Document ID: EPA-HQ-OPP-2007-0937-0011
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2009-02-12T05:00Z

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

Environmental Protection                and Toxic Substances		          
      December, 2008

Agency					      (7508P)						

 Reregistration 

	Eligibility Decision

	for 

	Para-dichlorobenzene

Revised December 2008

TABLE OF CONTENTS

  TOC \o "1-3" \h \z \u    HYPERLINK \l "_Toc219091054"  I. 
Introduction	  PAGEREF _Toc219091054 \h  8  

  HYPERLINK \l "_Toc219091055"  II.  Chemical Overview	  PAGEREF
_Toc219091055 \h  9  

  HYPERLINK \l "_Toc219091056"  A.  Regulatory History	  PAGEREF
_Toc219091056 \h  9  

  HYPERLINK \l "_Toc219091057"  B.  Chemical Identification	  PAGEREF
_Toc219091057 \h  9  

  HYPERLINK \l "_Toc219091058"  C.  Use Profile	  PAGEREF _Toc219091058
\h  9  

  HYPERLINK \l "_Toc219091059"  D.  Estimated Usage of Pesticide	 
PAGEREF _Toc219091059 \h  10  

  HYPERLINK \l "_Toc219091060"  III.  Summary of Para-dichlorobenzene
Risk Assessments	  PAGEREF _Toc219091060 \h  11  

  HYPERLINK \l "_Toc219091061"  A.  Human Health Risk Assessment	 
PAGEREF _Toc219091061 \h  11  

  HYPERLINK \l "_Toc219091062"  1.  Toxicity of Para-dichlorobenzene	 
PAGEREF _Toc219091062 \h  11  

  HYPERLINK \l "_Toc219091063"  2.  Carcinogenicity of
Para-dichlorobenzene	  PAGEREF _Toc219091063 \h  14  

  HYPERLINK \l "_Toc219091064"  3.  Metabolites and Degradates	  PAGEREF
_Toc219091064 \h  15  

  HYPERLINK \l "_Toc219091065"  4.  Dietary Risk (Food + Water)	 
PAGEREF _Toc219091065 \h  15  

  HYPERLINK \l "_Toc219091066"  5.  Residential Non-Cancer Risk	 
PAGEREF _Toc219091066 \h  15  

  HYPERLINK \l "_Toc219091067"  6.  Residential Cancer Risk	  PAGEREF
_Toc219091067 \h  18  

  HYPERLINK \l "_Toc219091068"  7.  Aggregate Risk	  PAGEREF
_Toc219091068 \h  20  

  HYPERLINK \l "_Toc219091069"  8.  Occupational Risk	  PAGEREF
_Toc219091069 \h  20  

  HYPERLINK \l "_Toc219091070"  9.  Human Incident Data	  PAGEREF
_Toc219091070 \h  21  

  HYPERLINK \l "_Toc219091071"  B.  Environmental Risk Assessment	 
PAGEREF _Toc219091071 \h  21  

  HYPERLINK \l "_Toc219091072"  A.  Determination of Reregistration
Eligibility	  PAGEREF _Toc219091072 \h  22  

  HYPERLINK \l "_Toc219091073"  B.  Public Comment Period	  PAGEREF
_Toc219091073 \h  22  

  HYPERLINK \l "_Toc219091074"  C.  Regulatory Position	  PAGEREF
_Toc219091074 \h  23  

  HYPERLINK \l "_Toc219091075"  1.  Regulatory Rationale	  PAGEREF
_Toc219091075 \h  23  

  HYPERLINK \l "_Toc219091076"  2.  Endocrine Disruptor Effects	 
PAGEREF _Toc219091076 \h  24  

  HYPERLINK \l "_Toc219091077"  3.  Endangered Species	  PAGEREF
_Toc219091077 \h  24  

  HYPERLINK \l "_Toc219091078"  D.  Labeling Requirements	  PAGEREF
_Toc219091078 \h  24  

  HYPERLINK \l "_Toc219091079"  V.  What Registrants Need to Do	 
PAGEREF _Toc219091079 \h  25  

  HYPERLINK \l "_Toc219091080"  A.  Manufacturing Use Products	  PAGEREF
_Toc219091080 \h  25  

  HYPERLINK \l "_Toc219091081"  1.  Additional Generic Data Requirements
  PAGEREF _Toc219091081 \h  25  

  HYPERLINK \l "_Toc219091082"  2.  Labeling for Manufacturing-Use
Products	  PAGEREF _Toc219091082 \h  25  

  HYPERLINK \l "_Toc219091083"  B.   End-Use Products	  PAGEREF
_Toc219091083 \h  25  

  HYPERLINK \l "_Toc219091084"  1.  Additional Product-Specific Data
Requirements	  PAGEREF _Toc219091084 \h  25  

  HYPERLINK \l "_Toc219091085"  2.  Labeling for End-Use Products	 
PAGEREF _Toc219091085 \h  25  

  HYPERLINK \l "_Toc219091086"  C.  Labeling Changes Summary Table	 
PAGEREF _Toc219091086 \h  26  

  HYPERLINK \l "_Toc219091087"  Appendix B	  PAGEREF _Toc219091087 \h 
31  

 Glossary of Terms and Abbreviations   

ai		Active Ingredient

CFR		Code of Federal Regulations

DCI		Data Call-In

DNT		Developmental Neurotoxicity

EC		Emulsifiable Concentrate Formulation

EPA		Environmental Protection Agency

EUP		End-Use Product

FIFRA	Federal Insecticide, Fungicide, and Rodenticide Act

FFDCA	Federal Food, Drug, and Cosmetic Act

GLN		Guideline Number

HCF		Heath Care Facility

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.

LIP		Label Improvement Program

LOC		Level of Concern

LOAEL	Lowest Observed Adverse Effect Level

mg/kg/day	Milligram Per Kilogram Per Day

mg/L		Milligrams 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

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

NOAELHEC    No Observed Adverse Effect Level Human Equivelant Dose.

OPP		EPA Office of Pesticide Programs

OPPTS	EPA Office of Prevention, Pesticides and Toxic Substances

PII		Primary Irritation Index

PK		Pharmacokinetic

ppb		Parts Per Billion

ppm		Parts per Million

RED		Reregistration Eligibility Decision

RfC		Reference Concentration

RfD		Reference Dose

SF		Safety Factor

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

TEAM	Total Exposure Assessment Methodology 

TGAI		Technical Grade Active Ingredient

USDA	United States Department of Agriculture

UF		Uncertainty Factor

UFdb		Database Uncertainty Factor 

PARA-DICHLOROBENZENE TEAM

Office of Pesticide Programs:

Health Effects Risk Assessment

William H. Donovan, Ph.D.

Sayed Tadayon

George Ghali, Ph.D.

