Document ID: EPA-HQ-OPPT-2004-0085-0031
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2004-06-17T04:00Z

ECONOMIC
ANALYSIS
OF
PROPOSED
SIGNIFICANT
NEW
USE
RULE
FOR
CERTAIN
POLYBROMINATED
DIPHENYLETHERS
 
DOES
NOT
CONTAIN
TSCA
CBI
 
Prepared
by:

Economic
and
Policy
Analysis
Branch
Economics,
Exposure
and
Technology
Division
Office
of
Pollution
Prevention
and
Toxics
U.
S.
ENVIRONMENTAL
PROTECTION
AGENCY
1200
PENNSYLVANIA
AVENUE,
N.
W.
WASHINGTON,
DC
20460
June
18,
2004
i
CONTRIBUTORS
The
EPA
analyst
responsible
for
this
report
was
Timothy
Lehman.
Analytical
and
draft
preparation
support
was
provided
by
Abt
Associates
Inc.
under
EPA
Contract
No.
68­
W­
02­
077.
ii
ABSTRACT
This
report
estimates
the
costs
of
the
proposed
Significant
New
Use
Rule
(
SNUR)
for
certain
polybrominated
diphenylethers
that
comprise
the
commercial
pentabromodiphenyl
ether
(
pentaBDE)
and
octabromodiphenyl
ether
(
octaBDE)
products.
EPA
proposes
to
designate
as
a
Significant
New
Use
"
any
manufacture
or
import
for
any
use
of
pentaBDE
and
octaBDE
on
or
after
January
1,
2005."
Therefore
a
firm
intending
to
manufacture
or
import
either
of
these
chemicals
would
be
required
to
submit
a
SNUN,
incurring
an
estimated
submission
cost
of
$
6,956
per
chemical.
If
the
firm
undertakes
testing
to
support
the
submission
of
a
SNUN,
costs
could
range
from
roughly
$
339,000
to
over
$
1.4
million
per
chemical,
but
could
be
substantially
lower
if
not
all
recommended
tests
are
performed.

If
the
firm
chooses
to
avoid
a
Significant
New
Use
by
refraining
from
manufacturing
or
importing
either
of
these
chemicals
as
of
January
1,
2005,
it
can
avoid
submission
and
testing
costs,
but
may
incur
"
hidden"
costs,
not
quantified
here,
if
it
foregoes
profitable
opportunities
it
would
otherwise
have
undertaken.

Costs
estimated
here
are
for
one
chemical
at
one
site,
and
reflect
SNUR
restrictions
and
testing
specific
to
each
chemical,
although
in
this
case
there
are
no
distinctions
between
the
two
chemicals
in
either
restrictions
or
testing.
EPA
receives
an
average
of
ten
notices
per
year
due
to
SNURs.
The
number
of
firms
affected
but
not
making
submissions
is
not
known,
and
costs
are
not
aggregated.
iii
TABLE
OF
CONTENTS
Page
CONTRIBUTORS
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i
ABSTRACT
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ii
LIST
OF
TABLES
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v
1.0
INTRODUCTION
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1
2.0
COSTS
ASSOCIATED
WITH
SUBMITTING
A
SIGNIFICANT
NEW
USE
NOTIFICATION
(
SNUN)
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2
2.1
Costs
for
Submitting
a
SNUN
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3
2.2
Costs
of
Developing
and
Submitting
Testing
Data
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4
3.0
EXPORT
NOTIFICATION
COSTS
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5
4.0
AGENCY
COSTS
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6
5.0
ADDITIONAL
ANALYSES
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6
5.1
Regulatory
Flexibility
Act
(
RFA)
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6
5.2
Unfunded
Mandates
Reform
Act
(
UMRA)
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8
5.3
Paperwork
Reduction
Act
(
PRA)
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8
5.4
Executive
Order
12866
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8
5.5
Executive
Order
13132
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8
5.6
Executive
Order
12898
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8
5.7
Executive
Order
13045
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9
APPENDIX
A
LIST
OF
CHEMICAL
NAMES
AND
CAS
NUMBERS
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A­
1
APPENDIX
B
INFLATORS
AND
WAGE
RATES
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B­
1
B.
1.
Derivation
of
Loaded
Wage
Rates
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B­
1
B.
2.
Derivation
of
Inflation
Factors
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B­
6
APPENDIX
C
COSTS
OF
TESTING
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.
C­
1
APPENDIX
D
COSTS
OF
SUBMITTING
A
SNUN
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D­
1
APPENDIX
E
AGENCY
COSTS
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E­
1
iv
APPENDIX
F
REFERENCES
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F­
1
v
LIST
OF
TABLES
Table
1
Compliance
Options
and
Associated
Costs
Incurred
by
a
Firm
due
to
SNUR
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2
Table
2
Cost
of
Submitting
a
SNUN
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4
Table
3
Ranges
of
Costs
of
Recommended
Testing
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5
Table
4
Cost
per
Chemical
of
Submission
of
SNUN
With
and
Without
Testing
Costs
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5
Table
A­
1
Chemical
Names
and
CAS
Numbers
Referenced
in
this
SNUR
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A­
1
Table
B­
1
Derivation
of
Loaded
Wage
Rates
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B­
4
Table
B­
2
Derivation
of
Inflation
Factors
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B­
6
Table
C­
1.
Developmental
Neurotoxicity
Tests
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C­
2
Table
C­
2.
Developmental
Toxicity
Tests
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C­
2
Table
C­
3.
Reproductive
Toxicity
Tests
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.
C­
3
Table
C­
4.
Tests
on
Developmental
Effects
in
Fish
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C­
4
Table
D­
1
Industry
Costs
for
SNUN
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D­
1
Table
E­
1
Agency
Costs
for
SNUN
and
Other
Submission
Review
and
Processing
.
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E­
2
1
1.0
INTRODUCTION
This
report
presents
the
U.
S.
Environmental
Protection
Agency
(
EPA),
Office
of
Pollution
Prevention
and
Toxics'
(
OPPT's)
analysis
of
the
potential
costs
incurred
as
a
result
of
a
Significant
New
Use
Rule
(
SNUR)
being
promulgated
for
certain
polybrominated
diphenyl
ethers
that
comprise
2
commercial
products,
pentabromodiphenyl
ether
and
octabromodiphenyl
ether
(
hereafter,
pentaBDE
and
octaBDE).
EPA
promulgates
a
SNUR
for
a
substance
when
potential
uses
could
result
in
increased
exposure
to
or
releases
of
the
substance,
and
in
turn
an
unreasonable
risk
to
health
or
the
environment.
Appendix
A
lists
the
generic
or
specific
chemical
name
and
CAS
number
for
each
of
the
chemicals
covered
under
this
SNUR.

A
SNUR
specifies
the
conditions
under
which
the
manufacture,
import,
and/
or
processing
of
a
substance
is
allowed
without
prior
notice
to
EPA,
thus
defining
its
permissible
uses
that
do
not
constitute
a
"
Significant
New
Use."
Anything
that
exceeds
what
is
specified
as
allowable
in
the
SNUR
is
considered
a
Significant
New
Use
and
triggers
a
submission
to
EPA.

The
SNUR
discussed
in
this
report
specifies
that
any
manufacture
or
importing
of
pentaBDE
and/
or
octaBDE
for
any
use
constitutes
a
Significant
New
Use.
This
effectively
indicates
that
a
firm
intending
to
manufacture
or
import
either
of
these
two
chemicals
must
submit
a
Significant
New
Use
Notification
(
SNUN)
to
do
so.
Alternatively,
a
firm
can
decide
not
to
manufacture,
import,
or
process
these
two
chemicals.
It
thus
has
two
options:

C
Option
1:
Submission
of
a
SNUN.
If
the
firm
intends
to
manufacture
or
import
either
of
the
two
chemicals
listed
in
this
SNUR,
it
must
submit
a
Significant
New
Use
Notification
(
SNUN).
A
SNUN
indicates
to
EPA
that
the
firm
would
like
to
manufacture,
import,
or
process
the
chemical
for
a
Significant
New
Use,
which,
in
this
case,
means
any
manufacture
or
importing
of
these
chemicals.
The
SNUN
must
be
provided
to
EPA
at
least
90
days
before
the
firm
plans
to
commence
the
manufacture,
import,
or
processing
of
the
substance;
it
provides
EPA
with
the
opportunity
to
evaluate
the
intended
use
and,
if
necessary,
to
prohibit
or
limit
that
activity
before
it
occurs.
If
EPA
allows
the
manufacture
or
importing
of
these
chemicals,
then
the
costs
associated
with
this
option
are
the
costs
of
submitting
the
SNUN
(
including
user
fee)
plus
the
possible
costs
of
following
Option
2
during
EPA
review
of
the
SNUN.

