Document ID: EPA-HQ-OAR-2003-0197-0017
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2005-10-07T04:00Z

Changes
shown
starting
after
"
outline"
on
page
9
were
at
the
request
of
OMB.

6560­
50­
P
ENVIRONMENTAL
PROTECTION
AGENCY
40
CFR
Part
63
[
OAR­
2003­
0197;
FRL
­
]

RIN
2060­
AK09
Ethylene
Oxide
Emissions
Standards
for
Sterilization
Facilities
AGENCY:
Environmental
Protection
Agency
(
EPA).

ACTION:
Proposed
decision;
request
for
public
comment.

SUMMARY:
On
December
6,
1994,
we
promulgated
Ethylene
Oxide
Emission
Standards
for
Sterilization
Facilities
(
59
FR
62585).
The
national
emission
standards
limit
and
control
hazardous
air
pollutants
(
HAP)
that
are
known
or
suspected
to
cause
cancer
or
have
other
serious
health
or
environmental
effects.

Section
112(
f)(
2)
of
the
Clean
Air
Act
(
CAA)
directs
EPA
to
assess
the
risk
remaining
(
residual
risk)
after
the
application
of
national
emission
standards
controls
and
revise
as
necessary
to
protect
public
health.
Also,
CAA
section
112(
d)(
6)
requires
us
to
review
and
to
revise
the
national
emission
standards
as
necessary
by
taking
into
account
developments
in
practices,
processes,
and
control
technologies.
The
proposal
announces
a
decision
and
requests
public
comments
on
the
residual
risk
assessment
and
technology
review
for
the
national
emission
standards.
We
2
are
proposing
no
further
action
at
this
time
to
revise
the
national
emission
standards.

DATES:
Comments.
Submit
comments
on
or
before
[
INSERT
DATE
60
45
DAYS
AFTER
DATE
OF
PUBLICATION
OF
THIS
PROPOSED
ACTION
IN
THE
FEDERAL
REGISTER],
or
30
days
after
the
date
of
any
public
hearing,
if
later.

Public
Hearing.
If
anyone
contacts
the
EPA
requesting
to
speak
at
a
public
hearing
by
[
INSERT
DATE
20
15DAYS
AFTER
DATE
OF
PUBLICATION
OF
THIS
PROPOSED
ACTION
IN
THE
FEDERAL
REGISTER],
a
A
public
hearing
will
be
held
on
[
INSERT
DATE
2815
DAYS
AFTER
DATE
OF
PUBLICATION
OF
THIS
PROPOSED
ACTION
IN
THE
FEDERAL
REGISTER]
and
if
that
date
falls
on
a
weekend,
the
hearing
will
be
held
the
next
business
day.

ADDRESSES:
Submit
your
comments,
identified
by
Docket
ID
No.
OAR­
2003­
0197
(
Legacy
Docket
A­
88­
03),
by
one
of
the
following
methods:

$
Federal
eRulemaking
Portal:

http://
www.
regulations.
gov.
Follow
the
on­
line
instructions
for
submitting
comments.

$
Agency
Website:
http://
www.
epa.
gov/
edocket.

EDOCKET,
EPA's
electronic
public
docket
and
comment
system,
is
EPA's
preferred
method
for
receiving
comments.
Follow
the
on­
line
instructions
for
submitting
comments.

$
E­
mail:
a­
and­
r­
docket@
epa.
gov
$
Fax:
(
202)
566­
1741
3
$
Mail:
Air
Docket,
EPA,
Mailcode:
6102T,
1200
Pennsylvania
Avenue,
NW,
Washington,
DC
20460.

Please
include
a
total
of
two
copies.

$
Hand
Delivery:
EPA,
1301
Constitution
Avenue,
NW,

Room
B102,
Washington,
DC
20460.
Such
deliveries
are
only
accepted
during
the
Docket's
normal
hours
of
operation,
and
special
arrangements
should
be
made
for
deliveries
of
boxed
information.

Instructions:
Direct
your
comments
to
Docket
ID
No.

OAR­
2003­
0197
(
Legacy
Docket
A­
88­
03).
The
EPA's
policy
is
that
all
comments
received
will
be
included
in
the
public
docket
without
change
and
may
be
made
available
online
at
http://
www.
epa.
gov/
edocket,
including
any
personal
information
provided,
unless
the
comment
includes
information
claimed
to
be
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
Do
not
submit
information
that
you
consider
to
be
CBI
or
otherwise
protected
through
EDOCKET,
regulations.
gov,

or
e­
mail.
The
EPA
EDOCKET
and
the
federal
regulations.
gov
websites
are
"
anonymous
access"
systems,
which
means
EPA
will
not
know
your
identity
or
contact
information
unless
you
provide
it
in
the
body
of
your
comment.
If
you
send
an
e­
mail
comment
directly
to
EPA
without
going
through
EDOCKET
or
regulations.
gov,
your
e­
mail
address
will
be
automatically
captured
and
included
as
part
of
the
comment
that
is
placed
in
the
public
docket
and
made
available
on
4
the
Internet.
If
you
submit
an
electronic
comment,
EPA
recommends
that
you
include
your
name
and
other
contact
information
in
the
body
of
your
comment
and
with
any
disk
or
CD­
ROM
you
submit.
If
EPA
cannot
read
your
comment
due
to
technical
difficulties
and
cannot
contact
you
for
clarification,
EPA
may
not
be
able
to
consider
your
comment.

Electronic
files
should
avoid
the
use
of
special
characters,

any
form
of
encryption,
and
be
free
of
any
defects
or
viruses.

Docket:
All
documents
in
the
docket
are
listed
in
the
EDOCKET
index
at
http://
www.
epa.
gov/
edocket.
Although
listed
in
the
index,
some
information
is
not
publicly
available,
i.
e.,
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
in
EDOCKET
or
in
hard
copy
at
the
Air
and
Radiation
Docket,
EPA/
DC,
EPA
West,
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
is
(
202)
566­
1744,
and
the
telephone
number
for
the
Air
and
Radiation
Docket
is
(
202)
566­
1742.

Public
Hearing.
If
a
The
public
hearing
is
held,
it
will
begin
at
10:
00
a.
m.
and
will
be
held
at
the
EPA
5
facility
complex
in
Research
Triangle
Park,
North
Carolina,

or
at
an
alternate
facility
nearby.
Persons
interested
in
presenting
oral
testimony
or
inquiring
as
to
whether
a
public
hearing
is
to
be
held
must
contact
Mr.
David
Markwordt,
Policy,
Planning
and
Standards
Group
(
C439­
04),

Emission
Standards
Division,
EPA,
Research
Triangle
Park,
NC
27711,
telephone
(
919)
541­
0837
at
least
2
days
in
advance
of
the
hearing.

