SEQ CHAPTER \h \r 1 United States			Prevention, Pesticides		EPA
739-R-06-006

Environmental Protection		and Toxic Substances		July 2006

Agency				(7510P)

Reregistration Eligibility Decision for Alkylbenzene Sulfonates

  SEQ CHAPTER \h \r 1  TOC \f UNITED STATES ENVIRONMENTAL PROTECTION
AGENCY

WASHINGTON, D.C.  20460

OFFICE OF

PREVENTION, PESTICIDES

AND TOXIC SUBSTANCES

CERTIFIED MAIL

Dear Registrant:

	This is to inform you that the Environmental Protection Agency
(hereafter referred to as EPA or the Agency) has completed its review of
the available data and public comments received related to the
preliminary risk assessments for the antimicrobial   SEQ CHAPTER \h \r 1
alkylbenzene sulfonates (ABS).  The enclosed Reregistration Eligibility
Decision (RED) document was approved on July 27, 2006.

Based on its review, EPA is now publishing its Reregistration
Eligibility Decision (RED) and risk management decision for alkylbenzene
sulfonates and its associated human health and environmental risks.  A
Notice of Availability will be published in the Federal Register
announcing the publication of the RED.

The RED and supporting risk assessments for alkylbenzene sulfonates are
available to the public on the U.S. Federal Government website
HYPERLINK "http://www.regulations.gov"  www.regulations.gov . The docket
is EPA-HQ-OPP-2006-0156.

The alkylbenzene sulfonates RED was developed through EPA’s public
participation process, published in the Federal Register on September
10, 2004, which provides opportunities for public involvement in the
Agency’s pesticide tolerance reassessment and reregistration programs.
 Developed in partnership with USDA and with input from EPA’s advisory
committees and others, the public participation process encourages
robust public involvement starting early and continuing throughout the
pesticide risk assessment and risk mitigation decision making process.
The public participation process encompasses full, modified, and
streamlined versions that enable the Agency to tailor the level of
review to the level of refinement of the risk assessments, as well as to
the amount of use, risk, public concern, and complexity associated with
each pesticide.  Using the public participation process, EPA is
attaining its strong commitment to both involve the public and meet
statutory deadlines.

Please note that the alkylbenzene sulfonates risk assessment and the
attached RED document concern only this particular pesticide.  This RED
presents the Agency’s conclusions on the dietary, drinking water,
occupational, residential and ecological risks posed by exposure to
alkylbenzene sulfonates alone.  This document also identifies both
generic and product-specific data that the Agency intends to require in
Data Call-Ins (DCIs).  Note that DCIs, with all pertinent instructions,
will be sent to registrants at a later date.  Additionally, for
product-specific DCIs, the first set of required responses will be due
90 days from the receipt of the DCI letter.  The second set of required
responses will be due eight months from the receipt of the DCI letter.

As part of the RED, the Agency has determined that alkylbenzene
sulfonates will be eligible for reregistration provided that all the
conditions identified in this document are satisfied.  Sections IV and V
of this RED document describe the necessary labeling amendments for
end-use products and data requirements.  Instructions for registrants on
submitting the revised labeling can be found in the set of instructions
for product-specific data that will accompany this DCI.

If you have questions on this document or the label changes relevant to
this reregistration decision, please contact the Chemical Review
Manager, Heather Garvie, at<PHONE_NUMBER>.  For questions about product
reregistration and/or the Product DCI that will follow this document,
please contact Adam Heyward at<PHONE_NUMBER>.

						Sincerely,

						Frank T. Sanders

						Director, Antimicrobials Division

REREGISTRATION ELIGIBILITY

DECISION

for

Alkylbenzene Sulfonates

List D

CASE 4006

								Approved By:

					Frank T. Sanders				Director, Antimicrobials Division

								July 27, 2006

Attachment

Table of Contents

Alkylbenzene Sulfonates Reregistration Team
……………………………………	i

Glossary of Terms and
Abbreviations……………………………………………..	ii

Executive
Summary………………………………………………………
………....	iv

I.
Introduction……………………………………………………
…………………..

1

II. Chemical
Overview………………………………………………………
…….	...

3

	A. Regulatory
History……………………………………………………..
...	3

	B. Chemical Identification
………………………………………………...	4

                        1. Sodium Dodecylbenzene
Sulfonate………………………………	4

                                    a. Chemical
Overview……………………………………….	4

                                    b. Use
Profile…………………………………………………	4

	            2.  Dodecylbenzene Sulfonic
Acid…………………………………...	5

                                    a. Chemical
Overview……………………………………….	5

                                    b. Use
Profile…………………………………………………	6

                        3.  Benzenesulfonic acid, C10-16-alkyl
derivatives………………...	7

                                    a. Chemical
Overview……………………………………….	7

                                    b. Use
Profile…………………………………………………	7

III. Summary of Alkylbenzene Sulfonates Risk
Assessments…………………….	9

	A. Human Health Risk
Assessment………………………………………...	9

		1. Toxicity of Alkylbenzene Sulfonates
……………………………	9

		2. FQPA Safety
Factor………………………………………………	13

		3. Population Adjusted Dose
(PAD)………………………………...	13

			a. Acute PAD…………………………………………………
14

			b. Chronic PAD……………………………………………...
14

		4. Dietary Exposure
Assumptions…………………………………..	14

		5. Dietary (Food) Risk
Assessment………………………………….	15

			a. Acute and Chronic Dietary Risk ………………………...	15

			b. Dietary Exposure for Inert Ingredient Uses ……………	17

                                    c. Dietary Risk from Drinking
Water……………………...  	18

		6. Residential Risk
Assessment…...…………………………………	19

			a.
Toxicity………..…………………………………………...
19

			b. Residential Handler …..…………………………………..
21

                                                i. Exposure Scenarios,
Data and Assumptions……..	21

                                                ii. Residential Handler
Risk Estimates……………..	22

                                    c. Residential
Post-Application……………………………..	24

		7. Aggregate
Risk……………………………………………………	24

			a. Short-Term Aggregate Risk……………………………...	25

			b. Chronic Aggregate Risk ……………………………...…..
26

		8. Occupational Exposure and
Risk………………………………...	27

			a. Occupational Toxicity…………………………………….
28

			b. Occupational Handler Exposure…………………………	28

			c. Occupational Handler Risk Summary…………………...	28

                                    d. Occupational Post-Application
Exposure……………….	32

	B. Environmental Risk
Assessment………………………………………..	32

		1. Environmental Fate and
Transport……………………………...	32

		2. Ecological
Risk…………………………………………………….	33

                        3.  Risk to Listed
Species…………………………………………….	34

IV. Risk Management, Reregistration, and Tolerance Reassessment
Decision…	36

	A. Determination of Reregistration
Eligibility……………………………	36

	B. Public Comments and
Responses……………………………………….	36

	C. Regulatory
Position………………………………………………………
37

		1. Food Quality Protection Act
Findings…………………………...	37

			a. "Risk Cup" Determination……………………………….	37

			b. Determination of Safety to U.S. Population…………….	37

			c. Determination of Safety to Infants and Children………	38

			d. Endocrine Disruptor Effects……………………………..	38

			e. Cumulative Risks………………………………………….
39

		2. Tolerance
Summary………………………………………………	39

	D. Regulatory
Rationale……………………………………………………..
41

		1. Human Health Risk Management……………………………….
41

			a. Dietary (Food) Risk Mitigation………………………….	41

			b. Drinking Water Risk Mitigation………………………..	41

			c. Residential Risk Mitigation………………………………	41

			d. Occupational Risk Mitigation……………………………	42

				i. Handler Risk Mitigation ………………………….	42

				ii. Post-Application Risk Mitigation….…………….	42

		2. Environmental Risk Management…………………………...…..
42

		3. Listed Species
Considerations…………………………..………..	42

			a. The Endangered Species Act…….……………………….	42

			b. General Risk Mitigation…………...……………………..
43

V. What Registrants Need to
Do……………………………………………………	44

	A. Manufacturing-Use
Products……………………………………………	46

		1. Additional Generic Data Requirements…………………………
46

		2. Labeling for Technical and Manufacturing-Use Products……..	46

	B. End-Use
Products…………………………………………………...…
…	46

		1. Additional Product-Specific Data Requirements………….........
46

	2. Labeling for End-Use Products that Contain Alkylbenzene
Sulfonates as an Inert
Ingredient…………………………………………...	48

VI.
Appendices……………………………………………………
………………….	49

	A. Table of Use Patterns for Alkylbenzene Sulfonates
…………………...	50

	B. Table of Generic Data Requirements and Studies Used to Make the
Reregistration
Decision……………………………………………………...
57

	C. Technical Support
Documents…………………………………………..	63

	D. Bibliography
Citations…………………………………………………...	65

	E. Generic Data
Call-In……………………………………………………..	69

	F. Product Specific Data
Call-In……………………………………………	70

	G. Batching of End-Use
Products…………………………………………..	71

	H. List of All Registrants Sent the Data
Call-In…………………………...	72

	I. List of Available
Forms…………………………………………………...	73

Alkylbenzene Sulfonates Reregistration Team

  SEQ CHAPTER \h \r 1 Health Effects Risk Assessment

Deborah Smegal

Ayaad Assaad

Talia Milano

Cassi Walls

Kerry Leifer

Najm Shamim

Robert Quick

Ecological Risk Assessment

Rick Petrie

Environmental Fate Risk Assessment

Talia Milano

Registration Support

Adam Heyward

Risk Management

Heather Garvie

Jennifer Slotnick

GLOSSARY OF TERMS AND ABBREVIATIONS  XE "Glossary of Terms and
Abbreviations"

a.i.		Active Ingredient

aPAD		Acute Population Adjusted Dose

APHIS		Animal and Plant Health Inspection Service

ARTF		Agricultural Re-entry Task Force

BCF		Bioconcentration Factor

CDC		Centers for Disease Control

CDPR		California Department of Pesticide Regulation

CFR		Code of Federal Regulations

ChEI		Cholinesterase Inhibition

CMBS		Carbamate Market Basket Survey

cPAD		Chronic Population Adjusted Dose

CSFII		USDA Continuing Surveys for Food Intake by Individuals

CWS		Community Water System

DCI		Data Call-In

DEEM		Dietary Exposure Evaluation Model

DL		Double layer clothing {i.e., coveralls over SL}

DWLOC	Drinking Water Level of Comparison

EC		Emulsifiable Concentrate Formulation

EDSP		Endocrine Disruptor Screening Program

EDSTAC	Endocrine Disruptor Screening and Testing Advisory Committee

EEC		Estimated Environmental Concentration.  The estimated pesticide
concentration in an environment, such as a terrestrial ecosystem.

EP		End-Use Product

EPA		U.S.  Environmental Protection Agency

EXAMS		Tier II Surface Water Computer Model

FDA		Food and Drug Administration

FFDCA		Federal Food, Drug, and Cosmetic Act

FIFRA		Federal Insecticide, Fungicide, and Rodenticide Act

FOB		Functional Observation Battery

FQPA		Food Quality Protection Act

FR		Federal Register

GL		With gloves

GPS		Global Positioning System

HIARC		Hazard Identification Assessment Review Committee

IDFS		Incident Data System

IGR		Insect Growth Regulator

IPM		Integrated Pest Management

RED		Reregistration Eligibility Decision

LADD		Lifetime Average Daily Dose

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

LCO		Lawn Care Operator

LD50		Median Lethal Dose.  Statistically derived single dose causing
death in 50% of the test animals when administered by the route
indicated (oral, dermal, inhalation), expressed as a weight of substance
per unit weight of animal, e.g., mg/kg.

LOAEC		Lowest Observed Adverse Effect Concentration

LOAEL		Lowest Observed Adverse Effect Level

LOC		Level of Concern

LOEC		Lowest Observed Effect Concentration

mg/kg/day	Milligram Per Kilogram Per Day

MOE		Margin of Exposure

MP		Manufacturing-Use Product

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

MRL		Maximum Residue Level

N/A		Not Applicable

NASS		National Agricultural Statistical Service

NAWQA	USGS National Water Quality Assessment

NG 		No Gloves

NMFS		National Marine Fisheries Service

NOAEC		No Observed Adverse Effect Concentration

NOAEL		No Observed Adverse Effect Level

NPIC		National Pesticide Information Center

NR		No respirator

OP		Organophosphorus

OPP		EPA Office of Pesticide Programs

ORETF		Outdoor Residential Exposure Task Force

PAD		Population Adjusted Dose

PCA		Percent Crop Area

PDCI		Product Specific Data Call-In

PDP		USDA Pesticide Data Program

PF10		Protections factor 10 respirator

PF5		Protection factor 5 respirator

PHED		Pesticide Handler’s Exposure Data

PHI		Pre-harvest Interval

ppb		Parts Per Billion

PPE		Personal Protective Equipment

PRZM		Pesticide Root Zone Model

RBC		Red Blood Cell

RED		Reregistration Eligibility Decision

REI		Restricted Entry Interval

RfD		Reference Dose

RPA		Reasonable and Prudent Alternatives

RPM		Reasonable and Prudent Measures

RQ		Risk Quotient

RTU		(Ready-to-use)

RUP		Restricted Use Pesticide

SCI-GROW	Tier I Ground Water Computer Model

SF		Safety Factor

SL		Single layer clothing

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

STORET	Storage and Retrieval

TEP		Typical End-Use Product

TGAI		Technical Grade Active Ingredient

TRAC 		Tolerance Reassessment Advisory Committee

TTRS		Transferable Turf Residues

UF		Uncertainty Factor

USDA		United States Department of Agriculture

USFWS		United States Fish and Wildlife Service

USGS		United States Geological Survey

WPS		Worker Protection StandardEXECUTIVE SUMMARY  XE "Executive
Summary"

The Environmental Protection Agency (hereafter referred to as EPA or the
Agency) has completed preliminary risk assessments and its review of
error correction and public comments on the human health and
environmental risk assessments for alkylbenzene sulfonates and is
issuing its risk management decision.  The Agency will accept public
comments on this decision and supporting documents for 60 days following
publication.  The Agency has decided alkylbenzene sulfonates are
eligible for reregistration provided all measures outlined in this
document are implemented.  If during the comment period the Agency
receives new or additional information that substantially changes the
risk assessment findings or the risk management decision, the Agency
will issue an amendment to this document.

