United States			Office of Prevention, Pesticides	EPA 739-RO-8009

  		Environmental Protection 		And Toxic Substances		September 2008

			Agency				(7510P)

			_________________________________________________________________

  SEQ CHAPTER \h \r 1 Reregistration Eligibility    Decision for
Triclosan

List B

Case No. 2340  SEQ CHAPTER \h \r 1

Reregistration Eligibility Decision (RED) Document

for

Triclosan

Approved by:	                                     .

	Frank T. Sanders

	Director

Antimicrobials Division

Date:	                                     .

	September 18, 2008

TABLE OF CONTENTS

  TOC \o "1-3" \h \z \u    HYPERLINK \l "_Toc202226944"  ABSTRACT
PAGEREF _Toc202226944 \h  7

  HYPERLINK \l "_Toc202226945"  I.	Introduction	  PAGEREF _Toc202226945
\h  8

  HYPERLINK \l "_Toc202226946"  II.	Chemical Overview	9

  HYPERLINK \l "_Toc202226947"  A.	Regulatory History	9

  HYPERLINK \l "_Toc202226948"  B.	Chemical Identification	9

  HYPERLINK \l "_Toc202226948"  C.	Use and Usage	11

  HYPERLINK \l "_Toc202226949"  III.	Summary of Triclosan Risk
Assessments	  PAGEREF _Toc202226949 \h  12

  HYPERLINK \l "_Toc202226950"  A.	Human Health Risk Assessment
PAGEREF _Toc202226950 \h  12

  HYPERLINK \l "_Toc202226951"     HYPERLINK \l "_Toc202226952"  1.
Toxicity Profile	  PAGEREF _Toc202226952 \h  12

  HYPERLINK \l "_Toc202226953"  2.	Dietary Exposure and Risk from Food
and Drinking Water	  PAGEREF _Toc202226953 \h  15

  HYPERLINK \l "_Toc202226954"  3.	Residential Exposure and Risk
PAGEREF _Toc202226954 \h  17

  HYPERLINK \l "_Toc202226955"  4.	Aggregate Exposure and Risk	  PAGEREF
_Toc202226955 \h  23

  HYPERLINK \l "_Toc202226956"  5.	Occupational Exposure and Risk	26

  HYPERLINK \l "_Toc202226957"  6.	Incident Reports	  PAGEREF
_Toc202226957 \h  27

  HYPERLINK \l "_Toc202226958"  B.	Environmental Fate and Ecological
Hazard Assessment	28

  HYPERLINK \l "_Toc202226959"  1.	Environmental Fate	  PAGEREF
_Toc202226959 \h  28

  HYPERLINK \l "_Toc202226960"  2.	Ecological Hazard	  PAGEREF
_Toc202226960 \h  29

  HYPERLINK \l "_Toc202226961"  3.	Risk to Listed Species	  PAGEREF
_Toc202226961 \h  32

  HYPERLINK \l "_Toc202226962"  IV.	Reregistration and Risk Management
Decisions	  PAGEREF _Toc202226962 \h  34

  HYPERLINK \l "_Toc202226963"  A.	Determination of Reregistration
Eligibility	  PAGEREF _Toc202226963 \h  34

  HYPERLINK \l "_Toc202226964"  1.	Reregistration Eligibility Decision
PAGEREF _Toc202226964 \h  34

  HYPERLINK \l "_Toc202226965"  2.	Regulatory Rationale	  PAGEREF
_Toc202226965 \h  36

  HYPERLINK \l "_Toc202226966"  B.	Risk Management Decision	  PAGEREF
_Toc202226966 \h  39

  HYPERLINK \l "_Toc202226967"  1.	Risk Mitigation Measures	  PAGEREF
_Toc202226967 \h  39

  HYPERLINK \l "_Toc202226968"  2.	Product Label Amendments	  PAGEREF
_Toc202226968 \h  40

  3.     Antimicrobial
Resistance..............................................................
.......................	..40

  4.     Post-Red
Activities..............................................................
...................................41

  HYPERLINK \l "_Toc202226969"  V.	What Registrants Need to Do	  PAGEREF
_Toc202226969 \h  42

  HYPERLINK \l "_Toc202226970"  A.	Manufacturing Use Products	  PAGEREF
_Toc202226970 \h  42

  HYPERLINK \l "_Toc202226971"  1.	Generic Data Requirements	  PAGEREF
_Toc202226971 \h  42

  HYPERLINK \l "_Toc202226972"  B.	End-Use Products	  PAGEREF
_Toc202226972 \h  45

  HYPERLINK \l "_Toc202226973"  1.	Product Specific Data Requirements
PAGEREF _Toc202226973 \h  45

  HYPERLINK \l "_Toc202226974"  2.	Labeling for End-Use Products
PAGEREF _Toc202226974 \h  46   Triclosan Reregistration Team

Office of Pesticide Programs:

Environmental Fate and Effects Risk Assessment

Genevieve Angle

Srinivas Gowda

Patricia Jennings

Rick Petrie

Health Effects Risk Assessment

Jonathan Chen

Vicki Dellarco

Timothy Leighton

Tim McMahon

A. Najm Shamim

Risk Management

Heather Garvie

Diane Isbell

Office of General Counsel

Philip Ross

Glossary of Terms and Abbreviations  TC "Glossary of Terms and
Abbreviations" \f C \l "1"

AGDCI	Agricultural Data Call-In

ai			Active Ingredient

aPAD			Acute Population Adjusted Dose

AR			Anticipated Residue

BCF			Bioconcentration Factor

CFR			Code of Federal Regulations

cPAD			Chronic Population Adjusted Dose

CSF			Confidential Statement of Formula

CSFII			USDA Continuing Surveys for Food Intake by Individuals

DCI			Data Call-In

DEEM			Dietary Exposure Evaluation Model

DFR			Dislodgeable Foliar Residue

EC			Emulsifiable Concentrate Formulation

EDWC			Estimated Drinking Water Concentration

EEC			Estimated Environmental Concentration

EPA			Environmental Protection Agency

EXAMS		Exposure Analysis Modeling System

EUP			End-Use Product

FCID			Food Commodity Intake Database

FDA			Food and Drug Administration

FIFRA			Federal Insecticide, Fungicide, and Rodenticide Act

FFDCA	Federal Food, Drug, and Cosmetic Act

FQPA			Food Quality Protection Act

FOB			Functional Observation Battery

G			Granular Formulation

GENEEC		Tier I Surface Water Computer Model

GLN			Guideline Number

HAFT			Highest Average Field Trial

IR			Index Reservoir

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

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

LOC			Level of Concern

LOD			Limit of Detection

LOAEL	Lowest Observed Adverse Effect Level

µg/g			Micrograms Per Gram

µg/L			Micrograms Per Liter

mg/kg/day		Milligram Per Kilogram Per Day

mg/L			Milligrams Per Liter

MOE			Margin of Exposure

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

MUP			Manufacturing-Use Product

NA			Not Applicable

NAWQA		USGS National Water Quality Assessment

NPDES	National Pollutant Discharge Elimination System

NR			Not Required

NOAEL	No Observed Adverse Effect Level

OP			Organophosphate

OPP			EPA Office of Pesticide Programs

OPPTS		EPA Office of Prevention, Pesticides and Toxic Substances

PAD			Population Adjusted Dose

PCA			Percent Crop Area

PDP			USDA Pesticide Data Program

PHED			Pesticide Handler's Exposure Data

PHI			Preharvest Interval

ppb			Parts Per Billion

PPE			Personal Protective Equipment

ppm			Parts Per Million

PRZM/EXAMS	Tier II Surface Water Computer Model

Q1*			The Carcinogenic Potential of a Compound, Quantified by EPA's
Cancer Risk Model

RAC			Raw Agriculture Commodity

RED			Reregistration Eligibility Decision

REI			Restricted Entry Interval

RfD			Reference Dose

RQ			Risk Quotient

SCI-GROW		Tier I Ground Water Computer Model

SAP			Science Advisory Panel

SF			Safety Factor

SLC			Single Layer Clothing

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

TGAI			Technical Grade Active Ingredient

TRR			Total Radioactive Residue

USDA			United States Department of Agriculture

USGS			United States Geological Survey

UF			Uncertainty Factor

UV			Ultraviolet

WPS			Worker Protection Standard

ABSTRACT

	The Environmental Protection Agency (EPA or the Agency) has completed
the human health and environmental risk assessments for
5-Chloro-2-(2,4-dichlorophenoxy)phenol (triclosan) and is issuing its
reregistration eligibility and risk management decisions.  The risk
assessments, which are summarized in this document, are based on review
of registrant-submitted data supporting the use patterns of currently
registered products, citations from the open literature, and additional
information received through the public docket.  The risk assessments
have been revised, as needed, according to information received since
they were first made available to the public in May 2008.  After
considering the risk assessments and risk mitigation options, the Agency
developed its reregistration eligibility and risk management decisions
for uses of triclosan.  As a result of this review, EPA has determined
that all uses of triclosan are eligible for reregistration, with the
exception of the paint use, provided that the risk mitigation and data
requirements outlined in this document are fully implemented.  The
reregistration eligibility decision is discussed fully in this document.
 The Agency is aware that research is ongoing regarding triclosan.  The
outcomes of this further research may require the Agency to revisit this
decision in the future. Further, given the rapidly developing scientific
database for triclosan, the Agency intends to accelerate the schedule
for the registration review process for this chemical.  Currently, the
Agency intends to begin that process in 2013, ten years earlier than
originally planned.

  SEQ CHAPTER \h \r 1 Introduction

	This document is the Environmental Protection Agency’s (EPA or “the
Agency”) Reregistration Eligibility Decision (RED) for all currently
registered uses of 5-Chloro-2-(2,4-dichlorophenoxy)phenol (triclosan).
This document also summarizes the human health and environmental
exposure and associated risks used to make the reregistration
eligibility decision.

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, and amended again by
the Food Quality Protection Act of 1996 (FQPA) and the Pesticide
Registration Improvement Act of 2003 (PRIA) to set time frames for the
issuance of Reregistration Eligibility Decisions.  FIFRA calls for the
development and submission of data to support the reregistration of an
active ingredient, as well as a review of all data submitted to the U.S.
Environmental Protection Agency (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 hazards arising from the currently
registered uses of a 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" criteria
of FIFRA.

The Agency made its reregistration eligibility decision for triclosan
based on the required data, the current guidelines for conducting
acceptable studies to generate such data, and published scientific
literature.  The Agency has found that currently registered uses of
triclosan, with the exception of the use as a materials preservative in
paint (which has been requested to be voluntarily cancelled by the
registrants), are eligible for reregistration provided the conditions
and requirements for reregistration identified in this reregistration
eligibility decision (RED) are implemented.

This document consists of six sections: Section I contains the
regulatory framework for reregistration reassessment; Section II
provides an overview of the chemical, including a profile of its use and
usage; Section III gives an overview of the human health and ecological
risk assessments; Section IV presents the Agency’s reregistration
eligibility and risk management decisions; Section V summarizes label
changes necessary to implement the risk mitigation measures outlined in
Section IV; and Section VI includes the appendices, related supporting
documents, and Data Call-In (DCI) information.  The revised risk
assessment documents and related addenda are not included in this
document, but are available in the Public Docket at   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov  under docket
number EPA-HQ-OPP-2007-0513.

  SEQ CHAPTER \h \r 1 Chemical Overview

Regulatory History

		Triclosan is regulated by both the U.S. EPA and the U.S. Food and Drug
Administration (FDA).  The EPA regulates the antimicrobial uses of
triclosan when used as a bacteriostat, fungistat, mildewstat, and
deodorizer.  EPA-registered products containing triclosan as the active
ingredient are formulated as ready-to-use, pelleted/tableted,
emulsifiable concentrate, soluble concentrate, and impregnated
materials.  Triclosan is used in commercial, institutional and
industrial premises and equipment; residential and public access
premises; and as a material preservative.  Commercial, institutional and
industrial premises and equipment uses include conveyor belts, fire
hoses, dye bath vats and ice making equipment.  As a material
preservative, triclosan is used in many products including adhesives,
fabrics, vinyl, plastics (toys, toothbrushes), polyethylene,
polyurethane, polypropylene, floor wax emulsions, textiles (footwear,
clothing), caulking compounds, sealants, rubber, and latex paints.
There are a multitude of residential and public access premises uses
including direction application to HVAC coils (limited to commercial
applicators), and use as a materials preservative in toys, paints,
mattresses, clothing, brooms, mulch, floors, shower curtains, awnings,
tents, toilet bowls, urinals, garbage cans, refuse container liners,
insulation, concrete mixtures, grouts, and upholstery fabrics. The
FDA-regulated uses include hand soaps, toothpaste, deodorants, laundry
detergent, fabric softeners, facial tissues, antiseptics for wound care,
and medical devices.

No direct food use is associated with triclosan; therefore, no tolerance
or tolerance exemption has been established.  However, dietary exposure
and risk were assessed for the indirect food uses of triclosan involving
pulp and paper use, ice-making equipment, adhesives, cutting boards,
conveyor belts, and counter top use.

Chemical Identification

Triclosan Molecular Structure:

Common Name:		2,4,4’-Trichloro-2’-hydroxydiphenyl ether

				Phenol, 5-chloro-2-(2,4-dichlorophenoxy)-

				5-Chloro-2-(2,4-dichlorophenoxy)phenol

				Irgasan DP-300R

				Irgaguard B1000

				VIV-20

OPP Chemical Codes: 	054901

CAS Registry No.:  	3380-34-5

Case Number:		2340

Molecular Formula:		C12H7Cl302

Chemical Characteristics for Technical Grade Active Triclosan:

Molecular Weight	289.541

Color	White crystals

Physical State	White crystalline powder

Specific Gravity	1.55 x 103 kg/m3 at 22˚C

Dissociation Constant	 pKa=8.14 at 20°C

pH	N/A

Stability	Stable at normal conditions

Melting Point	56.5  o  C

Boiling Point	N/A

Water Solubility	0.012 g/l at 20˚C

Octanol-Water Partition constant ( LogKOW)	4.8 at 25˚C

Vapor Pressure	5.2E-6 mm Hg at 25˚C

2.2E-6 mm Hg at 20˚C

Manufacturers: 	Ciba Corporation and Har-Met International, Inc.

