United States		                Prevention, Pesticides
           EPA 738-R-07-010

Environmental Protection               and Toxic Substances
       September 12, 2008

Agency					      (7508P)

 Reregistration

	Eligibility Decision

	for

	Naphthalene

TABLE OF CONTENTS

  TOC \o "1-3" \h \z \u    HYPERLINK \l "_Toc213557882"  I.
Introduction	  PAGEREF _Toc213557882 \h  8

  HYPERLINK \l "_Toc213557883"  II.  Chemical Overview	  PAGEREF
_Toc213557883 \h  8

  HYPERLINK \l "_Toc213557884"  A.	Regulatory History	  PAGEREF
_Toc213557884 \h  8

  HYPERLINK \l "_Toc213557885"  B.  Chemical Identification	  PAGEREF
_Toc213557885 \h  9

  HYPERLINK \l "_Toc213557886"  C.  Use Profile	  PAGEREF _Toc213557886
\h  9

  HYPERLINK \l "_Toc213557887"  D.  Estimated Usage of Pesticide
PAGEREF _Toc213557887 \h  10

  HYPERLINK \l "_Toc213557888"  III.  Summary of Naphthalene Risk
Assessments	  PAGEREF _Toc213557888 \h  10

  HYPERLINK \l "_Toc213557889"  A.  Human Health Risk Assessment
PAGEREF _Toc213557889 \h  10

  HYPERLINK \l "_Toc213557890"  1.  Toxicity of Naphthalene	  PAGEREF
_Toc213557890 \h  11

  HYPERLINK \l "_Toc213557891"  2.  Carcinogenicity of Naphthalene
PAGEREF _Toc213557891 \h  16

  HYPERLINK \l "_Toc213557892"  3.  Metabolites and Degradates	  PAGEREF
_Toc213557892 \h  17

  HYPERLINK \l "_Toc213557893"  4.  Endocrine Disruption	  PAGEREF
_Toc213557893 \h  17

  HYPERLINK \l "_Toc213557894"  5.  Dietary Risk (Water Only)	  PAGEREF
_Toc213557894 \h  17

  HYPERLINK \l "_Toc213557895"  6.  Residential (Non-Occupational)
Exposure Risk	  PAGEREF _Toc213557895 \h  20

  HYPERLINK \l "_Toc213557896"  7.  Aggregate Risk	  PAGEREF
_Toc213557896 \h  24

  HYPERLINK \l "_Toc213557897"  8.  Occupational Risk	  PAGEREF
_Toc213557897 \h  24

  HYPERLINK \l "_Toc213557898"  9.  Human Incident Data	  PAGEREF
_Toc213557898 \h  24

  HYPERLINK \l "_Toc213557899"  B.  Environmental Risk Assessment
PAGEREF _Toc213557899 \h  25

  HYPERLINK \l "_Toc213557900"  1.  Environmental Fate and Transport
PAGEREF _Toc213557900 \h  26

  HYPERLINK \l "_Toc213557901"  2.  Terrestrial Organisms	  PAGEREF
_Toc213557901 \h  27

  HYPERLINK \l "_Toc213557902"  3.  Aquatic Organisms	  PAGEREF
_Toc213557902 \h  31

  HYPERLINK \l "_Toc213557903"  IV.  Risk Management, Reregistration,
and Tolerance Reassessment Decision	  PAGEREF _Toc213557903 \h  34

  HYPERLINK \l "_Toc213557904"  A.  Determination of Reregistration
Eligibility	  PAGEREF _Toc213557904 \h  34

  HYPERLINK \l "_Toc213557905"  B.  Public Comment Period	  PAGEREF
_Toc213557905 \h  35

  HYPERLINK \l "_Toc213557906"  C.  Regulatory Position	  PAGEREF
_Toc213557906 \h  36

  HYPERLINK \l "_Toc213557907"  1.  Regulatory Rationale	  PAGEREF
_Toc213557907 \h  36

  HYPERLINK \l "_Toc213557908"  2.  Endocrine Disruptor Effects
PAGEREF _Toc213557908 \h  39

  HYPERLINK \l "_Toc213557909"  3.  Endangered Species	  PAGEREF
_Toc213557909 \h  40

  HYPERLINK \l "_Toc213557910"  D.  Labeling Requirements	  PAGEREF
_Toc213557910 \h  40

  HYPERLINK \l "_Toc213557911"  V.  What Registrants Need to Do
PAGEREF _Toc213557911 \h  40

  HYPERLINK \l "_Toc213557912"  A.  Manufacturing Use Products	  PAGEREF
_Toc213557912 \h  40

  HYPERLINK \l "_Toc213557913"  1.  Additional Generic Data Requirements
  PAGEREF _Toc213557913 \h  40

  HYPERLINK \l "_Toc213557914"  2.  Labeling for Manufacturing-Use
Products	  PAGEREF _Toc213557914 \h  41

  HYPERLINK \l "_Toc213557915"  B.   End-Use Products	  PAGEREF
_Toc213557915 \h  41

  HYPERLINK \l "_Toc213557916"  1.  Additional Product-Specific Data
Requirements	  PAGEREF _Toc213557916 \h  41

  HYPERLINK \l "_Toc213557917"  2.  Labeling for End-Use Products
PAGEREF _Toc213557917 \h  41

  HYPERLINK \l "_Toc213557918"  C.  Labeling Changes Summary Table
PAGEREF _Toc213557918 \h  42

  HYPERLINK \l "_Toc213557919"  Appendix A.  Use Patterns Eligible for
Reregistration for Naphthalene	  PAGEREF _Toc213557919 \h  46

  HYPERLINK \l "_Toc213557920"  Appendix B .    HYPERLINK \l
"_Toc213557921"  Data Supporting Guideline Requirements for the
Reregistration of   Naphthalene	  PAGEREF _Toc213557921 \h  47

  HYPERLINK \l "_Toc213557922"  Appendix C.  Technical Support Documents
  PAGEREF _Toc213557922 \h  49

  HYPERLINK \l "_Toc213557923"  Appendix D.  Citations Considered to be
Part of the Database Supporting the Reregistration Decision
(Bibliography)	  PAGEREF _Toc213557923 \h  50

 Glossary of Terms and Abbreviations

ai		Active Ingredient

CFR		Code of Federal Regulations

DCI		Data Call-In

EC		Emulsifiable Concentrate Formulation

EDSTAC      Endocrine Disruptor Screening and Testing Advisory Committee

EEC		Estimated Environmental Concentration

EPA		Environmental Protection Agency

EUP		End-Use Product

FIFRA	Federal Insecticide, Fungicide, and Rodenticide Act

FIRST 	FQPA Index Reservoir Screening Tool

FFDCA	Federal Food, Drug, and Cosmetic Act

GLN		Guideline Number

HED		Health Effects Division

HDT		Highest Dose Tested

IRIS 		Integrated Risk Information System

LADD	Lifetime Average Daily Dose

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

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

LOC		Level of Concern

LOAEL	Lowest Observed Adverse Effect Level

mg/kg/day	Milligram Per Kilogram Per Day

mg/L		Milligrams Per Liter

µmol		Millimoles Per Liter

MOA		Mode of Action

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

NAWQA	National Water-Quality Assessment Program

NCEA	National Center for Environmental Assessment

NDETF	Non-Dietary Exposure Task Force

NLAA	Not Likely to Adversely Affect

NR		Not Required

NOAEL	No Observed Adverse Effect Level

NTP		National Toxicology Program

OPP		EPA Office of Pesticide Programs

OPPTS	EPA Office of Prevention, Pesticides and Toxic Substances

PCC		Poison Control Center

PII		Primary Irritation Index

PK		Pharmacokinetic

ppb		Parts Per Billion

POD		Point of Departure

ppm		Parts per Million

RED		Reregistration Eligibility Decision

REI		Restricted Entry Interval

RfC		Reference Concentration

RfD		Reference Dose

SCI-GROW  Screening Concentration In Ground Water

SF		Safety Factor

TREX		Terrestrial Residue Exposure (T-REX)

USDA	United States Department of Agriculture

USGA	US Geological Survey

UF		Uncertainty Factor

UFdb		Database Uncertainty Factor

NAPHTHALENE TEAM

Office of Pesticide Programs:

Health Effects Risk Assessment

Wade Britton

Danette Drew

John Liccione, Ph.D.

Ecological Fate and Effects Risk Assessment

Stephen Carey

Mark Corbin

Biological and Economics Analysis Assessment

Rafael Prieto

Steve Jarboe

LaVerne Dobbins

Registration Division

Dan Peacock

John Hebert

Risk Management

Molly Clayton

Kevin Costello

Abstract

	The Environmental Protection Agency (EPA or the Agency) has completed
the human health and ecological risk assessments for naphthalene and is
issuing its risk management decision.  The human health and ecological
risk assessments, which are summarized below, are based on the review of
the required target database supporting the use patterns of currently
registered products.  As a result of this review, EPA has determined
that naphthalene-containing products are eligible for reregistration,
provided that risk mitigation measures described in this document are
adopted and labels are amended accordingly.  That decision is discussed
fully in this document.

	Naphthalene is an insecticide; the majority of its pesticidal use is as
a moth repellant to protect garments from insect damage (indoor) and as
an animal repellant against nuisance vertebrate pests (indoor and
outdoor).  There are no food uses, and all registered products of
naphthalene are intended for residential uses only.  The indoor products
are formulated as mothballs or flakes, while outdoor products are
formulated as flakes or granules.  Of the risk scenarios assessed, only
the risk from episodic ingestion of mothballs by toddlers was of
concern.  Mitigation measures, including special packaging and
precautionary label language, will be required to address this potential
risk of concern.

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
naphthalene.  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 ecological 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 naphthalene 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-2008-0343.

II.  Chemical Overview

Regulatory History

	The Agency’s predecessor for pesticide registrations, the U.S.
Department of Agriculture (USDA), first registered a product containing
naphthalene in 1948.  The Agency issued a Registration Standard for this
active ingredient in 1981 and required submission or citation of the
following data: chemistry; environmental fate and effects; acute,
subchronic, chronic human health effects; and efficacy data.  In the
latter half of the 1990s, the Agency initiated a Label Improvement
Program (LIP) to update the precautionary text, use directions, storage,
and disposal instructions to reduce exposure to naphthalene, especially
when used in homes.

	Currently, there are 9 registered naphthalene products.  One is a
manufacturing-use product and 8 are end-use products.  All are
registered under Section 3 of  FIFRA.  There are no Special Local Need
(SLN) registrations under Section 24(c) of FIFRA.  The Agency has
registered products for domestic, indoor use to kill moths inside of
airtight spaces (closets, chests, and garment bags) and to repel bats,
tree squirrels, and birds from attics and wall voids.  There are
naphthalene products for domestic, outdoor use to repel rabbits, snakes,
Norway rats, roof rats, and house mice.

 	B.  Chemical Identification

	NAPHTHALENE:

	Naphthalene is a white, crystalline solid with a characteristic odor.

Common Name:		Naphthalene

Chemical Class:		Insecticide

PC Code:	055801

Case Number:			0022

CAS Registry Number:	91-20-3

Molecular Weight:		128.18 g/mole

Empirical Formula:		  SEQ CHAPTER \h \r 1 C10H8

Technical Registrants:	Reochem, Inc.

	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 naphthalene eligible for reregistration is contained in Appendix
A.

Type of Pesticide:  Insecticide and repellant.

Target Organism:  The primary target pests are moths and nuisance
vertebrate pests (squirrels, rats, rabbits, bats, etc).

Use Sites:  Naphthalene is registered for use on indoor and outdoor
residential use sites.  It is used indoors as a moth repellant, and
placed in closed drawers, closets, and other storage areas.  It is also
used in attics as a squirrel and bat repellant.  Outdoors, it is used
around garden and building peripheries to repel animals such as snakes
and rabbits.

Use Classification:  Naphthalene products are designated as general use.

Formulation Types:  Balls, granules, and flakes.

Application Methods:  By hand.

Application Rates:  Actual application rates for naphthalene products
are imprecise, based on formulation type and application method.  It is
registered for use on indoor sites as a moth repellant in mothballs and
flakes at rates ranging from 0.25 pounds of active ingredient per 12
cubic feet (0.25 lb ai/12 ft3) to 0.37 lb ai/12 ft3.  When used indoors
as an animal repellant, it is formulated as a flake and applied at a
rate of 1 lb ai/400 ft3 (or 1 oz/3 ft3 for smaller spaces).  When used
outdoors and formulated as granules or flakes, it is applied at rates
ranging from 0.56 lb ai/treated area to 10.8 lb ai/treated area.

Application Timing:  Registered labels for indoor moth treatment use
recommend keeping the product in an airtight space for a minimum of
seven days.  Re-treatment is recommended when the mothballs have
dissipated.  Since moths are active all year, there is the potential for
continual treatment indoors.  One moth control label recommends
re-treatment twice per year.  Re-treatment for indoor/outdoor repellant
uses is recommended as needed to maintain odor intensity.  Hot weather,
wind, and rain may diminish the effectiveness of the product and
necessitate re-treatment.

	D.  Estimated Usage of Pesticide

	      Approximately 7.5 million lbs of naphthalene are marketed on
average per year as a pesticide.  The vast majority of the usage is in
indoor moth repellant products.

            Pesticide usage accounts for a small portion of total US
naphthalene exposure.  More than 90% of total naphthalene usage comes
from other sources.  Naphthalene is produced as a naturally occurring
constituent of fossil fuels (i.e., petroleum and coal) as well as a
byproduct of combustion of organic matter (e.g., it is generated by
burning wood).  Approximately 369 million lbs. of naphthalene is
consumed by the Department of Defense annually, and 1.84 billion lbs. of
naphthalene is consumed in the US jet fuel market.

III.  Summary of Naphthalene Risk Assessments

		The following is a summary of EPA’s revised human health and
ecological risk assessments for naphthalene, as presented fully in the
documents, Phase 4 Amendment:  Response to Comments in Reference to
“Naphthalene: HED Chapter for the Reregistration Eligibility Decision
Document (RED)” dated August 22, 2008 and Revised Ecological Risk
Assessment for Reregistration Eligibility Decision (RED) for
Naphthalene, dated April 21, 2008.  These documents are available in the
OPP Public Docket, docket number EPA-HQ-OPP-2008-0343, and may also be
accessed through the Agency’s website at   HYPERLINK
"https://www.regulations.gov"  https://www.regulations.gov .  The
purpose of the following summary is to assist the reader by identifying
the key features and findings of the naphthalene human health and
ecological risk assessments, and to help the reader better understand
the conclusions reached in the assessments.

