6560­
50­
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
63
[
EPA­
HQ­
OAR­
2003­
0161,
FRL­
]

RIN
2060­
AK23
National
Emission
Standards
for
Magnetic
Tape
Manufacturing
Operations
AGENCY:
Environmental
Protection
Agency
(
EPA).

ACTION:
Final
action.

SUMMARY:
On
December
15,
1994,
we
promulgated
national
emission
standards
for
hazardous
air
pollutants
for
Magnetic
Tape
Manufacturing
Operations.
The
standards
limit
and
control
emissions
of
hazardous
air
pollutants
that
are
known
or
suspected
to
cause
cancer
or
have
other
serious
health
or
environmental
effect.

Section
112(
f)(
2)
of
the
Clean
Air
Act
directs
EPA
to
assess
the
risk
remaining
(
residual
risk)
after
the
application
of
national
emission
standards
for
hazardous
air
pollutants
controls
and
to
promulgate
more
stringent
standards,
if
necessary,
to
protect
public
health
with
an
ample
margin
of
safety
and
to
prevent
adverse
environmental
effects.
Also,
section
112(
d)(
6)
of
the
Clean
Air
Act
requires
EPA
to
review
and
revise
the
national
emission
standard
for
hazardous
air
pollutants,
as
necessary,
taking
into
account
developments
in
practices,
processes,
and
2
control
technologies.
On
October
24,
2005,
based
on
the
findings
from
our
residual
risk
and
technology
review,
we
proposed
no
further
action
to
revise
the
national
emission
standards
for
hazardous
air
pollutants
and
requested
public
comment.
Today's
final
action
responds
to
public
comments
received
on
the
proposed
action
and
announces
EPA's
final
decision
not
to
revise
the
standards.

DATES:
This
final
action
is
effective
on
[
INSERT
DATE
OF
PUBLICATION
OF
THE
FINAL
ACTION
IN
THE
FEDERAL
REGISTER].

ADDRESSES:
The
EPA
has
established
a
docket
for
this
action
under
Docket
ID
No.
EPA­
HQ­
OAR­
2003­
0161.
All
documents
in
the
docket
are
listed
on
the
www.
regulations.
gov
web
site.

Although
listed
in
the
index,
some
information
is
not
publicly
available,
i.
e.,
confidential
business
information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
Certain
other
material,
such
as
copyrighted
material,
is
not
placed
on
the
Internet
and
will
be
publicly
available
only
in
hard
copy
form.
Publicly
available
docket
materials
are
available
either
electronically
through
www.
regulations.
gov
or
in
hard
copy
at
the
HQ
EPA
Docket
Center,
Docket
ID
No.
EPA­
HQ­
OAR­
2003­
0161,
EPA
West
Building,
Room
B102,
1301
Constitution
Avenue,
NW,

Washington,
DC.
The
Public
Reading
Room
is
open
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Public
Reading
Room
3
is
(
202)
566­
1744,
and
the
telephone
number
for
the
HQ
EPA
Docket
Center
is
(
202)
566­
1742.
A
reasonable
fee
may
be
charged
for
copying
docket
materials.
FOR
FURTHER
INFORMATION
CONTACT:
For
questions
about
the
final
action,

contact
Mr.
H.
Lynn
Dail,
U.
S.
EPA,
Office
of
Air
Quality
Planning
and
Standards,
Sector
Policies
and
Programs
Division,
Natural
Resources
and
Commerce
Group
(
C539­
03),

Research
Triangle
Park,
North
Carolina
27711;
telephone
number:
(
919)
541­
2363;
fax
number:
(
919)
541­
5689;
e­
mail
address:
dail.
lynn@
epa.
gov.
For
questions
on
the
residual
risk
analysis,
contact
Ms.
Maria
Pimentel,
U.
S.
EPA,
Office
of
Air
Quality
Planning
and
Standards,
Health
and
Environmental
Impacts
Division,
Sector
Based
Assessment
Group
(
C404­
01),
Research
Triangle
Park,
North
Carolina
27711;
telephone
number:
(
919)
541­
5280;
fax
number:
(
919)

541­
0840;
e­
mail
address:
pimentel.
maria@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

Regulated
Entities.
The
regulated
categories
and
entities
affected
by
the
national
emission
standards
for
hazardous
air
pollutants
(
NESHAP)
include:

Category
NAICS
a
Code
Examples
of
Regulated
Entities
Industry
334613
322222
325992
Operations
at
major
sources
that
are
engaged
in
the
surface
coating
of
magnetic
tape.
Federal
government
Not
affected.
State,
local,
tribal
government
Not
affected.
4
a
North
American
Industry
Classification
System.

This
table
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
the
Magnetic
Tape
NESHAP.
To
determine
whether
your
facility
would
be
affected
by
the
Magnetic
Tape
NESHAP,

you
should
examine
the
applicability
criteria
in
40
CFR
Part
63.701(
a)
of
subpart
EE
(
NESHAP
for
Magnetic
Tape
Manufacturing
Operations).
If
you
have
any
questions
regarding
the
applicability
of
the
Magnetic
Tape
NESHAP
to
a
particular
entity,
contact
Mr.
Leonard
Lazarus,
U.
S.
EPA,

Office
of
Enforcement
and
Compliance
Assurance,
Office
of
Compliance,
Air
Compliance
Branch
(
2223A),
Ariel
Rios
Building,
1200
Pennsylvania
Avenue,
NW,
Washington,
DC
20460;
telephone
number:
(
202)
564­
6369;
fax
number:
(
202)

564­
0050;
e­
mail
address:
lazarus.
leonard@
epa.
gov.

World
Wide
Web
(
WWW).
In
addition
to
being
available
in
the
docket,
an
electronic
copy
of
today's
final
action
will
also
be
available
on
the
World
Wide
Web
through
the
Technology
Transfer
Network
(
TTN).
Following
signature,
a
copy
of
the
final
action
will
be
posted
on
the
TTN's
policy
and
guidance
page
for
newly
proposed
or
promulgated
rules
at
the
following
address:
www.
epa.
gov/
ttn/
oarpg.
The
TTN
provides
information
and
technology
exchange
in
various
areas
of
air
pollution
control.

Judicial
Review.
Under
section
307(
b)(
1)
of
the
CAA,
5
judicial
review
of
this
final
decision
is
available
only
by
filing
a
petition
for
review
in
the
United
States
Court
of
Appeals
for
the
District
of
Columbia
Circuit
by
[
INSERT
DATE
60
DAYS
AFTER
DATE
OF
PUBLICATION
OF
THE
FINAL
RULE
IN
THE
FEDERAL
REGISTER].
Under
section
307(
d)(
7)(
B)
of
the
CAA,

only
an
objection
to
a
rule
or
procedure
raised
with
reasonable
specificity
during
the
period
for
public
comment
can
be
raised
during
judicial
review.
Moreover,
under
section
307(
b)(
2)
of
the
CAA,
the
requirements
established
by
the
final
decision
may
not
be
challenged
separately
in
civil
or
criminal
proceedings
brought
to
enforce
these
requirements.

Section
307(
d)(
7)(
B)
of
the
CAA
further
provides
that
"
only
an
objection
to
a
rule
or
procedure
which
was
raised
with
reasonable
specificity
during
the
period
for
public
comment
(
including
any
public
hearing)
may
be
raised
during
judicial
review."
This
section
also
provides
a
mechanism
for
us
to
convene
a
proceeding
for
reconsideration,
"
if
the
person
raising
an
objection
can
demonstrate
to
the
EPA
that
it
was
impracticable
to
raise
such
objection
within
[
the
period
for
public
comment]
or
if
the
grounds
for
such
objection
arose
after
the
period
for
public
comment
(
but
within
the
time
specified
for
judicial
review)
and
if
such
objection
is
of
central
relevance
to
the
outcome
of
the
rule."
Any
person
seeking
to
make
such
a
demonstration
to
6
us
should
submit
a
Petition
for
Reconsideration
to
the
Office
of
the
Administrator,
U.
S.
EPA,
Room
3000,
Ariel
Rios
Building,
1200
Pennsylvania
Ave.,
NW,
Washington,
D.
C.

20460,
with
a
copy
to
both
the
person(
s)
listed
in
the
preceding
FOR
FURTHER
INFORMATION
CONTACT
section,
and
the
Associate
General
Counsel
for
the
Air
and
Radiation
Law
Office,
Office
of
General
Counsel
(
Mail
Code
2344A),
U.
S.