Ecological Fate and Effects Risk Assessment

Gary Orrick

Marietta Echeverria

Biological and Economics Analysis Assessment

Rafael Prieto

Steve Jarboe

LaVerne Dobbins

Registration Division

Dan Peacock

John Hebert

Risk Management

Molly Clayton

Kevin Costello

Para-dichlorobenzene Reregistration Eligibility Decision 

	The Reregistration Eligibility Decision (RED) document for
para-dichlorobenzene was signed on September 28, 2007.  In accordance
with the Agency’s public participation process, a public comment
period for the RED was conducted.  This comment period opened December
12, 2007 and closed February 11, 2008.  The comments received primarily
concerned the episodic ingestion risk estimates.  The Agency, in
response, re-evaluated the acute oral endpoint selection and agreed that
there were no effects attributable to a single dose, and revised the
human health risk assessment and the RED accordingly.  The HED Chapter
of the Reregistration Eligibility Decision Document (RED) for
Para-dichlorobenzene; Revised Version, dated April 1, 2008, other
supporting documents, and comments can be found in the docket at  
HYPERLINK "http://www.regulations.gov"  http://www.regulations.gov 
under docket identification (ID) number EPA-HQ-OPP-2007-0937.

The revisions made to para-dichlorobenzene RED are as follows:  

The acute oral endpoint and the risk estimate for episodic ingestion of
mothballs were removed from Section III.  After careful reconsideration
of the applicability of the toxicity endpoint selected for the previous
analysis of episodic ingestion of mothballs, the Agency concluded that
an acute oral RfD is not necessary for para-dichlorobenzene.  For
further discussion of acute oral risk, see Section III of this document.

In Section III, the acute dermal toxicity category was changed from III
to IV in Table 1, as this was a typographical error.  

 

In Section IV, the requirement of special packaging to mitigate risk
from episodic ingestion of mothballs was removed.

In Section V, Table 6 was revised to remove the requirement for special
packaging of mothballs, and the “keep out of reach of children”
language was modified to be consistent with other chemicals with similar
warning statements.

Abstract 

	

	The Environmental Protection Agency (EPA or the Agency) has completed
the human health and ecological risk reregistration memorandum for the
para-dichlorobenzene and is issuing its risk management decision.  The
human health risk assessment and ecological risk reregistration
memorandum, 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 para-dichlorobenzene-containing products are eligible for
reregistration, provided that risk mitigation measures are adopted and
labels are amended accordingly.  That decision is discussed fully in
this document.  

	Para-dichlorobenzene is a fumigant insecticide.  The majority of its
pesticidal use is as a moth repellant to protect garments from insect
damage and in and around birdcages for the control of lice and ticks. 
There are no outdoor uses registered for para-dichlorobenzene;
therefore, ecological risk was not assessed.  Since para-dichlorobenzene
does not have any food or other outdoor uses, the only uses assessed are
indoor residential uses and a single occupational use.  There were no
risk estimates 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 risk assessment,
ecological reregistration memorandum, and reregistration eligibility
decision (RED) for para-dichlorobenzene.  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 risk assessment and ecological reregistration memorandum; 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 para-dichlorobenzene 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-2007-0937.

	

II.  Chemical Overview

Regulatory History

	The Agency's predecessor for pesticide registrations, the U.S.
Department of Agriculture (USDA), first registered a product containing
para-dichlorobenzene in 1947.  The Agency has never issued a
Registration Standard for this product.  However, in the early 1990s,
the Agency required the technical registrant to supply acute toxicity
data on the technical product.  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 para-dichlorobenzene and other chemicals,
especially when used in homes. 

	Currently, the Agency has 28 products registered; of those, 5 are
manufacturing-use products and 23 are end-use products.  All are
registered under Section 3 of the Federal Insecticide, Fungicide,
Rodenticide Act (FIFRA).  There are no Special Local Needs (SLNs)
registrations.  Most products (18) are for moth and carpet beetle
control inside of airtight spaces (closets, chests, and garment bags) in
homes.  Some products (3) are also used indoors to kill lice and mites
on birds in cages.  One product is used to kill wax moths in empty
beehives and bee houses stored indoors. Also, one product is used to
repel Norway rats and house mice from indoor storage areas and to repel
gray squirrels from attics.

 	B.  Chemical Identification

	PARA-DICHLOROBENZENE:

	Para-dichlorobenzene is a colorless or white crystalline   HYPERLINK
"http://en.wikipedia.org/wiki/Solid" \o "Solid"  solid  with a strong,
pungent   HYPERLINK "http://en.wikipedia.org/wiki/Odor" \o "Odor"  odor
. 

Common Name:		Para-dichlorobenzene

Chemical Name:		1,4-dichlorobenzene

Other Names:			PDCB, P-Dichlorobenzene

Chemical Class:		Fumigant Insecticide

PC Code:	061501	

Case Number:			3058

CAS Registry Number:	106-46-7

Molecular Weight:		147

Empirical Formula:		  SEQ CHAPTER \h \r 1 C6H4Cl2

Technical Registrants:	PPG Industries, Inc. and Solutia, 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 para-dichlorobenzene eligible for reregistration is contained in
Appendix A.

Type of Pesticide:  Fumigant Insecticide.

Target Organism:  The primary target pests are moths, carpet beetles,
lice, and mites.  

Use Sites:  Para-Dichlorobenzene is limited to indoor use only.  It is
used as a moth and beetle repellant in products which are applied to
commercial and residential use sites such as closets and storage
containers, and to repel lice and mites from bird cages.  It is also
used in empty bee supers (stored indoors), to repel wax moths.  When
formulated into varpal rope, it is used in attics to repel snakes, mice,
rats, squirrels, and bats.

Use Classification:  Para-dichlorobenzene products are designated as
general use.

Formulation Types:  Cakes, crystals, balls, sachetes, impregnated
strips, blocks, varpel rope, and flakes.

Application Methods:  By hand.

Application Rates:  It is applied as a moth repellant in moth balls,
flakes, crystals, cakes, and sachetes at rates ranging from 0.01 pounds
of active ingredient per cubic foot (lbs ai/ft3) to 0.02 lbs ai/ft3. 
When formulated into a block, it is applied at a maximum application
rate of 0.025 lbs ai/ft3.  When formulated into Varpel rope, it is
applied at a rate of 50 feet of product per 5,000 ft3.  It is applied to
beehives at a maximum application rate of 0.19 lbs ai/hive.  When
applied in bird cages, the maximum application rate is 0.017 lbs
ai/cage.  

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

para-dichlorobenzene labels, although some labels recommend
re-application after six 

months, while others recommend use as needed.

	D.  Estimated Usage of Pesticide

	      Approximately 5 million lbs of para-dichlorobenzene are marketed
on average per year.  The majority of the usage is in moth repellant
products.  However, detailed usage information is not available.

III.  Summary of Para-dichlorobenzene Risk Assessments

	The following is a summary of EPA’s revised human health risk
assessment for para-dichlorobenzene, as presented fully in the HED
Chapter of the Reregistration Eligibility Decision Document (RED) for
Para-dichlorobenzene; Revised Version, dated April 1, 2008.  Since there
are no outdoor uses of para-dichlorobenzene, an ecological risk
assessment was not required, as is described in the
Para-dichlorobenzene: EFED Memorandum in Support of the Reregistration
Eligibility Decision, dated September 28, 2007.  These documents are
available in the OPP Public Docket, docket number EPA-HQ-OPP-2007-0937,
and may also be accessed through the Agency’s website at   HYPERLINK
"https://www.regulations.gov"  https://www.regulations.gov .  Hard
copies of these documents may be found in the OPP public docket under
this same docket number.  The purpose of the following summary is to
assist the reader by identifying the key features and findings of the
paradichlorbenzene human health risk assessment and to help the reader
better understand the conclusions reached in the assessment.  

