Document ID: EPA-HQ-OPPT-2004-0006-0010
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2005-09-12T04:00Z

Page
1
of
6
IUR
Petition
Review
Report
April
17,
2005
CASRNs
and
TSCA
Inventory
Chemical
Names:
67701­
03­
5
fatty
acids,
C16­
18
68308­
53­
2
fatty
acids,
soya
Petitioners
and
Petition
Docket
Numbers:
Keller
and
Heckman
OPPT­
2004­
0071
The
Soap
and
Detergent
Association
(
SDA)
OPPT­
2004­
0006
Note:
The
petitions
contained
additional
chemicals.
These
additional
chemicals
are
addressed
in
other
petition
review
reports.

Summary
of
Decision:
The
petition
review
group
recommends
a
denial
for
this
petition
as
EPA
has
a
current
interest
in
the
processing
and
use
information
collected
under
the
Inventory
Update
Reporting
rule
(
IUR)
(
see
40
CFR
Part
710)
for
fatty
acids,
C16­
18
(
CASRN
67701­
03­
5)
and
fatty
acids,
soya
(
CASRN
68308­
53­
2).
This
recommendation
is
based,
in
part,
on
the
determination
by
the
petition
review
group
that
there
is
a
direct
application
of
the
IUR
processing
and
use
information
to
complement
data
collected
by
or
identified
for
use
under
the
HPV
Challenge
Program.
See
Considerations
A,
C,
D,
and
E.

Background:
EPA
received
two
petitions
requesting
that
fatty
acids,
C16­
18
(
CASRN
67701­
03­
5)
and
fatty
acids,
soya
(
CASRN
68308­
53­
2)
be
added
to
the
40
CFR
710.46(
b)(
2)(
iv)
list
of
specific
chemical
substances
which
are
exempt
from
the
reporting
of
industrial
processing
and
use
and
commercial/
consumer
use
information
required
by
40
CFR
710.52(
c)(
4).
The
chemical
substances
included
on
this
"
partial
exemption"
list
are
substances
for
which
EPA
has
previously
determined
that
there
is
a
low
current
interest
in
the
IUR
processing
and
use
information.
However,
as
stated
in
the
preamble
to
the
amendment
to
the
IUR
rule
promulgated
on
January
7,
2003
(
68
FR
854),
"...
the
need
for
processing
and
use
information
...
changes
over
time.
The
inclusion
of
a
chemical
substance
under
this
partial
exemption
is
not
based
on
the
potential
risks
of
a
chemical.
This
partial
exemption
is
solely
intended
to
provide
a
tool
to
assist
the
Agency
in
better
managing
the
collection
of
processing
and
use
information..."
and
is
also
"
based
on
the
Agency's
current
need
for
collecting
IURA
processing
and
use
information."
(
68
FR
855)
Additionally,
the
preamble
states,
"
In
determining
whether
there
is
low
current
interest
in
IURA
processing
and
use
information
related
to
a
specific
chemical
substance,
EPA
will
look
to
the
specific
circumstances
surrounding
the
chemical
in
question,
and
may
use
one
or
more
of
the
considerations
identified
below,
and/
or
considerations
not
identified
below,
to
make
an
informed
decision."
The
considerations
used
by
EPA
in
reviewing
this
petition
and
an
analysis
of
how
those
considerations
relate
to
the
chemicals
identified
in
this
petition
are
set
forth
below.

Discussion:
The
petition
review
group
considered
information
submitted
with
the
petitions,
as
well
as
other
information
including
(
but
not
limited
to):
whether
the
petition
substances
are
1See
the
attached
list
of
acronyms
at
the
end
of
this
report.

