Document ID: EPA-HQ-OW-2003-0002-0038
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-03-12T05:00Z

Plan
for
the
Assessment
of
Detection
and
Quantitation
Limits
Under
Section
304(
h)
of
the
Clean
Water
Act
Draft:
December
4,
2001
Version
03
U.
S.
Environmental
Protection
Agency
Office
of
Water
Office
of
Science
and
Technology
Acknowledgments
This
plan
was
prepared
by
Charles
E.
White,
Maria
Gomez­
Taylor,
Henry
D.
Kahn,
William
A.
Telliard,
and
Khouane
Ditthavong
of
the
Engineering
and
Analysis
Division
in
EPA's
Office
of
Water.
Harry
McCarty
with
DynCorp
I&
ET
and
Dale
Rushneck
with
Interface,
Inc.
provided
assistance
under
EPA
Contract
No.
68­
C­
01­
091,
and
Sidina
Dedah
with
Science
Applications
International
Corporation
provided
assistance
under
EPA
Contract
No.
68­
C­
99­
233.

Questions
or
comments
regarding
this
plan
should
be
addressed
to:

Charles
E.
White,
Statistician
Engineering
and
Analysis
Division
(
4303)
Office
of
Science
and
Technology
USEPA
Office
of
Water
1200
Pennsylvania
Avenue,
NW
Washington,
DC
20460
White.
Charles­
E@
EPA.
Gov
Plan
for
Detection
and
Quantitation,
Draft
Version
03
(
December
4,
2001)
Page
1
Plan
for
the
Assessment
of
Detection
and
Quantitation
Limits
Under
Section
304(
h)
of
the
Clean
Water
Act
Introduction
EPA
promulgated
Method
1631B:
Mercury
in
Water
by
Oxidation,
Purge
and
Trap,
and
Cold
Vapor
Atomic
Fluorescence
Spectrometry
on
June
8,
1999
(
64
FR
30417).
The
method
was
developed
specifically
to
measure
concentrations
of
mercury
at
ambient
water
quality
criteria
levels,
and
includes
a
method
detection
limit
(
MDL)
of
0.2
ng/
L
(
ppt).
This
MDL
is
approximately
400­
times
lower
than
previously
approved
methods
for
measurement
of
mercury.

Following
promulgation,
a
law
suit
was
filed
challenging
EPA
on
the
validity
of
the
method.
The
basis
of
the
challenge
included
several
specific
aspects
of
Method
1631
itself
as
well
as
the
procedures
used
to
establish
the
specific
MDL
and
minimum
level
of
quantitation
(
ML)
published
in
the
method.

In
order
to
settle
the
lawsuit,
EPA
entered
into
a
settlement
agreement
with
the
Alliance
of
Automobile
Manufacturers,
Inc.,
the
Chemical
Manufacturers
Association,
and
the
Utility
Water
Act
Group
(
collectively
the
"
Petitioners")
and
the
American
Forest
and
Paper
Association
("
Intervenor")
on
October
19,
2000.
Clause
6
of
the
settlement
agreement
required
EPA
to:

reassess
EPA's
method
detection
limit
(
MDL;
40
CFR
136,
Appendix
B)
and
minimum
level
of
quantitation
(
ML)
procedures
according
to
a
schedule
;

perform
an
external
peer
review
of
this
reassessment,

perform
an
external
peer
review
of
any
alternative
procedures
under
consideration;
and

propose
a
revised
or
alternate
procedure,
if
warranted
This
document
contains
the
detailed
plan
for
the
reassessment
called
for
in
Clause
6
and
for
complying
with
the
schedule
specified
in
the
settlement
agreement.

Origins
of
the
Office
of
Water's
Detection
and
Quantitation
Concepts
Section
304(
h)
of
the
Clean
Water
Act
requires
that
the
EPA
Administrator
"
promulgate
guidelines
establishing
test
procedures
for
the
analysis
of
pollutants"
to
be
monitored
and
regulated
under
the
National
Pollutant
Discharge
Elimination
System
(
NPDES).
To
meet
the
requirements
of
Section
304(
h),
EPA
proposes
and
promulgates
test
methods
at
40
CFR
part
136.
The
approved
methods
have
been
drawn
from
a
variety
of
sources,
including
methods
developed
by
EPA
as
well
as
methods
from
voluntary
consensus
standards
bodies
(
VCSBs)
such
as
the
American
Public
Health
Association
(
APHA)
which
publishes
Standard
Methods
for
the
Examination
of
Water
and
Wastewater
and
the
American
Society
for
Testing
and
Materials
(
ASTM).

