1
Supporting
Statement
for
Information
Collection
Request
Renewal
NESHAP
40
CFR
Part
63
Subpart
O:
National
Emissions
Standards
for
Hazardous
Air
Pollutants
(
NESHAP)
for
Commercial
Ethylene
Oxide
Sterlization
and
Fumigation
Operations
EPA
ICR
#:
1666.05
1.
Identification
of
the
Information
Collection.

a.
Title
and
Number
of
the
Information
Collection.
"
Reporting
and
Recordkeeping
Requirements
for
the
Reporting
and
Recordkeeping
Requirements
for
the
National
Emission
Standards
for
Hazardous
Air
Pollutants
(
NESHAP)
for
Commercial
Ethylene
Oxide
Sterilization
and
Fumigation
Operations."
This
is
an
extension
of
a
currently
approved
collection
that
has
been
assigned
EPA
tracking
number
1666.05.
The
Information
Collection
Request
(
ICR)
was
approved
at
proposal
under
OMB
Control
number
2060­
0283.

b.
Short
Characterization.
Respondents
are
owners
or
operators
of
new
and
existing
commercial
ethylene
oxide
(
EO)
sterilization
and
fumigation
facilities
that
using
1
ton
of
EO
after
promulgation
of
the
NESHAP
in
1994.
There
are
an
estimated
total
of
100
commercial
EO
sterilization
and
fumigation
operations
nationwide.
The
number
of
new
operations
is
expected
to
be
low
because
limited
net
growth
is
predicted
for
this
industry.
It
is
expected,
however,
that
a
small
number
of
new
sterilizers
will
be
added
to
replace
or
expand
existing
capacity
and
that
few
new
facilities
will
be
constructed.

2.
Need
for
Use
of
the
Collection.

a.
Need/
Authority
for
the
Collection.
The
Agency
is
required
under
Section
112(
d)
of
the
Clean
Air
Act,
as
amended,
to
regulate
emissions
of
hazardous
air
pollutants
listed
in
section
112(
b).
One
of
the
pollutants,
EO,
is
emitted
in
significant
quantities
from
commercial
EO
sterilization
and
fumigation
operations.

In
the
Administrator's
judgement,
EO
emitted
from
commercial
EO
sterilization
and
fumigation
operations
causes,
or
contributes
significantly
to
air
pollution
that
may
reasonably
be
anticipated
to
endanger
public
health
or
welfare.
Consequently,
the
NESHAP
for
EO
emissions
has
been
developed
for
this
source
category.

The
NESHAP
for
EO
operations
requires
facility
owners
or
operators
to
record
and
report
certain
records.
2
Certain
records
and
reports
are
necessary
to
enable
the
Administrator
to:
(
1)
identify
new,
modified,
reconstructed,

and
existing
sources
subject
to
the
standards
and
(
2)
ensure
that
the
standards,
which
are
based
on
maximum
achievable
control
technology
(
MACT)
and
generally
available
control
technology
(
GACT),
are
being
achieved.

These
records
and
reports
are
required
under
the
General
Provisions
of
40
CFR
part
63,
subpart
A
[
as
authorized
under
sections
101,
112,
114,
116,
and
301
of
the
Clean
Air
Act
as
amended
by
Pub.
L
101­
549
(
U.
S.
C.

7401,7412,
7414,
7416,
7601)].

b.
Use/
Users
of
the
Data.
The
information
will
be
used
by
Agency
enforcement
personnel
to:
(
1)

identify
new,
modified,
reconstructed,
and
existing
sources
subject
to
the
standards;
(
2)
ensure
that
MACT
and
GACT
are
being
properly
applied;
and
(
3)
ensure
that
any
emission
control
system
employed
by
the
owner
or
operator
of
a
commercial
EO
sterilization
and
fumigation
facility
to
meet
the
standards
is
being
properly
operated
and
maintained
on
a
continual
basis.

In
addition,
records
and
reports
are
necessary
to
enable
the
Agency
to
identify
facilities
that
may
not
be
in
compliance
with
the
standards.
Based
on
reported
information,
the
Agency
can
decided
which
facilities
should
be
inspected
and
what
records
or
processes
should
be
inspected
at
the
facilities.
The
records
that
facilities
maintain
would
indicated
to
the
Agency
whether
owners
or
operators
are
in
compliance
with
the
standards
and
whether
plant
personnel
are
operating
and
maintaining
control
equipment
properly.
In
order
to
minimize
the
burden,
much
of
the
information
the
Agency
would
need
to
determine
compliance
through
such
an
inspection
would
only
be
recorded
and
would
not
need
to
be
routinely
reported
to
the
Agency.

