Document ID: EPA-HQ-OECA-2003-0035-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2004-02-26T05:00Z

SF­
83
SUPPORTING
STATEMENT
ENVIRONMENTAL
PROTECTION
AGENCY
NESHAP
for
Pharmaceuticals
Production
(
40
CFR
part
63,
subpart
GGG)

1.
Identification
of
the
Information
Collection
1(
a)
Title
of
the
Information
Collection
NESHAP
for
Pharmaceuticals
Production
(
40
CFR
part
63,
subpart
GGG)

1(
b)
Short
Characterization/
Abstract
The
National
Emission
Standards
for
Hazardous
Air
Pollutants
(
NESHAP)
for
Pharmaceuticals
Production
was
proposed
on
April
2,
1997,
and
promulgated
on
September
21,
1998.
These
standards
apply
to
facilities
in
pharmaceuticals
productions
that
are
major
sources
of
hazardous
air
pollutants
(
HAP).
The
affected
facilities
encompass
all
pharmaceuticals
manufacturing
operations
that
include
process
vents,
storage
tanks,
equipment
components,
and
wastewater
systems
commencing
construction
or
reconstruction
after
the
date
of
that
proposal.
This
information
is
being
collected
to
assure
compliance
with
40
CFR
part
63,
subpart
GGG.
HAP
emissions
are
the
pollutants
regulated
under
this
subpart.

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
in
general,
are
required
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
will
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.

There
is
an
annual
average
of
101
respondents
that
will
be
subject
to
the
standard,
and
it
is
estimated
that
there
will
be
no
new
growth
in
the
industry
over
the
next
three
years,
though
one
of
the
existing
sources
per
year
will
become
subject
to
the
standard
over
the
next
three
years
due
to
the
reconstruction
of
an
existing
affected
facility.
The
average
annual
cost
to
industry
over
the
next
three
years
of
this
Information
Collection
Request
(
ICR)
is
estimated
to
be
$
10,006,462.

In
the
development
of
this
Information
Collection
Request
(
ICR),
we
addressed
the
Office
of
Management
and
Budget
(
OMB)
"
Terms
of
Clearance"
(
TOC)
on
the
active
ICR.
The
TOC
are
as
follows:
2
This
collection
is
approved
for
three
years.
Before
resubmitting
this
collection
to
OMB
for
revision
or
renewal,
EPA
should
verify
the
burden
estimates
in
consultation
with
the
regulated
community.

EPA
has
addressed
the
item
of
concern
in
the
TOC
as
instructed
by
OMB
in
the
active
ICR.
See
Section
3(
c),
Consultations.

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
will
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
pollutant
emissions
from
pharmaceuticals
production
(
predominately
methanol,
methylene
chloride
and
toluene)
cause
or
contribute
to
air
pollution
that
may
reasonably
be
anticipated
to
endanger
public
health
or
welfare.
Therefore,
the
NESHAP
was
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
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
is
the
result
of
operation
of
the
affected
facilities.
The
subject
standards
are
achieved
by
the
reduction
of
HAP
emissions
using
3
control
technology
and
leak
detection
and
repair
procedures.
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
and
leaks
are
being
detected
and
repaired
and
the
regulations
are
being
met.
Performance
test
reports
are
needed
as
these
are
the
Agency's
records
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
GGG.

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
a
local
agency
can
be
sent
to
the
Administrator
in
lieu
of
the
report
required
by
the
Federal
standards.
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
68
FR
27059
on
May
19,
2003.
No
comments
were
received
on
the
burden
published
in
the
Federal
Register.
4
3(
c)
Consultations
For
this
information
collection,
we
referenced
the
most
recent
ICR,
the
preparer
of
the
active
ICR,
and
accessed
the
most
recent
data
available
on
the
Air
Facility
System
(
AFS)
database
as
maintained
by
the
Office
of
Compliance.
We
reviewed
information
available
from
the
United
States
Census
Bureau
via
the
internet,
and
other
websites
covering
pharmaceuticals
production.
We
consulted
with
EPA's
Office
of
Air
Quality
Planning
and
Standards,
Information
Transfer,
and
the
Program
Integration
Division
of
the
Pharmaceutical
Research
and
Manufacturers
of
America
(
PhRMA),
Mr.
Thomas
White,
(
202)
835­
3400;
and
Noramco
Incorporated,
Mr.
Vincent
Kranz,
(
302)
652­
3840.