	Alkylbenzene sulfonates are used largely as food-contact sanitizers in
food processing plants and eating establishments.  They are also used as
disinfectants and sanitizers for agricultural, commercial,
institutional, industrial, and public access uses.  Approximately
300,000 pounds of alkylbenzene sulfonates are used in EPA registered
antimicrobial products.  However, the largest overall use of
alkylbenzene sulfonates is in household laundry and dish detergents.
The alkylbenzene sulfonates   SEQ CHAPTER \h \r 1 are listed on the EPA
High Production Volume (HPV) Challenge Program.  HPV chemicals are those
that are manufactured or imported into the U.S. in production volumes
greater than one million pounds per year.

Overall Risk Summary

An acute dietary assessment was not conducted because there are no
adverse effects attributable to a single dose seen in animal studies.
Chronic dietary risk estimates were provided for the general U.S.
population and all population subgroups.  All chronic dietary risk
estimates are below the Agency’s level of concern.

Because there are no adverse effects attributable to acute exposure, an
acute aggregate assessment was not conducted.  An intermediate-term
aggregate assessment was not conducted because there are no residential
exposures of this duration.  Therefore, only short-term and chronic
aggregate assessments were conducted.  In addition, because there are no
long-term residential exposures, the chronic aggregate assessment only
considered food and drinking water exposures.  The short-term aggregate
assessment considers both the active and inert uses of the alkylbenzene
sulfonates.  The chronic aggregate assessment considers average dietary
exposure (food and drinking water) from both the active food contact
sanitizer uses and the inert uses on agricultural commodities.  The
dietary exposures from the fruit and vegetable wash were not considered
because it would be overly conservative to assume simultaneous exposure
to alkylbenzene sulfonates from three different use patterns.   The
short-term aggregate oral and inhalation risks are not of concern for
adults or children.  In addition, the chronic aggregate assessment found
no risk of concern for children or adults.

	The Agency’s human heath risk assessment indicates that there are
four occupational handler inhalation scenarios with MOEs less than the
target of 100.  These four scenarios have MOEs between 90 and 93.
Although these MOEs are below the Agency target of 100, the Agency is
not requiring mitigation since the risk assessment is based on
conservative assumptions and the MOEs are very close to the target so
that the Agency does not have risk concerns.

	Dermal exposures were not considered in the risk assessment because a
toxicological endpoint was not established for this route of exposure.

An environmental risk assessment was also conducted for alkylbenzene
sulfonates.  Due to limited potential for environmental exposure,
environmental risks are below the Agency’s level of concern.

Dietary Risk

The Agency conducted three chronic dietary exposure and risk assessments
for alkylbenzene sulfonates: (1) as an active ingredient in food contact
sanitizing solutions; (2) as an active ingredient in a fruit and
vegetable wash; and (3) as an inert ingredient in pesticide formulations
that may be applied to growing agricultural crops, raw agricultural
commodities after harvest, and to animals.  An acute dietary assessment
was not conducted because there are no adverse effects attributable to a
single dose in animal studies.

The dietary risk estimates for the active ingredient, total food contact
sanitizing uses are below the Agency’s level of concern for the
general U.S. population for all age groups (less than 11% of the cPAD).
The dietary risk estimates for the fruit and vegetable wash are also
below the Agency’s level of concern for all age groups (less than
71.2% of the cPAD).

The dietary risk estimates for the inert ingredient uses are below the
Agency’s level of concern for the general U.S. population (24% of the
cPAD) and all population subgroups (84% of the cPAD for children 1-2
years of age).  There is no concern for aggregate food and drinking
water exposures to the alkylbenzene sulfonates resulting from their use
as inert ingredients in pesticide products.

The chronic dietary risk assessment concludes that risk estimates are
below the Agency’s level of concern for the general U.S. population
and all subpopulations.  Therefore, no mitigation measures are
necessary.

Drinking Water Risk

There are no currently registered outdoor uses of alkylbenzene
sulfonates as active ingredients.  However, the potential exists for
transport into drinking water resulting from the pesticidal inert
ingredient uses of alkylbenzene sulfonates.  Therefore, the Agency
estimated drinking water concentrations resulting from the inert
ingredient uses of these substances.  The Agency did not estimate acute
drinking water risks for the inert ingredient use because an acute
dietary endpoint (i.e., aPAD) was not selected as there were no effects
attributable to a single dose exposure in animal studies.  The Agency
concluded that there are no risk concerns for the general U.S.
population and all population subgroups for drinking water exposures to
the alkylbenzene sulfonates as pesticide inert ingredients.

Residential Risk

Residential handler and post-application exposure scenarios were
assessed using high end exposure scenarios, end-use product application
methods and use rates for inert uses.  For each of the use scenarios,
the Agency assessed residential handler (applicator) inhalation exposure
and post application incidental ingestion by toddlers.  All margins of
exposure (MOEs) for short-term inhalation exposure for residential
handlers are above the target MOE of 100 and, therefore, not of concern,
with the exception of the flea and tick product where the MOE was 87.
However, this screening level assessment was conducted using
conservative assumptions because it assumes a person treats his/her pet
with 0.5 cans of flea product that contains 24% alkylbenzene sulfonates
every day for a month.  All MOEs for residential post-application
exposure are above the target of MOE of 100 and, therefore, are not of
concern.  Therefore the Agency does not have risk concerns.

Aggregate Risk

The chronic aggregate assessment considers average dietary exposure
(food and drinking water) from both the active food contact sanitizer
uses and the inert uses on agricultural commodities.  The dietary
exposures from the fruit and vegetable wash were not considered because
it would be overly conservative to assume simultaneous exposure to
alkylbenzene sulfonates from three different use patterns.  Oral and
inhalation exposure and risk estimates were conservatively combined for
the aggregate risk assessment.  Both short-term and chronic aggregate
assessments were conducted.  The short-term aggregate oral and
inhalation risks are not of concern for adults, as the total aggregate
MOE is 340 which is greater than the target of 100.  For children, the
aggregate risk estimate is very close to the target MOE of 100 (MOE=99).
 Because of the conservative nature of the assessment, the Agency does
not have any risks of concern for children.  The chronic aggregate
assessment found no risk of concern for children or adults.

Occupational Risk

	The Agency’s human heath risk assessment indicates that there are
four occupational handler inhalation scenarios with MOEs less than the
target of 100.  These four scenarios have MOEs between 90 and 93.  The
Agency is not requiring mitigation because the conservative assumptions
used in the risk assessment, combined with the nearness of the MOE to
the target, do not suggest concerns.

	For most of the occupational scenarios, postapplication dermal exposure
is not expected to occur or is expected to be negligible based on the
application rates and chemical properties of alkylbenzene sulfonates.

Alkylbenzene sulfonates are dermal irritants at concentrations greater
than 20%.  Almost all of the labels require the use of gloves by
workers.

Ecological Risk

	Minimal or no environmental exposure to terrestrial or aquatic
organisms is expected to occur from the majority of alkylbenzene
sulfonate antimicrobial indoor pesticide uses given that only a very
small number of total alkylbenzene sulfonates pounds are used for these
purposes.

Available data suggest that the alkylbenzene sulfonates may be more
toxic to aquatic organisms as the number of carbons in the chain
increase.  Available data also indicate that the alkylbenzene sulfonates
are slightly toxic to green algae.

The inert agricultural uses of alkylbenzene sulfonates are not expected
to adversely affect avian or mammalian species on an acute or chronic
basis. Aquatic organisms are also not expected to be adversely affected
by inert alkylbenzene sulfonates use acutely or chronically due to the
low estimated level of alkylbenzene sulfonates in water.

Use of alkylbenzene sulfonates in agricultural pesticide formulations is
not expected to result in significant environmental exposure, therefore,
no adverse effects (NE) to listed species are anticipated.

Regulatory Decision

The Agency has completed its review and has determined that the data are
sufficient to support reregistration of all supported products
containing alkylbenzene sulfonates.  The Agency is issuing this RED for
alkylbenzene sulfonates, as announced in a Notice of Availability
published in the Federal Register.  The RED and supporting risk
assessment documents for alkylbenzene sulfonates are available to the
public on the U.S. Federal Government website   HYPERLINK
"http://www.regulations.gov"  www.regulations.gov . The docket is
EPA-HQ-OPP-2006-0156.

This RED document includes guidance and time frames for making any
necessary label changes for products containing alkylbenzene sulfonates.

Summary of Mitigation Measures

Since no risks of concern were identified, no specific mitigation
measures are needed for alkylbenzene sulfonates.

Data Requirements

Additional confirmatory data is required to complete the reregistration
of alkylbenzene sulfonates.  A complete list of data gaps is presented
Section V and Appendix B (Table of Generic Data Requirements).  In
addition, product-specific data is required for all products containing
alkylbenzene sulfonates as described in Section V of this document.

I.  Introduction  XE "I. Introduction"

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was
amended in 1988 to accelerate the reregistration of products with active
ingredients registered prior to November 1, 1984 and amended again by
the Pesticide Registration Improvement Act of 2003 to set time frames
for the issuance of Reregistration Eligibility Decisions.  The amended
Act calls for the development and submission of data to support the
reregistration of an active ingredient, as well as a review of all
submitted data by the U.S. Environmental Protection Agency (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 the pesticide; to determine the need for
additional data on health and environmental effects; and to determine
whether or not the pesticide meets the “no unreasonable adverse
effects” criteria of FIFRA.

On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was
signed into law.  This Act amends FIFRA to require tolerance
reassessment.  The Agency has decided that, for those chemicals that
have tolerances and are undergoing reregistration, the tolerance
reassessment will be initiated through this reregistration process.  The
Act also requires that by 2006, EPA must review all tolerances in effect
on the day before the date of the enactment of the FQPA.  FQPA also
amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require a
safety finding in tolerance reassessment based on factors including
consideration of cumulative effects of chemicals with a common mechanism
of toxicity.  This document presents the Agency’s revised human health
and ecological risk assessments and the Reregistration Eligibility
Decision (RED) for alkylbenzene sulfonates (ABS).

	The alkylbenzene sulfonates case is comprised of three active
ingredients: sodium dodecylbenzene sulfonate, dodecylbenzene sulfonic
acid and alklybenzene sulfonic acid. Sodium dodecylbenzene sulfonate and
dodecylbenzene sulfonic acid (DDBSA) were first registered with the EPA
on September 25, 1968 and February 24, 1969.  C10-16 alkylbenzene
sulfonic acid was registered on September 20, 1988.

As the case currently stands, sodium dodecylbenzene sulfonate (PC Code
079010) has three active products.  Dodecylbenzene sulfonic acid (PC
Code 098002) has 18 active products.    C10-16-alkylbenzene sulfonic
acid (PC Code 190116) has one active product.  For a list of all the
current products, please see Appendix A.  In addition, these chemicals
are also used as inert ingredients in other pesticide products.

	Alkylbenzene sulfonates are antimicrobial pesticides that are used
largely as food-contact sanitizers in food processing plants and eating
establishments.  They are also used as disinfectants and sanitizers for
agricultural, commercial, institutional, industrial, and public access
uses.

	Tolerance exemptions for the active food-contact sanitizer uses of
these ingredients have been established and can be found at 40 CFR
180.940(b) and (c).

	The Agency has concluded that the FQPA Safety Factor for alkylbenzene
sulfonates should be removed (equivalent to 1X), based on the available
data and the risk assessment that does not underestimate risks for
infants and children.   A number of developmental studies via the oral
route have been performed with alkylbenzene sulfonates in rats, mice and
rabbits.  The available information in these studies does not suggest
any qualitative or quantitative evidence for susceptibility between the
fetuses and maternal animals.  The alkylbenzene sulfonates were tested
in several multigeneration studies in rats, and there were no effects on
offspring in any of these tests at doses up to 250 mg/kg/day.

The Food Quality Protection Act (FQPA) requires that 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.  The reason for consideration of other substances is due to
the possibility that low-level exposures to multiple chemical substances
that cause a common toxic effect by a common toxic mechanism could lead
to the same adverse health effect that would occur at a higher level of
exposure to any of the substances individually.  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 for alkylbenzene sulfonates and any other substances.
Alkylbenzene sulfonates do not appear to produce a toxic metabolite
produced by other substances.  For the purposes of this action,
therefore, EPA has not assumed that alkylbenzene sulfonates have a
common mechanism of toxicity with other substances.  For information
regarding EPA’s efforts to determine which chemicals have a common
mechanism of toxicity and to evaluate the cumulative effects of such
chemicals, see the policy statements released by EPA’s Office of
Pesticide Programs concerning common mechanism determinations and
procedures for cumulating effects from substances found to have a common
mechanism on EPA’s website at     HYPERLINK
"http://www.epa.gov/pesticides/cumulative."
http://www.epa.gov/pesticides/cumulative.

This document presents the Agency’s decision regarding the
reregistration eligibility of the registered uses of alkylbenzene
sulfonates.  In an effort to simplify the RED, the information presented
herein is summarized from more detailed information which can be found
in the technical supporting documents for alkylbenzene sulfonates
referenced in this RED.  The revised risk assessments and related
addenda are not included in this document, but are available in the
Public Docket at     HYPERLINK "http://www.epa.gov/edocket"
www.regulations.gov .

