Document ID: EPA-HQ-OPP-2006-0986-0014
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2007-09-26T04:00Z

United States						Prevention, Pesticides		EPA 738-R-07-001

Environmental Protection			and Toxic Substances		

Agency							(7508P)						

 Reregistration 

	Eligibility Decision

	for Allethrins

Reregistration Eligibility Decision (RED) for 

Allethrins

List C

Case No. 0437

Approved by: _____________________                      

Pete Caulkins, Ph.D., Acting Director

Special Review and Reregistration Division

Date: June 29, 2007TABLE OF CONTENTS

  TOC \o "1-3" \h \z \u    HYPERLINK \l "_Toc174177170"  I. 
Introduction	  PAGEREF _Toc174177170 \h  1  

  HYPERLINK \l "_Toc174177171"  II.  Chemical Overview	  PAGEREF
_Toc174177171 \h  2  

  HYPERLINK \l "_Toc174177172"  A.	Regulatory History	  PAGEREF
_Toc174177172 \h  2  

  HYPERLINK \l "_Toc174177173"  B.	Chemical Identification	  PAGEREF
_Toc174177173 \h  3  

  HYPERLINK \l "_Toc174177174"  C.  Use Profile	  PAGEREF _Toc174177174
\h  5  

  HYPERLINK \l "_Toc174177175"  D.  Estimated Usage of Pesticide	 
PAGEREF _Toc174177175 \h  6  

  HYPERLINK \l "_Toc174177176"  III.  Summary of Allethrins Risk
Assessments	  PAGEREF _Toc174177176 \h  7  

  HYPERLINK \l "_Toc174177177"  A.  Human Health Risk Assessment	 
PAGEREF _Toc174177177 \h  7  

  HYPERLINK \l "_Toc174177178"   1. Toxicity of Allethrins	  PAGEREF
_Toc174177178 \h  7  

  HYPERLINK \l "_Toc174177179"  3.  Metabolites and Degradates	  PAGEREF
_Toc174177179 \h  11  

  HYPERLINK \l "_Toc174177180"  4.  Dietary Exposure and Risk (Food +
Water)	  PAGEREF _Toc174177180 \h  11  

  HYPERLINK \l "_Toc174177181"  5.  Residential Exposure and Risk	 
PAGEREF _Toc174177181 \h  11  

  HYPERLINK \l "_Toc174177182"  6.  Occupational Exposure and Risk	 
PAGEREF _Toc174177182 \h  15  

  HYPERLINK \l "_Toc174177183"  B.  Environmental Risk Assessment	 
PAGEREF _Toc174177183 \h  17  

  HYPERLINK \l "_Toc174177184"  1.  Adverse Ecological Incidents	 
PAGEREF _Toc174177184 \h  20  

  HYPERLINK \l "_Toc174177185"  2.  Endangered Species Considerations	 
PAGEREF _Toc174177185 \h  20  

  HYPERLINK \l "_Toc174177186"  IV.  Risk Management, Reregistration,
and Tolerance Reassessment Decision	  PAGEREF _Toc174177186 \h  22  

  HYPERLINK \l "_Toc174177187"  A.  Determination of Reregistration
Eligibility	  PAGEREF _Toc174177187 \h  22  

  HYPERLINK \l "_Toc174177188"  B.  Public Comment Period	  PAGEREF
_Toc174177188 \h  22  

  HYPERLINK \l "_Toc174177189"  C.  Regulatory Position	  PAGEREF
_Toc174177189 \h  22  

  HYPERLINK \l "_Toc174177190"  1.  Regulatory Rationale	  PAGEREF
_Toc174177190 \h  22  

  HYPERLINK \l "_Toc174177191"  2.  Endocrine Disruptor Effects	 
PAGEREF _Toc174177191 \h  26  

  HYPERLINK \l "_Toc174177192"  3.  Endangered Species	  PAGEREF
_Toc174177192 \h  26  

  HYPERLINK \l "_Toc174177193"  D.  Labeling Requirements	  PAGEREF
_Toc174177193 \h  27  

  HYPERLINK \l "_Toc174177194"  V.  What Registrants Need to Do	 
PAGEREF _Toc174177194 \h  28  

  HYPERLINK \l "_Toc174177195"  A.  Manufacturing Use Products	  PAGEREF
_Toc174177195 \h  28  

  HYPERLINK \l "_Toc174177196"  1.  Additional Generic Data Requirements
  PAGEREF _Toc174177196 \h  28  

  HYPERLINK \l "_Toc174177197"  2.  Labeling for Manufacturing-Use
Products	  PAGEREF _Toc174177197 \h  28  

  HYPERLINK \l "_Toc174177198"  B.   End-Use Products	  PAGEREF
_Toc174177198 \h  28  

  HYPERLINK \l "_Toc174177199"  1.  Additional Product-Specific Data
Requirements	  PAGEREF _Toc174177199 \h  28  

  HYPERLINK \l "_Toc174177200"  2.  Labeling for End-Use Products	 
PAGEREF _Toc174177200 \h  29  

  HYPERLINK \l "_Toc174177201"  C.	Labeling Changes Summary Table	 
PAGEREF _Toc174177201 \h  30  

 Glossary of Terms and Abbreviations   

ai		Active Ingredient

CFR		Code of Federal Regulations

CSF		Confidential Statement of Formula      

DCI		Data Call-In

DFR		Dislodgeable Foliar Residue

DNT		Developmental Neurotoxicity

EC		Emulsifiable Concentrate Formulation

EEC		Estimated Environmental Concentration

EPA		Environmental Protection Agency

EUP		End-Use Product

FIFRA	Federal Insecticide, Fungicide, and Rodenticide Act

FFDCA	Federal Food, Drug, and Cosmetic Act

G		Granular Formulation

GLN		Guideline Number

HP		High pressure

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

LOAEL	Lowest Observed Adverse Effect Level

LP		Low pressure

mg/kg/day	Milligram Per Kilogram Per Day

mg/L		Milligrams Per Liter

MOE		Margin of Exposure 

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

MUP		Manufacturing-Use Product

N/A		Not Applicable

NDETF	Non-Dietary Exposure Task Force

NLAA	Not Likely to Adversely Affect

NR		Not Required

NOAEL	No Observed Adverse Effect Level

OPP		EPA Office of Pesticide Programs

OPPTS	EPA Office of Prevention, Pesticides and Toxic Substances

PCA		Percent Crop Area

PHED		Pesticide Handler's Exposure Data 

PHI		Preharvest Interval

ppb		Parts Per Billion

PPE		Personal Protective Equipment

ppm		Parts per Million

RED		Reregistration Eligibility Decision

REI		Restricted Entry Interval

RfD		Reference Dose

RQ		Risk Quotient

SF		Safety Factor

SLC		Single Layer Clothing

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

TGAI		Technical Grade Active Ingredient

USDA	United States Department of Agriculture

UF		Uncertainty Factor

UFdb		Database Uncertainty Factor 

ALLETHRINS TEAM

Office of Pesticide Programs:

Health Effects Risk Assessment

Kit Farwell

Timothy Dole

Toiya Goodlow

Whang Phang

Ecological Fate and Effects Risk Assessment

Melissa Panger

Cheryl Sutton

Biological and Economics Analysis Assessment

Margaret Ervin

Angel Chiri

Registration Division

Ann Sibold

Richard Gebken

Risk Management

Molly Clayton

Neil Anderson

Abstract 

	

	The Environmental Protection Agency (EPA or the Agency) has completed
the human health and environmental risk assessments for the allethrins
and is issuing its risk management decision.  The allethrin series of
pyrethroid insecticides includes bioallethrin (PC code 004003), esbiol
(004004), esbiothrin (004007, formerly 004003/004004), and pynamin forte
(004005).  The allethrins are not registered for use on food, and they
have no U.S. tolerances associated with their use; therefore, they are
not subject to Food Quality Protection Act (FQPA).  The risk
assessments, which are summarized below, are based on the review of the
required database supporting the use patterns of currently registered
products and additional data provided by the technical registrants,
Valent BioSciences Corporation and Sumitomo Chemical Company, Ltd.

	The allethrins are used to control flying and crawling insects in a
number of commercial, horticultural and residential applications. 
Commercial applications include space, broadcast and crack and crevice
treatment in a variety of commercial, industrial, residential, and
institutional sites.  Horticultural applications include foliar and
fogger treatment on non-food plants.  Residential uses include pest
control in homes and outdoor domestic structures, on gardens and direct
application to cats, dogs and horses.  The registered uses of the
allethrins are not expected to adversely impact groundwater or surface
water; therefore, a drinking water assessment was not performed. 
Because there are no food uses or potential exposures to drinking water,
the reregistration action considered potential residential,
occupational, and ecological risk.  

	For residential handler risk, all scenarios assessed were greater than
the Agency’s Level of Concern (LOC), i.e., the Margins of Exposure
(MOEs) were above 1000.  For residential post-application risk, the MOEs
are all greater than the target MOE of 1000 after mitigation measures
are incorporated, except for inhalation exposures from yard and patio
total release foggers.  However, the Agency does not anticipate a risk
of concern from this use.

	       Occupational handler and post-application inhalation exposures
were assessed.  Most of the inhalation MOEs are greater than the
Agency’s target occupational MOE of 100 without respirators, and
therefore, the inhalation risks are not of concern.  The high pressure
handwand scenario is of concern without respirators and requires a dust
mask to achieve the target MOE.  The space spray fogger scenario is also
of concern and requires a PF50 full face respirator with appropriate
cartridges to achieve the target MOE, as well as a maximum concentration
reduction from 3.0% ai to 1.5% ai in product.  The MOEs for the
occupational post-application scenarios assessed exceed the Agency’s
target MOE of 00 and are not of concern.  

	The Agency evaluated potential ecological risk from both indoor and
outdoor uses of the allethrins.  The technical registrant voluntarily
agreed to cancel pet shampoos and dips; therefore, there is no longer
potential ecological exposure from indoor products containing
allethrins, and no further mitigation is necessary for indoor uses. 
Although current label uses include several potentially large-scale
outdoor uses, they are not being supported by the technical registrant. 
Since outdoor uses will be limited to localized spot treatments, no
additional mitigation measures for these uses are required.

I.  Introduction

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

	

This document summarizes EPA’s human health and ecological risk
assessments and reregistration eligibility decision (RED) for the
allethrins.  The document consists of six sections.  Section I contains
the regulatory framework for reregistration; Section II provides an
overview of the chemical and a profile of its use and usage; Section III
gives an overview of the human health and environmental effects risk
assessments; Section IV presents the Agency's decision on reregistration
eligibility and risk management; and Section V summarizes the label
changes necessary to implement the risk mitigation measures outlined in
Section IV.  Finally, the Appendices list related information,
supporting documents, and studies evaluated for the reregistration
decision.  The risk assessments for the allethrins and all other
supporting documents are available in the Office of Pesticide Programs
(OPP) public docket (http://www.regulations.gov) under docket number
EPA-HQ-OPP-2006-0986.