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

A.  Human Health Risk Assessment

	The human health risk assessment incorporates potential exposure,
hazard, and risks from all sources, which for naphthalene are indoor and
outdoor residential use.  Naphthalene has no registered food or
occupational uses.  The Agency’s human health assessment considers all
U.S. populations, including infants and young children.  For more
information on the naphthalene human health risk assessments, see Phase
4 Amendment:  Response to Comments in Reference to “Naphthalene: HED
Chapter for the Reregistration Eligibility Decision Document (RED)”
dated August 22, 2008, and Naphthalene:  Phase 4 Amendment:  Response to
Comments In Reference to “Naphthalene: Occupational and Residential
Exposure Assessment and Recommendations for the Reregistration
Eligibility Decision Document”, dated August 8, 2008.

 .		1.  Toxicity of Naphthalene

	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 naphthalene.

			a.  Acute Toxicity Profile

	Naphthalene is considered slightly toxic on an acute basis by the oral
and dermal routes (Toxicity Category III).  It is considered to be
moderately toxic by the inhalation route (Toxicity Category II).  It is
categorized also as slightly toxic for primary eye and skin irritation
(Toxicity Category III).  Naphthalene did not induce delayed contact
sensitivity (dermal sensitization) when tested in guinea pigs.  The
acute toxicity profile for naphthalene is summarized in Table 1 below.

Table 1.  Acute Toxicity Profile for Naphthalene

Guideline

	Study Type	Master Record Identification (MRID)	Results	Toxicity

: 2649 mg/kg (♂+♀)	III

870.1200	Acute Dermal	257229	LD50 >2000  mg/kg (♂+♀)	III

870.1300	Acute Inhalation	257902	LC50 > 0.4 mg/L (77.7 ppm) (♂+♀)	II

870.2400	Primary Eye Irritation	257228	Slight-moderate irritation	III

870.2500	Primary Skin Irritation	257227	Moderate irritation	III

870.2600	Dermal Sensitization	00148173	Nonsensitizer – guinea pig	N/A

These technical acute toxicity values included in this document are for
informational purposes only.  The data supporting these values may or
may not meet the current acceptance criteria.

Toxicological Endpoints

	Based on the use pattern, the standard toxicology database for
naphthalene is complete for assessing dermal and oral exposure risks to
humans.  There is no reproductive study on naphthalene, nor is one
required since this is a nonfood use pesticide.

	Naphthalene inhalation studies include nose-only, i.e. compound
introduced directly to the nose (4-week, 13-week, and subchronic 90-day
neurotoxicity) and chamber studies (2 year) in rodents, which involves
whole body exposures.  These studies indicate that naphthalene is a
nasal toxicant in rodents at low experimental concentrations.  Although
standard inhalation rodent toxicity studies are available, some
mechanism studies have raised the issue of notable species differences
(in regard to respiratory toxicity and metabolism) and the applicability
of the rodent model as a default approach to estimate human risk
following inhalation exposures.  There is support from published studies
and ongoing research on naphthalene that indicate that risk estimates
would be considerably less than those using default procedures when
known species differences between rodents and primates (including
humans) in metabolism and respiratory toxicity are factored into the
estimates.  The mechanism data are not yet complete and ongoing
research, when completed, is expected to significantly refine the
potential toxicity hazard associated with human exposure to naphthalene
via inhalation.  At this time, dose range and endpoints have been
qualitatively characterized for the purposes of estimating human
inhalation (cancer and non-cancer) risk.  See Phase 4 Amendment:
Response to Comments in Reference to “Naphthalene: HED Chapter for the
Reregistration Eligibility Decision Document (RED)” dated August 22,
2008 for additional information.

	Subchronic oral toxicity of naphthalene is manifested by body weight
changes, organ weight changes and/or clinical signs of toxicity
following gavage treatment to rats.  In a 90-day dermal toxicity study
in the rat, effects were noted only at the high dose of 1000 mg/kg/day.
Because effects were seen only at the limit dose, dermal toxicity is not
likely a concern.  There was no evidence of developmental toxicity in
the rat or rabbit.  The toxicological endpoints used in the human health
risk assessment for naphthalene are listed in Table 2 below.

	To estimate residential (dermal and incidental oral) risk, the Agency
calculates a margin of exposure (MOE), which is the ratio of the point
of departure (POD) selected for risk assessment to the exposure.  The
POD is typically a No Observed Adverse Effects Level (NOAEL) or a Lowest
Observed Adverse Effects Level (LOAEL).  This MOE is compared to a level
of concern (LOC), which is the same value as the uncertainty factor (UF)
applied to a particular toxicity study.  In the case of the naphthalene
risk assessment for acute dietary exposure, the endpoint selected
occurred following a single exposure and is relevant for all
populations, including infants and children.  A UF of 1000 was applied
to account for the use of a LOAEL because there is no NOAEL (10X), in
addition to the standard uncertainty factors (UF) of 10X for
intraspecies extrapolation and 10X for interspecies variation.

	For chronic oral exposure, an UF of 10X has been applied to the chronic
RfD to account for extrapolation from subchronic to chronic oral
exposure, in addition to the 100-fold uncertainty factor applied to
account for inter and intraspecies differences.  The composite
uncertainty factor of 1000-fold would address the lack of reproductive
toxicity data.  The target MOE (i.e., level of concern) for incidental
oral and dermal exposures is 100 (10X for intraspecies extrapolation and
10X for interspecies variation).

Table 2.  Toxicological Doses and Endpoints for Naphthalene for Use in
Human Health Risk Assessments

Exposure/

Scenario	Point of Departure (POD)	Uncertainty Factors (UF)	Level of
Concern for Risk Assessment (LOC)	Study, MRID,  and Toxicological
Effects

Acute Dietary

All populations including infants and children 	LOAEL =  400 mg/kg/day

	UFA= 10X

UFH = 10X

UFL= 10X

	aRfD=0.4 mg/kg/day

	Acute Oral Neurotoxicity Study – Rat (44282801)

NOAEL = not identified.

LOAEL = 400 mg/kg/day based on hunched posture in females, head shaking
in males and females, and reduced motor activity in males and females.

Chronic Dietary

All populations including infants and children	NOAEL= 100 mg/kg/day

	UFA= 10X

UFH = 10X

UFS = 10X

	cRfD = 0.1 mg/kg/day

	National Toxicology Program (NTP) Subchronic Rat Study (NTP 1980a)

NOAEL = 100 mg/kg/day

LOAEL = 200 mg/kg/day based on significant decreases in body
weights/body weight gains.

Episodic Ingestion (Short-term; 1-30 days)	NOAEL= 50

mg/kg/day	UFA= 10X

UFH= 10X

	MOE= 100

(residential)	NTP Developmental Rat Study (NTP 1991)

NOAEL = 50 mg/kg/day

LOAEL= 150  mg/kg/day based on maternal effects –transient clinical
signs of lethargy and slow breathing, and significant decreases in body
weights/body weight gains and decreased food and water consumption.

Dermal (Short-Term; 1-30 days)

	Dermal NOAEL= 300 mg/kg/day

	UFA= 10X

UFH= 10X

	MOE=  100

(residential)	90-Day Dermal Toxicity Study –Rat (40021801)

NOAEL = 300 mg/kg/day

LOAEL = 1000 mg/kg/day based on atrophy of seminiferous tubules in
males, and nonneoplastic lesions in the cervical lymph node
(hyperplasia), liver (hemosiderosis), thyroid thyroglossal duct cysts,
kidneys (pyelonephritis), urinary bladder (hyperplasia) and skin
(acanthosis, hyperkeratosis) in females.

Inhalation (Short-term; 1-30 days)

	Inhalation

LOAEL

= 10 ppm or

52 mg/m3

NOAEL

= 3 ppm or

16 mg/m3

	N/A

	N/A	4-Week (Nose-Only) Inhalation – Rat (42934901)

NOAEL = 3 ppm

LOAEL = 10 ppm based increased incidence and severity of nasal lesions
(slight disorganization, rosette formation, basal cell hyperplasia,
erosion, atrophy, and degenerate cells in the olfactory epithelium; loss
of bowman’s glands; respiratory epithelium hypertrophy; rosette
formation in the septal organ of Masera and fusion of the turbinates).

Inhalation (Intermediate-term; 1-6 months)

	Inhalation

LOAEL

= 2 ppm or

 10 mg/m3

NOAEL

= 1 ppm or

5.2 mg/m3	N/A	N/A	13-Week (nose-only) Inhalation Rat Study (44956401);
Subchronic (nose-only) Neurotoxicity Rat Study (44856401)

NOAEL = 1 ppm (Subchronic neurotoxicity study)

NOAEL (13 week inhalation study) – not identified.

LOAEL = 2 ppm  (13 week inhalation study) based on increased incidence
and severity of nasal lesions (degeneration, atrophy and hyperplasia of
basal cells of the olfactory epithelium; rosette formation of olfactory
epithelium; loss of Bowman’s glands; hypertrophy of respiratory
epithelium).

LOAEL = 10 ppm (subchronic neurotoxicity study) based on
atrophy/disorganization of the olfactory epithelium and hyperplasia of
the respiratory and transitional epithelium.

Inhalation (Long-term; > 6 months)

	Inhalation LOAEL

= 10 ppm or

52 mg/m3

	N/A	N/A	NTP ChronicToxicity and Carcinogenicity Studies in the Rat and
Mouse (NTP 1992)

NOAEL = not identified

LOAEL (rat study) = 10 ppm based on  increased incidence and severity of
atypical (basal cell) hyperplasia, atrophy, chronic inflammation, and
hyaline degeneration of the olfactory epithelium; hyperplasia, squamous
metaplasia, hyaline degeneration, and goblet cell hyperplasia of the
respiratory epithelium; and glandular hyperplasia and squamous
metaplasia.

Point of Departure (POD) = A data point or an estimated point that is
derived from observed dose-response data and  used to mark the beginning
of extrapolation to determine risk associated with lower environmentally
relevant human exposures.  NOAEL = no observed adverse effect level.
LOAEL = lowest observed adverse effect level.  UF = uncertainty factor.
UFA = extrapolation from animal to human (interspecies).  UFH =
potential variation in sensitivity among members of the human population
(intraspecies).  UFL = use of a LOAEL to extrapolate a NOAEL.  UFS = use
of a short-term study for long-term risk assessment.  UFDB = to account
for the absence of key date (i.e., lack of a critical study).  RfD =
reference dose.  MOE = margin of exposure.  LOC = level of concern.  N/A
= not applicable.

2.  Carcinogenicity of Naphthalene

	In the National Toxicology Program (NTP) chronic studies, carcinogenic
effects have been observed in both rats and mice following inhalation
exposure to naphthalene.  In the rat, nasal tumors included
neuroblastomas of the olfactory epithelium and adenomas of the
respiratory epithelium.  There was also an increase in the incidences of
adenoma of the respiratory epithelium.  The NTP concluded that “under
the conditions of this 2-year inhalation study, there was clear evidence
of carcinogenic activity of naphthalene in male and female F344/N rats
based on increased incidences of respiratory epithelial adenoma and
olfactory epithelial neuroblastoma of the nose.”

	In the mouse study, male mice had statistically significant increased
incidences of liver adenomas, and adenomas and carcinomas combined.
Female mice exhibited increased incidences of alveolar/bronchiolar
adenomas, and adenomas and carcinomas combined.  The NTP concluded that
“under the conditions of this 2-year inhalation study, there was no
evidence of carcinogenic activity’ of naphthalene in male B6C3F1 mice
exposed to 10 or 30 ppm.  There was “some evidence of carcinogenic
activity” of naphthalene in female B6C3F1 mice, based on increased
incidences of pulmonary alveolar/bronchiolar adenomas.

	The carcinogenic and noncarcinogenic potential of naphthalene is
currently undergoing review by the EPA Integrated Risk Information
System (IRIS).  The EPA process of regulating pesticides allows for
re-evaluation at any time if relevant new information becomes available.
Thus, when the IRIS assessment is finalized, OPP would determine whether
the human health hazard potential of naphthalene warrants revisiting.

		3.  Metabolites and Degradates

	A number of degradates were identified in the open literature.  A
degradation pathway for naphthalene was proposed, which ultimately
resulted in catechol.  Transitional degradates included
cis-1,2-dihydroxy-1,2-dihydronaphthalene, 1,2-dihydroxy-naphthalene,
2-hydroxchromene-2-carboxylate (HCCA),
trans-o-hydroxy-benzylidenpyruvate (tHBPA), salicyladehyde, and
salicylate.  However, there are no environmental fate data for these
degradates, and therefore, exposure estimates are for parent only.  For
additional details, refer to the Revised Ecological Risk Assessment for
Reregistration Eligibility Decision (RED) for Naphthalene, dated April
21, 2008.

            4.  Endocrine Disruption

EPA is required under the Federal Food, Drug, and Cosmetic Act (FFDCA),
to develop a screening program to determine whether certain substances
(including all pesticide active and other ingredients) “may have an
effect in humans that is similar to an effect produced by a naturally
occurring estrogen, or other such endocrine effects as the Administrator
may designate.”  Following 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 the
Program include evaluations of potential effects in wildlife.  For
pesticide chemicals, 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 additional appropriate screening and/or testing protocols being
considered under the Agency’s EDSP have been developed, naphthalene
may be subjected to further screening and/or testing to better
characterize effects related to endocrine disruption.

Dietary Risk (Water Only)

	There are no agricultural or food-related pesticide uses of
naphthalene; therefore, no dietary exposure from food is expected.
There is potential for drinking water exposure, since naphthalene is
registered for residential outdoor use an animal repellant.