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.
The
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
violates
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
record
retention
requirement
is
consistent
with
the
Part
70
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
(
CBI)
(
see
40
CFR
2;
41
FR
36902,
September
1,
1976;
5
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
to
the
recordkeeping
and
reporting
requirements
are
pharmaceuticals
production
manufacturing
operations.
The
United
States
Standard
Industrial
Classification
(
SIC)
codes
for
the
respondents
affected
by
the
standards
are
SIC
2833
and
2834,
which
correspond
to
the
North
American
Industry
Classification
System
(
NAICS)
325411
and
325412
for
pharmaceuticals
production
manufacturing
operations.

4(
b)
Information
Requested
None
of
these
reporting
or
recordkeeping
requirements
violates
any
of
the
regulations
established
by
OMB
at
5
CFR
part
1320,
Section
1320.5.

(
i)
Data
Items
All
data
recorded
and/
or
reported
in
this
ICR
are
required
by
National
Emission
Standards
for
Hazardous
Air
Pollutants
for
Pharmaceuticals
Production
(
40
CFR
part
63,
subpart
GGG).

A
source
must
make
the
following
reports:

Notification
Reports
Standard
Citation
by
Section
Change
in
area
source
status
(
as
applicable)
63.1(
c)(
5)

Notification
of
construction/
reconstruction
63.5(
b)(
4),
63.5(
d),
and
63.1260(
c)

Notification
of
applicability
63.9(
a)
6
Notification
Reports
Standard
Citation
by
Section
Notification
of
initial
startup
63.9(
b),
63.9(
d),
and
63.1260(
b)

Notification
of
initial
performance
test
63.7(
b)(
1),
63.7(
b)(
2),
63.7(
f),
63.7(
h)
and
63.9(
e)

Reschedule
initial
performance
test
63.7(
b)(
2)

Notification
of
CMS
performance
evaluation
and
results
63.8(
e)(
2),
63.9(
g)(
1),
63.9(
e)(
5),
63.10(
e)(
2),
and
63.1260(
d)

Notification
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)

Reports
of
startup,
shutdown,
and
malfunction
63.10(
d)(
5),
and
63.1260(
i)

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

Rescheduled
initial
performance
test
63.7(
b)(
2)

Pre­
compliance
report
63.1260(
e)

Notification
of
compliance
status
report
(
NOCSR)
63.9(
f)

Physical
or
operational
change
63.1260(
g)(
2)(
vii),
and
63.1260(
h)(
1)
7
Notification
Reports
Standard
Citation
by
Section
Periodic
Reports
63.1260(
g)

Excess
emissions
reports
63.10(
e)(
3),
and
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)

Periods
of
planned
routine
maintenance
63.1260(
g)(
2)

New
operating
scenarios
63.1260(
g)(
2)

Change
in
activity
covered
by
pre­
compliance
report
or
change
in
the
status
of
a
control
device.
63.1260(
h)(
2)

Reports
of
leak
detection
and
repair
(
LDAR)
63.1260(
j)

Reports
of
emissions
averaging
63.1260(
k)

Source
status
report
63.1260(
g),
and
63.1260(
h)

A
source
must
keep
the
following
records:

Recordkeeping
Recordkeeping
requirements
63.10(
a)

All
reports
and
notifications
66.10(
b)(
1),
and
63.1259(
a)(
1)
8
Recordkeeping
Record
of
applicability
63.10(
b)(
3),
and
63.1259(
a)(
2)

Records
of
startup,
shutdown,
and
malfunction
63.1259(
a)(
3)

Records
of
sources
with
continuous
monitoring
systems
(
CMS)
63.10(
c)(
1)­(
14),
and
63.1259(
a)(
4)

Application
for
approval
of
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)

Records
of
the
rolling
annual
total
emissions
(
as
applicable)
63.1259(
b)(
4)

Number
of
batches
per
year,
operating
hours
per
year,
and
uncontrolled
and
controlled
emissions
for
each
process
(
as
appropriate)
63.1259(
b)(
5)

Wastewater
concentration
per
point
of
determination
(
POD)
or
process
63.1259(
b)(
6)

Number
of
storage
tank
turnovers
per
year
(
as
applicable)
63.1259(
b)(
7)

Daily
schedule
or
log
of
operating
scenarios
63.1259(
b)(
8)

Description
of
worst­
case
operating
conditions
63.1259(
b)(
9)

Periods
of
planned
routine
maintenance
63.1259(
b)(
10)

Records
of
operating
scenarios
63.1259(
c)

Records
of
LDAR
program
63.1259(
d)

Records
of
emissions
averaging
63.1259(
e)

Records
of
delay
of
repair
63.1259(
f)

Records
of
wastewater
stream
or
residual
transfer
63.1259(
g)
9
Recordkeeping
Records
of
extensions
63.1259(
h)

Records
of
inspections
63.1259(
i)

Records
should
be
retained
for
5
years
63.10(
b)(
1)

Electronic
Reporting
Presently,
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
20
percent
of
the
respondents
use
electronic
reporting.

