United
States
Prevention,
Pesticides
EPA
739­
R­
05­
004
Environmental
Protection
and
Toxic
Substances
September
2005
Agency
(
7510C)

Reregistration
Eligibility
Decision
for
Oleic
Acid
Sulfonates
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
(
EPA)
has
completed
its
review
of
the
available
data
on
the
antimicrobial,
sulfonated
oleic
acid,
sodium
salt.
The
Reregistration
Eligibility
Decision
(
RED)
was
approved
in
the
form
of
a
decision
memorandum
which
summarized
the
regulatory
decision
for
sulfonated
oleic
acid,
sodium
salt
on
September
30,
2004.
The
memorandum
was
approved
and
signed
on
September
30,
2004.

Based
on
the
Agency's
review
of
sulfonated
oleic
acid,
sodium
salt,
the
Reregistration
Eligibility
Decision
(
RED),
risk
management
decision
and
associated
human
health
and
environmental
risk
assessments
are
now
being
published.
A
Notice
of
Availability
will
be
published
in
the
Federal
Register
announcing
the
publication
of
the
RED.

The
RED
and
supporting
documents
for
sulfonated
oleic
acid,
sodium
salt
will
be
available
to
the
public
in
EPA's
Pesticide
Docket
OPP­
2005­
0261
at:
http://
www.
epa.
gov/
edockets.

Please
note
that
the
attached
RED
document
pertains
only
to
sulfonated
oleic
acid,
sodium
salt
and
presents
the
Agency's
conclusions
on
the
dietary,
drinking
water,
occupational
and
ecological
risks
posed
by
exposure
to
sulfonated
oleic
acid,
sodium
salt
alone.
This
document
also
identifies
product­
specific
data
for
which
the
Agency
intends
to
issue
Data
Call­
Ins
(
DCIs).
Note
that
DCIs,
with
all
pertinent
instructions,
will
be
sent
to
registrants
at
a
later
date.
At
this
time,
generic
confirmatory
data
are
required.
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
sulfonated
oleic
acid,
sodium
salt
is
eligible
for
reregistration.
Sections
IV
and
V
of
the
oleic
acid
sulfonates
RED
document
describe
product­
specific
and
generic
data
requirements.

If
you
have
questions
pertaining
to
this
document,
please
contact
the
Chemical
Review
Manager,
K.
Avivah
Jakob,
at
(
703)
305­
1328
or
Jennifer
Slotnick
at
(
703)
305­
0601.
For
questions
regarding
product
reregistration
and
or
the
product
DCI
that
accompanies
this
document,
please
contact
Adam
Heyward
at
(
703)
308­
6422.

Sincerely,

Frank
T.
Sanders
Director,
Antimicrobials
Division
REREGISTRATION
ELIGIBILITY
DECISION
for
Oleic
Acid
Sulfonates
List
D
Case
No.
4069
Approved
By:

Frank
T.
Sanders
Director,
Antimicrobials
Division
September
29,
2005
TABLE
OF
CONTENTS
Oleic
Acid
Sulfonates
Reregistration
Team..............................................................................
i
Glossary
of
Terms
and
Abbreviations
.....................................................................................
ii
Executive
Summary
..................................................................................................................
v
I.
Introduction......................................................................................................................
1
II.
Chemical
Overview
..........................................................................................................
3
A.
Regulatory
History
..................................................................................................
3
B.
Chemical
Identification
...........................................................................................
3
1.
Technical
Sulfonated
Oleic
Acid,
Sodium
Salt
.................................................
3
a.
9­
Octadecenoic
acid
(
9Z­),
sulfonated,
sodium
salt
(
Primary­
Ingredient)
..............................................................................................
3
2.
By­
Product
Sulfonated
Oleic
Acid,
Sodium
Salt
..............................................
4
a.
Octadecanoic
acid,
sulfo,
sodium
salt
....................................................
4
C.
Use
Profile................................................................................................................
5
III.
Summary
of
Sulfonated
Oleic
Acid,
Sodium
Salt
Risk
Assessment
...............................
6
A.
Human
Health
Risk
Assessment
.............................................................................
6
1.
Toxicity
of
Sulfonated
Oleic
Acid,
Sodium
Salt................................................
6
2.
Food
Quality
Protection
Act
(
FQPA)
Safety
Factor.........................................
8
3.
Population
Adjusted
Dose
(
PAD)
......................................................................
8
4.
Dietary
and
Residential
Risk
Assessment
.........................................................
8
5.
Aggregate
Risk...................................................................................................
9
6.
Occupational
Exposure......................................................................................
9
7.
Human
Incident
Data
........................................................................................
9
B.
Environmental
Risk
Assessment
...........................................................................
10
1.
Environmental
Fate
and
Transport
................................................................
10
2.
Ecological
Risk.................................................................................................
10
a.
Toxicity
(
Hazard)
Assessment
.............................................................
10
b.
Risk
to
Threatened
and
Endangered
Species......................................
11
IV.
Risk
Management,
Reregistration
and
Tolerance
Reassessment
.................................
12
A.
Determination
of
Reregistration
Eligibility..........................................................
12
B.
Public
Comments
and
Responses..........................................................................
12
C.
Regulatory
Position
...............................................................................................
13
1.
Food
Quality
Protection
Act
(
FQPA)
Findings
..............................................
13
a.
"
Risk
Cup"
Determination..................................................................
13
b.
Determination
of
Safety
for
U.
S.
Population.......................................
13
c.
Determination
of
Safety
to
Infants
and
Children................................
13
d.
Endocrine
Disruptor
Effects
................................................................
14
e.
Cumulative
Risks
.................................................................................
14
2.
Tolerance
Reassessment
Summary
.................................................................
15
a.
Tolerance
Exemptions
and
Tolerance
Reassessment..........................
15
b.
Codex
Harmonization
..........................................................................
16
D.
Regulatory
Rationale.............................................................................................
16
1.
Listed
Species
Considerations
.........................................................................
17
a.
The
Endangered
Species
Act................................................................
17
b.
General
Risk
Mitigation.......................................................................
18
2.
Labeling............................................................................................................
18
a.
Label
Amendment
................................................................................
18
V.
What
Registrants
Need
to
Do.........................................................................................
19
A.
Manufacturing­
Use
Products
................................................................................
21
1.
Additional
Generic
Data
Requirements..........................................................
21
B.
End­
Use
Products
..................................................................................................
21
1.
Additional
Product­
Specific
Data
and
Efficacy
Requirements......................
21
VI.
Appendices......................................................................................................................
22
A.
Table
of
Use
Patterns
for
Trichloromelamine
......................................................
23
B.
Table
of
Generic
Data
Requirements
and
Studies
Used
to
Make
the
Reregistration
Decision
.........................................................................................
25
C.
Technical
Support
Documents
..............................................................................
30
D.
Bibliography
Citations
..........................................................................................
31
E.
Generic
Data
Call­
In
.............................................................................................
33
F.
Product­
Specific
Data
Call­
In
...............................................................................
34
G.
Batching
of
End­
Use
Products
..............................................................................
35
H.
List
of
All
Registrants
Sent
the
Data
Call­
In........................................................
36
I.
List
of
Available
Forms
.........................................................................................
37
i
Oleic
Acid
Sulfonates
Reregistration
Team
Health
Effects
Risk
Assessment
Deborah
Smegal
Tim
McMahon
Environmental
Fate
and
Ecological
Risk
Assessment
Deborah
Smegal
Najm
Shamim
Registration
Support
Adam
Heyward
Risk
Management
K.
Avivah
Jakob
Jennifer
Slotnick
Ben
Chambliss
ii
GLOSSARY
OF
TERMS
AND
ABBREVIATIONS
AE
Acid
Equivalent
AD
Antimicrobials
Division
ADTC
Antimicrobials
Division
Toxicology
Endpoint
Selection
Committee
a.
i.
Active
Ingredient
aPAD
Acute
Population
Adjusted
Dose
AR
Anticipated
Residue
ARC
Anticipated
Residue
Contribution
BCF
Bioconcentration
Factor
CAS
Chemical
Abstracts
Service
CI
Cation
CNS
Central
Nervous
System
cPAD
Chronic
Population
Adjusted
Dose
CSF
Confidential
Statement
of
Formula
CFR
Code
of
Federal
Regulations
CSFII
USDA
Continuing
Surveys
for
Food
Intake
by
Individuals
DCI
Data
Call­
In
DEEM
Dietary
Exposure
Evaluation
Model
DFR
Dislodgeable
Foliar
Residue
DRES
Dietary
Risk
Evaluation
System
DWEL
Drinking
Water
Equivalent
Level
(
DWEL)
The
DWEL
represents
a
medium
specific
(
i.
e.,
drinking
water)
lifetime
exposure
at
which
adverse,
noncarcinogenic
health
effects
are
not
anticipated
to
occur.
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
EPISUIT
Environmental
Protection
Agency,
Estimation
Program
Interface
Suite
FAO
Food
and
Agriculture
Organization
FDA
Food
and
Drug
Administration
FFDCA
Federal
Food,
Drug,
and
Cosmetic
Act
FIFRA
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
Fl.
oz.
Fluid
Ounces
FOB
Functional
Observation
Battery
FQPA
Food
Quality
Protection
Act
FWS
United
States
Fish
and
Wildlife
Services
G
Granular
Formulation
GENEEC
Tier
I
Surface
Water
Computer
Model
GLC
Gas
Liquid
Chromatography
GLN
Guideline
Number
GM
Geometric
Mean
GRAS
Generally
Recognized
as
Safe
as
Designated
by
FDA
HA
Health
Advisory
(
HA).
The
HA
values
are
used
as
informal
guidance
to
municipalities
and
other
organizations
when
emergency
spills
or
contamination
situations
occur.
HAFT
Highest
Average
Field
Trial
HDT
Highest
Dose
Tested
HPV
High
Production
Volume
IDS
Incident
Data
System
IR
Index
Reservoir
LC50
Median
Lethal
Concentration.
A
statistically
derived
concentration
of
a
substance
that
iii
can
be
expected
to
cause
death
in
50%
of
test
animals.
It
is
usually
expressed
as
the
weight
of
substance
per
weight
or
volume
of
water,
air
or
feed,
e.
g.,
mg/
l,
mg/
kg
or
ppm.
LD50
Median
Lethal
Dose.
A
statistically
derived
single
dose
that
can
be
expected
to
cause
death
in
50%
of
the
test
animals
when
administered
by
the
route
indicated
(
oral,
dermal,
inhalation).
It
is
expressed
as
a
weight
of
substance
per
unit
weight
of
animal,
e.
g.,
mg/
kg.
LEL
Lowest
Effect
Level
LOC
Level
of
Concern
LOD
Limit
of
Detection
LOAEL
Lowest
Observed
Adverse
Effect
Level
MATC
Maximum
Acceptable
Toxicant
Concentration
MCLG
Maximum
Contaminant
Level
Goal
(
MCLG)
The
MCLG
is
used
by
the
Agency
to
regulate
contaminants
in
drinking
water
under
the
Safe
Drinking
Water
Act.
mg/
kg/
day
Milligram
Per
Kilogram
Per
Day
mg/
L
Milligrams
Per
Liter
MOE
Margin
of
Exposure
MP
Manufacturing­
Use
Product
MPI
Maximum
Permissible
Intake
MRID
Master
Record
Identification
(
number).
EPA's
system
of
recording
and
tracking
studies
submitted.
NA
Not
Applicable
N/
A
Not
Applicable
NAWQA
USGS
National
Water
Quality
Assessment
NMFS
National
Marine
Fishery
Service
NOEC
No
Observable
Effect
Concentration
NOEL
No
Observed
Effect
Level
NOAEL
No
Observed
Adverse
Effect
Level
NPDES
National
Pollutant
Discharge
Elimination
System
NPTN
National
Pesticide
Telecommunications
Network
NR
Not
Required
OP
Organophosphate
OPP
EPA
Office
of
Pesticide
Programs
OPPTS
EPA
Office
of
Prevention,
Pesticides
and
Toxic
Substances
Pa
Pascal,
the
pressure
exerted
by
a
force
of
one
newton
acting
on
an
area
of
one
square
meter.
PAD
Population
Adjusted
Dose
PCC
National
Poison
Control
Center
PADI
Provisional
Acceptable
Daily
Intake
PAG
Pesticide
Assessment
Guideline
PAM
Pesticide
Analytical
Method
PCA
Percent
Crop
Area
PDP
USDA
Pesticide
Data
Program
PHED
Pesticide
Handler's
Exposure
Data
PHI
Preharvest
Interval
ppb
Parts
Per
Billion
PPE
Personal
Protective
Equipment
ppm
Parts
Per
Million
PRN
Pesticide
Registration
Notice
PRZM/
EXAMS
Tier
II
Surface
Water
Computer
Model
Q1*
The
Carcinogenic
Potential
of
a
Compound,
Quantified
by
the
EPA's
Cancer
Risk
Model
RAC
Raw
Agriculture
Commodity
RBC
Red
Blood
Cell
RED
Reregistration
Eligibility
Decision
REI
Restricted
Entry
Interval
RfD
Reference
Dose
iv
RQ
Risk
Quotient
RS
Registration
Standard
RUP
Restricted
Use
Pesticide
SAP
Science
Advisory
Panel
SAR
Structure
Activity
Relationship
Assessment
SCI­
GROW
Tier
I
Ground
Water
Computer
Model
SF
Safety
Factor
SLC
Single
Layer
Clothing
SLN
Special
Local
Need
(
Registrations
Under
Section
24(
c)
of
FIFRA)
TC
Toxic
Concentration.
The
concentration
at
which
a
substance
produces
a
toxic
effect.
TD
Toxic
Dose.
The
dose
at
which
a
substance
produces
a
toxic
effect.
TEP
Typical
End­
Use
Product
TGAI
Technical
Grade
Active
Ingredient
TLC
Thin
Layer
Chromatography
TMRC
Theoretical
Maximum
Residue
Contribution
torr
A
unit
of
pressure
needed
to
support
a
column
of
mercury
1
mm
high
under
standard
conditions.
TRR
Total
Radioactive
Residue
UF
Uncertainty
Factor
Fg/
g
Micrograms
Per
Gram
Fg/
L
Micrograms
Per
Liter
USDA
United
States
Department
of
Agriculture
USGS
United
States
Geological
Survey
UV
Ultraviolet
WHO
World
Health
Organization
WP
Wettable
Powder
WPS
Worker
Protection
Standard
v
EXECUTIVE
SUMMARY
The
Environmental
Protection
Agency
(
EPA
or
the
Agency)
has
completed
its
human
health
and
environmental
review
for
sulfonated
oleic
acid,
sodium
salt
and
is
issuing
its
risk
management
decision.
The
Agency
has
decided
that
sulfonated
oleic
acid,
sodium
salt
is
eligible
for
reregistration.
The
following
Reregistration
Eligibility
Decision
(
RED)
addresses
the
use
of
sulfonated
oleic
acid,
sodium
salt
as
a
bacteriacide
and
sanitizer
for
food­
contact
sanitizing
solutions.
As
an
active
ingredient,
sulfonated
oleic
acid,
sodium
salt
is
used
as
a
sanitizer
for
non­
porous
dairy,
beverage,
brewery
and
food
processing
equipment.
Sulfonated
oleic
acid,
sodium
salt
is
formulated
as
a
liquid
concentrate.
The
following
RED
reassesses
the
exemption
from
the
requirement
for
a
tolerance
for
sulfonated
oleic
acid,
sodium
salt.
The
tolerance
exemption
for
sulfonated
oleic
acid,
sodium
salt
is
listed
in
40
CFR
180.940
(
c)
(
69
FR
23136,
Apr.
28,
2004).