Page
2
of
6
included
in
TRI,
IRIS,
or
IARC;
OECD
HPV
SIDS
program
status;
HPV
Challenge
Program
status;
and
their
inclusion
in
other
regulatory
programs
administered
by
EPA.
1
The
petition
from
SDA
(
docket
number
OPPT­
2004­
0006)
stated
that
these
two
chemicals
are
included
as
part
of
larger
categories
under
the
OECD/
ICCA
HPV
Chemicals
initiative
in
order
to
help
meet
objectives
of
minimizing
testing
and
costs
and
completing
assessments
earlier,
and
to
ensure
the
data
summaries
for
the
categories
were
as
robust
as
possible.
SDA
further
states
that
the
presence
of
the
chemicals
in
the
categories
"
does
not
imply
a
concern
or
high
interest
for
these
substances,
but
rather
that
existing
data
for
these
substances
could
be
used
to
support
the
characterizations
of
other
substances
in
the
category."
The
petitioner
requested
that
these
two
substances
be
granted
a
partial
exemption
on
the
basis
that
"
HPV
chemical
program
sponsorship
does
not
indicate
an
ongoing
interest
in
processing
and
use
data
and
that
these
substances
should
not
have
been
removed
from
the
initial
partial
exemption
list
on
that
basis."
Despite
the
statements
in
the
SDA
petition,
none
of
these
chemical
substances
were
ever
included
on
the
initial
partial
exemption
list.
Additionally,
as
discussed
in
the
document
"
Methodology
Used
for
the
Initial
Selection
of
Chemicals
for
the
Inventory
Update
Rule
Amendments
(
IURA)
`
Low
Current
Interest'
Partial
Reporting
Exemption,"
because
sponsorship
under
the
HPV
Challenge
Program
will
result
in
the
availability
of
hazard
screening
information,
EPA
did
not
consider
these
chemicals
to
be
of
low
current
interest
for
purposes
of
the
reporting
of
IUR
processing
and
use
information.

The
petition
from
SDA
did
not
link
information
furnished
in
the
petition
to
specific
considerations
cited
in
40
CFR
710.46(
b)(
2)(
ii),
but
provided
general
statements
as
described
previously.
Such
general
statements
alone
are
of
limited
use
in
establishing
a
rationale
for
adding
a
chemical
to
the
IUR
partial
exemption
list.

The
petition
from
Keller
and
Heckman
(
docket
number
OPPT­
2004­
0071)
did
link
information
in
their
petition
to
specific
considerations
cited
in
40
CFR
710.46(
b)(
2)(
ii).
This
information
is
included
in
the
discussion
below.

Consideration
A:
Production
volume.

The
petition
review
group
found
that
there
was
at
least
one
site
reporting
to
the
2002
IUR
with
a
production
volume
for
each
of
the
two
substances
of
300,000
pounds
or
greater.

Consideration
B:
The
substance's
chemical
and
physical
properties
or
potential
for
persistence,
bioaccumulation,
health
effects,
or
environmental
effects.

The
petition
from
Keller
and
Heckman
included
excerpts
from
the
Kirk­
Othmer
Encyclopedia
of
Chemical
Technology
to
address
Consideration
B
for
these
two
substances.
The
excerpts
from
Kirk­
Othmer
were
for
broad
categories
such
as
"
Fats
and
Fatty
Oils"
and
offered
little
information
2Risk
is
composed
of
hazard
and
exposure.
In
order
to
screen
for
potential
risk
in
the
U.
S.,
both
hazard
data
and
exposure­
related
data
relative
to
U.
S.
situations
are
needed.
Exposure
is
based
upon
manufacturing,
processing,
and
use
scenarios,
all
of
which
change
over
time
as
technology
and
other
societal
effects
change.
The
changing
nature
of
exposure
scenarios
means
the
potential
risks
associated
with
a
chemical
can
also
change,
and
therefore
the
collection
of
exposure­
related
information
over
time
is
fundamental
to
identifying
potential
risks.
(
See
68
FR
848,
852
for
further
discussion)

3For
additional
information
on
uses
of
IUR
processing
and
use
information,
see
IURA
Data
Use
Plan,
located
in
EPA's
electronic
docket
OPPT­
2002­
0054,
item
number
0261.

Page
3
of
6
specific
to
the
individual
substances.
The
petition
from
the
SDA
did
not
address
this
consideration.

Consideration
C:
The
information
needs
of
EPA,
other
federal
agencies,
tribes,
states,
and
local
governments,
as
well
as
members
of
the
public.