(
ii)
Respondent
Activities
Respondent
Activities
Read
instructions.

Plan
compliance
strategy
(
includes
preparing
implementation
plans)

Perform
initial
performance
test,
Reference
Methods
1,
2,
3,
4,
18,
25
and
26
test,
and
repeat
performance
tests
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.
10
Respondent
Activities
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.

Currently,
sources
are
using
automated
monitoring
equipment
that
provides
parameter
data.
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.

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.

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
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
11
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
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.

5(
d)
Collection
Schedule
The
specific
frequency
for
each
information
collection
activity
within
this
request
is
shown
in
Table
1:
Annual
Industry
Burden
for
NESHAP
for
Pharmaceuticals
Production
(
40
CFR
part
63,
subpart
GGG).

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.
12
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
158,179
hours
(
Total
Labor
Hours
from
Table
1).
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
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%)
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
monitors
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/
Startu
p
Cost,
(
B
X
C)
(
E)
Annual
O&
M
Costs
for
One
Respondent
(
F)
Number
of
Respondents
with
O&
M
(
G)
Total
O&
M,
(
E
X
F)
13
Capital/
Startup
vs.
Operation
and
Maintenance
(
O&
M)
Costs
Data­
logger
and
Thermocouple
$
4,400
1
$
4,400
$
4,158
1
$
4,158
The
total
capital/
startup
costs
for
this
ICR
are
$
4,400.
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
$
4,158.
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
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
$
8,558.
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.

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
$
118,996
(
rounded).
This
cost
is
based
on
the
following
hourly
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:
Average
Annual
EPA
Burden
­
NESHAP
for
Pharmaceuticals
Production
(
40
CFR
part
63,
subpart
GGG).
14
6(
d)
Estimating
the
Respondent
Universe
and
Total
Burden
and
Costs
Based
on
our
research
for
this
ICR,
approximately
101
existing
sources
are
currently
subject
to
the
standard.
It
is
estimated
that
an
additional
one
source
per
year
from
this
pool
will
become
subject
to
the
regulation
over
the
next
three
years
due
to
reconstruction
of
an
existing
affected
facility.

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
Respondents
(
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
1
100
0
1
100
2
1
101
0
1
101
3
1
102
0
1
102
Average
1
101
0
1
101
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
101.
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
15
Total
Annual
Responses
1
Weighted
Average.
See
Table
1
for
details.
1
6
101
6.21
0
632
(
rounded)

The
number
of
Total
Annual
Responses
is
632.
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
for
Respondents
are
$
10,006,462.
The
annual
labor
costs
are
not
shown
on
the
OMB
83­
I
form.
Details
regarding
these
estimates
may
be
found
in
Table
1.
Average
Annual
Industry
Burden,
NESHAP
for
Pharmaceuticals
Production
(
40
CFR
part
63,
subpart
GGG).

Note
that
the
total
annual
capital
and
O&
M
cost
to
the
regulated
entity
is
$
8,000.
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
are
attached.
The
annual
public
reporting
and
recordkeeping
burden
for
this
collection
of
information
is
estimated
to
average
250
hours
per
response.

6(
f)
Reasons
for
Change
in
Burden
The
adjustment
decrease
in
burden
from
the
most
recently
approved
ICR
is
due
to
a
decrease
in
the
number
of
sources.
Our
data
indicate
that
there
are
101
sources,
including
one
additional
source
due
to
reconstruction,
compared
to
the
active
ICR
that
shows
103
sources.
There
are
no
new
facilities
being
constructed
at
this
time.
Reconstruction
of
facilities
is
the
only
expected
activity.

The
increase
in
labor
costs
associated
with
this
ICR
is
due
to
the
increase
in
labor
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
16
estimated
to
average
250
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;
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
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
0035,
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
Ave.,
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,
DC.
20503,
Attention:
Desk
Office
for
EPA.
Please
include
the
EPA
Docket
ID
Number
OECA­
2003­
0035
and
OMB
Control
Number
2060­
0358
in
any
correspondence.