°
Option
2:
Decision
not
to
manufacture,
import,
or
process
the
substance.
The
firm
may
decide
simply
not
to
proceed
to
manufacture,
import,
or
process
these
chemical.
While
this
option
avoids
the
costs
of
submitting
a
SNUN,
it
entails
the
"
hidden"
cost
of
the
profit
that
will
be
foregone
as
a
result
of
not
engaging
in
the
commercial
activity
originally
planned.
Similarly,
if
the
firm
would
have
used
a
given
amount
of
the
substance
in
the
production
of
another
product
and
must
substitute
to
a
more
costly
substance,
it
will
incur
those
additional
"
hidden"
costs
of
production.
If
the
firm
elects
to
produce
for
R&
D
purposes
only,
it
may
have
costs
associated
with
R&
D
recordkeeping.
2
If
the
firm
makes
a
submission,
there
will
be
a
period
during
which
EPA
will
review
the
SNUN
submitted.
Even
if
EPA
grants
the
firm's
request,
in
addition
to
the
submission
costs,
the
firm
would
incur
the
costs
resulting
from
following
Option
2
for
the
length
of
the
EPA
review
period.
The
options
available
to
a
firm
considering
the
manufacture,
import,
and/
or
processing
of
one
of
the
chemicals
covered
under
this
SNUR,
and
the
possible
types
of
associated
costs
to
the
firm,
are
summarized
in
Table
1.

Table
1
Compliance
Options
and
Associated
Costs
Incurred
by
a
Firm
due
to
SNUR*

Option
Costs
1
Submit
a
Significant
New
Use
Notice
(
SNUN),
indicating
to
EPA
that
the
firm
would
like
to
manufacture,
import,
or
process
the
chemical
for
a
Significant
New
Use.
In
this
SNUR,
any
manufacture
or
importing
of
these
chemicals
is
a
"
significant
new
use."
Costs
of
submitting
a
SNUN,
including
user
fee.
Testing
costs
are
also
possible,
but
only
for
a
small
minority
of
chemicals.

2
Decide
not
to
manufacture,
import,
or
process
the
substance,
or
manufacture
only
for
R&
D
(
The
R&
D
exemption
is
covered
in
40
CFR
§
721.47).
Cost
of
the
profit
foregone
as
a
result
of
not
engaging
in
the
commercial
activity
originally
planned.
R&
D
recordkeeping
costs
if
manufacture
for
R&
D.

§
numbers
refer
to
40
CFR
721
(
in
the
Code
of
Federal
Regulations)

The
remainder
of
this
report
presents
estimates
of
the
quantified
portion
of
costs
associated
with
the
SNUR
being
promulgated
for
pentaBDE
and
octaBDE.
Section
2
presents
estimates
of
the
quantifiable
costs
incurred
by
manufacturers,
importers,
and/
or
processors
who
submit
a
SNUN
(
Option
1).
Section
3
addresses
one­
time
export
notification
costs.
Section
4
presents
estimates
of
the
costs
to
EPA
of
administering
the
SNUR,
while
Section
5
presents
an
analysis
of
other
impacts,
as
required
by
various
statutes
and
executive
orders.

2.0
COSTS
ASSOCIATED
WITH
SUBMITTING
A
SIGNIFICANT
NEW
USE
NOTIFICATION
(
SNUN)

As
indicated
in
the
introduction,
this
SNUR
specifies
that
any
manufacture
or
importing
of
pentaBDE
and/
or
octaBDE
for
any
use
constitutes
a
Significant
New
Use.
This
effectively
indicates
that
a
firm
intending
to
manufacture
or
import
either
of
these
two
chemicals
must
submit
a
Significant
New
Use
Notification
(
SNUN)
to
do
so
(
Option
1).
Although
the
firm
may
alternatively
decide
simply
not
to
proceed
to
manufacture,
import,
or
process
these
chemicals
(
Option
2),
and
this
option
also
entails
costs,
these
costs
are
not
readily
quantifiable
and
are
not
discussed
further.
In
this
section,
we
present
estimates
of
the
costs
associated
with
the
3
submission
of
a
SNUN.
Unless
otherwise
indicated,
all
costs
are
in
year
2002
dollars.
Wage
rates
and
inflators
used
are
given
in
Appendix
B.

2.1
Costs
for
Submitting
a
SNUN
Under
40
CFR
§
721.5,
manufacturers,
importers,
or
processors
who
would
like
to
undertake
a
Significant
New
Use
of
a
PMN
substance
listed
in
a
SNUR
are
required
to
submit
a
Significant
New
Use
Notice
(
SNUN).
For
example,
they
could
submit
a
SNUN
if
they
wish
to
produce
above
the
volume
limit
listed
in
the
SNUR
for
a
given
chemical,
since
any
production
beyond
that
volume
would
be
defined
as
a
Significant
New
Use.
Because
the
SNUR
discussed
in
this
report
specifies
that
any
production
or
importing
of
pentaBDE
and/
or
octaBDE
constitutes
a
Significant
New
Use,
a
firm
wishing
to
produce
or
import
either
of
these
two
chemicals
would
have
to
submit
a
SNUN.
The
notice
form
used
to
submit
a
SNUN
is
the
same
as
that
for
a
PMN,
and
the
costs
of
submitting
a
SNUN
are
estimated
based
on
the
costs
incurred
to
submit
a
PMN.
This
option
could
have
the
following
costs:

#
Costs
of
preparing
the
SNUN.

#
Cost
of
the
$
2500
user
fee.

#
Costs
of
complying
with
SNUR
restrictions
(
i.
e.,
of
avoiding
production
or
importing)
while
the
SNUN
is
being
processed;
costs
of
complying
with
any
restrictions
resulting
from
the
SNUN
review.

#
The
SNUN
submitter
may
need
to
perform
some
of
the
tests
listed
in
the
batch
SNUR.
Testing
costs
are
discussed
in
Section
2.2
below.

Another
option
available
to
sites
before
the
SNUR
is
promulgated
is
to
seek
an
advance
compliance
exemption
under
§
721.45(
h).
The
submission
cost
for
the
option
is
the
same
as
that
for
a
SNUN,
but
by
negotiating
an
advance
compliance
agreement
with
EPA
a
company
can
diminish
the
loss
of
profits
due
to
delay.
This
option
is
not
available
after
the
SNUR
is
promulgated.

The
costs
for
submitting
a
SNUN
are
estimated
to
be
equivalent
to
the
costs
of
completing
a
PMN
submission.
In
its
Regulatory
Impact
Analysis
for
the
amendments
to
the
PMN
regulations,
EPA
relied
on
industry
estimates
of
the
effort
needed
to
collect
and
compile
all
data
required
for
a
PMN
submission,
prepare
the
form,
and
submit
the
form
and
data
to
EPA
(
RIB
1994).
These
estimates,
based
on
a
1991
survey
conducted
by
the
Chemical
Manufacturers
Association,
indicate
that
the
average
effort
required
to
prepare
and
submit
a
PMN
is
between
95
and
114
hours.
This
analysis
uses
the
average
of
the
estimated
hours
for
each
step,
resulting
in
a
cost
of
$
4,456.
The
costs
associated
with
these
labor
time
estimates
are
derived
in
Appendix
D.
The
cost
of
preparing
a
SNUN,
shown
in
Table
2
below,
is
$
6,956,
including
the
$
2,500
user
fee
4
(
as
shown
in
Appendix
D).
In
addition,
as
was
mentioned
above,
there
could
be
testing
costs,
delay
costs,
or
other
costs
not
included
in
Table
2.

Table
2
Cost
of
Submitting
a
SNUN
Hours
Total
Labor
Cost
(
wage
×
hours)

Costs
of
preparing
submission
105
$
4,456
User
fees
$
2,500
TOTAL
$
6,956
Figures
are
rounded
to
whole
dollars.
(
See
Appendix
D
for
derivation).
Costs
shown
in
this
table
do
not
include
possible
testing
costs.