	

II.  Chemical Overview

  Regulatory History

The allethrin series of pyrethroid insecticides includes bioallethrin
(PC code 004003), esbiol (004004), esbiothrin (004007, formerly
004003/004004), and pynamin forte (004005).  Historically, there were
two other members of the series, which have since been cancelled. 
Allethrin (allyl homolog of cinerin I), in its liquid form was assigned
PC code 004001, and was cancelled in 1992.  Allethrin in its solid form
was assigned PC code 004002, and was cancelled in 1991.  For a number of
years, products containing esbiothrin were assigned a dual PC code
(004003/004004), which led to some confusion in naming the active
ingredients in registered pesticide products.  To resolve this issue, in
2006, EPA established a separate PC code for products containing
esbiothrin (004007).  Due to the long history of the allethrins and the
similarity between the allethrin compounds, there has been some
additional confusion surrounding the allethrins nomenclature.  During
the reregistration process for the allethrins, the EPA has been in
coordination with the two allethrins registrants, Valent BioSciences
Corporation and Sumitomo Chemical Company, to help resolve some of these
issues.  To clarify, the revised chemical names, common names, and CAS
numbers for the allethrins are listed in the next section, Chemical
Identification.

	EPA published a Registration Standard for the allethrins series in
1988, Guidance for the Reregistration of Pesticide Products Containing
Allethrin Stereoisomers as the Active Ingredient (EPA 540/RS-88/063,
issued March 24, 1988).  The purpose of the Registration Standard was to
“provide an orderly mechanism by which pesticide products containing
the same active ingredient can be reviewed and standards set for
compliance with the Federal Insecticide, Fungicide and Rodenticide Act
(FIFRA).”  It also identified studies that were acceptable to meet the
data requirements of the currently registered uses, additional studies
necessary to support continued registration, and labeling revisions.  It
further identified steps registrants were required to take to maintain
their registration or apply for new registrations.  A data call-in (DCI)
was issued as part of the Registration Standard, followed by a second
DCI, which was issued on October 6, 1995.

 B.	Chemical Identification

	ALLETHRINS:

lack an α-cyano substituent.  

Chemical Class:		Sythetic pyrethroid

Case Number:			0437

PC Code:	Bioallethrin (004003), esbiol (004004), esbiothrin (004007),
and pynamin forte (004005)

Molecular Weight:		302.4

Empirical Formula:		  SEQ CHAPTER \h \r 1 C19H26O3

Technical Registrants:	Valent BioSciences Corporation (bioallethrin,
esbiol, esbiothrin), Sumitomo Chemical Company, Ltd. (pynamin forte)

See below for a listing of common names, chemical names, PC codes, and
CAS numbers. 

Bioallethrin:						        

OPP Chemical Code:  004003	

Chemical Name:  (RS)-3-allyl-2-methyl-4-oxocyclopent-2-enyl
(1R,3R)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate

Common name:  “bioallethrin (BSI)”

CAS number:  260359-57-7 

Composition:  consists of [1R,trans;1R] + [1R,trans;1S] in an
approximate ratio of 1:1

Esbiol: (also called S-Bioallethrin for some products)     

OPP Chemical Code:  004004   

Chemical name:  (S)-3-allyl-2-methyl-4-oxocyclopent-2-enyl
(1R,3R)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate

Common name:  “allethrin (ISO)”.  (“Esbiol” is not an authorized
common name.)  

CAS number:  28434-00-6

Composition:  consists predominately [> 96%] of the (S)(1R,3R)
enantiomer.

Esbiothrin:						 

OPP Chemical Code:  004007	

	

Chemical name:  (RS)-3-allyl-2-methyl-4-oxocyclopent-2-enyl
(1R,3R)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate

Common name:  “allethrin (ISO)”.  (“Esbiothrin” is not an
authorized common name.)

CAS number:   260359-57-7  

Composition:  consists of [1R,trans;R] + [1R,trans;S] in approximate
ratio of 1:3.

Pynamin Forte:				

OPP Chemical Code:  004005	

  

Chemical Name:  (RS)-3-allyl-2-methyl-4-oxocyclopent-2-enyl (1R,3R;
1R,3S)-2,2-dimethyl-3-(2-methylprop-1-enyl)cyclopropanecarboxylate

Common name:  “allethrin (ISO)”.  (“d-allethrin” is the chemical
listed in the title of the WHO Specifications and Evaluations document,
but is not recognized as an authorized common name; “d-cis/trans
allethrin” is listed in information from the registrants as an even
more appropriate name, but they state it also is not an authorized
common name.)

CAS number:  231937-89-6

Composition:  consists of [1R,trans;1R] + [1R,trans;1S] + [1R,cis;1R] +
[1R,cis;1S] in an approximate ratio of 4:4:1:1

	Two of the technical compounds have the same CAS Number; both
esbiothrin and bioallethrin are 260359-57-7, since they are primarily
comprised of the same two enantiomers.  However, it would be preferable
to have separate CAS Nos. assigned for these two technical products.  In
addition, note that the common names listed above are not distinctive,
since there are three technical products currently known as “allethrin
(ISO)”.  To resolve this, Valent Biosciences Corporation has informed
the Agency that there are efforts on-going to assign distinctive common
names for the respective technical products.  

	The analytical method used to verify the chemical identify of the
members of the allethrin series can only distinguish the presence of
trans and cis isomers.  However, current analytical methods cannot
determine their relative proportions in a sample.  Since the different
members of the allethrin series differ primarily in their relative
proportions of the cis and trans isomers, the current Enforcement
Analytical Method does not adequately distinguish the different members
of the allethrin series.  To address this area of uncertainty, the two
technical registrants have agreed to submit analytical methods which
will distinguish between the four allethrin technical products.  

	C.  Use Profile

	

	The following information on the currently registered uses includes an
overview of use sites and application methods.  A detailed table of the
uses of allethrins eligible for reregistration is contained in Appendix
A.

Type of Pesticide:  Synthetic pyrethroid.  The allethrins are
insecticides, and are typically used as a “knock-down” agent.  A
different, residual pesticide is co-formulated with the allethrin in the
end-use products to kill the target pests.

Target Organism:  The primary target pests are wasps and hornets,
roaches, ants,

fleas, and mosquitos.

 a cyano group at the α carbon position of the alcohol moiety).  The
allethrins are axonic poisons that block the closing of the sodium gates
in the nerves, and, thus, prolong the return of the membrane potential
to its resting state leading to hyperactivity of the nervous system
which can result in paralysis and/or death.  

Use Sites:  Commercial applications include space, broadcast and crack
and crevice treatments in a variety of commercial, industrial,
residential, and institutional sites.  Horticultural applications
include foliar and fogger treatment on non-food plants.  Residential
uses include pest control in homes and outdoor domestic structures, on
gardens, and direct application to pets.  There are no food uses for the
allethrins, and a Federal Register final rule revoking all tolerances
was published on September 29, 2004.	

Use Classification:  The allethrins products are designated as general
use; however, 

some products are registered for use by pest control operators (PCOs)
only. 

Formulation Types:  Pressurized liquid, ready-to-use (RTU) liquids,
emulsifiable concentrates, liquid concentrates, pet shampoos and dips,
mosquito coils and mats.

Application Methods:  Allethrins are applied by power, mechanical, and
commercial sprayer; aerosol can; and thermal fogger.  

Application Rates:  Typical concentrations of active ingredients (ai) in
residential use products, including ready to use (RTU) (e.g. ant and
roach sprays, wasp and hornet sprays) and indoor and outdoor aerosols or
aqueous sprays for crawling and flying insects, range between 0.05 % and
0.25%.  Total release aerosol (TRA) foggers are typically 0.6% to 3%
(total volume of the can versus the area it is designed to treat).  Mats
range between 7% and 24% and release active ingredient into the air by
heating the mat.  Coils range from 0.1% to 0.3% in concentration and
also release active ingredient into the air by burning of the coil (the
active is volatilized off of the coil just behind the burning part of
the coil.). 

Application Timing:  The application timing is generally not mentioned
on existing 

allethrins labels, although some indicate re-application permitted after
two weeks, while 

others recommend use as needed.

	D.  Estimated Usage of Pesticide

	      Less than 30,000 lbs of allethrins are marketed on average per
year.  Of the four allethrins, bioallethrin is the predominant form of
allethrin sold in the U.S.  Pynamin forte is used exclusively in the mat
and coil formulations.  The majority of allethrins are used in the
consumer market (i.e. homeowner uses in space and surface sprays for
flying and crawling insects), and a small amount is sold into the
institutional/industrial market.

III.  Summary of Allethrins Risk Assessments

	The following is a summary of EPA’s revised human health and
ecological risk assessments for the allethrins, as presented fully in
the documents, revised Allethrins:  Revised HED Chapter of the
Reregistration Eligibility Decision Document (RED) for Bioallethrin
(004003), Esbiol (004004), Esbiothrin (004007), and Pynamin Forte
(004005) and Section 3 Registration Action for Use in Food Handling
Establishments: Esbiothrin and Esbiol, dated June 27, 2007, the Response
to Comments (Phase 3) and Revised Environmental Fate and Ecological Risk
Assessment in Support of the Reregistration of the Allethrins, dated
April 4, 2007.  The purpose of this summary is to assist the reader by
identifying the key features and findings of these risk assessments, and
to help the reader better understand the conclusions reached in the
assessments.  

	The human health and ecological risk assessment documents and
supporting information listed in Appendix C were used to reach the
safety finding and regulatory decision for the allethrins.  While the
risk assessments and related addenda are not included in this document,
they are available from the OPP Public Docket, located at   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov , under docket
number EPA-HQ-OPP-2006-0986. 

	EPA's use of human studies in the allethrins risk assessment is in
accordance with the Agency's Final Rule promulgated on January 26, 2006,
related to Protections for Subjects in Human Research, which is codified
in 40 CFR Part 26.  

