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

**Environmental Protection and Toxic Substances**

![](media/image1.wmf){width="1.41875in"
height="0.4979166666666667in"}**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**

[**I. Introduction** 1](#__RefHeading___Toc174177170)

[**II. Chemical Overview** 2](#__RefHeading___Toc174177171)

[**A.** **Regulatory History** 2](#__RefHeading___Toc174177172)

[**B.** **Chemical Identification** 3](#__RefHeading___Toc174177173)

[**C. Use Profile** 5](#__RefHeading___Toc174177174)

[**D. Estimated Usage of Pesticide** 6](#__RefHeading___Toc174177175)

[**III. Summary of Allethrins Risk Assessments**
7](#__RefHeading___Toc174177176)

[**A. Human Health Risk Assessment** 7](#__RefHeading___Toc174177177)

[**1. Toxicity of Allethrins** 7](#__RefHeading___Toc174177178)

[**3. Metabolites and Degradates** 11](#__RefHeading___Toc174177179)

[**4. Dietary Exposure and Risk (Food + Water)**
11](#__RefHeading___Toc174177180)

[**5. Residential Exposure and Risk** 11](#__RefHeading___Toc174177181)

[**6. Occupational Exposure and Risk** 15](#__RefHeading___Toc174177182)

[**B. Environmental Risk Assessment** 17](#__RefHeading___Toc174177183)

[**1. Adverse Ecological Incidents** 20](#__RefHeading___Toc174177184)

[**2. Endangered Species Considerations**
20](#__RefHeading___Toc174177185)

[**IV. Risk Management, Reregistration, and Tolerance Reassessment
Decision** 22](#__RefHeading___Toc174177186)

[**A. Determination of Reregistration Eligibility**
22](#__RefHeading___Toc174177187)

[**B. Public Comment Period** 22](#__RefHeading___Toc174177188)

[**C. Regulatory Position** 22](#__RefHeading___Toc174177189)

[**1. Regulatory Rationale** 22](#__RefHeading___Toc174177190)

[**2. Endocrine Disruptor Effects** 26](#__RefHeading___Toc174177191)

[**3. Endangered Species** 26](#__RefHeading___Toc174177192)

[**D. Labeling Requirements** 27](#__RefHeading___Toc174177193)

[**V. What Registrants Need to Do** 28](#__RefHeading___Toc174177194)

[**A. Manufacturing Use Products** 28](#__RefHeading___Toc174177195)

[**1. Additional Generic Data Requirements**
28](#__RefHeading___Toc174177196)

[**2. Labeling for Manufacturing-Use Products**
28](#__RefHeading___Toc174177197)

[**B. End-Use Products** 28](#__RefHeading___Toc174177198)

[**1. Additional Product-Specific Data Requirements**
28](#__RefHeading___Toc174177199)

[**2. Labeling for End-Use Products** 29](#__RefHeading___Toc174177200)

[**C.** **Labeling Changes Summary Table**
30](#__RefHeading___Toc174177201)

**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

LC~50~ 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.

LD~50~ 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

UF~db~ Database Uncertainty Factor

**ALLETHRINS TEAM**

**Office of Pesticide Programs:**

[Health Effects Risk Assessment]{.underline}

Kit Farwell

Timothy Dole

Toiya Goodlow

Whang Phang

[Ecological Fate and Effects Risk Assessment]{.underline}

Melissa Panger

Cheryl Sutton

[Biological and Economics Analysis Assessment]{.underline}

Margaret Ervin

Angel Chiri

[Registration Division]{.underline}

Ann Sibold

Richard Gebken

[Risk Management]{.underline}

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.

[]{#__RefHeading___Toc174177170 .anchor}**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.

[]{#__RefHeading___Toc174177171 .anchor}**II. Chemical Overview**

A.  []{#__RefHeading___Toc174177172 .anchor}**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.

[]{#__RefHeading___Toc174177173 .anchor}**B. Chemical Identification**

**ALLETHRINS:**

![](media/image2.png){width="2.34375in" height="2.0833333333333335in"}

The allethrins are synthetic pyrethroids, and are structurally very
similar to cinerin I in naturally occurring pyrethrum. When allethrin
was first synthesized in 1948, it was the first pyrethroid developed,
and it differs from more recently developed pyrethroids in its
photo-lability. The more-recently developed pyrethroids have structural
modifications (*i.e*., alterations to the isobutenyl group attached to
the cyclopropane moiety) that make them more persistent than the early
generation pyrethroids, such as allethrin. Therefore, allethrin is among
the least persistent of all pyrethroids and is less persistent than
allethrins, cyallethrins, cyfluthrin, cyhalothrin, deltamethrin,
fenvalerate, tefluthrin, and tralomethrin. The allethrins subject to
reregistration differ only in the percentage of stereoisomers present.
There are three asymmetric carbons and, thus, eight potential isomers;
however, four isomers are present in the greatest concentration for
these products. One of the stereoisomers, d trans of d component
(isomer), is recognized as being the most insecticidally active and
toxicologically significant of the four isomers . Allethrins are
sometimes classified as type I pyrethroids, since they 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: Number range CHAPTERC~19~H~26~O~3~

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]{.underline}:**

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]{.underline}**: (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:]{.underline}**

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:]{.underline}**

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.

[]{#__RefHeading___Toc174177174 .anchor}**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.

**Mode of Action:** The allethrins are a type I pyrethroid (i.e.,
lacking 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.

[]{#__RefHeading___Toc174177175 .anchor}**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.

[]{#__RefHeading___Toc174177176 .anchor}**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]{.underline} 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
[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.

[]{#__RefHeading___Toc174177177 .anchor}**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]{.underline}
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.