Part
B
of
the
Supporting
Statement
This
part
is
not
applicable
because
no
statistical
methods
were
used
in
collecting
this
information.
17
Table
1:
Average
Annual
Industry
Burden
­
NESHAP
for
Pharmaceuticals
Production
(
40
CFR
part
63,
subpart
GGG)

Burden
Item
(
A)
Respondent
Hours
per
Occurrence
(
B)
Number
of
Occurrences
Per
Respondent
Per
Year
(
C)
Hours
Per
Respondent
Per
Year
(
C=
A
x
B)
(
D)
Number
of
Respondents
Per
Year
(
E)
Technical
Hours
Per
Year
@$
64.13
(
CXD)
(
F)
Management
Hours
Per
Year
@$
93.09
(
E
x
0.05)
(
G)
Clerical
Hours
Per
Year
@$
39.65
(
E
x
0.1)
(
H)
Total
Costs
Per
Year
a
1.
APPLICATIONS
N/
A
2.
SURVEY
AND
STUDIES
N/
A
3.
REPORTING
REQUIREMENTS
New
Sources
b
A.
Read
Instructions
1
1
1
1
1
0.05
0.1
$
72.74
B.
Required
Activities
Initial
Performance
Test
New
Reconstructed
Wastewater
Quality
control
plan
for
CMS
Develop
record
system
Train
personnel
Repeat
performance
test
c
1,983
661
271
60
40
40
60
1
1
1
1
1
1
1
1,983
661
271
60
40
40
60
0
1
0
1
1
1
0.2
0
661
0
60
40
40
12
0
33.05
0
3
2
2
0.6
0
66.1
0
6
4
4
1.2
$
0
$
48,087.41
$
0
$
4,364.97
$
2,909.98
$
2,909.98
$
872.99
C.
Write
Report
Notification
of
construction/
reconstruction
Notification
of
physical/
operational
changes
d
Notification
of
anticipated
startup
Notification
of
actual
startup
Notification
of
initial
performance
test
Notification
of
applicability
standards
Notification
of
demonstration
of
CMS
Notification
of
compliance
status
(
NOCSR)

Implementation
plan
(
emission
averaging)

Startup,
shutdown
and
malfunction
Semiannual
reports
e
Quarterly
report
of
excess
emissions
and
CMS
performance
f
Leak
detection
and
repair
(
LDAR)
reports
g
2
8
2
2
2
2
2
120
180
40
3
20
432
1
3
1
1
1
0
1
1
0
1
2
4
1
2
24
2
2
2
0
2
120
0
40
6
80
432
1
101
1
1
1
0
1
1
0
1
91
10
101
2
2424
2
2
2
0
2
120
0
40
546
800
43,632
0
121.2
0
0
0
0
0
6
0
2
27.3
40
2,181.6
0
242.4
0
0
0
0
0
12
0
4
54.6
80
4,363.2
$
128.26
$
176,344.79
$
128.26
$
128.26
$
128.26
$
0
$
128.26
$
8,729.94
$
0
$
2,909.98
$
39,721.23
$
58,199.60
$
3,174,206.12
18
Burden
Item
(
A)
Respondent
Hours
per
Occurrence
(
B)
Number
of
Occurrences
Per
Respondent
Per
Year
(
C)
Hours
Per
Respondent
Per
Year
(
C=
A
x
B)
(
D)
Number
of
Respondents
Per
Year
(
E)
Technical
Hours
Per
Year
@$
64.13
(
CXD)
(
F)
Management
Hours
Per
Year
@$
93.09
(
E
x
0.05)
(
G)
Clerical
Hours
Per
Year
@$
39.65
(
E
x
0.1)
(
H)
Total
Costs
Per
Year
a
4.
Recordkeeping
Requirements
Records
of
operating
parameters
for
control
devices
h
830
1
830
101
83,830
4,191.5
8,383
$
6,098,590.58
Records
of
operating
conditions
exceeding
last
performance
test
i
8
1
8
10
80
4
8
$
5,819.96
Records
of
startup,
shutdown
and
malfunction
2
26
52
101
5,252
262.6
525.2
$
382,080.37
Total
137,548
6,876.9
13,753.8
$
10,006,461.94
TOTAL
ANNUAL
BURDEN
(
rounded)
158,179
$
10,006,462
Assumptions:

a.
Assume
that
all
tasks
are
to
be
performed
by
managerial,
technical
and
clerical
personnel.
This
ICR
uses
the
following
labor
rates:
$
93.09
for
Managerial
labor,
$
64.13
for
Technical
labor
and
$
39.65
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
rates
have
been
increased
by
110%
to
account
for
the
benefit
packages
available
to
those
employed
by
private
industry.