Estimated Drinking Water Exposure

	  SEQ CHAPTER \h \r 1  A Tier I aquatic exposure assessment was
conducted using FIRST (FQPA Index Reservoir Screening Tool), which is a
program that calculates acute, as well as longer-term, estimated
environmental concentration (EEC) values in surface water.  FIRST
considers reduction in dissolved pesticide concentration due to
adsorption of a pesticide to soil or sediment, incorporation,
degradation in soil before washoff to a water body, direct deposition of
spray drift into the water body, and degradation of the pesticide within
the water body.

	Given the limited use of this compound in an outdoor setting and the
fact that it is applied in a band around ornamentals, planting beds, and
building perimeters as a repellent, an adjustment to the modeled EEC was
made assuming 4.1% of a typical residential lot would be treated.  The
resultant FIRST EEC has been adjusted by this factor.

	Two scenarios were modeled to represent both high and low use
scenarios.  The high use scenario was modeled at 10.8 lbs active
ingredient/acre (ai/A) with six applications per year, while the low use
scenario was modeled at 0.56 lbs ai/A with six applications per year.
The modeling results are summarized in Table 3.

Table 3.  Results of FIRST Modeling for Naphthalene

Use Site	Application Rate (lbs/acre)	Number of Applications

(interval)	Peak EEC (ppb)	Annual Average EEC (ppb)

Ornamentals for rabbit & dog repellent	10.8

	6

(2 months)	43.4	6.5

Ornamentals for snake repellent	0.56	6

(2 months)	2.2	0.3

	Unaccounted for in this exposure assessment is the fact that
naphthalene is volatile.  Given the potential volatility of this
compound and the fact that the Tier I model used to estimate exposure
does not account for volatility as a route of dissipation, it is likely
that the exposure estimates derived above are over-predictions of
potential exposure to naphthalene in drinking water derived from surface
water sources.

	The Tier I Screening Concentration in Ground Water (SCI-GROW) model was
used to estimate naphthalene residues in groundwater.  Because the EECs
for groundwater residues (ranging from 4.5 to 0.2 ppb) are lower than
those for surface water, the FIRST surface water exposure estimates are
used for the drinking water risk assessment and are considered to be
protective.

	b.  Reference Dose

	  SEQ CHAPTER \h \r 1

	  SEQ CHAPTER \h \r 1  Dietary risk assessment incorporates both
exposure to and toxicity of a given pesticide.  For chemicals with no
food uses, such as naphthalene, acute and chronic dietary risk is
expressed as a percentage of the acute or chronic Reference Dose (RfD).
The RfD is the POD (NOAEL or LOAEL) divided by uncertainty factors
(UFs).  A total UF of 1000 was applied to both the acute and chronic
LOAELs to calculate the acute and chronic RfDs, respectively.  To
estimate risks from potential dietary exposure to naphthalene, exposure
estimates are compared to the acute or chronic RfDs.  An acute or
chronic exposure that is less than100% of the acute or chronic RfD is
not of concern.

		           c.  Dietary (Drinking Water Only) Risk Estimates

	The dietary exposure and risk estimates resulting from intake of water
with residues of naphthalene were determined for the general U.S.
population and all population sub-groups using the Dietary Exposure
Evaluation Model (DEEM-FCID), which uses food consumption data from the
U.S. Department of Agriculture’s Continuing Surveys of Food Intakes by
Individuals (CSFII) from 1994-1996 and 1998.  The screening-level acute
drinking water assessment using the DEEM-FCID Model was reported at the
95th percentile of exposure for the general U.S. population and all of
its sub-groups.  It is based exclusively on the peak EEC of 43.4 ppb for
all direct and indirect drinking water sources.  Risk estimates were all
found to be well below the 100% acute Reference Dose (aRfD) threshold
level of concern.  The acute drinking water exposure for naphthalene was
estimated to be 0.0023 mg/kg/day at 0.6% of the aRfD for the general
U.S. population.  The acute drinking water exposure for the most highly
exposed population subgroup, all infants, was estimated to be 0.0085
mg/kg/day at 2.1% of the aRfD.

	The chronic screening-level drinking water assessment is another
conservative evaluation based exclusively on the annual average EEC of
6.5 ppb for all direct and indirect drinking water sources.  Risk
estimates were all found to be well below the 100% chronic Reference
Dose (cRfD) threshold level of concern.  The chronic drinking water
exposure for naphthalene was estimated to be 0.0001 mg/kg/day at 0.1% of
the cRfD for the general U.S. population.  The chronic drinking water
risk for the most highly exposed population sub-group, all infants, was
estimated to be 0.0004 mg/kg/day at 0.4% of the cRfD.

	As previously noted, a drinking water assessment for naphthalene was
carried out by the Agency for its use as a pest repellant outdoors
around the home.  This screening-level assessment relied on modeling
analyses to calculate EECs for drinking water.  Given the potential
volatility of this compound and the fact that the Tier I model used to
estimate exposure does not account for volatility as a route of
dissipation it is likely that the EECs are overestimated.  Additionally,
the dietary (drinking water only) assessment used only the high end EECs
from a maximum use rate and the resulting risk estimates, while not of
concern, can be considered upper bound.  Although a number of potential
water degradates have been identified, the drinking water assessment is
only for the parent compound naphthalene.  There were no data on the
environmental fate of the degradates, or on the toxicity of the
degradates in relation to the parent.  However, given the overall
conservative nature of the water assessment it is unlikely that risks
from exposure to naphthalene in drinking water were underestimated.

	Available water monitoring data, while non-targeted, indicate that
naphthalene was infrequently detected in water supplies, and those
detects were usually well below the Health Reference Level (HRL) of 140
ppb.  EPA’s Office of Water has concluded that the regulation of
naphthalene in drinking water is unlikely to represent a meaningful
opportunity for health risk reduction.  While it is not known if detects
in ambient water are from pesticide or industrial uses, it should be
noted that about 190,000 lbs of naphthalene a year is used for outdoor
pest control compared to the approximately 1.8 billion lbs of
naphthalene used for the US jet fuel market.

Residential (Non-Occupational) Exposure Risk

	The Agency has determined that there is a potential for exposure
(dermal and inhalation) in residential settings during the application
process for homeowners who purchase and use pesticide products
containing naphthalene.  There is also a potential for postapplication
inhalation exposure from inhabiting indoor areas previously treated with
naphthalene, as well as potential (postapplication) episodic ingestion
exposure to toddlers.

	To quantitatively estimate residential risks, the Agency calculates a
margin of exposure (MOE), which is the ratio of the endpoint derived
from a toxicity study (NOAEL) to the exposure.  This MOE is compared to
a level of concern (LOC), which is the same value as the uncertainty
factor (UF) applied to the endpoint.  For naphthalene, the uncertainty
factors are 100 for both dermal and episodic ingestion exposures.  A
summary of naphthalene residential risk follows.  For further
information on residential risk, refer to the Naphthalene:  Phase 4
Amendment:  Response to Comments In Reference to “Naphthalene:
Occupational and Residential Exposure Assessment and Recommendations for
the Reregistration Eligibility Decision Document,” dated September 10,
2008.

	A quantitative exposure assessment was performed for homeowners
applying naphthalene in the residential environment (dermal) and for
toddler episodic (oral) ingestion of naphthalene used for indoor/outdoor
treatments.  Human health risk estimates were not calculated for
postapplication inhalation scenarios because of the uncertainties
associated with extrapolating animal (rodent) data to humans as
discussed previously in this document.  Rather than quantifying
inhalation (cancer and noncancer) risks to humans, the levels of ambient
naphthalene measured in the human exposure study were compared directly
to the levels resulting in 1) no adverse effects in the rodent studies
(NOAELs) and 2) a toxic effect in rodents (LOAELs).  This comparison
provides a sense of the difference between actual naphthalene
concentrations that a human may encounter and the doses which elicit
either no adverse response or a toxic response in rodents.

	a.  Residential Handler Risk

 	The Agency determined that there is potential for exposure in
residential settings during the application process for homeowners who
purchase and use naphthalene-containing products.  According to label
instructions, homeowners must physically place naphthalene formulations
into indoor storage areas and around the perimeter of outdoor areas to
be protected.  The Agency anticipates handler dermal and inhalation
exposure during the application process.  However, as previously
described, the Agency did not select an inhalation endpoint, nor is
there inhalation exposure data available to assess this handler
scenario.  Furthermore, data for acute (15 minute) inhalation exposure
were used in conjunction with animal studies to derive a direct
comparison for postapplication inhalation exposure to areas treated with
naphthalene.  The Agency assumes that the acute postapplication
inhalation assessment is protective for handler inhalation exposure.
Measured concentrations of naphthalene would likely be greater in the
acute post-application exposure scenario due to the time allotted in the
exposure study (4-6 days) for the vapors of the product to accumulate in
the enclosed areas that would be accessed than a handler would
experience during an application event.  Therefore, only dermal handler
exposure was quantitatively assessed.

	Applications of naphthalene are expected to be short-term in nature
because the products are typically applied only intermittently and
usually on a seasonal basis, i.e. when storing winter clothes or when
outdoor pests are active.  As a result, no intermediate-term or
long-term exposure scenarios were assessed for handlers.

		Exposure data for the residential handler dermal assessment were taken
from the exposure study, “Estimation of Homeowner Exposure to
LX1298-01 (Naphthalene) Resulting from Simulated Residential Use as an
Insect Repellent” (MRID 43716501).  EPA determined that this study
utilized adult human subjects that were intentionally exposed, and
therefore, required review of its ethical conduct; the study has
received that review, and it was concluded that there are no regulatory
barriers to EPA’s reliance on this study in its actions under FIFRA.
In the study, dermal handler exposure data was derived from the result
of monitoring a person weighing out and placing mothballs in a closet
and dresser at three different locations.  In addition, standard
assumptions for residential applicators were used.

The residential handler dermal MOEs for both scenarios assessed
(applying mothballs and animal repellant treatments) were greater than
100 (MOE = 28,000 and 17,000, respectively) and, therefore, are below
the Agency’s LOC.

Residential Postapplication Risk

 Episodic Ingestion Risk

	Naphthalene applications are made indoors for moth treatments and
indoors/outdoors for animal repellency.  The Agency anticipates that
toddlers could come in contact with naphthalene formulations inside a
treated home or in treated outdoor areas.  While labels specify that
indoor moth treatments be made in airtight containers, it is assumed
that a toddler could potentially access these areas and ingest
naphthalene products.  Outdoor applications of naphthalene are labeled
for use around the perimeter of areas to be protected.  While a toddler
could potentially access outdoor treated areas, naphthalene incident
reports indicate that a large majority of incidents for children under
six years old are from ingestion of indoor products.

	Inhalation and episodic ingestion routes of exposure were not combined
for toddlers in order to differentiate the occurrence of a discrete
accidental event (assessed to give a worst-case estimate of risk) from
the expected daily exposure via the inhalation route.  It would not be
appropriate to combine episodic exposure for comparison to a short-(or
longer) term endpoint.

	The Agency’s standard assumptions and risk assessment procedures were
used to derive the potential dose rate of a toddler ingesting one
mothball, which was then compared to the incidental oral endpoint to
calculate an MOE.  In addition, the Agency estimated the amount of a
single mothball that a toddler could ingest to result in an MOE of 100.

	Toddler episodic ingestion of one naphthalene mothball results in an
MOE < 1 and, therefore, is of concern (LOC = 100).  An oral dose of 0.5
mg/kg/day would be required to result in an MOE of 100.  This dose is
equivalent to a toddler ingesting less than 1% of one mothball.

	It is important to note that the episodic ingestion MOE is calculated
from an endpoint derived from a developmental oral rat study in which
dams were repeatedly treated with a high oral bolus dose and the
resulting clinical signs (lethargy and slow breathing) and body weight
decrement were transient.  The effects were attributed to the
administration of a high bolus and were not permanent; the animals
displayed quick recovery.  There were no persistent effects or
treatment-related deaths.  While the episodic ingestion of naphthalene
by a toddler results in an MOE below the LOC, and does represent an
exposure concern, the effects of this type of exposure, if any, are not
expected to be severe.  The study results are consistent with what might
be inferred from the incident reports, which are described in more
detail below.

Inhalation (Cancer and Noncancer) Risk

	The Agency has determined that there is potential for inhalation
exposure to adults and children from naphthalene applications made
indoors for moth treatments and animal repellency, and to a lesser
extent, outdoors for animal repellency.  While labels specify that
treated indoor areas should be airtight to be effective, the Agency
anticipates that naphthalene will volatilize and be inhaled by adults
accessing treated areas (i.e., containers, dresser drawers, closets,
etc.) and by adults and children that inhabit treated areas exposed to
ambient concentrations of naphthalene.  Exposures from accessing treated
areas are expected to be acute (approximately 15 minutes) in duration,
and exposures from inhabiting treated areas are short-(<1 month),
intermediate- (1-6 months), and long-term (>6 months) in duration.

	As previously described, there is support from published studies and
ongoing research on naphthalene that indicate that risk estimates,
factoring in known species differences between rodents and primates
(including humans) in metabolism and respiratory toxicity, would be
considerably less than those using default procedures.  Therefore,
rather than quantifying inhalation risks to humans, the levels of
ambient naphthalene measured in the human exposure study were compared
directly to the levels resulting in a 1) no adverse effects in the
rodent studies (NOAELs) and 2) a toxic effect in rodents (LOAELs).  This
comparison provides a sense of the difference between actual naphthalene
concentrations that a human may encounter and the doses which elicit
either no adverse response or a toxic response in rodents.

	Anticipated acute and short-term exposures were calculated using
standard assumptions and the results of the aforementioned naphthalene
exposure study (MRID 43716501).  The 15 minute (acute) and 24 hour
(short-term) samples resulted in average concentrations of 0.85 and 0.66
mg/m3 of naphthalene, respectively.  These values were compared directly
to the animal LOAEL (10 ppm or 52 mg/m3) and NOAEL (3 ppm or 16 mg/m3)
selected for acute and short-term exposure durations.

	Estimated acute and short-term exposures to naphthalene in residences
are 20X and 30X, respectively, below the rodent dose resulting in no
adverse effects (NOAEL).  Anticipated acute and short-term exposures to
naphthalene in residences are 60X and 80X, respectively, below the
rodent dose resulting in respiratory toxicity, specifically olfactory
epithelium lesions (LOAEL).

