Document ID: EPA-HQ-ORD-2004-0013-0005
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2005-02-07T05:00Z

SF­
83
SUPPORTING
STATEMENT
Application
for
Reference
and
Equivalent
Method
Determination
1.
IDENTIFICATION
OF
THE
INFORMATION
COLLECTION
1(
a)
Title
Application
for
Reference
and
Equivalent
Method
Determination
(
Renewal);
EPA
ICR
Number
0559.08;
OMB
Control
Number
2080­
0005.

1(
b)
Short
Characterization
(
Abstract)
Under
the
air
pollutant
monitoring
regulations
in
40
CFR
part
58,
certain
state
and
local
air
monitoring
agencies
are
required
to
operate
and
maintain
ambient
air
monitoring
networks
to
determine
attainment
or
non­
attainment
with
the
National
Ambient
Air
Quality
Standards
(
NAAQS)
(
40
CFR
50).
To
help
ensure
the
accuracy
and
quality
of
the
air
monitoring
data
obtained
in
these
monitoring
networks,
the
regulations
further
require
that
the
pollutant
measurement
methods
used
must
be
designated
by
the
EPA
as
either
reference
or
equivalent
methods.
Regulatory
requirements
for
designation
of
air
monitoring
methods
by
the
EPA
as
reference
or
equivalent
methods
are
set
forth
in
40
CFR
part
53
(
http://
www.
gpoaccess.
gov/
cfr/
retrieve.
html).
The
principle
requirement
is
testing
of
the
method
according
to
prescribed
test
procedures
to
demonstrate
that
the
method
meets
indicated
design
and
performance
specifications,
is
quantitatively
comparable
(
provides
equivalent
pollutant
measurements)
to
a
reference
method,
or
both
(
depending
on
the
type
of
method).
Applicants
who
seek
to
have
an
ambient
air
pollutant
measurement
method
designated
by
the
EPA
as
a
reference
or
equivalent
method
must
conduct
the
required
tests
of
the
candidate
method
and
submit
the
test
results
and
associated
information
to
the
EPA
in
an
application
for
reference
or
equivalent
method
determination
(
40
CFR
§
50.4).
Usually,
the
applicant
is
a
manufacturer
or
vendor
of
an
instrumental
air
analyzer
(
called
an
automated
method)
or
an
air
sampler
(
manual
method)
who
wishes
to
have
its
method
(
product)
designated
by
the
EPA
so
that
state
and
local
air
monitoring
agencies
can
purchase
the
analyzer
or
sampler
for
use
in
their
air
monitoring
networks
under
40
CFR
part
58.
Only
about
5
applications
are
expected
annually.
Accordingly,
the
primary
type
of
collection
is
an
application
for
EPA­
designation
of
a
method
used
for
ambient
air
pollutant
measurement.
The
information
is
collected
by
the
Process
Modeling
Research
Branch,
Human
Exposure
and
Atmospheric
Sciences
Division,
National
Exposure
Research
Laboratory
(
NERL)
of
EPA's
Office
of
Research
and
Development,
which
receives
and
processes
the
applications.
The
information
being
collected
via
the
application
is
a
detailed
description
of
the
nature
of
the
method
and
measurement
principle
employed
by
the
method,
the
operational
instructions
and
calibration
procedure
associated
with
the
method,
method
test
results,
descriptions
of
the
test
apparatus
and
test
procedures
used,
and
other
related
information
required
by
40
CFR
part
53.
This
information
is
used
by
the
Process
Modeling
Research
Branch
to
determine
whether
the
method
is
qualified
to
be
designated
by
the
EPA
as
a
reference
or
equivalent
method.
Such
designation
of
the
method
allows
it
to
be
used
by
state
and
local
air
monitoring
agencies
in
their
required
air
surveillance
networks.
The
information
is
2
submitted
in
the
form
of
text,
data
tables,
diagrams,
copies
of
strip
chart
or
data
acquisition
system
records,
instruction
or
operation
manuals,
or
other
items
as
appropriate.
The
information
is
usually
stored
as
submitted,
but
some
information
may
be
microfilmed
or
stored
electronically.
Subsequent
to
designation
of
a
method
as
a
reference
or
equivalent
method,
a
manufacturer
or
user
of
the
method
may
submit
a
request
for
approval
of
a
modification
to
the
method.
The
information
submitted
in
such
a
request
is
similar
in
nature
to
that
in
an
application,
but
is
usually
of
a
greatly
reduced
scope,
since
it
deals
only
with
the
specific
aspects
of
the
proposed
change
or
changes
to
the
method.
Usually,
the
frequency
of
submission
of
requests
for
approval
of
modifications
is
higher
than
that
for
applications.
An
associated
recordkeeping
requirement
(
40
CFR
53.9(
f))
stipulates
that
vendors
of
designated
methods
must
maintain
a
list
of
the
names
and
addresses
of
all
ultimate
purchasers
of
such
methods
so
that
they
can
be
notified
in
the
event
that
the
designation
has
been
canceled
or
that
the
method
must
be
modified
or
adjusted
to
maintain
designated
status.

2.
NEED
FOR
AND
USE
OF
THE
COLLECTION
2(
a)
Need/
Authority
for
the
Collection
The
information
submitted
under
this
request
for
information
collection
is
needed
to
determine
whether
specific
methods
intended
for
use
in
measuring
the
quantitative
concentrations
of
certain
atmospheric
pollutants
are
adequate
for
purposes
of
pollutant
monitoring
to
determine
attainment
or
non­
attainment
with
the
NAAQS
set
forth
in
40
CFR
50
(
http://
www.
gpoaccess.
gov/
cfr/
retrieve.
html).
These
methods
are
primarily
commercial
instrumental
air
analyzers
used
for
continuous
atmospheric
monitoring
or
commercial
air
samplers
used
to
collect
integrated
air
samples
for
laboratory
analyses,
but
they
may
also
include
noncommercial
manual
methods
used
for
noncontinuous
air
monitoring.
Under
the
provisions
of
40
CFR
53,
an
applicant
conducts
prescribed
performance
tests
of
a
monitoring
method
and
submits
the
test
results,
a
detailed
description
of
the
method,
and
other
associated
information
to
EPA.
If
EPA
determines,
on
the
basis
of
the
submitted
information
and
test
results,
that
the
method
meets
the
design,
performance,
and/
or
comparability
requirements
specified
in
40
CFR
53,
the
method
is
designated
as
either
a
reference
or
equivalent
method,
as
appropriate.
Under
40
CFR
58
Appendix
B,
EPA
requires
state
and
local
air
monitoring
and
control
agencies
to
use
either
reference
or
equivalent
methods
in
their
federally
required
air
monitoring
networks
to
help
ensure
the
accuracy
and
quality
of
the
air
monitoring
data
they
collect
for
determining
attainment
or
non­
attainment.
The
authority
to
collect
this
information
is
Section
301(
a)
of
the
Clean
Air
Act
[
42
U.
S.
C.
sec.
1857g(
a)],
as
amended
by
sec.
15(
c)(
2)
of
Public
Law
91­
604,
84
Stat.
1713.
The
information
is
collected
according
to
the
provisions
set
forth
in
40
CFR
part
53.

2(
b)
Practical
Utility/
Users
of
the
Data
Upon
receipt
by
the
Process
Modeling
Research
Branch,
an
application
is
logged
and
an
acknowledgment
of
receipt
is
sent
to
the
applicant,
as
required
by
the
regulation.
The
application
is
then
technically
reviewed
by
the
Branch,
and
any
additional
tests
or
information
needed
to
3
complete
the
technical
review
or
to
make
the
reference
or
equivalent
method
determination
is
formally
requested
from
the
applicant
in
accordance
with
the
provisions
of
the
regulation.
If
the
technical
evaluation
of
the
application
indicates
that
all
requirements
are
satisfied
and
that
the
method
fully
qualifies
for
designation
as
a
reference
or
equivalent
method,
a
notice
of
designation
for
the
method
is
prepared
and
sent
through
the
Laboratory
Director
of
ORD's
National
Exposure
Research
Laboratory
for
publication
in
the
Federal
Register.
If
not,
a
request
for
additional
tests
or
information
may
be
sent
to
the
applicant,
the
applicant
may
be
notified
that
additional
tests
will
be
conducted
by
EPA
before
a
determination
can
be
made,
or
the
applicant
may
be
notified
that
the
application
is
rejected.
Following
approval
of
the
designation
by
the
NERL
Laboratory
Director
and
publication
of
the
notice
of
designation,
notification
of
the
designation
is
sent
to
the
applicant,
and
the
method
is
added
to
the
List
of
Designated
Reference
and
Equivalent
Methods
maintained
by
the
Process
Modeling
Research
Branch.
This
list
identifies
all
methods
that
have
been
designated
as
reference
or
equivalent
methods
and
is
posted
at
http://
www.
epa.
gov/
ttn/
amtic/
criteria.
html,
where
it
is
available
to
the
EPA
Regional
Offices,
state
and
local
air
monitoring
agencies,
and
other
interested
users
of
air
monitoring
methods.
Based
on
applications
received
under
this
program,
EPA
has
designated
151
reference
and
equivalent
methods
as
of
July
2004.
Many
of
these
methods
are
currently
in
service
in
ambient
air
monitoring
networks
in
all
50
states,
obtaining
air
quality
data
used
by
EPA
to
determine
attainment
or
non­
attainment
of
the
NAAQS
in
all
regions
of
the
United
States.
There
is
also
an
associated
recordkeeping
requirement
such
that
an
applicant
who
offers
designated
reference
or
equivalent
methods
for
sale
must
maintain
an
accurate
and
current
list
of
the
names
and
mailing
addresses
of
all
ultimate
purchasers
of
such
methods.
For
a
period
of
seven
years
after
publication
of
a
reference
or
equivalent
method
designation,
the
applicant
must
notify
all
ultimate
purchasers
of
the
method
within
30
days
if
the
designation
is
canceled
or
if
adjustment
of
the
method
is
determined
by
EPA
to
be
necessary
to
avoid
cancellation
of
the
method
designation.
This
purchaser
name
and
address
information
is
not
required
to
be
reported
to
EPA.