This document consists of six sections.  Section I is the Introduction.
Section II, Chemical Overview, provides regulatory history, a profile of
the use and usage of alkylbenzene sulfonates and a basic overview of the
chemical.  Section III, Summary of Alkylbenzene Sulfonates Risk
Assessments, gives an overview of the human health and environmental
assessments, based on the data available to the Agency.  Section IV,
Risk Management, Reregistration, and Tolerance Reassessment Decision,
presents the reregistration eligibility and risk management decisions.
Section V, What Registrants Need to Do, summarizes the necessary label
changes based on the risk mitigation measures, if any, outlined in
Section IV.  Finally, the Appendices list all use patterns eligible for
reregistration, bibliographic information, related documents and how to
access them, and Data Call-In (DCI) information.II. Chemical Overview
XE "II. Chemical Overview"

A.  Regulatory History   XE "II. Chemical Overview:A. Regulatory
History"

	The alkylbenzene sulfonates case is comprised of three active
ingredients.  Sodium dodecylbenzene sulfonate (PC Code 079010) and
dodecylbenzene sulfonic acid or DDBSA (PC Code 098002) were first
registered with the EPA on September 25, 1968 and February 24, 1969,
respectively.  C10-16-alkylbenzene sulfonic acid (PC Code 190116) was
not registered until 1988.  According to the unregistered technical
manufacturers, at least some of the technical material contains a carbon
mixture (C10-16) in the alkyl string and not pure C12 (as the name
dodecyl- implies).  As the case currently stands, sodium dodecylbenzene
sulfonate has three active products.  Dodecylbenzene sulfonic acid has
18 active products.  C10-16-alkylbenzene sulfonic acid has one active
product.

	These chemicals are antimicrobials used largely as food-contact
sanitizers in food processing plants and eating establishments.  They
are also used as disinfectants and sanitizers for agricultural,
commercial, institutional, industrial, and public access uses.  In
addition to the pesticidal uses, the linear alkylbenzene sulfonate (LAS)
surfactants are used in laundry and dish detergents as well as many
other common uses.  As inert ingredients in pesticide products, the
chemicals are used in residential and outdoor agricultural settings.

The DDBSA Steering Committee/Joint Venture (“Joint Venture”) formed
on January 23, 1992 in response to EPA’s October 23, 1989 notice
initiating reregistration under FIFRA § 4 for List D of active
pesticide ingredients.  Current Joint Venture Members include:  Acuity
Specialty Products/Zep;  Alex C. Fergusson, Inc.;  Anderson Chemical
Co.;  DeVere Chemical Co., Inc.;  Ecolab, Inc.;  Hydrite Chemical Co.;
JohnsonDiversey, Inc.;  Morgan-Gallacher, Inc.;  Oakite Products, Inc.;
Quadra Chemical, Inc.;  Thatcher Company;  and West Agro, Inc.

Exemptions from the requirement of a tolerance for the active
food-contact sanitizer uses of these ingredients have been established
in the 40 CFR 180.940(b) and (c).

B.  Chemical Identification

Figure 1: Sodium Dodecylbenzene Sulfonate (also named as dodecylbenzene
sulfonic acid, sodium salt)

1.  Sodium Dodecylbenzene Sulfonate (079010)

a. Chemical Overview

	Common Name:			Sodium dodecylbenzene sulfonate

Chemical Name:			Alkyl(C12) benzenesulfonic acid, sodium salt

						Benzenesulfonic acid, dodecyl-, sodium salt

						Dodecylbenzene sodium sulfonate

						Dodecylbenzenesulfonic acid, sodium salt

						Sodium laurylbenzenesulfonate

	OPP Chemical Codes: 		079010

CAS Registry No.:  			25155-30-0

Case Number:			4006

Empirical Formula:			C18H29NaO3S / C12H25C6H4SO3Na

Molecular Weight:  			348.5

Highest Percentage of Active:	3.6%

End-Use Product Distributors:	Oakite Products Inc.

Microcide Inc.

b. Use Profile

Type of pesticide:			Disinfectant 			Sanitizer

					Microbiocide			Microbiostat

					Bacteriocide			Bacteriostat

Use Sites:

FOOD HANDLING/STORAGE ESTABLISHMENT PREMISES AND EQUIPMENT

	Fruit and Vegetable Wash Water

	Food Processing, Handling, and Storage Plant Surfaces, Equipment, and
Premises

	Milk and Dairy Processing Plant Surfaces, Equipment, and Premises

	Meat and Poultry Processing Plant Surfaces, Equipment, and Premises

	Eating Establishment Food Contact Surfaces, Equipment and Utensils

	Food Dispensing Equipment

	Vending Machines

	Soft Custard Equipment

COMMERCIAL, INSTITUTIONAL, INDUSTRIAL PREMISES AND EQUIPMENT

	Mine Acid Control

2.  Dodecylbenzene Sulfonic Acid (098002)

a. Chemical Overview

	Common Name:			Dodecylbenzene sulfonic acid

	Chemical Name:  			Dodecylbenzene sulfonic acid

	OPP Chemical Codes: 		098002

CAS Registry No.:			27176-87-0

Case Number:  			4006

∙SO3H

Molecular Weight:  			326.5

Highest Percentage of Active:	15.67%

End-Use Product Distributors:	Anderson Chemical Co.	Diverseylever

					ZEP Manufacturing Co.	Ecolab, Inc.

					Hydrite Chemical Co.		West Argo Inc.

					Devere Company Inc.		US Chemical Corp.

					Morgan-Gallacher Inc.	Drexel Chemical Co.

					FiveStar Affiliates Inc

Alex C. Fergusson, Inc.

International Chemical Corp.

Chemical Systems of Florida Inc.

b. Use Profile:

	Type of Pesticide:			Sanitizer			Disinfectant

						Virucide			Bacteriocide

						Bacteriostat

	Use Sites:

	AGRICULTURAL PREMISES AND EQUIPMENT

	Dairy Farms (enclosed premise treatment)

	Milking Equipment

	Teat Liner

FOOD HANDLING/STORAGE ESTABLISHMENTS PREMISES AND EQUIPMENT

	Dairy Equipment, Premises, and Utensils

	Milk Storage (bulk)

	Fruit and Vegetable Wash Water

	Food/Milk Transportation Vehicles

	Food Processing Plant Equipment, Premises, and Surfaces

	Bakery Processing Equipment

	Brewery Process Plant Equipment and Surfaces

	Cannery Processing Equipment

	Milk and Dairy Processing Plant Equipment, Premises, and Surfaces

Potato Washing Machines

Fruit and Vegetable Processing Equipment

Meat and Poultry Processing Plant Equipment, Premises, and Surfaces

Winery Processing Equipment

Egg Processing Equipment

Beverage Processing Equipment and Surfaces

Fish Processing Equipment

Eating Establishment Equipment, Glassware, Utensils, Surfaces

Food Vending Machines

Food Dispensing Equipment

Food Store/Market/Supermarket Premises

	Seed Houses/Stores/Storage Areas/Warehouses

COMMERCIAL, INSTITUTIONAL, INDUSTRIAL PREMISES AND EQUIPMENT

	Research Animal Facilities (enclosed premise treatment)

	Zoo Premises (enclosed premise treatment)

	Airports

	Campgrounds

	Commercial Transportation Facilities

	Aircraft (non feed/food)

	Buses (non feed/food)

	Ships

	Railroad Trains

Commercial Premises and Equipment

Shower Stalls

Urinals

Toilet Bowls

RESIDENTIAL AND PUBLIC ACCESS PREMISES

	Boat Premises

	Automobiles

MEDICAL PREMISES AND EQUIPMENT

	Sickroom Premises

3.  Benzenesulfonic acid, C10-16-alkyl derivatives (190116)

a. Chemical Overview

	Common Name:			Benzenesulfonic acid, C10-16-alkyl derivs.

	Chemical Name:  			C10-16-Alkylbenzene sulfonic acid

	OPP Chemical Codes: 		190116

CAS Registry No.:			68584-22-5

Case Number:  			4006

Empirical Formula:  		C16-22H30O3S / C10-16H25C6H4∙SO3H

Molecular Weight:  			324

Highest Percentage of Active:	25.6%

End-Use Product Distributors:	Kay Chemical Co.

Quadra Chemicals, Inc.

b. Use Profile:

	Type of Pesticide:			Sanitizer		Bacteriocide

						Bacteriostat

	Use Sites:

	AGRICULTURAL PREMISES AND EQUIPMENT

	Dairy/Milking Equipment and Utensils

FOOD HANDLING/STORAGE ESTABLISHMENTS PREMISES AND EQUIPMENT

	Milk Storage (bulk)

	Food Processing Plant Equipment and Surfaces

Meat and Poultry Processing Plant Equipment and Premises

	Milk and Dairy Processing Plant Equipment and Premises

Beverage Processing Plant Equipment, Premises, and Surfaces

Eating Establishment Equipment, Utensils, and Surfaces

III. Summary of Alkylbenzene Sulfonates Risk Assessments  XE "III.
Summary of 2,4-DB Risk Assessments"

	The purpose of this summary is to assist the reader by identifying the
key features and findings of these risk assessments and to help the
reader better understand the conclusions reached in the assessments.
The human health and ecological risk assessment documents and supporting
information listed in Appendix C were used to formulate the safety
finding and regulatory decision for alkylbenzene sulfonates.  While the
risk assessments and related addenda are not included in this document,
they are available from the U.S. Federal Government Public Docket at
HYPERLINK "http://epa.gov/dockets."  www.regulations.gov.   The docket
identification number is EPA-HQ-OPP-2006-0156. 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.

A.  Human Health Risk Assessment

The Agency’s use of human studies in the alkylbenzene sulfonates 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.    XE "III. Summary of 2,4-DB Risk
Assessments:A. Human Health Risk Assessment"

1.  Toxicity of Alkylbenzene Sulfonates  XE "III. Summary of 2,4-DB Risk
Assessments:A. Human Health Risk Assessment: 1. Toxicity of 2,4-DB"

	A brief overview of the toxicity studies used for determining endpoints
in the risk assessments are outlined below in Table 1.  Further details
on the toxicity of alkylbenzene sulfonates can be found in the
“Alkylbenzene Sulfonates (ABS) Toxicology Chapter for the
Reregistration Eligibility Decision (RED) Document,” dated July 06 ,
2006; and “  SEQ CHAPTER \h \r 1 Sulfonates (ABS) Revised Risk
Assessment for the Reregistration Eligibility Decision (RED)
Document,” dated July 19, 2006. These documents are available on the
U.S. Federal Government Public Docket website at www.regulations.gov.

	The Agency has reviewed all toxicity studies submitted for alkylbenzene
sulfonates and has determined that the toxicological database is
sufficient for reregistration.  The studies have been submitted to
support guideline requirements.  Major features of the toxicology
profile are presented in Table 1.

Table 1.  Acute Toxicity Studies for Alkylbenzene Sulfonates

Guideline No./ Study Type

MRID No.

Results

Toxicity Category

870.1100 Acute oral toxicity	43498402

43498408

43498430	LD50 = range from 404 to over 5000 mg/kg 	III-IV

870.1200 Acute dermal toxicity	94032006	LD50 = 1200 mg/kg	II

870.1300 Acute inhalation toxicity	Open Literature	LC50 = 0.31 mg/L	II

870.2400 Acute eye irritation	43498405	Corneal opacity not reversed at
72 hours.	I

870.2500 Acute dermal irritation	40359306	Severe irritation at 72 hours
II

870.2600 Skin sensitization	Open Literature	Non-Sensitizer

	  SEQ CHAPTER \h \r 1  The doses and toxicological endpoints selected
by the Agency for the various exposure scenarios are summarized below in
Table 2.

Table 2. Summary of Toxicological Dose and Endpoints for Alkylbenzene
Sulfonates

Exposure

Scenario	Dose Used in Risk Assessment, UF 	Special FQPA SF*, endpoint
and Level of Concern for Risk Assessment	Study and Toxicological Effects

Acute Dietary

(All populations)	No endpoint was selected.  No effects are attributable
to a single dose in animal studies.

Chronic Dietary

(All populations)	Systemic/

Reproductive NOAEL= 50  mg/kg/day

UF = 100

Chronic RfD =

 0.5 mg/kg/day

	FQPA SF = 1X

cPAD =

chronic RfD

 FQPA SF

= 0.5 mg/kg/day	NOAEL = 40 mg/kg/day (0.07%) and LOAEL= 114 mg/kg/day
(0.2%) based on increased caecum weight and slight kidney damage in a 6
month rat dietary study (Yoneyama et al  1972  Ann. Rep. Tokyo Metrop.
Res. Lab. Public Health 24:409-440)

plus

Systemic/Reproductive NOAEL = 50 mg/kg/day and LOAEL = 250 mg/kg/day
based on decreased Day 21 female pup body weight (Buehler, E. et al.
1971. Tox. Appl. Pharmacol. 18:83-91)

plus

NOAEL = 85 mg/kg/day and LOAEL= 145 mg/kg/day from 9 month drinking
water rat study based on decreased body weight gain, and serum/
biochemical and enzymatic changes in the liver and kidney  (Yoneyama et
al. 1976 Ann. Rep. Tokyo Metrop. Res. Lab. Public Health 27(2):105-112)

General Toxicity Observations

Acute Toxicity. Alkylbenzene sulfonates exhibit a wide range of acute
toxicity via the oral route in rats (LD50s of 404 – 1980 mg/kg), with
a narrower range in mice (LD50s of 1259-2300 mg/kg).  This spans the
acute oral toxicity categories of III-IV.  Alkylbenzene sulfonates are
classified as acute toxicity category II for the dermal and inhalation
routes of exposure.  They are irritants to the eye (category I) and skin
(category II), and are not skin sensitizers.

Absorption, Distribution, Metabolism, Excretion.  In animal tests (oral
– monkeys, pigs, rats), alkylbenzene sulfonates are readily absorbed
from the gastrointestinal tract, are distributed throughout the body,
and are extensively metabolized.  Excretion is via both the urine and
feces.  Available dermal absorption data (rats and guinea pigs) indicate
that alkylbenzene sulfonates are poorly absorbed from the skin, although
prolonged contact may lead to irritation and thus compromise the skin to
permit more absorption (WHO, 1996 and HERA, 2004).

Repeated Dose Toxicity (Subchronic and Chronic).  There have been many
oral repeated dose studies performed with alkylbenzene sulfonates
ranging from a 28-day study in monkeys to nine month studies conducted
with rats and mice.  There have also been repeated dose dermal (guinea
pigs, rabbits, and rats) and inhalation studies (dogs and monkeys).
Collectively, animal data suggests that the liver, kidney and caecum
(for oral studies) are the major target organs for toxicity.  The liver
and kidney effects were dose and duration related in that mild effects
(organ weight changes and serum enzyme/clinical chemistry changes
indicative of mild organ effects) were seen at lower doses, but
increased in severity with both dose and time.