Among
considerations
for
approval
of
a
method
at
40
CFR
136
are
the
demonstrated
performance
characteristics
of
precision,
bias,
and
detection
and/
or
quantitation
limit.
Among
these
characteristics,
detection
and
quantitation
limits
have
been
the
most
controversial.
Broadly
Plan
for
Detection
and
Quantitation,
Draft
Version
03
(
December
4,
2001)
Page
2
speaking,
detection
refers
to
the
capability
of
an
analytical
procedure
to
identify
or
indicate
the
presence
of
an
analyte
in
a
sample.
The
detection
limit
is
the
concentration
level
at
which
the
determination
is
made
to
report
that
an
analyte
has
been
found
or
"
detected"
in
a
sample.
Quantitation
refers
to
the
capability
for
measurement
of
an
analyte;
that
is,
associating
a
measured,
numerical
value
with
the
concentration
of
analyte
in
a
sample.
The
quantitation
limit
is
the
lowest
concentration
at
which
a
quantified,
measured
value
for
the
amount
of
an
analyte
in
a
sample
is
reported.

EPA's
Method
Detection
Limit
and
Minimum
Level
of
Quantitation
EPA's
Environmental
Monitoring
and
Support
Laboratory
in
Cincinnati,
OH
(
EMSL­
Ci),
developed
a
procedure
for
determining
a
detection
limit,
known
as
the
method
detection
limit
(
MDL)
as
one
measure
of
method
performance.
The
MDL
was
defined
by
Glaser
et
al.
in
an
article
in
Environmental
Science
and
Technology
in
1981
(
ES&
T,
Vol.
15,
No.
12,
pp
1426­
1435,
1981)
as:

"...
the
minimum
concentration
of
a
substance
that
can
be
identified,
measured,
and
reported
with
99%
confidence
that
the
analyte
concentration
is
greater
than
zero
and
is
determined
from
replicate
analyses
of
a
sample
of
a
given
matrix
containing
analyte."

On
October
26,
1984,
the
MDL
procedure
was
promulgated
as
Appendix
B
to
40
CFR
part
136.
Both
the
MDL
concept
and
the
specific
definition
at
part
136
were
widely
adopted
by
other
Program
Offices
within
EPA.
The
MDL
has
also
been
used
extensively
in
the
environmental
analytical
chemistry
community
outside
EPA.

Prior
to
the
formal
development
of
the
MDL,
EPA
included
the
term
"
minimum
level"
(
ML)
or
"
minimum
level
of
quantitation"
in
some
gas
chromatography/
mass
spectrometry
(
GC/
MS)
methods
that
were
proposed
on
December
3,
1979,
and
subsequently
promulgated
on
October
26,
1984.
This
original
definition
of
the
ML
did
not
involve
the
MDL,
but
was
an
effort
to
recognize
the
importance
of
mass
spectral
identification
and
calibration
in
establishing
the
quantitative
performance
of
GC/
MS
procedures.
The
ML
was
defined
as:

"...
the
lowest
level
at
which
the
analytical
system
shall
give
recognizable
mass
spectra
(
background
corrected)
and
acceptable
calibration
points."

