater and estuarine/marine fish and invertebrates.

The table below shows the effect of spray buffers on the concentration
of cypermethrin that AgDRIFT simulates in the standard pond. These
values reflect the typical spray conditions described above, and an
application rate of 0.1 lb ai/acre:

Table 9.   tc "Table 16.  Acute and Chronic RQs for Benthic Organisms
Exposed to Cypermethrin " \f D  Effect of Various Buffers on EECs 

Buffer (ft)	0	50	100	150	200

Concentration (µg a.i./L)	

0.73	

0.44	

0.31	

0.24	

0.20

When a buffer of 150 feet is simulated, the resulting concentration of
cypermethrin in the pond resulting from drift alone is reduced by
two-thirds. This is sufficient to reduce the EEC below the acute
level-of-concern of 0.5 for estuarine/marine fish (RQ = 0.24 µg
a.i./L/0.95 µg a.i./L = 0.25). This reduction would not reduce the risk
quotients for drift alone below the acute LOC for freshwater fish (RQs
of 0.61), but the reduction in exposure could lead to lower levels of
mortality, and perhaps be sufficiently protective for less sensitive
species. The toxicity reference values for freshwater and
estuarine/marine invertebrates (LC50 = 0.0036 and 0.0048 µg a.i./L,
respectively) are so low that even a two-third reduction in exposure
still results in RQs far above the LOC (RQ = 67 and 50, respectively).

The use of a spray buffer would reduce exposure under conditions other
than the typical conditions described above, but conditions more
conducive to spray drift could result in unacceptable exposure from
drift alone regardless of the buffer. For instance, if the wind speed
(10 mph) and release height (10 ft) are kept the same as above, but a
very fine-to-fine DSD is simulated instead of a fine-to-medium DSD, much
greater exposure to cypermethrin could result.

Table 10.   tc "Table 16.  Acute and Chronic RQs for Benthic Organisms
Exposed to Cypermethrin " \f D  Effect of Various Buffers Using
Fine-to-Fine Droplets on EECs 

Buffer (ft)	0	50	100	150	200

Concentration (µg a.i./L)	

1.7	

1.2	

0.96	

0.8	

0.68

The resulting amount of spray drift would lead to more than three times
the exposure at 150 feet than if the fine-to-medium DSD were used, and
the resulting EECs would still exceed the LOC for all aquatic taxa.

䔀潣剬獩呒剒剒൒ግ匠充䌠䅈呐ER \h \r 1 In addition to
these potential acute and chronic risks from agricultural uses, aquatic
organisms may be exposed to cypermethrin from non-agricultural uses, as
well.  The Agency has received and considered the results of a published
study that measured pyrethroid residues in stream sediments adjacent to
an urban subdivision in California. The study found toxic residue levels
of cypermethrin and other pyrethroids in stream sediments that receive
runoff from the subdivisions via storm drains and summer over-irrigation
of landscapes and lawns (Weston, et al., 2005).  Although bifenthrin was
the major pyrethroid found, cypermethrin concentrations were also of
toxic significance to aquatic invertebrates. Weston’s work is
significant because it documents the presence of pyrethroids in the
sediments of creeks near residential areas.  Since most of the use of
cypermethrin is in non-agricultural settings, urban uses pose additional
risks to aquatic systems that the Agency cannot quantitatively assess at
this time.  EPA currently is evaluating appropriate modeling approaches
to assess risks from urban runoff (see Chapter IV for further
discussion).

b.	Risk to Terrestrial Organisms

				i.	Bird and Mammal Toxicity

  SEQ CHAPTER \h \r 1 Results of acute toxicity studies on birds suggest
that cypermethrin is practically non-toxic to slightly toxic to avian
species (LD50 >2,000 mg a.i./kg body weight; LC50 > 2,634 mg a.i./kg
diet) on an acute basis. Chronic avian studies showed no adverse effects
at 50 mg a.i./kg diet (the highest dose tested), but the study was
incomplete because a LOAEC was not determined 

Mammalian data suggest that cypermethrin is moderately toxic (LD50 = 247
mg/kg body weight) on an acute basis.  A chronic study in rats showed
adverse effects (decreased body weight and body weight gain) in adults
and offspring (NOAEC = 5.0 mg a.i./kg/ body weight/day; 100 mg a.i./kg
diet).

Table 11.  Cypermethrin Toxicity Reference Values for Terrestrial
Organisms tc "Table 13.  Cypermethrin Toxicity Reference Values (TRVs)
for Terrestrial Organisms " \f D  .

Exposure Scenario	Species 	Exposure Duration	Toxicity Reference Value

	Reference

Mammals

Acute

(Dose-based)	rat	single oral dose	LD50 (M): 247 mg/kg/ body wt	MRID
00056800

Chronic

(Dietary-based  and 

Dose-based)	rat	3 generation reproduction study

	NOAEL (toxicity to parents and offspring) = 5.0 mg/kg/day

 

LOAEC  = (toxicity to parents and offspring) = 25 mg/kg/day	MRID
00090040

Birds

Acute 

(Dose-based)	bobwhite quail	single oral dose	LD50 >2,000 mg a.i./kg body
wt	MRID 44546024

Acute 

(Dietary-based)	mallard duck	5-day dietary	LC50 >2,634 mg a.i./kg diet
MRID 00090071

Chronic 

(Dietary-based)	mallard duck and 

bobwhite quail	Avian reproduction 	NOAEC >50 mg a.i./kg diet	MRID
42322902

MRID 42322901

 tc "a.     Terrestrial " \l 4 

				ii.	Bird and Mammal Exposure 

  SEQ CHAPTER \h \r 1 The Agency assessed exposure to terrestrial
organisms by first predicting the amount of cypermethrin residues found
on animal food items and then using information on typical food
consumption by various species of birds and mammals to determine the
amount of pesticide consumed.  The amount of residues on animal feed
items is based on the Fletcher nomogram, which is a model developed by
Hoerger and Kenaga (1972) and modified by Fletcher (1994), and the
current maximum application rates for cypermethrin.  

Estimated exposure concentrations for terrestrial receptors were
determined using the standard screening-level exposure model, TREX
(v.1.1), which is a simulation model that, in addition to incorporating
the nomogram relationship, also includes pesticide degradation in the
estimation of EECs.    SEQ CHAPTER \h \r 1 TREX considers exposure only
in the area where cypermethrin is applied.  The underlying assumption is
that most, if not all, of the applied pesticide will settle in the use
area.  However, depending on weather conditions and type of application,
spray drift of pesticides may occur, increasing the likelihood of
wildlife exposure outside the use area.  Since cypermethrin is applied
via spray methods, spray drift is likely to occur and in some cases
could be a significant source of exposure.

 

Four crop usage scenarios were assessed: cotton, pecans, lettuce, and
canola.  Cypermethrin maximum dose-based EECs ranged from 1.2-122 mg/kg
body weight for birds, and 0.1-102 mg/kg body weight for mammals.

					iii.	Bird and Mammal Risk 

  SEQ CHAPTER \h \r 1 For birds, all acute, dose-based and dietary based
RQs are below the LOC for acute risk (LOC 0.5) and endangered species
(LOC 0.1) for all crop uses.  However, the acute endangered species LOC
(0.1) is exceeded for 15g and 35g mammals feeding on short grass
(dose-based RQs 0.1-0.2) for all crop scenarios, and for 15g mammals
feeding on broadleaf plants/small insects in cotton (RQ = 0.11).

Chronic, dietary-based RQs for birds are all below the LOC for chronic
risk (LOC 1).  It was not possible to calculate a chronic dose-based RQ
for birds because there were no acceptable dose-based toxicity values
for birds available.  For mammals, chronic, dose-based RQs range from
<0.1 to 9.3 (15g mammals feeding on short grass in cotton), exceeding
the chronic LOC (1) for most scenarios.  The chronic dietary-based RQ
(1.1) exceeded the chronic LOC (1) for mammals feeding on short grass in
cotton.

					iv.	Non-target Insect Toxicity, Exposure and Risk

Results of available toxicity studies indicate that cypermethrin is
highly toxic to honey bees (LD50 = 0.023 - 0.56 ug/bee) and very toxic
to earthworms (LC50 = 26.09 ug/cm2) on an acute contact basis.  Thus,
honey bees and other non-target terrestrial invertebrates (e.g.
beneficial insects and listed insects) are expected to be at risk for
acute effects (lethality).  No   SEQ CHAPTER \h \r 1 RQ values for
non-target insects were derived; however, risks can be assessed
qualitatively.  Cypermethrin toxicity data show that it is very highly
toxic to honey bees and is considered to be highly toxic on both a
contact and an oral basis.  Cypermethrin was also found to be highly
toxic to honey bees exposed to foliage that had been sprayed with a
cypermethrin formulation (Cymbush 3E).  In addition, cypermethrin has
also been shown to be highly toxic to earthworms.  Based on these
results, acute risks to non-target insects and terrestrial invertebrates
are anticipated for the uses considered in this assessment.

					v.	  SEQ CHAPTER \h \r 1 Terrestrial Plants						

  SEQ CHAPTER \h \r 1 As for aquatic plants, toxicity data are not
available for terrestrial plants and risks could not be assessed.
Cypermethrin is not expected to be phytotoxic based on its mode of
action, and no incidents involving terrestrial plants have been reported
to the Agency.

			c.	Ecological Incidents

  SEQ CHAPTER \h \r 1 A total of 10 aquatic incidents involving
cypermethrin exposure have been reported to EPA and tracked by   SEQ
CHAPTER \h \r 1 Ecological Incident Information System (EIIS).  All
incidents were categorized according to the Certainty Index as follows:
possible (3 reports); probable (3 reports); and highly probable (4
reports).  Although in about half of these aquatic incidents the source
of cypermethrin was not reported, several fish kills were attributed to
termiticide use of cypermethrin. 

A total of five incidents involving terrestrial organisms (birds, goats,
dog) were noted. The incident involving birds (5000 sparrows) was
attributed to birds eating insects that had been killed from
cypermethrin use the previous night on an eggplant crop. 

  SEQ CHAPTER \h \r 1 

Endangered Species Concerns

The Agency’s screening level ecological risk assessment for endangered
species results in the determination that cypermethrin will have no
direct acute effects on threatened and endangered birds.  However,
potential indirect effects to any species dependent upon a species that
experiences effects cannot be precluded from use of cypermethrin.  These
findings are based solely on EPA’s screening level assessment and do
not constitute “may effect” findings under the Endangered Species
Act.  

  SEQ CHAPTER \h \r 1 For birds, all acute RQs are below the endangered
species LOC (0.1) for all crop uses.  The Agency’s acute endangered
species LOC for birds was not exceeded in the screening level
assessment, but one incident involving acute effects on birds was
reported.

For mammals, the acute endangered species LOC (0.1) is exceeded for 15g
and 35g mammals feeding on short grass (dose-based RQs 0.1-0.2) for all
crop scenarios  and aquatic organisms (LOC = 0.05) were exceeded.   The
maximum calculated acute RQs for all organisms resulted from modeling
cypermethrin use on North Carolina cotton; the maximum screening level
acute RQs which exceed acute LOCs are shown in Table 12, below.

Table 12. Maximum acute RQs in screening level assessment.

Organism	Maximum Acute RQ

Mammals	0.2

Freshwater fish	5.2

Freshwater invertebrates	558.3

Estuarine/marine fish	2.1

Estuarine/marine invertbrates	423

Benthic organisms (sediment exposure)	48

Benthic organisms (pore water exposure)	12

The Agency’s screening level assessment results in the determination
that cypermethrin will have no direct chronic effects on birds (all RQs
are less than the chronic LOC of 1.0).  However, the chronic LOC is
exceeded for mammals, freshwater and estuarine/marine invertebrates, and
benthic organisms. The maximum calculated chronic RQs for all organisms
resulted from modeling cypermethrin use on North Carolina cotton; the
maximum screening level chronic RQs which exceed the chronic LOC are
shown in Table 13, below.

Table 13. Maximum chronic RQs in screening level assessment.

Organism	Maximum Chronic RQ

Mammals (dose-based risk)	9.3

Freshwater invertebrates	325.4

Estuarine/marine invertbrates	246

Benthic organisms (sediment exposure)	244

Benthic organisms (pore water exposure)	60

No data were submitted to evaluate the risk of cypermethrin exposure to
non-target terrestrial plants.  However, the agency has determined that
cypermethrin will have no effect on listed plants.  Also, no incident
reports have reliably linked cypermethrin or any other synthetic
pyrethroid to phytoxic effects despite the fact that pyrethroids are
often applied on or near agricultural crops.  

All of these findings are based solely on EPA’s screening level
assessment and do not constitute “may effect” findings under the
Endangered Species Act.  Rather, this assessment serves as a screen to
determine the need for any species specific assessments that will
evaluate whether exposure may be at levels that could cause harm to
specific listed species and their critical habitat.   That assessment
refines the screening-level assessment to take into account  the
geographic area of pesticide use in relation to the listed species, the
habits and habitat requirements of the listed species, etc.  If the
Agency’s species specific assessments result in the need to modify use
of the pesticide in specific geogrpahic areas, those changes to the
pesticide’s registration will take through the process described in
the Agency’s Federal Register Notice (54 FR 27984) regarding
implementation of the Endangered Species Protection Program.

IV.	Risk Management, Reregistration, and Tolerance Reassessment Decision

									

A.	Determination of Reregistration Eligibility and Tolerance
Reassessment

Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after
submission of relevant data concerning an active ingredient, whether or
not products containing the active ingredient are eligible for
reregistration.  The Agency has previously identified and required the
submission of the generic data to support reregistration of products
containing cypermethrin and has determined that the data are sufficient
to support reregistration. 	