3.
NONDUPLICATION,
CONSULTATIONS,
AND
OTHER
COLLECTION
CRITERIA
3(
a)
Nonduplication
Since
the
purpose
and
nature
of
the
information
requested,
as
specified
in
the
regulation,
is
highly
specialized,
it
is
very
unlikely
that
any
other
agency
collects
or
is
planning
to
collect
such
information.
The
regulatory
requirements
for
the
information
are
very
explicit
in
describing
the
tests
that
must
be
conducted,
how
they
are
to
be
conducted,
and
the
way
that
the
test
results
are
to
be
submitted
and
interpreted.
It
is
therefore
difficult
or
impossible
to
use
similar
data
not
obtained
in
accordance
with
the
regulation
requirements.
However,
if
information
necessary
for
a
specific
application
is
duplicative
of
information
contained
in
a
previously
submitted
application
or
otherwise
already
in
the
EPA's
possession,
the
previously
submitted
information
may
be
cited
and
4
need
not
be
resubmitted.
Also,
where
possible,
method
test
or
performance
information
obtained
by
or
for
other
testing
or
regulatory
organizations,
including
foreign
organizations,
may
be
used
to
support
or
corroborate
submitted
test
information
or
to
obviate
the
need
for
special
or
supplemental
test
results
which
may
otherwise
be
required.

3(
b)
Public
Notice
Required
Prior
to
ICR
Submission
to
OMB
Public
notice
of
this
Information
Collection
Request
was
published
in
the
Federal
Register
on
August
27,
2004
(
69
FR
52663).
A
60­
day
public
comment
period
was
announced.

3(
c)
Consultations
During
both
the
original
development
of
the
40
CFR
53
regulation
and
several
subsequent
amendments,
multiple
non­
EPA
persons
and
agencies
were
consulted
for
advice
and
review
of
draft
regulations
and
support
documents.
These
included
state
and
local
air
monitoring
or
control
agency
personnel
in
the
Standing
Air
Monitoring
Work
Group
(
SAMWG).
As
the
regulation
proceeded
through
the
formal
rule­
making
process,
additional
public
comments
were
received
from
additional
non­
EPA
individuals
and
agencies.
These
comments
and
suggestions
were
carefully
reviewed
and
incorporated
into
the
regulation
to
the
greatest
extent
possible.
The
regulation
has
been
amended
several
times
since
its
initial
promulgation,
and
each
time
additional
comments
have
been
solicited,
evaluated,
and
appropriate
changes
incorporated
into
the
regulation.
The
most
recent
amendment
of
the
regulation
occurred
on
July
18,
1997
(
62
FR
38784).
These
amendments
to
40
CR
part
53
were
proposed
on
December
13,
1996,
and
comments
were
received
from
7
respondents
(
Docket
A­
96­
51).
A
list
of
the
names
and
affiliations
of
the
respondents
is
provided
in
Appendix
A
to
this
supporting
statement.
Also,
the
SAMWG
was
again
consulted
for
comments
and
advice.
A
list
of
the
non­
EPA
SAMWG
personnel
is
included
in
Appendix
A
to
this
Supporting
Statement.
In
addition,
Process
Modeling
Research
Branch
personnel
frequently
discuss
method
performance
and
testing
issues
with
representatives
of
many
of
the
air
monitoring
manufacturers
during
application
processing,
during
preliminary
consultations,
at
technical
meetings,
and
during
occasional
visits
by
such
representatives
to
the
Branch
Office.
Some
of
the
most
recent
consultations
are
listed
here:

Larry
Hackworth,
Zedek
Corporation,
Durham,
NC
Bill
Roe,
Grimm
Technologies,
Inc.,
Douglasville,
GA
Tom
Merrifield,
BGI
Incorporated,
Waltham,
MA
David
Gobeli,
MetOne
Instruments,
Grants
Pass,
OR
Kevin
J.
Goohs,
Thermo
Environmental
Corp.,
Franklin,
MA
Edward
Hoopes,
Advanced
Pollution
Instrumentation,
San
Diego,
CA
Gerald
McGowan,
Teledyne
Monitor
Labs,
Englewood,
CO
Peter
Phaedonos,
Ecotech
Pty.
Ltd.,
Blackburn,
Victoria,
Australia
Lucien
Lonigro,
SERES,
Provence,
France
3(
d)
Effects
of
Less
Frequent
Collection
5
Since
the
information
is
collected
only
once
for
each
application,
less
frequent
collection
is
not
possible.
Modest
recordkeeping
is
required,
but
the
information
in
these
records
is
not
required
to
be
reported.

3(
e)
General
Guidelines
Record
retention
over
3
years.
Section
53.9
of
40
CFR
53
requires
applicants
who
offer
analyzers
or
samplers
for
sale
as
reference
or
equivalent
methods
to
maintain
records
of
the
names
and
current
mailing
addresses
of
all
ultimate
purchasers
of
such
analyzers
or
samplers
for
a
period
of
seven
years
from
the
date
of
designation
of
the
method
as
a
reference
or
equivalent
method.
This
recordkeeping
requirement
is
necessary
because
the
regulation
further
requires
such
an
applicant
to
notify
all
purchasers
of
the
designated
analyzer
or
sampler
during
that
seven
year
period
if
the
reference
or
equivalent
method
designation
is
canceled
or
if
adjustment
or
modification
of
the
designated
analyzer
or
sampler
is
required
to
maintain
its
designated
status.
Seven
years
is
representative
of
the
estimated
useful
life
of
such
instruments.
This
recordkeeping
requirement
is
quite
modest,
and
there
are
no
periodic
reporting
requirements
associated
with
the
recordkeeping.
Submission
of
confidential
information.
Submission
of
information
that
is
claimed
by
the
applicant
to
be
confidential
business
information
may
be
necessary
to
make
a
reference
or
equivalent
method
determination.
The
Process
Modeling
Research
Branch
has
instituted
procedures
to
protect
the
confidentiality
of
any
submitted
information
identified
as
such,
in
accordance
with
40
CFR
53.15
and
40
CFR
part
2.
This
information
collection
adheres
to
all
of
the
other
general
guidelines.

3(
f)
Confidentiality
and
Sensitive
Questions
Confidentiality.
The
Process
Modeling
Research
Branch
has
instituted
procedures
to
protect
the
confidentiality
of
any
submitted
information
identified
as
such,
in
full
accordance
with
40
CFR
53.15
and
all
applicable
provisions
of
40
CFR
part
2.
Sensitive
Questions.
No
information
concerning
sexual
behavior
or
attitudes,
religious
beliefs,
or
other
information
of
a
similarly
sensitive
nature
is
collected.

4.
THE
RESPONDENTS
AND
THE
INFORMATION
REQUESTED
4(
a)
Respondents/
NAIC
Codes
Since
the
collection
of
this
information
is
voluntary
and
related
to
application
for
a
benefit,
the
information
is
collected
only
from
entities
for
which
the
benefit
is
sufficient
to
justify
the
costs
of
the
required
testing
and
submission
of
an
application.
The
largest
category
of
applicants
is
manufacturers
or
vendors
(
NAIC
#
334513)
of
air
monitoring
instruments
suitable
for
use
by
state
and
local
air
monitoring
agencies
in
their
federally
required
air
surveillance
monitoring
networks,
and
agents
acting
for
instrument
manufacturers
or
vendors.
Other
potential
applicants
include
state
or
local
air
monitoring
agencies
(
NAIC
#
924110),
analytical
laboratories
(
NAIC
#
541380),
and
the
EPA
(
NAIC
#
924110).
6
4(
b)
Information
Requested
(
i)
Data
Items,
Including
Recordkeeping
Requirements
Information
requested:

1.
A
clear
identification
of
the
candidate
method,
which
will
distinguish
it
from
all
other
methods
such
that
the
method
may
be
referred
to
unambiguously.
This
identification
must
consist
of
a
unique
series
of
descriptors
such
as
title,
identification
number,
analyte,
measurement
principle,
manufacturer,
brand,
model,
etc.,
as
necessary
to
distinguish
the
method
from
all
other
methods
or
method
variations,
both
within
and
outside
the
applicant's
organization.
[
§
53.4(
b)(
1)]
2.
A
detailed
description
of
the
candidate
method,
including
but
not
limited
to
the
following:
The
measurement
principle,
manufacturer,
name,
model
number
and
other
forms
of
identification,
a
list
of
the
significant
components,
schematic
diagrams,
design
drawings,
and
a
detailed
description
of
the
apparatus
and
measurement
procedures.
Drawings
and
descriptions
pertaining
to
candidate
methods
or
samplers
for
PM
2.5
must
meet
all
applicable
requirements
in
Reference
1
of
Appendix
A
of
part
53
subpart
A,
using
appropriate
graphical,
nomenclature,
and
mathematical
conventions
such
as
those
specified
in
References
3
and
4
of
Appendix
A
of
part
53
subpart
A.
[
§
53.4(
b)(
2)]
3.
A
copy
of
a
comprehensive
operation
or
instruction
manual
providing
a
complete
and
detailed
description
of
the
operational,
maintenance,
and
calibration
procedures
prescribed
for
field
use
of
the
candidate
method
and
all
instruments
utilized
as
part
of
that
method
[
§
53.4(
b)(
3)].
(
i)
As
a
minimum
this
manual
shall
include:
(
A)
Description
of
the
method
and
associated
instruments.
(
B)
Explanation
of
all
indicators,
information
displays,
and
controls.
(
C)
Complete
setup
and
installation
instructions,
including
any
additional
materials
or
supplies
required.
(
D)
Details
of
all
initial
or
startup
checks
or
acceptance
tests
and
any
auxiliary
equipment
required.
(
E)
Complete
operational
instructions.
(
F)
Calibration
procedures
and
a
description
of
the
required
or
recommended
calibration
equipment
and
standards.
(
G)
Instructions
for
verification
of
correct
or
proper
operation.
(
H)
Trouble­
shooting
guidance
and
suggested
corrective
actions
for
abnormal
operation.
(
I)
Required
or
recommended
routine,
periodic,
and
preventative
maintenance
and
maintenance
schedules.
(
J)
Any
calculations
required
to
derive
final
concentration
measurements.
7
(
K)
Appropriate
references
to
the
applicable
Appendix
of
part
50,
Reference
6
of
Appendix
A
of
part
53
subpart
A,
and
any
other
pertinent
EPA
guidelines.
(
ii)
The
manual
shall
also
include
adequate
warning
of
potential
safety
hazards
that
may
result
from
normal
use
and/
or
malfunction
of
the
method
and
a
description
of
necessary
safety
precautions.
[
See
also
§
53.9(
b).]
For
samplers
and
automated
methods,
the
manual
shall
include
a
clear
description
of
all
procedures
pertaining
to
installation,
operation,
preventive
maintenance,
and
troubleshooting
and
shall
also
include
parts
identification
diagrams.
[
§
53.4(
b)(
3)]
4.
Statements
that
the
candidate
method
has
been
tested
in
accordance
with
the
procedures
described
in
subparts
B,
C,
D,
E,
and/
or
F
of
40
CFR
53
(
as
applicable),
and
that
the
method,
analyzer,
or
sampler
tested
is
representative
of
the
candidate
method
described
in
the
application.
[
§
53.4(
b)(
4)
and
(
6)]
5.
Descriptions
of
test
facilities
and
test
configurations,
test
data,
records,
calculations,
and
test
results
as
specified
in
subparts
B,
C,
D,
E,
and/
or
F
of
40
CFR
part
53,
as
applicable.
Salient
requirements
from
these
references
include
the
following:
(
i)
The
applicant
shall
maintain
and
include
records
of
all
relevant
measuring
equipment,
including
the
make,
type,
and
serial
number
or
other
identification,
and
most
recent
calibration
with
identification
of
the
measurement
standard
or
standards
used
and
their
National
Institute
of
Standards
and
Technology
(
NIST)
traceability.
(
ii)
Test
data
shall
be
collected
according
to
the
standards
of
good
practice
and
by
qualified
personnel.
Calculations
or
data
manipulations
shall
be
explained
in
detail
so
they
can
be
verified.
Test
anomalies
or
irregularities
shall
be
documented
and
explained
or
justified.
[
§
53.4(
b)(
5)]
6.
For
candidate
automated
methods
and
candidate
manual
methods
for
PM
10
and
PM
2.5,
the
application
shall
also
contain
the
following
[
§
53.4(
c)]:
(
i)
A
detailed
description
of
the
quality
system
that
will
be
utilized
in
production
of
the
method,
if
the
candidate
method
is
designated
as
a
reference
or
equivalent
method.
(
ii)
A
description
of
the
durability
characteristics
of
such
analyzers
or
samplers.
[
See
also
§
53.9(
c).]
7.
For
candidate
reference
and
equivalent
methods
for
PM
2.5,
the
applicant
must
submit
documentation
verifying
that
the
reference
or
equivalent
method
samplers
will
be
manufactured
in
an
ISO­
9001­
registered
and
maintained
facility.
[
§
53.51(
b)(
1)]
8.
For
candidate
reference
and
equivalent
methods
for
PM
2.5,
the
applicant
must
submit
information
related
to
designation
testing
and
product
manufacturing,
confirmed
by
an
ISO­
certified
auditor.
[
§
53.51(
f)]
9.
Also
for
candidate
reference
or
equivalent
methods
for
PM
2.5,
the
applicant
shall
provide
to
EPA
for
test
purposes
one
sampler
or
analyzer
that
is
representative
of
the
sampler
or
analyzer
associated
with
the
candidate
method.
This
analyzer
or
8
sampler
may
be
subjected
to
various
tests
that
EPA
determines
to
be
necessary
or
appropriate
under
§
53.5(
f),
and
such
tests
may
include
special
tests
not
described
in
this
part.
Arrangements
for,
and
the
cost
of,
return
shipment
are
the
responsibility
of
the
applicant.
[
§
53.4(
d)]
10.
Identification
of
confidential
or
proprietary
information
(
if
applicable).
[
§
53.15]

Maintain
records
on:

1.
Section
53.9(
f)
of
40
CFR
53
requires
applicants
who
offer
analyzers
or
samplers
for
sale
as
reference
or
equivalent
methods
to
maintain
records
of
the
names
and
current
mailing
addresses
of
all
ultimate
purchasers
of
such
analyzers
or
samplers
for
a
period
of
seven
years
from
the
date
of
designation
of
the
method
as
a
reference
or
equivalent
method.
This
recordkeeping
requirement
is
necessary
because
that
Section
of
the
regulation
further
requires
such
an
applicant
to
notify
all
purchasers
of
the
analyzer
or
sampler
if
the
reference
or
equivalent
method
designation
is
canceled
or
if
adjustment
or
modification
of
the
analyzer
or
sampler
is
required
to
maintain
its
designated
status.
This
recordkeeping
requirement
is
quite
modest,
and
there
are
no
periodic
reporting
requirements
associated
with
the
recordkeeping.
[
53.9(
f)]
2.
For
PM
2.5
methods,
quality
control
and
quality
assurance
records
and
documentation
must
be
maintained
as
required
by
ISO
9001
facility
registration
or
equivalent
standards
[
§
53.51(
b),
§
53.9(
h),
and
§
53.9(
i)].

(
ii)
Respondent
Activities
Typical
or
representative
respondent
activities
are
as
follows:

1.
Obtain
a
copy
of
the
40
CFR
50
and
40
CFR
53
regulations.
2.
Study
the
application
requirements
and
become
familiar
with
the
specific
test
procedures;
obtain
assistance
from
the
Branch,
if
needed.
3.
Plan
the
required
tests
and
determine
requirements
for
test
equipment,
instruments,
facilities,
standards,
materials,
personnel,
and
any
contractual
services
needed.
4.
Obtain
required
test
equipment,
instruments,
facilities,
standards,
and
materials
and
arrange
for
required
personnel.
Arrange
for
contractual
services,
if
needed.
5.
Train
personnel.
6.
Assemble
the
test
equipment,
set
up
the
test
apparatus
and
facilities,
and
run
practice
tests
as
may
be
needed.
7.
Carry
out
all
required
tests
and
obtain
required
test
results.
8.
Compile
all
test
results,
test
parameters,
instrument
readings,
measurement
data,
and
other
pertinent
test
documentation.
9.
Prepare
descriptions,
tables,
diagrams,
illustrations,
strip
chart
records,
calculations,
statements,
and
other
documents
as
necessary.
10.
Assemble
final
application
and
submit
it
to
EPA.
9
11.
Respond
to
any
requests
from
EPA
for
additional
tests
or
information
that
may
be
determined
to
be
necessary
to
make
the
final
reference
or
equivalent
method
determination.
12.
Maintain
records
of
ultimate
purchasers
of
designated
analyzers
or
samplers.
13.
Obtain
or
maintain
ISO
9001
registration
for
the
test
and
manufacturing
facility
(
for
PM
2.5
method
designation
only).
14.
Calibrate
and
maintain
testing
instruments.

(
Because
of
their
specific
nature,
none
of
these
items
may
be
considered
"
customary
and
usual
business
practice,"
although
somewhat
similar
types
of
tests
and
facilities
may
be
used
during
product
design,
development,
and
production
quality
control.)