Persons
interested
in
attending
the
public
hearing
should
also
call
Mr.
Markwordt
to
verify
the
time,
date,
and
location
of
the
hearing.
The
public
hearing
will
provide
interested
parties
the
opportunity
to
present
data,
views,

or
arguments
concerning
the
proposed
action.
at
least
2
days
in
advance
of
the
hearing.
See
FOR
FURTHER
INFORMATION
CONTACT
section
below
for
Mr.
Markwordt's
contact
information.
If
no
one
contacts
Mr.
Markwordt
in
advance
of
the
hearing
with
a
request
to
present
oral
testimony
at
the
hearing,
we
will
cancel
the
hearing.

The
public
hearing
will
provide
interested
parties
the
opportunity
to
present
data,
views,
or
arguments
concerning
the
proposed
action.

FOR
FURTHER
INFORMATION
CONTACT:
For
questions
on
the
decision
on
the
technology
review,
contact
Mr.
David
Markwordt,
EPA,
Office
of
Air
Quality
Planning
and
Standards
(
OAQPS),
Emission
Standards
Division,
Planning
and
Standards
Group
(
C439­
04),
Research
Triangle
Park,
North
Carolina
6
27711,
telephone
(
919)
541­
0837,
facsimile
number
(
919)
541­
0942,
electronic
mail
(
e­
mail)
address:

"
markwordt.
david@
epa.
gov."
For
questions
on
the
residual
risk
analysis,
contact
Mr.
Mark
Morris,
EPA,
OAQPS,
Emission
Standards
Division,
Risk
and
Exposure
Assessment
Group
(
C404­
01),
Research
Triangle
Park,
North
Carolina
27711,

telephone
(
919)
541­
5416,
facsimile
number
(
919)
541­
0840,

electronic
mail
(
e­
mail)
address:
"
morris.
mark@
epa.
gov."

For
additional
information
on
this
proposed
decision,
review
the
reports
listed
in
the
SUPPLEMENTARY
INFORMATION
section.

General
and
technical
information.
Mr.
David
Markwordt,

EPA,
Office
of
Air
Quality
Planning
and
Standards,
Emission
Standards
Division,
Planning
and
Standards
Group
(
C439­
04),

Research
Triangle
Park,
North
Carolina
27711,
telephone
(
919)
541­
0837,
facsimile
number
(
919)
541­
0942,
electronic
mail
(
e­
mail)
address:
"
markwordt.
david@
epa.
gov."

Residual
risk
assessment
information.
Mr.
Mark
Morris,

EPA,
OAQPS,
Emission
Standards
Division,
Risk
and
Exposure
Assessment
Group
(
C404­
01),
Research
Triangle
Park,
North
Carolina
27711,
telephone
(
919)
541­
5416,
facsimile
number
(
919)
541­
0840,
electronic
mail
(
e­
mail)
address:

"
morris.
mark@
epa.
gov."

SUPPLEMENTARY
INFORMATION:

Regulated
Entities.
The
regulated
categories
and
entities
affected
by
the
national
emission
standards
include:
7
Category
NAICS*
Examples
of
regulated
entities
Industry....
3841,3842...........
2834,5122,2831,2833.
2099,5149,2034,2035,
2046................
7399,7218,8091......
Medical
suppliers
Pharmaceuticals
Spice
manufacturers
Contract
sterilizers
*
North
American
Information
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
national
emission
standards.
To
determine
whether
your
facility
would
be
affected
by
the
national
emission
standards,
you
should
examine
the
applicability
criteria
in
40
CFR
63.360.
If
you
have
any
questions
regarding
the
applicability
of
the
national
emission
standards
to
a
particular
entity,
consult
the
person
listed
in
the
preceeding
FOR
FURTHER
INFORMATION
CONTACT
section.

either
the
air
permit
authority
for
the
entity
or
your
EPA
regional
representative
as
listed
in
40
CFR
63.13.

Worldwide
Web
(
WWW).
In
addition
to
being
available
in
the
docket,
an
electronic
copy
of
today's
proposed
decision
will
also
be
available
on
the
WWW
through
the
Technology
Transfer
Network
(
TTN).
Following
signature,
a
copy
of
the
proposed
decision
will
be
posted
on
the
TTN's
policy
and
guidance
page
for
newly
proposed
or
promulgated
rules
at
the
following
address:
http://
www.
epa.
gov/
ttn/
oarpg/.
The
TTN
provides
information
and
technology
exchange
in
various
areas
of
air
pollution
control.
If
more
information
8
regarding
the
TTN
is
needed,
call
the
TTN
HELP
line
at
(
919)

541­
5384.

Reports
for
Public
Comment.
We
have
prepared
two
summary
memoranda
covering
the
rationale
for
the
proposed
decision
and
the
residual
risk
analyses.
These
memoranda
are
entitled:
"
Technology
Review
and
Residual
Risk
Development
for
the
Ethylene
Oxide
Commercial
Sterilization
NESHAP,"
and
"
Residual
Risk
Assessment
for
the
Ethylene
Oxide
Commercial
Sterilization
Source
Category."
Both
reports
are
in
the
Docket
No.
OAR­
2003­
0197
(
Legacy
Docket
A­
88­
03).
See
the
preceding
Docket
section
for
docket
information
and
availability.

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

I.
Background
A.
What
is
the
statutory
authority
for
these
actions?
B.
What
is
our
approach
for
developing
residual
risk
standards?
C.
What
are
the
current
standards?
D.
What
are
the
results
of
the
residual
risk
assessment?
E.
What
are
our
conclusions
regarding
the
need
for
more
stringent
standards
under
section
112(
f)(
2)?
F.
How
are
we
addressing
GACT
at
Area
Sources
for
purposes
of
Section
112(
f)?

G.
What
are
the
results
of
the
technology
review?

II.
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
9
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
&
Safety
Risks
H.
Executive
Order
13211:
Actions
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
I.
National
Technology
Transfer
Advancement
Act
I.
Background
A.
What
is
the
statutory
authority
for
these
actions?

Section
112
of
the
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
national
emission
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
10
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.

On
December
6,
1994,
59
FR
62585,
we
promulgated
national
emission
standards
for
Ethylene
Oxide
Commercial
Sterilization
and
Fumigation
Operations.
In
that
final
rule,
we
set
MACT
for
major
sources
under
section
112(
d)(
2).

As
for
area
sources,
we
established
a
MACT
standard
for
certain
emission
points
pursuant
to
section
112(
d)(
2),
and
a
GACT
standard
for
other
emission
points
pursuant
to
section
112(
d)(
5).

