Document ID: EPA-HQ-OPPT-2002-0067-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-02-20T05:00Z

OPPT­
2002­
0067­
0002
COMMENT
AND
RESPONSE
DOCUMENT
FOR
REVISED
POLICY
STATEMENT
OF
SECTION
8(
e)
OF
TSCA
RECEIVED
OPPT
NCIC
2003
FEB
20
PM
4:
06
1
02/
2003
GENERAL
COMMENTS
COMMENT:
Once
EPA
finalizes
its
new
section
8(
e)
guidance,
it
should
only
be
applied
prospectively.
The
Agency
itself
has
admitted
that
the
nature
and
scope
of
section
8(
e)
reporting
requirements
for
environmental
information
have
not
been
clear,
and
it
took
the
unusual
step
of
suspending
its
prior
guidance.
Moreover,
many
additional
Federal
and
state
reporting
requirements
have
been
enacted
since
TSCA
became
effective
in
1976,
further
muddying
the
regulatory
waters.

The
confusion
associated
with
the
scope
of
environmental
reporting
under
section
8(
e),

and
the
absence
of
Agency
attention
to
the
issue,
contrasts
sharply
with
the
long
history
of
healthrelated
section
8(
e)
guidance
and
reporting.
Given
this
history,
and
the
continuing
questions
raised
about
the
Agency's
proposal
new
guidance,
it
would
be
inappropriate
to
apply
the
guidance
retroactively.

RESPONSE:
Given
the
circumstances
noted
by
the
commenter,
the
suspension
of
the
previous
guidance,
the
emphasis
on
health
and
environmental
effects
reporting,
the
length
of
time
required
to
propose
revised
guidance,
and
the
greater
specificity
of
the
revised
guidance,
EPA
has
concluded
that
the
revised
guidance
will
be
enforced
prospectively.
This
means
that
companies
will
not
have
to
review
preexisting
files
for
information
that
may
be
subject
to
section
8(
e)

reporting.
These
preexisting
files
would
only
come
into
"
play"
if
data
obtained
by
a
company
after
the
effective
date
of
the
guidance
triggered
a
review
of
such
data
and
in
doing
so
the
combination
of
data
met
the
section
8(
e)
reporting
criteria.

COMMENT:
The
draft
preamble
language
will
be
important
because
it
may
contain
examples
as
well
as
explanations
of
key
terms
used
in
the
proposed
guidance.
In
this
respect,
the
preamble
2
language
will
supplement
the
revised
policy
text.
Consequently,
EPA
should
make
the
draft
preamble
language
available
for
public
comment.
Additionally,
because
the
July
13,
1993
proposal
contained
many
troubling
statements
that
improperly
expanded
the
potential
scope
of
section
8(
e)
reporting,
EPA
should
expressly
state
that
the
preamble
to
the
July
13,
1993
Federal
Register
notice
has
been
withdrawn
and
should
be
disregarded
in
its
entirety.

RESPONSE:
The
Agency
disagrees.
The
preamble
to
the
final
revised
guidance
is
meant
to
serve
as
a
broad
statement
of
EPA's
policy
on
the
implementation
of
TSCA
section
8(
e)
as
modified
in
response
to
public
comment.
As
such
the
preamble
is
inherently
EPA's
official
avenue
to
convey
public
policy
subject
to
normal
EPA
administration
and
OMB
review.

However,
EPA
believes
that
the
joint
development
of
a
question
and
answer
document
will
provide
ample
opportunity
to
develop
and
present
the
necessary
examples
and
reporting
scenarios
that
will
frame
industry's
reporting
responsibilities.
Finally,
EPA
sees
no
need
to
withdraw
the
preamble
of
the
July
13,
1993,
notice
because
the
controlling
documents
will
be
the
final
preamble
and
guidance
text,
this
document,
and
the
question
and
answer
document.

COMMENT:
Although
the
change
from
15
working
days
to
30
calendar
days
is
not
a
major
change
(
a
net
gain
of
nine
calendar
days),
the
change
is
supported
for
the
submission
of
health
effects
data.
Longer
time
frames
should
be
considered
for
environmental
effects
data
and
release
and
detection
data
(
environmental
contamination).

RESPONSE:
EPA
agrees
for
the
most
part
with
the
comments.
The
reporting
period
will
be
30
calendar
days
for
health
and
environmental
effects
data.
Longer
time
frames
(
90
days)
for
reporting
non­
emergency
contamination
data
are
provided
(
see
below
under
non­
emergency
chemical
contamination
reporting).
3
COMMENT:
Part
IV
of
the
policy
text
defines
"
immediately"
to
mean
"
within
30
calendar"
days
from
obtaining
information.
Does
"
immediate"
in
the
context
of
supplementary
submissions
mean
30
calendar
days?

RESPONSE:
Yes.

COMMENT:
EPA
should
retain
the
"
if
appropriate"
language
regarding
"
supplemental
information."
EPA
should
confirm
that
"
supplemental
information"
must
be
submitted
under
section
8(
e)
only
if
it
is
new
"
substantial
risk"
information
that
is
independently
reportable
under
the
statutory
standard.

RESPONSE:
EPA
is
retaining
the
original
language
regarding
the
submission
of
"
supplementary
information."
EPA
did
not
specifically
propose
a
change
to
this
reporting
standard.
The
change
was
editorial
in
nature.
Only
information
meeting
the
section
8(
e)
statutory
requirement
must
be
submitted
within
the
required
time
frames.

COMMENT:
Given
the
changes
to
the
policy
statement,
i.
e.,
notices
submitted
within
30
calendar
days
and
the
option
to
report
under
state
and
other
Federal
requirements
with
different
reporting
time
frames,
it
may
be
more
clear
to
delete
"
within
30
calendar
days"
and
substitute
the
following
to
the
Note.
At
the
end
of
Part
II:

"
that
such
information
is
properly
reported
to
EPA
under
the
provisions
of
the
policy
statement."

RESPONSE:
EPA
agrees.
Language
has
been
changed
to
add
"
properly"
reported.

COMMENT:
The
date
when
one
"
obtains
knowledge"
under
TSCA
section
8(
e),
like
the
"
initiation"
of
a
potentially
reportable
monitoring
or
modeling
study
under
TSCA
section
8(
d)
[
40
CFR
716],
is
incapable
of
clear
definition.
"
Knowledge"
of
contamination
occurs
when
the
4
analytical
laboratory
reports
the
results
of
its
first
analyses.
However,
as
recognized
by
the
EPA,

the
mere
presence
of
a
chemical
in
environmental
media
is
not
(
and
should
not
be)
per
se
section
8(
e)
reportable
information.
It
may
take
several
months
after
the
receipt
of
analyses
before
engineering
studies
can
begin
to
put
physical
parameters
around
the
"
amount,
extent
and
pattern"

of
contamination.
Because
the
determination
of
significant
risk
can
take
considerable
time,
the
90
day
clock
for
reporting
environmental
contamination
should
begin
once
a
determination
of
significance
has
been
made.

RESPONSE:
Regarding
when
the
"
clock"
starts,
EPA
agrees
that
this
should
occur
when
the
company
obtains
the
requisite
information
to
make
the
section
8(
e)
determination.
This
may
be
many
months
or
even
years
after
the
non­
emergency
release
occurred.

COMMENT:
Because
of
the
vagaries
of
mail
delivery
it
may
be
difficult
to
ensure
that
a
submission
is
received
by
EPA
not
later
than
30
calendar
days
after
obtaining
the
information.

EPA
should
change
the
requirement
to
postmarked
by
the
30th
calendar
day.

RESPONSE:
EPA
disagrees.
The
reporting
obligation
is
that
EPA
"
receives"
the
notice
within
30
calendar
days.
A
notice
"
postmarked"
within
30
calendar
days
may
not
necessarily
be
"
received"
by
EPA
within
the
time
period.
Also,
postmarking
provides
no
guarantee
to
the
submitter
that
the
notice
has
actually
been
received
by
the
Agency
in
a
timely
manner
as
does
United
States
Postal
Service
registered
mail
or
mail
handled
by
commercial
delivery
services
that
guarantee
delivery
dates.
The
burden
is
on
the
reporting
entity
to
make
certain
the
reporting
deadline
is
met.

COMMENT:
In
the
guidance
for
reporting
information
about
non­
emergency
incidents
of
environmental
contamination,
EPA
should
clarify
whether
emissions
from
facilities
which
are
5
wholly
regulated
under
FIFRA
or
FFDCA
need
be
considered
for
reporting
under
section
8(
e)
of
TSCA.

RESPONSE:
Environmental
emissions/
releases
from
manufacturing
facilities
are
not
regulated
under
FIFRA
and
FFDCA.
Therefore,
such
release
are
potentially
subject
to
reporting
under
section
8(
e).

COMMENT:
EPA
should
exempt
from
section
8(
e)
reporting
field
tests
conducted
on
research
and
development
(
R&
D)
pesticides
or
clarify
that
such
tests
would
normally
not
be
reportable
because
of
a)
the
situation
does
not
represent
widespread
exposure
at
the
R
&
D
stage
of
development
and
b)
the
contamination
is
not
previously
unsuspected
(
because
it
is
known,

intentional,
and
under
controlled
conditions).