5.
THE
INFORMATION
COLLECTED
 
AGENCY
ACTIVITIES,
COLLECTION
METHODOLOGY,
AND
INFORMATION
MANAGEMENT
5(
a)
Agency
Activities
1.
Make
available
copies
of
the
40
CFR
53
regulation
and
other
helpful
material,
establish
specific
interpretation
of
regulatory
requirements
if
necessary,
and
provide
guidance
or
technical
assistance
to
applicants.
2.
Receive
applications,
file
applications
and
associated
information,
send
acknowledgment
of
receipt
to
applicant,
maintain
confidentiality
of
application
material
identified
as
confidential
business
information.
3.
Carry
out
comprehensive
technical
review
of
application
information;
identify
any
inadequacies
and
request
additional
tests
or
information
as
determined
to
be
required.
If
necessary,
arrange
for
special
auxiliary
tests,
as
may
be
determined
to
be
required.
4.
Upon
determination
of
designation,
prepare
and
publish
a
Notice
of
Designation
in
the
Federal
Register
and
notify
the
applicant
of
designation.
5.
Maintain
a
List
of
Designated
Reference
and
Equivalent
Methods
and
make
the
list
available
on
the
Internet
(
www.
epa.
gov/
ttn/
amtic/
criteria.
html).
6.
Technically
evaluate
and
approve
requests
(
or
take
other
action,
as
appropriate)
for
proposed
modifications
to
designated
reference
or
equivalent
methods
from
applicants,
manufacturers,
and
users.
7.
Provide
program
support,
including
management,
program
planning,
computer
software
and
data
calculation
systems,
regulation
development
and
maintenance,
administrative
support,
and
quality
assurance
guidance.
10
5(
b)
Collection
Methodology
and
Management
The
nature
of
this
information
collection
does
not
lend
itself
readily
to
use
of
high
technology
and
automation.
The
number
of
applications
submitted
per
year
is
few,
and
the
information
contained
in
each
application
is
extensive,
diverse,
varies
for
different
types
of
methods,
and
is
highly
specific
to
the
subject
method.
Where
possible,
applicants
are
allowed
to
submit
test
results
or
measurement
data
obtained
with
automated
digital
data
acquisition
systems,
analog
or
digital
chart
recorders,
or
other
automated
or
semi­
automated
devices.
Entire
test
sequences
may
by
automated,
if
feasible,
at
the
applicant's
discretion.
Optional
data
entry
forms
(
hard
copy)
are
suggested
to
help
define
the
test
readings
required,
to
facilitate
calculations,
and
to
present
summarized
results.
Use
of
electronic
spreadsheets
is
encouraged
for
compilation
and
submission
of
test
data.
Similarly,
there
is
no
need
to
store
the
information
in
machine­
readable
form
because
the
information
submitted
is
normally
used
only
once,
it
is
not
compiled
with
information
from
other
applications,
no
composite
statistical
analysis
or
report
of
the
information
is
generated,
and
no
rapid
retrieval
of
selected
data
is
needed.
For
the
occasional
need
to
retrieve
the
archived
information
after
the
initial
analysis,
paper
or
microfilm
files
serve
acceptably.
The
cost
of
a
rapid
data
or
record
retrieval
system
is
not
justified.
The
information
in
each
application
is
evaluated
for
accuracy,
completeness,
appropriateness,
and
credibility
by
a
technical
analyst.
To
the
extent
possible,
techniques
used
are
evaluated,
calculations
are
verified,
measurements
are
confirmed,
test
results
are
corroborated,
and
supporting
information
is
substantiated.
Custom­
designed
computer
programs
may
be
used
to
calculate
test
results
accurately
and
uniformly.
Additional
technical
analysts
may
evaluate
portions
of
the
application
or
the
entire
application
when
results
appear
to
be
inadequate
or
marginal.
If
the
information
provided
by
the
applicant
is
insufficient
or
inconclusive,
additional
information,
explanations,
or
tests
may
be
requested
to
clarify
data
or
resolve
issues
to
complete
the
evaluation
of
the
application.
If
necessary,
the
Process
Modeling
Research
Branch
may
conduct
its
own
tests
of
the
method,
or
carry
out
supplemental
testing
that
may
be
determined
to
be
needed
because
of
unique
technical
issues
not
resolved
by
the
formally
specified
tests.
Finally,
monitoring
data
quality
is
assessed
continually
as
the
method
is
used
in
state
and
local
monitoring
networks,
and
follow
up
tests
can
be
conducted
if
any
performance
questions
arise.
The
submitted
information
is
accessible
to
the
public
by
inspection
and
copying
of
Process
Modeling
Research
Branch
files;
modest
requests
for
copies
of
specific
information
to
be
mailed
or
faxed
are
generally
fulfilled
by
branch
personnel.
Information
identified
as
Confidential
Business
Information
is
available
only
to
the
extent
allowed
under
the
Freedom
of
Information
Act
in
accordance
with
40
CFR
part
2.

5(
c)
Small
Entity
Flexibility
Although
the
applicable
regulations
contain
no
special
provisions
for
small
entities,
the
information
collection
burden
for
small
entities
is
minimized
in
several
ways.
These
include
providing
additional,
specialized
assistance
such
as
augmented
and
customized
guidance,
instructions,
and
suggestions
for
conducting
tests;
carefully
defining
the
minimum
information
requirements
for
specific
applications;
furnishing
certain
hard­
to­
obtain
or
special
reagents
or
other
materials,
standards,
or
calibration
equipment;
making
available
special
test
sites,
facilities
11
or
equipment;
identifying
applicable
information
already
on
file
that
need
not
be
duplicated;
offering
recommendations
for
compiling
the
application
information;
providing
suggested
language
for
instruction
or
operation
manuals;
and
accepting
handwritten
or
similarly
informal
but
acceptable
information
submission.

5(
d)
Collection
Schedule
For
the
most
part,
applications
are
voluntary
and
are
accepted
whenever
they
are
received
from
applicants,
rather
than
on
any
required
schedule.
Following
receipt
of
an
application,
the
regulation
requires
EPA
to
respond
to
the
applicant
within
120
calendar
days
with
one
of
the
following
actions:
(
1)
designation
of
the
method
as
a
reference
or
equivalent
method,
(
2)
rejection
of
the
method,
(
3)
notification
and
specification
of
additional
information
required,
(
4)
notification
and
specification
of
additional
tests
required,
or
(
5)
notification
and
specification
of
additional
tests
to
be
conducted
by
EPA,
before
a
determination
can
be
made
[
§
53.5].
Response
to
requests
for
approval
of
modifications
to
designated
methods
must
be
within
30
days
[
§
53.14(
c)].
12
6.
ESTIMATING
THE
BURDEN
AND
COST
OF
THE
COLLECTION
6(
a,
b)
Estimating
Respondent
Burden
and
Cost
In
attempting
to
estimate
respondent
burden,
it
is
important
to
recognize
that
each
application
is
unique.
The
actual
number
of
burden
hours
and
cost
required
to
submit
a
specific
application
will
vary
widely,
depending
on
many
factors.
These
factors
include
the
pollutant
for
which
the
method
is
applicable,
whether
the
method
qualifies
as
a
reference
method
or
an
equivalent
method,
the
measurement
principle
utilized,
the
design
and
configuration
of
the
analyzer
or
sampler,
the
test
facilities
available
to
the
applicant,
availability
and
location
of
suitable
field
testing
sites,
weather
and
other
conditions
at
field
testing
sites,
the
level
of
training
or
experience
of
the
personnel
involved,
problems
encountered
during
the
tests,
and
other
special
or
unique
situations
related
to
the
testing
of
the
method.
To
obtain
information
for
use
in
estimating
costs,
nine
vendors
of
monitoring
devices
who
have
submitted
applications
for
designation
in
the
past
were
contacted
(
see
Appendix
B).
The
information
obtained
in
this
informal
survey
was
compiled
in
conjunction
with
Process
Modeling
Research
Branch
estimates
to
produce
a
composite
estimate
of
costs
for
application
submittal.
For
purposes
of
estimating
this
composite
respondent
burden,
a
representative
breakdown
of
weighted
composite
respondent
burden
hours
is
given
in
Table
1,
which
shows
a
weighted
average
total
burden
of
859.5
hours
per
application.
Descriptions
of
the
various
application
categories
and
the
weighting
factors
used
to
derive
the
composite
weighted
burden
hours
are
given
in
Appendix
B.
Average
total
burdens
for
various
categories
of
applications
could
range
from
150
hours
for
PM
10
monitors
to
possibly
1800
hours
or
more
for
PM
2.5
Class
II
equivalent
samplers.
It
is
estimated
that
5
applications
will
be
received
per
year.
Respondent
burdens
for
submitting
requests
for
approval
of
modifications
to
designated
reference
or
equivalent
methods
are
usually
(
although
not
necessarily)
much
lower;
however,
they
vary
even
more
widely.
Estimates
for
such
burdens
range
from
2
hours
to
perhaps
200
hours,
with
most
less
than
50
hours.
For
purposes
of
this
ICR,
we
have
estimated
a
weighted
respondent
burden
breakdown
as
shown
in
Table
2.
It
is
estimated
that
an
average
of
14
modification
requests
will
be
received
per
year,
with
an
average
burden
of
30
hours
each.
13
Table
1.
Composite
Weighted
Respondent
Burden
Hours
and
Costs
for
a
Full
Application.