3.
Nonduplication,
Consultation,
and
Other
Collection
Criteria.

a.
Nonduplication.
A
search
of
EPA's
ongoing
ICR's
revealed
no
duplication
of
informationgathering
efforts.
However,
certain
reports
required
by
State
or
local
agencies
may
duplicate
information
required
by
the
standards.
In
such
cases,
a
copy
of
the
report
submitted
to
the
State
or
local
agency
can
be
proved
to
the
Administrator
in
lieu
of
the
report
required
by
the
standards.

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
on
June
18,
1997
(
62
FR
33068).
OMB
reviewed
EPA's
clearance
request
for
EPA
ICR
No.
1666.05
and
3
published
notice
of
the
approval
in
the
Federal
Register
on
April
18,
2000
(
65
FR
20813).
No
comments
were
received
in
response
to
the
Agencies
solicitation
on:
(
i)
whether
the
proposed
collection
of
information
is
necessary
for
the
proper
performance
of
the
functions
of
the
agency,
including
whether
the
information
will
have
practical
utility;
(
ii)
ways
to
evaluate
the
accuracy
of
the
agency's
estimate
of
the
burden
of
the
proposed
collection
of
information,
including
the
validity
of
the
methodology
and
assumptions
used;
(
iii)
methods
to
enhance
the
quality,

utility,
and
clarity
of
the
information
to
be
collected;
or
(
iv)
minimize
the
burden
of
the
collection
of
information
on
those
who
are
to
respond,
including
through
the
use
of
appropriate
automated
electronic,
mechanical,
or
other
technological
collection
techniques
or
other
forms
of
information
technology,
e.
g.,
permitting
electronic
submission
of
responses.

c.
Consultation.
The
collection
was
discussed
with
Joe
Hadley,
Executive
Director,
Ethylene
Oxide
Sterilization
Assocation
(
202­
296­
6300).
In
general,
the
discussion
centered
on
the
number
of
facilities
the
association
expected
would
continue
to
operate
over
the
coming
three
years
and
the
possiblity
of
new
facilities
being
built.
Our
understand
was
that
the
association
anticipated
numbers
would
remain
relatively
stable
and
no
particular
changes
were
needed
to
the
scope
of
the
ICR.

d.
Effects
of
Less
Frequent
Collection.
If
the
relevant
information
were
collected
less
frequently
by
the
owner
or
operator,
the
Agency
would
not
be
reasonably
assured
that
a
plant
is
in
compliance
with
the
standards.
The
frequency
of
collection
for
the
monitored
control
technique
parameters
was
based
on
information
collected
during
visits
and
source
testing
at
commercial
EO
sterilization
and
fumigation
operations
and
on
recommendations
from
control
technique
vendors.
Less
frequent
collection
could
result
in
improper
maintenance
of
the
control
systems
and
possible
exceeding
the
applicable
emission
limits.

e.
General
Guidelines.
The
five
year
record
retention
period
will
exceed
the
three
year
retention
period
required
by
5
CFR
1320.6;
however,
the
five
year
period
is
consistent
with
the
General
Provisions
of
40
CFR
part
63
and
the
permit
requirements
under
Title
V
of
the
Clean
Air
Act.

f.
Confidentiality
and
Sensitive
Questions.

(
i)
Confidentiality.
All
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
4
Confidentiality
of
Business
Information
(
see
40
CFR
2;
41
FR
26902,
September
1,
1976;
amended
by
43
FR
39999,
September
8,
1978;
43
FR
42251,
September
28,
1978;
44
FR
17674,
March
23,
1979).

(
ii)
Sensitive
Questions.
This
section
is
not
applicable
because
this
ICR
does
not
involve
matters
of
a
sensitive
nature.

4.
Respondents
and
the
Information
Requested.

a.
Respondents/
SIC
Codes.
Respondents
are
owners
or
operators
of
commercial
EO
sterilization
operations.
The
respondents
affected
by
this
standard
are
found
in
the
following
Standard
Industrial
Classification
(
SIC)
codes:
3841
and
3842
(
medical
equipment
suppliers);
2832,
2833,
2834,
and
5122
(
pharmaceutical
suppliers);
2211,
2821,
2879,
3069,
3079,
3569,
3677,
3693,
3999,
and
5086
(
other
health­
related
facilities);
2034,

2035,
2046,
2099,
and
5149
(
spice
manufacturers);
7218,
7399,
and
8091
(
contract
sterilizers);
8231,
and
8411
(
libraries,
museums,
and
archives);
and
0279,
7391,
7397,
8071,
and
8922
(
laboratories).

b.
Information
Requested.

