Document ID: EPA-HQ-OEI-2003-0033-0001
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-07-29T04:00Z

OMB
83­
I
SUPPORTING
STATEMENT
1.
Identification
of
the
Information
Collection
ICR
Title:
Quality
Assurance
Specification
and
Requirements
OMB
Control
Number:
2080­
0033
This
is
a
request
for
the
renewal
of
an
existing
Information
Collection
Request
(
ICR)
due
to
expire
on
08/
31/
00.
This
ICR
covers
the
quality
assurance
(
QA)
paperwork
burden
that
appears
at
40
CFR
30.54,
40
CFR
31.45,
40
CFR
35.260,
and
35.6055.
These
are
subsections
from
40
CFR
Part
30
­
Grants
and
Agreements
with
Institutions
of
Higher
Education,
Hospitals,
and
Other
Non­
Profit
Organizations,
40
CFR
Part
31
­
Uniform
Administrative
Requirements
for
Grants
and
Cooperative
Agreements
to
State
and
Local
Governments,
and
40
CFR
Part
35
­
State
and
Local
Assistance
(
Attachments
1­
3).
The
information
collection
activity
involves
the
development
and
implementation
of
QA
practices
consisting
of
policies,
procedures,
specifications,
standards,
and
documentation
sufficient
to
produce
data
of
quality
adequate
to
meet
project
objectives
and
to
minimize
loss
of
data
due
to
out­
of­
control
conditions
or
malfunctions.
Specifically,
this
refers
to
the
preparation
of
QA
management
and
project
plans.
The
quality
system
of
the
recipient
of
40
CFR
Part
30
assistance
must
comply
with
the
requirements
of
ANSI/
ASQC
E4,
"
Specifications
and
Guidelines
for
Quality
Systems
for
Environmental
Data
Collection
and
Environmental
Technology
Programs."
A
clarifying
statement
for
all
organizations
receiving
EPA
financial
assistance
under
40
CFR
Part
31
and
40
CFR
Part
35
has
been
issued
by
the
Office
of
Grants
and
Debarment
(
Attachment
4).
This
clarifying
statement
defines
Agency­
wide
criteria
for
meeting
the
requirements
under
the
applicable
CFRs
and
is
consistent
with
Agency
policy
since
1988.
It
cites
the
ANSI/
ASQC
E4
as
a
national
consensus
standard
that
applies
to
all
recipients.
All
QA
submissions
are
reviewed
and
approved
by
an
EPA
certified
project
officer
and/
or
a
designated
QA
officer.

Based
on
files
maintained
by
the
Grants
Administration
Division,
EPA
has
received
an
average
of
4000
applications
for
financial
assistance
annually
for
the
last
three
years.
Approximately
3900
of
these
were
awarded
each
year.
Excluding
training,
fellowships,
and
construction
grants,
it
is
estimated
that
53%
(
or
about
2100)
of
the
awarded
grants
include
environmental
data
measurements
for
non­
profit
organization
research
or
for
State,
local,
and
Tribal
governments.

The
existing
ICR
authorized
two
types
of
information
collection
activities:
(
1)
the
preparation
of
a
written
QA
narrative
statement
for
exploratory
research
projects
proposed
by
non­
profit
organizations;
and
(
2)
a
QA
plan
that
describes
the
basic
QA
aspects
of
projects
proposed
by
State,
local,
or
Tribal
agencies
that
employ
environmentally
related
measurements.
Although
these
documents
appeared
to
be
somewhat
different
in
past
surveys,
it
is
now
recognized
that
the
ultimate
use
of
the
data
by
the
Agency
determines
the
extensiveness
of
the
documentation.
For
this
ICR
extension,
the
data
collected
is
an
average
for
all
types
of
QA
documentation
received
from
either
type
of
institution.
An
informal
survey
of
the
amount
and
type
of
QA
plans
generated
by
assistance
agreements
handled
by
EPA
certified
project
officers
and
designated
QA
officers
was
conducted
through
the
QA
Managers.
The
purpose
of
the
informal
survey
was
to
update
the
burden
hours
associated
with
this
information
collection
for
the
fourth
3­
year
review.
The
survey
encompassed
approximately
82%
of
grants
awarded
in
fiscal
year1999
involving
environmental
data
measurements.
The
informal
survey
revealed
that
the
quantity
of
QA
plans
being
developed
and
reviewed
has
increased
significantly
from
the
1996
survey
of
1497
to
1940.
The
preparation
time
is
estimated
to
remain
at
an
average
of
85
hours
per
plan,
for
an
average
cost
of
$
2210
per
plan.