The Agency has completed its assessment of the dietary, residential,
occupational and ecological risk associated with the use of
cypermethrin.  Based on this assessment the Agency has sufficient
information to make decisions as part of the tolerance reassessment
process under FFDCA and reregistration process under FIFRA, as amended
by FQPA.  The Agency has determined that cypermethrin containing
products are eligible for reregistration provided that label amendments
are made as outlined in this RED.  Appendix A summarizes the uses of
cypermethrin that are eligible for reregistration.  Appendix B
identifies the generic data requirements that the Agency reviewed as
part of its determination of reregistration eligibility, and lists the
submitted studies that the Agency found acceptable.  

Based on its evaluation of cypermethrin, the Agency has determined that
cypermethrin products, unless labeled and used as specified in this
document, would present risks inconsistent with FIFRA and FQPA. 
Accordingly, should a registrant fail to implement any of the
reregistration requirements identified in this document, the Agency may
take regulatory action to address the risk concerns from the use of
cypermethrin.  If all changes outlined in this document are incorporated
into the product labels, then all current risks for cypermethrin will be
adequately mitigated for the purposes of this determination.  Once an
Endangered Species assessment is completed, further changes to these
registrations may be necessary as explained under “Endangered Species
Concerns” above.     

	

B.	Public Comments and Responses

Through the Agency’s public participation process, EPA worked with
stakeholders and the public to reach the regulatory decisions for
cypermethrin.  EPA released its cypermethrin preliminary risk
assessments for public comment on December 28, 2005, for a 60-day public
comment period (Phase 3 of the public participation process).  During
the public comment period, the Agency received comments from the
technical registrants, the California water quality control boards, the
California Stormwater Quality Association, and other stakeholders. These
comments in their entirety, responses to the comments, as well as the
preliminary and revised risk assessments, are available in the public
docket (EPA-HQ-OPP-2005-0293) at http://www.regulations.gov.

C.	Regulatory Position

	1.	Food Quality Protection Act Findings

		a.	“Risk Cup” Determination

Even though cypermethrin tolerances are not included in EPA’s baseline
tolerance reassessment counts, EPA assessed the risks associated with
cypermethrin.  EPA has concluded that the tolerances for cypermethrin
meet FQPA safety standards.  In reaching this determination, EPA has
considered the available information on the special sensitivity of
infants and children, as well as aggregate exposure from food and
residential sources.  

		b.	Determination of Safety to U.S. Population

The Agency has determined that the established tolerances for
cypermethrin, with amendments and changes as specified in this document,
meet the safety standards under the FQPA amendments to section
408(b)(2)(D) of the FFDCA, as amended by FQPA, and that there is a
reasonable certainty no harm will result to the general population or
any subgroup from the use of cypermethrin.  In reaching this conclusion,
the Agency has considered all available information on the toxicity, use
practices, and the environmental behavior of cypermethrin.  As discussed
in Section III, aggregate acute, short-, intermediate-, and long-term
risks from food, drinking water, and residential exposures are below the
Agency’s LOC.  

		c.	Determination of Safety to Infants and Children

EPA has determined that the established tolerances for cypermethrin,
with amendments and changes as specified in this document, meet the
safety standards under the FQPA amendments to section 408(b)(2)(C) of
the FFDCA, that there is a reasonable certainty of no harm for infants
and children.  The safety determination for infants and children
considers factors on the toxicity, use practices and environmental
behavior noted above for the general population, but also takes into
account the possibility of increased dietary exposure due to the
specific consumption patterns of infants and children, as well as the
possibility of increased susceptibility to the toxic effects of
cypermethrin residues in this population subgroup.  

In determining whether or not infants and children are particularly
susceptible to toxic effects from exposure to residues of cypermethrin,
the Agency considered the completeness of the hazard database for
developmental and reproductive effects including a developmental
neurotox study, the nature of the effects observed, and other
information.  The FQPA Safety Factor has been reduced to 1X, because
there are no residual uncertainties for pre- and/or post-natal toxicity,
exposure is not underestimated, and there is no evidence of increased
susceptibility. 

	2.	Endocrine Disruptor Effects

The available database provides no evidence that cypermethrin induces
endocrine disruption. 

EPA is required under the FFDCA, as amended by FQPA, to develop a
screening program to determine whether certain substances (including all
pesticide active and other ingredients) “may have an effect in humans
that is similar to an effect produced by a naturally occurring estrogen,
or other endocrine effects as the Administrator may designate.” 
Following recommendations of its Endocrine Disruptor Screening and
Testing Advisory Committee (EDSTAC), EPA determined that there was a
scientific basis for including, as part of the program, the androgen and
thyroid hormone systems, in addition to the estrogen hormone system. 
EPA also adopted EDSTAC’s recommendation that EPA include evaluations
of potential effects in wildlife.  For pesticides, EPA will use FIFRA
and, to the extent that effects in wildlife may help determine whether a
substance may have an effect in humans, FFDCA authority to require the
wildlife evaluations.  As the science develops and resources allow,
screening of additional hormone systems may be added to the Endocrine
Disruptor Screening Program (EDSP).  In the available toxicity studies
on cypermethrin submitted for registration purposes, there was no
estrogen, androgen, and/or thyroid mediated toxicity. When the
appropriate screening and/or testing protocols being considered under
the EDSP have been developed, cypermethrin may be subject to additional
screening and/or testing.

		3.	Cumulative Risks

	

Cypermethrin is a member of the pyrethroid class of pesticides. 
Although all pyrethroids alter nerve function by modifying the normal
biochemistry and physiology of nerve membrane sodium channels, available
data shows that there are multiple types of sodium channels and that
these compounds may act on different isoforms of the sodium channel and
with other ion channels in producing their clinical signs.  It is
currently unknown whether the pyrethroids as a class have similar
effects on all channels or whether modifications of different types of
sodium channels would have a cumulative effect.  Nor do we have a clear
understanding of effects on key downstream neuronal function e.g., nerve
excitability, or how these key events interact to produce their compound
specific patterns of neurotoxicity.  Without such understanding, there
is no basis to make a common mechanism of toxicity finding.  Therefore,
EPA is not currently following a cumulative risk approach based on a
common mechanism of toxicity for the pyrethroids because the Agency has
determined further study is needed regarding the assumptions of dose
additivity and common mechanism(s) of toxicity to appropriately identify
a group or subgroups for such an assessment.  There is ongoing research
by the EPA’s Office of Research and Development and pyrethroid
registrants to evaluate the differential biochemical and physiological
actions of pyrethroids in mammals.  The Agency anticipates the majority
of this research to be completed by 2007.  When available, the Agency
will consider this research and make a determination of common mechanism
as a basis for assessing cumulative risk.  For information regarding
EPA’s procedures for cumulating effects from substances found to have
a common mechanism on EPA’s website at     HYPERLINK
"http://www.epa.gov/pesticides/cumulative/." 
http://www.epa.gov/pesticides/cumulative/ .

D.	Tolerance Reassessment Summary 

	

  SEQ CHAPTER \h \r 1 The Codex Alimentarius Commission has established
several maximum residue limits (MRLs) for cypermethrin residues in/on
various plant and livestock commodities.  The Codex and U.S. tolerances
are in harmony with respect to MRL/tolerance expression.  Both regulate
the parent compound, cypermethrin.

Special efforts to increase harmony between recommended US tolerance
levels and Codex MRLs were made for the following commodities: 1)
poultry, meat (0.05 ppm instead of no tolerance), and 2) meat of cattle,
goat, sheep, and horse (0.20 instead of 0.05 ppm).  The following
conclusions can be made regarding efforts to harmonize the U.S.
tolerances with the Codex MRLs with respect to MRL/tolerance level:  (i)
compatibility between the U.S. tolerances and Codex MRLs exists for bulb
onions; meat byproducts; poultry, meat; and meat of cattle, goat, sheep,
and horse; and (ii) incompatibility of the U.S. tolerances and Codex
MRLs remains for Brassica vegetables, cottonseed, lettuce, and milk,
because of differences in good agricultural practices and determination
of secondary residue levels in livestock commodities.  No questions of
compatibility exist with respect to commodities where Codex MRLs have
been established but U.S. tolerances do not exist, or vice versa.

  SEQ CHAPTER \h \r 1 A summary of cypermethrin tolerance reassessments
is presented in Table 14.

Table 14. Tolerance Reassessment Summary for Cypermethrin.

Commodity	Current Tolerance

(ppm)	Tolerance Reassessment (ppm)	Comment/Correct Commodity Definition

Tolerances listed under 40 CFR 180.418(a)(1):

Brassica, head and stem	2.0	2.0	[Brassica, head and stem, subgroup]

Brassica, leafy	14.0	14.0	[Brassica, leafy greens, subgroup]

Cattle, fat	0.05	1.0

	Cattle, meat	0.05	0.20	Harmonize with Codex MRL

Cattle, mbyp	0.05	0.05	[Cattle, meat byproducts]

Cottonseed	0.5	0.50	[Cotton, undelinted seed]

Goats, fat	0.05	1.0	[Goat, fat]

Goats, meat	0.05	0.20	[Goat, meat] Harmonize with Codex MRL

Goats, mbyp	0.05	0.05	[Goat, meat byproducts]

Hogs, fat	0.05	0.10	[Hog, fat]

Hogs, meat	0.05	0.05	[Hog, meat]

Hogs, mbyp	0.05	—	Residue data support removal of tolerance. 

Horses, fat	0.05	1.0	[Horse, fat]

Horses, meat	0.05	0.20	[Horse, meat] Harmonize with Codex MRL

Horses, mbyp	0.05	0.05	[Horse, meat byproducts]

Lettuce, head	10.0	4.0	Residue data support reduction of tolerance. 

Milk	0.05	2.5	[Milk, fat (reflecting 0.10 in whole milk)]

Onions, bulb	0.1	0.10	[Onion, bulb]

Onions, green	6.0	6.0	Residue data support a tolerance level of 3.0 ppm
for zeta-cypermethrin / [Onion, green]

Pecans	0.05	0.05

	Sheep, fat	0.05	1.0

	Sheep, meat	0.05	0.20	Harmonizes with Codex MRL

Sheep, mbyp	0.05	0.05	[Sheep, meat byproducts]

Tolerances That Need To Be Proposed under 40 CFR 180.418(a)(1):

Cotton gin byproducts	--	11

	Egg	–	0.05

	Poultry, fat	–	0.05

	Poultry, meat	–	0.05	Harmonizes with Codex MRL

Tolerances That Need To Be Changed under 40 CFR 180.418(a)(2):

Hog, fat	1.0	0.10	Updated dietary burden supports lower tolerance level.
 

Hog, meat	0.2	0.05	Updated dietary burden supports lower tolerance
level.  

Hog, meat byproducts	0.05	None	Updated dietary burden eliminates need
for tolerance.  

Lettuce, head	10.00	None	Covered by Vegetable, leafy, except Brassica, 
group 04.

Poultry, meat byproducts	0.05	None	Updated dietary burden eliminates
need for tolerance.  

E.	Regulatory Rationale 

The Agency has determined that cypermethrin is eligible for
reregistration provided that the risk mitigation measures and label
amendments specified in this RED are implemented.  The following is a
summary of the rationale for managing risks associated with the use of
cypermethrin.  

1.	Human Health Risk Mitigation

a.	Dietary, drinking water, residential, and aggregate risk mitigation

Cypermethrin dietary (food + drinking water), residential, and aggregate
risks were below the Agency’s level of concern.  Moreover, the risk
assessments are protective of the general U.S. population and all
population subgroups, including infants and young children. Therefore,
no mitigation is necessary for these scenarios.

Worker risk mitigation

i.	Handler risk mitigation

A number of application scenarios involving aerial, ground, or handheld
equipment result in risks above EPA’s level of concern (MOE < 100 or
ARI < 1). The following mitigation measures are necessary to address
occupational risks that exceed the Agency’s level of concern:

Mixing, loading and applying liquid formulations

For motorized ground and aerial equipment, risks are below EPA’s level
of concern at baseline and therefore, no mitigation is needed. For
handheld application equipment, risks are below the level of concern
with the addition of chemical resistant gloves.

For liquid formulations, chemical-resistant gloves are required for all
hand-held application methods.

Mixing, loading and applying wettable powder formulations

For wettable powder formulations, all products must be repackaged in
water soluble bags.

For wettable powder formulations, chemical-resistant gloves are required
for all hand-held application methods.

One registrant with a wettable powder product for use in industrial,
commercial, and residential settings has requested to reformulate their
product into a dry flowable or prill formulation, rather than
repackaging it into water soluble bags. Although risks can not be
calculated due to lack of exposure data for dry flowables, EPA is
confident that the risks to mixer, loader, and applicators of dry
flowables products would be lower than those for liquid products, and
thus below the Agency’s level of concern with the addition of chemical
resistant gloves.

For dry-flowable or prill formulations, chemical-resistant gloves are
required for all hand-held application methods.

Additional mitigation for aerial applications

Closed cockpits are required.

Human flagging is prohibited.