[]{#__RefHeading___Toc174177178 .anchor}. **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 (UF~DB~) 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 |                    |        |                  |         |
| P        |                    |        |                  |         |
| rofile - |                    |        |                  |         |
| Bioalle  |                    |        |                  |         |
| thrins** |                    |        |                  |         |
+----------+--------------------+--------+------------------+---------+
| **Gui    | **Study Type**     | **     | **Results**      | **T     |
| deline** |                    | MRID** |                  | oxicity |
|          |                    |        |                  | Catego  |
|          |                    |        |                  | ry^a^** |
+----------+--------------------+--------+------------------+---------+
| 870.1100 | Acute Oral         | 00     | LD~50~: 709      | III     |
|          |                    | 151444 | mg/kg (M)        |         |
|          |                    |        |                  |         |
|          |                    |        | 1042 mg/kg (F)   |         |
+----------+--------------------+--------+------------------+---------+
| 870.1200 | Acute Dermal       | 41     | LD~50~ \> 3000   | III     |
|          |                    | 155801 | mg/kg (M&F)      |         |
+----------+--------------------+--------+------------------+---------+
| 870.1300 | Acute Inhalation   | 42     | LC~50~ : 2.51    | IV      |
|          |                    | 906902 | mg/L             |         |
+----------+--------------------+--------+------------------+---------+
| 870.2400 | Primary Eye        | 41     | Slight to        | III     |
|          | Irritation         | 155803 | moderate         |         |
|          |                    |        | irritant         |         |
+----------+--------------------+--------+------------------+---------+
| 870.2500 | Primary Skin       | 41     | Very slight      | IV      |
|          | Irritation         | 155805 | dermal irritant  |         |
+----------+--------------------+--------+------------------+---------+
| 870.2600 | Dermal             | 41     | Negative         | N/A     |
|          | Sensitization      | 155807 |                  |         |
+----------+--------------------+--------+------------------+---------+

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 |                    |        |                  |         |
| P        |                    |        |                  |         |
| rofile - |                    |        |                  |         |
| Esbiol** |                    |        |                  |         |
+----------+--------------------+--------+------------------+---------+
| **Gui    | **Study Type**     | **     | **Results**      | **T     |
| deline** |                    | MRID** |                  | oxicity |
|          |                    |        |                  | Catego  |
|          |                    |        |                  | ry^a^** |
+----------+--------------------+--------+------------------+---------+
| 870.1100 | Acute Oral         | 00     | LD~50~: 574.5    | II      |
|          |                    | 151460 | mg/kg (M)        |         |
|          |                    |        |                  |         |
|          |                    |        | 412.9 mg/kg (F)  |         |
+----------+--------------------+--------+------------------+---------+
| 870.1200 | Acute Dermal       | 41     | LD~50~ \> 2000   | III     |
|          |                    | 155802 | mg/kg            |         |
+----------+--------------------+--------+------------------+---------+
| 870.1300 | Acute Inhalation   | 41     | LC~50~ : 1.32    | III     |
|          |                    | 670801 | mg/L (M)         |         |
|          |                    |        |                  |         |
|          |                    |        | 1.23 mg/L (F)    |         |
+----------+--------------------+--------+------------------+---------+
| 870.2400 | Primary Eye        | 41     | Moderate ocular  | III     |
|          | Irritation         | 155804 | irritant         |         |
+----------+--------------------+--------+------------------+---------+
| 870.2500 | Primary Skin       | 41     | Not a dermal     | IV      |
|          | Irritation         | 155806 | irritant.        |         |
+----------+--------------------+--------+------------------+---------+
| 870.2600 | Dermal             | 41     | Not a sensitizer | N/A     |
|          | Sensitization      | 155808 |                  |         |
+----------+--------------------+--------+------------------+---------+

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 -  |                  |        |                  |         |
| Es         |                  |        |                  |         |
| biothrin** |                  |        |                  |         |
+------------+------------------+--------+------------------+---------+
| **G        | **Study Type**   | **     | **Results**      | **T     |
| uideline** |                  | MRID** |                  | oxicity |
|            |                  |        |                  | Catego  |
|            |                  |        |                  | ry^a^** |
+------------+------------------+--------+------------------+---------+
| 870.1100   | Acute Oral       | 00     | LD~50~: 432      | II      |
|            |                  | 151449 | mg/kg (M)        |         |
|            |                  |        |                  |         |
|            |                  |        | 378.0 mg/kg (F)  |         |
+------------+------------------+--------+------------------+---------+
| 870.1200   | Acute Dermal     | 00     | LD~50~ \> 2000   | III     |
|            |                  | 151451 | mg/kg            |         |
+------------+------------------+--------+------------------+---------+
| 870.1300   | Acute Inhalation | 00     | LC~50~: 2.63     | III     |
|            |                  | 151452 | g/m              |         |
|            |                  |        | ^3^-unacceptable |         |
+------------+------------------+--------+------------------+---------+
| 870.2400   | Primary Eye      | 00     | Minimally        | IV      |
|            | Irritation       | 151454 |                  |         |
+------------+------------------+--------+------------------+---------+
| 870.2500   | Primary Skin     | 00     | Slightly         | III     |
|            | Irritation       | 151453 |                  |         |
+------------+------------------+--------+------------------+---------+
| 870.2600   | Dermal           | 42     | Negative         | N/A     |
|            | Sensitization    | 907001 |                  |         |
+------------+------------------+--------+------------------+---------+

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**    |                  |        |                  |         |
+------------+------------------+--------+------------------+---------+
| **G        | **Study Type**   | **     | **Results**      | **T     |
| uideline** |                  | MRID** |                  | oxicity |
|            |                  |        |                  | Catego  |
|            |                  |        |                  | ry^a^** |
+------------+------------------+--------+------------------+---------+
| 870.1100   | Acute Oral       | 41     | LD~50~s=         | III     |
|            |                  | 017101 |                  |         |
|            |                  |        | M: 2150 mg/kg    |         |
|            |                  |        |                  |         |
|            |                  |        | F: 900 mg/kg     |         |
+------------+------------------+--------+------------------+---------+
| 870.1200   | Acute Dermal     | 41     | M: 2660 mg/kg    | III     |
|            |                  | 017102 |                  |         |
|            |                  |        | F: 4390 mg/kg    |         |
+------------+------------------+--------+------------------+---------+
| 870.1300   | Acute Inhalation | 41     | LC50 \> 3.875    | IV      |
|            |                  | 017103 | mg/L             |         |
+------------+------------------+--------+------------------+---------+
| 870.2400   | Primary Eye      | 41     | Slight irritant  | III     |
|            | Irritation       | 017104 |                  |         |
+------------+------------------+--------+------------------+---------+
| 870.2500   | Primary Skin     | 41     | Negative         | IV      |
|            | Irritation       | 017104 |                  |         |
+------------+------------------+--------+------------------+---------+
| 870.2600   | Dermal           | 41     | Negative         | N/A     |
|            | Sensitization    | 017105 |                  |         |
+------------+------------------+--------+------------------+---------+