	EPA's use of human studies in the para-dichlorobenzene 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 para-dichlorobenzene are
indoor residential uses and a single occupational use.  There are no
registered food uses for para-dichlorobenzene, and since there are no
outdoor uses, drinking water exposure is not anticipated.  A dietary
risk assessment was not conducted due to the absence of potential
drinking water and food exposure.  The Agency’s human health
assessment considers all U.S. populations, including infants and young
children.  For more information on the para-dichlorobenzene human health
risk assessment, see HED Chapter of the Reregistration Eligibility
Decision Document (RED) for Para-dichlorobenzene; Revised Version, dated
April 1, 2008.

 .		1.  Toxicity of Para-dichlorobenzene

	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 para-dichlorobenzene and has
determined that the toxicological database is reliable and sufficient
for reregistration.  

			a.  Acute Toxicity Profile 

	

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

Table 1.  Acute Toxicity Profile for Para-dichlorobenzene 

Guideline	Study Type	MRID	Results	Toxicity Categorya

870.1100

	Acute Oral 	40521001	LD50 = 3863 mg/kg (males)

LD50 = 3790 mg/kg (females)	III

870.1200

	Acute Dermal 	40521001	LD50 >6000 mg/kg	IV

870.1300

	Acute Inhalation 	41410901	LC50 = > 6.00 mg/L, highest attainable
concentration	IV

870.2400

	Primary Eye Irritation 	42205301	Conjunctivitis and corneal opacity
cleared in 10 days, iritis cleared in 72 hours, vascularization of the
cornea cleared in 10 or 13 days.  The maximum total irritation scores
ranged from 20 to 47 indicating a mild irritant.	II

870.2500

	Primary Dermal Irritation 	42205302	Moderate to severe erythema
persisted for 48-72 hours in most animals. Primary irritation index
(PII) = 2.9	III

870.2600

	Skin Sensitization 	42205303	Negative under the condition of the test. 
N/A

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

Toxicological Endpoints 

	     The toxicological endpoints used in the human health risk
assessment for para-dichlorobenzene are listed in Table 2 below.  The
toxicity of para-dichlorobenzene has been investigated in several animal
species by the oral and inhalation routes under chronic and subchronic
exposure conditions.  Oral studies in rodents and non-rodent species
indicate that the liver and kidney are common and primary target
organs/tissues.  Decreased body weight, reduced organ weights, and
changes in hematological parameters are considered some of the common
effects for this chemical.  The volatility of this material makes the
inhalation route the most likely route of human exposure under the
current use profile as a moth repellent.  Oral exposure is unlikely
under the current use profile, and may be limited to episodic ingestion
by children.  Inhalation exposure was assessed for the following
exposure durations:  short-term (1-30 days), intermediate-term (1- 6
months), or chronic (> 6 months).  Dermal exposures are expected to be
short-term in nature; therefore, intermediate-term and chronic dermal
endpoints were not selected.  Inhalation (short-term, intermediate-term
and chronic) and short-term dermal exposures have been assessed.  

	The available database is considered adequate to characterize any
potential for prenatal or postnatal risks for infants and children based
on the current use profile for para-dichlorobenzene.  The data available
on para-dichlorobenzene included two acceptable prenatal inhalation
developmental toxicity studies in rats and rabbits and a two-generation
inhalation reproduction study in rats.  The data provided no indication
of increased sensitivity of either fetal animals to (in utero) exposure
to para-dichlorobenzene or offspring exposed post-natally to
para-dichlorobenzene.  Furthermore, the No Observed Adverse Effect Level
(NOAEL) of 20 ppm generated in the chronic inhalation
toxicity/carcinogenicity study and the NOAEL of 55 ppm generated in the
13-week inhalation toxicity study in rats provided the most sensitive
endpoints for all exposure duration scenarios.  The regulatory endpoints
defined below exceed effect levels seen in the developmental and
reproductive toxicity studies in rats and rabbits and, therefore, will
be protective of all population subgroups, including infants and
children.   

	Para-dichlorobenzene has low acute toxicity via the oral route of
exposure with an acute LD50 of 3790 mg/kg body weight (bw).  It also has
low acute inhalation toxicity (Category IV).  An endpoint was chosen for
short-term incidental oral exposure.  A NOAEL of 25 mg/kg/day generated
in the 28-day feeding study in dogs, based on increased liver weight in
males and females, increased alkaline phosphatase and irritation of the
gastrointestinal tract in females observed at the next higher dose
level, LOAEL, of 75 mg/kg/day was selected.  There were no effects
attributable to a single oral exposure.  Since there was no endpoint
identified that could be attributable to an acute exposure, there is no
acute oral endpoint selected.  An acute inhalation neurotoxicity study
in rats only showed effects (e.g., decreased forelimb and hind limb grip
strength and decreased motor activity) at 600 ppm (approximately 678
mg/kg bw which is near the oral limit dose of 1000 mg/kg bw).  The
inhalation study would result in direct delivery of the test compound
into the blood compared to an oral exposure which involves a first pass
effect of the liver prior to delivery to the blood.  Furthermore, a
90-day oral (gavage) study in rats found clinical signs (tremors, poor
motor response, ocular discharge and hypothermia) and death at a dose of
1200 mg/kg/day, which is higher than a limit dose of 1000 mg/kg bw per
day.  The only effect seen at the lower doses (600 mg/kg bw per day) was
decreases in bw gain, which are not attributable to a single dose.  The
Agency of Toxic Substances and Disease Registry has not derived an acute
oral MRL (minimal risk level) for para-dichlorobenzene, and noted the
lack of any clear evidence of hepatic or renal effects in rats or mice
treated orally with a single dose of para-dichlorobenzene (up to 2790
mg/kg for rats; up to 1,200 mg/kg for mice).  In addition, no apparent
toxicity was noted in rats or mice administered ≤ 300 mg/kg/day or ≤
600 mg/kg/day, respectively, for 5 days/week for 1 week.  

To estimate residential (dermal, incidental oral, and inhalation) and
occupational (dermal and inhalation) non-cancer risks, the Agency
calculates a margin of exposure (MOE), which is the ratio of the NOAEL
selected for risk assessment to the exposure.  This MOE is compared to a
level of concern which is the same value as the uncertainty factor (UF)
applied to a particular toxicity study.  For para-dichlorobenzene, the
target MOE (i.e., level of concern) dermal exposures is 100.  This
includes the standard uncertainty factors (UF) of 10X for intraspecies
extrapolation and 10X for interspecies variation.  For inhalation
exposure, a UF of 30 was used to account for both intraspecies
extrapolation (10X) and interspecies variations (3X), although
traditionally, the uncertainty factor for interspecies extrapolation is
10X.  The 10X is often considered to be made up of two components, each
equal to a half-log value: 3.16 for pharmacokinetics, which describes
how a chemical gets to the target tissue, and 3.16 for pharmacodynamics,
which describes how the target tissue responds to the chemical.  A full
interspecies factor of 10X was not used in this case because the
reference concentration (RfC) methodology developed by the Agency was
followed in which dosimetry adjustments were used to derive a No
Observed Adverse Effect Level Human Equivelant Dose (NOAELHEC), which
accounts for the pharmacokinetic component of the interspecies
extrapolation, thus allowing a reduction of the interspecies factor from
10X to 3X. 