The human health assessment estimated risks to mixers, loaders and
applicators making groundboom and aerial applications to sod farms at
0.74 lbs a.i./A. Application to sod farms is allowed through two Special
Local Need registrations (FL SLN 890033, and CA SLN 840214). The Florida
SLN allows application to Anheuser Busch sod farms using a soil
injection rig only. The registrant (Syngenta) has been unable to verify
whether or not this SLN is still in use and is not opposed to canceling
it, since it is still tied to a former registrant’s product and has
never been updated to reflect the change of product ownership. In any
case, EPA does not anticipate risks of concern to human health (or
aquatic organisms) from this soil injection use on sod farms.  The
California SLN allows both groundboom and aerial application to sod
farms. The registrant (FMC) has no record of this SLN and does not think
it is currently active., since it is still tied to a former
registrant'osed to cancelling on rig, only. The registrant has been
unable to verify whether

Withdraw FL SLN 890033 and CA SLN 840214, for use on sod farms

Mixing, loading and applying granular formulations

  SEQ CHAPTER \h \r 1 In February 2006, a granular product was
registered for use on lawns and outside of homes to kill fire ants
(application to fire ant mounds).  Although no data were available to
assess the risks of this use for cypermthrin, the Agency believes that
the risks from this granular cypermethrin product will not exceed those
for liquid products, which are below EPA’s level of concern for this
scenario.  No mitigation is needed for this use.

Applying ready-to-use (RTU) formulations

No risks exceeded EPA’s level of concern, and no mitigation is needed.

ii.	Post-application risk mitigation

 Agricultural uses

EPA did not assess occupational postapplication risks to agricultural
workers following treatments to agricultural crops, since no short- or
intermediate-term dermal endpoints of concern were identified and
long-term dermal exposures are not expected for tasks involving any of
the registered crop use patterns.

As per the Worker Protection Standard, a restricted-entry interval of 12
hours is required for agricultural uses.

Non-agricultural (industrial, commercial, and residential) uses

EPA did not assess occupational post-application exposures and risks
following applications to residential and commercial lawns, and in and
around industrial, commercial, and residential premises, since no short-
or intermediate-term dermal endpoints of concern were identified and
long-term exposures are not expected for tasks involving any of the
registered use patterns.

No new mitigation is required, but existing precautionary label
statements and use directions intended to be protective of human health
must be retained (see label table in Section V. for examples).

Additional recommendations based on incident reports 

  SEQ CHAPTER \h \r 1 Based on documented incident reports involving
cypermethrin, skin and eye protection is recommended for agricultural
handlers making broadcast applications.  Bystanders should vacate indoor
areas receiving treatment and the area should be appropriately
ventilated afterwards before persons reenter the premises.  Further
study is needed to determine whether labels should advise of potential
allergy or asthma-like problems among sensitive individuals.

2.	Environmental Risk Mitigation

The Agency has conducted a screening-level ecological and environmental
risk assessment for the registered agricultural uses of cypermethrin. 
Based on the available data, the Agency has identified potential acute
risks of concern to freshwater and estuarine/marine invertebrates and
fish, benthic organisms, mammals, earthworms, and non-target insects,
and potential chronic risks of concern to freshwater and
estuarine/marine invertebrates, benthic organisms, and mammals.

Risk from non-agricultural uses of cypermethrin could not be
quantitatively assessed at this time, but is expected based on the risks
from agricultural uses, the high proportion of use of cypermethrin in
outdoor non-agricultural areas (e.g. for nuisance pest control around
structures and on lawns, and as a pre-construction termiticide), and the
limited existing data showing the presence of cypermethrin in California
urban creeks at concentrations toxic to benthic invertebrates.
Mitigation to address the ecological risks from agricultural and
non-agricultural cypermethrin applications is described below.

		 

a.	Mitigation to Address Risks to Non-Target Organisms from Agricultural
Uses

To address ecological risks from agricultural uses of cypermethrin, the
following mitigation measures are required:

Decrease total yearly application rates, and increase re-treatment
intervals

The maximum rate per application will be maintained at 0.1 lbs a.i./A
for all crops. However, the following changes will be made to reduce the
frequency of application and total pounds applied per year:

For cotton:

Limit the total amount of product applied to 0.4 lbs ai/A/year (reduced
from 0.6 lbs ai/A/year).

Increase the minimum re-treatment interval to 5 days (increased from 3
days).

For pecans:

Limit the total amount of product applied to 0.5 lbs ai/A/year (reduced
from 0.6 lbs ai/A/year).

Establish a minimum re-treatment interval of 7 days.  

For head lettuce, head and stem brassicas (such as broccoli), leafy
brassicas (such as canola), and bulb vegetables (such as onions):

Limit the total amount of product applied to 0.6 lbs ai/A/year.

Establish a minimum re-treatment interval of 7 days.

Prohibit high-rate, high-ecological-impact use sites

Remove the use sites:  agricultural uncultivated areas, fencerows, and
hedgerows (application rate of 3.4 lbs ai/A) from product labels, and
prohibit use on these sites

Prohibit use on rights-of-way

Prohibit use on sod farms

Require the following mitigation to reduce spray drift from agricultural
applications

EPA understands the history of spray drift language development with the
Pyrethroid Working Group (PWG), and the desire of registrants to
maintain a level playing field among the pyrethroids with respect to
spray drift restrictions. Since the current spray drift labeling for
pyrethroids is over ten years old, EPA would like to update it as
described below and in chapter 5 of this RED, and have all PWG
pyrethroid products adopt these restrictions by early 2007.  EPA is
willing to meet with the PWG to discuss any issues concerning these
spray drift label statements, and welcomes comments from other
stakeholders during the 60-day post-RED comment period. 

For groundboom and aerial applications, use medium or coarser spray
nozzles

For motorized ground or aerial applications, apply only when the wind
velocity is 3 to 10 mph for all crops other than cotton; for cotton,
apply only when the wind velocity is 3 to 15 mph

Do not make ground or aerial applications during temperature inversions

For airblast applications to tree crops, direct spray into the canopy,
and turn off outward pointing nozzles at row ends and when spraying
outer two rows

For groundboom, chemigation, or airblast applications, do not apply
within 25 feet of water bodies or aquatic habitat

For aerial applications, do not apply within 150 feet of water bodies or
aquatic habitat; increase this no spray buffer zone to 450 feet when
making an ultra low volume (ULV) application

For aerial applications, do not release spray at a height greater than
10 feet above the ground or crop canopy, when spraying within 1000 feet
of water bodies or aquatic habitat

See Section V and the label table for required spray drift label
statements.

Require the following mitigation to reduce run-off from agricultural
fields

Construct and maintain a 10-foot-wide vegetative filter strip of grass
or other permanent vegetation between the field edge and any water body
or aquatic habitat (USDA, NRCS. 2000. Conservation Buffers to Reduce
Pesticide Losses.  Natural Resources Conservation Service. Fort Worth,
Texas.)

Mitigation to Address Risks to Non-Target Organisms from
Non-Agricultural Uses

Estimating risk from non-agricultural uses of pyrethroids

The Office of Pesticide Programs (OPP) strives to estimate pesticide
exposure through all significant routes of exposure from both
agricultural and non-crop uses. However, the ecological risk assessments
for pyrethroid insecticides focus predominantly on the agricultural uses
for these insecticides, because pesticide transport models are available
to estimate potential aquatic exposure.  Based on laboratory toxicity
tests with terrestrial and aquatic animals, aquatic exposure would be
more likely to cause adverse effects in the environment.

However, sales data indicate that non-crop uses of the pyrethroids
comprise a much larger fraction of total use than agricultural uses. 
The use of pyrethroids in urban and suburban settings has increased
since the phase-out of these uses of the organophosphate insecticides
diazinon and chlorpyrifos.  Sales data indicate that the majority of
urban use of cypermethrin is for structural pest control, such as for
control of termites or ants.  Other outdoor non-crop uses include
landscape maintenance, and homeowner lawn and garden use.  Indoor uses
include nuisance insect control, and termite applications.

For pyrethroids with relevant indoor uses (not including cypermethrin),
the Agency uses a “down-the-drain” model to perform a
screening-level aquatic risk assessment.  In these simulations, waste
water containing pesticide residue flows into a building drain and
passes through a sanitary sewer and publicly owned treatment works
(POTW) before being discharged to surface water. However, no analogous
exposure model has been developed to allow a similar screening-level
assessment for pesticides applied in an outdoor urban setting, like
cypermethrin. As a result, the Agency has had to take a qualitative
approach to characterize the potential aquatic risk from urban and
suburban use of pyrethroids.

For outdoor urban uses, it is assumed that runoff water from rain and/or
lawn watering may transport pesticides to storm sewers and then directly
to surface water.  Conceptually, a greater contribution to pyrethroid
loading to surface water bodies would be expected from application to
impervious surfaces such as walkways, driveways or the sides of
buildings, than to lawns or bare ground, because of the pyrethroids’
strong affinity to bind to organic carbon in soils.  However, the Agency
is unaware of any model which can simulate the different application
methods for urban use and the physical representation of the urban
landscape, storm sewer and receiving water configuration. 

There are models available which can be calibrated to simulate sites and
pesticides for which extensive flow and pollutant data have been
collected in advance. The HSPF/NPSM model, for instance, which is
included in the Office of Water’s BASINS shell, has been used to
calibrate stream flow and copper pesticide use data to simulate loading
of these pesticides consistent with concentrations measured in surface
water monitoring.  Risk assessors with the California Department of
Environmental Protection confirmed in conversations with the Agency that
they also have used watershed models to calibrate to previously
collected flow and pesticide monitoring data, but that they did not know
of any models capable of predicting concentrations of pyrethroids that
might occur because of outdoor urban uses.

Development of a screening model which could simulate the fate and
transport of pesticides applied in an urban setting would require a
large body of data which is currently unavailable.  For instance, an
urban landscape cannot be simulated as easily as an agricultural field. 
The PRZM model simulates runoff from an agricultural field using readily
available data describing surface soil characteristics and laboratory
data detailing the persistence and mobility of pesticides in these
soils.  The agricultural field simulated is homogenously planted to a
single crop, and soil and water are transported from the field to a
receiving water body with dimensions consistent with USDA farm-pond
construction guidelines.

By contrast, an urban landscape or suburban housing development consists
of impervious surfaces such as streets and sidewalks, and pervious
surfaces such as lawns and parkland.  One could expect much greater
mobility for pesticides applied to impervious surfaces, but laboratory
soil metabolism studies may not provide an accurate measure of the
persistence of pesticides on these surfaces.  The path runoff water and
eroded sediment might take is less obvious for an urban setting than an
agricultural field.  First, an urban landscape cannot be considered
homogeneous, as the proportion of impervious and pervious surfaces
varies for different locations.  In addition, the flow path of runoff
water and sediment is not necessarily a direct path over land, but can
pass below ground through storm sewer networks, or be directed or slowed
by pumping stations or temporary holding ponds.

Finally, the timing and magnitude of urban uses is less well defined for
urban uses than agricultural uses.  While agricultural uses would occur
within a predictable window during the growing season, the need for
urban uses could occur at different times each year, and might occur at
different times within the same watershed.  In addition, since records
of how and to what extent pyrethroids are applied by homeowners are less
well defined than for professional applications, it is harder to
estimate the total load to model.

Pyrethroid monitoring data

The Agency considers surface water monitoring data in addition to
modeling results when they are available.  However, surface water
monitoring for pyrethroids has been limited, perhaps because the
pyrethroids would more likely be associated with aquatic sediment than
the water column.  The USGS NAWQA program included permethrin (another
pyrethroid currently undergoing reregistration) as the only pyrethroid
among its pesticide analytes, and detected it in 0.15% of 1185
agricultural stream samples from 78 sample locations.  Permethrin was
not detected in 803 urban stream samples taken from 33 sample locations.
 The NAWQA program also analyzed for cis-permethrin in bed sediments,
and had similar detection rates in between the agricultural (1.5%) and
urban (1.0%) land use sites; trans-permethrin was detected in 0.8% of
bed sediment samples. 

More recently, researchers from the University of California-Berkeley
have published studies which reported transport of pyrethroids to stream
bed sediment as a result of urban uses. In 2004, Weston, et al.
collected sediment from creeks draining a residential area in Rosedale,
California.  The sediments were analyzed for 7 pyrethroids (including
cypermethrin and permethrin), as well as for other insecticides.  All of
the pyrethroids were detected in the bed sediment from at least one
sampling location.  The researchers exposed the aquatic amphipod
Hyalella azteca to the 21 sediment samples they collected; pesticide
concentrations in 9 of these samples was sufficient to cause 90%
mortality in the amphipods after a 10-day exposure.  The concentrations
of pyrethroids detected in the sediments were above the level expected
to cause 50% mortality in H. azteca, suggesting that the pyrethroids
were responsible for the observed toxicity.

In a subsequent study, Weston, et al. collected samples from 15 urban
creeks in California and 12 in Tennessee. Toxicity to H. azteca was
observed at least once with sediments taken from 12 of the 15 California
sampling sites.  In most cases, the toxicity could be accounted for by
the concentrations of pyrethroids detected in the sediment.  Pyrethroids
were rarely detected in the Tennessee sediment samples, and exposure to
the Tennessee sediments did not prove to be toxic to H. azteca.

Future steps

The results of the Weston, et al. studies has led a number of
organizations, such as the California State Water Resources Control
Board (SWRCB) to submit comments to the Agency during the reregistration
process of several pyrethroid insecticides, calling for mitigation
measures to prevent pyrethroid surface-water contamination.  However,
the lack of knowledge which makes it difficult to develop an urban
pesticide transport model also makes it difficult to identify meaningful
mitigation at this time.  The Agency has developed some initial
mitigation options during the reregistration process, and intends to
identify steps which can be taken to allow a greater understanding of
potential ecological risk from urban pyrethroid uses.

One reason that broad mitigation measures cannot be adopted during
reregistration is that only three pyrethroid insecticides are required
to be reviewed for reregistration in 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 reregistration, but also other pyrethroids such as bifenthrin
and lambda-cyhalothrin. 

