Document ID: EPA-HQ-RCRA-2002-0025-0008
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2002-09-09T04:00Z

RESPONSES
TO
PUBLIC
COMMENTS
SUBMITTED
REGARDING
THE
MAY
8,
1998
FEDERAL
REGISTER
NOTICE
(64
FR
2635)
OF
EPA'S
INTENT
TO
PROPOSE
REMOVING
REQUIRED
USES
OF
SW­
846
METHODS
FROM
THE
RCRA
REGULATIONS
September
2002
Prepared
by:

Science
Applications
International
Corp.
11251
Roger
Bacon
Drive
Reston,
VA
20190
Prepared
for:

U.
S.
Environmental
Protection
Agency
Office
of
Solid
Waste
1200
Pennsylvania
Avenue
Washington,
DC
20460
EPA
Contract
No.
68­
W0­
0122,
WA
No.
0­
5
SAIC
Project
No.
06­
6312­
08­
4045­
XXX
Introduction
On
May
8,
1998
(63
FR
25430),
the
U.
S.
Environmental
Protection
Agency
(the
Agency
or
EPA)
published
a
notice
of
intent
to
reform
the
implementation
of
RCRA­
related
methods
and
monitoring.
One
reform
measure
included
removing
unnecessary
required
uses
of
SW­
846
methods
from
the
RCRA
regulations.
The
Agency
posed
four
specific
questions
to
the
public
regarding
this
topic.
This
document
summarizes
the
public
comments
on
each
of
the
four
questions
and
provides
the
Agency's
responses.
This
response
to
comment
document
was
developed
for
inclusion
in
the
docket
to
the
proposed
rule
to
remove
unnecessary
required
uses
of
SW­
846
methods
(Methods
Innovation
Rule
or
MIR).
Any
mention
of
a
proposed
rule
in
the
comment
responses
refers
to
the
MIR.
I
­
1
I.
Are
Any
of
the
Required
Uses
of
SW­
846
Methods
in
the
RCRA
Regulations
for
Other
than
Method­
defined
Parameters
Necessary?

1.
Comment:
One
commenter
(Washington
State
Dept.
of
Ecology)
believed
that
some
regulations
should
include
testing
requirements
and
indicate
which
testing
method
is
appropriate.
The
commenter
gave
the
following
regulations
as
examples:
40
CFR
261.21(
a)(
2),
characteristic
of
ignitable
solids;
40
CFR
261.23,
characteristic
of
reactivity;
40
CFR
261.3(
a)(
2)(
v),
rebuttable
presumption
for
used
oil;
and
Appendix
III
to
Part
261.
The
commenter
also
stated
that
his
State
government
needs
assurance
that
EPA
will
dedicate
personnel
to
provide
training
and
guidance
documents
regarding
which
methods
will
satisfy
regulatory
requirements.

Response:
The
Agency
does
not
agree
with
the
commenter's
examples
of
regulations
that
should
include
method­
specific
testing
requirements.
The
40
CFR
261.21(
a)(
2)
(characteristic
for
ignitable
solids)
and
40
CFR
262.23
(reactivity
characteristic)
regulations
currently
do
not
mention
any
specific
methods
and
a
demonstration
of
whether
a
waste
exhibits
these
hazardous
waste
characteristics
instead
relies
on
generator
knowledge.
The
Agency
believes
that
there
are
no
test
methods
capable
of
accurately
identifying
those
characteristics
in
a
waste.
If
such
methods
existed,
EPA
would
revise
the
regulations
to
require
use
of
the
methods,
since
they
would
be
used
to
analyze
a
method­
defined
parameter.
Regarding
the
third
example,
40
CFR
261.3(
a)(
2)(
v),
the
MIR
proposed
rule
is
revising
this
used
oil
rebuttable
presumption
regulation
to
clarify
that
appropriate
methods
other
than
SW­
846
methods
are
options
for
the
demonstration.
EPA
does
not
believe
it
is
necessary
to
require
specific
methods
because
this
demonstration
could
be
made
for
many
different
types
of
wastes
or
analytes
and
is
not
dependent
on
any
particular
method
technology
to
generate
a
correct
answer.
Regarding
the
last
example,
Appendix
III
to
Part
261,
"Chemical
Analysis
Test
Methods,"
purposely
does
not
include
testing
requirements.
Its
role
is
only
to
refer
readers
to
Chapter
Two
of
SW­
846
for
guidance
on
method
selection.

Regarding
the
need
for
training
of
regulatory
personnel,
the
Agency
will
offer
guidance
to
the
States,
EPA
Regions
and
the
regulated
community
regarding
the
implementation
of
this
rule
by
means
of
training
modules,
workshops,
and
fact
sheets.
The
Agency
has
already
developed
and
presented
at
many
different
national
locations
a
relevant
training
module
entitled
"Analytical
Strategy
for
the
RCRA
Program."
The
Agency
is
currently
developing
another
module
to
assist
regulated
entities
and
others
in
the
determination
of
applicable
methods.
EPA
is
also
developing
checklists
and
other
tools
that
may
be
used
to
document
appropriate
method
performance.

2.
Comment:
One
commenter
(California
Dept.
of
Toxic
Substances
Control)
agreed
that
EPA
should
limit
required
uses
of
SW­
846
methods
to
method­
defined
parameters.
The
commenter
added
that
EPA
should
provide
a
list
of
these
methods
for
public
comment.
The
commenter
believed
that
Method
3050
is
used
for
a
method­
defined
parameter,
and
that
this
method
should
be
included
in
the
aforementioned
list.
The
Agency
should
continue
to
require
SW­
846
methods
for
all
other
uses,
but
allow
a
PBMS
approach
in
specific
instances
upon
approval
of
the
regulating
agency.

Response:
The
Agency
agrees
that
any
required
uses
of
SW­
846
methods
should
be
restricted
to
method­
defined
parameters.
The
MIR
proposed
rule
lists
those
SW­
846
methods
that
will
remain
incorporated
by
reference
in
the
RCRA
regulations
at
40
CFR
260.11(
a).
The
public
can
I
­
2
comment
on
the
list.
The
list
does
not
include
Method
3050,
"Acid
Digestion
of
Sediments,
Sludges,
and
Soils,"
because
it
is
a
preparatory
method
that
is
not
required
by
RCRA
regulation
for
analysis
of
a
method­
defined
parameter.

The
Agency
disagrees
that
a
PBMS
approach
should
only
be
allowed
on
an
individual
basis
if
approved
by
the
regulatory
agency.
EPA
currently
allows
a
PBMS
approach
throughout
many
of
its
RCRA
regulations
and
does
not
normally
require
approval
or
advanced
notification
to
use
it.
Such
an
approach
would
be
counter
to
the
purpose
of
adopting
PBMS.
When
regulated
entities
decide
to
use
a
PBMS
approach,
EPA
does
recommend
that
they
consult
with
their
regulating
authorities
(State
or
Federal)
during
development
of
performance
goals
and
during
method
selection.