Overall
Risk
Summary
Hazard
Profile/
Human
Health
Risk
Upon
reviewing
the
available
toxicity
information,
the
Agency
has
concluded
that
there
are
no
endpoints
of
concern
for
repeated
oral,
dermal,
or
inhalation
exposure
to
sulfonated
oleic
acid,
sodium
salt
based
on
the
low
toxicity
observed
in
acute
studies
and
the
Structure
Activity
Relationship
(
SAR)
assessments
conducted
by
the
Agency.
Therefore
a
quantitative
human
health
risk
assessment
was
not
conducted
for
this
RED.
There
are
no
indications
of
special
sensitivity
of
infants
or
children
resulting
from
exposure
to
sulfonated
oleic
acid,
sodium
salt;
therefore,
the
FQPA
Safety
Factor
has
been
removed
(
i.
e.,
reduced
to
1X)
for
sulfonated
oleic
acid,
sodium
salt.
The
Agency
has
no
risk
concerns
for
sulfonated
oleic
acid,
sodium
salt
with
respect
to
human
exposure.

The
Food
and
Drug
Administration
(
FDA)
has
approved
the
indirect
food
use
of
sulfonated
oleic
acid
up
to
200
ppm
for
food
processing
equipment
and
glass
bottles
for
milk.
This
level
of
clearance
is
greater
than
the
Agency=
s
level
of
concern
for
indirect
food
uses
of
antimicrobial
pesticides
(
i.
e.,
>
200
ppb);
therefore,
the
Agency
believes
that
sulfonated
oleic
acid,
sodium
salt
is
of
a
low
order
of
toxicity.
Furthermore,
the
Agency
recognizes
that
sulfonated
oleic
acid,
sodium
salt
is
a
fatty
acid
derivative.
Fatty
acids
are
processed
by
known
metabolic
pathways
within
the
body
and
are
necessary
for
normal
cellular
functioning.
As
the
exposures
anticipated
from
the
indirect
food
uses
(
as
well
as
non­
dietary
dermal
and
or
inhalation
exposure)
are
insignificant
in
comparison
to
levels
encountered
for
fatty
acids
in
the
normal
human
diet,
use
of
this
chemical
in
pesticide
products
is
unlikely
to
pose
any
significant
hazard
to
the
general
population
or
to
any
subgroup
including
infants
and
children.

Environmental
Risk
The
Agency
conducted
a
Structure
Activity
Relationship
(
SAR)
assessment
to
assess
the
environmental
risks
of
sulfonated
oleic
acid,
sodium
salt.
The
result
of
this
analysis
predicts
low
to
moderate
toxicity
concern
for
ecological
effects
from
sulfonated
oleic
acid,
sodium
salt.
Sulfonated
oleic
acid,
sodium
salt
shows
a
tendency
to
be
immobile,
a
moderate
to
strong
vi
tendency
to
bind
tightly
to
sediment
and
soils,
and
undergoes
microbial
degradation
within
a
couple
of
weeks,
which
is
expected
to
mitigate
any
potential
for
risk.
The
EPA
believes
that
this
compound
will
not
cause
unreasonable
adverse
effects
on
the
environment.

The
Agency
has
no
risk
concerns
for
sulfonated
oleic
acid,
sodium
salt
with
respect
to
nontarget
organisms.
The
Agency
expects
no
effects
to
listed
species
or
critical
habitat
and
therefore
makes
a
"
No
Effect"
determination
for
sulfonated
oleic
acid,
sodium
salt.

Regulatory
Decision
The
Agency
has
determined
that
sulfonated
oleic
acid,
sodium
salt
is
eligible
for
reregistration
provided
that
requested
additional
confirmatory
data,
which
is
needed
to
fulfill
data
gaps,
are
submitted
to
the
Agency.

Summary
of
Mitigation
Measures
Because
no
risks
of
concern
were
identified,
no
specific
mitigation
measures
are
needed
for
sulfonated
oleic
acid,
sodium
salt.

Data
Requirements
Additional
confirmatory
and
product­
specific
data
are
required
to
complete
the
reregistration
of
sulfonated
oleic
acid,
sodium
salt
as
described
in
Section
V
of
this
document.
1
I.
Introduction
The
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
was
amended
in
1988
to
accelerate
the
reregistration
of
products
with
active
ingredients
registered
prior
to
November
1,
1984.
The
amended
Act
calls
for
the
development
and
submission
of
data
to
support
the
reregistration
of
an
active
ingredient
(
a.
i.),
as
well
as
a
review
of
all
submitted
data
by
the
U.
S.
Environmental
Protection
Agency.
Reregistration
involves
a
thorough
review
of
the
scientific
database
underlying
a
pesticide's
registration.
The
purpose
of
the
Agency's
review
is
to
reassess
the
potential
risks
arising
from
the
currently
registered
uses
of
the
pesticide;
to
determine
the
need
for
additional
data
on
health
and
environmental
effects;
and
to
determine
whether
or
not
the
pesticide
meets
the
"
no
unreasonable
adverse
effects"
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
human
health
and
ecological
risk
assessments
and
the
Reregistration
Eligibility
Decision
(
RED)
for
sulfonated
oleic
acid,
sodium
salt.

As
an
active
ingredient,
sulfonated
oleic
acid,
sodium
salt
is
used
as
a
sanitizer
for
nonporous
dairy,
beverage,
brewery
and
food
processing
equipment.
For
these
uses,
sulfonated
oleic
acid,
sodium
salt
is
formulated
as
a
liquid
concentrate.

The
Agency
has
concluded
that
the
FQPA
Safety
Factor
for
sulfonated
oleic
acid,
sodium
salt
should
be
removed
(
equivalent
to
1X)
based
on:
(
1)
the
structural
activity
relationship
analysis
(
SARs)
conducted
for
sulfonated
oleic
acid,
sodium
salt
and
available
data
for
other
anionic
surfactants
(
e.
g.,
linear
alkylbenzene
sulfonates
and
alcohol
sulfates)
found
no
concerns
for
potential
sensitivity
to
infants
and
children
since
all
developmental
effects
occurred
at
or
above
those
dose
levels
associated
with
maternal
effects;
and
(
2)
the
risk
assessment
does
not
underestimate
the
potential
exposure
for
infants
and
children.

Risks
summarized
in
this
document
are
those
that
result
only
from
the
use
of
the
active
ingredient
sulfonated
oleic
acid,
sodium
salt.
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
sulfonated
oleic
acid,
sodium
salt
and
any
other
substances.
Sulfonated
2
oleic
acid,
sodium
salt
does
not
appear
to
produce
a
toxic
metabolite
produced
by
other
substances.
For
the
purposes
of
this
action,
therefore,
EPA
has
not
assumed
that
sulfonated
oleic
acid,
sodium
salt
has
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
http://
www.
epa.
gov/
pesticides/
cumulative.

This
document
presents
the
Agency's
decision
regarding
the
reregistration
eligibility
of
the
registered
uses
of
sulfonated
oleic
acid,
sodium
salt.
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
sulfonated
oleic
acid,
sodium
salt
referenced
in
this
RED.
The
risk
assessments
and
related
addenda
are
not
included
in
this
document,
but
are
available
in
the
Public
Docket
at
http://
www.
epa.
gov/
edocket.

This
document
consists
of
six
sections.
Section
I
is
the
introduction.
Section
II
provides
a
chemical
overview,
a
profile
of
the
use
and
usage
of
sulfonated
oleic
acid,
sodium
salt
and
its
regulatory
history.
Section
III,
Summary
of
Sulfonated
Oleic
Acid,
Sodium
Salt
Risk
Assessment,
gives
an
overview
of
the
human
health
and
environmental
assessments,
based
on
the
information
available
to
the
Agency.
Section
IV,
Risk
Management,
Reregistration
and
Tolerance
Reassessment,
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
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.
3
II.
CHEMICAL
OVERVIEW
A.
Regulatory
History
Sulfonated
oleic
acid,
sodium
salt
is
registered
as
an
active
ingredient,
no­
rinse
sanitizer
for
food
processing
facilities.
The
active
ingredient
consists
of
two
chemical
constituents,
one
as
the
primary
ingredient
(
9­
octadecenoic
acid
(
9Z­),
sulfonated,
sodium
salt,
CAS
No.
68443­
05­
0)
and
the
other
as
a
by­
product
of
manufacturing
(
octadecanoic
acid,
sulfo,
sodium
salt,
CAS
No.
67998­
94­
1).
There
is
currently
one
registered
product
containing
2.66%
of
sulfonated
oleic
acid,
sodium
salt
(
approximately
200
ppm)
as
an
active
pesticide
ingredient
(
PER­
VAD7
Low
Foam
Anionic
Acid
Sanitizer,
Reg.
No.
875­
90).