2.2
Costs
of
Developing
and
Submitting
Testing
Data
Testing
may
be
conducted
to
support
the
submission
of
a
SNUN.
The
SNUR
identifies
the
toxicological
endpoints
of
concern
for
pentaBDE
or
octaBDE
as
likely
to
include
endocrine
disruption
(
especially
the
thyroid),
neurodevelopmental
toxicity,
developmental
and
reproductive
toxicity,
cancer,
avian
reproduction,
effects
in
the
aquatic
or
terrestrial
food
chains,
and
cancer,
and
that
more
needs
to
be
understood
about
the
environmental
fate
and
the
exposure
pathways
that
lead
to
PBDE
presence
in
wildlife
and
people.
Although
testing
or
monitoring
to
address
such
data
needs
is
not
required
in
the
SNUR,
it
may
sometimes
be
provided
by
the
submitter
to
support
submission
of
a
SNUN.

A
SNUR
typically
lists
recommended
tests
by
guideline
numbers
which
can
be
used
to
look
up
published
test
protocols.
Testing
costs
for
each
substance
are
calculated
by
adding
up
costs
for
individual
test
protocols
listed
in
the
SNUR
for
that
substance.
The
costs
for
individual
test
protocols
have
been
developed
by
EPA
over
the
years
to
support
TSCA
rule
development.

For
this
SNUR,
however,
specific
recommended
tests
with
guideline
numbers
were
not
given.
Instead,
only
general
types
of
endpoints
(
e.
g.,
developmental
neurotoxicity)
were
identified,
as
described
above.
Detailed
information
on
tests
that
might
be
used
to
address
these
data
gaps
fall
within
each
general
type
is
given
in
Appendix
C.
Table
3
below
summarizes
the
cost
ranges
for
the
different
types
of
recommended
tests.
Costs
have
been
inflated
to
2002
dollars.
Table
4
gives
the
cost
of
submission
of
a
SNUN
both
with
and
without
possible
test
costs.
5
Table
3
Ranges
of
Costs
of
Recommended
Testing
Test
Type
Range
of
Costs
Developmental
neurotoxicity
$
180,206
­
$
336,839
Developmental
toxicity
$
65,772
­
$
106,716
Reproductive
toxicity
$
51,875
­
$
890,156*
Endocrine
disruption
NA
Developmental
effects
in
fish
$
34,483
­
$
72,512
Reproductive
effects
in
fish
NA
Sum
of
"
low
end"
costs:**
$
332,336
Sum
of
"
high
end"
costs:**
$
1,410,679
*
The
cost
of
one
of
the
reproductive
toxicity
tests
was
not
available.
The
range
shown
here
assumes
that
this
test
cost
was
somewhere
within
the
bounds
of
those
test
costs
for
which
information
was
available.
**
Sums
do
not
include
the
costs
of
endocrine
disruption
tests
or
tests
on
reproductive
effects
in
fish,
for
which
no
information
is
available..
***
Source:
TSCA
Test
Guideline
Cost
Estimates
(
EPAB
2003)
(
See
Appendix
C
for
details.)

Table
4
Cost
per
Chemical
of
Submission
of
SNUN
With
and
Without
Testing
Costs*

Without
Testing
Costs
a
With
Testing
Costs
b
Cost
Hours
Cost
Range
Hours
Range
Low
High
Low
High
$
6,956
105
$
339,292
$
1,417,635
3,248
14,463
*
Costs
are
the
same
for
both
chemicals
covered
in
this
SNUR.
a
Costs
without
testing
include
one­
time
costs
of
SNUN
($
4,456)
plus
a
$
2,500
user
fee.
b
If
testing
is
also
needed,
costs
could
be
higher,
although
how
much
higher
depends
on
how
many
tests
are
run
and
how
expensive
each
test
is.
The
"
low"
end
of
the
cost
range
assumes
all
the
least
costly
tests
are
run.
The
"
high"
end
assumes
all
the
most
costly
tests
are
run.
Similarly,
the
"
low"
hours
estimate
assumes
that
all
the
least
time
consuming
tests
are
run
and
the
"
high"
hours
estimate
assumes
that
all
the
most
time
consuming
tests
are
run
(
See
Appendix
C.)
Neither
the
cost
nor
the
hour
ranges
include
the
two
categories
of
tests,
endocrine
disruption
and
reproductive
effects
in
fish,
for
which
estimates
were
not
available.
If
full
testing
is
not
needed,
costs
would
be
lower.
For
individual
test
costs
and
hour
burdens,
see
Tables
C­
1
through
C­
4.

3.0
EXPORT
NOTIFICATION
COSTS
Under
Section
12(
b)
of
TSCA,
exporters
must
notify
EPA
if
they
export
or
intend
to
export
a
chemical
substance
or
mixture:

C
For
which
submission
of
data
is
required
under
Section
4
or
5(
b);
6
C
For
which
an
order
has
been
issued
under
Section
5;
C
For
which
a
rule
has
been
proposed
or
promulgated
under
Section
5
or
6;
or
C
With
respect
to
which
an
action
is
pending
or
relief
has
been
granted
under
Section
5
or
7.

Notifications
must
be
submitted
in
writing
and
must
include
the
following
information:
exporter's
name
and
address,
name
of
the
regulated
chemical,
the
date(
s)
of
export
or
intended
export,
the
importing
country
(
or
countries),
and
the
section
of
TSCA
under
which
EPA
has
taken
action.
This
is
a
one­
time
notification
requirement,
and
the
exporter
need
only
submit
the
notice
when
it
is
exporting
a
particular
chemical
for
the
first
time
to
a
country
for
which
it
has
not
previously
submitted
a
notification.

In
an
economic
analysis
of
an
amendment
to
the
rules
implementing
TSCA
Section
12(
b),
EPA
estimated
that
the
one­
time
cost
of
preparing
and
submitting
an
export
notification
was
$
62.60
in
1992
(
Silagi
1992),
or
$
89.29
when
inflated
to
2002
dollars
by
a
factor
of
approximately
1.43,
from
the
Employment
Cost
Index
for
White
Collar
Occupations
(
BLS
2003a;
see
Appendix
B).
The
total
costs
of
export
notification
will
vary
per
chemical,
depending
on
the
number
of
required
notifications
(
i.
e.,
number
of
countries
to
which
the
chemical
is
exported).
EPA
is
unable
to
make
any
estimate
of
the
likely
number
of
export
notifications
for
chemicals
covered
in
this
SNUR.

4.0
AGENCY
COSTS
EPA's
costs
to
review
and
process
industry
submissions
(
SNUNs,
requests
to
modify
SNUR,
and
requests
for
equivalency
determination)
are
assumed
to
be
the
same
as
EPA
costs
to
review
PMNs.
These
costs
are
estimated
at
$
4,034
per
case.
The
Agency
actions
required,
fulltime
equivalent
(
FTE)
staff
needs,
and
extramural
costs
such
as
for
contractor
support
are
derived
in
Appendix
E
from
EPA's
analysis
of
the
Agency
costs
of
processing
PMN
submissions
(
RIB
1994),
with
updates
to
2002
prices.
The
original
EPA
analysis
used
a
range
of
salaries,
but
this
analysis
uses
only
the
average
salary.
See
Appendix
E
for
details.

5.0
ADDITIONAL
ANALYSES
This
section
presents
additional
analysis
of
other
potential
impacts
of
this
rulemaking,
as
required
under
various
statutes
and
executive
orders.

5.1
Regulatory
Flexibility
Act
(
RFA)

The
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et.
seq.),
as
amended
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act,
requires
regulators
to
consider
the
impact
of
regulations
on
small
entities,
in
particular
small
businesses.
EPA's
experience
to
date
is
that,
in
1Bona
fides
are
submitted
to
EPA
by
manufacturers
and
importers
to
determine
a
chemical's
TSCA
Chemical
Inventory
and
regulatory
status.

2
Due
to
timing
and
resource
limitations,
another
possible
source
of
data
­­
the
year
2002
industry
reporting
under
the
1986
Inventory
Update
Rule
(
51
FR
21438)
­­
was
not
tapped
for
this
report.

7
response
to
the
promulgation
of
SNURS
covering
over
1000
chemicals
,
the
Agency
receives
an
average
of
only
ten
notices
per
year.
Of
those
SNUNs
submitted,
none
appear
to
be
from
small
entities
in
response
to
any
SNUR.
In
fact,
EPA
expects
to
receive
few,
if
any,
SNUNs
from
either
large
or
small
entities
in
response
to
any
SNUR.

This
leaves
open
the
question
of
how
many
small
businesses
are
affected
but
do
not
submit
SNUNs.
For
example,
businesses
may
change
their
behavior
in
order
to
use
a
chemical
in
a
manner
that
avoids
triggering
the
SNUR.