	Anticipated intermediate- and long-term exposures were also calculated
using standard assumptions; however, because of the lack of a
naphthalene-specific study of an appropriate duration, a different
exposure study was used to assess these durations of exposure
(“Polycyclic Aromatic Hydrocarbon Exposure of Children in Low-Income
Families, Chuang et al., 1999”).  This study was reviewed for its
ethical conduct, and it was concluded that it does not meet the
regulatory definition of research involving intentional human exposure.
Therefore, it is not required to undergo ethical review and that there
are no regulatory, ethical, or policy barriers to using this study for
risk assessment.  The study was conducted to observe exposures to
polycyclic aromatic hydrocarbons (PAHs), including naphthalene, inside
of 24 homes from air, dust, soil, and food.  This study is not specific
to intermediate- or long-term exposure durations, nor does naphthalene
necessarily originate from a mothball source; however, it has been
identified as the best available data source to account for naphthalene
volatilization and dissipation over time.  Due to the uncertainty
associated with the use of an exposure study which is not specific to
the duration assessed, the Agency selected the most conservative
exposure value (i.e., maximum concentration observed) to represent
intermediate- and long- term exposure levels.  During reregistration for
naphthalene, a Data Call-In will be issued requiring a confirmatory
chamber study to determine levels of naphthalene in the air resulting
from use of mothballs at the maximum label rate.

	The indoor ambient samples which pertain to the air concentrations of
naphthalene resulted in a maximum level of 0.0097 mg/m3.  This exposure
value was directly compared to the animal LOAEL for olfactory epithelium
lesions selected for intermediate- (2 ppm or 10 mg/m3 identified in a
nose-only study) and long-term (10 ppm or 52 mg/m3 identified in an
exposure chamber study) durations, as well as to the NOAEL selected for
the intermediate-term duration (1 ppm or 5.2 mg/m3).  A NOAEL was not
identified for long-term inhalation exposure.

	Intermediate- and long-term exposures to naphthalene in residences are
1000X and 5400X, respectively, below the animal dose (LOAEL) resulting
in respiratory toxicity (olfactory epithelium lesions) and
intermediate-term exposure is 540X below the animal dose NOAEL.  The
long-term duration was not assessed since a NOAEL was not identified.

	Generally, in the absence of information on kinetics/dynamics, it is
assumed that humans may be 10 times more sensitive than animals (10X
interspecies factor).  The current research indicates that primates,
thus humans, are less sensitive than rodents because of differences in
the rate of bioactivation of naphthalene as well as anatomical and
physiological differences in the nose and respiratory tract.  These
critical differences between primates and rodents have not been
accounted for in this assessment.  Thus, with consideration of
differences in dosimetry and species metabolism of naphthalene, the
margins of exposure for human inhalation risk assessment are likely
larger than the differences calculated here between the rodent NOAELs
and LOAELs and the measured ambient naphthalene levels from the best
available exposure study.

	Studies determining the differences in nasal metabolism of naphthalene
between rodents and primates are part of ongoing research.  There are no
data to indicate that humans have a slower rate of clearance, but if
they did, then there would be a longer time for humans to produce the
active metabolite.  These issues are being addressed in current
pharmacokinetic research.

7.  Aggregate Risk

          An aggregate risk assessment for all expected routes of
exposure was not performed as there is no common toxicity among all the
routes of exposure.  A short-term aggregate risk assessment could be
performed by combining short-term incidental oral exposure and
average/background dietary (in this case drinking water) exposures.
However, a short-term aggregate risk assessment was not performed for
naphthalene since the short-term incidental oral exposure risk estimate
alone exceeds the LOC, and combining with other routes of exposure would
only further exceed the LOC.

				 8.  Occupational Risk

           Naphthalene pesticide products are not registered for
occupational use and, therefore occupational exposure to the pesticidal
uses of naphthalene is not anticipated and has not been assessed

	            9.  Human Incident Data

	Four databases were consulted for poisoning incident data on
naphthalene for the period of 1993 to 2005.  These include: OPP Incident
Data System (IDS), Poison Control Centers (PCC), California Department
of Pesticide Regulation, and National Institute of Occupational Safety
and Health’s Sentinel Event Notification System for Occupational Risks
(NIOSH SENSOR).  A summary of the findings from the “Review of
Naphthalene Incident Reports,” dated June 25, 2007 is as follows:

Naphthalene produces a disproportionately high number of exposure
incidents when compared to the composite average of exposure incidents
reported for all other pesticides.  This pattern observed in the
combined population (occupational, non-occupational, children) is
largely due to the frequency of reported incidents among children less
than 6 years;

Exposure to children is much higher than a typical pesticide;

Naphthalene PCC data show average results of about 1647 exposures/year,
133 symptomatic cases/year, and 310 cases/year seen in a heath care
facility;

No apparent annual trend is evident in the 13 year-span of data
collected, as the number of reported incidents/year has remained
relatively stable;

NIOSH/SENSOR data indicate that indoor uses of naphthalene are
responsible for a large number of cases; and

The large majority of incidents for children under 6 years of age were
from ingestion of mothball products used indoors.

	Reported incidents of naphthalene ingestion among children account for
the majority of reported exposures, and occur with much greater
frequency than for most other pesticides.  This may be attributed to the
widespread use of naphthalene products in homes and the ease of
accessing the product as it is applied as loose mothballs.  The severity
of the reported incidents are much lower than for other pesticides as a
whole.  From a 13-year period of PCC data, approximately 7% of
naphthalene incidents in children resulted in any symptoms at all, and
less than 1% had moderate or major symptoms.  Symptoms that did occur
(both adults and children; all routes of exposure) were not
life-threatening and include nausea, vomiting, headache, dizziness,
drowsiness/lethargy, eye irritation, respiratory irritation, and dermal
edema and erythema.

	B.  Environmental Risk Assessment

          Indoors, naphthalene is used principally as mothballs, and
this use is not considered likely to result in exposure to non-target
organisms (other than humans), and therefore, is not considered in the
ecological risk assessment.  It is also used indoors in attics as an
animal repellant (e.g., Chaperone Squirrel and Bat Repellent), and while
there is potential for exposure to animals from this use, it only
affects pest species trying to enter homes.  Currently, four registered
naphthalene products include outdoor uses.  These products are
formulated as flakes or granules, and are applied in a band around
ornamentals, planting beds and gardens as an animal repellent.  The
following is a summary of EPA’s revised ecological risk assessment for
naphthalene, as presented fully in the Revised Ecological Risk
Assessment for Reregistration Eligibility Decision (RED) for
Naphthalene, dated April 21, 2008.  This document is available in the
OPP Public Docket, docket number EPA-HQ-OPP-2008-0343, and may also be
accessed through the Agency’s website at   HYPERLINK
"https://www.regulations.gov"  https://www.regulations.gov .

         For naphthalene, ecological risk was assessed to determine the
potential for acute effects (i.e., lethality) to mammals, birds, fish
and invertebrates using screening-level risk assessment models.  Risk
was assessed for the treated site for birds and mammals, and in an
adjacent pond for freshwater fish and invertebrates.  Ecotoxicity data
on sublethal (e.g., reproductive, growth) effects were not available, so
chronic risk was not addressed.

           SEQ CHAPTER \h \r 1 To estimate potential ecological risk,
EPA integrates the results of exposure and ecotoxicity studies using the
risk quotient method.  A risk index (RQ or LD50/ft2) is calculated by
dividing acute estimated environmental concentrations (EECs) by
ecotoxicity values for various wildlife species.  The LD50/ft2 (for
terrestrial animals) or RQ (for aquatic animals) is then compared to the
Agency’s Levels of Concern (LOCs), which serve as criteria for
categorizing potential risk to non-target species.  At the screening
level, the Agency presumes that there is not an unreasonable risk for a
particular category if the risk quotient is below the LOC.  If
calculated RQs exceed the LOC, the Agency presumes that there is a
potential for risk in that category.  See Table 4 below for the
Agency’s ecological LOCs.  Risk characterization provides further
information on potential adverse effects and the possible impact of
those effects by considering the fate of the chemical and its degradates
in the environment, organisms potentially at risk, and the nature of the
effects observed.

Table 4.  EPA’s  Ecological Levels of Concern (LOCs) and Risk
Presumptions

If a calculated RQ is greater than the LOC presented, then the Agency
presumes that…	LOC

terrestrial animals	LOC

aquatic animals	LOC

plants

Acute Risk …there is potential for acute risk; regulatory action may
be warranted in addition to restricted use classification	0.5	0.5	1.0

Acute Endangered Species …endangered species may be adversely affected
0.1	0.05	1.0

Chronic Risk …there is potential for chronic risk	1	1	NA

	 1.  Environmental Fate and Transport

	There are no acceptable fate studies for naphthalene.  A single
supplemental study has been provided which summarizes open literature
data on adsorption/desorption and aerobic soil metabolism data (MRID
45346801).  Other fate parameters needed to conduct the ecological
assessment have either been extrapolated from the open literature data
(e.g., aerobic aquatic metabolism half life) or conservatively assumed
to be stable (photolysis and hydrolysis).  The lack of these data
provides uncertainty to this assessment.  Elimination of this
uncertainty would require submission of additional data for these fate
processes.  However, the data used in the assessment are sufficient to
allow evaluation of potential risk, and no additional environmental fate
data are needed for current outdoor uses of naphthalene.

	Open literature data indicated that the solubility of naphthalene
ranged from 30 to 31.7 mg/L and that the Koc ranged from 200 to 1470 for
a variety of soils from North America, Europe and China.  The study
citation concluded that naphthalene was bound relatively rapidly to
soils with a sustained desorption over days to weeks.  For
biodegradation, naphthalene degraded with aerobic soil metabolism
half-lives between 3.5 and 40 days with no appreciable degradation under
anaerobic conditions.  Possible dissipation processes affecting
naphthalene include volatilization, bioaccumulation, adsorption, and
leaching.  Volatilization is the method by which naphthalene is
effective as an animal repellant.  Data suggest that once in air,
naphthalene should degrade or dissipate rapidly.  Naphthalene
principally dissipates via direct sublimation from granules, but data
suggests that if naphthalene does enter soil, up to 30% of loss from
soil can occur due to volatilization.

	Additional open literature data describe both aerobic soil degradation
and adsorption values that are consistent with values described above,
although under certain conditions degradation from soil may be somewhat
longer.  In addition, these data suggest that naphthalene degrades
rapidly by aqueous photolysis.  The data also suggest that under certain
conditions naphthalene dissipates rapidly from open water systems,
although it is unclear whether the dissipation observed was due to
degradation or lumped dissipation processes including transport out of
the systems by flowing water.  Finally, these data confirm that
naphthalene is relatively stable under anaerobic conditions.

	A number of transformation products were identified in the various open
literature studies.  The study author proposed a degradation pathway for
naphthalene, which ultimately resulted in catechol.  Transitional
transformation products included
cis-1,2-dihydroxy-1,2-dihydronapthalene, 1,2-dihydroxy-napthalene,
2-hydroxchromene-2-carboxylate (HCCA),
trans-o-hydroxy-benzylidenpyruvate (tHBPA), salicyladehyde, and
salicylate.  There are no registrant submitted environmental fate data
on these degradation products that would allow for an approximation of
environmental fate inputs, the available open literature data are
sparse, and there are no available toxicity data for these compounds.
Therefore, these degradates were not quantitatively assessed in the
exposure assessment, and risk estimates are based on the parent only.

Terrestrial Organisms

	a.  Exposure

	      Naphthalene’s outdoor products are formulated as flakes or
granules, and are applied in bands 1 to 12 inches wide around ornamental
plants, gardens, or building perimeters (snake products only).  For
birds and rabbits, naphthalene products are formulated with 100%
naphthalene ai.  This is roughly equivalent to an application rate of
10.8 lbs ai/A.  Snake repellant products consist of 7% naphthalene (i.e.
0.56 lbs ai/A).  For modeling purposes, granules are used as a surrogate
for flakes.  The Tier-1 model, T-REX  (Terrestrial Residue Exposure),
was used to estimate terrestrial exposure and risk values for
naphthalene.  Input values on avian and mammalian toxicity, as well as
chemical application and foliar dissipation half-life data, are required
to run the model.  A default dissipation half-life of 35 days was
assumed.  The LD50/ft2 is used to estimate risk for granular
formulations through row and banded applications.    SEQ CHAPTER \h \r 1
  SEQ CHAPTER \h \r 1 The appropriate T-REX input parameters were
selected from the product labels.  For the method of application using
granules (or flakes), one row length of 209 feet with a 1-foot bandwidth
and 0% incorporation was assumed.  These parameters are summarized in
Table 5 below.  Since naphthalene is used only as a granular or flake
application, exposures to animals foraging on food items with
naphthalene residues (short and tall grass, broadleaves, seeds) are not
estimated in this assessment.

Table 5.  Input Parameters for T-REX Analysis

Application Type	Formulation	Input	Guidance	Comments

Rows/Band 	Granular	Number of Row, Length	Row spacing is the amount of
space (inches) between crop rows and is obtained from the product label.
	Only one row was assumed. A row length of 209 foot was used assuming
application occurs on one side of a one-acre field.

Band width	Bandwidth is the width of the applied pesticide row (inches)
and is obtained from the product label.  	A 12 inch bandwidth was
obtained from the Dr. T’s Snake-A-Way label (registration # 58630-1),
which is the greatest labeled bandwidth.

% Incorporated	Value depends on the method of application:

T-Banded – covered with specified amount of soil: 99% In-furrow,
drill, or shanked-in: 99%

Side-dress, banded, mix, or lightly incorporate with soil: 85%

Broadcast, mix, or lightly incorporated: 85%

Side-dress, banded, unincorporated: 0%

Broadcast, aerial broadcast, unincorporated: 0%	Not incorporated
according to labels.

Weight of granule	Estimated from data obtained from registrant	38 mg

	b.  Toxicity

	Effects characterization describes the potential effects a pesticide
can produce in an organism, and is generally based on
registrant-submitted studies or studies found in the open literature
which describe acute and chronic toxicity effects for various animals.
Table 6 summarizes the toxicity effects and reference values used to
assess risks for naphthalene to terrestrial organisms.