Highest Percent of

Active Ingredient:		99%

Formulation Types Registered:  ready-to-use, pelleted/tableted,
emulsifiable concentrate, soluble concentrate, and impregnated materials

 Use and Usage

Triclosan was first registered by the EPA in 1969, and currently there
are 20 antimicrobial registrations.  A detailed table of the uses of
triclosan eligible for reregistration can be found in Appendix A.

Type of Pesticide:		Fungicide, Bacteriostat

Use Sites for EPA Registrations:

				Commercial, institutional and industrial premises and equipment:
conveyor belts, fire hoses, dye bath vats and ice making equipment.

				As a material preservative: adhesives, fabrics, vinyl, plastics
(toys, toothbrushes), polyethylene, polyurethane, polypropylene, floor
wax emulsions, textiles (footwear, clothing), caulking compounds,
sealants, rubber, and latex paints.

				Residential and public access premises: direction application to
HVAC coils (limited to commercial applicators), use as a materials
preservative in toys, paints, mattresses, clothing, brooms, mulch,
floors, shower curtains, awnings, tents, toilet bowls, urinals, garbage
cans, refuse container liners, insulation, concrete mixtures, grouts,
and upholstery fabrics.

Target Pests:		Bacteria, fungi

	Formulations:		EPA-registered products containing triclosan as the
active 	ingredient are formulated as ready-to-use, pelleted/tableted,
emulsifiable concentrate, soluble concentrate, and impregnated
materials.

	Application Methods:	Direct application of triclosan in a manufacturing
setting via closed system, open pour or metered pump; direct application
to HVAC coils (spray); residential and occupational handler painting
using brush or airless sprayer (using end-use product where triclosan is
used as the materials preservative)

   SEQ CHAPTER \h \r 1 Summary of Triclosan Risk Assessments

	The purpose of this section is to summarize EPA’s human health and
ecological risk conclusions for triclosan to help the reader better
understand EPA’s risk management decisions.  The human health and
ecological risk assessment documents and supporting information listed
in Appendix C were used to formulate the safety finding and regulatory
decision for triclosan. The full risk assessments and related supporting
documents are available at   HYPERLINK "http://www.regulations.gov"
http://www.regulations.gov  under docket number EPA-HQ-OPP-2007-0513.
Hard copies of these documents may be found in the OPP public docket
which is located in Room S-4400, One Potomac Yard, 2777 South Crystal
Drive, Arlington, VA, and is open Monday through Friday, excluding
Federal holidays, from 8:30 a.m.to 4:00 p.m.

	EPA developed this RED for triclosan through a modified, 4–Phase
public participation process.  The Agency uses public participation
processes to involve the public in developing pesticide reregistration
decisions. EPA released its preliminary risk assessments for 60-day
public comment in May 2008.  Comments were incorporated into the final
risk assessments which were used to make this reregistration eligibility
decision.

	The Agency is aware of recent research conducted by the Office of
Research and Development on the effects of triclosan on thyroid
homeostasis in the rat (US EPA, 2008). These data were considered in
selection of the incidental oral endpoint, but the current endpoint was
retained, as further investigation is needed on the effects of triclosan
on the thyroid.  The Agency will continue to monitor the toxicity
profile of triclosan and will amend the assessment as needed.

The Agency’s use of human studies in the triclosan 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.

Human Health Risk Assessment

EPA has conducted a human health risk assessment for triclosan to
support the reregistration eligibility decision.  EPA evaluated the
submitted toxicology, product and residue chemistry, and
occupational/residential exposure studies as well as available open
literature and determined that the data are adequate to support this
reregistration eligibility decision.  A summary of the human health risk
assessment findings and conclusions is provided below.

Toxicity Profile

The toxicological database for triclosan is adequate to support a
reregistration eligibility decision.  Major features of the toxicology
profile are presented below.  Detailed information is available in the
5-Chloro-2-(2,4-dichlorophenoxy)phenol (Triclosan): Toxicology Chapter
for the Reregistration Eligibility Decision (RED) Document, dated August
29, 2008.

Acute Toxicity Profile

	Triclosan has low acute toxicity via the oral and dermal routes
(Category IV) and moderate acute toxicity via the inhalation route
(Category II).  It is moderately irritating to the eye (Category II), is
a moderate to mild dermal irritant (Category III), and not a skin
sensitizer.  Table 1 presents the acute toxicity profile for triclosan.

Table 1.  Acute Toxicity Profile for Triclosan

Guideline Number	Study Type/

Test substance (% a.i.)	MRID Number/

Citation	Results	Toxicity Category

870.1100

(§81-1)	Acute Oral- Rat Triclosan (99.7% a.i.)	43206901	LD50: >5000
mg/kg	IV

870.1200

(§81-2)	Acute Dermal- Rabbit

Triclosan (97% a.i.)	94044 	LD50: >9300 mg/kg	IV

870.1300

(§81-3)	Acute Inhalation- Rat

Triclosan (100.5% a.i.)	42306902, 43310501	LC50: >0.15 mg/L	II

870.2400

(§81-4)	Primary Eye Irritation- Rabbit

Triclosan (97% a.i.)	 94045	moderately irritating	II

870.2500

(§81-5)	Primary Dermal Irritation- Rabbit

Triclosan (% a.i. not provided)	42306903	PII: 3.5 at 72 hours 	III

870.2600

(§81-6)	Dermal Sensitization- Guinea Pig          Triclosan (99.7%
a.i.)	43206502	Not a Sensitizer	N/A

Toxicological Endpoints

	  SEQ CHAPTER \h \r 1 The toxicological endpoints used in the human
health risk assessment are presented in Table 2.  The uncertainty and
safety factors used to account for interspecies extrapolation,
intraspecies variability, and for completeness of the database are also
presented.  The Agency is aware of recent research conducted by the
Office of Research and Development on the effects of triclosan on
thyroid homeostasis in the rat (US EPA, 2008). These data were
considered in selection of the incidental oral endpoint, but the current
endpoint was retained, as further investigation is needed on the effects
of triclosan on the thyroid.  The Agency will continue to monitor the
toxicity profile of triclosan and will amend the assessment as needed.

Table 2.  Summary of Triclosan Toxicological Endpoints

Exposure

Scenario	Dose Used in Risk Assessment	Uncertainty  factors for Risk
Assessment	Study and Toxicological Effects

Acute Dietary

(general population)	NOAEL = 30 mg/kg

 arid = 0.3 mg/kg/day	Interspecies = 10x

Intraspecies = 10x

DBSS = 1x

UF = 100	Chronic Toxicity study in Baboons

MRID 133230

LOAEL = 100 mg/kg/day, based on clinical signs of toxicity such as
vomiting, failure to eat and diarrhea

Chronic Dietary

(all populations)	NOAEL = 30 mg/kg

 crud = 0.3 mg/kg/day	Interspecies = 10x

Intraspecies = 10x

DBSS = 1x

UF = 100	Chronic Toxicity study in Baboons

MRID 133230

LOAEL = 100 mg/kg/day, based on clinical signs of toxicity such as
vomiting, failure to eat and diarrhea

Short-Term/ Intermediate-Term Incidental Oral (1-30 days; 30 days- 6
months)	NOAEL = 30 mg/kg

 	 Interspecies = 10x

Intraspecies = 10x

DBSS = 1x

UF = 100	Chronic Toxicity study in Baboons

MRID 133230

LOAEL = 100 mg/kg/day, based on clinical signs of toxicity

Dermal (short-term)	NOAEL = 0.6 mg/animal (100 µg/cm2)

	Interspecies = 3x

Intraspecies = 3x

DBSS =1x

MOE  = 10	14-day dermal toxicity study in the mouse

MRID 44389708

LOAEL = 1.5 mg/kg/day, based on treatment-related dermal irritation at
the treatment site and on increased liver weights

Dermal (intermediate term)	NOAEL = 40 mg/kg

	 Interspecies = 10x

Intraspecies = 10x

DBSS =1x

MOE  = 100	90-day Dermal Toxicity in Rats

MRID 43328001

LOAEL = 80 mg/kg/day, based on increased incidence occult blood in the
urine.

Dermal (long-term)	NOAEL = 40 mg/kg

	 Interspecies = 10x

Intraspecies = 10x

DBSS =3x (lack of chronic dermal study)

MOE  = 300	90-day Dermal Toxicity in Rats

MRID 43328001

LOAEL = 80 mg/kg/day, based on increased incidence occult blood in the
urine.

Inhalation (all durations)	LOAEL = 3.21 mg/kg/day

	MOE = 1000 a	21-Day Inhalation Toxicity study in the rat

MRID 0087996

LOAEL = 3.21 mg/kg/day [males], based on increased total leucocyte count
and increased serum alkaline phosphatase

Cancer (oral)	In accordance with the EPA Final Guidelines for Carcinogen
Risk Assessment (March 29, 2005), the HED CARC classified triclosan as
“Not Likely to be Carcinogenic to Humans”.

UF = uncertainty factor, DBSS = database uncertainty [special
sensitivity] factor, NOAEL = no observed adverse effect level, LOAEL =
lowest observed adverse effect level, PAD = population adjusted dose (a
= acute, c = chronic) RfD = reference dose, MOE = margin of exposure,
LOC = level of concern, NA = Not Applicable

aMOE of 1000 was applied to the inhalation endpoint. The inhalation
toxicity study lacked sufficient data with which to convert the animal
doses to human equivalent concentrations (HECs) in accordance with
Agency policy.   A LOAEL value was selected as the endpoint for
inhalation risk assessment; therefore, the use of the LOAEL value from
the animal study and uncertainty in determination of what the HEC would
be warrants the MOE of 1000.

Dietary Exposure and Risk from Food and Drinking Water

	Dietary exposure and risk were assessed for the indirect food uses of
triclosan involving pulp and paper use, ice-making equipment, adhesives,
cutting boards, conveyor belts, and counter top use.  As no residue
chemistry data were submitted to the Agency for triclosan, the standard
methods developed by the FDA were used to estimate the potential
migration of residues.  A detailed explanation is found within the
Dietary Risk Assessment for Triclosan, dated August 11, 2008. None of
the individual scenarios for the various indirect food uses for
triclosan presented risks of concern for either adults or children.

	Exposures can occur where there is the possibility of indirect food
migration (including paper/pulp use, use in ice-making equipment,
adhesives, cutting boards, counter tops, and conveyer belts).  The
National Health and Nutrition Surveys (NHANES) are a series of U.S.
national surveys of the health and nutrition status of the
non-institutionalized civilian population conducted by the Centers for
Disease Control and Prevention.  The NHANES data are believed to be a
more accurate predictor of aggregate exposure because not only are the
data triclosan specific, they are also based on actual consumer use of
the various triclosan products as they co-occur in practice (see the
Residential Post Application/Bystander Risk Summary section of this RED
document for a full explanation of the NHANES data).  The NHANES data
accounts for indirect dietary and water exposures more effectively than
the use of standard models that the Agency normally would use to
estimate the potential migration of residues.  We are presenting the
dietary model results as additional information regarding the pathways
of exposure.

EPA-registered products containing triclosan are largely used indoors as
a materials preservative.  However, there is potential for effluents
from EPA-registered products containing this chemical to contact fresh
water environments.  Triclosan was detected in both raw and finished
drinking water in Southern California at levels of 56 and 49 ng/L,
respectively (Loraine and Pettigrove, 2006).  Using the assumption of 2L
consumption per day for adults, the intake of triclosan is estimated at
98 ng/person/day or 1.4 ng/kg/day for a 70 kg adult.  Comparing this
intake value to the selected reference dose for triclosan (0.3 mg/kg/day
or 300,000 ng/kg/day), the intake of triclosan in drinking water using
the measured value from Loraine and Pettigrove study does not present a
risk of concern.  Triclosan degrades with an average half-life value of
5.2 ( 1.7 days. Therefore, based on the EPA use patterns, and the
relatively short half-life, the potential for effluents from
EPA-registered products to impact drinking water sources is negligible.
Therefore a quantitative drinking water assessment was not conducted.
For additional information see the Dietary Risk Assessment for
Triclosan, dated August 11, 2008.

Non-cancer dietary risk is expressed as a percentage of a level of
concern.  The level of concern is the dose at or below which no
unreasonable adverse health effects to any human population subgroup are
expected to occur.  This dietary level of concern is termed the
population adjusted dose (PAD), which reflects the reference dose (RfD),
either acute or chronic, adjusted for (divided by) any database
uncertainty (special sensitivity) factor.  In the case of triclosan, the
special sensitivity factor is 1x (estimated risks that are less than
100% of the PAD are below EPA’s level of concern).  The acute PAD
(aPAD) is the highest predicted dose to which a person could be exposed
on a single day with no expected adverse health effect.  The chronic PAD
(cPAD) is the highest predicted dose to which a person could be exposed
over the course of a lifetime with no expected adverse health effect.

	Using conservative assumptions, the Agency estimated dietary exposure
to triclosan when used in adhesives, pulp and paper, ice-making
equipment, countertops and cutting boards and conveyer belts (see Table
3 below).  Because the aPAD and cPAD are well below 100%, dietary
exposure does not exceed the Agency’s level of concern.  For
additional information on these calculations please see the Dietary Risk
Assessment for Triclosan, dated August 11, 2008.