B.
Chemical
Identification
1.
Technical
Sulfonated
Oleic
Acid,
Sodium
Salt
a.
9­
Octadecenoic
acid
(
9Z­),
sulfonated,
sodium
salt
(
Primary
Ingredient)

O
O
S
O
O­
Na+

Sulfonated
Oleic
acid,
sodium
salt
O
Common
Name:
Sulfonated
oleic
acid,
sodium
salt
Chemical
Name:
9­
Octadecenoic
acid
(
9Z­),
sulfonated,
sodium
salt
Other
Name:
Sodium
sulfonated
oleic
acid
Chemical
Family:
Fatty
Acid
Salts
Case
Number:
4069
CAS
Registry
Number:
68443­
05­
0
OPP
Chemical
Code:
079064
Molecular
weight:
384.51
Empirical
Formula:
C18H33NaO5S
4
Basic
Manufacturers:
DiversyLever
9­
Octadecenoic
acid
(
9Z­),
sulfonated,
sodium
salt
is
a
fatty
acid
derivative
with
a
melting
point
of
312oC.
9­
Octadecenoic
acid
(
9Z­),
sulfonated,
sodium
salt
is
dispersible
in
water.
The
vapor
pressure
of
9­
octadecenoic
acid
(
9Z­),
sulfonated,
sodium
salt
is
less
then
1
x
10­
6
mmHg,
and
the
boiling
point
is
greater
then
400oC.

2.
By­
Product
Sulfonated
Oleic
Acid,
Sodium
Salt
a.
Octadecanoic
acid,
sulfo,
sodium
salt
O
O
S
O
O
O
Na
Common
Name:
Sulfonated
oleic
acid,
sodium
salt
Chemical
Name:
Octadecanoic
acid,
sulfo,
sodium
salt
Other
Names:
Sodium
sulfonated
oleic
acid
Chemical
Family:
Fatty
Acid
Salts
Case
Number:
4069
CAS
Registry
No.:
67998­
94­
1
OPP
Chemical
Code:
To
be
established.

Molecular
Weight:
386.52
Empirical
Formula:
C18H35NaO5S
Basic
Manufacturers:
DiverseyLever
Octadecanoic
acid,
sulfo,
sodium
salt
is
a
fatty
acid
derivative
with
a
melting
point
of
311.7oC.
Octadecanoic
acid,
sulfo,
sodium
salt
has
a
water
solubility
of
608
mg/
L.
The
estimated
vapor
pressure
of
octadecanoic
acid,
sulfo,
sodium
salt
is
2.29
x
10­
20
mmHg,
and
its
boiling
point
is
712oC.
5
C.
Use
Profile
The
following
section
provides
information
on
the
currently
registered
uses
of
the
sulfonated
oleic
acid,
sodium
salt
product.
Included
is
an
overview
of
the
use
sites
and
application
methods
of
sulfonated
oleic
acid,
sodium
salt.
Please
refer
to
Appendix
A
for
a
comprehensive
table
of
uses
of
sulfonated
oleic
acid,
sodium
salt
eligible
for
reregistration.

Type
of
Pesticide:
Bacteriacide/
Sanitizer
Target
Organism(
s):
Sulfonated
oleic
acid,
sodium
salt
is
used
as
a
bacteriacide
for
animal
pathogenic
bacteria
(
g­
and
g+).

Use
Sites:
Food
Uses:
Sulfonated
oleic
acid,
sodium
salt
is
an
indirect
food
contact
sanitizer
that
is
used
on
non­
porous
dairy,
beverage,
brewery
and
food
processing
equipment.

Use
Classification:
Sulfonated
oleic
acid,
sodium
salt
is
categorized
as
a
general
use
pesticide.

Formulation
Types:
The
sulfonated
oleic
acid,
sodium
salt
product
is
formulated
as
a
liquid
soluble
concentrate.

Application
Rates/
Methods:
Sulfonated
oleic
acid,
sodium
salt
can
be
applied
manually
by
diluting
1
fl.
oz.
of
the
product
per
gallon
of
water
(
providing
aproximatly
200
ppm
of
anionic
active
agent).
The
chemical
is
applied
to
surfaces
in
a
variety
of
methods,
which
include
brushing,
flooding,
immersion,
or
coarse
droplet
spraying
of
the
sanitizing
solution.
6
III.
SUMMARY
OF
SULFONATED
OLEIC
ACID,
SODIUM
SALT
RISK
ASSESMENTS
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
sulfonated
oleic
acid,
sodium
salt.
While
the
risk
assessments
and
related
addenda
are
not
included
in
this
document,
they
are
available
from
the
OPP
Public
Docket
and
may
also
be
accessed
on
the
Agency's
website
at
http://
epa.
gov/
dockets.
Hard
copies
of
these
documents
may
be
found
in
the
OPP
public
docket
under
docket
number
OPP­
2005­
0261.
The
OPP
public
docket
is
located
in
Room
119,
Crystal
Mall
II,
1801
Bell
Street,
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
1.
Toxicity
of
Sulfonated
Oleic
Acid,
Sodium
Salt
A
brief
overview
of
the
toxicity
of
sulfonated
oleic
acid,
sodium
salt
is
presented
below.
Further
information
on
the
toxicity
of
sulfonated
oleic
acid,
sodium
salt
can
be
found
in
the
document
Oleic
Acid
Sulfonates
and
Related
Compounds:
Antimicrobials
Division
Risk
Assessment
for
the
Reregistration
Eligibility
Decision
(
RED)
Document
and
for
Tolerance
Reassessment
(
Smegal,
2004)
and
in
the
memorandum
Similarity
of
Linear
Alkylbenzene
Sulfonates
and
Alcohol
Sulfates
to
Sulfonated
Oleic
Acid
with
Respect
to
Toxicity
(
McMahon,
2004),
which
are
available
on
the
Agency's
website
in
the
EPA
Docket
at
http://
www/
epa.
gov/
edockets.

The
Agency
has
reviewed
all
toxicity
studies
submitted
for
sulfonated
oleic
acid,
sodium
salt
and
has
determined
that
the
toxicological
database
is
sufficient
for
reregistration.
The
toxicological
database
for
sulfonated
oleic
acid,
sodium
salt
is
currently
comprised
of
unpublished
studies
submitted
to
the
Agency;
however,
limited
data
is
available
for
sulfonated
oleic
acid,
sodium
salt.
Given
the
limited
toxicity
data
available
for
sulfonated
oleic
acid,
sodium
salt,
the
Agency
conducted
Structure
Activity
Relationship
(
SAR)
assessments
as
well
as
considered
toxicity
data
for
other
anionic
surfactants
that
are
believed
to
be
toxicologically
similar
to
sulfonated
oleic
acid,
sodium
salt
(
e.
g.,
linear
alkyl
benzene
sulfonate
and
alcohol
sulfates).
Based
on
data
provided
to
the
Agency,
the
EPA
believes
that
alcohol
sulfates
have
a
greater
similarity
to
oleic
acid
sulfonates
than
do
the
linear
alkylbenzene
sulfonates,
which
contain
a
benzene
ring.
7
Table
1.
Acute
Toxicity
of
Sulfonated
Oleic
Acid,
Sodium
Salt
Test
Species
Results
MRID
>
5000
mg/
kg
(
Toxicity
Category
IV)
41861503
Oral
LD50
Rat
>
5000
mg/
kg
(
a)
(
Toxicity
Category
IV)
43423804
Dermal
LD50
Rabbit
>
2000
mg/
kg
(
Toxicity
Category
III)
41861503
>
207
mg/
L
(
1­
Hour)
(
Toxicity
Category
IV)
41861503
Inhalation
LC50
Rat
>
2.02
mg/
L
(
4­
Hour)(
a)
(
Toxicity
Category
IV)
44008401
Dermal
Irritation
Rabbit
Slight
Erythema
and
Edema
(
Toxicity
Category
IV)

Eye
Irritation
Rabbit
24­
Hr:
19.3;
48­
Hr:
12.3;
72­
Hr:
13.3;
7­
Day:
1
(
Toxicity
Category
II)
41861503
(
a)
Contains
2.6%
sulfonated
oleic
acid,
sodium
salt
(
active)

General
Toxicity
Observations
Upon
reviewing
the
available
toxicity
information,
the
Agency
has
concluded
that
there
are
no
endpoints
of
concern
for
repeated
oral,
dermal,
or
inhalation
exposure
to
sulfonated
oleic
acid,
sodium
salt.
This
conclusion
is
based
on
low
toxicity
observed
in
acute
studies
and
Structure
Activity
Relationship
(
SAR)
assessments.
SAR
assessments
were
performed
in
June
2004
by
the
Office
of
Pollution
Prevention
and
Toxics
(
OPPT),
and
it
was
found
that
sulfonated
oleic
acid,
sodium
salt
absorption
is
expected
to
be
poor
from
the
skin,
moderate
from
the
gastrointestinal
tract
and
good
from
the
lungs.
There
is
concern
for
surfactant
effects
on
the
lung
and
irritation
to
the
eye,
skin
(
chronic),
mucous
membranes
and
lungs
based
on
surfactant
properties
of
the
compound.
Sulfonated
oleic
acid,
sodium
salt
is
judged
to
be
of
low
to
moderate
toxicity
concern.
There
are
no
concerns
for
mutagenicity,
carcinogenicity,
developmental
or
reproductive
effects.

The
FDA
has
approved
the
indirect
food
use
of
sulfonated
oleic
acid
up
to
200
ppm
for
food
processing
equipment
and
glass
bottles
for
milk.
This
level
of
clearance
is
greater
than
the
Agency's
Level
of
concern
for
indirect
food
uses
of
antimicrobial
pesticides
(
i.
e.,
>
200
ppm);
therefore,
the
Agency
believes
that
sulfonated
oleic
acid,
sodium
salt
is
of
a
low
order
of
toxicity.
Furthermore,
the
Agency
recognizes
that
sulfonated
oleic
acid,
sodium
salt
is
a
fatty
acid
derivative.
Fatty
acids
are
processed
by
known
metabolic
pathways
within
the
body
and
are
necessary
for
normal
cellular
functioning.
As
the
exposures
anticipated
from
the
indirect
food
uses
(
as
well
as
non­
dietary
dermal
and
or
inhalation
exposure)
are
insignificant
in
comparison
to
levels
encountered
for
fatty
acids
in
the
normal
human
diet,
use
of
these
chemicals
in
pesticide
products
is
unlikely
to
pose
any
significant
hazard
to
the
general
population
or
to
any
subgroup
8
including
infants
and
children.

Carcinogenicity
Classification
Based
on
the
SAR
assessments,
there
are
no
concerns
of
carcinogenicity
for
sulfonated
oleic
acid,
sodium
salt;
therefore,
no
carcinogenic
analysis
is
required.

Mutagenicity
Potential
Based
on
the
SAR
assessments
of
sulfonated
oleic
acid,
sodium
salt,
and
information
on
structurally
similar
chemicals,
there
are
no
concerns
for
mutagenicity;
therefore,
no
mutagenicity
analysis
is
required.

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,
residential
exposures,
or
to
compensate
for
an
incomplete
database.
The
FQPA
Safety
Factor
has
been
removed
(
i.
e.,
reduced
to
1X)
for
sulfonated
oleic
acid,
sodium
salt
for
the
following
reasons:
(
1)
The
structural
activity
relationship
(
SARs)
analyses
conducted
for
sulfonated
oleic
acid,
sodium
salt
and
the
available
data
for
other
anionic
surfactants
(
e.
g.,
linear
alkylbenzene
sulfonates
and
alcohol
sulfates)
found
no
concerns
for
potential
sensitivity
to
infants
and
children
because
all
developmental
effects
occurred
at
or
above
those
dose
levels
associated
with
maternal
effects;
and,
(
2)
The
risk
assessment
does
not
underestimate
the
potential
risk
for
infants
and
children.
As
confirmatory
data
to
the
SARs
conducted
by
the
Agency,
a
prenatal
developmental
toxicity
study
for
sulfonated
oleic
acid,
sodium
salt
is
needed.

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.
Since
toxicological
endpoints
for
the
risk
assessment
were
not
identified
based
on
the
available
data,
RfDs
and
PADs
have
not
been
calculated
for
sulfonated
oleic
acid,
sodium
salt.

4.
Dietary
and
Residential
Risk
Assessment
Dietary
exposure
could
potentially
occur
from
the
use
of
sulfonated
oleic
acid,
sodium
salt
as
an
active
ingredient
in
food­
contact
sanitizing
solutions.
However,
risk
estimates
have
not
been
calculated
for
potential
exposures
to
sulfonated
oleic
acid,
sodium
salt
on
food,
in
drinking
water,
or
as
a
result
of
use
in
residential
settings
because
there
are
no
toxicological
endpoints
of
concern
according
to
a
review
of
the
available
toxicity
information
and
SARs
assessments.
There
are
no
residential
uses
of
sulfonated
oleic
acid,
sodium
salt
and
therefore
risk
estimates
were
not
calculated
for
potential
exposures
in
residential
settings.
9
The
Agency
believes
the
possibility
of
surface
and
ground
water
contamination
is
low
because
sulfonated
oleic
acid,
sodium
salt
shows
a
moderate
to
strong
tendency
to
bind
tightly
with
soils
and
sediments
and
shows
a
tendency
to
be
immobile.

