Document ID: EPA-HQ-OPPT-2002-0067-0001
Agency: epa
Document Type: Notice
Title: TSCA Section 8(e); Notification of Substantial Risk; Policy Clarification and Reporting Guidance
Posted Date: 2003-06-03T04:00Z

33129
Federal
Register
/
Vol.
68,
No.
106
/
Tuesday,
June
3,
2003
/
Notices
may
not
conduct
or
sponsor,
and
a
person
is
not
required
to
respond
to
a
collection
of
information
unless
it
displays
a
currently
valid
OMB
control
number.
The
OMB
control
number
for
EPA's
regulations,
after
initial
display
in
the
final
rule,
are
listed
in
40
CFR
part
9.

VI.
References
1.
U.
S.
EPA,
OPPT.
I.
Ethylene
Dichloride
(
107
 
06
 
2).
Pp
24
 
27
In:
``
TSCA
Section
4
Findings
for
21
Hazardous
Air
Pollutants:
A
Supporting
Document
for
Proposed
Hazardous
Air
Pollutants
(
HAPs)
Test
Rule.''
(
June
25,
1996).
2.
The
HAP
Task
Force.
Letter
from
Peter
E.
Voytek
to
Charles
M.
Auer
with
attachment
entitled:
``
Proposal
for
Pharmacokinetics
Study
of
Ethylene
Dichloride,
November
22,
1996.''
(
November
22,
1996).
3.
U.
S.
EPA.
Letter
from
Charles
M.
Auer
to
Peter
E.
Voytek
with
attachment
entitled:
``
Preliminary
EPA
Technical
Analysis
of
Proposed
Industry
Pharmacokinetics
(
PK)
Strategy
for
Ethylene
Dichloride,
June,
1997.''
(
June
26,
1997).
4.
The
HAP
Task
Force.
Letter
from
Peter
E.
Voytek
to
Charles
M.
Auer,
U.
S.
EPA.
(
March
19,
1999).
5.
U.
S.
EPA.
Letter
from
Charles
M.
Auer
to
Peter
E.
Voytek,
HAP
Task
Force,
Re:
ECA
Development
of
Ethylene
Dichloride
(
EDC)
(
OPPTS
42197C,
with
attachment:
``
EDC
ECA
 
DRAFT,
dated
February,
2001.''
(
February
13,
2001).
6.
Final
Enforceable
Consent
Agreement
for
Ethylene
Dichloride
and
Accompanying
Testing
Consent
Order,
signed
by
EPA
on
May
13,
2003.
7.
D'Souza,
R.
W.,
Francis,
W.
R.,
Bruce
R.
D.,
and
Andersen,
M.
E.
Physiologically
based
phamacokinetic
model
for
ethylene
dichloride
and
its
application
in
risk
assessment.
Pp
286
 
301,
In:
Pharmacokinetics
in
Risk
Assessment.
National
Academy
Press.
Washington,
D.
C.
(
1987).
8.
D'Souza,
R.
W.,
Francis,
W.
R.,
and
Andersen,
M.
E.
Physiological
model
for
tissue
glutathione
depletion
and
increased
resynthesis
after
ethylene
dichloride
exposure.
Journal
of
Pharmacology
and
Experimental
Therapeutics
245(
2):
563
 
568.
1988.
9.
Daniel,
F.
B.,
Robinson,
M.,
Olson,
G.
R.,
York,
R.
G.,
and
Condie,
L.
W.
Ten
and
ninety­
day
toxicity
studies
of
1,2­
dichloroethane
in
Sprague­
Dawley
rats.
Drug
and
Chemical
Toxicology
17:
463
 
477.
1994.
10.
Alumot,
E.,
Nachtomi,
E.,
Mandel,
E.,
Holstein,
P.,
Bondi,
A.,
and
Herzberg,
M.
Tolerance
and
acceptable
daily
intake
of
chlorinated
fumigants
in
the
rat
diet.
Food,
Cosmetics
and
Toxicology
14:
105
 
110.
(
1976).
11.
Rao,
K.
S.,
Murray,
J.
S.,
Deacon,
M.
M.,
John,
J.
A.,
Calhoun,
L.
L.,
and
Young,
J.
T.
Teratogenicity
and
reproduction
studies
in
animals
inhaling
ethylene
dichloride.
Banbury
Report
5:
149
 
166.
(
1980).
12.
Lane,
R.
W.,
Riddle,
B.
L.,
and
Borzelleca,
J.
F.
Effects
of
1,2­
dichloroethane
and
1,1,1­
trichloroethane
in
drinking
water
on
reproduction
and
development
in
mice.
Toxicology
and
Applied
Pharmacology
63:
409
 
421.
1982.
13.
Payan,
J.
P.,
Saillenfait,
A.
M.,
Bonnet,
P.,
Fabry,
J.
P.,
Langonne,
I.,
and
Sabate
J.
P.
Assessment
of
the
developmental
toxicity
and
placental
transfer
of
the
1,2­
dichloroethane
in
rats.
Fundamental
and
Applied
Toxicology
28:
187
 
198.
1995.
14.
Sherwood,
R.
L.,
O'Shea,
W.,
Thomas,
P.
T.,
Ratajczak,
H.
V.,
and
Aranyi,
C.
Effects
of
inhalation
of
ethylene
dichloride
on
pulmonary
defenses
of
mice
and
rats.
Toxicology
and
Applied
Pharmacology
91:
491
 
496.
1987.
15.
U.
S.
EPA,
OPPTS.
``
Burden
Estimates
for
the
Enforceable
Consent
Agreement
for
Ethylene
Dichloride.''
(
January
31,
2002).

List
of
Subjects
Environmental
protection,
Hazardous
chemicals.

Dated:
May
13,
2003.
Stephen
Johnson,
Assistant
Administrator
for
Prevention,
Pesticides
and
Toxic
Substances.

[
FR
Doc.
03
 
13721
Filed
6
 
2
 
03;
8:
45
am]

BILLING
CODE
6560
 
50
 
S
ENVIRONMENTAL
PROTECTION
AGENCY
[
OPPT
 
2002
 
0067;
FRL
 
7287
 
4]

TSCA
Section
8(
e);
Notification
of
Substantial
Risk;
Policy
Clarification
and
Reporting
Guidance
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

SUMMARY:
EPA
is
hereby
finalizing
revisions
to
certain
parts
of
EPA's
``
Statement
of
Interpretation
and
Enforcement
Policy;
Notification
of
Substantial
Risk''
(
policy
statement)
issued
March
16,
1978,
concerning
the
reporting
of
``
substantial
risk''
information
pursuant
to
section
8(
e)
of
the
Toxic
Substances
Control
Act
(
TSCA).
EPA
is
making
these
revisions
after
having
considered
public
comments
that
were
solicited
in
1993
and
1995.
Specifically,
the
revisions
address
the
reporting
of
information
on
the
release
of
chemical
substances
to,
and
the
detection
of
chemical
substances
in,
environmental
media,
the
reporting
deadline
for
written
``
substantial
risk''
information,
and
the
circumstances
under
which
certain
information
need
not
be
reported
to
EPA
under
section
8(
e)
of
TSCA.
EPA
is
republishing
the
policy
statement
in
its
entirety
in
this
document,
including
both
those
portions
of
the
policy
statement
that
are
revised
and
those
portions
that
are
not
affected
by
any
revisions.
Since
the
policy
statement
was
published
in
1978,
this
republication
is
intended
to
ensure
that
a
single
reference
source
for
the
TSCA
section
8(
e)
policy
and
guidance
is
easily
available
to
the
regulated
community
and
other
interested
parties.
FOR
FURTHER
INFORMATION
CONTACT:
For
general
information
contact:
Barbara
Cunningham,
Director,
Environmental
Assistance
Division
(
7408M),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
202)
554
 
1404;
e­
mail
address:
TSCAHotline
epa.
gov.
For
technical
information
contact:
Richard
Hefter,
Chief,
High
Production
Volume
Chemicals
Branch,
Risk
Assessment
Division,
Office
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460
 
0001;
telephone
number:
(
202)
564
 
7649;
e­
mail
address:
hefter.
richard@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
General
Information
A.
Does
this
Action
Apply
to
Me?

You
may
be
potentially
affected
by
this
action
if
you
manufacture,
process,
import,
or
distribute
in
commerce
chemical
substances
and
mixtures.
Potentially
affected
entities
may
include,
but
are
not
limited
to:
 
Chemical
manufacturers,
processors,
and
distributors
(
NAICS
325)
 
Petroleum
refiners
and
distributors
(
NAICS
324)
 
Manufacturers
of
plastic
parts
and
components
(
NAICS
325211)
 
Paints
and
coatings
and
adhesive
manufacturing
(
NAICS
3255)
 
Cleaning
compounds
and
similar
products
manufacturing
(
NAICS
3256)
 
Electronics
manufacturing
(
NAICS
334
and
335)
 
Automobiles
manufacturing
(
NAICS
3361)

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3
6:
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2002­
0067­
0001
33130
Federal
Register
/
Vol.
68,
No.
106
/
Tuesday,
June
3,
2003
/
Notices
 
Aircraft
manufacturing
(
NAICS
336411)
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
this
unit
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
action
might
apply
to
certain
entities.
To
determine
whether
you
or
your
business
may
be
affected
by
this
action,
you
should
carefully
examine
the
applicability
provisions
in
Unit
VIII.,
Part
II.,
of
this
document.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
technical
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

B.
How
Can
I
Get
Copies
of
this
Document
and
Other
Related
Information?
1.
Docket.
EPA
has
established
an
official
public
docket
for
this
action
under
docket
identification
(
ID)
number
OPPT
 
2002
 
0067.
The
official
public
docket
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received,
and
other
information
related
to
this
action.
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
EPA
Docket
Center,
Rm.
B102
 
Reading
Room,
EPA
West,
1301
Constitution
Ave.,
NW.,
Washington,
DC.
The
EPA
Docket
Center
is
open
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
EPA
Docket
Center
Reading
Room
telephone
number
is
(
202)
566
 
1744
and
the
telephone
number
for
the
OPPT
Docket,
which
is
located
in
EPA
Docket
Center,
is
(
202)
566
 
0280.
2.
Electronic
access.
You
may
access
this
Federal
Register
document
electronically
through
the
EPA
Internet
under
the
``
Federal
Register''
listings
at
http://
www.
epa.
gov/
fedrgstr/.
Information
about
the
Office
of
Prevention,
Pesticides
and
Toxic
Substances
(
OPPTS)
and
OPPTS­
related
programs
is
available
from
http://
www.
epa.
gov/
opptsmnt/.
An
electronic
version
of
the
public
docket
is
available
through
EPA's
electronic
public
docket
and
comment
system,
EPA
Dockets.
You
may
use
EPA
Dockets
at
http://
www.
epa.
gov/
edocket/
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
official
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Although
not
all
docket
materials
may
be
available
electronically,
you
may
still
access
any
of
the
publicly
available
docket
materials
through
the
docket
facility
identified
in
Unit
I.
B.
1.
Once
in
the
system,
select
``
search,''
then
key
in
the
appropriate
docket
ID
number.