RESPONSE:
EPA
agrees
that
they
would
not
normally
be
reportable
because
the
exposure
is
not
widespread
and
previously
unsuspected.
However,
if
health
or
environmental
effects
are
seen
then
reporting
should
be
considered.
Also,
if
the
substance
has
started
the
regulatory
review
process
under
FIFRA
it
would
not
be
subject
to
section
8(
e)
reporting.
A
chemical
substance
which
is
in
the
process
of
R&
D
as
a
pesticide
is
subject
to
TSCA
until
such
time
as
the
manufacturer
or
importer
demonstrates
the
intent
to
produce
a
pesticide
by
submitting
to
the
Agency
an
application
for
an
"
Experimental
Use
Permit"
or
registration
under
FIFRA.

COMMENT:
The
inclusion
of
activities
associated
with
the
use
of
chemicals
in
the
1978
Policy
Statement
is
inappropriate.
Chemical
use
involves
activities
that
support,
promote,
or
contribute
to
the
person's
operations,
where
the
chemical
used
does
not
become
part
of
a
distributed
product.
Examples
of
chemicals
that
are
used
and
not
processed
are
chemical
processing
aids
such
as
catalysts,
solvents,
or
reaction
terminators.
Other
examples
would
be
manufacturing
aids
6
such
as
lubricants,
refrigerants,
or
metalworking
fluids,
or
chemicals
used
for
other
purposes
such
as
cleaners,
degreasers,
or
fuels.
Substantial
risk
information
concerning
chemicals
that
are
used
by
the
person
receiving
the
information
should
not
be
subject
to
section
8(
e)
reporting
unless
the
person
also
manufactures,
processes,
or
distributes
the
chemical.

Moreover,
the
Agency
should
consider
exempting
from
the
section
8(
e)
reporting,
the
use
of
paints
and
coatings
in
the
manufacture
of
articles
where
paints,
coatings,
and
other
surface
treatments
are
used
to
apply
a
film
to
the
article
and
are
not
incorporated
as
a
significant
component
of
the
article.

RESPONSE:
EPA
agrees
that
information
obtained
on
substances
that
are
only
"
used"
as
illustrated
by
the
commenter
is
not
subject
to
reporting.
This
includes
chemical
processing
aids
such
as
catalysts,
reaction
solvents,
etc.
Section
8(
e)
only
applies
to
information
obtained
on
a
substance
that
is
manufactured,
processed,
or
distributed
in
commerce.
However,
EPA
does
not
agree
that
the
application
of
paints
and
coatings
on
articles,
even
if
only
a
minor
component,

should
be
exempted.
While
a
minor
component
of
the
article,
the
application
of
the
substance
or
mixture
may
result
in
significant
workplace
exposures
and
as
such
any
information
obtained
concerning
its
hazard
potential
could
be
cause
for
section
8(
e)
reporting.
In
addition,

the
substance
or
mixture
could
have
many
other
uses
that
could
lead
to
significant
environmental
or
human
exposure.

COMMENT:
This
policy
mandates
the
reporting
of
substantial
risk
information
within
specified
periods
of
time.
Failure
to
report
can
result
in
a
civil
penalty
and
possible
criminal
prosecution
under
TSCA
section
16.
The
government,
under
section
7
of
TSCA
can
seek
judicial
relief
to
compel
submittal
of
section
8(
e)
information
and
to
otherwise
restrain
any
violation
of
section
7
8(
e).
In
addition,
personal
liability
accrues
to
all
officials
responsible
and
having
authority
for
an
organization's
execution
of
section
8(
e).
Given
these
considerations,
this
policy
constitutes
a
rulemaking
and
should
be
treated
accordingly.

RESPONSE:
In
proposing
and
finalizing
the
revised
guidance
EPA
followed
notice
and
comment
procedures
that
would
be
followed
as
if
it
were
a
rulemaking.
In
addition,
internal
EPA
and
OMB
review
of
the
guidance
is
similar
to
the
reviews
that
would
be
required
of
a
rulemaking.
Section
8(
e)
of
TSCA
is
self­
implementing,
in
contrast
to
other
parts
of
TSCA
which
involve
rulemaking,

and
as
such
is
subject
to
TSCA
sections
15
and
16.
Specifically
section
15(
3)
states
that
"
It
shall
be
unlawful
for
any
person
to
fail
or
refuse
to***(
B)
submit
reports,
notices,
or
other
information,***
as
required
by
this
Act
or
a
rule***."

COMMENT:
Information
a
company
voluntarily
self­
discloses
to
EPA
under
a
program
administered
by
EPA
should
not
need
to
be
reported.

The
regulated
community
has
been
encouraged
by
the
Department
of
Justice
Criminal
Enforcement
Guidelines,
U.
S.
Commission
Sentencing
Guidelines,
and
Working
Draft
Recommendations
by
the
Advisory
Working
Group
on
Environmental
Sanctions
to
the
United
States
Sentencing
Commission
(
March
5,
1993),
to
self­
disclose
potential
violations
and
information
to
EPA.
Because
the
goal
of
TSCA
section
8(
e)
is
for
EPA
to
be
aware
of
substantial
risk
information,
self­
disclosure
of
information
to
EPA
should
also
satisfy
TSCA
section
8(
e).

RESPONSE:
EPA
does
not
agree
that
such
a
blanket
exception
should
apply.
Although
the
CAP
allowed
numerous
companies
to
self­
disclose
information
to
EPA,
it
was
not
without
cost
(
although
it
was
substantially
reduced).
EPA's
enforcement
policy
addresses
and
allows
for
8
mitigated
penalties
in
cases
of
self
disclosure.
Such
an
issue
is
best
handled
on
a
case­
by­
case
basis.

REPORTING
NON­
EMERGENCY
AND
EMERGENCY
SITUATIONS
OF
CHEMICAL
CONTAMINATION
COMMENT:
As
drafted,
the
proposal
expands
the
reporting
required
by
the
1978
policy
statement
by
either
dropping
or
adding
concepts
that
define
the
scope
of
this
part.
For
instance,

the
term
"
previously
unsuspected"
is
conspicuously
absent
from
the
proposed
clarification.

Deletion
of
the
phrase
will
result
in
unnecessary
over
reporting
as
well
as
duplicative
reporting.

The
focus
of
section
8(
e)
should
be
on
new
or
previously
unsuspected
information.

EPA
added
the
term
"
may
seriously
threaten"
as
a
factor
in
determining
substantial
risk.

This
runs
counter
to
the
statute
which
uses
the
term
"
presents
a
substantial
risk,"
implying
that
a
much
higher
level
of
certainty
is
required
than
a
standard
that
uses
"
may."
No
reason
was
given
that
supports
such
a
change.
Further,
in
finalizing
the
1978
document,
EPA
rejected
using
the
term
"
may."

Similarly,
EPA
states
that
the
toxicity
of
the
detected
substance
should
be
considered
in
conjunction
with
the
magnitude
of
the
contamination.
However,
instead
of
allowing
companies
to
rely
on
the
known
hazard
profile
of
the
substance,
EPA
introduces
the
concept
of
"
suspected
toxicity"
as
a
reporting
threshold.
"
Suspected
toxicity"
is
analogous
to
the
use
of
the
term
"
may"

discussed
above.
The
1978
policy
statement
indicates
that
evidence
that
"
reasonably
supports
the
conclusion"
of
substantial
risk
should
"
reliably
ascribe
the
effect
to
the
chemical"
and
that
a
serious
effect
would
be
reportable
if
one
or
more
chemicals
was
"
strongly
implicated."
The
9
criterion
of
"
suspected
toxicity"
is
totally
inconsistent
with
the
concepts
of
"
reliably
ascribe"
and
"
strongly
implicated"
in
the
1978
guidance.
The
phrase,
"
suspected
toxicity,"
should,
therefore,

be
deleted
in
the
final
guidance
and
only
"
known
toxicity,"
in
conjunction
with
other
factors,

should
be
considered
in
determining
possible
section
8(
e)
reporting.

RESPONSE:
The
term
"
previously
unsuspected"
was
not
carried
over
from
the
preamble
discussion
to
the
policy
text.
There
is
no
indication
in
the
proposal
that
the
concept
was
deleted.

Thus,
only
reporting
of
environmental/
product
contamination
that
was
"
previously
unsuspected"

by
EPA
and
meets
the
other
criteria
should
be
considered
for
section
8(
e)
reporting.
Known
constituents
of
products,
substances
for
which
companies
have
permits
to
discharge,
and
substances
monitored
in
workplace
air,
for
example,
would
not
be
"
previously
unsuspected."

Contamination
by
a
substance
that
was
"
previously
unsuspected"
is
information
that
is
not
known
to
the
Agency.
For
instance,
it
would
include
information
about
the
discovery
in
off­
site
ground
water
of
a
substance
that
had
been
manufactured
at
the
site
for
many
years.
It
may
not
be
surprising
given
the
production
history
of
the
substance,
but
it
is
new
information
about
actual,

measured
contamination.
Manufacture,
processing,
and
distribution
in
commerce
of
substances
does
not
presuppose
environmental
contamination
or
knowledge
about
such
contamination
by
EPA.