The next opportunity to assess the pyrethroids as a group will occur
during the Registration Review program, for which the Agency issued a
proposed rule in July 2005 and plans to issue the final rule and
implement the program in 2006.  The purpose of Registration Review is to
ensure the periodic review of all pesticides to make sure they continue
to meet current scientific and regulatory requirements, with the goal of
reviewing each pesticide every fifteen years.  The pyethroids are
tentatively scheduled for re-evaluation under the proposed Registration
Review program in 2010.

A number of steps are planned for the intervening years which should
improve the Agency’s ability to assess the level of aquatic exposure
to pyrethroids from urban use. One step is to better identify what
conditions in an urban setting might lead to greater vulnerability to
transport to urban water bodies.  Although the Weston papers reported
sediment toxicity from samples from California but not Tennessee, the
authors could only speculate what differences in use or geography made
an area more vulnerable to exposure than the other.

Further investigation into the dominant urban uses and application
practices of pyrethroids around the country would help provide a clearer
picture of relative vulnerability.  The SWRCB commented that structural
pest control is likely a major source of pyrethroids in urban runoff,
and suggested best management practices (BMP).  The Pyrethroid Working
Group (PWG) indicated that irrigation of lawns in areas of California
with little rainfall during the application season could be a major
contributor, and has contacted organizations such as Responsible
Industry for a Sound Environment (RISE) and the Coalition for
Urban/Residential Environmental Stewardship (CURES) to develop BMPs as
part of their product stewardship plan.  As further sediment monitoring
studies are published describing parts of the country with different
weather and pest pressures, more detailed usage data will make it easier
to correlate the causes of pyrethroid use practices.

The Agency will also continue in its efforts to develop a
screening-level model for urban pesticide uses.  Advances in the
resolution of GIS databases may allow better representation of the
impervious and pervious portions of a typical urban landscape.  As it
becomes clearer which uses are most likely to lead to transport of
pyrethroids to surface water, the conceptual model of how urban
transport should be simulated will be more focused.

Finally, the Agency will evaluate available published literature and
call-in data to resolve data gaps to ensure a robust comparison of the
potential ecological risk of all the pyrethroids during Registration
Review.  Toxicity data cited by several commenters from published
literature are included in the Agency's ECOTOX database.  The Agency
will evaluate the quality of studies to identify those to be included in
the risk assessments during Registration Review. The PWG has performed
some toxicity studies identified by the Agency as data gaps, such as
sediment invertebrate toxicity tests and those studies are in review.

Interim mitigation required for reregistration

Until the Agency can perform a quantitative risk assessment for the
non-agricultural uses of cypermethrin, the Agency believes that certain
interim mitigation measures are warranted. These mitigation measures are
intended to reduce the runoff and drainage to storm sewers, surface
water, and aquatic habitats associated with the current industrial,
commercial, and residential uses of cypermethrin, and to address
potential risks to aquatic organisms from these existing use patterns.
These mitigation measures should also help to reduce off-site exposure
and risk to terrestrial organisms.

To reduce runoff and drift to water bodies, and to address potential
ecological risks from non-agricultural (industrial, commercial, and
residential) uses of cypermethrin, the following mitigation measures are
required:

For products with indoor and/or outdoor nuisance pest control uses
(other than termiticides)

Limit all outdoor non-termite applications to spot and crack-and-crevice
applications, only, except for the following barrier, perimeter, band or
broadcast spray applications, which are permitted:

Barrier, perimeter or band applications to soil or vegetation around
structures;

Broadcast applications to vegetated residential or commercial
landscapes, including lawns and turf;

Band applications to building foundations, up to a maximum height of 3
feet.

Other than number (3), above, all outdoor non-termite applications to
impervious surfaces such as sidewalks, driveways, patios, porches and
structural surfaces (such as windows, doors, and eaves) are limited to
spot and crack-and-crevice applications, only.

Reduce the maximum broadcast application rate for residential,
commercial, and industrial lawns to 0.44 lbs ai/A (0.0101 lbs ai/1000
ft2) for all formulations.  (Maximum rate was 0.74 lbs ai/A).

For outdoor uses, do not apply within 10 feet of storm drains. Do not
apply within 25 feet of rivers, fish ponds, lakes, streams, reservoirs,
marshes, estuaries, bays, or oceans.

Prohibit application directly into drains, or to any area where drainage
to storm sewers, water bodies, or aquatic habitat can occur. When making
an application around or near a floor drain, limit the application to a
spot treatment and do not allow the product to enter the drain during or
after the application. The use site “Application around or near floor
drains” should be listed separately from other indoor use sites on the
label, with these restrictions.

Broadcast applications to exterior surfaces of boats are prohibited.
Applications to exterior surfaces of boats are limited to spot
treatments, only. Use inside boats, ships, and other vessels is
permitted. Do not allow product to drain or wash off into water bodies
or aquatic habitat. The use site “Application in and on boats”
should be listed separately from other use sites on the label, with
these restrictions.

Cover any water inhabited by fish (such as aquariums and ornamental fish
ponds) during treatment, and turn aquarium systems off.

Remove birds and other pets.  Do not allow pets to enter treated areas
or contact treated surfaces until sprays have dried.

Do not apply when windy (sustained wind speeds or gusts above 10 mph).

After application, do not over-water the treated area to the point of
runoff. Do not apply when raining or when rain is expected within 8
hours.

Rinse application equipment over lawn or garden area only. Do not allow
rinse water to flow into drains (including storm drains), street
gutters, sewers, drainage ditches, water bodies, or aquatic habitat.

Comments were received concerning use of cypermethrin in “swimming
pool water systems.” Application to swimming pool water systems, or to
swimming pools in general, is not a labeled use of cypermethrin.
Cypermethrin may be applied as a broadcast treatment to lawns and other
vegetated areas around swimming pools, or as a spot or crack-and-crevice
treatment to impermeable surfaces (such as tiled walkways) around pools.

A granular product was registered on February 23, 2006 (EPA registration
# 28293-367).  This product is for application to fire ant mounds on
lawns and outside of homes. EPA does not believe that this product, when
used according to label directions (very limited, targeted use),
presents a risk of concern to non-target organisms. 

For pre-construction subterranean termite control

During the phase 3 comment period for cypermethrin, EPA received
comments from California water regulatory agencies concerning the
potential for runoff and aquatic risk from pre-construction
(non-injected) termite applications.  Commenters also submitted label
statements for this use.  After receiving input from the   HYPERLINK
"http://www.aspcro.org/"  Association of Structural Pest Control
Regulatory Officials  (ASPCRO), EPA developed the proposed label
statements listed below.  EPA would like to invite further stakeholder
input on these statements during the post-RED comment period for
cypermethrin.

If concrete slabs cannot be poured over the treated soil on the day of
application, the treated soil must be covered with a waterproof covering
(such as polyethylene sheeting).

Do not treat soil that is water-saturated or frozen. Do not treat when
raining or when rain is expected within 8 hours. All treated areas must
covered (with a waterproof covering) before it starts to rain. If a
waterproof cover is used, storm water runoff must be diverted around the
treatment area to prevent water from contacting or collecting in the
treatment area.

Do not apply within 10 feet of storm drains. Do not apply within 25 feet
of rivers, fish ponds, lakes, streams, reservoirs, marshes, estuaries,
bays, or oceans.

Do not make on-grade applications when sustained wind speeds or gusts
are above 10 mph.

			c.	Endangered Species

The Agency has developed the Endangered Species Protection Program to
identify pesticides whose use may cause adverse impacts on endangered
and threatened species, and to implement mitigation measures that
address these impacts. The Endangered Species Act (ESA) requires federal
agencies to ensure that their actions are not likely to jeopardize
listed species or adversely modify designated critical habitat. To
analyze the potential of registered pesticide uses that may affect any
particular species, EPA uses basic toxicity and exposure data developed
for the REDs and considers it in relation to individual species and
their locations by evaluating important ecological parameters, pesticide
use information, geographic relationship between specific pesticide uses
and species locations, and biological requirements and behavioral
aspects of the particular species, as part of a refined species-specific
analysis. When conducted, this species-specific analysis will take into
consideration any regulatory changes recommended in this RED that are
being implemented at that time. 

Following this future species-specific analysis, a determination that
there is a likelihood of potential impact to a listed species or its
critical habitat may result in: limitations on the use of cypermethrin,
other measures to mitigate any potential impact, or consultations with
the Fish and Wildlife Service or the National Marine Fisheries Service
as necessary. If the Agency determines use of cypermethrin “may
affect” listed species or their designated critical habitat, EPA will
employ the provisions in the Services regulations (50 CFR Part 402).
Until that species-specific analysis is completed, the risk mitigation
measures being implemented through this RED will reduce the likelihood
that endangered and threatened species may be exposed to cypermethrin at
levels of concern. EPA is not requiring specific cypermethrin label
language at the present time relative to threatened and endangered
species. If, in the future, specific measures are necessary for the
protection of listed species, the Agency will implement them through the
Endangered Species Protection Program.

3.	Benefits of Cypermethrin Use and Available Alternatives

Pyrethrin and synthetic pyrethroids, including cypermethrin, cyfluthrin,
deltamethrin, esfenvalerate, lambda cyhalothrin, permethrin, resmethrin,
sumithrin, tetramethrin, and tralomethrin, are available to control a
wide variety of nuisance, lawn and garden plant, structural, and public
health arthropod pests.  Pyrethroids may be applied inside residential
areas as a crack and crevice, area, or spot spray. They may also be
applied in areas adjacent to or surrounding residential areas as a
perimeter treatment to prevent the movement of pests into houses and as
a spot and yard treatment.  Usage data are sparse and generally do not
distinguish between chemicals within the class or differentiate the
amounts used on various residential sites.  The recent loss of
chlorpyrifos and diazinon for residential pest control has resulted in a
greater reliance on pyrethrins and synthetic pyrethroids, as a class,
among residential users.  Most pyrethroids have similar efficacy and
cost.  In the absence of any one pyrethroid, homeowners and professional
applicators would most likely simply substitute another pyrethroid
insecticide.  Users might also substitute insecticides from other
chemical classes (e.g. organophosphates, carbamates, and neonicotinoids)
and nonchemical control techniques (e.g. sanitation or exclusion). 
Given the options for substitution, the economic impacts of restricting
any one chemical would not likely be significant; also, the impact on
risk of restricting any one pyrethroid is uncertain and might increase
given the substitute available.

V.	What Registrants Need to Do

	

The Agency has determined that cypermethrin is eligible for
reregistration provided that the mitigation measures and label changes
identified in this RED are implemented.  Registrants will need to amend
their product labeling to incorporate the label statements set forth in
the Label Changes Summary Table (table 16).  The Agency intends to issue
Data Call-Ins (DCIs) requiring generic and product specific data. 
Generally, the registrant will have 90 days from receipt of a DCI to
complete and submit response forms or request time extensions and/or
waivers with a full written justification.  For product-specific data,
the registrant will have eight months to submit data and amended labels.
 

A.	Manufacturing Use Products

1.	Additional Generic Data Requirements

	The generic data base supporting the reregistration of cypermethrin for
currently registered uses has been reviewed and determined to be
substantially complete.  However, the data listed below are necessary to
confirm the reregistration eligibility decision documented in this RED. 

Table 15. Guideline Requirements for Cypermethrin

Data Requirement	Old Guideline Number	New OPPTS Guideline No.

  SEQ CHAPTER \h \r 1 Life-Cycle Aquatic Invertebrate, Freshwater:	72-4
(b)	850.1350

Additional Residue Chemistry Clarifications

  SEQ CHAPTER \h \r 1 Other needed label changes pertain to the
following: 1) minimum retreatment intervals, 2) minimum aerial
application volumes, and 3) impractical cotton forage grazing/feeding
restrictions.

2.	Labeling Requirements

To ensure compliance with FIFRA, manufacturing use product (MUP)
labeling should be revised to comply with all current EPA regulations,
PR Notices, and applicable policies.  The MUP labeling should bear the
labeling contained in Table 16.

3.	Spray Drift Management

	The Agency has been working closely with stakeholders to develop
improved approaches for mitigating risks to human health and the
environment from pesticide spray and dust drift.  As part of the
reregistration process, the EPA will continue to work with all
interested parties on this important issue.

		

	B. 	End-Use Products 

		

	             1.    Additional Product-Specific Data Requirements

Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of
eligibility has been made.  The Registrant must review previous data
submissions to ensure that they meet current EPA acceptance criteria and
if not, commit to conduct new studies.  If a registrant believes that
previously submitted data meet current testing standards, then the study
MRID numbers should be cited according to the instructions in the
Requirement Status and Registrants Response Form provided for each
product.  The Agency intends to issue a separate product-specific data
call-in (PDCI), outlining specific data requirements.  For any questions
regarding the PDCI, please contact Jane Mitchell at (703) 308-8061.

2.    Labeling for End-Use Products

To be eligible for reregistration, labeling changes are necessary to
implement measures outlined in Section IV above.  Specific language to
incorporate these changes is specified in table 16.  Generally,
conditions for the distribution and sale of products bearing old
labels/labeling will be established when the label changes are approved.
 However, specific existing stocks time frames will be established
case-by-case, depending on the number of products involved, the number
of label changes, and other factors.Labeling Changes Summary Table 16		
		

In order to be eligible for reregistration, amend all product labels to
incorporate the risk mitigation measures outlined in Section IV.  The
following table describes how language on the labels should be amended.

  Table XX: Summary of Labeling Changes for Cypermethrin

Description	

Amended Labeling Language	

Placement on Label

For all Manufacturing Use Products	“Only for formulation into an
insecticide for the following use(s) [fill blank only with those uses
that are being supported by MP registrant].”