In
1994,
in
response
to
concerns
voiced
by
both
the
regulated
community
and
some
State
regulatory
agencies,
EPA
refined
the
definition
of
the
ML,
relating
it
to
the
American
Chemical
Society's
definition
of
the
limit
of
quantitation
(
LOQ),
which
is
defined
as
10
times
the
standard
deviation
of
replicate
blank
or
low
concentration
measurements
(
see
Analytical
Chemistry
Vol.
52,
p.
2242,
1980,
and
Vol.
55,
2210­
2218,
1983).
Thus,
the
ML
became
related
to
the
MDL
and
was
often
calculated
as
3.18
times
the
MDL,
because
the
MDL
is
commonly
determined
as
3.14
times
the
standard
deviation
of
7
replicate
measurements
and
10
divided
by
3.14
equals
3.18.
This
calculation
makes
the
ML
analogous
to
the
ACS
LOQ
(
i.
e.,
the
ML
is
defined
as
10
times
the
standard
deviation
used
to
determine
the
MDL).
Plan
for
Detection
and
Quantitation,
Draft
Version
03
(
December
4,
2001)
Page
3
Organization
of
this
Plan
For
the
purposes
of
this
plan,
EPA
has
identified
16
events
or
tasks
to
be
completed
as
part
of
the
assessment
of
detection
and
quantitation
limits.
Each
event
is
summarized,
the
analytical
methodology
is
discussed,
and
currently
envisioned
supporting
materials
are
listed.
Each
event
is
indexed
to
specific
requirements
in
the
Settlement
Agreement.
The
schedule
for
the
event
is
presented
graphically
on
the
last
page
of
this
plan.
[
Assignment
information
(
STAT,
AMT,
SASB)
will
not
be
included
in
the
version
circulated
to
the
public.]

Planned
Events
Where
listed,
data
sets
indicated
are
those
that
will
be
considered
in
the
evaluation.
Other
data
sets
may
be
considered
at
a
later
time.

1.
Finalize
Internal
Draft
of
Detailed
Plan
The
detailed
Plan
for
reassessment
of
detection
and
quantitation
procedures
is
developed
here.
The
analytical
(
statistical)
methodology
will
address
issues
suggested
in
the
scientific
literature
and
issues
developed
in
settlement
discussions.

2.
Agency
Workgroup
Review
of
Plan
The
Agency
Workgroup
for
detection
and
quantitation
will
review
and
comment
on
this
plan.
This
Agency
Workgroup
is
comprised
of
measurement
analysts
and
statisticians
representing
different
Offices
within
EPA.
Time
and
resources
allowing,
the
plan
may
also
be
reviewed
and
commented
on
by
outside
reviewers.
Comments
from
these
and
other
sources
will
be
reviewed
by
the
Core
Workgroup
and
the
Plan
will
be
revised
where
appropriate.
The
Core
Workgroup
is
comprised
of
measurement
analysts
and
statisticians
within
the
Office
of
Science
and
Technology
who
have
primary
responsibility
for
developing
and
implementing
this
plan.

3.
Issues
Development
Properties
considered
for
detection/
quantitation
estimates
are
to
be
developed
in
relation
to
the
issues
listed
in
this
section.
At
least
two
drafts
of
the
issue
development
papers
are
planned,
in
addition
to
the
final
set
of
papers
that
incorporates
comments
from
peer
review.

a.
Concepts
of
the
Lower
Limit
to
Measurement
[
STAT
(
Chuck)]

Summarizes
the
results
of
a
literature
review
on
detection
and
quantitation.
Includes
a
history
of
the
MDL
in
EPA's
water
program,
data
censoring,
and
how
different
interest
groups
see
the
issues.
[
We
will
revise
a
review
that
was
completed
in
1998
to
bring
it
up
to
date.]

b.
Concepts
in
Relation
to
Office
of
Water
Applications
[
STAT]

Under
section
304(
h)
of
the
Clean
Water
Act,
EPA
is
required
to
promulgate
measurement
methods
to
support
the
development
of
permits
under
the
National
Plan
for
Detection
and
Quantitation,
Draft
Version
03
(
December
4,
2001)
Page
4
Pollution
Discharge
Elimination
System
(
NPDES).
Specific
applications
supporting
this
mission
are
listed
below.
While
there
are
many
similarities
among
applications
with
regard
to
use
and
interpretation
of
detection
and
quantitation
estimates,
differences
among
the
applications
also
exist.
For
each
application
listed,
methods
for
determining
detection
and
quantitation
estimates
and
their
use
will
be
evaluated
based
on
a
literature
review
and
statistical
theory.

i.
Method
Performance
Verification
at
a
Lab
[
AMT]

