LABORATORY
QUALITY
ASSURANCE
EVALUATION
PROGRAM
Information
Collection
Request:

Supporting
Statement
U.
S.
ENVIRONMENTAL
PROTECTION
AGENCY
Office
of
Ground
Water
and
Drinking
Water
August
2005
Table
of
Contents
1.
Identification
of
the
Information
Collection
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1(
a)
Title
of
the
Information
Collection
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1(
b)
Short
Characterization
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2.
Need
For
and
Use
of
the
Collection
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2
2(
a)
Need/
Authority
for
the
Collection
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2
2(
b)
Practical
Utility/
Users
of
the
Data
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3.
Non­
duplication,
Consultations,
and
Other
Collection
Criteria
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2
3(
a)
Non­
duplication
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2
3(
b)
Public
Notice
Required
Prior
to
ICR
Submission
to
OMB
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3
3(
c)
Consultations
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3
3(
d)
Effects
of
Less
Frequent
Collections
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4
3(
e)
General
Guidelines
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4
3(
f)
Confidentiality
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4
4.
The
Respondents
and
the
Information
Requested
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4
4(
a)
Respondents/
SIC
Codes
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4
4(
b)
Information
Requested
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5
5.
The
Information
Collected
­
Agency
Activities,
Collection
Methodology,
and
Information
Management
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5
5(
a)
Agency
Activities
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5
5(
b)
Collection
Methodology
and
Management
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6
5(
c)
Small
Entity
Flexibility
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7
5(
d)
Collection
Schedule
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7
6.
Estimating
the
Burden
and
Cost
of
the
Collection
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8
6(
a)
Estimating
Respondent
Burden
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8
6(
b)
Estimating
Respondent
Costs
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10
6(
c)
Estimating
Agency
Burden
and
Costs
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11
6(
d)
Estimating
the
Respondent
Universe
and
Total
Burden
and
Costs
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13
6(
e)
Bottom
Line
Burden
Hours
and
Cost
Tables
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13
6(
f)
Reasons
for
Change
in
Burden
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14
6(
g)
Burden
Statement
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14
APPENDIX
A
Federal
Register
Notice:
[
published
December
29,
2000]
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.
A­
1
APPENDIX
B
Second
Federal
Register
Notice
[
published
March
4,
2002]
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B­
1
APPENDIX
C
Laboratory
QA
Program
Application
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C­
1
APPENDIX
D
Laboratory
QA
Program
Application
Cover
Letter
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D­
1
APPENDIX
E
Respondent
Burden
Tables
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E­
1
APPENDIX
F
Agency
Burden
Tables
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F­
1
APPENDIX
G
Total
Respondent
and
Agency
Burden
Tables
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G­
1
APPENDIX
H
Federal
Register
Notice:
[
published
June
3,
2005]
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H­
1
APPENDIX
I
Comments
on
Federal
Register
Notice:
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I­
1
1
Information
Collection
Request
Section
1:
Part
A
of
the
Supporting
Statement
1.
Identification
of
the
Information
Collection
1(
a)
Title
of
the
Information
Collection
EPA
Laboratory
Quality
Assurance
Evaluation
Program
for
Analysis
of
Cryptosporidium
under
the
Safe
Drinking
Water
Act
OMB
Number:
2040
­
0246
U.
S.
EPA
Tracking
Number:
2067.03
1(
b)
Short
Characterization
The
U.
S.
Environmental
Protection
Agency
(
EPA)
is
requesting
a
renewal
of
the
information
collection
request
(
ICR)
for
the
Laboratory
Quality
Assurance
Evaluation
Program
for
Analysis
of
Cryptosporidium
under
the
Safe
Drinking
Water
Act
(
Laboratory
QA
Program).
This
voluntary
program
applies
to
public
and
private
laboratories
that
analyze
water
samples
for
Cryptosporidium.
The
program
will
help
ensure
that
laboratories
meet
the
quality
assurance
and
quality
control
criteria
of
EPA
Method
1622
and
EPA
Method
1623
(
EPA,
2001a,
2001b)
when
using
these
methods
for
the
determination
of
the
identity
and
concentration
of
Cryptosporidium
in
source
water
by
filtration,
immunomagnetic
separation
(
IMS),
and
immunofluorescence
assay
(
FA)
microscopy.
In
addition,
the
program
will
assist
in
determining
capacity
at
laboratories
to
support
monitoring
under
the
Long
Term
2
Enhanced
Surface
Water
Treatment
Rule
(
LT2ESWTR).

Information
collection
activities
required
under
the
Lab
QA
Program
include:
a
laboratory
participation
application;
initial
performance
testing
(
IPT)
results;
an
on­
site
evaluation
of
laboratory
performance
and
data
quality;
and
ongoing
performance
testing
(
OPT)
results.
All
materials
are
being
collected
by
the
Office
of
Ground
Water
and
Drinking
Water
(
OGWDW).
This
information
collection
will
provide
EPA
with
data
to
verify
that
the
laboratories
are
capable
of
producing
reliable
data
from
the
analysis
of
Cryptosporidium
using
EPA
Method
1622
and
EPA
Method
1623.

The
information
collection
will
involve
approximately
65
laboratories
at
a
total
cost
of
approximately
$
274,897
or
3,980
labor
hours
annually.
The
estimated
total
Agency
burden,
including
contractual
costs,
is
estimated
at
$
362,272,
or
3,388
labor
hours
annually
(
Appendix
G).
2
2.
Need
For
and
Use
of
the
Collection
2(
a)
Need/
Authority
for
the
Collection
The
information
collection
is
needed
by
EPA
to
support
the
Cryptosporidium
data
gathering
activities
that
will
be
required
under
the
LT2ESWTR.
The
Laboratory
QA
Program
is
being
renewed
in
advance
of
the
LT2ESWTR
because
the
Cryptosporidium
laboratory
evaluation
program
must
be
in
place
and
operational
before
the
implementation
of
the
LT2ESWTR.
In
addition,
EPA
plans
to
propose
under
the
LT2ESWTR
that
drinking
water
plants
monitoring
their
source
waters
for
Cryptosporidium
prior
to
rule
implementation
may
apply
to
have
these
data
"
grandfathered."
Renewing
the
Laboratory
QA
Program
will
help
ensure
that
qualified
laboratories
are
available
to
drinking
water
plants
that
are
interested
in
pursuing
this
option.

2(
b)
Practical
Utility/
Users
of
the
Data
Information
collected
under
the
Laboratory
QA
Program
will
be
used
by
EPA
to
verify
that
Cryptosporidium
occurrence
data
are
generated
by
qualified
laboratories
that
can
perform
the
analyses
acceptably.
Use
of
qualified
laboratories
for
source
water
monitoring
by
drinking
water
utilities
will
help
ensure
that
the
data
collected
are
of
known
and
reliable
quality.
Data
quality
could
potentially
be
compromised
in
the
absence
of
a
program
such
as
the
Laboratory
QA
Program.

A
list
of
laboratories
that
meet
or
continue
to
meet
the
evaluation
program
criteria
will
be
made
available
to
the
public
at
http://
www.
epa.
gov/
safewater/
lt2/
cla_
final.
html
and
will
provide
a
resource
to
aid
drinking
water
utilities
(
and
others
interested
in
monitoring
water
for
Cryptosporidium
occurrence
for
the
protection
of
public
health)
in
selecting
a
qualified
analytical
laboratory.
Successful
participation
in
the
voluntary
Laboratory
QA
Program
also
will
qualify
laboratories
to
analyze
samples
for
Cryptosporidium
monitoring
programs
requiring
sample
analyses
only
by
qualified
laboratories.

3.
Non­
duplication,
Consultations,
and
Other
Collection
Criteria
3(
a)
Non­
duplication
The
information
requested
from
the
respondents
under
this
ICR
is
not
available
from
other
sources.
The
information
requested
will
be
used
to
assess
the
current
ability
of
a
laboratory
to
reliably
analyze
Cryptosporidium
in
water
using
EPA
Method
1622
and
EPA
Method
1623.
Information
submitted
for
previous
programs,
such
as
the
Information
Collection
Rule,
would
not
be
applicable
because
older
analytical
methods
were
used
and
quality
control
requirements
were
different.
The
determination
that
this
information
is
not
available
from
other
sources
was
made
by
the
Office
of
Ground
Water
and
Drinking
Water
Technical
Support
Center
(
TSC),
who
will
be
administering
the
Laboratory
QA
Program,
and
TSC's
contractors,
both
of
which
have
worked
closely
since
1996
with
the
limited
community
of
capable
laboratories
that
will
be
affected
by
this
information
collection.
3
3(
b)
Public
Notice
Required
Prior
to
ICR
Submission
to
OMB
A
copy
of
the
first
Federal
Register
notice
which
announces
EPA's
renewal
of
the
Lab
QA
Program
and
requests
public
comment
on
the
ICR
(
prior
to
submitting
the
ICR
to
the
Office
of
Management
and
Budget
(
OMB))
is
attached
in
Appendix
A.
Further
details
on
the
Laboratory
Quality
Assurance
Program
have
been
added
in
Appendix
B.
EPA
also
has
developed
a
webpage
to
provide
further
information
on
the
program.
the
website
can
be
accessed
at
http://
www.
epa.
gov/
safewater/
lt2/
cla_
final.
html.

Comments
were
received
on
the
original
ICR
and
are
summarized
below
with
the
Agency's
responses.

Commenters
expressed
concern
that
the
Lab
QA
Program
does
not
address
the
Agency's
obligation
under
the
FACA
Agreement
in
Principle
to
identify
adequate
laboratory
capacity
to
implement
LT2ESWTR.
The
Lab
QA
Program
does
assess
laboratory
capacity
through
questions
on
the
application
on
current
and
potential
laboratory
capacity
to
analyze
Cryptosporidium
samples
and
the
on
site
evaluations.
This
information
is
being
compiled
as
laboratory
applications
are
received,
and
will
be
updated
during
on­
site
evaluations.
Comments
were
received
on
the
burden
estimates.
Because
laboratories
that
wish
to
begin
using
EPA
Methods
1622
and
1623
are
required
by
the
methods
to
purchase
the
equipment
necessary
to
demonstrate
initial
acceptable
performance,
and
because
this
is
a
method
requirement,
rather
than
a
program
requirement
(
laboratories
can
perform
the
methods
without
ever
participating
in
the
program),
the
burden
estimates
assume
that
no
capital
costs
will
be
incurred
by
laboratories
participating
in
the
program
over
and
above
the
costs
that
would
be
incurred
simply
to
use
the
method.
Because
the
program
application
requires
the
laboratories
applying
for
approval
under
the
program
to
submit
initial
performance
data,
laboratories
that
meet
these
requirements
should
already
have
the
capacity
to
perform
Methods
1622
or
1623
and
therefore
will
not
incur
start­
up
costs.
Commenters
wanted
to
know
if
training
would
be
available
for
labs
needing
help.
EPA
will
provide
limited
training
to
laboratories
needing
assistance
with
the
performance
of
Methods
1622
and
1623.
Information
on
training
will
be
posted
on
EPA's
website
as
it
becomes
available
and
an
on­
line
module
providing
training
on
microscopic
examination
of
samples
for
Method
1622
and
1623
will
soon
be
available.
Commenters
wanted
to
know
the
earliest
date
that
acceptable
grandfathered
data
could
be
generated.
EPA
is
aware
of
the
issues
regarding
grandfathered
data
acceptability
and
has
addressed
these
issues
in
the
proposed
LT2ESWTR.
These
issues
are
outside
of
the
scope
of
this
ICR.

3(
c)
Consultations
EPA
conducted
meetings
with
representatives
of
the
drinking
water
treatment
industry
and
the
community
of
laboratories
expected
to
seek
EPA
recognition
under
the
Laboratory
Quality
Assurance
Evaluation
Program
in
Cincinnati,
OH,
on
January
23
and
March
12­
13,
2001,
and
in
Washington,
DC,
on
February
13­
14,
2001.
EPA
presented
and
discussed
draft
plans
for
the
laboratory
evaluation
program
at
these
meetings
and
sought
input
from
the
drinking
water
4
utility
and
laboratory
representatives
that
attended
these
meetings.

Four
laboratories
were
contacted
for
burden
estimates
for
participating
in
the
Lab
QA
Program.
Each
laboratory
was
asked
to
estimate
the
loaded
cost
of
a
manager/
hr,
a
technician/
hr,
and
an
average
cost
for
a
1623
sample.
The
following
laboratories
have
supplied
burden
estimates
for
participating
in
the
Lab
QA
Program:
°
CH
Diagnostic
and
Consulting
Services
°
City
of
San
Diego
°
City
of
Los
Angeles
Department
of
Water
and
Power
°
Lab/
Cor,
Inc
EPA
provides
questionaires
to
each
laboratory
after
their
on­
site
evaluation
to
provide
feedback
on
the
auditor
process
and
the
auditors.
EPA
has
used
the
feedback
received
from
the
laboratories
to
improve
the
audit
process.

3(
d)
Effects
of
Less
Frequent
Collections
Under
the
Laboratory
QA
Program,
EPA
plans
on
requiring
laboratories
to
analyze
single­
blind
OPT
samples
three
times
per
year.
This
frequency
is
the
minimum
necessary
to
enable
EPA
to
independently
verify
that
laboratories
continue
to
perform
in
a
acceptable
manner.
Less
frequent
OPT
samples
would
not
sufficiently
capture
a
laboratory's
performance
over
time.
Laboratories
will
be
required
to
report
OPT
results
within
15
days
of
analysis.
Reporting
OPT
sample
results
at
this
frequency
allows
EPA
to
respond
in
a
timely
manner
to
any
problems
the
laboratory
may
be
having
with
analysis
of
Cryptosporidium
in
water.

3(
e)
General
Guidelines
The
Laboratory
QA
Program
adheres
to
all
of
OMB's
general
guidelines
for
information
collection.

3(
f)
Confidentiality
The
Laboratory
QA
Program
does
not
ask
any
confidential
or
sensitive
questions.

4.
The
Respondents
and
the
Information
Requested
4(
a)
Respondents/
SIC
Codes
The
following
is
a
list
of
SIC
codes
associated
with
laboratories
affected
by
the
requirements
of
this
ICR:

8734
­
Services:
Testing
Laboratories
5
4(
b)
Information
Requested
(
i)
Data
Items
Report
on:
°
Laboratory
participation
application
information
°
Initial
proficiency
testing
(
IPT)
data
°
Ongoing
proficiency
testing
(
OPT)
data
°
Documentation
of
corrective
actions
taken
in
response
to
any
deficiencies
noted
during
the
on­
site
evaluation
Maintain:
°
IPT
data
°
OPT
data
(
ii)
Respondent
Activities
°
Completing
laboratory
participation
application
(
1
time
only)
(
See
Appendix
C)
°
Analyzing
IPT
samples
(
set
of
8
samples,
1
time
only
for
new
laboratories)
and
reporting
IPT
data
°
Analyzing
OPT
samples
(
set
of
3
samples,
2
times
first
year
only,
3
times
per
year,
per
method
version),
reporting
OPT
data,
and
reporting
volume
of
LT2
samples
expected
°
Hosting
on­
site
evaluation
(
1
time
per
three
year
period)

5.
The
Information
Collected
­
Agency
Activities,
Collection
Methodology,
and
Information
Management
5(
a)
Agency
Activities
Agency
activities
associated
with
the
OGWDW's
Laboratory
QA
Program
consist
of
the
following:
°
Maintaining
a
database
to
review,
store,
and
report
on
laboratory
PT
results
°
Maintaining
a
database
to
store
and
report
on
laboratory
evaluations
°
Reviewing
laboratory
participation
applications
and
notifying
laboratories
of
application
status
(
1
time
per
laboratory
per
three
year
period)
°
Preparing
and
distributing
IPT
samples
(
1
time
per
new
laboratory,
per
method
version)
°
Tracking
receipt
of
and
reviewing
IPT
data
(
1
time
per
new
laboratory,
per
method
version)
°
Conducting
on­
site
evaluations
and
re­
evaluations
of
the
laboratories
seeking
EPA
recognition
of
laboratory
capability
and
reporting
on
the
results
of
these
on­
site
evaluations
(
1
time
per
laboratory
every
three
years)
°
Preparing
and
distributing
OPT
samples,
which
may
include
confounding
organisms
(
2
times
first
year
only,
3
times
per
year,
per
laboratory,
per
method
version)
°
Tracking
receipt
of
and
reviewing
OPT
data
and
entering
the
data
into
a
database
(
2
times
first
year
only,
3
times
per
year,
per
laboratory,
per
method
version)
°
Developing,
generating,
and
distributing
reports
on
laboratory
status
(
3
times
per
year)
6
5(
b)
Collection
Methodology
and
Management
Laboratories
interested
in
obtaining
EPA
recognition
of
laboratory
capability
to
perform
analyses
using
EPA
Method
1622
and
EPA
Method
1623
should
submit
applications
to
EPA.
EPA
will
evaluate
the
applications
for
completeness
and
compare
the
information
to
the
recommended
criteria
specified
in
the
Federal
Register
Notice.
The
criteria
include:
1.
Recommended
personnel
criteria:
Principal
Analyst/
Supervisor
(
one
per
laboratory)
should
have:
°
BS/
BA
in
microbiology
or
closely
related
field
°
A
minimum
of
one
year
of
continuous
bench
experience
with
Cryptosporidium
and
immunofluorescent
assay
(
IFA)
microscopy
°
A
minimum
of
six
months
experience
using
EPA
Method
1622
and/
or
EPA
Method
1623
°
A
minimum
of
100
samples
analyzed
using
EPA
Method
1622
and/
or
EPA
Method
1623
(
minimum
50
samples
if
the
person
was
an
analyst
approved
to
conduct
analysis
for
the
ICR
Protozoan
Method
(
EPA,
1996))
for
the
specific
analytical
procedure
they
will
be
using
°
Submit
to
EPA,
along
with
the
application
package,
resumes
detailing
the
qualifications
of
the
laboratory's
proposed
principal
analyst/
supervisor
Other
Analysts
(
no
minimum
number
of
analysts
per
laboratory)
should
have:
°
Two
years
of
college
(
or
equivalent)
in
microbiology
or
closely
related
field
°
A
minimum
of
six
months
of
continuous
bench
experience
with
Cryptosporidium
and
IFA
microscopy
°
A
minimum
of
three
months
experience
using
EPA
Method
1622
and/
or
EPA
Method
1623
°
A
minimum
of
50
samples
analyzed
using
EPA
Method
1622
and/
or
EPA
Method
1623
(
minimum
25
samples
if
the
person
was
an
analyst
approved
to
conduct
analysis
for
the
ICR
Protozoan
Method)
for
the
specific
analytical
procedures
they
will
be
using
°
Submit
to
EPA,
along
with
the
application
package,
resumes
detailing
the
qualifications
of
the
laboratory's
proposed
other
analysts
Technician(
s)
(
no
minimum
number
of
technicians
per
laboratory)
should
have:
°
Three
months
experience
with
the
specific
parts
of
the
procedure
they
will
be
performing
°
A
minimum
of
50
samples
analyzed
using
EPA
Method
1622
and/
or
EPA
Method
1623
(
minimum
25
samples
if
the
person
was
an
analyst
approved
to
conduct
analysis
for
the
ICR
Protozoan
Method)
for
the
specific
analytical
procedures
they
will
be
using
°
Submit
to
EPA,
along
with
the
application
package,
resumes
detailing
the
qualifications
of
the
laboratory's
proposed
technician(
s)
2.
Recommended
laboratory
criteria:
°
Appropriate
instrumentation
as
described
in
EPA
Methods
1622
and
1623
(
EPA,
2001a,
b)

°
Equipment
and
supplies
as
described
in
EPA
Methods
1622
and
1623
(
EPA
2001a,
7
2001b)
°
Detailed
laboratory
standard
operating
procedures
for
each
version
of
the
method
that
the
laboratory
will
use
to
conduct
the
Cryptosporidium
analyses
°
Laboratory
should
provide
a
current
copy
of
the
table
of
contents
of
their
laboratory's
quality
assurance
plan
for
protozoa
analyses
°
EPA
Method
1622
or
EPA
Method
1623
initial
demonstration
of
capability
(
IDC)
data,
which
include
precision
and
recovery
(
IPR)
test
results
and
matrix
spike/
matrix
spike
duplicate
(
MS/
MSD)
test
results
for
Cryptosporidium.
EPA
intends
to
evaluate
the
IPR
and
MS/
MSD
results
against
the
performance
acceptance
criteria
in
the
April
2001
version
of
EPA
Method
1622
or
EPA
Method
1623
(
EPA,
2001a,
2001b).

During
on­
site
evaluations,
EPA
will
evaluate
laboratories'
performance
of
the
methods,
as
well
as
laboratories'
data
recording
and
quality
control
practices
using
standardized
checklists.
Every
three
years
the
laboratories
will
submit
a
new
application.

IPT
and
OPT
data
will
be
reviewed
against
the
requirements
of
Method
1622/
1623
and
the
recommended
criteria
specified
in
Federal
Register
Notice.
Data
for
the
IPT
and
OPT
samples
will
be
entered
into
and
stored
in
a
QC
database
with
automated
data
review
and
calculation
functions.
Automating
data
review
functions
reduces
resources
required
for
data
review
and
ensures
that
all
samples
are
reviewed
in
a
consistent
manner.

5(
c)
Small
Entity
Flexibility
The
Laboratory
QA
Program
is
a
voluntary
program;
any
entity
that
believes
this
program
will
impose
undue
burden
is
not
required
to
participate
in
the
Laboratory
QA
Program.
Laboratories
will
still
be
able
to
analyze
Cryptosporidium
in
water
for
any
purpose
where
evaluation
of
laboratory
capability
is
not
required.

Small
businesses
are
defined
as
any
business
that
is
independently
owned
and
operated
and
not
dominant
in
its
field
as
defined
by
the
Small
Business
Administration
(
SBA)
regulations
under
Section
3
of
the
Small
Business
Act.

Small
businesses
may
opt
to
seek
EPA
recognition
of
laboratory
capability
to
perform
Cryptosporidium
water
analyses
using
only
one
version
of
EPA
Method
1622
and
EPA
Method
1623
and
reduce
the
burden
associated
with
participation
in
the
Laboratory
QA
Program.