As
the
commenters
note,
the
issue
of
using
"
may"
as
in
"
may
present"
and
now
as
"
may
seriously
threaten"
was
addressed
in
1978
when
EPA
agreed
to
drop
the
term.
While
the
proposed
text
does
not
address
"
present"
or
"
may
present,"
the
use
of
the
term
as
in
"
may
seriously
threaten"
implies
that
the
"
presents"
standard
has
been
degraded
to
"
may
present."
EPA
agrees
that
the
level
of
evidence
embodied
in
the
1978
policy
statement
should
be
maintained
and
10
thus
"
may"
was
removed.
Similarly,
the
concept
of
"
suspected"
toxicity
was
removed.
While
agreeing
to
these
changes
EPA
must
reiterate
that
the
phrase
"
reasonably
supports
the
conclusion"
of
substantial
risk
is
not
identical
to
a
conclusive
demonstration
of
substantial
risk.

COMMENT:
The
proposed
language
for
Part
V(
b)(
1)
refers
to
"[
I]
nformation
that
pertains
to
widespread
chemical
contamination..."
EPA
has
not
specifically
defined
the
term,
"
widespread,"

in
its
proposed
Notice
of
Clarification
(
July
13,
1993;
58
FR
37735),
but
rather
has
given
three
examples
of
what
would
constitute
"
widespread."
EPA
states
in
the
preamble
that
the
term,

"
widespread,"
would
include,
for
example,
presence
in
a
product
that
is
distributed
commercially,

multiple
(
e.
g.,
three
or
more)
reports
of
contamination
(
even
in
a
single
environmental
medium)

involving
different
sites
inside
and/
or
outside
the
boundaries
of
a
facility,
or
presence
in
more
that
one
environmental
medium
(
e.
g.,
discovery
of
a
chemical
in
both
soil
and
groundwater).

These
examples
of
"
widespread"
are
inappropriately
broad
and
will
lead
to
considerable
and
needless
overreporting
of
environmental
release/
contamination
information.
Presence
in
a
product
that
is
distributed
commercially
does
not
necessarily
constitute
widespread
distribution
in
environmental
media.
Whether
the
chemical
is
ever
released
to
the
environment
or
whether
humans
are
ever
exposed
to
the
contamination
depends
upon
the
type
of
product
and
its
intended
uses.

Many
products
distributed
commercially
are
mixtures,
which
intentionally
contain
substances
(
e.
g.,
solvents)
that
are
known
to
cause
serious
health
or
environmental
effects,
but
which
are
necessary
for
the
products'
performance
properties.
They
may
also
contain
unintentional
impurities
of
a
toxic
nature.
These
intentional
and
unintentional
(
but
known)
toxic
substances
are
addressed
on
the
products's
Material
Safety
Data
Sheet
(
MSDS)
and
label.
11
Proper
handling
and
disposal
information
is
included
on
the
MSDS.
There
is
no
need
to
inform
EPA
of
any
known
product
contamination
or
presence
of
toxic
materials
in
a
product,
provided
one's
customers
are
adequately
informed
and
instructed
in
the
proper
use,
handling,
and
disposal
of
the
product.

One
aspect
of
product
contamination
that
EPA
has
not
addressed,
but
needs
to,
is
the
degree
of
contamination
and
whether
it
presents
a
significant
risk
to
exposed
populations.
There
are
levels
of
product
contamination
below
which
there
is
no
health
or
environmental
concern
and,

therefore,
would
not
be
section
8(
e)
reportable,
under
any
circumstances,
even
if
previously
unsuspected.
Product
contamination
should
be
considered
for
section
8(
e)
reporting
only
if
it
is
previously
unsuspected
and
truly
presents
a
substantial
risk,
because
of
both
significant
toxicity
at
the
levels
found
and
actual
or
high
probability
of
exposure
to
humans
or
non­
human
organisms.

EPA's
example
of
multiple
(
three
or
more)
reports
of
contamination
(
even
in
a
single
environmental
medium),
involving
different
sites
inside
and/
or
outside
the
boundaries
of
a
facility,

does
not
correspond
to
or
should
not
be
defined
as
"
widespread"
in
all
cases.
This
example
fails
to
take
into
account
the
amount,
extent,
and
pattern
of
contamination
and,
if
taken
literally,
could
lead
to
thousands
of
unnecessary
reports
under
section
8(
e).

Presence
of
contamination
in
more
than
one
environmental
medium
is
also
an
inappropriately
simplistic
example.
A
spill
to
soil
or
water
of
a
liquid
or
solid
chemical
with
an
appreciable
vapor
pressure
will
always
involve
releases
to
air
as
well.
Land
spills
near
a
river
or
other
body
of
water
will
almost
always
involve
some
releases
to
the
water,
particularly
if
it
rains
before
the
spill
is
contained
or
cleaned
up.
Yet,
these
types
of
spills
may
not
be
widespread
at
all.

A
better
and
much
more
narrow
definition
of
"
widespread"
needs
to
be
developed
by
12
EPA.
EPA
should
consider
contamination
to
be
"
widespread"
only
if
there
is
a
substantial
likelihood
that
widespread
or
significant
exposure
of
humans
or
non­
human
organisms
to
the
contaminant
will
occur.

If
EPA,
however,
has
difficulty
accepting
a
definition
of
"
widespread"
in
terms
of
actual
or
likely
exposure,
then
the
Agency
should
define
the
term
based
on
the
following
considerations:

a)
Containability
(
can
the
distribution
in
environmental
media
be
controlled?);
b)
Manageability
(
able
to
be
cleaned
up
with
known
or
available
technology);
c)
Movement
off­
site
(
e.
g.,
towards
a
residential
area(
s)
or
body
of
water
that
is
a
drinking
water
supply
or
environmental
habitat);
d)

Any
other
relevant
factors
(
e.
g.,
amount,
extent,
and/
or
pattern
of
contamination,
etc.).

The
proposed
language
could
be
simplified
while
still
emphasizing
that
all
four
aspects
of
a
possible
scenario
for
section
8(
e)
reporting
must
be
present,
i.
e.,
widespread,
previously
unsuspected,
known
serious
effects,
and
actual
or
high
probability
of
exposure.
Proposed
text
follows:

"
Widespread
and
previously
unsuspected
distribution
in
environmental
media
of
a
chemical
substance
or
mixture
known
to
cause
serious
adverse
effects,
when
coupled
with
information
that
widespread
or
significant
exposure
to
humans
or
non­
human
organisms
has
occurred
or
that
there
is
a
substantial
likelihood
that
such
exposure
will
occur."

To
illustrate
the
practical
application
of
the
proposed
language
under
Part
V(
b)(
1),
a
company
should
address
the
following
steps:

A.
Considerations
for
Section
8(
e)
Reportability
of
Non­
Emergency
Situations
of
Chemical
Contamination
Involving
Humans
and/
or
the
Environment
13
1.
Known
Significant
Toxicity
(
to
humans
or
non­
human
organisms)

2.
Previously
Unsuspected
distribution
in
environmental
media
3.
Widespread
distribution
in
environmental
media
­
Amount,
extent,
and/
or
pattern
of
contamination
­
Containability
(
can
the
contamination
be
controlled)

­
Manageability
(
able
to
be
cleaned
up)

­
Movement
off­
site
(
particularly
towards
a
residential
area(
s)
or
body
of
water
that
is
a
drinking
water
source,
etc.)

­
Any
other
relevant
or
appropriate
factors
4.
Exposure:
Actual
or
high
probability
of
significant
level
of
exposure
to
humans
or
non­

human
organisms.

B.
Section
8(
e)
Reportability
Determination
1.
Consideration
of
all
four
factors
above
in
their
entirety.

2.
If
one
or
more
of
the
above
four
factors
are
non­
operative,
the
information
is
not
section
8(
e)

reportable.

3.
If
all
four
factors
above
are
operative,
the
information
should
be
considered
for
immediate
reporting
under
section
8(
e)
(
unless
the
information
has
or
will
be
reported
under
an
EPA
administered
statute
or
EPA
approved
or
delegated
state
program,
within
the
required
time
frame
for
reporting
information
under
such
authority.)

The
above
approach
is
fairly
easy
to
apply
and
will
result
in
consistent
reporting
to
EPA
of
information
that
truly
presents
a
substantial
risk
to
the
environment.
14
RESPONSE:
EPA
agrees
that
its
discussion
of
what
would
constitute
"
widespread"

contamination
and
the
examples
provided
are
of
limited
value
and
could
cause
overreporting
.

