Document ID: EPA-HQ-OAR-2003-0148-0001
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-06-24T04:00Z

1
SF­
83
SUPPORTING
STATEMENT
ENVIRONMENTAL
PROTECTION
AGENCY
STANDARDS
OF
PERFORMANCE
NESHAP,
Subpart
GGG,
Pharmaceuticals
Production
1.
Identification
of
the
Information
Collection
1(
a)
Title
of
the
Information
Collection
ICR
for
NESHAP,
Subpart
GGG
­
Pharmaceuticals
Production;
OMB
Control
Number
2060­
0358;
EPA
ICR
Number
1781.02
1(
b)
Short
Characterization/
Abstract
In
general
all
NESHAP
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,
in
general,
of
all
sources
subject
to
NESHAP.
This
information
is
used
by
the
Agency
to
identify
sources
subject
to
the
standards
to
insure
that
the
maximum
achievable
control
technologies
are
being
applied.

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
5
years
following
the
date
of
such
measurements,
maintenance
reports,
and
records.
All
reports
are
sent
to
the
delegated
State
or
Local
authority
and
are
entered
into
the
AIRS
database.
In
the
event
that
there
is
no
such
delegated
authority,
the
reports
are
sent
directly
to
the
EPA
Regional
Office.

The
National
Emission
Standards
for
Hazardous
Air
Pollutants
(
NESHAP)
for
Pharmaceuticals
Production
were
proposed
on
April
2,
1997
and
promulgated
on
September
21,
1998.
These
standards
apply
to
the
facilities
in
Pharmaceuticals
Production
that
are
major
sources
of
hazardous
air
pollutants
(
HAP).
The
affected
facility
is
all
pharmaceutical
manufacturing
operations
including
process
vents,
storage
tanks,
equipment
components,
and
wastewater
systems
commencing
construction
or
reconstruction
after
the
date
of
proposal.
This
information
is
being
collected
to
assure
compliance
with
40
CFR
Part
63
Subpart
GGG..

Approximately
100
sources
are
currently
subject
to
the
standard,
and
it
is
estimated
that
there
will
be
no
new
growth
in
the
industry;
with
the
exception
of
one
reconstruction
in
the
industry.
By
definition
of
affected
facility
in
Subpart
GGG,
there
is
one
affected
facility
per
plant.
These
estimates
were
obtained
through
the
course
of
the
regulation
development
through
consultations
with
industry
and
trade
associations,
such
as
the
Pharmaceutical
Research
and
Manufacturers
Association
(
PhRMA).
2
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,
HAP
emissions
(
predominantly
methanol,
methylene
chloride,
and
toluene)
from
Pharmaceuticals
Production
cause
or
contribute
to
air
pollution
that
may
reasonably
be
anticipated
to
endanger
public
health
or
welfare.
Therefore
NESHAP
were
promulgated
for
this
source
category
at
40
CFR
Part
63
Subpart
GGG.

2(
b)
PRACTICAL
UTILITY/
USERS
OF
THE
DATA
The
control
of
emissions
of
hazardous
air
pollutants
(
HAP)
from
Pharmaceuticals
Production
requires
not
only
the
installation
of
properly
designed
equipment,
but
also
the
operation
and
maintenance
of
that
equipment.
Emissions
of
HAP
from
Pharmaceuticals
Production
are
the
result
of
operation
of
the
pharmaceuticals
manufacturing
operations.
These
standards
rely
on
the
reduction
of
HAP
emissions
by
air
pollution
control
devices,
suppression
and
control
of
HAP
in
liquids,
and
leak
detection
and
repair
procedures.
The
required
notifications
are
used
to
inform
the
Agency
or
delegated
authority
when
a
source
becomes
subject
to
the
standard.
The
reviewing
authority
may
then
inspect
the
source
to
check
if
the
pollution
control
devices
are
properly
installed
and
operated
and
leaks
are
being
detected
and
repaired
and
the
standard
is
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
standard,
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
3
described
in
this
ICR
is
used
by
the
Agency
to
ensure
that
facilities
affected
by
the
NESHAP
continue
to
operate
the
control
equipment
and
achieve
compliance
with
the
regulation.
Adequate
monitoring,
recordkeeping,
and
reporting
is
necessary
to
ensure
compliance
with
these
standards,
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
recordkeeping
and
reporting
requested
is
required
under
40
CFR
Part
63
Subpart
GGG.

3(
a)
Nonduplication
If
the
standard
has
not
been
delegated
the
information
is
sent
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
regulation
to
implement
the
Federal
Regulation,
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
Standard.
Therefore,
no
duplication
exists.

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
on
March
31,
2000.

3(
c)
Consultations
No
comments
were
received
on
the
burden
published
in
the
Federal
Register.