5(
d)
Collection
Schedule
The
Laboratory
QA
Program
is
a
voluntary
program.
No
laboratories
are
required
to
participate
or
submit
any
information.

Any
laboratory
not
currently
wishing
to
participate
in
the
Laboratory
QA
Program
may
submit
an
application
for
laboratory
participation
at
any
time.
After
the
laboratory
application
has
been
evaluated
by
EPA
and
found
to
be
acceptable,
EPA
will
provide
the
8
laboratory
with
IPT
samples.
The
laboratory
will
submit
IPT
sample
data
to
EPA
within
15
days
of
receipt
of
the
IPT
samples.
After
successful
completion
of
the
IPT
samples,
the
laboratory
will
receive
a
set
of
OPT
samples
every
four
months.
Laboratories
that
are
currently
participating
in
the
program
and
have
already
been
evaluated
during
the
original
ICR
time
frame
may
be
asked
to
submit
and
updated
application
and
be
re­
evaluated
during
the
period
for
this
ICR
renewal.
Laboratories
that
have
successfully
completed
the
audit
process
will
not
be
evaluated
more
than
once
per
three
year
period.

6.
Estimating
the
Burden
and
Cost
of
the
Collection
6(
a)
Estimating
Respondent
Burden
Below
are
summaries
of
respondent
burden
hours
for
this
information
collection.
EPA
consulted
with
fewer
than
nine
respondents
from
the
community
of
laboratories
that
have
or
may
have
voluntarily
applied
for
EPA
approval
of
laboratory
capability
to
perform
Cryptosporidium
analyses
using
EPA
Method
1622
and
EPA
Method
1623
to
obtain
burden
hour
estimates.
For
specific
burden
breakdowns,
refer
to
the
Laboratories
Seeking
Approval
for
One
Method
and
Laboratories
Seeking
Approval
for
Two
Methods
burden
tables
in
Appendix
E.

Laboratories
may
seek
EPA
approval
of
laboratory
capability
for
each
version
of
EPA
Method
1622
and
EPA
Method
1623
that
they
wish
to
use
for
field
sample
monitoring.
Therefore,
laboratories
seeking
EPA
approval
of
laboratory
capability
to
perform
Cryptosporidium
analyses
for
one
method
version
incur
different
burden
hours
and
costs
than
laboratories
seeking
EPA
recognition
for
two
versions
of
the
method.
Hence,
there
are
separate
burden
tables
for
laboratories
seeking
EPA
recognition
for
one
method
(
Table
1,
Appendix
E)
and
laboratories
seeking
EPA
recognition
for
two
methods
(
Table
2).
Currently
there
are
46
laboratories
participating
in
the
EPA
Lab
QA
Program
for
one
method
version
and
4
that
participate
for
2
method
versions.
EPA
estimates
that
9
additional
laboratories
will
seek
EPA
approval
for
one
method
for
a
total
of
55
and
6
additional
laboratories
will
seek
EPA
recognition
for
two
methods
for
a
total
of
10.

Laboratories
will
submit
only
one
application
every
three
years,
regardless
of
the
number
of
method
versions
for
which
they
seek
EPA
recognition.
The
laboratory
participation
application
requires
the
following:
1)
completing
the
application
form
and
a
self­
audit
checklist;
2)
providing
resumes
for
each
staff
member
seeking
EPA
recognition
under
the
program;
3)
providing
copies
of
existing
laboratory
procedures
for
each
version
of
the
method
for
which
the
laboratory
is
seeking
EPA
recognition;
and
4)
providing
the
results
of
initial
demonstration
of
capability
data
for
each
version
of
the
method
for
which
the
laboratory
is
seeking
EPA
recognition.
There
is
not
a
deadline
for
application
submission,
and
laboratories
can
submit
applications
at
any
time.
Since
laboratories
only
have
to
submit
the
application
one
time
per
three
year
period,
the
number
of
laboratories
expected
to
submit
applications
were
evenly
distributed
over
a
three
year­
period
to
estimate
burden
hours
and
costs
per
year
(
e.
g.,
laboratories
seeking
approval
for
one
method,
55
9
laboratories/
3
years
=
approximately
18
labs/
year;
laboratories
seeking
approval
for
two
methods,
10
laboratories/
3
years
=
approximately
3
laboratories
per
year).
Burden
hours
and
costs
associated
with
submitting
the
completed
application
package
for
the
laboratories
applying
for
EPA
recognition
of
one
method
are
estimated
at
238
labor
hours
per
year.
Burden
hours
associated
with
submitting
the
completed
application
package
for
the
laboratories
applying
for
EPA
recognition
of
two­
method
versions
are
estimated
at
53
labor
hours
per
year
(
Appendix
E).

Each
new
laboratory
will
analyze
a
separate
set
of
IPT
samples,
(
8
samples
per
set)
for
each
version
of
the
method
for
which
they
are
seeking
EPA
recognition.
The
burden
for
this
task
includes
all
labor
associated
with
the
actual
process
of
analyzing
and
documenting
the
data
for
each
set
of
IPT
samples.
Since
laboratories
only
have
to
analyze
a
set
of
IPT
samples
once,
the
number
of
laboratories
expected
to
analyze
IPT
samples
were
evenly
distributed
over
a
3­
year
period
to
estimate
burden
hours
per
year
(
Appendix
E).
Laboratories
that
are
already
participating
in
the
Lab
QA
Program
will
not
have
to
repeat
their
IPT
analysis
and
are
not
included
in
the
burden
estimates.
Burden
hours
for
all
laboratories
analyzing
one
set
of
IPT
samples
(
for
one
method
version)
are
estimated
at
120
labor
hours
per
year.
Burden
hours
for
all
laboratories
analyzing
two
sets
of
IPT
samples
(
for
two
method
versions)
are
estimated
at
160
labor
hours
per
year
Each
laboratory
seeking
EPA
recognition
of
laboratory
capability
under
the
Laboratory
QA
Program
will
undergo
one
on­
site
evaluation
every
three
years,
regardless
of
the
number
of
methods
for
which
the
laboratory
seeks
EPA
recognition.
However,
this
evaluation
may
require
a
longer
amount
of
time
if
the
laboratory
requests
recognition
for
more
than
one
method
version.
The
burden
hours
associated
with
this
task
include
time
required
to
attend
short
briefings
by
the
auditors
before
and
after
the
audit,
demonstrate
the
techniques
for
the
methods
for
which
they
are
seeking
EPA
recognition,
participate
in
discussions
with
the
auditors,
and
respond
to
any
deficiencies
noted
in
the
audit
report.
Because
laboratories
will
only
undergo
an
on­
site
evaluation
one
time
every
three
years,
the
number
of
laboratories
expected
to
be
evaluated
were
evenly
distributed
over
a
three
year
period
to
estimate
burden
hours
per
year
(
e.
g.,
laboratories
seeking
approval
for
one
method
=
55
laboratories/
3
years
=
approximately
18
labs/
year;
laboratories
seeking
approval
for
two
methods
=
10
laboratories/
3
years
=
approximately
3
laboratories
per
year).
Burden
hours
associated
with
the
on­
site
evaluation
for
all
laboratories
applying
for
EPA
recognition
of
one
method
version
are
estimated
at
458
labor
hours
per
year.
Burden
hours
for
all
laboratories
applying
for
laboratory
capability
recognition
of
two
method
versions
are
estimated
at
102
labor
hours
per
year
(
Appendix
E).

will
analyze
a
set
of
OPT
samples,
which
may
include
confounding
organisms
(
3
samples
per
set)
every
four
months
for
each
method
for
which
they
are
seeking
EPA
recognition.
Laboratories
will
also
submit
the
estimated
volume
of
LT2
samples
expected
per
month.
The
burden
estimates
associated
with
this
task
include
all
labor
associated
with
the
actual
process
of
analyzing
and
documenting
the
data
for
each
set
of
OPT
samples.
During
the
first
year
of
participation
in
10
the
Laboratory
QA
Program,
new
laboratories
will
analyze
two
sets
of
OPT
samples
(
plus
one
set
of
IPT
samples)
for
each
method
version
and
laboratories
already
participating
in
the
program
will
analyze
three
sets
of
OPT
samples.
During
the
second
and
third
years
of
participation
all
laboratories
will
analyze
three
sets
of
OPT
samples
(
no
IPT
samples).
The
burden
hours
and
costs
in
the
burden
tables
(
Appendix
E)
are
weighted
to
take
into
account
the
laboratories
that
only
had
to
analyze
2
sets
of
OPT
samples
the
first
year.
Burden
hours
for
all
laboratories
analyzing
one
set
of
OPT
samples
every
four
months
(
for
one
method
version)
are
estimated
at
2503
labor
hours
per
year.
Burden
hours
and
costs
for
all
laboratories
using
two
method
versions
(
which
require
two
sets
of
OPT
samples
every
four
months)
are
estimated
at
347
labor
hours
6(
b)
Estimating
Respondent
Costs
Below
are
summaries
of
the
costs
for
this
information
collection.
EPA
consulted
with
fewer
than
nine
respondents
from
the
community
of
laboratories
that
have
or
may
have
voluntarily
applied
for
EPA
recognition
of
laboratory
capability
to
perform
Cryptosporidium
analyses
using
EPA
Method
1622
and
EPA
Method
1623
to
obtain
labor
and
operations
and
maintenance
(
O&
M)
cost
estimates,
which
include
overhead
costs.
For
specific
cost
breakdowns,
refer
to
the
Laboratories
Seeking
Approval
for
One
Method
and
Laboratories
Seeking
Approval
for
Two
Methods
tables
in
Appendix
E.

It
is
assumed
that
the
laboratories
wishing
to
participate
in
this
program
are
already
performing
one
or
two
versions
of
either
EPA
Method
1622
and
EPA
Method
1623
for
the
analysis
of
Cryptosporidium
and
already
have
the
necessary
equipment
to
perform
the
analysis,
therefore
no
capital
or
startup
costs
were
included
in
the
cost
estimates.
For
each
task
total
costs
were
based
on
the
combined
labor
and
O&
M
costs
for
that
task.

Cryptosporidium
analyses
for
one
method
version
incur
different
costs
than
laboratories
seeking
EPA
recognition
for
two
versions
of
the
method.
Hence,
there
are
separate
tables
for
laboratories
seeking
EPA
recognition
for
one
method
and
laboratories
seeking
EPA
recognition
for
two
methods.
EPA
estimates
that
55
laboratories
will
seek
EPA
recognition
for
one
method
and
10
laboratories
will
seek
EPA
recognition
for
two
methods.

Respondent
costs
associated
with
submitting
the
completed
application
package
for
the
laboratories
applying
for
EPA
recognition
of
one
method
is
$
11,364
per
year
(
approximately
18
respondents/
year).
Costs
associated
with
submitting
the
completed
application
package
for
the
laboratories
applying
for
EPA
recognition
of
two­
method
is
estimated
cost
of
$
2,703
per
year
(
approximately
3
respondents/
year)
(
Appendix
E).

Respondent
costs
associated
with
analysis
of
IPT
samples
(
total
of
8
samples)
includes
labor
and
O&
M
costs,
which
are
estimated
at
$
175
per
analytical
sample.
Because
laboratories
only
have
to
analyze
a
set
of
IPT
samples
once,
the
number
of
laboratories
expected
to
analyze
IPT
samples
were
evenly
distributed
over
a
3­
year
period
to
estimate
burden
hours
and
costs
per
year.
Laboratories
already
participating
in
the
PT
program
are
11
not
included
in
this
estimate.
The
costs
for
analyzing
one
set
of
IPT
samples
for
all
laboratories
applying
for
EPA
recognition
of
one
method
version
(
approximately
18
laboratories
per
year)
are
estimated
at
$
9,156
per
year.
The
costs
for
all
laboratories
applying
for
laboratory
capability
recognition
of
two
method
versions
(
approximately
2
laboratories
per
year)
are
estimated
at
$
12,208
per
year.

The
costs
associated
with
the
on­
site
evaluation
for
all
laboratories
applying
for
EPA
recognition
of
one
method
version
(
approximately
18
laboratories
per
year)
are
estimated
at
$
20,020.20
per
year.
The
costs
for
all
laboratories
applying
for
laboratory
capability
recognition
of
two
method
versions
(
approximately
3
laboratories
per
year)
are
estimated
at
$
4,534.20
per
year.

Cost
estimates
associated
with
the
analysis
of
OPT
samples
every
four
months
includes
all
labor
and
analytical
costs
associated
with
the
actual
process
of
analyzing
and
documenting
the
data
for
each
set
of
OPT
samples.
Labor
and
costs
are
estimated
at
$
175
per
analytical
sample.
Costs
for
all
laboratories
analyzing
one
set
of
OPT
samples
every
four
months
(
for
one
method
version)
are
estimated
$
188,760
per
year.
Costs
for
all
laboratories
using
two
method
versions
(
which
require
two
sets
of
OPT
samples
every
four
months)
are
estimated
at
$
26,152
per
year
6(
c)
Estimating
Agency
Burden
and
Costs
Below
are
Agency
burden
hours
and
associated
financial
costs
pertaining
to
implementation
of
the
Laboratory
QA
Program.
For
a
specific
breakdown
of
burden
hours
and
financial
costs,
refer
to
the
Agency
Burden
table
in
Appendix
F.
Costs
and
burden
hours
are
broken
out
based
on
activities
completed
by
the
Agency
and
supporting
contractors.
Based
on
the
2005
GS
schedule
for
the
Washington
DC/
Baltimore
area
and
the
standard
government
benefits
multiplication
factor
of
1.6,
EPA
estimates
an
average
hourly
cost
of
$
79.70/
hour
for
Agency
legal
staff,
$
67.74/
hour
for
Agency
management
staff,
$
40.22/
hour
for
Agency
technical
staff,
and
$
17.47/
hour
for
Agency
clerical
staff.
Based
on
the
published
schedule
of
contractor
labor
rates
for
the
years
covered
by
this
program,
the
average
loaded
burden
hours
and
costs
for
contractor
labor
were
estimated
at
$
110.00/
hour
for
expert
staff,
$
95.00/
hour
for
management
staff,
and
$
62.00/
hour
for
technical
staff.

Agency
burden
is
estimated
based
on
the
labor
hours
associated
with
performing
each
task
per
laboratory
seeking
laboratory
capability
recognition.
To
get
the
total
annual
cost
hours
and
costs
are
then
multiplied
by
the
estimated
number
of
respondents
and
added
to
the
capital
and
O&
M
costs.
The
burden
associated
with
each
information
collection
task
is
shown
in
a
separate
row
of
the
burden
table.
It
is
estimated
that
65
laboratories
(
approximately
22
laboratories
per
year)
will
seek
EPA
recognition
under
the
Laboratory
Quality
Assurance
Evaluation
Program.
Maintenance
of
a
QC
database
and
lab­
audit
database
are
not
affected
by
the
number
of
laboratories
seeking
EPA
recognition
because
these
costs
and
labor
hours
will
be
incurred
independent
of
the
number
of
laboratories
12
participating
in
the
program.

To
facilitate
data
storage
and
data
review,
the
Agency
will
maintain
a
QC
database.
The
Agency
burden
associated
with
maintenance
of
the
QC
and
lab
audit
databases
is
estimated
at
6.5
labor
hours
and
a
total
Agency
cost
of
$
425
per
year.

The
Agency
will
review
the
laboratory
participation
applications
to
ensure
that
all
the
required
information
has
been
submitted
and
that
each
laboratory
applicant
has
the
necessary
experience
and
qualifications
to
acceptably
analyze
water
samples
for
Cryptosporidium.
The
labor
hours
and
costs
associated
with
this
task
include
reviewing
the
laboratory
application
and
notifying
the
laboratory
if
their
application
is
acceptable
or
requires
submission
of
additional
information.
Since
each
laboratory
will
only
be
required
to
submit
an
application
one
time,
the
number
of
laboratories
expected
to
seek
EPA
recognition
is
evenly
distributed
over
three
years
in
order
to
determine
labor
hours
and
costs
per
year.
The
Agency
burden
associated
with
review
of
laboratory
participation
applications
is
estimated
at
118.8
labor
hours
and
a
cost
of
$
7,954
per
year.

To
test
the
ability
of
the
laboratory
to
acceptably
analyze
water
samples
for
Cryptosporidium,
the
Agency
will
distribute
IPT
and
OPT
samples
to
the
laboratories
participating
in
the
Laboratory
Quality
Assurance
Evaluation
Program.
The
labor
hours
and
costs
associated
with
this
task
include
notifying
laboratories
when
they
will
receive
their
next
samples,
preparing
the
samples,
and
shipping
the
samples
to
the
laboratories.
All
the
capital
startup
costs
associated
with
preparing
the
performance
testing
samples
are
included
in
the
costs
of
preparing
the
IPT
samples.
Because
each
laboratory
will
only
be
required
to
analyze
IPT
samples
once,
the
number
of
laboratories
expected
to
analyze
IPT
samples
is
evenly
distributed
over
three
years
in
order
to
determine
labor
hours
and
costs
per
year
The
Agency
burden
associated
with
preparation
of
IPT
samples
is
estimated
at
10
labor
hours
per
year
and
a
cost
of
$
2,230
per
year.
The
Agency
burden
associated
with
preparation
of
the
OPT
samples
is
estimated
at
300
labor
hours
per
year,
and
a
total
Agency
cost
of
$
55,124
per
year.

The
Agency
will
perform
on­
site
evaluations
of
each
laboratory
to
determine
if
the
laboratory
has
the
required
equipment
and
facilities,
has
an
appropriate
QC
program
in
place,
and
is
performing
the
method
properly.
Labor
hours
and
costs
include
scheduling
the
on­
site
evaluation,
travel,
conducting
the
evaluation,
documenting
the
results
of
the
evaluation,
notifying
the
laboratory
of
the
results
of
their
evaluation,
and
tracking
the
progress
and
costs
of
these
activities.
The
Agency
burden
associated
with
performing
onsite
evaluations
is
estimated
at
2,467.8
labor
hours
per
year
and
a
cost
of
$
264,513
per
year.

The
Agency
will
review
the
IPT
data
submitted
by
the
laboratory
to
verify
that
the
data
submission
is
complete,
the
method
requirements
were
met,
and
that
the
laboratory's
performance
was
acceptable.
After
the
review
is
complete,
the
Agency
will
notify
the
laboratory
whether
their
performance
on
the
IPT
samples
was
acceptable.
The
Agency
burden
associated
with
reviewing
IPT
data
is
estimated
at
22.5
labor
hours
per
year
and
a
13
cost
of
$
1531
per
year.

On
an
ongoing
basis,
the
Agency
will
review
OPT
data
submitted
by
the
laboratories
to
verify
that
the
data
submission
is
complete,
the
method
requirements
were
met,
and
that
the
laboratories'
performance
was
acceptable.
The
labor
hours
and
costs
associated
with
reviewing
these
data
include
data
entry
into
the
QC
database,
automated
data
review,
and
notification
of
the
laboratory
regarding
the
results.
The
Agency
burden
associated
with
reviewing
OPT
data
is
based
on
an
estimated
450
labor
hours
per
year
and
a
cost
of
$
29,728
per
year.

The
Agency
will
post
the
status
of
the
laboratories
that
will
be
participating
in
the
Laboratory
QA
Program
on
the
LT2
website
http://
www.
epa.
gov/
safewater/
lt2/
aprvlabs.
html.
The
labor
hours
and
costs
associated
with
these
reports
include
generation
of
the
reports
and
posting
of
laboratory
status
on
an
EPA
website.
The
Agency
burden
associated
with
the
status
reports
is
based
on
and
estimated
12
hours
per
year
and
a
cost
of
$
768
per
year.

6(
d)
Estimating
the
Respondent
Universe
and
Total
Burden
and
Costs
The
affected
entities
include
public
and
private
water
testing
laboratories.
EPA
estimates
that
65
laboratories
(
approximately
22
laboratories
per
year)
will
seek
EPA
recognition
under
the
Laboratory
QA
Program.
The
respondent
total
burden
and
cost
are
provided
in
the
Total
Respondent
and
Agency
Burden
Tables
in
Appendix
G
and
are
described
in
greater
detail
in
Sections
6(
a)
­
6(
c).

6(
e)
Bottom
Line
Burden
Hours
and
Cost
Tables
(
i)
Respondent
Tally
Refer
to
the
burden
table
in
Appendix
G
titled,
Total
Respondent
and
Agency
Burden
Tables,
for
a
specific
breakdown
of
the
respondent
costs.
The
Laboratory
QA
Program
will
affect
approximately
65
respondents
(
22
laboratories
per
year).
The
respondents
will
engage
in
4
different
tasks
(
refer
to
Section
4(
b)(
ii))
involving
3,980
labor
hours
and
costing
approximately
$
166,393
per
year
for
labor.
Respondents
will
invest
$
0.00
per
year
in
capital/
start­
up
costs
and
$
108,504
per
year
in
O&
M
costs.

(
ii)
Agency
Tally
Refer
to
the
burden
table
in
Appendix
G
titled,
Total
Agency
and
Agency
Burden
Tables,
for
a
summary
of
Agency
costs.
Eight
Agency
tasks
are
associated
with
the
Laboratory
QA
Program.
These
tasks
will
involve
approximately
3,388
labor
hours
annually
resulting
in
a
cost
of
$
268,985
per
year
for
labor.
The
Agency
will
invest
approximately
$
0.00
per
year
in
capital/
start­
up
costs
and
$
93,783
per
year
in
O&
M
costs.
14
6(
f)
Reasons
for
Change
in
Burden
Changes
in
burden
have
occurred
due
to
inflation,
an
increase
in
the
respondent
universe,
and
re­
evaluation
of
hours
for
tasks.
Inflation
has
increased
all
O&
M
and
labor
costs
accordingly.
The
increase
in
the
respondent
universe
has
increased
the
overall
burden
costs
for
the
respondents.
EPA's
original
estimates
for
hours
to
participate
and
maintain
the
Laboratory
Quality
Assurance
Evaluation
Program
were
made
before
the
program
began.
Because
the
program
has
been
continuing,
the
estimates
have
been
re­
evaluated
based
on
actual
time
spent
on
the
tasks,
causing
the
burden
estimates
to
change.
Burden
estimates
have
also
changed
based
on
some
tasks
such
as
the
development
of
the
QC
database
and
audit
checklist
not
being
applicable
to
this
renew
ICR.