The
EPA
is
then
required
to
Section
112(
d)(
6)
provides
that
EPA
review
these
technology­
based
standards
and
to
revise
them
"
as
necessary
(
taking
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,
first,

that
EPA
prepare
a
Report
to
Congress
discussing
(
among
other
things)
methods
of
calculating
risk
posed
(
or
potentially
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
effects
to
persons
in
proximity
to
emitting
sources,
11
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
phase.

Section
112(
f)(
2)
requires
us
to
determine
for
each
section
112(
d)
source
category
whether
the
national
emission
standards
protect
public
health
with
an
ample
margin
of
safety.
If
the
national
emission
standards
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
one
in
one
million,"

EPA
must
promulgate
residual
risk
standards
for
the
source
category
(
or
subcategory)
which
as
necessary
to
provide
an
ample
margin
of
safety.
The
EPA
must
also
adopt
more
stringent
standards
to
prevent
an
adverse
environmental
effect
(
defined
in
section
112(
a)(
7)
as
"
any
significant
and
widespread
adverse
effect
.
.
.
to
wildlife,
aquatic
life,

or
natural
resources
.
.
.."),
but
must
consider
cost,

energy,
safety,
and
other
relevant
factors
in
doing
so.

Section
112(
f)(
5)
expressly
provides,
however,
that
EPA
is
not
required
to
conduct
any
review
under
section
112(
f)

or
promulgate
any
emissions
limitations
under
that
subsection
for
any
area
source
listed
pursuant
to
section
12
112(
c)(
3)
for
which
EPA
has
issued
GACT
standards.
Thus,

although
EPA
has
discretion
to
conduct
a
residual
risk
review
under
section
112(
f)
for
area
sources
for
which
it
has
established
GACT,
it
is
not
required
to
do
so.
See
CAA
section
112(
f)(
5).

B.
What
is
our
approach
for
developing
residual
risk
standards?

Following
our
initial
determination
that
the
risk
to
the
individual
most
exposed
to
emissions
from
a
source
in
the
category
for
the
emissions
category
considered
exceeds
a
1­
in­
1
million
lifetime
excess
cancer
risk,
our
approach
to
developing
residual
risk
standards
is
based
on
a
two­
step
determination
of
acceptable
risk
and
ample
margin
of
safety.

The
first
step,
consideration
of
acceptable
risk,
is
only
a
starting
point
for
the
analysis
that
determines
the
final
standards.
The
second
step
determines
the
ample
margin
of
safety
which
corresponds
to
the
levels
at
which
the
standards
are
set.

The
terms
"
individual
most
exposed,"
"
acceptable
level,"
and
"
ample
margin
of
safety"
are
not
specifically
defined
in
the
CAA.
However,
section
112(
f)(
2)(
B)
retains
EPA's
interpretation
of
the
terms
"
acceptable
level"
and
"
ample
margin
of
safety"
provided
in
our
1989
rulemaking
(
54
FR
38044,
September
14,1989),
However,
CAA
section
112(
f)(
2)(
B)
refers
positively
to
the
interpretation
of
these
terms
in
our
1989
rulemaking
(
54
FR
38044,
September
13
1
This
reading
is
confirmed
by
the
Legislative
History
to
CAA
section
112(
f);
see,
e.
g.,
"
A
Legislative
History
of
the
Clean
Air
Act
Amendments
of
1990,"
vol.
1,
page
877
(
Senate
Debate
on
Conference
Report).

2
Legislative
History,
vol.
1,
p.
877,
stating,
".
.
.
[
T]
the
managers
intend
that
the
Administrator
shall
interpret
this
requirement
[
to
establish
standards
reflecting
an
ample
margin
of
safety]
in
a
manner
no
less
protective
of
the
most
exposed
individual
than
the
policy
set
forth
in
the
Administrator's
benzene
regulations
.
.
.."

3
"
Residual
Risk
Report
to
Congress,"
March
1999,
EPA­
453/
R­
99­
001,
page
ES­
11.
at
page
ES­
11,
EPA­
453/
R­
99­
001
(
March
1999).
EPA
prepared
this
Report
to
Congress
in
accordance
with
CAA
section
112(
f)(
1).
The
Report
discusses
(
among
other
things)
methods
of
calculating
risk
posed
(
or
potentially
posed)
by
sources
after
implementation
of
the
NESHAP,
the
public
health
significance
of
those
risks,
the
means
and
costs
of
controlling
them,
actual
health
effects
to
persons
in
proximity
to
emitting
sources,
and
recommendations
as
14,
1989),"
National
Emission
Standards
for
Hazardous
Air
Pollutants
(
NESHAP):
Benzene
Emissions
from
Maleic
Anhydride
Plants,
Ethylbenzene/
Styrene
Plants,
Benzene
Storage
Vessels,
Benzene
Equipment
Leaks,
and
Coke
By­
Product
Recovery
Plants,"
(
Benzene
NESHAP).
We
read
CAA
section
112(
f)(
2)(
B)
as
essentially
directing
EPA
us
to
use
the
interpretation
set
out
in
that
notice1
or
to
utilize
approaches
affording
at
least
the
same
level
of
protection.
2
We
likewise
notified
Congress
in
our
"
Residual
Risk
Report
to
Congress"
its
Residual
Risk
Report
that
we
intended
to
use
the
Benzene
NESHAP
approach
in
making
CAA
section
112(
f)

residual
risk
determinations.
3
14
to
legislation
regarding
such
remaining
risk.

4
Id.
at
B­
4.
In
the
Benzene
NESHAP
(
54
FR
38044­
45,
September
14,1989),
we
stated
as
an
overall
objective:

...
i[
I]
n
protecting
public
health
with
an
ample
margin
of
safety,
we
strive
to
provide
maximum
feasible
protection
against
risks
to
health
from
hazardous
air
pollutants
by:
(
1)
protecting
the
greatest
number
of
persons
possible
to
an
individual
lifetime
risk
level
no
higher
than
approximately
1
in
1
million;
and
(
2)
limiting
to
no
higher
than
approximately
1
in
10
thousand
[
i.
e.,
100
in
a
million]
the
estimated
risk
that
a
person
living
near
a
facility
would
have
if
he
or
she
were
exposed
to
the
maximum
pollutant
concentrations
for
70
years.

As
explained
more
fully
in
our
Residual
Risk
Report
to
Congress,
these
goals
are
not
"
rigid
line[
s]
for
acceptability,"
but
rather
broad
objectives
to
be
weighed
"
with
a
series
of
other
health
measures
and
factors."
4
C.
What
are
the
current
standards?