One
commenter
suggested
that
"
widespread"
be
defined
in
terms
of
a
number
of
considerations
that
when
combined
with
other
factors
(
toxicity,
exposure,
previously
unsuspected)
would
determine
reportability.
In
general,
EPA
supports
this
approach
because
it
would
be
impossible
to
define
the
myriad
combinations
of
data
that
would
define
"
widespread."
For
instance,
three
or
more
reports
of
contamination
in
an
environmental
medium
may
be
meaningless
if
it
were
three
out
of
a
hundred
samples
taken
on
the
site
or
nearby
area,
but
it
may
be
significant
if
contamination
was
detected
in
the
well
water
of
three
nearby
homes.
While
the
commenter
proposed
five
elements
to
consider
when
determining
if
contamination
is
"
widespread"
(
i.
e.,

amount,
extent,
and/
or
pattern
of
contamination;
containability;
manageability;
movement
off­
site;

other
factors),
EPA
believes
that
two
of
the
factors,
containability
and
manageability,
should
not
be
used
because
they
are
more
appropriately
risk
management
considerations
rather
than
risk
notification
elements.
Companies
should
thus
consider
whether
or
not
contamination
is
found
offsite
and
if
it
is,
the
amount,
extent,
and
or/
pattern
of
contamination
and
any
other
relevant
factors.

Similar
considerations
should
be
used
regarding
contamination
in
products
distributed
in
commerce.
While
the
contamination
may
be
"
widespread"
because
of
commercial
distribution,

companies
need
to
consider
whether
the
contamination
in
the
product
is
available
to
expose
users
of
the
product
or
others
during
disposal.
If
the
contaminant
is
tightly
bound,
such
as
in
a
plastic
product,
there
would
be
no
or
minimal
exposure.
Thus,
a
substantial
risk
notice
would
not
be
required.
However,
if
there
was
the
potential
for
exposure,
companies
would
still
need
to
15
consider
the
contaminant's
concentration
which
bears
on
the
level
of
exposure,
the
toxicity
of
the
contaminant,
and
whether
it
is
unsuspected
contamination.
Known,
toxic
constituents,
such
as
may
be
listed
in
the
MSDS,
even
if
widely
commercially
distributed
would
not
trigger
section
8(
e)

reporting.

Workplace
exposure
would
be
treated
similarly.
It
would
need
to
be
previously
unsuspected
by
EPA,
result
in
contamination
to
major
areas
of
the
work
site
thus
leading
to
actual
or
potential
exposure,
and
have
known,
significant
toxicity.
Contamination
of
workplace
air
or
surfaces
by
substances
known
to
the
manufacturer
and
EPA,
such
as
OSHA
regulated
substances,

would
not
need
to
be
examined
for
section
8(
e)
reporting
under
Part
V(
b)(
1)
because
they
are
not
"
previously
unsuspected."
However,
a
sudden
release
of
a
large
quantity
of
an
OSHA
regulated
substance,
may
need
to
be
considered
for
EIEC
reporting
depending
on
the
quantity
and
toxic
properties
of
the
substance.

Finally,
EPA
agrees
that
the
suggested
text
which
embodies
the
concepts
of
widespread
distribution,
previously
unsuspected
distribution,
known
significant
toxicity,
and
actual
or
probable
significant
exposure,
in
combination
with
other
unmodified
sections
of
the
policy
statement,
is
responsive
to
the
comments.

COMMENT:
Additional
examples
and/
or
case
studies
need
to
be
provided
by
the
Agency
to
confirm
that
section
8(
e)
reporting
is
not
required
under
the
following
circumstances:

Groundwater
concentrations
that
are
below
drinking
water
standards.

Soil
concentrations
that
are
below
RCRA
action
levels,
State
action
levels
or
State
cleanup
levels.

Groundwater
or
soil
contamination
that
is
analyzed
through
customary
risk
evaluation
mechanisms
to
be
below
actionable
levels.
16
Environmental
information
generated
in
the
following
regulatory
contexts:

RCRA
closure
activities

RCRA
corrective
action
activities

RCRA
UST
activities

CERCLA
cleanup
activities

State
Superfund
cleanup
activates

PCB
cleanup
activities

Clean
Air
Act
Activities
RESPONSE:
EPA
agrees
with
the
general
framework
of
the
comment.
The
comment
addresses
two
aspects
of
section
8(
e)
reporting.
First,
the
use
of
chemical­
specific
quantity
benchmarks
to
determine
reporting
and,
second,
the
reporting
of
data
under
other
EPA/
state
authorities.
EPA
requested
comment
on
the
use
of
benchmarks,
but
did
not
advance
the
concept
in
the
proposal.

However,
given
the
fact
that
the
Agency
has
developed
such
benchmarks
for
numerous
programs,

and
the
desire
to
produce
less
ambiguous
guidance,
EPA
believes
that
the
use
of
such
benchmarks
such
as
RfD's,
MCL's,
RCRA
action
levels,
etc.,
is
reasonable
in
the
section
8(
e)
decision
making
process.
A
"
Note"
to
that
effect
has
been
added
to
Part
V(
b)(
1).

The
other
part
of
the
comment
concerns
the
submission
of
data
under
other
EPA/
state
authorities.
With
the
exception
of
the
State
Superfund
activity
(
unless
specifically
known
by
EPA
or
as
related
to
an
authorized
site
remediation
activity),
section
8(
e)
reporting
would
not
be
required
if
submitted
within
90
days
of
obtaining
the
information.

COMMENT:
Under
the
recently
proposed
guidance,
it
would
appear
EPA
may
now
be
17
considering
that
the
mere
presence
of
a
toxicant
in
the
environment,
without
any
evidence
of
an
effect,
is
sufficient
to
trigger
substantial
risk
reporting.
For
example,
the
proposed
guidance
states:

In
other
words,
information
regarding
a
non­
emergency
chemical
release
or
detection
event,
in
and
of
itself,
regardless
of
whether
effects
were
observed
associated
with
that
particular
release
or
detection,
may
be
reportable....

The
Agency
has
failed
to
recognize
that
environmental
contamination
is
not
an
"
effect."
The
actual
or
potential
for
harm
to
human
health
or
ecological
systems
that
may
be
caused
by
environmental
contamination
is
the
effect
for
which
evidence
must
reasonably
support
the
conclusion
of
a
substantial
risk.
The
1978
Policy
Statement
states
that
a
"
substantial
risk"
is
a
"
risk
of
considerable
concern
because
of
(
a)
the
seriousness
of
the
effect
and
(
b)
the
fact
or
probability
of
its
occurrence."
This
clearly
led
industry
to
believe
there
must
be
a
serious
effect
coupled
with
the
fact
or
probability
of
its
occurrence
before
the
section
8(
e)
reporting
threshold
is
reached.
The
industry
requests
EPA
clarify
whether
an
"
effect"
is
a
necessary
element
of
a
determination
of
reportability.
The
industry
believes
that
EPA
should
state
that,
unless
actual
harm
or
the
significant
potential
for
harm
to
human
health
or
the
environment
is
shown,
there
is
no
duty
to
report.

In
addition,
this
effect
must
be
unknown
to
EPA
to
be
reportable.
For
example,
that
a
common
industrial
solvent
which
leaks
into
groundwater
may
present
a
risk
to
potable
water
supplies
is
well
known.
EPA
should
clarify
that
effect
scenarios
known
to
EPA
are
not
reportable
18
under
section
8(
e).

RESPONSE:
EPA
does
not
agree
with
the
commenter's
interpretation
of
the
proposed
guidance
and
the
reporting
scenarios
presented.
Indeed
contamination
is
not
an
"
effect,"
however
Part
V(
b)
is
separated
into
two
main
parts.
Part
V(
b)(
1)
concerns
situations
of
environmental
contamination
by
a
substance
that
because
of
its
toxicity
has
the
potential
to
cause
a
serious
effect.
While
Part
V(
b)(
2­
5)
concern
effects
actually
observed.
For
reporting
under
Part
V(
b)(
1)

effects
do
not
need
to
be
observed.
The
observation
of
health
or
environmental
effects
would
be
reported
under
Part
V(
a)
and
(
b)(
2­
5),
respectively.

Finally,
for
Part
V(
b)(
1)
it
does
not
matter
whether
the
potential
effect
is
known.
What
is
unknown,
and
potentially
triggering
the
reporting,
is
the
new
exposure
information.
The
discovery
of
previously
unsuspected
contamination
of
potable
water
supplies
by
a
wellcharacterized
solvent
would
be
reportable
even
though
the
characteristics
of
the
hazard
are
known.

COMMENT:
The
Agency's
incorporation
of
the
withdrawn
Part
V(
c)
language
to
define
the
term
"
widespread
environmental
distribution"
is
not
very
helpful
because
the
practical
application
of
the
"
sliding
scale"
of
exposure/
hazard
factors
is
most
formidable
(
as
proposed
in
July
1993)
.

To
use
the
"
sliding
scale,"
it
is
necessary
to
engage
a
multidisciplined
team
of
toxicologists,
medical
professionals,
engineers
and
lawyers
to
review
scientific
literature,

toxicologic
information,
geologic,
hydrogeologic
information,
and
government
(
state/
federal)

regulations
and
standards
in
order
to
make
judgements
about
the
effect,
if
any,
of
the
presence
of
parts
per
million
concentrations
of
contaminants
identified
in
affected
media
(
e.
g.,
soil,
air,
surface
water,
ground
water).
19
At
a
minimum,
the
proposed
"
sliding
scale"
requires:

(
1)
a
review
of
the
known
toxicity
and
physical
property
data
of
each
contaminant
(
from
a
search
of
toxicity
databases)
which
may
include
a
large
number
of
studies
and
toxicity
endpoints;

(
2)
an
assessment
of
the
quality
of
available
environmental
sampling
and
sample
analysis
data;

(
3)
an
assessment
of
the
potential
for
environmental
migration
for
the
contaminants
(
based
upon
evolving
monitoring
data);

(
4)
a
determination
of
whether
the
state
or
federal
government
(
including
EPA,
OSHA)

has
established
an
exposure
limitation
for
each
chemical
and
the
significance,
if
any,
of
that
limit
to
the
environmental
media
being
addressed;

(
5)
some
extrapolation
of
the
toxicity
summary
effects
to
the
typical
parts­

permillion
parts­
per­
billion
concentrations
of
contaminants
identified
at
the
site
of
sampling
and/
or
modeled
media.