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.

b.  **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 (BMD~10~) 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 BMDL~10~ value was 267 ppm, which is
> the lower 95% confidence limit on the BMD~10~. 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 UF~DB~ 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.        |         |           |           |                      |
| T         |         |           |           |                      |
| oxicology |         |           |           |                      |
| Endpoints |         |           |           |                      |
| for the   |         |           |           |                      |
| All       |         |           |           |                      |
| ethrins** |         |           |           |                      |
+===========+=========+===========+===========+======================+
| **Ex      | **Point | **Un      | **RfD,    | **Study and          |
| posure/** | of      | certainty | PAD,      | Toxicological        |
|           | Depa    | Factors** | Level of  | Effects**            |
| **S       | rture** |           | Concern** |                      |
| cenario** |         |           |           |                      |
+-----------+---------+-----------+-----------+----------------------+
| I         | NOAEL = | UF~A~ =   | Re        | 30-day dog           |
| ncidental | 20      | 10x       | sidential | (esbiothrin).        |
| Oral      | mg      |           | LOC for   |                      |
| S         | /kg/day | UF~H~ =   | MOE =     | LOAEL = 63 mg/kg/day |
| hort-Term |         | 10x       | 1000.     | based on elevated    |
|           |         |           |           | liver enzymes and    |
| (1-30     |         | UF~DB~ =  |           | increased liver      |
| days)     |         | 10x       |           | weight               |
+-----------+---------+-----------+-----------+----------------------+
| I         | B       | UF~A~ =   | Re        | 6-month dog          |
| ncidental | MDL~10~ | 10x       | sidential | (Bioallethrin).      |
| Oral      | = 8     |           | LOC for   |                      |
| Intermed  | mg      | UF~H~ =   | MOE =     | BMDL~10~ based on    |
| iate-Term | /kg/day | 10x       | 1000.     | based on microscopic |
|           |         |           |           | liver changes        |
| (1-6      |         | UF~DB~ =  |           | (hepatocellular      |
| months)   |         | 10x       |           | degeneration)        |
+-----------+---------+-----------+-----------+----------------------+
| Dermal    | N/A     | N/A       | N/A       | No systemic toxicity |
|           |         |           |           | at 1000 mg/kg/day    |
| (all      |         |           |           | with esbiothrin or   |
| d         |         |           |           | esbiol and           |
| urations) |         |           |           | negligible dermal    |
|           |         |           |           | absorption with      |
|           |         |           |           | pyrethrins (0.22%)   |
+-----------+---------+-----------+-----------+----------------------+
| I         | NOAEL = | UF~A~ =   | Re        | 28-day inhalation    |
| nhalation | 1.3     | 10x       | sidential | study in rats        |
|           | mg      |           | LOC for   | (esbiol). LOAEL =    |
| (all      | /kg/day | UF~H~ =   | MOE =     | 6.5 mg/kg/day based  |
| d         |         | 10x       | 1000.     | on clinical signs in |
| urations) |         |           |           | females (limb        |
|           |         | UF~DB~ =  | Occ       | tremors, hunched     |
|           |         | 10x       | upational | posture,             |
|           |         |           | LOC for   | vocalization during  |
|           |         |           | MOE =     | handling)            |
|           |         |           | 100.      |                      |
+-----------+---------+-----------+-----------+----------------------+
| Cancer    | C       |           |           |                      |
| (oral,    | lassifi |           |           |                      |
| dermal,   | cation: |           |           |                      |
| in        | Sug     |           |           |                      |
| halation) | gestive |           |           |                      |
|           | e       |           |           |                      |
|           | vidence |           |           |                      |
|           | of      |           |           |                      |
|           | ca      |           |           |                      |
|           | rcinoge |           |           |                      |
|           | nicity, |           |           |                      |
|           | but not |           |           |                      |
|           | suf     |           |           |                      |
|           | ficient |           |           |                      |
|           | to      |           |           |                      |
|           | assess  |           |           |                      |
|           | human   |           |           |                      |
|           | carci   |           |           |                      |
|           | nogenic |           |           |                      |
|           | po      |           |           |                      |
|           | tential |           |           |                      |
|           | (esbio  |           |           |                      |
|           | thrin). |           |           |                      |
+-----------+---------+-----------+-----------+----------------------+
| NOAEL =   |         |           |           |                      |
| no        |         |           |           |                      |
| observed  |         |           |           |                      |
| adverse   |         |           |           |                      |
| effect    |         |           |           |                      |
| level. UF |         |           |           |                      |
| =         |         |           |           |                      |
| un        |         |           |           |                      |
| certainty |         |           |           |                      |
| factor.   |         |           |           |                      |
| UF~A~ =   |         |           |           |                      |
| extr      |         |           |           |                      |
| apolation |         |           |           |                      |
| from      |         |           |           |                      |
| animal to |         |           |           |                      |
| human     |         |           |           |                      |
| (intra    |         |           |           |                      |
| species). |         |           |           |                      |
| UF~H~ =   |         |           |           |                      |
| potential |         |           |           |                      |
| variation |         |           |           |                      |
| in        |         |           |           |                      |
| se        |         |           |           |                      |
| nsitivity |         |           |           |                      |
| among     |         |           |           |                      |
| members   |         |           |           |                      |
| of the    |         |           |           |                      |
| human     |         |           |           |                      |
| p         |         |           |           |                      |
| opulation |         |           |           |                      |
| (inter    |         |           |           |                      |
| species). |         |           |           |                      |
| UF~DB~ =  |         |           |           |                      |
| database  |         |           |           |                      |
| un        |         |           |           |                      |
| certainty |         |           |           |                      |
| factor.   |         |           |           |                      |
| BMDL~10~  |         |           |           |                      |
| = bench   |         |           |           |                      |
| mark dose |         |           |           |                      |
| level.    |         |           |           |                      |
| MOE =     |         |           |           |                      |
| margin of |         |           |           |                      |
| exposure. |         |           |           |                      |
| LOC =     |         |           |           |                      |
| level of  |         |           |           |                      |
| concern.  |         |           |           |                      |
| N/A = not |         |           |           |                      |
| ap        |         |           |           |                      |
| plicable. |         |           |           |                      |
+-----------+---------+-----------+-----------+----------------------+

> **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.\"

[]{#__RefHeading___Toc174177179 .anchor}**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]{.underline} Section 3 Registration Action for Use in Food Handling
Establishments: Esbiothrin and Esbiol,* dated December June 27, 2007.