3.
Comment:
One
commenter
(Laidlaw
Environmental
Services)
noted
that
additional
methods
"should
be
required."
The
commenter
listed
Method
1312
"Synthetic
Precipitation
Leaching
Procedure,"
Method
1320
"Multiple
Extraction
Procedure,"
and
Method
5035,
"Closed
System
Purge­
and­
Trap
and
Extraction
for
Volatile
Organics
in
Soil
and
Waste
Samples."

The
commenter
also
noted
that
"holding
times
for
analytical
parameters
specified
in
SW­
846
must
remain
defined."
However,
the
commenter
stated
that
many
of
the
currently
defined
holding
times
have
no
technical
basis
and
review
and
revision
is
very
much
needed.

Response:
The
methods
listed
by
the
commenter
are
not
required
by
any
RCRA
regulation
and
EPA
does
not
plan
to
add
regulations
which
require
those
methods.
There
is
no
regulatory
reason
to
do
so
at
this
time.
Two
of
them
(Methods
1312
and
1320)
are
used
in
the
analysis
of
method­
defined
parameters.
(A
method
may
exist
for
the
analysis
of
an
MDP
and
still
not
be
part
of
a
regulation.)
Method
5035
is
not
used
in
the
analysis
of
a
method­
defined
parameter.

Regarding
holding
times
specified
in
SW­
846,
the
Agency
believes
that
this
issue
is
outside
the
scope
of
the
present
proposed
rule.
However,
the
Agency
is
developing
new
guidance
on
holding
times
for
volatile
compounds.
The
appropriate
SW­
846
methods
will
be
revised
as
necessary
to
reflect
that
guidance
once
it
is
issued.
Alternate
holding
times
to
those
published
may
be
employed
provided
that
the
generator
or
analyst
can
demonstrate
appropriate
analyte
stability.

4.
Comment:
One
commenter
(ACIL
Environmental
Sciences
Section)
agreed
that
there
are
no
necessary
required
uses
of
SW­
846
for
other
than
method­
defined
parameters.
The
commenter
supported
removal
of
SW­
846
"incorporation
by
reference"
in
40
CFR
260.11,
and
any
other
specific
mention
of
the
manual
in
the
RCRA
regulations,
except
for
method­
defined
parameters.
In
addition,
the
commenter
believed
that
EPA
should
provide
guidance
on
which
SW­
846
methods
are
appropriate
for
given
monitoring
applications
(e.
g.,
similar
to
the
list
of
recommended
methods
in
Part
264
for
Appendix
IX
groundwater
monitoring).
However,
this
guidance
should
clearly
indicate
that
other
options
are
possible
under
a
PBMS
approach.

Response:
A
complete
list
of
appropriate
or
recommended
methods
for
all
RCRA
monitoring
requirements
is
not
practical.
Whether
any
method
is
appropriate
for
any
given
monitoring
situation
is
a
project­
and
matrix­
specific
issue.
It
was
relatively
easy
to
provide
examples
in
Appendix
IX
to
Part
264
for
a
matrix
such
as
groundwater.
However,
any
list
of
example
appropriate
methods,
including
the
one
in
Part
264
for
groundwater
monitoring,
becomes
quickly
outdated
due
to
the
many
and
frequent
advances
in
method
development.
(It
is
for
this
I
­
3
reason
that
the
Agency
is
proposing
to
remove
the
SW­
846
methods
listed
in
Appendix
IX
to
Part
264.)
Given
this
environment
and
the
Agency's
plan
to
promote
a
PBMS
approach,
it
is
not
likely
that
the
Agency
will
publish
any
more
similar
lists
in
the
regulations.
In
addition,
developing
a
list
of
SW­
846
methods
to
cover
most
circumstances
would
be
very
difficult,
and
may
discourage
the
consideration
of
other
methods
from
other
sources.
Instead,
EPA
recommends
that
regulated
entities
consult
with
their
regulating
authorities
for
guidance
during
method
selection.
In
addition,
the
Agency
does
not
plan
on
issuing
lists
of
"recommended"
methods,
because
"recommended"
is
too
easily
misconstrued
to
be
"required"
and
thus
defeats
the
purpose
of
this
rulemaking
and
goes
counter
to
EPA's
policy
on
PBMS.

5.
Comment:
Two
commenters
(Chemical
Manufacturer's
Association
and
Ford
Motor
Company)
requested
clarification
regarding
the
term
"method­
defined"
parameter
and
more
method
examples.
In
addition,
one
commenter
(Ford
Motor
Company)
believed
that
all
parameters
are
"method­
defined"
because
any
change
made
to
a
method
will
have
an
impact
on
the
end
result
with
a
strong
dependence
on
the
matrix.
The
commenter
cited
the
following
example
actions
as
capable
of
altering
results:
altering
the
pH,
solvent,
reagents,
extraction
time
or
conditions
in
a
preparation
step;
the
manner
in
which
the
reagents,
glassware
and
equipment
are
prepared,
calibrated
and
maintained;
changing
the
chromatographic
or
chemical
separation
technique;
and
altering
the
use
of
the
determinative
step
(e.
g.,
Office
of
Water's
Streamlining
Proposal).

Response:
In
the
proposed
rule,
the
Agency
clarifies
the
term
"method­
defined
parameter
(MDP)"
and
provides
several
examples
of
methods
used
for
such
a
parameter.
An
MDP
is
a
measurable
property
where
the
analytical
result
is
wholly
dependant
on
the
process
or
technology
used
to
make
the
measurement.
The
property
can
be
correctly
measured
by
only
one
particular
method.
Some
method­
defined
properties
are
not
required
analyses
in
the
RCRA
regulations
and
some
are.
Examples
of
RCRA­
required
method­
defined
parameters
and
their
SW­
846
methods
include
Method
1311,
"The
Toxicity
Characteristic
Leaching
Procedure"
(TCLP),
used
to
determine
whether
waste
leaching
potential
is
greater
than
the
levels
specified
in
the
toxicity
characteristic
at
40
CFR
261.24;
Method
9040,
"pH
Electrometric
Measurement,"
used
to
demonstrate
whether
a
waste
exhibits
the
corrosivity
characteristic
based
on
pH
levels;
and
Method
9095,
"Paint
Filter
Liquids
Test,"
used
to
demonstrate
the
absence
or
presence
of
free
liquids
in
wastes
managed
in
RCRA­
regulated
treatment,
storage,
and
disposal
facilities.

Some
of
the
method
changes
mentioned
by
one
of
the
commenters
might
affect
a
result.
However,
such
changes
are
part
of
the
process
to
optimize
a
particular
method
to
maximize
analytical
performance,
e.
g.,
recovery
of
the
analytes
of
concern
from
a
given
matrix,
and
should
not
be
confused
with
method
use
to
analyze
a
method­
defined
parameter
as
defined
by
this
proposed
action.