The
FDA
has
approved
the
indirect
food
use
of
sulfonated
oleic
acid
up
to
200
ppm
for
food
processing
equipment
and
glass
bottles
for
milk.
This
level
of
clearance
is
greater
than
the
Agency
=

s
level
of
concern
for
indirect
food
uses
of
antimicrobial
pesticides
(
i.
e.,
>
200
ppb);
therefore,
the
Agency
believes
that
sulfonated
oleic
acid,
sodium
salt
is
of
a
low
order
of
toxicity.
Furthermore,
the
Agency
recognizes
that
sulfonated
oleic
acid,
sodium
salt
is
a
fatty
acid
derivative.
Fatty
acids
are
processed
by
known
metabolic
pathways
within
the
body
and
are
necessary
for
normal
cellular
functioning.
As
the
exposures
anticipated
from
the
indirect
food
uses
(
as
well
as
non­
dietary
dermal
and
or
inhalation
exposure)
are
insignificant
in
comparison
to
levels
encountered
for
fatty
acids
in
the
normal
human
diet,
use
of
this
chemical
in
pesticide
products
is
unlikely
to
pose
any
significant
hazard
to
the
general
population
or
to
any
subgroup
including
infants
and
children.

5.
Aggregate
Risk
The
Food
Quality
Protection
Act
amendments
to
the
Federal
Food,
Drug,
and
Cosmetic
Act
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"(
FFDCA,
Section
408(
b)(
2)(
A)(
ii)).
Aggregate
exposure
will
typically
include
exposures
from
food,
drinking
water,
residential
uses
of
a
pesticide
and
other
non­
occupational
sources
of
exposure;
however,
it
is
important
to
note
that
there
are
no
residential
uses
of
sulfonated
oleic
acid,
sodium
salt.

Toxicological
endpoints
for
the
sulfonated
oleic
acid,
sodium
salt
risk
assessment
were
not
identified
based
on
the
available
data
and
therefore
an
aggregate
risk
assessment
was
not
conducted
for
sulfonated
oleic
acid,
sodium
salt
6.
Occupational
Exposure
The
occupational
exposure
assessment
for
sulfonated
oleic
acid,
sodium
salt
addresses
potential
exposures
and
risks
to
humans
who
may
be
exposed
in
"
occupational
settings."
An
occupational
risk
assessment
is
required
for
an
active
ingredient
if
certain
toxicological
criteria
are
triggered
and
there
is
potential
exposure
to
handlers
(
mixers,
loaders,
applicators,
etc.)
during
use
or
to
persons
entering
treated
sites
after
application
is
complete.
For
sulfonated
oleic
acid,
sodium
salt
there
is
potential
for
exposure;
however,
there
are
no
toxicological
endpoints
of
concern
according
to
a
review
of
the
available
toxicity
data
and
SAR
analysis.

7.
Human
Incident
Data
In
evaluating
incidents
to
humans,
the
Agency
reviewed
reports
from
the
National
Poison
Control
Centers
(
PCC),
the
Agency
=

s
Office
of
Pesticide
Program
=

s
Incident
Data
System
(
IDS),
10
the
California
Pesticide
Illness
Surveillance
Program,
and
the
National
Pesticide
Telecommunications
Network
(
NPTN).
In
the
data
sources
available
to
the
Agency,
no
reports
of
serious
illness
have
been
associated
with
human
exposure
to
sulfonated
oleic
acid,
sodium
salt.

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
sulfonated
oleic
acid,
sodium
salt
use
sites
and
any
associated
uncertainties.
For
further
information
concerning
all
aspects
about
the
environmental
risk
assessment
refer
to
the
product
chemistry,
environmental
fate
and
ecological
toxicology
in
the
sulfonated
oleic
acid,
sodium
salt
risk
assessment
available
on
the
Agency's
website
in
the
EPA
Docket
at
http://
www/
epa.
gov/
edockets.

1.
Environmental
Fate
and
Transport
Sulfonated
oleic
acid,
sodium
salt
shows
a
moderate
to
strong
tendency
to
bind
with
soils
and
sediments
and
has
a
tendency
to
be
immobile;
however,
various
degradation
models
indicate
that
the
dissipation
pathway
of
sulfonated
oleic
acid,
sodium
salt
is
via
biodegradation
in
soils
and
sediments
and
that
sulfonated
oleic
acid,
sodium
salt
dissipates
within
a
maximum
of
a
couple
of
weeks.
Therefore,
the
possibility
of
surface
and
ground
water
contamination
from
sulfonated
oleic
acid,
sodium
salt
is
low.

Sulfonated
oleic
acid,
sodium
salt
does
not
appear
to
persist
in
air
for
a
long
period
of
time
and
has
an
approximant
half­
life
of
six
hours.
There
are
no
hydrolytic
studies
reported
for
sulfonated
oleic
acid,
sodium
salt.
Various
fate
models
indicate
that
the
half­
lives
of
oleic
acid
sulfonates
in
water
will
be
similar
to
their
half­
lives
in
soils
and
sediments
suggesting
that
(
aerobically
or
anaerobically)
sulfonated
oleic
acid,
sodium
salt
will
likely
degrade
in
aquatic
systems
as
readily
as
it
does
in
soils
and
sediments.

In
general,
sulfonated
oleic
acid,
sodium
salt
is
not
persistent
in
air,
water,
or
soils
and
does
not
bio­
accumulate
in
aquatic
organisms.
The
Agency
at
this
time
has
no
concerns
regarding
the
fate
and
transport
processes
of
sulfonated
oleic
acid,
sodium
salt
in
air,
soils
or
water.

2.
Ecological
Risk
a.
Toxicity
(
Hazard)
Assessment
The
Agency
conducted
Structure
Activity
Relationship
(
SAR)
assessments
for
sulfonated
oleic
acid,
sodium
salt
as
a
result
of
there
being
no
available
eco­
toxicity
data
(
USEPA
2004).
The
results
of
the
assessments
are
presented
in
Table
2.
Sulfonated
oleic
acid,
sodium
salt
is
of
moderate
toxicity
concern.
It
was
found
that
the
greater
the
length
of
the
hydrophobe
to
the
sulfonic
acid,
the
greater
the
toxicity
and
surfactancy.
Sulfonated
oleic
acid,
sodium
salt
has
a
low
potential
for
persistence,
bioaccumulation
and
toxicity.
Also,
sulfonated
oleic
acid,
sodium
salt
is
immobile,
binds
moderately
to
strongly
to
sediment
and
soils
and
undergoes
microbial
11
degradation
within
a
few
weeks,
which
is
expected
to
mitigate
any
potential
for
risk.
EPA
believes
that
sulfonated
oleic
acid,
sodium
salt
will
not
cause
unreasonable
adverse
effects
on
the
environment.
Adequate
review
of
labeling
will
reflect
the
results
of
the
end­
product
acute
toxicity
testing
and
therefore
should
address
all
concerns.

Sulfonated
oleic
acid,
sodium
salt's
labeled
use
as
an
active
ingredient
food­
contact
sanitizer
is
not
expected
to
result
in
significant
environmental
exposure.
Therefore,
adverse
effects
on
endangered/
threatened
terrestrial
and
aquatic
animal
species
are
not
anticipated.
However,
the
Agency
is
requesting
confirmatory
eco­
toxicity
data
to
support
the
registered
uses
of
sulfonated
oleic
acid,
sodium
salt
as
an
active
pesticide
ingredient.
This
information
will
fulfill
labeling
data
requirements
in
the
event
that
there
is
an
accidental
spill
of
the
chemical
during
transport.
For
more
information
regarding
the
requested
confirmatory
data
please
refer
to
Section
V
of
this
document.

Table
2:
Ecotoxicity
of
Oleic
Acid
Sulfonates
Parameter
Oleic
acid,
sulfonated,
sodium
salt
(
octadecanoic
acid,
sulfo,
sodium
salt)
67998­
94­
1
9­
Octadecenoic
acid
(
9Z­),
sulfonated,
sodium
salt
68443­
05­
0
Fish
96­
Hour
LC50
(
mg/
L)
$
100,
predicted
$
50,
predicted
Daphnid
48­
Hour
LC50
(
mg/
L)
$
100,
predicted
$
40,
predicted
Green
Algae
96­
Hour
LC50
(
mg/
L)
$
100,
predicted
$
50,
predicted
Chronic
Fish
Value
(
mg/
L)
$
20,
predicted
$
8,
predicted
Chronic
Daphnid
Value
(
mg/
L)
$
20,
predicted
$
6,
predicted
Chronic
Algal
Value
(
mg/
L)
$
30,
predicted
>
10,
predicted
SAR
Conclusions
Moderate
concern
for
toxicity
Moderate
concern
for
toxicity
b.
Risk
to
Threatened
and
Endangered
Species
Due
to
the
low
likelihood
of
exposure
and
low
toxicity
of
sulfonated
oleic
acid,
sodium
salt,
the
Agency
expects
no
effects
to
listed
species
or
critical
habitat
and
therefore
the
Agency
makes
a
"
No
Effect"
determination
for
sulfonated
oleic
acid,
sodium
salt.
12
IV.
RISK
MANAGEMENT,
REREGISTRATION
AND
TOLERANCE
REASSESMENT
DECSION
A.
Determination
of
Reregistration
Eligibility
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
generic
(
i.
e.,
active
ingredient­
specific)
data
to
support
reregistration
of
products
containing
sulfonated
oleic
acid,
sodium
salt
as
an
active
ingredient.
The
Agency
has
completed
its
review
of
the
generic
data
and
has
determined
that
the
data
are
sufficient
to
support
reregistration
of
all
products
containing
sulfonated
oleic
acid,
sodium
salt.

The
Agency
has
completed
its
assessment
of
the
dietary,
occupational
and
ecological
risks
associated
with
the
use
of
pesticide
products
containing
the
active
ingredient
sulfonated
oleic
acid,
sodium
salt.
Based
on
a
review
of
the
data
and
other
available
information
for
the
active
ingredient,
sulfonated
oleic
acid,
sodium
salt,
the
Agency
has
concluded
that
they
have
sufficient
information
on
the
human
health
and
ecological
effects
of
sulfonated
oleic
acid,
sodium
salt
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
sulfonated
oleic
acid,
sodium
salt
containing
products
are
eligible
for
reregistration
provided
that
current
data
gaps
and
confirmatory
data
needs
are
addressed.
Appendix
A
summarizes
the
uses
of
sulfonated
oleic
acid,
sodium
salt
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
sulfonated
oleic
acid,
sodium
salt
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
Risk
assessments
for
sulfonated
oleic
acid,
sodium
salt
were
not
issued
for
public
comment
per
the
Agency's
public
participation
process
because
no
toxicological
endpoints
were
identified,
and
as
such,
these
assessments
were
qualitative
in
nature.
To
ensure
that
an
opportunity
is
presented
to
the
public
to
comment
on
the
risk
assessments
and
risk
management
decisions
for
sulfonated
oleic
acid,
sodium
salt,
the
Agency
will
implement
a
public
comment
period
on
the
oleic
acid
sulfonates
RED
document.
13
C.
Regulatory
Position
1.
Food
Quality
Protection
Act
Findings
a.
"
Risk
Cup"
Determination
As
part
of
the
FQPA
tolerance
reassessment
process,
EPA
has
concluded
that
there
are
no
endpoints
of
concern
for
oral,
dermal,
or
inhalation
exposure
to
sulfonated
oleic
acid,
sodium
salt
based
on
a
review
of
the
available
toxicity
information.
The
Agency
has
concluded
that
the
established
tolerance
exemption
for
sulfonated
oleic
acid,
sodium
salt
meets
the
FQPA
safety
standards
and
that
the
risk
from
dietary
(
food
sources
only)
exposure
is
within
the
"
risk
cup."
An
aggregate
assessment
was
not
conducted
for
exposures
through
food,
drinking
water
and
residential
exposure
since
toxicological
endpoints
for
the
risk
assessment
of
sulfonated
oleic
acid,
sodium
salt
were
not
identified
based
on
the
available
data.
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.

b.
Determination
of
Safety
to
U.
S.
Population
As
part
of
the
FQPA
tolerance
reassessment
process,
EPA
assessed
the
risks
associated
with
sulfonated
oleic
acid,
sodium
salt.
The
Agency
has
determined
that
the
established
tolerance
exemption
for
sulfonated
oleic
acid,
sodium
salt
meets
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
the
use
of
sulfonated
oleic
acid,
sodium
salt
as
an
active
ingredient
in
food­
contact
sanitizing
solutions.
In
reaching
this
conclusion,
the
Agency
has
considered
all
available
information
on
the
toxicity,
use
practices,
exposure
scenarios
and
environmental
behavior
of
sulfonated
oleic
acid,
sodium
salt.