[]{#__RefHeading___Toc174177180 .anchor}**4. Dietary Exposure and Risk
(Food + Water)**

Number range CHAPTERNumber range CHAPTERThere 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.

[]{#__RefHeading___Toc174177181 .anchor}**5. Residential Exposure and
Risk**

[Number range CHAPTER]{.mark}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 BMDL~10~) 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) UF~DB~ 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]{.underline} 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 databaseNumber range CHAPTER (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    **Amount of     **Amount of **Inhalation
                         Active       Product Used    AI Used per MOE**
                         Ingredient   per Day**       Day**       
                         (AI) in                                  
                         Product**                                

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

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

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

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

**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]{.underline} 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]{.underline}
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 | *MOE |
|                              |                    | Popu     | \*** |
|                              |                    | lation** |      |
+------------------------------+--------------------+----------+------+
| **Incidental Oral Exposures  |                    |          |      |
| (Short-Term)**               |                    |          |      |
+------------------------------+--------------------+----------+------+
| Fogger Treatment - Carpet    | 3.6 mg/m^3^        | Children | 3600 |
| Floors                       |                    |          |      |
|                              |                    |          | 5200 |
| Fogger Treatment - Vinyl     |                    |          |      |
| Floors                       |                    |          |      |
+------------------------------+--------------------+----------+------+
| PCO Surface Treatment -      | 3.0% spray (1 gal  | Children | **   |
| Carpet Floors                | / 1000 ft^2^)      |          | 20** |
|                              |                    |          |      |
| PCO Surface Treatment -      |                    |          | **   |
| Vinyl Floors                 |                    |          | 28** |
+------------------------------+--------------------+----------+------+
| PCO Surface Treatment -      | 0.1% spray (0.5    | Children | 1200 |
| Carpet Floors                | gal / 1000 ft^2^)  |          |      |
|                              |                    |          | 1700 |
| PCO Surface Treatment -      |                    |          |      |
| Vinyl Floors                 |                    |          |      |
+------------------------------+--------------------+----------+------+
| Consumer Spot Treatment -    | 0.5% Spray         | Children | 1100 |
| Carpet Floors                |                    |          |      |
|                              |                    |          | 1700 |
| Consumer Spot Treatment -    |                    |          |      |
| Vinyl Floors                 |                    |          |      |
+------------------------------+--------------------+----------+------+
| Consumer Spot Treatment -    | 0.25% Spray        | Children | 2200 |
| Carpet Floors                |                    |          |      |
|                              |                    |          | 3400 |
| Consumer Spot Treatment -    |                    |          |      |
| Vinyl Floors                 |                    |          |      |
+------------------------------+--------------------+----------+------+
| Treated Pets -- Spray        | 0.32% a.i.         | Children | 2    |
| Formulations                 |                    |          | ,100 |
+------------------------------+--------------------+----------+------+
| **Incidental Oral Exposures  |                    |          |      |
| (Intermediate-Term)**        |                    |          |      |
+------------------------------+--------------------+----------+------+
| Fogger Treatment - Carpet    | 3.6 mg/m^3^        | Children | 3000 |
| Floors                       |                    |          |      |
|                              |                    |          | 4400 |
| Fogger Treatment - Vinyl     |                    |          |      |
| Floors                       |                    |          |      |
+------------------------------+--------------------+----------+------+
| PCO Surface Treatment -      | 3.0% spray (1 gal  | Children | **   |
| Carpet Floors                | / 1000 ft^2^)      |          | 16** |
|                              |                    |          |      |
| PCO Surface Treatment -      |                    |          | **   |
| Vinyl Floors                 |                    |          | 24** |
+------------------------------+--------------------+----------+------+
| PCO Surface Treatment -      | 0.1% spray (0.5    | Children | 960  |
| Carpet Floors                | gal /1000 ft^2^)   |          |      |
|                              |                    |          | 1400 |
| PCO Surface Treatment -      |                    |          |      |
| Vinyl Floors                 |                    |          |      |
+------------------------------+--------------------+----------+------+
| Consumer Spot Treatment -    | 0.5% Spray         | Children | 960  |
| Carpet Floors                |                    |          |      |
|                              |                    |          | 1400 |
| Consumer Spot Treatment -    |                    |          |      |
| Vinyl Floors                 |                    |          |      |
+------------------------------+--------------------+----------+------+
| Consumer Spot Treatment -    | 0.25% Spray        | Children | 1900 |
| Carpet Floors                |                    |          |      |
|                              |                    |          | 2800 |
| Consumer Spot Treatment -    |                    |          |      |
| Vinyl Floors                 |                    |          |      |
+------------------------------+--------------------+----------+------+
| Treated Pets -- Spray        | 0.32% a.i.         | Children | **8  |
| Formulations                 |                    |          | 60** |
+------------------------------+--------------------+----------+------+
| **Inhalation Exposures       |                    |          |      |
| (Short/Intermediate-Term)**  |                    |          |      |
+------------------------------+--------------------+----------+------+
| Space Spray -- 0.50% Product | 0.80 mg/m^3^       | Children | **6  |
|                              |                    |          | 50** |
|                              | (based upon the    | Adults   |      |
|                              | NDETF study)       |          | 2100 |
+------------------------------+--------------------+----------+------+
| Space Spray -- 0.25% Product | 0.40 mg/m^3^       | Children | 1300 |
|                              |                    |          |      |
|                              | (based upon the    | Adults   | 4200 |
|                              | NDETF study)       |          |      |
+------------------------------+--------------------+----------+------+
| Space Spray -- 0.10% Product | 0.16 mg/m^3^       | Children | 3050 |
|                              |                    |          |      |
|                              | (based upon the    | Adults   | 1    |
|                              | NDETF study)       |          | 0000 |
+------------------------------+--------------------+----------+------+
|                              | 0.35 mg/m^3^       | Children | 1400 |
|                              |                    |          |      |
|                              | (Based upon Raid   | Adults   | 4800 |
|                              | label 4822-513)    |          |      |
+------------------------------+--------------------+----------+------+
| Mosquito Coils               | 2 coils per patio  | Children | 7000 |
|                              |                    |          |      |
|                              |                    | Adults   | 1    |
|                              |                    |          | 4000 |
+------------------------------+--------------------+----------+------+
| Fly Mats                     | 2 mats per patio   | Children | 1800 |
|                              |                    |          |      |
|                              |                    | Adults   | 3600 |
+------------------------------+--------------------+----------+------+
| Hand Held Yard and Patio     | 3 second spray per | Children | 3100 |
| Fogger                       | patio              |          |      |
|                              |                    | Adults   | 6200 |
+------------------------------+--------------------+----------+------+
| Hand Held Yard and Patio     | 9 second spray per | Children | 1000 |
| Fogger                       | patio              |          |      |
|                              |                    | Adults   | 2200 |
+------------------------------+--------------------+----------+------+
| Total Release Yard and Patio | 6 oz. fogger /     | Children | **1  |
| Fogger                       | yard & patio       |          | 60** |
|                              |                    | Adults   |      |
|                              |                    |          | 310  |
+------------------------------+--------------------+----------+------+
| Total Release Yard and Patio | Two 1.5 ounce      | Children | **6  |
| Fogger                       | foggers / patio    |          | 50** |
|                              |                    | Adults   |      |
|                              |                    |          | 1300 |
+------------------------------+--------------------+----------+------+