A.  Human Health Risk Assessment

	The human health risk assessment incorporates potential exposure,
hazard, and risks from all sources, which for the allethrins is limited.
 There are no registered food uses for the allethrins.  The majority of
allethrins use is in consumer home products (indoor and outdoor surface
and space sprays).  There are also commercial and horticultural uses for
the allethrins.  Although the allethrins human health risk assessment
considered a pending new use for the allethrins in food handling
establishments, this use, and the risks associated with it, are not
subject to reregistration at this time.  The pending use in food
handling establishements will not be included in the reregistration
eligibility decision for the allethrins.  The Agency will address this
action separately.  For more information on the human health risk
assessment, see Allethrins:  Revised HED Chapter of the Reregistration
Eligibility Decision Document (RED) for Bioallethrin (004003), Esbiol
(004004), Esbiothrin (004007), and Pynamin Forte (004005) and Section 3
Registration Action for Use in Food Handling Establishments: Esbiothrin
and Esbiol, dated June 27, 2007, which is available under docket number
EPA-HQ-OPP-2006-0986.

 .		1.  Toxicity of Allethrins

	Toxicity assessments are designed to predict whether a pesticide could
cause adverse health effects in humans (including short-term or acute
effects, such as skin or eye damage, and lifetime or chronic effects,
such as cancer, developmental effects, or reproductive effects), and the
level or dose at which such effects might occur.  The Agency has
reviewed all toxicity studies submitted for the allethrins and has
determined that the toxicological database is reliable and sufficient
for reregistration.  However, there are no developmental neurotoxicity
or comparative neurotoxicity studies in adults and offspring available
for the allethrins.  Since the allethrins database is currently
incomplete with respect to data on potential pre- and postnatal
toxicity, the Agency applied a ten fold (10x) database uncertainty
factor (UFDB) to account for this lack of data.  A study will be
required to address uncertainty surrounding potential pre- and postnatal
toxicity of the allethrins.  The registrants should consult with the
Agency before beginning this study.  

			a.  Acute Toxicity Profile 

	

	Pyrethroids are neurotoxicants which act by prolonging the opening of
the sodium channel in nervous tissue, resulting in a hyperexcitable
state.  As explained previously, the allethrins are classified as type I
pyrethroids.  Neurotoxicity in rats of type I pyrethroids is
characterized as tremor, prostration, enhanced startle response, and
aggressive behavior.  Similar signs were observed in the guideline
studies in which clinical signs of neurotoxicity were noted.  The acute
toxicity profile for each of the allethrins is summarized in Tables 1-4
below.

Table 1.  Acute Toxicity Profile - Bioallethrins

Guideline	Study Type	MRID	Results	Toxicity Categorya

870.1100	Acute Oral	00151444	LD50: 709 mg/kg (M)

1042 mg/kg (F)           	III

870.1200	Acute Dermal	41155801	LD50 > 3000 mg/kg (M&F)           	III

870.1300	Acute Inhalation	42906902	LC50 : 2.51 mg/L          	IV

870.2400	Primary Eye Irritation	41155803	Slight to moderate irritant	III

870.2500	Primary Skin Irritation	41155805	Very slight dermal irritant	IV

870.2600	Dermal Sensitization	41155807	Negative	N/A

These technical acute toxicity values included in this document are for
informational purposes only. 

 The data supporting these values may or may not meet the current
acceptance criteria.

Table 2.  Acute Toxicity Profile - Esbiol

Guideline	Study Type	MRID	Results	Toxicity Categorya

870.1100	Acute Oral	00151460	LD50: 574.5 mg/kg (M)

412.9 mg/kg (F)           	II

870.1200	Acute Dermal	41155802	LD50 > 2000 mg/kg 	III

870.1300	Acute Inhalation	41670801	LC50 : 1.32 mg/L (M)

1.23 mg/L (F)          	III

870.2400	Primary Eye Irritation	41155804	Moderate ocular irritant	III

870.2500	Primary Skin Irritation	41155806	Not a dermal irritant.	IV

870.2600	Dermal Sensitization	41155808	Not a sensitizer	N/A

These technical acute toxicity values included in this document are for
informational purposes only. 

 The data supporting these values may or may not meet the current
acceptance criteria.

Table 3.  Acute Toxicity Profile - Esbiothrin

Guideline	Study Type	MRID	Results	Toxicity Categorya

870.1100	Acute Oral	00151449	LD50: 432 mg/kg (M)

378.0 mg/kg (F)           	

II

870.1200	Acute Dermal	00151451	LD50 > 2000 mg/kg	III

870.1300	Acute Inhalation	00151452	LC50: 2.63 g/m3-unacceptable 	III

870.2400	Primary Eye Irritation	00151454	Minimally 	IV

870.2500	Primary Skin Irritation	00151453	Slightly 	III

870.2600	Dermal Sensitization	42907001	Negative	N/A

These technical acute toxicity values included in this document are for
informational purposes only. 

 The data supporting these values may or may not meet the current
acceptance criteria.

Table 4.  Acute Toxicity Profile – Pynamin Forte

Guideline	Study Type	MRID	Results	Toxicity Categorya

870.1100	Acute Oral	41017101	LD50s=

M:  2150 mg/kg

F:  900 mg/kg	III

870.1200	Acute Dermal	41017102	M:  2660 mg/kg

F:  4390 mg/kg 	III

870.1300	Acute Inhalation	41017103	LC50 > 3.875 mg/L	IV

870.2400	Primary Eye Irritation	41017104	Slight irritant	III

870.2500	Primary Skin Irritation	41017104	Negative	IV

870.2600	Dermal Sensitization	41017105	Negative	N/A

These technical acute toxicity values included in this document are for
informational purposes only. 

 The data supporting these values may or may not meet the current
acceptance criteria.

Toxicological Endpoints 

	     The toxicological endpoints used in the human health risk
assessment for the allethrins are listed in Table 5 below.  The observed
endpoints for risk assessment were based on neurotoxicity and liver
toxicity.  Because observed endpoints for risk assessment were at the
same or lower dose at which developmental and reproductive toxicity
occurred, there were no concerns for sensitivity of offspring.  Clinical
signs of neurotoxicity occurred in an inhalation study with esbiol.  The
point of departure (POD) for intermediate-term incidental oral exposure
was selected based upon a benchmark dose analysis because of the 6x
difference between the NOAEL (6 mg/kg/day) and the LOAEL (36 mg/kg/day).
 A 10% response for the benchmark dose (BMD10) was selected because of
the mild nature of the lesions, characterized as "acute swelling of
hepatocytes," which did not progress in severity at the high dose.  The
selected BMDL10 value was 267 ppm, which is the lower 95% confidence
limit on the BMD10.  This dietary concentration was converted to a
mg/kg/day dose.  Only inhalation and incidental oral endpoints have been
assessed, because no systemic effects were observed at the limit dose in
the dermal toxicity studies in test animals, and no toxicity endpoint
was selected for dermal exposure

	The target MOE (i.e., level of concern) for residential incidental oral
and inhalation exposures is 1000.  This includes the standard
uncertainty factors of 10X for interspecies extrapolation, 10X for
intraspecies variation, and an additional 10X UFDB due to lack of data
on potential pre- and postnatal toxicity.  The target MOE for
occupational inhalation exposures is 100 because the database
uncertainty factor does not apply to occupational exposures.  The
uncertainty factors (UF) used to account for interspecies extrapolation
and intraspecies variability are also described in Table 5. 

Table 5.  Toxicology Endpoints for the Allethrins

Exposure/

Scenario	Point of Departure	Uncertainty Factors	RfD, PAD, Level of
Concern	Study and Toxicological Effects

Incidental Oral Short-Term 

(1-30 days)	NOAEL = 20 mg/kg/day	UFA = 10x

UFH = 10x

UFDB = 10x

	Residential LOC for MOE = 1000.

	30-day dog  (esbiothrin).  

LOAEL = 63 mg/kg/day based on elevated liver enzymes and increased liver
weight

Incidental Oral Intermediate-Term 

(1-6 months)	BMDL10 = 8 mg/kg/day

	UFA = 10x

UFH = 10x

UFDB = 10x

	Residential LOC for MOE = 1000.

	6-month dog (Bioallethrin).  

BMDL10 based on based on microscopic liver changes (hepatocellular
degeneration)

Dermal 

(all durations)	N/A	N/A	N/A	No systemic toxicity at 1000 mg/kg/day with
esbiothrin or esbiol and negligible dermal absorption with pyrethrins
(0.22%)

Inhalation

(all durations)	NOAEL = 1.3 mg/kg/day	UFA = 10x

UFH = 10x

UFDB = 10x

	Residential LOC for MOE = 1000.

Occupational LOC for MOE = 100.	28-day inhalation study in rats
(esbiol).  LOAEL = 6.5 mg/kg/day based on clinical signs in females
(limb tremors, hunched posture, vocalization during handling)

Cancer (oral, dermal, inhalation)	Classification:  Suggestive evidence
of carcinogenicity, but not sufficient to assess human carcinogenic
potential (esbiothrin).  

NOAEL = no observed adverse effect level.  UF = uncertainty factor.  UFA
= extrapolation from animal to human (intraspecies).  UFH = potential
variation in sensitivity among members of the human population
(interspecies).  UFDB = database uncertainty factor.  BMDL10 = bench
mark dose level.  MOE = margin of exposure.  LOC = level of concern. 
N/A = not applicable.

2.  Carcinogenicity of Allethrins

Genetic toxicity studies with esbiol, esbiothrin, bioallethrin, and
pynamin forte were negative for mutagenicity.  Carcinogenicity studies
were conducted with esbiothrin and pynamin forte.  In these studies, the
only evidence of carcinogenicity was rare benign kidney tumors in male
rats treated with esbiothrin.  Doses in the mouse carcinogenicity study
were considered inadequate and the cancer classification for esbiothrin
is "suggestive evidence of carcinogenicity, but not sufficient to assess
human carcinogenic potential."  

		3.  Metabolites and Degradates

The Agency reviewed the metabolism of allethrins, and concluded that for
tolerance expression and risk assessment, the parent compound,
allethrin, is the only residue of toxicological concern.  For additional
details, refer to Allethrins:  Revised HED Chapter of the Reregistration
Eligibility Decision Document (RED) for Bioallethrin (004003), Esbiol
(004004), Esbiothrin (004007), and Pynamin Forte (004005) and Section 3
Registration Action for Use in Food Handling Establishments: Esbiothrin
and Esbiol, dated December June 27, 2007.

4.  Dietary Exposure and Risk (Food + Water)

	  SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1 There are no food uses for
the allethrins currently registered; therefore, dietary exposure is not
of concern.  Although the human health risk assessment previously cited
includes a dietary assessment for a proposed new use in food handling
establishments, this action is not included in the allethrins
reregistration case, and is outside the scope of this RED.  The Agency
will address this action separately.  Because there are no outdoor,
broadcast uses registered, the use of allethrins products is not
expected to adversely impact groundwater or surface water (the sources
of drinking water); therefore, a drinking water assessment was not
performed. 