EPA,
1200
Pennsylvania
Ave.,
NW,
Washington,
D.
C.
20004.

Outline.
The
information
presented
in
this
preamble
is
organized
as
follows:

I.
Background
A.
What
is
the
statutory
authority
for
this
action?
B.
What
did
the
Magnetic
Tape
NESHAP
accomplish?
C.
What
were
the
conclusions
of
the
residual
risk
assessment?
D.
What
were
the
conclusions
of
the
technology
review?
E.
What
was
the
proposed
action?
II.
Today's
Action
A.
What
is
today's
final
action?
B.
What
comments
were
received
on
the
proposed
action?
III.
Statutory
and
Executive
Order
Reviews
A.
Executive
Order
12866,
Regulatory
Planning
and
Review
B.
Paperwork
Reduction
Act
C.
Regulatory
Flexibility
Act
D.
Unfunded
Mandates
Reform
Act
E.
Executive
Order
13132,
Federalism
F.
Executive
Order
13175,
Consultation
and
Coordination
with
Indian
Tribal
Governments
G.
Executive
Order
13045,
Protection
of
Children
from
Environmental
Health
and
Safety
Risks
H.
Executive
Order
13211,
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
I.
National
Technology
Transfer
and
Advancement
Act
I.
Background
A.
What
is
the
statutory
authority
for
this
action?
7
Section
112
of
the
Clean
Air
Act
(
CAA)
establishes
a
two­
stage
regulatory
process
to
address
emissions
of
hazardous
air
pollutants
(
HAP)
from
stationary
sources.
In
the
first
stage,
after
EPA
has
identified
categories
of
sources
emitting
one
or
more
of
the
HAP
listed
in
the
CAA,

section
112(
d)
calls
for
us
to
promulgate
national
technology­
based
emission
standards
for
sources
within
those
categories
that
emit
or
have
the
potential
to
emit
any
single
HAP
at
a
rate
of
10
tons
or
more
per
year
or
any
combination
of
HAP
at
a
rate
of
25
tons
or
more
per
year
(
known
as
"
major
sources"),
as
well
as
for
certain
"
area
sources"
emitting
less
than
those
amounts.
These
technology­
based
standards
must
reflect
the
maximum
reductions
of
HAP
achievable
(
after
considering
cost,
energy
requirements,
and
non­
air
health
and
environmental
impacts)

and
are
commonly
referred
to
as
maximum
achievable
control
technology
(
MACT)
standards.
For
area
sources,
CAA
section
112(
d)(
5)
provides
that,
in
lieu
of
MACT,
the
Administrator
may
elect
to
promulgate
standards
or
requirements
which
provide
for
the
use
of
generally
available
control
technologies
or
management
practices,
and
such
standards
are
commonly
referred
to
as
generally
available
control
technology
(
GACT)
standards.

The
EPA
is
then
required
to
review
these
technologybased
standards
and
to
revise
them
"
as
necessary,
taking
8
into
account
developments
in
practices,
processes
and
control
technologies,"
no
less
frequently
than
every
8
years.

The
second
stage
in
standard­
setting
is
described
in
section
112(
f)
of
the
CAA.
This
provision
requires
that
EPA
prepare
a
Report
to
Congress
describing,
among
other
things,

methods
of
estimating
risks
posed
by
sources
after
implementation
of
the
MACT
standards,
the
public
health
significance
of
those
risks,
the
means
and
costs
of
controlling
them,
actual
health
risks
to
persons
in
proximity
to
emitting
sources,
and
recommendations
as
to
legislation
regarding
such
remaining
risk.
The
EPA
prepared
and
submitted
this
report
("
Residual
Risk
Report
to
Congress,"
EPA­
453/
R­
99­
001)
in
March
1999.
The
Congress
did
not
act
on
any
of
the
recommendations
in
the
report,

triggering
the
second
stage
of
the
standard­
setting
process,

the
residual
risk
stage..
Section
112(
f)(
2)
requires
us
to
determine
for
each
section
112(
d)
source
category,
except
area
source
categories
for
which
we
issued
a
generally
available
control
technology
standard,
whether
the
NESHAP
protects
public
health
with
an
ample
margin
of
safety.
If
the
NESHAP
for
HAP
"
classified
as
a
known,
probable,
or
possible
human
carcinogen
do
not
reduce
lifetime
excess
cancer
risks
to
the
individual
most
exposed
to
emissions
from
a
source
in
the
category
or
subcategory
to
less
than
9
one
in
one
million,"
we
must
decide
whether
additional
reductions
are
necessary
to
provide
an
ample
margin
of
safety.
As
a
part
of
this
decision,
we
may
consider
costs,

technological
feasibility,
uncertainties,
or
other
relevant
factors.
We
must
determine
whether
more
stringent
standards
are
necessary
to
prevent
an
adverse
environmental
effect
(
defined
in
section
112(
a)(
7)
as
"
any
significant
and
widespread
adverse
effect,
which
may
reasonably
be
anticipated
to
wildlife,
aquatic
life,
or
other
natural
resources,
including
adverse
impacts
on
populations
of
endangered
or
threatened
species
or
significant
degradation
of
environmental
quality
over
broad
areas"),
but
in
making
this
decision
we
must
consider
cost,
energy,
safety,
and
other
relevant
factors.

B.
What
did
the
Magnetic
Tape
NESHAP
accomplish?

On
December
15,
1994,
we
promulgated
the
NESHAP
for
Magnetic
Tape
Manufacturing
Operations
(
59
FR
64580)
and
required
existing
sources
to
comply
with
the
NESHAP
by
December
15,
1996.

The
Magnetic
Tape
NESHAP
covers
HAP
emissions
from
surface
coatings
used
in
the
manufacture
of
magnetic
and
optical
recording
media
used
in
audio,
video,
computer
and
magnetic
stripe
tape
and
disks.
The
emission
units
regulated
by
the
Magnetic
Tape
NESHAP
are
storage
tanks,
mix
preparation
equipment,
coating
operations,
waste
handling
10
devices,
condenser
vents
in
solvent
recovery,
particulate
transfer
operations,
wash
sinks
for
cleaning
removable
parts,
equipment
for
flushing
fixed
lines,
and
wastewater
treatment
operations.
The
Magnetic
Tape
NESHAP
regulates
only
those
sources
located
at
major
sources.
During
the
development
of
the
NESHAP,
we
identified
25
existing
magnetic
recording
media
and
magnetic
stripe
facilities,
of
which
14
were
considered
major
and,
therefore,
subject
to
the
NESHAP.
Currently,
there
are
only
six
magnetic
tape
manufacturing
facilities
remaining
in
the
United
States,
all
of
which
are
major.

In
general,
the
current
NESHAP
requires
an
overall
HAP
control
efficiency
of
at
least
95
percent
for
emissions
from
each
solvent
storage
tank,
piece
of
mix
preparation
equipment,
coating
operation,
waste
handling
device,
or
condenser
vent
in
solvent
recovery.
If
an
incinerator
is
used
to
control
these
emissions
points,
an
outlet
HAP
concentration
of
no
greater
than
20
parts
per
million
by
volume
by
compound
may
be
met,
instead
of
achieving
95
percent
control,
as
long
as
the
efficiency
of
the
capture
system
is
100
percent.
If
a
coating
with
a
HAP
content
no
greater
than
0.18
kilograms
per
liter
(
1.5
pounds
per
gallon)
of
coatings
solids
is
used,
that
coating
operation
does
not
require
further
control.

