1
3/
29/
06
EPA's
Responses
to
OMB's
Comments
on
EPA
Draft
Proposed
Rule,
"
Standards
Applicable
to
Generators
of
Hazardous
waste;
Subpart
K
 
Standards
Applicable
to
Academic
Laboratories"

Preamble
1.
On
page
10,
in
the
preamble
outline,
Section
IV.
A
is
mislabeled
as
"
IV.
E".
Please
change
"
E"
to
"
A".

Response:
EPA
has
made
this
edit
to
the
preamble.

2.
On
page
61,
before
the
discussion
about
the
definition
of
"
laboratory
clean­
out",
recommend
insertion
of
the
following
new
paragraph:

"
EPA
is
seeking
comment
on
whether
the
definition
of
laboratory
should
be
limited
to
those
within
a
college
or
university.
Non­
academic
laboratories
face
many
of
the
same
problems
that
academic
laboratories
face:
a
large
number
of
points
of
generation,
and
relatively
small
volume
of
hazardous
waste
generated.
Such
laboratories,
however,
may
not
include
students.
The
Agency
is
interested
in
public
comment
on
whether
nonacademic
laboratories
would
benefit
from
the
additional
options
being
provided
under
this
proposed
rule,
as
well
as
whether
expanding
the
definition
to
include
non­
academic
laboratories
would
lead
to
unintended,
adverse
consequences
for
human
health
or
the
environment.
If
the
Agency
were
to
conclude
that
non­
academic
laboratories
should
be
included
within
the
scope
of
this
rulemaking,
it
would
remove
the
phrase
"
within
a
college
or
university"
from
the
proposed
definition
of
laboratory,
and
it
would
make
conforming
changes
to
the
regulatory
text
(
e.
g.,
the
phrase
"
a
college
or
university"
would
be
replaced
by
"
an
entity",
the
term
"
academic
laboratories"
would
be
replaced
by
"
laboratories")
to
ensure
that
non­
academic
laboratories
are
provided
the
same
options
that
academic
laboratories
are
provided.
(
See
also
discussion
under
Section
IV.
B.
1.)"

Response:
EPA
would
prefer
to
include
the
following
language
on
page
61
of
the
preamble
before
the
discussion
of
the
definition
of
"
laboratory
clean­
out".

"
In
addition,
EPA
is
seeking
comment
on
whether
to
expand
the
scope
of
this
alternative
set
of
regulations
to
include
other
laboratories
outside
of
colleges
and
universities
that
have
similar
hazardous
waste
generation
patterns.
For
example,
this
could
include
all
government
and
private
laboratories
which
generate
large
numbers
of
different
waste
streams,
each
in
relatively
small
quantities
that
are
stored
and
used
in
containers
that
can
be
easily
manipulated
by
one
person.
Such
an
expansion
in
scope
would
not
include
production
scale
manufacturing
laboratories,
as
they
do
not
have
similar
production
patterns
and
unique
circumstances
which
this
rulemaking
is
intended
to
address.
EPA
is
particularly
interested
in
comments
that
provide
data
showing
similarities
or
differences
between
college
and
university
laboratories
and
laboratories
at
other
institutions,
with
regard
to
hazardous
waste
generation
patterns
and
challenges.
Additionally,
EPA
seeks
comments
on
whether
such
an
expansion
of
scope
might
lead
to
unintended,
adverse
2
consequences
for
human
health
or
the
environment.
If
the
Agency
were
to
conclude
that
certain
other
laboratories
should
be
included
within
the
scope
of
this
rulemaking,
it
would
alter
the
definition
to
reflect
those
laboratories
covered
by
the
final
rule
to
ensure
that
the
specific
types
of
non­
academic
laboratories
which
EPA
has
determined
meet
the
same
criteria
are
provided
the
same
options
that
academic
laboratories
are
provided.
(
See
discussion
under
Section
IV.
B.
1.)."