2.
Need
for
and
Use
of
the
Collection
2(
a)
Need/
Authority
for
the
Collection.
This
ICR
is
necessary
because
of
the
information
collection
and
reporting
requirements
included
in
40
CFR
30.54,
40
CFR
31.45,
and
40
CFR
35.260
and
35.6055.
These
regulations
implement
OMB
Circular
A­
119,
Federal
Participation
in
the
Development
and
Use
of
Voluntary
Consensus
Standards
and
in
Conformity
Assessment
Activities
(
February
1998).
The
information
collected
is
needed
to
assure
that
environmental
monitoring
and
research
projects
awarded
financial
assistance
will
produce
data
of
known
and
documented
quality.
The
EPA
spends
millions
of
dollars
annually
in
financial
assistance
grants
to
support
environmental
monitoring
and
research
projects
that
further
the
Agency's
goals
to
protect
and
improve
environmental
quality.
The
EPA
has
established
a
policy
(
EPA
Order
5360.1
CHG
1)
(
Attachment
5)
that
all
environmental
data
collection
activities
funded
or
required
by
the
Agency
must
participate
in
a
centrally
managed
QA
program.
This
policy
requires
all
extramural
projects
involving
environmental
measurements
to
adhere
to
QA
guidelines.
The
intent
of
this
policy
is
to
ensure
that
all
data
used
in
environmental
protection
efforts
will
be
valid,
scientifically
sound,
legally
defensible,
and
of
known
and
documented
quality.

2(
b)
Practical
Utility/
Users
of
the
Data.
The
appropriate
EPA
Office
and
its
designated
QA
Manager
and/
or
EPA
certified
Project
Officer
use
the
information
collected
as
a
basis
for
recommending
approval
of
financial
assistance
grants
for
projects
involving
environmental
measurements.
In
addition,
collection
of
data
is
contingent
upon
approval
of
QA
plans
to
ensure
that
data
are
of
adequate
quality
for
their
intended
use
by
EPA
programs.
The
Agency
has
been
criticized
through
internal
management
reviews,
OIG,
and
GAO
audits
for
failings
in
this
area.
In
1992,
environmental
data
quality
was
identified
as
a
Federal
Managers'
Financial
Integrity
Act
(
FMFIA)
weakness
for
all
appropriations.
The
responsible
management
cited
was
the
Director,
Quality
Assurance
Division
(
now
reorganized
as
the
Quality
Staff
in
the
Office
of
Environmental
Information).
In
view
of
the
heightened
awareness
throughout
EPA
of
QA
of
the
use
of
data
collected
by
others,
the
scrutiny
of
submitted
QA
plans
has
increased.
This
has
resulted
in
more
attention
being
given
to
the
preparation
of
QA
plans
by
grantees.
3.
Nonduplication,
Consultations,
and
Other
Collection
Criteria
3(
a)
Nonduplication.
Subsequent
to
a
thorough
review
of
information
systems
and
files
at
EPA
headquarters
and
throughout
the
ten
EPA
regions,
it
has
been
determined
that
there
is
no
duplication
of
this
ICR
internally
within
the
Agency
or
by
any
other
Federal
Agency.

3(
b)
Public
Notice
Required
Prior
to
ICR
Submission
to
OMB.
A
notice
about
this
renewal
was
published
in
the
Federal
Register.
The
public
comment
period
closed
May
22,
2000.
No
public
comments
were
received.

3(
c)
Consultations.
40
CFR
Part
30
and
40
CFR
Part
31
were
both
subjected
to
public
review
and
comment
prior
to
the
effective
date
of
the
final
rule.
Except
for
some
suggestions
for
clarity,
there
were
no
serious
objections
raised
to
the
QA
specifications
and
requirements
contained
in
these
regulations.
Regional
QA
Managers
interact
with
their
State
counterparts
concerning
their
grant
QA
plan
submissions.
In
addition,
all
EPA
QA
Managers
were
asked
to
inform
interested
parties
when
updating
burden
information
and
to
forward
comments
received
at
any
time
since
the
last
renewal.
No
comments
were
forwarded
concerning
this
renewal.
In
addition,
the
ICR
for
collection
of
information
under
general
regulation
for
assistance
programs
was
renewed
recently,
and
received
no
public
comment.