Detection
and
quantitation
estimates
are
used
to
evaluate
the
performance
of
individual
labs
in
application
of
a
particular
method.
This
issue
will
be
considered
in
regard
to
existing
measurement
methods
and
to
measurement
methods
to
be
developed
in
the
future.

ii.
Method
Development
and
Promulgation
[
AMT]

Detection
and
quantitation
estimates
are
often
integral
parts
of
measurement
methods
at
the
time
they
are
published
or
promulgated.
This
application
will
be
considered
in
light
of
the
appropriate
use
and
interpretation
of
detection
and
quantitation
estimates
in
methods
development.

iii.
Effluent
Guidelines
Development
[
STAT]

Detection
and
quantitation
estimates
are
fundamental
in
various
ways
to
the
collection
and
analysis
of
data
used
in
the
development
of
technology
based
regulations
for
the
treatment
of
wastewater.

iv.
Water
Quality
Based
Effluent
Limits
[
STAT]

Detection
and
quantitation
estimates
relate
in
various
ways
to
the
development
of
water
quality
based
regulations
for
the
discharge
of
wastewater.

v.
Permit
Compliance
Monitoring
[
STAT]

Evaluation
will
focus
on
the
appropriate
definition
and
use
of
detection
and
quantitation
estimates
in
the
monitoring
of
wastewater
discharges
for
permit
compliance.

vi.
Non­
Regulatory
Studies
and
Monitoring
[
STAT]

Detection
and
quantitation
estimates
are
integral
to
the
design
and
implementation
of
non­
regulatory
studies
and
monitoring
of
ambient
water
and
wastewater
discharges.

vii.
Descriptive
versus
Prescriptive
Uses
of
Lower
Limits
to
Measurement
[
STAT]
Plan
for
Detection
and
Quantitation,
Draft
Version
03
(
December
4,
2001)
Page
5
The
procedures
used
to
develop
detection
and
quantitation
estimates
will
be
evaluated
against
the
objectives
of
describing
the
expected
capability
of
a
new
measurement
method
as
used
by
any
group
of
labs,
as
used
by
a
highly
proficient
lab,
or
some
other
standard.

viii.
Use
of
a
pair
of
related
detection
and
quantitation
procedures
in
all
Office
of
Water
applications.
[
STAT]

The
evaluation
will
examine
whether
a
single
set
of
detection
and
quantitation
procedures
that
are
designed
to
work
together
may
be
adequate
to
meet
the
requirements
of
the
different
applications
for
detection
and
quantitation
estimates
listed
above.

c.
Criteria
for
the
Selection
and
Appropriate
Use
of
Statistical
Models
[
STAT]

Evaluate
the
extent
to
which
models
are
useful
in
the
analysis
and
interpretation
of
data
that
may
be
used
in
estimation
of
detection
and
quantification
levels.
Analysis
will
be
based
on
a
literature
review,
EPA's
Episode
6000
data,
and
statistical
theory.
EPA's
Episode
6000
data
were
collected
for
the
purpose
of
evaluating
the
functional
relationship
between
measurement
variation
and
spike
concentrations.
These
single
lab
generated
data
include
measurement
results
over
a
wide
range
of
concentrations
from
a
variety
of
measurement
techniques.
Other
data
sets
including
interlab
data
used
in
the
development
of
methods
1631
for
mercury
and
1638
for
a
number
of
metals
by
ICPMS
may
also
be
considered.

d.
Methodology
for
Parameter
Estimation
[
STAT]

Evaluate
statistical
methodologies
used
for
estimation
of
model
parameters.
Such
methodologies
may
include
maximum
likelihood,
least
squares,
Bayesian,
iterative
estimation,
closed
form
estimation,
and
others.
Precision
and
bias
will
be
evaluation
factors.
Analysis
will
be
based
on
a
literature
review,
EPA's
Episode
6000
data,
simulations,
and
statistical
theory.

e.
Statistical
Tolerance
and
Prediction
[
STAT
(
Henry)]

Evaluate
the
use
of
statistical
tolerance
and
prediction
in
the
development
of
detection/
quantitation
procedures.
Analysis
will
be
based
on
a
literature
review
and
statistical
theory.