(
i)
Data
items.
The
attachment,
Source
Data
and
Information
Requirements,
summarizes
the
recordkeeping
and
reporting
requirements.

(
ii)
Respondent
activities.
The
respondent
activities
required
by
the
standards
in
the
next
three
years
are
listed
in
the
first
column
of
Table
2.

5.
Information
Collected
­­
Agency
Activities,
Collection
Methodology,
and
Information
Management.

a.
Agency
Activities.
Agency
activities
for
the
period
covered
by
this
ICR
are
provided
in
Table
1.

b.
Collection
Methodology
and
Management.
Following
notification
of
startup,
the
reviewing
authority
might
inspect
the
source
to
check
if
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,
and
note
the
operating
conditions
under
which
compliance
was
achieved.
Data
obtained
during
periodic
visits
by
Agency
personnel
from
records
maintained
by
the
respondents
are
tabulated
and
published
for
internal
Agency
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.
5
Information
contained
in
the
reports
is
entered
into
the
Aerometric
Information
Retrieval
System
(
AIRS)

Facility
Subsystem
(
AFS)
which
is
operated
and
maintained
by
EPA's
Office
of
Air
Quality
Planning
and
Standards
(
OAQPS).
The
AFS
is
EPA's
database
for
the
collection,
maintenance,
and
retrieval
of
compliance
and
annual
emission
inventory
data
for
over
100,000
industrial
and
government­
owned
facilities.
EPA
uses
AFS
for
tracking
air
pollution
compliance
and
enforcement
by
local
and
State
regulatory
agencies,
EPA
Regional
Offices
and
Headquarters.
EPA
can
edit,
store,
retrieve
and
analyze
the
data
via
PC
terminals.

The
records
required
by
this
NSPS
must
be
retained
by
the
owner
or
operator
for
(
two)
years.

c.
Small
Entity
Flexibility.
The
Agency
does
not
expect
that
any
commercial
EO
sterilization
facilities,
including
small
businesses,
subject
to
the
standards
would
experience
adverse
impacts
related
to
the
cost
of
the
required
recordkeeping
and
reporting.
The
information
collection
requirements
are
the
minimum
necessary
to
demonstrate
compliance.

d.
Collection
Schedule.
Information
contained
in
the
initial,
one­
time
only
reports
will
be
entered
into
the
AIRS/
AFS
operated
and
maintained
by
OAQPS.
Data
obtained
during
periodic
visits
by
Agency
personnel
from
records
maintained
by
the
respondents,
and
information
provided
in
semiannual
reports
will
be
tabulated
and
published
for
internal
EPA
use
in
compliance
with
enforcement
programs.
A
schedule
for
collecting
information
and
publishing
data
does
not
apply
because
reports
and
recordkeeping
are
triggered
by
action
of
the
respondents.

6.
Estimating
the
Burden
and
Cost
of
the
Collection
Table
2
documents
the
computation
of
individual
burdens
for
each
of
the
recordkeeping
and
reporting
requirements
applicable
to
the
industry.
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.

a.
Estimating
Respondent
Burden.
The
average
annual
burden
to
industry
over
the
next
three
years
from
these
recordkeeping
and
reporting
requirements
is
estimated
at
7,328.03
person­
hours.
These
hours
are
based
on
Agency
studies
and
background
documents
from
the
development
of
the
standards
or
test
methods,
Agency
6
knowledge
and
experience
with
the
NESHAP
program,
the
previously
approved
ICR,
and
any
comments
received
about
time
to
prepare
reports.

b.
Estimating
Respondent
Costs
(
i)
Estimating
Labor
Costs.
This
ICR
uses
labor
rates
on
an
hour
basis
of
technical
personnel
at
$
33,

management
at
$
49,
and
clerical
at
$
15,
plus
110%
overhead
burden.

(
ii)
Estimating
Capital
and
Operations
and
Maintenance
Costs.
The
type
of
industry
costs
associated
with
the
information
collection
activity
in
the
standards
are
labor
and
Continuous
Monitoring
Systems.
The
respondent
costs
have
been
calculated
on
the
basis
of
discussions
with
owners
and
operators
of
affected
facilities.
The
average
annual
burden
to
industry
over
the
next
three
years
of
the
ICR
is
estimated
to
be
$
195,000.