Several
solvents
and
particulate
HAP
are
used
in
the
11
magnetic
tape
manufacturing
industry.
Currently,
the
solvents
used
to
the
greatest
extent
are
methyl
ethyl
ketone
(
MEK)
and
the
HAP
toluene,
and
the
particulate
HAP
are
cobalt
and
cobalt
compounds.
At
the
time
of
promulgation
of
the
NESHAP,
however,
the
solvents
in
use
included
MEK,

cyclohexanone,
acetone,
and
isopropyl
alcohol
and
the
HAP
toluene,
methyl
isobutyl
ketone,
toluene
diisocyanate,

ethylene
glycol,
methanol,
xylenes,
ethyl
benzene,
and
acetaldehyde;
and
the
particulate
HAP
included
chromium,

cobalt,
and
their
respective
compounds.
Several
of
these
compounds
are
no
longer
used
in
the
industry.
The
compound
MEK
and
the
HAP
toluene
are
used
at
all
facilities.
At
the
time
of
promulgation
of
the
magnetic
tape
NESHAP,
MEK
was
a
listed
HAP,
and
we
estimated
that
HAP
emissions,
including
MEK
and
toluene,
would
be
reduced
by
2,080
megagrams
per
year
(
Mg/
yr)
(
2,300
tons
per
year
(
tpy))
from
a
baseline
of
4,060
Mg/
yr
(
4,470
tpy).
Methyl
ethyl
ketone
was
later
delisted
by
EPA
in
70
FR
75047,
December
19,
2005.

C.
What
were
the
conclusions
of
the
residual
risk
assessment?

As
required
by
section
112(
f)(
2)
of
the
CAA,
we
prepared
a
risk
assessment
to
determine
the
residual
risk
posed
by
magnetic
tape
manufacturing
operations
after
implementation
of
the
NESHAP.
We
compiled
a
list
of
the
six
magnetic
tape
manufacturing
facilities
still
in
operation
in
12
the
United
States
based
on
inventory
information
we
gathered
from
a
number
of
manufacturing
facilities
and
State
environmental
program
offices
(
e.
g.,
whether
these
facilities
were
still
operating
and
manufacturing
magnetic
tape).

The
major
compounds
emitted
by
the
magnetic
tape
manufacturing
source
category
are
MEK
and
the
HAP
toluene,

which
comprise
97
percent,
by
tpy,
of
all
emissions
in
the
source
category.
The
six
magnetic
tape
manufacturing
facilities
have
MEK
and
HAP
emissions
ranging
from
3.9
to
214
Mg/
yr
(
4.3
to
236
tpy).
At
the
time
of
proposal,
MEK
was
a
listed
HAP,
and
the
nationwide
annual
HAP
emissions,

including
MEK
and
toluene,
were
estimated
to
be
468
Mg/
yr
(
516
tpy).
Methyl
ethyl
ketone
has
since
been
delisted.

Using
these
data,
we
modeled
exposure
concentrations
surrounding
the
six
facilities,
calculated
the
risk
of
possible
chronic
cancer
and
noncancer
health
effects,

evaluated
whether
acute
exposures
might
exceed
relevant
health
thresholds,
and
investigated
human
health
multipathway
and
ecological
risks.

The
emissions
data
used
in
the
residual
risk
assessment
represent
actual
levels
of
emissions
for
the
base
year.
We
have
no
reason
to
believe
that
there
is
a
substantial
amount
of
over
control
compared
to
what
is
allowed
under
the
MACT
standard.
Therefore,
the
results
of
the
risk
assessment
13
represent
our
approximation
of
the
maximum
risks
which
would
be
allowed
under
compliance
with
the
NESHAP.

Consistent
with
the
tiered
modeling
approach
described
in
the
Residual
Risk
Report
to
Congress
of
March
1999
(
EPA­

453/
R­
99­
001),
the
risk
assessment
for
this
source
category
started
with
a
simple
assessment,
which
used
healthprotective
assumptions
in
lieu
of
site­
specific
data.
The
results
demonstrated
negligible
risks
for
potential
chronic
cancer,
chronic
noncancer,
and
acute
noncancer
health
endpoints.
Also,
no
significant
human
health
multipathway
or
ecological
risks
were
identified.
Had
the
resulting
risks
been
determined
to
be
non­
negligible,
a
more
refined
analysis
with
site­
specific
data
would
have
been
necessary.

The
assessment
is
described
in
detail
in
the
memorandum
"
Residual
Risk
Assessment
for
the
Magnetic
Tape
Manufacturing
Source
Category,"
available
in
the
docket.

Since
our
assessment
shows
that
sources
subject
to
the
Magnetic
Tape
Manufacturing
NESHAP
pose
maximum
lifetime
excess
cancer
risks
which
are
significantly
less
than
1
in
1
million,
EPA
concluded
that
public
health
is
protected
with
an
ample
margin
of
safety,
and
since
noncancer
health
risks
and
ecological
risks
were
also
found
to
be
insignificant
for
this
source
category,
EPA
is
not
obligated
to
adopt
standards
under
section
112(
f)
of
the
CAA.
Because
risks
contributed
by
MEK
are
a
negligible
part
of
the
overall
14
risk,
the
delisting
of
MEK
has
essentially
no
effect
on
the
risk
assessment
performed
for
the
proposed
rule.

D.
What
were
the
conclusions
of
the
technology
review?

Section
112(
d)(
6)
of
the
CAA
requires
EPA
to
review,

and
revise
as
necessary
(
taking
into
account
developments
in
practices,
processes,
and
control
technologies),
emission
standards
promulgated
under
section
112
no
less
often
than
every
8
years.
As
we
stated
in
the
preamble
to
the
Coke
Ovens
residual
risk
rule
(
70
FR
20009),
and
as
discussed
below,
the
facts
underlying
a
section
112(
f)
determination
should
be
key
factors
in
making
any
subsequent
section
112(
d)(
6)
determinations.
For
this
and
several
other
source
categories,
we
were
under
consent
decree
deadlines
to
complete
both
the
section
112(
d)(
6)
technology
review
and
the
section
112(
f)(
2)
residual
risk
analysis
by
the
same
date.
As
a
result,
we
conducted
the
two
reviews
concurrently
and
did
not
have
the
results
of
the
section
112(
f)(
2)
analysis
before
we
began
the
section
112(
d)(
6)

technology
review.

We
reviewed
available
information
about
the
industry,

talked
with
industry
representatives,
and
contacted
several
facilities
in
the
industry
to
investigate
available
emission
control
technologies
and
the
potential
for
additional
emission
reductions.
We
did
not
identify
any
additional
control
technologies
beyond
those
that
are
already
in
15
widespread
use
within
the
source
category
(
e.
g.,
carbon
adsorbers,
condensers).
The
only
developments
identified
involve
improvements
in
the
performance
of
existing
technologies
or
increased
frequency
of
inspections
and
testing,
which
would
achieve
only
small
incremental
emission
reductions.
However,
we
did
discover
that
new
product
developments
(
optical
recording
media
and
solid
state
recording
media)
may
eventually
supplant
magnetic
tape,
but
these
media
are
not
considered
magnetic
tape
and
would
not
be
covered
under
the
Magnetic
Tape
NESHAP.
Therefore,
our
investigation
did
not
identify
any
significant
developments
in
practices,
processes,
or
control
technologies
in
the
magnetic
tape
manufacturing
industry
since
promulgation
of
the
original
standards
in
1994.
We
undertook
the
technology
assessment
for
this
source
category
consistent
with
our
policy
in
the
Coke
Ovens
residual
risk
rule
(
70
FR
20008­

20009).

E.
What
was
the
proposed
action?

On
October
24,
2005,
based
on
the
findings
from
our
residual
risk
and
technology
review,
we
proposed
no
further
action
to
revise
the
NESHAP
(
70
FR
61417)
and
requested
public
comment.

II.
Today's
Action
A.
What
is
today's
final
action?

Today's
final
action
responds
to
public
comments
16
received
on
the
proposed
action
and
announces
our
final
decision
not
to
revise
the
standards.

B.
What
comments
were
received
on
the
proposed
action?

In
the
proposed
action,
we
requested
public
comment
on
our
residual
risk
review
and
our
technology
review
and
on
issues
of
delisting
the
source
category
and
conducting
future
technology
reviews.
By
the
end
of
the
public
comment
period,
comments
from
five
entities
had
been
received.
A
summary
of
these
comments
and
EPA's
responses
are
provided
in
the
sections
below.

1.
Residual
Risk
Determination
Comment:
Three
commenters
supported
EPA's
decisions
for
the
magnetic
tape
source
category.
The
commenters
supported
EPA's
conclusion
that
no
changes
to
the
existing
NESHAP
for
magnetic
tape
manufacturing
were
required
to
satisfy
the
requirements
of
section
112(
f).
The
commenters
noted
that
EPA
correctly
reviewed
the
magnetic
tape
sources,

followed
the
tiered
risk
assessment
approach
described
in
its
Residual
Risk
Report
to
Congress,
and,
using
a
conservative
methodology,
determined
that
no
source
in
the
category
had
a
maximum
individual
cancer
risk
exceeding
the
1­
in­
1­
million
level
for
triggering
promulgation
of
a
residual
risk
standard
under
section
112(
f).

