Page
1
of
7
IUR
Petition
Review
Report
April
17,
2005
CASRNs
and
TSCA
Inventory
Chemical
Names:
97­
63­
2
2­
propenoic
acid,
2­
methyl­,
ethyl
ester
97­
86­
9
2­
propenoic
acid,
2­
methyl­,
2­
methylpropyl
ester
97­
88­
1
2­
propenoic
acid,
2­
methyl­,
butyl
ester
688­
84­
6
2­
propenoic
acid,
2­
methyl­,
2­
ethylhexyl
ester
Alternate
Chemical
Names
Used
in
Petition:
The
petition
request
used
non­
TSCA
Inventory
chemical
names
for
some
of
the
chemicals
listed
above.
See
Table
1
at
the
end
of
this
report
for
the
chemical
names
used
in
the
petition
request
that
differ
from
the
TSCA
Inventory
chemical
names.

Petitioner
and
Docket
Number:
Methacrylate
Producers
Association,
Inc.
OPPT­
2004­
0007
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
the
four
substances
listed
above.
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,
E,
and
"
Other."

Background:
EPA
received
a
petition
requesting
that
the
four
chemicals
listed
above
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.
1See
the
attached
list
of
acronyms
at
the
end
of
this
report.

Page
2
of
7
Discussion:
The
petition
review
group
considered
information
submitted
with
the
petition,
as
well
as
other
information
including
(
but
not
limited
to):
whether
the
petition
substances
are
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
stated
that
these
four
chemicals
were
under
review
in
the
OECD
HPV
SIDS
program;
since
the
submission
of
the
petition,
the
review
was
completed
and
agreed
upon
during
SIAM
18,
held
in
April
2004.
The
petition
stated
that
the
information
provided
in
each
chemical's
dossier,
SIAR,
and
SIAP
"
should
be
sufficient
for
EPA
to
make
the
necessary
determination
to
include
these
chemicals
on
the
list
for
partial
reporting
exemption
under
IURA."
The
petition
offered
to
provide
draft
documents
and
noted
that
once
the
reviews
are
complete
the
documents
will
be
available
through
a
specified
website.
The
SIAP,
summarizing
the
OECD
HPV
SIDS
review,
is
now
publicly
available.

The
petition
did
not
link
information
to
specific
considerations
cited
in
40
CFR
710.46(
b)(
2)(
ii),
but
provided
a
general
citation
to
OECD
HPV
SIDS
review
documents,
as
noted
above,
on
these
chemicals.
General
citations
alone
are
of
limited
use
in
establishing
a
rationale
for
adding
a
chemical
to
the
IUR
partial
exemption
list.

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
four
chemicals
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
did
not
identify
specific
information
from
the
OECD
HPV
SIDS
review
that
pertained
to
consideration
B.
The
OECD
review
placed
all
four
chemicals
in
a
category,
and
used
methyl
methacrylate
(
MMA)
(
CAS
80­
62­
6),
the
C1
ester,
as
a
robust
reference
chemical.
The
SIAP
contained
summary
results
of
a
variety
of
studies
associated
with
human
health
and
the
environment
and
a
conclusion
that
these
chemicals
"
possess
properties
indicating
a
hazard
for
human
health
(
skin
sensitization,
skin
and
eye
irritation)."
It
went
on
to
say
that
2­
propenoic
acid,
2­
methyl­,
ethyl
ester
(
CASRN
97­
63­
2),
2­
propenoic
acid,
2­
methyl­,
2­
methylpropyl
ester
(
CASRN
97­
86­
9),
and
2­
propenoic
acid,
2­
methyl­,
butyl
ester
(
CASRN
97­
88­
1)
"
possess
properties
indicating
a
hazard
for
the
environment"
and
2­
propenoic
acid,
2­
methyl­,
2­
ethylhexyl
ester
(
CASRN
688­
84­
6)
has
properties
suggesting
a
"
potential
concern
for
bioaccumulation."
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.