II.
Background
A.
What
Action
is
the
Agency
Taking?

The
Agency
is
revising
and
clarifying
certain
provisions
of
the
TSCA
section
8(
e)
policy
statement
issued
in
1978.
Specifically
the
Agency
is
changing
the
interpretation
that
section
8(
e)
notices
should
be
submitted
within
15
working
days
by
lengthening
the
reporting
period
to
30
calendar
days.
The
Agency
is
revising
and
clarifying
the
guidance
regarding
the
release
and
detection
of
chemical
substances
in
environmental
media,
which
includes
previously
unsuspected
chemical
contamination
such
as
in
soil
and
ground
water,
and
emergency
incidents
of
environmental
contamination
such
as
spills
to
water
and
releases
to
the
atmosphere.
Also,
the
Agency
is
expanding
the
types
of
information
that
it
believes
need
not
be
reported
under
section
8(
e)
and
changing
the
reporting
periods
to
provide
additional
time
for
industry
compliance
with
TSCA
section
8(
e).
In
addition,
EPA
is
updating
certain
reporting
contact
phone
numbers
and
the
address
for
reporting
section
8(
e)
notices.
While
the
Agency
is
only
revising
portions
of
the
1978
guidance
it
has
issued
in
earlier
documents,
EPA
is
including
in
this
Federal
Register
document,
along
with
the
revised
guidance,
those
portions
of
earlier
guidance
documents
that
are
not
being
changed.
In
that
way,
members
of
the
regulated
community
will
be
able
to
find
all
current
EPA
guidance
on
compliance
with
section
8(
e)
in
this
Federal
Register
document,
without
having
to
consult
older
documents
as
well.
The
Agency
is
including
in
this
guidance
document
its
preferences
for
how
and
where
section
8(
e)
notices
should
be
submitted.
Although
these
preferences
could
be
codified
in
procedural
rules
under
the
Administrative
Procedures
Act
(
APA),
5
U.
S.
C.
551
et
seq.,
EPA
is
not
at
this
time
adopting
them
as
rules.
While
submitters
of
section
8(
e)
notices
are
not
therefore
obligated
to
comply
with
the
preferences
articulated
in
this
document,
EPA
encourages
submitters
to
consider
and
follow
them
when
preparing
and
submitting
TSCA
section
8(
e)
notices.
Finally,
the
bulk
of
this
document
contains
EPA's
guidance
on
certain
types
of
information
it
currently
believes
generally
meet
the
statutory
standard
of
``
information
which
reasonably
supports
the
conclusion
that
such
substance
or
mixture
presents
a
substantial
risk
of
injury
to
health
or
the
environment.''
Some
of
this
guidance
is
new,
and
reflects
public
comment
following
the
Agency's
requests
for
comments
in
1993
and
1995.
As
noted
earlier,
this
document
also
contains
earlier
guidance
issued
on
section
8(
e)
that
has
not
been
changed
and
that
is
being
reprinted
here
for
the
convenience
of
all
interested
persons.
During
the
Compliance
Audit
Program
(
CAP)
(
see
Unit
II.
C.),
EPA
reviewed
the
provisions
in
the
reporting
guidance
for
incidents
involving
chemical
contamination
of
the
environment.
The
changes
set
out
in
this
document
were
developed
as
a
result
of
that
review.
In
1993,
EPA
issued
a
Federal
Register
notice
(
58
FR
37735,
July
13,
1993)
that
proposed
changes
to
the
reporting
guidance.
In
1995,
after
consideration
of
comments
received
on
the
1993
proposal,
EPA
sought
additional
public
comment
on
proposed
changes
to
the
reporting
guidance
(
60
FR
14756,
March
20,
1995)
(
FRL
 
4937
 
6).
Unit
III.
describes
the
changes
EPA
proposed,
the
comments
received
on
the
proposed
changes,
and
the
Agency's
resolution
of
the
issues
raised
by
the
comments.

B.
What
is
the
Agency's
Authority
for
Taking
this
Action?
TSCA
section
8(
e)
states,
``
Any
person
who
manufactures,
[
imports,]
processes,
or
distributes
in
commerce
a
chemical
substance
or
mixture
and
who
obtains
information
which
reasonably
supports
the
conclusion
that
such
substance
or
mixture
presents
a
substantial
risk
of
injury
to
health
or
the
environment
shall
immediately
inform
the
[
EPA]
Administrator
of
such
information
unless
such
person
has
actual
knowledge
that
the
Administrator
has
been
adequately
informed
of
such
information.''
15
U.
S.
C.
2607(
e).
EPA
hopes
and
expects
that
this
guidance
will
be
useful
to
manufacturers,
including
importers,
processors,
and
distributers
of
chemical
substances
in
fulfilling
their
responsibilities
under
section
8(
e).
This
guidance
is
not,
however,
a
substitute
for
rulemaking
and
it
does
not
impose
any
binding
requirements
upon
either
the
regulated
community
or
the
Agency.
In
any
particular
set
of
circumstances,
any
person
who
has
a
question
about
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June
3,
2003
/
Notices
the
applicability
of
section
8(
e)
to
certain
information
is
welcome
to
contact
EPA.
In
responding
to
such
person,
the
Agency
will
consider
the
guidance
contained
in
this
document,
but
the
guidance
will
not
be
determinative.
It
is
also
important
to
point
out
that
the
guidance
provided
will
not
be
unalterable,
and
that
the
Agency
may
revise
this
guidance
without
notice
or
an
opportunity
to
comment.
EPA
has
sought
public
comment
on
this
guidance
so
that
it
can
ensure
the
utility
of
the
guidance
for
the
intended
audience.
If
it
becomes
necessary,
the
Agency
will
revise
this
guidance.

C.
What
is
the
Agency's
Current
Policy
on
and
Interpretation
of
the
TSCA
Section
8(
e)
Reporting
Requirements?
The
section
8(
e)
reporting
requirements
became
effective
on
January
1,
1977,
the
effective
date
of
TSCA.
The
statutory
language
of
section
8(
e)
requires
the
exercise
of
a
certain
degree
of
judgment
in
determining
what
information
must
be
reported.
Although
section
8(
e)
is
self­
implementing,
EPA
issued
a
proposed
policy
statement
in
the
Federal
Register
of
September
9,
1977
(
42
FR
45362),
and
sought
public
comment
with
regard
to
the
Agency's
interpretation
and
implementation
of
section
8(
e).
Following
receipt
and
consideration
of
public
comments,
on
March
16,
1978
(
43
FR
11110)
(
FRL
 
849
 
2),
EPA
issued
a
final
TSCA
section
8(
e)
policy
statement
hereinafter
cited
as
the
``
1978
Policy
Statement.''
The
1978
Policy
Statement
described
the
types
of
information
that
EPA
considers
reportable
under
section
8(
e)
and
described
the
procedures
for
reporting
such
information
to
EPA.
In
the
Federal
Register
of
February
1,
1991
(
56
FR
4128),
the
Agency
announced
a
one­
time
voluntary
TSCA
section
8(
e)
CAP.
The
CAP
was
designed
primarily
to:
(
1)
Obtain
any
section
8(
e)
information
that
was
required
to
have
been
submitted
to
EPA
before
the
CAP,
and
(
2)
encourage
companies
to
voluntarily
search
(``
audit'')
their
files
for
data
reportable
under
section
8(
e).
The
TSCA
section
8(
e)
CAP
established
a
schedule
of
monetary
penalties
for
failure
to
submit
section
8(
e)
data
before
the
CAP,
and
also
established
a
ceiling
on
penalties
that
would
be
collected
from
any
single
company.