Two
of
the
commenters
stated
that
EPA
was
correct
to
focus
its
section
112(
f)
residual
risk
analysis
on
the
17
sources
in
the
magnetic
tape
source
category
subject
to
section
112(
d)
requirements,
and
not
consider
risk
from
outside
that
source
category.
According
to
the
commenters,

the
statutory
language
and
construction
of
section
112(
f)

shows
that
Congress
was
directing
EPA
to
perform
residual
risk
analyses
for
individual
source
categories.

Response:
We
acknowledge
the
commenters'
support
for
our
health­
protective
methodology
and
our
conclusions
in
the
proposed
notice.
However,
we
do
not
agree
that
our
section
112(
f)
residual
risk
analyses
must
always
focus
only
on
the
sources
in
the
category
subject
to
section
112(
d)

requirements
or
that
Congress
intended
to
limit
all
residual
risk
analyses
to
the
individual
source
categories
in
question.
As
we
stated
in
the
preamble
to
the
Coke
Ovens
residual
risk
rule,
"
EPA
disagrees
that
section
112(
f)

precludes
EPA
from
considering
emissions
other
than
those
from
the
source
category
or
subcategory
entirely."
Rather,

we
have
concluded
that,
when
the
statutory
risk
trigger
is
exceeded,
the
two­
step
approach
set
forward
in
the
Benzene
NESHAP
remains
the
approach
that
we
should
follow
in
determinations
under
section
112(
f).
At
the
first
step,

when
determining
"
acceptable
risk,"
we
will
consider
risks
that
result
from
emissions
from
the
source
category
only.

However,
during
the
second
step,
we
must
determine
whether
additional
reductions
should
be
required
to
protect
public
18
health
with
"
an
ample
margin
of
safety."
One
of
the
factors
that
we
can
consider
in
this
second
step
is
environmental
levels
of
HAP
due
to
emissions
from
sources
outside
the
source
category
being
assessed.
This
could
include
ambient
background
concentrations
of
HAP,
as
well
as
co­
location
of
other
emission
sources
that
augment
the
identified
risks
from
the
source
category.

2.
Delisting
the
Source
Category
At
proposal,
we
requested
comment
on
whether
it
would
be
appropriate
to
delist
the
magnetic
tape
source
category
under
section
112(
c)(
9)
based
on
the
possibility
that
HAP
emissions
from
the
source
category
would
be
sufficiently
low
even
in
the
absence
of
MACT
standards.

Comment:
One
commenter
opposed
delisting
the
magnetic
tape
source
category,
stating
that
if
the
source
category
was
delisted,
there
would
be
nothing
to
prevent
sources
from
increasing
their
HAP
emissions
substantially
or
changing
their
processes
to
emit
new
HAP,
resulting
in
HAP
levels
unacceptable
to
public
health
and
the
environment.
The
commenter
indicated
that
such
an
approach
ignores
the
possibility
that
HAP
emissions
were
reduced
to
an
acceptable
level
because
of
the
MACT
requirements
and
that
emissions
could
increase
again
without
the
MACT
standard
in
place.

Furthermore,
the
commenter
believed
that
Congress
did
not
intend
for
the
residual
risk
review
to
result
in
delisting
19
of
regulated
source
categories;
if
Congress
had
wanted
to
make
delistings
dependent
on
or
linked
to
the
outcome
of
the
residual
risk
process,
it
would
have
specifically
mandated
this
in
the
CAA,
which
it
did
not.

Two
commenters
argued
that
delisting
a
source
category
does
not
affect
the
applicability
of
an
existing
NESHAP
and
cited
the
delisting
action
following
the
Asbestos
NESHAP
as
support
for
their
argument.
They
also
noted
that
EPA
said
in
its
proposal
that
no
further
section
112(
d)(
6)
reviews
are
required
unless
there
is
a
significant
change
to
the
source
category.
Consequently,
the
commenters
saw
no
benefit
in
delisting
the
magnetic
tape
source
category.

However,
they
were
not
opposed
to
such
an
action.

One
commenter
supported
delisting
the
magnetic
tape
source
category
under
the
authority
of
section
112(
c)(
9)

based
on
EPA's
finding
of
negligible
risks
(
0.01
in
1
million).
The
commenter
stated
that
EPA's
request
for
comment
implied
that
it
interpreted
the
CAA
to
allow
delisting
on
the
basis
of
low
risk
only
before
a
MACT
standard
is
issued;
however,
section
112(
c)(
9)
provides
EPA
with
the
authority
to
delist
a
source
category
whenever
the
Administrator
makes
a
determination
that
the
risks
are
below
the
risk
criteria
in
the
CAA
and
does
not
limit
this
authority
to
sources
not
yet
subject
to
a
MACT
or
GACT
standard.
According
to
the
commenter,
limiting
EPA's
20
discretion
to
delist
source
categories
prior
to
issuing
MACT
or
GACT
standards
also
conflicts
with
the
required
sequence
of
duties
under
section
112,
which
does
not
require
EPA
to
conduct
a
risk
analysis
until
a
residual
risk
evaluation
is
required
8
years
after
MACT
standards
are
issued;

consequently,
EPA
is
unlikely
to
have
sufficient
data
on
which
to
base
a
delisting
decision
until
many
years
after
MACT
standards
have
been
promulgated.
Furthermore,
the
commenter
stated
it
is
possible
that
source
categories
found
to
be
low­
risk
after
MACT
standards
were
imposed
may
have
been
low­
risk
before
the
standards
were
imposed,
especially
magnetic
tape
facilities,
where
the
risk
assessment
showed
risks
two
orders
of
magnitude
below
the
statutory
criteria
for
delisting
under
section
112(
c)(
9).
Finally,
the
commenter
noted
that
if
EPA
was
concerned
that
the
source
category
would
exceed
risk
levels
if
MACT
controls
were
not
applicable,
it
could
use
section
112(
c)(
9)
to
keep
in
place
those
MACT
requirements
needed
to
sustain
the
low­
risk
determination
and
delisting.
According
to
the
commenter,

those
requirements
could
be
established
as
part
of
the
delisting
decision
and
maintained
in
the
title
V
permit,
as
was
done
in
the
NESHAP
for
Plywood
and
Composite
Wood
Products.

Response:
Based
on
our
risk
assessment
of
the
magnetic
tape
source
category,
we
have
concluded
that
these
sources
21
are
low­
risk
and,
therefore,
that
no
further
standards
are
required
to
protect
public
health
with
an
ample
margin
of
safety
or
to
protect
the
environment.
However,
we
agree
with
the
commenter
who
argues
that
this
conclusion
is
based,

at
least
in
part,
on
the
fact
that
the
MACT
requirements
for
these
sources
limit
HAP
emissions.
Further,
we
disagree
with
the
comment
that
delisting
will
not
affect
the
viability
of
the
existing
NESHAP.
The
commenter
cited
the
delisting
action
following
the
Asbestos
NESHAP
as
support
for
their
argument,
noting
that
the
applicability
of
that
rule
was
not
affected
by
delisting.
However,
the
Asbestos
NESHAP
was
established
under
part
61,
which
is
not
directly
relevant
in
this
situation
since
the
Magnetic
Tape
NESHAP
is
a
part
63
rule.
If
we
delist
this
source
category,
it
is
our
conclusion
that
existing
magnetic
tape
sources
would
no
longer
be
subject
to
the
NESHAP
and,
thus,
HAP
emissions
would
no
longer
be
limited
by
this
rule.
If
sources
begin
emitting
HAP
at
levels
exceeding
those
allowed
under
the
NESHAP,
risks
could
increase,
and
the
basis
for
our
finding
that
the
source
category
is
low­
risk
could
be
compromised.