Because
no
toxicological
endpoints
were
identified
for
sulfonated
oleic
acid,
sodium
salt,
a
qualitative
risk
assessment
was
conducted.
Based
on
this
assessment,
risks
are
not
of
concern
for
sulfonated
oleic
acid,
sodium
salt.

c.
Determination
of
Safety
to
Infants
and
Children
The
EPA
has
determined
that
the
established
tolerance
exemption
for
sulfonated
oleic
acid,
sodium
salt
meets
the
safety
standards
under
the
FQPA
amendments
to
section
408(
b)(
2)(
C)
of
the
FFDCA,
and
that
there
is
a
reasonable
certainty
of
no
harm
for
infants
and
children.
The
safety
determination
for
infants
and
children
considers
the
toxicity,
use
practices
and
environmental
behavior
of
sulfonated
oleic
acid,
sodium
salt
as
noted
above
for
the
general
population.
The
safety
determination
for
infants
and
children
also
takes
into
consideration
the
possibility
of
increased
dietary
exposure
due
to
the
specific
consumption
patterns
of
infants
and
children,
as
well
as
the
possibility
of
increased
susceptibility
to
the
toxic
effects
of
sulfonated
oleic
acid,
sodium
salt
residues
in
this
population
subgroup.
14
In
determining
whether
or
not
infants
and
children
are
particularly
susceptible
to
toxic
effects
from
exposure
to
residues
of
sulfonated
oleic
acid,
sodium
salt,
the
Agency
considered
the
completeness
of
the
hazard
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
sulfonated
oleic
acid,
sodium
salt
because
there
is
no
pre­
or
post­
natal
evidence
for
increased
susceptibility
following
exposure;
however,
a
prenatal
developmental
toxicity
study
for
sulfonated
oleic
acid,
sodium
salt
is
required
as
confirmatory
data
to
support
the
Agency's
SARs
findings.
The
risk
assessment
does
not
underestimate
the
potential
exposure
for
infants
and
children.

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
is
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,
use
FFDCA
authority
to
require
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,
sulfonated
oleic
acid,
sodium
salt
may
be
subject
to
additional
screening
and
or
testing.

e.
Cumulative
Risks
Risks
summarized
in
this
document
are
those
that
result
only
from
the
use
of
sulfonated
oleic
acid,
sodium
salt
as
an
active
ingredient
in
food­
contact
sanitizers.
The
Food
Quality
Protection
Act
(
FQPA)
requires
that
the
Agency
consider
"
available
information"
concerning
the
cumulative
effects
of
a
particular
pesticide's
residue
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
the
EPA
has
followed
a
cumulative
risk
approach
based
on
a
common
mechanism
of
toxicity,
the
EPA
has
not
made
a
common
mechanism
of
toxicity
finding
for
sulfonated
oleic
acid,
sodium
salt.
For
further
information
regarding
the
EPA
=

s
efforts
to
determine
which
chemicals
have
a
common
15
mechanism
of
toxicity
and
to
evaluate
the
cumulative
effects
of
such
chemicals,
refer
to
the
EPA
=

s
website
at:
http://
www.
epa.
gov/
pesticides/
cumulative/.

2.
Tolerance
Reassessment
Summary
a.
Tolerance
Exemptions
and
Tolerance
Reassessment
A
tolerance
exemption
for
residues
of
sulfonated
oleic
acid,
sodium
salt
is
established
under
40
CFR
180.940(
c)
(
69
FR
23136,
Apr.
28,
2004).

A
tolerance
exemption
is
currently
established
for
sulfonated
oleic
acid,
sodium
salt
when
used
in
accordance
with
good
manufacturing
practice
as
an
ingredient
in
antimicrobial
pesticide
formulations,
provided
that
the
substance
is
applied
on
a
semi­
permanent
or
permanent
foodcontact
surface
(
other
than
being
applied
on
food
packaging)
with
adequate
draining
before
contact
with
food.
When
used
as
an
ingredient
in
antimicrobial
pesticide
formulations,
sulfonated
oleic
acid,
sodium
salt
may
be
applied
to:
food­
processing
equipment
and
utensils
(
40
CFR
180.940(
c)).

Sulfonated
oleic
acid,
sodium
salt
(
CAS
No.
68443­
05­
0)
has
limitations
for
the
ready­
touse
end­
use
concentration
not
to
exceed
200
parts
per
million
(
ppm).
The
Agency
is
proposing
to
amend
the
current
tolerance
exemption
for
the
active
ingredient,
sulfonated
oleic
acid,
sodium
salt,
to
increase
the
chemicals
current
tolerance
limit
of
200
ppm
to
230
ppm.
Increasing
the
existing
tolerance
limit
from
200
ppm
to
230
ppm
will
account
for
rates
currently
labeled
on
the
registered
product.

A
new
tolerance
exemption
180.940(
b)
to
account
for
the
use
of
sulfonated
oleic
acid,
sodium
salt
as
an
active
ingredient
in
food­
contact
sanitizing
solutions
for
dairy
processing
equipment
is
needed
to
support
this
use.
16
Table
3.
Tolerance
Reassessment
Summary
Tolerance
Exemptions
Listed
Under
40
CFR
§
180.940
(
c)

Nomenclature
or
Synonyms
Use
Site/
Pattern
(
Pesticidal)
Current
Limit
(
ppm)
Tolerance
Reassessment
(
ppm)
Correct
Definition/
Comment
Sulfonated
oleic
acid,
sodium
salt
Food­
contact
sanitizing
solutions
for
foodprocessing
equipment
and
utensils.
200
ppm
(
enduse
concentration)
230
ppm
(
enduse
concentration)
Sulfonated
oleic
acid,
sodium
salt
(
9­
octadecenoic
acid
(
9Z­),
sulfonated,
sodium
salt)
is
exempted
from
the
requirement
of
a
tolerance
as
an
antimicrobial
pesticide
when
used
in
accordance
with
good
manufacturing
practice
as
an
ingredient
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.
(
40
CFR
180.940(
c)).

Tolerance
Exemption
to
be
Proposed
Under
40
CFR
§
180.940
(
b)

Nomenclature
or
Synonyms
Use
Site/
Pattern
(
Pesticidal)
Current
Limit
(
ppm)
Tolerance
Reassessment
(
ppm)
Correct
Definition/
Comment
Sulfonated
oleic
acid,
sodium
salt
Sanitizing
solutions
for
dairy
processing
equipment,
and
foodprocessing
equipment
and
utensils.
200
ppm
(
enduse
concentration)
230
ppm
(
enduse
concentration)
Sulfonated
oleic
acid,
sodium
salt
(
9­
octadecenoic
acid
(
9Z­),
sulfonated,
sodium
salt)
is
exempted
from
the
requirement
of
a
tolerance
as
an
antimicrobial
pesticide
when
used
in
accordance
with
good
manufacturing
practice
as
an
ingredient
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.
(
40
CFR
180.940(
b)).

b.
Codex
Harmonization
Currently
there
are
no
codex
MRLs
established
for
sulfonated
oleic
acid,
sodium
salt.

D.
Regulatory
Rationale
The
Agency
has
determined
that
sulfonated
oleic
acid,
sodium
salt
is
eligible
for
reregistration
provided
that
requested
additional
confirmatory
data,
which
is
needed
to
fulfill
data
gaps,
are
submitted
to
the
Agency.

The
following
is
a
summary
of
the
rationale
for
managing
risks
associated
with
the
use
of
sulfonated
oleic
acid,
sodium
salt
as
an
active
ingredient.
The
Agency
feels
there
is
reasonable
certainty
of
no
harm
resulting
from
exposure
to
sulfonated
oleic
acid,
sodium
salt
as
an
active
17
ingredient
(
sanitizer)
to
the
general
population
and
to
infants
and
children
in
particular.
The
Agency
also
believes
there
is
a
low
to
moderate
toxicity
concern
for
ecological
effects
based
on
the
Structure
Activity
Relationship
(
SAR)
assessment
that
the
Agency
has
conducted.
As
a
result
of
the
expected
low
risk
for
toxicity
and
low
human
and
environmental
exposure
rates
from
sulfonated
oleic
acid,
sodium
salt,
the
Agency
determined
that
a
qualitative
approach
to
assessing
human
health
risks
and
ecological
risks
from
exposure
to
sulfonated
oleic
acid,
sodium
salt
was
appropriate.
Therefore,
no
mitigation
measures
are
necessary
at
this
time.

However,
the
Agency
is
requesting
confirmatory
eco­
toxicity
data
to
further
support
the
findings
of
the
SAR
conducted
by
the
Agency.
The
confirmatory
eco­
toxicity
data
to
support
the
registered
use
of
sulfonated
oleic
acid,
sodium
salt
as
a
pesticide
active
ingredient
is
a
FIFRA
data
requirement
for
labeling
in
the
event
that
there
is
an
accidental
spill
during
transport
of
the
chemical.

1.
Listed
Species
Considerations
a.
The
Endangered
Species
Act
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)
significantly
reduce
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
it
is
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
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
­
18
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
the
low
toxicity
of
sulfonated
oleic
acid,
sodium
salt,
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
Sulfonated
oleic
acid,
sodium
salt
end­
use
products
(
EPs)
may
also
contain
other
registered
pesticides.
Although
the
Agency
is
not
proposing
any
mitigation
measures
for
products
containing
sulfonated
oleic
acid,
sodium
salt
specific
to
federally
listed
threatened
and
endangered
species,
the
Agency
needs
to
address
potential
risks
from
other
end­
use
products.
Therefore,
the
Agency
requires
that
users
adopt
all
threatened
and
endangered
species
risk
mitigation
measures
for
all
active
ingredients
in
the
product.
If
a
product
contains
multiple
active
ingredients
with
conflicting
threatened
and
endangered
species
risk
mitigation
measures,
the
more
stringent
measure(
s)
should
be
adopted.

2.
Labeling
a.
Label
Amendment
Currently,
no
label
amendments
are
necessary
in
order
for
sulfonated
oleic
acid,
sodium
salt
products
to
be
eligible
for
reregistration.
19
V.
WHAT
REGISTRANTS
NEED
TO
DO
The
Agency
has
determined
that
sulfonated
oleic
acid,
sodium
salt
is
eligible
for
reregistration
provided
that
additional
data
are
submitted
to
confirm
this
decision.
In
the
near
future,
the
Agency
intends
to
issue
Data
Call­
In
Notices
(
DCIs)
requiring
product­
specific
data
and
additional
generic
(
technical
grade)
data.
Generally,
registrants
will
have
90
days
from
receipt
of
a
DCI
to
complete
and
submit
response
forms
or
to
request
time
extension
and
or
waiver
requests
with
a
full
written
justification.
For
product­
specific
data,
the
registrant
will
have
eight
months
to
submit
data
and
amended
labels.
For
generic
data,
due
dates
can
vary
depending
on
the
specific
studies
being
required.
Below
is
a
table
of
additional
generic
data
that
the
Agency
intends
to
require
for
sulfonated
oleic
acid,
sodium
salt
to
be
eligible
for
reregistration.
The
additional
data
requirements
that
the
Agency
intends
to
obtain
will
include,
among
other
things,
submission
of
the
following:

The
registrant
needs
to
submit
the
following
items:

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

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

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

Within
the
time
limit
specified
in
the
generic
DCI:

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

Please
contact
Jennifer
Slotnick
at
(
703)
305­
0601
with
questions
regarding
generic
reregistration.

By
US
mail:
By
express
or
courier
service:
Document
Processing
Desk
(
DCI/
SRRD)
Document
Processing
Desk
(
DCI/
SRRD)
Jennifer
Slotnick
Jennifer
Slotnick
US
EPA
(
7510C)
Office
of
Pesticide
Programs
(
7510C)
1200
Pennsylvania
Ave.,
NW
Room
266A,
Crystal
Mall
2
Washington,
DC
20460
1801
S.
Bell
Street
Arlington,
VA
22202
20
The
registrant
needs
to
submit
the
following
items
for
each
product.

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

1.
Completed
response
forms
to
the
PDCI
(
i.
e.,
PDCI
response
form
and
requirements
status
and
registrant's
response
form);
and
2.
Submit
any
time
extension
or
waiver
requests
with
a
full
written
justification.