Experience
with
Parts
V(
b)(
1)
and
V(
c)
of
the
1978
Statement
of
Interpretation
shows
that
developing
a
"
sliding
scale"
assessment
is
extremely
resource
intensive.
Its
application
in
the
context
of
TSCA
section
8(
e)
requires
extraordinary
efforts
to
acquire
new
information.
As
a
practical
matter,
the
"
sliding
scale"
cannot
be
used
to
address
environmental
contamination
involving
multiple
chemical
contaminants,
particularly
during
the
early
period
of
an
environmental
investigation
when
information
about
the
source,
migration
or
expected
concentration
of
the
contaminants
in
environmental
media
is
not
fully
known.

RESPONSE:
EPA
agrees
that
for
situations
of
environmental
contamination
a
"
sliding
scale"

approach,
i.
e.,
weighing
the
toxicity
or
exposure
relative
to
the
seriousness
of
the
effect
or
the
20
magnitude
of
the
exposure
is
difficult
to
employ.
However,
companies
would
still
need
to
judge
the
seriousness
of
the
toxicity
of
the
contaminant,
the
extent
of
the
contamination,
and
the
likelihood
of
actual
exposure.
The
scheme
presented
by
the
commenter
regarding
the
steps
required
and
level
effort
needed
determine
if
a
"
substantial
risk"
notice
is
needed
is
far
more
rigorous
than
needed.
The
purpose
is
not
to
obtain
conclusive
evidence
but
to
obtain
sufficient
information
that
"
reasonably
supports"
the
section
8(
e)
determination.
The
exact
boundaries
of
the
contamination
do
not
need
to
be
determined,
exhaustive
database
searches
for
toxicity
data
need
not
be
performed,
nor
do
quantitative
risk
assessments
need
to
be
undertaken.
It
is
not
unreasonable
to
expect
that
companies
are
knowledgeable
of
the
basic
toxicological
profiles
of
the
substances
they
manufacture,
process,
and/
or
distribute
and
are
familiar
with
the
surrounding
community.
This
basic
knowledge
coupled
with
detection
data
and
other
pertinent
data
should
enable
a
company
to
make
the
section
8(
e)
determination.

COMMENT:
Under
Part
V(
c)
the
term
"
immediately"
is
ambiguous
and
subject
to
different
interpretations.
"
Immediately"
should
be
clearly
defined
as
a
time
no
later
than
24
hours
after
the
person
has
actual
knowledge
of
the
substantial
risk.
There
may
be
a
variety
of
situations
that
would
not
allow
the
instantaneous
reporting
of
the
substantial
risk
information,
including
incomplete
investigation
of
an
incident
or
logistical
problems,
such
as
the
lack
of
access
to
a
telephone.
These
situations
would
not
allow
for
immediate
reporting.
Therefore,
the
regulated
community
should
have
some
leeway
in
reporting,
that
still
assures
that
EPA
will
receive
the
information
expeditiously.

RESPONSE:
EPA
believes
the
current
language
of
the
Policy
Statement
is
appropriate
and
offers
sufficient
flexibility
to
respondents.
The
reporting
standard
is
when
the
person
"
has
knowledge
of
21
the
incident."
This
may
involve
a
number
of
pieces
of
information
such
as
the
toxicity
profile
of
the
substance,
the
amount
released,
whether
the
release
has
been
contained
in
any
fashion,

whether
the
release
is
ongoing,
and
other
factors.
Obtaining
the
required
information
could
take
minutes
to
hours.
An
exhaustive
data
search
or
risk
assessment
is
not
required
to
determine
if
the
circumstances
of
the
release
"
reasonably
supports"
the
section
8(
e)
determination.
Thus
EPA
does
not
believe
a
set
time
frame
in
this
instance
is
needed.
In
addition,
EPA
is
not
aware
that
the
current
reporting
structure
has
caused
compliance
problems
for
the
regulated
community.

INFORMATION
WHICH
NEED
NOT
BE
REPORTED
COMMENT:
Documents,
reports
and
studies
submitted
to
EPA
for
informational
purposes
only
should
satisfy
the
requirements
of
TSCA
Section
8(
e)
as
well.

RESPONSE:
EPA
does
not
agree.
The
purpose
of
requiring
section
8(
e)
reporting
to
be
identified
as
such
or
allowing
such
information
to
be
submitted
under
other
mandatory
reporting
requirements
is
to
ensure
that
it
is
available
in
a
timely
manner
to
the
program
office
that
can
best
react
to
the
data
or
refer
it
to
the
proper
office.
Voluntary
submission
of
information
could
occur
in
such
a
way
that
the
receiving
office
or
individual
is
not
aware
that
it
is
"
substantial
risk"

information
that
may
need
to
be
reviewed
elsewhere.

COMMENT:
In
proposed
PART
VII(
a)(
1­
6)
(
July
13,
1993)
the
first
sentence
of
paragraph
(
a)

differs
from
the
preamble
discussion
which
indicates
that
information
need
not
be
reported
if
it
is
"
obtained
solely
from
the
following
sources:."
As
used,
the
term
"
solely"
is
confusing
and
unnecessary
and
should
be
deleted.
This
term
suggests
that
information
obtained
from
other
nonlisted
sources
must
be
reported
under
section
8(
e)
even
though
it
also
is
included
in
one
of
the
sources
identified
by
EPA.
EPA's
guidance
should
indicate
that
information
contained
in
the
22
identified
sources
is
not
reportable
under
section
8(
e)
regardless
of
where
else
the
same
information
may
appear.
EPA's
intent
might
be
better
expressed
by
indicating
in
the
preamble
that
the
availability
of
information
from
any
of
the
listed
sources
will
not
excuse
a
failure
to
report
that
information
if
it
was
available
earlier
from
another
source.

RESPONSE:
While
the
term
"
solely"
is
used
in
the
preamble,
it
did
not
appear
in
the
refined
policy
text.
EPA
agrees
that
"
solely"
should
be
deleted.
The
exclusions
are
not
restricted
to
information
that
only
appears
in
one
of
the
sources
listed.
As
the
commenter
notes,
the
availability
of
information
from
any
of
the
listed
sources
will
not
excuse
a
failure
to
report
that
information
if
it
was
obtained
earlier
from
a
non­
exempt
source.

COMMENT:
EPA
should
clarify
the
phrase
"
made
available
to
the
general
public
by
EPA
or
another
Federal
agency."
The
exemption
should
incorporate
all
information
in
the
possession
of
a
Federal
agency
(
which
is
available
through
documents,
Freedom
of
Information
Act
requests,
or
other
means),
whether
or
not
it
has
been
officially
published
and
actively
distributed.
In
practical
terms
there
is
no
difference
between
draft
and
final
reports.
EPA
should
consider
itself
adequately
informed
of
this
information.
This
should
extend
to
State
reports
if
an
EPA
official
is
listed
on
the
distribution
list
or
the
company
has
actual
knowledge
that
EPA
has
received
or
is
aware
of
the
existence
of
the
report.

RESPONSE:
EPA
disagrees
that
it
should
consider
itself
"
adequately
informed"
of
all
information
in
the
possession
of
Federal
agencies.
Given
that
the
vast
majority
of
information
received
by
the
other
Federal
agencies
is
not
identified
to
EPA
in
any
systematic
manner,
it
would
be
impossible
for
EPA
to
be
assured
of
an
acceptable
level
of
knowledge
of
this
information.
For
instance,
if
a
company
knew
that
a
researcher
at
NCI
was
evaluating
a
potential
test
substance
and
23
sent
him
a
copy
of
a
just
completed
toxicity
study,
that
study
would
remain
unknown
to
EPA
unless
the
researcher
independently
sent
the
report
to
EPA.
The
result
would
be
that
the
study
is
in
the
possession
of
a
Federal
agency
and,
under
the
commenter's
scheme,
need
not
be
reported
to
EPA.
Thus,
EPA
would
not
have
knowledge
of
the
information
on
a
timely
basis.
A
company
could
avoid
a
section
8(
e)
reporting
obligation
by
simply
sending
data
to
another
agency
on
an
FYI
basis.

EPA
does
agree
that
information
published
or
made
available
to
the
public
in
final
as
well
as
draft
reports
need
not
be
reported.
Further,
EPA
has
added
language
to
Part
VII
to
exempt
from
reporting
information
developed
by
other
Federal
agencies
in
which
EPA
is
collaborating
in
some
fashion
(
see
Part
VII(
a)(
2))
.
Also,
companies
need
not
report
information
contained
in
state
reports
if
there
is
actual
knowledge
that
EPA
is
aware
of
the
information.