We
have
already
documented
that
emissions
from
magnetic
tape
manufacturing
operations
were
substantially
higher
at
promulgation,
compared
to
more
recent
emissions
estimates
(
after
the
standards
were
implemented).
As
noted
in
the
October
24,
2005
proposal
(
70
FR
61419)
and
previously
in
22
this
action,
HAP
emissions
at
promulgation
were
estimated
to
be
4,060
Mg/
yr
(
4,470
tpy),
while
HAP
emissions
in
2000
were
estimated
to
be
468
Mg/
yr
(
516
tpy)­­
a
difference
of
almost
90
percent,
some
of
which
is
due
to
compliance
with
the
MACT
standard
and
some
of
which
is
due
to
19
plant
closures
since
1994.
These
HAP
emissions
estimates
include
MEK,
which
has
since
been
delisted
as
a
HAP.
More
recent
information
suggests
that
the
delisting
of
MEK
may
result
in
one
plant
reducing
its
emissions
to
below
the
major
source
levels.
If
the
potential­
to­
emit
limit
for
this
facility
is
below
the
major
source
threshold
due
to
the
delisting
of
MEK,
it
would
become
an
area
source
and
as
such
would
no
longer
be
subject
to
the
magnetic
tape
manufacturing
NESHAP.
Nonetheless,

since
compliance
with
the
MACT
standard
is
part
of
the
basis
for
our
low­
risk
determination,
we
believe
that
our
policy
objectives
are
best
served
if
we
do
not
delist
the
magnetic
tape
source
category.

Contrary
to
one
commenter's
contention,
we
did
not
intend
to
imply
through
our
request
for
comments
that
we
interpret
section
112(
c)(
9)
of
the
CAA
to
apply
only
before
a
MACT
standard
has
been
promulgated.
We
were
simply
seeking
comment
on
the
use
of
section
112(
c)(
9)
after
the
MACT
standard.
However,
for
the
reasons
presented
above,
we
have
decided
not
to
use
section
112(
c)(
9)
to
delist
the
magnetic
tape
source
category
23
The
Agency
would
like
to
remove
the
burden
of
the
repetitive
review
of
Section
112
standards
for
low
risk
source
categories.
At
the
same
time,
we
think
it
is
appropriate
to
maintain
the
MACT
controls,
in
this
case.
We
plan
to
further
investigate
approaches
for
removing
low­
risk
source
categories
from
the
Section
112
universe
while
maintaining
MACT­
level
controls.
An
example
of
a
similar
approach
is
found
in
the
Plywood
and
Composite
Wood
Products
MACT
where
we
allow
a
subcategory
of
facilities
to
reduce
emissions
to
acceptable
risk
levels
through
Title
5
permits
and
remove
them
from
the
MACT
universe.

3.
Future
Technology
Reviews
At
proposal,
we
requested
comment
on
"
the
notion
that,

barring
any
unforeseeable
circumstances
which
might
substantially
change
this
source
category
or
its
emissions,

we
would
have
no
obligations
to
conduct
future
technology
reviews
under
CAA
section
112(
d)(
6)."
We
suggested
this
approach
because
of
the
low­
risk
finding
for
this
source
category
under
section
112(
f).

Comment:
One
commenter
disagreed
that
low
risk
from
a
source
category
at
this
time
should
absolve
EPA
of
its
obligation
to
conduct
future
technology
reviews.
The
commenter
stated
that,
without
periodic
reviews
of
source
categories
and
technology
in
the
future
reviews,
EPA
would
not
be
aware
of
any
technologies
that
have
been
developed
or
24
any
"
unforeseeable
circumstances"
related
to
the
source
category
to
which
EPA
refers
in
the
notice.
Furthermore,

the
commenter
believed
that
Congress
did
not
intend
for
the
residual
risk
review
to
result
in
the
removal
of
EPA's
obligation
to
conduct
future
technology
reviews
under
section
112(
d)(
6);
if
Congress
had
wanted
to
make
technology
reviews
dependent
on
or
linked
to
the
outcome
of
the
residual
risk
process,
it
would
have
specifically
mandated
this
in
the
CAA,
which
it
did
not.

Three
commenters
stated
that
EPA
has
no
obligation
to
conduct
a
technology
review
in
the
case
of
Magnetic
Tape.

According
to
the
commenters,
because
the
residual
risk
provisions
of
the
CAA
were
not
triggered
by
the
magnetic
tape
source
category's
remaining
low
risk,
even
an
initial
technology
review
was
unnecessary.
The
commenters
noted
that
EPA
only
used
the
results
of
the
section
112(
f)(
2)

residual
risk
analysis
to
conclude
that
future
section
112(
d)(
6)
technology
reviews
would
not
be
required.
The
commenters
stated
that
EPA's
use
of
a
formal
technology
review
as
the
basis
for
its
conclusion
under
section
112(
d)(
6)
that
the
NESHAP
did
not
need
to
be
revised
was
inconsistent
with
EPA's
prior
stated
position
in
the
Coke
Ovens
residual
risk
rule
(
70
FR
20009)
on
determining
the
need
for
a
technology
review
under
section
112(
d)(
6).
One
commenter
stated
that
if
the
Coke
Ovens
criteria
for
when
a
25
technology
review
is
not
"
necessary"
under
the
CAA
are
sound
for
subsequent
technology
reviews,
then
they
are
also
sound
for
initial
reviews,
as
in
the
case
of
Magnetic
Tape.

Another
commenter
stated
that,
where
the
ample
margin
of
safety
set
in
the
residual
risk
rule
is
largely
based
on
cost
or
technical
feasibility,
then
further
future
review
under
section
112(
d)(
6)
may
remain
viable,
and
additional
controls
may
not
be
precluded
if
feasible,
cost­
effective
control
measures
are
identified
in
the
future.

Response:
We
stated
in
the
preamble
to
the
Coke
Ovens
residual
risk
rule
that
if
the
ample
margin
of
safety
analysis
for
the
section
112(
f)
standard
is
not
based
at
all
on
the
availability
or
cost
of
particular
control
technologies,
then
advances
in
air
pollution
control
technology
should
not
justify
revising
the
MACT
standard
pursuant
to
section
112(
d)(
6)
because
the
section
112(
f)

standard
would
continue
to
assure
an
adequate
level
of
safety.
We
agree
that
a
technology
review
is
required
every
8
years.
However,
if
the
ample
margin
of
safety
analysis
for
a
section
112(
f)
standard
shows
that
remaining
risk
for
non­
threshold
pollutants
falls
below
1
in
1
million
and
for
threshold
pollutants
falls
below
a
similar
threshold
of
safety,
then
further
revision
should
not
be
needed
because
an
ample
margin
of
safety
has
already
been
assured.
In
these
situations,
it
is
difficult
to
conceive
of
a
case
26
where
the
development
of
new
technology,
or
of
inexpensive
control
strategies,
would
cause
us
to
require
additional
requirements
for
a
source
category.
If
the
availability
and/
or
costs
of
technology
are
part
of
the
rationale
for
the
ample
margin
of
safety
determination,
it
is
reasonable
to
conclude
that
changes
in
those
costs
or
in
the
availability
of
technology
could
alter
our
conclusions
regarding
the
ample
margin
of
safety.
For
this
reason,
we
agree
with
the
comment
that
subsequent
technology
reviews
would
be
appropriate
and
revisions
may
also
be
appropriate
if
the
ample
margin
of
safety
established
by
the
residual
risk
process
considers
cost
or
technical
feasibility.

We
disagree
with
the
comment
that
we
should
not
have
conducted
an
initial
technology
review
under
section
112(
d)(
6)
for
the
magnetic
tape
source
category.
As
we
noted
in
the
preamble
to
the
Coke
Ovens
residual
risk
rule,

we
believe
that
the
findings
that
underlie
a
section
112(
f)

determination
should
be
key
factors
in
making
any
subsequent
section
112(
d)(
6)
determinations.
As
indicated
by
the
inclusion
of
the
word
"
subsequent"
in
this
rationale,
we
believe
that
we
are
obligated
to
perform
the
initial
section
112(
d)(
6)
analysis.
The
timing
requirements
for
the
initial
section
112(
d)(
6)
analysis
coincide
with
those
for
the
residual
risk
analysis.
Thus,
it
is
appropriate
for
us
to
conduct
both
analyses
at
the
same
time
and
for
the
results
27
of
the
risk
analysis
to
impact
future
section
112(
d)(
6)

technology
reviews,
even
though
these
results
do
not
negate
either
the
need
to
perform
the
initial
review
or
the
need
to
perform
subsequent
reviews
under
section
112(
d)(
6).