Table 2.  Endpoints Used for Assessing Residential Risks for
Para-dichlorobenzene

Exposure

Scenario	Dose Used in Risk Assessment	Level of Concern (LOC) for Risk
Assessment	Study and Toxicological Effects

Incidental Oral Short-Term (1-30 days)	NOAEL= 25 mg/kg/day	UFA= 10x

UFH= 10x

Total UF= 100X

	4-Week oral toxicity study-dog  

NOAEL= 25 mg/kg/day

LOAEL= 75 mg/kg/day, based on increased liver weight in males and
increased alkaline phosphatase and liver weight, irritation to GI tract
in females.

Dermal Short-Term (1-30 days)	NOAEL > 300 mg/kg/day	UFA= 10x

UFH= 10x

Total UF= 100X

	21-day dermal-rat

 NOAEL > 300 mg/kg/day (HDT) LOAEL > 300 mg/kg/day.

Inhalation Short- Term (1-30 days)	NOAEL= 150 ppm  or 

NOAELHEC= 180.36 mg/m3

	UFA= 3x

UFH= 10x

Total UF= 30X

	28-Day inhalation toxicity - dog 

Decreased body weight and food consumption, hematological and clinical
chemistry changes,  increased absolute and relative liver weight, liver
histopathological changes, decreased absolute heart weight and absolute
and relative adrenal weights seen in both sexes at the next higher dose,
LOAEL, of 500 ppm. 

Inhalation Intermediate-Term (1-6 months)

	NOAEL= 55 ppm

NOAELHEC= 58.92 mg/m3	UFA= 3x

UFH= 10x

Total UF= 30X

	13-Week Inhalation toxicity - mouse 

hematological changes seen at the next higher dose, LOAEL, of 120 ppm. 

Inhalation- Chronic exposure (6-12 months)	NOAEL= 20 ppm 

NOAELHEC=  0.56 ppm or 3.4 mg/m3	UFA= 3x

UFH= 10x

Total UF= 30X

	Toxicity/carcinogenicity– rat

Olfactory epithelium changes observed at the next higher dose, NOAEL, of
75 ppm

Cancer (oral, dermal, inhalation)	Not Likely to be Carcinogenic to
Humans below doses that do not perturb normal liver homeostasis.

  

Based on the Integrated Risk Information System (IRIS) evaluation draft
document of May 2006, the low dose linear extrapolation approach was
suggested.  “The recommended inhalation risk unit for
para-dichlorobenzene is 4x10-3(mg/m3)-1, based on hepatocellular tumors
in male and female mice.”  

NOAEL = no observed adverse effect level.  NOAELHEC = no observed
adverse effect level human equivelant dose.  UF = uncertainty factor. 
UFA = extrapolation from animal to human (intraspecies).  UFH =
potential variation in sensitivity among members of the human population
(interspecies).   N/A = not applicable.

2.  Carcinogenicity of Para-dichlorobenzene

	In its meeting of 02/21/2007, the Health Effect Division (HED) Cancer
Assessment Review Committee (CARC) determined that para-dichlorobenzene
has been tested adequately by the oral and inhalation routes in two
acceptable carcinogenicity studies in rats and mice.  The treatment was
associated with increased liver tumors in both sexes of mice dosed
orally or exposed to para-dichlorobenzene via inhalation, and increased
incidences of renal tumors in male, but not female, rats when the
chemical was administered orally but not via inhalation.  The male rat
kidney tumors were judged to have been produced via the
nongenotoxic-cytotoxic alpha-2u-globulin pathway, which is considered to
be specific to the male rat with no counterpart for human beings and,
thus, not relevant for human cancer risk assessment.  

	In accordance with the EPA’s Final Guidelines for Carcinogen Risk
Assessment (March 2007), the CARC classified para-dichlorobenzene as
“Not Likely to be Carcinogenic to Humans” based on evidence that a
non-mutagenic mode of action (MOA) involving mitogenesis was established
for para-dichlorobenzene induced liver tumors in mice and that the
carcinogenic effects are not likely below a defined dose that does not
perturb normal liver homeostasis (e.g., increased liver cell
proliferation).  Mitogenic chemicals act by promoting the clonal
expansion of preneoplastic cells by stimulating cell proliferation.  A
mitogenic chemical stimulates cell proliferation in the target organ
without obvious cytotoxicity or cell death.  Another important feature
of this MOA is that the mitogenic effect is not persistent over time;
instead, it is resolved and then is manifested within proliferative
foci, which are considered preneoplastic lesions.  Through continuous
exposure, it is these preneoplastic lesions that develop into tumors. 
This liver mode of action is generally associated with an increase in
metabolizing enzymes.  In the case of para-dichlorobenzene, there is a
good dose correlation between liver tumors, hepatic microsomal enzyme
induction, and cell proliferation in the absence of overt liver toxicity
consistent with mitogenesis.  Dose concordant morphologic
characteristics, i.e., liver hypertrophy and liver weight increases,
were consistent with this mitogenic mouse liver response.  

		3.  Metabolites and Degradates

	

	As this chemical only has indoor uses, no plant, livestock, or water
metabolism studies were submitted, nor or are they required.  The Agency
reviewed the metabolism of para-dichlorobenzene using the only data
available (rat), which show the conjugates of 2,5-dichlorophenol in
urine after ingestion of para-dichlorobenzene.  This does not present a
concern, since the primary route of exposure is inhalation, and no
metabolites were detected in an inhalation study.  Furthermore, the
Agency is not aware of any degradate formed at the site of application
to which people might be exposed by the potential routes of exposure
(ingestion, dermal contact, or inhalation).

4.  Dietary Risk (Food + Water)

	  SEQ CHAPTER \h \r 1   SEQ CHAPTER \h \r 1 There are no food uses
currently registered for para-dichlorobenzene; therefore, dietary
exposure is not of concern.  Furthermore, since there are no outdoor
uses for para-dichlorobenzene, drinking water exposure is not
anticipated.  Due to the lack of potential food and drinking water
exposure, a dietary assessment for para-dichlorobenzene was not
conducted.