3(
d)
Effects
of
Less
Frequent
Collection
Less
frequent
information
collection
would
decrease
the
margin
of
assurance
that
facilities
are
continuing
to
meet
the
required
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
in
5
CFR
1320.6.
4
3(
f)
Confidentiality
The
required
information
consists
of
emissions
data
and
other
information
that
have
been
determined
not
to
be
private.
However,
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
Codes
The
respondents
of
the
recordkeeping
and
reporting
requirements
are
producers
of
material
described
by
Standard
Industrial
Classification
(
SIC)
codes
2833
and
2834
and
are
producers
of
material
whose
manufacturing
process
is
described
by
North
American
Industrial
Classification
System
(
NAICS)
codes
325411
and
325412.

4(
b)
INFORMATION
REQUESTED
(
i)
Data
Items
All
data
in
this
ICR
that
is
recorded
and/
or
reported
is
required
by
40
CFR
Part
63
Subpart
GGG.
A
source
must
make
the
following
reports
and
keep
the
following
records.

Reports
for
NESHAP
­
SUBPART
GGG
Change
in
area
source
status
(
as
applicable)
63.1(
c)(
5)

Construction/
reconstruction
63.5(
b)(
4),
63.5(
d),
63.1260(
c)

Applicability
63.9(
a)

Initial
notifications
(
and
implementation
plans
for
facilities
using
emissions
averging)
63.9(
b)
or
(
d),
63.1260(
b)

Notification
of
performance
test
or
delay,
alternative
test
methods
or
waivers
63.7(
b)(
1)
&
(
2),
63.7(
f),
63.7(
h)
63.9(
e)
Reports
for
NESHAP
­
SUBPART
GGG
5
Notification
for
CMS
performance
evaluation
&
results
63.8(
e)(
2),
63.9(
g)(
1),
63.9(
e)(
5),
63.10(
e)(
2),
63.1260(
d)

Notification
that
criterion
to
continue
use
of
alternative
to
relative
accuracy
testing
has
been
exceeded
63.9(
g)(
3)

Notification
of
Compliance
Status
63.9(
h),
63.1260(
f)

Initial
performance
test
results
63.10(
d)(
2)

Progress
Reports
for
Compliance
Extensions
(
as
applicable)
63.10(
d)(
4)

Startup,
shutdown,
malfunction
reports
63.10(
d)(
5)

Initial
performance
test
(
notification,
test
plan,
and
emission
profile)
63.7(
b)(
1)
and
(
c),
63.9(
e),
63.1257(
b)(
8)
63.1260(
l)

Rescheduled
initial
performance
test
63.7(
b)(
2)

Precompliance
report
63.1260(
e)

Notification
of
Compliance
status
Report
(
NOCSR)
63.9(
f)

Physical
or
operational
change
63.1260(
g)(
2)(
vii),
63.1260(
h)(
1)

Periodic
Reports
63.1260(
g)

Excess
emissions
reports
63.10(
e)(
3)
63.1260(
g)(
2)

Reports
on
monitoring
data
with
days
when
average
values
are
outside
established
ranges
(
including
operating
logs)
63.1260(
g)(
2)

Reports
of
periods
when
monitoring
data
is
not
collected
due
to
excursions
63.1260(
g)(
2)

Reports
of
leaks
of
vapor
suppression
equipment
63.1260(
g)(
2)

Reports
of
vapor
collection
systems
equipped
with
a
bypass
line
63.1260(
g)(
2)
Reports
for
NESHAP
­
SUBPART
GGG
6
Periods
of
Planned
Routine
Maintenance
63.1260(
g)(
2)

New
Operating
Scenarios
63.1260(
g)(
2)

Notice
of
change
in
activity
since
Precompliance
report
or
change
in
control
device
status
63.1260(
h)(
2)

LDAR
reporting
requirements
63.1260(
j)

Reports
of
startup,
shutdown,
and
malfunction
63.1260(
i)

Reports
of
emissions
averaging
63.1260(
k)

Source
status
report
63.1260(
g)
and
(
h)

Recordkeeping
for
NESHAP
­
SUBPART
GGG
Recordkeeping
requirements
63.10(
a)

Data
retention
63.10(
b)(
1),
63.1259(
a)(
1)

Applicability
63.10(
b)(
3),
63.1259(
a)(
2)

Startup,
shutdown,
and
malfunction
plan
63.1259(
a)(
3)

CMS
63.10(
c)(
1)­(
14),
63.1259(
a)(
4)

Construction/
Reconstruction
63.1259(
a)(
5)

Records
of
equipment
operation
63.1259(
b)

Operating
Parameters
63.1259(
b)(
1)