Table 3. Dietary Exposure to Triclosan

Use	%
偡䑁⠍偡䑁㴠〠㌮‰杭欯⽧慤⥹┇挠䅐⁄挨䅐⁄‽⸰〳
洠⽧杫搯祡ܩ䄇桤獥癩ݥ摁汵㩴ഠ⸰〰㌰〯㌮‰⁸〱⤰
㴠〠ㄮ┰഍䌍楨摬›」〮〰⼷⸰〳砠〱‰‽⸰㌲ܥ摁汵
㩴†

0.0003 mg/kg/day ∕ 0.3 mg/kg/day x100 = 0.10%

Child:

0.0007 mg/kg/day ∕ 0.30 mg/kg/day x 100  = 0.23 %

Pulp and Paper	Adult:

0.00039 mg/kg/day ∕ 0.30 mg/kg/day x 100 Adult: 0.00039 mg/kg/day/0.30
mg/kg/day x 100 = 0.13%

Child:

0.00092 mg/kg/day ∕ 0.37 mg/kg/day = 0.30%	Adult:

0.00039 mg/kg/day/0.30 mg/kg/day x 100 = 0.13%

Child:

0.00092 mg/kg/day / 0.037 mg/kg/day = 0.30%

Ice-Making Equipment	Adult:

1.13 x10-8  mg/kg/day/ 0.30 mg/kg/day = 3.76 x 10-8  x 100 = 3.76 x 10-6
 %

Child:

2.65 x 10-8  mg/kg/day /0.30 mg/kg/day = 8.83 x 10-8  x 100 =  8.83  x
10-6  %	Adult:

1.13 x10-8  mg/kg/day/ 0.30 mg/kg/day = 3.76 x 10-8  x 100 = 3.76 x 10-6
 %

Child:

2.65 x 10-8  mg/kg/day /0.30 mg/kg/day = 8.83 x 10-8  x 100 =  8.83  x
10-6  %

Countertops and cutting boards	Adult:

0.0286 mg/kg/day/ 0.30 mg/kg/day = 9.53%

Child:

0.1333 mg/kg/day/ 0.3 mg/kg/day x 100 = 44.3%

	Adult:

0.0286 mg/kg/day/ 0.30 mg/kg/day = 9.53%

Child:

0.1333 mg/kg/day/ 0.3 mg/kg/day x 100 = 44.3%

Conveyer Belt Use	Adult:

0.0000123 mg/kg/day/0.30 mg/kg/day x 100 = 0.041%

Child:  0.000057 mg/kg/day / 0.30 mg/kg/day x 100 = 0.019%

	Adult:

0.0000123 mg/kg/day/0.30 mg/kg/day x 100 = 0.041%

Child:  0.000057 mg/kg/day / 0.30 mg/kg/day x 100 = 0.019%

Residential Exposure and Risk

To assess residential handler risks, the Agency used surrogate unit
exposure data from the Chemical Manufacturers Association (CMA)
antimicrobial exposure study and the Pesticide Handlers Exposure
Database (PHED) (the NHANES data most likely do not capture intermittent
uses of triclosan such as home owners using paint that has been
preserved with triclosan because the NHANES sampling is from a discrete
sampling timeframe).  Residential post-application/bystander exposures
were assessed using the NHANES biological monitoring data from the
general population for ages 6+ years old as well as bounding estimates
for infant exposure using EPA’s standard assumptions   In addition,
the post-application assessment looked at the potential for incidental
dermal irritation as well as systemic dermal exposure as there is the
potential for adults and children to contact impregnated textiles and
fabrics such as clothing items and mattresses.  Although the
contribution of dermal exposure to the aggregate exposure is represented
in the NHANES data, a post-application screening-level clothing
assessment to represent exposure to treated textiles and fabrics is
provided.  Infant-specific pathways of exposure were also assessed, as
the NHANES data do not take into account the potential exposure pathways
of triclosan-treated products for younger children such as putting
objects and/or hands into their mouths.

	There are no EPA-registered products containing triclosan that can be
applied by a homeowner in a residential setting.  However, triclosan can
be used as an in-can preservative for latex paint, and articles treated
with triclosan in an occupational setting also have the potential for
post-application residential exposure (e.g. as a materials preservative
in mattresses, clothing, tooth brush bristles, plastic toys, garbage
bags, paper, playground equipment, sponges, furniture, footwear, etc.).
Triclosan can also be used by service contractors to control, prevent,
and inhibit the growth of fungi, mildew, mold, and bacteria on coils in
residential heating, ventilating, and air conditioning (HVAC) systems.

Residential non-cancer risk estimates are typically expressed as a
margin of exposure (MOE) which is a ratio of the dose from a
toxicological study selected for risk assessment, typically a NOAEL, to
the predicted exposure (MOE = dose ÷ exposure).  Estimated MOEs are
then compared to the “target MOE” which represents the dose selected
for risk assessment and uncertainty factors (UF) applied to that dose
(target MOE = dose × uncertainty factors).  The standard UF is 100x,
which includes 10x for interspecies extrapolation (to account for
differences between laboratory animals and humans) and 10x for
intraspecies variation (to account for differences within the same
species).  Additional uncertainty or safety factors may also be applied.

	There is the potential for individuals in residential settings to be
exposed to triclosan following application of products containing
triclosan.  Table 4 presents the representative scenarios used to
estimate residential risk from products containing triclosan.

Table 4. Representative Uses Associated with Residential Exposure to
Triclosan

Representative Use	Application Method	Example Registration Number

	Application Rate

Paint (Latex)	Brush and airless sprayer	42182-1	0.1 lb a.i./gallon

[up to 1% product x 99% a.i. x 10 lb/gal paint density = 0.099 lb
a.i./gallon of paint]

Textiles

(exposures to treated  articles are represented by exposure to mattress
and clothing)	N/Aa	70404-5	Round to 2% a.i. in finished textiles and
mattresses.

(Rates range up to the finished product containing  2%  formulated
product by weight.  Triclosan product contains 99% a.i.. )

Plastic

(exposures to plastic treated articles are represented by plastic toys)
N/Aa	42182-1	0.5% a.i.

(0.1% to 0.5% product x 99% a.i.)

(a ) The handler’s scenarios were not assessed because the products
can only be applied occupationally

Residential Handler Risk Summary

	Handler exposures were assessed for the in-can preservative use in
paint.  Dermal exposures for the short-term duration were not assessed
because no systemic dermal toxicity was observed.  Dermal irritation was
observed in the toxicity study using a test substance containing 99
percent active ingredient (a.i.).  Residential uses are at or below 1 to
2 percent a.i. are not expected to cause irritation.  For additional
information, please see the Revised Triclosan Occupational and
Residential Exposure Assessment, dated September 8, 2008.

	The estimated risk from exposure to triclosan in residential settings
does not exceed the Agency’s level of concern for inhalation during
the paint brush application (MOE= 4,000; target MOE = 1000).
However, the estimated risk from exposure to triclosan in residential
settings is of concern during the airless sprayer application (MOE= 180;
target MOE = 1000).  Personal protective equipment (PPE) such as
respirators is not a viable mitigation option for residential paint uses
for an in-can preservative.  Mitigating with PPE is only a viable option
for pesticide-labeled products (i.e., a label is needed to inform
workers to wear PPE).  Therefore, the Agency can direct workers using
pesticide-labeled products (concentrated form) at the manufacturing
setting to wear PPE to mitigate dermal irritation.  Conversely, for
in-can material preservatives there is no pesticide label that goes with
the preserved product to inform the workers/painters that PPE is needed
(i.e., there is no pesticide label on a can of paint). However, a
request has been received by the Agency from the registrants to
voluntarily cancel the paint use (inclusive of stains and coatings).
Once the action to terminate the paint use is completed, any risks
associated with triclosan-treated paint will be mitigated.  For
additional information on how the residential assessment was conducted
see the Revised Triclosan Occupational and Residential Exposure
Assessment, dated September 8, 2008.

Table 5. Triclosan Short-Term Residential Handler Inhalation Exposures
and MOEs

Exposure Scenario

Application Method	Application Method	Application Rate	Quantity Handled/
Treated per day

Unit Exposure

(mg/lb a.i.)	Daily Dose (mg/kg/day) c	MOE d

(Target MOE = 1000)

Painting	Paint brush	0.1 lb a.i./gal	2 gallons	0.28	0.0008	4,000

	Airless sprayer

15 gallons	0.83	0.018	180

a	Application rates are the maximum application rates determined from
EPA registered labels for triclosan.

b	Amount handled per day values are estimates or label instructions.

c	Daily dose (mg/kg/day) = [unit exposure (mg/lb a.i.) x application
rate (% a.i. weight or lb a.i./gal) x quantity treated (lb/day or
gal/day) x absorption factor (1.0 for inhalation)]/ Body weight (70 kg
for inhalation).

d	MOE = LOAEL / Daily Dose.  [Where short-term inhalation LOAEL = 50
mg/m3 or a dose of 3.21 mg/kg/day]. Target MOE = 1000.

				b.   Residential Post Application/Bystander Risk Summary

For EPA-registered products, triclosan may be used as an active
ingredient in textiles and fabrics (e.g., mattresses and clothing/bibs)
and plastic products (e.g., toys, cutting boards, etc).  Exposures can
occur where there is the possibility of indirect food migration,
including paper/pulp use, use in ice-making equipment, adhesives,
cutting boards, counter tops, and conveyer belts.  In addition to
EPA-regulated uses, the residential post-application assessment also
includes an aggregate assessment of the FDA uses such as toothpaste,
hand soaps, and deodorants.   The aggregate assessment includes both
EPA- and FDA-registered uses because the biological monitoring
methodology, NHANES, used to collect the samples from the general
population does not allow for separation of the contribution of
individual products to total exposure.  Although the aggregate
exposure/risk assessment using the NHANES data provides an encompassing
review of all triclosan-treated products, it does not include exposures
to children under the age of 6 years old.  Children under the age of 6
years exhibit unique activities that do not occur at older ages.
Therefore, a separate assessment for children under 6 years old has been
conducted.  In addition, dermal and inhalation route-specific
assessments were also conducted.

rinary concentrations (μg/L) of triclosan
(2,4,4’-trichloro-2’-hydroxydiphenyl ether) were measured on a
random sample of 2,517 participants of ages 6 and over.  These
measurements represent concentrations in spot urine samples.  The
corresponding human dose (mg/kg/day) was not measured or estimated by
NHANES.  The NHANES urinary metabolite concentration data collection
efforts were not designed to directly determine the dose and CDC has not
reported dose estimates for triclosan based on NHANES measurement data.
The NHANES 2003-2004 data were obtained from the NHANES website:
HYPERLINK "http://www.cdc.gov/nchs/nhanes.htm"
www.cdc.gov/nchs/nhanes.htm    See the Triclosan Occupational and
Residential Exposure Assessment, dated September 8, 2008 for more
details on NHANES.

The NHANES results are believed to be representative of a range of acute
to chronic exposures to children and adults because of the relatively
short half-life of triclosan in urine (i.e., 11 hours) and the often
daily use of triclosan products such as hand soaps and tooth paste.  The
upper range of exposures is important because of the uncertainties in
converting the spot urine concentrations to a dose; because the
pharmacokinetic data appears to be highly variable for triclosan; and
because the use of triclosan by the NHANES population is unknown.
Interpreting the NHANES data for triclosan as representing a range of
acute to chronic exposures is also supported by the fact that the 2,517
samples selected for analyses of triclosan were randomly selected from
the total NHANES random population of 9,643, and therefore, “…the
representative design of the survey was maintained” (Calafat et al
2007).  Given the uncertainties in aggregating screening-level single
use exposure estimates and assumptions on co-occurrence of uses, the
NHANES data are viewed to be a reasonable data set to use for predicting
aggregate risks.

The Agency used conservative assumptions assessing the spot urine
concentrations to err on the side of overestimating the potential dose.
Conservative assumptions used in the assessment include:  1) assumptions
used by Cohen (2008) for the dose conversion (e.g., 95th percentile of
urinary volume assumed for all individuals); 2) the characterization of
the risks if one were to assume the pharmacokinetics of triclosan at the
lowest (most conservative) urinary excretion (urinary excretion ranged
from 24 to 83 percent with a median of 54 percent); and 3) the inclusion
of these conservative assumptions even at the upper percentile of
exposure.  Future refinements to using the NHANES data for the triclosan
risk assessment should focus on refining these parameters.

		The residential post-application assessment is protective of long-term
exposure.  The results of the NHANES aggregate risks using the most
conservative methodology option assessed for those 6+ years old indicate
mean MOEs ranging from 4,700 to 19,000. At the 99th percentile the MOEs
range from 260 to 1,700.  For infants 6 to 12 months old, the mean
NHANES 6-11 year old MOEs combined with bounding estimates for
infant-specific activities for nursing, object-to-mouth, and
hand-to-mouth exposures indicate an aggregate MOE of 390.  At the 99th
percentile NHANES distribution combined with the infant-specific
activities indicate a MOE of 290.  Including exposures to the
FDA-regulated soaps and toothpaste for 6-11 year olds is a conservative
assessment of exposure from these products to 6 to 12 month olds.

	Based on the low vapor pressure of triclosan and the lack of aerosol
generation over time by the application methods (excluding bystanders in
the vicinity of airless spraying of paint which triggers risks of
concern), inhalation exposure is expected to be minimal.  This
expectation is confirmed by the MOEs estimated to be in the millions for
breathing triclosan-contaminated dust.  The potential for dermal
irritation to occur from direct contact with products treated at low
concentrations of triclosan are expected to be minimal.  See the Revised
Triclosan Occupational and Residential Exposure Assessment, dated
September 8, 2008, for more detailed information.

Dermal Irritation

The potential for dermal irritation to occur from incidental dermal
exposures from products (impregnated textiles, fabrics such as clothing
items and mattresses) treated at low concentrations of triclosan are
expected to be minimal.

Dermal Systemic

	There is the potential for dermal-specific route of exposure to adults
and children contacting impregnated textiles and fabrics such as
clothing items and mattresses.  The contribution of dermal exposure to
the aggregate exposure is represented in the NHANES data.  Nonetheless,
a post-application screening-level clothing assessment to represent
exposure to treated textiles and fabrics is provided.  The
route-specific dermal toxicological endpoint for the intermediate-term
exposure duration is used to represent all textile uses.  Long-term
duration was not assessed because transferable triclosan residues from
treated textiles and fabrics are not expected to be available
continuously at the levels used in this screening-level assessment.

	The dermal MOEs for adults and toddlers are equal to or above the
target MOE of 100.  The calculations of the intermediate-term
post-application dermal doses and MOEs for adults and toddlers wearing
treated clothing are shown in Table 4.9 of the Revised Triclosan
Residential and Occupational Risk Assessment, dated September 8, 2008.