Also,
for
the
purposes
of
this
rulemaking,
whether
or
not
any
method
change
would
change
a
result
is
not
what
defines
an
MDP.
What
defines
an
MDP
method,
in
the
context
of
this
rule,
is
whether
it
is,
as
written,
used
to
define
a
regulatory
parameter.
Sometimes
the
"parameter"
cited
by
the
regulation
was
developed
in
conjunction
with
the
method.
For
example,
the
TCLP
test
is
used
to
determine
if
a
waste
exhibits
the
characteristic
of
toxicity.
The
TCLP
was
the
test
used
to
develop
the
particular
leachate
of
concern
(a
waste
extract)
and
the
regulatory
thresholds
specified
in
the
regulations.
The
TCLP
was
developed
to
emulate
the
leachate
that
might
be
generated
if
the
waste
was
co­
disposed.
No
other
method
is
known
to
yield
the
same
leachate
from
a
waste
as
the
TCLP.
Also,
the
TCLP
is
used
only
to
generate
the
leachate
itself,
I
­
4
and
is
not
used
to
specifically
determine
the
analyte
levels
in
the
leachate.
Any
reliable
and
appropriate
method
can
be
used
to
determine
the
total
constituent
levels
in
a
TCLP
leachate.
The
determinative
measurement
of
the
leachate
itself
does
not
involve
measurement
of
an
MDP.

The
Agency
also
notes
that
adoption
of
a
PBMS
approach
does
not
mean
that
any
change
to
a
method
should
be
made.
As
noted
above,
method
modifications
are
primarily
done
to
improve
characterization
performance
for
certain
analytes
in
a
given
sample
matrix.
Obviously,
method
changes
should
be
avoided
if
they
will
adversely
affect
its
ability
to
accurately
characterize
the
analytes
of
concern
in
the
matrix
of
concern
and
if
performance
objectives
cannot
be
met.
Performance
factors
of
concern
might
include
precision,
accuracy
(or
bias),
recovery,
representativeness,
comparability,
and
sensitivity
(detection,
quantitation,
or
reporting
limits).
Regulated
entities
should
demonstrate
and
document
that
any
procedure,
even
an
unchanged
method,
is
capable
of
providing
appropriate
performance
for
its
intended
application.

6.
Comment:
One
commenter
(American
Petroleum
Institute)
said
that
EPA
should
provide
more
specific
information
as
to
its
plans
for
revising
the
regulations
to
remove
SW­
846
requirements.
The
FR
notice
merely
stated
that
EPA
may
"remove"
required
uses
of
SW­
846
except
where
SW­
846
defines
the
regulatory
parameters.
The
commenter
added
that
this
explanation
does
not
identify
specifically
which
rules
the
EPA
believes
require
use
of
SW­
846,
or
which
of
those
rules
use
SW­
846
to
define
parameters.
The
commenter
provided
a
listing
of
regulations
that
specify
the
use
of
SW­
846.

Response:
The
Agency
provides
specific
information
in
the
MIR
proposed
rule
on
how
the
regulations
will
be
revised
to
remove
unnecessary
required
uses
of
SW­
846
methods.
With
the
exception
of
40
CFR
261.24
(toxicity
characteristic),
all
the
regulatory
references
listed
by
the
commenter
are
proposed
for
revision
by
the
MIR
rule.
The
Agency
believes
that
these
required
uses
of
SW­
846
methods
are
unnecessary
and
should
be
removed
from
the
RCRA
regulations.
The
Agency
intends
to
restrict
the
required
uses
of
SW­
846
to
only
those
cases
where
the
SW846
method
defines
the
regulatory
parameter.
Such
is
the
case
of
40
CFR
261.24,
the
toxicity
characteristic,
which
specifies
the
use
of
SW­
846
Method
1311,
"The
Toxicity
Characteristic
Leaching
Procedure"
(TCLP).
II
­
1
II.
What
Might
Be
the
Economic
Impact
on
the
Regulated
Community
and
Other
Entities
(e.
g.,
Small
Businesses)
as
a
Direct
Result
of
the
Removal
of
Certain
Required
Uses
of
SW­
846
Methods?

1.
Comment:
One
commenter
(Washington
State
Dept.
of
Ecology)
believed
that
the
immediate
impact
on
the
regulated
community
may
be
a
feeling
of
uncertainty
as
a
result
of
the
removal
of
certain
required
uses
of
SW­
846
methods.
Members
of
the
regulated
community
may
wonder
if
they
have
spent
their
money
to
use
a
correct
test
method.
Regulating
agencies
may
experience
a
degree
of
uncertainty
as
well.
The
commenter
also
anticipated
cost
increases
to
State
governments
that
are
associated
with
training
regulatory
staff,
such
as
compliance
personnel,
to
evaluate
analytical
results.

Another
commenter
(EDF)
stated
that,
given
limited
program
resources
at
the
State
and
Federal
levels,
it
may
not
be
either
feasible
or
appropriate
to
devote
substantial
program
resources
toward
the
review
of
new
and
unproven
testing
methods
selected
by
various
members
of
the
regulated
community.
At
a
minimum,
EPA
must
carefully
evaluate
each
proposed
rule
change
in
this
regard.

Response:
The
Agency
believes
that
communication
and
training,
at
all
levels,
will
help
address
any
concerns
that
the
regulated
community
and
regulatory
agencies
may
have
regarding
implementation
of
the
proposed
revisions.
The
Agency
plans
to
provide
guidance
to
all
parties
through
training
modules,
workshops
and
other
outreach
activities.
The
Agency
believes
that
such
communication
and
training
efforts
will
help
ensure
consistency
in
implementation
of
this
rule
and
help
limit
any
associated
costs.
Each
data
generating
effort
is
project­
specific
and
has
different
analytical
needs,
and
this
approach
to
monitoring
is
more
adaptable
to
those
differences.
The
Agency
recommends
that
members
of
the
regulated
community
work
with
the
regulating
authorities
during
development
of
performance
criteria
and
method
selection.
This
approach
in
particular
should
help
diminish
uncertainty
within
the
regulated
community.
A
strong
EPA
Headquarters
leadership
will
be
present
to
enable
implementation
of
this
approach
to
RCRA­
related
monitoring.
The
Agency
does
not
believe
that
the
proposed
revisions
will
result
in
significant
cost
increases
to
State
governments
for
training
staff
on
how
to
evaluate
data.
Under
RCRA,
regardless
of
the
method
used,
the
States
should
already
be
conducting
reviews
of
analytical
results.
If
States
and
regulated
entities
are
not
currently
evaluating
the
data
against
project
DQOs
and
other
project­
specific
requirements,
then
they
are
not
adequately
documenting
the
effectiveness
of
the
data
and
the
correctness
of
related
decisions.

Finally,
as
noted
in
the
proposed
rule,
we
specify
that
only
appropriate
methods
should
be
used
in
lieu
of
the
required
SW­
846
methods
(e.
g.,
and
thus
not
just
any
new
method),
and
that
such
methods
should
be
published
by
reliable
sources
and
accepted
as
such
by
the
scientific
community.
This
process
for
method
selection
is
no
different
then
that
generally
practiced
during
compliance
with
existing
regulations
which
do
not
explicitly
require
a
particular
method.