  Table 6.  Toxicity of Naphthalene to Terrestrial Animals and Plants tc
"Table #. Acute 96-hour toxicity of flumetsulam to freshwater animals "
\f D

Taxon	Test Organism	Test Type	Endpoint	Value	Ecotoxicity Category

Bird	Bobwhite quail

Colinus virginianus	Acute Oral	LD50	2690 mg/kg bw1	Practically nontoxic

Subacute Dietary	LC50	>5620 mg/kg diet	Practically nontoxic

	Mallard duck

Anas platyrhynchos	Subacute Dietary	LC50	No data	Not available

Mammal	Rat

Rattus norvegicus	Acute Oral	LD50	2649 mg/kg bw	Practically nontoxic

Beneficial insects	Honey bee

Apis mellifera	Acute Contact	LD50	No data	Not available

Soil Invertebrates	Folsomia candida	Chronic Effects on Soil
Invertebrates (reproduction and survival)	NOAEC

LOAEC	88 µmol/kg soil

409 µmol/kg soil	None

	Enchytaeus crypticus

NOAEC

LOAEC	220 µmol/kg soil

2045 µmol/kg soil	None

Terrestrial plants	Monocots and dicots	Seedling emergence and Vegetative
vigor	EC25

NOAEC

LOAEC	No data	Not available

1.  Body weight

c.  Risk to Terrestrial Organisms

				i.  Birds

          	At a rate of 10.8 lbs ai/A, risk estimates for birds of all
the weight classes, exceed the Agency’s LOC.  However, naphthalene is
a repellent and it is manufactured to ensure that birds will avoid the
naphthalene products (e.g., Dr.T’s Rabbit, Squirrel, Bat, and Bird
Repellent, reg. # 58630-2).

	Although it may be unlikely that birds will consume naphthalene
granules, since it is not formulated as an attractant but as a repellent
to terrestrial animals and is comprised of granules with a strong odor
of coal tar, it is uncertain if the repellent nature of the compound
will be sufficient to keep birds away entirely.  Therefore, further
steps were taken to characterize the potential for acute risk to avian
species by evaluating how many granules a bird would need to ingest in
order to trigger the Agency’s LOC; these estimates are presented in
Table 7.

Table 7.  Estimate of the number of granules ingested to reach an EEC
exceeding the adjusted LD50 LOC for birds at 10.8 lbs ai/A

	Bird Size (grams)

	20	100	1000

No. of Consumed Granules Required 	Adjusted LD50	1	7	92

	Acute Risk LOC (0.5)	0.51	4	46

	Endangered Species LOC (0.1)	0.1	0.65	10

EEC = 112.46 mg/square feet (excluding row spacing, bandwidth, and # of
rows input parameters).

	While the Agency believes it is unlikely that birds will consume
naphthalene, it is possible that a bird might accidentally ingest it,
and if that occurs, the screening-level assessment indicates that a
small bird (20 g) will exceed the Agency’s LOC at 1 granule if eating
avian/mammalian repellant product.  These risk estimates assume that
birds eat granules containing 100% ai immediately following application,
before loss of naphthalene to sublimation.  One of the outdoor
formulations of naphthalene, “Dr. T’s Snake-A-Way”, consists of
granules that contain 7% naphthalene ai; therefore, a bird would have to
consume over 14 times more of the snake repellant granules to exceed an
LOC.

		Because no toxicity data are available on avian reproductive risk, the
Agency was unable to assess chronic risk to birds.

                                                ii.  Terrestrial-phase
Amphibians and Reptiles

	            The Agency currently uses data on surrogate species, birds,
to assess risk to non-target terrestrial-phase amphibians and reptiles.
Based on the evaluation of potential risks to birds, potential risks to
reptiles and terrestrial-phase amphibians are also higher than the
Agency’s levels of concern.  However, naphthalene is a repellent and
it is formulated to repel reptiles (e.g., Dr. T’s Snake-A-Way).

			            iii.  Mammals

	The acute risk estimates (LD50/ft2) to terrestrial mammals, as a result
of the assessed uses of naphthalene at 10.8 and 0.56 lbs ai/acre exceed
the LOCs for acute risk and endangered species.  As for birds, the risk
estimates are based on a granular formulation.

Table 8.  Mammalian LD50/ft2 (RQs) from Direct Ingestion of Naphthalene
Granules

Weight Class	LD50/ft2 A	LOCs Exceeded

10.8 lb ai/A - EEC/Toxicity (adjusted mg/ft2 / adjusted LD50)

15 g	268.18	Acute Risk, Endangered Species

35 g	142.05	Acute Risk, Endangered Species

1000 g	11.49	Acute Risk, Endangered Species

0.56 lb ai/A - EEC/Toxicity (adjusted mg/ft2 / adjusted LD50)

15 g	13.91	Acute Risk, Endangered Species

35 g	7.37	Acute Risk, Endangered Species

15 g	13.91	Acute Risk, Endangered Species

A Mammal LD50 = 2649 mg/kg

         	Curently, T-REX does not have the capacity to estimate the
minimum foraging area needed to allow for direct ingestion of sufficient
mass of naphthalene to achieve a dose that exceeds the LOC for mammals.
However, naphthalene is a repellent and it is manufactured to ensure
that mammals will avoid the naphthalene flakes (e.g., Chaperone Squirrel
and Bat Repellent, reg. # 2724-685).

	      Because no toxicity data is available on mammalian reproductive
risk, the Agency was unable to assess chronic risk to mammals.

				iv.  Non-Target Insects

	EPA does not estimate RQs for terrestrial non-target insects.
Furthermore, the Agency has no insect toxicity data for naphthalene.

				v.  Terrestrial Plants

           The Agency currently uses terrestrial plant data to estimate
potential risks to non-target terrestrial plants from surface water
runoff.  Some naphthalene labels state that the products should not be
applied directly to foliage or stems.  This statement indicates that
there is a possibility of phytotoxicity.  In addition, open literature
suggests that naphthalene is selectively phytotoxic to plants.  However,
terrestrial plant studies have not been submitted for naphthalene, nor
has data been located in published literature.  Therefore, the potential
risks to terrestrial plants are unknown.

3.  Aquatic Organisms

Exposure

            Risk to aquatic animals was assessed using Generic Estimated
Environmental Concentration (GENEEC2), a Tier 1 model that estimates
concentrations in a 1-hectare, 2-meter-deep water body adjacent to a
10-hectare treated site that drains into the water body.  Since there
are no liquid outdoor use formulations of naphthalene and granular
applications are assumed, this water body is also assumed to receive no
drift from the treated site.  The model assumes an area is 100% treated.
 Given the limited size of the outdoor area treated (it is applied in a
band around ornamentals, planting beds and gardens) an adjustment of
4.1% to the modeled EEC was made to account for the use pattern.

	Two scenarios were modeled to represent high and low naphthalene use
scenarios.  The high use scenario was modeled at 10.8 lbs ai/A with six
applications per year, while the low use scenario was modeled at 0.56
lbs ai/A with six applications per year.  The EECs are summarized in
Table 9.

Table 9.  Results of GENEEC2 Modeling for Naphthalene Use on Ornamentals

Use Site	Application Rate (lbs/acre)	Number of Applications

(interval)	Peak EEC (ppb)	4 day EEC (ppb)	21 day EEC (ppb)	60-day EEC
(ppb)	90-day EEC (ppb)

Ornamentals for rabbit & dog repellent	10.8	6

(2 months)	26.9	26.6	25.2	22.4	20.5

Ornamentals for snake repellent	0.56	6

(2 months)	1.4	1.4	1.3	1.2	1.1

	Unaccounted for in this exposure assessment is the fact that
naphthalene is volatile.  No product chemistry data are available, but
an estimate of the vapor pressure was made using EpiSuite
(http://www.epa.gov/opptintr/exposure/pubs/episuite.html).  EpiSuite
reported an experimentally derived value for vapor pressure of 8.5 x10-2
mm Hg (which is consistent with the registrant reported value of 10.5
Pa, or 7.8 x 10-2 mm Hg), suggesting that naphthalene is volatile.
Given the volatility of this compound and the fact that the Tier I model
used to estimate exposure does not account for volatility as a route of
dissipation, it is likely that the exposure estimates derived above are
over-predictions of potential exposure.  However, it is unknown from the
open literature data used in this assessment whether the systems were
closed or flow-through.  If the aerobic metabolism data (and hence the
half-life used in this assessment) were flow-through, then the
degradation reported would include volatilization as a process.

	It is possible that naphthalene may leach to groundwater.  An overview
of US Geological Survey (USGS) National Water-Quality Assessment Program
(NAWQA) groundwater data indicates that of 6,977 samples only 37
detections of naphthalene were found.  While the maximum concentration
detected was 70 ppb, there are a number of possible sources of
naphthalene contamination of groundwater, including many with
significantly higher usage (e.g., petroleum, jet fuel).  Thus it appears
that leaching is not likely a significant route of exposure for the
pesticidal use of naphthalene.  Potential groundwater leaching was
assessed using SciGrow, and a concentration of 16.3 ppb at the highest
application rate (10.8 lbs ai/A x 6 applications) and 0.84 ppb at the
lowest rate (0.56 lbs ai/A x 6 applications) was estimated.  These
values are below the surface water concentrations predicted by GENEEC2,
are lower than the NAWQA values described above, and assume a much
broader area of application than anticipated for this use pattern (bands
surrounding gardens and planting beds).  Given the lines of evidence
described, it is expected that as an exposure route for ecological risk
assessment, naphthalene in groundwater resulting from pesticidal use is
minimal.

          Unlike the drinking water assessment described in the human
health risk assessment section of this document, the exposure values
used in the ecological risk assessment do not include the Index
Reservoir (IR).  These factors represent a drinking water reservoir, not
the variety of aquatic habitats relevant to a risk assessment for
aquatic animals, such as ponds adjacent to treated fields.  Therefore,
the EEC values used to assess exposure and risk to aquatic animals are
not the same as those used to assess exposure and risk to humans from
pesticides in drinking water.

			b.  Toxicity

	Available freshwater and estuarine/marine fish and invertebrate acute
toxicity data suggest that naphthalene is moderately toxic to most
aquatic test species (Table 10).  Chronic freshwater fish reproduction
data indicates that survival and growth are affected.  Aquatic plant
growth studies with green algae were less sensitive than animals, and
naphthalene is categorized as slightly toxic to green alga.  No toxicity
study with aquatic vascular plants is available for this ecological risk
assessment.

 Table 10.  Toxicity of Naphthalene to Aquatic Organisms and Plants

Taxon	Test Organism	Endpoint	Value1

(mg a.i./L)	Ecotoxicity Category

Freshwater Fish	Rainbow trout

Onchorhynchus mykiss	96-hr LC50

NOAEC (mortality)

NOAEC (sublethal)	2.0

0.86

0.86	Moderately Toxic

	Bluegill sunfish

Lepomis macrochirus	96-hr LC50

NOAEC (mortality)

NOAEC (sublethal)	3.2

1.4

1.4	Moderately Toxic

	Coho salmon

Oncorhynchus kisutch	40D NOAEC

40D LOAEC	0.37

0.67	None

Freshwater Invertebrate	Water flea

Daphnia magna	48-hr EC50

NOAEC (mortality)

NOAEC (sublethal)	1.6

0.48

>8.8	Moderately Toxic

Estuarine/

Marine

Fish	Fathead minnow

Pimephales promelas	96-hr LC50

NOAEC (mortality)

NOAEC (sublethal)	6.6

NR

NR	Moderately Toxic

Chronic NOAEC

Chronic LOAEC	0.62

NR	None

Estuarine /

Marine

Invertebrates	Pacific oyster

Crassostrea gigas	96-hr EC50

NOAEC (mortality)

NOAEC (sublethal)	199

NR

NR	Practically Nontoxic

	Grass shrimp

Palaemonetes pugio	96-hr LC50

NOAEC (mortality)

NOAEC (sublethal)	2.35

NR

NR	Moderately Toxic

Vascular Plant	Duckweed

Lemna gibba	7-day EC50

NOAEC	No data	No Data

Non-vascular Plant	Green algae

Chlorella vulgaris	48-hr EC50

NOAEC         LOAEC	33

NR

NR	Slightly Toxic

 1Bolded values indicate toxicity thresholds used to calculate risk
quotients.

			c.  Risk to Aquatic Organisms

           RQs for naphthalene do not exceed the acute LOC for aquatic
animals and aquatic nonvascular plants (i.e., fish, aquatic-phase
amphibians, invertebrates, and algaes) when used at six applications, 60
days apart, at the highest application rate (10.8 lbs ai/A).  Therefore,
minimal acute risk is also expected from the lower application rate
(0.56 lbs ai/A).  Risks to aquatic vascular plants are also unknown due
to lack of ecotoxicity data.  Aquatic organism risk estimates based on
the maximum application rate are presented in Table 11 below.

Table 11.  Risks to Aquatic Animals and Plants for Naphthalene Use on
Ornamentals

Taxon	Species	Toxicity Endpoint	EEC (µg/L)	RQ1	LOCs Exceeded2

Freshwater Fish	Rainbow trout

Onchorhynchus mykiss	96-hr LC50 = 2.0 mg/L

(or 2000 µg/L)	26.9 (peak)	0.013	None

	Coho salmon

Oncorhynchus kisutch	40-day NOAEC = 0.37 mg/L

(or 370 µg/L)	22.4 (60D)	0.06	None

Freshwater Invertebrate	Water flea          Daphnia magna	48-hr LC50 =
1.6 mg/L

(or 1600 µg/L)	26.9 (peak)	0.017	None

Marine/estuarine Fish	Fathead minnow

Pimephales promelas	LC50 = 6.6 mg/L

(or 6600 µg/L)	26.9 (peak)	<0.01	None

NOAEC = 0.62 mg/L

(or 620 µg/L)	22.4 (60D)	0.04	None

Marine/estuarine Invertebrate	Grass shrimp

Palaemonetes pugio	LC50 = 2.35 mg/L

(or 2350 µg/L)	26.9 (peak)	0.01	None

Vascular Plant	Duckweed

Lemna gibba	No data	26.9 (peak)	Not available

Freshwater Non-Vascular Plant	Green Algae            Chlorella vulgaris
EC50 = 33 mg/L

(or 33000 µg/L)	26.9 (peak)	<0.01	None

1 Acute risk quotients= EEC/LC50; Chronic Risk Quotients =EEC/NOAEC.

2 Aquatic animal acute LOC:  >0.05 for endangered species and  >0.5 for
non-listed  species; LOC for aquatic plants: >1; Chronic LOC for aquatic
animals: >1.

			d.  Endangered Species

	The acute risk to birds, terrestrial-phase amphibians and reptiles, and
mammals exceed the endangered species LOC, and therefore there is a
potential for direct effect to these taxa.  In addition, there is a
potential for indirect effects to species that depend on them.  The data
are currently insufficient to determine if there is a potential for
direct or indirect effect to terrestrial or aquatic plants.
Naphthalene is not likely to affect aquatic animals (fish or
invertebrates) directly; the potential for indirect effects depends on
whether naphthalene could affect semi-aquatic or aquatic plants.

			e.  Ecological Incidents

  SEQ CHAPTER \h \r 1  	          A search of the EIIS (Environmental
Incident Information System) database for ecological incidents (run on
May 31, 2007) identified one ecological incident involving naphthalene.
The incident reported includes possible impact to fish.  See table 12
for further detail.