D.
The
Reason
for
Issuing
Revised
Guidance
Companies
considering
whether
to
participate
in
the
CAP
had
raised
questions
about
Parts
V.(
b)(
1)
and
V.(
c)
of
the
1978
Policy
Statement.
Those
sections
outlined
the
reportability
of
data
on
``
widespread
and
previously
unsuspected
distribution
in
environmental
media''
and
``
emergency
incidents
of
environmental
contamination,''
respectively.
In
order
to
answer
the
questions
raised
by
the
companies,
the
Agency
reviewed
existing
section
8(
e)
guidance
and
determined
that
Parts
V.(
b)(
1)
and
V.(
c)
of
the
1978
Policy
Statement
needed
clarification
and
refinement.
Therefore,
in
the
Federal
Register
of
June
20,
1991
(
56
FR
28458),
EPA
announced
that
the
Agency
was
suspending
application
of
Parts
V.(
b)(
1)
and
V.(
c)
of
the
1978
Policy
Statement.
That
Federal
Register
document
also
stated
that
EPA
was
going
to
provide
more
specific
guidance
about
the
types
of
information
on
environmental
releases
and
detection
of
environmental
contamination
that
should
be
submitted
under
section
8(
e).
Phase
2
of
the
CAP,
which
was
to
deal
with
data
on
environmental
contamination,
would
be
triggered
by
publication
of
that
revised
guidance
(
phase
1
of
the
CAP
had
dealt
with
studies
of
``
effects''
of
toxic
substances
on
health
or
the
environment.).
On
July
13,
1993,
EPA
issued
a
Federal
Register
document
(
58
FR
37735)
that
proposed
changes
to
the
1978
Policy
Statement,
clarifying
the
types
of
environmental
contamination
data
that
EPA
believes
are
subject
to
section
8(
e)
reporting.
Comments
received
on
the
proposed
changes
took
issue
with
a
number
of
the
revisions
proposed
by
the
Agency
as
well
as
with
the
original
guidance.
Based
on
the
comments
received,
it
became
apparent
that
any
final
guidance
would
likely
be
significantly
different
from
previous
guidance
and
should
therefore
be
applied
prospectively.
Since
the
CAP
was
essentially
a
retrospective
exercise,
the
decision
to
make
substantial
revisions
in
the
guidance
for
reporting
on
environmental
contamination
called
into
question
the
utility
of
carrying
out
phase
2.
Consequently,
the
Agency,
in
consultation
with
CAP
participants,
decided
to
conclude
the
CAP
after
phase
1
``
effects''
reporting.
Letters
were
sent
to
CAP
participants
announcing
the
change
in
the
program,
and
the
CAP
was
terminated
on
May
15,
1996.
EPA
reached
final
settlements
with
CAP
participants,
announced
those
settlements
on
October
15,
1996,
and
collected
payment
for
stipulated
penalties.

III.
Section
8(
e)
Policy
Clarifications
and
Revisions
EPA's
interpretation
of
section
8(
e)
is
that
it
requires
the
reporting
of
certain
``
substantial
risk''
information
concerning
the
release
of
chemical
substances
to,
and
the
detection
of
chemical
substances
in,
any
environmental
medium.
In
order
to
enhance
implementation
of
TSCA
section
8(
e),
EPA
is,
in
this
Federal
Register
document,
publishing
a
complete
version
of
the
policy
statement
which
reflects
comments
received
on
proposed
refinements
to
the
policy
statement
published
on
July
13,
1993
(
58
FR
37735),
and
March
20,
1995
(
60
FR
14756).
EPA
has
also
decided
to
reinstate
application
of
Part
V.(
c)
relating
to
``
emergency
incidents
of
environmental
contamination,''
which
was
suspended
on
June
20,
1991
(
56
FR
28458).

A.
What
Changes
were
Proposed
in
1993?

In
a
notice
published
in
the
Federal
Register
on
July
13,
1993
(
58
FR
37735),
EPA
proposed
the
following
changes
to
the
1978
Policy
Statement:
1.
Revise
the
1978
reporting
guidance
as
to
when
the
discovery
of
``
widespread
and
previously
unsuspected
[
chemical]
distribution
in
environmental
media''
would
trigger
a
substantial
risk
notice
under
section
8(
e).
EPA
indicated
that
the
key
elements
to
consider
would
be
the
known
hazard
potential
of
the
contaminant,
how
``
widespread''
the
substance
is
in
the
environment,
and
the
potential
for
actual
human
or
environmental
exposure.
EPA
further
stated
that
the
weight
to
be
given
exposure
considerations
would
be
judged
in
light
of
hazard
potential,
i.
e.,
the
more
hazardous
the
chemical
the
less
one
would
weigh
exposure
considerations.
2.
Expand
the
categories
of
information
cited
in
the
1978
reporting
guidance
that
EPA
believed
no
longer
need
to
be
reported
to
under
section
8(
e).
The
major
change
proposed
was
intended
to
reduce
the
potential
for
TSCA
section
8(
e)
submissions
to
be
duplicative
of
reporting
under
other
mandates,
by
allowing
an
exemption
for
information
reported
under
other
EPA
reporting
requirements
(
including
those
delegated
to
the
states).
Also,
a
clarification
of
what
would
constitute
``
corroborative''
data
not
subject
to
reporting
was
proposed.
3.
Change
the
interpretation
that
section
8(
e)
notices
for
information
other
than
``
emergency
incidents
of
environmental
contamination''
should
be
submitted
within
15
working
days
by
lengthening
the
reporting
period
to
30
calendar
days.

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4.
Eliminate
the
need
to
follow
up
an
emergency
release
notification
under
Part
V.(
c)
with
a
written
report.
5.
Clarify
standards
for
claiming
CBI
in
section
8(
e)
notices.
6.
Correct
the
address
under
Part
IX.
of
the
1978
Policy
Statement.

B.
Summary
of
Public
Comments
on
the
1993
and
1995
Proposed
Revisions
and
EPA's
Responses
In
addition
to
the
brief
summaries
of
public
comments
and
Agency
responses
presented
in
this
Federal
Register
document,
EPA
has
prepared
a
``
response
to
comments''
document
that
addresses
in
greater
detail
the
significant
comments
it
received
on
the
proposed
changes.
The
public
version
of
the
``
response
to
comments''
document,
which
does
not
contain
any
CBI
information,
is
publicly
available
in
the
docket
described
in
Unit
I.
B.
1
of
this
document.
1.
Comments
on
the
1993
proposed
changes.
EPA
received
comments
from
49
companies
and
industry
associations
in
response
to
the
1993
Federal
Register
document.
Commenters
suggested
that
EPA's
proposed
plan
for
environmental
reporting
lacked
criteria
that
were
sufficiently
clear
to
enable
companies
to
separate
``
routine''
releases,
which
need
not
be
reported,
from
the
``
extraordinary''
releases,
which
were
to
be
reported
under
section
8(
e).
Commenters
stated
that
EPA
should
provide
clearer
criteria
for
determining
when
a
situation
presents
a
``
substantial
risk,''
and
should
provide
as
many
``
bright
lines''
as
possible
to
indicate
what
would
and
would
not
be
reportable
under
section
8(
e).
Specifically,
commenters:
 
Questioned
EPA's
interpretation
of
when
contamination
would
be
``
widespread.''
 
Stated
that
only
a
contaminant's
``
known''
toxicity
should
be
considered.
 
Stated
that
for
contamination
to
be
reportable,
it
must
be
``
previously
unsuspected''
contamination.
 
Stated
that
the
contamination
must
result
in
actual
or
high
probability
of
significant
exposure
to
humans
or
nonhuman
organisms.
 
Stated
that
any
contamination
to
be
reported
under
section
8(
e)
must
``
present''
a
substantial
risk
rather
than
only
a
speculative
``
may
present.''
 
Proposed
that
EPA
establish
a
decision
tree
that
companies
could
follow
to
determine
whether
to
report
incidents
involving
environmental
contamination
under
section
8(
e).
Commenters
stated
that
if
companies
had
sequential
criteria,
they
would
be
in
a
much
better
position
to
comply
with
the
reporting
requirements
of
section
8(
e).
 
Supported
the
change
to
the
section
8(
e)
notice
reporting
period
from
15
working
days
to
30
calendar
days.
The
bulk
of
the
remaining
comments
concerned
circumstances
under
which
companies
need
not
report
information
to
EPA.
EPA
had
proposed
to
exempt
from
reporting
under
TSCA
section
8(
e)
information
companies
were
required
to
report
under
other
EPA
authorities
(
including
those
delegated
to
the
States).
However,
the
exemption
would
only
apply
if
the
information
was
submitted
under
the
other
authorities
within
30
days
of
obtaining
the
information.
Commenters
believed
that
this
would
offer
little
relief
because
many
of
the
other
authorities
have
reporting
periods
longer
than
30
days.
The
companies
would
either
have
to
accelerate
their
reporting
under
authorities
other
than
TSCA
section
8(
e)
or
submit
two
reports,
one
within
30
days
under
section
8(
e)
and
another
within
the
time
frame
of
the
other
requirement.
The
commenters
suggested
allowing
a
longer
time
frame,
i.
e.,
90
days
or
longer,
for
that
information
submitted
under
authorities
other
than
TSCA
section
8(
e).
Commenters
also
suggested
expanding
the
``
other
authorities''
exemption
to
include
reporting
under
all
Federal
environmental
statutes
as
well
as
State
laws
and
regulations,
especially
when
a
site
is
undergoing
remediation
for
contamination
with
hazardous
waste
and
any
environmental
or
health
threats
associated
with
those
contaminants
are
being
addressed
in
the
course
of
the
remediation.
Finally,
EPA
received
comments
on
the
relationship
of
the
revised
guidance
to
phase
2
of
the
CAP.
The
sentiment
expressed
by
all
those
who
commented
on
this
issue
was
that,
given
the
limited
guidance
in
the
1978
Policy
Statement,
EPA's
suspension
of
the
guidance
section
on
environmental
contamination,
and
the
likelihood
that
EPA's
final
guidance
would
be
essentially
``
new,''
the
final
guidance
should
only
be
enforced
prospectively.
Consequently,
companies
should
not
be
subject
to
any
liability
for
past
failures
to
report
under
the
criteria
of
the
``
new''
guidance.
2.
EPA's
response
to
comments
on
the
1993
proposed
changes;
the
1995
proposed
draft
guidance.
In
response
to
the
comments
received
on
the
1993
proposed
changes
to
the
1978
guidance,
on
March
20,
1995,
EPA
issued
revised
proposed
guidance
to
address
the
commenters'
concerns.
First,
in
the
1995
notice,
EPA
proposed
clarifications
to
the
situations
involving
environmental
contamination
which
EPA
believes
would
need
to
be
reported.
Language
suggested
in
comments
to
the
1993
notice
was
adopted,
specifying
that
the
contamination
must
be
``
previously
unsuspected,''
that
``
exposure''
has
occurred
or
there
is
a
substantial
likelihood
that
it
will
occur,
and
that
the
chemical(
s)
in
question
is
``
known''
to
cause
serious
adverse
effects.
EPA
stated
that
information
on
those
effects
could
be
obtained
from
several
sources:
 
Databases
available
to
the
public
(
online
or
in
paper
versions),
such
as
the
National
Library
of
Medicine
(
NLM)
databases
(
Toxline,
Medline,
Hazardous
Substances
Data
Bank,
etc.),
National
Institute
for
Occupational
Safety
and
Health
(
NIOSH)
Registry
of
Toxic
Effects
of
Chemical
Substances
(
RTECS),
EPA's
Aquatic
Toxicity
Information
Retrieval
database
(
AQUIRE)
(
Now
the
Ecotoxicology
(
ECOTOX)
database)
www.
epa.
gov/
ecotox/.
 