Within
eight
months
from
the
receipt
of
the
PDCI:

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

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

3.
Five
copies
of
the
draft
label
incorporating
all
label
amendments
outlined
in
Table
13
of
this
document;

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

5.
If
applicable,
a
completed
form
certifying
compliance
with
cost
share
offer
requirements
(
EPA
Form
8570­
32);
and
6.
The
product­
specific
data
responding
to
the
PDCI.

Please
contact
Adam
Heyward
at
(
703)
308­
6422
with
questions
regarding
product
reregistration
and/
or
the
PDCI.
All
materials
submitted
in
response
to
the
PDCI
should
be
addressed
as
follows:

By
US
mail:
By
express
or
courier
service:
Document
Processing
Desk
(
PDCI/
PRB)
Document
Processing
Desk
(
PDCI/
PRB)
Adam
Heyward
Adam
Heyward
US
EPA
(
7510C)
Office
of
Pesticide
Programs
(
7510C)
1200
Pennsylvania
Ave.,
NW
Room
266A,
Crystal
Mall
2
Washington,
DC
20460
1801
South
Bell
Street
Arlington,
VA
22202
21
A.
Manufacturing­
Use
Products
There
are
currently
no
registered
manufacturing­
use
products
for
sulfonated
oleic
acid,
sodium
salt;
therefore,
the
end­
use
manufacturer
is
responsible
for
the
submission
of
any
generic
data
requirements
requested
by
the
Agency.

1.
Additional
Generic
Data
Requirements
The
generic
data
base
supporting
the
reregistration
of
sulfonated
oleic
acid,
sodium
salt
for
the
above
eligible
uses
has
been
reviewed
and
determined
to
be
substantially
complete.
However,
the
following
additional
data
requirements
have
been
identified
by
the
Agency
as
confirmatory
and
are
included
in
the
generic
DCI
for
this
RED.

Table
4:
Data
Requirements
for
the
Reregistration
Eligibility
Decision
of
Sulfonated
Oleic
Acid,
Sodium
Salt
Guideline
Study
Name
New
OPPTS
Guideline
No.
Old
Guideline
No.

Dermal
Sensitization
870.2600
81­
6
90­
Day
Oral
Toxicity
Study
in
Rodents
with
TGAI
870.3100
82­
1a
Prenatal
Developmental
Toxicity
Study
in
Rodents
870.3700
83­
3
Fresh
Water
Fish
Acute
Toxicity
Study
with
TGAI
850.1075
72­
1
Fresh
Water
Invertebrate
Acute
Toxicity
Study
with
TGAI
850.1010
72­
2
Avian
Acute
Oral
Toxicity
Study
with
TGAI
850.2100
71­
1
B.
End­
Use
Products
1.
Additional
Product­
Specific
Data
and
Efficacy
Requirements
Section
4(
g)(
2)(
B)
of
FIFRA
calls
for
the
Agency
to
obtain
any
needed
product­
specific
data
regarding
the
pesticide
after
a
determination
of
eligibility
has
been
made.
The
registrant
must
review
previous
data
submissions
to
ensure
that
they
meet
current
EPA
acceptance
criteria
and
if
not,
commit
to
conduct
new
studies.
If
a
registrant
believes
that
previously
submitted
data
meet
current
testing
standards,
the
study
MRID
numbers
should
be
cited
according
to
the
instructions
in
the
Requirement
Status
and
Registrants
Response
Form
provided
for
each
product.
The
Agency
intends
to
issue
a
separate
Product­
Specific
Data
Call­
In
(
PDCI),
outlining
specific
data
requirements.

Efficacy
data
are
required
to
ensure
that
the
described
labeled
use
of
sulfonated
oleic
acid,
sodium
salt
as
a
food­
contact
sanitizer
in
end­
use
products
is
accurate
and
effective.
The
Registrant
must
submit
as
efficacy
data
to
the
Agency,
Guideline
No.
810.2100
(
m)(
2),
AOAC
Germicidal
and
Detergent
Sanitizers
Method
Study
(
Reg.
No.
875­
90)
for
sulfonated
oleic
acid,
sodium
salt.
22
VI.
APENDICIES
23
Appendix
A:
Use
Patterns
Eligible
for
Reregistration
Use
Site
Formulation
Method
of
Application
Application
Rate/
No.
of
applications
Use
Limitations
Food
handling/
storage
establishments
premises
and
equipment
Beverage
Processing
Equipment
Liquid
Concentrate
(
Reg
No.
875­
90)
Brushing;

Flooding;
Immersion;

Coarse
Droplet
Spraying
;
Circulation
Sanitizing
1
fl.
ounce
of
Per­
Vad
per
gallon
of
water
(
providing
200
ppm
of
anionic
active
agent).

Thoroughly
wet
all
surfaces
by
listed
application
methods.

Allow
sanitizer
to
contact
surface
for
at
least
1
minute.

Allow
surfaces
to
drain
adequately
before
resuming
operation.
Do
not
reuse
circulated
sanitizer
for
additional
sanitizing.

Brewery
Processing
Equipment
Liquid
Concentrate
(
Reg.
No.
875­
90)
Flooding;
Immersion;

Coarse
Droplet
Spraying;
Circulation
Sanitizing
1
fl.
ounce
of
Per­
Vad
per
gallon
of
water
(
providing
200
ppm
of
anionic
active
agent).

Thoroughly
wet
all
surfaces
by
listed
application
methods.

Allow
sanitizer
to
contact
surface
for
at
least
1
minute.

Allow
surfaces
to
drain
adequately
before
resuming
operation.
Do
not
reuse
circulated
sanitizer
for
additional
sanitizing.

Food
Processing
Equipment
Liquid
Concentrate
(
Reg.
No.
875­
90)
Flooding;
Immersion;

Coarse
Droplet
Spraying;
Circulation
Sanitizing
1
fl.
ounce
of
Per­
Vad
per
gallon
of
water
(
providing
200
ppm
of
anionic
active
agent).

Thoroughly
wet
all
surfaces
by
listed
application
methods.

Allow
sanitizer
to
contact
surface
for
at
least
1
minute.

Allow
surfaces
to
drain
Do
not
reuse
circulated
sanitizer
for
additional
sanitizing.
24
Use
Site
Formulation
Method
of
Application
Application
Rate/
No.
of
applications
Use
Limitations
adequately
before
resuming
operation.

Food
Contact
Surfaces
(
Hard
Non­
Porous)
Liquid
concentrate
(
Reg
No.
875­
90)
Flooding;
Immersion;

Coarse
Droplet
Spraying;
Circulation
Sanitizing
1
fl.
ounce
of
Per­
Vad
per
gallon
of
water
(
providing
200
ppm
of
anionic
active
agent).

Thoroughly
wet
all
surfaces
by
listed
application
methods.

Allow
sanitizer
to
contact
surface
for
at
least
1
minute.

Allow
surfaces
to
drain
adequately
before
resuming
operation.
Do
not
reuse
circulated
sanitizer
for
additional
sanitizing.

Milk
Processing
Equipment
Liquid
concentrate
(
Reg.
No.
875­
90)
Flooding;
Immersion;

Coarse
Droplet
Spraying;
Circulation
Sanitizing
1
fl.
ounce
of
Per­
Vad
per
gallon
of
water
(
providing
200
ppm
of
anionic
active
agent).

Thoroughly
wet
all
surfaces
by
listed
application
methods.

Allow
sanitizer
to
contact
surface
for
at
least
1
minute.

Allow
surfaces
to
drain
adequately
before
resuming
operation.
Do
not
reuse
circulated
sanitizer
for
additional
sanitizing.
25
Appendix
B:
Studies
Used
to
Support
the
Reregistration
of
Oleic
Acid
Sulfonates
Guide
to
Appendix
B
Appendix
B
lists
the
generic
(
not
product
specific)
data
requirements
which
support
the
re­
registration
of
oleic
acid
sulfonates.
These
requirements
apply
to
sulfonated
oleic
acid
in
all
products,
including
data
requirements
for
which
a
technical
grade
active
ingredient
is
the
test
substance.
The
data
table
is
organized
in
the
following
formats:

1.
Data
Requirement
(
Columns
1
and
2).
The
data
requirements
are
listed
by
Guideline
Number.
The
first
column
lists
the
new
Part
158
Guideline
Numbers,
and
the
second
column
lists
the
old
Part
158
Guideline
Numbers.
Each
Guideline
Number
has
an
associated
test
protocol
set
forth
in
the
Pesticide
Assessment
Guidance,
which
are
available
on
the
EPA
website.

2.
Guideline
Description
(
Column
3).
Identifies
the
guideline
type.

3.
Use
Pattern
(
Column
4).
This
column
indicates
the
standard
Antimicrobial
Division
use
patterns
categories
for
which
the
generic
(
not
product
specific)
data
requirements
apply.
The
following
number
designations
are
used
in
Appendix
B:

(
1)
Agricultural
premises
and
equipment
(
2)
Food
handling/
storage
establishment
premises
and
equipment
(
3)
Commercial,
institutional
and
industrial
premises
and
equipment
(
4)
Residential
and
public
access
premises
(
5)
Medical
premises
and
equipment
(
6)
Human
water
systems
(
7)
Materials
preservatives
(
8)
Industrial
processes
and
water
systems
(
9)
Antifouling
coatings
(
10)
Wood
preservatives
(
11)
Swimming
pools
(
12)
Aquatic
areas
4.
Bibliographic
Citation
(
Column
5).
If
the
Agency
has
data
in
its
files
to
support
a
specific
generic
Guideline
requirement,

this
column
will
identity
each
study
by
a
"
Master
Record
Identification"
(
MRID)
number.
The
listed
studies
are
considered
"
valid"
and
acceptable
for
satisfying
the
Guideline
requirement.
Refer
to
the
Bibliography
appendix
for
a
complete
citation
of
each
study.
26
DATA
REQUIREMENT
CITATION(
S)

New
Guideline
Number
Old
Guideline
Number
Study
Title
Use
Pattern
MRID
Number
PRODUCT
CHEMISTRY
830.1550
61­
1
Product
Identity
and
Composition
2
43057701
830.1600
830.1620
830.1650
61­
2a
Starting
Materials
and
Manufacturing
Process
2
43057701
830.1670
61­
2b
Formation
of
Impurities
/
Discussion
of
Impurities
2
43057701
830.1700
62­
1
Preliminary
Analysis
2
43057702
830.1750
62­
2
Certification
of
Limits
2
43057702
830.1800
62­
3
Analytical
Method
2
43057702
830.6302
63­
2
Color
2
43057703
830.6303
63­
3
Physical
State
2
43057703
830.6304
63­
4
Odor
2
43057703
830.7050
None
UV/
Visible
Absorption
2
Waived1
830.7200
63­
5
Melting
Point
2
Inapplicable
830.7220
63­
6
Boiling
Point
2
430577032
830.7300
63­
7
Density
2
430577032
830.7840
830.7860
63­
8
Solubility
2
430577032
830.7950
63­
9
Vapor
Pressure
2
43057703
830.7370
63­
10
Dissociation
Constant
in
Water
2
Inapplicable
1
Study
waived
because
the
chemical
structure
shows
that
it
will
not
absorb
in
the
UV
spectral
region.