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.  An absence of reports does not necessarily equate to an
absence of incidents given the nature of incident reporting.

 Table 12. Naphthalene Ecological Incident

Formulation	Crop	Date and Location	Species Affected	Number Found	Residue

Analysis	App. Rate, Method, etc.

Unknown	N/A	May 2003, Craven Co., NC	Unknown fish	2,000	No	Treated
directly

IV.  Risk Management, Reregistration, and Tolerance Reassessment
Decision

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

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

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

	Based on its evaluation of naphthalene, the Agency has determined that
products containing naphthalene, 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 will take
regulatory action to address the risk concerns from the use of
naphthalene.  If all changes outlined in this document are incorporated
into the product labels, then all current risks for naphthalene will be
adequately mitigated for the purposes of this determination under FIFRA.

	B.  Public Comment Period

	Through the Agency’s public participation process, EPA worked with
stakeholders and the public to reach the regulatory decision for
naphthalene.  EPA released the naphthalene preliminary risk assessments
for public comment on May 14, 2008, 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 July 14, 2008,
the Agency received comments from registrants (technical and end use),
Honeywell, and the Naphthalene Council.  These comments in their
entirety, responses to the comments, as well as the preliminary and
revised risk assessments, are available in the public docket
(EPA-HQ-OPP-2008-0343) at http:www.regulations.gov.  In brief, the
comments included the following:

Landis International, the agent for the technical registrant (Reochem,
Inc.), agrees to conduct the required exposure study (Guideline
875.2500).

An end use registrant, Willert Home Products, suggested that 1)
packaging is not necessary to reduce potential risk from episodic
ingestion of mothballs, since the symptoms described in incident reports
are not severe in nature; and 2) the aquatic exposure modeling
overestimates the amount of naphthalene product typically applied.

Honeywell International Inc. stated that the carbon adsorption
coefficient used in the ecological risk assessment was unreasonably low
and thus led to an unrealistically high estimate of the risks
naphthalene poses to drinking water.

	C.  Regulatory Position

		1.  Regulatory Rationale

	The Agency has determined that products containing naphthalene 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 naphthalene.  Where labelling revisions are
warranted, specific language is set forth in the summary table of
Section V.

Dietary Risk

	There are no agricultural or food uses of naphthalene; therefore, no
dietary exposure from food is expected.  However, there is potential for
drinking water exposure from the outdoor uses of naphthalene.  The acute
and chronic risk estimates were found to be well below the 100%
Reference Dose (RfD) level of concern.  Overall dietary exposure to
naphthalene via drinking water is expected to be insignificant, and
thus, no mitigation measures are required.

Residential Risk

Handlers

	For residential risk, the MOEs for all handler scenarios assessed were
17,000 or greater, which is greater than the Agency’s MOE of 100, and
therefore, no mitigation measures are required.

Episodic Ingestion

	Toddler episodic ingestion of one naphthalene mothball results in an
MOE < 1 (LOC = 100).  While this represents an exposure concern, the
effects of this type of exposure, if any, are not expected to be severe.
 The episodic ingestion MOE is calculated from an endpoint derived from
a developmental oral rat study in which dams were repeatedly treated
with a high oral bolus dose, and the resulting clinical signs (lethargy
and slow breathing) and body weight decrement were transient.  The
effects were attributed to the administration of a high bolus and were
not permanent; the animals displayed quick recovery.  There were no
persistent effects or treatment-related deaths.

	The study results are consistent with symptoms described in the
incident reports.  Reported incidents of naphthalene ingestion among
children account for the majority of reported naphthalene exposures.
This may be attributed to the widespread use of naphthalene products in
homes and the ease of accessing the product as it is applied as loose
mothballs.  The severity of the reported incidents are much lower than
for other pesticides as a whole.  From a 13-year period of PCC data
(1993-2005), approximately 7% of naphthalene incidents in children
resulted in any symptoms at all and less than 1% had moderate or major
symptoms.  Symptoms that did occur (both adults and children; all routes
of exposure) were not life-threatening and included nausea, vomiting,
headache, dizziness, drowsiness/lethargy, eye irritation, and dermal
edema and erythema.  Of greater concern than the potential health
effects is the accessibility of the indoor use product to young
children, as evidenced by the large number of reported incidents.

	Limiting accessibility to naphthalene is expected to significantly
reduce the number of incidents, including those that may result in
symptoms.  To that end, the Agency has conducted risk mitigation
discussions with the naphthalene end-use registrants.  Since the large
majority of naphthalene incidents for children under 6 years of age were
from episodic ingestion of indoor use mothball products, the Agency
determined that mothballs can no longer be marketed in such a way that
individual mothballs are applied to areas accessible to children.

	The registrants have agreed to take product stewardship steps to ensure
that products are packaged in a way that would discourage children from
eating the product.  Loose mothballs will no longer be sold, and there
are several formulation and packaging options that registrants can
employ instead.  Mothballs can be sold in sachets, for example, if made
with a tear- and moisture-resistant wrapping material.  Mothballs can
also be packaged in plastic containers that allow for volatilization,
but which would prohibit direct contact with the naphthalene product
enclosed.  Alternatively, naphthalene could be formulated into larger
sized cake or block products (minimum of 2.5 inches in diameter), which
incident data show are not an exposure source of concern for episodic
ingestion.  The registrants further agreed that cake and block products
will also be enclosed in plastic, metal or cardboard packaging while in
use.  The implementation of packaging mitigation measures is required
within 5 years (September 2013).  See Table 13 for details on packaging
requirements.

	  In addition, the Agency will require prominently displayed
precautionary label language on packaging which warns consumers of a
possible episodic ingestion risk to children and to keep product out of
reach of children (see Table 13).  These new product labelling
requirements will be implemented within 12 months (September 2009).  The
Agency is confident that based on the rigorous nature of the mitigation
measures to be implemented, episodic ingestion exposures will be reduced
to such an extent that this scenario no longer poses a risk of concern.

Postapplication Inhalation (Cancer and Noncancer)

	A quantification of cancer risk for exposures via inhalation, or
derivation of an inhalation reference concentration (RfC) for the
nonfood-pesticidal uses of naphthalene was not performed.  This is
because, as described in Section III of this document, there is support
from published studies and ongoing research on naphthalene that indicate
that risk estimates, factoring in known species differences between
rodents and humans (including humans) in metabolism and respiratory
toxicity, would be considerably less than those using default
procedures.  Pharmacokinetic research may quantify the species
difference and is forthcoming (approximately 2-3 years).

	Anticipated acute and short-term inhalation exposures to naphthalene in
residences are estimated to be 20X and 30X below the rodent dose (NOAEL)
resulting in no adverse effects, respectively. Anticipated acute and
short-term inhalation exposures to naphthalene in residences are
estimated to be 60X and 80X, respectively, below the rodent dose (LOAEL)
resulting in respiratory toxicity (olfactory epithelium lesions).

	Anticipated intermediate-term inhalation exposures to naphthalene in
residences are estimated to be 540X below the rodent dose (NOAEL)
resulting in no adverse health effects.  Intermediate- and long-term
inhalation exposures to naphthalene in residences are estimated to be
1000X and 5400X, respectively, below the rodent dose (LOAEL) resulting
in respiratory toxicity (olfactory epithelium lesions).

	These inhalation exposure estimates do not represent a risk of concern
to the Agency.  The carcinogenic and noncarcinogenic potential of
naphthalene is currently undergoing review by EPA Integrated Risk
Information System (IRIS).  The EPA process of regulating pesticides
allows for re-evaluation at any time if relevant new information becomes
available. Thus, when the IRIS assessment is finalized OPP would
determine whether the human health hazard potential of naphthalene
warrants revisiting.  Similarly, when pharmacokinetic research is
complete the Agency will revisit naphthalene inhalation risk.

			c.  Aggregate Risk

	An aggregate risk assessment for all expected routes of exposure was
not performed as there is no common toxicity among all the routes of
exposure.  A short-term aggregate risk assessment could be performed by
combining short-term incidental oral exposure and average/background
dietary (in this case drinking water) exposures, but this was not done
for naphthalene since the short-term incidental oral exposure risk
estimate alone exceeds the LOC, and combining with other routes of
exposure would only further exceed the LOC.  As previously described,
while the episodic ingestion of naphthalene by a toddler results in an
MOE less then the target MOE, the effects of this type of exposure, if
any, are transient and are not expected to be severe.

	However, the Agency is requiring extensive mitigation measures,
including special packaging of indoor use products and prominent
precautionary label language.  These mitigation measures are expected to
reduce the potential for episodic ingestion to such an extent that this
scenario no longer represents a risk of concern.  Furthermore,
naphthalene’s highly conservative dietary risk estimates for potential
drinking water exposure are far below the Agency’s LOC and are not of
concern.

				d.  Occupational Risk

	    Naphthalene pesticide products are not registered for occupational
use and, therefore, occupational exposure to the pesticidal uses of
naphthalene is not anticipated and has not been assessed.

Ecological Risk

Birds, Terrestrial-phase amphibians, and Reptiles

              Based on a screening-level assessment, naphthalene may
pose an acute risk to birds, terrestrial-phase amphibians and reptiles.
The ecological assessment was conducted with conservative use
assumptions: six applications per year were assumed, the highest
application rate was used (10.8 lbs ai/A, although some products are
labeled for use at 0.56 lbs ai/A), and the model did not account for
volatilization.  Furthermore, animal repellant products are formulated
as flakes and granules, but the assessment was conducted for granules
only due to modeling limitations.  While there is some potential for a
bird to accidentally ingest a granule of naphthalene during gritting
activities, it is unlikely that a bird would consume naphthalene in
flake form.  The modeling limitations, the conservative assumptions, and
the uncertainty surrounding volatility may have resulted in an
over-estimate of risk.  Based on the conservative nature of the risk
assessment and the fact that naphthalene is a bird repellant, the Agency
does not anticipate a risk of concern and is not requiring mitigation
measures for the naphthalene animal repellent products.

Mammals

	When marketed as a rabbit repellent, the use directions instruct the
user to place the product in small bands around ornamentals; this use is
limited to small areas during the growing season.  While the acute risk
estimates to terrestrial mammals exceed the Agency’s LOCs, as for
birds, the assessment was highly conservative and may have
over-estimated risk.  In addition, the incident data show very little
history of pet exposure.  The Agency does not anticipate risk of concern
to mammals from the outdoor uses of naphthalene, based on the use
pattern (localized treatments around ornamentals as an animal
repellant), and is not requiring mitigation.

Aquatic Organisms

            Acute risk is not expected for freshwater animals,
aquatic-phase amphibians and aquatic nonvascular plants, and therefore,
no mitigation is required.

Non-Target Insects and Plants

            Due to lack of toxicity data, risks to honey bees and to
terrestrial and aquatic vascular plants can not be quantified; however,
given its method of application and use as a repellent around gardens,
effect on insects and plants are not anticipated.

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

	Following recommendations of its Endocrine Disruptor Screening and
Testing Advisory Committee (EDSTAC), EPA determined that there was a
scientific basis for including, as part of the program, the androgen and
thyroid hormone systems, in addition to the estrogen hormone system.
EPA also adopted EDSTAC’s recommendation that EPA include evaluations
of potential effects in wildlife.  For pesticides, EPA will use FIFRA,
and to the extent that effects in wildlife may help determine whether a
substance may have an effect in humans, FFDCA authority to require the
wildlife evaluations.  As the science develops and resources allow,
screening of additional hormone systems may be added to the Endocrine
Disruptor Screening Program (EDSP).

	When the appropriate screening and/or testing protocols being
considered under the EDSP have been developed, individual pesticides may
be subject to additional screening and/or testing to better characterize
effects related to possible endocrine disruption.

		3.  Endangered Species

	The Endangered Species Act required federal agencies to ensure that
their actions are not likely to jeopardize listed species or adversely
modify designated critical habitat.  The Agency has developed the
Endangered Species Protection Program to identify pesticides whose use
may cause adverse impacts on federally listed endangered and threatened
species, and to implement mitigation measures that address these
impacts.  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.

	  SEQ CHAPTER \h \r 1  For naphthalene, the acute risk to birds,
terrestrial-phase amphibians and reptiles, and mammals exceed the
endangered species LOC, and therefore there is a potential for direct
effect to these taxa.  In addition, there is a potential for indirect
effects to species that depend on them.  The data are currently
insufficient to determine if there is a potential for direct or indirect
effect to terrestrial or aquatic plants.   Naphthalene is not likely to
affect aquatic animals (fish or invertebrates) directly; the potential
for indirect effects depends on whether naphthalene could affect
semi-aquatic or aquatic plants.

 tc "E.	Regulatory Rationale " \l 2

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

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

V.  What Registrants Need to Do

	The Agency has determined that products containing naphthalene are
eligible for reregistration provided that the required risk mitigation
measures, including product packaging, are adopted and label amendments
are made.  The Agency intends to issue Data Call-In Notices (DCIs)
requiring generic and 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.  Table 13 describes the packaging
requirements and label amendments that the Agency is requiring for
naphthalene products to be eligible for reregistration.