The
Ethylene
Oxide
Emission
Standards
for
Sterilization
Facilities
were
promulgated
on
December
6,

1994
(
59
FR
62585)
and
cover
ethylene
oxide,
the
only
HAP
emitted
from
the
sterilization/
fumigation
process.
The
national
emission
standards
regulate
both
major
and
area
sources;
the
emission
points
regulated
are
the
main
sterilization
and
aeration
room
vents.
The
standards
for
major
sources
require
that
sources
reduce
main
sterilization
and
aeration
room
vent
emissions
by
99
percent.
The
standards
for
area
sources
require
that
15
sources
reduce
main
sterilization
vent
emissions
by
99
percent.

During
the
development
of
the
national
emission
standards,
we
estimated
that
there
were
approximately
188
facilities
nationwide,
of
which
47
were
major
sources.

Usually,
these
operations
are
not
located
at
facilities
with
other
types
of
HAP­
emitting
sources.
The
majority
of
sterilization
facilities
process
on
a
contract
basis,
but
some
medical
supply
and
spice
manufacturers
sterilize
their
own
products.
We
estimated
that
the
national
emission
standards
would
reduce
emissions
of
ethylene
oxide
by
1,000
tons
annually.

D.
What
are
the
results
of
the
residual
risk
assessment?

As
required
by
Pursuant
to
CAA
section
112(
f)(
2),
we
prepared
a
risk
assessment
to
determine
the
residual
risk
posed
by
ethylene
oxide
sterilization
facilities
after
implementation
of
the
ethylene
oxide
national
emission
standards.
The
number
of
facilities
in
the
source
category
has
decreased
since
the
development
of
the
national
emission
standards
for
various
reasons,
including
industry
consolidation.
We
developed
a
list
of
76
facilities
that
currently
comprises
both
the
entire
major
and
area
source
categoryies,
based
on
information
primarily
from
the
following
three
sources:
(
1)
the
1999
National
Emissions
Inventory
(
NEI),
(
2)
the
2000
Toxics
Release
Inventory
(
TRI),
and
(
3)
the
Ethylene
Oxide
Sterilization
Association
16
(
EOSA).
We
used
these
data
sources
for
emissions
and
emission
point
release
parameters
in
dispersion
modeling.

As
stated
previously,
consistent
with
Section
112(
f)(
2),
EPA
must
determine
for
each
section
112(
d)

source
category
whether
the
MACT
standards
protect
public
health
with
an
ample
margin
of
safety.
Because
MACT
and
GACT
are
both
required
of
some
area
sources,
risk
attributed
to
GACT
emission
points
are
included
in
the
over
all
modeled
risks
for
MACT.
Therefore,
the
risks
presented
below
are
higher
than
just
those
risks
attributed
solely
to
emission
points
for
which
we
established
MACT
in
1994.

Using
this
the
above­
noted
information,
we
modeled
ambient
concentrations
near
these
facilities
and
calculated
the
risk
of
possible
chronic
cancer
and
noncancer
health
effects
and
evaluated
whether
acute
exposures
might
exceed
relevant
health
thresholds.
We
found
that
individual
lifetime
cancer
risks
exceeded
1­
in­
1
million
in
areas
near
44
of
the
76
modeled
sources,
and
approximately
250,000
people
live
in
these
areas.
Individual
lifetime
cancer
risks
exceeded
10­
in­
1
million
in
areas
near
19
sources,

and
approximately
7,300
people
live
in
these
areas.
The
highest
calculated
individual
lifetime
cancer
risk
was
90­

in­
1
million
at
one
facility.

An
EPA
assessment
for
ethylene
oxide
is
currently
under
way.
The
EPA
has
not
yet
completed
a
full
evaluation
of
the
data
on
which
it
will
determine
an
EPA
cancer
unit
17
risk
estimate
for
ethylene
oxide.
When
that
evaluation
is
complete,
the
resulting
unit
risk
estimate
for
ethylene
oxide
could
be
higher
than
the
California
EPA
(
CalEPA)

cancer
unit
risk
factor
used
in
the
risk
assessment
for
the
source
category.
The
EPA
is
also
developing
an
acute
reference
exposure
value
for
ethylene
oxide,
which
could
be
lower
than
the
acute
benchmarks
used
in
the
risk
assessment.
The
schedule
for
both
of
these
actions
can
be
found
at:
http://
cfpub.
epa.
gov/
iristrac.

Under
section
112(
o)(
7)
of
the
CAA,
we
are
required
to
issue
revised
cancer
guidelines
prior
to
the
promulgation
of
the
first
residual
risk
rule
under
section
112(
f)
(
an
implication
being
that
we
should
consider
these
revisions
in
the
various
residual
risk
rules).
We
have
issued
revised
cancer
guidelines
and
also
supplemental
guidance
which
deal
specifically
with
assessing
the
potential
added
susceptibility
from
early­
life
exposure
to
carcinogens.

The
supplemental
guidance
provides
an
approach
for
adjusting
risk
estimates
to
incorporate
the
potential
for
increased
risk
due
to
early­
life
exposures
to
chemicals
that
are
thought
to
be
carcinogenic
by
a
mutagenic
mode
of
action.
We
are
currently
evaluating
the
available
scientific
information
associated
with
ethylene
oxide
to
see
if
"
age
dependent
adjustment
factors"
should
be
applied
when
assessing
cancer
risk
for
early­
life
exposures
which
cause
cancer
through
a
mutagenic
mode.
If
the
scientific
18
information
indicates
that
it
is
appropriate
to
apply
age
dependent
adjustment
factors,
then
we
will
reassess
the
risks
from
exposure
to
ethylene
oxide
prior
to
the
promulgation
of
the
final
rule.

Estimated
annual
cancer
incidence
rates
were
also
calculated
from
predicted
individual
cancer
risks
for
the
people
reported
to
reside
in
the
U.
S.
census
blocks
within
the
modeled
area
around
each
facility
(
i.
e.,
within
50
kilometers).
For
the
44
facilities
for
which
estimated
maximum
individual
cancer
risk
is
greater
than
1­
in­
1
million,
the
summed
estimated
annual
cancer
incidence
is
0.01
cases
per
year.
Across
all
76
modeled
facilities,
the
total
estimated
annual
incidence
is
0.04
cases
per
year.

We
estimated
that
values
presented
here
are
incremental
rates
based
on
modeled
concentrations
and
2000
U.
S.
census
data,
and
they
should
not
be
interpreted
as
actual
cancer
incidence
rates
derived
from
observations
of
disease
occurrence
over
time
(
such
as
cancer
incidence
rates
that
may
be
reported
based
on
epidemiological
studies).