Reports
to
EPA
or
other
government
agencies.
 
Unpublished
data
known
to
the
person
or
entity
subject
to
reporting.
As
regards
the
issue
of
what
is
meant
by
``
known''
to
cause
serious
adverse
effects,
EPA
did
not
mean
that
the
effects
must
be
conclusively
shown
and
did
not
intend
a
higher
standard
of
certainty
than
for
the
``
effects''
reporting
part
of
the
1978
Policy
Statement.
In
that
notice,
EPA
stated
that
all
that
is
needed
for
an
effect
to
be
``
known''
is
that
the
information
reasonably
supports
that
the
chemical
can
cause
the
effect(
s)
of
concern.
This
issue
is
addressed
in
the
1978
Policy
Statement
in
EPA's
response
to
comments
that
questioned
the
use
of
``
may
suggest''
language
regarding
information
obtained
and
the
reporting
of
substantial
risk
information
(
see
Supplementary
Information
paragraph
(
3)
of
the
1978
Policy
Statement).
In
addition,
EPA
agreed
to
allow
the
use
of
``
benchmark
levels''
to
help
determine
if
the
information
should
be
reported.
EPA
has
established
benchmark
levels
for
various
substances.
Benchmark
levels
are
concentrations
that
either
trigger
a
regulatory
response,
or
concentrations
above
which
a
substance
is
presumed
to
present
a
risk
to
health
and/
or
the
environment.
For
instance,
the
Agency
has
developed
Reference
Doses
(
RfD's)
for
numerous
substances
under
its
Integrated
Risk
Information
System
(
IRIS).
Reference
doses
establish
a
level
of
exposure
where
no
adverse
effects
would
be
expected
to
be
manifested.
Thus,
if
a
person
found
groundwater
contaminated
with
a
chemical
at
a
level
that
did
not
exceed
the
RfD
for
that
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substance,
the
person
could
assume
that
a
substantial
risk
does
not
exist.
It
should
be
noted
that
benchmark
levels
are
often
medium­
specific,
so
their
use
should
be
limited
accordingly.
Examples
of
certain
benchmark
levels
can
be
found
at
the
following
EPA
Web
sites:
http://
www.
epa.
gov/
iris/
and
http://
www.
epa.
gov/
ost/
drinking/
standards/
dwstandards.
pdf.
Second,
EPA
increased
the
number
of
types
of
information
that
it
believed
need
not
be
reported
under
TSCA
section
8(
e).
The
types
of
information
proposed
to
be
exempted
included:
 
Draft
and
final
reports
made
available
to
the
public
by
other
Federal
agencies.
 
Data
obtained
from
scientific
journals
and
databases,
including,
but
not
limited
to,
those
to
which
EPA
subscribes.
 
Information
obtained
from
news
publications
and
radio/
television
broadcasts.
 
Information
obtained
at
scientific
meetings
or
conferences
where
EPA
is
the
sponsor,
where
the
information
is
presented
by
an
EPA
employee
or
contractor
acting
on
behalf
of
EPA,
and
at
other
similar
meetings,
provided
that
such
information
is
cited
or
abstracted
in
a
scientific
journal
or
database
within
90
days
of
a
person
subject
to
reporting
under
section
8(
e)
obtaining
such
information.
The
rationale
for
these
proposed
changes
was
to
relieve
persons
who
are
potentially
subject
to
reporting
under
section
8(
e)
from
the
burden
of
considering
information
from
secondary
sources
when
the
secondary
source
does
not
provide
sufficient
information
for
a
person
to
judge
whether
the
information
should
be
reported.
For
instance,
a
manufacturer
of
a
chemical
might
obtain
a
news
article
about
research
done
by
another
company.
A
person
reading
the
article
would
need
the
underlying
study
to
evaluate
the
true
significance
of
the
results
of
the
research
and,
based
on
that
evaluation,
make
a
judgment
as
to
whether
there
is
a
substantial
risk
of
injury
to
human
health
or
the
environment.
In
such
a
case,
the
potential
reporting
obligation
falls
on
the
company
that
generated
the
research
discussed
in
the
news
article.
Third,
EPA
retained
the
interpretation
proposed
in
the
1993
Federal
Register
notice
that
section
8(
e)
notices
for
information
other
than
``
emergency
incidents
of
environmental
contamination,''
should
be
submitted
within
30
calendar
days.
EPA
continues
to
believe
that
the
change
from
15
working
days
to
30
calendar
days
would
significantly
relieve
the
burden
on
persons
subject
to
section
8(
e)
reporting
without
substantially
affecting
EPA's
ability
to
appropriately
evaluate
and
respond
in
a
timely
manner
to
the
reported
information.
Fourth,
EPA
identified
the
group
of
statutes
for
which
exemptions
would
be
granted
from
reporting
of
nonemergency
information
under
TSCA
section
8(
e),
specifying
the
other
statutes
administered
by
EPA
and
those
for
which
implementation
was
delegated
to
the
States.
The
maximum
allowable
reporting
period,
in
lieu
of
reporting
under
section
8(
e),
under
those
other
authorities
was
increased
from
30
to
90
days
from
the
date
reportable
non­
emergency
situations
of
chemical
contamination
was
obtained
by
a
person
subject
to
section
8(
e),
i.
e,
persons
reporting
to
the
other
authorities
within
the
90
 