	

                        5.  Residential Non-Cancer Risk

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

  

	To estimate residential (inhalation and dermal) risks, the Agency
calculates a margin of exposure (MOE), which is the ratio of the
toxicity endpoint (NOAEL or NOAELHEC) selected for risk assessment 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 a particular
toxicity study.  For para-dichlorobenzene, the uncertainty factor is 100
for dermal exposure and 30 for short-term, intermediate-term, and
chronic inhalation exposures.  A summary of para-dichlorobenzene
residential risk follows.  For further information on residential risk,
refer to the HED Chapter of the Reregistration Eligibility Decision
Document (RED) for Para-dichlorobenzene; Revised Version, dated April 1,
2008.

	a.  Residential Handler Non-Cancer Risks

	The Agency determined that there is the potential for residential
handlers to be exposed to para-dichlorobenzene during application.  Of
para-dichlorobenzene’s registered residential uses, the application of
mothballs to sites such as closets and drawers by hand were considered
the exposure scenarios with the greatest potential for exposure.  The
Agency anticipates handler inhalation exposure during the application
process; however, appropriate inhalation handler exposure data are not
available to assess this scenario, therefore, only dermal exposure was
assessed for residential handlers.  Exposure data does exist for
short-term exposure from post-application inhalation exposure to areas
treated with para-dichlorobenzene, and this exposure scenario has been
assessed.  The Agency assumes that the short-term post-application
inhalation assessment is protective for handler inhalation exposure,
since measured concentrations of para-dichlorobenzene would likely be
greater due to the time allotted in the exposure study for the product
to accumulate in the enclosed areas that were treated.  Since handler
dermal exposure durations are expected to be short-term only,
intermediate-term and chronic dermal exposures were not assessed.  Since
there were no chemical-specific exposure data addressing the use of a
hand for indoor mothball applications, the dermal unit exposure values
were based on surrogate data from naphthalene, another chemical which is
also used in mothballs. 

The residential handler dermal MOEs for both scenarios assessed (closets
and drawers) were greater than 100 (MOE = 33,000 and 224,000,
respectively) and, therefore, are below the Agency’s LOC.

		b.  Residential Post-Application Non-Cancer Risks

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

	

	Of the registered residential uses of para-dichlorobenzene, the
greatest potential for post-application inhalation exposures is
anticipated after moth ball applications are made to areas such as
closets and dresser drawers.  For para-dichlorobenzene, the adult and
toddler inhalation exposure estimates are the same, since the endpoints
derived from the inhalation toxicity studies (all durations) were
adjusted for pharmacokinetic (PK) differences when NOAELHECs were
calculated.  Therefore, post-application inhalation risk was assessed
for adults only.  There is also a potential for post-application
exposure to children ingesting mothballs.  The Agency does not consider
ingestion of mothballs to be a routine behavior, but instead considers
this an episodic event.  Since no endpoint attributable to an acute oral
exposure was identified, episodic ingestion of para-dichlorobenzene was
not assessed. 

	Since no chemical-specific post-application data were submitted in
support of para-dichlorobenzene, the Agency used exposure data from a
naphthalene study, “Estimation of Homeowner Exposure to LX1298-01
(Naphthalene) Resulting from Simulated Residential Use as an Insect
Repellent”, for the short-term inhalation assessment.  The Agency
determined that this study provided the best currently available
estimate of exposure levels to para-dichlorobenzene vapors for
short-term durations, because it was based on the maximum label use rate
for naphthalene, which matches that of para-dichlorobenzene.  Therefore,
the naphthalene homeowner exposure study was used as a surrogate for
estimating para-dichlorobenzene levels for the short-term inhalation
exposure scenario.  In this study, concentrations were measured over a
three day period near the treatment location (closets and drawers) and
throughout the house.  The average exposure levels corresponding to
these locations were 0.85 and 0.66 mg/m3, respectively.  Due to the
similar use and retreatment rates for mothballs containing naphthalene
and para-dichlorobenzene, the Agency anticipates that the exposure
levels of these chemicals when formulated as mothballs are similar. 
However, para-dichlorobenzene has a higher vapor pressure than
naphthalene, and this indicates that the use of naphthalene data as a
surrogate for para-dichlorobenzene does not necessarily result in a
conservative risk estimate.  To address this uncertainty, the Agency
will require a confirmatory chamber study to determine levels of
para-dichlorobenzene in the air resulting from use of mothballs at the
maximum label rate.        

	For intermediate- and long-term post-application inhalation assessment,
the Agency used studies conducted by EPA entitled “Total Exposure
Assessment Methodology (TEAM)” to estimate exposure values.  Among
other things, these studies measured indoor residential concentrations
of para-dichlorobenzene.  The data indicate a seasonal dependence of the
para-dichlorobenzene levels.  The Agency used maximum mean concentration
of 36.2 ug/m3 (winter value) to assess intermediate-term scenarios.  For
long-term assessment, an average of the seasonal value (21 ug/m3) was
used.  

	       Ingestion of moth balls containing para-dichlorobenzene is a
potential source of exposure because children can eat them if they are
found in treated closets or dressers.  If a toddler were to eat a moth
ball containing para-dichlorobenzene, the event is most likely to be
“episodic”, that is, a one-time occurrence that is not likely to be
repeated.  For para-dichlorobenzene, an acute dietary endpoint was not
selected, since an appropriate endpoint could not be attributed to a
single oral dose; therefore, no episodic assessment was performed.  The
residential post-application MOEs for para-dichlorobenzene are
summarized in Table 3 below.

Table 3.  Para dichlorobenzene Non-Cancer Residential Post-Application
Risk 

Source of  exposure	Exposed Population	MOE

Inhalation Short –Term

Mothballs	Adult  (Accessing Treated Areas)	212

	Adult (Inhabiting Treated Home)	273

Inhalation Intermediate –Term

Mothballs	Adult	1650

Inhalation Long- –Term

Mothballs	Adult	160

Residential Cancer Risk

	Generally, when the Agency determines that there is a plausible MOA for
a carcinogen, a low dose linear extrapolation for cancer is not
conducted.  However, the Integrated Risk Information System (IRIS)
program is currently reviewing the mode of action evidence for
para-dichlorobenzene and has not yet made a determination of
non-linearity.  IRIS is a database of human health effects that may
result from exposure to various substances found in the environment, and
it is maintained by EPA’s National Center for Environmental Assessment
(NCEA).  IRIS was initially developed for EPA staff in response to a
growing demand for consistent information on chemical substances for use
in risk assessments, decision-making and regulatory activities.  The
information in IRIS is intended for those without extensive training in
toxicology, but with some knowledge of health sciences.  Since NCEA has
not yet made a non-linearity determination, for the purposes of the
present assessment, the Agency is presenting a linear low-dose
extrapolation risk for cancer.

	A draft IRIS document on para-dichlorobenzene was recently circulated
for external peer review (Revised Final Draft, May 2006.
EPA/635/R-03/015).  In this document, NCEA concluded that a cancer risk
assessment should be based on a low-dose linear extrapolation model, and
the final draft of May 2006 provided two slope factors for hepatic
tumors in male and female mice.  The first was based on oral exposure
(table 5-5, page 136), 1.7x10-2 (mg/kg/day)-1 and 4.0x10-3 (mg/kg/day)-1
for males and females, respectively.  The second was based on inhalation
exposure (pages 141 and 142), 4.5x10-3 (mg/m3)-1 and 4.3x10-3 (mg/m3)-1,
for males and females, respectively.  NCEA recommended an overall unit
risk for both males and females of 4x10-3(mg/m3)-1 based on inhalation
exposure.  This unit risk should not be used with exposures exceeding
the point of departure (23mg/m3), because above this level the fitted
dose-response model better characterizes what is known about
para-dichlorobenzene inhalation carcinogenicity.  In addition to the
slope factors, the draft IRIS document provided Bench Mark Concentration
Doses at which a 10% response for liver tumors was seen in the mice (BMC
10) and its 95% lower bound (BMCL 10) based on inhalation exposures. 
The (BMC 10) and (BMCL 10) for hepatocellular adenoma or carcinoma in
female mice were 41.3 mg/m3 and 22.9 mg/m3, respectively.