For the purposes of this hazard assessment, several studies were
considered collectively to determine a no-observable adverse effect
level (NOAEL) of 50 mg/kg/day for the chronic dietary endpoint.  This is
based on:  increased caecum weight and slight kidney damage (at a NOAEL
of 40 mg/kg/day and at a LOAEL of 114 mg/kg/day in the six month rat
study); reduced body weight in 21-day old pups (at a NOAEL of 50
mg/kg/day and a LOAEL of 250 mg/kg/day in a reproductive toxicity rat
study); and significant decreases in renal biochemical parameters (at a
NOAEL of 85 mg/kg/day and a LOAEL of 145 mg/kg/day in a nine month
drinking water study in rats).

Developmental Toxicity.  A number of developmental studies via the oral
and dermal routes have been performed with alkylbenzene sulfonates in
rats, mice and rabbits; there were also several subcutaneous injection
developmental studies reported in mice (WHO, 1996).  In these
developmental studies, there is varying quality in the more than 20
studies submitted.  However, it is concluded that some developmental
effects (including some terata) were observed at high doses at which
maternal toxicity was observed and the available information does not
suggest any qualitative or quantitative susceptibility differences
between fetuses and maternal animals.

Reproductive Toxicity.  Alkylbenzene sulfonates were tested in several
multigeneration studies in rats.  There were no effects on reproductive
parameters in any of these tests at doses up to 250 mg/kg/day.

Carcinogenicity.  The available long-term studies that assessed
carcinogenicity were older studies (pre-1970) that would not be
acceptable under current standards due to low number of animals used,
insufficient number of doses and duration of dosing, and limited
histopathological examinations.  However, the limited studies provide no
evidence of carcinogenicity in animals given alkylbenzene sulfonates
orally.

Genotoxicity.  The toxicological data show that alkylbenzene sulfonates
were not genotoxic in vitro or in vivo.

Neurotoxicity.  There is no evidence in the available toxicity studies
or scientific literature to indicate neurotoxic effects of the
alkylbenzene sulfonates in humans or laboratory animals.

Endocrine Disruption Potential.  EPA is required under the Federal Food
Drug and Cosmetic Act (FFDCA), as amended by FQPA, to develop a
screening program to determine whether certain substances (including all
pesticide active and other ingredients) “may have an effect in humans
that is similar to an effect produced by a naturally occurring estrogen,
or other such endocrine effects as the Administrator may designate.”
Following recommendations of its Endocrine Disruptor and Testing
Advisory Committee (EDSTAC), EPA determined that there was a scientific
basis for including, as part of the program, the androgen and thyroid
hormone systems, in addition to the estrogen hormone system.  EPA also
adopted EDSTAC’s recommendation that the Program include evaluations
of potential effects in wildlife.  For pesticide chemicals, EPA will use
FIFRA and, to the extent that effects in wildlife may help determine
whether a substance may have an effect in humans, FFDCA authority to
require the wildlife evaluations.  As the science develops and resources
allow, screening of additional hormone systems may be added to the
Endocrine Disruptor Screening Program (EDSP).  When the appropriate
screening and/or testing protocols being considered under the Agency’s
Endocrine Disrupting Screening Program (EDSP) have been developed,
alkylbenzene sulfonates may be subjected to additional screening and/or
testing to better characterize effects related to endocrine disruption.

2.  FQPA Safety Factor  XE "III. Summary of 2,4-DB Risk Assessments:A.
Human Health Risk Assessment: 2. FQPA Safety Factor"

	The FQPA Safety Factor (as required by the Food Quality Protection Act
of 1996) is intended to provide an additional 10-fold safety factor
(10X), to protect for special sensitivity in infants and children to
specific pesticide residues in food, drinking water, or residential
exposures, or to compensate for an incomplete database.  The FQPA Safety
Factor has been removed (i.e., reduced to 1X) for alkylbenzene
sulfonates based on: (1) a lack of evidence that alkylbenzene sulfonates
will induce neurotoxic effects, (2) no quantitative or qualitative
evidence of increased susceptibility to the fetus following in utero
exposure in the prenatal developmental toxicity studies, and (3) no
quantitative or qualitative evidence of increased susceptibility to the
offspring when adults are exposed in the two-generation reproductive
study.  The FQPA Safety Factor assumes that the exposure databases
(food, drinking water, and residential) are complete and that the risk
assessment does not underestimate the potential risk for infants and
children.  These criteria have been met for alkylbenzene sulfonates.
Based on the analysis of submitted developmental toxicity studies, the
Agency determined that no special FQPA Safety Factor was needed since
there were no residual uncertainties for pre- and/or postnatal toxicity.

3.  Population Adjusted Dose (PAD)  XE "III. Summary of 2,4-DB Risk
Assessments:A. Human Health Risk Assessment: 3. Population Adjusted Dose
(PAD)"

	Dietary risk is characterized in terms of the Population Adjusted Dose
(PAD), which reflects the reference dose (RfD), either acute or chronic,
that has been adjusted to account for the FQPA Safety Factor (SF).  This
calculation is performed for each population subgroup.  A risk estimate
that is less than 100% of the acute or chronic PAD is not of concern.

	a. Acute PAD  XE "III. Summary of 2,4-DB Risk Assessments:A. Human
Health Risk Assessment: 3. Population Adjusted Dose (PAD): a. Acute PAD"

Acute dietary risk is assessed by comparing acute dietary exposure
estimates (in mg/kg/day) to the acute Population Adjusted Dose (aPAD).
Acute dietary risk is expressed as a percent of the aPAD.  An acute
dietary assessment for alkylbenzene sulfonates was not conducted because
there are no adverse effects attributable to a single dose exposure in
animal studies.

b. Chronic PAD  XE "III. Summary or 2,4-DB Risk Assessments:A. Human
Health Risk Assessment: 3. Population Adjusted Dose (PAD): b. Chronic
PAD"

	Chronic dietary risk for alkylbenzene sulfonates is assessed by
comparing chronic dietary exposure estimates (in mg/kg/day) to the
chronic Population Adjusted Dose (cPAD).  Chronic dietary risk is
expressed as a percent of the cPAD.  The cPAD is the chronic reference
dose (0.5 mg/kg/day) modified by the FQPA safety factor.  The chronic
RfD is 0.5 mg/kg/day for all populations, using a NOAEL of 50 mg/kg/day
based on a weight of evidence from three toxicological studies that
observed decreased pup body weight at 250 mg/kg/day and increased caecum
weight, slight kidney damage at 114 mg/kg/day and significant decreases
in renal biochemical parameters at 145 mg/kg/day.  The NOAELs in the
three studies used to develop the chronic endpoint are 40, 50 and 85
mg/kg/day as shown in Table 2. An uncertainty factor of 100 (10X for
interspecies extrapolation, 10X for intraspecies variability) was
applied to the NOAEL to obtain the chronic RfD.  The alkylbenzene
sulfonates cPAD is 0.5 mg/kg/day based on a reference dose of 0.5
mg/kg/day, which includes the incorporation the FQPA safety factor (1X)
for the overall U.S. population or any population subgroups.

Dietary Exposure Assumptions   XE "III. Summary of 2,4-DB Risk
Assessments:A. Human Health Risk Assessment: 4. Exposure Assumptions"

Chronic dietary exposure assessments for alkylbenzene sulfonates were
conducted for the following uses: (1) as active ingredients in food
contact sanitizing solutions; (2) as active ingredients in a fruit and
vegetable wash; and (3) as inert ingredients in pesticide formulations
that may be applied to growing agricultural crops, raw agricultural
commodities after harvest, and to animals (pet product).

In the absence of residue data for residues of alkylbenzene sulfonates
on treated food contact surfaces, the Agency estimated residue levels
that may occur in food from the application rates on food contact
surfaces.  As mentioned previously, to determine the Estimated Daily
Intake (EDI), the Agency has used an FDA model.  The maximum percentage
of active ingredient for dodecylbenzene sulfonates in food handling
establishments from the various labels is 400 ppm.   The Agency
estimates that use of this product results in food residues of 530  SEQ
CHAPTER \h \r 1  ppb (µg/kg).  The Agency assumed that food can contact
4000 cm2 of treated surfaces, utensils, glassware, or pots and pans and
that 100% of the pesticide migrates to food based on the standard
assumptions used in the FDA Sanitizing Solution Guidelines.  It was
assumed that an adult and child consume 3000 and 1500 grams of food per
day, respectively that will contact the treated surfaces.

The Agency used the FDA milk truck model to estimate residues in milk
that could result from the use of alkylbenzene sulfonates in the food
processing equipment, as representative of the potential uses in the
food processing industry.  As a conservative measure, the Agency
assessed the maximum application rate of 400 ppm for dodecylbenzene
sulfonates, as listed on the labels, although the current tolerance
exemption has a limitation of 5.5 ppm for dairy processing equipment.
The Agency estimates that use of this product results in maximum milk
residues of 10  SEQ CHAPTER \h \r 1  ppb (µg/kg).  The Agency will be
proposing a change to the 40 CFR 180.940(b) to have the end-use
concentration not to exceed 400 ppm, rather than the current limitation
of 5.5 ppm.

The Agency also estimated dietary exposure from the fruit and vegetable
wash of the alkylbenzene sulfonates.  This use is regulated by the FDA
in 21 CFR 173.315, which permits the wash solution to contain
dodecylbenzene sulfonic acid up to a maximum application rate of 0.2%
(2000 ppm), without a potable rinse.  The Agency assumed this maximum
application rate of 2000 ppm in wash solution, along with assumptions
for Thompson Seedless grapes as a surrogate to represent residues on all
treated fruits and vegetables.  The model estimates dodecylbenzene
sulfonic acid residues of 9.25 ppm.  Most of the pesticide labels are in
compliance with this limitation.  One label however, allows a vegetable
wash solution containing 0.31% (3100 ppm) dodecylbenzene sulfonic acid,
but requires a potable rinse following washing.  The Agency plans to
establish 0.2% as the maximum application rate that can be used without
a potable rinse.

As inert ingredients in pesticide formulations, a conservative screening
level dietary exposure model, Exposure Evaluation Model (DEEM™), was
used that assumed 100% of all commodities, and 100% of all crops were
treated with the alkylbenzene sulfonates, with no limitation on the
fraction of inert ingredient.  A complete explanation of the assumptions
used in the generic screening model for estimating inert ingredient
dietary exposure is given in Appendix A of the Inert Ingredient Dietary
Risk Assessment for Linear Alkyl Benzenesulfonate.

Dietary (Food) Risk Assessment

a. Acute and Chronic Dietary Risk

		Generally, a dietary risk estimate that is less than 100% of the acute
or chronic PAD does not exceed the Agency’s risk concerns.  A summary
of chronic risk estimates for active uses is shown in Table 3.  A
summary of chronic risk estimates for inert uses is shown in Table 4.
SEQ CHAPTER \h \r 1   XE "III. Summary of 2,4-DB Risk Assessments:A.
Human Health Risk Assessment: 5. Dietary (Food) Risk Assessment"  Based
on the pesticide labels, the Agency assessed dietary exposure that could
result from the use of alkylbenzene sulfonates in the food service
industry (treated surfaces, dishes, utensils, glassware, pots and pans),
in the food processing industry (food processing equipment such as
breweries and beverage plants, meat and poultry processing plants, milk
and dairy products/packing plants etc), and as a fruit and vegetable
wash.  For additional information, please see the Dietary Exposure
Assessments for the Reregistration Eligibility Decision and the Inert
Ingredient Dietary Risk Assessment for Linear Alkyl Benzenesulfonate
documents.

The daily estimates for food handling establishments, food processing
equipment and the fruit and vegetable wash were conservatively used to
assess chronic dietary risks, which are shown below in Table 3.  As
noted previously, an acute dietary assessment was not conducted because
there were no adverse effects attributable to a single dose exposure in
animal studies.

The dietary risk estimates for the total food contact sanitizing uses
are below the Agency’s level of concern for all age groups (less than
11% of the cPAD).  In addition, the dietary risk estimates for the fruit
and vegetable wash for adults and young children are below the
Agency’s level of concern for all age groups (less than 71.2% of the
cPAD).  These risk estimates are based on a number of conservative
assumptions, and thus may overestimate the actual risks.

Table 3.  Summary of Dietary Exposure and Risk for Alkylbenzene
Sulfonates

Pesticidal Active Uses

Use	Population Subgroup	Chronic Dietary

Dietary Exposure

(mg/kg/day) a	% cPAD b

Food Service Industry (treated surfaces, utensils, glassware, etc)	adult
male	0.023  	4.6

	females (13-50 years)	0.027	5.4

	infants/children	 0.053	10.6

Food Processing Industry (Food Processing Equipment) 	adult male	0.00043
0.086

	females (13-50 years)	0.0005	0.1

	infants/children	0.001	0.2

Total Food Contact Surface Sanitizing Uses	adult male	0.023	4.6

	females (13-50 years)	0.027	5.4

	infants/children	0.054	10.8

Fruit and Vegetable Wash	U.S population	  0.0979	19.6

	children 1-2 yrs	0.3558	71.2

	children 3-5 yrs	0.2573	51.5

NA=not applicable

a-- 	chronic exposure analysis based on body weights of 70 kg, 60 kg,
and 15 kg for adult males, females and children, respectively.

b--	%PAD = dietary exposure (mg/kg/day) / cPAD, where cPAD=0.5 mg/kg/day
for all populations.

	              b. Dietary Exposure for Inert Ingredient Uses

Included in this RED is the reassessment of alkylbenzene sulfonates when
used as an inert ingredient in pesticide products. Alkylbenzene
sulfonates are used as solvents, surfactants, dispersants, detergents,
or wetting agents.  Some of these products are designed for use in
agricultural settings (pre- and post-harvest and when applied to
animals), where there is a potential for dietary exposure.

 Inert Dietary Exposure Assumptions

cluded in the Dietary Exposure Evaluation Model (DEEM™).  The
conservative nature of this assessment is believed to capture all
potential dietary exposures, including those from direct application to
animals.