day
time
frame
would
be
exempt
from
reporting
the
information
under
section
8(
e).
EPA
believed
that
extending
the
time
for
reporting
non­
emergency
situations
of
chemical
contamination
would
allow
for
those
instances
where
assembling
several
types
of
information
in
order
to
determine
whether
section
8(
e)
applies
could
take
more
than
30
days
and
was
consistent
with
the
majority
of
the
reporting
periods
under
the
other
statutes.
Fifth,
if
the
Federal
government
or
a
State
requires
that
information
be
submitted
on
a
site
remediation
program
carried
out
under
Federal
or
State
regulations,
that
information
would
not
have
to
be
separately
submitted
under
section
8(
e)
beyond
an
initial
section
8(
e)
notification.
The
Agency
believed
that
once
the
chemical
contamination
situation
has
been
identified,
such
as
by
a
notice
under
section
8(
e),
and
the
site
is
undergoing
remediation,
little
if
any
additional
benefit
is
gained
by
subsequent
section
8(
e)
reporting
concerning
that
chemical
contamination
situation
at
the
same
site.
Sixth,
usually
only
the
person
who
operates
or
owns
a
site
at
which
environmental
contamination
has
occurred
would
have
the
responsibility
to
report
under
section
8(
e).
It
is
unlikely
that
a
person
not
associated
with
a
site
as
an
owner
or
operator
would
have
access
to
a
sufficiently
wide
range
of
information
about
an
environmental
contamination
situation
to
determine
whether
data
on
the
contamination
meet
the
test
for
section
8(
e)
reporting.
This
is
unlike
the
acquisition
of
effects
test
data,
because
data
on
effects
are
not
site­
specific
and
have
general
applicability
for
production
and
use
of
the
chemical
of
interest
in
the
United
States.
Similarly,
persons
subject
to
section
8(
e)
would
not
have
to
report
information
obtained
about
a
site
outside
the
United
States
unless
there
is
potential
for
contamination
from
that
site
to
enter
the
United
States.
Seventh,
because
of
the
number
of
changes
made
to
the
proposed
guidance
in
the
1995
Federal
Register
notice
and
the
fact
that
it
represented
a
significant
change
from
the
original
guidance
suspended
on
June
20,
1991,
the
Agency
concluded
that
the
revised
guidance
when
issued
should
be
applied
prospectively.
This
eliminates
the
need
for
companies
to
review
files
currently
in
their
possession
for
information
that
may
be
subject
to
section
8(
e)
reporting
in
accordance
with
the
revised
guidance.
However,
data
in
such
files
could
be
subject
to
section
8(
e)
reporting
if
data
obtained
by
a
company
after
issuance
of
the
revised
guidance
triggered
a
review
of
such
preexisting
data
and
in
doing
so
the
combination
of
preexisting
and
new
data
met
the
section
8(
e)
reporting
criteria.
Eighth,
the
Agency
stated
that
it
would
develop,
in
cooperation
with
interested
parties,
a
``
question
and
answer''
(
Q.
and
A.)
document
that
would
provide
further
detail
and
``
real
world''
examples
to
further
assist
persons
in
fulfilling
their
section
8(
e)
reporting
responsibilities
as
regards
the
revised
guidance.
The
Agency
stated
that
it
intends
to
work
with
interested
parties
to
prepare
such
a
Q.
and
A.
document,
which
EPA
expects
to
have
available
several
months
from
the
issuance
of
the
final
reporting
guidance.
At
that
time,
the
Agency
intends
to
post
the
Q.
and
A.
document
on
the
TSCA
section
8(
e)
homepage
(
http://
www.
epa.
gov/
oppt/
tsca8e).
A
copy
may
also
be
obtained
from
the
contacts
listed
under
FOR
FURTHER
INFORMATION
CONTACT.
As
additional
examples,
or
questions
and
answers
are
identified
as
being
of
potential
value
to
share
broadly,
the
Agency
will
refine
this
Q.
and
A.
document.
Finally,
some
commenters
requested
an
additional
opportunity
to
review
the
revised
draft
guidance
developed
in
response
to
the
extensive
comments
of
the
proposed
revisions
in
the
July
13,
1993
Federal
Register
notice.
On
March
20,
1995
(
58
FR
37735),
the
Agency
published
a
notice
of
availability
in
the
Federal
Register
of
the
revised
draft
guidance
and
allowed
45
days
for
comment.
The
1995
draft
guidance
substantially
responded
to
the
comments
received
on
the
1993
proposed
revisions.
3.
Comments
on
the
1995
proposed
changes
and
EPA's
response.
In
response
to
the
Agency's
request
for
comment
on
the
revised
draft
guidance
published
in
1995,
EPA
received
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/
Vol.
68,
No.
106
/
Tuesday,
June
3,
2003
/
Notices
comments
from
22
companies
and
trade
associations.
The
commenters
generally
agreed
that
the
changes
made
by
EPA
addressed
most
of
their
major
comments
on
the
1993
proposed
guidance,
and
that
the
1995
revised
guidance
was
a
significant
improvement.
For
example,
the
Monsanto
Company
stated:
``
The
reproposed
guidance,
as
summarized
in
the
draft
policy
text
for
public
comment
dated
March
9,
1995,
is
a
significant
improvement
over
the
guidance
published
July
13,
1993.
The
reproposed
guidance
significantly
minimizes
the
duplicative
over­
reporting
burden
that
characterized
the
earlier
guidance
document.
We
support
the
reproposed
guidance
document
and
believe
it
is
generally
consistent
with
the
Congressional
intent
of
the
original
drafters
of
TSCA,
as
well
as
current
Agency
and
Congressional
efforts
to
reform
government
reporting
requirements
to
minimize
duplicative
and
unneeded
over­
reporting.
The
reproposed
guidance
document
on
environmental
release/
contamination
is
a
significant
move
in
the
direction
of
clarifying
the
Agency's
need
for
information
that
reasonably
supports
a
conclusion
of
substantial
risk.''
(
Ref.
1).
In
addition
to
their
statements
of
support
for
the
proposed
changes,
the
commenters
requested
a
number
of
clarifications/
definitions
of
terms,
editorial
rewordings,
and
other
less
substantive
changes
that
are
addressed
in
a
``
response­
to­
comments''
document
that
can
be
found
in
the
docket
as
described
in
Unit
I.
B.
1.
Commenters
expressed
strong
support
for
making
the
new
guidance
prospective,
ending
the
CAP
at
phase
1,
and
developing
a
Q.
and
A.
document.
As
previously
discussed,
EPA
is
in
agreement
with
those
comments.
One
major
area
where
industry
commenters
requested
further
changes
was
the
exemption
from
reporting
under
section
8(
e)
for
data
submitted
to
EPA
or
other
agencies
under
other
authorities.
The
commenters
were
concerned
about
the
extent
to
which
exemptions
from
reporting
under
section
8(
e)
would
be
granted
for
reporting
under
authorities
other
than
EPA
statutes
administered
either
by
the
Agency
or,
where
implementation
of
an
EPA
statute
has
been
delegated
to
the
States.
EPA
had
proposed
to
reduce
the
potential
for
duplicative
submission
under
TSCA
section
8(
e)
authorities
by
allowing
an
exemption
to
reporting
under
section
8(
e)
for
all
information
which
is
required
to
be
reported
under
other
EPA
statutes
including
where
implementation
had
been
delegated
to
the
States,
and
where
such
reporting
was
required
to
be
submitted
within
90
days
of
being
obtained.
Industry
commenters
also
questioned
the
length
of
the
time
period
for
reporting
proposed
by
EPA.
Industry
commenters
requested
that
the
exemption
be
expanded
to:
(
1)
Include
any
mandatory
reporting
requirement
whether
Federal,
State,
or
local,
and
(
2)
allow
reporting
within
the
time
frame
provided
by
the
individual
reporting
authorities.
Regarding
expanding
the
section
8(
e)
policy
statement
list
of
reporting
authorities
that
would
fall
under
a
reporting
exemption
in
Part
VII.
of
the
policy
statement,
the
July
1993
and
March
1995
proposals
included
an
exemption
to
reporting
only
if
the
information
was
to
be
submitted
under
EPA
statutes,
including
statutes
such
as
the
Clean
Air
Act,
where
implementation
has
been
delegated
in
large
part
to
the
States.
Delegation
of
implementation
allowed
a
clear
``
nexus''
to
be
shown
between
a
State
reporting
requirement
and
EPA,
thus
following
the
statutory
language
of
section
8(
e)
which
does
not
require
reporting
if
a
company
has
``
actual
knowledge
that
the
Administrator
has
been
adequately
informed
of
such
information.''
The
commenters
would
have
EPA
expand
the
reporting
exemption
by
including
any
Federal,
State,
or
local
reporting
requirements.
The
issue
of
expanding
the
reporting
authorities
is
problematic
because
of
the
statutory
language
in
section
8(
e).
However,
it
is
also
relevant
to
look
to
the
purpose
of
TSCA,
and
section
8(
e)
in
particular,
in
light
of
the
legislative
history
concerning
how
TSCA
should
be
implemented.
TSCA
was
designed
to
fill
a
number
of
regulatory
gaps.
Those
included
review
of
``
new''
chemicals,
collection
of
test
data
on
new
and
existing
chemicals,
and
regulation
of
chemicals
to
address
risks
associated
with
chemicals'
production,
use,
or
disposal.
Specifically,
regarding
the
submission
of
test
data,
Congress
wanted
to
avoid
the
potential
for
industry
to
withhold
``
information
which
would
have
revealed
hazards
associated
with
these
chemicals
at
a
much
earlier
date''
(
Ref.
2).
Thus,
the
reporting
requirement
of
section
8(
e)
of
TSCA
was
established
so
that
the
Agency
would
be
``
adequately
informed''
to
enable
it
to
take
corrective
action
if
necessary.
While
Congress
envisioned
TSCA
as
filling
a
major
gap
in
the
regulatory
framework
protecting
human
health
and
the
environment,
it
also
directed
the
Administrator
to
avoid
duplicating
existing
(
and
future)
regulatory
and
enforcement
authorities.
Given
the
statutory
language
of
section
8(
e),
it
is
hard
to
make
a
case
that
the
Administrator
is
adequately
informed
of
reporting
under
State
or
local
authorities,
other
than
those
reporting
requirements
that
originate
in
laws
administrated
by
EPA
in
which
the
United
States
Congress
has
provided
for
delegation
to
the
States,
and
such
delegation
has
occurred.
Except
where
such
delegation
of
EPA
authority
has
occurred,
the
Agency
believes
reporting
to
a
state
government
may
not
result
in
EPA
getting
important
information
in
a
timely
manner
and,
therefore,
EPA
does
not
believe
it
is
appropriate
to
exempt
from
section
8(
e),
information
that
is
reported
to
state
governments.
However,
at
least
some
information
reported
under
other
Federal
authorities
could
be
viewed
differently.
While
there
is
not
a
direct
statutory
``
nexus,''
often
there
is
a
considerable
amount
of
interagency
cooperation
in
dealing
with
environmental
contamination
situations,
e.
g.,
the
National
Response
Center.
To
the
extent
EPA
Headquarters
and
the
Regions
become
involved
in
joint
cleanups,
assessments,
etc.,
or
act
in
advisory
roles
with
other
Federal
agencies,
the
Administrator
could
reasonably
be
considered
to
be
adequately
informed.
The
Agency
believes
that
information
reported
under
other
Federal
authorities
for
site­
specific
contamination
within
90
calendar
days
or
immediately
pursuant
to
a
mandatory
reporting
requirement
qualifies
for
exemption
from
section
8(
e)
reporting.
While
this
approach
reduces
the
role
of
section
8(
e)
in
the
reporting
of
sitespecific
release/
contamination
information,
Congress'
goal
in
passing
TSCA
to
ensure
that
important
health
and
environmental
related
information
are
reported
in
a
timely
fashion
will
still
be
met.
Further,
since
there
is
now
a
considerable
array
of
Federal
health
and
environmental
reporting
requirements,
including
section
8(
e),
which
provide
such
information
and
for
which
there
is
enhanced
public
access,
Congress's
goal
is
not
considered
to
be
compromised
by
some
of
the
expanded
exemptions.
However,
product
contamination
information
that
could
be
required
to
be
submitted
to
the
Consumer
Product
Safety
Commission
(
CPSC)
under
their
regulations
is
not
analogous.
CPSC
has
a
more
narrow
purview
(
i.
e.,
consumer
product
safety)
and
could
not
adequately
assess
or
address
chemical
contamination
from
a
product
that
may
also
have
industrial/
commercial
applications
or
may
present
potential
environmental
risks
during
its
manufacture
and
processing.
In
such
instances,
reporting
to
EPA,
as
well
as
CPSC
would
allow
EPA,
consistent
with
the
intent
of
TSCA,
to
address
all
the
potential
risks
presented,
where
appropriate.
Consequently,
EPA
has
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/
Notices
concluded
that
section
8(
e)
reporting
will
continue
to
be
required
for
chemical
product
contamination,
because
EPA,
uniquely
among
Federal
agencies,
has
the
authority
to
address
all
potential
health
and
environmental
risk
aspects
of
a
chemical's
life
cycle.
Regarding
the
issue
of
expanding
the
reporting
exemption
in
Part
VII.
of
the
section
8
policy
statement
to
allow
reporting
within
the
time
frame
provided
by
the
individual
reporting
authorities,
as
originally
proposed
in
1993,
companies
would
not
be
required
to
report
information
under
section
8(
e)
if
the
information
was
required
to
be
submitted
under
other
EPA
or
EPAdelegated
authorities,
so
long
as
the
other
statute
required
reporting
within
30
days
from
the
day
a
person
who
was
required
to
report
obtained
information
required
to
be
submitted.
Commenters
noted
that
only
a
few
of
the
regulations
required
reporting
within
30
days,
so
the
exemption
would
be
of
limited
value
given
that
companies
would
still
be
required
to
report
the
information
under
section
8(
e)
as
well
as
under
the
other
regulations.
To
address
this
concern,
the
reporting
policy
is
being
changed.
Companies
would
be
exempt
from
reporting
information
under
section
8(
e)
as
long
as
the
company
complies
with
the
relevant
reporting
requirement
of
another
statute,
as
described
in
Part
VII.
of
the
TSCA
section
8(
e)
policy
and
guidance,
that
requires
reporting
within
90
days
from
the
day
a
person
obtained
information
required
to
be
submitted.
This
change
was
based
on
information
submitted
by
industry
showing
that
roughly
70
percent
of
the
reporting
requirements
have
reporting
periods
of
90
days
or
less
(
see
Ref.
3
at
page
29,
Table
1).
Further,
an
examination
of
the
cited
reporting
requirements
shows
that
the
90
 