Activity
Management
Professional/

Technical
Clerical
Total
Labor
Contractor
O&
M
cost
In­
house
O&
M
Total
O&
M
Capital/

Startup
($)
O&
M
+

Startup
Total
$

Average
fully
loaded
hourly
rate
($/
hr.)
$
123.31
$
72.05
$
37.11
hr/
yr
$/
yr
hr/
yr
$/
yr
hr/
yr
$/
yr
hr/
yr
$/
yr
$/
yr
$/
yr
$/
yr
$/
yr
$/
yr
$/
yr
1.
Obtaining
Regulations
&
Other
Relevant
Materials
from
EPA;
Searching
Data
Sources
5.9
$
731
14.7
$
1,056
4.7
$
173
25.3
$
1,960
$
0
$
0
$
0
$
0
$
0
$
1,960
2.
Becoming
Familiar
with
Test
Procedures
and
Application
Requirements
6.2
$
761
42.9
$
3,091
4.7
$
173
53.8
$
4,026
$
0
$
0
$
0
$
0
$
0
$
4,026
3.
Planning
Tests,
Determining
Requirements
for
Test
Equipment,
Supplies,
Personnel
1.9
$
231
20.0
$
1,437
0.6
$
23
22.5
$
1,692
$
0
$
0
$
0
$
0
$
0
$
1,692
4.
Obtaining
Required
Equipment,
Instruments,

Facilities,
Materials;
Arranging
for
Personnel
3.4
$
424
20.0
$
1,437
0.6
$
23
24.0
$
1,884
$
0
$
0
$
0
$
1,993
$
1,993
$
3,877
5.
Training
Personnel
0.0
$
0
7.2
$
517
0.0
$
0
7.2
$
517
$
0
$
0
$
0
$
0
$
0
$
517
6.
Assembling
Test
Equipment;
Setting
Up
Test
Apparatus
&
Facilities;
Running
Practice
Tests
0.6
$
77
51.4
$
3,706
0.0
$
0
52.1
$
3,783
$
665
$
969
$
1,634
$
1,563
$
3,196
$
6,979
7.
Carrying
Out
Tests
&
Obtaining
Test
Results
3.1
$
385
111.9
$
8,065
0.0
$
0
115.1
$
8,450
$
6,858
$
0
$
6,858
$
0
$
6,858
$
15,308
8.
Compiling
Test
Results,
Parameters,
Instrument
Readings,
&
Other
Test
Documentation
2.5
$
308
29.2
$
2,104
1.3
$
46
33.0
$
2,458
$
399
$
0
$
399
$
0
$
399
$
2,857
9.
Preparing
Text,
Data,
Calculations,
Diagrams,

Tables,
&
Other
Test
Documents
3.4
$
424
28.9
$
2,081
1.3
$
46
33.6
$
2,552
$
166
$
0
$
166
$
0
$
166
$
2,718
10.
Assembling
Final
Application
and
Submitting
Application
to
EPA
3.8
$
462
22.8
$
1,640
4.3
$
158
30.8
$
2,260
$
0
$
0
$
0
$
0
$
0
$
2,260
11.
Responding
to
EPA
Requests
for
Additional
Tests
or
Information
0.9
$
116
6.7
$
483
0.6
$
23
8.3
$
622
$
0
$
0
$
0
$
0
$
0
$
622
12.
Recordkeeping
Including
Lists
of
Customers,

Notifications
for
Recall,
Etc.
0.0
$
0
1.3
$
90
8.3
$
308
9.6
$
398
$
0
$
0
$
0
$
0
$
0
$
398
13.
ISO
9001
Registration
or
Equivalent:

a.
Startup
Cost
for
Establishing
ISO
9001
20.5
$
2,530
11.3
$
817
0.0
$
0
31.9
$
3,347
$
2,333
$
2,333
$
0
$
2,333
$
5,680
b.
ISO
9001
Maintenance
Cost
34.2
$
4,217
115.2
$
8,300
162.9
$
6,045
312.3
$
18,562
$
2,167
$
0
$
2,167
$
2,167
$
20,729
14.
Calibrating,
Maintaining,
&
Recertifying
Equipment
1.3
$
154
79.3
$
5,710
1.3
$
46
81.8
$
5,910
$
653
$
133
$
786
$
0
$
786
$
6,697
15.
Additional
Costs:
(
Please
Describe)
0.0
$
0
10.6
$
766
8.1
$
302
18.8
$
1,067
$
0
$
604
$
604
$
0
$
604
$
1,671
Totals
87.8
$
10,821
573.2
$
41,299
198.6
$
7,368
859.5
$
59,489
$
13,241
$
1,705
$
14,946
$
3,555
$
18,502
$
77,990
14
Table
2.
Composite
Weighted
Respondent
Burden
Hours
and
Costs
for
a
Modification
Request
Activity
Management
Professional/

Technical
Clerical
Total
Labor
Contractor
O&
M
cost
In­
house
O&
M
Total
O&
M
Capital/

Startup
($)
O&
M
&

Startup
Total
$

Average
fully
loaded
hourly
rate
($/
hr.)
$
123.31
$
72.05
$
37.11
hr/
yr
$/
yr
hr/
yr
$/
yr
hr/
yr
$/
yr
hr/
yr
$/
yr
$/
yr
$/
yr
$/
yr
$/
yr
$/
yr
$/
yr
1.
Obtaining
Regulations
&
Other
Relevant
Materials
from
EPA;
Searching
Data
Sources
0.0
$
0
0.0
$
0
0.0
$
0
0.0
$
0
0.0
0.0
$
0
0.0
0.0
$
0
2.
Becoming
Familiar
with
Test
Procedures
and
Application
Requirements
0.2
$
29
1.6
$
117
0.2
$
7
2.0
$
152
0.0
0.0
$
0
0.0
0.0
$
152
3.
Planning
Tests,
Determining
Requirements
for
Test
Equipment,
Supplies,
Personnel
0.1
$
9
0.8
$
54
0.0
$
1
0.8
$
64
0.0
0.0
$
0
0.0
0.0
$
64
4.
Obtaining
Required
Equipment,
Instruments,

Facilities,
Materials;
Arranging
for
Personnel
0.1
$
16
0.8
$
54
0.0
$
1
0.9
$
71
0.0
0.0
$
0
75.3
75.3
$
147
5.
Training
Personnel
0.0
$
0
0.3
$
20
0.0
$
0
0.3
$
20
0.0
0.0
$
0
0.0
0.0
$
20
6.
Assembling
Test
Equipment;
Setting
Up
Test
Apparatus
&
Facilities;
Running
Practice
Tests
0.0
$
3
1.9
$
140
0.0
$
0
2.0
$
143
25.1
36.6
$
62
59.1
120.8
$
264
7.
Carrying
Out
Tests
&
Obtaining
Test
Results
0.1
$
15
4.2
$
305
0.0
$
0
4.3
$
319
259.2
0.0
$
259
0.0
259.2
$
579
8.
Compiling
Test
Results,
Parameters,
Instrument
Readings,
&
Other
Test
Documentation
0.1
$
12
1.1
$
80
0.0
$
2
1.2
$
93
15.1
0.0
$
15
0.0
15.1
$
108
9.
Preparing
Text,
Data,
Calculations,
Diagrams,

Tables,
&
Other
Test
Documents
0.1
$
16
1.1
$
79
0.0
$
2
1.3
$
96
6.3
0.0
$
6
0.0
6.3
$
103
10.
Assembling
Final
Application
and
Submitting
Application
to
EPA
0.1
$
17
0.9
$
62
0.2
$
6
1.2
$
85
0.0
0.0
$
0
0.0
0.0
$
85
11.
Responding
to
EPA
Requests
for
Additional
Tests
or
Information
0.0
$
4
0.3
$
18
0.0
$
1
0.3
$
24
0.0
0.0
$
0
0.0
0.0
$
24
12.
Recordkeeping
Including
Lists
of
Customers,

Notifications
for
Recall,
Etc.
0.0
$
0
0.0
$
0
0.0
$
0
0.0
$
0
0.0
0.0
$
0
0.0
0.0
$
0
13.
ISO
9001
Registration
or
Equivalent:

a.
Startup
Cost
for
Establishing
ISO
9001
0.0
$
0
0.0
$
0
0.0
$
0
0.0
$
0
$
0
0.0
0.0
$
0
b.
ISO
9001
Maintenance
Cost
1.3
$
159
4.4
$
314
6.2
$
229
11.8
$
702
81.9
0.0
$
82
81.9
$
784
14.
Calibrating,
Maintaining,
&
Recertifying
Equipment
0.0
$
6
3.0
$
216
0.0
$
2
3.1
$
223
24.7
5.0
$
30
0.0
29.7
$
253
15.
Additional
Costs:
(
Please
Describe)
0.0
$
0
0.4
$
29
0.3
$
11
0.7
$
40
0.0
22.8
$
23
0.0
22.8
$
63
Totals
2.3
$
286
20.6
$
1,487
7.0
$
260
30.0
$
2,033
$
412
$
64
$
477
$
134
$
611
$
2,644
14
16
Table
3.
Summary
of
Annual
Respondent
Burden
Hours
and
Cost.