“This product must not be formulated into end-use products that
contain directions for use on sod farms, agricultural uncultivated
areas, fencerows, hedgerows, or rights-of-way. These use sites must be
removed from all end-use product labels and any special need
registration must be canceled. 

“This product must not be formulated into wettable powder end use
formulations unless they are packaged in water soluble bags.”

“This product must not be formulated into end-use products that
contain directions for use on both agricultural crops and for other
uses, such as in and around residential, commercial and industrial sites
or on farm animals.  This product may only be formulated into end-use
products that with directions for use for agricultural crop (WPS) uses
only, or end-use products with directions for use for
non-agricultural-crop (Non-WPS) uses only.” 	

Directions for Use

One of these statements may be added to a label to allow reformulation
of the product for a specific use or all additional uses supported by a
formulator or user group	“This product may be used to formulate
products for specific use(s) not listed on the MP label if the
formulator, user group, or grower has complied with U.S. EPA submission
requirements regarding support of such use(s).”

“This product may be used to formulate products for any additional
use(s) not listed on the MP label if the formulator, user group, or
grower has complied with U.S. EPA submission requirements regarding
support of such use(s).”	

Directions for Use

Environmental Hazards Statements Required by the RED and Agency Label
Policies 

	 “This pesticide is toxic to fish, aquatic invertebrates, oysters and
shrimp. Do not discharge effluent containing this product into lakes,
streams, ponds, estuaries, oceans, or other waters unless in accordance
with the requirements of a National 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 Statement 

End Use Products for WPS (agricultural) use ONLY

(Products labeled for non-agricultural occupational uses must have
separate registrations.)

Restricted Use Pesticide required for all products.

	“RESTRICTED USE PESTICIDE Due to Toxicity to fish, aquatic
invertebrates, oysters and shrimp. 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.”
 	Front Panel and Directions for Use 

Handler PPE Requirements Established by the RED  for Wettable Powder
Formulations packaged into water soluble bags.

Note:  Wettable powder formulations must be packaged in Water Soluble
Bags to be eligible for Reregistration.  As an alternative, a dry
flowable formulation may be developed.	“Personal Protective Equipment
(PPE)

“Some materials that are chemical-resistant to this product are
(registrant inserts correct chemical-resistant material). If you want
more options, follow the instructions for category [registrant inserts
A,B,C,D,E,F,G,or H] on an EPA chemical-resistance category selection
chart.” 

“Mixers, loaders, applicators, and other handlers must wear: 

> Long-sleeve shirt and long pants, 

> Shoes plus socks”

“See engineering controls for additional requirements.”

	Precautionary Statements under Hazards to Humans and Domestic Animals 

Handler PPE Requirements Established by the RED1 for Liquid Concentrate
and Dry Flowable formulations.	“Personal Protective Equipment (PPE)

“Mixers, loaders, applicators, and other handlers must wear the
following: 

> Long-sleeve shirt and long pants,

> Shoes and socks,

 “See engineering controls for additional requirements.”  

	

Precautionary Statement under Hazards to Humans and Domestic Animals 

User Safety Requirements	“Follow manufacturer's instructions for
cleaning/maintaining PPE. If no such instructions for washables exist,
use detergent and hot water. Keep and wash PPE separately from other
laundry.

“Discard clothing and other absorbent materials that have been
drenched or heavily contaminated with this product’s concentrate. Do
not reuse them.”

	Precautionary Statements under: Hazards to Humans and Domestic Animals
immediately following PPE Requirements

(Must be placed in a box.)

Engineering controls for Wettable Powder Formulations, formulated into
water soluble bags.

Note:  Wettable powder formulations must be packaged in Water Soluble
Bags to be eligible for Reregistration.  As an alternative, a dry
flowable formulation may be developed.	“Engineering controls” 

“Water-soluble packets when used correctly qualify as a closed
mixing/loading system under the Worker Protection Standard for
Agricultural Pesticides [40 CFR 170.240(d)(4)].    Mixers and loaders
using water-soluble packets must :

-wear the personal protective equipment required in the PPE section of
this labeling for mixers and loaders, and 

 -be provided, and must have immediately available for use, and must
wear in an emergency, such as a broken package, spill, or equipment
breakdown a NIOSH-approved respirator with:

-- a dust/mist filter with MSHA/NIOSH approval number prefix TC-21C or 

-- any N, R, P, or HE filter.”

Instruction to Registrant: Drop the “N” type prefilter from the
respirator statement, if the pesticide product contains, or is used
with, oil.

“Pilots must use an enclosed cockpit that meets the requirements
listed in the Worker Protection Standard (WPS) for agricultural
pesticides [40 CFR 170.240(d)(6)].”

“  SEQ CHAPTER \h \r 1 Human flagging is prohibited.  Flagging to
support aerial application is limited to use of the Global Positioning
System (GPS) or mechanical flaggers.”

	Precautionary Statements under Hazards to Humans and Domestic Animals
Immediately following the User Safety Requirements 

Engineering controls for Liquids and Dry Flowables 	“Engineering
controls” 

 “Pilots must use an enclosed cockpit that meet the requirements
listed in the Worker Protection Standard (WPS) for agricultural
pesticides [40 CFR 170.240(d)(6)].

“  SEQ CHAPTER \h \r 1 Human flagging is prohibited.  Flagging to
support aerial application is limited to use of the Global Positioning
System (GPS) or mechanical flaggers.”	Precautionary Statements:
Hazards to Humans and Domestic Animals Immediately following the User
Safety Requirements 

 

User Safety Recommendations	  SEQ CHAPTER \h \r 1 “USER SAFETY
RECOMMENDATIONS”

“Users should wash hands with plenty of soap and water before eating,
drinking, chewing gum, using tobacco, or using the toilet”

“Users should remove clothing/PPE immediately if pesticide gets
inside.  Then wash thoroughly and put on clean clothing.”

“Users should remove PPE immediately after handling this product. 
Wash the outside of gloves before removing.  As soon as possible, wash
thoroughly and change into clean clothing.”	

Immediately following Engineering Controls

(Must be placed in a box.)

Environmental Hazards 	“ ENVIRONMENTAL HAZARDS” 

“This pesticide is toxic to fish, aquatic invertebrates, oysters and
shrimp. Do not apply directly to water, or to areas where surface water
is present or to intertidal areas below the mean water mark.  Do not
apply when weather conditions favor drift from treated areas.  Drift and
runoff from treated areas may be hazardous to aquatic organisms in
neighboring areas.  Do not contaminate water when disposing of equipment
wash waters.”

“This pesticide is highly toxic to bees exposed to direct treatment or
residues on blooming crops or weeds. Do not apply this product or allow
it to drift to blooming crops if bees are visiting the treatment
area.”

 	

Precautionary Statements under Environmental Hazards 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)	“Do not enter or allow worker entry into treated areas during
the restricted entry interval (REI) of 12 hours.”	Place in the
Direction for Use, In Agricultural Use Requirements Box 

Early Entry Personal Protective Equipment for products with directions
for use within the scope of the WPS	“PPE required for early entry to
treated areas that is permitted under the Worker Protection Standard and
that involves contact with anything that has been treated, such as
plants, soil, or water, is:

* coveralls,

* shoes plus socks

* chemical-resistant gloves made of any waterproof material”	Place in
the Directions for Use In Agricultural Use Requirements box, immediately
following the REI

General Application Restrictions 	“Do not apply this product in a way
that will contact workers or other persons, either directly or through
drift. Only protected handlers may be in the area during application.”

	Place in the Directions for Use directly above the Agricultural Use
Box.

Buffer Zones	“BUFFER ZONES”

Vegetative Buffer Strip

Construct and maintain a 10-foot-wide vegetative filter strip of grass
or other permanent vegetation between the field edge and any water body
or aquatic habitat (such as lakes, reservoirs, rivers, streams, marshes,
natural ponds, estuaries, and commercial fish ponds). Refer to the
following publication for information on constructing and maintaining
effective vegetative buffers:

 Conservation buffers to Reduce Pesticide Losses. Natural Resources
Conservation Service. USDA, NRCS. 2000. Fort Worth, Texas. 21 pp.  
HYPERLINK "http://www.in.nrcs.usda.gov/technical/agronomy/newconbuf.pdf"
 http://www.in.nrcs.usda.gov/technical/agronomy/newconbuf.pdf ”

Buffer Zone for Ground Applications

For ground-boom, chemigation, or airblast applications, do not apply
within 25 feet of water bodies or other aquatic habitats (such as lakes,
reservoirs, rivers, streams, marshes, ponds, estuaries, and commercial
fish ponds).  

Buffer Zone for ULV Aerial Applications

For ultra-low-volume (ULV) aerial application, do not apply within 450
feet of water bodies or other aquatic habitats (such as lakes,
reservoirs, rivers, streams, marshes, ponds, estuaries, and commercial
fish ponds). 

Buffer Zone for NonULV Aerial Applications

For all aerial application, except ULV aerial applications, do not apply
within 150 feet of water bodies or other aquatic habitats (such as
lakes, reservoirs, rivers, streams, marshes, ponds, estuaries, and
commercial fish ponds). 

	Place in Directions for Use under the heading: “BUFER ZONES”

Spray Drift	“Spray drift requirements”

(1)   SEQ CHAPTER \h \r 1 For groundbloom and aerial applications, use
only medium or coarser spray nozzles according to ASABE (S572)
definition for standard nozzles. Aerial applicators must consider flight
speed and nozzle orientation in determining droplet size.

(2) For cotton: make aerial or ground applications when the wind
velocity is 3 to 15 mph. Do not apply when the wind speed is greater
than 15 mph. For all non-aerial applications, wind speed must be
measured adjacent to the application site on the upwind side,
immediately prior to application.  

(3)   SEQ CHAPTER \h \r 1 For all crops other than cotton: make aerial
or ground applications when the wind velocity is 3 to 10 mph. Do not
apply when the wind speed is greater than 10 mph. For all non-aerial
applications, wind speed must be measured adjacent to the application
site on the upwind side, immediately prior to application.

(4)   SEQ CHAPTER \h \r 1 Do not make aerial or ground applications into
temperature inversions.

(5)   SEQ CHAPTER \h \r 1 For ground boom applications, apply with
nozzle height no more than 4 feet above the ground or crop canopy.

(6) 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.

 

(7) For aerial applications, do not release spray at a height greater
than 10 feet above the ground or crop canopy when spraying within 1000
feet of water bodies or aquatic habitat.

(8) For aerial applications, the outermost nozzles must not exceed 60%
of the wingspan or 80% of the rotor blade diameter.

(9)   SEQ CHAPTER \h \r 1 When aerial 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.”

	Directions for Use

Other Application Restrictions (Risk Mitigation)   

(Note: The maximum application rate and maximum seasonal rates specified
in this table must be listed as pounds or gallons of formulated product
per acre, not just as pounds active ingredient)

 	Any directions for use on sod farms, agricultural uncultivated areas,
fencerows, hedgerows, and rights-of-way must be removed from all product
labels. Special Local Need registrations with these uses must be
cancelled. 

Products must be amended to reflect the following maximum application
rates (a.i./A), minimum re-treatment intervals and maximum annual
application rates

Cotton:

Maximum single application rate of 0.1 lbs a.i./A 

Minimum re-treatment interval of 5 days 

Maximum annual application rate of 0.4 lbs a.i./A/year 

 

“Do not make more than 10 synthetic pyrethroid applications (of one
product or combinations of products) to cotton in one growing season.”
 

Pecans:

Maximum single application rate of 0.1 lbs a.i./A

Minimum re-treatment interval of 7 days

Maximum annual application rate of 0.5 lbs a.i./A/year 

All other crops:  

Maximum application rate of 0.1 lbs a.i./A

Minimum re-treatment interval of 7 days

Maximum seasonal application rate of 0.6 lbs a.i./A

	

Place in the Directions for Use   

End Use Products Primarily Intended for Occupational Use
(Non-Agricultural)

Handler PPE Requirements Handler PPE Requirements Established by the RED
for Wettable Powder Formulations packaged into water soluble bags.

Note:  Wettable powder formulations must be packaged in Water Soluble
Bags to be eligible for Reregistration.  As an alternative, a dry
flowable formulation may be developed.

	“Personal Protective Equipment (PPE)

“Some materials that are chemical-resistant to this product are
(registrant inserts correct chemical-resistant material). If you want
more options, follow the instructions for category [registrant inserts
A,B,C,D,E,F,G,or H] on an EPA chemical-resistance category selection
chart.” 

“Mixers, loaders, applicators, and other handlers must wear: 

> Long-sleeve shirt and long pants,

> Shoes plus socks,

> Chemical resistant gloves for mixers loaders and applicators using
handhold or handheld nozzles” 

“See engineering controls for additional requirements”

	

Precautionary Statements  under Hazards to Humans and Domestic Animals 

Handler PPE Requirements Established by the RED1 for Liquid Concentrate,
Granular and Dry Flowable formulations 	“Personal Protective Equipment
(PPE)

“Some materials that are chemical-resistant to this product are
(registrant inserts correct chemical-resistant material).   If you want
more options, follow the instructions for category [registrant inserts
A,B,C,D,E,F,G,or H] on an EPA chemical-resistance category selection
chart.” 

“Mixers, loaders, applicators, and other handlers must wear the
following: 

> Long-sleeve shirt and long pants,

> Shoes and socks,

> Chemical resistant gloves for mixers loaders and applicators using
handhold or handheld nozzles” 

	

Precautionary Statements under Hazards to Humans and Domestic Animals 

Handler PPE Requirements Established by the RED1  for Ready-To-Use
Products (total release foggers, aerosols, pump sprays, wipes, ear tags)

	“Personal Protective Equipment (PPE)

“Handlers must wear: 

> Long-sleeve shirt and long pants,

> Shoes plus socks.”