Data
and
resources
were
not
available
to
estimate
the
number
of
small
businesses
affected
by
the
current
rule.
However,
a
1989
analysis
suggested
that
few
small
businesses
would
be
affected
by
SNURs
for
chemicals
that
have
undergone
PMN
review.
The
1989
report
estimated
that
9%
of
firms
subject
to
SNURs
would
be
small
businesses,
based
on
the
portion
of
PMN
submitters
who
were
small
businesses.
(
Long
1989)
The
cutoff
for
"
small
business"
was
$
40
million
in
sales,
which
is
consistent
with
the
definition
used
at
40
CFR
700.43
to
set
PMN
fees.

Past
bona
fide
submissions
also
suggest
that
few
firms
other
than
possibly
some
PMN
submitters
will
be
affected.
1
EPA
has
received
few
bona
fides
indicating
interest
in
manufacturing
or
importing
chemicals
subject
to
past
SNURs.
EPA
also
has
received
few
public
comments
during
rulemaking
on
SNURs
covering
PMN
chemicals.
For
example,
a
SNUR
published
in
the
Spring
of
2003
covering
62
chemicals
resulted
in
industry
comments
on
only
three
PMNs,
none
from
small
businesses
(
EPA
Docket
#
OPPT­
2002­
0060).
2
It
remains
possible
that
some
small
businesses
are
affected
by
SNURs
without
EPA
being
aware,
if
the
firms
have
made
no
submissions
or
comments
to
EPA.
However,
even
if
a
small
business
were
interested
in
supplying
a
SNUR
chemical,
the
SNUR's
impact
on
profits
is
generally
expected
to
be
minor.
For
example,
the
firm
may
have
a
small
expense
of
keeping
records
and/
or
of
changing
workplace
practices
to
comply
with
restrictions.
If
modifying
production
practices
would
be
overly
costly,
or
if
the
firm
wishes
to
engage
in
a
Significant
New
Use
but
believes
that
expensive
testing
is
needed
to
support
a
submission
to
EPA,
it
may
instead
forego
production,
thus
sacrificing
profits.
The
amounts
of
lost
profits,
if
any,
were
not
quantified
for
this
report,
but
usually
should
be
low.
This
is
because
SNUR
chemicals
are
relatively
new
and
few
compared
to
the
many
thousands
of
chemicals
on
the
TSCA
Inventory,
and
so
are
unlikely
to
be
central
to
a
firm's
business.

Based
on
these
considerations
and
on
the
limited
data
available,
EPA
expects
that
any
8
compliance
with
a
SNUR
will
not
have
a
significant
economic
impact
on
a
substantial
number
of
small
entities.

5.2
Unfunded
Mandates
Reform
Act
(
UMRA)

EPA
has
determined
that
this
SNUR
does
not
impose
any
enforceable
duty
or
contain
any
unfunded
mandate
as
described
in
the
Unfunded
Mandates
Reform
Act
of
1995
(
P.
L.
104­
4).

5.3
Paperwork
Reduction
Act
(
PRA)

According
to
the
Paperwork
Reduction
Act
(
PRA),
44
USC
3501
et
seq.,
an
agency
may
not
conduct
or
sponsor,
and
a
person
is
not
required
to
respond,
to
a
collection
of
information
that
requires
Office
of
Management
and
Budget
(
OMB)
approval
under
the
PRA,
unless
it
has
been
approved
by
OMB
and
displays
a
currently
valid
OMB
control
number.
The
information
collection
requirements
related
to
this
action
have
already
been
approved
by
OMB
pursuant
to
the
PRA
under
OMB
control
number
2070­
0012
(
EPA
ICR
No.
574).
This
action
does
not
impose
any
additional
burden
requiring
OMB
approval.

5.4
Executive
Order
12866
Executive
Order
12866,
Regulatory
Planning
and
Review,
requires
OMB
review
for
rules
with
an
impact
on
the
economy
of
$
100
million
or
more,
or
with
any
other
potential
significant
impact.
OMB
has
previously
determined
that
this
type
of
SNUR
is
not
a
"
significant
regulatory
action"
that
would
require
OMB
review
under
this
E.
O.

5.5
Executive
Order
13132
Executive
Order
13132,
Federalism
(
64
FR
43255,
August
10,
1999),
requires
EPA
to
develop
an
accountable
process
to
ensure
"
meaningful
and
timely
input
by
State
and
local
officials
in
the
development
of
regulatory
policies
that
have
federalism
implications."
This
action
does
not
have
federalism
implications
because
it
will
not
have
substantial
direct
effects
on
the
States,
on
the
relationship
between
the
national
government
and
the
States,
or
on
the
distribution
of
power
and
responsibilities
among
the
various
levels
of
government.

5.6
Executive
Order
12898
This
action
does
not
involve
special
considerations
of
environmental
justice
related
issues
as
required
by
Executive
Order
12898,
Federal
Actions
to
Address
Environmental
Justice
in
9
Minority
Populations
and
Low­
Income
Populations
(
59
FR
7629,
February
16,
1994).

5.7
Executive
Order
13045
Executive
Order
13045,
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997),
requires
EPA
to
identify
and
assess
environmental
health
and
safety
risks
that
may
disproportionately
affect
children.
This
type
of
analysis
is
required
for
rules
that
will
have
an
impact
of
$
100
million
or
more
only.
This
impact
of
this
SNUR
will
be
less
than
$
100
million
and
therefore
no
analysis
of
such
impacts
on
children
is
required.
APPENDIX
A
LIST
OF
CHEMICAL
NAMES
AND
CAS
NUMBERS
A­
1
APPENDIX
A
LIST
OF
CHEMICAL
NAMES
AND
CAS
NUMBERS
Table
A­
1
Chemical
Names
and
CAS
Numbers
Referenced
in
this
SNUR
No.
CAS
Name
1
32534­
81­
9
(
generic)
Pentabromodiphenyl
ether
2
32536­
52­
0
(
generic)
Octabromodiphenyl
ether
APPENDIX
B
INFLATORS
AND
WAGE
RATES
3
Many
Labor
hourly
rates
in
this
analysis
are
lower
than
hourly
rates
for
the
same
labor
categories
in
an
earlier
SNUR
economic
analysis
(
EPAB
1999).
EPA
does
not
mean
to
suggest
that
actual
hourly
rates
declined.
Rather,
the
apparent
decline
is
due
to
a
changed
method
of
calculating
hourly
costs
for
the
same
labor
categories.
There
were
three
changes:
(
1)
Previously
the
17%
overhead
was
applied
to
wages­
plus­
fringe
benefits.
Now
it
is
applied
only
to
wages.
(
See
Appendix
B,
footnote
3.)
This
change
reduces
calculated
overhead.
(
2)
Before,
most
wage
rates
were
based
on
older
data
and
then
inflated
to
current
dollars.
Here,
most
wage
rates
are
based
on
recent
data.
(
3)
Finally,
fringe
benefits
were
based
on
an
assumed
percent
of
wages.
Here,
private
industry
fringe
benefits
are
based
on
actual
fringe
benefits
taken
from
recent
BLS
data.

4
Employer
Costs
for
Employee
Compensation,
Private
industry
workers,
Goods­
producing
industries,
white­
collar
occupations,
as
published
by
the
U.
S.
Department
of
Labor,
Bureau
of
Labor
Statistics.
The
December
2002
values
for
these
series
are
listed
in
Table
11
of
the
Employer
Costs
for
Employee
Compensation
Summary,
released
March
18,
2003.

B­
1
APPENDIX
B
INFLATORS
AND
WAGE
RATES
This
appendix
provides
a
brief
discussion
of
the
wage
rates,
inflators,
and
methods
that
were
used
to
derive
the
final
"
fully
loaded"
wages
and
costs
of
equipment
and
supplies
used
in
the
calculation
of
the
quantified
costs
for
each
of
the
possible
options.
Base
hourly
wages
for
relevant
labor
categories
were
loaded
with
factors
for
benefits
and
overhead
to
derive
a
loaded
hourly
rate.
If
the
loaded
hourly
rate
was
not
already
in
year
2002
dollars,
it
was
then
inflated
to
year
2002
dollars
by
multiplying
by
the
appropriate
inflation
factor.
The
derivation
of
fully
loaded
wages
in
year
2002
dollars,
for
each
of
the
labor
categories
used
in
the
report,
is
discussed
in
Section
B.
1
and
is
summarized
in
Table
B.
1.
The
derivation
of
the
different
inflation
factors
used
to
inflate
wages
and/
or
costs
of
equipment
and
supplies
to
year
2002
dollars
is
discussed
in
Section
B.
2
and
is
summarized
in
Table
B.
2.