Labor
hours
Labor
cost
O
&
M
Capital
&
startup
Total
nonlabor
Total
cost
Composite
application
859.5
$
59,489
$
14,946
$
3,555
$
18,502
$
77,990
Number
of
respondents
5
5
5
5
5
5
Subtotal
4,298
$
297,445
$
74,730
$
17,775
$
92,510
$
389,950
Composite
modification
request
30
$
2,033
$
477
$
134
$
611
$
2,644
Number
of
respondents
14
14
14
14
14
14
Subtotal
420
$
28,462
$
6,678
$
1,876
$
8,554
$
37,016
Totals,
all
responses
4,718
$
325,907
$
81,408
$
19,651
$
101,064
$
426,966
As
summarized
in
Table
3,
the
total
weighted
composite
burden
estimate
for
applications
from
Table
1,859.5
hours,
was
multiplied
by
the
expected
number
of
applications
(
5)
yielding
4298
total
labor
hours
for
applications.
The
estimated
average
burden
for
applications
for
approval
of
modifications
of
existing
methods
(
30
hours)
was
multiplied
by
the
number
of
modification
applications
expected
(
14)
resulting
in
420
additional
burden
hours.
The
grand
total
estimated
labor
burden
is
thus
4,298
+
420
=
4,718
hours,
reported
on
line
13c
of
Form
OMB
83­
I,
for
a
total
of
19
responses,
reported
on
lines
13a
and
13b.
The
current
OMB
inventory
for
ICR
2080­
0005
lists
4,718
hours
as
well
(
line
13d),
and
the
difference
is
thus
0
hours,
reported
on
line
13e
of
Form
OMB
83­
I.
Lines
13f1
and
13f2
are
both
zero
because
there
is
no
difference
to
explain.
Respondent
labor
costs
associated
with
the
weighted
composite
representative
burden
hours
breakdown
discussed
above
are
also
shown
in
Table
1,
using
fully
loaded
hourly
labor
rates
of
$
123.31
for
managerial
staff,
$
72.05
for
professional/
technical
staff,
and
$
37.11
for
clerical
staff.
These
rates
were
derived
from
cost
estimates
provided
in
direct
consultation
with
manufacturers
who
have
previously
submitted
applications
for
reference
or
equivalent
method
designations
(
see
Appendix
B
to
this
supporting
statement).
Since
these
cost
estimates
were
provided
about
6
years
ago,
they
have
been
adjusted
by
factors
of
1.280,
1.264,
and
1.237,
respectively,
which
represent
the
6­
year,
non­
seasonally­
adjusted
change
in
the
Employment
Cost
Index
for
these
labor
categories
in
private
industry,
obtained
from
Bureau
of
Labor
Statistics
(
BLS)
data.
Although
use
of
seasonally­
adjusted
ECI
data
are
recommended
for
this
adjustment,
such
seasonally
adjusted
data
for
these
labor
categories
were
not
available
from
the
BLS.
Since
the
time
period
of
adjustment
is
an
integral
number
of
years,
seasonal
adjustments
should
have
no
significant
effect.
17
Test
equipment
capital
costs
and
associated
operating
and
maintenance
costs
related
to
this
information
collection
are
very
difficult
to
estimate.
There
is
no
specifically
prescribed
equipment
or
apparatus
that
must
be
used,
and
in
some
cases
there
are
a
number
of
alternatives.
Many
applicants
are
also
the
developers
of
the
candidate
analyzers
or
samplers
and,
accordingly,
have
some
of
the
test
equipment
needed
as
part
of
their
normal
equipment
inventory.
A
few
tests,
such
as
those
for
particulate
matter
inlet
performance,
require
a
highly
specialized
wind
tunnel
test
facility,
but
the
applicant
may
elect
to
avoid
these
tests
by
using
a
previously
tested
inlet.
Some
applicants
may
lack
some
of
the
required
equipment
and
have
to
acquire
it
directly,
but
they
may
also
consider
borrowing,
renting,
or
otherwise
gaining
access
to
suitable
equipment
without
purchasing
it.
Finally,
some
applicants
choose
to
contract
out
a
portion
of
or
the
entire
testing
and
application
process.
Similarly,
costs
for
supplies
consumed
during
testing
and
application
preparation
vary
with
the
particular
test
situation.
To
some
extent,
these
costs
can
be
significantly
different,
depending
on
which
of
several
alternative
approaches
to
some
of
the
test
procedures
is
selected
by
the
applicant.
These
estimates
are
derived
primarily
from
an
informal
survey
of
nine
manufacturers
of
instruments
previously
designated
as
reference
or
equivalent
methods
(
see
Appendix
B).
Our
experience
based
on
conducting
these
tests
or
similar
tests
in
our
own
laboratory
and
preparing
equivalent
or
similar
test
reports
also
influenced
the
estimates.
Survey
results
covered
manufacturers
of
several
types
of
instruments.
The
survey
results
were
compiled
and
summarized
to
estimate
costs
for
general
categories
of
instruments
(
i.
e.,
gas
analyzers,
PM
10
monitors).
The
category
descriptions
and
weighting
factors
used
are
given
in
Appendix
B
to
this
supporting
statement.
Since
these
cost
estimates
were
provided
about
6
years
ago,
the
non­
labor
costs
(
except
capital/
startup
costs)
have
been
adjusted
by
a
factor
of
1.064,
which
was
derived
as
a
weighted
average
of
the
1997­
to­
2003
change
in
the
Producer
Price
Index
for
"
measuring
and
controlling
instruments"
(
1.064,
40%),
"
engineering
and
scientific
instruments"
(
1.061,
50%),
and
"
total
manufacturing
industries"
(
1.075,
10%)
obtained
from
Bureau
of
Labor
Statistics
data.
Projected
future
application
plans
from
the
instrument
manufacturers
and
Process
Modeling
Research
Branch
records
of
past
applications
were
used
to
estimate
the
number
of
expected
applications
and
the
likely
distribution
of
the
total
number
of
applications
among
each
of
the
application
categories.
These
distribution
estimates
were
used
with
the
category
cost
estimates
to
arrive
at
a
weighted
composite
cost
estimate
for
a
"
typical"
or
model
reference
or
equivalent
method
application,
as
presented
in
Table
1.
Note
that
these
burden
hours
and
cost
estimates
include
those
for
recordkeeping.
As
summarized
in
Table
3,
the
composite
estimated
total
annualized
capital
and
startup
cost
for
applications
(
Table
1),
multiplied
by
the
estimated
5
applications
per
year,
results
in
a
total
estimated
annualized
capital
and
startup
cost
of
$
17,775.
The
corresponding
cost
for
the
estimated
14
modification
applications
(
Table
2)
is
$
1,876.
The
total
annualized
capital
and
startup
cost
for
all
respondents,
$
19,651,
is
reported
as
$
20
(
thousand)
on
line
14a
of
form
OMB
83­
I.
Similarly,
the
composite
estimated
operating
and
maintenance
cost
for
applications
from
Table
1
($
14,946),
multiplied
by
the
estimated
5
applications
per
year,
gives
an
estimated
total
annualized
O&
M
cost
of
$
74,730,
and
the
corresponding
O
&
M
cost
estimates
for
the
14
estimated
modification
applications
from
Table
2
is
$
6,678.
The
total
O
&
M
cost
for
all
18
respondents,
$
81,408,
is
reported
as
$
81
(
thousand)
on
line
14b
of
for
OMB
83­
I.
The
total
estimated
annualized
non­
labor
cost
is
thus
$
101,064,
which
is
reported
as
$
101
(
thousand)
on
line
14c
of
form
OMB
83­
I.
The
current
OMB
inventory
for
ICR
2080­
0005
is
listed
as
$
89
(
thousand)
on
line
14d,
and
the
difference,
$
101

$
89
=
$
12
(
thousand),
is
reported
on
line
14e.
This
difference
is
reported
as
an
adjustment
(
line
14f2)
because
it
is
due
to
revised
cost
estimates
for
some
respondents
as
well
as
adjustments
made
in
the
labor
and
non­
labor
cost
estimates
over
the
last
three
years,
based
on
the
Bureau
of
Labor
Statistics
Employment
Cost
Index
and
Producer
Price
Index
data.
None
of
the
difference
is
due
to
program
change;
hence,
zero
is
reported
on
line
14f1.

6(
c)
Estimating
Agency
Burden
and
Cost
The
agency
burden
and
cost
estimates
are
given
in
Table
4.
They
are
based
on
our
experience
in
collecting
this
information
and
operating
the
Reference
and
Equivalent
Method
Program
for
many
years
and
include
processing
of
both
full
applications
and
modification
requests.
The
costs
are
based
on
technical
staff
labor
at
the
GS­
12/
13
level,
at
$
35/
hr.,
using
the
locally
applicable
hourly
salary
table
for
2004
for
the
locality
pay
area
of
"
Rest
of
U.
S."
This
rate
was
raised
to
$
56
per
hour
to
include
a
1.6
multiplier
for
overhead.
Similarly
determined
clerical
costs
were
based
on
a
loaded
labor
rate
of
$
25/
hr.
As
indicated
previously,
there
is
no
way
to
predict
the
exact
number
of
applications
that
will
be
received
in
a
given
year,
so
actual
cost
could
deviate
from
these
estimates.