	The alkylbenzene sulfonates assessed in this document are constituents
of a larger group of compounds that have a tolerance exemption as an
inert ingredient in 40 CFR 180.910 and 180.930.   The tolerance
exemption is listed as Alkyl (C8-C24) benzenesulfonic acid and its
ammonium, calcium, magnesium, potassium, sodium and zinc salts.

Inert Dietary Risk from Food

Table 4 provides a summary of the results of the chronic dietary risk
estimates for alkylbenzene sulfonates as an inert ingredient.

Based on the use of the screening level inert ingredient dietary
exposure model, there are no risk concerns associated with dietary
exposures as the estimated dietary exposures for the U.S. population and
all population subgroups are below 100% of the cPAD.  As noted, a number
of conservative assumptions were used in this screening level dietary
risk assessment of inert uses.

Table 4.  Summary of Dietary Exposure and Risk for Alkylbenzene
Sulfonates as Inert Ingredients

Population Subgroup	Chronic Dietary

	Dietary Exposure

(mg/kg/day) 	% cPAD a

U.S. population	0.12  	24

females (13-50 years)	0.087	17

children 1-2 yrs	 0.422	84

children 3-5 yrs	0.31	62

a--	%PAD = dietary exposure (mg/kg/day) / cPAD, where cPAD=0.5 mg/kg/day
for all population

c. Dietary Risk from Drinking Water

The drinking water exposure analysis is based on a derivation of
estimated upper bound drinking water concentrations from these
substances’ use as pesticidal inert ingredient from the FQPA Index
Reservoir Screening Tool (FIRST).  The results of the FIRST modeling
analysis and the conservative assumptions utilized as inputs into the
inert ingredient drinking water exposure assessment model are provided
in Appendix B of the Inert Ingredient Dietary Risk Assessment for Linear
Alkyl Benzenesulfonate.

For chronic drinking water exposures to linear alkylbenzene sulfonates
as inert ingredients, the Drinking Water Level of Comparison (DWLOC)
range for chronic exposure is 38-1500 µg/L for the general U.S.
population and 8-500 µg/L for children 1-2 years old.  The Estimated
Drinking Water Concentration (EDWC) used to assess chronic (non-cancer)
dietary risk from drinking water is 6.6 µg/L.  The chronic estimated
concentration is below the DWLOCs for the general U.S. population and
all population subgroups.  Drinking water risks, therefore, are not of
concern.

	The Agency did not estimate acute drinking water risks for the inert
ingredient use because an acute dietary endpoint (i.e., aPAD) was not
selected as there were no effects attributable to a single dose
exposure.

The estimated chronic drinking water concentration and drinking water
level of concern for chronic exposure to linear alkyl benzenesulfonates
is given in Table 5.

Table 5.  Chronic Drinking Water Exposure Estimates for

Inert Ingredient Uses of Alkylbenzene Sulfonates

Population Subgroup	EDWC1

(µg/L)	%cPAD2	DWLOC3 (µg/L)

U.S. Population (total)	6.6	<0.1%	38 -1,500

Children (1-2 years)	6.6	<0.1%	8 - 500

1 Estimated Drinking Water Concentration (EDWC) for chronic drinking
water exposure as determined by the use of FIRST modeling analysis
described above for inert ingredient use.  [The EDWC for linear alkyl
benzenesulfonates is the value reported as the “Adjusted Annual
Average (Chronic) Untreated Water

Concentration”]

2 %cPAD = drinking water exposure (mg/kg/day) /  cPAD, where cPAD=0.5
mg/kg/day for all populations.  It was assumed that a 15 kg child
ingests 1 L water per day and that a 70 kg adult ingests 2L water per
day.

3 Drinking Water Level of Comparison (DWLOC) is the maximum contribution
from water allowed in the diet based on food and drinking water from
inert use only.  In this case, since the allowable risk contribution
from food is based on a screening level model, the use of a single,
deterministic value for the DWLOC is not appropriate.  Rather a DWLOC
range is given, with the values in the range corresponding to an upper
value of range of drinking water concentrations ranging from 100% of the
cPAD (i.e., assuming no food exposure) to a lower value that considers
food exposures to be at the dietary screening level value.

6.  Residential Risk Assessment

	Residential exposure assessment considers all potential pesticide
exposure, other than exposure due to residues in food or in drinking
water. Exposure may occur during treatment of outdoor residential turf,
while cleaning indoor hard surfaces, or while using pet flea and tick
products. Each route of exposure (oral, dermal, inhalation) is assessed,
where appropriate, and risk is expressed as a Margin of Exposure (MOE),
which is the ratio of estimated exposure to an appropriate NOAEL. Based
on its use patterns, alkylbenzene sulfonates has been assessed for the
residential mixing/loading/applicator (or “handler”) exposure for
applications by homeowners using an aerosol spray or by using a
ready-to-use liquid with a low pressure hand wand, a hose or a
sprinkling can. An inhalation post-application assessment was not
conducted because the vapor pressure of the alkylbenzene sulfonates is
extremely low (5.1x10-10 to 6x10-15 mmHg).  In addition, a dermal
assessment was not conducted because of the lack of a dermal
toxicological endpoint.  Post application incidental ingestion by
toddlers that may contact turf, hard surfaces or a pet treated with
pesticide products containing alkylbenzene sulfonates is expected to be
minimal, and all the scenarios evaluated have MOEs above 100.

a. Toxicity

The toxicological endpoints and associated uncertainty factors used for
assessing the non-dietary risks for alkylbenzene sulfonates are listed
in Table 6.

A MOE greater than or equal to 100 is considered adequately protective
for the residential exposure assessment for the incidental oral and
inhalation routes of exposure. The MOE of 100 includes 10X for
interspecies extrapolation and 10X for intraspecies variation.

Table 6. Summary of Toxicological Dose and Endpoints for Assessing
Occupational and Residential Risk for Alkylbenzene Sulfonates

Exposure

Scenario	Dose Used in Risk Assessment, UF 	Special FQPA SF*, endpoint
and Level of Concern for Risk Assessment	Study and Toxicological Effects

Short-Term Incidental Oral (1-30 days)

	Oral NOAEL= 50 mg/kg/day

UF = 100	Residential LOC for MOE < 100 	NOAEL = 40 mg/kg/day (0.07%) and
LOAEL= 114 mg/kg/day (0.2%) based on increased caecum weight and slight
kidney damage in a 6 month rat dietary study (Yoneyama et al  1972  Ann.
Rep. Tokyo Metrop. Res. Lab. Public Health 24:409-440)

plus

Systemic/Reproductive NOAEL = 50 mg/kg/day and LOAEL = 250 mg/kg/day
based on decreased Day 21 female pup body weight (Buehler, E. et al.
1971. Tox. Appl. Pharmacol. 18:83-91)

plus

NOAEL = 85 mg/kg/day and LOAEL= 145 mg/kg/day from 9 month drinking
water rat study based on decreased body weight gain, and serum/
biochemical and enzymatic changes in the liver and kidney  (Yoneyama et
al. 1976 Ann. Rep. Tokyo Metrop. Res. Lab. Public Health 27(2):105-112)

Short-, Intermediate- and Long-Term Inhalation (1 to 30 days, 1-6
months, >6 months)

	Inhalation study NOAEL= 1mg/m3 detergent dust combined with up to 0.1
mg/m3 enzyme dust

Equivalent to approximately 0.14 mg/kg/day (a)

(inhalation absorption rate = 100%)

purity= 13% active ingredient

UF = 100	Residential LOC for MOE < 100

Occupational LOC for MOE < 100 	Subchronic Inhalation Monkey Study

LOAEL = 10 mg/m3 detergent combined with 0.1 mg/m3 enzyme dust.
Toxicological effect is weight loss and decreased weight gain (W.
Coates, et al 1978. Tox. Appl. Pharmacol. 45: 477-496)  This air
concentration is equivalent to approximately 1.4 mg/kg/day (a)

Dermal Endpoint	Quantification of dermal risk is not required since: 1)
the alkylbenzene sulfonates are surfactants that are dermal irritants at
concentrations generally greater than 20% solution.  The requirement of
the dermal toxicity studies with the end-use products will determine the
personal protective clothing necessary to protect against irritation
during product use; 2) no systemic toxicity was seen following repeated
dermal applications to rabbits at 200 mg/kg/day (with an end use
product), and  3) no developmental toxicity concerns were seen following
repeated dermal applications to pregnant mice, rats or rabbits
(developmental effects were seen either in the presence of maternal
toxicity or at doses higher than those that caused maternal toxicity).

Cancer (oral, dermal, inhalation)	No evidence of carcinogenicity in
reported studies in rats

Equation used to convert inhalation air concentration to a dose= mg/L*
absorption*respiratory volume (L/hr)*duration (hrs) * activity factor /
body weight.  Thus, 0.001 mg/L * 1*67.94 L/hr (based on default
respiratory volumes for a New Zealand Rabbit which is used as a
surrogate for a cynomolgus monkey) * 6 hrs * 1 / 2.98 kg (body weight
for New Zealand Rabbit used as a surrogate for cynomolgus monkey, study
reports monkey body weight ranges from 1.6 to 3.7 kg).

b. Residential Handler

i. Exposure Scenarios, Data and Assumptions

Residential exposure may occur for alkylbenzene sulfonates during
applications of turf treatment, hard surface cleaners and pet flea and
tick products. A number of assumptions, or estimates, such as adult body
weight and area treated per application, are made by the Agency for
residential risk assessment. Also, note that residential handlers are
sometimes addressed somewhat differently than occupational handlers in
that homeowners are assumed to complete all elements of an application
(mix/load/apply) without the use of personal protective equipment.

The quantitative exposure/risk assessment developed for residential
handlers is based on these scenarios:

	1)	outdoor residential turf treatment (ready to use liquid),

	2)	indoor hard surface cleaner (ready to use liquid), and

	3)	pet flea and tick products (aerosol can spray).

	For the purposes of this screening level assessment, the Agency
selected representative scenarios for the vast majority of products,
based on end-use product application methods and use amounts.  The above
scenarios reflect high-end exposure and risk estimates for all products
represented in a residential setting.

For most residential scenarios, the Agency used EPA’s Pesticide Inert
Risk Assessment Tool (PiRat) to estimate residential applicator and
post-application exposures and risks from the use of alkylbenzene
sulfonates as an inert ingredient in representative residential
products.  For the assessment of the pet products and hard surface
cleaners, the Agency used assumptions in the Residential Standard
Operating Procedures (SOPs).  Typically, most products used in a
residential setting result in exposures occurring over a short-term
duration.  Thus, the residential handler and postapplication scenarios
are assumed to be of short- term duration (1-30 days).

	An inhalation post-application assessment was not conducted because the
vapor pressure of the alkylbenzene sulfonates is extremely low
(5.1x10-10 to 6x10-15 mmHg) and not expected to result in inhalation
exposure.  In addition, a dermal assessment was not conducted because of
the lack of a dermal toxicological endpoint was not identified in animal
studies.

ii. Residential Handler Risk Estimates

Based on toxicological criteria and potential for exposure, the Agency
has conducted incidental oral and inhalation exposure assessments. As
noted previously, MOEs greater than or equal to 100 for the inhalation
route of exposure and 100 for incidental oral exposure are considered
adequately protective for the residential exposure assessment.

	A summary of the residential handler exposures and risk are presented
in Table 7. For residential handlers that handle products containing
alkylbenzene sulfonates as inert ingredients, the short-term inhalation
MOEs were above the target MOE of 100, and thus, do not exceed the
Agency’s level of concern, with the exception of the flea and tick
product where the MOE was 87 for the high-end formulation containing 24%
alkylbenzene sulfonates.  This scenario is conservative because it
assumes a person treats their pet with 0.5 cans of flea product that
contains 24% alkylbenzene sulfonates every day for a month. It is
unlikely that a person would treat his/her pet every day for one month.
Therefore, the Agency is not requiring risk mitigation.  In addition,
there are no risk concerns for the majority of pet products containing
2% alkylbenzene sulfonates.

Table 7. Estimates of  Inhalation Exposures and Risks to Residential
Handlers of

Alkylbenzene Sulfonates as Inert Ingredients

(Short-Term Duration)

Product Use

Application Method

Area Treated/Quantity Handleda	Inhalation Exposure (mg/kg/day)
Inhalation MOEsc

(Target MOE ≥ 100)

Outdoor Products

Ready to Use Liquid Turf spot/gardensb

Low pressure handwand; MLAP	1000 ft2/day (spot)	7.07x10-6	20,000

Hose end sprayer; MLAP	2x104 ft2/day

 (full broadcast)	4.48x10-5	3,100

Backpack; MLAP	1000 ft2/day (spot)	7.07x10-6	20,000

	Sprinkling can; MLAP

2.24x10-6	63,000

Indoor Products

Ready to Use Liquid (hard surface cleaner)d,e	Low pressure handwand;
MLAP	0.5 gallons/day	1.37x10-4	1.000

Pet Flea and Tick  Productf	Aerosol Can Spray	0.5 6 oz can	1.61x10-3	87

a:  Standard PiRat model input parameters, except for pet products and
hard surface cleaner, which are based on an AD assumption.

b: percent formulation used = 11%; an application rate of 0.00015 lb
product/ft2 was assumed for all scenarios and the body weight = 70kg.

c:  MOEs = NOAEL / exposure where inhalation NOAEL = 0.14 mg/kg/day and
the target MOE ≥ 100

d: % formulation used =  8%

e: An application rate of 8 lb/gallon, which is the density of water,
was assumed for all scenarios and the body weight =70kg.

f= % formulation = 24%.

c. Residential Post-Application

Residential post application exposures occur when bystanders contact
areas in which the antimicrobial end use product has recently been
applied. For alkylbenzene sulfonates there are no residential
postapplication risk concerns for the household products that contain
alkylbenzene sulfonates as an inert ingredient as shown on Table 8.
All of the scenarios evaluated have short-term MOEs above 100, and thus
are not of concern including postapplication incidental oral risks to
children that may contact turf, hard surfaces or a pet treated with
pesticide products containing alkylbenzene sulfonates as an inert
ingredient.  The postapplication MOEs range from 106 to 7,400.