4.
General
Approach
to
Technology
Reviews
Comment:
Three
commenters
stated
that
action
is
not
necessarily
required
under
section
112(
d)(
6)
even
if
a
residual
risk
rule
does
not
reduce
cancer
risks
for
all
persons
to
a
level
below
1
in
1
million.
Two
of
the
commenters
noted
that
EPA
had
already
rejected
such
a
"
bright
line"
approach
under
section
112(
f)
in
the
Coke
Ovens
residual
risk
rule;
instead,
it
serves
as
a
trigger
point
to
evaluate
whether
additional
reductions
are
necessary
to
provide
an
ample
margin
of
safety.
The
third
commenter
cited
the
legislative
history
of
the
1990
amendments
to
the
CAA
as
support
that
Congress
had
rejected
provisions
requiring
sources
to
meet
a
1­
in­
1­
million
standard.
According
to
this
commenter,
EPA's
proposed
interpretation
of
section
112(
d)(
6)
of
requiring
successive
reviews
unless
sources
achieve
this
risk
level
implies
that
sources
must
meet
a
1­
in­
1­
million
standard
to
avoid
future
regulation,
and
if
Congress
had
intended
this
"

technologybased
downward
revision
of
the
standard,
there
would
have
been
no
need
for
section
112(
f).

Noting
that
EPA's
risk
estimates
are
upper
bound
28
estimates
that
likely
overstate
risks,
the
first
two
commenters
stated
that
a
"
bright
line"
approach
should
not
be
employed
under
section
112(
d)(
6)
any
more
than
it
should
be
employed
under
section
112(
f);
instead,
they
stated
that
EPA
should
make
determinations
of
whether
a
technology
review
is
necessary
on
a
case­
by­
case
basis
for
each
category.

The
third
commenter
stated
that
section
112(
d)(
6)

should
be
more
appropriately
viewed
as
a
regulatory
backstop
authority,
similar
to
the
case­
by­
case
"
MACT
hammer"

provisions
of
section
112(
j),
to
ensure
that
available
advances
in
technology
will
be
applied
in
the
event
EPA
fails
to
issue
residual
risk
standards
under
section
112(
f).

The
commenter
stated
that
once
EPA
has
established
a
residual
risk
standard
under
section
112(
f)
that
is
"
acceptable"
or
"
safe"
and
protective
with
an
"
ample
margin
of
safety,"
then
it
must
find
that
a
separate
revision
of
the
MACT
standard
under
section
112(
d)(
6)
is
not
necessary.

Response:
We
agree
with
the
commenters
who
indicated
that
it
would
be
sufficient
not
to
revise
MACT
standards
citing
section
112(
d)(
6)
even
if
cancer
risks
are
greater
than
or
equal
to
1
in
1
million.
For
example,
it
may
be
the
case
that
a
technology
review
is
performed,
but
no
change
in
the
standard
results
from
that
review.
In
the
preamble
to
the
residual
risk
rule
for
Coke
Ovens,
we
have
applied
a
29
similar
logic
to
the
need
for
subsequent
technology
revisions
under
section
112(
d)(
6).
As
we
stated
in
the
Coke
Ovens
rule,
if
the
ample
margin
of
safety
analysis
for
a
section
112(
f)
standard
shows
that
the
remaining
risk
for
non­
threshold
pollutants
falls
below
1
in
1
million
and
for
threshold
pollutants
falls
below
a
similar
threshold
of
safety,
then
further
revision
would
not
be
needed
because
an
ample
margin
of
safety
has
already
been
assured.

5.
Context
of
the
Residual
Risk
Program
Comment:
One
commenter
strongly
recommended
that
EPA
carefully
lay
out
the
context
and
framework
of
the
residual
risk
program
in
the
determination
for
each
source
category.

The
commenter
stated
that
this
was
especially
important
because
of
the
unique
nature
of
the
program
compared
to
other
EPA
programs
with
which
the
public
is
familiar.

The
commenter
specifically
recommended
that
EPA
mention
the
two­
stage
regulatory
process
(
MACT
and
residual
risk)

used
to
control
HAP
emissions
from
major
stationary
sources
and
to
determine
whether
the
MACT
technology
controls
provide
an
ample
margin
of
safety.
The
commenter
noted
that
the
residual
risk
program
is
different
from
other
EPA
programs,
in
that
additional
controls
will
be
necessary
for
only
some
of
the
listed
categories
of
sources,
because
in
some
cases,
the
cancer
risk
will
be
less
than
the
1­
in­
1­

million
trigger,
or,
if
it
is
greater,
EPA
may
determine
30
that
the
current
emission
level
provides
the
public
with
an
ample
margin
of
safety.

The
commenter
also
recommended
that
EPA
put
into
the
proper
context
the
relatively
small
contribution
of
major
stationary
sources
to
the
risks
from
air
toxics­­
about
11
percent
in
1999
and
expected
to
be
even
smaller
as
sources
come
into
compliance
with
the
latest
MACT
rules.

Finally,
the
commenter
recommended
that
EPA
present
the
risks
from
air
toxics
in
context
with
the
risks
from
ambient
(
criteria)
air
pollutants
to
make
clear
to
the
public
how
the
air
toxics
risk
estimates
are
much
more
conservative
and
to
avoid
any
misperceptions
by
the
public
that
the
risk
estimates
for
ambient
air
pollutants
are
comparable
to
the
risk
estimates
for
air
toxics.
Without
a
program
of
public
education
on
this
issue,
the
commenter
indicated
the
public
may
incorrectly
believe
that
the
ample
margin
of
safety
decisions
in
the
residual
risk
rules
are
less
stringent
than
EPA
knows
them
to
be,
resulting
in
public
lawsuits
against
EPA's
decisions
or
overregulation
by
EPA
to
compensate
for
the
gap
in
public
knowledge.
The
commenter
recommended
that
EPA
include
preamble
language
in
future
EPA
decisions
describing
the
criteria
it
used
to
determine
the
ample
margin
of
safety
and
presenting
the
incremental
risk/
incremental
cost
approach
in
the
fuller
context
for
the
residual
risk
program.
31
Response:
We
agree
that
it
is
important
to
provide
context
for
any
residual
risk
rule.
In
the
preamble
of
the
current
rule,
we
describe
the
MACT
program
and
its
impact
on
the
magnetic
tape
source
category.
We
also
describe
our
statutory
authority
and
our
obligations
to
assess
risks
to
human
health
and
the
environment
under
section
112(
f)
of
the
CAA,
as
well
as
the
requirement
to
further
regulate
categories
of
sources
if
any
of
the
estimated
individual
cancer
risks
exceed
the
statutory
trigger
level
of
1
in
1
million.

We
agree
that
our
risk
assessment
for
the
magnetic
tape
source
category
appropriately
contains
a
number
of
healthprotective
assumptions,
resulting
in
a
screening
assessment
that
is
designed
to
overestimate,
rather
than
underestimate,

risks.
The
results
demonstrate
negligible
risks
for
potential
chronic
cancer,
chronic
noncancer,
and
acute
noncancer
health
endpoints.
Also,
no
significant
human
health
multipathway
or
ecological
risks
were
identified.

Had
the
resulting
risks
been
determined
to
be
nonnegligible
a
more
refined
analysis
with
site­
specific
data
would
have
been
conducted.
Such
an
assessment
would
be
more
data­
intensive;
however,
it
would
also
present
a
more
accurate
estimate
of
risks
which
could
then
be
used
as
the
basis
for
regulatory
action.
However,
since
the
findings
of
the
screening
risk
assessment
for
the
magnetic
tape
source
32
category
were
negative
(
i.
e.,
the
statutory
cancer
risk
trigger
level
was
not
exceeded),
it
was
not
necessary
to
conduct
a
more
refined
risk
assessment
using
more
sitespecific
data.
Since
these
activities
were
not
relevant
to
this
action,
a
complete
discussion
of
them
in
the
context
of
a
full
discussion
of
the
residual
risk
program
was
not
deemed
necessary
or
appropriate.
The
details
of
our
risk
assessment
can
be
found
in
the
docket
in
the
memo
titled,

"
Residual
Risk
Assessment
for
the
Magnetic
Tape
Manufacturing
Source
Category."