2.
Comment:
One
commenter
(Chemical
Manufacturer's
Association)
believed
that
functioning
under
PBMS
as
a
result
of
the
removal
of
certain
required
uses
of
SW­
846
methods
could
have
a
favorable
economic
impact
if
certain
controls
are
put
into
place
to
limit
costs
connected
to
demonstrating
and
documenting
method
performance.
II
­
2
Response:
Although
the
commenter
did
not
provide
specific
examples
of
method
performance
cost
controls,
the
Agency
generally
disagrees
that
controls
in
demonstrating
method
performance
should
be
put
in
place
to
limit
costs.
The
Agency
believes
that
QC
measures
or
other
activities
to
demonstrate
adequate
method
performance
should
be
identified
during
the
planning
stage.
The
types
and
numbers
of
such
measures
are
project­
specific
considerations
and
should
not
be
controlled
in
general
terms.
EPA
expects
project
planners
to
try
to
control
costs
through
all
stages
of
the
project,
to
the
degree
possible
without
sacrificing
effective
data.
In
addition,
the
Agency
believes
that
demonstrating
that
a
method
other
than
SW­
846
is
appropriate
should
not
involve
much
more
than
what
already
is
done
for
any
sampling
and
analysis
effort
under
RCRA,
e.
g.,
when
showing
that
SW­
846
methods
are
appropriate
for
a
given
analyte
and
matrix.
The
proposed
action
does
not
add
any
new
regulatory
requirements
or
require
any
additional
reports
beyond
those
already
required.

3.
Comment:
Two
commenters
(ACIL
Environmental
Sciences
Section
and
American
Petroleum
Institute)
believed
that
the
regulated
community
should
benefit
from
cost
effective
monitoring
programs
as
a
result
of
the
removal
of
certain
required
uses
of
SW­
846
methods.
However,
both
commenters
stated
that
there
will
be
little
economic
benefit
to
the
regulated
community
if
EPA/
OSW­
HQ
and
EPA/
ORD
do
not
provide
effective
guidance
and
support
to
the
EPA
Regions
and
States.
Another
commenter
believed
that
there
will
be
no
beneficial
impact
on
the
regulated,
unless
and
until
authorized
States
incorporate
the
changes.
The
commenter
was
confident
that,
if
guidance
is
provided,
the
States
will
implement
the
changes
and
allow
use
of
the
PBMS
approach,
in
lieu
of
strict
use
of
SW­
846
methods.

Response:
The
Agency
agrees
with
the
commenters
that
the
regulated
community
stands
to
benefit
from
the
use
of
cost­
effective
monitoring
technologies
once
the
unnecessary
required
uses
of
SW­
846
methods
are
eliminated.
The
Agency
believes
that
additional
flexibility
in
method
use,
as
provided
by
the
proposed
revisions,
will
provide
opportunities
for
cost
savings
in
RCRA­
relating
sampling
and
analysis
efforts.
Appropriate
project
planning
leading
to
proper
cost­
effective
method
selection
will
have
a
significant
effect
on
reduction
of
analytical
costs,
an
option
which
is
currently
available
under
the
many
existing
regulations
which
do
not
unnecessarily
require
specific
methods.

Adoption
of
the
proposed
revisions
by
authorized
States
is
one
key
factor
for
successful
nationwide
implementation
of
this
rule.
State
participation
will
help
ensure
that
all
members
of
the
regulated
community
fully
benefit
from
the
new
flexibility
allowed
as
a
result
of
removing
unnecessary
requirements
to
use
SW­
846
methods.
However,
authorized
States
are
not
required
to
adopt
the
regulatory
revisions.

The
Agency
also
agrees
that
training
of
all
parties
involved
­­
the
States,
EPA
Regions,
and
the
regulated
community
­­
is
important
to
successful
implementation
of
this
rule.
The
Agency
plans
to
offer
training
at
all
levels
in
order
to
ensure
that
the
proposed
revisions
are
implemented
in
as
consistent
manner
as
possible
(given
the
project­
specific
nature
of
the
sampling
and
analysis
efforts)
and
that
any
associated
costs
are
kept
to
a
minimum.
The
Agency
plans
to
offer
guidance
regarding
the
implementation
of
this
rule
by
means
of
training
modules,
workshops,
fact
sheets
and
other
outreach
activities.
Over
the
past
few
years,
the
Agency
has
provided
relevant
program­
specific
training
(e.
g.,
"Analytical
Strategy
for
the
RCRA
Program:
A
II
­
3
Performance­
Based
Approach")
for
EPA
Headquarters,
Regional,
and
State
personnel
involved
in
RCRA
activities
that
include
sampling
and
analysis.
The
Agency
also
plans
to
offer
other
courses
on
the
evaluation
of
data
and
permit
writing
from
a
PBMS
and
effective
data
standpoint.

4.
Comment:
One
commenter
(Ford
Motor
Company)
noted
that
the
impact
on
the
regulated
community
and
other
entities
is
wholly
dependent
upon
the
Agency's
PBMS
implementation
plan
which
has
yet
to
be
defined.
The
commenter
stated
that
this
could
have
a
negative
impact
on
independent
testing
laboratories.
The
impact
on
small
businesses
will
be
influenced
by
how
much
PBMS
drives
the
cost
of
analysis
up.
Large
corporations
with
their
own
analytical
testing
capabilities
will
likely
save
money
in
testing
costs
under
PBMS.
However,
the
compliance
and
enforcement
issues
could
easily
outweigh
any
benefits
gained
through
the
system.

Response:
The
commenter
did
not
give
specific
examples
of
negative
impacts
and
compliance
issues
that
might
outweigh
any
benefits,
therefore,
the
Agency
cannot
fully
respond
to
the
comment.
However,
the
Agency
provides
in
the
proposed
rule
some
information
on
how
it
plans
to
implement
a
PBMS
approach
for
RCRA­
related
sampling
and
analysis
efforts.
In
addition,
the
OSW
Methods
Team
web
site
provides
information
regarding
the
RCRA
methods
program
approach
to
PBMS
implementation.
A
copy
of
the
OSW's
PBMS
implementation
plan
(which
addresses
PBMS
implementation
within
the
RCRA
Program)
can
be
found
at
http://
www.
epa.
gov/
epaoswer/
hazwaste/
test/
pbms.
htm.

The
Agency
expects
that
the
proposed
action
to
remove
unnecessary
required
uses
of
SW­
846,
when
finalized,
will
promote
overall
cost
effectiveness
and
help
reduce
costs.
The
proposed
action
lifts
restrictions
to
use
methods
other
than
SW­
846,
effectively
increasing
the
choices
of
appropriate
analytical
methods
available
to
the
regulated
community.
Thus,
regulated
entities
can
select
methods
that
are
more
appropriate
and
cost­
effective
for
their
particular
applications.

The
Agency
also
believes
that
demonstrating
and
documenting
method
performance
under
a
PBMS
approach
generally
should
not
entail
additional
costs.
Demonstrating
that
a
method
is
appropriate,
whether
it
is
an
SW­
846
method
or
another
method,
should
not
involve
much
more
that
what
already
should
be
done
for
any
RCRA
sampling
and
analysis
effort.