Pollution
Prevention
(
as
applicable)
63.1259(
b)(
2)

CMS
Checks
(
as
applicable)
63.1259(
b)(
3)

Rolling
Annual
Total
Emissions
(
as
applicable)
63.1259(
b)(
4)

Number
of
batches
per
year,
operating
hours
per
year,
uncontrolled
and
controlled
emissions
per
batch
(
as
appropriate)
63.1259(
b)(
5),
(
b)(
6)

WW
concentration
per
POD
or
process
63.1259(
b)(
7)
Recordkeeping
for
NESHAP
­
SUBPART
GGG
7
Number
of
storage
tank
turnovers
per
year
(
as
applicable)
63.1259(
b)(
8)

Daily
schedule
or
log
of
operating
scenarios
63.1259(
b)(
9)

Description
of
worst
case
operating
scenarios
for
control
devices
63.1259(
b)(
10)

Periods
of
planned
routine
maintenance
for
storage
tanks
63.1259(
b)(
11)

Records
of
operating
scenarios
63.1259(
c)

Records
of
leak
detection
and
repair
programs
63.1259(
d)

Records
of
emissions
averaging
63.1259(
e)

Records
of
delay
of
repairs
63.1259(
f)

Records
of
wastewater
stream
and
residual
transfer
63.1259(
g)

Records
of
extensions
63.1259(
h)

Records
of
inspections
63.1259(
i)

(
ii)
Respondent
Activities
Respondent
Activities
for
NESHAP
­
SUBPART
GGG
Read
instructions.

Plan
compliance
strategy
(
includes
preparing
implementation
plans)

Train
personnel
Perform
initial
testing
and
establish
operating
range
parameters
Information
gathering
(
includes
equipment
inspections
and
monitoring
data
collection)

Compile
and
review
collected
information
to
demonstrate
compliance
Prepare
formal
reports
Manage
and
record
information
It
is
estimated
that
20
percent
of
the
information
will
be
collected
and
recorded
electronically.

5.
The
Information
Collected
­­
Agency
Activities,
Collection
Methodology,
and
Information
Management
8
5(
a)
Agency
Activities
EPA
conducts
the
following
activities
in
connection
with
the
acquisition,
analysis,
storage,
and
distribution
of
the
required
information.

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
Aerometric
Information
Retrieval
System
(
AIRS)
database.

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
and
note
the
operating
conditions
under
which
compliance
was
achieved.
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
AIRS
which
is
operated
and
maintained
by
EPA's
Office
of
Air
Quality
Planning
and
Standards.
AIRS
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
AIRS
for
tracking
air
pollution
compliance
and
enforcement
by
Local
and
State
regulatory
agencies,
and
EPA
Regional
Offices
and
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
The
recordkeeping
and
reporting
requirements
were
selected
within
the
context
of
this
specific
subpart
and
the
specific
process
equipment
and
pollutants.
The
impact
on
small
businesses
was
accounted
for
in
the
regulation
development.
The
requirements
reflect
the
burden
on
small
businesses.
Even
though,
the
recordkeeping
and
reporting
requirements
are
the
same
for
small
and
larger
businesses.
To
the
extent
that
larger
businesses
can
use
economies
of
scale
to
reduce
their
burden,
the
overall
burden
will
be
reduced.
The
Agency
considers
these
requirements
9
the
minimum
needed
to
ensure
compliance
and,
therefore,
cannot
reduce
them
further
for
small
businesses.

5(
d)
Collection
Schedule
The
specific
frequency
for
each
information
collection
activity
within
this
request
is
shown
in
Table
2:
Industry
Burden..

6.
Estimating
the
Burden
and
Cost
of
the
Collection
Table
2
documents
the
computation
of
individual
burdens
for
the
recordkeeping
and
reporting
requirements
applicable
to
the
industry
for
each
of
the
subparts
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
at
161,326
person­
hours.
These
hours
are
based
on
Agency
studies
and
background
documents
from
the
development
of
the
standards
or
test
methods,
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:
$
73.93
per
hour
for
Executive,
Administrative,
and
Managerial,
$
54.94
per
hour
for
Technical,
and
$
34.42
per
hour
for
Clerical.
These
rates
are
from
the
United
States
Department
of
Commerce
Bureau
of
Labor
Statistics,
March
1999,
Table
10:
Employment
Costs
for
Private
Industry
by
Occupational
and
Industry
Group.
The
rates
are
from
column
1:
Total
compensation.
The
wage
rates
have
been
loaded
by
adding
110%
overhead.