4The
OECD
HPV
SIDS
program,
while
it
is
not
U.
S.
based,
is
a
program
where
OECD
member
countries
are
combining
their
resources
to
investigate
the
hazards
associated
with
different
chemicals.
This
allows
all
of
the
countries
to
benefit
from
this
information.
The
U.
S.
uses
information
collected
during
and
generated
by
the
OECD
HPV
SIDS
program
as
a
starting
point
for
assessing
domestic
issues.

Page
3
of
7
Consideration
C:
The
information
needs
of
EPA,
other
federal
agencies,
tribes,
states,
and
local
governments,
as
well
as
members
of
the
public.

The
petition
review
group
found
that
2­
propenoic
acid,
2­
methyl­,
2­
methylpropyl
ester
(
CASRN
97­
86­
9);
2­
propenoic
acid,
2­
methyl­,
butyl
ester
(
CASRN
97­
88­
1);
and
2­
propenoic
acid,
2­
methyl­,
2­
ethylhexyl
ester
(
CASRN
688­
84­
6)
are
part
of
the
HPV
Challenge
Program.
The
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.

The
petition
referred
EPA
to
the
OECD
HPV
SIDS
review
documents
of
these
four
substances,
but
did
not
identify
specific
information
within
those
documents
that
would
address
consideration
D.
The
results
of
the
OECD
HPV
SIDS
review,
as
documented
in
the
SIAP,
indicate
that
further
work
may
be
warranted.
In
the
case
of
human
health,
the
SIAP
indicates
that
countries
may
wish
to
evaluate
exposure
scenarios
not
reviewed
by
the
sponsor
country.
Concerns
for
the
environment
were
identified.
For
2­
propenoic
acid,
2­
methyl­,
ethyl
ester
(
CASRN
97­
63­
2),
2­
propenoic
acid,
2­
methyl­,
2­
methylpropyl
ester
(
CASRN
97­
86­
9),
and
2­
propenoic
acid,
2­
methyl­,
butyl
ester
(
CASRN
97­
88­
1),
concerns
for
very
high
exposure
levels
were
identified.
For
2­
propenoic
acid,
2­
methyl­,
2­
ethylhexyl
ester
(
CASRN
688­
84­
6),
concerns
for
bioaccumulation
were
identified
and
further
work
within
the
OECD
HPV
program
is
planned.
With
the
collection
of
IUR
processing
and
use
data
for
these
chemicals,
the
U.
S.
will
be
able
to
identify
domestic
situations
by
combining
the
OECD
HPV
SIDS
hazard
data4
with
the
IUR
Page
4
of
7
exposure­
related
information,
thereby
identifying
new
or
revised
exposure
scenarios.
These
new
or
revised
scenarios
will
likely
have
differing
potential
risk
screening
results
than
the
previous
scenarios
and
will
be
specific
to
situations
in
the
U.
S.
See
consideration
E
below
for
further
discussion
of
the
IUR
exposure­
related
processing
and
use
information.

Consideration
E:
The
availability
of
comparable
processing
and
use
information.

The
petition
referred
EPA
to
the
OECD
HPV
SIDS
review
documents
of
these
four
substances,
but
did
not
identify
specific
information
within
those
documents
that
addresses
consideration
E.
The
SIAP
for
these
four
substances
(
dated
April
2004)
contains
some
general
information
on
uses
and
global
production,
identifying
that
these
four
chemicals
are
used
by
industry
to
make
polymers.
The
polymers
are
then
used
for
applications
such
as
automotive
coatings,
nail
sculpturing,
inks
and
dental
products,
and
others.
The
uses
vary
among
the
four
chemicals.
The
SIAR,
which
as
of
April
2005
is
still
in
draft
form
and
not
publicly
available,
adds
the
percent
of
each
chemical
in
each
application.
The
U.
S.
information
was
obtained
from
a
marketing
firm
in
an
apparently
proprietary
study
that
was
published
in
1999
and
2002.
Based
upon
information
in
the
SIAR,
it
appears
that
the
2002
report
is
the
first
one
to
include
the
amount
of
chemical
used
in
each
application
category.
Other
information
was
provided
by
Japanese
sources.