Infant-Specific Exposure Pathways

While NHANES data are measured exposures that represent the real world
co-occurrence of triclosan-treated products, it is necessary to use
screening-level deterministic assessments as well as to make assumptions
of potential co-occurrence of triclosan-treated products for younger
children.  An assessment of infants in the 6 to 12 month old age group
has been selected to represent the high end of exposure activities of
children less then six years old to triclosan-treated products.  This
age group is considered the high end of exposure based on the
characteristics discussed in Table 2 presented in USEPA (2005) and the
likelihood of these activities co-occurring.  USEPA (2005) indicates
that this age group includes behaviors that would lend themselves to
potentially expose children to triclosan-treated products.
Characteristics of children at this age that potentially exposes
children to triclosan that would not have been captured by the 6-11 year
old age category in NHANES include nursing, increasingly likely to mouth
nonfood items, and “development of personal dust clouds” as a
characteristic relevant to inhalation exposure.

Infant-specific activities resulting in potential exposures that are not
accounted for by the 6-11 year old age group in NHANES that are likely
to co-occur include:

Nursing (i.e., triclosan-contaminated breast milk);

Object-to-mouth exposures (e.g., mouthing of plastic items such as toys,
combs & brushes, playground equipment);

Hand-to-mouth exposure (e.g., residues in dust stuck to children’s
hands); and;

Inhalation of triclosan-contaminated dust.

Other potential exposure pathways for infants in the 6 to 12 month old
age group that are captured – and overestimated for the 6 to 12 month
olds -- by the NHANES age groups 6-11 years old include:

Brushing teeth with triclosan-treated tooth paste;

Washing hands with triclosan-treated antibacterial soap;

Exposure to impregnated fabrics and textiles such as
clothing/sportswear, blankets, mattresses, tooth brush bristles, etc.
that may be treated with triclosan; and

Exposure to impregnated polymers and plastics such as food contact
surfaces (e.g., cutting boards, conveyor belts, counter and table tops).

	The MOEs for each of the infant-specific exposure pathways are listed
below.  See the Revised Triclosan Occupational and Residential Exposure
Assessment, dated September 8, 2008 for the details of this assessment
including MOE calculations.

Nursing

The daily dose for an infant 6 to 12 months old is estimated to be 0.005
mg/kg/day.  The MOE is 6000 (i.e., chronic NOAEL of 30 mg/kg/day / daily
dose 0.005 mg/kg/day) which is above the target MOE of 100 and therefore
indicate no risks of concern.

Object-to-mouth

	The MOE of 430 is above the target MOE of 100 and is not of concern.

Hand-to-mouth

	The calculation of the short- and intermediate-term oral doses
(toxicological endpoint selected is also protective of the long-term
duration) and the oral MOEs are shown in Table 4.6 of the Revised
Triclosan Residential and Occupational Risk Assessment, dated September
8, 2008.  The oral MOEs are above the target MOE of 100 (short-term MOE
= 1E+6 and the intermediate- and long-term MOE = 6.7E+6).

Dust Inhalation

The resulting route-specific inhalation MOEs are in the millions, with a
target MOE = 1,000.   Therefore, inhalation to triclosan-contaminated
dust is considered to be negligible.

Aggregate Exposure and Risk

	The Agency performed an assessment of the aggregate exposure to
triclosan.  Aggregate exposure is the total exposure to a single
chemical (or its residues) that may occur from dietary (i.e., food and
drinking water), residential, and other non-occupational sources
including triclosan FDA uses such as hand soaps and toothpaste, and from
all known or plausible exposure routes (oral, dermal, and inhalation).
An aggregate risk assessment was conducted using the single selected
toxicological endpoint for acute dietary, short-term (1-30 days),
intermediate-term (1-6 months), and chronic (several months to lifetime)
exposure durations. Inhalation aggregate risks are minimal based on the
low vapor pressure of triclosan and uses such as tooth paste, hand soap,
and impregnated textiles that do not involve inhalation as the primary
route of exposure.  Further discussion of inhalation exposure can be
found in the Revised Triclosan Occupational and Residential Exposure
Assessment, dated September 8, 2008.

	In performing aggregate exposure and risk assessments, the Office of
Pesticide Programs has published guidance outlining the necessary steps
to perform such assessments (General Principles for Performing Aggregate
Exposure and Risk Assessments, November 28, 2001; available at
http://www.epa.gov/pesticides/trac/science/aggregate.pdf).  Steps for
deciding whether to perform aggregate exposure and risk assessments are
listed, which include:  identification of toxicological endpoints for
each exposure route and duration; identification of potential exposures
for each pathway (food, water, and/or residential);  reconciliation of
durations and pathways of exposure with durations and pathways of health
effects; determination of which possible residential exposure scenarios
are likely to occur together within a given time frame; determination of
magnitude and duration of exposure for all exposure combinations;
determination of the appropriate technique (deterministic or
probabilistic) for exposure assessment; and determination of the
appropriate risk metric to estimate aggregate risk.

	In the case of triclosan, population-based biological monitoring data
are available to assess the co-occurrence of uses to develop an
aggregate exposure assessment.  The population-based biological
monitoring data are believed to be a more accurate predictor of
aggregate exposure because not only are the data triclosan specific,
they are also based on actual consumer use of the various triclosan
products as they co-occur in practice.  Although the aggregate
exposure/risk assessment using the NHANES data provides an encompassing
review of all triclosan-treated products, it does not include exposures
to children under the age of 6 years old.  Children under the age of 6
years exhibit unique activities that do not occur at older ages.
Therefore, a separate assessment for children under 6 years old has been
included.  The potential dermal-specific route of exposure to adults and
children contacting impregnated textiles and fabrics such as clothing
items and mattresses is represented in the NHANES data.

		a. Aggregate Risk for Children (6 years) to Adults

All exposure durations were assessed using the selected oral NOAEL of 30
mg/kg/day with a target MOE of 100.  The oral endpoint was selected to
represent the various oral exposure scenarios that are expected from
antimicrobial exposure to triclosan. The calculated MOEs are
representative of all exposure durations.  The NHANES data show that
74.6% of the samples had detectable levels of total (free plus
conjugated) triclosan.  Tables 5.1 and 5.2 in the   SEQ CHAPTER \h \r 1
5-Chloro-2-(2,4-dichlorophenoxy)phenol (Triclosan) Risk Assessment for
the Reregistration Eligibility Decision (RED) Document, dated September
15, 2008 provide the mean and 99th percentiles, respectively, of the
spot urine concentration to dose conversion prior to correcting for the
54% triclosan urinary excretion (in units of ug/kg/day); the
pharmacokinetic 54% corrected daily dose converted to units of
mg/kg/day; and the MOEs (for each of the three basic concentration to
dose conversion methods).  Aggregate exposures and risks are presented
for the following age groups and subpopulations: all age groups; ages
6-11; ages 12-19; ages 20-59; ages >=60; males; females,
Mexican-American; White, non-Hispanic; and Black, non-Hispanic.

The results of the aggregate risks at both the mean and 99th percentile
do not trigger risks of concern.  The mean MOEs range from 4,700 to
19,000 (target MOE = 100).  The MOEs at the 99th percentile of the dose
range from 260 to 1,700 (target MOE = 100).  The MOE is 120 when
applying the lowest and most conservative percent urinary excretion from
the results of the pharmacokinetic data (i.e., 24 percent) to the most
conservative dose conversion method (i.e., Geigy’s 95th percentile of
daily urine volumes). In conclusion, even with the reliance of
conservative assumptions in estimating risks to account for the
considerable uncertainties in converting spot urine concentration to
dose, the NHANES data as analyzed for triclosan sufficiently
characterize the aggregate risks as meeting the definition of not
resulting in unreasonable adverse effects.

	b. Aggregate Risk for Infants

	While NHANES data are measured exposures that represent the real world
co-occurrence of triclosan-treated products, it is necessary to use
screening-level deterministic assessments as well as to make assumptions
of potential co-occurrence of triclosan-treated products for younger
children.  USEPA (2005) Guidance on Selecting Age Groups for Monitoring
and Assessing Childhood Exposures to Environmental Contaminants, an
internally and externally scientific peer reviewed document, provides
the basis of the age group selection.  The age group of 6 to 12 months
old was selected to represent behavioral activities of children younger
than 6 years old that are exposed to triclosan-treated products.
Characteristics of children at this age that potentially exposes
children to triclosan that would not have been captured by the 6-11 year
old age category in NHANES include nursing, increasingly likely to mouth
nonfood items (e.g., toys, combs & brushes, playground equipment), and
“development of personal dust clouds” as a characteristic relevant
to inhalation exposure.   The aggregate risks for infants 6 to 12 months
old have been estimated by combining the mean NHANES distribution with
the infant-specific bounding risks, with the exception of the inhalation
risks as they were considered negligible (MOEs in the millions and
therefore these risks do not effect the aggregate results).  See the
Revised Triclosan Residential and Occupational Risk Assessment, dated
September 8, 2008 for more information on the infant-specific exposure
pathways.  The aggregate MOE from the measured mean of the 6-11 year old
NHANES subjects combined with the bounding risks from nursing,
object-to-mouth, and hand-to-mouth indicate a long-term MOE of 390
(target MOE = 100).  The 99th percentile of the NHANES dose (when using
the 95% urine volume to estimate the 99th percentile dose) is combined
with the infant-specific bounding risks and indicates a long-term MOE of
290 (target MOE = 100). See the Triclosan Residential and Occupational
Exposure Assessment, dated September 8, 2008 for more information
regarding the infant aggregate exposure assessment.

Occupational Exposure and Risk

Because triclosan is currently registered for use in occupational
settings (including HVAC coil spray applications, as a materials
preservative in paints and in industrial processes and water systems for
pulp and paper), occupational handlers have the potential to be exposed
to triclosan through mixing, loading or applying a pesticide or
following application of products containing triclosan. Table 6 presents
the representative occupational uses assessed for triclosan.
Occupational non-cancer risks are presented as margins of exposure
(MOE).

Table 6.  Representative Exposure Scenarios Associated with Occupational
Exposures to Triclosan

Representative Use	Method of Application	Exposure Scenario	Example
Registration #	Application Rate

Commercial/Industrial/Institutional Premises (Use Category III)

HVAC coil applications	Airless sprayer	ST/IT Handler:

Inhalation	82523-1	6.1E-4 lb ai/10 ft2

(0.85 pints/10 ft2 x 1 gal/8 pts x 8.34 lb/gal x 0.69% ai)

Painting

(commercial painters)	Paint brush,

Airless sprayer	ST/IT Handler:

Inhalation	42182-1	0.1 lb a.i./gallon

[up to 1% product x 99% a.i. x 10 lb/gal paint density = 0.099 lb
a.i./gallon of paint]

Material Preservatives (Use Category VII)

Paint

	Liquid pour,

Powder	ST/IT Handler: inhalation	42182-1	0.1 lb a.i./gallon

[up to 1% product x 99% a.i. x 10 lb/gal paint density = 0.099 lb
a.i./gallon of paint]

  SEQ CHAPTER \h \r 1 Industrial processes and water systems (Use
Category VIII)

Pulp and Paper

	Metered pump

	ST/IT Handler: Inhalation

	70404-5

	2% a.i. by weight of paper product

(2% product by weight x 99% a.i. for paper mulch )

Note :  other labels for paper and paper board have lower rates,
42182-1 and 3090-165)

	To assess handler risk, the Agency used surrogate unit exposure data
primarily from the proprietary Chemical Manufacturers Association (CMA)
Antimicrobial Exposure Study (USEPA 1999) and the Pesticide Handlers
Exposure Database (PHED) (USEPA 1998).  For the occupational scenarios
in which CMA data were insufficient, other data and methods were
applied.   For additional information, please see the Revised Triclosan
Residential and Occupational Exposure Assessment, dated September 8,
2008.

Using conservative assumptions, most estimated risks from exposure to
triclosan in occupational settings did not exceed the Agency’s level
of concern during application.  However, Table 7 presents the
application occupational risks for triclosan that exceeded EPA’s level
of concern.  The calculated dermal MOEs were below the target MOE of 100
for the commercial painters (both applying by brush and airless sprayer)
and the application during pulp & paper manufacture.  The inhalation
MOEs are below the target MOE of 1000 for the airless sprayer (paint),
the paint manufacturing, and the pulp and paper.  However, a request has
been received by the Agency from the registrants to voluntarily cancel
the paint use (inclusive of stains and coatings).  Once the action to
terminate the paint use is completed, any risks associated with
triclosan-treated paint will be mitigated.  See Section IV of this
document for EPA’s triclosan risk management strategy.

Table 7.  Short- and Intermediate-Term Inhalation and Intermediate-Term
Dermal Risks Associated with Occupational Handlers

Exposure Scenario

Method of Application

Unit Exposure

(mg/lb a.i.) 	Application Rate	Quantity Handled/ Treated per day

Daily Dose (mg/kg/day)a

MOEb

(Target MOEs = 1000 for inhalation;  100 for dermal)

Inhalation 	Dermal

	Inhalation

	Dermal

	Inhalation

	Dermal

  SEQ CHAPTER \h \r 1 Commercial, Institutional and Industrial Premises
and Equipment (Use Site Category III )

HVAC	Airless sprayer	0.83	38	6.1E-4 lb ai/10ft2	Large building 1000 ft2
0.00072	0.033	4,500	1,200

Painting (commercial)	Paint brush	0.26	180	0.1 lb a.i./gal	5 gallons
0.002	1.3	1,600	31

	Airless sprayer	0.83	38

50 gallons	0.059	2.7	54	1

Material Preservatives (Use Site Category VII)

Paint (manufacturing process)	Liquid pour	0.00346	0.135 (gloves)	0.99%
a.i.	20,000 lbs	0.0098	0.38	330	110

	Liquid pump	0.000403	0.00629 (gloves)

200,000 lbs	0.011	0.18	290	220

Industrial Processes and Water Systems (Use Site Category VIII)

Pulp and Paper	Metering pump	0.000403	0.00629 (gloves)	2% a.i.	500 tons
0.115	1.8	Require closed loading systems to mitigate the exposure/risk

a	Daily dose (mg/kg/day) = [unit exposure (mg/lb a.i.) x absorption
factor (1 for inhalation and 1 for dermal) x application rate x quantity
treated / body weight (70 kg).

	b	MOE = LOAEL or NOAEL  (mg/kg/day) / daily dose [Where inhalation
LOAEL = 3.21 mg/kg/day for all inhalation exposure durations and the IT
dermal NOAEL is 40 mg/kg/day from a dermal route-specific study].
Target MOE = 1000 for inhalation and 100 for dermal.