2
Based
on
formula
with
50%
active
ingredient
(
a.
i.).
27
DATA
REQUIREMENT
CITATION(
S)

New
Guideline
Number
Old
Guideline
Number
Study
Title
Use
Pattern
MRID
Number
830.7550
830.7560
830.7570
63­
11
Partition
Coefficient
(
Octanol/
Water)
2
Inapplicable
830.7000
63­
12
pH
2
43057703
830.6313
63­
13
Stability
2
43057703
830.6314
63­
14
Oxidizing/
Reducing
Action
2
Inapplicable
830.6315
63­
15
Flammability
2
Inapplicable
830.6316
63­
16
Explodability
2
Inapplicable
830.6317
63­
17
Storage
Stability
2
Inapplicable
830.7100
63­
18
Viscosity
2
Inapplicable
830.6319
63­
19
Miscibility
2
Inapplicable
830.6320
63­
20
Corrosion
Characteristics
2
Inapplicable
830.6321
63­
21
Dielectric
breakdown
voltage
2
Inapplicable
ECOLOGICAL
EFFECTS
850.2100
71­
1
Avian
Acute
Oral
Toxicity
Test
2
Data
Gap
850.2200
71­
2
Avian
Dietary
Toxicity
2
Inapplicable
850.1075
72­
1
Fish
Acute
Toxicity
­
Freshwater
2
Data
Gap
850.1010
72­
2
Acute
Aquatic
Invertebrate
Toxicity
2
Data
Gap
850.1075
72­
3a
Acute
Estuarine/
Marine
Toxicity
­
Fish
2
Inapplicable
72­
3b
Acute
Estuarine/
Marine
Toxicity
­
Invertebrate
(
Mollusk)
2
Inapplicable
850.1025
72­
3c
Estuarine/
Marine
Toxicity
­
Invertebrate
(
Shrimp)
2
Inapplicable
TOXICOLOGY
870.1100
81­
1
Acute
Oral
­
Rat
2
41861503,
43423804
28
DATA
REQUIREMENT
CITATION(
S)

New
Guideline
Number
Old
Guideline
Number
Study
Title
Use
Pattern
MRID
Number
870.1200
81­
2
Acute
Dermal
­
Rabbit
2
41861503
870.1300
81­
3
Acute
Inhalation
­
Rat
2
41861503,
44008401
870.2400
81­
4
Primary
Eye
Irritation
­
Rabbit
2
41861503
870.2500
81­
5
Primary
Dermal
Irritation
­
Rabbit
2
41861503
870.2600
81­
6
Dermal
Sensitization
2
Data
Gap
82­
1a
90­
Day
Feeding­
Rodent
2
Data
Gap
870.3100
82­
1b
90­
Day
Feeding­
Non­
Rodent
2
Inapplicable
870.3200
82­
2
21/
28­
Day
Dermal
Toxicity
­
Rat
2
Inapplicable
870.3250
82­
3
90­
day
Dermal
Toxicity
­
Rodent
2
Inapplicable
870.3465
82­
4
90­
Day
Inhalation
­
Rat
2
Inapplicable
870.3700
83­
3
Developmental
Toxicity
2
Data
Gap
870.3800
83­
4
Reproduction
and
Fertility
Effects
­
2
Generation
Repro
2
Inapplicable
870.4100
83­
1a
Chronic
Feeding
Toxicity
­
Rodent
2
Inapplicable
870.4300
83­
5
Combined
Chronic
Toxicity/
Carcinogenicity
2
Inapplicable
870.4100
83­
1b
Chronic
Feeding
Toxicity
­
Non­
Rodent
(
dog)
2
Inapplicable
870.4200
83­
2a
Oncogenicity
­
Rat
2
Inapplicable
870.4300
83­
2b
Oncogenicity
­
Mouse
2
Inapplicable
870.5265
84­
2
Bacterial
Reverse
Mutation
Assay
2
Waived3
870.5385
84­
2
Micronucleus
Assay
2
Waived3
870.5375
84­
2
Cytogenic
assay
with
human
lymphocytes
2
Waived3
870.5550
84­
2
UDS
Assay
2
Waived
3
3
Study
waived
because
based
on
the
SAR
assessments
and
information
on
structurally
similar
chemicals,
there
are
no
concerns
for
mutagenicity;
therefore,
no
mutagenicity
analysis
is
required.
29
DATA
REQUIREMENT
CITATION(
S)

New
Guideline
Number
Old
Guideline
Number
Study
Title
Use
Pattern
MRID
Number
870.7485
85­
1
General
Metabolism
2
Inapplicable
870.7600
85­
2
Dermal
Absorption
2
Inapplicable
OCCUPATIONAL/
RESIDENTIAL
EXPOSURE
875.2400
875.2900
133­
3
Dermal
Passive
Dosimetry
2
Inapplicable
875.2500
875.2900
133­
4
Inhalation
Passive
Dosimetry
2
Inapplicable
875.1200
875.1600
233
Dermal
Indoor
Exposure
2
Inapplicable
875.1400
875.1600
234
Inhalation
Indoor
Exposure
2
Inapplicable
ENVIRONMENTAL
FATE
835.2120
161­
1
Hydrolysis
2
Inapplicable
30
Appendix
C:
Technical
Support
Documents
Additional
documentation
in
support
of
this
RED
is
maintained
in
the
OPP
docket,
located
in
Room
119,
Crystal
Mall
#
2,
1801
Bell
Street,
Arlington,
VA.
The
OPP
docket
is
open
Monday
through
Friday,
excluding
legal
holidays,
from
8:
30
am
to
4:
00
pm.

All
documents
in
hard
copy
form
may
be
viewed
in
the
OPP
docket
room
or
downloaded
or
viewed
via
the
Internet
at
the
following
web­
sites:

http://
www.
epa.
gov/
pesticides/
antimicrobials
http://
www.
epa.
gov/
edockets
There
are
two
technical
supporting
documents
for
the
sulfonated
oleic
acid,
sodium
salt
RED.
These
documents
include:

 
U.
S.
Environmental
Protection
Agency
(
USEPA).
Memorandum
from
D.
Smegal
&
N.
Shamim
to
K.
Boyle.
Oleic
Acid
Sulfonates
and
Related
Compounds:
Antimicrobials
Division
Risk
Assessment
for
the
Reregistration
Eligibility
Decision
(
RED)
Document
and
for
Tolerance
Reassessment,
(
Barcode
D308389).
September
30,
2004.

 
U.
S.
Environmental
Protection
Agency
(
USEPA).
Memorandum
from
T.
McMahon
to
D.
Smegal.
Similarity
of
Linear
Alkylbenzene
Sulfonates
and
Alcohol
Sulfates
to
Sulfonated
Oleic
Acid
with
Respect
to
Toxicity,
(
Barcode
D308387).
September
23,
2004.

 
U.
S.
Environmental
Protection
Agency
(
USEPA).
Memorandum
from
T.
McMahon.
Sulfonated
Oleic
Acid­
Report
of
the
Antimicrobials
Division
Toxicology
Endpoint
Selection
Committee.
May
6,
2003.
31
Appendix
D:
Generic
Data
Requirements
and
Studies
Used
to
Make
the
Reregistration
Decision
(
Bibliography)

MRID
STUDIES
MRID#
Citation
41861503
Slover,
A.
(
1991)
Toxicity
Test
Results:
Sodium
Salt
of
Sulfonated
Oleic
Acid:
Lab
Project
Number:
8020529.
Unpublished
study
prepared
by
Morgan
Gallacher,
Inc.
17
p.

43423804
Christopher,
S.
(
1994)
PER­
VAD:
Acute
Peroral
Toxicity
Testing
Using
the
Rat:
Lab
Project
Number:
94N1449.
Unpublished
study
prepared
by
Union
Carbide
Corp.,
Bushy
Run
Research
Center.
28
p.

44008401
Douds,
D.
(
1996)
An
Acute
Whole­
Body
Inhalation
Toxicity
Study
in
Rats
with
PER­
VAD:
Final
Report:
Lab
Project
Number:
3385.6.
Unpublished
study.

OPEN
LITERATURE
JohnsonDiversey.
Memorandum
from
F.
Heitfeld
to
L.
Amadio.
Toxicity
Review
of
Sulfonated
Oleic
Acid,
Sodium
Salt.
September
2,
2004.

INTERNAL
LITERATURE
U.
S.
Environmental
Protection
Agency
(
USEPA).
Memorandum
from
D.
Smegal
&
N.
Shamim
to
K.
Boyle.
Oleic
Acid
Sulfonates
and
Related
Compounds:
Antimicrobials
Division
Risk
Assessment
for
the
Reregistration
Eligibility
Decision
(
RED)
Document
and
for
Tolerance
Reassessment,
(
Barcode
D308389).
September
30,
2004.

U.
S.
Environmental
Protection
Agency
(
USEPA).
2002.
Memorandum
from
K.
Boyle
and
K.
Leifer
to
F.
Forrest.
IIFG
Decision
Documents
on
Reassessment
of
Exemptions
from
the
Requirement
of
a
Tolerance
for
Fatty
Acids.
July
21,
2002.

U.
S.
Environmental
Protection
Agency
(
USEPA).
2002.
Memorandum
from
S.
C.
Termes
&
H.
Craven
to
M.
Perry.
Tolerance
Review
of
Compounds
Known
as
Fatty
Acids,
Fatty
Acid
Salts,
and
Fatty
Acid
Esters,
and
Fatty
Acid
Derivatives
Classified
as
Inert
Ingredients
in
Terrestrial
and/
or
Aquatic
Agricultural
and
Non­
Agricultural
Uses.
May
15,
2002.

U.
S.
Environmental
Protection
Agency
(
USEPA).
Memorandum
from
T.
McMahon
to
D.
Smegal.
Similarity
of
Linear
Alkylbenzene
Sulfonates
and
Alcohol
Sulfates
to
Sulfonated
Oleic
Acid
with
Respect
to
Toxicity,
(
Barcode
D308387).
September
23,
2004.
32
U.
S.
Environmental
Protection
Agency
(
USEPA).
Memorandum
from
T.
McMahon.
Sulfonated
Oleic
Acid­
Report
of
the
Antimicrobials
Division
Toxicology
Endpoint
Selection
Committee.
May
6,
2003.

U.
S.
Environmental
Protection
Agency
(
USEPA),
2004.
Overview
of
the
Ecological
Risk
Assessment
Process
in
the
Office
of
Pesticide
Programs
U.
S.
Environmental
Protection
Agency
­
Endangered
and
Threatened
Species
Effects
Determinations,
Appendix
A,
Section
IIB,
pg.
81.
U.
S.
Environmental
Protection
Agency.
January
24,
2004.
http://
www.
epa.
gov/
oppfead1/
endanger/
consultation/
ecorisk­
overview.
pdf.

U.
S.
Environmental
Protection
Agency
(
USEPA).
2004.
Structure
Activity
Relationship
(
SAR)
for
Octadecanoic
acid,
sulfo,
sodium
salt
(
67998­
94­
1);
9­
Octadecen­
1­
ol,
hydrogensulfate
sodium
salt,
(
Z)­
(
1847­
55­
8);
9­
Octadecenoic
acid,
12­(
Sulfooxy)­,
Disodiumsalt
[
R­(
Z)]
(
61702­
68­
9);
9­
Octadecenoic
Acid,
12­(
Sulfooxy)­,
Monosodium
Salt,
(
9Z,
12R)­
(
29704­
46­
9);
9­
Octadecenoic
acid,
12­(
sulfooxy)­,
sodium
salt
,
(
9Z,
12R)­
(
8043­
44­
5);
Octadecanoic
acid,
9(
or
10)­
sulfooxy)­
monosodium
salt
(
68964­
56­
7);
Octadecanoic
acid,
9(
or
10)­(
sulfooxy)­,
sodium
salt
(
68331­
91­
9);
Octadecanoic
acid,
9­(
sulfooxy)­,
sodium
salt
(
68413­
72­
9);
Octadecanoic
acid,
9­(
sulfooxy)­,
disodium
salt­
(
65151­
76­
0);
9­
Octadecenoic
acid
(
9Z)­
sulfonated,
sodium
salt
(
68443­
05­
0);
9­
Octadecenoic
acid
(
9Z)­
sulfonated
(
68988­
76­
1).
Structure
Activity
Team
Report.
OPPT.
June
8,
2004.

WEBSITE
REFRENCES
Environmental
Protection
Agency,
2005.
"
Estimation
Program
Interface
(
EPI)
Suite".
http://
www.
epa.
gov/
oppt/
exposure/
docs/
episuite.
htm.
2005.

Human
and
Environmental
Risk
Assessment
(
HERA),
2004.
"
Linear
Alkylbenzene
Sulphonate
(
CAS
No.
68411­
30­
3)".
May
2004.
http://
www.
heraproject.
com/
RiskAssessment.
cfm
Human
and
Environmental
Risk
Assessment
(
HERA),
2002.
"
Human
and
Environmental
Risk
Assessment
on
the
Ingredients
of
European
Household
Cleaning
Products,
Alcohol
Sulphates
Human
Health
Risk
Assessment,
Draft".
December
2002.
http://
www.
heraproject.
com/
RiskAssessment.
cfm
33
Appendix
E.
Generic
Data
Call­
In
The
Agency
intends
to
issue
a
Generic
Data
Call­
In
(
DCI)
at
a
later
date.
See
Chapter
V
of
the
oleic
acid
sulfonates
RED
for
a
list
of
studies
that
the
Agency
plans
to
require.
34
Appendix
F:
Product
Specific
Data
Call­
In
The
Agency
intends
to
issue
a
Product
Specific
Data
Call­
In
(
DCI)
at
a
later
date
for
the
oleic
acid
sulfonates
RED.
35
Appendix
G:
EPA's
Batching
of
Sulfonated
Oleic
Acid,
Sodium
Salt
Products
for
Meeting
Acute
Toxicity
Data
Requirements
for
Reregistration
Batching
of
sulfonated
oleic
acid,
sodium
salt
products
is
unnecessary
and
will
not
be
conducted
to
meet
acute
toxicity
data
requirements
for
reregistration
as
a
result
of
there
being
only
one
registered
product
for
sulfonated
oleic
acid,
sodium
salt.