            Cancer risk estimates resulting from exposures to
para-dichlorobenzene were calculated for homeowners handling mothballs
and individuals living in homes treated with mothballs and inhaling
mothball vapors.  A Lifetime Average Daily Dose (LADD) was calculated
and then multiplied by a slope factor of 4x10-3(mg/m3)-1, which was
calculated by NCEA based on dose response data for hepatic tumors in
male and female mice exposed to para-dichlorobenzene via inhalation. 
The estimates of cancer risk are based on the assumption of low dose
linearity and range from 7.1 x 10-9 for dermal exposure during the
application of mothballs to 6.0 x 10-5 for post-application inhalation
exposure to mothballs.

	For the estimation of cancer risk for dermal exposures of homeowners
handling mothballs, dermal exposures were compared to inhalation
endpoints.  Cancer risks were assessed for dermal exposures using an
inhalation endpoint, since systemic effects (liver tumors) were noted in
the inhalation studies for para-dichlorobenzene.  The slope factor is
based on these systemic effects.  If the toxic effects after inhalation
exposures were localized (nose only) and not systemic, it would not be
appropriate to include a cancer risk for dermal exposures that relied
upon a toxic endpoint for localized effects resulting from inhalation
exposures.  

Residential Handler Cancer Risk

	For the residential handler cancer risk estimate, a highly conservative
assumption that adult individuals are exposed annually for 50 years out
of a 70 year lifetime was used. In addition, the cancer risk estimates
are conservative because the LADD calculated for dermal exposures do not
include a dermal absorption factor; instead, 100% dermal absorption has
been assumed. 

	Estimated cancer risks for dermal exposures of adults handling
mothballs during application are below 1 x 10-6 using the linear
approach and, therefore, are below the Agency’s levels of concern. 
The cancer risks for dermal exposures of handlers are presented below in
Table 4.

Table 4.  Para-dichlorobenzene Cancer Risks for Adults During Mothball
Application (Dermal Exposures)

Application Method	

Exposed Individual	

Location	Dermal Average Daily Dose (mg/kg/day)	

LADD (mg/kg/day)	

Cancer Risk 

Hand	Adult	Closet	0.0091	3.55 x 10-5	4.9 x 10-8

Drawer	0.00134	5.20 x 10-6	7.1 x 10-9

			            b.  Residential Post-Application Cancer Risk

	        Estimated para-dichlorobenzene cancer risks for
post-application inhalation exposures are presented below in Table 5.

Table 5.  Para-dichlorobenzene Post Application Cancer Risk Assessment
for Inhalation Exposures

Exposed Individual	Inhalation Average Daily Dose (ug/m3)	LADD (ug/m3)
Cancer Risk

Adult	21	15	6.0 x 10-5

	Using linear low dose extrapolation and a slope factor of 4.0x10-3
(mg/m3)-1, the cancer risk estimates could be as high as 6 x 10-5.  For
the residential post-application cancer risk estimate, a highly
conservative assumption that homeowners are exposed annually for 50
years out of a 70 year lifetime was used.  

The linear low dose extrapolation model provides a range of cancer
risks.  As with all linear low dose extrapolation models, the range is
bracketed by an upper bound and a lower bound on these risks.  The 6 x
10-5 cancer risk estimate represents an upper bound on cancer risk for
exposures to para-dichlorobenzene, but the cancer risk could be as low
as zero.  This is independent of the strengths and weaknesses of the
cancer data.  OPP believes that the carcinogenic risks are below the
upper bound and may be closer to zero for para-dichlorobenzene for
several reasons.  In addition to the inherent uncertainty in the linear
low dose extrapolation model estimates discussed above, as described in
Section 2: Carcinogenicity of Para-dichlorobenzene, available evidence
indicates that the mechanism leading to tumor formation in the livers of
mice after exposure to para-dichlorobenzene is based on sustained
mitogenic stimulation and proliferation of hepatocytes.  This
information forms the basis of a plausible mode of action for
tumorigenesis in the mice livers.  In addition, the BMCL10 (the lower
limit of the benchmark concentration central estimate for a 10% response
above background.  Note:  a 10% response is at the limit of sensitivity
in most cancer bioassays) for hepatocellular adenoma or carcinoma
formation in female mice is 22.9 mg/m3.  If the BMCL10 is compared to
the measured concentrations of para-dichlorobenzene in people’s homes
(0.021 mg/ m3), the   BMCL10 is 1000 times higher than actual exposures.
 That is, there is a 1000-fold margin of safety between the
concentration at which there is a 10% tumor response in test animals, at
the lowest measurable incidence, and actual measured exposure in
people’s homes.  Consequently, OPP believes the carcinogenic risk from
this use is not of concern for the following reasons: 1) there is
mechanistic data to support a lower cancer risk estimate based on a
mitogenic mode of carcinogenic action, 2) conservatisms in the exposure
estimates, and 3) a large margin of safety between estimated human
exposure and the point at which there is a measurable (10%) tumor
response.

7.  Aggregate Risk

           Since para-dichlorobenzene does not have outdoor uses
registered, which could result in drinking water exposure, or any food
uses, which could result in dietary exposure, a dietary risk assessment
was not conducted.  Similarly, because dietary risk is not expected, an
aggregate assessment combining residential, food, and drinking water
exposure was not conducted.  The Agency did not aggregate adult dermal
exposures while handling para-dichlorobenzene products with inhalation
post-application exposures, because there were no dermal effects noted
at the highest dose tested (HDT).  

				 8.  Occupational Risk 

           The only occupational use of para-dichlorobenzene arises from
use in empty beehives.  Exposure from this activity is expected to be
no higher than the handler (dermal) and post-application (inhalation)
exposures from the indoor residential use of mothballs which were
assessed.  Risk estimates for residential handler and post-application
exposures are protective of this occupational use and below levels of
concern. As a result, a separate risk assessment for occupational
exposures (handler and post-application) was not conducted for
para-dichlorobenzene.

	            9.  Human Incident Data

	In evaluating incidents to humans, the Agency reviewed reports from the
National Poison Control Centers (PCC), the Agency’s Office of
Pesticide Program’s Incident Data System (IDS), the California
Pesticide Illness Surveillance Program, National Pesticide Information
Center, and the National Institute for Occupational Safety and
Health’s (NIOSH) Sentinel Event Notification System for Occupational
Risk (SENSOR) program.

	The summary findings for the period 1993 to 2005 for
para-dichlorobenzene, primarily from PCC data are:

The proportion of symptomatic cases among those exposed in all
population groups evaluated (occupation, non-occupational, children)
were not significantly different from the overall, national composite
average.  Specifically, the proportion of symptoms among those followed
and the proportion hospitalizations among those seen at a health care
facility (HCF) is lower than the composite of all chemicals.  