	Occupational post-application dermal and inhalation exposures are
assumed to be negligible based on the use patterns.

Incident Reports

There are no incident reports associated with exposure to end-use
products containing triclosan.B.  Environmental Fate and Ecological
Hazard Assessment

	The Agency has conducted an environmental fate assessment and an
ecological hazard assessment for triclosan to support the reregistration
eligibility decision.  It should be noted that an ecological risk
assessment is not ordinarily conducted when the registered use patterns
are considered to be “indoor use” because of the limited potential
for these use patterns to result in environmental exposure.  However,
triclosan has been detected in natural waterways; therefore, the Agency
believes it is prudent to conduct a qualitative risk assessment using
surface water monitoring data.

The following risk characterization is intended to describe the
magnitude of the estimated ecological hazards and environmental risks
associated with the use of EPA-registered triclosan products.  The
Agency evaluated the submitted environmental fate and ecological studies
as well as available open literature and determined that the data are
adequate to support a reregistration eligibility decision.  In addition,
a Tier 1, Down-the-Drain (DTD) module and a Probabilistic Dilution Model
(PDM) was performed to simulate industrial process wastewater releases,
resulting from the uses of triclosan as a material preservative.  The
Down-the-Drain (DTD) module estimates concentrations of triclosan found
in surface water to which aquatic organisms may be exposed as a result
of potential releases of triclosan from consumer uses and the
Probabilistic Dilution Model (PDM) estimates the number of days per year
that the concentration of triclosan in surface water exceeds the
concentration of concern for aquatic organisms.  For detailed
discussions of all aspects of the environmental risk assessment, see the
Revised Environmental Fate Assessment of Triclosan for the Issuance of
the Reregistration Eligibility Decision Document, dated September 11,
2008, and the Revised Ecological Hazard and Environmental Risk
Assessment of Triclosan  for the Reregistration Eligibility Decision
(RED) Document, dated September 11, 2008.

Environmental Fate

Hydrolysis

	Triclosan [5-chloro-2-(2,4-dichlorophenoxy)phenol] is a white
crystalline powder with low solubility in water (12 ppm).  Triclosan is
hydrolytically stable under abiotic and buffered conditions over the pH
4-9 range based on data from a preliminary test at 50°C.
Photolytically, triclosan degrades rapidly under continuous irradiation
from artificial light at 25°C in a pH 7 aqueous solution, with a
calculated aqueous photolytic half-life of 41 minutes.  One major
degradation product has been identified, DCP (2,4-dichlorophenol), which
was a maximum of 93.8-96.6% of the applied triclosan at 240 minutes
post-treatment.

	In soil, triclosan is expected to be immobile based on an estimated Koc
of 9,200.  Triclosan is not expected to volatilize from soil (moist or
dry) or water surfaces based on an estimated Henry’s Law constant of
1.5 x 10-7 atm-m3/mole.  Triclosan exists partially in the dissociated
form in the environment based on a pKa of 7.9, and anions do not
generally adsorb more strongly to organic carbon and clay than their
neutral counterparts.  In aquatic environments, triclosan is expected to
adsorb to suspended solids and sediments and may bioaccumulate (Kow
4.76), posing a concern for aquatic organisms.  There is a low to
moderate potential for bioconcentration in aquatic organisms based on a
BCF range of 2.7 to 90.  HYPERLINK
"http://en.wikipedia.org/wiki/Image:Triclosan.png" \o "Triclosan"
INCLUDEPICTURE
"http://upload.wikimedia.org/wikipedia/commons/thumb/f/fc/Triclosan.png/
200px-Triclosan.png" \* MERGEFORMATINET

Biodegradability

	Hydrolysis is not expected to be an important environmental fate
process due to the stability of triclosan in the presence of strong
acids and bases.  However, triclosan is susceptible to degradation via
aqueous photolysis, with a half-life of <1 hour under abiotic
conditions, and up to 10 days in lake water.  An atmospheric half-life
of 8 hours has also been estimated based on the reaction of triclosan
with photochemically produced hydroxyl radicals.  Additionally,
triclosan may be susceptible to biodegradation based on the presence of
methyl-triclosan following wastewater treatment.

Ecological Hazard

As mentioned previously, the Agency used surface water monitoring data
to evaluate the ecological risks associated with the antimicrobial uses
of triclosan.  In addition, the Agency used toxicity endpoints from
ecological toxicity studies to estimated environmental concentrations
based on environmental fate characteristics and pesticide use data. The
toxicity endpoints used in the ecological hazard assessment were
obtained from guideline toxicity studies conducted for wildlife, aquatic
organisms, and plants (40 CFR §158.2060).   A summary of the submitted
data is provided below.

Environmental Toxicity

Toxicity to Birds

	One available acute oral study on the bobwhite quail indicates that
triclosan is only slightly toxic to birds (LD50 of 825 mg/kg).  A
subacute dietary study using the TGAI may be required on a case-by-case
basis depending on the results of lower-tier ecological studies and
pertinent environmental fate characteristics in order to establish the
toxicity of a chemical to avian species.  The preferred-test species is
either the mallard duck or bobwhite quail.  The results of these two
acceptable studies indicate that triclosan is relatively nontoxic to
avian species through subacute dietary exposure (LC50 of >5000 ppm).

Toxicity to Terrestrial Animals

Refer to the 5-Chloro-2-(2,4-dichlorophenoxy)phenol (Triclosan): Risk
Assessment for the Reregistration Eligibility Decision (RED) Document
dated September 15, 2008 for details on the available acute mammalian
toxicity studies submitted for human health assessment and for
information on triclosan’s potential as an endocrine disruptor.

Toxicity to Aquatic Animals

	One acute toxicity study is required to establish the toxicity of
triclosan to freshwater fish.  The preferred test species is either the
rainbow trout (Oncorhynchus mykiss), a coldwater fish, or the bluegill
(Lepomis macrochirus), a sunfish.  For triclosan, acute studies are
available for the rainbow trout and the bluegill and for the fathead
minnow (Pimephales promelas).  The acute toxicity values from these
studies categorize triclosan as being highly toxic to freshwater fish
(96-hr LC50 of 0.26 – 0.288 mg/L).  A precautionary label statement is
required.

	One study is required to establish the acute toxicity (EC50) of
triclosan to freshwater invertebrates.  The preferred test species is
Daphnia magna, a water flea.  Two studies categorize triclosan as being
highly toxic to freshwater invertebrates (48-hr LC50 of 0.39-0.42 mg/L)
and therefore a precautionary label statement is required.  However,
neither study satisfied the guideline requirement (OPPTS 850.1010) for
current uses.

	Acute toxicity testing with estuarine and marine organisms is required
when an end-use product is intended for direct application to the
marine/estuarine environment or the active ingredient is toxic to
aquatic organisms and is expected to reach this environment via other
transport pathways.  At this time this testing is not required for
triclosan, but is dependent upon the results of environmental modeling
and monitoring which are required to support reregistration of triclosan
(see Revised Ecological Hazard and Environmental Risk Assessment Science
Chapter for the Triclosan Reregistration Eligibility Decision (RED)
Document, dated September 11, 2008).

	Chronic toxicity testing (fish early life stage and aquatic
invertebrate life cycle) is required for pesticides when certain
conditions of use and environmental fate apply.  The preferred
freshwater fish test species is the fathead minnow.  At this time this
testing is not required for triclosan, but is dependent upon the results
of environmental modeling and monitoring which are required to support
reregistration of triclosan (see Revised Ecological Hazard and
Environmental Risk Assessment Science Chapter for the Triclosan
Reregistration Eligibility Decision (RED) Document, dated September 11,
2008).

Toxicity to Plants

	Non-target plant phytotoxicity testing is required for pesticides when
certain conditions of use and environmental fate apply.  At this time
this testing is not required for triclosan, but is dependent upon the
results of environmental modeling and monitoring which are required to
support reregistration of triclosan (see Revised Ecological Hazard and
Environmental Risk Assessment Science Chapter for the Triclosan
Reregistration Eligibility Decision (RED) Document, dated September 11,
2008).

	Testing has been conducted with triclosan on several aquatic plant
species.  Testing is normally conducted with one species of aquatic
vascular plant (Lemna gibba) and four species of algae:  (1) freshwater
green alga, Selenastrum capricornutum, (2) marine diatom, Skeletonema
costatum, (3) freshwater diatom, Navicula pelliculosa, and (4) bluegreen
cyanobacteria, Anabaena flos-aquae.  The rooted aquatic macrophyte rice
(Oryza sativa) is also tested in seedling emergence and vegetative vigor
tests.

	Four studies that evaluate the toxicity of triclosan to freshwater
aquatic plants have  been submitted. Results of these studies are
presented in Table 6 of the Revised Ecological Hazard and Environmental
Risk Assessment Science Chapter for the Triclosan Reregistration
Eligibility Decision (RED) Document, dated September 11, 2008.  Note
that in a search of the available data on triclosan, the U.S. EPA’s
Office of Water found an EC50 as low as 0.0007 mg/L for the green alga
Scenedesmus subspicatus and an EC25 as low as 0.00067 mg/L for the
blue-green alga Anabaena flos-aquae (U.S. EPA, 2007).

	The guideline requirement for an algal toxicity test (850.5400, 123-2)
is partially fulfilled.  One additional algal toxicity test under
850.5400 is outstanding: a test with the freshwater green alga,
Selenastrum capricornutum.  The other non-target aquatic plant toxicity
requirement, floating freshwater aquatic macrophyte duckweed (Lemna
gibba), guideline 850.4400, is satisfied.  Studies on the rooted
freshwater macrophyte rice (Oryza sativa), 850.4225 and 850.4250 (2
tests on seedling emergence and vegetative vigor) have not been
submitted.

Toxicity to Honeybees

	Honeybee toxicity data are not needed based on the current uses of
triclosan.

Ecological Exposure and Risk

	An ecological risk assessment is not typically conducted for the types
of triclosan uses registered with the EPA because of the limited
potential for ecological exposure.  However, since triclosan has been
detected in natural waters, a qualitative environmental risk assessment
was performed using monitoring levels of triclosan found in waterways
and toxicity values from the tables in section I of the Ecological
Hazard and Environmental Risk Assessment Science Chapter for the
Triclosan Reregistration Eligibility Decision (RED) Document, dated
September 11, 2008 to develop risk quotients (RQs) and compare them to
levels of concern (LOCs) for triclosan.  LOCs were not exceeded for fish
but were exceeded for aquatic plants.  The RQs were based on published
literature, submitted data and USGS monitoring data.  A meta-analysis of
literature, plus exposure modeling was used to conduct a probabilistic
assessment of triclosan.  This analysis sheds light on the difficulties
associated with relating laboratory data to field effects and concludes
that additional studies may be needed to refine scientific knowledge of
metabolites and degradates, bioaccumulation factors, endocrine-related
effects, and community level impacts.  There were no acceptable acute
toxicity studies for freshwater invertebrates or estuarine and marine
organisms nor were there any acceptable chronic toxicity studies
available for aquatic organisms.  Therefore, risk to these species could
not be assessed at this time.  The hazard assessment will be used to
meet current labeling needs and to determine hazard endpoints for
ecological organisms potentially exposed in the event of a spill or
other potential environmental releases.

	In addition, the Agency performed consumer environmental modeling for
triclosan.  See the Appendix to the Revised Ecological Hazard and
Environmental Risk Assessment Science Chapter for the Triclosan
Reregistration Eligibility Decision (RED) Document, dated September 11,
2008 titled Estimates of Exposures and Risks To Aquatic Organisms from
Releases of Triclosan to Surface Water as a Result of Uses Under EPA’s
Jurisdiction, and the Revised Environmental Fate Science Chapter for the
Triclosan Reregistration Eligibility Decision (RED) Document, dated
September 11, 2008.  The consumer environmental modeling (DTD module and
PDM) assumed that all triclosan used in the manufacture of the
antimicrobial uses is released into surface waters.  After adjustments,
these models concluded that estimated concentrations of triclosan in
surface water do not exceed concentrations of concern for acute risk
presumptions for any of the aquatic organisms and plants (vascular and
non-vascular).  As discussed in the Revised Ecological Hazard and
Environmental Risk Assessment Science Chapter for the Triclosan
Reregistration Eligibility Decision (RED) Document, dated September 11,
2008, only acute concentrations of concern were evaluated for aquatic
organisms since acceptable chronic aquatic data are not available.
However, considering the low probability of triclosan being released
into household wastewater and surface waters from the antimicrobial
uses, the Agency also concludes that chronic aquatic risks are unlikely
from consumer uses of triclosan-treated plastic and textile items.
Therefore, Agency can reasonably conclude that the antimicrobial uses of
triclosan (e.g., triclosan-treated plastic and textile items in
households) are unlikely to contribute significant quantities of
triclosan into household wastewater and eventually to surface water.

	As discussed in the Revised Environmental Fate Science Chapter for the
Triclosan Reregistration Eligibility Decision (RED) Document, dated
September 11, 2008, little is known about how much, if any, triclosan is
released from industrial sites (where triclosan is incorporated into
plastic and textile items) into effluents and the environment (e.g.,
surface waters).  Considering this, the Agency is requiring that the
technical registrants perform environmental modeling and monitoring to
address this issue.  Until the Agency receives these data it is unable
to calculate risk quotients specific to these industrial scenarios.
However, the Agency does not anticipate risks of concern.  The confirm
this, the modeling and monitoring data will be required.  In the event a
new risk of concern is identified, the Agency will revisit the issue.
The registrants are required to sample effluents from such facilities
and receiving (surface) waters adjacent to these facilities, determining
the extent and duration of triclosan and major degradates/metabolites
(e.g., triclosan methyl).  Depending on the results of this monitoring,
further ecological effects data may be required.  In addition, four
studies to address bioaccumulation potential will also be called-in. See
Chapter V. of this RED document and the Revised Ecological Hazard and
Environmental Risk Assessment Science Chapter for the Triclosan
Reregistration Eligibility Decision (RED) Document, dated September 11,
2008, for more information on the potential ecological effects data to
be called in.