	Precautionary Statements under Hazards to Humans and Domestic Animals 

User Safety Requirements

	“Follow manufacturer's instructions for cleaning/maintaining PPE. If
no such instructions for washables exist, use detergent and hot water.
Keep and wash PPE separately from other laundry.

Discard clothing and other absorbent materials that have been drenched
or heavily contaminated with this product’s concentrate. Do not reuse
them.”	Precautionary Statements under: Hazards to Humans and Domestic
Animals immediately following PPE Requirements

(Must be placed in a box.)

Engineering controls for Wettable Powder Formulations, formulated into
water soluble bags.

Note:  Wettable powder formulations must be packaged in Water Soluble
Bags to be eligible for Reregistration.  As an alternative, a dry
flowable formulation may be developed.	“Engineering controls” 

“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 a
NIOSH-approved respirator with:

-- a dust/mist filter with MSHA/NIOSH approval number prefix TC-21C or 

-- any N, R, P, or HE filter.”

Instruction to Registrant: Drop the “N” type prefilter from the
respirator statement, if the pesticide product contains, or is used
with, oil.	Precautionary Statements: Hazards to Humans and Domestic
Animals Immediately following the User Safety Requirements

User Safety Recommendations	  SEQ CHAPTER \h \r 1 “USER SAFETY
RECOMMENDATIONS”

“Users should wash hands with plenty of soap and water before eating,
drinking, chewing gum, using tobacco, or using the toilet”

“Users should remove clothing/PPE immediately if pesticide gets
inside.  Then wash thoroughly and put on clean clothing.”

“Users should remove PPE immediately after handling this product. 
Wash the outside of gloves before removing.  As soon as possible, wash
thoroughly and change into clean clothing.”

	

Immediately following Engineering Controls

(Must be placed in a box.)

Environmental Hazard Statements	For products that have outdoor uses:

“This product is extremely toxic to fish, aquatic invertebrates,
oysters and shrimp. Do not apply directly to or near water. Drift and
run-off may be hazardous to fish in water adjacent to treated areas.  Do
not contaminate water when disposing of equipment, washwater, or
rinsate.  See Directions for Use for additional precautions and
requirements.”     

	Precautionary Statements under Environmental Hazards immediately
following the User Safety Recommendations

Entry Restrictions for Products Applied as a Spray	“Do not allow
persons or pets to contact treated surfaces until sprays have dried.”
Directions for Use under General Precautions and Restrictions.

Entry Restrictions for products applied as a Total Release Fogger
Products	“Do not allow persons or pets to enter the treated area,
until vapors, mists, and aerosols have dispersed, and the treated area
has been thoroughly ventilated.”

	Directions for Use under General Precautions and Restrictions 

General Application Restrictions

	“Do not apply this product in a way that will contact people or pets,
either directly or through drift.”

“Do not remain in treated area.  Exit area immediately and remain
outside the treated area until aerosols, vapors, and mists have
dispersed and the treated area has been thoroughly ventilated.”
Directions for Use under General Precautions and Restrictions.

Application Restrictions for End-Use Products labeled for use or that
can be used for outdoor applications 

	“Restrictions For Outdoor Uses”

“For outdoor applications, this product may only be applied as a spot
treatment or crack-and-crevice treatment, except for the following
permitted uses:

Barrier, perimeter or band applications may be made to soil or
vegetation around structures;

Broadcast applications may be made to vegetated residential or
commercial landscapes, including lawns and other turfgrass;

Band applications may be made to building foundations, up to a maximum
height of 3 feet.

Other than application to building foundations, all outdoor applications
to impervious surfaces such as sidewalks, driveways, patios, porches and
structural surfaces (such as windows, doors, and eaves) are limited to
spot treatments or crack-and-crevice applications, only.”

“For outdoor applications, do not apply within 10 feet of storm
drains. Do not apply within 25 feet of rivers, fish ponds, lakes,
streams, reservoirs, marshes, estuaries, bays, and oceans.” 

“Do not apply when windy (sustained wind speeds or gusts above 10
mph).” 

 

“After application, do not over-water the treated area to the point of
runoff. Do not apply when raining or when rain is expected within 8
hours of application.”

“Rinse application equipment over turfgrass (lawn) area only.  Do not
allow rinse water to flow into drains (including storm drains), street
gutters, sewers, drainage ditches, water bodies, or other aquatic
habitats.”

“Do not allow applications to contact water inhabited by fish, such as
aquariums and ornamental fish ponds that are located in/near structures
being treated. Cover any water inhabited by fish during treatment, and
turn aquarium systems off.”

	Directions for Use under the heading:  “Restrictions For Outdoor
Uses”

Application Restrictions for end-use products labeled for or that can be
used on residential lawns or turfgrass at commercial or industrial
sites.

(Note: The maximum application rates specified must be listed as pounds
or gallons of formulated product per acre or per square feet, not just
as pounds active ingredient)

	“Applications to Lawns and Other Turfgrass Sites”

Labels must be amended to reflect the following maximum application rate
on lawns and other turfgrass of 0.44 lbs ai/A (0.0101 lbs ai/1000 ft2).

	Directions for Use under the heading:  Applications to Lawns and Other
Turfgrass Sites

Application Restrictions for end-use products labeled for or that can be
used near or around swimming pools

	“Applications Around Swimming Pools”

“Do not apply directly to swimming pools or swimming pool systems” 

“This product may be applied as a broadcast treatment to lawns and
other vegetated areas around swimming pools, or as a spot treatment or
crack-and-crevice treatment to impermeable surfaces (such as tiled
walkways) around pools.”

	Directions for Use under the heading:  Applications Around Swimming
Pools

Application Restrictions for end-use products labeled for or that can be
used near or around floor drains	The use site “Applications around or
near floor drains” must be listed separately from other use sites on
the label along with these restrictions.

 

 “Applications Around or Near Floor Drains”

“Do not apply directly into floor drains, or to any area where
drainage to storm sewers, water bodies, or other aquatic habitat can
occur.  When making an application around or near a floor drain, limit
the application to a spot treatment and do not allow the product to
enter the drain during or after the application.”	Directions for Use
under the heading:  Applications Around or Near Floor Drains

Application Restrictions for end-use products labeled for or that can be
used in or on boats	“Applications In and On Boats”

The use site “Application in and on boats” should be listed
separately from other use sites on the label, along with these
restrictions.

“Broadcast applications to exterior surfaces of boats are prohibited.
Applications to exterior surfaces of boats are limited to spot
treatments only. However, do not apply to boat surfaces which contact
water.”

“Use inside boats, ships, and other vessels is permitted. Do not allow
product to drain or wash off into water bodies or other aquatic
habitat.” 

	Directions for Use under the heading:  Applications In and on Boats

Application Restrictions for end-use products labeled for or that can be
used near or around aircraft

	“Applications Near or Around Aircraft”

“Do not apply to aircraft cabins.”	Directions for Use under the
heading:  Applications Near or Around Aircraft 

Application Restrictions for end-use products labeled for termite
control

	“Termite Control”

“All leaks resulting in the deposition of termiticide in locations
other than those prescribed on this label must be cleaned up prior to
leaving the application site. Do not allow people or pets to contact
contaminated areas or to reoccupy the contaminated area of the structure
until the clean up is completed.” 

	Directions for Use under the heading:  Termite Control

Application Restrictions for end-use products labeled for subterranean
termite control

 

	“Subterranean Termite Control”

“Use anti-backflow equipment or procedures to prevent siphonage of
pesticide back into water supplies.”

“Do not treat soil beneath structures that contain wells or
cisterns.”

“Care should be taken that the treatment solution is not introduced
into the gravel and/or pipe drainage system which may be located on the
exterior of the foundation in close proximity to the footing of the
structure.”

“Care must be taken to avoid runoff. Do not treat soil that is
water-saturated or frozen. Do not treat when raining or when rain is
expected within 8 hours.”

“Consult state and local specifications for recommended distance of
treatment areas from wells. Refer to Federal Housing Administration
Specifications for guidance on preconstruction treatments.”

	Directions for Use under the heading:  Subterranean Termite Control

Application Restrictions for end-use products labeled for
preconstruction subterranean termite control

	“Preconstruction Applications for Subterranean Termite Control”

“If concrete slabs cannot be poured over the treated soil on the day
of application, the treated soil must be covered with a waterproof
covering (such as polyethylene sheeting).”

“Do not treat soil that is water-saturated or frozen. Do not treat
when raining or when rain is expected within 8 hours. All treated areas
must covered (with a waterproof covering) before it starts to rain.
Storm water runoff must be diverted around the treatment area to prevent
water from contacting or collecting in the treatment area.”

“Do not apply within 10 feet of storm drains. Do not apply within 25
feet of rivers, fish ponds, lakes, streams, reservoirs, marshes,
estuaries, bays, or oceans.”

“Do not make on-grade applications when sustained wind speeds or gusts
are above 10 mph.”

“Whenever possible, make termite control applications near the
structure foundation using soil injection.”  

	Directions for Use under the heading:  “Preconstruction Applications
for Subterranean Termite Control”

Application Restrictions for end-use products labeled for or that can be
used indoors for uses other than termite control.

	“Restrictions For Indoor Uses” 

“Do not use water-based sprays in conduits, motor housings, junction
boxes, switch boxes, or other electrical equipment because of possible
shock hazard.”

Pet Restrictions:  “Do not apply to pets.  Remove birds and other
pets.  Do not allow pets to enter treated areas or contact treated
surfaces until sprays have dried.  Cover any water inhabited by fish
(such as aquariums and ornamental fish ponds) during treatment, and turn
aquarium systems off.”

 “During any indoor surface application, do not allow dripping or
runoff to occur. During any application to ceilings of a structure,
cover surface below with plastic shielding or similar material.”

 

“Do not apply this product in any room being used as a living, eating,
or recovery area by patients, the elderly, or the infirm when they are
in the room.”

“Do not apply to classrooms when in use.” 

“Do not apply to areas of institutions (including libraries, sport
facilities, etc.) when occupants are present in the immediate treatment
area.”

“Do not use as a space spray”

“Use only in well-ventilated areas.”

“Do not use concentrate or emulsion in fogging equipment.” (Non RTU
Formulations only)

“Do not use in food areas of food handling establishments,
restaurants, or other areas where food is commercially prepared or
processed. Do not use in serving areas while food is exposed or facility
is in operation. Serving areas are areas where prepared foods are
served, such as dining rooms, but excluding areas where foods may be
prepared or held. In the home, all food processing surfaces and utensils
should be covered during treatment or thoroughly washed before use.
Exposed food should be covered or removed.”

“Do not use in warehouses while raw agricultural commodities for food
or feed, and/or raw or cured tobacco are being stored.” 

“Do not use in greenhouses where crops for food or feed are grown.”

	Directions for Use under the heading:  “Restrictions For Indoor
Uses”

End Use Products Primarily Intended for Consumer Residential Use

Environmental Hazard Statements, except for impregnated ready-to-use
products, such as ear tags or animal wipes

	“This product is extremely toxic to fish, aquatic invertebrates,
oysters and shrimp.  Do not apply directly to or near water.  Drift and
run-off may be hazardous to fish in water adjacent to treated areas.  Do
not contaminate water when disposing of equipment, washwater, or
rinsate.  See Directions for Use for additional precautions and
requirements.”     

	Precautionary Statements under Environmental Hazards 

  SEQ CHAPTER \h \r 1 Homeowner User Safety Recommendations Statements

	  SEQ CHAPTER \h \r 1 “User Safety Recommendations”

“Users should wash hands with plenty of soap and water before eating,
drinking, chewing gum, using tobacco, or using the toilet.”

“Users should remove clothing immediately if pesticide gets inside. 
Then wash thoroughly and put on clean clothing.”	Precautionary
Statements under: Hazards to Humans and Domestic Animals

Entry Restrictions for Products Applied as a Spray	

“Do not allow adults, children or pets to enter the treated area or
contact treated surfaces until sprays have dried.”	Directions for Use
Under General Precautions and Restrictions.

Entry Restrictions for Total Release Fogger Products	“Do not allow
adults, children, or pets to enter the treated area, until vapors,
mists, and aerosols have dispersed, and the treated area has been
thoroughly ventilated.”

	Directions for use under General Precautions and Restrictions

Entry Restrictions for end-use products applied dry (granulars)	“Do
not allow adults, children, or pets to enter the treated area or contact
treated surfaces until dusts have settled.”  	Directions for use under
General Precautions and Restrictions

General Application Restrictions 	Products applied as a spray: 

“Do not apply this product in a way that will contact any person, pet,
either directly or through drift.  Keep people and pets out of the area
during application.  Exit area immediately and remain outside the
treated area until sprays have dried.” 

Total Release Fogger Products:

“Do not apply this product in a way that will contact any person or
pet, either directly or through drift.  Keep people and pets out of the
area during application.  Exit area immediately and remain outside the
treated area until the area is thoroughly ventilated and until aerosols,
vapors, and/or mists have dispersed.” 

Products applied dry (granulars):

“Do not apply this product in a way that will contact any person, pet,
either directly or through drift.  Keep people and pets out of the area
during application.  Exit area immediately and remain outside the
treated area until dusts have settled. 	Place in the Direction for Use

Application Restrictions for End-Use Products labeled for use or that
can be used for outdoor applications 

	“Application to Outdoor Sites”

“For outdoor applications, this product may only be applied as a spot
treatment or crack-and-crevice treatment, except for the following
permitted uses:

Barrier, perimeter or band applications may be made to soil or
vegetation around structures;

Broadcast applications may be made to vegetated residential or
commercial landscapes, including lawns and other turfgrass;

Band applications may be made to building foundations, up to a maximum
height of 3 feet.