day
period
will
capture
reports
that
otherwise
would
be
required
under
section
8(
e),
namely
newly
found
environmental
contamination
from
spills,
leaking
tanks,
and
other
types
of
releases.
By
and
large,
the
types
of
reporting
for
which
the
statutory
time
limits
for
filing
of
mandatory
reports
are
longer
than
90
days
include
periodic
summary
reports,
minor
operating
changes
allowed
by
permits,
etc.
It
appears
that
most
or
all
of
the
exposure­
related
or
site­
specific
release/
detection
information
that
might
be
considered
reportable
under
section
8(
e)
would
be
required
to
be
reported
under
other
authorities
within
90
days
of
such
information
being
obtained.
Therefore,
there
would
be
a
negligible
reduction
of
the
reporting
burden
if
authorities
whose
reporting
time
limits
exceed
90
days
were
also
exempted
from
reporting
under
section
8(
e).
Also,
such
a
change
seems
inconsistent
with
the
statutory
language
that
substantial
risk
information
be
``
immediately''
reported.
Given
that
a
90
 
day
limit
appears
to
resolve
most
of
the
problem
with
potentially
duplicative
reporting,
and
that
longer
limits
may
not
be
consistent
with
the
statutory
directive
for
``
immediate
reporting,''
EPA
has
decided
to
keep
the
reporting
time
limit
at
90
days
as
proposed
in
the
1995
draft
guidance.
Additionally,
as
proposed
in
the
1993
and
reproposed
1995
draft
guidance,
EPA
is
adopting
the
interpretation
that
section
8(
e)
notices
for
information
other
than
``
emergency
incidents
of
environmental
contamination''
should
be
submitted
within
30
calendar
days.
Thus
the
Agency
is
changing
in
this
guidance
document
its
interpretation
of
the
term
``
immediately''
in
this
context.
EPA
believes
the
term
should
be
interpreted
more
flexibly
based
upon
the
Agency's
experience
of
processing
and
use
of
data
reported
under
section
8(
e)
and
comments
received
from
interested
parties.
EPA
has
concluded
that,
with
the
exception
of
reporting
related
to
emergency
incidents
of
environmental
contamination,
section
8(
e)
reports
should
be
submitted
to
EPA
within
30
calendar
days
of
obtaining
the
reportable
information,
instead
of
the
15
working
days
that
was
articulated
in
previous
guidance.
The
Agency
believes
that
application
of
this
interpretation
for
the
statutory
term
``
immediately''
will
not
adversely
impact
section
8(
e)'
s
purpose
of
assuring
that
the
Agency
becomes
aware
of
important
risk­
related
information
in
a
timely
manner.
In
addition,
providing
30
calendar
days
for
reporting
to
the
Agency
is
consistent
with
the
regulations
under
the
Paperwork
Reduction
Act
(
PRA),
44
U.
S.
C.
3501
et
seq.,
which
provides
that
agencies
should
not
require
a
written
response
in
fewer
than
30
days
after
receipt
without
demonstrating
that
it
is
necessary
to
satisfy
a
statutory
requirement
or
other
substantial
need
(
5
CFR
1320.5(
d)(
2)(
ii)).
Although
TSCA
section
8(
e)
clearly
provides
the
necessary
statutory
justification
to
require
a
shorter
response
time,
the
Agency
is
using
the
minimum
time
frame
established
under
the
PRA
to
respond
to
the
commenters
who
indicated
the
need
for
additional
time
to
process
a
submission.

C.
EPA's
reinstatement
of
Part
V.(
c)
``
Emergency
incidents
of
environmental
contamination.''
Part
V.(
c)
of
the
1978
Policy
Statement,
which
addresses
what
constitutes
a
``
substantial
risk''
in
the
context
of
emergency
incidents
of
environmental
contamination,
was
suspended
on
June
20,
1991
(
56
FR
28458).
EPA
has
decided,
for
the
following
reasons,
to
reinstate
Part
V.(
c):
 
EPA
is
making
a
number
of
changes
to
the
reporting
guidance
that
would
affect
emergency
incident
reporting.
Changes
include
reporting
to
the
National
Response
Center,
elimination
of
follow­
up
written
section
8(
e)
reports,
and
expansion
of
the
list
of
authorities
persons
could
report
under
in
lieu
of
section
8(
e).
 
Part
V.(
c)
includes
the
basic
elements
of
the
new
Part
V.(
b)(
1)
guidance:
The
adverse
effect(
s)
in
question
have
been
ascribed
to
the
chemical;
human
or
environmental
exposure
may
occur;
exposure
(
in
this
case,
an
emergency
release)
threatens
humans
and/
or
non­
human
organisms
with
serious
adverse
effects.
 
EPA
believes
such
reporting
under
section
8(
e)
is
still
necessary.
Although
many
release
incidents
are
covered
under
other
statutes,
there
may
be
instances
where
chemicals
that
have
not
yet
been
reviewed
for
release
reporting
under
other
EPA
programs
have
the
requisite
hazard
characteristics
to
require
a
response/
notification
if
there
is
a
release
to
the
environment.
In
this
regard,
EPA
agrees
with
a
comment
from
the
Chemical
Manufacturers
Association
(
CMA
 
CMA
is
now
the
American
Chemistry
Council)
indicating
that,
if
EPA
retains
the
distinction
between
emergency
and
non­
emergency
situations
of
environmental
contamination,
``
emergency''
should
be
defined.
CMA
stated:
``
CMA
believes
an
`
emergency'
should
be
defined
as
a
situation
in
which
a
significant
threat
to
human
health
or
the
environment
is
imminent
or
already
present,
and
where
immediate
action
is
necessary
to
abate
the
hazard.
Such
an
approach
would
be
consistent
with
the
Agency's
previous
description
of
non­
emergency
situations
of
environmental
contamination
as
situations
which
do
not
require
immediate
action,
but
nevertheless
reasonably
support
the
conclusion
of
`
substantial
risk.'''
(
Ref.
4).
EPA
believes
that
revised
Part
V.(
b)(
1),
the
reinstated
Part
V.(
c),
and
the
reporting
procedures
adequately
make
the
distinction
described
by
CMA
in
that
a
``
substantial
risk''
in
this
context
is
an
``
emergency
incident
of
environmental
contamination''
that
``
seriously
threatens''
humans
or
the
environment.

IV.
Claims
of
Confidentiality
for
Data
Submitted
under
TSCA
Section
8(
e)
In
general,
health
and
safety
information
submitted
to
EPA
 
even
as
confidential
 
may
be
released
to
the
VerDate
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21:
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02,
2003
Jkt
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PO
00000
Frm
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33136
Federal
Register
/
Vol.
68,
No.
106
/
Tuesday,
June
3,
2003
/
Notices
public,
except
as
noted
below.
EPA
considers
information
contained
in
a
notice
of
substantial
risk
under
TSCA
section
8(
e)
to
be
health
and
safety
information
and,
therefore,
covered
by
the
term
``
health
and
safety
study,''
as
defined
in
section
3(
6)
of
TSCA.
TSCA
section
3(
6)
defines
a
``
health
and
safety
study''
as
``
any
study
of
any
effect
of
a
chemical
substance
or
mixture
on
health
or
the
environment
or
on
both,
including
the
underlying
data
and
epidemiological
studies,
studies
of
occupational
exposure
to
a
chemical
substance
or
mixture,
toxicological,
clinical,
and
ecological
studies
of
a
chemical
substance
or
mixture,
and
any
test
performed
pursuant
to
this
Act.''
Under
TSCA
section
14(
b),
health
and
safety
information
may
be
disclosed
to
the
public
(
i.
e.,
may
not
be
protected
as
confidential).
However,
the
section
does
not
authorize
public
release
of
information
concerning
the
manufacturing
process
of
a
chemical
substance
or
mixture
which
is
the
subject
of
submitted
health
and
safety
information,
including
data
``
disclosing
the
portion
of
the
mixture
comprised
by
any
of
the
chemical
substances
in
the
mixture.''
In
the
legislative
history
of
TSCA,
the
Conference
Committee
stated
that
``[
i]
t
is
intended
that
the
term
(
health
and
safety
studies)
be
interpreted
broadly.
Not
only
is
information
which
arises
as
a
result
of
a
formal,
disciplined
study
included,
but
other
information
relating
to
the
effects
of
a
chemical
substance
or
mixture
on
health
and
the
environment
is
also
included.
Any
data
that
bears
on
the
effects
of
a
chemical
substance
on
health
or
the
environment
would
be
included.''
(
Ref.
5).
EPA
believes
that
TSCA
section
8(
e)
information,
such
as
information
or
underlying
data
from
studies
carried
out
to
investigate
the
effects
of
a
chemical
(
or
a
mixture
of
chemicals)
on
health
or
the
environment,
or
reports
concerning
the
effects
of
unintentional
or
accidental
releases
or
exposures,
is
information
that
``
bears
on
the
effects
of
a
chemical
substance
on
health
or
the
environment.''
Therefore,
incident
information,
exposure
studies,
and
their
underlying
data
should
be
considered
covered
under
the
term
``
health
and
safety
study.''
To
the
extent
that
information
contained
in
a
section
8(
e)
substantial
risk
report
falls
within
the
meaning
of
the
term
``
health
and
safety
study''
under
TSCA,
it
will
not
be
afforded
TSCA
``
Confidential
Business
Information''
(
CBI)
protection
except
as
noted
in
the
following
paragraph.
EPA
considers
chemical
identity
to
be
part
of,
the
underlying
data
to,
a
health
and
safety
study.
See,
for
example,
40
CFR
716.3
and
40
CFR
720.3(
k).
Consequently,
the
confidential
identity
of
a
chemical
substance
will
not
be
protected
by
EPA
unless
otherwise
provided
for
under
section
14
of
TSCA
and
the
interpreting
regulations
in
40
CFR
part
2.
EPA
urges
persons
submitting
data
under
TSCA
section
8(
e)
to
observe
the
limitations
imposed
on
CBI
claims
by
section
14
and
the
applicable
regulations
at
40
CFR
part
2,
subpart
B,
in
order
to
save
both
Agency
and
submitter
resources.