3. Risk to Listed Species

Section 7 of the Endangered Species Act, 16 U.S.C. Section 1536(a)(2),
requires all federal agencies to consult with the National Marine
Fisheries Service (NMFS) for marine and anadromous listed species, or
the United States Fish and Wildlife Services (FWS) for listed wildlife
and freshwater organisms, if they are proposing an "action" that may
affect listed species or their designated habitat.  Each federal agency
is required under the Act to insure that any action they authorize,
fund, or carry out is not likely to jeopardize the continued existence
of a listed species or result in the destruction or adverse modification
of designated critical habitat.  To jeopardize the continued existence
of a listed species means “to engage in an action that reasonably
would be expected, directly or indirectly, to reduce appreciably the
likelihood of both the survival and recovery of a listed species in the
wild by reducing the reproduction, numbers, or distribution of the
species” (50 CFR §402.02).

To facilitate compliance with the requirements of the Endangered Species
Act subsection (a)(2) the Environmental Protection Agency, Office of
Pesticide Programs has established procedures to evaluate whether a
proposed registration action may directly or indirectly reduce
appreciably the likelihood of both the survival and recovery of a listed
species in the wild by reducing the reproduction, numbers, or
distribution of any listed species (U.S. EPA 2004).  After the
Agency’s screening-level risk assessment is performed, if any of the
Agency’s Listed Species LOC Criteria are exceeded for either direct or
indirect effects, a determination is made to identify if any listed or
candidate species may co-occur in the area of the proposed pesticide
use.  If determined that listed or candidate species may be present in
the proposed use areas, further biological assessment is undertaken.
The extent to which listed species may be at risk then determines the
need for the development of a more comprehensive consultation package as
required by the Endangered Species Act.

	For certain use categories, the Agency assumes there will be minimal
environmental exposure, and only a minimal toxicity data set is required
(Overview of the Ecological Risk Assessment Process in the Office of
Pesticide Programs U.S. Environmental Protection Agency - Endangered and
Threatened Species Effects Determinations, 1/23/04, Appendix A, Section
IIB, pg.81). Chemicals in these categories therefore do not undergo a
full screening-level risk assessment, and are considered to fall under a
no effect determination. This preliminary analysis indicates that there
is a potential for triclosan use to overlap with listed species and that
a more refined assessment is warranted, to include direct, indirect and
habitat effects.  The more refined assessment should involve clear
delineation of the action area associated with proposed use of triclosan
and best available information on the temporal and spatial co-location
of listed species with respect to the action area.  This analysis has
not been conducted for this assessment and therefore an endangered
species effect determination will not be made at this time.  The refined
endangered species assessment will be performed under the Registration
Review program (see   HYPERLINK
"http://www.epa.gov/oppsrrd1/registration_review/"
http://www.epa.gov/oppsrrd1/registration_review/  for more information)
and will include a species by species analysis.

   SEQ CHAPTER \h \r 1 Reregistration and Risk Management Decisions

Determination of Reregistration Eligibility

Reregistration Eligibility Decision

Section 4(g)(2)(A) of FIFRA calls for EPA to determine, after submission
of relevant data concerning an active ingredient, whether or not
products containing the active ingredient are eligible for
reregistration.  EPA has previously identified and required the
submission of the generic (i.e., active ingredient-specific) data
required to support reregistration of products containing triclosan as
an active ingredient.  The Agency has reviewed these generic data, and
has determined that the data are sufficient to support a reregistration
eligibility decision for all products containing triclosan.

The Agency completed its assessment of the residential, occupational,
indirect dietary and ecological risks associated with the use of
pesticide products containing the active ingredient triclosan.  The
Agency has determined that most triclosan containing products are
eligible for reregistration provided that: 1) all risk mitigation
measures are implemented; 2) current data gaps and confirmatory data
requirements are addressed; and 3) label amendments are made as
described in Section V.  Use as a materials preservative in paint
(inclusive of stains and coatings) has been requested to be voluntarily
cancelled by the registrants and is not eligible for reregistration.
Appendix A summarizes the uses of triclosan 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 triclosan and lists the submitted studies that the Agency
found acceptable.  Data gaps are identified as generic data requirements
that have not been satisfied with acceptable data.

The Agency considered the available information and has determined that
the uses of triclosan that appear in Appendix A of this document will
not pose unreasonable risks to humans or the environment if the
conditions and requirements for reregistration outlined in this document
are implemented.  Unless labeled and used as specified in this document,
triclosan would present risks inconsistent with FIFRA.  Accordingly,
should a registrant fail to implement any of the conditions and
requirements for reregistration identified in this document, the Agency
may take regulatory action to address the potential risk concerns from
the use of triclosan.

Endocrine Disruption Effects

	Under the Federal Food Drug and Cosmetic Act (FFDCA), as amended by
FQPA, the Agency is required 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 was scientific
basis for including, as part of the program, the androgen and thyroid
hormone systems, in addition to the estrogen hormone system.  EPA also
adopted EDSTAC’s recommendation that the Program include evaluations
of potential effects in wildlife.  For pesticide chemicals, EPA will use
FIFRA and, to the extent that effects in wildlife may help determine
whether a substance may have an effect in humans, FFDCA has authority to
require the wildlife evaluations.  As the science develops and resources
allow, screening of additional hormone systems may be added to the
Endocrine Disruptor Screening Program (EDSP).

 	There is some evidence that triclosan disrupts thyroid hormone
homeostasis and interacts with the androgen and estrogen receptors. The
available evidence is summarized in the
5-Chloro-2-(2,4-dichlorophenoxy)phenol (Triclosan): Toxicology Chapter
for the Reregistration Eligibility Decision (RED) Document, dated August
29, 2008. The Agency is aware that research is ongoing regarding
endocrine effects of triclosan, and this further research may require
future modification to the risk assessment and the RED for triclosan.
The EPA process of regulating pesticides allows for reevaluation at any
time if new information becomes available.

b. Cumulative Risks

	Risks summarized in this document are those that result only from the
use of triclosan.  The Food Quality Protection Act (FQPA) requires that,
when considering whether to establish, modify, or revoke a tolerance,
the Agency consider “available information” concerning the
cumulative effects of a particular pesticide’s residues and “other
substances that have a common mechanism of toxicity.”  Unlike other
pesticides for which EPA has followed a cumulative risk approach based
on a common mechanism of toxicity, EPA has not made a common mechanism
of toxicity finding as to triclosan.  The Agency acknowledges that
triclocarban has been detected along with triclosan in the environment.
Although there may be some structural similarity between triclosan and
triclocarban, these chemicals belong to two different classes
(hydroxyphenylether and hydroxyphenylurea respectively).   Further,
there is not necessarily a relationship between the mechanism of
antimicrobial activity and mechanism of toxicity in mammals. As defined
in the Office of Pesticide Programs’ 2002 document “Guidance on
Cumulative Risk Assessment of Pesticide Chemicals that Have a Common
Mechanism of Toxicity,” available at:   HYPERLINK
"http://www.epa.gov/pesticides/trac/science/cumulative_guidance.pdf_"
http://www.epa.gov/pesticides/trac/science/cumulative_guidance.pdf ,
common mechanism of toxicity refers to “two or more pesticide
chemicals or other substances that cause a common toxic effect by the
same, or essentially the same, sequence of major biochemical
events…”  There is currently insufficient evidence characterizing
major biochemical events between triclosan and triclocarban to suggest
that these two chemicals share a common mechanism of toxicity.

c. Public Comments and Response

Through EPA’s public participation process, EPA worked with
stakeholders and the public to reach the regulatory decisions for
triclosan.  During the public comment period on the risk assessments,
which closed on July 7, 2008, the Agency received multiple comments from
the technical registrants, members of the public, and various
environmental groups.   All comments are available at   HYPERLINK
"http://www.regulations.gov"  http://www.regulations.gov  under docket
number EPA-HQ-OPP-2007-0513.  The Agency’s official responses will
also be posted in the public docket.

Regulatory Rationale

With the exception of the paint use which has been requested to be
voluntarily cancelled by the registrants, the Agency has determined that
triclosan is eligible for reregistration provided that the risk
mitigation and data requirements outlined in this document are fully
implemented.  A summary of EPA’s rationale for reregistering and
managing risks associated with triclosan is presented below.  Where
labeling revisions are warranted, specific language is set forth in the
summary tables of Section V. of this document.

Performing Residential Activities

	There are no EPA registered products containing triclosan that can be
applied directly by the homeowner.  However, there is a homeowner
application of triclosan when it is used as an in-can preservative for
latex paint.  To estimate the potential risks associated with this
exposure, the Agency assessed handler exposures for the in-can
preservative use in paint.  The calculated inhalation MOEs are above the
target MOE of 1000 for the paint brush scenario but below the target MOE
for the airless sprayer scenario (i.e., MOE = 180).  Because the
estimated risks associated with treated paints exceeded EPA’s level of
concern by such a large degree – in some cases by more than several
orders of magnitude – the Agency believes that this use does not meet
the “no unreasonable adverse effects” criteria of FIFRA.  Personal
protective equipment (PPE) such as respirators is not a viable
mitigation option for residential paint uses for an in-can preservative.
 The paint use (inclusive of stains and coatings) has been requested to
be voluntarily cancelled by the registrants and is not eligible for
reregistration.  Once the action to terminate the paint use is
completed, any risks associated with triclosan-treated paint will be
mitigated.

Based on the aggregate risk assessment, the Agency believes that certain
other residential uses of triclosan (see Appendix A) result in
significantly lower exposure and risk. Therefore, residential uses other
than paints, stains, and coatings meet the “no unreasonable adverse
effects” criteria of FIFRA and are eligible for reregistration.

Performing Occupational Activities

There is the potential for workers to be exposed to triclosan during the
application of triclosan products in an occupational setting (handler
exposure). However, occupational post-application exposures are assumed
to be negligible based on the use patterns.  To estimate the potential
risks associated with occupational handler exposure, the Agency assessed
representative application scenarios including treated paints and the
industrial processes and water systems use for pulp and paper.

Short-term dermal irritation exposures and risks were not estimated for
occupational handler exposures.  Instead, dermal irritation exposures
and risks will be mitigated using default PPE requirements based on the
toxicity of the end-use products.  For occupational uses dermal
irritation risks are mitigated by requiring the user to wear PPE (e.g.,
chemical resistant gloves and clothing).  Mitigating with PPE is only a
viable option for pesticide-labeled products (i.e., a label is needed to
inform workers to wear PPE).  Therefore, the Agency often requires
workers using pesticide-labeled products (concentrated form) in the
manufacturing setting (where workers are applying the active ingredient
to the paint itself) to wear PPE to mitigate dermal irritation.
Conversely, for in-can material preservatives there is no pesticide
label that goes with the preserved product  to inform the
workers/painters that PPE is needed ( there is no pesticide label on a
can of paint).  Thus PPE is only a viable option in an occupational
setting where triclosan is being applied to the paint, but not a viable
option when occupational handlers are actually applying the paint
itself.

	For the intermediate-term dermal risks, the MOEs were above the target
MOE of 100, and therefore, not of concern except for the commercial
painter and material preservative uses for pulp and paper.  The
intermediate-term MOEs for using a paint brush/roller and an airless
sprayer are 31 and 1, respectively (target MOE = 100). Again, because
triclosan is used as a material preservative in the paint, the use of
chemical resistant gloves on the label is impractical. However, the
paint use (inclusive of stains and coatings) has been requested to be
voluntarily cancelled by the registrants.  Once the action to terminate
the paint use is completed, any risks associated with triclosan-treated
paint will be mitigated. For the pulp and paper use, dermal risks will
be mitigated by requiring the use of a closed delivery system.

For the occupational handler inhalation exposure and risk assessment,
the MOEs were below the target MOE for all scenarios except for the
brush application for paints.  The inhalation MOE for commercial use of
an airless sprayer for paints is 54 (target MOE = 1000), for liquid pour
and liquid pump during paint manufacturing 330 and 290 (target MOE =
1000), respectively.  The paint use (inclusive of stains and coatings)
has been requested to be voluntarily cancelled by the registrants.  Once
the action to terminate the paint use is completed, any risks associated
with triclosan-treated paint will be mitigated.  For the pulp and paper
use, inhalation risks can be mitigated by requiring the use of a closed
delivery system.

However, the Agency believes that certain other occupational uses of
triclosan (see Appendix A) result in significantly lower exposure and
risk.  Therefore, occupational uses other than paints, stains, and
coatings meet the “no unreasonable adverse effects” criteria of
FIFRA and are eligible for reregistration provided the mitigation
measures and associated label changes presented in Table 8 and Table 10
are implemented.

Ecological Risk Management

	A qualitative environmental risk assessment was performed using
monitoring levels of triclosan found in waterways and toxicity values
from the tables in section I of the Ecological Hazard and Environmental
Risk Assessment Science Chapter for the Triclosan Reregistration
Eligibility Decision (RED) Document, dated September 11, 2008 to develop
risk quotients (RQs) and compare them to levels of concern (LOCs) for
triclosan.  LOCs were not exceeded for fish but were exceeded for
aquatic plants.  In addition, the Agency performed consumer
environmental modeling for triclosan.  The consumer environmental
modeling assumed that all triclosan used in the manufacture of the
antimicrobial uses is released into surface waters.  After adjustments,
these models concluded that estimated concentrations of triclosan in
surface water do not exceed concentrations of concern for acute risk
presumptions for any of the aquatic organisms and plants (vascular and
non-vascular).  Considering the low probability of triclosan being
released into household wastewater and surface waters from the
antimicrobial uses, the Agency also concludes that chronic aquatic risks
are unlikely from consumer uses of triclosan-treated plastic and textile
items.  Therefore, Agency can reasonably conclude that the antimicrobial
uses of triclosan (e.g., triclosan-treated plastic and textile items in
households) are unlikely to contribute significant quantities of
triclosan into household wastewater and eventually to surface water.