6(
g)
Burden
Statement
The
reporting
and
record­
keeping
burden
for
this
collection
is
estimated
to
average
19
hours
annually
per
laboratory
(
the
combined
total
hours
per
year
for
one
and
two
method
laboratories
divided
by
65
laboratories
divided
by
3.3
activities
per
year).

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
Number
OW­
2002­
0012,
which
is
available
for
public
viewing
at
the
EPA
Water
Docket
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
EPA
Water
Docket
is
(
202)
566­
2426.
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
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
15
Office
of
Information
and
Regulatory
Affairs,
Office
of
Management
and
Budget,
725
17th
Street,
NW,
Washington,
DC
20503,
Attention:
Desk
Officer
for
EPA.
Please
include
the
EPA
Docket
ID
Number
OW­
2002­
0012
and
OMB
Control
Number
2040­
0246
in
any
correspondence.

Summary
of
Comments
on
Federal
Register
notice
can
be
found
below
and
the
complete
list
of
comments
and
responses
are
included
in
Appendix
I.

Four
sets
of
comments
were
received.

One
comment
was
received
concerning
the
frequency
of
the
on­
site
evaluations
being
inadequate
given
the
potential
changes
in
laboratory
personnel
during
LT2
monitoring.
Another
comment
stated
the
current
frequency
is
adequate.
As
indicated
in
this
supporting
statement,
laboratories
will
be
audited
every
three
years.
Priority
will
be
given
to
those
laboratories
anticipated
to
analyze
the
most
samples
during
LT2
and
those
that
have
undergone
significant
personnel
and
facility
changes.

One
commenter
felt
that
the
PT
samples
and
audit
slides
were
not
challenging
enough
and
were
not
representative
of
real­
world
samples.
Another
commenter
recommended
a
lower
frequency
of
proficiency
test
samples.
EPA
is
considering
the
use
of
confounding
organisms
in
the
PT
samples
and
audit
slides
to
make
the
samples
more
realistic
and
challenging.

One
commenter
indicated
that
the
estimated
burden
hours
were
not
sufficient
for
the
required
tasks.
EPA
is
confident
that
the
burden
hours
estimated
are
sufficient
to
accomplish
all
of
the
activities
included
in
the
Lab
QA
Program
after
consulting
multiple
laboratories
and
reevaluation
of
previous
estimates.

One
comment
addressed
the
need
to
confirm
that
laboratories
are
maintaining
performance
criteria.
EPA
believes
that
the
OPT
samples
analyzed
three
times
a
year
are
sufficient
in
testing
the
laboratory
performance.

Commenters
noted
that
the
Lab
QA
program
is
a
valuable
tool
for
laboratories
as
well
as
their
clients
and
that
it
is
appropriate
that
EPA
continue
to
provide
this
service.
Commenters
said
that
the
on­
site
evaluation
was
helpful
and
that
EPA
sent
qualified
and
knowledgeable
auditors
who
provided
good
feedback
to
improve
their
laboratory's
work.

One
comment
indicated
that
more
QA/
QC
is
needed
and
that
EPA
has
not
demonstrated
sufficient
laboratory
capacity
for
LT2
implementation.
APPENDIX
A
Federal
Register
Notice:
Laboratory
Quality
Assurance
Evaluation
Program/
Information
Collection
Request
[
Published
December
29,
2000]
A­
1
ENVIRONMENTAL
PROTECTION
AGENCY
[
FRL­
7152­
6]
Laboratory
Quality
Assurance
Evaluation
Program
for
Analysis
of
Cryptosporidium
under
the
Safe
Drinking
Water
Act;
Agency
Information
Collection:
Proposed
Collection;
Comment
Request
AGENCY:
Environmental
Protection
Agency.
ACTION:
Notice;
Request
for
Comment.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
SUMMARY:
Today's
notice
invites
comment
on
the
U.
S.
Environmental
Protection
Agency's
(
EPA's)
proposed
Laboratory
Quality
Assurance
Evaluation
Program
for
Analysis
of
Cryptosporidium
under
the
Safe
Drinking
Water
Act
(
Lab
QA
Program)
(
Section
I).
EPA
also
plans
to
submit
to
the
Office
of
Management
and
Budget
(
OMB)
for
review
and
approval
an
Information
Collection
Request
(
ICR)
associated
with
information
collections
under
the
proposed
Lab
QA
Program
(
Section
II).
EPA
is
requesting
comments
on
specific
aspects
of
the
proposed
Lab
QA
Program
and
the
ICR.
Finally,
EPA
solicits
comments
on
its
intention
to
seek
an
emergency
clearance
from
OMB
to
begin
collecting
data
from
laboratories
that
are
interested
in
participating
in
the
Lab
QA
Program
prior
to
OMB's
final
approval
of
the
ICR.

DATES:
The
Agency
requests
comments
on
today's
notice.
Comments
must
be
received
or
post­
marked
by
midnight
May
3,
2002.
If
EPA
does
not
receive
adverse
comments
on
or
before
April
3,
2002
regarding
EPA's
request
for
an
emergency
clearance,
the
Agency
intends
to
seek
a
90­
day
emergency
clearance
from
OMB
to
begin
collecting
data
from
laboratories
that
are
interested
in
participating
in
the
Lab
QA
Program.

ADDRESSES:
Please
send
an
original
and
three
copies
of
your
written
comments
and
enclosures
(
including
references)
to
the
W­
01­
17
Comment
Clerk,
Water
Docket
(
MC­
4101),
EPA,
1200
Pennsylvania
Avenue,
NW,
Washington,
DC
20460.
Due
to
the
uncertainty
of
mail
delivery
in
the
Washington,
DC
area,
in
order
to
ensure
that
all
comments
are
received
please
send
a
separate
copy
of
your
comments
via
electronic
mail
(
e­
mail)
to
Mary
Ann
Feige,
EPA,
Office
of
Ground
Water
and
Drinking
Water,
feige.
maryann@
epa.
gov,
or
mail
to
the
attention
of
Mary
Ann
Feige,
EPA,
Technical
Support
Center,
26
West
Martin
Luther
King
Drive
(
MS­
140),
Cincinnati,
Ohio
45268.
Hand
deliveries
should
be
delivered
to:
EPA's
Water
Docket
at
401
M
Street,
SW,
Room
EB57,
Washington,
DC
20460.
Please
make
certain
to
reference
EPA
ICR
No.
2052.02
and
OMB
Control
No.
2040­
0229.

FOR
FURTHER
INFORMATION:
For
a
copy
of
the
ICR,
contact
Sharon
Gonder
at
EPA
by
phone
at
(
202)
564­
5256
or
by
email
at
gonder.
sharon@
epa.
gov
or
download
off
the
Internet
at
http://
www.
epa.
gov/
icr
and
refer
to
EPA
ICR
No.
2052.02.
For
technical
inquiries,
contact
Mary
Ann
Feige,
EPA,
Office
of
Ground
Water
and
Drinking
Water,
Technical
Support
Center,
26
West
Martin
Luther
King
Drive
(
MS­
140),
Cincinnati,
Ohio
A­
2
45268,
fax
number,
(
513)
569­
7191,
e­
mail
address,
feige.
maryann@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

Submission
of
comments.

Individuals
who
want
EPA
to
acknowledge
receipt
of
their
comments
should
enclose
a
self­
addressed,
stamped
envelope.
No
facsimiles
(
faxes)
will
be
accepted.
Comments
may
also
be
submitted
electronically
to
ow­
docket@
epamail.
epa.
gov.
Electronic
comments
must
be
submitted
as
an
ASCII,
WP5.1,
WP6.1
or
WP8
file
avoiding
the
use
of
special
characters
and
form
of
encryption.
Electronic
comments
must
be
identified
by
docket
number
W­
01­
17.
Comments
and
data
will
also
be
accepted
on
disks
in
WP5.1,
6.1,
8
or
ASCII
file
format.
Electronic
comments
on
this
notice
may
be
filed
online
at
many
Federal
Depository
Libraries.

Availability
of
docket.

The
record
for
this
notice
has
been
established
under
docket
number
W­
01­
17,
and
includes
supporting
documentation
as
well
as
printed,
paper
versions
of
electronic
comments.
The
record
is
available
for
inspection
from
9
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays
at
the
Water
Docket,
EB
57,
EPA
Waterside
Mall,
401
M
Street,
SW,
Washington,
DC
20460.
For
access
to
docket
materials,
please
call
(
202)
260­
3027
to
schedule
an
appointment.

Section
I:
Laboratory
Quality
Assurance
Evaluation
Program
for
Analysis
of
Cryptosporidium
under
the
Safe
Drinking
Water
Act
In
September
2000,
the
Stage
2
Microbial
and
Disinfection
Byproducts
Federal
Advisory
Committee
(
Committee)
signed
an
Agreement
in
Principle
(
Agreement)
(
65
FR
83015,
Dec.
29,
2000)
(
EPA,
2000)
with
consensus
recommendations
for
two
future
drinking
water
regulations:
the
Long
Term
2
Enhanced
Surface
Water
Treatment
Rule
(
LT2ESWTR)
and
the
Stage
2
Disinfectants
and
Disinfection
Byproducts
Rule.
The
LT2ESWTR
is
to
address
risk
from
microbial
pathogens,
specifically
Cryptosporidium,
and
the
Stage
2
DBPR
is
to
address
risk
from
disinfection
byproducts.
The
Committee
recommended
that
the
LT2ESWTR
require
public
water
systems
(
PWSs)
to
monitor
their
source
water
for
Cryptosporidium
using
EPA
Method
1622
or
EPA
Method
1623.
Additional
Cryptosporidium
treatment
requirements
for
PWSs
would
be
based
on
the
source
water
Cryptosporidium
levels.
EPA
intends
to
take
into
account
the
Committee's
advice
and
recommendations
embodied
in
the
Agreement
when
developing
the
regulations.
To
support
Cryptosporidium
monitoring
under
the
LT2ESWTR,
the
Committee
Agreement
recommended
that
"
compliance
schedules
for
the
LT2ESWTR...
be
tied
to
the
availability
of
sufficient
analytical
capacity
at
approved
laboratories
for
all
large
and
medium­
size
affected
systems
to
initiate
Cryptosporidium
and
E.
coli
monitoring..."(
65
FR
A­
3
83015,
Dec.
29,
2000)
(
EPA,
2000).
Further,
the
Agreement
recommended
that
Cryptosporidium
monitoring
by
large
and
medium
systems
begin
within
six
months
following
rule
promulgation.
Given
the
time
necessary
for
EPA
to
approve
a
sufficient
number
of
laboratories
to
assure
adequate
capacity
for
LT2ESWTR
monitoring,
EPA
would
need
to
begin
laboratory
evaluation
prior
to
promulgation
of
the
rule
in
order
to
accommodate
such
an
implementation
schedule.
Another
factor
that
warrants
initiation
of
the
Lab
QA
Program
prior
to
promulgation
of
the
LT2ESWTR
is
grandfathering
of
monitoring
data.
The
Agreement
recommends
that
systems
with
"
historical"
Cryptosporidium
data
that
are
equivalent
to
data
that
would
be
collected
under
the
LT2ESWTR
be
afforded
the
opportunity
to
use
those
"
historical"
(
grandfathered)
data
in
lieu
of
collecting
new
data
under
LT2ESWTR.
EPA
intends
to
propose
such
grandfathering
provisions
in
the
LT2ESWTR.
If
EPA
indicates
that
laboratories
meet
the
criteria
in
the
Lab
QA
Program
described
today
prior
to
finalizing
the
LT2ESWTR,
systems
could
develop
monitoring
data
prior
to
the
LT2ESWTR
in
anticipation
of
using
it
as
grandfathered
data.
EPA's
Office
of
Ground
Water
and
Drinking
Water
plans
to
request
from
OMB
an
emergency
clearance
that
would
enable
expeditious
implementation
of
a
voluntary
Lab
QA
Program
to
support
Cryptosporidium
monitoring
under
the
LT2ESWTR.
As
such,
the
Agency
could
begin
to
evaluate
laboratories
that
can
reliably
measure
for
Cryptosporidium
using
EPA
Method
1622
and
Method
1623.
During
the
effective
period
of
the
emergency
clearance,
EPA
intends
to
submit
to
OMB
for
review
and
approval
a
final
ICR
in
order
to
continue
data
collection
for
the
Lab
QA
Program.
As
part
of
today's
notice,
EPA
is
inviting
comment
on
the
Lab
QA
Program.
Under
the
Lab
QA
Program,
EPA
would
evaluate
labs
on
a
case­
by­
case
basis
through
evaluating
their
capacity
and
competency
to
reliably
measure
for
the
occurrence
of
Cryptosporidium
in
surface
water
using
EPA
Method
1622
or
EPA
Method
1623.
The
intent
of
this
notice
is
not
to
propose
establishing
the
Lab
QA
Program
through
a
rulemaking.
Rather,
the
criteria
described
in
section
I.
C.
are
intended
to
provide
guidance
to
laboratories
that
are
interested
in
participating
in
the
Lab
QA
Program.
EPA
has
not
yet
proposed
rulemaking
on
use
of
such
"
historical"
data
nor
on
the
methods
themselves
under
the
LT2ESWTR.
As
noted
above,
EPA
intends
to
propose
allowing
systems
to
use
equivalent
"
historical"
data
in
lieu
of
collecting
new
data.
EPA
anticipates
the
data
generated
by
labs
which
meet
the
evaluation
criteria
would
be
very
high
quality,
thus
increasing
the
likelihood
that
such
data
would
warrant
consideration
as
acceptable
"
grandfathered"
data.
However,
lab
evaluation
would
not
guarantee
that
data
generated
will
be
acceptable
as
"
grandfathered"
data,
nor
would
failure
to
meet
evaluation
criteria
necessarily
preclude
use
of
"
grandfathered"
data.
For
these
reasons,
EPA
is
not
establishing
the
Lab
QA
Program
through
rulemaking,
but
rather
as
a
discretionary
and
voluntary
program
under
the
Safe
Drinking
Water
Act,
section
1442
(
42
USC
300j­
1(
a)).

A.
What
is
the
purpose
of
the
laboratory
quality
assurance
evaluation
program?

The
purpose
of
the
Lab
QA
Program
is
to
identify
laboratories
that
can
reliably
measure
for
the
occurrence
of
Cryptosporidium
in
surface
water.
Existing
laboratory
certification
programs
do
not
include
Cryptosporidium
analysis.
This
program
is
designed
to
assess
and
confirm
the
capability
of
laboratories
to
perform
Cryptosporidium
analyses.
A­
4
The
program
will
assess
whether
laboratories
meet
the
recommended
personnel
and
laboratory
criteria
in
today's
notice.
This
evaluation
program
is
voluntary
for
laboratories.
In
the
LT2ESWTR,
however,
EPA
intends
to
require
systems
to
use
approved
(
or
certified)
laboratories
when
conducting
Cryptosporidium
monitoring
under
the
LT2ESWTR.

B.
Why
has
EPA
selected
Methods
1622
and
1623
as
the
basis
for
determining
the
data
quality
of
laboratories
that
measure
for
Cryptosporidium?

EPA
Method
1622
and
EPA
Method
1623
were
developed
as
improved
alternatives
to
the
ICR
Protozoan
Method
(
EPA,
1996).
EPA
validated
Method
1622
for
the
determination
of
Cryptosporidium
in
ambient
water
in
August
1998
and
distributed
an
interlaboratory
validated
draft
method
in
January
1999.
In
addition,
EPA
validated
Method
1623
for
the
simultaneous
determination
of
Cryptosporidium
(
and
Giardia)
in
ambient
water
in
February
1999
and
distributed
a
validated
draft
method
in
April
1999.
In
April
2001,
EPA
revised
and
updated
Method
1622
(
EPA­
821­
R­
01­
026)
(
EPA,
2001a)
and
Method
1623
(
EPA­
821­
R­
01­
025)
(
EPA,
2001b)
based
on
the
following:
laboratory
feedback,
the
development
of
equivalent
filters
and
antibodies
for
use
with
the
methods,
and
method
performance
data
generated
during
the
ICR
Supplemental
Surveys
(
EPA,
2001e).
The
results
of
these
studies
are
documented
in
the
Method
1622
interlaboratory
validation
study
report
(
EPA­
821­
R­
01­
027)
(
EPA,
2001c)
and
the
Method
1623
interlaboratory
validation
study
report
(
EPA­
821­
R­
01­
028)
(
EPA,
2001d).

C.
What
criteria
should
I
use
to
determine
if
my
laboratory
should
apply?

A
laboratory
that
is
interested
in
participating
in
the
Lab
QA
Program
currently
should
be
operating
in
accordance
with
its
QA
plan
(
developed
by
the
laboratory)
for
Cryptosporidium
analyses.
In
addition,
an
interested
laboratory
should
demonstrate
its
capacity
and
competency
to
analyze
Cryptosporidium
using
the
following
recommended
criteria:
1.
Recommended
personnel
criteria:
Principal
Analyst/
Supervisor
(
one
per
laboratory)
should
have:
°
BS/
BA
in
microbiology
or
closely
related
field
°
A
minimum
of
one
year
of
continuous
bench
experience
with
Cryptosporidium
and
immunofluorescent
assay
(
IFA)
microscopy
°
A
minimum
of
six
months
experience
using
EPA
Method
1622
and/
or
EPA
Method
1623
°
A
minimum
of
100
samples
analyzed
using
EPA
Method
1622
and/
or
EPA
Method
1623
(
minimum
50
samples
if
the
person
was
an
analyst
approved
to
conduct
analysis
for
the
ICR
Protozoan
Method
(
EPA,
1996))
for
the
specific
analytical
procedure
they
will
be
using
°
Submit
to
EPA,
along
with
the
application
package,
resumes
detailing
the
qualifications
of
the
laboratory's
proposed
principal
analyst/
supervisor
Other
Analysts
(
no
minimum
number
of
analysts
per
laboratory)
should
have:
°
Two
years
of
college
(
or
equivalent)
in
microbiology
or
closely
related
field
A­
5
°
A
minimum
of
six
months
of
continuous
bench
experience
with
Cryptosporidium
and
IFA
microscopy
°
A
minimum
of
three
months
experience
using
EPA
Method
1622
and/
or
EPA
Method
1623
°
A
minimum
of
50
samples
analyzed
using
EPA
Method
1622
and/
or
EPA
Method
1623
(
minimum
25
samples
if
the
person
was
an
analyst
approved
to
conduct
analysis
for
the
ICR
Protozoan
Method)
for
the
specific
analytical
procedures
they
will
be
using
°
Submit
to
EPA,
along
with
the
application
package,
resumes
detailing
the
qualifications
of
the
laboratory's
proposed
other
analysts
Technician(
s)
(
no
minimum
number
of
technicians
per
laboratory)
should
have:
°
Three
months
experience
with
the
specific
parts
of
the
procedure
they
will
be
performing
°
A
minimum
of
50
samples
analyzed
using
EPA
Method
1622
and/
or
EPA
Method
1623
(
minimum
25
samples
if
the
person
was
an
analyst
approved
to
conduct
analysis
for
the
ICR
Protozoan
Method)
for
the
specific
analytical
procedures
they
will
be
using
°
Submit
to
EPA,
along
with
the
application
package,
resumes
detailing
the
qualifications
of
the
laboratory's
proposed
technician(
s)
2.
Recommended
laboratory
criteria:
°
Appropriate
instrumentation
as
described
in
EPA
Methods
1622
and
1623
(
EPA,
2001a,
b)