f.
Criteria
for
Design
of
Detection
and
Quantification
Studies,
Including
Selection
of
Concentration
Levels
[
AMT/
STAT]

Selection
of
spiking
levels
and
other
related
factors
in
the
design
of
detection
and
quantitation
studies
will
be
considered.
Analysis
will
be
based
on
a
literature
review,
EPA's
Episode
6000
data,
simulations,
and
statistical
theory.
Plan
for
Detection
and
Quantitation,
Draft
Version
03
(
December
4,
2001)
Page
6
g.
Sources
of
Variability
[
STAT
(
Henry)]

The
estimation
of
various
sources
of
variability
and
their
impact
will
be
considered
for
a
number
of
sources.
These
sources
include
within
and
between
lab
variability,
variability
over
time,
and
variability
associated
with
calibration.

h.
Incorporate
Elements
of
Probability
Design
[
STAT
(
Henry)]

Appropriate
ways
to
integrate
randomization
into
design
of
studies
aimed
at
determining
detection
and
quantitation
levels
will
be
considered.
Analysis
will
be
based
on
a
literature
review
and
statistical
theory.

i.
False
Positives
and
False
Negatives
[
STAT]

Appropriate
ways
to
deal
with
false
positive
and
false
negative
measurements
in
the
context
of
detection
and
quantitation.
A
false
positive
is
a
measurement
result
indicating
the
presence
of
a
substance
in
a
sample
that
does
not
contain
the
substance.
A
false
negative
is
a
measurement
result
indicating
that
a
sample
does
not
contain
a
substance
that
is
in
fact
present
in
the
sample.
Analysis
will
be
based
on
a
literature
review
and
statistical
theory.

j.
Measurement
Quality
over
the
Life
of
a
Method
[
AMT]

Measurement
quality
of
an
analytical
method
is
expected
to
improve
as
experience
in
using
the
method
accumulates.
This
phenomenon
has
been
observed
widely.
EPA
will
discuss
why
this
happens,
present
supporting
data
from
EPA
performance
evaluation
studies,
and
consider
the
implications
for
detection
and
quantitation.

k.
Matrix
effects
[
AMT]

The
sample
matrix
which
is
the
collection
of
all
substances
in
a
sample,
may
have
an
effect
on
the
ability
of
a
measurement
process
to
identify
and
quantify
substances.
Analysis
of
the
influence
of
matrix
effects
on
detection
and
quantitation
will
be
based
on
measurement
theory
and
experience.

l.
Background
Contamination
[
AMT]

Background
contamination
of
a
sample
is
the
addition
of
the
substance
of
interest
from
extraneous
sources
in
the
lab
or
field.
For
example,
methylene
chloride
is
among
the
analytes
of
interest
in
the
class
of
compounds
known
as
volatile
organics.
It
is
also
commonly
used
in
laboratories
as
the
solvent
to
extract
organic
compounds
from
environmental
samples.
As
a
result,
it
is
not
unusual
for
the
residual
methylene
chloride
vapors
in
the
laboratory
to
increase
the
concentration
of
methylene
chloride
measured
in
a
sample.
Analytical
methods
for
volatile
organics
include
quality
control
samples
such
as
field
and
laboratory
blanks
that
can
be
used
to
identify
when
such
contamination
occurs.
The
evaluation
of
the
effects
of
contamination
on
detection
limit
estimates
will
Plan
for
Detection
and
Quantitation,
Draft
Version
03
(
December
4,
2001)
Page
7
considered
on
the
basis
of
theoretical
considerations,
professional
judgement
and
the
results
of
the
analysis
of
quality
control
samples.

m.
Outliers
[
STAT
(
Henry)]

Outliers
are
measurement
results
generated
by
a
different
process
than
the
one
under
study.
Analysis
will
be
based
on
a
literature
review
and
statistical
theory.

n.
Instrument
Non­
Response
[
STAT
(
Henry)]

Instruments
do
not
always
produce
a
measurement
result
from
an
appropriately
prepared
sample.
Sometimes
this
is
due
to
uncontrollable
instrument
limitations,
sometimes
it
is
due
to
uncontrollable
instrument
settings
(
thresholds)
established
by
the
manufacturer,
and
sometimes
it
is
due
to
controllable
thresholds.
Analysis
will
be
based
on
a
literature
review
and
statistical
theory.