The
highest
chronic
noncancer
hazard
index
was
0.03.

This
means
that
the
highest
lifetime
exposures
to
ethylene
oxide
were
only
3
percent
of
the
chronic
noncancer
reference
concentration
(
RfC).
Finally,
we
found
that
acute
exposures,
which
were
calculated
by
assuming
the
maximum
hourly
emissions
rate
and
worst­
case
meteorological
conditions,
did
not
exceed
any
of
the
relevant
health
19
thresholds
for
acute
effects
for
ethylene
oxide.

We
are
also
required
to
consider
an
adverse
impacts
environmental
effect
to
the
environment
(
e.
g.,
ecological
risks)
as
a
part
of
a
residual
risk
assessment.
Regarding
the
inhalation
exposure
pathway
for
terrestrial
mammals,
we
contend
conclude
that
human
toxicity
values
for
the
inhalation
pathway
are
generally
protective
of
terrestrial
mammals.
Because
the
maximum
cancer
and
noncancer
hazards
to
humans
from
inhalation
exposure
are
relatively
low,
we
expect
there
to
be
no
significant
and
widespread
adverse
effects
to
terrestrial
mammals
from
inhalation
exposure
to
ethylene
oxide
from
commercial
sterilization
facilities.

Some
HAP
which
are
persistent
and
bioaccumulative
can
also
pose
risks
via
pathways
other
than
inhalation
(
e.
g.,

by
depositing
to
the
ground
and
entering
the
food
chain).

The
EPA
has
developed
a
list
of
persistent,

bioaccumulative,
and
toxic
(
PBT)
HAP
based
on
information
from
the
Pollution
Prevention
program,
the
Great
Waters
program,
the
TRI,
and
additional
analysis
conducted
by
the
Office
of
Air
Quality
Planning
and
Standards.
Ethylene
oxide
is
not
on
the
list
of
PBT.
Consequently,
we
conclude
the
noninhalation
risks
to
be
minimal
for
this
source
category,
and
we
conclude
that
a
quantitative
risk
assessment
for
multipathway
exposures
is
unnecessary.

The
details
of
this
analysis
can
be
found
in
our
"
Memorandum:
Data
and
Assumptions
Used
for
the
Screening­
20
5
Although
we
conducted
a
risk
assessment
which
included
emissions
from
those
vents
for
which
we
set
GACT
in
1994,
we
are
exercising
our
discretion
under
section
112(
f)(
5)
not
to
undertake
the
112
(
f)(
2)
analysis
for
those
GACT
emission
points.
See
CAA
sections
112(
f)(
2)(
A),(
B)
and
(
f)(
5).
The
discussion
in
this
section
of
the
preamble,
therefore,
is
limited
to
those
emission
points
for
which
we
established
MACT
in
1994.
level
Residual
Risk
Analysis
of
the
Commercial
Ethylene
Oxide
Sterilizers
and
Fumigators
Source
Category"
and
the
supporting
"
Memorandum:
Residual
Risk
Assessment
for
Ethylene
Oxide
Commercial
Sterilization
Source
Category."

See
"
Reports
for
Public
Comment"
in
the
SUPPLEMENTARY
INFORMATION
section
above
for
information
on
obtaining
these
reports.

E.
What
are
our
conclusions
regarding
the
need
for
more
stringent
standards
under
section
112(
f)(
2)?

In
the
first
step
of
the
decision­
making
process
under
section
112(
f)(
2),
the
determination
of
acceptability,
we
note
that
the
maximum
individual
excess
lifetime
cancer
risk
associated
with
any
facility
with
MACT
in
the
category
is
less
than
what
we
would
normally
consider
as
the
upper
limit
of
acceptable
risk
(
i.
e.,
less
than
100­
in­
1
million).
5
Therefore,
we
are
satisfied
that
these
sources
represent
acceptable
risk
without
the
need
for
further
more
stringent
controls.

In
the
second
step
of
the
ample
margin
of
safety
framework
under
section
112(
f)(
2),
we
consider
setting
standards
at
a
level
which
may
be
equal
to,
or
lower
than,
21
the
acceptable
risk
level
and
which
protects
public
health
with
an
ample
margin
of
safety.
In
making
the
determination,
we
considered
the
estimate
of
health
risk
and
other
health
information
along
with
additional
factors
relating
to
the
appropriate
level
of
control,
including
costs
and
economic
impacts
of
controls,
technological
feasibility,
uncertainties,
and
other
relevant
factors.

Because
our
conservative
risk
estimates
suggest
facilities
in
the
category
continue
to
pose
risks
exceeding
1­
in­
1
million
after
the
application
of
MACT,
we
considered
additional
controls,
such
as
new
technology
or
alternative
controls,
to
reduce
emissions
and
associated
risks.
In
2001,
while
investigating
the
safety
issue
associated
with
chamber
exhaust
vents,
we
did
not
find
any
new
technology
or
alternative
controls
for
any
of
the
vents­­
chamber,

sterilizer
or
aeration
room
vents.
We
also
found
no
data
to
support
the
addition
of
down
stream
control
devices
to
existing
control
means
as
a
way
of
further
reducing
emissions.
This
discussion
can
be
found
in
our
"
Memorandum:
Technology
Review
and
Residual
Risk
Data
Development
for
the
Ethylene
Oxide
Commercial
Sterilization
NESHAP."
We
concluded
that
further
controls
would
not
meaningfully
reduce
emissions
at
controlled
from
emission
vents
controlled
with
MACT
at
both
major
and
area
sources.

For
uncontrolled
vents
at
area
sources,
we
concluded
no
additional
control
should
be
required
because
an
ample
22
margin
of
safety
(
considering
cost,
technical
feasibility,

and
other
factors)
has
been
achieved
by
the
national
emission
standards.

While
no
additional
control
measures
for
controlled
emission
vents
controlled
with
MACT
have
been
identified
that
would
result
in
a
meaningful
reduction
of
emissions,

we
are
aware
of
existing
State
rules
which
have
control
limits
exceeding
the
99
percent
MACT
requirement.
The
State
of
California's
emissions
reductions
requirement
for
the
main
sterilizer
vent
is
99.9
percent;
this
requirement
was
enacted
prior
to
promulgation
of
the
Federal
requirements.

We
do
not
have
data
to
confirm
that
all
facilities
are
capable
of
achieving
99.9
percent
on
a
continuous
basis.