The
petition
from
Keller
and
Heckman
reported
that
neither
substance
has
been
the
subject
of
information
collection
requirements
by
ATSDR
or
the
ITC;
the
petition
from
the
SDA
did
not
address
this
consideration.
Both
substances
are
part
of
EPA's
HPV
Challenge
Program.
SDA
stated
that
the
fact
that
these
chemicals
are
sponsored
does
not
indicate
an
ongoing
interest
in
processing
and
use
data
for
these
chemicals.
However,
EPA's
HPV
Challenge
Program
seeks
to
collect
and,
where
necessary,
develop
a
screening­
level
hazard
data
set
for
chemicals
produced
or
imported
in
large
quantities
in
the
United
States.
EPA
plans
to
screen
and,
as
needed,
further
assess
chemicals
included
under
the
HPV
Challenge
Program.
For
this
purpose,
the
IUR
processing
and
use
information
is
needed
by
EPA
to
put
the
hazard
data
into
context,
complementing
the
HPV
Challenge
Program
submission
by
providing
EPA
with
exposure­
related
information.
2
IUR
reporting
is
needed
at
least
once
and,
potentially,
periodically
thereafter
to
more
accurately
and
realistically
gauge
potential
exposure
and
provide
information
needed
for
screening,
assessing,
and
managing
exposures
and
risk.
Other
important
uses
of
the
reported
information,
even
for
low
hazard
chemicals,
may
include
comparative
exposure
analyses,
identification
of
safer
substitutes,
or
pollution
prevention
investigations.
3
Consideration
D:
The
availability
of
other
complementary
risk
screening
information.

To
address
this
consideration,
the
petition
from
Keller
and
Heckman
noted
that
these
two
substances
are
similar
to
substances
that
are
already
partially
exempt,
differing
in
the
composition
of
the
fatty
acids.
It
was
not
clear
how
this
similarity
related
to
complementary
risk
screening
information.

Since
both
substances
are
included
in
the
HPV
Challenge
Program
and
are
sponsored
through
the
ICCA
HPV
Initiative
(
as
described
in
the
SDA
petition),
additional
hazard
data
may
become
available.
However,
effective
risk
screening
and
risk
management
require
both
exposure
information
and
hazard
information.
The
availability
of
hazard
information
for
these
substances
coupled
with
the
IUR
processing
and
use
information
as
an
indicator
of
potential
exposure
will
facilitate
a
more
effective
screening
of
this
and
other
substances
based
on
either
exposure
or
risk.
Page
4
of
6
Consideration
E:
The
availability
of
comparable
processing
and
use
information.

The
petition
from
Keller
and
Heckman
indicated
that
the
processing
and
use
of
these
substances
is
well­
characterized,
and
included
excerpts
from
the
Kirk­
Othmer
Encyclopedia
of
Chemical
Technology.
The
excerpts,
however,
are
from
1984,
raising
a
concern
for
the
timeliness
and
usefulness
of
the
exposure­
related
data
presented
therein.
Since
exposure
scenarios
change
based
on
uses
and
available
technology,
information
quickly
becomes
outdated
and
of
limited
use.
The
IUR
information
is
needed
to
provide
current
processing
and
use
data
for
the
United
States.
Additionally,
IUR
data
encompass
information
not
included
in
the
Kirk­
Othmer
Encyclopedia,
such
as
the
relative
importance
of
each
use,
and
therefore
the
excerpts
are
not
judged
to
provide
comparable
processing
and
use
data.
For
instance,
the
IUR
collects
data
on
the
function
of
the
chemical
in
the
industrial
processing
and
use
category,
the
NAICS
code
associated
with
the
use,
the
amount
of
the
chemical
going
to
each
use
category,
and
the
number
of
potentially
exposed
workers
and
the
number
of
sites
associated
with
each
use.
For
commercial
and
consumer
uses,
the
IUR
collects
data
on
the
amount
of
the
chemical
in
various
use
categories,
the
concentration
of
the
chemical
in
the
use
category,
and
the
likelihood
of
inclusion
in
products
intended
for
children.
Furthermore,
IUR
information
is
updated
every
four
years,
is
quantitative,
and
is
specific
to
the
United
States.