6.
IRIS
Data
for
Acrylonitrile
Comment:
According
to
one
commenter,
EPA
should
not
have
relied
on
the
outdated
unit
cancer
risk
value
for
acrylonitrile
contained
in
EPA's
Integrated
Risk
Information
System
(
IRIS)
in
conducting
its
residual
risk
assessment
of
the
magnetic
tape
manufacturing
industry.
Although
EPA
concluded
that
there
were
no
issues
to
be
addressed
regarding
acrylonitrile
because
the
facility
emitting
acrylonitrile
presented
a
potential
cancer
risk
of
only
1
in
100
million,
the
commenter
stated
that
it
was
inappropriate
for
EPA
to
use
the
acrylonitrile
value
in
IRIS
in
its
assessment
because
EPA
was
already
aware
the
value
was
severely
out­
of­
date.
According
to
the
commenter,
the
IRIS
profile
itself
indicates
that
there
are
one
or
more
significant
new
studies
based
on
a
screening­
level
review
of
33
the
more
recent
toxicology
literature.
The
commenter
also
noted
that
EPA
was
aware
that
numerous
new
studies
had
been
conducted
on
assessing
the
cancer
risk
from
acrylonitrile
because
its
staff
were
briefed
on
an
assessment
of
those
new
studies,
received
copies
of
the
assessment
report,
and
attended
a
peer
review
meeting
on
the
report.
The
commenter
also
noted
that
a
summary
of
the
cancer
assessment
was
published
in
October
2005.

Response:
We
agree
that
our
IRIS
assessment
for
acrylonitrile
does
not
consider
studies
published
after
1991,
and
we
are
currently
developing
an
assessment
that
includes
newer
information.
Our
staff
reviewed
the
assessment
described
(
and
funded)
by
the
commenter
and
determined
that
it
has
several
substantial
shortcomings.

First,
the
assessment
concludes
that
the
mode
of
action
(
MOA)
is
nonlinear,
but
does
not
provide
evidence
or
analysis
sufficient
to
demonstrate
nonlinearity
or
to
identify
a
nonlinear
MOA.
The
independent
peer
panel
that
reviewed
this
assessment
noted
that
the
data
do
not
allow
unequivocal
determination
of
acrylonitrile's
MOA(
s),
and
could
not
rule
out
a
genotoxic
MOA.
Given
the
negligible
contribution
of
the
acrolitrile
risk
estimates
in
this
assessment,
we
determined
that
it
was
reasonable
and
protective
to
continue
to
use
linear
low­
dose
extrapolation.

Second,
the
assessment
provides
a
supplemental
linear
unit
34
risk
value
but
bases
it
upon
animal
data
rather
than
human
data,
despite
the
fact
that
adequate
human
data
were
available.
Using
these
human
data
would
have
produced
a
higher
inhalation
unit
risk
estimate
(
i.
e.,
closer
to
the
current
IRIS
assessment
value).
Third,
the
linear
unit
risk
value
came
from
a
reanalysis
of
animal
data
already
considered
in
EPA's
1991
IRIS
assessment
for
inhalation
carcinogenicity,
and
rejected
because
better
human
data
were
available
even
then.
For
these
reasons
we
concluded
that
the
commentor's
study
should
not
be
used
in
lieu
of
the
current
IRIS
assessment.

III.
Statutory
and
Executive
Order
Reviews
A.
Executive
Order
12866,
Regulatory
Planning
and
Review
Under
Executive
Order
12866
(
58
FR
51735,
October
4,

1993),
EPA
must
determine
whether
a
regulatory
action
is
"
significant"
and,
therefore,
subject
to
Office
of
Management
and
Budget
(
OMB)
review
and
the
requirements
of
the
Executive
Order.
The
Executive
Order
defines
a
"
significant
regulatory
action"
as
one
that
is
likely
to
result
in
a
rule
that
may:

(
1)
Have
an
annual
effect
on
the
economy
of
$
100
million
or
more,
or
adversely
affect
in
a
material
way
the
economy,
a
sector
of
the
economy,
productivity,
competition,

jobs,
the
environment,
public
health
or
safety,
or
State,

local,
or
tribal
governments
or
communities;
35
(
2)
Create
a
serious
inconsistency
or
otherwise
interfere
with
an
action
taken
or
planned
by
another
agency;

(
3)
Materially
alter
the
budgetary
impact
of
entitlements,
grants,
user
fees,
or
loan
programs,
or
the
rights
and
obligations
of
recipients
thereof;
or
(
4)
Raise
novel
legal
or
policy
issues
arising
out
of
legal
mandates,
the
President's
priorities,
or
the
principles
set
forth
in
the
Executive
Order.

Pursuant
to
the
terms
of
Executive
Order
12866,
OMB
has
notified
EPA
that
it
considers
this
a
"
significant
regulatory
action"
within
the
meaning
of
the
Executive
Order.
The
EPA
has
submitted
this
action
to
OMB
for
review.

Changes
made
in
response
to
OMB
suggestions
or
recommendations
will
be
documented
in
the
public
record.

B.
Paperwork
Reduction
Act
This
action
does
not
impose
any
information
collection
burden.
It
will
not
change
the
burden
estimates
from
those
previously
developed
and
approved
for
the
existing
NESHAP.

However,
OMB
has
previously
approved
the
information
collection
requirements
contained
in
the
existing
regulation
(
59
FR
64580,
December
15,
1994)
under
the
provisions
of
the
Paperwork
Reduction
Act
(
44
U.
S.
C.
3501,
et
seq.)
and
has
assigned
OMB
control
number
2060­
0326
(
EPA
ICR
No.
1678.05).

A
copy
of
the
OMB
approved
Information
Collection
Request
(
ICR)
may
be
obtained
from
Susan
Auby,
by
mail
at
the
Office
36
of
Environmental
Information,
Collection
Strategies
Division,
U.
S.
EPA
(
2822T),
1200
Pennsylvania
Avenue,
NW,

Washington,
DC
20460,
by
e­
mail
at
auby.
susan@
epa.
gov,
or
by
calling
(
202)
566­
1672.
A
copy
may
also
be
downloaded
off
the
Internet
at
www.
epa.
gov/
icr.
Include
the
ICR
or
OMB
number
in
any
correspondence.

Burden
means
the
total
time,
effort,
or
financial
resources
expended
by
persons
to
generate,
maintain,
retain,

or
disclose
or
provide
information
to
or
for
a
Federal
agency.
This
includes
the
time
needed
to
review
instructions;
develop,
acquire,
install,
and
utilize
technology
and
systems
for
the
purposes
of
collecting,

validating,
and
verifying
information,
processing
and
maintaining
information,
and
disclosing
and
providing
information;
adjust
the
existing
ways
to
comply
with
any
previously
applicable
instructions
and
requirements;
train
personnel
to
be
able
to
respond
to
a
collection
of
information;
search
data
sources;
complete
and
review
the
collection
of
information;
and
transmit
or
otherwise
disclose
the
information.

An
agency
may
not
conduct
or
sponsor,
and
a
person
is
not
required
to
respond
to,
a
collection
of
information
unless
it
displays
a
currently
valid
OMB
control
number.

The
OMB
control
numbers
for
EPA's
regulations
in
40
CFR
are
listed
in
40
CFR
Part
9.
37
C.
Regulatory
Flexibility
Act
The
Regulatory
Flexibility
Act
(
RFA)
generally
requires
an
agency
to
prepare
a
regulatory
flexibility
analysis
of
any
rule
subject
to
notice
and
comment
rulemaking
requirements
under
the
Administrative
Procedure
Act
or
any
other
statute
unless
the
agency
certifies
that
the
rule
will
not
have
a
significant
economic
impact
on
a
substantial
number
of
small
entities.
Small
entities
include
small
businesses,
small
organizations,
and
small
governmental
jurisdictions.

For
purposes
of
assessing
the
impact
of
today's
final
action
on
small
entities,
a
small
entity
is
defined
as:
(
1)

a
small
business
whose
parent
company
has
fewer
than
500
to
1,000
employees,
depending
on
the
size
definition
for
the
affected
NAICS
code
(
as
defined
by
Small
Business
Administration
size
standards);
(
2)
a
small
governmental
jurisdiction
that
is
a
government
of
a
city,
county,
town,

school
district,
or
special
district
with
a
population
of
less
than
50,000;
and
(
3)
a
small
organization
that
is
any
not­
for­
profit
enterprise
which
is
independently
owned
and
operated
and
is
not
dominant
in
its
field.