Table 8. Summary
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(Target MOE ≥ 100

Ready to Use Liquid Turf spot/gardensd	Incidental ingestion: hand to
mouth	1.08x10-2	4,600

Ready to Use Liquid

(hard surface cleaner)a, e

0.0068	7,400

Pet Flea and Tick  Productf	Incidental ingestion: hand to mouth	0.4739
106

a: The representative use sites assessed through using PiRAT for
incidental oral post application exposures to toddlers are turf
products.  Exposure from hard surface cleaner and pet products was based
on AD assumptions.

b: The body weight used in this calculation was 15kg, which is assumed
to be the body weight of a toddler.

≥ 100.

d: % formulation used =  11%

e:  % formulation used =  8%

f:  % formulation used = 24%

	7.  Aggregate Risk   XE "III. Summary of 2,4-DB Risk Assessments:6.
Aggregate Risk"

	The Food Quality Protection Act amendments to the Federal Food, Drug,
and Cosmetic Act (FFDCA, Section 408(b)(2)(A)(ii)) require “that there
is a reasonable certainty that no harm will result from aggregate
exposure to pesticide chemical residue, including all anticipated
dietary exposures and other exposures for which there are reliable
information.”  Aggregate exposure will typically include exposures
from food, drinking water, residential uses of a pesticide, and other
non-occupational sources of exposure.  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, and from plausible exposure routes (oral,
dermal, and inhalation).

		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:
HYPERLINK "http://www.epa.gov/pesticides/trac/science/aggregate.pdf"
http://www.epa.gov/pesticides/trac/science/aggregate.pdf  .  Steps for
deciding whether to perform aggregate exposure and risk assessments are
listed and 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.

	Typically, aggregate risk assessments are conducted for acute (1 day),
short-term (1-30 days), intermediate-term (1-6 months) and chronic (6
months to lifetime) exposures.  However, an acute aggregate assessment
was not conducted because there are no adverse effects attributable to
acute exposure.  An intermediate-term aggregate assessment was not
conducted because there are no residential exposures of this duration.
In addition, because there are no long-term residential exposures, the
chronic aggregate assessment only considered food and drinking water.
Thus, only short-term and chronic aggregate assessments were conducted.
Oral and inhalation exposure and risk estimates were conservatively
combined for the aggregate risk assessment because these endpoints both
identify adverse effects on body weight.  Dermal exposures were not
considered in the risk assessment because a toxicological endpoint was
not established.

Short- Term Aggregate Risk

		   This assessment considers both the active and inert uses of the
alkylbenzene sulfonates.  For children, the short-term aggregate
assessment includes average dietary exposure (food and drinking water)
from both the active food contact sanitizer uses and the inert uses on
agricultural commodities, in addition to estimated incidental oral
exposures to children from residential uses such as hard surface
cleaning products as an inert ingredient.  For adults, the aggregate
assessment includes dietary (food and drinking water) from both active
and inert uses and residential inhalation exposures from wiping a hard
surface cleaning products since this scenario represents the highest
exposure from the inert use.  The residential handler scenario for pet
flea and tick products (inhalation MOE of 87) was not included in the
aggregate assessment.  The pet flea and tick product assumes a person
treats his/her pet with 0.5 cans of flea product that contains 24%
alkylbenzene sulfonates every day for a month.  The Agency does not have
any risks of concern for this scenario because it is very conservative
in nature.

	    The aggregate oral and inhalation risks are not of concern for
adults, as the total aggregate MOE is 340 which is greater than the
target of 100.  For children, the aggregate risk estimate is very close
to the target MOE of 100 (MOE = 99).  As noted previously, several
conservative assumptions were used in this assessment, and thus the
Agency does not have any risk concerns.  The assumptions and equations
are presented in the footnotes on Table 9.

           Table 9 presents a summary of the short-term aggregate risk
MOEs.

Table 9. Summary of Short-Term Aggregate Risk Estimates

Exposure Scenario	Dose a

(mg/kg/day)	Total MOEb

(Target MOE≥100)

	Child

	Adult

	Child

	Adult

Oral Exposure

Dietary Exposure

     Food Contact Sanitizer         	0.054	0.027	926

(10.8% of  cPAD)	1,850

(5.4% of cPAD)

     Inert Ingredient Uses (Food)	0.422	0.12	118

(84% of cPAD)	417

(24% of the cPAD)

Drinking Water Exposure  (Inert) c	0.00044 	0.000189 	114,000

(<1% of cPAD	227,000

(<1% of cPAD)

Hard Surface Cleaner (2% Inert)	0.0068	NA	7,400	NA

Inhalation Exposure

Handler of hard surface cleaning products (2% Inert)	NA	0.000137	NA
1,000

Total Aggregate Dose and MOE	0.5	0.147	99	340

NA= Not applicable

Chronic dietary exposure for females 13-50 years for sanitizer use.  The
total general population dietary exposure was used to assess inerts,
since this population has higher exposure than females 13-50 years.

  SEQ CHAPTER \h \r 1 MOE = NOAEL (mg/kg/ day) / potential dose rate
(mg/kg/day) [Where short-term oral NOAEL = 50 mg/kg/day].  Target MOE
≥ 100.

Exposure estimates assume a 15 kg child ingests 1L water/day and that a
60 kg adult female ingests 2L water per day of 6.6 ppb (the chronic
estimated drinking water concentration (EDWC) based on the inert
ingredient use.

b. Chronic Aggregate Risk  XE "III. Summary of 2,4-DB Risk
Assessments:6. Aggregate Risk:b. Chronic Aggregate Risk"

		The chronic aggregate assessment considers average dietary exposure
(food and drinking water) from both the active food contact sanitizer
uses and the inert uses on agricultural commodities.  The dietary
exposures from the fruit and vegetable wash were not considered because
it would be overly conservative to assume simultaneous exposure to
alkylbenzene sulfonates from three different use patterns.   As shown on
Table 10, the dietary aggregate risk is 95% of the cPAD for children,
while for adults it is 29% of the cPAD.

	It should also be recognized that the majority of the uses of
alkylbenzene sulfonates are not in pesticide products, but rather are
used in household laundry and dish detergents.  Over 800 million pounds
of these compounds are produced each year, while only 300,000 pounds are
used in EPA registered antimicrobial products.  The Agency did not
consider potential exposure and risks from the numerous other
residential exposures to alkylbenzene sulfonates because the Agency
lacks reliable information at this time.

	Table 10 presents a summary of the chronic aggregate risk estimates.
SEQ CHAPTER \h \r 1

Table 10.

Summary of Chronic Aggregate Risk Estimates

Exposure Scenario	Dose a

(mg/kg/day)	%cPADb

	Child

(15 kg)	Adult

	Child

(15 kg)	Adult

Oral Exposure

Dietary Exposure

     Food Contact Sanitizer         	0.054	0.027	10.8%	5.4%

     Inert Ingredient Uses (Food)	0.422	0.12	84% 	24%

Drinking Water Exposure  (Inert) c	0.00044 	0.000189 	<1% 	<1%

Total Aggregate Dose and Risk	0.476	0.147	95% 	29%

NA= Not applicable

Chronic dietary exposure for females 13-50 years for sanitizer use.  The
total general population dietary exposure was used to assess inerts,
since this population has higher exposure than females 13-50 years.

%cPAD = dietary exposure (  SEQ CHAPTER \h \r 1 mg/kg/day) / cPAD, where
cPAD -= 0.5 mg/kg/day for all populations.

Exposure estimates assume a 15 kg child ingests 1L water/day and that a
60 kg adult female ingests 2L water per day containing 6.6 ppb
alkylbenzene sulfonates.  The 6.6 ppb estimate is based on the chronic
estimated drinking water concentration (EDWC)) resulting from
agricultural use of products that contain the alkylbenzene sulfonates as
an inert ingredient.

8.  Occupational Exposure and Risk

Workers can be exposed to a pesticide through mixing, loading, and/or
applying a pesticide, or re-entering treated sites. Occupational
handlers of alkylbenzene sulfonates include workers in a variety of
occupational settings. Additionally, postapplication exposures are
likely to occur in these settings. The representative scenarios selected
for assessment were evaluated using maximum application rates as
recommended on the product labels for alkylbenzene sulfonates.

Occupational risk is assessed for exposure at the time of application
(termed “handler” exposure) and is assessed for exposure following
application, or post-application exposure. Application parameters are
generally defined by the physical nature of the formulation (e.g.,
formula and packaging), by the equipment required to deliver the
chemical to the use site, and by the application rate.

Occupational risk for all of these potentially exposed populations is
measured by a Margin of Exposure (MOE) which determines how close the
occupational exposure comes to a No Observed Adverse Effect Level
(NOAEL) from toxicological studies. In the case for alkylbenzene
sulfonates, MOEs greater than 100 for inhalation exposures are not of
concern to the Agency for short- and intermediate-term exposures. For
workers entering a treated site, MOEs are calculated for each day after
application to determine the minimum length of time required before
workers can safely re-enter.  XE "III. Summary of 2,4-DB Risk
Assessments:7. Occupational Risk"

a. Occupational Toxicity

Table 6 provides a listing of the toxicological endpoints used in the
occupational risk assessment for alkylbenzene sulfonates.

b. Occupational Handler Exposure

		The Agency has determined that there is potential for dermal and
inhalation worker exposure to alkylbenzene sulfonates at various use
sites when used at various use sites including agricultural premises,
food handling, and commercial/institutional/industrial premises.
Representative scenarios were selected for evaluation based on the use
sites and maximum application rates for all three of the active
ingredients in this assessment.  As noted previously, the Agency did not
select a dermal endpoint, and thus only inhalation exposure and risk
estimates are presented.

To assess the handler risks, the Agency used surrogate unit exposure
data from both the proprietary Chemical Manufacturers Association (CMA)
antimicrobial exposure study and the Pesticide Handlers Exposure
Database (PHED).  Short-, and intermediate-term inhalation risks to
occupational handlers for sanitizing scenarios, and estimated risks are
presented in Table 11.

The Agency also calculated a total MOE for one of the active
ingredients, sodium dodecylbenzene sulfonate based on the label use
directions, which recommend the same product be used for both cleaning
and sanitizing.  Short-, and intermediate-term inhalation risks to
occupational handlers cleaning and sanitizing with products that contain
sodium dodecylbenzene sulfonate are shown in Table 12.

c. Occupational Handler Risk Summary

	The occupational handler risk assessment included only inhalation
exposures because the Agency did not select a dermal endpoint.  For the
occupational handler inhalation risk assessment, the short- and
intermediate- term risks calculated at baseline exposure (no
respirators) were above target MOEs for all scenarios (i.e., inhalation
MOEs were >100), except:

Short-Term and Intermediate-Term inhalation exposure from cleaning hard
surfaces via wiping in the food handling category, inhalation MOE = 93.

Due to the conservative nature of the assessment, the Agency does not
have a risk concern for this scenario.

The Agency also calculated a total MOE for one of the active
ingredients, sodium dodecylbenzene sulfonate based on the label use
directions, which recommend the same product be used for both cleaning
and sanitizing.  As shown on Table 12, all total inhalation MOEs for
cleaning and sanitizing (baseline) were above the target MOE of 100 for
all scenarios, except the following:

Short-Term and Intermediate-Term inhalation exposure from cleaning
indoor hard surfaces via wiping and then following with sanitizing via
immersion/flooding in the food handling premises category, inhalation
MOE = 93.

Short-Term and Intermediate-Term inhalation exposure from cleaning
indoor hard surfaces via wiping and then following with sanitizing via
low pressure spray in the food handling premises category, inhalation
MOE  = 90.

Short-Term and Intermediate-Term inhalation exposure from cleaning
indoor hard surfaces via sponge/mesh/wiping and then sanitizing via
immersion/flooding in the food handling premises category, inhalation
MOE = 90.

	Again, due to the conservative nature of the assessment, risk estimates
making a lot of assumptions, and the MOEs being so close to the target,
the Agency does not have a risk concern for these scenarios.

Table 11. Short-, and Intermediate-Term Inhalation Risks for
Occupational Handlers for Sanitizing

(Representative Scenarios)

Exposure Scenario	Method of Application	Application Rate  (lb ai/
gallon)	Quantity Handled/

Treated per day (gallons)	Baseline

Inhalation MOE (a)

(Target MOE≥100)

Agricultural Premises and Equipment

Application to hard surfaces

	Brush	0.0667	0.26	2,000

	Mechanical Foam	0.0667	0.26	430

	Flooding	0.00183	10	280

	Cleaning in place (CIP)

0.00195

	10,000	1,200

	High Pressure spray	0.00326	40	630

	Immersion	0.00334	10	160

	Low pressure spray	0.00334	10	430

	Trigger Pump Spray	0.00334	0.26	8,700

Food  Handling

Application to indoor hard surfaces 	Brush	0.0667

0.26

2,000

	Mechanical Foam	0.0667	0.26	430

	Immersion	0.00334	10	160

	Trigger Pump Spray	0.00334	0.26	8,700

	Low pressure handwand

(clean) 	0.00603	2	1,200

	High pressure spray (sanitize)	0.0115	40

180

	Immersion, flooding for RTU (sanitize)	0.003	10	170

	Mopping	0.00244	2	840

	Wiping (clean) 	0.00603	0.26	93

	Sponge/mesh wipe (clean) 	0.003	0.26	190

	Cleaning in Place (CIP) (clean and sanitize)

0.00358

	10,000	680

Food dispensing equipment	Cleaning in Place (CIP) (clean)

0.00603	10,000	400

	Cleaning in Place (CIP) (sanitize)

0.00302	10,000	810

Fruits and vegetables	Immersion	0.00455	10	110

	Trigger pump spray	0.003	0.26	9,700

Commercial/Institutional Premises

Application to indoor hard surfaces (includes utensils and silverware)
Brush	0.0667	0.26	2,000

	Mechanical Foam	0.0667	0.26	430

	Immersion	0.00334	10	160

	Low Pressure Handwand	0.00334	2	2,200

	Trigger Pump Spray	0.00334	0.26	8,700

Shower stalls and toilets	Mopping	0.0177	2	120

	Swabbing after a liquid pour	0.0177	0.26	1,100

 (a)	MOE = NOAEL  (mg/kg/day) / Daily Dose [Where short-and
intermediate-term

≥ 100.