	

                        5.  Residential Exposure and Risk

		  SEQ CHAPTER \h \r 1 Residential exposure assessments consider all
potential non-occupational pesticide exposure.  For allethrins, the
Agency has evaluated potential exposure and risk to allethrins for
homeowners who handle (mix, load, and apply) products containing
allethrins.  The Agency also evaluated potential post-application risk
to adults and children entering allethrins-treated areas.

  

	To estimate residential (inhalation and incidental oral) risks, the
Agency calculates a margin of exposure (MOE), which is the ratio of the
toxicity endpoint (NOAEL or BMDL10) selected for risk assessment to the
exposure.  This MOE is compared to a level of concern, which is the same
value as the uncertainty factor (UF) applied to a particular toxicity
study.  The standard UF is 100x (10x to account for interspecies
extrapolation and 10x for intraspecies variation).  Since the allethrins
database is currently incomplete with respect to data on potential pre-
and postnatal toxicity, the Agency applied a ten fold (10x) UFDB to
account for this lack of data.  A study will be required to address
uncertainty surrounding potential pre- and postnatal toxicity of the
allethirns.  Thus, the target level of concern for the allethrins is
1000.  A summary of the allethrins residential risk follows.  For
further information on residential risk, refer to Allethrins:  Revised
HED Chapter of the Reregistration Eligibility Decision Document (RED)
for Bioallethrin (004003), Esbiol (004004), Esbiothrin (004007), and
Pynamin Forte (004005) and Section 3 Registration Action for Use in Food
Handling Establishments: Esbiothrin and Esbiol, dated December June 27,
2007.

	a.  Residential Handler Risks

	       The Agency determined that there is the potential for
residential handlers to be exposed to allethrins during pesticide
applications from aerosol cans made in indoor and outdoor residential
settings to several use sites.  While some allethrin products are
packaged as ready-to-use (RTU) trigger sprayer bottles, the handler
risks calculated from aerosol can application are protective of risks
from trigger sprayer applications because the unit exposure values are
lower for trigger sprayer application.  Only short-term (1-30 days)
inhalation exposures were assessed because of the infrequency of use
associated with the residential homeowner products.  Dermal exposures
were not assessed, because no dose or endpoints were selected from
available toxicity studies for dermal exposure.  

 

	    Pesticide handler exposure database  SEQ CHAPTER \h \r 1  (PHED)
unit exposure values were used to assess exposures, because
chemical-specific monitoring data were not available.  The following
assumptions were also used in estimating risks from residential handler
exposure to allethrins:

The body weight of an adult handler is 70 kg.

One aerosol can is used per day.  This assumption is based upon the HED
Science Advisory Committee on Exposure SOP 12: “Recommended Revisions
to the Standard Operating Procedures for Residential Exposure
Assessment” (2/22/2001).	

An aerosol can contains 9 to 16 ounces by weight of product based upon
currently registered labels.

The percent ai in the products ranges from 0.10 to 0.50 percent by
weight based upon currently registered labels.

 	    Risk to homeowners handling allethrins products are below the
Agency’s LOC.  The inhalation MOEs for all scenarios assessed are
greater than 1000 (ranging from 15,000 to 70,000).  See Table 6 for
further detail.

Table 6.  Residential Handler Risks for Aerosol Can Applications

Use Scenario	Percent Active Ingredient (AI) in Product	Amount of Product
Used per Day	Amount of AI Used per Day 	Inhalation MOE

Indoor Surface or Space Spray 	0.50	One 15 ounce can	0.0047 lb	15,000

Pet and Bedding Spray	0.32	One  9 ounce can	0.0018 lb	39,000

Hand Held Yard and Patio Fogger	0.15	One 16 ounce can	0.0015 lb	46,000

Wasp and Hornet Nests	0.10	One 16 ounce can	0.0010 lb	70,000

		b.  Residential Post-Application Risks

The Agency uses the term “post-application” to describe exposures to
individuals that occur as a result of being in an environment that has
been previously treated with a pesticide.  Unlike residential handler
exposure, where the Agency assumed only adults will be handling and
applying allethrins products, individuals of varying ages can
potentially be exposed when reentering or performing activities in areas
that have been previously treated.  

	 For the allethrins, inhalation exposures may occur when consumer-use
space spray products, patio foggers, mosquito coils, or fly mats are
used; therefore, inhalation exposures were assessed for adults and
toddlers for these scenarios.  Inhalation risk following application of
space sprays by a professional applicator was not assessed, because
treated areas are vacated prior to application and ventilated prior to
re-occupancy; therefore, the Agency believes little or no
post-application inhalation exposure will occur.  Only short-term
exposure was considered for inhalation risk, since the endpoint for
inhalation exposures is the same for all durations of exposure.

	Incidental oral exposures may occur after surface applications of the
allethrins are made by a consumer or professional applicator to
residential areas such as carpets, vinyl and flooring.  Incidental oral
exposures for these scenarios were, therefore, assessed for both adults
and toddlers.  Incidental oral exposure may also occur through contact
with pets that have been treated with pet sprays or shampoos. 
Incidental oral exposures from pet spray applications were calculated;
these MOEs are also protective of dip or shampoo applications, since the
shampoos and dips are used at lower dilution rates than the spray
formulations.  Because there are different toxicological endpoints for
short- and intermediate-term incidental oral exposures, MOEs for both
durations were calculated.  

	Only inhalation and incidental oral exposures have been assessed;
dermal exposures were not assessed, because no dose or endpoints were
selected from available toxicity studies for dermal exposure.  The
following scenarios were assessed:

Toddler incidental oral ingestion of residues on indoor surfaces after
fogger treatment.

Toddler incidental oral ingestion of residues on indoor surfaces after
PCO broadcast surface treatment.

Toddler incidental oral ingestion of residues on indoor surfaces after
consumer spot surface treatment.

Inhalation exposures from space spray application

Inhalation exposures from mosquito coils and fly mats

Inhalation exposures from yard and patio foggers

Incidental oral exposures from pet sprays

	Exposure data for assessing post-application exposures from the use of
foggers and aerosols in indoor residential settings were based upon
pyrethrin studies conducted by the Non-Dietary Exposure Task Force
(NDETF).  The pyrethrin study data are considered applicable for
allethrin because of the structural similarity between pyrethrin and
allethrin.  The residential risk assessment is also based on current
label rates and use instructions, as well as on estimates of what and
how much homeowners typically treat, such as the size of a house or spot
treatment, from the Agency’s standard operating procedures for
residential exposures and best professional judgment.  For more
information on the daily volume handled and the area treated used in
each residential handler scenario, refer to both the Allethrins:  HED
Chapter of the Reregistration Eligibility Decision Document (RED). Phase
2 Error Correction Reregistration Action for Bioallethrin (004003),
Esbiol (004004), Esbiothrin (004007), and Pynamin Forte (004005) and
Section 3 Registration Action for Use in Food Handling Establishments:
Esbiothrin and Esbiol, dated December 20, 2006, and Allethrins:  Revised
HED Chapter of the Reregistration Eligibility Decision Document (RED)
for Bioallethrin (004003), Esbiol (004004), Esbiothrin (004007), and
Pynamin Forte (004005) and Section 3 Registration Action for Use in Food
Handling Establishments: Esbiothrin and Esbiol, dated June 27, 2007 risk
assessments, which are available under docket number
EPA-HQ-OPP-2006-0986.

	While the majority of the scenarios assessed are not of concern, there
are several scenarios with MOEs below 1000 (i.e, exceeding the
Agency’s LOC).  All of the residential post-application MOEs for the
allethrins are summarized in Table 7 below, and the use scenarios
exceeding the level of concern are in bold type.  Mitigation measures
addressing risk exceedances are discussed in Chapter IV of this
document. 

Table 7.  Allethrin Residential Post-Application Risk Summary

Source of Exposure	Application Rate	Exposed Population	MOE*

Incidental Oral Exposures (Short-Term)

Fogger Treatment - Carpet Floors  

Fogger Treatment - Vinyl Floors 	3.6 mg/m3	Children	3600

5200

PCO Surface Treatment - Carpet Floors  

PCO Surface Treatment - Vinyl Floors	3.0% spray (1 gal / 1000 ft2)
Children	20

28

PCO Surface Treatment - Carpet Floors  

PCO Surface Treatment - Vinyl Floors 	0.1% spray (0.5 gal / 1000 ft2)
Children	1200

1700

Consumer Spot Treatment - Carpet Floors  

Consumer Spot Treatment - Vinyl Floors 	0.5% Spray	Children	1100

1700

Consumer Spot Treatment - Carpet Floors  

Consumer Spot Treatment - Vinyl Floors 	0.25% Spray	Children	2200

3400

Treated Pets – Spray Formulations	0.32% a.i.	Children	2,100

Incidental Oral Exposures (Intermediate-Term)

Fogger Treatment - Carpet Floors  

Fogger Treatment - Vinyl Floors 	3.6 mg/m3	Children	3000

4400

PCO Surface Treatment - Carpet Floors  

PCO Surface Treatment - Vinyl Floors	3.0% spray (1 gal / 1000 ft2)
Children	16

24

PCO Surface Treatment - Carpet Floors  

PCO Surface Treatment - Vinyl Floors 	0.1% spray (0.5 gal /1000 ft2)
Children	960

1400

Consumer Spot Treatment - Carpet Floors  

Consumer Spot Treatment - Vinyl Floors 	0.5% Spray	Children	960

1400

Consumer Spot Treatment - Carpet Floors  

Consumer Spot Treatment - Vinyl Floors 	0.25% Spray	Children	1900

2800

Treated Pets – Spray Formulations        	0.32% a.i.	Children	860

Inhalation Exposures (Short/Intermediate-Term)

Space Spray – 0.50% Product 	0.80 mg/m3

(based upon the NDETF study)	Children

Adults	650

2100

Space Spray – 0.25% Product 	0.40 mg/m3

(based upon the NDETF study)	Children

Adults	1300

4200

Space Spray – 0.10% Product 	0.16 mg/m3

(based upon the NDETF study)	Children

Adults	3050

10000

	0.35 mg/m3

(Based upon Raid label 4822-513)	Children

Adults	1400

4800

Mosquito Coils	2 coils per  patio	Children

Adults	7000

14000

Fly Mats	2 mats per patio	Children

Adults	1800

3600

Hand Held Yard and Patio Fogger 	3 second spray per patio	Children

Adults	3100

6200

Hand Held Yard and Patio Fogger 	9  second spray per patio	Children

Adults	1000

2200

Total Release Yard and Patio Fogger	6 oz. fogger / yard & patio	Children

Adults	160

310

Total Release Yard and Patio Fogger	Two 1.5 ounce foggers / patio
Children

Adults	650

1300

*MOEs in bold font do not approach or exceed the target MOE of 1000
(i.e., indicate risks of concern).