V.
References
The
following
is
a
listing
of
the
documents
that
are
specifically
cited
in
this
guidance
document,
and
which
are
available
as
part
of
the
public
docket
described
in
Unit
I.
B.
1.:
1.
Monsanto
Company.
Letter
from
J.
Ronald
Condray.
Comment
#
12.
May
3,
1995.
2.
United
States
Congress.
(
1976)
Report
of
the
Senate
Committee
on
Commerce
on
S.
3149,
No.
94
 
698:
8.
3.
Chemical
Manufacturers
Association
(
CMA).
Comments
of
the
Chemical
Manufacturers
Association
on
TSCA
Section
8(
e)
Notice
of
Clarification.
October
28,
1993.
4.
Chemical
Manufacturers
Association
(
CMA).
Comments
of
the
Chemical
Manufacturers
Association
on
TSCA
Section
8(
e)
draft
policy
statement.
Comment
#
6,
p.
24.
May
4,
1995.
5.
United
States
Congress.
(
1976)
House
of
Representatives,
94th
Congress,
2d
Session.
H.
R.
Report
94
 
1679
(
Conference
Report
and
Debates):
58.

VI.
Statutory
and
Executive
Order
Reviews
As
discussed
in
Unit
II.
B.,
the
guidance
document
articulates
EPA's
preferences
for
how
and
where
TSCA
section
8(
e)
notices
should
be
submitted.
The
guidance
document
is
not
a
regulation,
and
submitters
of
TSCA
section
8(
e)
notices
are
not
obligated
to
comply
with
the
preferences.
Since
this
document
is
not
a
regulation
and
does
not
impose
any
new
binding
requirements
it
is
not
subject
to
review
by
the
Office
of
Management
and
Budget
(
OMB)
under
Executive
Order
12866,
entitled
Regulatory
Planning
and
Review
(
58
FR
51735,
October
4,
1993),
Executive
Order
13045,
entitled
Protection
of
Children
from
Environmental
Health
Risks
and
Safety
Risks
(
62
FR
19885,
April
23,
1997),
or
Executive
Order
13211,
entitled
Actions
Concerning
Regulations
That
Significantly
Affect
Energy
Supply,
Distribution,
or
Use
(
66
FR
28355,
May
22,
2001).
For
the
same
reason,
the
requirements
of
the
Regulatory
Flexibility
Act
(
RFA)
(
5
U.
S.
C.
601
et
seq.)
do
not
apply.
Pursuant
to
the
Paperwork
Reduction
Act
(
PRA),
44
U.
S.
C.
3501
et
seq.,
an
agency
may
not
conduct
or
sponsor,
and
a
person
is
not
required
to
respond
to,
an
information
collection
request
as
defined
by
the
PRA,
unless
it
displays
a
currently
valid
OMB
control
number.
The
OMB
control
numbers
for
EPA's
regulations,
after
appearing
in
the
Federal
Register,
are
listed
in
40
CFR
part
9
and
48
CFR
chapter
15,
and
included
on
the
related
collection
instrument
or
form,
if
applicable.
This
document
does
not
contain
any
new
information
collection
requirements
that
would
require
additional
OMB
review
and
approval
under
the
PRA.
The
information
collection
activities
related
to
the
submission
of
information
pursuant
to
TSCA
section
8(
e)
have
been
approved
by
OMB
under
OMB
control
number
2070
 
0046
(
EPA
ICR
No.
0794).
The
annual
respondent
burden
for
this
information
collection
activity
is
estimated
to
average
27
hours
per
initial
section
8(
e)
submission
and
5
hours
per
follow­
up/
supplemental
section
8(
e)
submission,
which
includes
the
average
time
for
processing,
compiling
and
reviewing
the
requested
data,
generating
the
request,
follow­
up
correspondence
with
EPA,
storing,
filing,
and
maintaining
the
data.
As
defined
by
the
PRA
and
5
CFR
1320.3(
b),
``
burden''
means
the
total
time,
effort,
or
financial
resources
expended
by
persons
to
generate,
maintain,
retain,
or
disclose
or
provide
information
to
or
for
a
Federal
agency.
This
includes
the
time
needed
to
review
instructions;
develop,
acquire,
install,
and
utilize
technology
and
systems
for
the
purposes
of
collecting,
validating,
and
verifying
information,
processing
and
maintaining
information,
and
disclosing
and
providing
information;
adjust
the
existing
ways
to
comply
with
any
previously
applicable
instructions
and
requirements;
train
personnel
to
be
able
to
respond
to
a
collection
of
information;
search
data
sources;
complete
and
review
the
collection
of
information;
and
transmit
or
otherwise
disclose
the
information.
This
document
will
have
a
negligible
impact
on
States,
local
or
Tribal
governments
because
they
do
not
generally
engage
in
activities
that
would
subject
them
to
reporting
requirements
under
TSCA
section
8(
e).
Further
this
guidance
document
imposes
no
requirements
on
any
entities,
and
instead
is
announcing
Agency
policies
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Notices
and
interpretations
that
generally
will
ease
the
reporting
burdens
under
section
8(
e).
This
action
will
not
have
substantial
direct
effects
on
State
or
tribal
governments,
on
the
relationship
between
the
Federal
government
and
States
or
Indian
tribes,
or
on
the
distribution
of
power
and
responsibilities
between
the
Federal
government
and
States
or
Indian
tribes.
As
a
result,
no
action
is
required
under
Executive
Order
13132,
entitled
Federalism
(
64
FR
43255,
August
10,
1999),
or
under
Executive
Order
13175,
entitled
Consultation
and
Coordination
with
Indian
Tribal
Governments
(
65
FR
67249,
November
6,
2000).
Nor
does
it
impose
any
enforceable
duty
or
contain
any
unfunded
mandate
as
described
under
Title
II
of
the
Unfunded
Mandates
Reform
Act
of
1995
(
UMRA)
(
Public
Law
104
 
4).
This
action
requires
no
special
considerations
under
Executive
Order
12898,
entitled
Federal
Actions
to
Address
Environmental
Justice
in
Minority
Populations
and
Low­
Income
Populations
(
59
FR
7629,
February
16,
1994);
or
Executive
Order
12630,
entitled
Governmental
Actions
and
Interference
with
Constitutionally
Protected
Property
Rights
(
53
FR
8859,
March
15,
1988).
This
action
does
not
involve
any
technical
standards
that
would
require
Agency
consideration
of
voluntary
consensus
standards
pursuant
to
section
12(
d)
of
the
National
Technology
Transfer
and
Advancement
Act
of
1995
(
NTTAA),
Public
Law
104
 
113,
section
12(
d)
(
15
U.
S.
C.
272
note).

VII.
Specific
Revisions
to
the
Policy
Statement
For
the
reasons
discussed
in
Unit
III.,
EPA
is
making
the
following
specific
changes
to
the
1978
Policy
Statement:
1.
Part
II.
Persons
Subject
to
the
Requirement
is
amended
by
revising
the
note
at
the
end
of
Part
II.
2.
Part
IV.
Requirement
That
a
Person
``
Immediately
Inform''
the
Administrator,
Part
VII.
Information
Which
Need
Not
Be
Reported,
and
Part
IX.
Reporting
Requirements
are
revised.
3.
Part
V.
What
Constitutes
Substantial
Risk
is
amended
by
revising
the
heading
of
paragraph
(
b)
and
paragraph
(
b)(
1)
and
adding
the
paragraph
heading
``
Environmental
effects.''
to
the
beginning
of
paragraphs
(
b)(
2)
through
(
b)(
5).

VIII.
Republication
of
TSCA
Section
8(
e)
Policy
Statement
and
Guidance
As
discussed
previously,
the
following
is
a
republication
of
the
entire
TSCA
section
8(
e)
Policy
Statement
and
Guidance,
as
amended:
I.
Definitions
The
definitions
set
forth
in
TSCA
section
3
apply
to
this
policy
statement.
In
addition,
the
following
definitions
are
provided
for
purposes
of
this
policy
statement:
The
term
manufacture
or
process
for
commercial
purposes
means
to
manufacture
or
process:
(
1)
For
distribution
in
commerce,
including
for
test
marketing
purposes,
(
2)
for
use
as
a
catalyst
or
an
intermediate,
(
3)
for
the
exclusive
use
by
the
manufacturer
or
processor,
or
(
4)
for
product
research
and
development.
The
term
person
includes
any
natural
person,
corporation,
firm,
company,
joint­
venture,
partnership,
sole
proprietorship,
association,
or
any
other
business
entity,
any
State
or
political
subdivision
thereof,
any
municipality,
any
interstate
body
and
any
department,
agency,
or
instrumentality
of
the
Federal
Government.
The
term
substantial­
risk
information
means
information
which
reasonably
supports
the
conclusion
that
a
chemical
substance
or
mixture
presents
a
substantial
risk
of
injury
to
health
or
the
environment.