Consideration
F:
Whether
the
potential
risks
for
the
chemical
substance
are
adequately
managed
by
EPA
or
another
agency
or
authority.

The
petition
from
Keller
and
Heckman
indicated
that
EPA,
NIOSH,
OSHA,
CPSC,
and
FDA
all
regulate
the
manufacture
and
use
of
these
petition
substances,
but
did
not
provide
information
specific
to
individual
chemicals
except
for
FDA
regulations.
The
petition
review
group
does
not
consider
that
the
FDA
regulations
cover
issues
under
the
purview
of
the
other
listed
regulatory
agencies
and
therefore
do
not
necessarily
address
all
of
the
potential
risks
associated
with
the
chemical
substance.
Sufficient
evidence
to
state
that
potential
risks
of
the
chemicals
substances
are
adequately
managed
was
therefore
not
included
in
the
petition.

The
SDA
petition
did
not
identify
or
discuss
any
risk
management
actions
taken
by
EPA
or
another
agency
or
authority
with
respect
to
the
petitioned
chemical(
s).
The
petition
did
not
explain
why
the
downstream
processing
and
use
information
should
be
of
low
current
interest
in
light
of
any
such
risk
management
actions.

Sources
Searched:
(
Note:
These
sources
are
typically
searched
or
reviewed
to
gather
information
presented
in
the
petition
review
report.)

American
Conference
of
Governmental
Industrial
Hygienists
(
ACGIH)
Threshold
Limit
Values
(
TLV­
TWA).
2003.
ACGIH,
Cincinnati
OH.
pp.
12­
61.

Agency
for
Toxic
Substances
and
Disease
Registry
(
ATSDR)
ToxFAQsTM
(
Frequently
asked
questions
about
contaminants
found
at
hazardous
waste
sites).
Available
at
http://
www.
atsdr.
cdc.
gov/
toxfaq.
html
California
Air
Resources
Board
List
of
Toxic
Air
Contaminant
Fact
Sheets,
available
at
http://
arbis.
arb.
ca.
gov/
toxics/
tac/
toctbl.
htm
Page
5
of
6
California
EPA,
Safe
Drinking
Water
and
Toxic
Enforcement
Act
of
1986:
List
of
chemicals
known
to
the
State
to
cause
cancer
or
reproductive
toxicity.
Listing
as
of
Nov.
14,
2003.
Available
at
http://
www.
oehha.
ca.
gov/
prop65/
CRNR_
notices/
list_
changes/
111403lsta.
html
International
Agency
of
Research
on
Cancer
(
IARC)
Overall
Evaluations
of
Carcinogenicity
to
Humans.
Available
at
http://
monographs.
iarc.
fr/
monoeval/
crthall.
html
Interagency
Testing
Committee
(
ITC)
Priority
Testing
List.
Available
at
http://
tsca­
itc.
syrres.
com/
Chemicals/

National
Advisory
Committee
Acute
Exposure
Guideline
Levels
(
AEGLs).
Available
at
http://
www.
epa.
gov/
oppt/
aegl/
index.
htm
Organisation
for
Economic
Cooperation
and
Development
(
OECD)
Integrated
HPV
Database,
http://
cs3­
hq.
oecd.
org/
scripts/
hpv/
index.
asp
United
Nations
Environment
Programme
(
UNEP)
persistent
organic
pollutants
(
POPs),
available
at
http://
www.
chem.
unep.
ch/
pops/
default.
html
United
Nations
Environment
Programme
(
UNEP)
Ozone
Secretariat,
Summary
Control
Measures,
available
at
http://
www.
unep.
org/
ozone/
Treaties_
and_
Ratification/
2B_
montreal_
protocol.
asp
U.
S.
EPA
Clean
Air
Act
(
CAA)
Hazardous
Air
Pollutants
(
HAPs).
Available
in
the
Clean
Air
Act,
section
112(
b),
available
at
http://
www.
epa.
gov/
air/
caa/
caa112.
txt
U.
S.
EPA.
Emergency
Planning
and
Community
Right­
to­
Know
Act
Section
313,
List
of
Toxic
Chemicals.
2001.
Office
of
Environmental
Information,
EPA
260­
B­
01­
001,
available
at
http://
www.
epa.
gov/
tri/
chemical/
chemlist2001.
pdf
U.
S.
EPA
HPV
(
High
Production
Volume)
Challenge
Program
and
Voluntary
Children's
Chemical
Evaluation
Program
(
VCCEP)
Web
sites
under
the
EPA
Chemical
Right­
to­
Know
Initiative,
http://
www.
epa.
gov/
chemrtk
U.
S.
EPA
Integrated
Risk
Information
System
(
IRIS)
Substance
List.
Available
at
http://
www.
epa.
gov/
iris/
subst/
index.
html
U.
S.
EPA.
National
Recommended
Water
Quality
Criteria:
2002.
Office
of
Water.
EPA­
822­
R­
02­
047.
Available
at
http://
www.
epa.
gov/
waterscience/
pc/
revcom.
pdf
U.
S.
EPA.
2004
Edition
of
the
Drinking
Water
Standards
and
Health
Advisories.
Office
of
Water.
EPA­
822­
R­
04­
005.
Available
at
http://
www.
epa.
gov/
waterscience/
drinking/
standards/
dwstandards.
pdf
U.
S.
EPA
Substance
Registry
System
(
SRS).
Available
at
http://
www.
epa.
gov/
srs/