				6.  Occupational Exposure and Risk 

            The occupational risk assessment addresses risks to workers
who may be exposed to allethrins when mixing, loading, or applying a
pesticide (i.e., handlers), and when entering treated sites for routine
tasks (post-application).  Exposure for workers generally occurs via the
dermal or inhalation route; however, only inhalation exposures have been
assessed because no systemic effects were observed at the limit dose in
the dermal toxicity studies in test animals, and no toxicity endpoint
was selected for dermal exposure.  The Agency assessed short (1 to 30
days), intermediate (30 days to several months) and long-term (> 6
months) exposure, although the risk results were essentially the same
since the toxicological endpoints for inhalation exposures are the same
for all durations of exposure.  The target MOE is 100 for short,
intermediate and long-term inhalation exposures.

Occupational exposure to allethrins was assessed using data from the
Pesticide Handler Exposure Database (PHED), and worker exposure and risk
estimates are based on the best data currently available to the Agency. 
In addition, standard default assumptions pertaining to average body
weight, work day, and area treated daily were used to calculate risk
estimates.  Application rates used in this assessment are derived
directly from current allethrin labels.  The occupational risk
assessment is summarized here.  For further detail, see the Allethrins: 
Revised HED Chapter of the Reregistration Eligibility Decision Document
(RED) for Bioallethrin (004003), Esbiol (004004), Esbiothrin (004007),
and Pynamin Forte (004005) and Section 3 Registration Action for Use in
Food Handling Establishments: Esbiothrin and Esbiol, dated June 27,
2007.

	

a.  Handler Exposure Risks

	Occupational handler exposure assessments are conducted by the Agency
using different levels of protection.  The Agency typically evaluates
all exposures with minimal protection and then adds protective measures
in a tiered approach to determine the level of protection necessary to
obtain appropriate MOEs.  Since only inhalation exposures are of
concern, only PPE relevant to the inhalation exposures were considered. 
The types of protection which were used to calculate inhalation
occupational exposure from allethrins are as follows:

Baseline:	            	No respirator

PF5 Respirator                           Filtering facepiece respirator
(i.e., dust mask) 					with a protection factor of 5

PF50 Respirator		   Full face respirator, with a protection factor of 50

	      Because most allethrin products are packaged in aerosol cans, the
majority of the allethrin uses involve potential application exposures
only; there are no mixing and loading exposures.  There are also a few
products packaged as ready-to-use (RTU) liquids or liquid concentrates,
which are applied with mechanical sprayers, compressed air sprayers or
foggers.  These products are used in non-food commercial/
industrial/institutional areas, non-food greenhouses and non-food animal
premises.  Based upon these labels, the Agency assessed the following
occupational handler scenarios: 

Pesticide Control Operator Scenarios

   SEQ CHAPTER \h \r 1 1) 	Mix/Load/Apply (M/L/A) liquids with backpack
sprayer or low-pressure (LP) handwand 

2) 	Mix/Load/Apply liquids with high-pressure (HP) handwand 

3)	Mix/Load/Apply liquids with a fogger

4) 	Apply with aerosol can. 

	     Risk estimates (i.e., MOEs) for the surface spray handler
scenarios are summarized in Table 8.  Most of the inhalation MOEs are
above the target MOE of 100 without respirators (i.e., No Resp.) and,
therefore, the inhalation risks are not of concern.  The HP handwand
scenario is of concern without respirators and requires a PF5 filtering
facepiece respirator (i.e., dust mask) to achieve the target MOE.  

Table 8.  Occupational Handler Risks from Surface Spray Applications

Exposure Scenario	Dilution	Spray Dilution (Percent ai)	Amount Sprayed
per Day	lb ai  handled per day	Inhalation MOE

M/L/A liquids with LP hand-wand or backpack sprayer	Undiluted	3	40
gallons	10	300 – No Resp.

M/L/A liquids with LP hand-wand or backpack sprayer	Diluted in water
0.11	40 gallons	0.37	8100 – No Resp.

M/L/A liquids with HP hand-wand (Greenhouse Use)	 Diluted in water	0.11
1000 gallons	9.2	81 – No Resp.

400 – PF5 Resp. 

Aerosol Can application	Undiluted	0.54	6  (16 oz) cans	0.032	2300 – No
Resp.

	      The risks for the space spray applications are summarized in
Table 9.  The MOEs are of concern (MOE < 100) when at all of the spray
dilutions when respirators are not worn.  At the highest spray dilution
rate (3.0%), the MOEs are still of concern with a PF50 Full Face
Respirators.

 

Table 9. Occupational Handler Risks from Space Spray Applications 

Label #	Spray Dilution	Application Rate 

(lb ai/1000 ft3)	Average Concentration

(mg/m3)	Respirator Worn	Inhalation MOE

432-870	3.0	0.0020	16	None

	1.4

1021-1478	1.5	0.0010	8.0

2.8

1021-1453	1.0	0.00067	5.4

4.2

432-870	3.0	0.0020	16	PF50 Full Face	70

1021-1478	1.5	0.0010	8.0

140

1021-1453	1.0	0.00067	5.4

210

                                  b.  Post-Application Exposure and Risk

	      The Agency uses the term “post-application” to describe
exposures to individuals that occur as a result of being in an
environment that has been previously treated with a pesticide (also
referred to as reentry exposure).  Allethrins are used as space sprays
in a wide variety of indoor areas such as greenhouses, commercial
institutions, and residences.  For most of the commercial applicator
labels, there are restrictions such as “Do not apply when people are
present” or “Do not allow unprotected persons to enter until treated
area has been thoroughly ventilated,” which minimize post-application
exposures.  Given the use characteristics, occupational post-
application inhalation exposures are anticipated primarily from time
metered device applications.  

	      To assess occupational post-application risk, a scenario that
involves the metered release into an industrial work area was evaluated.
 The resulting occupational post-application inhalation MOE is 850,
which is greater than the target MOE of 100 and, therefore, is not of
concern.  Furthermore, this risk estimate is conservative, because it
was assumed that the aerosols would remain airborne until they were
removed by ventilation and the effects of aerosol settling were not
considered.

	B.  Environmental Risk Assessment

The outdoor uses for the allethrins are predominantly limited to foggers
and spot treatments that are typically packaged as small, hand-held
spray units and mosquito repellents (mats and coils).  Although current
label uses include several large-scale outdoor uses, they are not being
supported.  Since the registrant agreed to modify labels to remove, or
limit to spot treatment only, any outdoor uses that could potentially be
used as a broadcast treatment, risk from broadcast uses were not
assessed.  Since the allethrins are currently registered for use in some
pet products (pet shampoos and dips), there is potential for aquatic
organism exposure from indoor use of the allethrins, via surface water
exposure following the release of household wastewater.  Therefore, the
Agency assessed ecological risk from both indoor and outdoor uses of
allethrins.  Because most of the standard methods used by the Agency for
assessing environmental risk are established for large-scale uses such
as applications to agricultural fields or public health uses, the
potential risk to the environment from allethrin spot treatment use is
assessed qualitatively by considering uses, application methods,
environmental fate properties, and toxicity data, and some risk
quotients (RQs) were calculated for illustrative purposes.

	A summary of the Agency’s environmental fate and effects risk
assessment is presented below.  For detailed discussion of all aspects
of the environmental risk assessment, please see the Response to
Comments (Phase 3) and Revised Environmental Fate and Ecological Risk
Assesment in Support of the Reregistration of the Allethrins, dated
April 4, 2007, which is available under docket number
EPA-HQ-OPP-2006-0986.

Terrestrial Organisms (Birds and Mammals)

	The potential for risk to non-listed terrestrial organisms is limited
or eliminated by the application methods described on the product
labels.  For instance, the use of Rainbow Wasp and Ant Spray (EPA Reg.
No.13283-13) is intended as a spot treatment on wasp or other stinging
insect hives.  The registrant described the typical use of the spray as
a 3-second directed application at a hive, which would result in an
application of about 0.156 g to an area of about 1000 cm2.  This rate is
equivalent to an application of about 13.8 lb ai/acre.

	If this application rate is used as input to the TeRrestrial Exposure
(T-REX) model, the acute and acute endangered species RQs for birds and
mammals would exceed levels of concern (LOC).  However, the exposure
scenario is too unrealistic to expect risk to birds and mammals.  To
reach that level of exposure, birds or mammals would essentially need to
consume the treated hive to ingest the allethrins applied by a directed
spray.

	The fogger application for the allethrins also represents an exposure
scenario that is unlikely to result in risk to non-listed birds and
mammals.  The risk assessment considered exposure from the Raid Yard
Guard Outdoor Fogger Formula VII (Reg. No. 4822-394), a total release
fogger which could affect flying insects in a 15-by-15 foot area,
releasing 1.07 g of allethrins along with another insecticide.  If all
the mass of allethrins were deposited in that 225 square-foot area, the
application would be equivalent to about 0.47 lb ai/acre, and the
resulting RQs would exceed the endangered species levels of concern for
birds and mammals.  However, that level of exposure to non-target birds
and mammals is very unlikely.  First, non-target animals would have to
derive all of their food from the 15-by-15 foot area in which a person
just placed a fogger, whether that area is a backyard patio or a lawn. 
Presumably, the fogger will have been placed in such an area so that
people can be present, which makes the likelihood of feeding less
likely.  In addition, the fogger application is designed to keep the
applied insecticides in the air, so that allethrins can work as a
knockdown agent while the other insecticide takes effect.  The applied
material is unlikely to deposit solely within the 15-by-15 foot area,
but would be dispersed over a wider area at a lower rate, dissipated by
wind and degraded by photolysis.

No guideline data were submitted to evaluate the risk of allethrin
exposure to non-target plants.  However, the allethrins are not expected
to induce phytotoxic effects because of their neural toxic mode of
action, and available efficacy studies indicated no phytotoxic effects. 

Although the Agency does not currently have standard LOCs for
terrestrial invertebrates, risk to non-target invertebrates were
considered.  Based on an average fresh weight per honey bee of 128
milligrams, the LD50 of honey bees (3.9 µg/bee) can be multiplied by
7.8 to determine the ppm toxicity.  Therefore, the contact LD50 of 3.4
µg/bee for allethrins can be converted to 26.5 ppm.  Using the
‘fruits/pods/seeds/large insects’ category in T-REX as a surrogate
for bees and an application rate of 13.8 lb a.i./acre results in an EEC
for bees of 207 ppm using upper-bound Kenaga values.  This equates to an
RQ of 7.8.  Since the Agency does not have standard LOCs for terrestrial
invertebrates, for illustration purposes, the LOCs for other terrestrial
animals was used (i.e., acute risk LOC = 0.5; acute endangered species
LOC = 0.1).  Using upper-bound Kenaga values, the application rate
needed to reach the acute risk LOC for bees is 3.5 lb a.i./acre (1,842
cans), and the application rate needed to reach the endangered species
LOC is 0.18 lb a.i./acre (95 cans of product).