3.
On
page
82,
just
before
Section
IV.
B.
2,
insert
the
following
new
paragraph:

"
If
the
Agency
were
to
conclude
that
non­
academic
laboratories
should
be
included
within
the
scope
of
this
rulemaking,
it
would
remove
the
phrase
"
within
a
college
or
university"
from
the
proposed
definition
of
laboratory,
and
it
would
make
conforming
changes
to
the
regulatory
text
(
e.
g.,
the
phrase
"
a
college
or
university"
would
be
replaced
by
"
an
entity",
the
term
"
academic
laboratories"
would
be
replaced
by
"
laboratories")
to
ensure
that
non­
academic
laboratories
are
provided
the
same
options
that
academic
laboratories
are
provided.
(
See
also
discussion
under
Section
IV.
A.)"

Response:
EPA
would
prefer
to
include
the
following
language
in
Section
IV.
B.
1,
on
page
82.

"
If
the
Agency
were
to
conclude
that
non­
academic
laboratories
should
be
included
within
the
scope
of
this
rulemaking,
it
would
alter
the
definition
to
reflect
those
laboratories
covered
by
the
final
rule
to
ensure
that
the
specific
types
of
non­
academic
laboratories
which
EPA
has
determined
meet
the
same
criteria
are
provided
the
same
options
that
academic
laboratories
are
provided."

4.
On
page
154,
Section
VI,
the
preamble
incorrectly
states
that
the
rule
is
not
a
significant
regulatory
action.
This
rule
has
been
designated
as
significant
by
OMB
because
it
raises
"
novel
legal
or
policy
issues
arising
out
of
legal
mandates,
the
President's
priorities,
or
the
principles
set
forth
in
the
Executive
Order."
Please
change
this
section
as
appropriate.

Response:
EPA
has
edited
Section
VI
to
state
that
this
rulemaking
is
a
significant
regulatory
action
due
to
the
novel
policy
issues
that
it
raises.

RIA
Questions
Below
are
the
answers
and/
or
responses
to
the
concerns
raised
by
OMB.
These
responses
are
included
in
the
body
of
the
document.

5.
On
page
9,
why
assume
that
only
28
states
adopt
the
rule?
We
are
under
the
impression
that
all
states
have
to
adopt
the
rule
since
the
rule
is
not
considered
to
be
less
stringent
than
existing
regulations.
3
Response:
Based
on
the
past
history
of
federal
regulations
that
authorized
states
have
incorporated
into
their
hazardous
waste
program,
EPA
uses
the
assumption
that
those
states
that
have
a
history
of
adopting
85%
or
more
of
EPA's
regulations
will
adopt
this
rule.
There
are
28
authorized
states
that
have
such
a
history.
EPA
also
includes
Iowa
where
the
hazardous
waste
program
is
federally
managed
and
Puerto
Rico.

The
proposed
rulemaking
includes
a
number
of
requirements
that
differ
from
the
existing
regulations
for
managing
hazardous
waste
at
academic
laboratories.
EPA
is
proposing
this
optional
set
of
requirements
(
in
Part
262
Subpart
K)
to
provide
a
more
flexible
regulatory
framework
that
addresses
the
unique
nature
of
hazardous
waste
generation
in
college
and
university
laboratories.
While
this
rulemaking
offers
greater
flexibility
and
less
stringency
in
some
areas,
the
rule
also
includes
some
provisions
that
are
more
stringent
than
the
existing
federal
regulations.

The
primary
provision
of
the
proposed
rulemaking
provides
colleges
and
universities
the
discretion
to
make
the
hazardous
waste
(
HW)
determination
for
unwanted
materials
generated
in
the
laboratory
at
a
location
other
than
the
laboratory
and
at
a
time
after
its
initial
generation.
This
key
provision
of
the
proposed
rule
is
less
stringent
than
existing
Federal
requirements,
which
specify
that
the
HW
determination
be
made
at
the
point
of
generation.

Additionally,
to
encourage
laboratory
clean­
outs
of
unwanted
and
unused
materials
from
laboratories,
the
rule
does
not
require
that
these
wastes
be
included
when
determining
RCRA
generator
status.

However,
in
developing
this
flexible
program
for
college
and
university
laboratories,
the
Agency
believes
it
is
necessary
to
include
some
provisions
which
are
not
part
of
the
existing
regulatory
framework.
These
additional
provisions
include
performance­
based
standards
for
waste
accumulation,
labeling
prior
to
the
hazardous
waste
determination,
student
instruction
requirements
and
the
development
of
a
laboratory
management
plan,
specifying
how
the
colleges
and
universities
will
comply
with
the
performance­
based
standards.