COMMENT:
In
the
revised
guidance
made
available
on
March
29,
1995,
EPA
provided
that
information
contained
in
draft
or
final
reports
made
available
to
the
general
public
by
EPA
or
other
Federal
agencies
was
not
subject
to
reporting.
This
makes
sense
for
reports
from
other
Federal
agencies,
but
is
unclear
with
respect
to
EPA
reports.
If
EPA
has
made
a
draft
or
final
report
available
to
a
person
or
company,
that
person
or
company
should
not
have
an
obligation
to
resubmit
the
information
contained
in
the
report
under
section
8(
e).
Thus,
we
assume
that,
at
least
with
respect
to
EPA
reports,
a
report
is
"
made
available
to
the
general
public"
when
it
is
made
available
to
any
member
of
the
general
public
(
individual
or
corporate).

RESPONSE:
EPA
agrees
with
the
commenter's
analysis
of
the
draft
guidance.
This
has
been
corrected
by
providing
two
guidance
provisions.
One
dealing
with
EPA
reports
(
Part
VII(
a)(
1))

and
one
for
other
Federal
reports
(
Part
VII(
a)(
2)).
The
EPA
exemption
is
broader
in
scope
24
because
there
are
greater
opportunities
for
persons
to
acquire
EPA
information
that
has
not
been
made
available
to
the
general
public,
such
as
cooperative
testing
efforts,
peer
review
panels,

advisory
committees,
etc.

COMMENT:
EPA
has
stated
that
"
general
information
concerning
the
data
bases
and
publications
to
which
the
EPA
headquarters
libraries
subscribe
is
available
from
the
Environmental
Assistance
Division."
Aside
from
the
fact
that
this
has
been
demonstrated
contrary
to
fact,
such
a
nebulous
(
and
potentially
changing)
list
is
untenable
unless
the
Agency
finds
a
way
to
continually
publicize
these
resources.
The
Agency
should
add
the
original
language
from
the
1978
policy
statement
which
lists
specific
data
bases
from
which
information
need
not
be
reported
to
its
list
of
sources.
This
should
be
broadened
to
include
all
data
bases
and
subscriptions
reasonably
available
to
a
serious
scientific
researcher,
not
merely
those
to
which
EPA
may
from
time
to
time
subscribe.
Moreover,
information
in
publications
or
data
bases
subscribed
to
by
any
EPA
regional
office
should
be
considered
available
to
EPA
even
if
an
EPA
Headquarters
library
does
not
subscribe
to
the
publication
or
data
base.

RESPONSE:
The
comments
regarding
EPA's
access
to
data
bases
and
scientific
publications
are
valid.
Companies
need
not
report
information
obtained
from
well
recognized
data
bases
and
scientific
publications.
The
limitation
in
the
proposal
to
only
those
data
bases
and
publications
to
which
the
EPA's
Headquarters
libraries
subscribes
has
been
removed.

COMMENT:
Moderate
to
large
size
chemical
companies
receive
tens
of
thousands
of
documents
annually
which
contain
health
and
safety
data.
These
range
from
studies
conducted
by
a
company
or
its
suppliers,
to
letters
notifying
customers
of
new
health
effects,
to
MSDSs.
Studies
and
letters
are
more
frequently
directed
toward
headquarters
where
health
and
regulatory
management
25
staff
are
located,
while
MSDSs
are
primarily
directed
to
the
people
who
work
with
the
chemical.

Studies
and
letters
highlight
new
data
in
some
detail,
while
MSDSs
do
not.
Because
MSDSs
are
required
by
OSHA
to
be
prepared,
updated,
and
widely
distributed,
EPA
should
consider
these
documents
as
"
published"
and
"
known
to
the
Administrator."
Generators
of
the
data,
and/
or
preparers
of
the
MSDSs,
would
still
be
responsible
for
reporting
"
new"
significant
risk
information
under
section
8(
e).

RESPONSE:
EPA
agrees
that
MSDSs
produced
as
a
result
of
OSHA
requirements
are
generally
available
on
data
bases
or
otherwise
known
to
EPA.
Generators
of
data
still
have
an
obligation
to
report
substantial
risk
information
to
EPA
within
30
days
of
obtaining
the
information.

COMMENT:
Allowing
itself
to
be
informed
of
a
situation
of
substantial
risk
from
national
media
sources
is
supported.
The
Agency
will
reduce
the
burden
on
the
regulated
community.
However,

EPA
should
consider
expanding
the
exemption
to
include
all
news
reports
but
at
a
minimum
those
broadcast
regionally.
Even
the
major
television
and
radio
networks
tailor
their
news
shows
to
their
regional
audiences.
EPA's
organizational
division
into
geographical
regions
should
provide
the
same
level
of
knowledge
of
information
contained
in
these
regional
news
reports
as
for
national
broadcasts.
On
a
broader
level
EPA
should
consider
all
news
reports
as
allegations.

News
reports
are
usually
given
by
people
with
little
technical
training
and
actual
data
is
rarely
provided.
This
would
be
especially
true
for
release
data.
A
company
has
no
way
of
evaluating
the
validity
of
information
about
the
release
of
a
substance
by
another
company
and
would
have
no
way
of
evaluating
the
factors
that
would
need
to
be
considered
to
make
a
substantial
risk
"
call."
Only
the
company
actually
releasing
the
chemical
has
access
to
such
information
and
the
reporting
obligation
should
be
theirs
alone.
Furthermore,
it
would
be
impossible
for
the
EPA
to
26
police
what
information
was
heard
by
anyone.

RESPONSE:
EPA
agrees
with
the
commenters
regarding
information
from
written
or
broadcast
news
reports.
Rarely
do
these
reports
provide
the
range
of
information
that
a
non­
generator
of
the
data
would
need
to
judge
whether
or
not
a
substantial
risk
exists.
Generators
of
the
data
have
an
obligation
to
report
to
EPA
even
if
they
release
the
study
results
to
the
media
because
there
is
no
assurance
that
the
media
report
will
accurately
convey
all
the
pertinent
information
on
the
situation
to
the
public
and
EPA.
The
reporting
exemption
is
not
designed
to
alleviate
generators
of
test
or
contamination
data
of
their
obligation
to
report
substantial
risk
notices
to
EPA,
because
they
do
not
have
any
control
over
when
and
what
will
be
reported.

COMMENT:
The
proposed
guidance
regarding
the
reportability
of
information
presented
at
scientific
meetings
should
be
revised.
Typically,
information
presented
in
such
forums
is
not
recorded
and
cited
in
an
abstract
or
publication
within
thirty
days
of
the
presentation.
Thus,
little
information
will
be
excluded
from
section
8(
e)
reporting
under
the
approach
proposed
by
EPA.

EPA
should
extend
the
publication
period
for
this
category
of
information
to
90
days.
EPA's
guidance
also
should
explicitly
state
that,
where
EPA
is
either
a
sponsor,
presenter,
member
or
participant
of
the
conference
or
meeting,
the
Agency
will
be
deemed
to
be
"
adequately
informed"

of
all
information
presented.
Further,
EPA
should
not
include
the
word
"
national"
or
phrase
"
held
within
the
U.
S."
Company
employees
should
not
be
required
to
consider
all
information
heard
at
a
public
scientific
conference
for
section
8(
e)
reporting
simply
because
the
conference
might
not
be
considered
to
be
national
or
is
not
held
in
the
U.
S.

RESPONSE:
EPA
agrees
that
information
presented
at
scientific
meetings
may
not
be
recorded
within
30
days,
thus
offering
a
minimal
reporting
burden
reduction.
Consequently,
EPA
agrees
27
that
a
reasonable
extension
to
90
days
is
appropriate.
Further,
as
long
as
the
information
presented
is
captured
within
90
days
and
is
accessible
under
PART
VII(
a)(
1­
4,7,8),
the
location
of
the
meeting
is
not
relevant.

EPA
does
not
fully
agree
that
any
information
presented
at
a
conference
where
EPA
is
a
sponsor,
presenter,
member,
or
participant
need
not
be
considered
for
reporting
under
section
8(
e).
It's
not
reasonable
to
assume
that
EPA
attendance
at
a
conference
means
that
EPA
is
aware
of
all
the
information
presented.
Large
conferences
have
numerous
concurrent
sessions
over
a
period
of
days,
thus
it
is
not
possible
to
conclude
that
the
Administrator
is
"
adequately
informed"

of
information
based
simply
on
EPA
attendance.
However,
EPA
agrees
that
information
presented
at
conferences
sponsored
or
co­
sponsored
by
EPA
or
presented
by
EPA
employees
or
EPA
contractors
need
not
be
reported.

COMMENT:
In
proposed
PART
VII(
b)
(
July
13,
1993)
EPA
states
that
it
maintains
its
position
under
Part
VII(
c)
of
the
1978
Policy
Statement
that
information
which
corroborates
well
established,
serious
adverse
effects
that
are
already
documented
need
not
be
reported.
EPA
should
revisit
its
1978
position
on
the
issue
of
what
is
meant
by
"
corroborate."
Further,
EPA
should
provide
examples
illustrating
its
definition
of
"
corroborate"
as
applied
to
incidents
of
nonemergency
contamination
or
occupational
exposure
information.