6(
d)
Estimating
the
Respondent
Universe
and
Total
Burden
and
Cost
Based
on
historical
data
for
application
submittals
and
other
information
available
to
the
Process
Modeling
Research
Branch,
it
is
estimated
that
5
applications
for
reference
or
equivalent
method
determination,
and
14
minor
applications
for
approval
of
modifications,
will
be
received
annually
during
the
time
period
covered
by
this
ICR.
Labor
and
other
costs
for
a
typical
designation
application
are
described
in
Section
6(
a,
b).
Total
annual
burden
and
cost
for
the
Information
Collection
are
summarized
in
Table
5.

6(
e)
Bottom­
Line
Burden
Hours
and
Costs
The
total
annual
burden
for
respondents
and
agency
is
shown
in
Table
5.
19
Table
4.
Representative
Annual
Agency
Burden
and
Cost
Collection
Activities
Burden
Hours
and
Costs
per
Year
Total
Hours
and
Costs
Tech.
Staff
Clerical
($
56/
hr)*
($
25/
hr)*

Provide
copies
of
regulation
and
assistance
materials
regulation
interpretation;
technical
assistance
100
27
127
$
5,600
$
675
$
6,275
Receive
applications;
administrative
activities
29
13
42
$
1,624
$
325
$
1,949
Technical
review
and
evaluation
304
32
336
$
17,024
$
800
$
17,824
Designation
activities
11
5
16
$
616
$
125
$
741
Maintain
&
distribute
List
of
Designated
Methods
94
32
126
$
5,264
$
800
$
6,064
Review
and
process
modification
requests
108
6
114
$
6,048
$
150
$
6,198
Program
support
72
11
83
$
4,032
$
275
$
4,307
Totals
Hours
Costs
718
126
844
$
40,208
$
3,150
$
43,358
*
Burdened
labor
rates
(
salary
×
1.6).
20
Table
5.
Total
Annual
Burden
and
Cost
Summary
Hours
Cost
Total
respondent
burden
and
cost
(
including
recordkeeping)
(
from
Table
3)
4,718
$
426,966
Total
Agency
in­
house
burden
and
cost
(
Table
4)
844
$
43,358
Total
Agency
contract
cost
0
$
100,000
Totals
5,562
$
570,324
6(
f)
Reasons
for
Change
in
Burden
(
i)
Respondent
burden
Since
there
has
been
no
change
in
program
requirements
nor
in
the
estimated
number
or
mix
of
applications
expected,
the
current
estimate
of
respondent
burden
hours
(
4,718)
is
the
same
as
the
previous
(
December
2001)
estimate.
The
total
annualized
cost
estimate
is
somewhat
higher
than
the
previous
estimate
because
of
the
adjustment
in
the
labor
rates
and
the
non­
labor
(
except
capital/
startup)
costs
based
on
the
BLS
ECI
and
PPI
data
and
because
of
a
revision
in
the
cost
estimates
for
the
minor
applications
for
approval
of
modifications.
As
noted
previously,
the
actual
respondent
cost
varies
widely,
depending
on
the
type
and
nature
of
the
application
submitted.
A
simple
request
for
approval
of
a
minor
modification
to
a
currently
designated
method
may
cost
only
a
few
dollars.
At
the
other
extreme,
the
full
cost
for
conducting
the
complete
complement
of
tests
and
submission
of
a
complete
application
for
designation
for
a
new
PM
2.5
analyzer,
for
example,
could
cost
$
100,000
or
more,
depending
on
the
exact
circumstances
and
facilities
available
to
the
applicant.
New
applications
are
often
related
to
previously
designated
instruments
that
have
been
redesigned
to
incorporate
new
technology
and
features.
Many
monitoring
instrument
manufacturers
redesign
and
update
their
air
monitoring
instruments
to
incorporate
advances
in
electronics
and
in
digital
and
microprocessor
circuitry,
adding
many
new
data
processing
and
user­
programmable
capabilities
Manufacturers
must
reapply
to
have
these
redesigned
analyzers
designated
(
or
redesignated
as
reference
or
equivalent
methods,
either
via
approval
of
modifications
or,
more
likely,
via
a
complete
reference
or
equivalent
method
application.
Such
redesign
may
extend
to
a
manufacturer's
entire
line
of
designated
pollutant
analyzers.
Burdens
may
or
may
not
be
somewhat
lower
for
these
types
of
applications.
On
the
other
hand,
air
monitoring
instrument
manufacturers
occasionally
produce
new
or
unconventional
types
of
instruments
for
which
they
seek
reference
or
equivalent
method
designation;
and
burdens
may
be
somewhat
higher
for
these
applications.
Since
each
application
is
unique,
there
are
many
variables
associated
with
each
situation
that
substantially
affect
the
cost
of
a
particular
application
or
submission.
21
(
ii)
Agency
burden
The
agency's
cost
to
process
the
information
depends
on
the
number
and
type
of
applications
or
requests
received.
The
agency
burden
has
similarly
increased
somewhat
from
the
previous
estimate,
reflecting
the
increase
in
the
staff
labor
rates.
Based
on
the
overall
submission
processing
experience
over
the
last
several
years
and
the
anticipated
number
and
allocation
of
applications
in
the
next
3
years,
the
annual
agency
burden
is
estimated
to
be
about
$
43,000,
with
an
additional
$
100,000
for
contract
support.

6(
g)
Burden
Statement
The
annual
public
reporting
burden
for
full
applications,
ranging
from
150
to1820
hours,
is
estimated
to
average
859.5
hours
per
application.
This
includes
a
recordkeeping
burden
related
to
full
applications
estimated
to
be
9.6
hours
per
application.
For
modifications
of
applications,
ranging
from
a
few
hours
to
several
hundred
hours,
the
burden
is
estimated
to
average
30
hours
per
application
or
a
total
of
48
hours
per
year
based
on
an
estimated
5
full
applications
per
year.
Based
on
total
hours
of
4,717.5
with19
responses,
the
average
burden
is
524
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
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.

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
No.
ORD­
2004­
0013,
which
is
available
for
public
viewing
at
the
Office
of
Environmental
Information
(
OEI)
Docket
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
Office
of
Environmental
Information
(
OEI)
Docket
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
view
public
comments,
access
the
index
listing
of
the
elements
of
the
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Once
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,
22
DC
20503,
Attention:
Desk
Office
for
EPA.
Please
include
the
EPA
Docket
ID
No.
ORD­
2004­
0013
and
OMB
control
number
(
2080­
0005)
in
any
correspondence.
23
Appendix
A
List
of
commenters
responding
to
EPA's
December
13,
1996
Proposed
part
53
Regulations,
Revised
Requirements
for
Designation
of
Reference
and
Equivalent
Methods
for
PM
2.5,
Docket
A­
96­
51.
Final
rules
were
promulgated
July
18,
1997.

Docket
ID
Name
Organization
IV­
D­
177
Unknown
Ventura
County
Air
Pollution
Control
District
IV­
D­
218
O'Connor,
M.
Indiana
Department
of
Environmental
Management
IV­
D­
220
Unknown
State
of
Alaska
IV­
D­
222
Unknown
Cal/
EPA
IV­
D­
228
Meyer,
M.
B.
Rupprecht
and
Patashnick
Company
NA*
Lundgren,
D.
A.
Academia
but
commenting
on
behalf
of
National
Mining
Association
NA*
DiBattista,
C.
State
of
Connecticut,
Department
of
Environmental
Protection
*
No
Number
Assigned
24
Standing
Air
Monitoring
Work
Group
(
SAMWG)
(
Non­
EPA
Personnel,
1996)