b.
Assume
that
there
will
be
one
modified
or
reconstructed
facility
constructed
each
year
for
the
next
three
years.

c.
Assume
that
20
percent
of
sources
will
repeat
performance
testing
each
year
due
to
failure.

d.
Assume
all
sources
will
require
an
average
of
three
processing
changes
per
facility
each
year
over
the
three
year
period
of
this
ICR.

e.
It
is
estimated
that
90
percent
of
affected
facilities
will
write
semiannual
reports.

f.
It
is
estimated
that
10
percent
of
the
affected
facilities
will
write
quarterly
reports
of
excess
emissions.

g.
Assume
that
it
will
take
respondent
432
hours
to
write
the
leak
detection
and
repair
report.

h.
Assume
that
all
sources
are
required
to
keep
records
of
operating
parameters
for
control
devices.

i.
Assume
that
10
percent
of
sources
are
required
to
keep
records
of
operating
conditions
exceeding
last
performance
tests.
19
Table
2:
Average
Annual
EPA
Burden
­
NESHAP
for
Pharmaceuticals
Production
(
40
CFR
part
63,
subpart
GGG)

Burden
Items
(
A)

EPA
hr./

Per
Occurrenc
e
(
B)
Occurrences/

year
(
C)
Technical
person­
hours
per
year
(
C=
AxB)
(
D)
Management
person­
hours
per
year
(
D=
Cx0.05)
(
E)
Clerical
person­
hours
per
Year
(
E=
Cx0.1)
(
F)
a
EPA
Cost
($)

Required
Activities
Initial
performance
test
Repeat
performance
test
24
24
1b
0.2
c
24
4.8
1.2
0.24
2.4
0.48
$
1,062.93
$
212.58
Report
Review
Notification
of
construction/
reconstruction
Review
of
notification
of
physical/
operational
changes
Notification
of
anticipated
startup
Notification
of
actual
startup
Review
of
notification
of
demonstration
of
CMS
Review
of
initial
notification
of
compliance
status
Review
of
initial
notification
of
compliance
status
and
implementation
plan
Existing
Plants
Semiannual
reports
Quarterly
reports
of
excess
emissions
and
CMS
performance
2
8
2
2
2
4
4
2
4
1d
303e
1
1
1
1
0
91f
10g
2
2,424
2
2
2
4
0
182
40
0.1
121.2
0.1
0.1
0.1
0.2
0
9.1
2
0.2
242.4
0.2
0.2
0.2
0.4
0
18.2
4
$
88.58
$
107,356.53
$
88.58
$
88.58
$
88.58
$
177.15
$
0
$
8,060.60
$
1,771.56
Total
2,686.8
134.34
268.68
$
118,995.67
TOTAL
ANNUAL
BURDEN
(
rounded)
2,687h
134h
269h
$
118,996
Assumptions:

a.
The
cost
is
based
on
the
hourly
labor
rate
of
$
39.49
for
technical
labor,
$
53.22
for
managerial
labor,
and
$
21.38
for
clerical
labor.
These
rates
are
from
the
20
Office
of
Personnel
Management
(
OPM)
"
2003
General
Schedule"
which
excludes
locality
rates
of
pay.

b.
Assume
that
there
will
be
one
new
source
(
respondent)
per
year
over
the
three
years
period
of
this
ICR.

c.
Assume
20
percent
of
initial
performance
tests
are
repeated
due
to
failure.

d.
Assume
that
one
source
will
reconstruct
their
affected
facility
each
year
over
the
three
years
period
of
this
ICR.

e.
Assume
that
all
source
will
require
an
average
of
three
processing
changes
per
facility
each
year
over
the
three
years
period
of
this
ICR
(
3x101=
303).

f.
Assume
that
90
percent
of
sources
would
be
required
to
submit
semiannual
reports.

g.
Assume
that
10
percent
of
sources
would
be
required
to
submit
quarterly
reports.

h.
Total
number
of
annual
burden
hours
for
Technical
+
Management
+
Clerical
in
this
ICR
is
3,090
(
rounded).