According
to
Webster's
Seventh
New
Collegiate
Dictionary,
corroborate
means
"
to
support
with
evidence
or
authority;
make
more
certain."
It
is
clear
that
this
definition
does
not
agree
with
EPA's
which,
in
practice,
has
equated
"
corroborate"
to
"
duplicate."
EPA
should
make
it
clear
that
reporting
is
not
required
for
information
which,
in
the
judgement
of
a
competent
scientific
investigator,
confirms
existing,
well­
documented
serious
effects
without
necessarily
28
duplicating
the
existing
information.

RESPONSE:
EPA
notes
the
comment
on
what
constitutes
corroborative
data
but
believes
that
the
scope
of
what
does
not
constitute
corroborative
data
is
adequately
stated
in
the
July
13,
1993,

preamble
(
thus
defining
the
range
of
corroborative
data).
The
exclusion
applies
only
to
health
and
environmental
effects
data.

COMMENT:
Regarding
proposed
PART
VII(
c­
d)
(
July
13,
1993),
EPA
correctly
notes
that
many
environmental
laws
and
regulations
have
been
promulgated
since
1978
requiring
the
submission
of
a
wide
range
of
environmental
monitoring
data.
EPA's
proposal
to
exclude
from
section
8(
e)
reporting
information
submitted
under
these
other
statutes
is
supported.
However,

little
if
any
benefit
is
seen
if
such
reporting
must
be
done
within
30
calendar
days.
The
30­
day
requirement
will
be
a
major
reporting
burden
to
industry
and
will
result
in
considerable
duplication
of
reports
to
the
government,
while
achieving
no
real
benefit.
Such
reporting
also
runs
counter
to
the
Paperwork
Reduction
Act.
Reporting
requirements
and
time
frames
for
each
program
are
chosen
so
as
to
permit
awareness
and
management
of
risk
by
those
agencies
that
have
primary
responsibility
for
each
of
the
regulated
areas.
Of
the
non­
emergency
reporting
requirements
studied,
only
27
percent
have
a
reporting
period
of
30
days.
For
example,
the
reporting
of
environmental
contamination
information
generated
during
an
ongoing
Superfund
remediation
investigation
to
EPA
under
section
8(
e)
within
30
days
is
unnecessary
and
a
wasteful
duplication
of
effort
if,
for
example,
the
remedial
investigation
protocol
requires
reporting
of
such
information
to
EPA
every
three
or
six
months.

All
environmental
release/
contamination
data
reported
under
existing
EPA
statutes
and
EPA
administered
state
programs,
within
the
time
frames
required
by
those
programs,
should
be
29
considered
"
known
to
the
Administrator"
and
be
excluded
entirely
from
reporting
under
section
8(
e).

RESPONSE:
EPA
agrees
that
a
significant
expansion
of
environmental
contamination
reporting
has
occurred
at
the
Federal
level
since
1978.
In
response,
EPA,
in
the
proposed
revisions,

expanded
the
scope
of
the
information
which
need
not
be
reported
by
updating
the
EPA
statutes
and
adding
state
programs
authorized
or
delegated
by
EPA.
The
proposed
30­
day
reporting
time
frame
would
apply.
However,
the
commenters
raise
a
valid
issue
of
the
utility
of
requiring
separate
reporting
of
information
to
EPA
under
TSCA
within
30
days
if
the
other
EPA
requirements
allow
60
or
90
days.
A
company
could
advance
their
reporting
under
the
other
requirements
to
within
30
days
to
avoid
TSCA
reporting,
but
the
net
effect
is
to
either
unilaterally
reduce
some
reporting
periods
to
30
days
or
to
force
duplicative
reporting
because
a
company
would
still
have
a
continuing
reporting
obligation
under
the
other
requirements.
Thus,
any
reduction
in
reporting
burdens
may
be
illusionary.

In
the
proposal,
EPA
rejected
allowing
longer
time
frames
because
substantial
risk
information
must
be
reported
"
immediately"
and
longer
time
frames
would
conflict
with
this
statutory
requirement.
However,
on
reflection,
the
more
appropriate
standard
to
use
is
whether
the
Administrator
is
"
adequately
informed
of
such
information."
As
a
general
rule,
it
would
appear
reasonable
that
the
Administrator
is
"
adequately
informed"
if
substantial
risk
information
concerning
environmental
contamination
is
submitted
to
the
Agency
under
the
varying
time
frames
of
the
non­
TSCA
requirements.
However,
it
is
also
reasonable
to
assume
that
being
"
adequately
informed"
includes
a
timeliness
component.
Otherwise
it
is
difficult
to
support
the
basis
of
section
8(
e)
which
is
to
force
the
submittal
of
substantial
risk
information
in
a
time
frame
30
that
allows
the
Agency
to
evaluate
the
risk
and
if
necessary
take
appropriate
action.
Time
frames
longer
than
a
few
months
quickly
erode
the
basic
purpose
of
section
8(
e).
Therefore,
allowing
reporting
under
other
EPA/
EPA­
state
requirements
up
to
90
days
is
a
reasonable
accommodation
that
avoids
significant
duplicative
reporting
while
assuring
that
important
environmental
contamination
data
is
submitted
on
a
timely
basis.
Based
on
an
analysis
by
a
commenter,
nearly
70
percent
of
non­
emergency
reporting
requirements
have
time
frames
of
up
to
90
days
and
this
includes
most
of
the
information
types
most
likely
to
constitute
substantial
risk
data.
Health
and
environmental
effects
data
would
still
be
subject
to
the
30­
day
time
frame.

COMMENT:
The
inclusion
of
the
Comprehensive
Environmental
Response,
Compensation
and
Liability
Act
(
CERCLA)
and
the
Resource
Conservation
and
Recovery
Act
(
RCRA)
under
section
8(
e)
reporting
is
nonsensical.
EPA
already
administers
these
programs
and
will
receive
all
required
filings.
Further,
the
agency
must
ask
itself
whether
the
mere
listing
of
a
site
on
the
NPL
automatically
triggers
a
finding
of
substantial
risk
for
the
site
and
consequently
section
8(
e)

reporting.
Additional
questions
the
agency
must
address
include
whether
an
individual
company
would
have
reporting
requirements
for
CERCLA
sites
when
that
company
is
contesting
the
accuracy
of
being
named
a
potentially
responsible
party
(
PRP)
for
the
site?
Could
a
PRP
group
or
contractor
report
for
a
CERCLA
site
and
remove
responsibility
from
the
individual
companies
or
must
all
(
often
several
hundreds
of
companies)
PRPs
report?

RESPONSE:
The
only
reason
CERCLA
and
RCRA
are
listed
is
to
avoid
duplicative
reporting
of
information
that
may
meet
both
section
8(
e)
and
another
EPA
statute's
requirements.
The
passage
of
these
other
statutes
did
not
negate
the
statutory
requirement
under
section
8(
e)
of
TSCA.
31
The
listing
of
a
site
on
the
NPL
would
not
trigger
section
8(
e).
What
could
trigger
reporting
is
if
a
current
manufacturer,
processor,
or
distributor
of
a
substance(
s)
obtains
information
about
contamination
by
that
substance(
s)
of
a
site
owned
or
controlled
by
the
company.
Under
Part
VII(
g)
only
the
person
controlling
the
site
is
responsible
for
reporting.

COMMENT:
We
strongly
recommend
that
EPA
include
in
this
category
[
information
that
does
not
need
to
be
reported]
reporting
of
emergency
releases
to
local
emergency
response
committees
as
created
under
EPCRA.
Although
these
committees
may
not
meet
the
formal
definition
of
delegated
or
authorized
by
EPA,
they
were
created
by
Congressional
action
with
the
clear
mandate
of
managing
risks
associated
with
emergency
releases.

RESPONSE:
EPA
agrees.
Because
local
emergency
response
committees
were
created
under
the
rubric
of
EPCRA,
there
is
a
strong
enough
nexus
to
EPA.

COMMENT:
Because
EPA
is
a
member
of
the
National
Response
Center,
persons
reporting
EIEC's
should
be
considered
to
have
met
their
section
8(
e)
obligations
if
they
report
incidents
to
the
National
Response
Center
instead
of
to
the
regional
EPA
contacts.

RESPONSE:
EPA
agrees.
The
National
Response
Center
telephone
number
has
been
added
to
Part
IX.

COMMENT:
EPA
should
expand
the
exemption
for
information
"
required"
to
be
submitted
in
connection
with
an
authorized
site
remediation
program
because
information
generated
during
a
site
remediation
may
often
exceed
what
is
expressly
required
by
statute
or
consent
agreement.