Mr.
Gustave
Von
Bodungen
LA
Dept.
of
Environmental
Quality
7290
Bluebonnet
Baton
Rouge,
LA
70810
Mr.
Miquel
Flores,
Chief
Monitoring
&
Data
Analysis
Branch
National
Park
Service
­
Air
12795
West
Alameda
Parkway
Lakewood,
CO
80228
Mr.
Douglas
L.
Tubbs
Ventura
Co.
APCD
669
County
Square
Drive
Ventura,
CA
93003
Mr.
Jeff
Cook
California
Air
Resources
Board
2020
L
Street
Sacramento,
CA
95814
Mr.
Robert
Ostrowski
Air
Management
Services
500
South
Broad
Street
Philadelphia,
PA
19146
Mr.
Charles
Pietarinen,
Chief
Bureau
of
Air
Monitoring
NJ
Dept.
of
Environmental
Protection
401
East
State
Street,
CN027
Trenton,
NJ
08625
Mr.
Ray
Bishop
Tulsa
City­
County
Health
Dept.
4616
East
15th
Street
Tulsa,
OK
74112­
6199
Mr.
Robert
Hannah
Dept.
of
Environmental
Quality
Office
of
Air
Quality
&
Rad.
Protection
7290
Bluebonnet
Baton
Rouge,
LA
70810
Mr.
Larry
Byrum
Div.
of
Environmental
Quality
4545
N.
Lincoln
Blvd.,
Suite
250
Oklahoma
City,
OK
73105­
3483
Ms.
Susan
S.
G.
Wierman
Executive
Director,
MARAMA
711
West
40th
Street,
Suite
318
Baltimore,
MD
21211
Mr.
Doyle
Pendleton
Texas
Natural
Resources
Commission
Monitoring
Operations/
MC165
PO
Box
13087
Austin,
TX
78711­
3087
Mr.
Harry
St.
Clair
Air
Quality
Programs
Hamilton
Co.
Dept.
of
Env.
Services
1632
Central
Parkway,
Room
201
Cincinnati,
OH
45210­
1604
Lee
Alter
NESCAUM
129
Portland
Street,
Suite
105
Boston,
MA
02114
Mr.
Mike
Gilroy
Puget
Sound
Air
Pollution
Control
Agency
110
Union
Street,
Suite
500
Seattle,
WA
98101­
2038
Mr.
Brian
Jennison
Director,
Air
Quality
Division
Washoe
Co.
Dist.
Health
Dept.
PO
Box
11130
Reno,
NV
89520­
0027
25
Appendix
B
Assumptions
and
Notes:
Determination
of
Burden
Hours
and
Cost
Estimates
for
Applications
for
Reference
and
Equivalent
Methods
Based
on
information
provided
by
an
informal
survey
of
nine
previous
applicants,
representative
burden
hours
and
cost
estimates
were
prepared
for
five
categories
of
applications:
Gas
Analyzers,
Open
Path
Analyzers,
PM
10
Monitors,
PM
2.5
Reference
and
Class
I
Equivalent
Samplers,
and
PM
2.5
Class
II
Equivalent
Samplers.
These
average
category
estimates
are
not
included
here
but
are
available
in
the
associated
Excel
spreadsheet
file,
ICR0559­
2004Supplemental
Tables.
xls,
as
Tables
E­
1
through
E­
5.
These
category
estimates
were
derived
as
described
below.

1)
Gas
Analyzers:
These
numbers
represent
mean
values
received
from
survey
respondents
for
gas
analyzer
designation
application
burden
and
costs.

2)
Open
Path
Analyzers:
No
useful
cost
figures
for
open
path
analyzers
were
received
from
survey
respondents.
It
was
assumed
that
the
cost
for
preparing
an
open
path
analyzer
designation
application
is
roughly
three
times
that
for
a
standard
gas
analyzer.
However,
a
typical
open
path
analyzer
would
likely
be
submitted
for
designation
for
three
or
more
pollutants
at
little
additional
cost
per
pollutant.
Consequently,
the
cost
per
designation
application
for
open
path
analyzers
was
assumed
to
be
the
same
as
that
for
a
typical
gas
analyzer.

3)
PM
10
Monitors:
These
numbers
represent
mean
values
received
from
survey
respondents
for
PM
10
monitor
designation
application
costs
and
include
both
PM
10
samplers
and
analyzers.

4)
PM
2.5
Reference
and
Class
I
Equivalent
Samplers:
These
numbers
represent
mean
values
received
from
survey
respondents
for
PM
2.5
Reference
and
Class
I
Equivalent
Method
Sampler
designation
application
costs.

5)
PM
2.5
Class
II
Equivalent
Samplers:
No
useful
cost
figures
for
PM
2.5
Class
II
Equivalent
Samplers
were
received
from
survey
respondents.
It
was
estimated
that
the
costs
for
PM
2.5
Class
II
Equivalent
samplers
are
approximately
1.35
times
higher
than
for
Reference/
Class
I
samplers.

Weighted
average,
composite
burden
and
cost
estimates
for
a
typical
designation
application
were
developed
by
summing
up
the
estimates
for
all
the
different
analyzer
categories,
after
multiplying
each
by
a
factor
based
on
the
expected
fraction
of
total
applications
expected
over
the
next
3
years
for
each
analyzer
category.
The
fractions
used
for
this
purpose
are
as
follows:

20%
Gas
Analyzers
5%
Open
Path
Analyzers
30%
PM
10
Monitors
40%
PM
2.5
Reference/
Class
I
Equivalent
Samplers
5%
PM
2.5
Class
II
Equivalent
Samplers
26
6)
ISO
9001:
No
useful
cost
figures
were
received
from
respondents.
Instead,
data
provided
to
EPA
by
four
ISO­
9001
consultants
were
reviewed
and
used
to
develop
ISO
9001
cost
estimates
as
detailed
below:

Contractor

s
Startup
Cost
for
Establishing
ISO
9001
includes
(
1)
a
pre­
assessment
meeting;
(
2)
preliminary
evaluations;
(
3)
registration
assessment;
(
4)
PM
2.5
checklist
including
evaluation
and
registration;
and
(
5)
training
costs.
These
costs
are
one­
time
fees
and
can
range
from
a
combined
total
of
$
15,250
to
$
34,500
depending
on
the
size
of
the
facility.
The
average
cost
is
therefore
about
$
24,900.
Annualizing
this
cost
over
a
three­
year
period
results
in
approximately
$
8,300
per
year.
Assuming
that
40
percent
of
the
companies
already
have
ISO
9001
programs
in
place,
the
annual
cost
is
$
4,980.
Assuming
further
that
these
costs
will
be
incurred
only
by
companies
applying
for
PM
2.5
methods
results
in
an
annual
cost
of
approximately
$
2,241.

Contractor

s
ISO
9001
Maintenance
Cost
includes
(
1)
continuous
assessment;
(
2)
ISO
file
maintenance
fee;
and
(
3)
continuous
checks
for
PM
2.5
checklist.
These
costs
are
annual
fees
and
can
range
from
a
combined
total
of
$
2,375
to
$
6,875
depending
on
the
size
of
the
facility.
The
average
cost
is
therefore
$
4,625
per
year.
Assuming
that
these
costs
will
be
incurred
only
by
companies
applying
for
PM
2.5
methods
results
in
an
annual
cost
of
approximately
$
2,081.

In­
House
Startup
Cost
for
Establishing
ISO
9001
includes
labor
cost
for
management,
technical/
professional,
and
clerical
staff.

a)
Management
Startup
Cost
for
Establishing
ISO
9001:
Management
labor
hours
range
from
32
hours
per
year
to
120
hours
per
year
depending
on
the
size
of
the
facility.
These
hours
are
used
for
management
reviews.
The
average
management
labor
hours
is
therefore
76
hours
per
year.
Assuming
that
40
percent
of
the
companies
already
have
ISO
9001
programs
in
place,
the
annual
burden
is
45.6
hours,
and
assuming
further
that
these
hours
will
be
incurred
only
by
companies
applying
for
PM
2.5
methods
results
in
an
annual
burden
of
20.5
hours.

b)
Technical/
Professional
Startup
Cost
for
Establishing
ISO
9001:
Technical/
professional
labor
hours
include
training
internal
ISO
coordinators
and
auditors.
It
is
assumed
that
2
to
5
technical/
professional
staff
are
involved
at
24
to
40
hours
per
staff,
resulting
in
48
to
200
hours
depending
on
the
size
of
the
facility.
The
average
technical/
professional
labor
hours
are
therefore
124
hours
per
year.
Annualizing
this
cost
over
a
three­
year
period
results
in
approximately
42
hours
per
year.
Assuming
that
40
percent
of
the
companies
already
have
ISO
9001
programs
in
place,
gives
a
burden
of
25.2
hours
per
year,
and
assuming
further
that
these
hours
will
be
incurred
only
by
companies
applying
for
PM
2.5
methods
results
in
an
annual
burden
of
11.3
hours.

c)
Clerical
Startup
Cost
for
Establishing
ISO
9001:
None
identified
In­
House
Maintenance
Cost
for
Establishing
ISO
9001
includes
labor
cost
for
management,
technical,
and
clerical
staff.

a)
Management
ISO
9001
Maintenance
Cost:
Management
labor
hours
range
from
32
hours
per
year
to
120
hours
per
year
depending
on
the
size
of
the
facility.
These
hours
are
used
for
management
reviews.
The
average
management
labor
hours
is
therefore
76
hours
per
year.
Assuming
that
these
hours
will
be
incurred
only
by
companies
applying
for
PM
2.5
methods
results
in
an
annual
burden
of
34.2
hours.
27
b)
Technical/
Professional
ISO
Maintenance
Cost:
Technical/
professional
labor
hours
include
reviewing,
recommending
revisions,
and
approving
internal
audits.
It
is
assumed
that
2
to
20
technical/
professional
staff
are
involved
at
16
to
24
hours
per
staff,
resulting
in
32
to
480
hours
per
year
depending
on
the
size
of
the
facility.
The
average
technical/
professional
labor
hours
is
therefore
256
hours
per
year.
Assuming
that
these
hours
will
be
incurred
only
by
companies
applying
for
PM
2.5
methods
results
in
an
annual
burden
of
115.2
hours.

c)
Clerical
ISO
Maintenance
Cost:
Clerical
labor
hours
include
drafting
new
or
revising
existing
SOPs,
and
training
SOP
writers.
It
is
assumed
that
48
to
675
clerical
hours
are
needed
for
these
tasks
depending
on
the
size
of
the
facility.
The
average
clerical
labor
hours
is
therefore
362
hours
per
year.
Assuming
that
these
hours
will
be
incurred
only
by
companies
applying
for
PM
2.5
methods
results
in
an
annual
burden
of
162.9
hours.