3(
d)
Effects
of
Less
Frequent
Collection.
The
frequency
of
collection
has
no
effect
on
the
content,
quality,
or
use
of
the
information
covered
by
this
ICR.

3(
e)
General
Guidelines.
This
ICR
conforms
to
all
guidelines
for
Federal
data
requestors
contained
in
5
CFR
1320.6,
and
OMB
Circular
A­
102
and
A­
110.

3(
f)
Confidentiality.
Confidentiality
is
not
applicable
to
this
ICR.

3(
g)
Sensitive
Questions.
Sensitive
questions
are
not
applicable
to
this
ICR.

4.
The
Respondents
and
the
Information
Requested
4(
a)
Respondents/
SIC
Codes.
The
respondents
are
administrators
of
environmental
quality
programs
(
SIC
#
951).

4(
b)
Information
Requested.

(
i)
Data
Items.
The
data
items
are
those
listed
in
the
relevant
regulations,
40
CFR
30.54
and
40
CFR
31.45.
In
addition,
guidance
is
available
that
will
be
final
pending
another
Federal
Register
notice.
These
are
EPA
Requirements
for
Quality
Management
Plans
(
EPA
QA/
R­
2)
(
Interim
Final,
November
1999)
and
EPA
Requirements
for
Quality
Assurance
Project
Plans
(
EPA
QA/
R­
5)
(
Interim
Final,
November
1999),
Attachments
6
and
7.
(
ii)
Respondent
Activities.
The
activities
required
by
respondents
completing
QA
plans
remain
the
same.
They
include
the
following:

­
read
the
regulation,
­
read
QA
guides,
and
­
prepare/
review
the
QA
plan.

The
EPA
QA
Managers
report
no
significant
change
in
the
length
of
time
for
this
activity
in
the
last
three
years.
However,
in
the
last
renewal,
narrative
statements
for
some
research
grants
were
considered
separately.
These
generally
are
less
time
consuming
to
prepare,
but
will
be
aggregated
with
the
others
for
this
renewal.

5.
The
Information
Collected
5(
a)
Agency
Activities.
Agency
activities
include
the
following:

­
Answer
respondents'
questions;
and
­
Review
and
approve
QA
plans.

5(
b)
Collection
Methodology
and
Management.
The
information
collected
is
part
of
the
application
package
for
financial
assistance
and
is
usually
collected
through
the
U.
S.
mail
or
delivered
by
courier
to
the
appropriate
EPA
office.
Because
of
the
size
of
the
completed
application
package
associated
with
the
ICR,
electronic
mail
or
computers
are
not
currently
used
for
collection.
When
the
grants
office
permits
electronic
submission,
QA
documentation,
which
is
usually
available
electronically,
will
be
included.

A
copy
of
the
information
collected
is
kept
on
file
with
the
EPA
QA
function
or
the
EPA
certified
project
officer,
and
the
original
returned
to
the
applicant
for
use
in
conducting
the
environmental
data
collection
activity
that
was
the
subject
of
the
application.

5(
c)
Small
Entity
Flexibility.
Small
entities
are
not
affected
by
this
information
collection.
Any
small
municipality
may
be
included
in
a
county
and/
or
State
application
for
assistance
and
thus
be
relieved
of
any
paper
burden
resulting
from
this
information
collection.
In
addition,
because
the
amount
and
type
of
QA
information
is
directly
related
to
the
collection
and
use
of
the
data,
the
EPA
considers
the
cost
of
QA
documentation
as
integral
to
the
projects
proposed
in
awarding
the
assistance.