U.
S.
Occupational
Safety
and
Health
Administration
(
OSHA)
Permissible
Exposure
Limits
(
PELs),
available
at
http://
www.
osha.
gov/
SLTC/
pel/
index.
html
List
of
Acronyms
Page
6
of
6
ACGIH
American
Conference
of
Governmental
Industrial
Hygienists
AEGL
Acute
Exposure
Guideline
Level
ARB
Air
Resources
Board
ATSDR
Agency
for
Toxic
Substances
and
Disease
Registry
CAA
Clean
Air
Act
CASRN
Chemical
Abstract
Service
Registry
Number
CICAD
Concise
International
Chemical
Assessment
Document
CPSC
Consumer
Product
Safety
Commission
EHC
Environmental
Health
Criteria
EPA
Environmental
Protection
Agency
EU
European
Union
FDA
Food
and
Drug
Administration
FFDCA
Federal
Food,
Drug,
and
Cosmetic
Act
FIFRA
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act
GRAS
Generally
Recognized
as
Safe
HAP
Hazardous
Air
Pollutant
HPV
High
Production
Volume
HSDB
Hazardous
Substances
Databank
IARC
International
Agency
of
Research
on
Cancer
ICCA
International
Council
of
Chemical
Associations
IFCS
International
Forum
on
Chemical
Safety
IPCS
International
Programme
on
Chemical
Safety
IRIS
Integrated
Risk
Information
System
IRPTC
International
Register
of
Potentially
Toxic
Chemicals
ITC
Interagency
Testing
Committee
IUCLID
International
Uniform
Chemical
Information
Database
IUR
Inventory
Update
Reporting
Rule
IURA
Inventory
Update
Reporting
Rule
Amendment
NAICS
North
American
Industry
Classification
System
NIOSH
National
Institute
for
Occupational
Safety
and
Health
OECD
Organisation
for
Economic
Cooperation
and
Development
OECD
HPV
SIDS
or
OECD
HPV
SIDS
program
OECD/
SIDS
HPV
Chemicals
Programme
OPP
Office
of
Pesticide
Programs
OPPT
Office
of
Pollution
Prevention
and
Toxics
OSHA
Occupational
Safety
and
Health
Administration
PEL
Permissible
Exposure
Limit
POP
Persistent
Organic
Pollutant
SIAM
SIDS
Initial
Assessment
Meeting
SIAP
SIDS
Initial
Assessment
Profile
SIAR
SIDS
Initial
Assessment
Report
SIDS
Screening
Information
Data
Set
SRS
Substance
Registry
System
TLV­
TWA
Threshold
Limit
Value
Time­
Weighted
Average
TRI
Toxics
Release
Inventory
TSCA
Toxic
Substances
Control
Act
UNEP
United
Nations
Environment
Programme
VCCEP
Voluntary
Children's
Chemical
Evaluation
Program