o.
Accepting
the
Procedures
of
Consensus
Organizations
[
AMT]

Measurement
methods,
detection
procedures,
and
quantitation
procedures
are
all
developed
by
voluntary
consensus
organizations.
The
National
Technology
Transfer
and
Advancement
Act
(
NTTAA)
and
OMB
Circular
A­
119
require
the
Agency
to
accept
consensus
standards
that
meet
the
needs
of
the
government
for
a
particular
application.
Analysis
will
be
based
on
legal
requirements,
regulation,
and
the
needs
of
the
Agency.

p.
Completeness
of
Measurement
Procedures
with
regard
to
Study
Design
and
Implementation
[
STAT]

Measurement
procedures
(
methods)
may
be
more
or
less
strictly
designed.
Variability
in
what
is
allowed
in
the
procedures
may
add
to
variability
in
the
measurement
results.
Analysis
will
be
based
on
statistical
theory.

q.
Under
what
Conditions
is
a
Measurement
Method
Described
by
a
Limit
Procedure
[
STAT]

A
detection
or
quantitation
limit
may
be
intended
for
one
purpose
but
developed
under
somewhat
different
conditions.
For
example,
it
is
difficult
to
develop
detection
and
quantitation
limits
for
routine
measurement
when
the
detection
and
quantitation
limits
must
be
established
before
routine
measurement
can
begin.
Analysis
will
be
based
on
statistical
theory.

r.
National
versus
Local
Standards
for
Measurement
[
AMT]

EPA
is
writing
national
standards
for
detection/
quantitation
estimates.
However,
local
governments
implementing
EPA
regulations
may
use
standards
that
equal
or
are
more
stringent
than
the
EPA
standards.
Proposed
procedures
for
detection
and
quantitation
Plan
for
Detection
and
Quantitation,
Draft
Version
03
(
December
4,
2001)
Page
8
may
impact
the
standards
used
by
local
governments.
Analysis
will
be
based
on
law,
regulation,
and
experience.

s.
Ability
of
Study
Managers,
Bench
Chemists,
and
Study
Statisticians
to
Do
What
Is
Required
by
a
Limit
Procedure
[
AMT]

Theoretically
appealing
procedures
may
not
be
practical
to
implement.
Analysis
will
be
based
on
experience.

t.
Cost
to
Implement
Limit
Procedures
[
AMT]

Technically
possible
and
theoretically
appealing
procedures
may
be
costly
to
implement.
Analysis
will
be
based
on
experience.

4.
Criteria
Development
[
STAT]

Based
on
the
evaluation
of
issues
presented
in
Event
3,
criteria
for
the
selection
of
detection
and
quantitation
methodology
will
be
developed.

5.
Evaluation
of
methods
from
Voluntary
Consensus
Standards
Bodies
(
VCSB)

Based
on
the
criteria
developed
in
Event
4,
a
number
of
VCSB
procedures
will
be
evaluated.
Such
standards
will
include
those
published
by
American
Chemical
Society
(
ACS),
American
Society
for
Testing
and
Materials
(
ASTM),
International
Standards
Organization
(
ISO),
and
the
International
Union
of
Pure
and
Applied
Chemistry
(
IUPAC).
EPA
plans
to
develop
one
draft
of
this
evaluation
in
addition
to
the
final
documentation
that
takes
into
account
comments
received
during
peer
review.

6.
Reassessment
of
Existing
Agency
Procedures
Based
on
the
criteria
developed
in
Event
4,
the
existing
method
detection
limit
(
MDL)
and
minimum
level
(
ML)
procedures
will
be
evaluated.
EPA
plans
to
develop
one
draft
of
this
evaluation
in
addition
to
the
final
documentation
that
takes
into
account
comments
received
during
peer
review.