°
Equipment
and
supplies
as
described
in
EPA
Methods
1622
and
1623
(
EPA
2001a,
2001b)
°
Detailed
laboratory
standard
operating
procedures
for
each
version
of
the
method
that
the
laboratory
will
use
to
conduct
the
Cryptosporidium
analyses
°
Laboratory
should
provide
a
current
copy
of
the
table
of
contents
of
their
laboratory's
quality
assurance
plan
for
protozoa
analyses
°
EPA
Method
1622
or
EPA
Method
1623
initial
demonstration
of
capability
(
IDC)
data,
which
include
precision
and
recovery
(
IPR)
test
results
and
matrix
spike/
matrix
spike
duplicate
(
MS/
MSD)
test
results
for
Cryptosporidium.
EPA
intends
to
evaluate
the
IPR
and
MS/
MSD
results
against
the
performance
acceptance
criteria
in
the
April
2001
version
of
EPA
Method
1622
or
EPA
Method
1623
(
EPA,
2001a,
2001b).
D.
How
can
I
obtain
an
application
package?
After
the
OMB
clearance
described
above,
EPA
plans
to
make
applications
available
on
EPA's
website
at
www.
epa.
gov/
safewater/
cryptolabapproval.
html.
Completed
applications
should
be
sent
to:
EPA's
Laboratory
Quality
Assurance
Evaluation
Program
Coordinator,
c/
o
Dyncorp
I&
ET,
Inc.,
6101
Stevenson
Avenue,
Alexandria,
VA
22304­
3540.
If
a
laboratory
does
not
have
access
to
the
Internet,
the
laboratory
may
contact
Dyncorp
I&
ET,
Inc.
to
request
an
application
package.
E.
If
I
demonstrate
my
laboratory's
capacity
and
competency
according
to
the
the
personnel
and
laboratory
criteria,
what
do
I
do
next?
After
the
laboratory
submits
to
EPA
an
application
package
including
supporting
documentation,
EPA
intends
to
conduct
the
following
steps
to
complete
the
process:
1.
Upon
receipt
of
a
complete
package,
EPA
contacts
the
laboratory
for
follow­
up
information
and
to
schedule
participation
in
the
performance
testing
program.
A­
6
2.
EPA
sends
initial
proficiency
testing
(
IPT)
samples
to
the
laboratory
(
unless
the
laboratory
has
already
successfully
analyzed
such
samples
under
EPA`
s
Protozoan
PE
program).
IPT
samples
packets
consist
of
eight
spiked
samples
shipped
to
the
laboratory
within
a
standard
matrix.
3.
The
laboratory
analyzes
IPT
samples
and
submits
data
to
EPA.
4.
EPA
conducts
an
on­
site
evaluation
and
data
audit.
5.
The
laboratory
analyzes
ongoing
proficiency
testing
(
OPT)
samples
three
times
per
year
and
submits
the
data
to
EPA.
OPT
sample
packets
consist
of
three
spiked
samples
shipped
to
the
laboratory
within
a
standard
matrix.
6.
EPA
contacts
laboratories
by
letter
within
60
days
of
their
laboratory
on­
site
evaluation
to
confirm
whether
the
laboratory
has
demonstrated
its
capacity
and
competency
for
participation
in
the
program.
F.
My
laboratory
has
already
submitted
initial
demonstration
of
capability
(
IDC)
and
initial
performance
testing
(
IPT)
data
as
part
of
the
EPA
Protozoan
Performance
Evaluation
(
PE)
Program.
Do
I
have
to
perform
this
demonstration
testing
again?
No.
If
a
laboratory
currently
participates
in
the
EPA
Protozoan
PE
Program
and
acceptable
IDC
and
IPT
data
have
already
been
submitted
(
for
the
version
of
the
method
that
the
laboratory
will
use
to
conduct
Cryptosporidium
analyses),
EPA
would
not
expect
the
laboratory
to
repeat
IDC
and
IPT
analyses.
Section
II:
Paperwork
Reduction
Act
The
information
collection
requirements
in
this
notice
have
been
submitted
for
approval
to
the
OMB
under
the
Paperwork
Reduction
Act,
44
U.
S.
C.
3501
et
seq.
An
ICR
document
has
been
prepared
by
EPA
(
ICR
No.
2052.02)
and
a
copy
may
be
obtained
from
Susan
Auby
by
mail
at
Collection
Strategies
Division;
EPA
(
2822);
1200
Pennsylvania
Ave.,
NW,
Washington,
DC
20460,
by
email
at
auby.
susan@
epamail.
epa.
gov,
or
by
calling
(
202)
260­
4901.
A
copy
may
also
be
downloaded
off
the
internet
at
http://
www.
epa.
gov/
icr.
Since
the
EPA
would
solicit
information
in
application
packages,
including
supporting
documentation,
analytical
data,
and
other
pertinent
information
from
laboratories
that
are
interested
in
participating
in
the
voluntary
Lab
QA
Program,
the
Agency
is
required
to
submit
an
ICR
to
OMB
for
review
and
approval.
Entities
potentially
affected
by
this
action
include
public
and
private
laboratories
that
wish
to
be
evaluated
to
determine
if
they
can
reliably
measure
for
the
occurrence
of
Cryptosporidium
in
surface
waters
that
are
used
for
drinking
water
sources
using
EPA
Method
1622
or
Method
1623.
The
burden
estimate
for
the
Lab
QA
Program
information
collection
includes
all
the
burden
hours
and
costs
required
for
gathering
information,
and
developing
and
maintaining
records
associated
with
the
Lab
QA
Program.
The
annual
public
reporting
and
recordkeeping
burden
for
this
collection
of
information
is
estimated
for
a
total
of
60
respondents
and
an
average
78
hours
per
response
for
a
total
of
4,676
hours
at
a
cost
of
$
123,650.
This
estimate
assumes
that
laboratories
participating
in
the
Lab
QA
program
have
the
necessary
equipment
needed
to
conduct
the
analyses.
Therefore,
there
are
no
start­
up
costs.
The
estimated
total
annual
capital
costs
is
$
0.00.
The
estimated
Operation
and
Maintenance
(
O&
M)
costs
is
$
133,880.
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
A­
7
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.
Comments
are
requested
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.
Send
comments
on
the
ICR
to
the
Director,
Collection
Strategies
Division;
EPA
(
2822);
1200
Pennsylvania
Ave.,
NW,
Washington,
DC
20460;
and
to
the
Office
of
Information
and
Regulatory
Affairs,
Office
of
Management
and
Budget,
725
17th
St.,
N.
W.,
Washington,
DC
20503,
marked
"
Attention:
Desk
Officer
for
EPA."
Include
the
ICR
number
in
any
correspondence.
Because
OMB
is
required
to
make
a
decision
concerning
the
ICR
between
30
and
60
days
after
March
4,
2002,
a
comment
to
OMB
is
best
assured
of
having
its
full
effect
if
OMB
receives
it
by
April
3,
2002.
The
final
ICR
approval
notice
will
respond
to
any
OMB
or
public
comments
on
the
information
collection
requirements
contained
in
today's
notice.
References
EPA.
1996.
ICR
Microbial
Laboratory
Manual.
Office
of
Research
and
Development.
EPA/
600/
R­
95/
178.
April
1996.
EPA.
2000.
Stage
2
Microbial
and
Disinfection
Byproducts
Federal
Advisory
Committee
Agreement
in
Principle.
Federal
Register.
Vol.
65,
pp.
83015­
83024.
December
29,
2000.
EPA.
2001a.
EPA
Method
1622:
Cryptosporidium
in
Water
by
Filtration/
IMS/
FA.
Office
of
Water.
Washington,
DC
20460.
EPA­
821­
R­
01­
026.
April
2001.
EPA.
2001b.
EPA
Method
1623:
Cryptosporidium
and
Giardia
in
Water
by
Filtration/
IMS/
FA.
Office
of
Water.
Washington,
DC
20460.
EPA­
821­
R­
01­
025.
April
2001.
EPA.
2001c
.
Interlaboratory
Validation
Study
Results
for
Cryptosporidium
Precision
and
Recovery
for
EPA
Method
1622.
Office
of
Water.
Washington,
DC
20460.
EPA­
821­
R­
01­
027.
April
2001.
EPA.
2001d.
Interlaboratory
Validation
Study
Results
for
the
Determination
of
Cryptosporidium
and
Giardia
Using
EPA
Method
1623.
Office
of
Water.
Washington,
DC
20460.
EPA­
821­
R­
01­
028.
April
2001.
EPA.
2001e.
Implementation
and
Results
of
the
Information
Collection
Rule
Supplemental
Surveys.
Office
of
Water.
Washington,
DC
20460.
EPA­
815­
R­
01­
003.
February
2001.

________________________
Date
APPENDIX
B
Federal
Register
Notice:
Laboratory
Quality
Assurance
Evaluation
Program/
Information
Collection
Request
[
Published
March
4,
2002]
B­
1
ENVIRONMENTAL
PROTECTION
AGENCY
[
FRL­
]
Agency
Information
Collection
Activities:
Submission
for
OMB
Review;
Comment
Request;
EPA
Laboratory
Quality
Assurance
Evaluation
Program
for
Analysis
of
Cryptosporidium
under
the
Safe
Drinking
Water
Act/
Laboratory
approval
for
the
Long
Term
2
Enhanced
Surface
Water
Treatment
Rule
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.
SUMMARY:
In
compliance
with
the
Paperwork
Reduction
Act
(
44
U.
S.
C.
3501
et
seq.),
this
document
announces
that
the
following
Information
Collection
Request
(
ICR)
has
been
forwarded
to
the
Office
of
Management
and
Budget
(
OMB)
for
review
and
approval:
EPA
Laboratory
Quality
Assurance
Evaluation
Program
for
Analysis
of
Cryptosporidium
under
the
Safe
Drinking
Water
Act,
OMB
Control
Number
2040­
0246,
expiration
date
of
July
31,
2002.
The
ICR
describes
the
nature
of
the
information
collection
and
its
expected
burden
and
cost;
where
appropriate,
it
includes
the
actual
data
collection
instrument.
DATES:
Comments
must
be
submitted
on
or
before
[
Insert
date
30
days
after
publication
in
the
FEDERAL
REGISTER].
ADDRESSES:
Send
comments,
referencing
EPA
ICR
No.
2067.02
and
OMB
Control
No.
2040­
0246,
to
the
following
addresses:
Susan
Auby,
U.
S.
Environmental
Protection
Agency,
Collection
Strategies
Division
(
Mail
Code
2822),
1200
Pennsylvania
Avenue,
N.
W.,
Washington,
DC
20460;
and
to
Office
of
Information
and
Regulatory
Affairs,
Office
of
Management
and
Budget
(
OMB),
Attention:
Desk
Officer
for
EPA,
725
17th
Street,
N.
W.,
Washington,
DC
20503.
FOR
FURTHER
INFORMATION
CONTACT:
For
a
copy
of
the
ICR
contact
Susan
Auby
at
EPA
by
phone
at
(
202)
260­
4901,
by
E­
mail
at
auby.
susan@
epamail.
epa.
gov,
or
download
off
the
Internet
at
http://
www.
epa.
gov/
icr
and
refer
to
EPA
ICR
No.
2067.02,
the
ICR
number
has
changed
from
the
last
notice.
All
requests
should
refer
to
EPA
ICR
No.
2067.02
and
not
EPA
ICR
No.
2052.02.
For
technical
inquiries,
contact
Mary
Ann
Feige,
EPA,
Office
of
Ground
Water
and
Drinking
Water,
Technical
Support
Center,
26
West
Martin
Luther
King
Drive
(
MS­
140),
Cincinnati,
Ohio
45268,
fax
number,
(
513)
569­
7191,
e­
mail
address,
feige.
maryann@
epa.
gov.
SUPPLEMENTARY
INFORMATION:
Title:
EPA
Laboratory
Quality
Assurance
Evaluation
Program
for
Analysis
of
Cryptosporidium
under
the
Safe
Drinking
Water
Act
(
OMB
Control
No.
2040­
0246
;
EPA
ICR
No.
2067.01
)
expiring
7/
31/
02
.
This
is
a
request
for
extension
of
a
currently
approved
collection.
Abstract:
Section
I:
Laboratory
Quality
Assurance
Evaluation
Program
for
Analysis
of
Cryptosporidium
Under
the
Safe
Drinking
Water
Act
In
September
2000,
the
Stage
2
Microbial
and
Disinfection
Byproducts
Federal
Advisory
Committee
(
Committee)
signed
an
Agreement
in
Principle
(
Agreement)
(
65
FR
83015,
Dec.
29,
2000)
(
EPA,
2000)
with
consensus
recommendations
for
two
future
drinking
water
regulations:
The
Long
Term
2
Enhanced
Surface
Water
Treatment
Rule
(
LT2ESWTR)
and
the
Stage
2
Disinfectants
and
Disinfection
Byproducts
Rule.
The
LT2ESWTR
is
to
address
risk
from
microbial
pathogens,
specifically
Cryptosporidium,
and
the
Stage
2
DBPR
is
to
address
risk
from
disinfection
byproducts.
The
Committee
recommended
that
the
LT2ESWTR
require
public
water
systems
(
PWSs)
to
monitor
their
source
water
for
Cryptosporidium
using
EPA
Method
1622
or
EPA
Method
1623.
Additional
Cryptosporidium
treatment
requirements
for
PWSs
would
be
based
on
the
source
water
Cryptosporidium
levels.
To
support
Cryptosporidium
monitoring
under
the
LT2ESWTR,
the
Committee
Agreement
recommended
that
  
compliance
schedules
for
the
B­
2
LT2ESWTR
*
*
*
be
tied
to
the
availability
of
sufficient
analytical
capacity
at
approved
laboratories
for
all
large
and
medium­
size
affected
systems
to
initiate
Cryptosporidium
and
E.
coli
monitoring
*
*
*
''
(
65
FR
83015,
Dec.
29,
2000)
(
EPA,
2000).
Further,
the
Agreement
recommended
that
Cryptosporidium
monitoring
by
large
and
medium
systems
begin
within
six
months
following
rule
promulgation.
Given
the
time
necessary
for
EPA
to
approve
a
sufficient
number
of
laboratories
to
assure
adequate
capacity
for
LT2ESWTR
monitoring,
EPA
would
need
to
begin
laboratory
evaluation
prior
to
promulgation
of
the
rule
in
order
to
accommodate
such
an
implementation
schedule.
Another
factor
that
warrants
initiation
of
the
Lab
QA
Program
prior
to
promulgation
of
the
LT2ESWTR
is
grandfathering
of
monitoring
data.
The
Agreement
recommends
that
systems
with
  
historical''
Cryptosporidium
data
that
are
equivalent
to
data
that
would
be
collected
under
the
LT2ESWTR
be
afforded
the
opportunity
to
use
those
  
historical''
(
grandfathered)
data
in
lieu
of
collecting
new
data
under
LT2ESWTR.
EPA
intends
to
propose
such
grandfathering
provisions
in
the
LT2ESWTR.
If
EPA
indicates
that
laboratories
meet
the
criteria
in
the
Lab
QA
Program
described
today
prior
to
finalizing
the
LT2ESWTR,
systems
could
develop
monitoring
data
prior
to
the
LT2ESWTR
in
anticipation
of
using
it
as
grandfathered
data.
Under
the
Lab
QA
Program,
EPA
would
evaluate
labs'
capacity
and
competency
to
reliably
measure
for
the
occurrence
of
Cryptosporidium
in
surface
water
using
EPA
Method
1622
or
EPA
Method
1623.
The
intent
of
this
notice
is
not
to
propose
establishing
the
Lab
QA
Program
through
a
rulemaking.
Rather,
the
criteria
described
in
section
I.
C.
are
intended
to
provide
guidance
to
laboratories
that
are
interested
in
participating
in
the
Lab
QA
Program.
EPA
anticipates
the
data
generated
by
labs
which
meet
the
evaluation
criteria
would
be
very
high
quality,
thus
increasing
the
likelihood
that
such
data
would
warrant
consideration
as
acceptable
  
grandfathered''
data.
However,
lab
evaluation
would
not
guarantee
that
data
generated
will
be
acceptable
as
  
grandfathered''
data,
nor
would
failure
to
meet
evaluation
criteria
necessarily
preclude
use
of
  
grandfathered''
data.
For
these
reasons,
EPA
is
not
establishing
the
Lab
QA
Program
through
rulemaking,
but
rather
as
a
discretionary
and
voluntary
program
under
the
Safe
Drinking
Water
Act,
section
1442
(
42
USC
300j­
1(
a)).
A.
What
Is
the
Purpose
of
the
Laboratory
Quality
Assurance
Evaluation
Program?
The
purpose
of
the
Lab
QA
Program
is
to
identify
laboratories
that
can
reliably
measure
for
the
occurrence
of
Cryptosporidium
in
surface
water.
Existing
laboratory
certification
programs
do
not
include
Cryptosporidium
analysis.
This
program
is
designed
to
assess
and
confirm
the
capability
of
laboratories
to
perform
Cryptosporidium
analyses.
The
program
will
assess
whether
laboratories
meet
the
recommended
personnel
and
laboratory
criteria
in
today's
notice.
This
evaluation
program
is
voluntary
for
laboratories.
In
the
LT2ESWTR,
however,
EPA
intends
to
require
systems
to
use
approved
(
or
certified)
laboratories
when
conducting
Cryptosporidium
monitoring
under
the
LT2ESWTR.
B.
How
Can
I
Obtain
an
Application
Package?
After
the
OMB
clearance
described
above,
EPA
plans
to
make
applications
available
on
EPA's
website
at
www.
epa.
gov/
safewater/
cryptolabapproval.
html.
Completed
applications
should
be
sent
to:
EPA's
Laboratory
Quality
Assurance
Evaluation
Program
Coordinator,
c/
o
DynCorp,
6101
Stevenson
Avenue,
Alexandria,
VA
22304­
3540.
If
a
laboratory
does
not
have
access
to
the
Internet,
the
laboratory
may
contact
DynCorp
to
request
an
application
package.
Applications
may
be
submitted
at
any
time.
C.
If
I
Demonstrate
My
Laboratory's
Capacity
and
Competency
According
to
the
Personnel
and
Laboratory
Criteria,
What
Happens
Next?
B­
3
After
the
laboratory
submits
to
EPA
an
application
package
including
supporting
documentation,
EPA
intends
to
conduct
the
following
steps
to
complete
the
process:
1)
Upon
receipt
of
a
complete
package,
EPA
contacts
the
laboratory
for
follow­
up
information
and
to
schedule
participation
in
the
performance
testing
program.
2)
EPA
sends
initial
proficiency
testing
(
IPT)
samples
to
the
laboratory.
IPT
samples
packets
consist
of
eight
spiked
samples
shipped
to
the
laboratory
within
a
standard
matrix.
3)
The
laboratory
analyzes
the
IPT
samples
and
submits
data
to
EPA.
EPA
intends
to
have
the
laboratory's
IPT
data
meet
the
IPT
criteria
of
greater
than
10%
mean
recovery
and
less
than
71%
relative
standard
deviation
(
these
criteria
were
developed
based
on
results
from
the
first
six
rounds
of
the
EPA
PE
program).
This
approach
will
be
used
unless
unforeseen
circumstances
merit
a
reassessment
of
the
approach.
4)
EPA
conducts
an
on­
site
evaluation
and
data
audit.
Checklist
for
evaluation
and
audit
is
included
in
ICR.
5)
The
laboratory
analyzes
ongoing
proficiency
testing
(
OPT)
samples
three
times
per
year
and
submits
the
data
to
EPA.
OPT
sample
packets
consist
of
three
spiked
samples
shipped
to
the
laboratory
within
a
standard
matrix.
The
results
of
the
laboratory's
OPT
data
must
meet
the
OPT
criteria
which
will
be
calculated
for
each
round
of
OPT
testing
using
only
the
data
from
that
round.
EPA
intends
to
calculate
the
lower
limit
as
less
than
2
standard
deviations
from
the
pooled
mean
using
log
it
transformed
data
and
intends
to
calculate
the
maximum
RSD
as
2
times
the
pooled
RSD.
This
approach
will
be
used
unless
unforeseen
circumstances
merit
a
reassessment
of
the
approach.
6)
EPA
contacts
laboratories
by
letter
within
60
days
of
their
laboratory
on­
site
evaluation
to
confirm
whether
the
laboratory
has
demonstrated
its
capacity
and
competency
for
participation
in
the
program.
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.
The
Federal
Register
document
required
under
5
CFR
1320.8(
d),
soliciting
comments
on
this
collection
of
information
was
published
on
March
4,
2002
(
FR
).
Three
comments
were
received.
Comments
requested
further
information
on
the
details
of
the
Lab
Quality
Assurance
Program.
In
response,
EPA
has
added
supplementary
information
to
the
ICR,
including
the
program
application,
which
includes
the
self­
audit
checklist
detailing
the
items
that
will
be
evaluated
during
the
on­
site
evaluation.
EPA
also
has
also
developed
a
webpage
to
provide
further
information
on
the
program.
The
website
can
be
accessed
at
http://
www.
epa.
gov/
safewater/
lt2/
cla_
final.
html.
Commenters
expressed
concern
that
the
Lab
QA
Program
does
not
address
the
Agency's
obligation
under
the
FACA
Agreement
in
Principle
to
identify
adequate
laboratory
capacity
to
implement
LT2ESWTR.
The
Lab
QA
Program
does
assess
laboratory
capacity
through
questions
on
the
application
on
current
and
potential
laboratory
capacity
to
analyze
Cryptosporidium
samples
and
the
on
site
evaluations.
This
information
will
be
compiled
as
laboratory
applications
are
received,
and
will
be
updated
during
on­
site
evaluations.
The
on­
site
evaluation
will
allow
EPA
to
validate
lab
capacity
reported
to
EPA.
Comments
were
received
on
the
burden
estimates.
Because
laboratories
that
wish
to
begin
using
EPA
Methods
1622
and
1623
are
required
by
the
methods
to
purchase
the
equipment
necessary
to
demonstrate
initial
acceptable
performance,
and
because
this
is
a
method
B­
4
requirement,
rather
than
a
program
requirement
(
laboratories
can
perform
the
methods
without
ever
participating
in
the
program),
the
burden
estimates
assume
that
no
capital
costs
will
be
incurred
by
laboratories
participating
in
the
program
over
and
above
the
costs
that
would
be
incurred
simply
to
use
the
method.
Because
the
program
application
requires
the
laboratories
applying
for
approval
under
the
program
to
submit
initial
performance
data,
laboratories
that
meet
these
requirements
should
already
have
the
capacity
to
perform
Methods
1622
or
1623
and
therefore
will
not
incur
start­
up
costs.
Commenters
wanted
to
know
if
training
would
be
available
for
labs
needing
help.
EPA
will
provide
limited
training
to
laboratories
needing
assistance
with
the
performance
of
Methods
1622
and
1623.
Information
on
training
will
be
posted
on
EPA's
website
as
it
becomes
available.
Commenters
wanted
to
know
the
earliest
date
that
acceptable
grandfathered
data
could
be
generated.
EPA
is
aware
of
the
issues
regarding
grandfathered
data
acceptability
and
will
address
these
issues
in
the
proposed
LT2ESWTR.
These
issues
are
outside
of
the
scope
of
this
ICR.
Burden
Statement:
The
annual
public
reporting
and
record
keeping
burden
for
this
collection
of
information
is
estimated
to
average
18
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.
Respondents/
Affected
Entities:
Testing
Laboratories
Estimated
Number
of
Respondents:
60.
Frequency
of
Response:
3
times
per
year.
Estimated
Total
Annual
Hour
Burden:
4347
hours.
Estimated
Total
Annualized
Capital,
O&
M
Cost
Burden:
$
123,380.
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
addresses
listed
above.
Please
refer
to
EPA
ICR
No.
2067.02
and
OMB
Control
No.
2040­
0246
in
any
correspondence.
APPENDIX
C
Lab
QA
Program
Application
April
30,
2002
C­
1
OMB
Control
Number:
2040­
0246
Expiration
Date:
10/
31/
05
Application
for
the
Laboratory
Quality
Assurance
Evaluation
Program
for
Analysis
of
Cryptosporidium
under
the
Safe
Drinking
Water
Act
Part
1.
Laboratory
Information
Laboratory
Name:
EPA
Lab
ID:

Address:

City:
State:
Zip:

Contact
Person:

Title:

Telephone:
Fax:

Email
address:

Type
of
laboratory
(
circle
one):
Commercial
Utility
State
Academic
Other
Was
your
laboratory
ICR­
approved
for
protozoa?

Yes

No
Is
your
laboratory
currently
participating
in
the
EPA
PT
Program?