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

[]{#__RefHeading___Toc174177182 .anchor}**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]{.underline} 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]{.underline}

> Number range CHAPTER1) 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       | **Di     | **Spray  | **     | **lb  | **I       |
| Scenario**       | lution** | Dilution | Amount | ai    | nhalation |
|                  |          | (Percent | S      | ha    | MOE**     |
|                  |          | ai)**    | prayed | ndled |           |
|                  |          |          | per    | per   |           |
|                  |          |          | Day**  | day** |           |
+------------------+----------+----------+--------+-------+-----------+
| M/L/A liquids    | U        | 3        | 40     | 10    | 300 -- No |
| with LP          | ndiluted |          | g      |       | Resp.     |
| hand-wand or     |          |          | allons |       |           |
| backpack sprayer |          |          |        |       |           |
+------------------+----------+----------+--------+-------+-----------+
| M/L/A liquids    | Diluted  | 0.11     | 40     | 0.37  | 8100 --   |
| with LP          | in water |          | g      |       | No Resp.  |
| hand-wand or     |          |          | allons |       |           |
| backpack sprayer |          |          |        |       |           |
+------------------+----------+----------+--------+-------+-----------+
| M/L/A liquids    | Diluted  | 0.11     | 1000   | 9.2   | **81 --   |
| with HP          | in water |          | g      |       | No        |
| hand-wand        |          |          | allons |       | Resp.**   |
| (Greenhouse Use) |          |          |        |       |           |
|                  |          |          |        |       | 400 --    |
|                  |          |          |        |       | PF5 Resp. |
+------------------+----------+----------+--------+-------+-----------+
| Aerosol Can      | U        | 0.54     | 6 (16  | 0.032 | 2300 --   |
| application      | ndiluted |          | oz)    |       | No Resp.  |
|                  |          |          | cans   |       |           |
+------------------+----------+----------+--------+-------+-----------+

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.     |          |              |              |          |        |
| Occupa |          |              |              |          |        |
| tional |          |              |              |          |        |
| H      |          |              |              |          |        |
| andler |          |              |              |          |        |
| Risks  |          |              |              |          |        |
| from   |          |              |              |          |        |
| Space  |          |              |              |          |        |
| Spray  |          |              |              |          |        |
| Ap     |          |              |              |          |        |
| plicat |          |              |              |          |        |
| ions** |          |              |              |          |        |
+========+==========+==============+==============+==========+========+
| *      | **Spray  | *            | **Average    | **Re     | **Inha |
| *Label | Di       | *Application | Con          | spirator | lation |
| \#**   | lution** | Rate**       | centration** | Worn**   | MOE**  |
|        |          |              |              |          |        |
|        |          | **(lb        | *            |          |        |
|        |          | ai/1000      | *(mg/m^3^)** |          |        |
|        |          | ft^3^)**     |              |          |        |
+--------+----------+--------------+--------------+----------+--------+
| 4      | 3.0      | 0.0020       | 16           | None     | *      |
| 32-870 |          |              |              |          | *1.4** |
+--------+----------+--------------+--------------+----------+--------+
| 102    | 1.5      | 0.0010       | 8.0          |          | *      |
| 1-1478 |          |              |              |          | *2.8** |
+--------+----------+--------------+--------------+----------+--------+
| 102    | 1.0      | 0.00067      | 5.4          |          | *      |
| 1-1453 |          |              |              |          | *4.2** |
+--------+----------+--------------+--------------+----------+--------+
| 4      | 3.0      | 0.0020       | 16           | PF50     | **70** |
| 32-870 |          |              |              | Full     |        |
|        |          |              |              | Face     |        |
+--------+----------+--------------+--------------+----------+--------+
| 102    | 1.5      | 0.0010       | 8.0          |          | 140    |
| 1-1478 |          |              |              |          |        |
+--------+----------+--------------+--------------+----------+--------+
| 102    | 1.0      | 0.00067      | 5.4          |          | 210    |
| 1-1453 |          |              |              |          |        |
+--------+----------+--------------+--------------+----------+--------+

**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.

[]{#__RefHeading___Toc174177183 .anchor}**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)]{.underline}

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 cm^2^. 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 LD~50~ of honey bees (3.9 µg/bee) can be multiplied by
7.8 to determine the ppm toxicity. Therefore, the contact LD~50~ 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]{.underline}

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
(LC~50~ = 2.1 ppb) and freshwater fish (LC~50~ = 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.

[]{#__RefHeading___Toc174177184 .anchor}**1. Adverse Ecological
Incidents**

[]{.mark}

Number range CHAPTERA 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.