(
ii)
Estimating
Capital
and
Operations
and
Maintenance
Costs
The
capital
start
up
costs
are
one
time
costs
when
a
facility
becomes
subject
to
the
standard.
For
this
industry
the
only
capital
cost
anticipated
are
the
purchase
of
customized
software
estimated
at
$
1400
and
the
purchase
of
a
datalogger
and
thermocouple
estimated
at
$
3000
(
an
average
of
2.31
per
facility
based
on
the
number
of
control
devices
found
during
10
regulation
development
(
231)
at
the
100
major
sources).
Neither
of
these
are
capitalized
so
the
annual
cost
is
the
total
cost
divided
by
the
period
of
the
ICR,
or
$
3388/
year
($
4400*
2.31/
3).
This
cost
is
shown
on
the
OMB
83­
I
form
in
block
14
letter
a:
Total
annualized
capital/
startup
costs.
The
numbers
in
block
14
of
the
OMB
83­
I
form
are
truncated
to
show
the
cost
in
thousands
of
dollars.

The
only
O&
M
that
is
associated
with
this
effort
is
the
O&
M
on
the
thermocouple
and
datalogger,
estimated
at
$
1800/
year,
based
on
experience
with
this
type
of
equipment
in
other
industries.
The
total
O&
M
is
therefore
$
4158/
year
($
1800*
2.31).
This
cost
is
shown
on
the
OMB
83­
I
form
in
block
14
letter
b:
Total
annual
costs
(
O&
M).
The
numbers
in
block
14
of
the
OMB
83­
I
form
are
truncated
to
show
the
cost
in
thousands
of
dollars.

The
total
respondent
costs
have
been
calculated
on
the
addition
of
the
capital
start
up
costs
and
the
annual
operations
and
maintenance
costs.
The
average
annual
cost
for
capital
and
operations
and
maintenance
costs
to
industry
over
the
next
three
years
of
the
ICR
is
estimated
to
be
$
7546
.
This
cost
is
shown
on
the
OMB
83­
I
form
in
block
14
letter
c:
Total
annualized
cost
requested.
The
numbers
in
block
14
of
the
OMB
83­
I
form
are
truncated
to
show
the
cost
in
thousands
of
dollars.

6(
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
AIRS
program.
Examination
of
records
to
be
maintained
by
the
respondents
will
occur
as
part
of
the
periodic
inspection
of
sources,
which
is
part
of
EPA's
overall
compliance
and
enforcement
program.

The
average
annual
Federal
Government
cost
during
the
3
years
of
the
ICR
is
estimated
to
be
$
112,996
(
from
Table
1).
This
cost
is
based
on
an
average
wage
of
a
GS
10
step
1
employee
rate,
$
35.89/
hour
(
17.09
hr
+
110%
overhead
=
$
35.89).
This
rate
is
from
OPM's
2000
General
Schedule,
excluding
locality
pay,
basic
rates
and
travel
associated
with
compliance
activities.
Details
upon
which
this
estimate
is
based
appear
in
Table
1.

6(
d)
Estimating
the
Respondent
Universe
and
Total
Burden
and
Costs
Respondant
Universe
Regulation
Title
(
A)
#
new
sources
per
year
(
B)
#
of
initial
reports
for
new
sources
(
C)
#
existing
sources
(
D)
#
of
reports
for
existing
sources
(
E)
total
annual
responses
(
AXB)+(
CXD)

Subpart
GGG
1
reconstructed
3
103
2
209
11
The
number
of
total
respondents
is
103.
This
number
is
in
column
A
of
the
Respondant
Universe
table.
It
is
shown
on
the
OMB
83­
I
form
in
block
13
a.
This
is
the
number
of
existing
sources
plus
the
number
of
new
sources
anticipated
in
one
year.
The
total
annual
responses
is
209.
This
number
is
in
column
E
of
the
Respondant
Universe
table.
It
is
shown
on
the
OMB
83­
I
form
in
block
13
b.
The
total
annual
labor
costs
are
$
8,708,620.
Details
upon
which
this
estimate
is
based
appear
in
Table
2.

6(
e)
Bottom
Line
Burden
Hours
And
Cost
Tables
See
attachments
for
burden
hours
and
costs
tables.

6(
f)
Reasons
for
Change
in
Burden
The
change
in
burden
from
the
most
recently
approved
ICR
is
due
to
an
adjustment.
The
labor
costs
have
been
updated.
Also,
several
first
year
requirements,
such
as
the
initial
notification,
are
no
longer
required.

6(
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
techniques
to
the
Director,
Collection
Strategies
Division,
Office
of
Environmental
Information
(
OEI),
U.
S.
Environmental
Protection
Agency,
Mail
Code
2822,
1200
Pennsylvania
Avenue,
NW,
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
1781.02
and
OMB
control
2060­
0358
number
in
any
correspondence.

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