As
part
of
the
proposed
rule,
the
Agency
is
seeking
more
comments
from
the
regulated
community
regarding
any
concerns
related
to
implementation
and
compliance
assessments.
The
public
should
provide
specific
examples
or
reasons
for
any
concerns.
III
­
1
III.
What
Concerns
Exist
Regarding
Implementation
and
Enforcement
of
the
Allowed
Use
of
"Other
Appropriate
Methods"
in
lieu
of
a
Specific
SW­
846
Method
for
RCRA­
related
Monitoring?

1.
Comment:
Some
commenters
(Washington
State
Dept.
of
Ecology
and
Ford
Motor
Company)
were
concerned
about
inconsistent
implementation
from
state
to
state.
One
commenter
(Washington
State
Dept.
of
Ecology)
believed
that
without
clear
guidance
from
the
EPA,
the
use
of
"other
appropriate
methods,"
in
lieu
of
a
specific
SW­
846
method
for
RCRArelated
monitoring,
would
leave
room
for
differing
interpretations
among
the
States
as
to
which
analyses
meet
the
regulatory
intent.
The
commenter
felt
that
this
situation
could
cause
a
great
deal
of
confusion
and
frustration
in
the
regulated
community.
This
problem
could
arise
due
to
the
shift
in
the
onus
of
determining
what
test
method
would
meet
the
regulatory
intent.
As
individual
State
authorities
become
responsible
for
implementing
RCRA
regulations,
selecting
methods
from
SW­
846,
or
some
other
source
of
analytical
test
methods
such
as
ASTM,
may
result
in
a
wide
variance
of
acceptable
methods
between
the
States.

Another
commenter
(Ford
Motor
Company)
noted
that
most
of
the
authorized
States
will
need
to
revise
their
programs
to
adopt
equivalent
requirements
under
State
law.
Otherwise,
different
methods
may
be
acceptable
for
the
same
waste
analysis
in
different
states.
The
commenter
stated
that
this
situation
is
a
result
of
the
PBMS
requirements
being
imposed
pursuant
to
preHSWA
authority.

Response:
In
the
proposed
rule,
the
Agency
provides
more
guidance
regarding
what
constitutes
an
appropriate
method
for
a
sampling
and
analysis
activity
under
RCRA.
In
general,
such
a
method
is
reliable
and
accepted
as
such
by
the
scientific
community
and
is
applicable
to
its
intended
use
–
i.
e.,
the
method
will
generate
effective
data.
It
is
not
problematic
that
different
methods
can
be
used
for
the
same
analytical
determination,
provided
that
the
correct
answer
is
reached.
Each
method
could
be
appropriate
and
meet
the
performance
goals
of
the
project.
Therefore,
different
methods
can
be
used
by
different
States
or
other
entities
for
related
decision­
making,
provided
that
appropriate
methods
are
used
and
project­
specific
performance
objectives
are
met.
Method
selection
and
use
decisions
are
project­
specific,
and
should
be,
given
the
wide
variety
of
matrices
and
analytes
of
concern
under
the
RCRA
regulations.

Second,
there
are
no
"PBMS
requirements"
which
must
be
adopted
by
the
States.
While
the
Agency
encourages
the
adoption
of
the
PBMS
approach,
authorized
States
are
not
required
to
revise
their
regulations
and
programs
to
incorporate
this
flexibility
in
method
selection
and
use.
This
is
because
the
proposed
rule
regulatory
changes
do
not
impose
additional
requirements
(in
fact,
they
instead
remove
existing
requirements)
and
do
not
broaden
the
scope
of
the
RCRA
regulations.
The
revisions
will
be
applicable
only
in
those
States
that
do
not
have
final
authorization.
Therefore,
in
authorized
States,
the
changes
will
not
be
applicable
until
and
unless
the
State
revises
its
program
to
adopt
the
revisions.

Finally,
the
Agency
believes
that
guidance
or
training
of
all
parties
involved
is
needed
to
assure
successful
implementation
of
the
revisions
proposed
in
this
rule.
The
Agency
will
provide
training
to
States,
Regions
and
the
regulated
community
in
the
form
of
training
modules,
workshops,
fact
sheets
and
other
outreach
efforts
to
ensure
consistent
implementation.
III
­
2
2.
Comment:
One
commenter
(California
Dept.
of
Toxic
Substances
Control)
noted
that
the
term
"other
appropriate
methods"
needs
to
be
defined
in
a
way
that
is
consistent
with
legal
standards.
The
commenter
offered
the
example
of
California
standards
which
require
that
data
be
generated
by
techniques
which
are
"generally
accepted
in
the
scientific
community."
The
commenter
suggested
that
in
order
to
determine
compliance
with
Federal
law,
the
definition
should
be
consistent
with
guidance
created
by
the
Supreme
court
in
the
Daubert
vs.
Merrill­
Dow
case.

Response:
In
the
proposed
rule,
the
Agency
clarifies
the
term
"other
appropriate
methods."
In
general,
the
Agency
considers
a
method
appropriate
for
sampling
and
analysis
activities
under
RCRA
if
it
is
reliable
and
accepted
as
such
by
the
scientific
community
and
applicable
to
its
intended
use
–
i.
e.,
the
method
will
generate
effective
data.
The
Agency
believes
this
description
is
consistent
with
the
case
cited
by
the
commenter,
which
addresses
the
concept
of
acceptance
in
the
scientific
community.

3.
Comment:
A
few
commenters
were
concerned
about
the
impact
on
regulatory
and
enforcement
practices.
One
commenter
(ACIL
Environmental
Sciences
Section)
noted
that
the
use
of
"other
appropriate
methods"
in
lieu
of
a
specific
SW­
846
method
for
RCRA­
related
monitoring
will
require
more
training
and
knowledge
of
regulatory
personnel.
This
represents
risk
for
regulatory
agencies
without
apparent
reward.
The
commenter
also
believed
that
discretionary
enforcement
policy
will
be
an
issue.
The
commenter
stated
that
regulatory
limits
are
enforced
without
real
consideration
of
confidence
limits
and
measurement
variability.
However,
approaches
such
as
the
DQO
process
and
PBMS
require
consideration
of
these
factors.

Another
commenter
(American
Petroleum
Institute)
stated
that,
a
final
concern
with
implementation
of
"other
appropriate
methods,"
in
lieu
of
a
specific
SW­
846
method,
is
the
need
to
demonstrate
that
the
method
will
meet
the
intended
use.
Also,
regulatory
personnel
presently
accept
SW­
846
because
it
is
the
"RCRA
Methods
Manual."
Regulatory
personnel
not
trained
in
chemistry
are
inclined
to
select
SW­
846
without
further
thought.
The
commenter
noted,
however,
that
PBMS
for
RCRA­
related
monitoring
will
require
more
training
and
knowledge
on
the
part
of
regulatory
personnel.
PBMS
may,
in
some
cases,
be
perceived
by
regulatory
personnel
as
entailing
some
burden
without
regulatory
benefit.