	Environmental modeling and monitoring specific to plastic and textile
facilities, where triclosan is incorporated into these items, is
required.  The technical registrants will be required via the DCI to
sample effluents from such facilities and receiving (surface) waters
adjacent to these facilities, determining the extent and duration of
triclosan and major degradates/metabolites (e.g., triclosan methyl).
Prior to beginning the environmental monitoring the registrants must
submit a protocol to the Agency for approval.  Depending upon the
results of this modeling and monitoring effort, the following ecological
effects data may be required (these studies are held in reserve):

Freshwater invertebrate acute study (850.1010) [Technical Grade Active
Ingredient (TGAI)];

Estuarine/marine fish acute study (850.1075) (TGAI)];

Estuarine/marine shrimp acute study (850.1035) (TGAI);

Estuarine/marine mollusk acute study (850.1025) (TGAI);

Fish early life-stage (freshwater) study (850.1400) (TGAI);

Aquatic invertebrate (freshwater) life-cycle study (850.1300) (TGAI);

Fish life-cycle study (850.1500) (TGAI);

Acute sediment toxicity to freshwater invertebrates (850.1735) (TGAI);

Acute sediment toxicity to estuarine invertebrates (850.1740) (TGAI);
and

Additional plant toxicity testing:  an additional algal toxicity test
(850.5400) with the freshwater green alga, Selenastrum capricornutum;
and studies on the rooted freshwater macrophyte, rice (Oryza sativa) –
850.4225 and 850.4250 (2 tests on seedling emergence and vegetative
vigor)

Oyster bioconcentration study – BCF (850.1710) (major
degradate/metabolite of triclosan – e.g., methyl triclosan)

Fish bioconcentration study – BCF (850.1730) (major
degradate/metabolite of triclosan – e.g., methyl triclosan)

13) Chironomid sediment toxicity test (850.1790) (major
degradate/metabolite of triclosan – e.g., methyl triclosan)

14) Aquatic food chain transfer (850.1850) (major degradate/metabolite
of triclosan – e.g., methyl triclosan)

15) Chronic sediment toxicity to freshwater and/or estuarine
invertebrates (no guideline number) (TGAI)

	In addition, four studies to address bioaccumulation potential will
also be required via the DCI (850.1850; 850.1710; 850.1730; and
850.1790).  Prior to conducting these studies, the registrants must
submit protocols to the Agency for approval.

Risk Management Decision

	Triclosan uses presented in Appendix A are eligible for reregistration
provided that registrants comply with the requirements outlined in this
document including implementing risk mitigation measures, amending
product labels, and submitting required confirmatory data.  In addition,
the Agency is aware of recent research conducted by the Office of
Research and Development on the effects of triclosan on thyroid
homeostasis in the rat (US EPA, 2008). These data were considered in
selection of the incidental oral endpoint, but the current endpoint was
retained, as further investigation is needed on the effects of triclosan
on the thyroid.  The Agency will continue to monitor the toxicity
profile of triclosan and will amend the assessment as needed.  Further,
given the rapidly developing scientific database for triclosan, the
Agency intends to accelerate the schedule for the registration review
process for this chemical.  Currently, the Agency intends to begin that
process in 2013, ten years earlier than originally planned.

Risk Mitigation Measures

Products containing triclosan are eligible for reregistration provided
that the registrants implement the risk mitigation measures presented in
Table 8.  Specific label language to implement these measures is
presented in Table 10.  In the future, registrants may request that the
Agency remove or reduce certain restrictions or mitigation measures upon
submission of acceptable toxicity and exposure studies that demonstrate
to the Agency that risk exposure to triclosan is below the Agency’s
level of concern.

Table 8.  Risk Mitigation Measures for Triclosan

Use Site	Risk(s) of Concern	Mitigation Measures

Paints, Stains, and Coatings	Residential handler inhalation exposure to
triclosan in paint when applying paint	A request has been received by
the Agency from the registrants to voluntarily cancel the paint use
(inclusive of stains and coatings).  Once the action to terminate the
paint use is completed, any risks associated with triclosan-treated
paint will be mitigated.  A request has been received by the Agency to
voluntarily cancel this use.  Once completed this action will address
any exposure to triclosan resulting from this use.

	Occupational handler dermal and inhalation exposure to triclosan when
applied to paint in manufacturing setting

Occupational handler inhalation exposure to triclosan when applying
paint

	Pulp and Paper	Occupational handler inhalation and dermal exposure to
triclosan when applied during pulp and paper manufacturing (used in the
industrial water processing systems)	Closed systems must be used

Product Label Amendments

Manufacturing-Use Products and End-Use Products are to be amended to
reflect the mitigation measures presented in Table 8 and the label
amendments presented in Table 10 (see Section V).

Antimicrobial Resistance

	Antimicrobial resistance differs from antibiotic resistance, the latter
of which can be a concern in hospital or medical settings.  There is
currently some research attempting to demonstrate a connection between
antimicrobial resistance and antibiotic resistance in regard to
triclosan, but the linkage has not been expressly proven.   The Agency
continues to look into the issue of antimicrobial resistance and its
links to antibiotic resistance through review of current literature and
membership in the Interagency Task Force on Antimicrobial Resistance.
The Task Force has a number of goals stated in the Public Health Action
Plan to Combat Antimicrobial Resistance (  HYPERLINK
"http://www.cdc.gov/drugresistance/actionplan/aractionplan.pdf"
http://www.cdc.gov/drugresistance/actionplan/aractionplan.pdf ).  Though
none of the goals are associated with a specific active ingredient, many
of the activities are expected to further our understanding of the
processes involved with antimicrobial resistance, which may subsequently
further our understanding of any potential resistance from the use of
triclosan.  Some of the goals are as follows:

Evaluate the benefits and risks incorporating antimicrobial,
disinfectant, or antiseptic chemicals into consumer products (e.g.,
soap, toys, kitchen utensils, clothes, paints, plastics, and film
preservatives) and of applying disinfectants and sanitizers to hard,
non-porous surfaces such as food-contact surfaces, hospital premises,
bathrooms, etc.  Consider whether they have any efficacy in reducing
infection and/or may play a role in promoting drug resistance;

Convene an expert group to consider how to incorporate antimicrobial
resistance (AR) issues into regulations governing the registration and
use of antimicrobials and antibiotic pesticides.  Invite external
experts, stakeholders, and the  public to provide input;

Determine which organisms and susceptibility to specific antimicrobial
drugs should be under surveillance and create a mechanism for periodic
updating of this list;

Develop and implement procedures for monitoring antimicrobial use in
human medicine, agriculture, veterinary medicine, and consumer products;

Conduct pilot studies to assess the extent of environmental
contamination by antimicrobial drug residues and drug-resistant
organisms that enter the soil or water from human and animal wastes.  If
contamination is detected, conduct appropriate surveillance in waste,
surface and ground water, and soil from agricultural areas in which
waste is used for fertilizer, and conduct studies to determine potential
impact on human and animal health;

Gather information on the relationship between antimicrobial pesticide
and herbicide use and the emergence of drug-resistance by monitoring;

Establish an ongoing mechanism to obtain periodic input from external
experts on AR issues.  This process will include ensuring from
stakeholders and partners in developing and reviewing federal efforts to
address antimicrobial resistance

Post-RED Activities

	The Agency recognizes that there is a considerable amount of ongoing
research regarding triclosan.  The Agency will track the progress of
these studies and, as new scientific data becomes available, will review
this data.  The Agency will then determine what, if any, changes to the
risk assessment and risk management decision are necessary.   The Agency
will also continue to participate actively in the Interagency Task Force
on Antimicrobial Resistance described above and evaluate information
that results from that activity. Further, given the rapidly developing
scientific database for triclosan, the Agency intends to accelerate the
schedule for the registration review process for this chemical.
Currently, the Agency intends to begin that process in 2013, ten years
earlier than originally planned

What Registrants Need to Do  SEQ CHAPTER \h \r 1

	The Agency has determined that triclosan is eligible for reregistration
provided that the conditions and requirements for reregistration
identified in this RED are implemented (see Section IV).  The
registrants will also need to amend product labeling for each product.

	The database supporting the reregistration of triclosan has been
reviewed and determined to be adequate to support a reregistration
eligibility decision.  However, additional confirmatory data are
required to support continued registration.

Manufacturing Use Products

Generic Data Requirements

The generic database supporting the reregistration of triclosan for
currently registered uses has been reviewed and determined to be
adequate to support a reregistration eligibility decision.  However, the
confirmatory data presented in Table 9 are required. CMA, PHED,
environmental fate and surface water monitoring studies are all
required.  The ecological studies are being held in reserve pending the
outcome of the surface water monitoring studies.  Specific deadlines are
set forth in the generic data call-in (GDCI), including those for
submission of initial responses and/or request for time extensions or
data waivers as well as for other required steps.  Deadlines for
submitting generic data are also set forth in the GDCI.

Table 9. Generic Data Required to Support Triclosan Registrations

EPA Guideline Number	Requirement Name

Ecological Studies

Special Study for Surface Water Modeling	Environmental modeling and
monitoring specific to plastic and textile facilities where triclosan is
incorporated into these items

850.1710	Oyster Bioconcentration Test

850.1730	Fish Bioconcentration Test

850.1850	Aquatic Food Chain Transfer

850.1790	Chironomid sediment toxicity test

Environmental Fate Study

835.4400	Anaerobic Aquatic Metabolism

Confirmatory CMA and PHED Studies

875.1700	Product Use Information (applicator)

875.2700	Product Use Information (post-applicator)

875.2800	Description of Human Activity

875.12001	Dermal Indoor Exposure

875.14002	Inhalation Indoor Exposure

875.2300	Indoor Surface Residue Dissipation (infant assessment for
mouthing toys)

875.1600	Applicator Exposure Monitoring Data Reporting

875.2900	Data Reporting and Calculations

Studies to be Held in Reserve Pending Outcome of Surface Water
Monitoring Data

850.1010	Aquatic invertebrate acute toxicity, test, freshwater daphnids

850.1075	Fish acute toxicity test, marine

850.1035	Mysid acute toxicity test

850.1025	Oyster acute toxicity test (shell deposition)

850.1300	Daphnid chronic toxicity test

850.1400	Fish early-life stage toxicity test

850.1500	Fish life cycle toxicity

850.1735	Whole sediment acute toxicity invertebrates, freshwater

850.1740	Whole sediment acute toxicity invertebrates, marine

850.4225	Seedling emergence, Tier II

850.4250	Vegetative vigor, Tier II

850.5400	Acute Algal Dose-Response Toxicity – Green Algae (Selenastrum
Capricornutum)

850.1710	Oyster bioconcentration study – BCF  (major

 degradate/metabolite of triclosan – e.g., methyl triclosan)

850.1730	Fish bioconcentration study – BCF  (major
degradate/metabolite

of triclosan – e.g., methyl triclosan)

850.1790	Chironomid sediment toxicity test (major degradate/metabolite

of triclosan – e.g., methyl triclosan

850.1850	Aquatic food chain transfer (major degradate/metabolite of

triclosan – e.g., methyl triclosan)

No current guideline number	Chronic sediment toxicity to freshwater
and/or estuarine

invertebrates (no guideline number) (TGAI)

1 & 2       These studies are required for all manufacturing settings
where “liquid pour” is the application method of triclosan

	Environmental modeling and monitoring specific to plastic and textile
facilities, where triclosan is incorporated into these items, is
required.  The technical registrants are required to sample effluents
from such facilities and receiving (surface) waters adjacent to these
facilities, determining the extent and duration of triclosan and major
degradates/metabolites (e.g., triclosan methyl). Prior to beginning the
environmental monitoring the registrants must submit a protocol to the
Agency for approval.  Depending upon the results of this modeling and
monitoring effort, the above aforementioned ecological effects data may
be required (these studies are held in reserve).

	Four studies to address bioaccumulation potential will also be
called-in (850.1850; 850.1710; 850.1730; and 850.1790).  Prior to
conducting these studies, the registrants must submit protocols to the
Agency for approval.

Surrogate dermal and inhalation unit exposure values were taken from the
proprietary Chemical Manufacturers Association (CMA) antimicrobial
exposure study or from the Pesticide Handler Exposure Database (PHED).
Since the CMA data are of poor quality, the Agency requires that
confirmatory data be submitted to support the occupational scenarios
assessed in this document.  The quantities handled/treated were
estimated based on information from various sources, including HED’s
Standard Operating Procedures (SOPs) for Residential Exposure
Assessments (USEPA, 2000 and 2001), and personal communication with
experts.  The individuals contacted have experience in these operations
and their estimates are believed to be the best available without
undertaking a statistical survey of the uses.  In certain cases, no
standard values were available for some scenarios.  Assumptions for
these scenarios were based on AD estimates and could be further refined
from input from registrants.

For triclosan technical grade active ingredient products, the registrant
is required to submit the following items:

Within 90 days from receipt of the generic data call-in (DCI):

1.  Completed response forms to the generic DCI (i.e., DCI response form
and requirements status and registrant’s response form); and

	2.  Submit any time extension and/or waiver requests with a full
written justification.

Within the time limit specified in the generic DCI:

1.  Cite any existing generic data which address data requirements or
submit new generic data responding to the DCI.

Please contact Heather Garvie at<PHONE_NUMBER> with questions regarding
generic reregistration.

By US mail:					By express or courier service:

Document Processing Desk			Document Processing Desk

Heather Garvie				Heather Garvie

Office of Pesticide Programs	(7510P)	Office of Pesticide Programs
(7510P)

U.S. Environmental Protection Agency	U.S. Environmental Protection
Agency

1200 Pennsylvania Ave., NW			One Potomac Yard, Room S-4900

Washington, DC 20460-0001			2777 South Crystal Drive

						Arlington, VA 22202

B.	End-Use Products

Product Specific Data Requirements

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

The PDCI will set forth specific deadlines including those pertaining to
submission of response forms or requests for time extensions and/or
waivers as well as for other required steps. Deadlines for submitting
product-specific data will also be provided.