5(
d)
Collection
Schedule.
The
information
collection
for
this
ICR
can
occur
at
anytime
during
EPA's
fiscal
year,
but
most
applications
for
financial
assistance
covered
by
the
ICR
are
collected
during
the
first
half
of
the
budget
year
to
ensure
processing
and
funding
from
current
year
program
funds.
The
collection
schedule
has
no
effect
on
the
quality,
content,
or
use
of
the
information
collected.
6.
Estimating
the
Burden
and
Cost
of
the
Collection
6(
a)
Estimating
Respondent
Burden.
Table
I
uses
information
obtained
from
the
QA
Managers
(
based
on
a
survey
of
actual
documents
reviewed)
in
the
EPA
to
determine
the
burden
of
this
information
collection.
To
estimate
the
burden
as
shown
in
Table
I,
we
have
not
revised
this
calculation
significantly
from
the
last
submission.
Preparers
(
and
reviewers)
usually
do
their
own
preparation
directly
with
personal
computers,
and
require
little,
if
any,
clerical
support.
To
determine
the
burden
hours
per
year,
we
used
the
means
of
the
labor
hour
estimates
from
our
survey.
This
number
(
85)
is
the
same
as
that
previously
reported
[
except
for
some
research
grant
narrative
statements,
as
noted
in
4(
b)(
ii)
above].
From
this
informal
survey,
the
number
of
respondents
was
1592
for
the
fiscal
year
1999.
This
number
was
extrapolated
to
the
average
of
all
grants
awarded
for
the
year
as
reported
by
EPA's
Grants
Administration
Division
(
GAD)
(
3630),
as
53%
requiring
environmental
data
collection
(
or
1940)
in
the
bottom
line
burden
estimates
shown
in
Table
I.
This
is
30%
greater
than
the
previous
number
reported
(
1497).
A
reasonable
explanation
may
be
that
more
funds
are
available
for
assistance
agreements
with
EPA
and
that
more
data
for
EPA
use
is
being
collected
through
extramural
agreements
rather
than
by
EPA
staff
directly.

6(
b)
Estimating
Respondent
Costs.
The
average
hourly
cost,
including
overhead,
is
calculated
from
our
informal
survey
at
$
26
for
preparers.
This
is
a
combined
figure
to
represent
all
respondents,
rather
than
as
previously,
where
State,
local,
and
other
government
respondents
were
segregated
from
non­
profit
institutions.
Many
QA
Managers
are
familiar
with
their
counterparts
in
these
organizations
and
can
give
reasonable
estimates
of
this
rate.

6(
c)
Estimating
Agency
Burden
and
Cost.
To
estimate
the
Agency's
burden
and
cost
we
used
the
survey
reported
hourly
rate
(
generally
GS­
13
or
an
equivalent
mid­
level
GS­
12)
with
prescribed
1.6
multiplier,
and
divided
by
2080
hours
to
arrive
at
the
hourly
rate
used
in
Table
II
($
42).
Since
the
application
records
are
maintained
on
file
as
part
of
normal
government
practice,
the
record
keeping
costs
were
considered
negligible.
The
Agency
total
hourly
burden
for
assistance
agreements
was
calculated
to
be
24
hours
for
each
of
1940
respondents,
or
46,560
hours.
The
cost
associated
with
each
response
of
$
1008,
times
1940
responses,
totals
$
1,955,520
for
the
Agency
burden.

6(
d)
Estimating
the
Respondent
Universe
and
Total
Burden
and
Costs.
The
respondent
total
hourly
burden
for
assistance
agreements
was
calculated
to
be
85
hours
for
each
of
1940
respondents,
or
164,900
hours.
The
cost
associated
with
each
response
of
$
2210,
times
1940
respondents,
totals
$
4,287,400
for
the
respondent
burden.

6(
e)
Bottom
Line
Burden
Hours
and
Cost
Tables.
From
our
best
knowledge
and
experience
with
the
information
activity
covered
by
this
ICR,
we
estimate
that
the
total
burden
and
cost
for
all
respondents
will
be
not
more
than
as
shown
in
the
table
as
above,
164,900
hours
and
$
4,287,400.
This
is
more
than
the
last
submission
($
1,498,038)
and
the
one
previous
to
that
($
2,609,300).
The
EPA
burden
is
as
reported
above,
with
46,560
hours
and
$
1,955,520
for
the
estimated
1940
responses.
This
amount
supports
the
QA
requirement
for
the
multi­
billion
dollar
assistance
agreement
program
in
EPA.
6(
f)
Reason
for
Changes
in
Burden.
The
reasons
for
the
changes
in
burden
estimates
are
both
"
program"
and
"
adjustment."
The
EPA
is
devoting
more
funds
(
an
adjustment)
to
assistance
agreements
as
it
delegates
more
programs
and
collects
fewer
data
intramurally.
An
adjustment,
as
a
result,
is
an
increase
of
443
agreements,
or
+
30%.
EPA
is
continuing
the
effort
to
document
QA
practices
commensurate
with
EPA's
use
of
the
data
collected
(
a
program
change).
This
ICR
burden
estimate
was
calculated
for
the
first
time
to
conservatively
minimize
the
difference
between
research
(
non­
profit)
and
State,
local,
and
Tribal
government
submissions
to
reflect
this
emphasis
on
the
intended
use
of
the
data
rather
than
the
type
of
award.
This
resulted
in
a
combined
higher
salary
hourly
estimate
of
$
26
for
the
preparer
and
a
substantial
increase
in
estimated
preparation
hours.
There
remains
a
great
range
of
estimates
within
submissions,
however,
for
these
hours.
QA
Managers
reported
that
research
grant
proposals
take
as
few
as
3
hours
to
prepare,
whereas
other
plans
may
take
as
many
as
220
hours.
The
longer
times
reflect
State,
local,
and
Tribal
grants,
where
there
is
a
significant
learning
curve
among
respondents
who
are
updating
documentation
to
comply
with
ANSI/
ASQC
E­
4
for
complex
environmental
monitoring
programs.
It
is
expected
that
once
these
QA
plans
are
in
place
that
they
will
be
updated
readily
and
the
preparer
hours
will
drop.
The
resulting
change
is
+
186%
in
burden
estimated
for
this
ICR
from
the
last
renewal
(
which
had
decreased
by
43%
from
the
previous
ICR).