Another
commenter
(EDF)
stated
that
the
PBMS
approach
presents
potentially
significant
enforcement
hurdles.
This
commenter
was
concerned
about
the
removal
of
required
uses
of
methods
involved
in
self­
implementing
regulations,
such
as
the
land
disposal
treatment
standards,
whereby
there
is
no
opportunity
prior
to
an
enforcement
action
to
review
the
validity
of
an
alternative
test
method.

Response:
The
Agency
will
offer
training
to
the
States,
Regions
and
the
regulated
community
regarding
implementation
of
this
rule
to
ensure
consistency
and
to
minimize
any
associated
implementation
and
enforcement
costs.
The
Agency's
goal
is
to
make
the
RCRA
Program
more
effective
and
efficient
by
focusing
monitoring
regulations
on
what
is
to
be
accomplished
by
the
monitoring
rather
than
by
focusing
on
the
technologies
used
for
the
measurements.
Rewards
will
include
the
cost
effectiveness
and
flexibility
in
employing
analytical
test
methods
for
RCRArelated
testing
and
in
the
use
of
new
and
innovative
technologies.
III
­
3
The
Agency
disagrees
with
one
of
the
commenters
that
RCRA
enforcement
personnel
do
not
consider
the
performance
or
appropriateness
of
a
method.
Enforcement
personnel
should
verify
that
the
method
used
by
the
regulated
entity
is
appropriate
for
its
intended
use.
For
example,
today
some
of
the
regulations
require
SW­
846
use
in
general.
However,
many
methods
in
SW­
846
may
have
the
same
target
analyte
and
yet
all
are
not
appropriate
for
a
given
matrix
and
project­
specific
data
quality
objective.
It
is
still
the
responsibility
of
the
regulated
entity
to
demonstrate
that
any
method
used
for
compliance
purposes,
whether
it
is
an
SW­
846
method
or
not,
meets
the
data
quality
requirements
for
its
intended
application.
Therefore,
both
the
regulated
entity
and
the
regulating
authority
must
evaluate
which
method
is
most
appropriate
for
a
given
analyte
and
waste
matrix.
Promulgation
of
the
MIR
will
not
change
this
approach.

Regarding
the
methods
required
as
part
of
the
self­
implementing
regulations
of
the
land
disposal
treatment
standards,
EPA
has
carefully
considered
the
impacts
of
each
proposed
revision
to
the
regulations,
and
determined
that
the
cyanide
methods
of
concern
to
the
commenter
should
remain
as
required
methods.

4.
Comment:
One
commenter
(American
Petroleum
Institute)
posed
two
questions
to
the
Agency.
First,
"How
does
the
EPA
intend
to
revise
rules
which
currently
allow
the
use
of
generator
process
knowledge
as
an
alternative
to
the
required
or
permitted
use
of
SW­
846
methods?"
Second,
"How
will
EPA
address
past
delisting
petitions
that
have
been
granted
based
upon
the
continuing
condition
that
testing
be
performed
under
SW­
846?"

Response:
Any
allowance
to
use
generator
"process
knowledge"
will
not
be
affected
by
the
proposed
revisions
and,
therefore,
will
remain
in
the
regulations
unchanged.
Regarding
past
delisting
petitions
that
require
use
of
SW­
846
methods,
the
Agency
is
proposing
to
remove
required
uses
of
SW­
846
methods
from
all
conditional
delistings.
This
is
consistent
with
the
other
proposed
revisions
to
remove
unnecessary
required
uses
of
SW­
846.
The
public
may
comment
on
the
proposed
changes
to
each
of
the
delistings.

5.
Comment:
Several
commenters
(American
Petroleum
Institute,
Ford
Motor
Company
and
(Chemical
Manufacturer's
Association)
were
concerned
about
the
issue
of
method
primacy.
One
commenter
(Ford
Motor
Company)
stated
that
method
primacy
is
the
key
concern
that
exists
regarding
implementation
and
enforcement
of
the
allowed
use
of
other
appropriate
methods
in
lieu
of
a
specific
SW­
846
method
for
RCRA­
related
monitoring.
The
commenter
asked:

°
How
will
either
the
regulator
or
regulated
entity
know
that
results
generated
by
a
PBMS
cannot
be
challenged?

°
How
will
the
regulated
community
know
that
the
"other
appropriate
method"
has
been
properly
validated,
documented
and
is
in
compliance
when
a
sample
is
analyzed?

°
When
differing
results
are
obtained
using
two
approved
performance­
based
methods,
which
result
is
correct
and
how
is
that
determined?

°
Will
the
regulator's
method
always
be
given
primacy
over
the
regulated
entity?

Another
commenter
(American
Petroleum
Institute)
noted
that
a
barrier
to
implementation
might
be
the
reluctance
of
members
of
the
regulated
community
to
use
"other
appropriate
methods"
III
­
4
because
test
results
generated
by
different
methods
performed
by
EPA
or
other
regulatory
agencies
may
be
disputed.

Another
commenter
(Chemical
Manufacturer's
Association)
noted
that
the
system,
if
implemented,
will
not
be
viable
unless
the
method
chosen
by
the
regulated
entity
is
the
exclusive
means
by
which
compliance
is
judged.

Response:
Many
concerns
about
method
primacy
disputes
are
not
well
founded.
Also,
the
first
commenter
made
several
incorrect
assumptions,
such
as
the
one
that
a
regulator's
method
always
would
be
given
primacy
and
that
PBMS
results
cannot
be
challenged.

Under
RCRA,
the
regulated
entity
is
responsible
for
making
the
correct
regulatory
decision
based
on
analytical
data
or
other
means.
Even
using
required
SW­
846
methods
does
not
relieve
them
of
this
responsibility.
The
regulated
entity
establishes
performance
criteria
and
demonstrates
the
performance
results
to
verify
that
a
method
is
appropriate.
Sometimes,
more
than
one
method
will
lead
to
the
right
compliance
decision,
which
is
not
a
surprise
given
the
wide
variety
of
method
technologies
and
performance
capabilities
(more
than
one
may
meet
or
exceed
project­
specific
performance
criteria).
Regulatory
personnel
in
turn
evaluate
the
completeness
of
the
method
performance
demonstration
to
determine
if
the
method
used
was
appropriate
and
if
the
correct
decision
was
made.

Therefore,
under
RCRA,
making
the
correct
regulatory
decision
is
of
primary
importance,
not
how
(e.
g.,
method
used)
one
gets
to
it.
Even
during
the
use
of
required
methods,
the
performance
data
must
be
evaluated
and
compared
with
project
performance
objectives.
A
decision
should
not
be
made
based
on
results
assumed
to
be
adequate
just
because
one
used
the
method
that
was
required
or
mentioned
by
a
particular
regulation.
The
Agency
hopes
that
information
in
the
proposed
rule
and
EPA­
developed
training
and
guidance
will
help
all
affected
parties
better
understand
these
principles.