[]{#__RefHeading___Toc174177185 .anchor}**2. Endangered Species
Considerations**

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 Effects^1^** **Indirect
                                                       Effects^2^**

  Terrestrial and semi-aquatic   None^3^               Possible^2^
  plants -- monocots                                   

  Terrestrial and semi-aquatic   None^3^               Possible
  plants - dicots                                      

  Insects                        None                  Possible

  Birds                          No acute/ Possible    Possible
                                 chronic^2^            

  Terrestrial phase amphibians   No acute/ Possible    Possible
                                 chronic^2^            

  Reptiles                       No acute/ Possible    Possible
                                 chronic^2^            

  Mammals                        None                  Possible

  Aquatic vascular plants        None^3^               Possible

  Freshwater fish                No acute/ Possible    Possible
                                 chronic^2^            

  Aquatic phase amphibians       No acute/ Possible    Possible
                                 chronic^2^            

  Freshwater crustaceans         No acute/ Possible    Possible
                                 chronic^2^            

  Mollusks                       No acute/ Possible    Possible
                                 chronic^2^            

  Marine/estuarine fish          No acute/ Possible    Possible
                                 chronic^4^            

  Marine/estuarine crustaceans   No acute/ Possible    Possible
                                 chronic^4^            
  ------------------------------------------------------------------------

^1^Although, 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.

[]{#__RefHeading___Toc174177186 .anchor}**IV. Risk Management,
Reregistration, and Tolerance Reassessment Decision**

[]{#__RefHeading___Toc174177187 .anchor}**A. Determination of
Reregistration Eligibility**

Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after
submission of relevant data concerning an active ingredient, whether or
not products containing the active ingredient are eligible for
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.

[]{#__RefHeading___Toc174177188 .anchor}**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.

[]{#__RefHeading___Toc174177189 .anchor}**C. Regulatory Position**

[]{#__RefHeading___Toc174177190 .anchor}**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]{.underline}

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)]{.underline}

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)]{.underline}

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:]{.underline}

-   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.

[]{#__RefHeading___Toc174177191 .anchor}**2. Endocrine Disruptor
Effects**

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.

[]{#__RefHeading___Toc174177192 .anchor}**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.

Number range CHAPTER 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.

[]{#__RefHeading___Toc174177193 .anchor}**D. Labeling Requirements**

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.

[]{#__RefHeading___Toc174177194 .anchor}**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.

[]{#__RefHeading___Toc174177195 .anchor}**A. Manufacturing Use
Products**

1.  []{#__RefHeading___Toc174177196 .anchor}**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]{.underline}

875.1400 Inhalation Exposure Indoor

[Residue Chemistry]{.underline}

1650. Submittal of Analytical Reference Standards

[Toxicology]{.underline}

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.

[]{#__RefHeading___Toc174177197 .anchor}**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.

[]{#__RefHeading___Toc174177198 .anchor}**B. End-Use Products**

[]{#__RefHeading___Toc174177199 .anchor}**1. Additional Product-Specific
Data Requirements**

Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed
product-specific data regarding the pesticide after a determination of
eligibility has been made. The Registrant must review previous data
submissions to ensure that they meet current EPA acceptance criteria and
if not, commit to conduct new studies. If a registrant believes that
previously submitted data meet current testing standards, then the study
MRID numbers should be cited according to the instructions in the
Requirement Status and Registrants Response Form provided for each
product. The Agency intends to issue a separate product-specific data
call-in (PDCI), outlining specific data requirements. For any questions
regarding the PDCI, please contact Bonnie Adler at 703-308-8523.

[]{#__RefHeading___Toc174177200 .anchor}**2. Labeling for End-Use
Products**

To be eligible for reregistration, labeling changes are necessary to
implement measures outlined in Section IV above. Specific language to
incorporate these changes is specified in 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.

