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<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 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<PHONE_NUMBER>.

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

 PAGE

  PAGE  vi

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[Federal Register: June 2, 2010 (Volume 75, Number 105)]
[Rules and Regulations]
[Page 30706-30708]
[DOCID:fr02jn10-8]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2010-0158]
RIN 1625-AA00

Safety Zone; Wilson Bay, Jacksonville, NC

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

-----------------------------------------------------------------------

SUMMARY: The Coast Guard is establishing a temporary safety zone on the
waters of Wilson Bay at Jacksonville, North Carolina for training
purposes. The safety zone is necessary to provide for the safety of the
general public and exercise participants from potential hazards
associated with low flying helicopters and vessels participating in
this multi agency exercise.

DATES: This rule is effective from 6 a.m. until 5 p.m. on June 9, 2010.

ADDRESSES: Comments and material received from the public, as well as
documents mentioned in this preamble as being available in the docket,
are part of docket USCG-2010-0158 and are available online by going to
http://www.regulations.gov, inserting USCG-2010-0158 in the ``Keyword''
box, and then clicking ``Search.'' This material is also available for
inspection or copying at the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or e-mail CWO4 Stephen Lyons, Waterways Management
Division Chief, Coast Guard Sector North Carolina; telephone (252) 247-
4525, e-mail<EMAIL_ADDRESS>If you have questions on
viewing the docket, call Renee V. Wright, Program Manager, Docket
Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    On April 2, 2010, we published a notice of proposed rulemaking
(NPRM) entitled Safety Zone: Wilson Bay, Jacksonville, NC in the
Federal Register (75 FR 16703). We received no comments on the proposed
rule. No public meeting was requested, and none was held.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Due to the need for immediate
action, the restriction of vessel traffic is necessary to protect life,
property and the environment; therefore, a 30-day notice is
impracticable. Delaying the effective date would be contrary to the
safety zone's intended objectives of protecting persons and vessels
involved in the event, and enhancing public and maritime safety.

Basis and Purpose

    The Onslow County North Carolina Emergency Services will be
conducting a multi agency exercise to test response capabilities of
water rescue services in a mass casualty scenario on the waters of
Wilson Bay, Onslow County, North Carolina from 6 a.m. to 5 p.m. June 9,
2010. The exercise is designed to train and test air and surface
personnel in the judgmental decisionmaking process necessary to safely
and effectively respond to a mass casualty incident. The exercise will
involve helicopters, vessels, safety craft, divers, and rescue
swimmers. This zone is necessary to establish a temporary restricted
area in Wilson Bay to ensure the safety of participants within the
exercise site.

Discussion of Comments and Changes

    We received no comments on the proposed rule. No public meeting was
requested, and none was held. The Coast Guard is implementing the rule
as proposed, without change.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order.
    Although this regulation will restrict access to the area, the
effect of this rule will not be significant because: (i) The safety
zone will only be in effect from 6 a.m. to 5 p.m. on June 9, 2010, (ii)
the Coast Guard will give advance notification via maritime advisories
so mariners can adjust their plans accordingly, and (iii) although the
safety zone will apply to a section of Wilson Bay, it will not restrict
vessel traffic in the federally marked channel.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and

governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed
rule would not have a significant economic impact on a substantial
number of small entities.
    This rule will affect the following entities, some of which may be
small entities: The owners or operators of recreational and fishing
vessels intending to transit the specified portion of Wilson Bay from 6
a.m. to 5 p.m. on June 9, 2010.
    This safety zone will not have a significant economic impact on a
substantial number of small entities for the following reasons. This
rule will only be in effect from 6 a.m. to 5 p.m. on June 9, 2010.
Although the safety zone will apply to the section of Wilson Bay, it
will not restrict vessel traffic in the federally marked channel.
Before the effective period, the Coast Guard will issue maritime
advisories widely available to the users of the waterway.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), in the NPRM we offered to
assist small entities in understanding the rule so that they could
better evaluate its effects on them and participate in the rulemaking
process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this rule under
that Order and have determined that it does not have implications for
federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule is categorically excluded, under figure 2-1, paragraph (34)(g), of
the Instruction. This rule establishes a temporary safety zone to
protect the general public and exercise participants from potential
hazards associated with low flying helicopters and vessels
participating in this multi agency exercise. An environmental analysis
checklist and a categorical exclusion determination are available in
the docket where indicated under ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6 and 160.5;
Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1

0
2. Add Sec.  165.T05-0158 to read as follows:

Sec.  165.T05-0158  Safety Zone; Wilson Bay, Jacksonville, NC.

    (a) Definitions. For the purposes of this section, Captain of the
Port means the Commander, Sector North Carolina. Representative means
any Coast Guard commissioned, warrant, or petty officer who has been
authorized to act on the behalf of the Captain of the Port.
    (b) Location. The following area is a safety zone: The safety zone
is established for the navigable waters, from the surface to the
seafloor, defined by enclosing an area south of a line drawn from New
River Channel Daybeacon 61 (34[deg]44'30'' N/077[deg]26'20'' W) to the
north tip of Ethridge Point (34[deg]44'37'' N/077[deg]26'06'' W) and
extending \1/2\ nautical mile south from the boundary line.
    (c) Regulations. (1) The general regulations contained in Sec.
165.23 of this part apply to the area described in paragraph (b) of
this section.
    (2) Persons or vessels requiring entry into or passage through any
portion of the safety zone must first request authorization from the
Captain of the Port, or a designated representative, unless the Captain
of the Port previously announced via Marine Safety Radio Broadcast on
VHF Marine Band Radio channel 22 (157.1 MHz) that this regulation will
not be enforced in that portion of the safety zone. The Captain of the
Port can be contacted at telephone number<PHONE_NUMBER> or by radio on
VHF Marine Band Radio, channels 13 and 16.
    (d) Enforcement. The U.S. Coast Guard may be assisted in the patrol
and enforcement of the zone by Federal, State, and local agencies.
    (e) Enforcement period. This section will be enforced from 6 a.m.
to 5 p.m. on June 9, 2010 unless cancelled earlier by the Captain of
the Port.

    Dated: May 17, 2010.
A. Popiel,
Captain, U.S. Coast Guard, Captain of the Port North Carolina.
[FR Doc. 2010-13116 Filed 6-1-10; 8:45 am]
BILLING CODE 9110-04-P