The
Agency
also
believes
that
regulated
entities
should
consult
with
their
regulating
authority
during
identification
of
performance
goals
and
the
selection
of
appropriate
methods.
Working
closely
with
their
regulating
agency,
they
should
identify
potentially
appropriate
methods
for
a
specific
project
before
sampling
and
analysis
begins.
This
is
recommended
even
for
required
uses
of
SW­
846.
Regulated
entities
should
include
performance
goals
in
the
QAPP
or
SAP
and
evaluate
how
well
the
method
meets
them
based
on
the
results
of
the
QC
data
or
other
performance
indicators.
If
a
method
does
not
meet
the
criteria,
another
might
be
selected,
again
in
consultation
with
the
regulating
authority.

The
Agency
acknowledges
that
an
appropriate
method
may
give
different
waste
analysis
results
at
different
times
and
two
appropriate
methods
may
give
different
results,
for
various
reasons.
Also,
any
result
can
be
"challenged,"
even
one
based
on
a
required
SW­
846
method.
For
these
and
other
reasons,
the
Agency
believes
that
it
is
important
that
adequate
performance
data
be
generated.
These
data
can
then
be
used
to
settle
any
disputes
that
arise.

6.
Comment:
One
commenter
(American
Petroleum
Institute)
believed
that,
for
groundwater
monitoring,
the
EPA
should
specify
designated
reference
methods
(DRMs),
both
for
sample
preparation
and
for
instrumental
analysis.
DRMs
should
be
used
in
resolving
compliance
issues.
The
commenter
believed
that
DRMs
would
not
preclude
the
use
of
PBMS,
and
could
provide
an
agreed­
upon
baseline
method
for
the
purpose
of
dispute
resolution.
Another
commenter
III
­
5
suggested
that
clearly
defined
standard
reference
or
referee
methods
are
needed
in
order
to
validate
performance­
based
methods
and
settle
disputes
which
may
arise.

Response:
The
Agency
disagrees
that
it
should
specify
reference
methods
for
ground
water
monitoring,
or
any
other
RCRA­
related
monitoring,
for
the
purpose
of
resolving
disputes
regarding
method
results.
This
approach
is
not
appropriate
given
that
a
wide
variety
of
matrices
and
analytes
of
concern
may
be
encountered
by
the
regulated
community
under
the
RCRA
Program,
and
any
one
reference
method
specified
by
the
Agency
may
not
be
appropriate
for
all
situations
and
thus
would
not
work
well
for
resolving
all
disputes.

Instead,
the
Agency
currently
recommends
the
use
of
reference
materials
or
standards
during
demonstrations
of
a
method's
performance.
Unfortunately,
for
the
RCRA
Program,
such
materials
are
not
available
in
a
wide
enough
variety
of
matrices
and
analytes
to
serve
all
program
needs.
Nevertheless,
although
reference
materials
may
not
be
available
for
every
analysis,
QC
checks
such
as
matrix
spikes,
matrix
spike
duplicates
and
use
of
the
method
of
standard
additions
can
be
used
to
accurately
demonstrate
method
performance
(precision
and
bias).

7.
Comment:
One
commenter
(Ford
Motor
Company)
stated
that
some
parts
of
the
RCRA
regulations
allow
both
SW­
846
methods
and
"alternate
methods
approved
by
the
administrator."
In
most
cases,
few
or
no
alternate
methods
have
been
approved
by
the
administrator,
which
has
restricted
the
regulated
community
to
using
the
SW­
846
methods.

Second,
the
commenter
raised
an
issue
regarding
the
impression
that
most
laboratories
and
auditors
simply
interpret
SW­
846
word­
by­
word
to
be
conservative
due
to
discrepancies
that
exist
between
the
editions.
The
commenter
stated
that,
if
the
first
or
second
editions
of
SW­
846
are
specified
in
a
State
rule
or
permit,
flexibility
may
be
denied.
The
commenter
noted
that
the
first
and
second
editions
of
SW­
846
gave
no
indication
that
they
were
only
intended
to
be
used
as
guidelines.
However,
the
third
edition
of
SW­
846
indicates
that
the
methods
can
be
used
with
some
flexibility.

Response:
Regarding
the
commenter's
complaint
about
method
approval
times,
the
proposed
rule
will
solve
such
problems
by
allowing
the
use
of
alternative
methods
without
a
lengthy
approval
process.
EPA
disagrees
with
the
commenter's
second
concern.
Within
the
Federal
regulations
and
those
of
any
authorized
States,
only
the
Third
Edition
of
SW­
846
should
be
cited
for
the
purposes
of
waste
analysis
under
the
RCRA
Program.
The
Third
Edition
replaced
previous
editions
in
1986.
The
Third
Edition
and
its
first
update
were
promulgated
in
1993.
IV
­
1
IV.
What
Concerns
Exist
Regarding
the
Impact
on
State
RCRA
Programs
of
the
Removal
of
Certain
Required
Uses
of
SW­
846
Methods
from
the
Federal
RCRA
Regulations?

1.
Comment:
One
commenter
(Eastman
Chemical
Company)
expressed
concerns
that
States
will
not
adopt
PBMS
and
will
continue
to
require
specified
methods.

Response:
It
is
true
that
authorized
States
are
not
required
to
change
their
regulations
and
programs
based
on
this
proposed
rule.
Thus,
States
may
continue
to
require
specific
SW­
846
methods
in
their
regulations
for
other
than
method­
defined
parameters.
The
Agency
will
recommend
that
States
adopt
the
revisions
proposed
as
part
of
this
rule
and
will
provide
guidance
regarding
implementation
of
the
Federal
changes.
EPA
hopes
that
such
guidance
will
mitigate
some
State
concerns
regarding
adoption
of
a
PBMS
approach
in
their
hazardous
waste
regulations.

2.
Comment:
One
commenter
(Washington
State
Dept.
of
Ecology)
noted
that
States
will
need
to
create
a
training
program
for
development
of
analytical
methods
that
comply
with
the
regulations.
In
addition,
training
will
have
to
be
provided
to
acquaint
regulatory
staff
with
appropriate
new
methods.
Another
commenter
(Chemical
Manufacturer's
Association)
stated
that
States
will
need
technical
assistance
and
training.

Response:
EPA
is
providing
and
will
continue
to
provide
training
to
the
States
and
other
regulating
entities
(e.
g.,
EPA
Regions)
on
the
principals
of
this
rule,
through
such
mechanisms
as
training
modules,
workshops,
and
fact
sheets.
EPA
currently
provides
program­
specific
training
through
the
training
module
"Analytical
Strategy
for
the
RCRA
Program:
A
Performance­
Based
Approach"
for
EPA
Headquarters,
Regional,
and
State
personnel.
EPA
plans
to
offer
other
courses
on
the
evaluation
of
data
and
permit
writing
from
a
PBMS
and
effective
data
standpoint.
Through
this
training
effort,
the
Agency
hopes
to
ensure
consistency
in
implementation
of
this
rule
by
the
States,
Regions,
and
regulated
community
and
help
limit
any
associated
costs.