B.
1.
Derivation
of
Loaded
Wage
Rates3
B.
1.1
Technical,
Managerial,
and
Clerical
Labor
The
basic
method
used
to
derive
loaded
wage
rates
for
technical,
managerial,
and
clerical
personnel
is
described
more
fully
in
Wage
Rates
for
Economic
Analysis
of
the
Toxics
Release
Inventory
Program
(
Rice,
2002).

December
2002
average
wages
for
technical,
managerial,
and
clerical
labor
were
taken
from
the
Employer
Costs
for
Employee
Compensation
(
ECEC)
report
from
the
Bureau
of
Labor
Statistics
(
BLS)
for
all
goods­
producing,
private
industries.
4
The
additional
cost
of
benefits,
such
as
paid
leave
and
insurance
("
fringe
benefits"),
specific
to
each
labor
category,
are
also
taken
from
the
same
BLS
series.
Fringe
benefit
as
a
percentage
of
wage
is
then
calculated
separately
for
each
labor
category.
For
example,
the
average
wage
rate
in
December
2002
for
technical
labor
was
$
27.00;
the
average
fringe
benefit
was
$
11.75.
So
fringe
benefit
as
a
percentage
of
wage
rate
for
technical
labor
was
11.75/
27.00,
or
approximately
43.5%.
5An
overhead
rate
of
17
percent
applied
to
wages
is
used
for
consistency
with
recent
EPAB
economic
analyses
for
two
major
rulemakings:
Wage
Rates
for
Economic
Analyses
of
the
Toxics
Release
Inventory
Program,
June
10,
2002,
and
the
Revised
Economic
Analysis
for
the
Amended
Inventory
Update
Rule:
Final
Report,
August
200
2.
In
reports
for
an
earlier
SNUR
(
EPAB
1999),
the
17%
was
applied
to
wages­
plus­
fringe
benefits.
Applying
it
only
to
wages
reduces
calculated
overhead.

B­
2
An
additional
loading
factor
of
17
percent
is
applied
to
wages
for
overhead.
5
This
overhead
loading
factor
is
added
to
the
benefits
loading
factor,
and
the
total
is
then
applied
to
the
base
wage
to
derive
the
fully
loaded
wage.
The
fully
loaded
wage
for
technical
labor,
for
example,
is
$
27.00*(
1+
0.435
+
0.17)
=
$
27.00*(
1.605)
=
$
43.34.

Fully
loaded
costs
for
managerial
and
clerical
labor
were
calculated
in
a
similar
manner.

B.
1.2
Production
Workers
For
production
workers,
the
wages
are
specific
to
the
chemical
industry,
but
the
fringe
benefits
factor
comes
from
a
different
BLS
series
and
is
for
blue
collar
workers
in
general.
The
December
2002
wage
for
production
workers,
taken
from
the
National
Employment,
Hours,
and
Earnings,
Average
Hourly
Earnings
of
Production
Workers
(
BLS,
2003c),
is
$
19.44.
Fringe
benefits
as
a
percentage
of
wage
in
December
2002
was
calculated
from
the
Employer
Costs
for
Employee
Compensation
­
December
2002:
Private
industry,
goods­
producing
workers
by
occupational
group
(
BLS
2003d),
by
dividing
total
benefits
for
blue­
collar
occupations
in
December
2002
($
7.37)
by
the
corresponding
December
2002
average
wage
among
blue­
collar
occupations
($
15.39).
The
result
is
47.9
percent.

As
with
other
labor
categories,
an
additional
loading
factor
of
17
percent
of
wages
was
applied
for
overhead.
The
loaded
wage
for
production
workers
was
thus
calculated
as
$
19.44*(
1
+
0.479
+
0.17)
=
$
19.44*(
1.649)
=
$
32.06.

B.
1.3
Industrial
Hygienists
For
the
wage
rate
for
Industrial
Hygienists
we
used
the
hourly
mean
wage
for
occupational
health
and
safety
specialists
and
technicians
(
BLS
SOC
29­
9010)
in
the
resin,
rubber,
and
artificial
fibers
manufacturing
industry
(
BLS
2004),
which
is
$
31.72
(
in
year
2002
dollars).
We
used
this,
rather
than
the
mean
or
median
wage
for
the
entire
SOC
29­
9010
because
it
appears
that
the
overall
mean
and
median
are
substantially
lower
due
to
lower
wages
paid
by
state
and
local
governments
and
hospitals,
compared
with
wages
paid
by
industry.
Because
state
and
local
governments
and
hospitals
employ
substantially
more
people
in
this
employment
category
than
industry,
the
overall
mean
hourly
wage
($
22.85)
and
median
hourly
wage
($
22.12)
are
substantially
lower
than
the
mean
hourly
wage
of
$
31.72
paid
by
the
resin,
rubber,
and
artificial
fibers
manufacturing
industry.
The
fringe
benefits
factor
came
from
recent
BLS
data
and
is
generic
to
professional
occupations.

Fringe
benefits
as
a
percentage
of
wages
in
December
2002
was
taken
from
Employee
6Calculations
are
based
on
unrounded
values,
so
the
total
may
not
equal
the
product
of
the
rounded
factors.

B­
3
Compensation
­
December
2002:
Private
industry,
goods­
producing
workers
by
occupational
group(
BLS
2003d),
by
dividing
total
benefits
for
professional
specialty
and
technical
occupations
in
December
2002
($
11.75)
by
the
corresponding
December
2002
average
wage
among
professional
specialty
and
technical
occupations
($
27.00).
The
result
is
43.5
percent.

An
additional
loading
factor
of
17
percent
of
wages
was
applied
for
overhead.
The
loaded
wage
for
industrial
hygienists
in
2002
dollars
was
thus
calculated
as
$
31.72*(
1
+
0.435
+
0.17)
=
$
31.72*(
1.605)
=
$
50.92.
Because
this
was
already
in
year
2002
dollars,
it
was
not
inflated
any
further.
6
B.
1.4
EPA
Staff
FTE
The
annual
salary
for
EPA
staff
used
for
calculations
of
Agency
costs
is
an
average
of
the
Office
of
Personnel
Management
(
OPM)
year
2002
annual
salaries
for
GS­
12
Steps
1
and
10
 
$
55,694
and
$
72,400,
respectively,
or
$
64,047.
Multiplying
by
an
assumed
loading
factor
of
1.6
to
reflect
fringe
benefits
and
overhead
(
OPPE
1992),
the
loaded
annual
salary
of
EPA
staff
was
calculated
to
be
$
102,475.
B­
4
Table
B­
1
Derivation
of
Loaded
Wage
Rates
Labor
Category
Data
Sources
Uninflated
wages
and
fringes
/
hour
Fringe
benefits
as
%
of
wage
Overhead
as
%
of
wage*
Fringe
+
Overhead
factor
Loaded
Wage
Rate
before
inflation
Inflation
factor
Loaded
Wage
Rate
(
2002
dollars)
Date
Wages
$
Fringe
benefits
$

Technical
BLS
Employer
Costs
for
Employee
Compensation,
Table
11.
Private
industry,
goods­
producing
industries,
Profess.
specialty
&
technical.
Dec
02.
[
BLS
2003d]
Dec
2002
$
27.00
$
11.75
43.5%
17%
1.605
$
43.34
1
$
43.34
Managerial
BLS
Employer
Costs
for
Employee
Compensation,
Table
11.
Private
industry,
goods­
producing
industries,
Exec,
admin,
&
managerial.
Dec
02.
[
BLS
2003d]
Dec
2002
$
33.09
$
14.57
44.0%
17%
1.610
$
53.29
1
$
53.29
Clerical
BLS
Employer
Costs
for
Employee
Compensation,
Table
11.
Private
industry,
goods­
producing
industries,
Admin
support,
incl.
clerica
l.
Dec
02.
[
BLS
2003d]
Dec
2002
$
14.89
$
6.54
43.9%
17%
1.609
$
23.96
1
$
23.96
Production
worker
Wage:
BLS
Natl
Em
pl,
Hrs,
and
Earnings:
Aver
Hourly
Earnings
of
Production
Workers,
Chem
&
Allied
Prod,
`
Annual'
(
EEU32280006)
[
BLS
2003c]

Fringes
%:
BLS
Employer
Costs
for
Employee
Compensation,
Table
11.
Private/
goods­
producing
industries,
bluecollar
occupations.
Dec
02.
[
BLS
2003d]
Dec
2002
$
19.44
­
47.89%
17%
1.6489
$
32.05
1
$
32.05
Labor
Category
Data
Sources
Uninflated
wages
and
fringes
/
hour
Fringe
benefits
as
%
of
wage
Overhead
as
%
of
wage*
Fringe
+
Overhead
factor
Loaded
Wage
Rate
before
inflation
Inflation
factor
Loaded
Wage
Rate
(
2002
dollars)
Date
Wages
$
Fringe
benefits
$