Table 12.  Short, and Intermediate Term Inhalation Risks to Occupational
Handlers

Cleaning and Sanitizing with Products That Contain Sodium Dodecylbenzene
Sulfonate

Representative Use	Method of CLEANING Application

(Baseline MOE)	Method of SANITIZING Application

(Baseline MOE)	Total  Inhalation MOE (Baseline) (Target MOE≥100)

Food Handling/Storage Establishments Premises and Equipment

Indoor Hard Surfaces (includes dishes and silverware)	High pressure
spray (1,100)	High pressure spray (180)	150

Brush (12,000)	1,000

	Brush

(75,000)	High pressure spray (180)	180

Brush (12,000)	10,000

	Low pressure spray (1,200)	Immersion/Flooding (1.4X106)	1,200

Low pressure spray (2,400)	800

	Wiping (93)	Immersion/Flooding (1.4X106)	93

Low pressure spray (2,400)	90

	Foam (4,000) 	Immersion/Flooding (1.4X106)	4,800

Low pressure spray (2,400)	1,600

	Brush (22,000)	Immersion/Flooding (1.4X106)	22,000

Low pressure spray (2,400)	2,000

	Sponge/Mesh/Wiping (190)	Immersion/Flooding (170)	90

Trigger Pump (9,700)	190

	Low Pressure Spray (2,400)	Immersion/Flooding (170)	160

Trigger Pump (9,700)	1,900

	Brush (45,000)	Immersion/Flooding (170)	170

Trigger Pump (9,700)	8,000

	CIP (680)	CIP (680)	340

Food dispensing equipment	CIP(400)	CIP (810)	270

d. Occupational Post-Application Exposure

	For most of the occupational scenarios, postapplication dermal exposure
is not expected to occur or is expected to be negligible based on the
application rates and chemical properties of these chemicals. The
alkylbenzene sulfonates have a low vapor pressure (5.1x10-10 to
6.02x10-15 mmHg), so that any standing solutions that may result in post
application exposure were deemed negligible.  For additional
information, please see the Occupational and Residential Exposure
Assessment for Alkylbenzene Sulfonates for the Reregistration
Eligibility Decision document, dated July 6, 2006.

B. Environmental Risk Assessment

A summary of the Agency’s environmental risk assessment is presented
below. The following risk characterization is intended to describe the
magnitude of the estimated environmental risks for alkylbenzene
sulfonates use sites and any associated uncertainties.

	For detailed discussions of all aspects of the environmental risk
assessment, see the Environmental Fate Assessment of Alkylbenzene
Sulfonates for the Reregistration Eligibility Decision and the
Ecological Hazard and Environmental Risk Assessment of Alkylbenzene
Sulfonates for the Reregistration Eligibility Decision document, dated
July 12, 2006.

Environmental Fate and Transport

  XE "III. Summary of 2,4-DB Risk Assessments:B. Environmental Risk
Assessment: 1. Environmental Fate and Transport"

	No fate studies for alkylbenzene sulfonates are available in US EPA’s
files.  Thus, the Agency has relied on scientific literature and the
Agency’s EPI Suite model to obtain different environmental properties
for the alkylbenzene sulfonates.  The EPI Suite model predicts that
alkylbenzene sulfonates are not likely to persist in water or microbial
soils and sediments.   The Agency also conducted a literature search to
further support the output parameters that were provided by the EPI
Suite model.  Extensive literature are available that describe the fate
and significance of alkylbenzene sulfonates in the environment from a
long history of detergent use.

	Environmental exposure modeling was not conducted for alkylbenzene
sulfonic acids and sulfonates because the currently registered uses are
indoor spray applications. Uses such as urinals and toilet bowls could
result in minimal exposure to the environment when flushed, however,
significant environmental exposure is not expected for the following
reasons:  total alkylbenzene sulfonate usage for these industrial
applications is very minor - a very small percentage of the total pounds
is used in antimicrobials; commercial only use precludes broad
environmental exposures that might occur with residential use;
applications are mostly sprayed on and allowed to air dry; alkylbenzene
sulfonate breakdown and degrade rapidly in the environment;
alkylbenzene sulfonates are significantly reduced by sewage treatment;
and industrial water treatment requires a NPDES permit in order to
discharge effluents.

2.   Ecological Risk   XE "III. Summary of 2,4-DB Risk Assessments:B.
Environmental Risk Assessment: 2. Ecological Risk "

	The ecological risk assessment integrates the results of the exposure
and ecotoxicity data to evaluate the likelihood of adverse ecological
effects.

  SEQ CHAPTER \h \r 1

Alkylbenzene sulfonates demonstrate low acute toxicity to birds,
moderate acute toxicity to freshwater fish, and low to high acute
toxicity to freshwater aquatic invertebrates depending on the length of
the carbon chain.  Supplemental acute studies indicate that alkylbenzene
sulfonates are moderately toxic to freshwater fish and slightly to
highly toxic to freshwater aquatic invertebrates depending on the length
of the carbon chain.  A summary of submitted data is provided in Table
13.

Table 13.  Acute Toxicity of Alkylbenzene Sulfonates

Species	Chemical, % active ingredient (ai)	Endpoint 	Toxicity Category
(TGAI)	Satisfies Guidelines/Comments	MRID

Birds

Northern bobwhite

(Colinus virginianus)	87.6%Carbon chain not identified. (Nacconal 90G
used)

LD50 >  1382 mg/kg

NOEL = 279 mg/kg

Slightly toxic

Yes.  Acceptable.

14 day test

41143901

Freshwater Fish

Fathead Minnow (Pimephales promelas)

14.0% (Carbon chain not identified.)

96hr LC50 =

3.4 mg/L

Moderately toxic

Yes.  Supplemental study.

44260002

Rainbow trout

 Oncorhynchus

     mykiss)

65.0%

C11, C12

96 hr LC50 =

1.68 mg/L

Moderately toxic

Yes.  Supplemental

study.

44260009

Freshwater Invertebrates

Waterflea

(Daphnia magna)

Not reported.

48-hr. EC50 = LAS-C10 = 29.5 mg/L, LAS-C12 = 6.84 mg/L, LAS-C14 = 0.80
mg/L, LAS-C16 = 0.20 mg/L.

C-10 = Slightly toxic, C14 = highly toxic.

Yes.  Supplemental study.

47025025

Green Algae

Selenastrum

capricornutum	Not

Reported.  (Carbon chain not identified.)	96 hr. EC50 =

     70.27 ppm	Slightly

toxic

Supplemental study.	42439803

The alkylbenzene sulfonates are used as inert ingredients in
agricultural herbicide formulations.  Preplant incorporated and
preemergence herbicide treatments are typically applied once per year to
the tilled, minimally tilled or no-tilled field before planting or
before crop emergence in the spring.  Spray applications are primarily
via ground boom spray and occasionally by aircraft.  Movement of the
alkylbenzene sulfonates from the treated field to the aquatic
environment can occur at the time of application due to spray drift, or
following application via surface water/soil flow or by percolation to
groundwater.  The FIRST model has predicted a maximum potential
concentration of 6.6 ppb alkylbenzene sulfonates in drinking water from
inert agricultural uses.  Available modeling and literature suggest that
these chemicals will most likely biodegrade rapidly in soil due to
microbial degradation.  In addition, aquatic organisms are also not
expected to be adversely affected by inert alkylbenzene sulfonates use
acutely or chronically due to the low estimated level of alkylbenzene
sulfonates in water.

	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
C.F.R. § 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. The active ingredient uses of
alkylbenzene sulfonic acids and sulfonates fall into this category for
the following reasons:

The amount that will actually reach the environment is very small based
on usage data for down-the-drain uses.

Use for toilets and urinals is limited (no home-owner or residential
uses are registered).

Breakdown of alkylbenzene sulfonate in the environment and via sewage
treatment is rapid and well documented in the literature.

The labeled antimicrobial uses of alkylbenzene sulfonic acids and
sulfonates are not expected to result in significant environmental
exposure. Therefore, no adverse effects (NE) to listed species are
anticipated.  Use of alkylbenzene sulfonates as inert ingredients in
agricultural pesticide formulations is not expected to result in
significant environmental exposure. Therefore, no adverse effects (NE)
to listed species are anticipated.

IV.   Risk Management, Reregistration, and Tolerance Reassessment
Decision  XE "IV. Risk Management, Reregistration, and Tolerance
Reassessment Decision"

A.  Determination of Reregistration Eligibility   XE "IV. Risk
Management, Reregistration, and Tolerance Reassessment Decision: A.
Determination of Reregistration Eligibility" \i

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

	The Agency has completed its assessment of the dietary, residential,
occupational, drinking water, and ecological risks associated with the
use of pesticide products containing the active ingredient alkylbenzene
sulfonates.  Based on a review of these data and on public comments on
the Agency’s assessments for the active ingredient alkylbenzene
sulfonates, the Agency has sufficient information on the human health
and ecological effects of alkylbenzene sulfonates to make decisions as
part of the tolerance reassessment process under FFDCA and
reregistration process under FIFRA, as amended by FQPA.  The Agency has
determined that alkylbenzene sulfonates-containing products are eligible
for reregistration provided that current data gaps and confirmatory data
needs are addressed.  Appendix A summarizes the uses of alkylbenzene
sulfonates 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 alkylbenzene sulfonates
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.

B.  Public Comments and Responses   XE "IV. Risk Management,
Reregistration, and Tolerance Reassessment Decision: B. Public Comments
and Responses" \i

Through the Agency’s public participation process, EPA worked with
stakeholders and the public to reach the regulatory decision for
alkylbenzene sulfonates.  During the public comment period on the risk
assessments, which closed on June 19, 2006, the Agency received numerous
comments from The DDBSA Steering Committee/Joint Venture (JV) and The
Council for LAB/LAS Environmental Research (CLER) and the European
Centre on Studies on LAB/LAS (ECOSOL) in response to EPA’s draft risk
assessment (RA) for alkylbenzene sulfonates.  The comments submitted
include areas of toxicology, chemical structure, risks, production
volumes, and exposure. The Agency’s responses to these comments are
incorporated into the risk assessment and revised chapters, which are
available on the U.S. Federal Government website at:    HYPERLINK
"http://www.regulations.gov"  www.regulations.gov
(EPA-HQ-OPP-2006-0156).  A Response to Comment document will be made
available on the public docket in the future.  In addition, comments
received by the registrants during Phase I of the RED process, are
available on the docket.

The Agency is providing a 60-day public comment period on this RED.

C.  Regulatory Position   XE "IV. Risk Management, Reregistration, and
Tolerance Reassessment Decision:C. Regulatory Posistion" \i

1.  Food Quality Protection Act Findings   XE "IV. Risk Management,
Reregistration, and Tolerance Reassessment Decision: C. Regulatory
Position: 1. Food Quality Protection Act Findings"

	a. “Risk Cup” Determination   XE "IV. Risk Management,
Reregistration, and Tolerance Reassessment Decision: C. Regulatory
Position: 1. Food Quality Protection Act Findings: a. "Risk Cup"
Determination"

	As part of the FQPA tolerance reassessment process, EPA assessed the
risks associated with alkylbenzene sulfonates.  The Agency has concluded
that the tolerance exemptions for the use of alkylbenzene sulfonates as
an active and as an inert ingredient meet the FQPA safety standards and
that the risk from dietary exposure (food sources only) is within the
“risk cup.”  An acute aggregate assessment was not conducted because
there are no adverse effects attributable to acute exposure.  An
intermediate-term aggregate assessment was not conducted because there
are no residential exposures of this duration.  In addition, because
there are no long-term residential exposures, the chronic aggregate
assessment only considered food and drinking water.  Thus, only
short-term and chronic aggregate assessments were conducted.

The Agency has determined that the human health risks from these
combined exposures are within acceptable levels.  In reaching this
determination, EPA has considered the available information on the
special sensitivity of infants and children, as well as aggregate
exposure from food, drinking water and residential uses.

b. Determination of Safety to U.S. Population   XE "IV. Risk Management,
Reregistration, and Tolerance Reassessment Decision:C. Regulatory
Position: 1. Food Quality Protection Act Findings: b. Determination of
Safety to U.S. Population"

	As part of the FQPA tolerance reassessment process, EPA assessed the
risks associated with alkylbenzene sulfonates.  The Agency has
determined that the established tolerance exemptions for alkylbenzene
sulfonates meet the safety standards under the FQPA amendments to
section 408(b)(2)(D) of the FFDCA, and that there is a reasonable
certainty no harm will result to the general population or any subgroup
from it’s use.  In reaching this conclusion, the Agency has considered
all available information on alkylbenzene sulfonates.

	Typically, aggregate risk assessments are conducted for acute (1 day),
short-term (1-30 days), intermediate-term (1-6 months) and chronic (6
months to lifetime) exposures. However, an acute aggregate assessment
was not conducted because there are no adverse effects attributable to
acute exposure of alkylbenzene sulfonates.  An intermediate-term
aggregate assessment was not conducted because there are no residential
exposures of this duration.  In addition, because there are no long-term
residential exposures, the chronic aggregate assessment only considered
food and drinking water.  Thus, only short-term and chronic aggregate
assessments were conducted.  The short-term and chronic aggregate risk
estimates associated with alkylbenzene sulfonates are well below the
Agency’s level of concern. Oral and inhalation exposure and risk
estimates were conservatively combined for the aggregate risk assessment
because these endpoints both identify adverse effects on body weight.
The aggregate oral and inhalation risks are not of concern for adults or
children. Dermal exposures were not considered in the risk assessment
because a toxicological endpoint was not established.

c. Determination of Safety to Infants and Children   XE "IV. Risk
Management, Reregistration, and Tolerance Reassessment Decision:C.
Regulatory Position: 1. Food Quality Protection Act Findings: c.
Determination of Safety to Infants and Children "

	EPA has determined that the currently registered uses of alkylbenzene
sulfonates, with changes as specified in this document, meet the safety
standards under the FQPA amendments to section 408(b)(2)(C) of the
FFDCA, that there is a reasonable certainty of no harm for infants and
children.  The safety determination for infants and children considers
factors of the toxicity, use practices, and environmental behavior noted
above for the general population, but also takes into account the
possibility of increased susceptibility to the toxic effects of
alkylbenzene sulfonates residues in this population subgroup.