7.
Development
of
Alternative
Procedures
Modified
MDL/
ML
procedures
or
one
or
more
alternate
procedures
will
be
developed
and
evaluated
against
the
criteria
developed
in
Event
4.
Such
alternatives
may
be
modifications
to
existing
procedures.
EPA
plans
to
develop
at
least
two
drafts
of
this
evaluation
in
addition
to
the
final
documentation
that
takes
into
account
comments
received
during
peer
review.
Plan
for
Detection
and
Quantitation,
Draft
Version
03
(
December
4,
2001)
Page
9
8.
Evaluate
Alternative
Procedures
Based
on
the
criteria
developed
in
Event
4,
the
alternative
procedures
developed
in
Event
7
will
be
evaluated.
EPA
plans
to
develop
at
least
two
drafts
of
this
evaluation
in
addition
to
the
final
documentation
that
takes
into
account
comments
received
during
peer
review.

9.
Assemble
Peer
Review
Package
The
peer
review
package
will
include
documentation
of
EPA's
issue
development,
criteria
development,
evaluation
of
procedures
discussed
above,
operational
definitions
for
any
procedures
to
be
proposed,
and
any
supporting
reports
generated
by
EPA.
EPA
plans
to
put
together
the
peer
review
package
over
a
period
of
about
two
weeks.

10.
External
Peer
Review
and
EPA
Response
[
SASB]

An
external
peer
review
will
be
conducted
concerning
the
findings
of
this
reassessment
of
existing
procedures
and
assessment
of
alternatives.
The
charge
to
the
external
peer­
review
panel
will
include
the
issues
specified
in
the
Settlement
Agreement.
The
Petitioner
and
Intervenor
will
simultaneously
review
and
comment
on
the
peer­
review
package.

11.
Select
Recommended
Option
The
Core
Workgroup
will
select
a
recommended
option
as
part
of
the
process
of
preparing
materials
for
briefing
management.

12.
Write
Federal
Register
Notice
/
Develop
Record
Write
the
Federal
Register
publication
announcing
the
results
of
EPA's
reassessment
of
existing
procedures
and
assessment
of
alternatives.
The
announcement
will
include
an
opportunity
for
public
comment
and
the
comment
period
will
be
no
less
than
120
days.
The
legal
record
of
this
action
is
developed
at
the
same
time.
A
first
draft
of
the
publication
will
be
produced
concurrently
with
the
end
of
peer
review,
multiple
drafts
are
expected
during
the
Agency
Review
process,
and
the
final
version
will
incorporate
peer
review
comments.

13.
Agency
Review,
Select
Proposed
Option,
and
Sign
Off
Brief
the
Agency
Workgroup
and
multiple
layers
of
EPA
management
to
establish
the
Agency's
proposed
option.

14.
OMB
Review
OMB
has
the
option
of
taking
ninety
days
to
review
any
proposed
regulation.
Plan
for
Detection
and
Quantitation,
Draft
Version
03
(
December
4,
2001)
Page
10
15.
Administrator
Signs
Notice
or
Proposal
EPA's
Administrator
reviews
and
signs
the
proposal.
The
notice
or
proposal
is
then
forwarded
to
the
Office
of
the
Federal
Register
for
publication.

16.
Meet
with
Petitioners
Under
the
Settlement
Agreement,
EPA
is
required
to
meet
with
petitioners
once
every
six
months
in
order
to
brief
them
on
the
progress
of
the
reassessment/
assessment.
A
copy
of
this
plan
will
be
provided
to
the
Petitioners
on
or
before
the
meeting
scheduled
for
December
2001.

Relationship
of
the
Plan
to
the
Settlement
Agreement
In
this
section,
the
pertinent
portion
of
the
settlement
agreement
is
quoted
and
events
in
the
plan
addressing
these
issues
are
identified
within
brackets.