Aquatic Organisms

There is potential for exposure to aquatic organisms from both the
outdoor and indoor uses of the allethrins, so both uses were assessed. 
The standard models used by the Agency to estimate transport to surface
water simulate application to agricultural fields, and cannot estimate
surface water concentrations which might result from spot treatments or
fogger use.  Therefore, for illustrative purposes, the aquatic exposure
that would result from spraying a can of Rainbow Wasp and Ant Spray (EPA
Reg. No. 13283-13) directly into the standard pond used in OPP aquatic
exposure model standard scenarios was determined.  Based on a pond
volume of 20 million liters and a total of 0.884 g of allethrin (a.i.),
and assuming no degradation or sorption, the resulting concentration in
the pond would be 0.0442 ppb.  In order to achieve an exposure
concentration equal to the toxic endpoints of concern for freshwater
invertebrates (LC50 = 2.1 ppb) and freshwater fish (LC50 = 7.9 ppb), it
would require the direct spraying of approximately 48 and 179 cans of
product.  To exceed the acute endangered species LOC of 0.05 for aquatic
animals, it would require the simultaneous release into a standard farm
pond of 2.4 cans (for freshwater invertebrates) and 9 cans (for
freshwater fish).  Thus, since actual use entails spraying a fraction of
a can in a spot treatment on land, aquatic risk of concern to aquatic
organisms from the outdoor uses of the allethrins is not anticipated. 

Since the allethrins are currently registered for use in some pet
products (pet shampoos and dips), there is potential for surface water
exposure following the release of household wastewater.  However, it
would require atypically large quantities of pet products containing
allethrins to reach an exposure concentration equal to the toxic
endpoints of concern for freshwater animals.  A “super size” bottle
(21.6 fluid ounces) of Hartz Control Flea and Tick Conditioning Shampoo
for Dogs (EPA Reg. No. 2596-124) contains 0.109% allethrin a.i. 
Assuming a conservative specific gravity for shampoo of 1.2 g/ml, a 21.6
ounce bottle of shampoo contains 766.6 g of product, including 0.836 g
a.i.  Therefore, a bottle of this product contains less active
ingredient than a can of the wasp and hornet spray used in the example
above and correspondingly higher numbers of bottles of shampoo would
have to be released into the pond to result in risk exceedances.

		1.  Adverse Ecological Incidents

  SEQ CHAPTER \h \r 1 A search of the EIIS (Environmental Incident
Information System) database for ecological incidents (run on Dec. 2,
2005) identified a total of one ecological incident involving an
allethrin (allethrin; PC Code: 004001).  The allethrin involved in the
incident is no longer registered (i.e., all of its uses have been
cancelled).  The incident occurred on a fish farm in Ventura County, CA,
in Dec. 2000, and it involved the death of 13,000 rainbow trout.  The
reported cause of the incident was an act of sabotage (i.e., it was the
result of intentional misuse).  The certainty index was reported as
“highly probable” and it was reported that, “(t)here seemed to be
no doubt about the cause of the fish kill,” although no tissue or
water samples were reported.  Because the number of documented kills in
EIIS is believed to be a very small fraction of total mortality caused
by pesticides for a variety of reasons, absence of reports does not
necessarily provide evidence of an absence of incidents given the nature
of the incident reporting.  

		2.   Endangered Species Considerations  tc "		1.	Endangered Species
Considerations " \l 3 

	Table 10 provides a matrix that depicts the potential for direct and
indirect effects to listed species resulting from the use of allethrins.
 

Table 10.  Listed species risk associated with direct or indirect
effects due to applications of allethrins 

Listed Taxon	Direct Effects1	Indirect Effects2

Terrestrial and semi-aquatic plants – monocots	None3	Possible2

Terrestrial and semi-aquatic plants - dicots	None3	Possible

Insects	None	Possible

Birds	No acute/ Possible chronic2 	Possible

Terrestrial phase amphibians	No acute/ Possible chronic2	Possible

Reptiles	No acute/ Possible chronic2	Possible

Mammals	None	Possible

Aquatic vascular plants	None3	Possible

Freshwater fish	No acute/ Possible chronic2 	Possible

Aquatic phase amphibians	No acute/ Possible chronic2	Possible

Freshwater crustaceans	No acute/ Possible chronic2	Possible

Mollusks	No acute/ Possible chronic2	Possible

Marine/estuarine fish	No acute/ Possible chronic4	Possible

Marine/estuarine crustaceans	No acute/ Possible chronic4	Possible

1Although, LOCs were not calculated, exposures are expected to be below
all Agency acute LOCs for all outdoor uses.

2 Because of a lack of chronic data for all taxa except mammals, the
potential for chronic direct effects or indirect effects cannot be
dismissed.

3 No guideline data were submitted to evaluate the risk of allethrin
exposure to non-target plants, however, the allethrins are not expected
to induce phytotoxic effects because of their neural toxic mode of
action.

4 No acute or chronic data are available.

Acute risks to listed species are not expected due to low application
rates and the types of uses being assessed.  Although the potential for
chronic risk to any listed animal cannot be dismissed at this time
because of a lack of available data, the very limited nature of
ecological exposure from use of allethrin-containing products indicates
that chronic risk is highly unlikely.  However, a Not Likely to
Adversely Affect (NLAA) determination for potential chronic risk to
listed species would require a more definitive assurance that adverse,
chronic effects would not occur.  

IV.  Risk Management, Reregistration, and Tolerance Reassessment
Decision

	A.  Determination of Reregistration Eligibility  tc "	A.	Determination
of Reregistration Eligibility " \l 2 

	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 (i.e., active ingredient-specific) data
required to support reregistration of products containing the allethrins
as active ingredients.  The Agency has completed its review of these
generic data, and has determined that the data are sufficient to support
reregistration of all products containing the allethrins.	

	The Agency has completed its assessment of the human health and
ecological risks associated with the use of pesticide products
containing the allethrins.  The Agency has determined that
allethrin-containing products are eligible for reregistration provided
that label amendments are made as outlined in Chapter V.  Appendix A
summarizes the uses of the allethrins that are eligible for
reregistration.  Appendix B identifies the generic data requirements
that the Agency reviewed as part of its determination of reregistration
eligibility of the allethrins, and lists the submitted studies that the
Agency found acceptable.  

	Based on its evaluation of the allethrins, the Agency has determined
that products containing allethrins, unless labeled and used as
specified in this document, would present risks inconsistent with FIFRA.
 Accordingly, should a registrant fail to implement any of the risk
mitigation measures identified in this document, the Agency may take
regulatory action to address the risk concerns from the use of the
allethrins.  If all changes outlined in this document are incorporated
into the product labels, then all current risks for the allethrins will
be adequately mitigated for the purposes of this determination under
FIFRA.  

	

	B.  Public Comment Period

	Through the Agency’s public participation process, EPA worked with
stakeholders and the public to reach the regulatory decisions for the
allethrins.  EPA released the allethrins preliminary risk assessments
for public comment on December 27, 2006, for a 60-day public comment
period (Phase 3 of the public participation process).  During the public
comment period on the risk assessments, which closed on February 26,
2007, the Agency received comments from the technical registrants, the
California Regional Water Quality Control Board, S.F. Bay Region, and
the California Stormwater Quality Association (CASQA).  These comments
in their entirety, responses to the comments, as well as the preliminary
and revised risk assessments, are available in the public docket
(OPP-2006-0986) at http:www.regulations.gov.

	C.  Regulatory Position

		1.  Regulatory Rationale

			

	The Agency has determined that products containing allethrins are
eligible for reregistration provided that specified label amendments are
made.  The following is a summary of the rationale for managing risks
associated with the use of allethrins.  Where labelling revisions are
warranted, specific language is set forth in the summary table of
Section V.

			a.  Human Health Risk Management

					

				i.  Occupational Risk Mitigation	

	The occupational handler exposure scenarios that were assessed included
surface spray applications using a low-pressure handwand, high-pressure
handwand or aerosol can, and indoor space spray applications using
handheld foggers.  All estimated MOEs for surface sprays are above the
target MOE of 100 and the risks are not of concern, except for the high
pressure handwand scenario.  This scenario is of concern with an MOE of
81 and a PF5 filtering facepiece respirator (i.e., a dust mask) is
required to achieve the target MOE.  The handheld fogger scenario is
also of concern with MOEs ranging from 1.4 (spray dilution rate of 3.0%)
to 4.2 (spray dilution of 1.0%) with no respirator.  To mitigate
occupational handler risk from handheld fogger applications, the maximum
spray dilution rate will be reduced from 3.0% to 1.5%, and a Full Face
respirator will be required, resulting in an MOE of 140, which is below
the Agency’s LOC. 

	Occupational post-application inhalation exposures were assessed, and
risks were below the Agency’s level of concern (i.e., MOEs were above
100 for all scenarios assessed); therefore, no mitigation measures are
required.

				ii.  Residential Risk Mitigation

Handler Risk

			

           Residential handler exposures were assessed for aerosol can
application to a variety of use sites.  All of the handler MOEs exceed
the target MOE of 1000; therefore, the handler risks are not of concern,
and no mitigation measures are required.   

Post-Application Risk (Inhalation Exposure)

	Residential post-application inhalation exposures from consumer-use
products were assessed for consumer-use space sprays, yard and patio
foggers, mosquito coils and fly mats.  The short/intermediate-term
inhalation MOEs for consumer-use space sprays, when assessed at the
highest labeled application rate of 0.50% ai, range from 650 to 2100 for
children and adults, respectively.  The registrant has agreed to reduce
the application rate on surface sprays to 0.25%, and when calculated at
this reduced rate, the MOEs range from 1300 to 4200 for children and
adults, respectively.  Since the lowest MOE (1300) is above the target
level of concern of 1000, no additional mitigation is necessary.  