While
this
rule
contains
a
set
of
performance­
based
provisions
that
provide
more
flexibility
than
the
existing
regulations,
it
also
includes
provisions
that
go
beyond
what
is
currently
required
under
the
existing
generator
regulations
governing
college
and
university
laboratories.
For
this
reason,
we
believe
that
this
rule
is
neither
more,
nor
less
stringent
than
the
current
regulations.
Therefore,
authorized
states
would
not
be
required
to
adopt
this
rulemaking.

6.
Are
the
cost
savings
discounted
at
both
3%
and
7%?
If
not,
please
do
so,
and
provide
NPV
estimates
of
cost
savings.

Response:
Our
current
analysis
assessed
annualized
cost
impact
estimates
using
only
a
seven
percent
(
7%)
discount
rate.
We
are
now
in
the
process
of
developing
estimates
4
using
the
three
percent
(
3%)
discount
rate.
This
work
is
expected
to
be
completed
no
later
than
Friday
April
7th.

7.
Is
it
EPA's
contention
that
its
preferred
option
maximizes
net
benefits?
If
so,
state
so.
If
not,
explain
the
justification
for
the
preferred
option.

Response:
The
Agency
did
not
monetize
benefits
for
the
preferred
option
or
any
alternative
approach
presented
in
our
proposed
action.
As
such,
we
are
not
able
to
directly
compare
monetized
net
benefits
of
the
preferred
option
with
any
of
the
alternatives.
However,
we
believe
that
the
collection
of
requirements,
as
presented
under
our
preferred
option
(
proposed),
optimizes
benefits
(
cost
savings)
to
college
and
university
laboratories
while
maintaining
necessary
protections
to
human
health
and
the
environment.

The
two
alternative
cost
options
we
present
in
the
analysis
were
designed
as
"
bounding
options,"
for
assessing
costs
associated
with
requirements
under
least
cost
and
highest
cost
regulatory
requirements.
We
believe
that
requirements
under
the
least
cost
scenario
do
not
ensure
adequate
protection
to
human
health
and
the
environment,
while
requirements
under
the
high
cost
scenario
are
overly
burdensome,
and
afford
only
marginally
improved
protections
over
the
proposed
approach.

The
proposed
requirements
under
the
preferred
option
are
designed
to
enhance
current
lab
waste
management
procedures
and
more
closely
resemble
how
colleges
and
universities
actually
operate
than
do
requirements
under
the
alternative
approaches.
Under
the
preferred
option,
we
expect
college
and
university
laboratories
to
realize
cost
savings
due
to
streamlined
and
simplified
requirements.
For
example,
combining
the
Laboratory
Management
Plan
(
LMP)
with
the
proposed
training
and
instruction
requirements,
and
requiring
affected
labs
to
address
the
performance­
based
training
and
instruction
requirements
in
their
LMPs
is
expected
to
assure
that
proper
training
will
be
provided
to
individuals
commensurate
with
their
duties.
This
is
expected
to
result
in
increased
compliance
and
ultimately
fewer
violations
and
fines.
The
proposed
requirements
are
also
expected
to
result
in
environmental
benefits
such
as
reduced
incidences
of
accidental
release
of
hazardous
wastes
or
other
potentially
harmful
"
unwanted
materials,"
minimized
repeat
exposure
to
hazardous
wastes,
and
generally
enhanced
overall
awareness
of
the
proper
handling
of
hazardous
materials.

The
Agency
has
worked
with
a
wide
range
of
stakeholders
in
the
development
of
this
proposal.
However,
we
are
requesting
comment
on
our
proposed
approach,
the
alternative
options,
and
all
aspects
of
our
supporting
economic
analysis
in
an
effort
to
ensure
that
the
collection
or
combination
of
requirements
finalized
by
the
Agency
will
optimize
net
societal
welfare.

8.
Please
add
a
qualitative
discussion,
and
if
feasible,
a
quantitative
estimate,
of
the
impact
of
expanding
the
rule
to
include
non­
academic
laboratories
as
described
in
the
previous
comments
on
the
preamble.
5
Response:
EPA
will
provide
a
response
by
April
7th.