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

  Additional Generic Data Requirements

	The generic data base supporting the reregistration of naphthalene for
currently registered uses has been reviewed and determined to be
substantially complete.  However, the Agency intends to issue a DCI
requiring a confirmatory chamber study (Guideline 875.2500) to determine
levels of naphthalene in the air resulting from use of mothballs at the
maximum label rate.  It is recommended that a study protocol be
submitted to the Agency for review and approval prior to the inception
of the study.  The Agency does not currently anticipate requiring
additional generic data.  Other entities are conducting ongoing
naphthalene research to address toxicology issues including:

More accurate assessment of species differences in metabolism and
clearance of naphthalene.

Cell proliferation data to provide linkage to cytotoxicity.

DNA adduct and mutagenicity studies in relevant target tissues in vivo
to confirm lack of direct DNA mutagenicity.

Physiologically Based Pharmacokinetic (PBPK) model under development
(2-3 years rough estimate) to better support the mode of action, and to
characterize species differences in metabolism, and address involvement
of multiples enzymes and clearance in humans versus rodents.  The PBPK
model may provide a more accurate determination of a human equivalent
dose to be used in inhalation risk assessment.

	These data will be included in future assessments of naphthalene.

		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 Table 13.

	B.   End-Use Products

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

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

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

		2.  Labeling for End-Use Products

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

	To be eligible for reregistration, labeling changes are necessary to
implement measures outlined in Section IV above.  Specific language to
incorporate these changes is specified in Table 13.  Generally,
conditions for the distribution and sale of products bearing old
labels/labeling will be established when the label changes are approved.
 However, specific existing stocks time frames will be established
case-by-case, depending on the number of products involved, the number
of label changes, and other factors.

   C.  Labeling Changes Summary Table

For naphthalene to be eligible for reregistration all naphthalene
mothball products must be packaged, and labels must be amended to
incorporate the risk mitigation measures, as outlined in Section IV.
Table 13 describes the packaging requirements and how language on the
labels should be amended.

Table 13.  Summary of Labeling Changes for Naphthalene

Description	Amended Labeling Language	Placement on Label

Manufacturing Use Products

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

Note to registrant:

Special packaging for moth repellant end use products are required to
reduce the risk that children will ingest the product. 	Directions for
use

For Manufacturing Use Products Formulated as Indoor Use Moth Repellant
Products	Note to registrant:

After September 30, 2013 formulation into loose mothball products is not
permitted. See End Use Product requirements for a description of
approved indoor moth repellant formulation types and packaging
specifications.	Directions for use

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

	Directions for Use

Environmental Hazards Statements 	“ENVIRONMENTAL 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.”
Precautionary Statements:  Environmental Hazards

End-Use Products

Availability Statements	“IMPORTANT:  Keep out of reach of children.”

“Do not place in areas accessible to children.”	Directions for Use

Indoor Moth Repellant Sachet Products	“IMPORTANT: It is illegal to
sell the sachets individually.”

“Do not open sachets.”	Directions for Use

For End Use Products Formulated as Indoor Use Moth Repellant Products
Note to registrant:

After September 30, 2013, naphthalene may no longer be formulated into
loose mothball products unless contained in sachets meeting the
following minimum manufacturing specifications:

Physical Property

Minimum Value

Test

Tear Initiation Machine Direction

2.2 lbs

ASTM D1004 Standard Test Method for Tear Resistance (Graves Tear) of
Plastic Film and Sheeting

Tear Initiation Transverse Direction

2.2 lbs

ASTM D1004

Tensile Strength Machine Direction

16,3000 psi

ASTM D882A Standard Test Method for Tensile Properties of Thin Plastic
Sheeting

Tensile Strength Transverse Direction

20,000 psi

ASTM D882A

Heat Seal Strength

500 g/in

285° F, 40 PSI, 1 sec HS/HS heat seal side to heat seal side

After September 30, 2013, naphthalene indoor moth repellant products
formulated as cakes or blocks must have a minimum diameter size of 2.5
inches. 	Directions for use

Precautionary Statement for All Indoor Moth Repellant Products

	Note to registrant:

The following statement will be placed within a shaded box within the
Precautionary Statements on the label.  The coloring of the box and text
will be such to provide a contrasting color to other label text.  The
shaded box must contain the following:

“Keep out of reach of children.  Do not place in areas accessible to
children.”

Include the following statement prominently on the front panel of
product packaging (in bold), “Keep out of reach of children.”

	Precautionary Statements

Appendix A.  Use Patterns Eligible for Reregistration for Naphthalene

Use Site	Formulation Type	Product Type	Maximum Application
Rate/Application2	Unit	Maximum Retreatment Interval

Attics, Basements, Etc. (indoor animal repellant use) 	Crystalline
Flakes	1 	lb ai/400 ft3 or  oz ai/3 ft3	7

Household/Domestic Dwellings Contents	Crystalline	Balls, Flakes, Sachets
0.37	lb ai/12  ft3	7

Garden or House Perimeter	Crystalline	Granules, Flakes	0.014	gal/ 1000
ft2	7

Appendix B

Data Supporting Guideline Requirements for the Reregistration of
Naphthalene

REQUIREMENT	Use Pattern	CITATION(S)

PRODUCT CHEMISTRY

New Guideline Number	Old Guideline Number	Study Description

830.1600	158.160	Description of Materials Used to Produce the Product
All	46862001

830.1620	158.162	Description of Production Process	All	43112501

830.1650	158.165	Formulation Process

46862001

830.1670	158.167	Formation of Impurities	All	46862001

830.1700	158.170	Preliminary Analysis	All	43170801

830.1800	158.180	Analytical Method	All	46862001

830.7050	N/A	UV/Visible Absorption	All	Data Gap

830.7550	63-11	Partition Coefficient	All	42335803

ECOLOGICAL EFFECTS

850.2100	71-1	Avian Acute Oral Toxicity	A, B	148176

850.2200	71-2	Avian Dietary Toxicity - Quail	A, B	00148175

850.1075	72-1	Freshwater Fish Acute Toxicity 	A, B	45030801, 44302701

850.1010	72-2	Invertebrate Toxicity	A, B	44302702

850.1400	72-4a	Freshwater Fish Early Life- Stage Toxicity 	A, B	46220970

TOXICOLOGY

870.1100	81-1	Acute Oral Toxicity 	A, B	00148174, 257224

870.1200	81-2	Acute Dermal Toxicity 	A, B	00148409, 257229

870.1300	81-3	Acute Inhalation Toxicity	A, B	00144557, 257902

870.2400	81-4	Primary Eye Irritation	A, B	00148408, 257228

870.2500	81-5	Primary Dermal Irritation	A, B	00148177, 257227

870.2600	81-6	Dermal Sensitization	A, B	00148173

Non-guideline

Acute Neurotoxicity – Rat	A, B	44282801

870.3250	82-3	90-Day Dermal – Rodent	A, B	40021801

870.3465	82-4	90-Day Inhalation - Rat	A, B	42835901

Non-guideline

90-Day Neurotoxicity – Mammal	A, B	44856401

Non-guideline

Oncogenicity – Rat	A, B	45630101

Non-guideline

Oncogenicity – Mouse	A, B	42458301

870.3700	83-3 	Teratogenicity - Rabbit	A,B	42195401, 00157145

870.3700	83-3	Prenatal Developmental – Rat	A, B	NTP 1991

870.3700	83-3	Prenatal Developmental – Rabbit	A, B	NTP 1992

870.5100	84-2	Gene Mutation – Ames	A, B	42071601

Non-guideline

Genotoxicity	A, B	42071604

870.5300	84-2	Structural Chromosome Aberration	A, B	42071603

870.5550	84-2	UDS Assay	A, B	42071604

870.5375	84-2	CHO Chromosome Aberration	A, B	NTP 2000

870.5375 	84-2	CHO Sister Chromatid Exchange	A, B	NTP 2000

870.6200	82-7	Acute Neurotoxicity (Oral) – Rat	A, B	44282801

870.5395	84-2	In Vivo Mouse Bone Marrow Micronucleus	A, B	42071603

870.5265	84-2	Gene Mutation in S.typhimurium	A, B	42071602

870.6200	82-7	Subchronic Neurotoxicity (Inhalation) – Rat	A, B
44856401

Non-guideline

4-Week Inhalation – Rat	A, B	42934901

Non-guideline

90-Day Oral Toxicity – Rat	A, B	NTP 1980a

Non-guideline

90-Day Oral Toxicity – B6C3F1 Mouse	A, B	NTP 1980b

Non-guideline

90-Day Oral Toxicity – DC1 Mouse	A, B	Shopp et al. 1984

Non-guideline

Chronic Toxicity/ Carcinogenicity (Chamber) Inhalation – Rat	A, B	NTP
2000

Non-guideline

Chronic Toxicity/Carcinogenicity (Chamber) Inhalation – Mouse	A, B	NTP
1992

OCCUPATIONAL/RESIDENTIAL EXPOSURE

Non-guideline

Indoor Air Monitoring	A, B	43716501

875.2500	133-4	Inhalation Exposure	A, B	Data Gap

ENVIRONMENTAL FATE

835.2120	161-1	Hydrolysis	A, B	45346801

835.1230	163-1	Sediment and Soil Adsorption/Desorption	A, B	45346801

Appendix C.	Technical Support Documents

	Additional documentation in support of this RED is maintained in the
OPP docket, located in Room S-4400, One Potomac Yard (South Building),
1777 S. Crystal Drive, Arlington, VA.  It is open Monday through Friday,
excluding legal holidays, from 8:30 am to 4 pm.

	The risk assessments and other supporting documents for naphthalene are
available in the Public Docket, under docket number   HYPERLINK
"http://www.regulations.gov/search/search_results.jsp?sid=11D6809E5945&N
e=2+8+11+8053+8054+8098+8074+8066+8084+8055&N=0&css=0&Ne=2+8+11+8053+805
4+8098+8074+8066+8084+8055"  EPA-HQ-OPP-2008-0343 , and on the
Agency’s web page,   HYPERLINK "http://www.regulations.gov."
http://www.regulations.gov.   The docket contains risk assessments and
related documents as of November, 2008.

	Technical support documents for the Naphthalene RED include the
following:

Health Effects Documents

1.  Phase 4 Amendment:  Response to Comments in Reference to
“Naphthalene: HED Chapter for the Reregistration Eligibility Decision
Document (RED)” dated August 22, 2008.

2.  Naphthalene:  Phase 4 Amendment:  Response to Comments In Reference
to “Naphthalene: Occupational and Residential Exposure Assessment and
Recommendations for the Reregistration Eligibility Decision Document,”
dated September 10, 2008.

3.  Review of Naphthalene Incident Reports, dated June 25, 2007.

Ecological Fate and Effects Documents

      1.  Revised Drinking Water Exposure Assessment for the Human
Health Risk Assessment for the Reregistration Decision Eligibility (RED)
of Naphthalene Incorporating the Registrant’s Error Correction
Comments, dated April 9, 2008.

     2.  Revised Ecological Risk Assessment for Reregistration
Eligibility Decision (RED) for Naphthalene, dated April 21, 2008.

Appendix D.	Citations Considered to be Part of the Database Supporting
the Reregistration Decision (Bibliography)

GUIDE TO APPENDIX D

1.	CONTENTS OF BIBLIOGRAPHY.  This bibliography contains citations of
all studies considered relevant by EPA in arriving at the positions and
conclusions stated elsewhere in the Reregistration Eligibility Document.
 Primary sources for studies in this bibliography have been the body of
data submitted to EPA and its predecessor agencies in support of past
regulatory decisions.  Selections from other sources including the
published literature, in those instances where they have been
considered, are included.

2.	UNITS OF ENTRY.  The unit of entry in this bibliography is called a
"study".  In the case of published materials, this corresponds closely
to an article.  In the case of unpublished materials submitted to the
Agency, the Agency has sought to identify documents at a level parallel
to the published article from within the typically larger volumes in
which they were submitted.  The resulting "studies" generally have a
distinct title (or at least a single subject), can stand alone for
purposes of review and can be described with a conventional
bibliographic citation.  The Agency has also attempted to unite basic
documents and commentaries upon them, treating them as a single study.

3.	IDENTIFICATION OF ENTRIES.  The entries in this bibliography are
sorted numerically by Master Record Identifier, or "MRID” number.
This number is unique to the citation, and should be used whenever a
specific reference is required.  It is not related to the six-digit
"Accession Number" which has been used to identify volumes of submitted
studies (see paragraph 4(d)(4) below for further explanation).  In a few
cases, entries added to the bibliography late in the review may be
preceded by a nine character temporary identifier.  These entries are
listed after all MRID entries.  This temporary identifying number is
also to be used whenever specific reference is needed.

4.	FORM OF ENTRY.  In addition to the Master Record Identifier (MRID),
each entry consists of a citation containing standard elements followed,
in the case of material submitted to EPA, by a description of the
earliest known submission.  Bibliographic conventions used reflect the
standard of the American National Standards Institute (ANSI), expanded
to provide for certain special needs.

a	Author.  Whenever the author could confidently be identified, the
Agency has chosen to show a personal author.  When no individual was
identified, the Agency has shown an identifiable laboratory or testing
facility as the author.  When no author or laboratory could be
identified, the Agency has shown the first submitter as the author.

b.	Document date.  The date of the study is taken directly from the
document.  When the date is followed by a question mark, the
bibliographer has deduced the date from the evidence contained in the
document.  When the date appears as (1999), the Agency was unable to
determine or estimate the date of the document.

c.	Title.  In some cases, it has been necessary for the Agency
bibliographers to create or enhance a document title.  Any such
editorial insertions are contained between square brackets.

d.	Trailing parentheses.  For studies submitted to the Agency in the
past, the trailing parentheses include (in addition to any
self-explanatory text) the following elements describing the earliest
known submission:

(1)	Submission date.  The date of the earliest known submission appears
immediately following the word "received."

(2)	Administrative number.  The next element immediately following the
word "under" is the registration number, experimental use permit number,
petition number, or other administrative number associated with the
earliest known submission.

(3)	Submitter.  The third element is the submitter.  When authorship is
defaulted to the submitter, this element is omitted.

Volume Identification (Accession Numbers).  The final element in the
trailing parentheses identifies the EPA accession number of the volume
in which the original submission of the study appears.  The six-digit
accession number follows the symbol "CDL," which stands for "Company
Data Library."  This accession number is in turn followed by an
alphabetic suffix which shows the relative position of the study within
the volume.