In
1994,
in
support
of
the
Federal
control
limit,
we
concluded
both
rules
are
sufficiently
stringent
to
require
application
of
the
same
technologies.
We
concluded
it
reasonable
to
assume
the
same
technologies
perform
similarly,
i.
e.,
those
facilities
outside
of
California
are
on
average
likely
to
achieve
emissions
reductions
similar
to
those
in
California.
We
concluded
that
tightening
the
current
standards
would
not
meaningfully
reduce
risks.

The
EPA
requests
comments
specifically
addressing
our
conclusion
that
the
tightening
of
the
current
standards
would
not
meaningfully
reduce
emissions
or
risks.
Both
EPA's
and
California's
rules
require
a
test
to
demonstrate
23
compliance
with
the
emissions
reductions
limit
and
continuous
monitoring
of
the
control
equipment
to
ensure
proper
operation
and
maintenance.
Initial
compliance
tests
are
performed
one
time
and
on
a
very
narrow
set
of
operating
conditions.
The
test
results
are
too
limited
to
determine
if
there
are
any
meaningful
differences
in
control
technology
lifetime
performance
associated
with
a
99
percent
and
99.9
percent
performance
limit.
Specifically,
there
are
several
questions
on
which
we
are
requesting
public
comment:

Are
there
available
test
data
demonstrating
achievability
of
99.9
percent
emissions
reductions
on
a
continuous
basis
for
the
main
sterilizer
vent?

Are
there
available
test
data
demonstrating
a
meaningful
difference
in
lifetime
control
performance
between
the
same
technology
when
it
is
subject
to
either
the
99
or
99.9
percent
emissions
reductions
requirement?

Are
there
available
test
data
demonstrating
all
similar
existing
control
technology
is
capable
of
achieving
99.9
percent
emissions
reductions
on
a
continuous
basis?

Are
there
available
data
showing
the
variance
in
long­
term
performance
for
similar
technology
complying
with
the
99
or
99.9
percent
emissions
reductions
limit?
24

Are
there
additional
costs
associated
with
increasing
the
percent
reduction
from
99
to
99.9
percent?

In
the
original
generally
available
control
technology
(
GACT)
determination
for
area
sources,
no
control
requirements
were
established
for
aeration
room
vents
and
main
sterilizer
vents
with
less
than
1
ton
per
year
of
ethylene
oxide
use
due
to
the
high
cost
(
59
FR
10598­
99).

There
are
two
uncontrolled
area
sources
with
estimated
risk
exceeding
1­
in­
1
million
with
the
highest
cancer
risk
at
17­
in­
1
million.
Controls
would
reduce
risk
at
the
plant
with
17­
in­
1
million
risk
below
1­
in­
1
million
risk
at
a
cost
effectiveness
of
approximately
$
50,000
per
ton.

We
also
considered
prohibiting
the
use
of
ethylene
oxide
for
new
facilities,
which
would
necessitate
the
use
of
an
alternative
sterilization
process.
The
Food
and
Drug
Administration
(
FDA)
has
primary
authority
to
regulate
the
use
of
sterilization
methods.
The
FDA
issued
guidance
(
510(
k)
Sterility
Review
Guidance
K90­
1,
August
30,
2002
("
FDA
Guidance"))
to
facilitate
nontraditional
sterilization
methods.
The
FDA
stated
in
the
guidance
that
the
FDA
"
has
had
little
or
no
experience
with
these
methods
for
achieving
sterilization
and
is
concerned
about
a
manufacturer's
ability
to
successfully
use
such
methods
without
adversely
affecting
the
sterility
assurance
level
.
.
.."
If
the
use
of
ethylene
oxide
were
prohibited,
manufacturers
of
products
25
requiring
sterilization
would
have
to
reconsider
the
device
and
packaging
material,
its
compatibility
with
the
nontraditional
sterilizing
agent,
the
packaging
configuration,
the
ability
of
the
nontraditional
sterilant
to
penetrate
the
packaging,
the
cost,
and
availability.

Because
these
nontraditional
sterilization
methods
are
less
known,
manufacturers
would
have
to
submit
to
FDA
their
validation
data
for
review.
Nontraditional
sterilization
operations
cannot
be
used
to
sterilize
materials
until
they
have
been
validated.
Prohibiting
the
use
of
ethylene
oxide
carries
the
risk
of
creating
a
void
where
some
products
may
not
be
able
to
be
sterilized
until
newer
systems
are
designed
and
validated.
Until
such
time
as
these
nontraditional
sterilization
techniques
may
be
used
under
FDA
rules,
these
techniques
are
not
considered
available
for
the
purpose
of
reducing
emissions.

Radiation
(
gamma
and
electron
beam)
can
be
used
to
sterilize
many
products.
Radiation
sterilization
has
been
used
for
about
half
of
the
products
sterilized
in
the
U.
S.

However,
these
sterilization
techniques
are
limited
in
their
applications.
For
example,
gamma
radiation
has
potentially
damaging
effects
on
products,
particularly
those
products
that
contain
polymers.
And,
radiation
technology
is
completely
different
from
chamber
sterilization.
Ethylene
oxide
and
radiation
technologies
(
both
gamma
and
e­
beam)

share
no
common
equipment.
Any
conversion
would
involve
26
scrapping
the
ethylene
oxide
chambers
and
the
related
specialized
equipment
and
systems,
and
likely
displacing
the
existing
workforce.
Additionally,
the
ethylene
oxide
sterilization
facility
would
not
meet
requirements
for
a
radiation
facility.
To
construct
a
radiation
facility,

special
shielding
(
huge
concrete/
lead
shields)
and
storage
pools
need
to
be
incorporated
into
the
design
of
both
the
building
and
the
process.

As
stated
previously,
further
controls
for
controlled
emission
vents
controlled
with
MACT
at
both
major
and
area
sources
do
not
meaningfully
reduce
emissions
or
the
corresponding
risks.,
and
control
requirements
at
uncontrolled
area
source
vents
would
achieve
minimal
risk
reduction
at
a
very
high
cost.
Further,
the
review
has
shown
that
both
the
noncancer
and
acute
risks
from
this
source
category
are
below
their
relevant
health
thresholds.

As
a
result,
we
conclude
that
no
additional
control
should
be
required
because
an
ample
margin
of
safety
(
considering
cost,
technical
feasibility,
and
other
factors)
has
been
achieved
by
the
national
emission
standards.

Thus,
we
conclude
that
the
level
of
risk
resulting
from
the
limits
in
the
national
emission
standards
is
acceptable
for
this
these
source
category
categories,
and
that
changes
to
the
national
emission
standards
are
not
required
to
satisfy
section
112(
f)
of
the
CAA.