(
iii)
Capital/
Start­
up
vs.
Operating
and
Maintenance
(
O&
M)
Costs.
Respondents
may
use
a
variety
of
equipment
to
ensure
compliance
with
the
applicable
recordkeeping
and
reporting
requirements.
Affected
sources
may
acquire
the
required
information
from
the
acid
scrubber
on
the
chamber
vent
via
a
dedicated
computer
linked
to
a
gas
chromatograph
attached
to
the
aeration
room
and
back
chamber
vents
(
chamber
exhaust
vents).

Capital
expenses
associated
with
a
dedicated
computer
are
approximately
$
2,500.
Capital
expenses
associated
with
a
gas
chromatograph
are
approximately
$
30,000.
Operation
and
maintenance,
including
calibration,
of
the
equipment
is
approximately
$
5,500
per
affected
facility.

c.
Estimating
Agency
Burden
and
Cost.
The
only
Federal
costs
are
user
costs
associated
with
analysis
of
the
reported
information.
Publication
and
distribution
of
the
information
are
part
of
the
Aerometric
Information
Retrieval
System
(
AIRS)
Facility
Subsystem
(
AFS)
which
is
operated
and
maintained
by
the
Agency's
Office
of
Air
Quality
Planning
and
Standards.
Examination
of
records
to
be
maintained
by
the
respondents
will
occur
as
part
of
the
periodic
inspection
of
sources,
which
is
part
of
the
Agency's
overall
compliance
and
enforcement
program.

The
average
annual
Federal
Government
cost
during
the
three
years
of
the
ICR
is
estimated
to
be
$
5,727.

This
cost
is
based
on
an
average
wage
of
a
GS10
step
1
employee
rate
and
travel
associated
with
compliance
activities.
Details
upon
which
this
estimate
is
based
appear
in
Table
1:
Agency
Burden.

d.
Estimating
the
Respondent
Universe
and
Total
Burden
and
Costs
7
The
number
of
existing
sources
subject
to
the
National
Emission
Standards
for
Hazardous
Air
Pollutants
for
Commercial
Ethylene
Oxide
Sterilization
and
Fumigation
Operations,
40
CFR
360
et.
seq
is
approximately
100.
The
number
of
new
sources
subject
to
this
subpart
is
approximately
6.
The
total
annual
labor
costs
are
$
494,450
and
total
annual
capital
and
O&
M
costs
to
the
regulated
entity
are
$
228,000.
Details
upon
which
this
estimate
is
based
appear
in
Table
2:
Industry
Burden.

e.
Bottom
Line
Burden
Hours
And
Cost
Tables
See
attached
Table
1.

f.
Reasons
for
Change
in
Burden.
There
is
no
change
in
burden.
The
Agency
expects
the
construction,
reconstruction,
or
modification
of
approximately
six
new
facilities
over
the
period
covered
by
this
information
collection.
New,
reconstructed,
or
modified
facilities
are
required
to
conduct
all
one­
time
reporting
and
recordkeeping
activities,
including
performing
emission
testing,
submitting
compliance
status
information
reports,
and
developing
recordkeeping
and
implementation
plans.
New,
reconstructed,
or
modified
facilities
are
also
required
to
provide
reports
on
their
compliance
status
and
periods
of
noncompliance
and
keep
and
maintain
records
on
control
device
maintenance,
inspections,
and
control
device
monitoring
parameters.

g.
Burden
Statement.
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
are
listed
in
40
CFR
Part
9
and
48
CFR
Chapter
15.

Send
comments
on
the
Agency's
need
for
this
information,
the
accuracy
of
the
provided
burden
estimates,

and
any
suggested
methods
for
minimizing
respondent
burden,
including
through
the
use
of
automated
collection
8
techniques
to
the
Director,
OPPE
Regulatory
Information
Division,
U.
S.
Environmental
Protection
Agency
(
2137),

401
M
St.,
S.
W.,
Washington,
D.
C.
20460;
and
to
the
Office
of
Information
and
Regulatory
Affairs,
Office
of
Management
and
Budget,
725
17th
Street,
NW,
Washington,
DC
20503,
Attention:
Desk
Officer
for
EPA.
Include
the
EPA
ICR
number
and
OMB
control
number
in
any
correspondence.