Other than application to building foundations, all outdoor applications
to impervious surfaces such as sidewalks, driveways, patios, porches and
structural surfaces (such as windows, doors, and eaves) are limited to
spot treatments or crack-and-crevice applications, only.”

“For outdoor uses, do not apply within 10 feet of storm drains. Do not
apply within 25 feet of rivers, fish ponds, lakes, streams, reservoirs,
marshes, estuaries, bays, and oceans.” 

“Do not apply when windy (sustained wind speeds or gusts above 10
mph).” 

 

“After application, do not over-water the treated area to the point of
runoff. Do not apply when raining or when rain is expected within 8
hours of application.”

“Rinse application equipment over treated area only.  Do not allow
rinse water to flow into drains (including storm drains), street
gutters, sewers, drainage ditches, water bodies, or aquatic habitat.”

“Do not allow applications to contact water inhabited by fish, such as
aquariums and ornamental fish ponds that are located in/near structures
being treated. Cover any water inhabited by fish during treatment, and
turn aquarium systems off.”

	Directions for use under the heading:  “Application to Outdoor
Sites”

Application Restrictions for end-use products labeled for or that can be
used on lawns, gardens, ornamentals, or other residential landscape
sites

(Note: The maximum application rates specified must be listed as pounds
or gallons of formulated product per acre or per square feet, not just
as pounds active ingredient)

	“Applications to Lawns, Gardens, Ornamentals, and Other Landscape
Sites”

Labels must be amended to reflect the following maximum application rate
of 0.44 lbs ai/A (0.0101 lbs ai/1000 ft2).    Rates must be expressed as
fluid ounces or lbs of formulated product.

	Directions for Use under the heading:  “Applications to Lawns,
Gardens, Ornamentals, and Other Landscape Sites”

Application Restrictions for end-use products labeled for or that can be
used near or around swimming pools

	“Applications Around Swimming Pools”

“Do not apply directly to swimming pools or swimming pool systems” 

“This product may be applied as a broadcast treatment to lawns and
other vegetated areas around swimming pools, or as a spot treatment or
crack-and-crevice treatment to impermeable surfaces (such as tiled
walkways) around pools.”

	Directions for Use under the heading:  “Applications Around Swimming
Pools”

Application Restrictions for end-use products labeled for or that can be
used near or around floor drains	“Applications Around or Near Floor
Drains”

“Do not apply directly into floor drains, or to any area where
drainage to storm sewers, water bodies, or other aquatic habitats can
occur.”

“When making an application around or near a floor drain, limit the
application to a spot treatment and do not allow the product to enter
the drain during or after the application.”

	Directions for Use under the heading:  “Applications Around or Near
Floor Drains”

Application Restrictions for end-use products labeled for or that can be
used in or on boats	“Applications In and on Boats”

“Broadcast applications to exterior surfaces of boats are prohibited.
Applications to exterior surfaces of boats are limited to spot
treatments only. Do not apply to boat surfaces that contact water.  Use
inside boats is permitted. Do not allow product to drain or wash off
into water bodies or other aquatic habitats.” 

	Directions for Use under the heading:  “Applications In and on
Boats”

Application Restrictions for End-Use Products labeled for use or that
can be used for indoor applications 

 

	“Application to Indoor Sites”

“Do not use water-based sprays in conduits, motor housings, junction
boxes, switch boxes, or other electrical equipment because of possible
shock hazard.”

“Do not apply to pets. Remove birds and other pets.  Do not allow pets
to enter treated areas or contact treated surfaces until sprays have
dried. Cover any water inhabited by fish (such as aquariums and
ornamental fish ponds) during treatment, and turn aquarium systems
off.”

 “During any indoor surface application, do not allow dripping or
runoff to occur. During any application to ceilings of a structure,
cover surface below with plastic shielding or similar material.”

 

“Do not use as a space spray.”  

“Use only in well-ventilated areas.” 

“Do not apply to classrooms when in use.” 

“Do not apply to areas of institutions (including libraries, sport
facilities, etc.) when occupants are present in the immediate treatment
area.”

“Do not use concentrate or emulsion in fogging equipment.” (all
formulations, except ready-to-use formulations)  

“All food preparation surfaces and utensils should be covered during
treatment or thoroughly washed before use. Exposed food should be
covered or removed.”

“Do not use in greenhouses where plants are grown for food.”

	

Directions for use under the heading:  “Application to Indoor Sites”

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.

2 If the product contains oil or bears instructions that will allow
application with an oil-containing material, the (N( designation must be
dropped.				



                                          Appendix A. Uses of
Cypermethrin Eligible for Reregistration

Appendix A. Uses of Cypermethrin Eligible for Reregistration

Appendix A:  Agricultural Uses of Cypermethrin Eligible for
Reregistration

Site

Application Type

Application Timing

Application Equipment	

Maximum Single Appl. Rate (ai)	Maximum Preharvest Interval  (PHI) (Days)
Minimum Reentry Interval (REI)	

Max.Yearly Application Rate

(ai).

	

Minimum Retreatment Interval (Days)	

Use Limitations 1

Maximum Application Rates for Registered Cypermethrin Agricultural Crop
Uses

Cotton

Foliar broadcast application

Ground, sprinkler irrigation,

 or aerial equipment	0.1 lb/A	14 days	12	

0.4 lbs a.i./A/year	5 days	Applications may be made in water or refined
vegetable oil.  When using water, applications may be made in a minimum
of 5 gal of finished spray/A using ground equipment or 1 gal of finished
spray/A using aerial equipment.  One quart of emulsified oil (minimum)
may be substituted for one quart of water in aerial applications.  When
using oil, applications may be made in a minimum of 1 qt/A in the
finished spray.  Applications may be made alone or as a tank mix with
other products approved for use on cotton.  The grazing or feeding of
cotton forage is prohibited.  

Do not make more than 10 synthetic pyrethroid applications (of one
product or combinations of products) to cotton in one growing season.

Pecans

Foliar broadcast application

Pre-shuck split

Ground equipment	0.1 lb/A	21 days	12	0.5 lbs a.i./A/year	7	

Ground applications may be made to the point of drip; 100 gal/A for
smaller trees and 200 to 300 gal/A for larger trees.  The grazing of
livestock in treated orchards or cutting of treated cover crops for feed
is prohibited. 

Head and stem Brassica, and  Leafy Brassica Greens sub groups

Foliar broadcast application

Ground or aerial equipment	0.1 lb/A	1 day	12	0.6 lbs a.i./A/year	

7	

Applications may be made in a minimum of 15 gal/A using ground equipment
or 5 gal/A using aerial equipment. 

Head lettuce and Onion, bulb& green (including garlic and shallots)
subgroups

 

Foliar broadcast application

Ground or aerial equipment	0.1 lb/A	5 days	12	0.6 lbs a.i./A/year	7	

Applications may be made in a minimum of 15 gal/A using ground equipment
or 5 gal/A using aerial equipment. 

Ornamental Plants

Groundboom  airblast, handgun	3.4 lb ai/A

	NA	NA	NA	NA	Do not allow children or pets to contact treated surfaces
until sprays have dried.

Low pressure                      handwand sprayer	0.008 lb ai/gal	NA	NA
0.4 lbs a.i./A	NA

	

Top Soil, Potting Soil

              

               Handgun	

3.4 lb ai/A

	NA	NA	0.4 lbs a.i./A	NA	Do not allow children or pets to contact
treated surfaces until sprays have dried.

Maximum Application Rates for Registered Cypermethrin uses in 
Food-Handling Establishments              

Spot or crack/crevice

 application

Brush or spray equipment	

0.2%	

NA	NA	

NA	

NA	

Application is allowed in non-food areas of food-handling establishments
(other than private residences) in which food is held, processed,
prepared or served.  

Use in food areas of food handling establishments, restaurants or other
areas where food is commercially prepared is prohibited.  The label
prohibits use in serving areas while food is exposed or facility is in
operation.  The label specifies that in the home all food processing
surfaces and utensils should be covered during treatment or thoroughly
washed before use; exposed food should be covered or removed. 

Application in warehouses where raw or cured tobacco is stored, or while
raw agricultural commodities for food or feed are being stored is
prohibited.  Applications may be repeated as necessary.

Spot or crack/crevice

 application

Brush or spray equipment	0.1%	NA	NA	NA	NA	

Applications may be repeated as necessary.

Do not allow children or pets to contact treated surfaces until sprays
have dried.

Appendix A:  Non-Agricultural Registered Uses of Cypermethrin



Site

      Application Type

     Application Timing

Application Equipment

	

Maximum Single Appl. Rate (ai)

	

Entry Prohibition

	

Use Limitations 1

Maximum Application Rates for Registered Cypermethrin Occupational (not
Agricultural Crop) Uses

Maximum Application Rates for Registered Cypermethrin uses in 
Food-Handling Establishments              

Spot or crack/crevice

 application

Brush or spray equipment	

0.2%	Do not allow children or pets in treated area until surfaces are
dry.	

Application is allowed in non-food areas of food-handling establishments
(other than private residences) in which food is held, processed,
prepared or served.  

Use in food areas of food handling establishments, restaurants or other
areas where food is commercially prepared is prohibited.  The label
prohibits use in serving areas while food is exposed or facility is in
operation.  The label specifies that in the home all food processing
surfaces and utensils should be covered during treatment or thoroughly
washed before use; exposed food should be covered or removed. 

Application in warehouses where raw or cured tobacco is stored, or while
raw agricultural commodities for food or feed are being stored is
prohibited.  Applications may be repeated as necessary.

Spot or crack/crevice

 application

Brush or spray equipment	

0.1%

Applications may be repeated as necessary.

Non-termite application 

Residential, Commercial and Industrial Lawns 	0.44 lb ai/A (liquid
concentrate)	Do not allow adults, children or pets to enter the treated
area or contact treated surfaces until sprays have dried.	Do not apply
when windy (sustained wind speeds or gusts above 10 mph).

Do not allow applications to contact water inhabited by fish, such as
aquariums and ornamental fish ponds that are located in/near structures
being treated. Cover any water inhabited by fish during treatment, and
turn aquarium systems off.

Do not apply this product in a way that will contact any person, pet,
either directly or through drift.  Keep people and pets out of the area
during application.  

	0.282 lb ai /cup/mound (granules) 	Do not allow adults, children, or
pets to enter the treated area or contact treated surfaces until dusts
have settled.

Exit area immediately and remain outside the treated area until dusts
have settled.

	Indoor and outdoor surfaces at residential, commercial and industrial
sites, animal premises 	0.0014 lb ai/fogger (broadcast) 	Do not remain
in treated area.  Exit area immediately and remain outside the treated
area until aerosols, vapors, and mists have dispersed and the treated
area has been thoroughly ventilated.

	Do not use in greenhouses where crops for food or feed are grown.

 

During any indoor surface application, do not allow dripping or runoff
to occur. During any application to ceilings of a structure, cover
surface below with plastic shielding or similar material. 

Do not apply this product in a way that will contact any person, pet,
either directly or through drift.  Keep people and pets out of the area
during application.  

 

Do not apply when windy (sustained wind speeds or gusts above 10 mph).

	0.005 lb ai/16 oz can	Do not allow adults, children or pets to enter
the treated area or contact treated surfaces until sprays have dried.

.017 lb ai/gallon (crack & crevice)

	0.282 lb ai /cup/mound (granules)	Do not allow adults, children, or
pets to enter the treated area or contact treated surfaces until dusts
have settled.

Exit area immediately and remain outside the treated area until dusts
have settled.

	Termite Applications

To soil and sides of buildings near to ground,  building perimeters,
masonry voids, and standing wood in uninhabited areas 	05 lb ai/gallon 
Do not remain in treated area.  Exit area immediately and remain outside
the treated area until aerosols, vapors, and mists have dispersed and
the treated area has been thoroughly ventilated.

All leaks resulting in the deposition of termiticide in locations other
than those prescribed on this label must be cleaned up prior to leaving
the application site. Do not allow people or pets to contact
contaminated areas or to reoccupy the contaminated area of the structure
until the clean up is completed. 

	Do not apply this product in a way that will contact people or pets,
either directly or through drift.

Care must be taken to avoid runoff. Do not treat soil that is
water-saturated or frozen. Do not treat when raining or when rain is
expected within 8 hours.

Termites applications to  preconstruction lumber and logs, and to soil
under firewood	

0.041 lb ai/gallon

Termite Applications to standing wood in uninhabited areas at
residential, commercial and industrial sites	0.008 lb ai/gallon

Termites: trees, utility poles, fenceposts, building voids	

0.05 lb ai/gallon

Livestock 

Cattle	

0.003 lb ai/2 ear tags	NA	Cover feed and water prior to treatment

Horses	

0.017 lb ai/gallon

	

0.00041 lb ai/wipe

Maximum Application Rates for Registered Cypermethrin Residential Uses

Indoor Spaces	0.0014 lb ai/ fogger	Do not allow adults, children, or
pets to enter the treated area, until vapors, mists, and aerosols have
dispersed, and the treated area has been thoroughly ventilated.

 

Keep people and pets out of the area during application.

	Do not apply this product in a way that will contact any person, pet,
either directly or through drift.  

Do not apply to pets.

Do not use as a space spray.

Use only in well-ventilated areas.