As
discussed
above,
the
EPA
is
developing
a
cancer
unit
27
risk
estimate
for
ethylene
oxide
that
could
be
higher
than
the
CalEPA
value
used
in
the
risk
assessment.
If
the
EPA
value
becomes
available
before
the
promulgation
of
the
final
rule,
and
that
value
is
higher
than
the
value
used
in
the
risk
assessment
supporting
this
conclusion,
we
will
reevaluate
whether
the
risks
are
acceptable
and
whether
an
ample
margin
of
safety
has
been
achieved.

F.
How
are
we
addressing
GACT
at
Area
Sources
for
purposes
of
Section
112(
f)?

As
noted
above,
section
112(
f)(
5)
provides
that
EPA
may,
but
is
not
required
to,
conduct
any
review
under
section
112(
f)
or
promulgate
any
emissions
limitations
under
that
subsection
for
any
area
source
for
which
an
emissions
standard
is
promugated
as
GACT.
The
CAA
clearly
permits
EPA
to
review
area
source
emissions
under
112(
f)(
2),
even
when
the
agency
issued
GACT
standards
under
section
112(
d)(
5)

during
its
initial
review.
What
is
less
clear
is
what
the
approach
should
be
when
the
agency
has
"
mixed"
its
emission
standards
(
i.
e.,
issued
both
MACT
and
GACT
standards)
for
an
area
source
category.
In
this
instance,
for
example,
EPA
has
issued
MACT
standards,
under
section
112(
d)(
1),
for
sterilizer
vents
and
chamber
exhaust
vents
and
GACT
standards,
under
section
112(
d)(
5),
for
aeration
room
vents.

This
leaves
open
the
question
of
which
emissions
points
28
should
be
reviewed
under
a
subsequent
section
112(
f)(
2)

review.
In
this
instance,
EPA
has
undertaken
an
analysis
under
112(
f)(
2)
for
the
area
emissions
standards
that
were
issued
as
MACT
standards,
but
the
agency
has
exercised
its
discretion
and
chosen
not
perform
an
112(
f)(
2)
analysis
for
those
emissions
points
for
which
we
established
GACT.
The
agency
may
have
other
alternatives
legally
available,

however.
For
example,
because
the
Administrator
is
not
required
to
perform
a
residual
risk
analysis
for
any
area
source
category
when
the
agency
has
previously
promulgated
"
an
emissions
standard"
pursuant
to
112(
d)(
5),
it
is
at
least
arguable
that,
by
using
the
singular
article
"
an",

Congress
intended
to
permit
the
agency
discretion
to
decline
to
review
the
area
source
category,
in
its
entirety,
under
section
112(
f)(
2)
in
appropriate
"
mixed"
cases.
The
agency
seeks
comment
on
the
agency's
range
of
discretion
under
112(
f)(
5)
and
suggestions
on
what
factors
should
guide
future
decisions
about
its
approach
in
future
rulemakings.

FG.
What
are
the
results
of
the
technology
review?

Section
112(
d)(
6)
of
the
CAA
requires
us
to
review
and
revise
as
necessary
(
taking
into
account
developments
in
practices,
processes,
and
control
technologies)
emission
standards
promulgated
under
this
section
no
less
often
than
every
8
years.
As
described
earlier
in
this
preamble,
29
during
the
ample
margin
of
safety
analysis,
which
considered
technical
feasibility,
cost,
and
emissions
reductions,
In
the
course
of
our
review,
we
investigated
emission
control
levels
and
the
potential
for
additional
emissions
reductions
from
existing
affected
facilities
within
the
ethylene
oxide
commercial
sterilization
source
category.
Because
the
three
vents
associated
with
these
facilities,
i.
e.,
the
main
sterilization,
aeration
room,
and
chamber
exhaust
emission
vents,
are
the
same
for
both
major
and
area
sources,
the
conclusions
concerning
technology
apply
to
both
source
categories.
We
found
that
additional
controls
for
emission
vents
controlled
with
either
MACT
or
GACT
would
achieve
at
best,
such
as
new
technology
or
other
alternatives,
would
not
meaningfully
reduce
risk
minimal
emission
and
risk
reductions
at
a
very
high
cost.
In
our
review,
we
did
not
identify
any
significant
developments
in
practices,

processes,
or
control
technologies
since
promulgation
of
the
national
emission
standards
in
1994.

For
new
major
sources
affected
facilities
where
MACT
requires
an
emission
reduction
of
99%,
we
considered
increasing
the
emissions
reductions
limit
to
99.9
percent
in
the
national
emission
standards.
A
new
limit
would
only
apply
to
affected
new
sources
(
a
new
facility
for
the
standards),
while
existing
sources
would
still
be
subject
to
the
current
limits.
As
stated
previously,
we
do
not
have
data
to
confirm
that
facilities
are
capable
of
achieving
30
99.9
percent
on
a
continuous
basis.
Therefore,
the
99
percent
emissions
reductions
requirement
of
the
national
emission
standards
is
considered
to
be
the
best
control
level
in
practice
nationally.
We
conclude
that
the
new
source
standard
for
the
emissions
reductions
limit
should
be
kept
the
same
as
that
for
existing,
and
that
no
further
revisions
to
the
National
Emission
Standards
for
Ethylene
Oxide
Sterilization
Facilities
are
needed.

In
the
original
generally
available
control
technology
(
GACT)
determination
for
new
area
sources,
no
control
requirements
were
established
due
to
the
high
cost
(
59
FR
10598­
99).
In
our
review,
we
did
not
identify
any
significant
developments
in
practices,
processes,
or
control
technologies
since
promulgation
of
the
national
emission
standards
in
1994
which
would
reduce
the
costs
of
applying
controls
to
new
area
sources.

Because
the
national
emission
standards
continue
to
represent
the
best
controls
that
can
be
implemented
nationally,
we
are
proposing
not
to
revise
the
National
Emission
Standards
for
Ethylene
Oxide
Sterilization
Facilities
under
CAA
section
112(
f)
or
112(
d)(
6).

II.
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
regulation
is
31
"
significant"
and,
therefore,
subject
to
Office
of
Management
and
Budget
(
OMB)
review
and
the
requirements
of
the
Executive
Order.
The
Executive
Order
defines
"
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
government
communities;

(
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
or
policy
issues
arising
out
of
legal
mandates,
the
President's
priorities,
or
the
principles
set
forth
in
the
Executive
Order.