	No Special FQPA Safety Factor is necessary to protect the safety of
infants and children.  In determining whether or not infants and
children are particularly susceptible to toxic effects from alkylbenzene
sulfonates residues, the Agency considered the completeness of the
database for developmental and reproductive effects, the nature of the
effects observed, and other information.  The FQPA Safety Factor has
been removed (i.e., reduced to 1X) for alkylbenzene sulfonates based on:
(1) there is no concern for developmental neurotoxicity resulting from
exposure to alkylbenzene sulfonates because there is no evidence
alkylbenzene sulfonates will induce neurotoxic effects; (2) there is no
quantitative or qualitative evidence of increased susceptibility to the
fetus following in utero exposure in the prenatal developmental toxicity
studies or to the offspring when adults are exposed in the
two-generation reproductive study; and (3) the risk assessment does not
underestimate the potential exposure for infants and children.

d. Endocrine Disruptor Effects   XE "IV. Risk Management,
Reregistration, and Tolerance Reassessment Decision:C. Regulatory
Position: 1. Food Quality Protection Act Findings: d. Endocrine
Disruptor Effects"

	EPA is required under the FFDCA, as amended by FQPA, to develop a
screening program to determine whether certain substances (including all
pesticide active and other ingredients) “may have an effect in humans
that is similar to an effect produced by a naturally occurring estrogen,
or other endocrine effects as the Administrator may designate.”
Following recommendations of its Endocrine Disruptor Screening and
Testing Advisory Committee (EDSTAC), EPA determined that there was a
scientific basis for including, as part of the program, the androgen and
thyroid hormone systems, in addition to the estrogen hormone system.
EPA also adopted EDSTAC’s recommendation that EPA include evaluations
of potential effects in wildlife.  For pesticides, EPA will use FIFRA
and, to the extent that effects in wildlife may help determine whether a
substance may have an effect in humans, FFDCA authority to require the
wildlife evaluations.  As the science develops and resources allow,
screening of additional hormone systems may be added to the Endocrine
Disruptor Screening Program (EDSP).

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

e. Cumulative Risks   XE "IV. Risk Management, Reregistration, and
Tolerance Reassessment Decision:C. Regulatory Position: 1. Food Quality
Protection Act Findings: e. Cumulative Risks"

	Risks summarized in this document are those that result only from the
use of alkylbenzene sulfonates.  The Food Quality Protection Act (FQPA)
requires that 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.”  The
reason for consideration of other substances is due to the possibility
that low-level exposures to multiple chemical substances that cause a
common toxic effect by a common toxic mechanism could lead to the same
adverse health effect as would a higher level of exposure to any of the
substances individually.  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 for
alkylbenzene sulfonates.  For information regarding EPA’s efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the policy
statements released by EPA’s Office of Pesticide Programs concerning
common mechanism determinations and procedures for cumulating effects
from substances found to have a common mechanism on EPA’s website at
  HYPERLINK "http://www.epa.gov/pesticides/cumulative/"
http://www.epa.gov/pesticides/cumulative/ .

2. Tolerance Summary

Active Ingredient Uses  XE "IV. Risk Management, Reregistration, and
Tolerance Reassessment Decision:C. Regulatory Position: 2. Tolerance
Summary" \i

Exemptions from the requirement of a tolerance for the active
food-contact sanitizer uses of these ingredients have been established
in the 40 CFR 180.940(b) and (c).

Table 14.  Tolerance Exemptions for Food Contact Sanitizer Uses (Active
Uses)

Tolerance Exemption Expression/

Chemical Name

CAS No.

PC Code

40 CFR Citation

Use Pattern (Pesticidal)

Benzenesulfonic acid, dodecyl-

27176-87-0

098002

180.940 (b)

food contact sanitizing solutions for dairy processing equipment, and
food processing equipment and utensils; end use concentration not to
exceed 5.5 ppm

NOTE:  The Agency will be proposing a change to 40 CFR 180.940(b) to
make the end use concentration not to exceed 400 ppm.

180.940 (c)	food contact sanitizing solutions for food processing
equipment and utensils; end use concentration not to exceed 400 ppm

 Benzenesulfonic acid dodecyl-, sodium salt

25155-30-0

079010

180.940 (c)

food contact sanitizing solutions for food processing equipment and
utensils; end use concentration not to exceed 430 ppm

Dodecylbenzenesulfonic acid (27176-87-0) and sodium dodecylbenzene
sulfonate (25155-30-0) have uses in food-contact surface sanitizing
solutions with tolerance exemptions as specified in 40 CFR 180.940 (b)
and (c), and summarized in Table 14.  Residues for these compounds are
exempt from the requirement of a tolerance when used in accordance with
good manufacturing practice as ingredients in an antimicrobial pesticide
formulation, provided that the substance is applied on a semi-permanent
or permanent food-contact surface (other than being applied on food
packaging) with adequate draining before contact with food.  Both
dodecylbenzene sulfonic acid, and sodium dodecylbenzene sulfonate have
limitations for the ready-to-use end-use concentration not to exceed 400
ppm and 430 ppm, respectively for food processing equipment and
utensils.  However, dodecylbenzene sulfonic acid has a much lower
limitation of 5.5 ppm for use on dairy processing equipment.  The Agency
estimates that the 430 ppm limitation for the sodium salt is equivalent
to approximately 400 ppm of the free acid form.  The Agency will be
proposing a change to the 40 CFR 180.940(b) to establish a maximum of
400 ppm for the end-use concentration of dodecylbenzenesulfonic acid,
rather than the current limitation of 5.5 ppm.  As previously stated,
the Agency used the FDA milk truck model to estimate residues in milk
that could result from the use of alkylbenzene sulfonates in the food
processing equipment.  The Agency assessed the maximum application rate
of 400 ppm for dodecylbenzene sulfonates (as listed on the labels),
although the current tolerance exemption has a limitation of 5.5 ppm for
dairy processing equipment.  This assessment indicated that risks are
not of concern for all subpopulations.

Inert Ingredient Uses

	Included in this document is the reassessment of the alkylbenzene
sulfonates when used as an inert ingredient in pesticidal products.   As
noted previously, some of the inert functions of alkylbenzene sulfonates
in the registered products are listed as solvent, surfactant,
dispersant, detergent, or wetting agent.  Some of these products are
designated for use in agricultural settings (i.e., pre- and post-harvest
and when applied to animals), where there is a potential for dietary
exposure.  The alkylbenzene sulfonates assessed in this document are
constituents of a larger group of compounds that have a tolerance
exemption as an inert ingredient in 40 CFR 180.910 and 180.930.   As
shown in Table 15, the tolerance exemption is listed as Alkyl (C8-C24)
benzenesulfonic acid and its ammonium, calcium, magnesium, potassium,
sodium and zinc salts.

Table 15.  Tolerance Exemptions for Inert Use

Tolerance Exemption Expression

40 CFR Citation

Use Pattern

Alkyl (C8-C24) benzenesulfonic acid and its ammonium, calcium,
magnesium, potassium , sodium and zinc salts

180.910 (a)

Surfactants, related adjuvants of surfactants

	180.930 (a)

	Surfactants, emulsifier, related adjuvants of surfactants

Residues listed in 40 CFR §180.910 are exempted from the requirement of
a tolerance when used as inert ingredients in pesticidal formulations
when applied to growing crops or to raw agricultural commodities after
harvest (i.e., pre- and post-harvest).  Residues listed in 40 CFR
§180.930 are exempted from the requirement of a tolerance when used as
inert ingredients in pesticidal formulations when applied to animals
only.

D.  Regulatory Rationale   XE "IV. Risk Management, Reregistration, and
Tolerance Reassessment Decision:D. Regulatory Rationale"

	The Agency has determined that alkylbenzene sulfonates are eligible for
reregistration provided that additional required data confirm this
decision.

1.  Human Health Risk Management   XE "IV. Risk Management,
Reregistration, and Tolerance Reassessment Decision: D. Regulatory
Rationale: 1. Human Health Risk Management"

	a. Dietary (Food) Risk Mitigation   XE "IV. Risk Management,
Reregistration, and Tolerance Reassessment Decision:D. Regulatory
Rationale:1. Human Health Risk Management: a. Dietary (Food) Risk
Mitigation"

The chronic dietary exposure estimates for both the active and inert
ingredient uses are   below the Agency’s level of concern for all age
groups.  Therefore, no mitigation measures are necessary at this time.

b. Drinking Water Risk Mitigation   XE "IV. Risk Management,
Reregistration, and Tolerance Reassessment Decision:D. Regulatory
Rationale: 1. Human Health Risk Management: b. Drinking Water Risk
Mitigation"

	The chronic drinking water exposure estimates for the inert ingredient
uses are below the Agency’s level of concern.  Significant drinking
water exposure is not expected to result from the active ingredient uses
of alkylbenzene sulfonates.  Therefore, no mitigation measures are
necessary at this time.

	c. Residential Risk Mitigation   XE "IV. Risk Management,
Reregistration, and Tolerance Reassessment Decision:D. Regulatory
Rationale: 1. Human Health Risk Management: c. Residential Risk
Mitigation"

Residential risk estimates for the uses of alkylbenzene sulfonates as
inert ingredients are below the Agency’s level of concern.  Therefore,
no mitigation measures are needed at this time for these uses, as none
present a risk of concern.

d. Occupational Risk Mitigation   XE "IV. Risk Management,
Reregistration, and Tolerance Reassessment Decision:D. Regulatory
Rationale: 1. Human Health Risk Management: d. Occupational Risk
Mitigation"

i. Handler Risk Mitigation  XE "IV. Risk Management, Reregistration, and
Tolerance Reassessment Decision:D. Regulatory Rationale: 1. Human Health
Risk Management: d. Occupational Risk Mitigation: i. Handler Exposure"

	  SEQ CHAPTER \h \r 1 The calculated short and intermediate-term
inhalation MOEs are greater than 100, and therefore, are not of concern
with the exception of the following scenarios:

Short-Term and Intermediate-Term inhalation exposure from cleaning hard
surfaces via wiping in the food handling category, inhalation MOE = 93.

Short-Term and Intermediate-Term inhalation exposure from cleaning
indoor hard surfaces via wiping and then following with sanitizing via
immersion/flooding in the food handling premises category, inhalation
MOE = 93.

Short-Term and Intermediate-Term inhalation exposure from cleaning
indoor hard surfaces via wiping and then following with sanitizing via
low pressure spray in the food handling premises category, inhalation
MOE  = 90.

Short-Term and Intermediate-Term inhalation exposure from cleaning
indoor hard surfaces via sponge/mesh/wiping and then sanitizing via
immersion/flooding in the food handling premises category, inhalation
MOE = 90.

Due to the conservative nature of the assessment, risk estimates making
a lot of assumptions, and the MOEs being so close to the target, the
Agency does not have a risk concern for these scenarios.

ii. Post-Application Risk Mitigation   XE "IV. Risk Management,
Reregistration, and Tolerance Reassessment Decision:D. Regulatory
Rationale: 1. Human Health Risk Management: d. Occupational Risk
Mitigation: ii. Post-Application Risk Mitigation"

	At this time, EPA does not foresee post-application exposures for the
occupational uses of alkylbenzene sulfonates; therefore, no mitigation
measures are necessary.

2.  Environmental Risk Management   XE "IV. Risk Management,
Reregistration, and Tolerance Reassessment Decision:D. Regulatory
Rationale: 2. Environmental Risk Mitigation"

	  SEQ CHAPTER \h \r 1 The Agency considers the uses of alkylbenzene
sulfonates assessed in this RED to be unlikely to result in any
appreciable exposure to terrestrial or aquatic organisms.  Therefore, no
risk mitigation measures are required.

	3.    XE "IV. Risk Management, Reregistration, and Tolerance
Reassessment Decision:D. Regulatory Rationale: 4. Threatened and
Endnagered Species Considerations"  Listed Species Considerations   XE
"IV. Risk Management, Reregistration, and Tolerance Reassessment
Decision:D. Regulatory Rationale: 4. Threatened and Endnagered Species
Considerations"

	a. The Endangered Species Act   XE "IV. Risk Management,
Reregistration, and Tolerance Reassessment Decision:D. Regulatory
Rationale: 4. Threatened and Endnagered Species Considerations: a. The
Endangered Species Program"

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 C.F.R. § 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.  Due to the low likelihood of exposure
and low toxicity of alkylbenzene sulfonates, the Agency expects no
effects to listed species or critical habitat and therefore makes a "No
Effect" determination for this chemical.

b. General Risk Mitigation   XE "IV. Risk Management, Reregistration,
and Tolerance Reassessment Decision:D. Regulatory Rationale: 4.
Threatened and Endnagered Species Considerations: b. General Risk
Mitigation"

Alkylbenzene sulfonates end-use products (EPs) may also contain other
registered pesticides.  Although the Agency is not proposing any
mitigation measures for products containing alkylbenzene sulfonates
specific to federally listed species, the Agency needs to address
potential risks from other end-use products.  Therefore, users should
adopt all listed species risk mitigation measures for all active
ingredients in the product.  If a product contains multiple active
ingredients with conflicting listed species risk mitigation measures,
the more stringent measure(s) should be adopted.

V.  What Registrants Need to Do  XE "V. What Registrants Need To Do"

The Agency has determined that alkylbenzene sulfonates are eligible for
reregistration provided that additional data that the Agency intends to
require confirm this decision.   The additional data requirements that
the Agency intends to obtain will include, among other things,
submission of the following:

For end-use products containing the active ingredient alkylbenzene
sulfonates, the registrants need to submit the following items as there
are no registered technical manufacturers: