Document ID: EPA-HQ-OECA-2003-0033-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2004-02-26T05:00Z

1
Facilities
that
use
limited
amounts
of
ethylene
oxide
(
EO),
as
specified
in
Sections
63.362
and
63.367,
are
only
required
to
record
EO
use
on
a
monthly
basis.
This
Information
Collection
Request
(
ICR)
estimates
that
10
percent
or
approximately
12
facilities
subject
to
this
standard
record
EO
use
on
a
monthly
basis.
SF­
83
SUPPORTING
STATEMENT
ENVIRONMENTAL
PROTECTION
AGENCY
NESHAP
for
Ethylene
Oxide
Emissions
from
Sterilization
Facilities
(
40
CFR
part
63,
subpart
O)
(
Renewal)

1.
Identification
of
the
Information
Collection
1(
a)
Title
of
the
Information
Collection
NESHAP
for
Ethylene
Oxide
Emissions
from
Sterilization
Facilities
(
40
CFR
part
63,
subpart
O)
(
Renewal)

1(
b)
Short
Characterization/
Abstract
The
National
Emission
Standards
for
Hazardous
Air
Pollutants
(
NESHAP)
for
the
regulations
published
at
40
CFR
part
63,
subpart
O
were
proposed
on
March
7,
1997,
and
promulgated
on
December
6,
1994.
These
regulations
apply
to
new
and
existing
commercial
ethylene
oxide
(
EO)
sterilization
and
fumigation
facilities
using
1
ton
of
EO
(
as
defined
in
40
CFR
Section
63.361)
after
December
6,
1994.
This
information
is
being
collected
to
assure
compliance
with
part
63,
subpart
O.

In
general,
all
NESHAP
standards
require
initial
notifications,
performance
tests,
and
periodic
reports.
Owners
or
operators
are
also
required
to
maintain
records
of
the
occurrence
and
duration
of
any
startup,
shutdown,
or
malfunction
in
the
operation
of
an
affected
facility,
or
any
period
during
which
the
monitoring
system
is
inoperative.
These
notifications,
reports,
and
records
are
essential
in
determining
compliance,
and
are
required
of
all
sources
subject
to
NESHAP.

Any
owner
or
operator
subject
to
the
provisions
of
this
part
shall
maintain
a
file
of
these
measurements,
and
retain
the
file
for
at
least
five
years
following
the
date
of
such
measurements,
maintenance
reports,
and
records.
All
reports
are
sent
to
the
delegated
state
or
local
authority.
In
the
event
that
there
is
no
such
delegated
authority,
the
reports
are
sent
directly
to
the
United
States
Environmental
Protection
Agency
(
EPA)
regional
office.

We
estimate
that
there
will
be
an
average
of
119
facilities
subject
to
this
regulation
over
the
next
three
years1.
In
addition,
we
estimate
that
two
(
2)
new
or
reconstructed
facilities
will
become
subject
to
the
subpart
O
standards
per
year
over
the
next
three
years.
The
Ethylene
Oxide
Sterilization
Association,
which
represents
the
vast
majority
of
facilities
subject
to
this
standard,
was
consulted
to
determine
these
estimates.
2
The
Office
of
Management
and
Budget
(
OMB)
approved
the
currently
active
information
collection
request
(
ICR)
without
any
"
Terms
of
Clearance."

2.
Need
for
and
Use
of
the
Collection
2(
a)
Need/
Authority
for
the
Collection
The
EPA
is
charged
under
Section
112
of
the
Clean
Air
Act,
as
amended,
to
establish
standards
of
performance
for
each
category
or
subcategory
of
major
sources
and
area
sources
of
hazardous
air
pollutants.
These
standards
are
applicable
to
new
or
existing
sources
of
hazardous
air
pollutants
and
shall
require
the
maximum
degree
of
emission
reduction.
In
addition,
Section
114(
a)
states
that
the
Administrator
may
require
any
owner
or
operator
subject
to
any
requirement
of
this
Act
to:

(
A)
Establish
and
maintain
such
records;
(
B)
make
such
reports;
(
C)
install,
use,
and
maintain
such
monitoring
equipment,
and
use
such
audit
procedures,
or
methods;
(
D)
sample
such
emissions
(
in
accordance
with
such
procedures
or
methods,
at
such
locations,
at
such
intervals,
during
such
periods,
and
in
such
manner
as
the
Administrator
shall
prescribe);
(
E)
keep
records
on
control
equipment
parameters,
production
variables
or
other
indirect
data
when
direct
monitoring
of
emissions
is
impractical;
(
F)
submit
compliance
certifications
in
accordance
with
Section
114(
a)(
3);
and
(
G)
provide
such
other
information
as
the
Administrator
may
reasonably
require.

In
the
Administrator's
judgment,
EO
emissions
from
sterilization
facilities
cause
or
contribute
to
air
pollution
that
may
reasonably
be
anticipated
to
endanger
public
health
or
welfare.
Therefore,
the
NESHAP
were
promulgated
for
this
source
category
at
40
CFR
part
63,
subpart
O.

2(
b)
Practical
Utility/
Users
of
the
Data
The
control
of
EO
emissions
from
sterilization
facilities
requires
not
only
the
installation
of
properly
designed
equipment,
but
also
the
operation
and
maintenance
of
that
equipment.
Emissions
of
EO
from
sterilization
facilities
are
the
result
of
operation
of
sterilization
chambers.
The
subject
standards
are
achieved
by
the
reduction
of
EO
emissions
using
acid­
water
scrubbers
or
catalytic/
thermal
oxidizers.
The
notifications
required
in
the
applicable
regulations
are
used
to
inform
the
Agency
or
delegated
authority
when
a
source
becomes
subject
to
the
requirements
of
the
regulations.
The
reviewing
authority
may
then
inspect
the
source
to
check
if
the
acid­
water
scrubbers
or
catalytic
oxidizers
or
thermal
oxidizers
are
operating
properly
and
the
regulations
are
3
being
met.
Performance
test
reports
are
needed
as
these
are
the
Agency's
record
of
a
source's
initial
capability
to
comply
with
the
emission
standards,
and
serve
as
a
record
of
the
operating
conditions
under
which
compliance
was
achieved.
The
semiannual
reports
are
used
for
problem
identification,
as
a
check
on
source
operation
and
maintenance,
and
for
compliance
determinations.
The
information
generated
by
the
monitoring,
recordkeeping
and
reporting
requirements
described
in
this
ICR
is
used
by
the
Agency
to
ensure
that
facilities
affected
by
the
NESHAP
continue
to
operate
the
control
equipment
in
compliance
with
the
regulation.
Adequate
monitoring,
recordkeeping,
and
reporting
are
necessary
to
ensure
compliance
with
the
applicable
regulations,
as
required
by
the
Clean
Air
Act.
The
information
collected
from
recordkeeping
and
reporting
requirements
is
also
used
for
targeting
inspections,
and
is
of
sufficient
quality
to
be
used
as
evidence
in
court.
This
standard
relies
on
acid­
water
scrubbers
or
catalytic/
thermal
oxidizers
to
reduce
emissions
of
EO.
The
notifications
required
in
the
applicable
regulations
are
used
to
inform
the
Agency
or
delegated
authority
when
a
source
becomes
subject
to
the
requirements
of
the
regulations.
The
reviewing
authority
may
then
inspect
the
source
to
check
if
the
pollution
control
devices
are
properly
installed
and
operated,
that
leaks
are
being
detected
and
repaired,
and
that
the
regulations
are
being
met.
Performance
test
reports
are
needed
as
these
are
the
Agency's
record
of
a
source's
initial
capability
to
comply
with
the
emission
standards,
and
serve
as
a
record
of
the
operating
conditions
under
which
compliance
was
achieved.

The
semiannual
reports
are
used
for
problem
identification,
as
a
check
on
source
operation
and
maintenance,
and
for
compliance
determinations.
The
information
generated
by
the
monitoring,
recordkeeping,
and
reporting
requirements
described
in
this
ICR
is
used
by
the
Agency
to
ensure
that
facilities
affected
by
the
NESHAP
continue
to
operate
the
control
equipment
in
compliance
with
the
regulation.
Adequate
monitoring,
recordkeeping,
and
reporting
are
necessary
to
ensure
compliance
with
the
applicable
regulations,
as
required
by
the
Clean
Air
Act.
The
information
collected
from
recordkeeping
and
reporting
requirements
is
also
used
for
targeting
inspections,
and
is
of
sufficient
quality
to
be
used
as
evidence
in
court.

3.
Nonduplication,
Consultations,
and
Other
Collection
Criteria
The
requested
recordkeeping
and
reporting
are
required
under
40
CFR
part
63,
subpart
O.

3(
a)
Nonduplication
If
the
subject
standards
have
not
been
delegated,
the
information
is
sent
directly
to
the
appropriate
EPA
regional
office.
Otherwise,
the
information
is
sent
directly
to
the
delegated
state
or
local
agency.
If
a
state
or
local
agency
has
adopted
their
own
similar
standards
to
implement
the
Federal
standards,
a
copy
of
the
report
submitted
to
the
state
or
local
agency
can
be
sent
to
the
Administrator
in
lieu
of
the
report
required
by
the
Federal
standards.
Therefore,
no
duplication
exists.
4
3(
b)
Public
Notice
Required
Prior
to
ICR
Submission
to
OMB
An
announcement
of
a
public
comment
period
for
the
renewal
of
this
ICR
was
published
in
the
Federal
Register
(
68
FR
27059)
on
May
19,
2003.
No
comments
were
received
on
the
burden
published
in
the
Federal
Register.

3(
c)
Consultations
In
estimating
the
burden
associated
with
this
standard,
EPA
consulted
with
Joe
Hadley,
Executive
Director,
Ethylene
Oxide
Sterilization
Association
at
(
202)
296­
6300.
Members
of
the
Ethylene
Oxide
Sterilization
Association
include
the
vast
majority
of
the
facilities
subject
to
this
standard.
As
part
of
this
consultation,
Mr.
Hadley
provided
an
estimate
of
the
affected
number
of
sources
subject
to
the
standard
and
provided
information
on
the
expected
growth
rate
of
the
EO
sterilization
industry.
The
association
estimates
that
there
are
approximately
117
existing
facilities
subject
to
this
standard
and
that
only
a
limited
number
of
new
facilities
will
become
subject
to
the
standard
over
the
next
three
years.
Based
on
this
consultation,
we
estimate
that
only
two
(
2)
facilities,
one
new
construction
and
one
reconstruction,
will
become
subject
to
the
standard
each
year
over
the
next
three
years.
Therefore,
over
the
next
three
years,
the
average
number
of
facilities
subject
to
this
standard
is
estimated
to
be
119.
Of
these
119
facilities,
we
estimate
that
10
percent,
or
approximately
12
facilities,
will
use
limited
amounts
of
EO
and,
therefore,
will
only
be
required
to
maintain
records
of
EO­
use
as
specified
in
Sections
63.362
and
63.367
of
the
standard.
In
addition,
we
assume
that
the
two
(
2)
new
facilities
added
per
year
will
not
be
limited
EO­
use
facilities
and
will
be
subject
to
the
emission
reduction
requirements
in
the
standard.

3(
d)
Effects
of
Less
Frequent
Collection
Less
frequent
information
collection
would
decrease
the
margin
of
assurance
that
facilities
are
continuing
to
meet
the
standards.
Requirements
for
information
gathering
and
recordkeeping
are
useful
techniques
to
ensure
that
good
operation
and
maintenance
practices
are
applied
and
emission
limitations
are
met.
If
the
information
required
by
these
standards
was
collected
less
frequently,
the
likelihood
of
detecting
poor
operation
and
maintenance
of
control
equipment
and
noncompliance
would
decrease.

3(
e)
General
Guidelines
None
of
these
reporting
or
recordkeeping
requirements
violate
any
of
the
regulations
established
by
OMB
at
5
CFR
Part
1320,
Section
1320.5.

These
standards
require
affected
facilities
to
maintain
all
records,
including
reports
and
notifications
for
at
least
five
years.
This
is
consistent
with
the
General
Provisions
as
applied
to
the
standards.
EPA
believes
that
the
five­
year
records
retention
requirement
is
consistent
the
part
70
5
permit
program
and
the
five­
year
statute
of
limitations
on
which
the
permit
program
is
based.
Also,
the
retention
of
records
for
five
years
would
allow
EPA
to
establish
the
compliance
history
of
a
source
and
any
pattern
of
compliance
for
purposes
of
determining
the
appropriate
level
of
enforcement
action.
Historically,
EPA
has
found
that
the
most
flagrant
violators
frequently
have
violations
extending
beyond
the
five
years.
EPA
would
be
prevented
from
pursuing
the
worst
violators
due
to
the
destruction
or
nonexistence
of
records
if
records
were
retained
for
less
than
five
years.

3(
f)
Confidentiality
Any
information
submitted
to
the
Agency
for
which
a
claim
of
confidentiality
is
made
will
be
safeguarded
according
to
the
Agency
policies
set
forth
in
Title
40,
chapter
1,
part
2,
Subpart
B
­
Confidentiality
of
Business
Information
(
see
40
CFR
2;
41
FR
36902,
September
1,
1976;
amended
by
43
FR
40000,
September
8,
1978;
43
FR
42251,
September
20,
1978;
44
FR
17674,
March
23,
1979).

3(
g)
Sensitive
Questions
None
of
the
reporting
or
recordkeeping
requirements
contain
sensitive
questions.

4.
The
Respondents
and
the
Information
Requested
4(
a)
Respondents/
SIC
and
NAICS
Codes
Respondents
are
owners
or
operators
of
commercial
EO
sterilization
facilities.
The
United
States
Standard
Industrial
Classification
(
SIC)
codes
and
corresponding
North
American
Industry
Classification
System
(
NAICS)
codes
for
EO
sterilization
facilities
are
listed
in
the
table
below.

Standard
Description
SIC
Codes
NAICS
Codes
40
CFR
part
63,
subpart
O
Medical
Equipment
Suppliers
3841,
3842
339112,
339113,

Pharmaceutical
Suppliers
2832,
2833,
2834,
5122
325411,
325412,
42221
Other
Health­
Related
Facilities
2211,
2821,
2879,
3069,
3079,
3569,
3677,
3693,
3999,
5086
31321,
325211,
32532,
333999,
334416,
337127
6
Standard
Description
SIC
Codes
NAICS
Codes
Spice
Manufacturers
2034,
2035,
2046,
2099,
5149
311423,
311421,
311941,
311942,
42249
Contract
Sterilizers
7218,
7399,
8091
812332
Libraries,
Museums,
and
Archives
8231,
8411
51412,
71211
Laboratories
0279,
7391,
7397,
8071,
8922
112519,
54199,
621512,
621511,
54169
4(
b)
Information
Requested
(
i)
Data
Items
All
data
in
this
ICR
that
is
recorded
and/
or
reported
is
required
by
the
NESHAP
for
Ethylene
Oxide
Emissions
from
Sterilization
Facilities
(
40
CFR
part
63,
subpart
O)

A
source
must
make
the
following
reports:

Notification
Reports
Notification
of
Applicability
63.9(
a)

Notification
of
Construction/
Reconstruction
63.9(
b)(
3)
and
(
4)

Notification
of
Actual
Start­
up
63.9(
b)(
2)
and
(
4)

Notification
of
Initial
Performance
Test
63.9(
e)

Notification
of
Compliance
Status
63.9(
h)

Requests
for
Extension
of
Compliance
63.9(
c)

Requests
for
Waivers
63.7(
h)

Request
for
Alternative
Methods/
Monitoring
63.8(
f)
7
Monitoring
Reports
Report
of
performance
test
results
63.10(
d)(
2)

Reports
of
noncompliance
(
including
excess
emission
reports)
63.10(
e)(
3)

A
source
must
keep
the
following
records:

Recordkeeping
Records
of
control
equipment
maintenance;
inspections;
malfunctions
(
occurrence,
duration,
and
corrections);
continuous
monitoring
systems
malfunctions
or
in
operations;
calibrations
and
parameters;
measurements
to
demonstrate
compliance;
performance
test
results;
daily
and
monthly
inspections;
and
documents
supporting
initial
notifications
and
notification
of
compliance
status
63.10(
c)(
1)
and
(
5),
63.10(
b)(
2)(
ii),
(
iv­
xii),
(
xiv)

Retain
records
for
five
years
following
the
date
of
each
occurrence,
measurement,
corrective
action,
maintenance
record,
or
report.
The
most
recent
two
years
of
records
must
be
retained
at
the
facility.
63.7(
g)(
3),
63.10(
b)(
1)

Emission
testing
(
occurrence/
duration)
63.10(
b)(
2)(
ii),
(
vi­
xii),
(
xiv)

Records
of
EO
use
(
retain
records
for
five
years)
63.9(
b)(
2)

Electronic
Reporting
Currently,
sources
are
using
monitoring
equipment
that
provides
parameter
data
in
an
automated
way,
e.
g.,
leaks
and
spills
of
mercury.
Although
personnel
at
the
source
still
need
to
evaluate
the
data,
this
type
of
monitoring
equipment
has
significantly
reduced
the
burden
associated
with
monitoring
and
recordkeeping.
In
addition,
some
regulatory
agencies
are
setting
up
electronic
reporting
systems
to
allow
sources
to
report
electronically
which
is
reducing
the
reporting
burden.
However,
electronic
reporting
systems
are
still
not
widely
used
by
the
regulatory
agencies.
It
is
estimated
that
approximately
10
percent
of
the
respondents
use
electronic
reporting.

(
ii)
Respondent
Activities
8
Respondent
Activities
Read
instructions.

All
monitoring
systems
and
equipment
must
be
installed,
operational,
and
properly
calibrated
before
the
performance
test.

Perform
initial
performance
test,
using
the
control
device
efficiency
procedures
in
Section
63.365
including
reference
methods
2,
2A,
2C,
or
2D
for
measuring
flow
rates,
18
or
25A
for
measuring
the
concentration
of
EO,
and
the
sampling
analysis
procedures
in
ASTM
D
3695­
88
for
measuring
ethylene
glycol
concentrations.
All
tests
are
repeated
if
necessary.

Write
the
notifications
and
reports
listed
above.

Enter
information
required
to
be
recorded
above.

Submit
the
required
reports
developing,
acquiring,
installing,
and
utilizing
technology
and
systems
for
the
purpose
of
collecting,
validating,
and
verifying
information.

Develop,
acquire,
install,
and
utilize
technology
and
systems
for
the
purpose
of
processing
and
maintaining
information.

Develop,
acquire,
install,
and
utilize
technology
and
systems
for
the
purpose
of
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.

Transmit,
or
otherwise
disclose
the
information.

5.
The
Information
Collected:
Agency
Activities,
Collection
Methodology,
and
Information
Management
5(
a)
Agency
Activities
EPA
conducts
the
following
activities
in
connection
with
the
acquisition,
analysis,
storage,
and
distribution
of
the
required
information.
9
Agency
Activities
Observe
initial
performance
tests
and
repeat
performance
tests
if
necessary.

Review
notifications
and
reports,
including
performance
test
reports,
and
excess
emissions
reports,
required
to
be
submitted
by
industry.

Audit
facility
records.

Input,
analyze,
and
maintain
data
in
the
Air
Facility
System
(
AFS).

5(
b)
Collection
Methodology
and
Management
Following
notification
of
startup,
the
reviewing
authority
might
inspect
the
source
to
determine
whether
the
pollution
control
devices
are
properly
installed
and
operated.
Performance
test
reports
are
used
by
the
Agency
to
discern
a
source's
initial
capability
to
comply
with
the
emission
standard.
Data
and
records
maintained
by
the
respondents
are
tabulated
and
published
for
use
in
compliance
and
enforcement
programs.
The
semiannual
reports
are
used
for
problem
identification,
as
a
check
on
source
operation
and
maintenance,
and
for
compliance
determinations.

Information
contained
in
the
reports
is
entered
into
the
AFS
which
is
operated
and
maintained
by
EPA's
Office
of
Compliance.
AFS
is
EPA's
database
for
the
collection,
maintenance,
and
retrieval
of
compliance
and
annual
emission
inventory
data
for
more
than
100,000
industrial
and
government­
owned
facilities.
EPA
uses
the
AFS
for
tracking
air
pollution
compliance
and
enforcement
by
local
and
state
regulatory
agencies,
EPA
regional
offices
and
EPA
headquarters.
EPA
and
its
delegated
Authorities
can
edit,
store,
retrieve
and
analyze
the
data.

The
records
required
by
this
regulation
must
be
retained
by
the
owner
or
operator
for
five
years.

5(
c)
Small
Entity
Flexibility
A
majority
of
the
affected
facilities
are
large
entities
(
e.
g.,
large
businesses).
However,
the
impact
on
small
entities
(
i.
e.,
small
businesses)
was
taken
into
consideration
during
the
development
of
the
regulation.
Due
to
technical
considerations
involving
the
process
operations
and
the
types
of
control
equipment
employed,
the
recordkeeping
and
reporting
requirements
are
the
same
for
both
small
and
large
entities.
The
Agency
considers
these
requirements
the
minimum
needed
to
ensure
compliance
and,
therefore,
cannot
reduce
them
further
for
small
entities.
To
the
extent
that
larger
businesses
can
use
economies
of
scale
to
reduce
their
burden,
the
overall
burden
will
be
reduced.
10
5(
d)
Collection
Schedule
The
specific
frequency
for
each
information
collection
activity
within
this
request
is
shown
in
Table
1:
Annual
Burden
of
Reporting
and
Recordkeeping
Requirements,
National
Emission
Standards
for
Hazardous
Air
Pollutants
(
NESHAP)
for
Ethylene
Oxide
Emissions
from
Sterilization
Facilities
(
40
CFR
part
63,
subpart
O).

6.
Estimating
the
Burden
and
Cost
of
the
Collection
Table
1
documents
the
computation
of
individual
burdens
for
the
recordkeeping
and
reporting
requirements
applicable
to
the
industry
for
the
subpart
included
in
this
ICR.
The
individual
burdens
are
expressed
under
standardized
headings
believed
to
be
consistent
with
the
concept
of
burden
under
the
Paperwork
Reduction
Act.
Where
appropriate,
specific
tasks
and
major
assumptions
have
been
identified.
Responses
to
this
information
collection
are
mandatory.

The
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.

6(
a)
Estimating
Respondent
Burden
The
average
annual
burden
to
industry
over
the
next
three
years
from
these
recordkeeping
and
reporting
requirements
is
estimated
to
be
8,662
hours.
These
hours
are
based
on
Agency
studies
and
background
documents
from
the
development
of
the
regulation,
Agency
knowledge
and
experience
with
the
NESHAP
program,
the
previously
approved
ICR,
and
any
comments
received.

6(
b)
Estimating
Respondent
Costs
(
i)
Estimating
Labor
Costs
This
ICR
uses
the
following
labor
rates:
$
93.09
per
hour
for
Executive,
Administrative,
and
Managerial
labor;
$
64.13
per
hour
for
Technical
labor,
and
$
39.65
per
hour
for
Clerical
labor.
These
rates
are
from
the
United
States
Department
of
Labor,
Bureau
of
Labor
Statistics,
June
2003,
"
Table
10.
Private
industry,
by
occupational
and
industry
group."
The
following
rates
are
from
column
1,
"
Total
compensation."
The
rates
have
been
increased
by
110
percent
to
account
for
the
benefit
packages
available
to
those
employed
by
private
industry.

Managerial
$
93.09
($
44.33
+
110%)
Technical
$
64.13
($
30.54
+
110%)
11
2
The
cost
of
the
computer
and
gas
chromatograph
are
estimated
to
be
$
2,500
and
$
30,000
respectively.
Clerical
$
39.65
($
18.88
+
110%)

(
ii)
Estimating
Capital/
Startup
and
Operation
and
Maintenance
Costs
The
type
of
industry
costs
associated
with
the
information
collection
activities
in
the
subject
standard(
s)
are
both
labor
costs
which
are
addressed
elsewhere
in
this
ICR
and
the
costs
associated
with
continuous
monitoring.
The
capital/
startup
costs
are
one­
time
costs
when
a
facility
becomes
subject
to
the
regulation.
The
annual
operation
and
maintenance
costs
are
the
ongoing
costs
to
maintain
the
monitor(
s)
and
other
costs
such
as
photocopying
and
postage.

(
iii)
Capital/
Startup
vs.
Operation
and
Maintenance
(
O&
M)
Costs
Capital/
Startup
vs.
Operation
and
Maintenance
(
O&
M)
Costs
(
A)
Continuous
Monitoring
Device
(
B)
Capital/
Startu
p
Cost
for
One
Respondent
(
C)
Number
of
New
Respondents
(
D)
Total
Capital/
Startup
Cost
(
BxC)
(
E)
Annual
O&
M
Costs
for
One
Respondent
(
F)
Number
of
Respondents
with
O&
M
(
G)
Total
O&
M,
(
ExF)

Computer
equipment
and
gas
chromatograph
used
to
continuously
monitor
EO
emissions
to
aeration
room
and
back
chamber
vents.
2
$
32,500
2
$
65,000
$
5,500
106
$
583,000
The
total
capital/
startup
costs
for
this
ICR
are
$
65,000.
This
is
the
total
of
column
D
in
the
above
table.
These
costs
are
shown
on
the
OMB
83­
I
form
in
block
14(
a),
Total
annualized
capital/
startup
costs.

The
total
operation
and
maintenance
(
O&
M)
costs
for
this
ICR
are
estimated
to
be
$
583,000.
This
is
the
total
of
column
G.
These
costs
are
shown
on
the
OMB
83­
I
form
in
block
14(
b),
Total
annual
costs
(
O&
M).

The
total
respondent
costs
in
block
14
have
been
calculated
as
the
addition
of
the
12
capital/
startup
costs,
and
the
annual
operation
and
maintenance
costs.
The
average
annual
cost
for
capital/
startup
and
operation
and
maintenance
costs
to
industry
over
the
next
three
years
of
the
ICR
is
estimated
to
be
$
648,000.
This
cost
is
shown
on
the
OMB
83­
I
form
in
block
14(
c),
Total
annualized
cost
requested.
The
numbers
in
block
14
of
the
OMB
83­
I
form
are
rounded
to
show
the
cost
in
thousands
of
dollars.
The
continuous
monitoring
costs
that
are
included
in
this
section
consist
only
of
those
capital/
startup
and
O&
M
costs
that
a
source
incurs
as
a
result
of
the
standard.
Some
continuous
monitoring
costs
may
not
be
included
in
this
section.
For
instance,
if
a
particular
industry
typically
utilizes
a
control
device
that
must
have
a
continuous
monitor
(
e.
g.,
temperature,
pressure
drop,
etc.)
to
function
properly,
and
the
recordkeeping
of
additional
measurements
beyond
the
minimum
is
required
by
the
standard,
then
there
is
no
capital/
startup
or
O&
M
cost,
but
there
is
a
labor
cost
to
record
the
additional
readings.
Such
a
cost
would
not
appear
in
this
section,
but
in
the
industry
burden
Section
6(
d)
below.

6(
c)
Estimating
Agency
Burden
and
Cost
The
only
costs
to
the
Agency
are
those
costs
associated
with
analysis
of
the
reported
information.
EPA's
overall
compliance
and
enforcement
program
includes
activities
such
as
the
examination
of
records
maintained
by
the
respondents,
periodic
inspection
of
sources
of
emissions,
and
the
publication
and
distribution
of
collected
information.

The
average
annual
Agency
cost
during
the
three
years
of
the
ICR
is
estimated
to
be
$
24,200.
This
ICR
uses
the
following
labor
rates:

Managerial
$
53.22
(
GS­
13,
Step
5,
$
33.26
x
1.6)
Technical
$
39.49
(
GS­
12,
Step
1,
$
24.68
x
1.6)
Clerical
$
21.38
(
GS­
6,
Step
3,
$
13.36
x
1.6)

These
rates
are
from
the
Office
of
Personnel
Management
(
OPM)
"
2003
General
Schedule"
which
excludes
locality
rates
of
pay.
These
rates
can
be
obtained
from
the
OPM
web
site,
http://
www.
opm.
gov/
oca/
payrates/
index/
htm.
Details
upon
which
this
estimate
is
based
appear
in
Table
2:
Annual
Agency
Burden
and
Cost,
NESHAP
for
Ethylene
Oxide
Emissions
from
Sterilization
Facilities,
attached.

6(
d)
Estimating
the
Respondent
Universe
and
Total
Burden
and
Costs
Based
on
our
research
for
this
ICR,
an
average
of
119
facilities
are
subject
to
the
standard
over
the
next
three
years.
However,
we
estimate
that
10
percent
or
approximately
12
facilities,
will
use
only
limited
amounts
of
EO
as
specific
in
Sections
63.362
and
63.367
and
therefore
will
not
be
required
to
submit
reports.
It
is
also
estimated
that
two
(
2)
new
or
reconstructed
sources
will
become
subject
to
the
regulation
in
the
next
three
years
and
that
both
of
these
facilities
will
be
required
to
submit
reports.
13
3
New
respondents
include
sources
with
constructed,
reconstructed
and
modified
affected
facilities.

4
Weighted
average.
Number
of
respondents
is
calculated
using
the
following
table
which
addresses
the
three
years
covered
by
this
ICR.

Number
of
Respondents
Respondents
That
Submit
Reports
Respondents
That
Do
Not
Submit
Any
Reports
Year
(
A)
Number
of
New
Respondents3
(
B)
Number
of
Existing
Respondents
(
C)
Number
of
Existing
Respondents
That
Keep
Records
but
Do
Not
Submit
Reports
(
D)
Number
of
Existing
Respondents
That
Are
Also
New
Respondents
(
E)
Number
of
Respondents
(
E=
A+
B+
C­
D)

1
2
105
12
1
118
2
2
106
12
1
119
3
2
107
12
1
120
Average
2
106
12
1
119
.
To
avoid
double­
counting
respondents,
column
D
is
subtracted.
As
shown
above,
the
average
Number
of
Respondents
over
the
three­
year
period
of
this
ICR
is
119.
This
number
appears
on
the
OMB
83­
I
form
in
block
13(
a),
Number
of
respondents.

The
total
number
of
annual
responses
per
year
is
calculated
using
the
following
table:

Total
Annual
Responses
(
A)
Number
of
New
Respondents
(
B)
Number
of
Reports
for
New
Respondents
(
C)
Number
of
Existing
Respondents
(
D)
Number
of
Reports
for
Existing
Respondents
(
F)
Number
of
Existing
Respondents
That
Keep
Records
but
Do
Not
Submit
Reports
(
E)
Total
Annual
Responses
E=(
AxB)+(
CxD)+
F
2
6.1
4
106
2
12
236
(
rounded)
14
The
number
of
Total
Annual
Responses
is
236.
This
number
is
shown
on
the
OMB
83­
I
form
in
block
13(
b),
Total
annual
responses.

The
Total
Hours
Requested
is
shown
on
the
OMB
83­
I
form
in
block
13(
c).
The
total
annual
labor
costs
are
estimated
to
be
$
547,959.
The
annual
labor
costs
are
not
shown
on
the
OMB
83­
I
form.
Details
regarding
these
estimates
may
be
found
in
Table
1:
Annual
Respondent
Burden
and
Cost,
NESHAP
for
Ethylene
Oxide
Emissions
from
Sterilization
Facilities
(
40
CFR
part
63,
subpart
O)

Note
that
the
total
annual
capital
and
O&
M
costs
to
the
regulated
entity
are
$
648,000.
This
number
is
shown
on
the
OMB
83­
I
form
in
block
14(
c),
Total
annualized
cost
requested.
These
costs
are
detailed
in
Section
6(
b)(
iii),
Capital/
Startup
vs.
Operation
and
Maintenance
(
O&
M)
Costs.

6(
e)
Bottom
Line
Burden
Hours
Burden
Hours
and
Cost
Tables
The
bottom
line
burden
hours
and
cost
tables
for
both
the
Agency
and
the
respondents
appear
in
Table
1:
Annual
Respondent
Burden
and
Costs,
NESHAP
for
Ethylene
Oxide
Emissions
from
Sterilization
Facilities
(
40
CFR
part
63,
subpart
O)
and
Table
2:
Annual
Agency
Burden
and
Cost,
NESHAP
for
Ethylene
Oxide
Emissions
from
Sterilization
Facilities
(
40
CFR
part
63,
subpart
O).

6(
f)
Reasons
for
Change
in
Burden
The
increase
in
burden
from
the
most
recently
approved
ICR
is
primarily
due
to
an
adjustment
in
the
number
of
sources
subject
to
the
standard,
specifically
an
increase
from
100
to
119
existing
facilities.
The
increase
in
the
O&
M
costs
is
due
to
an
error
in
the
previous
ICR.
The
previous
ICR
only
calculated
O&
M
costs
for
new
facilities.
It
did
not
account
for
O&
M
costs
associated
with
existing
facilities
subject
to
the
standard.
The
increase
in
labor
costs
associated
with
this
ICR
is
due
to
the
increase
in
wage
rates
provided
by
the
United
States
Department
of
Labor,
Bureau
of
Statistics.

6(
g)
Burden
Statement
The
annual
public
reporting
and
recordkeeping
burden
for
this
collection
of
information
is
estimated
to
average
37
hours
per
response.
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;
to
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;
to
15
adjust
the
existing
ways
to
comply
with
any
previously
applicable
instructions
and
requirements;
to
train
personnel
to
be
able
to
respond
to
a
collection
of
information;
to
search
data
sources;
to
complete
and
review
the
collection
of
information;
and
to
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
valid
OMB
Control
Number.
The
OMB
Control
Numbers
for
EPA's
regulations
are
listed
at
40
CFR
part
9
and
48
CFR
chapter
15.

To
comment
on
the
Agency's
need
for
this
information,
the
accuracy
of
the
provided
burden
estimates,
and
any
suggested
methods
for
minimizing
respondent
burden,
including
the
use
of
automated
collection
techniques,
EPA
has
established
a
public
docket
for
this
ICR
under
Docket
ID
Number
OECA­
2003­
0033,
which
is
available
for
public
viewing
at
the
Enforcement
and
Compliance
Docket
and
Information
Center
in
the
EPA
Docket
Center
(
EPA/
DC),
EPA
West,
Room
B102,
1301
Constitution
Avenue,
NW,
Washington,
DC.
The
EPA
Docket
Center
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
Reading
Room
is
(
202)
566­
1744,
and
the
telephone
number
for
the
Enforcement
and
Compliance
Docket
and
Information
Center
is
(
202)
566­
1752.
An
electronic
version
of
the
public
docket
is
available
through
EPA
Dockets
(
EDOCKET)
at
http://
www.
epa.
gov/
edocket.
Use
EDOCKET
to
submit
or
to
view
public
comments,
to
access
the
index
listing
of
the
contents
of
the
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
When
in
the
system,
select
"
search,"
then
key
in
the
Docket
ID
Number
identified
above.
Also,
you
can
send
comments
to
the
Office
of
Information
and
Regulatory
Affairs,
Office
of
Management
and
Budget,
725
17th
Street,
NW,
Washington,
D.
C.
20503,
Attention:
Desk
Office
for
EPA.
Please
include
the
EPA
Docket
ID
Number
OECA­
2003­
0033
and
OMB
Control
Number
2060­
0283
in
any
correspondence.

Part
B
of
the
Supporting
Statement
This
part
is
not
applicable
because
no
statistical
methods
were
used
in
collecting
this
information.