It
has
been
determined
that
today's
proposed
decision
is
a
"
significant
regulatory
action"
under
the
terms
of
Executive
Order
12866
because
it
raises
novel
legal
or
policy
issues
arising
out
of
legal
mandates,
the
President's
priorities,
or
the
principles
set
forth
in
the
Executive
Order.
Therefore,
today's
proposed
decision
was
submitted
to
OMB
for
review.
However,
today's
proposed
decision
will
result
in
no
additional
cost
impacts
beyond
those
estimated
32
for
the
current
national
emission
standards.
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
new
information
collection
burden
under
the
provisions
of
the
Paperwork
Reduction
Act,
44
U.
S.
C.
et
seq.
Today's
proposed
decision
will
not
change
the
burden
estimates
from
those
developed
and
approved
for
the
national
emission
standards.
In
1994,

OMB
approved
the
information
collection
requirements
for
the
national
emission
standards
under
the
provisions
of
the
Paperwork
Reduction
Act,
44
U.
S.
C.
3501
et
seq.,
and
assigned
OMB
control
number
2060­
0325,
for
ICR
1659.05.

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
33
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
are
listed
in
40
CFR
part
9
and
48
CFR
chapter
15.

EPA
has
established
a
public
docket
for
this
action,

which
includes
the
ICR,
under
Docket
ID
number
2003­
0197,

which
can
be
found
in
www.
epa.
gov/
edocket.
Today's
proposed
decision
will
not
change
the
burden
estimates
from
those
developed
and
approved
in
1994
for
the
national
emission
standards.

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
impacts
of
today's
proposed
decision
on
small
entities,
small
entity
is
defined
as:
(
1)
a
small
business
whose
parent
company
has
fewer
than
100
or
1,500
employees,
or
a
maximum
of
$
5
million
to
$
18.5
34
million
in
revenues,
depending
on
the
size
definition
for
the
affected
North
American
Industry
Classification
System
(
NAICS)
code;
(
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.
It
should
be
noted
that
the
small
business
definition
applied
to
each
industry
by
NAICS
code
is
that
listed
in
the
Small
Business
Administration
(
SBA)
size
standards
(
13
CFR
121).

After
considering
the
economic
impacts
of
today's
proposed
decision
on
small
entities,
I
certify
that
the
decision
will
not
have
a
significant
economic
impact
on
a
substantial
number
of
small
entities.
The
proposed
decision
will
not
impose
any
requirements
on
small
entities.
Today's
proposal
announces
a
decision
and
requests
public
comments
on
the
residual
risk
assessment
and
technology
review
for
the
national
emission
standards
and
imposes
no
additional
burden
on
facilities
impacted
by
the
national
emission
standards.
We
are
proposing
no
further
action
at
this
time
to
revise
the
national
emission
standards.
We
continue
to
be
interested
in
the
potential
impacts
of
the
proposed
decision
on
small
entities
and
welcome
comments
on
issues
related
to
such
impacts.

D.
Unfunded
Mandates
Reform
Act
35
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
UMRA),
Public
Law
104­
4,
establishes
requirements
for
Federal
agencies
to
assess
the
effects
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
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
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
36
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
today's
proposed
decision
does
not
contain
a
Federal
mandate
that
may
result
in
expenditures
of
$
100
million
or
more
to
State,
local,
and
tribal
governments
in
the
aggregate,
or
to
the
private
sector
in
any
1
year.
Therefore,
today's
proposed
decision
is
not
subject
to
the
requirements
of
sections
202
and
205
of
the
UMRA.
In
addition,
today's
proposed
decision
does
not
significantly
or
uniquely
affect
small
governments
because
it
contains
no
requirements
that
apply
to
such
governments
or
impose
obligations
upon
them.
Therefore,

today's
proposed
decision
is
not
subject
to
section
203
of
the
UMRA.

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"
is
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
proposed
decision
does
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.

Thus,
the
requirements
of
the
Executive
Order
do
not
apply
to
today's
proposed
decision.

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
6,
2000),
requires
EPA
to
develop
an
accountable
process
to
ensure
"
meaningful
and
timely
input
by
tribal
officials
in
the
development
of
regulatory
policies
that
have
tribal
implications."
"
Policies
that
have
tribal
implications"
is
defined
in
the
Executive
Order
to
include
regulations
that
have
"
substantial
direct
effects
on
one
or
more
Indian
tribes,
on
the
relationship
between
the
Federal
government
and
the
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
government
and
Indian
tribes."

Today's
proposed
decision
does
not
have
tribal
implications.
It
will
not
have
substantial
direct
effects
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
proposed
decision.

G.
Executive
Order
13045:
Protection
of
Children
from
Environmental
Health
and
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
the
Agency.

Today's
proposed
decision
is
not
subject
to
the
Executive
Order
because
it
is
not
economically
significant
as
defined
in
Executive
Order
12866
and
because
the
Agency
does
not
have
reason
to
believe
the
environmental
health
or
safety
risk
addressed
by
this
action
present
a
disproportionate
risk
to
children.
The
public
is
invited
to
submit
or
identify
peer­
reviewed
studies
and
data,
of
which
39
the
Agency
may
not
be
aware,
that
assessed
results
of
early
life
exposure
to
ethylene
oxide
commercial
sterilization
facility
emissions.

H.
Executive
Order
13211:
Actions
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
Today's
proposed
decision
is
not
a
"
significant
energy
action"
as
defined
in
Executive
Order
13211
(
66
FR
28355,

May
22,
2001),
because
it
is
not
likely
to
have
a
significant
adverse
effect
on
the
supply,
distribution,
or
use
of
energy.

Further,
we
have
concluded
that
today's
proposed
decision
is
not
likely
to
have
any
adverse
energy
impacts.

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

all
Federal
agencies
are
required
to
use
voluntary
consensus
standards
(
VCS)
in
their
regulatory
and
procurement
activities
unless
to
do
so
would
be
inconsistent
with
applicable
law
or
otherwise
impractical.
Voluntary
consensus
standards
are
technical
standards
(
e.
g.,
materials
specifications,
test
methods,
sampling
procedures,
business
practices)
developed
or
adopted
by
one
or
more
voluntary
consensus
bodies.
The
NTTAA
requires
Federal
agencies
to
provide
Congress,
through
annual
reports
to
OMB,
with
explanations
when
the
agency
does
not
use
available
and
applicable
VCS.

Today's
proposed
decision
does
not
involve
technical
40
standards.
Therefore,
the
requirements
of
the
NTTAA
are
not
applicable.

Ethylene
Oxide
Emissions
Standards
for
Sterilization
Facilities
­
Page
37
of
37
List
of
Subjects
in
40
CFR
Part
63
Environmental
protection,
Administrative
practice
and
procedures,
Air
pollution
control,
Intergovernmental
relations,
Reporting
and
recordkeeping
requirements.

Dated:

Stephen
L.
Johnson
Administrator