MRID

4898	Means, R.G. (1973) Preliminary evaluation of the effectiveness of
Mosquito Beater^(R)I, a granular repellent, against mosquitoes and
blackflies. Mosquito News 33(4):542-545. (Also~In~unpub- lished
submission received Jul 16, 1975 under 4-123; submitted by Bonide
Chemical Co., Inc., Yorkville, N.Y.; CDL:126291-A)

4900	Nowak, L.M. (1975) Interim Material Safety Data Sheet for Naphtha-
lene. (Unpublished study received May 6, 1977 under unknown admin. no.;
prepared by Ashland Oil, Inc., submitted by Kenova Chemical Co., St.
Louis, Mo.; CDL:229765-A)

4901	Samuel J. Milazzo Manufacturing Company (1967) Ten Day Test for
Milazzo Company Animal Chaser. (Unpublished study received Sep 12, 1967
under 8218-1; prepared in cooperation with United States Testing Co.,
Inc. and Hermel Exterminating; CDL:224446-A)

4902	Hunsberger, J.F. (1969) Testing Program. (Unpublished study re-
ceived Oct 28, 1969 under 8218-1; prepared by Allentown Testing
Laboratories, Inc., submitted by Samuel J. Milazzo Co., Pitts- ton, Pa.;
CDL:224446-B)

4903	Niper, R. (1963) Milazzo Brand Animal Chaser Test No. 1. (Unpub-
lished study including letter dated Dec 9, 1963 from R. Niper to Samuel
J. Milazzo, received Dec 17, 1963 under 8218-1; prepared by Monroe
County Society for the Prevention of Cruelty to Ani- mals, submitted by
Samuel J. Milazzo Co., Pittston, Pa.; CDL: 224446-C)

4904	Uni-Research (1973) Evaluation of Dog Repellent Product: Technical
Report. (Unpublished study received Dec 12, 1973 under 1663-11;
submitted by Grant Laboratories Div., Oakland, Calif.; CDL: 022675-A)

4906	Taylor, R.E. (1974) Acute Oral Toxicity (LDI50^). (Unpublished
study received Feb 26, 1974 under 779-29; prepared by Harris
Laboratories, Inc., submitted by Faesy & Besthoff, Inc., Edge- water,
N.J.; CDL:050215-A)

4907	Harmad Laboratories (1976) Use of Naphthalene as an Insecticide in
Controlling Lice and Fleas. (Unpublished study received Nov 16, 1976
under 1548-3; submitted by Vermex Co., Calabasas, Calif.; CDL:227450-A)

4908	Harmad Laboratories (1976) Use of Naphthalene as an Insecticide in
Controlling Mites. (Unpublished study received Nov 16, 1976 un- der
1548-3; submitted by Vermex Co., Calabasas, Calif.; CDL: 227450-B)

4909	Harmad Laboratories (1976) Use of Naphthalene as a General Insect-
icide. (Unpublished study received Nov 16, 1976 under 1548-3; submitted
by Vermex Co., Calabasas, Calif.; CDL:227450-C)

4911	Whitmire, H.E. (1958) Fly Larvicide Test Reports Made on Cubetoid
(L.L.) Liquid Larvicide Concentrate. (Unpublished study re- ceived Jan
16, 1958 under 499-110; submitted by Whitmire Re- search Laboratories,
Inc., St. Louis, Mo.; CDL:228313-A)

4912	Gerade, H.W. (19??) Di- and Tricyclic aromatic hydrocarbons. Pages
216-232,~In~Toxicology & Biochemistry of Aromatic Hydrocarbons. N.P.
(Also~In~unpublished submission received Jun 22, 1965 under 862-EX-4;
submitted by Sun Oil Co. of Pa., Philadelphia, Pa.; CDL:123931-A)

4913	Sun Oil Company of Pennsylvania (1959?) Toxicity of Naphthalene.
(Unpublished study received Jun 2, 1965 under 862-EX-3; CDL: 123930-A)

4914	Hamilton, D.W. (1964?) Results of Screening of Naphthalene, ENT No.
278 for Control of Third-Instar Japanese Beetle Grubs. (Un- published
study received Sep 23, 1965 under 862-EX-2; prepared by U.S.
Agricultural Research Service, Entomology Research Div., Japanese Beetle
Investigations, submitted by Sun Oil Co. of Pa., Philadelphia, Pa.;
CDL:123929-B)

5578	Coulter, JB. (1977) Field Trial Efficacy Test Evaluation Using
Vermex as a control for Fleas, Sarcoptic Mange, Ticks. (Un- published
study received Jun 2, 1977 under 1548-3; prepared by Brownsville Animal
Research Center for Harmad Laboratories; sub- mitted by Vermex Co.,
Calabasas, Calif.; CDL:230521-A)

12997	Innis, Speiden & Company (1941) The Larvacide Log (August). New
York: ISCO. (Also~In~unpublished submission received on unknown date
under unknown admin. no.; submitted by E.J. Scarey, New York, N.Y.;
CDL:222934-A)

19056	Baker, R.S.; Holstun, J.T., Jr. (1965) Weed Control in Cotton on
Tunica Clay: Line Project CR f1-19; Research Report CF-221. (Unpublished
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19915	Stout, D.M. (1964) (Efficacy of Cat Away as a Repellent). (Unpub-
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26091	Williamson, H.O.; McDuffie, W.E.; Jasper, R.L. (1972) (Grant's
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26232	Mississippi State University, Agricultural Experiment Station
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for Mississippi. State College, Miss.: MSU. (pp. 13, 24,48,50,54 only;
also~In~unpublished submission received Oct 2, 1967 under 8F0643;
submitted by Stauffer Chemical Co., Westport, Conn.; CDL:091116-S)

26929	Jasper, R.L. (1963) (Farnam Rotenox: Toxicity to Rats). (U.S.
Pharmacology Laboratory, unpublished report.)

32961	Brooks, D.M. (1959) Muskrat Damage: Prevention and Control. Indi-
anapolis, Ind.: Indiana, Dept. of Conservation, Div. of Fish & Game.
(Indiana W-2-R; also~In~unpublished submission received Oct 29, 1971
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33603	Davis, C.S.; Deal, A.S.; Hart, W.H.; et al. (1967) Pest and
Disease Control Program For Olives, 1967. ?: Univ. of California,
Agricultural Experiment Station, Extension Service. (Also~In~
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44481	Ralston Purina Company (1968) Health Product Specification. (Un-
published study received Dec 11, 1970 under 602-193; CDL: 004118-A)

51053	Grant Laboratories (1964) ?Data on Grant's Dog Repellent|. (Com-
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CDL:220938-A)

51355	Unkel, M.W. (1962) Letter sent to C.C. McDonell dated Jan 26, 1962
?Lice-kill tests on birds|. (Unpublished study received Jan 30, 1962
under unknown admin. no.; submitted by Hudson Associates, Inc., Hudson,
Ohio; CDL:108791-A)

53225	Strong Cobb Arner, Incorporated (1962) ?Effect of Pesticide
Tablets on Chicken and Parakeets|. (Unpublished study received Jan 30,
1962 under unknown admin. no.; submitted by Hudson Associates, Inc.,
Hudson, Ohio; CDL:108791-B)

57823	Bottimer, L.J. (1929) Notes on Paradichlorobenzene and Naphthalene
as repellents against clothes moth larvae. Journal of Economic
Entomology 22(Jun):570-573. (Also~In~unpublished submission re- ceived
May 25, 1977 under 38510-1; submitted by Specialty Organ- ics, Inc.,
Irwindale, Calif.; CDL:230291-A)

59195	Mallis, A. (1961) Letter sent to Sam C. Billings dated May 10,
1961 ?Results of studies on effect of PDB and Naphthalene against larvae
of fabric insects|. (Unpublished study received May 12, 1961 under
unknown admin. no.; submitted by Gulf Re- search Development Co.,
Pittsburgh, Pa.; CDL:228336-A)

59196	Feldmesser, J. (1965) Letter sent to K. Deane Groves dated Aug 5,
1965 ?Results with Naphthalene in laboratory and greenhouse tests|.
(U.S. Agricultural Research Service, Crops Research Div.; unpublished
study; CDL:123929-A)

60828	Grant Laboratories (1964) ?Efficacy of Grant's Dog Repellent|.
(Reports by various sources; unpublished study received May 21, 1964
under 1663-11; CDL:220937-A)

64153	Grant Laboratories (1964) ?Efficacy Studies on Dog Repellent|.
(Compilation; unpublished study received Jun 25, 1964 under 1663-11;
CDL:220938-A)

65068	Brookes, P.; Lawley, P.D. (1964) Evidence for the binding of poly-
nuclear aromatic hydrocarbons to the nucleic acids of mouse skin:
Relation between carcinogenic power of hydrocarbons and their binding to
deoxyribonucleic acid. Nature ?(May):782-784. (Published study)

65069	Harvey, R.G.; Halonen, M. (1968) Interaction between carcinogenic
hydrocarbons and nucleosides. Cancer Research 28(Nov):2183- 2186.
(Published study)

65070	Peters, A.C.; Thake, D.C. (1980) Subchronic Toxicity Study: Naph-
thalene (C52904), Fischer 344 Rats: Subcontract No. 76-34- 106002.
(Battelle; unpublished study)

65071	Peters, A.C.; Thake, D.C. (1980) Subchronic Toxicity Study: Naph-
thalene (C52904), B6C3F1 Mice: Subcontract No. 76-34-106002. (Battelle;
unpublished study)

68188	Shell Chemical Company (1966) ?Efficacy of Various Rodenticides
for Muskrats|. (Compilation of published data; unpublished study
received Oct 29, 1971 under 201-118; CDL:227781-C)

71774	Fletcher, D.W. (1980) Report to M & T Chemicals, Inc.: 12-day
Dietary LC50 Study with Biomet 300 in Bobwhite Quail: BLAL No. 80QC3.
(Unpublished study, including sponsor's validation of feed levels
report, R-1400-M, dated Jan 16, 1981, received Mar 26, 1981 under
5204-63; prepared by Bio-Life Associates, Ltd., submitted by M & T
Chemicals, Inc., Rahway, N.J.; CDL: 244674-B)

71775	Fletcher, D.W. (1980) Report to M & T Chemicals, Inc.: 12-day
Dietary LC50 Study with Biomet 300 in Mallard Ducklings: BLAL No. 80 DC
3. (Unpublished study, including sponsor's valida- tion of feed levels
report, R-1400-M, dated Jan 16, 1981, received Mar 26, 1981 under
5204-63; prepared by Bio-Life Associates, Ltd., submitted by M & T
Chemicals, Inc., Rahway, N.J.; CDL:244674-C)

73787	Whitmire Research Laboratories, Incorporated (1964) ?Effectiveness
of Outdoor Dog Away|. (Compilation; unpublished study received Jun 11,
1964 under 499-138; CDL:020041-A)

73788	Whitmire Research Laboratories, Incorporated (1964) ?Effectiveness
of Indoor Dog Away|. (Compilation; unpublished study received Jun 5,
1964 under 499-137; CDL:020042-A)

77011	Statham, C.N.; Melancon, M.J., Jr.; Lech, J.J. (1976) Bioconcen-
tration of xenobiotics in trout bile: A proposed monitoring aid for some
waterborne chemicals. Science 193(4254):680-681. (Al- so~In~unpublished
submission received May 14, 1981 under 6704- 45; submitted by U.S. Dept.
of Interior, Fish and Wildlife Serv- ice, Washington, D.C.;
CDL:245185-E)

89381	Moorefield, H.H. (1958) The Metabolism of 1-Naphthol (a Literature
Review): IN-58-6. (Unpublished study received Jan 5, 1960 under PP0243;
submitted by Union Carbide & Carbon Corp., New York, N.Y.; CDL:090270-D)

123791	Williamson, H.; McDuffie, W.; Jasper, R. (1969) ?Swash Spray or
Wash: Rat|. (Unpublished study received Oct 22, 1969 under 270- 40;
prepared by Pharmacology Laboratory, submitted by U.S. Environmental
Protection Agency, Beltsville, MD; CDL:118578-A)

125145	Industrial Bio-Test Laboratories, Inc. (1970) Protocol for ...:
Absorption of 14C-labeled Naphthalene in Albino Rats. (Unpub- lished
study received Jun 1, 1970 under 0F0991; submitted by William Cooper &
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127315	Gallo, M.; Silver, E. (1983) Napthalene Toxicity: Summary and
Doc- umentation. (Unpublished study received Mar 29, 1983 under un-
known admin. no.; prepared by UMDNJ-Rutgers Medical School, Dept. of
Environmental and Community Medicine, submitted by Getty Refining and
Marketing Co., Tulsa, OK; CDL:249909-A)

127316	Shrader, S. (1982) ?Study of the Chemical Napthalene P-20|: SL #
7155. (Unpublished study received Mar 29, 1983 under unknown admin. no.;
prepared by Shrader Analytical and Consulting Laboratories, Inc.,
submitted by Getty Refining and Marketing Co., Tulsa, OK; CDL:249909-B)

127317	Herbes, S. (1981) Rates of microbial transformation of polycyclic
aromatic hydrocarbons in water and sediments in the vicinity of a
coal-coking wastewater discharge. Applied and Environmental Microbiology
41(1):20-28. (Also In unpublished submission re- ceived Mar 29, 1983
under unknown admin. no.; submitted by Getty Refining and Marketing Co.,
Tulsa, OK; CDL:249909-C)

127318	Tattersfield, F. (1928) The decomposition of naphthalene in the
soil and the effect upon its insecticidal action. Ann. Appl. Biol.
XV:57-80. (Also In unpublished submission received Mar 29, 1983 under
admin. no.; submitted by Getty Refining and Marketing Co., Tulsa, OK;
CDL:249909-D)

127319	Fanburg, S. (1940) Exfoliative dermatitis due to naphthalene: Re-
port of a eruption resembling mycosins fungoides. Archives of
Dermatology and Syphilogy 42:53-58. (Also In unpublished sub- mission
received Mar 29, 1983 under unknown admin. no.; sub- mitted by Getty
Refining and Marketing Co., Tulsa, OK; CDL: 249909-F)