Pertinent
Excerpt
from
the
Settlement
Agreement
6.
Reassessment
of
Method
Detection
Limit
and
Minimum
Level
Procedures
a.
On
or
before
February
28,
2003,
EPA
shall
sign
and
forward
to
the
Office
of
the
Federal
Register
for
prompt
publication
a
notice
inviting
public
comment
on
a
reassessment
of
the
existing
Agency
procedures
for
determination
of
sensitivity
of
analytic
test
methods
for
aqueous
samples
[
Events
11and
15],
specifically,
EPA
procedures
for
determining
the
detection
limits
and
levels
of
quantitation
of
contaminants
in
aqueous
samples,
including,
at
a
minimum,
the
"
Definition
and
Procedure
for
Determination
of
the
Method
Detection
Limit"
published
at
40
C.
F.
R.
Part
136,
Appendix
B,
as
well
as
the
"
minimum
level"
procedures,
which
is
described
in
section
17.8
of
Method
1631B
[
Event
6].
The
notice
shall
invite
comment
on
EPA's
evaluation
of
one
or
more
alternative
procedures
for
determining
and
describing
test
sensitivity
[
Events
7
and
11].
The
notice
also
may
propose
modifications
to
the
existing
procedures
[
Events
7
and
11].
The
notice
shall
invite
public
comment
for
a
period
of
no
less
than
one
hundred
twenty
(
120)
days
[
Event
11].

b.
Prior
to
publishing
the
notice
inviting
public
comment
on
EPA
procedures
for
determining
test
sensitivity,
EPA
shall
submit
its
reassessment
of
existing
procedures
(
including
any
proposed
modifications
thereof)
and
its
evaluation
of
alternatives
for
peer
review
by
experts
in
the
field
of
analytical
chemistry
and
the
statistical
aspects
of
analytical
data
interpretation
[
Event
10].
In
its
charge
to
the
peer
review
panel,
EPA
shall
request
that
the
peer
review
consider:
criteria
for
selection
and
appropriate
use
of
statistical
models
[
Event
3.
c.];
methodology
for
parameter
estimation
[
Event
3.
d.];
statistical
tolerance
and
prediction
[
Event
3.
e.];
criteria
for
design
of
detection
and
quantification
studies,
including
selection
of
concentration
levels
("
spiking
levels")
[
Event
3.
f.];
interlaboratory
variability
[
Event
3.
g.];
and
incorporation
of
elements
of
probability
design
[
Event
3.
h.].
EPA
(
or
its
authorized
representative)
shall
conduct
the
Plan
for
Detection
and
Quantitation,
Draft
Version
03
(
December
4,
2001)
Page
11
peer
review
in
accordance
with
EPA's
current
peer
review
policies
in
the
January
1998
Science
Policy
Council
Handbook
(
EPA
100­
B­
98­
00),
including
any
subsequentlydeveloped
EPA
peer
review
documents
that
may
revise
or
amend
that
Handbook
[
Event
10].

[
c.
Note
­
there
is
no
clause
"
6.
c"
in
the
settlement
agreement]

d.
During
the
peer
review
period,
EPA
shall
also
provide
an
opportunity
for
concurrent
review
and
comment
by
the
Petitioners
and
Intervenor
[
Event
10].

e.
In
the
development
of
the
reassessment/
assessment
of
alternatives,
EPA
shall
provide
the
Petitioners
and
Intervenor
with
a
periodic
opportunity
to
meet
(
i.
e.,
every
six
(
6)
months)
on
the
Agency's
progress.
EPA
shall
prepare
and
present
the
Petitioners
and
Intervenor
with
the
Agency's
"
plan"
for
conducting
the
reassessment/
assessment
of
alternatives
on
or
before
the
second
such
periodic
meeting
[
Event
16].
Where
appropriate,
EPA
shall
provide
the
Petitioners
and
Intervenor
with
copies
of
relevant
documents
in
advance
of
such
meetings.

f.
On
or
before
September
30,
2004,
EPA
shall
sign
and
forward
to
the
Office
of
the
Federal
Register
for
prompt
publication
a
notice
taking
final
action
on
the
notice
described
in
subparagraph
6.
a.
Coincident
with
publication
of
the
notice
of
final
action,
EPA
shall
provide
Petitioners
and
Intervenor
an
opportunity
to
meet
to
discuss
the
implications
of
the
final
notice
and/
or
the
need
for
any
subsequent
EPA
action
in
light
of
the
final
notice
[
The
current
plan
does
not
include
events
occurring
after
signature
on
the
notice
or
proposal].
Plan
for
Detection
and
Quantitation,
Draft
Version
03
(
December
4,
2001)
Page
12