Yes

No
Number
of
field
samples
analyzed
by
your
laboratory
using
Method
1622/
1623:

Number
of
spiked
samples
analyzed
by
your
laboratory
using
Method
1622/
23:

Number
of
fields
samples
your
laboratory
can
currently
analyze
per
month
using
Method
1622/
1623:
Number
of
field
samples
your
laboratory
could
potentially
analyze
per
month
using
Method
1622/
1623
during
LT2:

Part
2.
Method
Information:
Versions
of
Method
1622/
1623
for
which
the
lab
is
seeking
evaluation
April
30,
2002
C­
2
Method
step
Method
1622
(
Cryptosporidium
only)
Method
1623
(
Cryptosporidium
&
Giardia)

Filtration
(
check
all
that
apply
and
indicate
the
volume
filtered
for
each)

Gelman
Envirochek
Gelman
HV
Envirochek
IDEXX
FiltaMax
Whatman
CrypTest
Other
(
describe)

Elution
(
check
all
that
apply)

Wrist
action
shaker
(
Envirochek)

Stomaching
of
FiltaMax
filter
FiltaMax
wash
station
plunger
Back
Wash/
Sonication
(
CrypTest)

Other
(
describe)

Concentration
(
check
all
that
apply)

Centrifugation
Filtration
through
membrane
Other
(
describe)

Purification
(
check
all
that
apply)

Dynal
anti­
Crypto,
Dynal
GC­
combo
Other
(
describe)

Staining
(
check
all
that
apply)

Waterborne
AquaGlo
Waterborne
Crypt­
a­
Glo
Waterborne
Giardi­
a­
Glo
Meridian
Merifluor
Other
(
describe)

Descriptions
of
"
other"
method
steps
and
other
comments:
April
30,
2002
C­
3
Part
3.
Personnel
Information
(
attach
additional
sheets
if
necessary)

1.
Principal
Analyst/
Supervisor
:
one
required
per
approved
laboratory
Name
Current
position
Academic
training/
degree(
s)
Time
in
current
position
No.
of
samples
processed
for
protozoa
analyses
No.
of
samples
processed
using
Methods
1622/
1623
Was
this
person
approved
as
an
analyst
under
the
ICR?

Yes

No
Portions
of
method
currently
performed
(
circle
all
that
apply):
Filtration
Elution
Concentration
IMS
Staining
Examination
2.
Analyst
or
Technician
(
circle
one)

Name
Current
position
Academic
training/
degree(
s)
Time
in
current
position
No.
of
samples
processed
for
protozoa
analyses
No.
of
samples
processed
using
Methods
1622/
1623
Was
this
person
approved
under
the
ICR?

Yes

No
If
yes
then
check
one:

Analyst

Technician
Portions
of
method
currently
performed
(
circle
all
that
apply):
Filtration
Elution
Concentration
IMS
Staining
Examination
3.
Analyst
or
Technician
(
circle
one)

Name
Current
position
Academic
training/
degree(
s)
Time
in
current
position
No.
of
samples
processed
for
protozoa
analyses
No.
of
samples
processed
using
Methods
1622/
1623
Was
this
person
approved
under
the
ICR?

Yes

No
If
yes
then
check
one:

Analyst

Technician
Portions
of
method
currently
performed
(
circle
all
that
apply):
Filtration
Elution
Concentration
IMS
Staining
Examination
4.
Analyst
or
Technician
(
circle
one)

Name
Current
position
Academic
training/
degree(
s)
Time
in
current
position
No.
of
samples
processed
for
protozoa
analyses
No.
of
samples
processed
using
Methods
1622/
1623
Was
this
person
approved
under
the
ICR?

Yes

No
If
yes
then
check
one:

Analyst

Technician
Portions
of
method
currently
performed
(
circle
all
that
apply):
Filtration
Elution
Concentration
IMS
Staining
Examination
5.
Analyst
or
Technician
(
circle
one)

Name
Current
position
Academic
training/
degree(
s)
Time
in
current
position
No.
of
samples
processed
for
protozoa
analyses
No.
of
samples
processed
using
Methods
1622/
1623
Was
this
person
approved
under
the
ICR?

Yes

No
If
yes
then
check
one:

Analyst

Technician
Portions
of
method
currently
performed
(
circle
all
that
apply):
Filtration
Elution
Concentration
IMS
Staining
Examination
April
30,
2002
C­
4
Part
4.
Laboratory
Equipment
Confirmation
Checklist
for
Methods
1622
and
1623
Key
Equipment
and
Reagents
Manufacturer/
Model
If
not
Present,
Proof
of
Purchase
Attached
(
Y/
N)

Filtration
and
elution
Flow
control
valve
­
0.5
gpm
Centrifugal
or
other
pump
Low­
flow
meter
or
graduated
container
Laboratory
shaker
for
agitating
capsule
filters
(
Envirochek
only)

Laboratory
shaker
side
arms
(
Envirochek
only)

Filter
housing
(
CrypTest
or
Filta­
Max)

Wash
station
(
Filta­
Max
only)

Stomacher
(
Filta­
Max
only)

Compressed
air
source
(
CrypTest
only)

Sonicator
(
CrypTest
only)

Concentration
Concentrator
apparatus
(
Filta­
Max
only)

1500
X
G,
swinging­
bucket
centrifuge
for
15
mL
­
250­
mL
tubes
Immunomagnetic
separation
Sample
mixer/
rotator
for
10­
mL
tubes
Magnetic
particle
concentrator
for
10­
mL
tubes
Magnetic
particle
concentrator
for
1.5­
mL
tubes
Flat­
sided
sample
tubes
Examination
Epifluorescence/
differential
interference
contrast
microscope
with
stage
and
ocular
micrometers
and
20X
to
100X
objectives
Excitation/
band
pass
microscope
filters
for
fluorescein
isothiocyanate
(
FITC)
assay
Excitation/
band­
pass
filters
for
4',
6­
diamidino­
2­
phenylindole
(
DAPI)
assay
The
above
application
information
is
complete
and
accurate
to
the
best
of
my
knowledge.

Name
and
Signature
Laboratory
Manager
or
Designee
Date
Submit
application
package
to:
Cryptosporidium
Laboratory
QA
Program
Coordinator,
CSC
Biology
Studies
Group,
6101
Stevenson
Avenue,
Alexandria,
VA
22304
April
29,
2002
C­
5
Audit
Checklist
(
To
Be
Used
for
Self­
Audit)

Part
A:
Facilities,
Equipment,
and
Quality
Assurance
Item
to
be
Evaluated
Classificatio
n
Yes,
No,
Unknown*,
or
NA
1
Laboratory
Equipment
and
Supplies
1.1
Reagent­
grade
water
testing
1.1.1
Is
reagent
water
tested
monthly
for
these
minimum
parameters:
conductivity,
total
chlorine
residual;
and
annually
for
metals­
Pb,
Cd,
Cr,
Cu,
Ni,
Zn?
Requirement
1.1.2
Were
the
results
for
the
above
parameters
acceptable,
total
chlorine
residual
not
greater
than
0.1
mg/
L,
conductivity
not
greater
than
2

mhos/
cm,
and
each
metal
not
greater
than
0.05
mg/
L
and
collectively
not
greater
than
0.1
mg/
L?
Requirement
1.1.3
Is
reagent
water
tested
monthly
for
heterotrophic
plate
count?
Requirement
1.1.4
Are
the
results
for
the
heterotrophic
plate
count
acceptable,
<
500/
mL?
Requirement
1.2
Laboratory
pH
meter:

1.2.1
Accuracy
±
0.1
units,
scale
graduations,
0.1
units?
Requirement
1.2.2
Is
a
record
maintained
for
pH
measurements
and
calibrations
used?
Requirement
1.2.3
Is
pH
meter
standardized
each
use
period
with
pH
7,
4
or
10
standard
buffers
(
selection
dependant
upon
desired
pH)?
Requirement
1.2.4
All
pH
buffers
are
dated
when
received
and
opened
and
are
discarded
before
expiration
date?
Requirement
1.3
Balances
(
top
loader
or
pan
balance):

1.3.1
Are
balances
calibrated
monthly
using
Class
S/
S­
1
weights,
or
weights
traceable
to
Class
S/
S­
1
weights?
Requirement
1.3.2
Is
correction
data
available
with
S/
S­
1
weights?
Requirement
1.3.3
Is
preventative
maintenance
conducted
yearly
at
a
minimum?
Recommendation
1.4
Autoclave:

1.4.1
Is
unit
equipped
with
a
temperature
gauge/
operational
safety
valve?
Requirement
1.4.2
Are
date,
contents,
sterilization
time
and
temperature
recorded
for
each
cycle?
Requirement
1.4.3
Is
a
maximum
registering
thermometer
or
continuous
monitoring
device
used
during
each
autoclave
cycle?
Requirement
1.4.4
Is
automatic
timing
mechanism
checked
with
stopwatch
quarterly?
Requirement
1.4.5
Are
spore
strips
or
ampules
used
monthly
to
confirm
sterilization?
Requirement
1.5
Refrigerator/
Freezer:

1.5.1
Is
refrigerator
able
to
maintain
temperature
of
1

C
to
5

C?
Requirement
1.5.2
Is
temperature
recorded
once
daily
for
days
in
use?
Requirement
1.6
Temperature
recording
device:

1.6.1
Are
calibration
of
glass/
mercury
thermometers
checked
annually
(
dial
thermometers
quarterly)
at
the
temperature
used
against
a
reference
NIST
thermometer
or
equivalent?
Requirement
1.7
Micropipetters:

1.7.
Have
micropipetters
been
calibrated
within
the
past
year?
[
Section
9.2.1]
Requirement
1.8
Centrifuge
1.8.1
Is
a
maintenance
contract
in
place,
or
internal
maintenance
protocol
available?
Requirement
1.8.2
Is
RPM
and
RCF
calibrated
yearly?
Requirement
1.9
General
1.9.1
Are
calibration
and
maintenance
records
complete
and
well
organized?
Recommendation
Item
to
be
Evaluated
Classificatio
n
Yes,
No,
Unknown*,
or
NA
April
29,
2002
C­
6
2
Quality
Assurance
2.1
Does
the
laboratory
have
a
formal
QA
laboratory
plan
prepared
and
ready
for
examination?
Requirement
2.2
Are
employee
resumes
present
and
complete?
Requirement
2.3
Is
a
training
protocol
for
new
employees
present?
Recommendation
2.4
Is
the
laboratory
performing
analyst
verification
of
examination
monthly
and
does
the
lab
have
corrective
action
procedures
in
place
if
criteria
are
not
met?
(
Section
10.5)
Requirement
2.5
Are
employee
training
records
available
and
up
to
date?
Requirement
2.5.1
Have
technicians/
analysts
analyzed
the
required
number
of
samples
using
Method
1622/
1623?
Requirement
2.6
Are
all
relevant
SOPs
present
and
current?
Requirement
2.7
Are
sampling
instructions
present
for
clients
collecting
and/
or
filtering
samples
in
the
field?
Requirement
2.8
Does
the
laboratory
have
criteria
for
sample
acceptance
and
corrective
action
procedures?
Requirement
2.9
Are
data
recording
procedures
present?
Requirement
2.9.1
Does
the
laboratory
have
an
SOP
for
checking
all
manual
calculations?
Requirement
2.10
Are
corrective
action
contingencies
present?
Requirement
2.10.1
For
OPR
failures?
[
Section
9.7.4]
Requirement
2.10.2
For
method
blank
contamination?
Requirement
2.10.3
For
positive/
negative
staining
control
failures?
Requirement
2.11
Does
the
quality
assurance
plan
specifically
address
requirements
for
Cryptosporidium
analysis
under
the
programs
for
which
the
laboratory
intends
to
analyze
samples?
Requirement
2.12
Is
a
laboratory
organization
chart
or
other
information
available
listing
staff
organization
and
responsibilities?
Does
it
identify
the
QA
manager?
Requirement
2.12.1
Is
the
QA
manager
separate
from
the
lab
manager?
Recommendation
2.13
Does
the
laboratory
have
a
list
of
preventative
maintenance
procedures
and
schedules?
Requirement
2.14
Date
range
covered
for
quality
control
(
QC)
sample
audit?

2.15
When
did
the
laboratory
begin
processing
samples
with
the
Envirochek
filter?
/
/

2.16
When
did
the
laboratory
begin
processing
samples
with
the
Filta­
Max
filter
(
if
applicable)?
/
/

2.17
When
did
the
laboratory
begin
processing
samples
with
the
CrypTest
filter
(
if
applicable)?
/
/

2.18
Approximately
how
many
field
samples
were
analyzed
using
methods
1622/
1623
since
the
lab
started
using
Method
1622/
1623?
Field
samples
___
MS_____

2.19
Have
acceptable
initial
precision
and
recovery
analyses
been
performed
for
each
version
of
the
method
the
laboratory
is
using?
Requirement
2.20
Were
method
blanks
run
once
per
week
or
per
20
samples
during
this
period?
[
Section
9.6.1]
Requirement
2.20.1
If
the
answer
to
2.20
is
no,
then
at
what
frequency
where
method
blanks
performed?

2.20.2
What
percentage
of
method
blanks
evaluated
were
without
contamination?

2.20.3
Was
an
acceptable
method
blank
associated
with
each
field
sample
examined?
Requirement
2.20.4
How
many
method
blanks
were
evaluated?

2.21
Were
ongoing
precision
and
recovery
(
OPR)
samples
run
once
per
week
or
per
20
samples
during
this
period?
[
Section
9.7]
Requirement
2.21.1
If
the
answer
to
2.21
is
no,
then
at
what
frequency
where
OPR
samples
performed?

2.21.2
What
percentage
of
OPR
samples
evaluated
met
the
recovery
criteria?
[
Table
3;
Section
9.7.3]
Item
to
be
Evaluated
Classificatio
n
Yes,
No,
Unknown*,
or
NA
April
29,
2002
C­
7
2.21.3
Does
the
laboratory
maintain
control
charts
of
OPR
results?
[
Section
9.7.5]
Requirement
2.21.4
Was
an
acceptable
OPR
associated
with
each
field
sample
examined?
Requirement
2.21.5
How
many
OPR
samples
were
evaluated?

2.21.6
How
many
OPR
samples
were
analyzed
during
the
past
six
months?

2.21.7
What
is
the
mean
and
relative
standard
deviation
of
the
recoveries
of
the
OPR
samples
analyzed
during
the
past
six
months?
Mean_______
RSD________

2.22
Were
matrix
spike
(
MS)
samples
analyzed
at
the
method
­
specified
frequency?
[
Section
9.1.8]
Requirement
2.22.1
If
the
answer
to
2.22
is
no,
then
at
what
frequency
were
MS
samples
analyzed?

2.22.2
How
many
MS
samples
were
evaluated?

2.22.3
How
many
MS
samples
were
analyzed
during
the
past
six
months?

2.22.4
What
is
the
mean
and
relative
standard
deviation
of
the
MS
samples
analyzed
during
the
past
six
months?
Mean_______
RSD________

2.23
Were
OPR
and
MS
samples
spiked
with
100
­
500
organisms?
[
Section
9.7]
Requirement
2.23.1
If
the
answer
to
2.23
is
no,
then
at
what
level
were
samples
spiked?

2.24
Are
the
laboratory
personnel
performing
the
QC
analyses
representative
of
the
personnel
seeking
approval
under
this
program?
Requirement
2.25
Does
the
laboratory
have
records
of
all
QC
checks
available
for
inspection?
Requirement
2.26
Does
the
laboratory
have
an
adequate
record
system
for
tracking
samples
from
collection
through
login
analysis,
and
data
reporting?
Requirement
2.27
Are
results
from
each
sample
maintained
electronically?

2.28
If
data
are
stored
electronically,
are
files
backed
up
on
more
than
one
disk
to
ensure
data
are
not
lost
in
the
eventuality
of
some
hardware
failure?
Requirement
2.29
If
data
is
stored
electronically,
does
the
laboratory
have
an
SOP
for
checking
the
accuracy
of
data
entry
into
an
electronic
system?
Requirement
2.30
Is
the
laboratory
using
the
April
2001
or
the
June
2003
version
of
Method
1622/
1623?
Requirement
3
Data
Recording
Procedures
3.1
Is
shipping
information
complete,
including
the
time
and
date
of
sample
receipt,
sample
condition,
and
noting
any
discrepancies
between
samples
on
the
traffic
report
and
samples
received?
Requirement
3.2
Do
sample
numbers
on
the
shipping
forms
match
the
sample
numbers
on
the
report
forms?
Requirement
3.3
Are
current
Method
1622/
1623
bench
sheets
used
to
record
sample
processing
data?
Recommendation
3.4
Are
all
primary
measurements
during
each
step
recorded,
including
all
raw
data
used
in
calculations?
Requirement
3.5
Name
of
analyst
or
technician
performing
the
elution
is
recorded?
Requirement
3.6
Date
and
time
of
elution
is
recorded?
Requirement
3.7
Name
of
analyst
or
technician
performing
the
concentration
is
recorded?
Requirement
3.8
Date
and
time
of
concentration
is
recorded?
Requirement
3.9
Are
batch
and
lot
numbers
of
reagents
used
in
the
analysis
of
the
sample
recorded?
Requirement
3.10
Lot
number
for
the
IMS
kit
is
recorded?
Requirement
3.11
Are
Method
1622/
1623
Cryptosporidium
report
forms
used
to
record
sample
examination
results?
Requirement
3.12
Name
of
examining
analyst
is
recorded?
Requirement
3.13
Date
and
time
of
sample
examination
is
recorded?
Requirement
3.14
Are
calculations
of
final
concentrations
and
recoveries
complete
and
correct?
Requirement
3.15
Do
values
recorded
on
the
data
sheets
match
the
reported
values?
Requirement
Item
to
be
Evaluated
Classificatio
n
Yes,
No,
Unknown*,
or
NA
April
29,
2002
C­
8
3.16
Are
mistakes
on
all
forms
crossed
out
with
a
single
line,
initialed,
and
dated?
Requirement
3.17
Are
data
always
recorded
in
pen?
Requirement
3.18
Are
hardcopy
records
well
organized,
complete,
and
easily
accessible?
Requirement
3.19
Does
the
laboratory
include
a
disclaimer
on
the
report
to
the
client
if
method
QC
requirements
were
not
met?
Recommendation
3.20
Is
the
manually
recorded
data
legible?
Requirement
3.21
Do
records
demonstrate
each
analyst's
characterization
of
3
oocysts
and
3
cysts
from
positive
control
for
each
microscopy
session?
[
Section
15.2.1.1]
Requirement
3.22
Data
shows
that
no
more
than
0.5
mL
of
pellet
was
used
per
IMS?
[
Section
13.2.4]
Requirement
4
Holding
Times
4.1
Samples
analyzed
according
to
December
1999
version
of
Method
1622/
1623
4.1.1
Is
time
from
initiation
of
sample
collection
to
completion
of
concentration
72
hours
or
less?
[
Section
8.1]
Requirement
4.1.2
Concentrate
is
held
no
longer
than
24
hours
between
IMS
and
staining?
[
Section
8.2]
Requirement
4.1.3
Are
stained
slides
read
and
confirmed
within
72
hours
of
staining?
[
Section
8.4]
Requirement
4.2
Samples
analyzed
according
to
April
2001
or
June
2003
version
of
Method
1622/
1623
4.2.1
Is
sample
elution
initiated
within
96
hours
of
sample
collection
or
field
filtration?
[
Section
8.2.1]
Requirement
4.2.2
Are
sample
elution,
concentration,
and
purification
steps
completed
in
one
work
day?
[
Section
8.2.2]
Requirement
4.2.3
Are
slides
stained
within
72
hours
of
application
of
the
purified
sample
to
the
slide?
[
Section
8.2.3]
Requirement
4.2.4
Are
stained
slides
read
and
confirmed
within
7
days
of
staining?
[
Section
8.2.4]
Requirement
5
Spike
enumeration
procedures
5.1
What
method
does
the
laboratory
currently
use
to
estimate
spike
doses:(
A)
flow­
sorted
spikes,
(
B)
well­
slide­
counted
spikes,
(
C)
hemacytometer­
counted
spikes,
or
(
D)
membrane­
filter­
counted
spikes
Circle
one:
A
B
C
D
5.1.1
If
flow­
sorted
spikes
are
used,
on
what
date
did
the
laboratory
begin
using
flow­
sorted
spikes?
/
/

5.1.2
If
counted
manually,
does
the
laboratory
follow
Method
1622/
1623
procedures
for
establishing
spike
level?
[
Section
11.3]
Requirement
5.1.3
What
were
the
relative
standard
deviations
of
the
last
four
spike
enumerations?
1.

2.

3.

4.

5.2
Source
of
oocysts
for
spikes
5.3
If
50­
L
samples
are
analyzed,
what
positive
control
procedure
does
the
laboratory
follow
for
OPR
and
MS
samples:
(
A)
spike
entire
50
L,
(
B)
spike
and
filter
10
L
before
filtering
40
L,
or
(
C)
filter
40
L
before
spiking
and
filtering
10
L.

*
Unknown
response
requires
an
explanation
Note:
All
section
references
in
[
]
refer
to
Method
1623
April
2001
April
29,
2002
C­
9
Part
B:
Sample
Processing
and
Examination
Item
to
be
evaluated
Classification
Yes,
No,
NA
or
Unknown
6
Laboratory
Facilities
and
Laboratory
Safety
6.1
Are
laboratory
coats
and
gloves
worn
in
the
laboratory?
Requirement
6.2
No
other
safety
or
facility
issues
were
observed?

7
Sample
Spiking
Technician:

7.1
What
method
does
laboratory
currently
use
to
estimate
spike
doses:(
A)
flow­
sorted
spikes,
(
B)
wellslide
counted
spikes,
(
C)
hemacytometer­
counted
spikes,
or
(
D)
membrane­
filter­
counted
spikes
Circle
one:
A
B
C
D
7.2
With
what
filter
type
did
the
laboratory
demonstrate
their
spiking
procedure?

7.3
Is
the
carboy
used
for
negative
control
randomly
selected
from
carboy
stock
to
check
efficacy
of
cleaning
system?
Requirement
7.4
If
flow­
sorted
spikes
are
used,
was
suspension
vial
vortexed
for
two
minutes
or
per
manufacturers
instr
uctio
ns?
[
Sec
tion
11.4
.3]
Method
Procedure
7.5
Was
the
suspension
vial
adequately
rinsed?
[
Section
11.4.3.1]
Method
Procedure
7.6
Does
the
laboratory
have
an
acceptable
SOP
for
sample
spiking?
Requirement
7.7
Other
than
the
issues
noted
for
items
7.2
through
7.6
(
if
any)
was
sample
spiking
demonstrated
successfully?