[]{#__RefHeading___Toc174177201 .anchor}**C. Labeling Changes Summary
Table**

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          | "Only for formulation into an   | Directions for  |
| Manufacturing    | ***insecticide*** for the       | use             |
| Use Products     | 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."                     |                 |
+------------------+---------------------------------+-----------------+
| One of these     | "This product may be used to    | Directions for  |
| statements may   | formulate products for specific | Use             |
| be added to a    | use(s) not listed on the MP     |                 |
| label to allow   | label if the formulator, user   |                 |
| reformulation of | group, or grower has complied   |                 |
| the product for  | with U.S. EPA submission        |                 |
| a specific use   | requirements regarding support  |                 |
| or all           | of such use(s)."                |                 |
| additional uses  |                                 |                 |
| supported by a   | "This product may be used to    |                 |
| formulator or    | formulate products for any      |                 |
| user group       | 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)."                        |                 |
+------------------+---------------------------------+-----------------+
| Environmental    | "ENVIRONMENTAL HAZARDS"         | Precautionary   |
| Hazards          |                                 | Statements:     |
| Statements       | "This pesticide is toxic to     | Environmental   |
|                  | fish and aquatic invertebrates. | Hazards         |
|                  | 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."                        |                 |
+------------------+---------------------------------+-----------------+
| **End-Use        |                                 |                 |
| Products         |                                 |                 |
| Intended for     |                                 |                 |
| Occupational Use |                                 |                 |
| (WPS and         |                                 |                 |
| Non-WPS)**       |                                 |                 |
+------------------+---------------------------------+-----------------+
| PPE              | "Personal Protective Equipment  | Immediately     |
| Requirements^1^  | (PPE)"                          | following/below |
| for Ready To Use |                                 | Precautionary   |
| (RTU)            | "Some materials that are        | Statements:     |
| Formulations     | chemical-resistant to this      | Hazards to      |
| (RTU Liquids and | product are \[registrant        | Humans and      |
| Pressurized      | inserts correct material(s)\]." | Domestic        |
| Liquids)         | For more options, follow the    | Animals         |
|                  | 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."               |                 |
+------------------+---------------------------------+-----------------+
| PPE Requirements | "Personal Protective Equipment  | Immediately     |
| for Liquid       | (PPE)"                          | following/below |
| Concentrates     |                                 | Precautionary   |
| including        | "Some materials that are        | Statements:     |
| Emulsifiable     | chemical-resistant to this      | Hazards to      |
| Concentrates     | product are \[registrant        | Humans and      |
|                  | inserts correct material(s)\]." | Domestic        |
| Note: If the use | For more options, follow the    | Animals         |
| of high pressure | instructions for category       |                 |
| handwands or     | \[insert A, B, C, D, E, F, G or |                 |
| handheld foggers | H\] on the chemical-resistance  |                 |
| in enclosed      | category selection chart.       |                 |
| areas is         |                                 |                 |
| prohibited or is | "Applicators and other handlers |                 |
| not feasible for | must wear:                      |                 |
| the end-use      |                                 |                 |
| product, the     | long-sleeved shirt and long     |                 |
| statement        | pants, and                      |                 |
| requiring        |                                 |                 |
| respirators for  | shoes and socks."               |                 |
| those uses may   |                                 |                 |
| be omitted.      | "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.   |                 |
+------------------+---------------------------------+-----------------+
| User Safety      | "Follow manufacturer's          | Precautionary   |
| Requirements     | instructions for                | Statements:     |
|                  | cleaning/maintaining PPE. If no | Hazards to      |
|                  | such instructions for washables | Humans and      |
|                  | exist, use detergent and hot    | Domestic        |
|                  | water. Keep and wash PPE        | Animals         |
|                  | separately from other laundry." | immediately     |
|                  |                                 | following the   |
|                  | "Discard clothing or other      | PPE             |
|                  | absorbent materials that have   | requirements    |
|                  | been drenched or heavily        |                 |
|                  | contaminated with this          |                 |
|                  | product's concentrate. Do not   |                 |
|                  | reuse them."                    |                 |
+------------------+---------------------------------+-----------------+
| User Safety      | "User Safety Recommendations"   | Precautionary   |
| Recommendations  |                                 | Statements      |
|                  | "Users should wash hands before | under: Hazards  |
|                  | eating, drinking, chewing gum,  | to Humans and   |
|                  | using tobacco, or using the     | Domestic        |
|                  | toilet."                        | Animals         |
|                  |                                 |                 |
|                  | "Users should remove clothing/  | (Must be placed |
|                  | PPE immediately if pesticide    | in a box.)      |
|                  | 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."                      |                 |
+------------------+---------------------------------+-----------------+
| Environmental    | "ENVIRONMENTAL HAZARDS"         | Precautionary   |
| Hazards          |                                 | Statements:     |
| Statements for   | "This pesticide is toxic to     | Hazards to      |
| Products Labeled | fish and aquatic invertebrates. | Humans and      |
| for Outdoor Uses | Do not apply directly to water, | Domestic        |
|                  | or to areas where surface water | Animals         |
|                  | 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."          |                 |
+------------------+---------------------------------+-----------------+
| Environmental    | "ENVIRONMENTAL HAZARDS"         | Precautionary   |
| Hazards          |                                 | Statements:     |
| Statements for   | "This product is toxic to fish  | Hazards to      |
| Products Labeled | and aquatic invertebrates. Do   | Humans and      |
| for Indoor Uses  | not contaminate water when      | Domestic        |
| Only             | disposing of equipment,         | Animals         |
|                  | 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.\"   |                 |
+------------------+---------------------------------+-----------------+
| Restricted-Entry | "Do not enter or allow worker   | Directions for  |
| Interval for     | entry into treated areas during | Use, Under      |
| Products with    | the restricted entry interval   | Agricultural    |
| Directions for   | (REI) of 12 hours."             | Use             |
| use Within Scope |                                 | Requirements    |
| of the Worker    |                                 | Box             |
| Protection       |                                 |                 |
| Standard for     |                                 |                 |
| Agricultural     |                                 |                 |
| Pesticides (WPS) |                                 |                 |
|                  |                                 |                 |
| *For Products    |                                 |                 |
| Subject to WPS   |                                 |                 |
| as required by   |                                 |                 |
| Supplement 3 of  |                                 |                 |
| PR Notice 93-7*  |                                 |                 |
+------------------+---------------------------------+-----------------+
| Early Entry      | "PPE required for early entry   | Directions for  |
| Personal         | to treated areas that is        | Use, in         |
| Protective       | permitted under the Worker      | Agricultural    |
| Equipment        | Protection Standard and that    | Use             |
|                  | involves contact with anything  | Requirements    |
| *For Products    | that has been treated, such as  | Box             |
| Subject to WPS   | plants, soil or water, is       |                 |
| as required by   |                                 |                 |
| Supplement 3 of  | coveralls, shoes and socks, and |                 |
| PR Notice 93-7*  | chemical-resistant gloves made  |                 |
|                  | of any waterproof material."    |                 |
+------------------+---------------------------------+-----------------+
| Entry            | **Entry Restriction for product | If no WPS uses  |
| Restrictions for | applied as a surface spray:**   | on the product  |
| Non WPS Uses     |                                 | label, place    |
|                  | "Do not enter or allow          | the appropriate |
|                  | unprotected persons to enter    | statement in    |
|                  | until treated areas have        | the Directions  |
|                  | dried."                         | for Use Under   |
|                  |                                 | General         |
|                  | **Entry Restriction for         | Precautions and |
|                  | products applied as a space     | Restrictions.   |
|                  | spray:**                        | If the product  |
|                  |                                 | also contains   |
|                  | "Do not allow unprotected       | WPS uses, then  |
|                  | persons to enter until vapors,  | create a        |
|                  | mists, and aerosols have        | N               |
|                  | dispersed, and the treated area | on-Agricultural |
|                  | has been thoroughly             | Use             |
|                  | ventilated."                    | Requirements    |
|                  |                                 | box as directed |
|                  | **Entry Restriction for         | in PR Notice    |
|                  | products formulated as total    | 93-7 and place  |
|                  | release aerosol foggers with    | the appropriate |
|                  | directions for use indoors:**   | statement       |
|                  |                                 | inside that     |
|                  | "Do not re-enter building for   | box.            |
|                  | four hours, then open exterior  |                 |
|                  | doors and windows and allow to  |                 |
|                  | air for 60 minutes before       |                 |
|                  | reoccupying area."              |                 |
+------------------+---------------------------------+-----------------+
| General          | "Do not apply this product in a | Place in the    |
| Application      | way that will contact workers   | Directions for  |
| Restrictions     | or other persons, either        | Use directly    |
|                  | directly or through drift. Only | above the       |
|                  | protected handlers may be in    | Agricultural    |
|                  | the area during application."   | Use Box         |
+------------------+---------------------------------+-----------------+
| Application      | Application rates for broadcast | Place in the    |
| Restrictions-    | use indoors in residential      | Directions      |
| Indoor Surface   | settings are limited to no      | Under           |
| Sprays in        | greater than 0.1% active        | Application     |
| Residential      | ingredient dilution strength.   | Restrictions.   |
| Settings         |                                 |                 |
|                  | **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."    |                 |
+------------------+---------------------------------+-----------------+
| Application      | Application rates for products  | Place in the    |
| Restrictions-    | labeled for indoor fogger use   | Directions      |
| Residential      | are limited to a maximum of     | Under           |
| Handheld Fogger  | 1.5% active ingredient dilution | Application     |
| Use              | strength.                       | Restrictions.   |
|                  |                                 |                 |
|                  | **NOTE to Registrant**: the     |                 |
|                  | end-use product label must      |                 |
|                  | provide specific dilution       |                 |
|                  | instructions for attaining this |                 |
|                  | maximum dilution strength.      |                 |
+------------------+---------------------------------+-----------------+
| Application      | "Outdoor uses are limited to    | Place in the    |
| Restrictions-    | spot treatments only. Broadcast | Directions      |
| Outdoor Uses,    | applications are prohibited."   | Under           |
| except on total  |                                 | Application     |
| release foggers  |                                 | Restrictions.   |
| for use          |                                 |                 |
| outdoors.        |                                 |                 |
+------------------+---------------------------------+-----------------+
| **End Use        |                                 |                 |
| Products         |                                 |                 |
| Primarily Used   |                                 |                 |
| by               |                                 |                 |
| Consum           |                                 |                 |
| ers/Homeowners** |                                 |                 |
+------------------+---------------------------------+-----------------+
| Environmental    | "ENVIRONMENTAL HAZARDS"         | Precautionary   |
|                  |                                 | Statements      |
| Hazards          | "This product is toxic to fish  | under           |
| Statement        | and shrimp aquatic              | Environmental   |
|                  | invertebrates. Do not apply     | Hazards         |
|                  | 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."                 |                 |
+------------------+---------------------------------+-----------------+
| Entry            | Products applied as a spray:    | Number range    |
| Restrictions     |                                 | CH              |
|                  | "DoNumber range CHAPTER not     | APTERDirections |
|                  | allow adults, children, or pets | for use under   |
|                  | to enter the treated area until | General         |
|                  | sprays have dried."             | Precautions and |
|                  |                                 | Restrictions    |
+------------------+---------------------------------+-----------------+
| General          | "Do not apply this product in a | Place in the    |
| Application      | way that will contact adults,   | Direction for   |
| Restrictions     | children, or pets, either       | Use             |
|                  | directly or through drift."     |                 |
+------------------+---------------------------------+-----------------+
| Application      | Surface and space sprays will   | Application     |
| Restrictions-    | be limited to concentrations no | Restrictions-   |
| for Indoor Use   | greater than 0.25% a.i.         | for Indoor Use  |
| at Residential   |                                 | at Residential  |
| Sites            | Surface spray uses are limited  | Sites           |
|                  | to spot treatments only.        |                 |
|                  | Broadcast surface applications  |                 |
|                  | are prohibited".                |                 |
+------------------+---------------------------------+-----------------+