B­
5
Industrial
hygienist
Wages:
BLS
Occupational
Employment
and
Wages,
2002,
SOC
29­
9010,
Resin,
rubber,
and
artificial
fibers
mfg.
industry
[
BLS
2004]

Fringes
%:
BLS
Employer
Costs
for
Employee
Compensation,
Table
11.
Private/
goods­
producing,
Professional
specialty
&
techn,
Dec
02.
[
BLS
2003d]

Inflation:
BLS
ECI,
White
Collar
Occupations,
Series
ECS11102I,
Fourth
Q
(
see
Table
B­
2)
[
BLS
2003a]
2002
$
31.72
­
43.5%
17%
1.605
$
50.92
1
$
50.92
EPA
staff
FTE
Office
of
Personnel
Management
(
OPM)
pay
rates
for
GS­
12
Steps
1
and
10
for
2002.
[
OPM
2003]
(
Average
of
$
55,694
and
$
72,400)
2002
$
64,047
per
year
­
­
­
1.6
$
102,475
per
year
1
$
102,475
per
year
*
An
overhead
rate
of
17
percent
applied
to
wages
is
used
for
consistency
with
recent
EPAB
economic
analyses
for
two
major
rulemakings:
Wage
Rates
for
Economic
Analyses
of
the
Toxics
Release
Inventory
Program,
June
10,
2002,
and
the
Revised
Economic
Analysis
for
the
Amended
Inventory
Update
Rule:
Final
Report,
August
2002.

Note:
Calculations
are
based
on
unrounded
values,
so
the
total
may
not
equal
the
product
of
the
rounded
factors.
B­
6
B.
2.
Derivation
of
Inflation
Factors
In
general,
costs
of
equipment
and
supplies
were
inflated
to
year
2002
dollars
using
the
Consumer
Price
Index
 
All
Urban
Consumers
(
not
seasonally
adjusted);
wages
were
inflated
using
the
appropriate
Employment
Cost
Index
(
ECI),
seasonally
adjusted.
In
those
cases
in
which
both
labor
and
equipment
and
supplies
were
involved
(
e.
g.,
test
costs),
we
used
the
inflator
corresponding
to
the
dominant
cost
category.
For
example,
test
costs
are
presumably
based
on
a
mix
of
labor
categories
and
include
the
costs
of
equipment
and
supplies.
Assuming
that
the
largest
component
of
test
costs
comes
from
labor,
we
used
the
ECI
for
private
industry,
all
workers.
Complete
information
on
the
derivation
of
the
inflation
factors
used
is
given
in
Table
B­
2
below.

Table
B­
2
Derivation
of
Inflation
Factors
Report
section
Item
Inflator
data
source
Starting
year
Inflator
for
starting
year
(
A)
Inflator
for
2002
(
B)
Inflation
factor
(
B)
/
(
A)

Chapter
3
Export
notification
BLS
Employ.
Cost
Index,
Seas.
Adj.,
White
Collar
Occupations
Series
ECS11102I,
Fourth
Q
1992
116.1
165.6
1.426
Appendix
C
Test
cost
BLS
Empl.
Cost
Index,
Seasonally
Adj,
Private
industry,
All
workers
(
Series
ID:
ECS10002I)
December
[
Published
Jan
2003]
varies
varies
162.5
varies*

Ex.
for
test
costed
out
in
1993
1993
119.9
162.5
1.355
Ex.
for
test
costed
out
in
2000
2000
151.1
162.5
1.075
Appendix
E
Agency
Extramural
costs
BLS
Employ.
Cost
Index,
Seas.
Adj.,
White
Collar
Occupations
Series
ECS11102I,
Fourth
Q
1993
120.4
165.6
1.375
*
Test
costs
were
first
estimated
in
different
years,
depending
on
the
test,
so
that
inflation
factors
vary
depending
on
when
the
test
was
costed
out.
APPENDIX
C
COSTS
OF
TESTING
C­
1
APPENDIX
C
COSTS
OF
TESTING
This
appendix
presents
detailed
information
on
the
costs
of
tests
within
each
of
several
categories
of
health
and
environmental
effects
endpoints
identified
for
the
two
chemicals
subject
to
the
current
SNUR.
The
SNUR
identifies
the
toxicological
endpoints
of
concern
for
pentaBDE
or
octaBDE
as
likely
to
include
endocrine
disruption
(
especially
the
thyroid),
neurodevelopmental
toxicity,
developmental
and
reproductive
toxicity,
cancer,
avian
reproduction,
effects
in
the
aquatic
or
terrestrial
food
chains,
and
cancer,
and
that
more
needs
to
be
understood
about
the
environmental
fate
and
the
exposure
pathways
that
lead
to
PBDE
presence
in
wildlife
and
people.
Tables
C­
1
through
C­
4
contain
information
on
those
tests
that
fall
within
the
categories
of
developmental
neurotoxicity,
developmental
toxicity,
reproductive
toxicity,
and
developmental
effects
in
fish,
respectively.
No
information
was
available
for
tests
in
the
categories
of
endocrine
disruption
and
reproductive
effects
in
fish.

Testing
Guidelines
For
some
or
all
chemicals
in
a
SNUR,
EPA
identifies
tests
that
can
be
used
by
submitters
to
characterize
risks
of
the
substances.
The
tests
are
recommended
in
the
SNUR,
not
mandatory,
and
they
are
usually
identified
by
guideline
numbers
which
can
be
used
to
look
up
published
test
protocols.
The
types
of
guidelines
are
described
below.

°
OPPTS
Harmonized.
Most
SNUR
tests
are
identified
by
their
OPPTS
number
from
the
series
of
OPPTS
Harmonized
Test
Guidelines
and
OPPTS
harmonized
public
drafts
not
yet
promulgated
as
OPPTS
guidelines.
For
example,
the
OPPTS
835
series
covers
Fate,
Transport
and
Transformation;
the
850
series
covers
Ecological
Effects,
and
the
870
series
covers
Health
Effects.
An
example
is
OPPTS
Guideline
850.1400,
Fish
Early
Life
Stage
Toxicity.
These
guidelines
may
have
equivalent
Code
of
Federal
Regulations
(
CFR)
or
Organization
for
Economic
Cooperation
and
Development
(
OECD)
guidelines.
They
are
available
electronically
on
EPA's
website.

°
CFR.
A
few
SNUR
tests
are
identified
as
coming
from
the
Code
of
Federal
Regulations.
An
example
is
the
two­
year
bioassay
test
at
40
CFR
799.9420.
These
CFR
guidelines
may
have
equivalent
OPPTS
harmonized
guidelines,
but
are
listed
in
the
SNUR
by
their
CFR
reference.

°
OECD.
A
few
SNUR
tests
are
identified
by
their
OECD
number.
The
OECD
guidelines
may
also
have
OPPTS
equivalents.
For
example,
OECD
407
28­
Day
Oral
Toxicity
in
Rats
is
essentially
equivalent
to
OPPTS
870.3050.

°
PBT
Category.
Finally,
for
some
chemicals,
the
SNUR
cites
tiered
testing
according
to
a
testing
strategy
published
in
the
Federal
Register
(
FR),
Category
for
Persistant,
C­
2
Bioaccumulative,
and
Toxic
New
Chemical
Substances,
November
4,
1999
(
64
FR
60194),
which
in
turn
refers
to
a
number
of
tests
by
OPPTS
or
OECD
guideline
number.

Testing
Costs
Information
on
those
tests
that
fall
within
each
of
the
test
categories
specified
in
the
SNUR
for
which
we
have
information
is
given
in
Tables
C1
­
C4.
This
information
includes
the
test
ID,
a
brief
description
of
the
test,
the
species
and
method
(
route)
used,
and
the
cost
and
hour
burden
of
testing.
The
costs
are
from
the
TSCA
Test
Guideline
Cost
Estimates
(
EPAB
2003)
and
are
in
year
2002
dollars.