Do not use concentrate or emulsion in fogging equipment.

Indoor surfaces	

0.005 lb ai/sixteen ounce can	Do not allow adults, children or pets to
enter the treated area or contact treated surfaces until sprays have
dried.	During any indoor surface application, do not allow dripping or
runoff to occur. During any application to ceilings of a structure,
cover surface below with plastic shielding or similar material.

  

Remove food and animals from premises prior to treatment.

Horses	0.017 lb ai/gallon	NA	Cover feed and water prior to treatment

	

0.00041 lb ai/wipe

  SEQ CHAPTER \h \r 1 Appendix B.  Table of Generic Data Requirements
and Studies Used to Make the Reregistration Decision for Cypermethrin 

  SEQ CHAPTER \h \r 1 Appendix B.  Table of Generic Data Requirements
and Studies Used to Make the Reregistration Decision for Cypermethrin 

GUIDE TO APPENDIX B

	Appendix B contains a listing of data requirements which support the
reregistration for active ingredients within the pyrethrins case covered
by this RED.  It contains generic data requirements that apply
pyrethrins in all products, including data requirements for which a
“typical formulation” is the test substance.

The data table is organized in the following formats:

Data requirement (Column 1).  The data requirements are listed in the
order in which they appear in 40 CFR 158.  The reference numbers
accompanying each test refer to the test protocols set in the Pesticide
Assessment Guidance, which is available from the National Technical
Information Service, 5285 Port Royal Road, Springfield, VA 22161.  (703)
487-4650.

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.

Terrestrial food

Terrestrial feed

Terrestrial non-food

Aquatic food

Aquatic non-food outdoor

Aquatic non-food industrial

Aquatic non-food residential

Greenhouse food

Greenhouse non-food

Forestry

Residential

Indoor food

Indoor non-food

Indoor medical

Indoor residential

3.  Bibliographic Citation (Column 3).  If the Agency has acceptable
data in its files, this column lists the identifying number of each
study.  This normally is the Master Record Identification (MRID) number,
but may be a “GS” number is no MRID number has been assigned.  Refer
to the Bibliography appendix for a complete citation of the study.

Data Requirement	Use Patterns	Citations

New Guideline Number	Old Guideline Number	Description

PRODUCT CHEMISTRY

830.1550	61-1	Product Identity and Composition	All	86966, 97866, 97869,
133028, 161909, 40513301, 41887001, 45462101 

830.1700	61-3   	 Discussion of Formation of Impurities	All	81566,
42068501, 40513301, 41887001, 45462101   

830.1700	62-1	Preliminary Analysis	All	46775902, 42043801, 41887002,
45462101, 45850201, 

830.1750	62-2	Certification of Limits	All	90032, 97865, 97868, 41887002,
45462101, 46775902

830.1800	62-3	Analytical Method	All	46775902, 42043801, 161909, 45462101

830.6302	61-2   	Description of Beginning Materials and Manufacturing
Process	All	81566, 90032, 97865, 97868, 102991, 115281, 133028, 161909,
40513301, 41887001,  42068501,45462101, 42854301, 

830.6302	63-0	Reports of Multiple phys/chem Characteristics	All
41887003, 102991, 133028, 161909, 40513301, 42868201, 42868202,  
45474201, 

  SEQ CHAPTER \h \r 1 830.6317	63-17	  SEQ CHAPTER \h \r 1 Storage
stability	All	133028, 161909, 45474201

830.7050	None	UV/Visible Absorption	All	46775902

830.7370	63-10	Dissociation Constants in Water	All	42650601

830.7550	63-11	Partition coefficient, shake flask method	All	161909

ECOLOGICAL EFFECTS

850.1010	72-2	Acute Toxicity to Freshwater Invertebrates	All	43293501,
44423501, 90071, 90072, 44546025,  41068004, 62793, 41968210, 43293501,
44074401, 44074402, 44074406, 44546031, 44546032, 152737, 90075

850.1075	72-1	Acute Toxicity to Freshwater Fish	All	62792, 65812, 88948,
41968208, 41968209, 44546028, 44546029, 65813, 88947, 88948, 89037, 
89038, 41068004, 41068003, 89039, 44546027, 65813,  44546030, 

850.1400	72-4 	Fish Early Life Stage/Aquatic Invertebrate Life Cycle
Study	All	DATA GAP, 155770, 42725301, 44546035, 45121822, 155772,  

850.1850	72-6 	Aquatic org. accumulation	All	42868203

850.2100	71-1	Avian Single Dose Oral Toxicity	All	44546024, 90070

850.2200	71-2	Avian Dietary Toxicity	All	90072, 90071, 132149, 44546025,
44546026

850.2300	71-4	Avian Reproduction	All	DATA GAP, 90074, 42322902,
42322901, 98036

875.2400	133-3 	Dermal passive dosimetry expo	All	44459801, 44518501

875.2500	133-4  	 Inhal. passive dosimetry expo	All	44459801,
44518501

TOXICOLOGY

None	82-7  	Subchronic Neurotoxicity	All	44962202, 43152002, 

850.1045	72-3	Panaeid Acute Toxicity Test	A, B, D	 90075 , 89049, 90075,
41968211, 41968212, 42444601, 44546033, 44546034, 44561210

850.1735	(NONE)	Whole Sediment Acute Toxicity Testing with Freshwater
Invertebrates (Chironomus tentans)	A, B, D	DATA GAP

850.3020	141-1

	Honey bee acute contact LD50	A, B, D	44544208

870.1100	81-1	Acute Oral Toxicity - Rat	All	56800, 40377701

870.1200	81-2	Acute Dermal Toxicity – Rabbit/Rat	All	56800, 40377701

870.1300	81-3	Acute Inhalation Toxicity – Rat	All	42395702

870.1400	83-1   	Chronic Toxicity	All	44536801, 112909, 112910,
42068503, 92027037,  

870.2400	81-4	Primary Eye Irritation  - Rabbit	All	56800, 40377701

870.2500	81-5	Primary Skin Irritation	All	56800, 40377701

870.2600	81-6	Dermal Sensitization	All	56800, 40377701

870.3150	82-1 	Subchronic Oral Toxicity: 90-Day Study	A, B, D	112929,
56802, 41776101, 44527002, 92027034

870.3200	82-2	21-Day Dermal – Rabbit/Rat	A, B, D	90035, 45010401

870.3465	82-4  	90-day inhal.-rat	A, B, D	43507101, 90040, 112912

870.3700	83-3	Teratogenicity -- 2 Species	A, B, D	56805, 41776102,
43776301, 43776302

870.3800	84-2  	Interaction with Gonadal DNA	All	90036, 90037, 90038,
126834, 92027042, 92027062, 92027043, 90039, 41599801, 

870.3800	83-4	2-Generation Reproduction – Rat	A, B, D	56804, 112912,
42068504, 90040, 41968204, 92027040, 112912,

870.4200	83-2  	Oncogenicity	All	112910, 112911, 92027038 

870.6200	81-8	Acute neurotoxicity screen study in rats	All	44962201,
43152001, 

870.7485	85-1	General Metabolism	A, B, D	41551102, 41551103, 41551104

ENVIRONMENTAL FATE

835.6200	164-2

	Aquatic Field Dissipation	A, B, D	44876107

RESIDUE CHEMISTRY

835.1240	163-1	Leaching/Adsorption/Desorption	A, B, D	42129003, 42129002

835.2120	161-1	Hydrolysis	A, B, D	42620501

835.2240	161-2	Photodegradation - Water	A, B, D	42395701

835.2410	161-3	Photodegradation - Soil	A, B, D	42129001

835.4100	162-1	Aerobic Soil Metabolism	A, B, D	42156601

835.4200	162-2

	Anaerobic Soil Metabolism	A, B, D	42156602

835.4300	162-4	Aerobic Aquatic Metabolism	A, B, D	45920801

835.4400	162-3	Anaerobic Aquatic Metabolism	A, B, D	44876105

835.6100	164-1	Terrestrial Field Dissipation	A, B, D	42459601

850.1730	165-4	Accumulation in Fish	A, B, D	42868203

860.1300	171-4A1	Characterization of Total Terminal Residue	All
42169901, 42169903

860.1300	171-4A2	Nature of the Residue in Plants

	A, B, D	58170, 90064, 98000, 125658, 42876301, 43775101, 127892,
43421301, 43270201 

860.1300	171-4A3	Nature of the Residue in Livestock

	A, B, D	89014, 42410001, 42876302, 43278002, 43278001 

860.1300	171-4B	Nature of Residue – Livestock (Goat)	A, B, D	35127,
125658, 41899802, 81571, 127892, 40880202, 43278003, 43775103, 43775104,
43775105, 43775106, 43775107,  43775108, 145249, 81574, 41470906,
42222804, 41274701, 41274702, 43328403, 43841302, 

860.1340	171-4C	Residue Analytical Method – Plants	A, B, D

	34562, 58170, 89415, 35127,  125658, 90027,  90028, 127892, 42177001,
43578201, 43578202, 92027056, 145249, 43009701, 43009702, 43516001,
43578203, 43578205, 43578206,  43775109, 43775110, 67376, 81575, 131670,
43578204, 90046, 90050, 132000, 132828, 43172001, 41390202, 41470901,  
42222801, 43278001, 41892605,  42201701, 42201704, 43328401, 43841301, 
43775102, 43899401, 43899402

860.1500	171-4K	Crop field trials	A, B, D	46775904

860.1520	171-4L	Magnitude of Residue in Processed Food/Feed – Apple
(juice and wet pomace)	A, B, D	46775904

 860.1540	171-5  	Reduction of residues	All	67377

OTHER

Non-guideline Study	Non-guideline Study	Data Waiver Rationale	All
46775903

Non-guideline Study	Non-guideline Study	Legal and regulatory documents
All	130888

Non-guideline Study	Non-guideline Study	Complete primary report --
experimental research	A, B, D	46775906, 131455, 46538902,  46670401,
46670402, 46670403, 43261603, 70562, 41054701,  89047

Non-guideline Study	Non-guideline Study	Opinion or commentary from
interested groups	All	46775901, 

Non-guideline Study	Non-guideline Study	Transmittal documents	All
44972201, 41390200, 41892600, 43578200, 43841300

APPENDIX C:  Technical Support Documents

APPENDIX C:  Technical Support Documents

  TC "Appendix C. Technical Support Documents" \f C \l "2"  

Additional documentation in support of this RED is maintained in the OPP
docket EPA-HQ-OPP-200X-0XXX.  This docket may be accessed in the OPP
docket room located at Room S-4900, One Potomac Yard, 2777 S. Crystal
Drive, Arlington, VA.  It is open Monday through Friday, excluding
Federal holidays, from 8:30 a.m. to 4:00 p.m.  All documents may be
viewed in the OPP docket room or downloaded or viewed via the Internet
at the following site:     HYPERLINK "http://www.epa.gov/REDs/" 
http://www.regulations.gov .

Appendix D. 	Citations Considered to be Part of the Data Base
Supporting the Reregistration Eligibility Decision

Appendix D. 	Citations Considered to be Part of the Data Base Supporting
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Guttmann, E. (1990) ICI Americas Inc. Phase 3 Summary of MRID 00112909.
Cypermethrin: One Year Oral Dosing Study in Dogs: CTL Report No.:
CTL/P/703; CTL Study No.: PD0398.: 8 p. 

92027038	Barber, J. (1990) ICI Americas Inc. Phase 3 Summary of MRID
00112911 and Related MRIDs 00133338, 00163497. Cypermethrin: Lifetime
Feeding Study in Mice: CTL Report Nos.: CTL/P/687, CTL/P/687A,
CTL/P/1614; CTL Study No.: PM0366.: 8 p. 

92027040	Guttmann, E. (1990) ICI Americas Inc. Phase 3 Summary of MRID
00112912. Cypermethrin: Three Generation Reproduction Study in the Rat:
CTL Report No.: CTL/P/683; CTL Study No.: RR0143.: 9 p. 

92027042	Callander, R. (1990) ICI Americas Inc. Phase 3 Summary of MRID
00090037. An Examination of Cypermethrin for Potential Mutagenicity
Using the Salmonella/Microsome Reverse Mutation Assay: CTL Report No.:
CTL/P/595; CTL Study Nos.: YV0017, YV0026, YV0199. Prepared by ICI
Central Toxicology Laboratory. 7 p. 

92027043	Mackay, J. (1990) ICI Americas Inc. Phase 3 Summary of MRID
00090038. Toxicity Studies with WL 43467: Chromosome Studies on Bone
Marrow Cells of Chinese Hamsters after Two Daily Oral Doses of WL 43467:
Report No.: TLGR.0136.77; Study No.: 1110; CTL Report No.: CTl/C/1052.
Prepared by Shell Research Ltd. 6 p. 

92027056	Leung, L. (1990) ICI Americas Inc. Phase 3 Summary of MRID
00071380. Cypermethrin (FMC 30980)-Storage Stability.: 9 p. 

92027062	Trueman, R. (1990) ICI Americas Inc. Phase 3 Reformat of MRID
00090037. An Examination of Cypermethrin for Potential Mutagenicity
Using the Salmonella/Microsome Reverse Mutation Assay: CTL Report No.:
CTL/P/595; CTL Study Nos.: YV0017, YV0199, YV0026. Prepared by ICI
Central Toxicology Laboratory. 40 p. 

APPENDIX E:  Generic Data Call-In

Note that a Data Call-In (DCI), with all pertinent instructions, will be
sent to the registrants.

APPENDIX F:  Product Specific Data Call-In

Note that a Data Call-In (DCI), with all pertinent instructions, will be
sent to the registrants.



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