For end-use products containing the active ingredient triclosan, the
registrant needs to submit the following items for each product.

Within 90 days from the receipt of the product-specific data call-in
(PDCI):

1.  Completed response forms to the PDCI (i.e., PDCI response form and
requirements status and registrant’s response form); and

2.  Submit any time extension or waiver requests with a full written
justification.

Within eight months from the receipt of the PDCI:

1.  Two copies of the confidential statement of formula (EPA Form
8570-4);

2.  A completed original application for reregistration (EPA Form
8570-1).  Indicate on the form that it is an “application for
reregistration”;

3.  Five copies of the draft label incorporating all label amendments
outlined in Table 17 of this document;

4.  A completed form certifying compliance with data compensation
requirements (EPA Form 8570-34);

5.  If applicable, a completed form certifying compliance with cost
share offer requirements (EPA Form 8570-32); and

6.  The product-specific data responding to the PDCI.

	Please contact Emily Mitchell at<PHONE_NUMBER> with questions
regarding product reregistration and/or the PDCI.  All materials
submitted in response to the PDCI should be addressed as follows:

By US mail:					By express or courier service:

Document Processing Desk			Document Processing Desk

Emily Mitchell				Emily Mitchell

Office of Pesticide Programs (7510P)	Office of Pesticide Programs
(7510P)

U.S. Environmental Protection Agency	U.S. Environmental Protection
Agency

1200 Pennsylvania Ave., NW			Room S-4900, One Potomac Yard

Washington, DC 20460-0001			2777 South Crystal Drive

						Arlington, VA 22202

Labeling for End-Use Products

	To be eligible for reregistration, labeling changes are necessary to
implement measures outlined in Section IV.  Specific language to
incorporate these changes is presented in Table 10.  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.

	Registrants may generally distribute and sell products bearing old
labels/labeling for 26 months from the date of the issuance of this
Reregistration Eligibility Decision document.  Persons other than the
registrant may generally distribute or sell such products for 52 months
from the approval of labels reflecting the mitigation described in this
RED. However, 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.  Refer to “Existing Stocks of
Pesticide Products; Statement of Policy,” Federal Register, Volume 56,
No. 123, June 26, 1991.

Table 10. Required Label Changes for Manufacturing and End-Use Products
Containing Triclosan

Description	Triclosan: Required Labeling Language	Placement on Label

Manufacturing-Use Products

For all Manufacturing Use Products	“Only for formulation as a
preservative 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 Required by the RED and Agency Label
Policies 	“Do not discharge effluent containing this product into
lakes, streams, ponds, estuaries, oceans, or other waters unless in
accordance with the requirements of a National Pollution Discharge
Elimination System (NPDES) permit and the permitting authority has been
notified in writing prior to discharge.  Do not discharge effluent
containing this product to sewer systems without previously notifying
the local sewage treatment plant authority.  For guidance contact your
State Water Board or Regional Office of the EPA."	Precautionary
Statements

For all Manufacturing Use Products that have toys as a use site	“When
used for formulation as a materials preservative for toys, the active
ingredient amount must be limited to no more than 0.5%.”

	Directions for Use

For all Products that state paint as a use site on the label	The paint
use site must be removed from the label. 	Directions for Use

For all Manufacturing Use Products	“When used in industrial process
waters for the manufacture of pulp and paper, a closed delivery systems
must be used.”	Directions for Use

VI. APPENDICES

Triclosan   SEQ CHAPTER \h \r 1 Appendix A:  Use Patterns Eligible for
Reregistration

Use Site	Formulation	Method of Application	Application Rate/ No. of
applications	Use Limitations

Commercial, institutional and industrial premises and equipment

Air Conditioning Heat Exchange Coils	82523-1

	Spray (Fine Mist)	0.85 US pts./ 10 sq ft. (400 ml/ m2)  based on a 4”
(100 mm) deep coil at 12 FPI. 	For application by a service contractor

Residential and public access premises

Air Conditioning Heat Exchange Coils	82523-1

	Spray (Fine Mist)	0.85 US pts./ 10 sq ft. (400 ml/ m2)  based on a 4”
(100 mm) deep coil at 12 FPI. 	For application by a service contractor

Materials preservatives

Personal Care Products: bristles & Handles of brushes (tooth, hair)
combs, incontinence care products, razors	42182-1

	Incorporated into production of end use product	.1% - 1% a.i. based on
weight of finished product	Distributors of products containing the
additive may not make claims of antimicrobial activity other than the
protection of the product against the growth of bacteria, mold, mildew
and fungi in or on the treated product.

	83884-9	incorporated in the fiber/textile or applied directly to it	.1%
- 1% a.i. based on weight of finished product 	Not for use in diapers

Textiles & Fibers Sanitizer (natural and Synthetic in contact with
Human Skin)	3090-165

	Incorporated into production of end use product	0.7 to 1.0% of product
based on weight of finished product	Do not use in the manufacture or
treatment of items that may come in contact with food. Do not use for
production of baby diapers or fibers for the production of baby diapers.
Do not use for the production of health care products or products
intended to decrease the transmission of disease. Finished products
incorporating the product may not make claims of antimicrobial activity
that exceed what is permitted in PR Notice 2000-1

Home Furnishings: blankets, cloths, countertops, curtains, draperies,
linens, napkins

	 42182-1

	Incorporated into production of end use product	.1% - 1% a.i. based on
weight of finished product	Distributors of products containing the
additive may not make claims of antimicrobial activity other than the
protection of the product against the growth of bacteria, mold, mildew
and fungi in or on the treated product.

	83884-9	incorporated in the fiber/textile or applied directly to it	.1%
- 1% a.i. based on weight of finished product 	Not for use in diapers

Textiles

	6390-25

	Padding or Exhaustion	Apply to leave 0.25% - 1.0% of product on the dry
weight of the fiber.	For manufacturing use only.

	10466-42

	Application directly to the textile	Apply 1%-1.5% of the product based
on weight of material being treated	None Listed

	10466-24

	Exhaustion, padding or co-treatment with resins and softeners	Add at 1
to 3.5% on weight of material being treated	Do not use for any
applications involving direct or indirect food contact or human or
animal drinking water contact applications.

	3090-215

	Incorporation into fiber	0.1% to .5% of product based on the weight of
material being treated	Do not use in the manufacture or treatment of
items that may come in contact with food. Do not use for production of
baby diapers or fibers for the production of baby diapers. Do not use
for the production of health care products or products intended to
decrease the transmission of disease. Finished products incorporating
the product may not make claims of antimicrobial activity that exceed
what is permitted in PR Notice 2000-1

	10466-27

	Padding or Exhaustion	1 to 5% based on fabric weight and durability
requirements.  Inclusive of air filters, cleaning cloths, non-woven
wipes

	Not to be used on food contact surfaces

	10466-42	Incorporation into textiles	1%-1.5% based on weight of
finished product

10466-38	Incorporated into PVC used in coated or laminated textiles
0.05% - 0.3% based on weight of finished product

83884-7	Incorporation into textiles	Up to 5% of the product based on
weight of the finished product

42182-1	Incorporated into production of end use product	.1% - 1% a.i.
based on weight of finished product	Distributors of products containing
the additive may not make claims of antimicrobial activity other than
the protection of the product against the growth of bacteria, mold,
mildew and fungi in or on the treated product.

	3090-165

	Pad, jig or dyeback	0.7 to 1.0% of Product; can also be used for paper
and leather	Do not use in the manufacture or treatment of items that may
come in contact with food. Do not use for production of baby diapers or
fibers for the production of baby diapers. Do not use for the production
of health care products or products intended to decrease the
transmission of disease. Finished products incorporating the product may
not make claims of antimicrobial activity that exceed what is permitted
in PR Notice 2000-1

	70404-5	Incorporation into product or applied as finish	.1%-2% based on
weight of finished product	Not for use in diapers

	83884-10	Incorporation into product or applied as finish	.1%-2% based
on weight of finished product	Not for use in diapers

	83884-9	incorporated in the fiber/textile or applied directly to it	.1%
- 1% a.i. based on weight of finished product 	Not for use in diapers

Carpets & Rugs

	42182-1

	Incorporated into production of end use product	.1% - 1% a.i. based on
weight of finished product	Distributors of products containing the
additive may not make claims of antimicrobial activity other than the
protection of the product against the growth of bacteria, mold, mildew
and fungi in or on the treated product.

	10466-27	Padding; exhaustion	1-4% based on weight of finished product

83884-9	incorporated in the fiber/textile or applied directly to it	.1%
- 1% a.i. based on weight of finished product 	Not for use in diapers

Shoe & Boot Spray	10466-42	Spray	1%-1.5% based on weight of finished
product

	PVC (foils, films, coatings, artificial leather, plastisols, extruded
and injection moulded articles, PVC tiles and fibers)	3090-219

	Incorporated into production of end use product	Apply such that the
finished product contains 0.5% to 1.4% by weight of the additive	Do not
use in the manufacture or treatment of items that may come in contact
with food. Do not use for production of baby diapers or fibers for the
production of baby diapers. Do not use for the production of health care
products or products intended to decrease the transmission of disease.
Finished products incorporating the product may not make claims of
antimicrobial activity that exceed what is permitted in PR Notice 2000-1

Plastics	2829-139

	Incorporated into production of end use product	Up to 2.5% a.i.	When
used for formulation as a materials preservative for toys, the active
ingredient amount must be limited to no more than 0.5%.

	2829-145	Incorporated into production of end use product	Up to 2.5%
a.i.	When used for formulation as a materials preservative for toys, the
active ingredient amount must be limited to no more than 0.5%.

	3090-215	Incorporation into plastic	0.1% to .5% of product based on the
weight of material being treated	Do not use in the manufacture or
treatment of items that may come in contact with food. Do not use for
production of baby diapers or fibers for the production of baby diapers.
Do not use for the production of health care products or products
intended to decrease the transmission of disease. Finished products
incorporating the product may not make claims of antimicrobial activity
that exceed what is permitted in PR Notice 2000-1

	4822-429

	Incorporated into production of end use product	0.06% a.i.	Impregnated
plastic bag; not for use for food storage

	42182-1	Incorporated into production of end use product	.1% - 1% a.i.
based on weight of finished product (some examples include toys, cutting
boards, toothbrush bristles & handles, storage containers, brooms)
Active concentration is limited to 0.5% for toys and ice-making
equipment; Distributors of products containing the additive may not make
claims of antimicrobial activity other than the protection of the
product against the growth of bacteria, mold, mildew and fungi in or on
the treated product.

	70404-5	Incorporated into production of end use product	.1% - 1% a.i.
based on weight of finished product

83884-10	Incorporation into product or applied as finish	.1%-2% based on
weight of finished product

10466-38	Incorporation into finished product	5-10% of product based on
weight of finished product

83884-9	incorporated in the plastic or applied directly to it	.15% - 1%
a.i. based on weight of finished product

	Synthetic cellulosic sponges	10466-27	Incorporated into manufacturing
process	1-4% based on weight of finished product

	Polymer Compounds

	42182-1

	Incorporated into production of end use product	.1% - 1% a.i. based on
weight of finished product	Distributors of products containing the
additive may not make claims of antimicrobial activity other than the
protection of the product against the growth of bacteria, mold, mildew
and fungi in or on the treated product.

	70404-5

	Incorporated into manufacturing process	.1% - 1% a.i. based on weight
of finished product

83884-10	Incorporation into product or applied as finish	.1%-2% based on
weight of finished product

3090-215	Incorporation into polymer	0.1% to .5% of product based on the
weight of material being treated	Do not use in the manufacture or
treatment of items that may come in contact with food. Do not use for
production of baby diapers or fibers for the production of baby diapers.
Do not use for the production of health care products or products
intended to decrease the transmission of disease. Finished products
incorporating the product may not make claims of antimicrobial activity
that exceed what is permitted in PR Notice 2000-1

	83884-9	incorporated in the polymer or applied directly to it	.15% - 1%
a.i. based on weight of finished product

	Pulp & Paper	42182-1

	Incorporation into finished product	.1% - 1% a.i. based on weight of
finished product	When used in industrial process waters for the
manufacture of pulp and paper, a closed delivery systems must be used;
Distributors of products containing the additive may not make claims of
antimicrobial activity other than the protection of the product against
the growth of bacteria, mold, mildew and fungi in or on the treated
product.

	3090-165	Pad, jig or dyeback	1% of product	When used in industrial
process waters for the manufacture of pulp and paper, a closed delivery
systems must be used.

Do not use in the manufacture or treatment of items that may come in
contact with food. Do not use for production of baby diapers or fibers
for the production of baby diapers. Do not use for the production of
health care products or products intended to decrease the transmission
of disease. Finished products incorporating the product may not make
claims of antimicrobial activity that exceed what is permitted in PR
Notice 2000-1

Floor coverings (carpets, rugs, mats, sealer/wax components	42182-1
Incorporated into production of end use product	.1% - 1% a.i. based on
weight of finished product (for example: adhesives, caulking, tiles,
whirlpools)	Distributors of products containing the additive may not
make claims of antimicrobial activity other than the protection of the
product against the growth of bacteria, mold, mildew and fungi in or on
the treated product.

Inks, Dispersions, Pigment Presscakes	10466-27	Formulation into end use
products intended to treat the article itself.	1-4% based on weight of
product	Not for use in food-grade inks

Construction & building materials	42182-1

	Incorporated into production of end use product	.1% - 1% a.i. based on
weight of finished product (for example: adhesives, caulking, tiles,
whirlpools)	Distributors of products containing the additive may not
make claims of antimicrobial activity other than the protection of the
product against the growth of bacteria, mold, mildew and fungi in or on
the treated product.

Polyethylene Sleeves for Buried Conduits	10466-38	Incorporated into
production of end use product	Up to 2% based on weight of finished
product

	Adhesvies	10466-27	Incorporated into production of end use product	1-4%