6(
g)
Burden
Statement.
Public
reporting
burden
for
this
collection
of
information
is
estimated
to
average
85
hours
per
response
for
QA
plans
prepared,
including
the
time
for
reviewing
the
regulation,
reading
QA
guides,
and
preparing
and
reviewing
the
QA
plan.

Burden
means
the
total
time,
effort,
or
financial
resources
expended
by
persons
to
generate,
maintain,
retain,
or
disclose
or
provide
information
to
or
for
a
Federal
agency.
This
includes
the
time
needed
to
review
instructions;
develop,
acquire,
install,
and
utilize
technology
and
systems
for
the
purposes
of
collecting,
validating,
and
verifying
information,
processing
and
maintaining
information,
and
disclosing
and
providing
information;
adjust
the
existing
ways
to
comply
with
any
previously
applicable
instructions
and
requirements;
train
personnel
to
be
able
to
respond
to
a
collection
of
information;
search
data
sources;
complete
and
review
the
collection
of
information;
and
transmit
or
otherwise
disclose
the
information.
An
agency
may
not
conduct
or
sponsor,
and
a
person
is
not
required
to
respond
to,
a
collection
of
information
unless
it
displays
a
currently
valid
OMB
control
number.
The
OMB
control
numbers
for
EPA's
regulations
are
listed
in
40
CFR
Part
9
and
48
CFR
Chapter
15.

Send
comments
on
the
Agency's
need
for
this
information,
the
accuracy
of
the
provided
burden
estimates,
and
any
suggested
methods
for
minimizing
respondent
burden,
including
through
the
use
of
automated
collection
techniques
to
the
Director,
Collection
Strategies
Division,
U.
S.
Environmental
Protection
Agency
(
2822),
1200
Pennsylvania
Avenue,
N.
W.,
Washington,
D.
C.
20460;
and
to
the
Office
of
Information
and
Regulatory
Affairs,
Office
of
Management
and
Budget,
725
17th
Street,
N.
W.,
Washington,
D.
C.
20503,
Attention:
Desk
Officer
for
EPA.
Include
the
EPA
ICR
number
and
OMB
control
number
in
any
correspondence.
TABLE
I.

Annual
Respondent
Burden/
Cost
Estimates
Collection
Activities
Burden
Hours
(
per
document)
Technical
Staff
@
$
26/
hour
Hours
Cost
1.
Read
Regulation
1
1
$
26
2.
Read
QA
Guides
4
4
$
104
3.
Prepare
Review
80
80
$
2080
TOTAL
85
$
2210
ANNUAL
BURDEN:
Hour
total
(
85)
x
number
of
respondents
(
1940)
=
164,900
hours
ANNUAL
COST:
Cost
total
($
2210)
x
number
of
respondents
(
1940)
=
$
4,287,400
TABLE
II.

Annual
Agency
Burden/
Cost
Estimates
Collection
Activities
Burden
Hours
(
per
document)
Technical
Staff
@
$
42/
hour
Hours
Cost
1.
Answer
Questions,
Review
QA
Plans
24
24
$
1008
TOTAL
24
$
1008
ANNUAL
BURDEN:
Hour
total
(
24)
x
number
of
respondents
(
1940)
=
21,340
hours
ANNUAL
COST:
Cost
total
($
1008)
x
number
of
respondents
(
1940)
=
$
1,955,520