> ^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       |                                            |             |
| A         |                                            |             |
| llethrins |                                            |             |
| Used in   |                                            |             |
| Coils and |                                            |             |
| Mats      |                                            |             |
| Only**    |                                            |             |
+===========+============================================+=============+
| **Desc    | **Amended Labeling Language**              | **Placement |
| ription** |                                            | on Label**  |
+-----------+--------------------------------------------+-------------+
| **Manu    |                                            |             |
| facturing |                                            |             |
| Use       |                                            |             |
| P         |                                            |             |
| roducts** |                                            |             |
+-----------+--------------------------------------------+-------------+
| For all   | "Only for formulation into an              | Directions  |
| Manu      | ***insecticide*** for the following use(s) | for use     |
| facturing | \[fill blank only with those uses that are |             |
| Use       | being supported by MP registrant\]."       |             |
| Products  |                                            |             |
+-----------+--------------------------------------------+-------------+
| One of    | "This product may be used to formulate     | Directions  |
| these     | products for specific use(s) not listed on | for Use     |
| s         | the MP label if the formulator, user       |             |
| tatements | group, or grower has complied with U.S.    |             |
| may be    | EPA submission requirements regarding      |             |
| added to  | support of such use(s)."                   |             |
| a label   |                                            |             |
| to allow  | "This product may be used to formulate     |             |
| refo      | products for any additional use(s) not     |             |
| rmulation | listed on the MP label if the formulator,  |             |
| of the    | user group, or grower has complied with    |             |
| product   | U.S. EPA submission requirements regarding |             |
| for a     | support of such use(s)."                   |             |
| specific  |                                            |             |
| use or    |                                            |             |
| all       |                                            |             |
| a         |                                            |             |
| dditional |                                            |             |
| uses      |                                            |             |
| supported |                                            |             |
| by a      |                                            |             |
| f         |                                            |             |
| ormulator |                                            |             |
| or user   |                                            |             |
| group     |                                            |             |
+-----------+--------------------------------------------+-------------+
| Envi      | "ENVIRONMENTAL HAZARDS"                    | Pr          |
| ronmental |                                            | ecautionary |
| Hazards   | "This pesticide is toxic to fish and       | Statements: |
| S         | aquatic invertebrates. Do not discharge    | En          |
| tatements | effluent containing this product into      | vironmental |
|           | lakes, streams, ponds, estuaries, oceans,  | Hazards     |
|           | 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."                        |             |
+-----------+--------------------------------------------+-------------+
| **End Use |                                            |             |
| Products  |                                            |             |
| Primarily |                                            |             |
| Used by   |                                            |             |
| Cons      |                                            |             |
| umers/Hom |                                            |             |
| eowners** |                                            |             |
+-----------+--------------------------------------------+-------------+
| Envi      | "ENVIRONMENTAL HAZARDS"                    | Pr          |
| ronmental |                                            | ecautionary |
|           | "This product is toxic to fish and shrimp. | Statements  |
| Hazards   | Do not apply directly to water. Do not     | under       |
| Statement | contaminate water when cleaning equipment  | En          |
|           | or disposing of equipment washwaters or    | vironmental |
|           | rinsate."                                  | Hazards     |
|           |                                            |             |
|           | "Drift and runoff may be hazardous to      |             |
|           | aquatic organisms in water adjacent to     |             |
|           | treated areas."                            |             |
+-----------+--------------------------------------------+-------------+