After
considering
the
economic
impact
of
today's
final
action
on
small
entities,
EPA
has
concluded
that
this
final
action
will
not
have
a
significant
economic
impact
on
a
substantial
number
of
small
entities.
The
final
action
will
38
not
impose
any
requirements
on
small
entities.
We
are
taking
no
further
action
at
this
time
to
revise
the
NESHAP.

D.
Unfunded
Mandates
Reform
Act
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
UMRA),
Public
Law
No.
104­
4,
establishes
requirements
for
Federal
agencies
to
assess
the
effect
of
their
regulatory
actions
on
State,
local,
and
tribal
governments
and
the
private
sector.
Under
section
202
of
the
UMRA,
EPA
generally
must
prepare
a
written
statement,
including
a
cost­
benefit
analysis,
for
proposed
and
final
rules
with
"
Federal
mandates"
that
may
result
in
expenditures
by
State,

local,
and
tribal
governments,
in
the
aggregate,
or
by
the
private
sector,
of
$
100
million
or
more
in
any
1
year.

Before
promulgating
an
EPA
rule
for
which
a
written
statement
is
needed,
section
205
of
the
UMRA
generally
requires
EPA
to
identify
and
consider
a
reasonable
number
of
regulatory
alternatives
and
adopt
the
least
costly,
most
cost­
effective,
or
least
burdensome
alternative
that
achieves
the
objectives
of
the
rule.
The
provisions
of
section
205
do
not
apply
when
they
are
inconsistent
with
applicable
law.
Moreover,
section
205
allows
EPA
to
adopt
an
alternative
other
than
the
least
costly,
most
cost­
effective,
or
least
burdensome
alternative
if
the
Administrator
publishes
with
the
final
rule
an
explanation
of
why
that
alternative
was
not
adopted.
Before
EPA
39
establishes
any
regulatory
requirements
that
may
significantly
or
uniquely
affect
small
governments,

including
tribal
governments,
it
must
have
developed
under
section
203
of
the
UMRA
a
small
government
agency
plan.
The
plan
must
provide
for
notifying
potentially
affected
small
governments,
enabling
officials
of
affected
small
governments
to
have
meaningful
and
timely
input
in
the
development
of
EPA
regulatory
proposals
with
significant
Federal
intergovernmental
mandates,
and
informing,

educating,
and
advising
small
governments
on
compliance
with
the
regulatory
requirements.

The
EPA
has
determined
that
the
final
action
does
not
contain
a
Federal
mandate
that
may
result
in
expenditures
of
$
100
million
or
more
for
State,
local,
and
tribal
governments
in
the
aggregate,
or
for
the
private
sector
in
any
1
year.
The
rule
imposes
no
enforceable
duty
on
State,

local,
or
tribal
governments,
or
the
private
sector.
Thus,

today's
final
action
is
not
subject
to
the
requirements
of
sections
202
and
205
of
the
UMRA.
In
addition,
EPA
has
determined
that
the
final
action
contains
no
regulatory
requirements
that
might
significantly
or
uniquely
affect
small
governments,
because
it
contains
no
requirements
that
apply
to
such
governments
or
impose
obligations
upon
them.

Therefore,
the
final
action
is
not
subject
to
the
requirements
of
section
203
of
the
UMRA.
40
E.
Executive
Order
13132,
Federalism
Executive
Order
13132,
entitled
"
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."

"
Policies
that
have
federalism
implications"
are
defined
in
the
Executive
Order
to
include
regulations
that
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."
Today's
final
action
does
not
have
federalism
implications.
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,
as
specified
in
Executive
Order
13132.
None
of
the
affected
facilities
are
owned
or
operated
by
State
or
local
governments.
Thus,
Executive
Order
13132
does
not
apply
to
the
final
action.

F.
Executive
Order
13175,
Consultation
and
Coordination
with
Indian
Tribal
Governments
Executive
Order
13175,
entitled
"
Consultation
and
Coordination
with
Indian
Tribal
Governments"
(
65
FR
67249,

November
9,
2000),
requires
EPA
to
develop
an
accountable
41
process
to
ensure
"
meaningful
and
timely
input
by
tribal
officials
in
the
development
of
regulatory
policies
that
have
tribal
implications."
The
final
action
does
not
have
tribal
implications
as
specified
in
Executive
Order
13175.

It
will
not
have
substantial
direct
effect
on
tribal
governments,
on
the
relationship
between
the
Federal
government
and
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
government
and
Indian
tribes,
as
specified
in
Executive
Order
13175.

Thus,
Executive
Order
13175
does
not
apply
to
today's
final
action.

G.
Executive
Order
13045,
Protection
of
Children
from
Environmental
Health
&
Safety
Risks
Executive
Order
13045
(
62
FR
19885,
April
23,
1997)

applies
to
any
rule
that:
(
1)
is
determined
to
be
"
economically
significant"
as
defined
under
Executive
Order
12866
and
(
2)
concerns
an
environmental
health
or
safety
risk
that
EPA
has
reason
to
believe
may
have
a
disproportionate
effect
on
children.
If
the
regulatory
action
meets
both
criteria,
EPA
must
evaluate
the
environmental
health
or
safety
effects
of
the
planned
rule
on
children,
and
explain
why
the
planned
regulation
is
preferable
to
other
potentially
effective
and
reasonably
feasible
alternatives
considered
by
EPA.

The
final
action
is
not
subject
to
the
Executive
Order
42
because
it
is
not
economically
significant
as
defined
in
Executive
Order
12866,
and
because
EPA
does
not
have
reason
to
believe
the
environmental
health
or
safety
risks
addressed
by
this
action
present
a
disproportionate
risk
to
children.

H.
Executive
Order
13211,
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
The
final
action
is
not
subject
to
Executive
Order
13211
(
66
FR
28355,
May
22,
2001)
because
it
is
not
an
economically
significant
regulatory
action
under
Executive
Order
12866.

I.
National
Technology
Transfer
Advancement
Act
Under
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
NTTAA),
Public
Law
No.
104­
113,

'
12(
d)
(
15
U.
S.
C.
272
note)
directs
EPA
to
use
voluntary
consensus
standards
(
VCS)
in
its
regulatory
activities,

unless
to
do
so
would
be
inconsistent
with
applicable
law
or
otherwise
impractical.
The
VCS
are
technical
standards
(
e.
g.,
materials
specifications,
test
methods,
sampling
procedures,
and
business
practices)
that
are
developed
or
adopted
VCS
bodies.
The
NTTAA
directs
EPA
to
provide
Congress,
through
OMB,
explanations
when
EPA
does
not
use
available
and
applicable
VCS.

The
final
action
does
not
involve
technical
standards.
43
Therefore,
EPA
is
not
considering
the
use
of
any
voluntary
consensus
standards.

J.
Congressional
Review
Act
The
Congressional
Review
Act,
5
U.
S.
C.
801
et
seq.,
as
added
by
the
Small
Business
Regulatory
Enforcement
Fairness
Act
of
1996,
generally
provides
that
before
a
rule
may
take
effect,

the
agency
promulgating
the
rule
must
submit
a
rule
report,

which
includes
a
copy
of
the
rule,
to
each
House
of
the
Congress
and
to
the
Comptroller
General
of
the
United
States.
The
EPA
will
submit
a
report
containing
the
final
action
and
other
required
information
to
the
U.
S.
Senate,

the
U.
S.
House
of
Representatives,
and
the
Comptroller
General
of
the
United
States
prior
to
publication
of
the
final
action
in
the
Federal
Register.
The
final
action
is
not
a
  
major
rule''
as
defined
by
5
U.
S.
C.
804(
2).
The
effective
date
of
this
final
action
is
[
INSERT
DATE
OF
PUBLICATION
OF
THE
FINAL
ACTION
IN
THE
FEDERAL
REGISTER].
Magnetic
Tape
Manufacturing
Operations
Page
44
of
44
List
of
Subjects
for
40
CFR
Part
63
Environmental
protection,
Administrative
practice
and
procedures,
Air
pollution
control,
Hazardous
substances,

Intergovernmental
relations,
Reporting
and
recordkeeping
requirements.

_________________
Dated:

______________________
Stephen
L.
Johnson,
Administrator.