The
proposed
revisions
will
not
require
that
States
institute
a
training
program
on
development
of
analytical
methods,
although
they
can
do
so
if
they
wish.
In
addition,
new
method
development
will
not
always
be
necessary,
given
the
many
potentially
appropriate
methods
that
exist
in
SW­
846
and
other
scientifically­
accepted
sources.
The
users
of
the
methods
will
just
have
to
continue
to
demonstrate
that
any
method
used
is
appropriate
based
on
performance
data,
which
is
not
different
from
what
is
currently
done.

3.
Comment:
One
commenter
(California
Dept.
of
Toxic
Substances
Control)
believed
that
difficulties
in
enforcement
and
compliance
as
well
as
delays
in
issuance
of
permits
will
be
the
main
impact
on
state
RCRA
programs.
The
commenter
recommended
that
authorized
State
agencies
maintain
the
required
uses
of
SW­
846
for
all
analyses,
but
be
given
the
discretion
of
allowing
an
alternative
performance­
based
method
measurement
system
in
lieu
of
SW­
846.
The
commenter
believed
that
in
this
way,
the
EPA
could
make
suggested
changes
to
SW­
846
available
to
the
regulated
community
and
authorized
agencies
would
have
the
discretion
of
allowing
these
changes
to
be
implemented.
Furthermore,
the
EPA
could
periodically
update
SW­
846
by
rulemaking,
but,
in
the
meantime,
a
mechanism
would
be
in
place
to
allow
more
flexibility
and
innovative
technologies.
IV
­
2
Response:
First,
authorized
States
will
not
be
required
to
adopt
the
Federal
changes
and
remove
required
uses
of
SW­
846
from
their
regulations,
although
EPA
encourages
them
to
do
so.
In
addition,
the
commenter's
suggested
approach
is
not
logical
and
would
be
very
difficult
to
legally
implement
and
enforce.
States
could
not
both
keep
required
uses
of
specific
methods
in
their
regulations
and
also
allow
the
flexibility
to
use
other
methods
­­
it
has
to
be
one
or
the
other.
A
method
can
be
either
required
or
not
required
­­
not
both.
States
may
adopt
the
Federal
agency's
approach
of
mentioning
a
specific
SW­
846
method
as
an
example
of
a
potentially
appropriate
method.

Regarding
the
updating
of
SW­
846,
the
Agency
wishes
to
avoid
the
rulemaking
process
for
most
future
SW­
846
updates.
The
rulemaking
process
is
lengthy
and
delays
the
timely
use
of
new
and
improved
monitoring
technologies
in
RCRA­
related
testing.
Because
of
the
required
uses
of
SW­
846,
the
Agency
has
to
issue
the
updates
as
a
proposed
rule,
request
public
comment,
and
then
promulgate
the
update
in
a
final
rule.
Removal
of
most
required
uses
of
SW­
846
methods
from
the
RCRA
regulations
will
promote
more
efficient
and
timely
releases
of
new
and
revised
SW­
846
methods.
A
rulemaking
will
be
necessary
only
when
revising
SW­
846
to
add
or
change
a
method­
defined
parameter
in
the
RCRA
regulations
(e.
g.,
a
revision
to
Method
1311,
the
TCLP).

4.
Comment:
One
commenter
(American
Petroleum
Institute)
believed
that
there
may
be
little
incentive
for
States
to
use
"other
appropriate
methods"
and
incur
the
costs
of
demonstrating
equivalency
and
reconciling
potential
bias
between
methods.
The
commenter
believed
that
the
current
lack
of
statistical
understanding
by
regulatory
agency
personnel,
engineering/
project
management
firms,
laboratories
and
the
regulated
community
make
the
prescriptive
approach
appear
less
risky
than
a
PBMS
approach.

Response:
The
Agency
agrees
that
States
may
be
hesitant
about
adopting
the
new
approach,
but
also
believes
that
demonstrating
that
a
method
is
appropriate
for
its
intended
use
does
not
represent
an
additional
burden
to
States,
other
regulators,
or
the
regulated
community.
After
all,
currently
under
RCRA,
regardless
of
the
method
used
­­
even
if
it
is
an
explicitly
required
method
­­
regulated
entities
should
be
demonstrating
that
the
method
is
appropriate
for
its
intended
use,
e.
g.,
that
it
can
adequately
quantitate
the
analytes
of
concern
in
the
particular
waste
matrix.
Following
a
so­
called
more
"prescriptive"
approach
does
not
relieve
the
regulated
community
from
such
a
demonstration.
The
States
in
turn
should
be
evaluating
the
completeness
of
such
a
demonstration,
regardless
of
which
method
is
used,
when
determining
compliance.
Therefore,
this
rule
does
not
directly
or
indirectly
propose
new
information
collection
requirements
that
must
be
processed
by
a
State.

The
Agency
will
need
more
information
on
the
concerns
regarding
method
equivalency,
reconciling
bias,
and
statistical
understanding
before
responding
further
to
this
kind
of
comment.
There
might
be
a
number
of
different
issues
of
concern
to
the
commenter.
For
instance,
regarding
"bias
between
methods,"
it
will
not
be
necessary
to
show
equivalency
with
a
previously
required
method.
The
regulated
entity
needs
to
only
show
that
a
particular
method
is
appropriate
to
its
current
use
and
meets
project
objectives.

5.
Comment:
One
commenter
(Ford
Motor
Company)
noted
that
a
determination
must
first
be
made
on
whether
or
not
existing
methods
are
able
to
meet
project
DQOs.
The
commenter
pointed
out
that
even
now
there
are
no
methods
available
which
can
meet
delisting
requirements
IV
­
3
when
all
Appendix
VIII
compounds
must
be
determined.
SW­
846
methods
are
unable
to
meet
QA/
QC
criteria
in
many
complex
waste
matrices.

The
commenter
questioned
whether
the
EPA
will
identify
suitable
alternate
methods
or
performance­
based
methods
which
can
meet
the
analysis
requirement
set
forth
under
RCRA.

Response:
In
general,
the
proposed
flexibility
will
help
resolve
problems
regarding
method
availability
by
allowing
selection
from
a
larger
universe
of
potentially
applicable
methods.
Regarding
delisting
demonstrations,
delisting
petitioners
usually
do
not
have
to
analyze
for
every
analyte
in
Appendix
VIII.
Petitioners
need
only
address
constituents
of
concern
to
their
particular
waste.
If
no
method
is
available,
then
delisting
petitioners
can
use
other
approaches
to
demonstrate
that
an
Appendix
VIII
analyte
would
not
be
present
at
levels
of
concern,
such
as
use
of
a
mass
balance
demonstration.
Also,
the
proposed
action
will
help
solve
any
problems
with
the
scope
of
appropriate
methods
in
SW­
846
because
it
will
allow
the
use
of
other
methods
from
other
sources.
In
addition,
the
flexibility
inherent
in
proper
use
of
SW­
846
methods
allows
method
modifications
that
could
expand
the
scope
of
analytes
and
increase
sensitivity.

The
Agency
will
retain
mention
of
SW­
846
methods
in
some
of
the
regulations
as
examples
of
possible
appropriate
methods
for
RCRA­
related
sampling
and
analysis.