Among children under the age of six, there were 3165 exposure cases to
para-dichlorobenzene while the entire population (all ages) of exposure
cases to para-dichlorobenzene has 4480; children represent the largest
portion of the total exposed in the population (70.6%). 

There was an average of about 344 exposures per year, 33 symptomatic
cases per year, and 38 cases per year seen in a heath care facility
(HCF) across all population groups. 

An irregular decreasing annual trend is evident in the 12 year-span of
data collected; the number of total exposed cases was reduced by half in
this period.

	B.  Environmental Risk Assessment

	Since there are no outdoor uses of para-dichlorobenzene, and indoor
uses of para-dichlorobenzene are not expected to result in ecological
exposure, an ecological risk assessment was not completed, as is
described in the Para-dichlorobenzene: EFED Memorandum in Support of the
Reregistration Eligibility Decision, dated May 8, 2007.  This
determination is confirmed in the Para-dichlorobenzene: Addendum to
EFED’s Memorandum in Support of the Reregistration Eligibility
Decision, dated September 28, 2007, which states that
para-dichlorobenzene is used for control of wax moths in empty beehives
(EPA Reg. No. 61617-2), but is not an outdoor use.  Label directions
instruct users to apply at a maximum rate of 0.19 lbs a.i. for hives in
storage.  Users are instructed to air out hives before reuse, because
residual para-dichlorobenzene would harm bees in a hive.  In addition,
para-dichlorobenzene must not be present in populated hives, because the
odor of para-dichlorobenzene could be absorbed by the honey, and
para-dichlorobenzene has no food tolerances.  

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
para-dichlorobenzene as active ingredients.  The Agency has completed
its review of these generic data, and has determined that the data are
sufficient to support reregistration of all products containing
para-dichlorobenzene.	

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

	Based on its evaluation of para-dichlorobenzene, the Agency has
determined that products containing para-dichlorobenzene, 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
para-dichlorobenzene.  If all changes outlined in this document are
incorporated into the product labels, then all current risks for
para-dichlorobenzene will be adequately mitigated for the purposes of
this determination under FIFRA.  

	

	B.  Public Comment Period

	Because the risks associated with the use of para-dichlorobenzene were
considered to be low, the Agency determined an expedited one phase RED
process was appropriate for para-dichlorobenzene, and a 60-day public
comment period was conducted with the publication of the
para-dichlorobenzene RED in December, 2007.   The comments received
primarily concerned the episodic ingestion risk estimates.  The Agency,
in response, revisited the acute oral endpoint selection and agreed that
there were no effects attributable to a single dose, and revised the
human health risk assessment and the RED accordingly.  The original and
revised risk assessments and REDs are available to the public through
EPA’s electronic public docket and comment system, Regulations.gov,
under docket identification (ID) number EPA-HQ-OPP-2007-0937.  In
addition, the para-dichlorobenzene RED document may be downloaded or
viewed through the Agency’s website at     HYPERLINK
"http://www.epa.gov/pesticides/reregistration/status.htm." 
http://www.epa.gov/pesticides/reregistration/status.htm. 

	C.  Regulatory Position

		1.  Regulatory Rationale

			

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

Residential Non-Cancer Risk

	For non-cancer residential risk, the MOEs for all handler scenarios
assessed were greater than 100 (i.e. were below the Agency’s LOC), and
therefore, no mitigation measures are required.  

	Residential post-application non-cancer risk (inhalation) was also
assessed.  The MOEs for all durations of post-application inhalation
exposure were greater than 30, i.e., the Agency’s LOC, and therefore,
no mitigation measures are required. 

Residential Cancer Risk

	Cancer risk estimates resulting from exposures to para-dichlorobenzene
were calculated for homeowners handling mothballs (dermal), and
individuals living in homes treated with mothballs and inhaling mothball
vapors using a linear low dose extrapolation model.  

 

	Estimated cancer risks for dermal exposures of adults handling
mothballs during application are below 1 x 10-6 using the linear
approach and, therefore, are below the Agency’s level of concern. 

	For the residential post-application inhalation risk estimate, OPP
determined that carcinogenic risk is also not of concern.  See Section
III of this document for a discussion of residential post-application
cancer risk.

Occupational Risk

	The only occupational use of para-dichlorobenzene arises from use in
empty beehives.  Exposure from this activity is expected to be no
higher than the handler (dermal) and post-application (inhalation)
exposures from the indoor residential use of mothballs which were
assessed.  Risk estimates for residential handler and post-application
exposures are protective of this occupational use and below levels of
concern. As a result, a separate risk assessment for occupational
exposures (handler and post-application) was not conducted for
para-dichlorobenzene.

Endocrine Disruptor Effects 

 tc ".	Endocrine Disruptor Effects " \l 4 

EPA is required under the FFDCA, as amended by FQPA, to develop a
screening program to determine whether certain substances (including all
pesticide active and other ingredients) “may have an effect in humans
that is similar to an effect produced by a naturally occurring estrogen,
or other such endocrine effects as the Administrator may designate.” 
Following the recommendations of its Endocrine Disruptor Screening and
Testing Advisory Committee (EDSTAC), EPA determined that there were
scientific bases for including, as part of the program, androgen and
thyroid hormone systems, in addition to the estrogen hormone system. 
EPA also adopted EDSTAC’s recommendation that the Program include
evaluations of potential effects in wildlife.  When the appropriate
screening and/or testing protocols being considered under the Agency’s
Endocrine Disrupter Screening Program (EDSP) have been developed and
vetted, para-dichlorobenzene may be subjected to additional screening
and/or testing to better characterize effects related to 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  The Agency has reviewed the registrations and
other information for para-dichlorobenzene and concludes that this
insecticide does not pose a risk of direct acute or chronic effects to
any species listed under the Endangered Species Act, since the
registered uses for para-dichlorobenzene will not result in outdoor
exposure to endangered species.

 tc "E.	Regulatory Rationale " \l 2 

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

	In order to be eligible for reregistration, various use and safety
information will be included in the labeling of all end-use products
containing para-dichlorobenzene.  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 para-dichlorobenzene
are eligible for reregistration provided that the required label
amendments are made.  The Agency intends to issue Data Call-In Notices
(DCIs) requiring product-specific data.  Generally, registrants will
have 90 days from receipt of a DCI to complete and submit response forms
or request time extension and/or waiver requests with a full written
justification.  For product-specific data, the registrant will have
eight months to submit data.  Below are the label amendments that the
Agency intends to require for para-dichlorobenzene 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
para-dichlorobenzene for currently registered uses has been reviewed and
determined to be substantially complete.  However, the Agency is
requiring a confirmatory chamber study (875.2500) to determine levels of
para-dichlorobenzene 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 prior to the inception of the study. 

		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 6.

	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 703-308-8585. 

		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 6.  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 para-dichlorobenzene to be eligible for reregistration, all
para-dichlorobenzene labels must be amended to incorporate the risk
mitigation measures outlined in Section IV.  Table 6 describes how
language on the labels should be amended.