	The 6 oz. yard and patio fogger, with MOEs ranging from 160 to 310,
will be voluntarily cancelled by the technical registrant.  The 1.5 oz.
yard and patio fogger scenario is only of concern when the product is in
the form of a total release fogger.  The yard and patio scenario is not
of concern when the product is in the form of a hand-held fogger. 
Although both product forms are on the same product label (registration
number 4822-394), the hand-held form is more typically found on retail
shelves and likely represents the majority of usage.  This is supported
by the Residential Exposure Joint Venture (REJV) survey which indicated
that most of the allethrin-containing yard and patio fogger products in
the household inventory were hand-held foggers.  The hand-held fogger
contains approximately 454 grams of product, which is enough for
approximately 9 sprays based upon the nozzle discharge rate of 6 grams
per second and a spray duration of 9 seconds.  By contrast, the total
release foggers can only be used once, because they discharge their
entire contents upon activation.  It should also be noted that the
toxicological point of departure (POD) selected to assess inhalation
exposures (see Table 5), which is a NOAEL of 1.3 mg/kg/day observed in
the inhalation study, may be an artifact of dose spacing, because it is
five times lower than the LOAEL of 6.5 mg/kg/day.  For this scenario,
the estimated MOE is 650 with a NOAEL of 1.3 mg/kg/day; however, with
only a slightly higher NOAEL of 2.0 mg/kg/day, the estimated MOE would
be 1000.  Considering the dose spacing for this study, the Agency has
minimal concern with an estimated MOE of 650 for this scenario; thus, no
mitigation is necessary.

Post-Application Risk (Incidental Oral Exposure)

	   Residential post-application incidental oral exposures were assessed
for consumer applied indoor foggers, PCO-applied broadcast surface
sprays, and consumer-applied spot treatment surface sprays.  The MOEs
for most consumer-use scenarios are greater than 1000, and are not of
concern.  The estimation of residue levels, and associated incidental
oral risk, that result from consumer surface applications using aerosol
can products for the allethrins were variable, depending upon the
products’ directions for use and the percent a.i. in the product. 
Although the application rates range from 0.5% to 0.05%, most of the
variability in estimated exposures was based on the use directions for
the products.  Some consumer-use surface sprays containing allethrins
specify that only spot treatments be made to areas such as cracks and
crevices in walls, corners of rooms, cabinets, closets, along and behind
baseboards, beneath and behind sinks, stoves, refrigerators and
cabinets, around plumbing and other utility installations and wherever
else these pests may find entrance.  Several labels also include
instructions to treat carpets by covering the entire surface until
slightly moist.  A broadcast use of a surface spray containing
allethrins is not typical, and these uses were not assessed, because the
registrant voluntarily agreed to amend labels to restrict use to spot
treatment only.  The incidental oral MOEs from consumer surface spray
products, when limited to spot treatments only, are greater than or
approaching the target MOE of 1000 and not of concern.  The technical
registrant also agreed to reduce the application rate to 0.25% for
consumer use surface sprays.  With this mitigation, the MOEs for
children with spot treatments applied to carpet are 1900, and therefore,
no additional mitigation is necessary.

	  Residential post-application incidental oral risk estimates from PCO
uses are less than the target MOE at the highest currently registered
concentration of 3% a.i, with MOEs ranging from 16 (intermediate-term
exposure on carpet) to 28 (short-term exposure on vinyl).  To mitigate
this risk, the registrant has agreed to limit the residential PCO
product labels to a 0.1% a.i. spray dilution rate, and amend labels to
reduce the volume of product to be applied from 1 gallon per 1000 sq ft
to 0.5 gallons per 1000 square feet.  This will result in
intermediate-term incidental oral MOEs for children greater than or
approaching the target MOE of 1000, and are not of concern.

	Risk to children playing with pets that have been treated with pet
sprays containing allethrins was also assessed.  The short- and
intermediate-term incidental oral MOEs were 2100 and 860, respectively. 
To mitigate risk from the pet sprays and other pet uses, the registrants
have agreed to cancel all pet uses.  Therefore, risk from pet sprays
containing allethrins is no longer of concern. 

The following is a summary of the human health mitigation measures:

The residential PCO product labels will be limited to a 0.1% spray
dilution rate, and language to labeling will be added reducing the
volume from 1 gallon per 1000 sq ft to 0.5 gallons per 1000 square feet.
 

The maximum spray dilution for indoor fogging applications will be
reduced from 3.0 percent (as listed on the Esbiol 300 Insect label, Reg.
No. 432-870) to 1.5 percent.

For occupational handlers applying surface sprays with high pressure
handwands, a PF5 filtering facepiece respirator (i.e. a dust mask) will
be required in order to reach the target MOE of 100.  

For occupational handlers applying space sprays with handheld foggers, a
PF50 Full Face respirator with appropriate cartridges will be required
in order to reach the target 	MOE of 100.  

The consumer surface spray product labels will be changed to require
spot treatment only.  The broadcast surface applications to rugs and
carpets will be eliminated.

The consumer surface and space sprays, with concentrations currently
ranging from 0.5% to 0.05% ai in products, will be limited to 0.25% ai. 

The use of the 6 ounce outdoor total release fogger will be deleted from
the Raid Yard Guard label (4822-394). 

The pet uses (aerosol sprays and shampoos) will be cancelled. 

                                   b.  Ecological Risk Management

	The Agency evaluated potential ecological risk from both indoor and
outdoor uses of the allethrins.  The technical registrant voluntarily
agreed to cancel pet shampoos and dips; therefore, there is no longer
potential ecological exposure from indoor products containing
allethrins, and no further mitigation is necessary for indoor uses.  

Although current label uses include several potentially large-scale
outdoor uses, they are not being supported by the technical registrant. 
Thus, the registrants have agreed to make the following changes to the
allethrins labels:

Uses on boat/ship hulls will be deleted. 

 

Kennels/stables and commercial premise uses (outdoor and area sprays)
will be deleted or limited to spot treatments.

 

Outdoor ornamental use sites will be specified and will be limited to
spot use.

Outdoor mosquito adulticide use will be deleted or limited to localized
spray. 

Outdoor commercial area space spray uses will be limited to localized
treatments. 

Perimeter spray uses will be limited to localized treatments. 

Uses in or on drainage systems, golf course turf, wide area/general
outdoor treatment, airports/landing fields, uncultivated agricultural
areas, and paved areas such as sidewalks and roads will all be deleted. 

	

	Because outdoor uses will be limited to localized spot treatments, no
additional mitigation measures for these uses are required.

		2.  Endocrine Disruptor Effects  tc ".	Endocrine Disruptor Effects "
\l 4 

	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).  

	When the appropriate screening and/or testing protocols being
considered under the EDSP have been developed, individual pesticides may
be subject to additional screening and/or testing.  However, in the
available toxicity studies for the allethrins, there was no evidence of
endocrine disruption.  

		3.  Endangered Species 

	The Endangered Species Act required federal agencies to ensure that
their actions are not likely to jeopardize listed species or adversely
modify designated critical habitat.  The Agency has developed the
Endangered Species Protection Program to identify pesticides whose use
may cause adverse impacts on federally listed endangered and threatened
species, and to implement mitigation measures that address these
impacts.  To assess the potential of registered pesticide uses that may
affect any particular species, EPA puts basic toxicity and exposure data
developed for the REDs into context for individual listed species and
considers ecological parameters, pesticide use information, the
geographic relationship between specific pesticide uses and species
locations and biological requirements and behavioral aspects of the
particular species.  When conducted, these analyses take into
consideration any regulatory changes recommended in this RED being
implemented at that time.  A determination that there is a likelihood of
potential effects to a listed species may result in limitations on the
use of the pesticide, other measures to mitigate any potential effects,
and/or consultations with the Fish and Wildlife Service or National
Marine Fisheries Service, as necessary.  If the Agency determines use of
allethrins “may affect” listed species or their designated critical
habitat, EPA will employ the provisions in the Services regulations (50
CFR Part 402).  

	The ecological assessment that EPA conducted for this RED does not, in
itself, constitute a determination as to whether specific species or
critical habitat may be harmed by the pesticide.  Rather, this
assessment serves as a screen to determine the need for any species
specific assessment that will evaluate whether exposure may be at levels
that could cause harm to specific listed species and their critical
habitat.  That assessment refines the screening-level assessment to take
into account the geographic area of pesticide use in relation to the
listed species, the habits and habitat requirements of the listed
species, etc.  If the Agency’s specific assessments for allethrins
result in the need to modify use of the pesticide, any geographically
specific changes to the pesticide’s registration will be implemented
through the process described in the Agency’s Federal Register Notice
(54 FR 27984) regarding implementation of the Endangered Species
Protection Program.  

	

	  SEQ CHAPTER \h \r 1  The Agency has reviewed data and other
information for the allethrins and concludes that this series of
insecticides does not pose a risk of direct acute effects to any species
listed under the Endangered Species Act, because EPA’s
screening-level, qualitative assessment indicates that these uses are
not likely to adversely affect listed species on an acute basis.  The
likelihood of adverse effects from chronic exposure to mammals is also
considered low.  However, the potential risk to all other taxa from
chronic exposure to allethrins cannot be assessed at this time due to a
lack of data.  

 tc "E.	Regulatory Rationale " \l 2 

	D.  Labeling Requirements  tc ".	Other Labeling Requirements " \l 3 

	In order to be eligible for reregistration, various use and safety
information will be included in the labeling of all end-use products
containing the allethrins.  For the specific labeling statements, refer
to Section V of this RED document.  		 

V.  What Registrants Need to Do

	The Agency has determined that products containing allethrins are
eligible for reregistration provided that the required label amendments
are made.  The Agency intends to issue Data Call-In Notices (DCIs)
requiring product-specific data.  Generally, registrants will have 90
days from receipt of a DCI to complete and submit response forms or
request time extension and/or waiver requests with a full written
justification.  For product-specific data, the registrant will have
eight months to submit data.  Below are the label amendments that the
Agency intends to require for the allethrins to be eligible for
reregistration.  

	A.  Manufacturing Use Products  tc "A.	Manufacturing Use Products " \l
2 

  Additional Generic Data Requirements 

	The generic data base supporting the reregistration of the allethrins
for currently registered uses has been reviewed and determined to be
substantially complete.  However, a few data gaps remain, and these are
listed below.

Occupational Exposure

875.1400  Inhalation Exposure Indoor

Residue Chemistry

Submittal of Analytical Reference Standards

Toxicology

Since the allethrins database is currently incomplete with respect to
data on potential pre- and postnatal toxicity, the Agency is requiring a
study to address this uncertainty.  The Agency is currently evaluating
whether a developmental toxicity study (DNT) or another comparative
toxicity study would be best-suited for addressing the concerns for
sensitivity to young animals.  The registrants should consult with the
Agency before beginning a study to fulfill this data requirement.    

		2.  Labeling for Manufacturing-Use Products

	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 Tables 11 and 12. 