This
"
voluntarily"
developed
data
should
not
be
separately
subject
to
section
8(
e)
reporting
when
the
main
data
generated
are
not.
32
RESPONSE:
The
commenter
is
correct
in
pointing
out
that
much
information
generated
at
these
sites
that
may
not
be
strictly
"
required."
EPA
agrees
that
differentiating
between
the
two
is
counterproductive
in
the
context
of
an
authorized
site
remediation.
Consequently,
the
guidance
language
has
been
modified
accordingly.
However,
the
intent
of
the
change
is
to
include
"
like
information"
such
as
additional
monitoring
data
that
are
site
specific.
It
does
not
include
voluntarily
generated
data
such
as
toxicological
studies
of
chemicals
that
have
broader
applicability.

COMMENT:
Many
companies
generate
environmental
information
in
regulatory
contexts
in
which
there
is
no
"
substantial
risk"
associated
with
the
information.
For
example,
companies
engaged
in
remedial
activities
routinely
will
identify
groundwater
and/
or
soil
readings
above
cleanup
or
"
action"
levels.
By
definition,
however,
the
sites
typically
represent
situations
that
are
being
supervised
and/
or
controlled
and
that
therefore
are
unlikely
to
pose
a
"
substantial
risk"

that
triggers
section
8(
e)
reporting
requirements.

RESPONSE:
In
revising
Part
VII,
EPA
added
paragraph
(
f)
which
would
exempt
from
reporting
data
developed
and
required
to
be
submitted
as
a
result
of
an
authorized
site
remediation
program.

COMMENT:
EPA
should
clarify
that
information
about
releases
and
detections
outside
the
United
States
need
not
be
considered
for
section
8(
e)
reporting.
EPA's
position
that
if
domestic
companies'
employees
come
into
possession
of
health
effects
information
(
e.
g.,
a
toxicology
study
conducted
overseas),
it
does
not
matter
that
the
information
was
not
initially
generated
in
the
33
United
States
is
understandable.
However,
the
situation
of
releases
and
detections
outside
the
United
States
is
definitely
not
analogous.
Information
that
a
chemical
substance
has
been
released
or
detected
in
another
country
is
not
directly
relevant
to
assessment
of
chemical
risks
posed
to
the
U.
S.
public
or
environment.

RESPONSE:
As
opposed
to
information
a
company
may
receive
from
a
source
outside
the
United
States
about
the
effects
of
a
substance,
EPA
believes
that
in
the
case
of
contamination
at
sites
outside
the
United
States
companies
have
no
obligation
to
consider
these
data
for
reporting
under
section
8(
e).
Further,
because
companies,
other
than
the
one
controlling
a
United
States
site
where
contamination
is
discovered,
would
not
have
access
to
the
range
of
data
needed
to
make
a
section
8(
e)
"
call,"
EPA
is
including
this
as
a
type
of
information
under
PART
VII(
h)
that
need
not
be
reported,
except
as
noted
in
the
caveat.

CONFIDENTIAL
BUSINESS
INFORMATION
COMMENT:
TSCA
section
14
does
not
obligate,
and
may
not
even
permit
EPA
to
disseminate
health
and
safety
studies.
EPA
has
discretion
to
disclose
health
and
safety
studies
which
contain
CBI
only
where
they
are
subject
to
a
FOIA
request.
Otherwise,
the
broad
CBI
protections
of
section
14(
a)
apply.

RESPONSE:
EPA
disagrees
with
this
comment.
Section
14(
b)
confers
the
authority
to
release
health
and
safety
data
from
health
and
safety
studies
which
are
not
restricted
from
release
by
the
second
sentence
of
section
14(
b)(
1).

COMMENT:
TSCA
section
14(
b)
does
not
apply
to
chemicals
not
offered
for
commercial
distribution
and
not
subject
to
section
4
testing
or
section
5
PMN
requirements.
Research
and
34
development
chemicals
are
excepted
from
this
disclosure.

RESPONSE:
EPA
disagrees
with
the
comment
that
research
and
development
chemicals
are
somehow
excepted
from
the
section
14(
b)
disclosure
requirements.

EPA's
long
held
position
is
that
research
and
development
activities
are
specifically
included
in
the
definition
of
commercial
distribution
for
purposes
of
complying
with
sections
8(
e)

and
14(
b).
43
Fed.
Reg.
11115
(
March
16,
1978)
(
Response
to
Comment
31).
See
also
40
CFR
§
§
716.55(
a)(
1)
and
717.3(
e)(
1).

COMMENT:
Even
for
substances
distributed
in
commerce,
TSCA
section
14(
b)
permits
CBI
treatment
of
the
identity
of
the
test
substance
where
the
submitter
provides
EPA
with
a
generic
chemical
name
and
the
study's
methodology
and
the
conclusions
are
available
for
public
review.

RESPONSE:
EPA
disagrees
with
this
comment.
EPA
has
consistently
found
that
chemical
identity
is
an
integral
part
of,
or
underlying
data
to
a
health
and
safety
study.
As
such,
chemical
identity
may
be
properly
claimed
as
CBI
only
in
the
limited
circumstances
found
in
section
14(
b)(
1)(
a).

The
utility
of
a
health
and
safety
study,
especially
for
chemicals
in
commercial
distribution,

is
greatly
enhanced
by
connection
to
a
specific
chemical
identity.
The
connection
the
specific
chemical
and
an
identified
hazard
allows
for
risk
analysis
and
management
by
all
segments
of
the
interested
public,
including
the
chemical
industry.
For
example,
there
have
been
a
number
of
instances
where
an
entire
industry
has
taken
immediate
voluntary
protective
actions
when
new,

readily
identifiable
hazards
are
reported
by
one
submitter
to
EPA
under
section
8(
e).
Such
actions
cannot
take
place
when
a
hazard
cannot
be
associated
with
a
specific
chemical.
35
COMMENT:
Reporting
requirements
under
TSCA
sections
8(
d)
and
8(
e)
create
an
increased
need
for
CBI
protection
for
chemical
identity.
In
particular,
research
and
development
and
site
limited
intermediates
and
catalysts
not
in
distribution
should
receive
CBI
protection
for
chemical
identity.

RESPONSE:
EPA
disagrees
with
this
comment.
Both
of
the
examples
in
the
comment
can
receive,
in
the
appropriate
circumstances,
CBI
protection
under
the
current
CBI
system.
It
can
be
proper
to
assert
a
CBI
claim
for
chemical
identity
for
a
new
chemical
compound
undergoing
research
and
development
activities.
Likewise,
it
can
be
appropriate
to
claim
as
confidential
the
specific
identity
of
a
site
limited
intermediate
or
catalyst
whose
disclosure
would
compromise
process
information.

COMMENT:
EPA
misinterprets
what
portion
of
a
mixture
means
in
section
14(
b).
Disclosure
of
information
greater
than
percentages
is
prohibited.

RESPONSE:
EPA
disagrees
with
this
comment.
The
language
"
disclosing
the
portion
of
the
mixture
comprised
by
any
of
the
chemicals
in
the
mixture"
in
the
second
sentence
of
section
14(
b)(
2)
was
taken
verbatim
from
the
House
of
Representatives
version
of
TSCA.
The
House
Report
accompanying
H.
R.
14032
clearly
explains
what
this
phrase
is
intended
to
mean.
The
report
explains
that;

[
i]
n
referring
to
data
"
disclosing
the
portion
of
the
mixture
comprised
by
any
of
the
chemicals
in
the
mixture,"
the
Committee
intends
to
protect
confidential
trade
secret
information
respecting
the
specific
formulation
of
a
mixture.
However,
the
Committee
does
not
intend
to
prohibit
the
Administrator
from
disclosing
the
chemical
substances
comprising
the
mixture
by
their
order
of
quantity
in
the
36
mixture.
H.
R.
Rep.
No.
94­
1341,
94th
Cong.,
2nd
Sess.
at
51
(
1976).

Given
this
guidance
in
the
legislative
history,
EPA
believes
that
it
is
consistent
with
the
statute
to
identify
all
chemicals,
by
either
non­
confidential
name
or
generic
name,
in
a
mixture
formulation
and
that
such
identification
can
be
made
in
order
of
quantity
in
the
mixture.

COMMENT:
TSCA
sections
14(
a)
and
14(
c)
provide
sufficient
information
about
confidential
chemical
identities
in
emergencies
that
chemical
identities
should
be
afforded
CBI
status.

RESPONSE:
In
a
very
limited
sense,
EPA
agrees
with
this
comment.
However,
reacting
to
emergencies
is
not
the
only
Agency
activity
supported
by
the
data
collected
by
section
8(
e).
EPA
is
increasingly
seeking
to
manage
and
mitigate
the
risks
identified
in
section
8(
e)
submissions
before
the
occurrence
of
an
emergency.
Indeed,
the
existence
of
an
emergency
can
sometimes
be
attributed
to
a
failure
of
EPA,
industry
and
the
marketplace
the
properly
manage
risks.

Disclosure
of
specific
chemical
identities
enhances
the
ability
of
the
Agency,
Industry
and
the
marketplace
to
proactively
address
hazards
and
risk.

COMMENT:
Submitter
identity
should
be
permitted
CBI
status.

RESPONSE:
EPA
agrees
with
this
comment
in
the
appropriate
circumstances.
However,
there
will
be
occasions,
such
as
when
a
site
limited
chemical
release
occurs,
where
submitter
identity
or
location
will
be
health
and
safety
data
and
subject
to
section
14(
b).