Table 6.  Summary of Labeling Changes for Para-dichlorobenzene

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].”	Directions for
use

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

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

Environmental Hazards Statements 	“ENVIRONMENTAL HAZARDS”

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

End-Use Products Intended for Occupational Use 

PPE Requirements Established by the RED

For All Formulations	“Personal Protective Equipment (PPE)”

“All applicators and other handlers must wear:

- Long sleeved shirt,

- Long pants,

- Shoes plus socks.”	Immediately following/below 

Precautionary Statements:  Hazards to Humans and Domestic Animals

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

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

	Precautionary Statements:  Hazards to Humans and Domestic Animals
immediately following the PPE requirements

User Safety Recommendations

	“User Safety Recommendations”

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

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

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

(Must be placed in a box.)

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

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

End-Use Products Intended for Residential Use

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

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

Appendix A.  Use Patterns Eligible for Reregistration for
Para-dichlorobenzene

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

Beehives- Empty	Crystalline	N/S1	0.1875	lb/hive	NS

Birds	Crystalline	N/S	0.0313	lb/cage	NS

Household/Domestic Dwellings Contents	Crystalline	Balls, Flakes,
Crystals, Cakes, and Sachets	0.02	lb/ft3	7

Household/Domestic Dwellings Contents	Crystalline	Block	0.0249	lb/ft3	7

Household/Domestic Dwellings Indoor Nonfood Handling Areas	Impregnated
Material	Varpel Rope	9.86	ft/1000 ft3	NS

Human Clothing	Crystalline	Balls, Flakes, Crystals, Cakes, and Sachets
0.02	lb/ft3	7

1.  Not specified.

2.  Para-dichlorobenzene has neither reentry interval restrictions nor
restrictions on the maximum number of application per year.

Appendix B

GUIDE TO APPENDIX B

Appendix B contains listings of data requirements which support the
reregistration for active ingredients within the case 3058 covered by
this Reregistration Eligibility Decision Document.  It contains generic
data requirements that apply to 3058 in all products, including data
requirements for which a "typical formulation" is the test substance.

									

	The data table is organized in the following format:

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

	2.  Use Pattern (Column 2).  This column indicates the use patterns for
which the data requirements apply.  The following letter designations
are used for the given use patterns:

				A	Terrestrial food

				B	Terrestrial feed

				C	Terrestrial non-food

				D	Aquatic food

				E	Aquatic non-food outdoor

				F	Aquatic non-food industrial

				G	Aquatic non-food residential

				H	Greenhouse food

				I	Greenhouse non-food

				J	Forestry

				K	Residential

				L	Indoor food

				M	Indoor non-food

				N	Indoor medical

				O	Indoor residential

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

Appendix B

Data Supporting Guideline Requirements for the Reregistration of 

Para-dichlorobenzene

REQUIREMENT	Use Pattern	CITATION(S)

PRODUCT CHEMISTRY

New Guideline Number	Study Description

830.1600	Description of Materials Used to Produce the Product	M	46460601

830.1620	Description of Production Process	M	46285301; 46460601

830.1670	Formation of Impurities	M	46285301; 46460601

830.1700	Preliminary Analysis	M	46285301

830.1800	Analytical Method	M	46285301                        

830.6302	Color	M	46285301

830.6303	Physical State	M	46285301

830.6304	Odor	M	46285301

830.6315	Flammability	M	46285301

830.6317	Storage Stability	M	46285301

830.6320	Corrosion Characteristics	M	46285301

830.7000	pH	M	46285301

830.7050	UV/Visible Absorption	M	Data Gap

830.7200	Melting Point	M	46285301

830.7220	Boiling Point/Boiling Range	M	46285301

830.7300	Density	M	46285301

830.7840	Water Solubility	M	46285301

830.7950	Vapor Pressure	M	46285301

TOXICOLOGY

870.1100	Acute Oral Toxicity – Rat	M	40521001

870.1200	Acute Dermal Toxicity – Rabbit	M	40521001 

870.1300	Acute Inhalation – Rat	M	41410901

870.2400	Acute Eye Irritation – Rabbit	M	42205301

870.2500	Acute Dermal Irritation -  Rabbit	M	42205302

870.2600	Skin Sensitization – Guinea Pig	M	42205303

870.3150	90-Day Oral Toxicity- Dog	M	43988801

870.3200	21-Day Dermal Toxicity – Rat	M	41315001

870.3465	90-Day Inhalation Toxicity – Dog	M	41822801

870.3700	Prenatal Developmental Toxicity 	M	42619601 (Rat); 40568001
(Rabbit)

870.3800	Reproduction and Fertility Effects – Rat	M	41108801

830.4100	Chronic Toxicity – Dog	M	43988802

870.4300	Combined Chronic Feeding/ Carcinogenicity	M	40521005 (Rat);
40521005 (Mouse)

870.5100	Bacterial Reverse Mutation 	M	40521004; 40568002; 40568003 

870.5275	Sex-linked Recessive Lethal Test in Drosophila Melanogaster	M
40521007

870.5300	Cytogenetics- Mouse Lymphoma Mutagenic Assay	M	40521007;
40521013; 40521014

870.5375	Cytogenetics – Sister Chromatid Exchange In CHO cells. 	M
43368448; 43868210; 40521007

870.5395	In Vitro Mammalian Cytogenetics Tests	M	43368447; 40521012

870.5450	Rodent Dominant Lethal Assay	M	40521011

870.5550	Unscheduled DNA Synthesis in Mammalian Cells in Culture	M
40521008

870.5900	In Vitro Sister Chromatid Exchange Assay	M	40521007

870.6200 	Acute Neurotoxicity Screening Battery	M	43350601

870.6200 	Subchronic Neurotoxicity Screening Battery – Rat	M	43350602

870.7485	General Metabolism	M	41697801

OCCUPATIONAL/RESIDENTIAL EXPOSURE

875.2400	Dermal Exposure	M	43716501

875.2500	Inhalation Exposure	M	Data Gap

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
para-dichlorobenzene are available in the Public Docket, under docket
number EPA-HQ-OPP-2007-0937, 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 December, 2007.  

	Technical support documents for the Para-dichlorobenzene RED include
the following:

Health Effects Documents

1.  Para-dichlorobenzene: Occupational and Residential Exposure
Assessment and Recommendations for the Reregistration Eligibility
Decision (RED), dated September 28, 2007.

      2.  HED Chapter of the Reregistration Eligibility Decision
Document (RED) for Para-dichlorobenzene;  Revised Version, dated April
1, 2008.

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

		

Ecological Fate and Effects Documents

      1.  Para-dichlorobenzene: EFED Memorandum in Support of the
Reregistration Eligibility Decision, dated May 8, 2007.  

      2.  Para-dichlorobenzene: Addendum to EFED’s Memorandum in
Support of the Reregistration Eligibility Decision, dated September 28,
2007.

	

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.

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) Standard Chlorine Chem Co Phase 3 Summary of MRID 40521009. Evaluation
of the Potential of p-Dichlorobenzene to Induce Unscheduled DNA
Synthesis or DNA Replication in the in vivo-in vitro Rat Kidney DNA
Repair Assay: Project No. LSC-2603. Prepared by SRI International. 13 p.

93085999	Standard Chlorine Chem Co (1990) Reregistration Phase 3
Response: Paradichlorobenzene. Correspondence and Supporting Material. 

 PAGE   

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