The
conclusion
of
the
OECD
HPV
SIDS
review
indicated
that
countries
may
wish
to
evaluate
exposure
scenarios
not
covered
by
the
report.
Although
the
U.
S.
was
one
of
the
sponsors
of
the
OECD
evaluation,
the
petition
review
group
recognizes
that
since
exposure
scenarios
change
based
on
uses
and
available
technology,
information
quickly
becomes
outdated
and
of
limited
use.
Because
of
this,
the
relative
importance
of
each
use
may
change
or
new
uses
may
develop.
EPA
believes
tracking
these
changes
is
important,
especially
since
the
SIAP
indicated
both
health
and
environmental
issues
for
these
four
chemicals.
The
IUR
provides
current
exposure­
related
processing
and
use
information
in
the
United
States
every
four
years.
This
facilitates
tracking
changes
in
use
patterns
and
the
identification
of
new
exposure
scenarios,
which
is
an
important
component
of
risk
screening.

Additionally,
the
IUR
contains
some
exposure­
related
data
elements
not
provided
in
the
OECD
HPV
SIDS
submission,
such
as
data
on
the
function
of
the
chemical
in
the
industrial
processing
and
use
category,
the
NAICS
code
associated
with
the
use,
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
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
Page
5
of
7
the
downstream
processing
and
use
information
should
be
of
low
current
interest
in
light
of
any
such
risk
management
actions.

Other
Considerations/
Notes:

The
SIAP,
which
contains
a
summary
of
the
SIAR,
contained
the
conclusion
that
all
four
chemicals
are
of
low
priority
for
further
work
within
the
OECD
HPV
SIDS
program
for
human
health,
and
that
three
of
the
substances
are
of
low
priority
for
further
work
for
the
environment.
A
designation
of
low
priority
for
further
work
within
the
OECD
HPV
SIDS
program
means
that
further
hazard
testing
is
not
needed
to
meet
the
purposes
of
OECD
HPV
SIDS
at
the
time
the
review
was
performed.
2­
Propenoic
acid,
2­
methyl­,
2­
ethylhexyl
ester
(
CASRN
688­
84­
6)
was
determined
to
be
a
candidate
for
further
work
for
the
environment
(
Ref.
1).
These
judgements,
however,
do
not
determine
the
approach
that
an
individual
OECD
member
country
must
take
in
considering
such
a
chemical.
Rather,
the
OECD
assessment
is
seen
as
a
starting
point
for
assessment
in
countries.
In
the
U.
S.
case,
it
is
a
starting
point
for
a
screening­
level
risk
assessment,
for
which
IUR
exposure
and
use
reporting
provides
screening­
level
exposure
information.
In
the
past
there
have
been
a
number
of
chemicals
identified
by
OECD
as
a
"
low
priority
for
further
work,"
but
for
which
EPA
wanted
to
make
a
confirmatory
priority
judgement
based
on
risk
­
i.
e.,
screening­
level
hazard
information
based
on
the
OECD
work
plus
screeninglevel
exposure
information
based
on
the
U.
S.
situation.

Table
1:
Chemical
Names
Used
in
Petition
that
Differ
from
TSCA
Inventory
Chemical
Names
CASRN
TSCA
Inventory
Chemical
Name
Chemical
Name
Used
in
Petition
97­
63­
2
2­
propenoic
acid,
2­
methyl­,
ethyl
ester
Ethyl
methacrylate
97­
88­
1
2­
propenoic
acid,
2­
methyl­,
butyl
ester
n­
Butyl
methacrylate
97­
86­
9
2­
propenoic
acid,
2­
methyl­,
2­
methylpropyl
ester
iso­
Butyl
methacrylate
688­
84­
6
2­
propenoic
acid,
2­
methyl­,
2­
ethylhexyl
ester
Ethylhexyl
methacrylate
Cited
Reference:
1)
SIAP
(
SIDS
Initial
Assessment
Profile)
for
ethyl
methacrylate,
iso­
butyl
methacrylate,
n­
butyl
methacrylate,
and
2­
ethylhexyl
methacrylate.
Dated
April
2004.
Available
on
the
Web
at
http://
cs3­
hq.
oecd.
org/
scripts/
hpv/
NewSIDS.
asp
Page
6
of
7
Sources
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reviewed
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in
the
petition
review
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National
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U.
S.
Occupational
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List
of
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Page
7
of
7
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