8
Envirochek
(
Complete
Sections
that
apply)

8.1
Envirochek
Filtration
Technician:

8.1.1Are
all
components
required
for
sample
filtration
present
and
in
good
condition?
[
Section
6.2]
Requirement
8.1.2Is
the
filter
assembly
set
up
correctly?
[
Figure
3,
pg
48]
Method
Procedure
8.1.3Is
the
pump
adequate
for
needs?
[
Section
6.3.3]
Requirement
8.1.4Is
the
appropriate
flow
rate
maintained
(
approximately
2L/
min)?
[
Section
12.2.1.2]
Method
Procedure
8.1.5Is
the
volume
filtered
measured
using
a
flow
meter
or
calibrated
carboy?
[
Section
12.2.4.2]
Requirement
8.1.6Is
the
system
well
maintained
and
cleaned
appropriately
following
use?
Requirement
8.1.7
Is
the
system
able
to
maintain
seal
during
use
with
no
leaks?
Requirement
8.1.8
Does
the
laboratory
have
an
acceptable
SOP
for
Envirochek
filtration?
Requirement
8.1.9Other
than
the
issues
noted
in
items
8.1.1
through
8.1.8,
was
Envirochek
filtration
demonstrated
successfully?

8.2
Envirochek
capsule
filter
elution
Technician:

8.2.1Is
the
elution
buffer
prepared
as
per
Method
1622/
1623?
[
Section
7.4]
Method
Procedure
8.2.2Is
the
wrist­
shaker
assembly
set
up
correctly?
[
Section
12.2.6.1.1]
Method
Procedure
8.2.3Does
the
eluting
solution
cover
the
membrane?
[
Section
12.2.6.2.2]
Method
Procedure
8.2.4Are
the
samples
shaken
at
an
appropriate
speed?
[
Section
12.2.6.2.3]
Method
Procedure
8.2.5Are
the
samples
shaken
three
times
for
5
minutes
each
time,
and
each
in
a
different
orientation?
[
Section
12.2.6.2]
Method
Procedure
8.2.6
Does
the
laboratory
have
an
acceptable
SOP
for
Envirochek
capsule
filter
elution?
Requirement
8.2.7Other
than
the
issues
noted
for
items
8.2.1
through
8.2.7
(
if
any)
was
Envirochek
filter
elution
demonstrated
successfully?

9
CrypTest
Item
to
be
evaluated
Classification
Yes,
No,
NA
or
Unknown
April
29,
2002
C­
10
9.1
CrypTest
Filtration
Technician:

9.1.1Are
all
components
required
for
sample
filtration
present
and
in
good
condition?
[
Section
6.2.3]
Requirement
9.1.2Is
the
filter
assembly
set
up
correctly?
Method
Procedure
9.1.3Is
the
pump
adequate
for
needs?
[
Section
6.3.3]
Requirement
9.1.4Is
the
appropriate
flow
rate
maintained
(
approximately
2L/
min)?
Method
Procedure
9.1.5Is
the
volume
filtered
measured
using
a
flow
meter
or
a
calibrated
carboy?
Requirement
9.1.6Is
the
system
well
maintained
and
cleaned
appropriately
following
use?
Requirement
9.1.7
Is
the
system
able
to
maintain
seal
during
use
with
no
leaks?
Requirement
9.1.8
Does
the
laboratory
have
an
acceptable
SOP
for
CrypTest
Filtration?
Requirement
9.1.9Other
than
the
issues
noted
in
items
9.1.3
through
9.1.10
(
if
any)
was
CrypTest
filtration
demonstrated
successfully?

9.2
CrypTest
cartridge
filter
elution
Technician:

9.2.1
Does
the
filter
seat
properly
in
the
filter
housing,
so
there
are
no
leaks?
Requirement
9.2.2Is
the
elution
buffer
prepared
according
to
manufacturer's
instructions?
[
Section
7.4.2]
Method
Procedure
9.2.3Is
an
appropriate
amount
of
elution
solution
backwashed
into
the
filter
housing?
(
approx.
150
mL)
Method
Procedure
9.2.4Is
the
assembly
well
sealed
(
no
leaks)?
Requirement
9.2.5
Is
sonication
performed
for
2
minutes?
Method
Procedure
9.2.6
Is
the
filter
elution
repeated,
according
to
the
manufacturer's
instructions?
Method
Procedure
9.2.7
Following
the
last
elution,
is
the
remaining
elution
buffer
driven
from
the
outlet
side
to
the
inlet
side
and
into
the
sam
ple
bottl
e?
Requirement
9.2.7.1
Is
the
regulated
compressed
air
source
used,
sufficient
to
drive
the
eluting
buffer
from
the
filter?
Requirement
9.2.8
After
elution
is
complete,
is
the
filter
removed
from
the
housing
and
the
base,
lid,
and
lip
of
the
filter
housing
rinsed
using
eluting
solution
and
added
to
the
sample
bottle?
Requirement
9.2.9
Does
the
laboratory
have
an
acceptable
SOP
for
CrypTest
elution?
Requirement
9.2.10
Other
than
the
issues
noted
in
items
9.2.1
through
9.2.9
(
if
any)
was
CrypTest
filter
elution
demonstrated
successfully?

10
Filta­
Max
10.1
Filta­
Max
filtration
Technician:

10.1.1
Are
all
components
required
for
sample
filtration
present
and
in
good
condition?
[
Section
6.2.4]
Requirement
10.1.2
Is
the
filter
assembly
set
up
correctly?
Method
Procedure
10.1.3
Is
appropriate
flow
rate
maintained
of
<
4
L
per
minute?
Method
Procedure
10.1.4
Is
the
volume
filtered
measured
correctly
using
a
flow
meter
or
calibrated
carboy?
Requirement
10.1.5
Is
system
well
maintained
and
cleaned
appropriately
following
use?
Requirement
10.1.6
Is
system
able
to
maintain
seal
during
use
with
no
leaks?
Requirement
10.1.7
Does
the
laboratory
have
an
acceptable
SOP
for
Filta­
Max
filtration?
Requirement
10.1.8
Does
the
laboratory
indicate
on
the
filter
housing
the
correct
direction
of
flow?
Requirement
Item
to
be
evaluated
Classification
Yes,
No,
NA
or
Unknown
April
29,
2002
C­
11
10.1.9
Other
than
the
issues
noted
in
items
10.1.1
through
10.1.8
(
if
any)
was
Filta­
Max
filtration
demonstrated
successfully?

10.2
Filta­
Max
filter
wash
station
elution
Technician:

10.2.1
Is
an
automatic
or
manual
wash
station
used?

10.2.2
Is
the
filter
wash
station
set
up
correctly?
Requirement
10.2.3
Is
PBST
used
to
elute
the
filter?
[
Section
7.4.2]
Method
Procedure
10.2.4
Is
an
appropriate
amount
of
PBST
used
for
each
wash?
(
approx.
600
mL)
Method
Procedure
10.2.5
During
the
first
wash,
is
the
plunger
moved
up
and
down
20
times?
Method
Procedure
10.2.6
Is
the
plunger
moved
up
and
down
gently
to
avoid
generating
excess
foam?
Method
Procedure
10.2.7
During
the
second
wash,
is
the
plunger
moved
up
and
down
10
times?
Method
Procedure
10.2.8
If
the
automatic
washer
is
used,
is
the
machine
operating
properly?
Requirement
10.2.9
Is
the
wash
station
cleaned
adequately
between
samples?
Requirement
10.2.10
Does
the
laboratory
have
an
acceptable
SOP
for
Filta­
Max
elution
with
the
wash
station?
Requirement
10.2.11
Other
than
the
issues
noted
for
items
10.2.2
through
10.2.10
(
if
any)
was
elution
of
the
Filtamax
filter
using
the
wash
station
demonstrated
successfully?

10.3
Filta­
Max
filter
stomacher
elution
Technician
10.3.1
Is
PBST
used
to
elute
the
filter?
[
Section
7.4.3.4]
Method
Procedure
10.3.2
Is
an
appropriate
amount
of
PBST
used
for
each
wash?
(
approx.
600
mL)
Method
Procedure
10.3.3
Are
two
washes
performed
for
5
minutes
each?
Method
Procedure
10.3.4
Is
the
stomacher
in
good
condition
and
operating
properly?
Requirement
10.3.5
Does
the
laboratory
have
an
acceptable
SOP
for
Filta­
Max
elution
using
a
stomacher?
Requirement
10.3.6
Other
than
the
issues
noted
for
items
10.3.1
through
10.3.5
(
if
any)
was
elution
of
the
Filta­
Max
filter
using
the
stomacher
demonstrated
successfully?

10.4
Filta­
Max
filter
sample
concentration
(
as
an
alternative
to
Section
11)
Technician:

10.4.1
Is
concentrator
set
up
correctly?
Requirement
10.4.2
Is
the
force
of
the
vacuum
maintained
below
30
cm
Hg?
Method
Procedure
10.4.3
Is
concentration
performed
after
each
of
the
washes?
Method
Procedure
10.4.4
Is
the
concentrate
from
the
first
wash
added
to
the
600mL
of
eluate
from
the
second
wash?
Method
Procedure
10.4.5
Is
the
sample
concentrated
so
that
some
liquid
remains
above
the
filter
(
enough
to
cover
the
stirb
ar
abo
ut
halfway
?
Method
Procedure
10.4.6
Is
the
stir
bar
and
concentration
tube
rinsed
after
each
concentration
and
the
liquid
added
to
the
concentrate?
Requirement
10.4.7
Was
the
filter
membrane
washed
twice?
Method
Procedure
10.4.8
Was
5
mL
of
PBST
used
each
time?
Method
Procedure
10.4.9
Is
the
membrane
adequately
washed
to
remove
oocysts
from
filter?
Method
Procedure
Item
to
be
evaluated
Classification
Yes,
No,
NA
or
Unknown
April
29,
2002
C­
12
10.4.10
Is
the
pellet
volume
determined?
Requirement
10.4.11
Is
there
a
set
of
standards
for
comparison
of
pellet
size?
Recommendation
10.4.12
Does
the
laboratory
have
an
acceptable
SOP
for
concentration
using
the
Filta­
Max
concentrator?
Requirement
10.4.13
Other
than
the
issues
noted
in
items
10.4.1
through
10.4.12
(
if
any)
was
sample
concentration
using
the
Filta­
Max
concentrator
demonstrated
successfully?

11
Concentration
11.1
Envirochek,
CrypTest,
and
Filta­
Max
filter
sample
centrifugation
Technician:

11.1.1
Is
the
sample
centrifuged
at
1500
x
G
using
a
swinging
bucket
rotor?
[
Section
13.2.1]
Method
Procedure
11.1.2
Are
the
centrifuge
tubes
properly
balanced
prior
to
centrifugation?
Requirement
11.1.3
Is
the
sample
centrifuged
for
15
minutes?
[
Section
13.2.1]
Method
Procedure
11.1.4
Is
the
centrifuge
slowly
decelerated
at
the
end
without
the
brake?
[
Section
13.2.1]
Method
Procedure
11.1.5
Is
the
pellet
volume
determined?
Requirement
11.1.6
Is
there
a
set
of
standards
for
comparison
of
pellet
size?
Recommendation
11.1.7
Does
the
laboratory
have
an
acceptable
SOP
for
sample
concentration?
Requirement
11.1.8
Is
residual
suspension
rinsed
from
all
containers
and
gloves?
Requirement
11.1.9
Other
than
the
issues
noted
in
items
11.1.1
through
11.1.8
(
if
any)
was
sample
concentration
demonstrated
successfully?

12
Reagents,
equipment
and
clean­
up
12.1
Source
for
reagent­
grade
water:

12.1.1
Is
still
or
DI
unit
maintained
according
to
manufacturer's
instructions?
Requirement
12.1.2
Is
reagent
grade
water
used
to
prepare
all
media
and
reagents?
[
Section
7.3]
Requirement
12.2
Centrifuge:

12.2.1
Does
centrifuge
have
a
swinging
bucket
rotor?
[
Section
6.8.1]
Requirement
12.2.2
Is
the
centrifugation
nomograph
for
determining
relative
centrifugal
force
located
close
to
the
centrifuge(
s)?
Requirement
12.3
SOP's
for
Reagents
12.3.1
Are
SOP's
available
for
the
preparation
of
all
essential
chemicals
and
reagents?
Requirement
12.3.2
Are
SOP's
posted
or
easily
accessible
at
the
bench?
Recommendation
12.3.3
Are
all
reagents
clearly
labeled
with
date
of
preparation,
technician
initials,
and
expiration
date?
Requirement
12.4
Clean­
up
12.4.1
Is
all
glassware
and
plasticware
washed
well
and
stored
appropriately
between
uses?
Requirement
12.4.2
Is
distilled
or
deionized
water
used
for
final
rinse?
Requirement
12.4.3
Is
an
SOP
available
for
glassware
washing?
Requirement
Item
to
be
evaluated
Classification
Yes,
No,
NA
or
Unknown
April
29,
2002
C­
13
13
Purification
and
Slide
Preparation
Technician:

13.1
What
IMS
kit/
manufacturer
is
used?

13.2
Is
the
supernatant
from
the
centrifuged
sample
aspirated
no
lower
than
5
mL
above
the
pellet?
[
Section
13.2.2]
Requirement
13.3
Is
the
pellet
vortexed
a
sufficient
time
for
resuspension?
[
Section
13.2.3]
Method
Procedure
13.4
Does
the
lab
have
an
appropriate
SOP
for
dividing
pellets
greater
than
0.5mL
into
subsamples
and
analyzing?
Requirement
13.5
Is
no
more
than
0.5
mL
of
pellet
used
per
IMS?
[
Section
13.2.4]
Method
Procedure
13.6
Is
the
leighton
tube
rotated
at
18
rpm
for
1
hour
at
room
temperature?
Method
Procedure
13.7
Is
the
resuspended
pellet
volume
quantitatively
transferred
to
the
Leighton
tube
(
2
rinses)?
[
Section
13.3.2.1]
Method
Procedure
13.8
Are
the
IMS
beads
thoroughly
resuspended
prior
to
addition
to
the
Leighton
tube?
[
Section
13.3.2.2]
Method
Procedure
13.9
Is
the
sample
quantitatively
transferred
from
the
Leighton
tube
to
the
microcentrifuge
tube
(
2
rinses)?
[
Section
13.3.2.13]
Method
Procedure
13.10
Is
standard
NaOH
(
5

L,
1N)
and
standard
HCl
(
50

L,
0.1N)
used?
[
See
note
on
pg
37]
Requirement
13.11
Is
sample
vortexed
vigorously
for
50
seconds
immediately
after
the
addition
of
acid
and
30
seconds
after
the
sample
has
set
for
10
minutes
at
room
temperature?
[
Section
13.3.3]
Method
Procedure
13.12
Is
a
second
dissociation
performed?
[
Section
13.3.3.10]
Method
Procedure
13.13
When
the
second
dissociation
is
performed,
does
the
laboratory:
(
A)
use
a
second
slide,
or
(
B)
add
the
additional
volume
to
the
original
slide?
Circle
one:
A
B
13.14
Are
the
slides
clearly
labeled
so
they
can
be
associated
with
the
correct
sample?
Requirement
13.15
What
type
of
slides
are
used?

13.16
Is
slide
dried
at
a)
room
temperature
or
b)
35
to
42
C?
[
Section
13.3.3.12]
Circle
one:
A
B
13.17
If
the
slide
is
warmed,
is
incubator
or
slide
tray
calibrated
and
labeled?
Requirement
13.18
Does
the
laboratory
have
an
acceptable
SOP
for
sample
purification?
Requirement
13.19
Other
than
the
issues
noted
in
items
13.1
through
13.18
(
if
any)
were
sample
purification
and
slide
preparation
performed
successfully?

14
Sample
staining
Technician:

14.1
What
staining
kit/
manufacturer
is
used?

14.2
Is
FITC
stain
applied
according
to
manufacturer's
directions?
Method
Procedure
14.3
Are
positive
and
negative
staining
controls
performed?
Requirement
14.4
Are
the
direct
labeling
reagents
applied
properly?
[
Section
15.2.1]
Method
Procedure
14.5
Are
the
slides
incubated
in
a
humid
chamber
in
the
dark
at
room
temperature
for
approximately
30
minutes
or
per
manufacturer's
directions?
[
Section
14.4]
Method
Procedure
14.6
Are
the
labeling
reagents
rinsed
away
properly
after
incubation,
without
disturbing
the
sample?
[
Section
14.5]
Method
Procedure
14.7
Was
the
working
DAPI
stain
prepared
the
day
it
was
used?
[
Section
7.7.2]
Method
Procedure
14.8
Is
stock
DAPI
stored
at
0
to
8oC
in
the
dark?
[
Section
7.7.2]
Method
Procedure
14.9
Is
the
DAPI
stain
applied
properly
and
allowed
to
stand
for
a
minimum
of
1
minute?
[
Section
14.6]
Method
Procedure
14.10
Is
the
DAPI
stain
rinsed
away
properly
without
disturbing
the
sample?
[
Section
14.7]
Method
Procedure
14.11
Is
the
mounting
media
applied
properly?
Method
Procedure
Item
to
be
evaluated
Classification
Yes,
No,
NA
or
Unknown
April
29,
2002
C­
14
14.11.1
What
type
of
mounting
media
is
used?

14.11.2
Are
all
the
edges
of
the
cover
slip
sealed
well
with
clear
fingernail
polish,
unless
Elvenol
is
used?
[
Section
14.9]
Method
Procedure
14.12
Are
the
finished
slides
stored
in
a
humid
chamber
in
the
dark
at
0
to
8oC
(
humid
chamber
not
required
for
Evenol)?
[
Section
14.10]
Method
Procedure
14.13
Does
the
laboratory
have
an
acceptable
SOP
for
sample
staining?
Requirement
14.14
Other
than
the
issues
noted
in
items
14.2
through
14.13
(
if
any)
was
sample
staining
demonstrated
successfully?

15
Microscope
and
Examination
15.1
Is
microscope
equipped
with
appropriate
excitation
and
band
pass
filters
for
examining
FITC
labeled
specimens?
(
Exciter
filter
­
450­
490
nm,
dichroic
beam­
splitting
mirror
­
510
nm,
barrier
or
suppression
filter:
515­
520
nm)?
[
Section
6.9.2]
Requirement
15.2
Is
microscope
is
equipped
with
appropriate
excitation
and
band
pass
filters
for
examining
DAPI
labeled
specimens?
(
Exciter
filter
­
340­
380
nm,
dichroic
beam­
splitting
mirror
­
400
nm,
barrier
or
suppression
filter
­
420
nm)
[
Section
6.9.3]
Requirement
15.3
Does
the
microscope
have
HMO
or
DIC,
objectives?
[
Section
6.9.1]
Requirement
15.4
Is
microscope
operation
easily
changed
from
epifluorescence
to
DIC/
HMO?
Recommendation
15.5
Does
the
microscope
have
a
20
X
scanning
objective?
[
Section
6.9.1]
Requirement
15.6
Does
the
microscope
have
a
100
X
oil
immersion
objective?
[
Section
6.9.1]
Requirement
15.7
Is
the
microscope
equipped
with
an
ocular
micrometer?
[
Section
6.9.1]
Requirement
15.8
Is
a
stage
micrometer
available
to
laboratory?
[
Section
10.3.5]
Requirement
15.9
Is
a
calibration
table
for
each
objective
located
close
to
the
microscope(
s)?
[
Section
10.3.5]
Requirement
15.10
Does
the
wattage
of
the
mercury
lamp
meet
the
microscope
specifications?
Requirement
15.11
Has
the
mercury
bulb
been
used
less
than
the
maximum
hours
recommended
by
the
manufacturer?
[
Section
10.3.2.11]
Recommendation
15.12
Does
the
positive
control
contain
Cryptosporidium
oocysts
at
the
appropriate
fluorescence
intensity
for
both
FITC
and
DIC?
Requirement
15.13
Does
the
laboratory
have
an
acceptable
SOP
for
sample
examination?
Requirement
15.14
Other
than
the
issues
noted
for
items
15.1
through
15.13
(
if
any)
were
other
microscope
or
examination
issues
acceptable?

Note:
All
section
references
in
[
]
refer
to
Method
1623
April
2001
April
29,
2002
C­
15
Initial
Demonstration
of
Capability
Data
Summary
Form
Laboratory
Name
EPA
Lab
ID
Date
Method
Information
Which
method
was
used?

Method
1622

Method
1623
Filter
used:
Elution
method:
Concentration
method:

IMS
kit
used:
Staining
kit
used:

Volume
of
water
spiked
(
L):
Volume
of
water
filtered
(
L):

Initial
Demonstration
of
Capability
Summary
Data
Sample
Giardia
(
not
required)
Cryptosporidium
Equivalent
Sample
Volume
Analyzed
(
to
nearest
1/
4
L)
Turbidity
(
NTU)
Estimated
No.
of
Cysts
Spiked
No.
of
Cysts
Detected
Estimated
No.
of
Oocysts
Spiked
No.
of
Oocysts
Detected
Method
blank
Spiked
reagent
water
1
Spiked
reagent
water
2
Spiked
reagent
water
3
Spiked
reagent
water
4
Mean
recovery
Precision
(
RSD)

Matrix
unspiked
Matrix
spike
1
Matrix
spike
2
Mean
recovery
Precision
(
RPD)
April
29,
2002
C­
16
Burden
Statement:
The
public
reporting
and
recordkeeping
burden
for
this
collection
of
information
is
estimated
to
average
19
hours
per
response.
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.
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
(
2822T),
1200
Pennsylvania
Ave.,
NW,
Washington,
D.
C.
20460.
Include
the
OMB
control
number
in
any
correspondence.
Do
not
send
the
completed
application
to
this
address.
APPENDIX
D
Lab
QA
Program
Application
Cover
Letter
D­
1
OMB
Control
Number:
2040­
0246
Expiration
Date:
10/
31/
05
United
States
Environmental
Protection
Agency
Office
of
Ground
Water
and
Drinking
Water
Standards
and
Risk
Management
Division
April
8,
2005
Dear
Laboratory
Manager:

Thank
you
for
your
interest
in
the
U.
S.
EPA's
Laboratory
Quality
Assurance
Evaluation
Program
for
Analysis
of
Cryptosporidium
under
the
Safe
Drinking
Water
Act
(
Lab
QA
Program).
This
is
a
voluntary
program
open
to
laboratories
analyzing
Cryptosporidium
in
water
using
EPA
Method
1622
and
EPA
Method
1623.
To
increase
the
likelihood
that
laboratories
analyzing
water
samples
for
Cryptosporidium
generate
reliable
data,
EPA
has
established
the
following
process
for
evaluating
laboratory
performance
and
quality
assurance
practices:

Step
1.
Application.
Laboratories
must
first
submit
the
Lab
QA
Program
application.
The
application
forms
are
enclosed
with
this
letter,
and
the
application
requirements
are
described
in
detail
below.
EPA
will
evaluate
laboratory
applications
to
confirm
the
following:
(
1)
the
laboratory
has
the
equipment
required
in
EPA
Method
1622
and/
or
EPA
Method
1623
(
April
2001
or
June
2003
version),
(
2)
laboratory
personnel
have
the
recommended
experience
to
analyze
samples,
and
(
3)
the
laboratory
has
successfully
completed
the
initial
precision
and
recovery
and
matrix
spike/
matrix
spike
duplicate
tests
specified
in
the
method.
Laboratories
that
do
not
meet
these
requirements
will
be
requested
to
correct
any
deficiencies
before
proceeding
to
the
next
step
in
the
evaluation
process.