Table
C­
1.
Developmental
Neurotoxicity
Tests
TestID
Description
Species
Method
Cost
HoursBurden
795.2500
Developmental
Neurotoxicity
Screen
Rats
dermal
$
239,490.44
2,736
795.2500
Developmental
Neurotoxicity
Screen
Rats
dietary
$
242,097.71
2,655
795.2500
Developmental
Neurotoxicity
Screen
Rats
gavage
$
188,021.08
2,195
795.2500
Developmental
Neurotoxicity
Screen
Rats
inhalation
$
336,838.85
3,098
799.
XXX
Developmental
Neurotoxicity
Study
Rats
dietary
$
233,076.92
2,291
799.
XXX
Developmental
Neurotoxicity
Study
Rats
gavage
$
234,314.90
2,312
870.6300
Developmental
Neurotoxicity
Study
Rats
gavage
$
181,263.40
1,788
870.6300
Developmental
Neurotoxicity
Study
Rats
dietary
$
180,205.78
1,771
Test
equivalents:
870.6300;
none;
OPP
83­
6;
OECD
none;
EPA
Pub
96­
239
Table
C­
2.
Developmental
Toxicity
Tests
TestID
Description
Species
Method
Cost
HoursBurden
798.4900
Developmental
Toxicity
{
2
species}
Hamsters
dermal
$
86,114.48
1,030
798.4900
Developmental
Toxicity
{
2
species}
Hamsters
dietary
$
83,984.63
993
798.4900
Developmental
Toxicity
{
2
species}
Hamsters
drinking
water
$
85,141.59
1,013
798.4900
Developmental
Toxicity
{
2
species}
Hamsters
gavage
$
85,036.41
1,011
798.4900
Developmental
Toxicity
{
2
species}
Hamsters
inhalation
$
94,042.27
1,140
798.4900
Developmental
Toxicity
{
2
species}
Mice
dermal
$
82,420.11
1,030
798.4900
Developmental
Toxicity
{
2
species}
Mice
dietary
$
80,290.25
993
798.4900
Developmental
Toxicity
{
2
species}
Mice
drinking
water
$
81,447.21
1,013
798.4900
Developmental
Toxicity
{
2
species}
Mice
gavage
$
81,342.03
1,011
798.4900
Developmental
Toxicity
{
2
species}
Mice
inhalation
$
90,347.90
1,140
798.4900
Developmental
Toxicity
{
2
species}
Rabbits
dermal
$
98,104.77
1,184
798.4900
Developmental
Toxicity
{
2
species}
Rabbits
dietary
$
95,948.62
1,144
798.4900
Developmental
Toxicity
{
2
species}
Rabbits
drinking
water
$
97,500.00
1,174
798.4900
Developmental
Toxicity
{
2
species}
Rabbits
gavage
$
97,447.41
1,173
798.4900
Developmental
Toxicity
{
2
species}
Rabbits
inhalation
$
106,716.22
1,307
798.4900
Developmental
Toxicity
{
2
species}
Rats
dermal
$
85,536.00
1,042
798.4900
Developmental
Toxicity
{
2
species}
Rats
dietary
$
83,761.12
1,010
798.4900
Developmental
Toxicity
{
2
species}
Rats
drinking
water
$
84,720.87
1,028
798.4900
Developmental
Toxicity
{
2
species}
Rats
gavage
$
84,668.28
1,027
798.4900
Developmental
Toxicity
{
2
species}
Rats
inhalation
$
93,726.74
1,157
OECD
414
Developmental
Toxicity
{
2
species}
Rabbits
gavage
$
75,084.27
760
OECD
414
Developmental
Toxicity
{
2
species}
Rats
gavage
$
65,772.47
706
Test
equivalents:
870.3700;
798.4900;
OPP
83­
3;
OECD
414;
EPA
Pub
96­
207
C­
3
Table
C­
3.
Reproductive
Toxicity
Tests
TestID
Description
Species
Method
Cost
HoursBurden
OECD
415
One­
Generation
Reproduction
Toxicity
Study
Rats
gavage
$
261,322.12
2,951
OECD
415
One­
Generation
Reproduction
Toxicity
Study
Mice
dietary
$
208,750.00
2,275
OECD
415
One­
Generation
Reproduction
Toxicity
Study
Mice
gavage
$
220,685.10
2,433
OECD
415
One­
Generation
Reproduction
Toxicity
Study
Rats
dietary
$
239,927.88
2,636
OECD
416
Two­
Generation
Reproduction
Toxicity
Study
Rats
dietary
$
339,076.36
3,396
OECD
416
Two­
Generation
Reproduction
Toxicity
Study
Mice
dietary
$
302,996.24
3,068
OECD
421
Reproduction/
Deveopmental
Toxicity
Screening
Test
Rats
gavage
$
51,875.00
445
798.4700
Reproduction/
Fertility
Effects
(
2­
Generation
Reproduction)
Rats
gavage
$
395,595.94
3,920
798.4700
Reproduction/
Fertility
Effects
(
2­
Generation
Reproduction)
Mice
dermal
$
411,403.92
4,506
798.4700
Reproduction/
Fertility
Effects
(
2­
Generation
Reproduction)
Mice
dietary
$
361,759.56
3,468
798.4700
Reproduction/
Fertility
Effects
(
2­
Generation
Reproduction)
Mice
drinking
water
$
363,245.10
3,495
798.4700
Reproduction/
Fertility
Effects
(
2­
Generation
Reproduction)
Mice
gavage
$
381,117.07
3,779
798.4700
Reproduction/
Fertility
Effects
(
2­
Generation
Reproduction)
Mice
inhalation
$
646,270.99
6,517
798.4700
Reproduction/
Fertility
Effects
(
2­
Generation
Reproduction)
Rats
capsule
$
0.00
0
798.4700
Reproduction/
Fertility
Effects
(
2­
Generation
Reproduction)
Rats
dermal
$
431,579.99
4,659
798.4700
Reproduction/
Fertility
Effects
(
2­
Generation
Reproduction)
Rats
drinking
water
$
383,421.18
3,648
798.4700
Reproduction/
Fertility
Effects
(
2­
Generation
Reproduction)
Rats
inhalation
$
684,343.97
6,643
798.4700
Reproduction/
Fertility
Effects
(
2­
Generation
Reproduction)
Rats
dietary
$
380,495.57
3,595
798.4700
(
mod)
Reproduction/
Fertility
Effects
(
2­
Generation
Reproduction)
(
w/
weights
of
all
reproductive
organs
of
P0
and
F1
male
animals)
Rats
inhalation
$
755,153.04
7,050
C­
4
799.9380
Reproduction/
Fertility
Effects
(
870.3800)
Rats
gavage
$
462,113.73
4,666
799.9380
Reproduction
and
Fertility
Effects
Rats
inhalation
$
890,156.25
9,449
870.3800
Reproduction/
Fertility
Effects
(
2­
Generation
Reproduction)
Rats
aerosol
$
698,186.56
7,624
870.3800
Reproduction/
Fertility
Effects
(
2­
Generation
Reproduction)
Rats
dietary
$
397,950.80
4,095
870.3800
Reproduction/
Fertility
Effects
(
2­
Generation
Reproduction)
Rats
gavage
$
529,717.65
5,024
870.3800
Reproduction/
Fertility
Effects
(
2­
Generation
Reproduction)
Rats
inhalation
$
715,262.95
7,600
Test
equivalents:
870.3800;
798.4700;
OPP
83­
4;
OECD
416;
EPA
Pub
96­
208
Table
C­
4.
Tests
on
Developmental
Effects
in
Fish
TestID
Description
Species
Method
Cost
HoursBurden
797.1600
Fish
Early
Life
Stage
Toxicity
Rainbow
Trout
flow­
through
$
60,225.05
386
797.1600
Fish
Early
Life
Stage
Toxicity
Brook
Trout
flow­
through
$
60,225.05
386
797.1600
Fish
Early
Life
Stage
Toxicity
Sheepshead
Minnow
flow­
through
$
45,172.57
302
797.1600
Fish
Early
Life
Stage
Toxicity
Fathead
Minnow
flow­
through
$
36,426.07
221
850.1400
Fish
Early
Life
Stage
Toxicity
Rainbow
Trout
semi­
static
$
72,512.02
504
850.1400
Fish
Early
Life
Stage
Toxicity
Sheepshead
Minnow
semi­
static
$
46,947.12
335
850.1400
Fish
Early
Life
Stage
Toxicity
Rainbow
Trout
flow­
through
$
52,560.10
432
850.1400
Fish
Early
Life
Stage
Toxicity
Sheepshead
Minnow
flow­
through
$
35,024.04
298
850.1400
Fish
Early
Life
Stage
Toxicity
Fathead
Minnow
semi­
static
$
46,406.25
328
850.1400
Fish
Early
Life
Stage
Toxicity
Fathead
Minnow
flow­
through
$
34,483.17
291
Test
equivalents:
850.1400;
797.1000;
OPP
72­
4;
OECD
210;
EPA
Pub
96­
121
APPENDIX
D
COSTS
OF
SUBMITTING
A
SNUN
7In
the
economic
analysis
for
an
earlier
SNUR
(
EPAB
1999),
EPA
estimated
SNUN
submission
costs
(
before
user
fee)
at
$
6005
to
$
7240
(
95
to
114
hours),
compared
with
$
4456
for
105
hours
here.
This
is
not
meant
to
suggest
that
actual
costs
declined.
Rather,
the
apparent
decline
is
due
to
a
revised
method
for
calculating
labor
rates.
The
method
was
revised
to
use
more
current
data
and
to
be
consistent
with
recent
EPAB
economic
analyses.
See
Appendix
B
for
details.
APPENDIX
D
COSTS
OF
SUBMITTING
A
SNUN
Estimates
of
the
costs
of
completing
a
SNUN
form
are
based
on
the
costs
of
completing
a
PMN
submission,
since
the
data
requirements
and
the
submission
form
are
essentially
identical.
EPA's
Regulatory
Impact
Analysis
(
RIA)
for
amendments
to
the
PMN
regulations
(
RIB
1994)
relied
on
industry
estimates
of
the
effort
needed
to
collect
and
compile
all
data
required
for
a
PMN
submission,
prepare
the
form,
and
submit
the
form
and
data
to
EPA
(
RIB
1994).
These
estimates,
based
on
a
survey
conducted
by
the
Chemical
Manufacturers
Association
(
CMA
1991),
indicate
that
the
average
effort
required
to
prepare
and
submit
a
PMN
is
95
to
114
hours.
For
this
analysis,
the
costs
of
a
preparing
a
SNUN
were
derived
using
the
2002
loaded
wage
rates
and
average
of
the
hours
for
clerical,
technical,
and
managerial
labor.
Wage
rate
derivations
are
discussed
in
Appendix
B.
As
shown
in
Table
D­
1,
the
resulting
cost
of
submitting
a
SNUN
is
$
6,956,
including
a
$
2500
user
fee.
7
Table
D­
1
Industry
Costs
for
SNUN
Labor
Category
Hours
Range*
Average
Hours
Loaded
Wage
Rate**
(
2002
dollars)
Total
Labor
Cost
(
loaded
wage
×
hours)