If
a
registrant
chooses
to
rely
upon
previously
submitted
acute
toxicity
data,
he/
she
may
do
so
provided
that
the
data
base
is
complete
and
valid
by
today's
standards,
the
formulation
tested
is
considered
by
EPA
to
be
similar
for
acute
toxicity,
and
the
formulation
has
not
been
significantly
altered
since
submission
and
acceptance
of
the
acute
toxicity
data.
The
Agency
must
approve
any
new
or
canceled
formulations
(
that
were
presented
to
the
Agency
after
the
publication
of
the
RED)
before
data
derived
from
them
can
be
used
to
cover
other
products.
Regardless
of
whether
new
data
is
generated
or
existing
data
is
referenced,
registrants
must
clearly
identify
the
test
material(
s)
by
an
EPA
Registration
Number.
If
more
than
one
Confidential
Statement
of
Formula
(
CSF)
exists
for
a
product,
the
registrant
must
indicate
the
formulation
tested
by
identifying
the
corresponding
CSF.

In
deciding
how
to
meet
the
product­
specific
data
requirements,
registrants
must
follow
the
directions
given
in
the
Data
Call­
In
(
DCI)
Notice
and
its
attachments
appended
to
the
RED.
The
DCI
Notice
contains
two
response
forms
that
are
to
be
completed
and
submitted
to
the
Agency
within
90
days
of
receipt.
The
first
form,
"
Data
Call­
In
Response,"
asks
whether
the
registrant
will
meet
the
data
requirements
for
each
product.
The
second
form,
"
Requirements
Status
and
Registrant's
Response,"
lists
the
product
specific
data
required
for
each
product,
including
the
standard
six
acute
toxicity
tests.
If
a
registrant
supplies
data
he/
she
must
select
one
of
the
following
options:
(
Option
1)
Developing
Data;
(
Option
4)
Submitting
an
Existing
Study;
(
Option
5)
Upgrading
an
Existing
Study;
or,
(
Option
6)
Citing
an
Existing
Study.
If
a
registrant
depends
on
another's
data,
he/
she
must
choose
among:
(
Option
2)
Cost
Sharing;
(
Option
3)
Offers
to
Cost
Share;
or,
(
Option
6)
Citing
an
Existing
Study.
36
Appendix
H:
List
of
Registrants
Sent
the
Data
Call­
In
A
list
will
be
posted,
at
a
later
date,
of
the
registrants
who
were
sent
a
copy
of
the
oleic
acid
sulfonates
RED
Data
Call­
In.
37
Appendix
I:
List
of
Available
Related
Documents
and
Electronically
Available
Forms
Pesticide
Registration
Forms
are
available
at
the
following
EPA
internet
site:

http://
www.
epa.
gov/
opprd001/
forms/

Online
Pesticide
Registration
Forms
are
in
PDF
format;
which,
to
be
properly
viewed,
requires
the
use
of
Acrobat
reader
software.

Instructions:
1.
Print
out
and
complete
appropriate
forms
(
Note:
Form
numbers
formatted
in
bold
print
may
be
filled
out
on
the
computer,
printed
and
submitted
to
the
Agency).

2.
The
completed
form(
s)
must
be
submitted
to
the
Agency
in
hard
copy
in
accord
with
existing
Agency
policy.

3.
Mail
the
form(
s),
along
with
any
additional
documents,
necessary
to
comply
with
the
EPA
regulations
pertaining
to
your
request.
Forms
may
be
mailed
to
the
Document
Processing
Desk
address
listed
below.

DO
NOT
fax
or
e­
mail
any
form(
s)
containing
'
Confidential
Business
Information'
(
CBI)
or
'
Sensitive
Information.'

If
you
have
any
problems
accessing
the
electronic
forms,
please
contact
Nicole
Williams
at
(
703)
308­
5551
or
by
e­
mail
at
williams.
nicole@
epa.
gov.

The
following
is
a
comprehensive
list
of
Agency
pesticide
registration
forms,
which
are
currently
available
on
the
internet.
Form
numbers,
titles
and
internet
address
locations
are
provided:

U.
S.
EPA
Pesticide
Registration
Forms
Form
Number
Title
Internet
Address
Location
8570­
1
Application
for
Pesticide
Registration/
Amendment
http://
www.
epa.
gov/
opprd001/
forms/
8570­
1.
pdf
8570­
4
Confidential
Statement
of
Formula
http://
www.
epa.
gov/
opprd001/
forms/
8570­
4.
pdf
8570­
5
Notice
of
Supplemental
Registration
of
Distribution
of
a
Registered
Pesticide
Product
http://
www.
epa.
gov/
opprd001/
forms/
8570­
5.
pdf
8570­
17
Application
for
an
Experimental
Use
Permit
http://
www.
epa.
gov/
opprd001/
forms/
8570­
17.
pdf
38
Form
Number
Title
Internet
Address
Location
8570­
25
Application
for/
Notification
of
State
Registration
of
a
Pesticide
To
Meet
a
Special
Local
Need
http://
www.
epa.
gov/
opprd001/
forms/
8570­
25.
pdf
8570­
27
Formulator's
Exemption
Statement
http://
www.
epa.
gov/
opprd001/
forms/
8570­
27.
pdf
8570­
28
Certification
of
Compliance
with
Data
Gap
Procedures
http://
www.
epa.
gov/
opprd001/
forms/
8570­
28.
pdf
8570­
30
Pesticide
Registration
Maintenance
Fee
Filing
http://
www.
epa.
gov/
opprd001/
forms/
8570­
30.
pdf
8570­
32
Certification
of
Attempt
to
Enter
into
an
Agreement
with
other
Registrants
for
Development
of
Data
http://
www.
epa.
gov/
opprd001/
forms/
8570­
32.
pdf
8570­
34
Certification
with
Respect
to
Citations
of
Data
(
PR
Notice
98­
5)
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices/
pr98­
5.
pdf
8570­
35
Data
Matrix
(
PR
Notice
98­
5)
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices/
pr98­
5.
pdf
8570­
36
Summary
of
the
Physical/
Chemical
Properties
(
PR
Notice
98­
1)
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices/
pr98­
1.
pdf
8570­
37
Self­
Certification
Statement
for
the
Physical/
Chemical
Properties
(
PR
Notice
98­
1)
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices/
pr98­
1.
pdf
Pesticide
Registration
Kit
The
U.
S.
EPA's
pesticide
registration
kit
can
be
accessed
at
the
following
web
address:

www.
epa.
gov/
pesticides/
registrationkit/

For
convenience
of
the
registrant,
the
US
EPA
has
assembled
an
online
registration
kit,
which
contains
the
following
pertinent
forms
and
information
needed
to
register
a
pesticide
product
with
the
U.
S.
Environmental
Protection
Agency's
Office
of
Pesticide
Programs
(
OPP):

1.
The
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
(
FIFRA)
and
the
Federal
Food,
Drug
and
Cosmetic
Act
(
FFDCA)
as
Amended
by
the
Food
Quality
Protection
Act
(
FQPA)
of
1996.

2.
Pesticide
Registration
(
PR)
Notices
39
a.
83­
3
Label
Improvement
Program­­
Storage
and
Disposal
Statements
b.
84­
1
Clarification
of
Label
Improvement
Program
c.
86­
5
Standard
Format
for
Data
Submitted
under
FIFRA
d.
87­
1
Label
Improvement
Program
for
Pesticides
Applied
through
Irrigation
Systems
(
Chemigation)
e.
87­
6
Inert
Ingredients
in
Pesticide
Products
Policy
Statement
f.
90­
1
Inert
Ingredients
in
Pesticide
Products;
Revised
Policy
Statement
g.
95­
2
Notifications,
Non­
notifications,
and
Minor
Formulation
Amendments
h.
98­
1
Self
Certification
of
Product
Chemistry
Data
with
Attachments
(
This
document
is
in
PDF
format
and
requires
the
Acrobat
reader.)

Other
PR
Notices
can
be
found
at
http://
www.
epa.
gov/
opppmsd1/
PR_
Notices
3.
Pesticide
Product
Registration
Application
Forms
(
These
forms
are
in
PDF
format
and
will
require
the
Acrobat
reader).

a.
EPA
Form
No.
8570­
1,
Application
for
Pesticide
Registration/
Amendment
b.
EPA
Form
No.
8570­
4,
Confidential
Statement
of
Formula
c.
EPA
Form
No.
8570­
27,
Formulator's
Exemption
Statement
d.
EPA
Form
No.
8570­
34,
Certification
with
Respect
to
Citations
of
Data
e.
EPA
Form
No.
8570­
35,
Data
Matrix
4.
General
Pesticide
Information
(
Some
of
these
forms
are
in
PDF
format
and
will
require
the
Acrobat
reader).

a.
Registration
Division
Personnel
Contact
List
b.
Biopesticides
and
Pollution
Prevention
Division
(
BPPD)
Contacts
c.
Antimicrobials
Division
Organizational
Structure/
Contact
List
d.
53
F.
R.
15952,
Pesticide
Registration
Procedures;
Pesticide
Data
Requirements
(
PDF
format)
e.
40
CFR
Part
156,
Labeling
Requirements
for
Pesticides
and
Devices
(
PDF
format)
f.
40
CFR
Part
158,
Data
Requirements
for
Registration
(
PDF
format)
g.
50
F.
R.
48833,
Disclosure
of
Reviews
of
Pesticide
Data
(
November
27,
1985)

Before
submitting
your
application
for
registration,
you
may
wish
to
consult
some
additional
sources
of
information.
These
include:

1.
The
Office
of
Pesticide
Programs'
website.

2.
The
booklet
"
General
Information
on
Applying
for
Registration
of
Pesticides
in
the
United
States",
PB92­
221811,
available
through
the
National
Technical
Information
Service
(
NTIS)
at
the
following
address:

National
Technical
Information
Service
(
NTIS)
40
5285
Port
Royal
Road
Springfield,
VA
22161
The
telephone
number
for
NTIS
is
(
703)
605­
6000.

3.
The
National
Pesticide
Information
Retrieval
System
(
NPIRS)
of
Purdue
University's
Center
for
Environmental
and
Regulatory
Information
Systems.
This
service
does
charge
a
fee
for
subscriptions
and
custom
searches.
You
can
contact
NPIRS
by
telephone
at
(
765)
494­
6614
or
through
their
website.

4.
The
National
Pesticide
Telecommunications
Network
(
NPTN)
can
provide
information
on
active
ingredients,
uses,
toxicology,
and
chemistry
of
pesticides.
You
can
contact
NPTN
by
telephone
at
(
800)
858­
7378
or
through
their
website:
http://
npic.
orst.
edu/

The
Agency
will
return
a
notice
of
receipt
of
an
application
for
registration
or
amended
registration,
experimental
use
permit,
or
amendment
to
a
petition
if
the
applicant
or
petitioner
encloses
with
his
submission
a
stamped,
self­
addressed
postcard.
The
postcard
must
contain
the
following
entries
to
be
completed
by
OPP:

1.
Date
of
receipt;
2.
EPA
identifying
number;
and
3.
Product
Manager
assignment.

Other
identifying
information
may
be
included
by
the
applicant
as
a
means
to
link
the
acknowledgment
of
receipt
to
the
specific
application
submitted.
The
EPA
will
stamp
the
date
of
receipt
and
provide
the
EPA
identifying
file
symbol
or
petition
number
for
the
new
submission.
The
identifying
number
should
be
used
whenever
you
contact
the
Agency
concerning
an
application
for
registration,
experimental
use
permit,
or
tolerance
petition.

To
assist
us
in
ensuring
that
all
data
you
have
submitted
for
the
chemical
are
properly
coded
and
assigned
to
your
company,
please
include
a
list
of
all
synonyms,
common
and
trade
names,
company
experimental
codes,
and
other
names
which
identify
the
chemical
(
including
"
blind"
codes
used
when
a
sample
was
submitted
for
testing
by
commercial
or
academic
facilities).
Please
provide
a
Chemical
Abstract
System
(
CAS)
number
if
one
has
been
assigned.