Step
2.
Proficiency
testing.
After
an
application
has
been
accepted,
the
laboratory
will
be
sent
a
set
of
eight
initial
proficiency
testing
(
IPT)
samples
consisting
of
a
suspension
of
oocysts
in
a
concentrated
matrix.
Laboratories
will
resuspend
these
spikes
in
reagent
water
to
produce
simulated
source
water
samples,
and
analyze
the
samples
using
the
version
of
Method
1622/
1623
that
the
laboratory
plans
to
use
for
routine
Cryptosporidium
analyses.
If
a
laboratory
wishes
to
be
evaluated
for
more
than
one
version
of
the
method,
the
laboratory
will
receive
a
set
of
eight
proficiency
test
(
PT)
samples
for
each
version.

Laboratory
IPT
data
will
be
evaluated
against
the
mean
recovery
and
precision
(
as
relative
standard
deviation)
for
the
IPT
samples
from
other
laboratories.
Laboratories
will
receive
two
opportunities
to
pass
the
IPT
test.
If
a
laboratory
fails
two
times,
it
will
not
be
eligible
for
another
set
until
after
the
laboratory
staff
has
received
additional
training
in
performing
the
method.

Laboratories
already
participating
in
the
EPA
Cryptosporidium
PT
Program,
may
use
the
initial
round
of
samples
from
the
PT
program
to
meet
the
IPT
sample
requirement.

Step
3.
On­
site
evaluation.
After
a
laboratory
passes
the
IPT,
an
on­
site
evaluation
of
the
laboratory
will
be
scheduled.
The
on­
site
evaluation
will
include
two
separate,
but
concurrent
assessments:
(
1)
assessment
of
the
laboratory's
sample
processing
and
analysis
procedures,
including
microscopic
examination,
and
(
2)
evaluation
of
the
laboratory's
personnel
qualifications,
quality
control
program,
equipment,
and
record
keeping
procedures.

Each
laboratory
will
receive
an
audit
report,
which
will
document
deficiencies,
if
any,
that
should
be
corrected
by
the
laboratory.
After
a
laboratory
has
corrected
any
deficiencies
noted
in
the
audit
report,
EPA
will
confirm
that
the
laboratory
meets
the
performance
criteria
of
the
Lab
QA
Program.

Laboratories
that
meet
the
program
performance
criteria
will
also
receive
a
set
of
three
ongoing
proficiency
testing
(
OPT)
samples
approximately
every
four
months
that
must
be
analyzed
in
the
same
manner
as
the
IPT
samples.
EPA
will
D­
2
evaluate
the
precision
and
recovery
data
for
OPT
samples
to
determine
if
the
laboratory
continues
to
meet
the
performance
criteria
of
the
Laboratory
QA
Program.

Application
Requirements
The
first
step
in
the
laboratory
evaluation
process
is
submission
of
a
laboratory
application
package.
The
following
materials
should
be
submitted
for
each
laboratory
application
package:

1.
Signed,
completed
application
form
(
attached).

2.
Completed
self­
audit
checklist
(
attached).
This
checklist
is
similar
to
the
checklist
that
will
be
used
to
audit
your
laboratory
during
the
on­
site
evaluation.

3.
Resumes
detailing
qualifications
of
your
laboratory's
proposed
principal
analyst/
supervisor
and
each
analyst
and
technician
listed
on
the
application
form
and
documentation
of
the
training,
including
the
list
of
samples
analyzed
by
each
and
the
time
period
during
which
the
samples
were
performed
(
the
list
for
each
analyst
and
technician
should
include
at
a
minimum
the
number
of
samples
specified
below
for
personnel
prerequisites).

The
recommended
personnel
prerequisites
for
the
laboratory
evaluation
program
are
as
follows:

Principal
Analyst/
Supervisor
(
one
required
per
laboratory)
°
BS/
BA
in
microbiology
or
closely
related
field
°
A
minimum
of
1
year
of
continuous
bench
experience
with
Cryptosporidium
and
IFA
microscopy
°
A
minimum
of
6
months
experience
using
EPA
Method
1622
and/
or
EPA
Method
1623
°
A
minimum
of
100
samples
analyzed
using
EPA
Method
1622
and/
or
EPA
Method
1623
(
minimum
50
samples
if
the
person
was
an
approved
analyst
for
Cryptosporidium
under
the
Information
Collection
Rule(
ICR))

Other
Analysts
(
no
minimum
requirement
per
laboratory)
°
Two
years
of
college
in
microbiology
or
equivalent
or
closely
related
field
°
A
minimum
of
6
months
of
continuous
bench
experience
with
Cryptosporidium
and
IFA
microscopy
°
A
minimum
of
3
months
experience
using
EPA
Method
1622
and/
or
EPA
Method
1623
°
A
minimum
of
50
samples
analyzed
using
EPA
Method
1622
and/
or
EPA
Method
1623
(
minimum
25
samples
if
the
person
was
an
ICR­
approved
analyst)

Technician
(
no
minimum
requirement
per
laboratory)
°
Three
months
experience
with
the
specific
parts
of
the
procedure
he/
she
will
be
performing
°
A
minimum
of
50
samples
analyzed
using
EPA
Method
1622
and/
or
EPA
Method
1623
(
minimum
25
samples
if
the
person
was
an
ICR­
approved
technician)
for
the
specific
analytical
procedures
they
will
be
using.

4.
Detailed
laboratory
standard
operating
procedures
(
SOP)
for
each
version
of
the
method
your
laboratory
plans
on
using
for
routine
Cryptosporidium
analyses.
SOP's
for
the
following
should
be
included:

°
Performance
of
each
method
step
including,
sample
spiking,
filtration,
elution,
concentration,
purification,
slide
preparation,
sample
staining
and
examination
°
Dividing
pellets
greater
than
0.5mL
°
Preparation
of
reagents
°
Dishwashing
°
Staff
training
°
Corrective
action
procedures
for
failing
to
meet
OPR,
method
blank,
staining
controls,
sample
acceptance,
and
performance
verification
criteria
D­
3
°
Sampling
procedures
to
be
followed
by
field
or
utility
personnel
°
Procedures
for
data
recording,
checking
manual
calculations,
and
checking
accuracy
of
all
data
transcriptions
5.
EPA
Method
1622
or
EPA
Method
1623
initial
demonstration
of
capability
(
IDC)
data
which
include
initial
precision
and
recovery
(
IPR)
test
results
and
matrix
spike
and
matrix
spike
duplicate
(
MS/
MSD)
test
results
for
Cryptosporidium.
The
IPR
test
consists
of
four
reagent
water
samples
spiked
with
between
100
­
500
oocysts
and
one
method
blank.
The
MS/
MSD
test
consists
of
one
unspiked
and
two
spiked
source
water
samples.
These
tests
are
described
in
Section
9
of
EPA
Method
1622
and
EPA
Method
1623
and
the
results
should
meet
the
criteria
in
the
method
(
April
2001
or
June
2003
version).
The
following
data
should
be
submitted:

°
Completed
EPA
Method
1622/
1623
bench
sheets
and
report
forms
for
each
of
the
eight
samples
(
attached)
°
Initial
demonstration
of
capability
summary
form
(
attached)
°
Spiking
suspension
preparation
data.
This
should
include
completed
flow­
cytometer
calibration
forms.

Laboratories
wishing
to
be
evaluated
for
more
than
one
version
of
the
method
(
different
volumes,
filters,
elution
and
concentration
procedures,
and
immunomagnetic
separation
kits)
should
submit
a
complete
set
of
IDC
data
for
each
version.

If
your
laboratory
currently
participates
in
the
EPA
PT
sample
program
and
the
required
IDC
data
have
already
been
submitted,
the
data
do
not
need
to
be
resubmitted.
Please
indicate
this
is
the
case
on
the
initial
demonstration
of
capability
summary
form.

6.
Table
of
contents
from
your
laboratory's
quality
assurance
plan.
The
quality
assurance
plan
should
specifically
address
the
requirements
of
Cryptosporidium
analysis
under
the
Lab
QA
Program.

7.
An
example
of
the
data
reporting
form
used
to
submit
Cryptosporidium
results
to
your
clients.

8.
A
statistical
summary
of
percent
recoveries
for
all
OPR
and
MS
samples
analyzed
at
your
laboratory
for
the
past
six
months.

Application
materials
should
be
submitted
to
the
following
address:

Cryptosporidium
Laboratory
QA
Program
Coordinator
CSC
Biology
Studies
Group
6101
Stevenson
Avenue
Alexandria,
VA
22304
When
your
application
package
has
been
received
and
reviewed,
you
will
be
notified
whether
it
is
complete
or
has
any
deficiencies.
After
your
application
has
been
accepted,
you
will
be
notified
of
when
you
should
expect
your
initial
set
of
PT
samples.
If
you
have
any
questions
about
the
laboratory
application
materials
or
evaluation
process,
please
feel
free
to
contact
either
me
at
moulton.
carrie@
epamail.
epa.
gov
or
Jennifer
Scheller
at
jscheller@
csc.
com.

Sincerely,

Carrie
Moulton
Manager,
Cryptosporidium
Laboratory
Approval
Program
Technical
Support
Center
26
West
Martin
Luther
King
Drive
Cincinnati,
OH
45268
D­
4
APPENDIX
E
Laboratories
Seeking
Approval
for
One
Method
and
Laboratories
Seeking
Approval
for
Two
Methods
Burden
Tables
E­
1
Complete
and
submit
application
0
3
9
1
13
18
238
$
­

$
138.00
$
396.00
$
15.00
$
549.00
$
­

$
$
72.00
11,364.30
$

Perform
and
report
initial
performance
tests
(
IPT)
0
4
32
4
40
3
120
$
­

$
184.00
$
1,408.00
$
60.00
$
1,652.00
$
­

$
$
1,400.00
9,156.00
$

Host
on­
site
evaluation
0
9
15
1
25
18
458
$
­

$
414.00
$
660.00
$
15.00
$
1,089.00
$
­

$
$
5.00
20,020.20
$

Perform
and
report
3
sets
of
ongoing
performance
tests
(
OPT)
0
5.8
35.3
4.4
45.5
55
2503
­

$
266.80
$
1,553.20
$
66.00
$
1,886.00
$
­

$
$
1,546.00
188,760.00
$

Task
Table
1.
Laboratories
Seeking
Approval
for
One
Method
Version
Legal
$
55.00/
hour
Management
$
46.00/
hour
Technical
$
44.00/
hour
Clerical
$
15.00/
hour
Respondent
Hours
Labor
Costs
Capital/
Startup
Costs
O&
M
Costs
Number
of
respondents/
year
Total
hours/
year
Total
cost/
year
E­
2
Complete
and
submit
application
0
3
12
1
16
3
53
$
­

$
138.00
$
528.00
$
15.00
$
681.00
$
­

$
138.00
$
2,702.70
$

Perform
and
report
initial
Performance
Tests
(
IPT)
0
8
64
8
80
2
160
$
­

$
368.00
$
2,816.00
$
120.00
$
3,304.00
$
­

$
2,800.00
$
12,208.00
$

Host
on­
site
evaluation
0
12
18
1
31
3
102
$
­

$
552.00
$
792.00
$
15.00
$
1,359.00
$
­

$
15.00
$
4,534.20
$

Perform
and
report
3
sets
of
ongoing
performance
tests
(
OPT)
for
two
method
versions
0
11.2
67.2
8.4
86.8
4
347
­

$
515.20
$
2,956.80
$
126.00
$
3,598.00
$
­

$
$
2,940.00
26,152.00
$

Number
of
respondents/
year
Total
hours/
year
Total
cost/
year
Table
2.
Laboratories
Seeking
Approval
for
Two
Method
Versions
Task
Legal
$
55.00/
hour
Management
$
46.00/
hour
Technical
$
44.00/
hour
Clerical
$
15.00/
hour
Respondent
Hours
Labor
Costs
Capital/
Startup
Costs
O&
M
Costs
APPENDIX
F
Agency
Burden
Table
F­
1
Maintain
QC
and
lab
audit
database
1
0.5
5
6.5
6.5
$
$
67.74
$
47.50
$
310.00
$
425.24
$
425.24
Review
laboratory
applications
1
0.5
4
5.5
22
118.8
$
$
67.74
$
47.50
$
248.00
$
363.24
$
5.00
7,953.98
$

Prepare
and
distribute
spiking
suspensions
for
IPTs
0.5
0.5
1
2
5
10
$
$
33.87
20.11
$
$
­
$
62.00
$
115.98
$
330.00
2,229.90
$

Review
IPT
data
1
0.5
3
4.5
5
22.5
$
$
67.74
$
47.50
$
186.00
$
301.24
$
5.00
1,531.20
$

Prepare
and
distribute
spiking
suspensions
for
OPTs
for
each
lab
for
each
method
version
0.5
0.5
3
4
75
300
$
$
33.87
20.11
$
$
­
$
186.00
$
239.98
495.00
$
55,123.50
$

Review
OPT
data
for
each
lab
for
each
method
version
0.5
0.5
5
6
75
450
$
$
33.87
$
47.50
$
310.00
$
391.37
$
5.00
29,727.75
$

Conduct
and
review
on­
site
evaluations
4
0.25
45
15
50
114
22
2467.8
$
$
270.96
4,950.00
$
$
1,425.00
$
3,100.00
$
9,745.96
2,500.00
$
264,512.74
$

Prepare,
generate,
and
distribute
reports
on
laboratory
status
1.5
1.5
9
12
12
$
$
101.61
­

$
$
103.62
$
558.00
$
763.23
5.00
$
768.23
$

Total
362,272.54
$

Technical
$
62.00/
hr
Task
Legal
GS
15
$
79.70/
hr
Management
GS
14
$
67.74/
hr
Technical
GS
11
$
40.22/
hr
Expert
$
110.00/
hr
Number
of
Labs
Total
hrs/
yr
Total
Costs
per
Year
Agency
Burden
Agency
hrs/
yr/
resp
Labor
cost/
yr/
resp
Capital
Startup
Cost
O
&
M
Costs
Clerical
GS
3
$
17.47/
hr
Management
$
95.00/
hr
APPENDIX
G
Total
Respondent
and
Agency
Burden
Tables
G­
1
Number
of
respondents
Number
of
Activities
Total
hours/
year
Total
Labor
cost/
year
Total
Annual
Capital
costs
Total
Annual
O&
M
Costs
Total
Annualized
Cost
One
Method
labs
55
4
3318
$
138,661.40
­
$
90,639.10
$
229,300.50
$
Two
Method
labs
10
4
662
27,732.00
$
­
$
17,864.90
$
45,596.90
$
Total
Burden
65
8
3980
166,393.40
$
­
$
108,504.00
$
274,897.40
$

Number
of
respondents
Number
of
Activities
Total
hours/
year
Total
Labor
cost/
year
Total
Annual
Capital
costs
Total
Annual
O&
M
Costs
Total
Annualized
Cost
Total
Burden
1
8
3388
268,984.54
$
­
$
93,783.00
$
362,272.54
$
Total
Agency
Burden
Total
Respondent
Burden
APPENDIX
H
Federal
Register
Notice
Laboratory
Quality
Assurance
Evaluation
Program/
Information
Collection
Request
[
Published
June
3,
2005]
H­
1
[
Federal
Register:
June
3,
2005
(
Volume
70,
Number
106)]
[
Notices]
[
Page
32607­
32609]
From
the
Federal
Register
Online
via
GPO
Access
[
wais.
access.
gpo.
gov]
[
DOCID:
fr03jn05­
73]

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

ENVIRONMENTAL
PROTECTION
AGENCY
[
OW­
2002­
0011,
FRL­
7921­
1]
Agency
Information
Collection
Activities:
Proposed
Collection;
Comment
Request;
Laboratory
Quality
Assurance
Evaluation
Program
for
Analysis
of
Cryptosporidium
Under
the
Safe
Drinking
Water
Act,
EPA
ICR
Number
2067.02,
OMB
Control
Number
2040­
0246
AGENCY:
Environmental
Protection
Agency.
ACTION:
Notice.

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

SUMMARY:
In
compliance
with
the
Paperwork
Reduction
Act
(
44
U.
S.
C.
3501
et
seq.),
this
document
announces
that
EPA
is
planning
to
submit
a
continuing
Information
Collection
Request
(
ICR)
to
the
Office
of
Management
and
Budget
(
OMB).
This
is
a
request
to
renew
an
existing
approved
collection.
This
ICR
is
scheduled
to
expire
on
October
31,
2005.
Before
submitting
the
ICR
to
OMB
for
review
and
approval,
EPA
is
soliciting
comments
on
specific
aspects
of
the
proposed
information
collection
as
described
below.

DATES:
Comments
must
be
submitted
on
or
before
August
2,
2005.

ADDRESSES:
Submit
your
comments,
referencing
docket
ID
number
OW­
2002­
0011,
to
EPA
online
using
EDOCKET
(
our
preferred
method),
by
e­
mail
to
ow­
docket@
epamail.
epa.
gov,
or
by
mail
to:
EPA
Docket
Center,
Environmental
Protection
Agency,
W­
01­
17
Comment
Clerk,
Water
Docket
(
MC­
4101),
EPA,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.

FOR
FURTHER
INFORMATION
CONTACT:
Sean
Conley,
Environmental
Protection
Agency,
Mail
Stop
4607M,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
202­
564­
1781;
fax
number:
202­
564­
3767;
e­
mail
address:
conley.
sean@
epa.
gov.
For
technical
inquiries,
contact
Carrie
Moulton,
EPA,
Office
of
Ground
Water
and
Drinking
Water,
Technical
Support
Center,
26
West
Martin
Luther
King
Drive
(
MS­
140),
Cincinnati,
Ohio
45268;
fax
number:
(
513)
569­
7191;
e­
mail
address:
moulton.
carrie@
epa.
gov.

SUPPLEMENTARY
INFORMATION:
EPA
has
established
a
public
docket
for
this
ICR
under
Docket
ID
number
OW­
2002­
0011,
which
is
available
for
public
viewing
at
the
Water
Docket
Docket
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
Water
Docket
is
(
202)
566­
2426.
An
electronic
version
of
the
public
docket
is
available
through
EPA
Dockets
(
EDOCKET)
at
http://
www.
epa.
gov/
edocket.
Use
EDOCKET
to
obtain
a
copy
of
the
draft
collection
of
information,
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
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.
H­
2
Any
comments
related
to
this
ICR
should
be
submitted
to
EPA
within
60
days
of
this
notice.
EPA's
policy
is
that
public
comments,
whether
submitted
electronically
or
in
paper,
will
be
made
available
for
public
viewing
in
EDOCKET
as
EPA
receives
them
and
without
change,
unless
the
comment
contains
copyrighted
material,
confidential
business
information
(
CBI),
or
other
information
whose
public
disclosure
is
restricted
by
statute.
When
EPA
identifies
a
comment
containing
copyrighted
material,
EPA
will
provide
a
reference
to
that
material
in
the
version
of
the
comment
that
is
placed
in
EDOCKET.
The
entire
printed
comment,
including
the
copyrighted
material,
will
be
available
in
the
public
docket.
Although
identified
as
an
item
in
the
official
docket,
information
claimed
as
CBI,
or
whose
disclosure
is
otherwise
restricted
by
statute,
is
not
included
in
the
official
public
docket,
and
will
not
be
available
for
public
viewing
in
EDOCKET.
For
further
information
about
the
electronic
docket,
see
EPA's
Federal
Register
notice
describing
the
electronic
docket
at
67
FR
38102
(
May
31,
2002),
or
go
to
http://
www.
epa.
gov/
edocket
Affected
entities:
Entities
potentially
affected
by
this
action
are
public
and
private
water
testing
laboratories.
EPA
estimates
that
a
total
of
65
laboratories
(
approximately
22
laboratories
per
year)
will
seek
EPA
recognition
under
the
Laboratory
QA
Program.

Title:
Laboratory
Quality
Assurance
Evaluation
Program
for
Analysis
of
Cryptosporidium
under
the
Safe
Drinking
Water
Act.

Abstract:
In
September
2000,
the
Stage
2
Microbial
and
Disinfection
Byproducts
Federal
Advisory
Committee
(
Committee)
signed
an
Agreement
in
Principle
(
Agreement)
(
65
FR
83015,
Dec.
29,
2000)
(
EPA,
2000)
with
consensus
recommendations
for
two
future
drinking
water
regulations:
the
Long
Term
2
Enhanced
Surface
Water
Treatment
Rule
(
LT2ESWTR)
and
the
Stage
2
Disinfectants
and
Disinfection
Byproducts
Rule.
The
LT2ESWTR
will
address
risk
from
microbial
pathogens,
specifically
Cryptosporidium.
The
Committee
recommended
that
the
LT2ESWTR
require
public
water
systems
(
PWSs)
to
monitor
their
source
water
for
Cryptosporidium
using
EPA
Method
1622
or
EPA
Method
1623.
Additional
Cryptosporidium
treatment
requirements
for
public
water
systems
(
PWSs)
would
be
based
on
the
source
water
Cryptosporidium
levels.
EPA
took
into
account
the
Committee's
recommendations
as
it
developed
the
proposed
LT2ESWTR,
which
was
published
on
August
11,
2003,
(
68
FR
47639),
and
is
taking
the
recommendations
into
account
as
it
develops
the
final
regulation.
In
the
LT2ESWTR
proposed
rule,
EPA
indicated
that
PWSs
would
be
required
to
use
approved
laboratories
when
conducting
Cryptosporidium
monitoring
under
the
LT2ESWTR.
EPA
also
indicated
that
laboratories
approved
to
analyze
Cryptosporidium
samples
under
the
rule
must
meet
the
criteria
in
the
Laboratory
Quality
Assurance
Evaluation
Program
(
Lab
QA
Program)
described
in
this
notice.
The
purpose
of
the
Lab
QA
Program
is
to
identify
laboratories
that
can
reliably
measure
for
the
occurrence
of
Cryptosporidium
in
surface
water.
Other
existing
laboratory
approval
programs
do
not
include
Cryptosporidium
analysis.