	B.   End-Use Products 

 tc "B. 	End-Use Products " \l 2 

		1.  Additional Product-Specific Data Requirements  tc "1.	Additional
Product-Specific Data Requirements " \l 3 

	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 Bonnie Adler at 703-308-8523.

		2.  Labeling for End-Use Products 

 tc "2.	Labeling for End-Use Products " \l 3 

	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 Tables 11 and 12.  Generally,
conditions for the distribution and sale of products bearing old
labels/labeling will be established when the label changes are approved.
 However, specific existing stocks time frames will be established
case-by-case, depending on the number of products involved, the number
of label changes, and other factors. 

	C.	Labeling Changes Summary Table  tc "C.	Labeling Changes Summary
Table " \l 2 

	In order to be eligible for reregistration, amend all product labels to
comply with the following table.  Tables 11 and 12 describe how language
on the labels should be amended.

Table 11.  Summary of Labeling Changes for All Allethrin Uses EXCEPT for
Use in Coils and Mats (See Table 12 for labeling requirements in coils
and mats.) 

Description	Amended Labeling Language	Placement on Label

Manufacturing Use Products

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].”

“Not for formulation into end use products with directions for use as
an application directly to pets.”  

“Formulation into ready-to-use total release foggers with directions
for use outdoors is limited to a maximum of 1.5 ounces of product per
container.”  

 “Formulation into products with directions for use as a spot
treatment is limited to a maximum 0.25% a.i. dilution strength.”

“Formulations with greater than 0.1% a.i. dilution strength must
contain directions for use limiting applications in indoor residential
settings to spot treatments only.  Indoor broadcast use must be
prohibited.”

“Formulation into products with directions for use as a broadcast
spray outdoors is prohibited.  Outdoor use is limited to spot treatments
only.”  (NOTE: outdoor broadcast use with ready-to-use total release
foggers is permitted.)

“Not for formulation into products for use in or on drainage systems,
golf course turf, airports/landing fields, uncultivated agricultural
areas, boat/ship hulls, and paved areas such as sidewalks and roads.”
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 	“ENVIRONMENTAL HAZARDS”

“This pesticide is toxic to fish and aquatic invertebrates.  Do not
discharge effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or other waters unless in accordance with the
requirements of a National Pollutant Discharge Eliminations System
(NPDES) permit and the permitting authority has been notified in writing
prior to discharge.  Do not discharge effluent containing this product
to sewer systems without previously notifying the local sewage treatment
plant authority.  For guidance, contact your State Water Board or
Regional Office of the Environmental Protection Agency.” 
Precautionary Statements:  Environmental Hazards

End-Use Products Intended for Occupational Use (WPS and Non-WPS)

PPE Requirements1 for Ready To Use (RTU) Formulations (RTU Liquids and
Pressurized Liquids)

	“Personal Protective Equipment (PPE)”

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

“Applicators and other handlers must wear:

long-sleeved shirt and long pants, and

shoes and socks.” 	Immediately following/below Precautionary
Statements:  Hazards to Humans and Domestic Animals

PPE Requirements for Liquid Concentrates including Emulsifiable
Concentrates

Note: If the use of high pressure handwands or handheld foggers in
enclosed areas is prohibited or is not feasible for the end-use product,
the statement requiring respirators for those uses may be omitted.
“Personal Protective Equipment (PPE)”

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

“Applicators and other handlers must wear:

long-sleeved shirt and long pants, and

shoes and socks.”

 “In addition to the above PPE, applicators using high-pressure
handwands in an enclosed area must wear a NIOSH-approved dust mist
filtering respirator with MSHA/NIOSH approval number

prefix TC-21C or a NIOSH-approved respirator with any N*, R, P, or HE
filter.”

“In addition to the above PPE, applicators using hand-held foggers in
an enclosed area must wear a full-face, or helmet/hood-style
NIOSH-approved respirator with:

-- a dust/mist filtering cartridge (MSHA/NIOSH approval number prefix
TC-21C), or

-- a canister approved for pesticides (MSHA/NIOSH approval number prefix
TC-14G), or 

-- a cartridge or canister with any N*,R, P or HE filter.”

*Instruction to Registrant:  Drop the "N" type prefilter from the
respirator statement, if the pesticide product contains or is used with
oil.	Immediately following/below Precautionary Statements:  Hazards to
Humans and Domestic Animals

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

User Safety Recommendations	“User Safety Recommendations”

“Users should wash hands before eating, drinking, chewing gum, using
tobacco, or using the toilet.”

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

“Users should remove PPE immediately after handling this product. 
Wash the outside of gloves before removing.  As soon as possible, wash
thoroughly and change into clean clothing.”	Precautionary Statements
under: Hazards to Humans and Domestic Animals

(Must be placed in a box.)

Environmental Hazards Statements for Products Labeled for Outdoor Uses
“ENVIRONMENTAL HAZARDS”

“This pesticide is toxic to fish and aquatic invertebrates.  Do not
apply directly to water, or to areas where surface water is present, or
to inter-tidal areas below the mean high water mark.  Do not contaminate
water when cleaning equipment or disposing of equipment washwater or
rinsate.”	Precautionary Statements: Hazards to Humans and Domestic
Animals

Environmental Hazards Statements for Products Labeled for Indoor Uses
Only 	“ENVIRONMENTAL HAZARDS”

 

“This product is toxic to fish and aquatic invertebrates.  Do not
contaminate water when disposing of equipment, washwater, or rinsate. 
See Directions for Use for additional precautions and requirements.”

For indoor commercial, industrial or institutional products packaged in
containers equal to or greater than 5 gallons or 50 lbs add the
following statement:

“Do not discharge effluent containing this product into lakes,
streams, ponds, estuaries, oceans, or other waters unless in accordance
with the requirements of a National Pollution Discharge Elimination
System (NPDES) permit and the permitting authority has been notified in
writing prior to discharge.  Do not discharge effluent containing this
product to sewer systems without previously notifying the local sewage
treatment plant authority.  For guidance contact your State Water Board
or Regional Office of the EPA."	Precautionary Statements: Hazards to
Humans and Domestic Animals

Restricted-Entry Interval for Products with Directions for use Within
Scope of the Worker Protection Standard for Agricultural Pesticides
(WPS) 

For Products Subject to WPS as required by Supplement 3 of PR Notice
93-7	“Do not enter or allow worker entry into treated areas during the
restricted entry interval (REI) of 12 hours.”

	Directions for Use, Under Agricultural Use Requirements Box

Early Entry Personal Protective Equipment 

For Products Subject to WPS as required by Supplement 3 of PR Notice
93-7	“PPE required for early entry to treated areas that is permitted
under the Worker Protection Standard and that involves contact with
anything that has been treated, such as plants, soil or water, is 

coveralls, shoes and socks, and chemical-resistant gloves made of any
waterproof material.”	Directions for Use, in Agricultural Use
Requirements Box

Entry Restrictions for Non WPS Uses	Entry Restriction for product
applied as a surface spray:

 “Do not enter or allow unprotected persons to enter until treated
areas have dried.”

Entry Restriction for products applied as a space spray:

 

“Do not allow unprotected persons to enter until vapors, mists, and
aerosols have dispersed, and the treated area has been thoroughly
ventilated.”

Entry Restriction for products formulated as total release aerosol
foggers with directions for use indoors:

“Do not re-enter building for four hours, then open exterior doors and
windows and allow to air for 60 minutes before reoccupying area.”	If
no WPS uses on the product label, place the appropriate statement in the
Directions for Use Under General Precautions and Restrictions.  If the
product also contains WPS uses, then create a Non-Agricultural Use
Requirements box as directed in PR Notice 93-7 and place the appropriate
statement inside that box.

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

Application Restrictions- Indoor Surface Sprays in Residential Settings
Application rates for broadcast use indoors in residential settings are
limited to no greater than 0.1% active ingredient dilution strength. 

 

NOTE to Registrant:  the end-use product label must provide specific
dilution instructions for attaining this maximum dilution strength.

“When applied as a broadcast spray indoors in residential settings,
use is limited to no more than 0.5 gallons dilute spray per 1000 square
feet.” 	Place in the Directions Under Application Restrictions.

Application Restrictions- Residential Handheld Fogger Use	Application
rates for products labeled for indoor fogger use are limited to a
maximum of 1.5% active ingredient dilution strength. 

NOTE to Registrant:  the end-use product label must provide specific
dilution instructions for attaining this maximum dilution strength.
Place in the Directions Under Application Restrictions.

Application Restrictions- Outdoor Uses, except on total release foggers
for use outdoors.

	“Outdoor uses are limited to spot treatments only.  Broadcast
applications are prohibited.”	Place in the Directions Under
Application Restrictions.

End Use Products Primarily Used by Consumers/Homeowners

Environmental 

Hazards Statement 	“ENVIRONMENTAL HAZARDS”

“This product is toxic to fish and shrimp aquatic invertebrates.  Do
not apply directly to water.  Do not contaminate water when cleaning
equipment or disposing of equipment washwaters or rinsate.”  “Drift
and runoff may be hazardous to aquatic organisms in water adjacent to
treated areas.” 	Precautionary Statements under Environmental Hazards 

Entry Restrictions 

	Products applied as a spray:

“Do  SEQ CHAPTER \h \r 1  not allow adults, children, or pets to enter
the treated area until sprays have dried.”	  SEQ CHAPTER \h \r 1
Directions for use under General Precautions and Restrictions

General Application Restrictions 	“Do not apply this product in a way
that will contact adults, children, or pets, either directly or through
drift.” 	Place in the Direction for Use 

Application Restrictions- for Indoor Use at Residential Sites	Surface
and space sprays will be limited to concentrations no greater than 0.25%
a.i.

Surface spray uses are limited to spot treatments only.  Broadcast
surface applications are prohibited”.  	Application Restrictions- for
Indoor Use at Residential 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.
   

Table 12.  Summary of Labeling Changes for Allethrins Used in Coils and
Mats Only

Description	Amended Labeling Language	Placement on Label

Manufacturing Use Products

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

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

“This pesticide is toxic to fish and aquatic invertebrates.  Do not
discharge effluent containing this product into lakes, streams, ponds,
estuaries, oceans, or other waters unless in accordance with the
requirements of a National Pollutant Discharge Eliminations System
(NPDES) permit and the permitting authority has been notified in writing
prior to discharge.  Do not discharge effluent containing this product
to sewer systems without previously notifying the local sewage treatment
plant authority.  For guidance, contact your State Water Board or
Regional Office of the Environmental Protection Agency.” 
Precautionary Statements:  Environmental Hazards

End Use Products Primarily Used by Consumers/Homeowners

Environmental 

Hazards Statement 	“ENVIRONMENTAL HAZARDS”

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 PAGE   

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