Clerical
12
­
14
13.0
$
23.96
$
311
Technical
67­
80
73.5
$
43.34
$
3,185
Managerial
16
­
20
18.0
$
53.29
$
959
Subtotal
95
­
114
104.5
$
4,456
User
fees
$
2,500
TOTAL
$
6,956
Figures
may
not
add
due
to
rounding.
*
Hours
range
for
each
labor
category
are
from
the
PMN
Amendments
RIA
(
RIB
1994)
**
Loaded
wages
include
fringe
benefits
and
overhead.
See
Appendix
B
for
derivation.
APPENDIX
E
AGENCY
COSTS
E­
1
APPENDIX
E
AGENCY
COSTS
EPA's
costs
to
review
and
process
industry
submissions
(
SNUNs,
requests
to
modify
SNUR,
and
requests
for
equivalency
determination)
are
assumed
to
be
the
same
as
EPA
costs
to
review
PMNs.
EPA's
costs
associated
with
SNUR
submissions
are
presented
in
Table
F­
1.
The
EPA
staff
level
(
GS­
12),
staff­
year
full­
time
equivalents
(
FTEs)
and
extramural
costs
such
as
costs
for
contractor
support
are
derived
from
the
costs
estimated
for
processing
PMN
submissions
(
RIB
1994).
The
percent
of
cases
are
from
RIB
1994
and
from
an
1999
SNUR
economic
analysis
(
EPAB
1999).
FTE
costs
have
been
calculated
using
2002
GS­
12
salary
data
(
OPM
2002)
and
a
loading
factor
of
1.6
to
reflect
fringe
benefits
and
overhead
(
OPPE
1992).

The
original
PMN
cost
estimates
were
presented
as
low
and
high
estimates,
based
on
the
most
junior
(
Step
1)
and
the
most
senior
(
Step
10)
GS­
12
pay
rates,
respectively.
For
simplicity,
this
analysis
uses
the
average
of
the
two
pay
rates.

The
GS­
12
costs
in
the
table
below
are
calculated
by
multiplying
the
number
of
FTEs
(
in
the
first
column)
by
the
fully
loaded
average
salary,
$
102,475.
This
shows
EPA
staff
cost
for
those
chemicals
requiring
this
review
step.
The
Extramural
Cost
column
shows
costs
for
contractor
support
and
other
outside
purchases
for
those
chemicals
requiring
this
review
step,
inflated
from
1993
prices
to
2002
using
the
Employment
Cost
Index,
Total
Compensation
for
White­
Collar
Occupations
(
BLS
2003a).
The
Weighted
Cost
column
is
calculated
by
multiplying
GS­
12
staff
cost
plus
extramural
costs
(
Unweighted
Cost)
by
the
percentage
of
cases
requiring
this
review
step.
This
calculation
yields
total
Agency
costs
for
submission
review
and
processing
of
$
4,034
per
case.
Table
E­
1
Agency
Costs
for
SNUN
and
Other
Submission
Review
and
Processing
Review
Step
EPA
FTE
EPA
staff
(
GS­
12)
(
a)
Extra­
mural
Cost
Unweighted
Cost
Pct.
of
Cases
Weighted
Cost
1993
dollars
2002
dollars
(
b)

(
1)
(
2)
(
3)
(
4)
(
5)=(
2)+(
4)
(
6)
(
7)=(
5)*(
6)

Prenotice
consultation
0.0024
$
245.94
4
$
5.52
$
251.46
41%
$
103.10
Administrative
prescreen/
notice
receipt/
user
fee
0.0024
$
245.94
92
$
126.96
$
372.90
100%
$
372.90
CRSS
(
Chemical
Review
and
Search
Strategy)
0.0025
$
256.19
268
$
369.84
$
626.03
100%
$
626.03
SAT
(
Structure
Activity
Team)
0.0006
$
61.49
14
$
19.32
$
80.81
100%
$
80.81
Engineering/
Exposure
0.0015
$
153.71
56
$
77.28
$
230.99
100%
$
230.99
Exposure/
Fate
0.0008
$
81.98
0
$
0.00
$
81.98
100%
$
81.98
Focus
0.0009
$
92.23
23
$
31.74
$
123.97
100%
$
123.97
Standard
Review
Functions
0.0219
$
2,244.21
511
$
705.18
$
2,949.39
29%
$
855.32
Division
Directors
Meeting
0.0129
$
1,321.93
113
$
155.94
$
1,477.87
15%
$
221.68
Order
Development/
Negotiation
Review
0.0171
$
1,752.33
22
$
30.36
$
1,782.69
3%
$
53.48
Post
Order
Data
Review
0.0886
$
9,079.30
0
$
0.00
$
9,079.30
3%
$
272.38
Order
Modification
0.2167
$
22,206.38
0
$
0.00
$
22,206.38
3%
$
666.19
New
Chemical
SNUR
Development
0.0277
$
2,838.56
85
$
117.30
$
2,955.86
7%
$
206.91
Notices
of
Commencement
0.0012
$
122.97
40
$
55.20
$
178.17
31%
$
55.23
FOIA
(
Freedom
of
Information
Act)
Requests
0.0333
$
3,412.42
287
$
396.06
$
3,808.48
1%
$
38.08
CBI
(
Confidential
Business
Information)
Substantiation
0.0004
$
40.99
3
$
4.14
$
45.13
100%
$
45.13
TOTAL
$
4,034
Sources:
FTEs
per
review
step
and
1993
extramural
costs
are
from
RIB
1994.
Percents
of
cases
are
from
RIB
1994
and
EPAB
1999.
GS­
12
salaries
are
from
OPM
2002.
(
a)
The
average
of
GS­
12
Step
1
and
G
S­
12
Step
10
salaries
for
2002
was
($
55,694
+
$
72,400)
/
2
=
$
64,047.
T
his
was
multiplied
by
an
assumed
loading
factor
of
1.6
to
reflect
fringe
benefits
and
overhead,
resulting
in
a
fully
loaded
cost
per
FTE
of
1.6
X
$
64,047
=
$
102.475.
(
b)
Extramural
costs
consist
of
contracting
support
and
other
purchases
directly
attributable
to
the
PMN
review
process.
They
were
inflated
from
1993
prices
to
2002
prices
using
a
factor
of
approximately
1.38
(
see
Appendix
B).
APPENDIX
F
REFERENCES
F­
1
APPENDIX
F
REFERENCES
29
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htm#
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