EPA
initiated
the
Lab
QA
Program
prior
to
promulgation
of
the
final
LT2ESWTR
to
provide
the
time
necessary
to
approve
a
sufficient
number
of
laboratories
to
assure
adequate
capacity
for
LT2ESWTR
monitoring.
Early
initiation
of
the
Lab
QA
Program
was
also
necessary
to
conform
with
the
Agreement
recommendation
that
water
systems
with
  
historical''
Cryptosporidium
data
that
are
equivalent
to
data
that
will
be
collected
under
the
LT2ESWTR
be
afforded
the
opportunity
to
use
those
  
historical''
data
in
lieu
of
collecting
new
data
under
LT2ESWTR.
In
the
LT2ESWTR
proposed
rule,
EPA
proposed
such
provisions
to
allow
water
systems
to
  
grandfather''
the
historical
data.

EPA
anticipates
the
data
generated
by
laboratories
which
meet
the
evaluation
criteria
would
be
very
high
quality,
thus
increasing
the
likelihood
that
such
data
would
warrant
consideration
as
acceptable
  
grandfathered''
data.
However,
laboratory
evaluation
would
not
guarantee
that
data
generated
will
be
acceptable
as
H­
3
  
grandfathered''
data,
nor
would
failure
to
meet
evaluation
criteria
necessarily
preclude
use
of
  
grandfathered''
data.
For
these
reasons,
EPA
established
the
Lab
QA
Program
as
a
discretionary
and
voluntary
program
under
the
Safe
Drinking
Water
Act,
section
1442
(
42
U.
S.
C.
300j­
1(
a)).
Through
today's
notice,
EPA
is
inviting
comment
on
the
continuation
of
the
Lab
QA
Program.
Under
the
Lab
QA
Program,
EPA
evaluates
laboratories
on
a
case­
by­
case
basis
through
evaluating
their
capacity
and
competency
to
reliably
measure
for
the
occurrence
of
Cryptosporidium
in
surface
water
using
EPA
Method
1622
or
EPA
Method
1623.
To
obtain
approval
under
the
program,
the
laboratory
must
submit
an
application
package
and
provide
a
demonstration
of
availability
of
qualified
personnel
and
appropriate
instrumentation,
equipment
and
supplies;
a
detailed
laboratory
standard
operating
procedure
for
each
version
of
the
method
that
the
laboratory
will
use
to
conduct
the
Cryptosporidium
analyses;
a
current
copy
of
the
table
of
contents
of
their
laboratory's
quality
assurance
plan
for
protozoa
analyses;
and
an
initial
demonstration
of
capability
(
IDC)
data
for
EPA
Method
1622
or
EPA
Method
1623,
which
include
precision
and
recovery
(
IPR)
test
results
and
matrix
spike/
matrix
spike
duplicate
(
MS/
MSD)
test
results
for
Cryptosporidium.

After
the
laboratory
submits
to
EPA
an
application
package
including
supporting
documentation,
EPA
and
the
laboratory
conduct
the
following
steps
to
complete
the
process:
1.
EPA
contacts
the
laboratory
for
follow­
up
information
and
to
schedule
participation
in
the
performance
testing
program.
2.
EPA
sends
initial
proficiency
testing
(
IPT)
samples
to
the
laboratory
(
unless
the
laboratory
has
already
successfully
analyzed
such
samples
under
EPA's
Protozoan
PE
program).
IPT
samples
packets
consist
of
eight
spiked
samples
shipped
to
the
laboratory
within
a
standard
matrix.
3.
The
laboratory
analyzes
IPT
samples
and
submits
data
to
EPA.
4.
EPA
conducts
an
on­
site
evaluation
and
data
audit.
5.
The
laboratory
analyzes
ongoing
proficiency
testing
(
OPT)
samples
three
times
per
year
and
submits
the
data
to
EPA.
OPT
sample
packets
consist
of
three
spiked
samples
shipped
to
the
laboratory
within
a
standard
matrix.
6.
EPA
contacts
laboratories
by
letter
within
60
days
of
their
laboratory
on­
site
evaluation
to
confirm
whether
the
laboratory
has
demonstrated
its
capacity
and
competency
for
participation
in
the
program.

The
procedure
for
obtaining
an
application
package,
the
criteria
for
demonstrating
capacity
and
competency,
and
other
guidance
to
laboratories
that
are
interested
in
participating
in
the
Lab
QA
Program,
are
provided
at
http://
www.
epa.
gov/
safewater/
lt2/
cla_
final.
html.

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
in
40
CFR
are
listed
in
40
CFR
part
9
and
48
CFR
Chapter
15.
The
EPA
is
soliciting
comments
to:
(
i)
Evaluate
whether
the
proposed
collection
of
information
is
necessary
for
the
proper
performance
of
the
functions
of
the
Agency,
including
whether
the
information
will
have
practical
utility;
(
ii)
Evaluate
the
accuracy
of
the
Agency's
estimate
of
the
burden
of
the
proposed
collection
of
information,
including
the
validity
of
the
methodology
and
assumptions
used;
(
iii)
Enhance
the
quality,
utility,
and
clarity
of
the
information
to
be
collected;
and
(
iv)
Minimize
the
burden
of
the
collection
of
information
on
those
who
are
to
respond,
including
through
the
use
of
appropriate
automated
electronic,
mechanical,
or
other
technological
collection
techniques
or
other
forms
of
information
technology,
e.
g.,
permitting
electronic
submission
of
responses.

Burden
Statement:
The
burden
estimate
for
the
Lab
QA
Program
H­
4
information
collection
includes
all
the
burden
hours
and
costs
required
for
gathering
information,
and
developing
and
maintaining
records
associated
with
the
Lab
QA
Program.
The
annual
public
reporting
and
record
keeping
burden
for
this
collection
of
information
is
estimated
for
a
total
of
65
respondents.
For
each
respondent,
an
average
of
19
hours
is
estimated
per
response,
with
3.3
responses
per
year,
for
a
total
of
3,980
hours
at
a
cost
of
$
166,393.
The
average
cost
per
response
is
estimated
at
$
776
per
response.
The
proposed
frequency
of
responses
is
three
times
a
year
for
analysis
and
reporting
of
PT
samples
and
once
every
three
years
for
the
on­
site
evaluation.
This
estimate
assumes
that
laboratories
participating
in
the
Lab
QA
program
have
the
necessary
equipment
needed
to
conduct
the
analyses.
Therefore,
there
are
no
start­
up
costs.
The
estimated
total
annual
capital
costs
is
$
0.00.
The
estimated
Operation
and
Maintenance
(
O&
M)
costs
is
$
108,504.

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.
APPENDIX
I
Comments
on
Federal
Register
Notice
I­
1
Comments
and
Responses
on
Federal
Register
Notice
Comment:
Beyond
OPT
testing,
the
program
does
not
include
a
component
for
ongoing
demonstration
of
adequately
skilled
staff
after
the
initial
submission
of
staff
qualifications.
Given
the
demand
for
skilled
staff
when
LT2ESWTR
is
promulgated,
there
will
be
considerable
pressures
on
laboratory
staff
that
could
lead
to
high
turnover
rates
that
will
impact
laboratory
performance.

Response:
EPA
recognizes
that
there
may
be
a
turnover
during
the
LT2
.
The
PT
program
and
the
on­
site
evaluations
as
well
as
the
ongoing
QC
required
by
the
method
will
provide
a
measure
of
ongoing
laboratory
performance.
EPA
is
evaluating
programs
for
providing
analyst
training
including
on­
line
microscopy
modules
and
train­
the­
trainer
programs.

EPA
is
also
working
with
UK
laboratories
that
have
had
similar
increases
in
capacity
as
is
anticipated
for
LT2
to
identify
strategies
for
training
and
retaining
laboratory
staff.
The
laboratories'
training
SOPs
are
reviewed
during
the
on­
site
evaluation
to
ensure
that
the
laboratories
have
appropriate
procedures
in
place
to
train
new
staff.

Comment:
The
initial
and
ongoing
proficiency
testing
samples
and
lab
audit
slides
are
not
sufficiently
challenging
to
distinguish
competent
microscopists
from
those
that
are
not.
Ideally,
these
slides
should
closely
resemble
actual
sample
slides.

Response:
EPA
is
investigating
the
possibility
of
adding
confounding
organisms
to
PT
samples
and/
or
audit
slides
to
make
them
more
challenging.
EPA
currently
adds
Tennessee
River
sediment
to
the
PT
samples
to
provide
a
more
realistic
sample.

Comment:
The
program
lacks
any
metrics
for
or
controls
to
prevent
laboratory
performance
degradation
as
the
volume
of
samples
increases
dramatically
with
ongoing
LT2ESWTR
implementation.
I­
2
Response:
The
PT
program
will
provide
an
ongoing
assessment
of
laboratory
performance
in
addition
to
the
ongoing
QC
that
is
required
by
Method
1622/
1623.
Ongoing
QC
requirements
include
analysis
of
ongoing
precision
and
recovery
samples,
method
blanks,
and
staining
controls
every
week
that
LT2
samples
are
analyzed
to
ensure
the
analytical
process
is
in
control
and
development
and
use
of
QC
charts
to
assess
ongoing
performance.

Comment:
The
program
is
not
open
to
the
performance­
based
nature
of
EPA
Method
1622
/
1623,
and
rigid
adherence
to
a
defined
method
will
likely
result
in
loss
of
valid
samples.
Consistent,
high
quality
method
performance
is
clearly
critical,
but
given
the
acceptable
performance
range
for
the
method
it
is
important
to
retain
reasonable
flexibility.

Response:
Laboratories
are
allowed
to
make
modifications
to
the
method
as
long
as
equivalent
performance
is
demonstrated
as
described
in
Section
9.1.2
of
the
method.
During
the
QA/
QC
application
process,
PT
program
and
on­
site
evaluation,
EPA
has
seen
many
laboratories
that
have
made
modifications
as
described
in
Method
1622/
1623.

Comment:
Frequency
of
lab
audits
is
inadequate
as
some
laboratories
were
audited
several
years
ago
and
personnel
and
facilities
have
changed.

Response:
EPA
will
be
re­
auditing
laboratories
and
will
focus
on
those
laboratories
that
are
anticipated
to
analyze
the
most
samples
for
LT2
and
those
that
have
undergone
significant
changes
in
personnel
and
facilities.

Comment:
Modify
initial
proficiency
test
(
IPT)
and
ongoing
proficiency
test
(
OPT)
samples
to
include
confounding
factors
such
as
algae,
debris,
and
organisms
that
are
similar
in
appearance
to
Cryptosporidium
oocysts.
Sample
modification
should
begin
with
the
next
round
of
samples
distributed
by
the
laboratory
approval
program.

Response:
EPA
is
investigating
the
possibility
of
adding
confounding
organisms
to
PT
samples
and/
or
audit
slides
to
make
them
more
challenging.
I­
3
Comment:
Modify
audit
procedures
to
provide
for
increased
laboratory
auditing
frequency.
There
should
be
a
regular
audit
schedule
so
that
the
audit
captures
current
practice
and
expectations.
The
audit
program
should
place
a
particular
focus
on
laboratories
where
facilities
have
changed
(
or
require
a
re­
certification
process
for
laboratories
that
experience
dramatic
"
change"
such
as
significant
turnover
in
laboratory
management
or
key
personnel,
significant
physical
changes
in
the
laboratory
facilities,
etc.).
Laboratories
experiencing
dramatic
surges
in
processing
capacity
also
deserve
focused
attention
by
the
audit
program.

Response:
EPA
will
be
re­
auditing
laboratories
and
will
focus
on
those
laboratories
that
are
anticipated
to
analyze
the
most
samples
for
LT2
and
those
that
have
undergone
significant
changes
in
personnel
and
facilities.
Another
comment
recommends
less
frequent
audits.
EPA
believes
current
frequency
is
adequate
in
light
of
extensive
QC
requirements.

Comment:
Require
that
laboratory
owners
/
operators
to
state
the
number
of
Method
1622/
1623
samples
that
the
laboratory
is
capable
of
processing
per
week
within
its
existing
equipment,
personnel,
and
quality
assurance
/
quality
control
plan
each
quarter.
This
should
be
required
when
the
laboratory
submits
its
OPR
samples.

a.
This
estimate
should
either
be
compared
to
or
based
on
an
EPA
determined
metric
that
reflects
the
requirements
of
Method
1622/
1623,
LT2ESWTR
requirements,
sound
laboratory
practice
and
QA/
QC
expectations.

b.
This
submittal
could
be
treated
as
Confidential
Business
Information
(
CBI).

c.
EPA
should
use
this
submittal
as
a
measure
of
whether
analytical
performance
within
that
laboratory
is
under
appropriate
control.

d.
In
using
this
measure
EPA
would
have
to
allow
enough
flexibility
for
laboratories
to
demonstrate
how
they've
streamlined
the
method
if
they
have
done
so.

Response:
EPA
has
been
collecting
information
on
laboratory
capacity
of
the
number
of
samples
laboratories
analyze
per
month
as
part
of
the
audit
application
and
plans
to
collect
this
information
with
increased
frequency
after
implementation.

EPA
will
request
that
laboratories
submit
with
their
PT
data
the
average
number
of
samples
they
are
currently
analyzing
per
week.
This
information
will
be
considered
confidential.
I­
4
Comment:
Ongoing
communication
with
laboratories
and
on­
site
evaluations
should
recognize
that
modification
of
the
method
is
anticipated
by
the
EPA:

"
In
recognition
of
advances
that
are
occurring
in
analytical
technology,
the
laboratory
is
permitted
to
modify
certain
method
procedures
to
improve
recovery
or
lower
the
costs
of
measurements,
provided
that
all
required
quality
control
(
QC)
tests
are
performed
and
all
QC
acceptance
criteria
are
met.
Method
procedures
that
can
be
modified
include
front­
end
techniques,
such
as
filtration
or
immunomagnetic
separation
(
IMS).
The
laboratory
is
not
permitted
to
use
an
alternate
determinative
technique
to
replace
immunofluorescence
assay
in
this
method
(
the
use
of
different
determinative
techniques
are
considered
to
be
different
methods,
rather
than
modified
version
of
this
method).
..."
(
EPA
Method
1623,
Section
9.1.2,
page
11)
[
emphasis
added]

Response:
EPA
agrees
that
communication
with
the
laboratories
is
important
and
acknowledges
that
laboratories
are
allowed
to
modify
Method
1623
as
stated
in
section
9.1.2.

Comment:
What
efforts
are
made
by
epa
that
once
approved
the
lab
standards
will
not
fail?
where
is
the
annual
testing
to
be
sure
standards
are
kept?

Response:
EPA
requires
ongoing
proficiency
testing
(
OPTs)
every
four
months
for
the
laboratories
participating
in
the
program.
This
ensures
that
laboratories
are
maintaining
method
performance.
Ongoing
QC
requirements
of
Method
1622/
1623
include
analysis
of
ongoing
precision
and
recovery
samples,
method
blanks,
and
staining
controls
for
every
20
samples
every
week
that
LT2
samples
are
analyzed
to
ensure
the
analytical
process
is
in
control
and
development
and
use
of
QC
charts
to
assess
ongoing
performance.

Comment:
EPA
currently
estimates
that
the
burden
of
this
information
collection
request
will
be
72
hours
per
respondent
annually,
where
the
respondent
burden
is
described
as
the
total
time,
effort,
or
I­
5
financial
resources
expended
by
persons
to
generate,
maintain,
retain,
or
disclose
or
provide
information
to
or
for
the
agency
under
this
program.
This
estimate
significantly
underestimates
the
burden
of
the
current
program.
The
program
requires:

1.
Submission
of
an
extensive
application
every
3
years;

2.
Processing
of
eight
initial
proficiency
testing
(
IPT)
samples
per
version
of
EPA
Method
1622
and
1623
employed
in
a
respondent
laboratory;

3.
Submission
to
an
on­
site
evaluation
of
the
laboratory
at
least
once;

4.
Correction
of
deficiencies
noted
in
the
on­
site
evaluation;

5.
Notice
to
EPA
when
an
employee
is
added
to
the
laboratory
with
required
EPA
Method
1622/
1623
training.

6.
Processing
of
three
ongoing
proficiency
testing
(
OPT)
samples
approximately
every
four
months
per
version
of
EPA
Method
1622
and
1623
employed
in
the
respondent
laboratory;

7.
Preparation
of
detailed
laboratory
standard
operating
procedures
for
each
version
of
the
method
used
for
routine
Cryptosporidium
analyses;
and
8.
Preparation
of
a
summary
of
percent
recoveries
for
all
OPR
and
MS
samples
analyzed
at
the
laboratory
for
the
past
six
months.

Response:
EPA
feels
that
the
burden
estimate
is
appropriate.
The
estimate
was
derived
with
input
from
the
laboratories.

Laboratories
will
only
need
to
submit
an
application
prior
to
their
audit.
If
it
is
a
re­
audit,
the
laboratories
will
only
be
required
to
submit
SOPs
that
have
changes
since
their
last
audit.
Only
laboratories
that
are
not
currently
participating
in
the
PT
program
will
be
required
to
analyzed
eight
initial
proficiency
testing
samples.
The
estimate
does
not
include
preparation
of
SOPs
and
the
laboratory
Quality
Assurance
Project
Plan,
which
are
part
of
formal
quality
assurance
program
as
required
by
Method
1622/
1623
and
are
not
specific
requirements
of
this
program.
Laboratories
are
only
required
to
submit
a
summary
of
the
percent
recoveries
for
OPR
and
MS
samples
as
part
of
their
application
which
is
required
no
more
than
once
every
three
years.
I­
6
Comment:
This
program
provides
an
independent
third­
party
evaluation
of
protozoan
testing
laboratories,
filters
and
method
modifications.
The
program
is
a
valuable
tool
for
laboratories
as
well
as
their
clients
and
we
believe
that
it
is
appropriate
that
EPA
continue
to
provide
this
service.

Response:
Thank
you.

Comment:
Considering
the
complexity
of
the
Cryptosporidium
analytical
methods
and
the
variability
that
can
occur
from
lab
to
lab,
it
is
important
to
retain
a
lab
certification/
approval
process
to
assist
the
labs
in
collecting
high
quality
data
and
to
assist
the
customers
of
the
labs
in
selecting
labs
wherein
they
can
have
confidence
in
the
results.
The
EPA's
Laboratory
Quality
Assurance
Evaluation
Program
is
important
to
maintain
until
the
States
obtain
their
own
capabilities
to
manage
a
similar
program
and
add
Cryptosporidium
to
their
list
of
certified
parameters.
In
our
opinion,
after
a
few
modifications
as
stated
above,
the
Lab
QA
Program
is
highly
beneficial
and
has
been
worth
our
lab's
investment
to
achieve
and
maintain
approval
for
Cryptosporidium
data
collection.

Response:
Thank
you.

Comment:
We
have
found
the
Lab
QA
Program
to
be
valuable
and
beneficial,
and
support
its
continuation.
We
found
most
helpful
the
on­
site
evaluation.
The
EPA
sent
qualified
and
knowledgeable
auditors
who
provided
good
feedback
to
improve
our
laboratory's
work.
If
a
similar
audit
is
done
every
3­
5
years
by
such
qualified,
lab­
based
staff
as
we
have
already
experienced
then
it
will
continue
to
provide
a
benefit
to
the
many
labs
that
are
audited.

Response:
Thank
you.
EPA
will
be
re­
auditing
laboratories
and
will
focus
on
those
laboratories
that
are
anticipated
to
analyze
the
most
samples
for
LT2
and
those
that
have
undergone
significant
changes
in
personnel
and
facilities.

Comment:
The
ongoing
laboratory
proficiency
testing
has
also
been
helpful,
especially
in
placing
in
context
the
information
about
our
lab
with
information
from
other
laboratories
and
from
other
methods
being
used.
This
provides
a
benchmark.
I­
7
However,
three
times
a
year
for
proficiency
testing
is
excessive
considering
the
quality
control
already
included
in
the
method.
We
suggest
that
a
frequency
of
once
a
year
would
be
adequate.

Response:
EPA
feels
that
three
sets
of
OPTs
are
necessary
to
ensure
continuing
acceptable
performance
especially
as
the
volume
of
samples
analyzed
by
laboratories
increases
during
LT2
monitoring.

Comment:
Given
the
LT2ESWTR
timeline,
under
which
most
surface
water
systems
will
conduct
sampling
within
a
year
or
two
of
rule
promulgation,
it
is
difficult
to
ascertain
from
this
Federal
Register
notice
the
availability
of
sufficient
laboratory
capacity.
Without
sufficient
capacity
of
appropriately
qualified
laboratories
that
results
in
high­
quality
Cryptosporidium
data,
systems
could
be
subject
to
inappropriate
LT2ESWTR
treatment
requirements.

Response:
EPA
realizes
the
importance
of
laboratory
capacity.
EPA
continuously
evaluates
the
capacity
as
more
laboratories
are
approved
to
perform
the
method.
EPA
is
evaluating
programs
for
providing
analyst
training,
including
online
microscopy
modules
and
train­
the­
trainer
programs,
to
allow
for
increased
laboratory
capacity.
EPA
is
also
working
with
UK
laboratories
that
have
had
similar
increases
in
capacity
as
is
anticipated
for
LT2
to
identify
strategies
for
training
and
retaining
laboratory
staff.