II.
Persons
Subject
to
the
Requirement
Persons
subject
to
section
8(
e)
requirements
include
both
natural
persons
and
business
entities
engaged
in
manufacturing,
processing,
or
distributing
in
commerce
a
chemical
substance
or
mixture.
In
the
case
of
business
entities,
the
president,
chief
executive
officer,
and
any
other
officers
responsible
and
having
authority
for
the
organization's
execution
of
its
section
8(
e)
obligations
should
ensure
that
the
organization
reports
substantial
risk
information
to
EPA.
The
business
organization
is
considered
to
have
obtained
any
information
which
any
officer
or
employee
capable
of
appreciating
the
significance
of
that
information
has
obtained.
It
is
therefore
incumbent
upon
business
organizations
to
establish
procedures
for
expeditiously
processing
pertinent
information
consistent
with
the
schedule
set
forth
in
Part
IV.
Those
officers
and
employees
of
business
organizations
who
are
capable
of
appreciating
the
significance
of
pertinent
information
are
also
subject
to
these
reporting
requirements.
An
employing
organization
may
relieve
its
individual
officers
and
employees
of
any
responsibility
for
reporting
substantial­
risk
information
directly
to
EPA
by
establishing,
internally
publicizing,
and
affirmatively
implementing
procedures
for
employee
submission
and
corporate
processing
of
pertinent
information.
These
procedures,
at
a
minimum,
should:
(
1)
Specify
the
information
that
officers
and
employees
must
submit;
(
2)
indicate
how
such
submissions
are
to
be
prepared
and
the
company
official
to
whom
they
are
to
be
submitted;
(
3)
note
the
Federal
penalties
for
failing
to
report;
and
(
4)
provide
a
mechanism
for
promptly
advising
officers
and
employees
in
writing
of
the
company's
disposition
of
the
report,
including
whether
or
not
the
report
was
submitted
to
EPA
(
and
if
not
reported,
informing
employees
of
their
right
to
report
to
EPA,
as
protected
by
TSCA
section
23).
An
employee
of
any
company
that
has
established
and
publicized
such
procedures,
who
has
internally
submitted
pertinent
information
in
accordance
with
them,
shall
have
discharged
his
section
8(
e)
obligation.
Establishment
of
such
procedures
notwithstanding,
all
officials
responsible
and
having
authority
for
the
organization's
execution
of
its
section
8(
e)
obligations
retain
personal
liability
for
ensuring
that
the
appropriate
substantial­
risk
information
is
reported
to
EPA.
Business
organizations
that
do
not
establish
such
procedures
cannot
relieve
their
individual
officers
and
employees
of
the
responsibility
for
ensuring
that
substantial­
risk
information
they
obtain
is
reported
to
EPA.
While
officers
and
employees
of
such
organizations
may
also
elect
to
submit
substantial­
risk
information
to
their
superiors,
for
corporate
processing
and
reporting,
rather
than
to
EPA
directly,
they
have
not
discharged
their
individual
section
8(
e)
obligation
until
EPA
has
received
the
information.
Note:
Irrespective
of
a
business
organization's
decision
to
establish
and
publicize
procedures
described
above,
the
business
organization
is
responsible
for
becoming
cognizant
of
any
``
substantial
risk''
information
obtained
by
its
officers,
employees,
and
agents,
and
for
ensuring
that
such
information
is
properly
reported
to
EPA.

III.
When
a
Person
Will
Be
Regarded
as
Having
Obtained
Information
A
person
obtains
substantial­
risk
information
at
the
time
he
first
comes
into
possession
of
or
knows
of
such
information.
Note:
This
includes
information
of
which
a
prudent
person
similarly
situated
could
reasonably
be
expected
to
possess
or
have
knowledge.
An
establishment
obtains
information
at
the
time
any
officer
or
employee
capable
of
appreciating
the
significance
of
such
information
obtains
it.

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/
Notices
IV.
Requirement
That
a
Person
``
Immediately
Inform''
the
Administrator
With
the
exception
of
certain
information
on
emergency
incidents
of
environmental
contamination
(
see
Part
V.(
c))
and
information
submitted
under
Part
VII.
(
c),
(
d)
and
(
e),
a
person
has
``
immediately
informed''
the
Administrator
if
information
is
received
by
EPA
not
later
than
the
30th
calendar
day
after
the
date
the
subject
person
obtained
such
information.
Supplementary
information
generated
after
a
section
8(
e)
notification
should,
if
appropriate,
be
immediately
reported
(
within
30
calendar
days
of
a
person
obtaining
the
information).
This
also
applies
to
submitter
responses
to
EPA
requests
for
additional
information
related
to
submitted
section
8(
e)
data.
Section
8(
e)
reporting
must
be
submitted
to
EPA
and
should
be
made
as
described
under
Part
IX.
For
emergency
incidents
of
environmental
contamination,
a
person
should
report
by
telephone
to
the
appropriate
contact
as
directed
in
Part
IX.
as
soon
as
the
person
has
knowledge
of
the
incident.
The
emergency
incident
report
should
contain
as
much
of
the
information
specified
in
Part
IX.
as
is
possible.
A
follow­
up
written
report
is
not
required.
Note:
Preexisting
information
(
i.
e.,
of
the
kind
described
under
Part
V.
(
b)(
1)
and
(
c))
that
predates
June
3,
2003,
is
not
subject
to
section
8(
e)
reporting
unless
its
review
is
triggered
by
a
person
obtaining
new
information
and
that
in
combination
with
the
preexisting
information
meets
the
criteria
for
section
8(
e)
reporting.

V.
What
Constitutes
Substantial
Risks
A
``
substantial
risk
of
injury
to
health
or
the
environment''
is
a
risk
of
considerable
concern
because
of
(
a)
the
seriousness
of
the
effect
(
see
subparts
(
a),
(
b),
and
(
c)
of
this
part
for
an
illustrative
list
of
effects
of
concern),
and
(
b)
the
fact
or
probability
of
its
occurrence.
(
Economic
or
social
benefits
of
use,
or
costs
of
restricting
use,
are
not
to
be
considered
in
determining
whether
a
risk
is
``
substantial.'')
These
two
criteria
are
differentially
weighted
for
different
types
of
effects.
The
human
health
effects
listed
in
subpart
(
a)
of
this
part,
for
example,
are
so
serious
that
relatively
little
weight
is
given
to
exposure:
The
mere
fact
the
implicated
chemical
is
in
commerce
constitutes
sufficient
evidence
of
exposure.
In
contrast,
the
remaining
effects
listed
in
subparts
(
b)
and
(
c)
of
this
part
must
involve,
or
be
accompanied
by
the
potential
for,
significant
levels
of
exposure
(
because
of
general
production
levels,
persistence,
typical
uses,
common
means
of
disposal,
or
other
pertinent
factors).
Note
that
information
on
the
effects
outlined
below
should
not
be
reported:
(
i)
If
the
respondent
has
actual
knowledge
that
the
Administrator
is
already
informed
of
them,
or
(
ii)
information
respecting
these
effects
can
be
obtained
either
directly
by
observation
of
their
occurrence,
or
inferred
from
designed
studies
as
discussed
in
Part
VI.
The
Agency
considers
effects
for
which
substantial­
risk
information
should
be
reported
to
include
the
following.
(
a)
Human
health
effects.
(
1)
Any
instance
of
cancer,
birth
defects,
mutagenicity,
death,
or
serious
or
prolonged
incapacitation,
including
the
loss
of
or
inability
to
use
a
normal
bodily
function
with
a
consequent
relatively
serious
impairment
of
normal
activities,
if
one
(
or
a
few)
chemical(
s)
is
strongly
implicated.
(
2)
Any
pattern
of
effects
or
evidence
which
reasonably
supports
the
conclusion
that
the
chemical
substance
or
mixture
can
produce
cancer,
mutation,
birth
defects
or
toxic
effects
resulting
in
death,
or
serious
or
prolonged
incapacitation.
(
b)
Non­
emergency
situations
involving
environmental
contamination;
environmental
effects
 
(
1)
Nonemergency
situations
of
chemical
contamination
involving
humans
and/
or
the
environment.
Information
that
pertains
to
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
nonhuman
organisms
has
occurred
or
that
there
is
a
substantial
likelihood
that
such
exposure
will
occur,
is
subject
to
reporting.
The
mere
presence
of
a
chemical
in
an
environmental
media,
absent
the
additional
information
noted
above,
would
not
trigger
reporting
under
section
8(
e).
Information
concerning
the
detection
of
chemical
substances
contained
within
appropriate
disposal
facilities
such
as
treatment,
storage
and
disposal
facilities
permitted
under
RCRA
should
not
be
reported
under
this
part.
Note:
From
time
to
time
EPA
establishes
concentrations
of
various
substances
in
different
media
that
trigger
a
regulatory
response
or
establish
levels
that
are
presumed
to
present
no
risk
to
human
health
or
the
environment.
For
example,
EPA
establishes
Maximum
Contaminant
Levels
(
MCLs)
in
drinking
water,
Ambient
Water
Quality
Criteria
for
receiving
bodies
of
water,
and
Reference
Doses
(
RfDs)
or
Concentrations
(
RfCs).
For
the
purposes
of
section
8(
e),
information
about
contamination
found
at
or
below
these
kinds
of
benchmarks
would
not
be
reportable.
Conversely,
information
about
contamination
found
at
or
above
benchmarks
that
trigger
regulatory
requirements,
such
as
Resource
Conservation
and
Recovery
Act
(
RCRA)
Toxicity
Characteristic
Limits,
is
to
be
considered
for
possible
reporting,
based
on
potential
exposure
to
humans
and/
or
nonhuman
organisms
and
other
relevant
factors.
(
2)
Environmental
effects.
Measurements
and
indicators
of
pronounced
bioaccumulation
heretofore
unknown
to
the
Administrator
(
including
bioaccumulation
in
fish
beyond
5,000
times
water
concentration
in
a
30­
day
exposure
or
having
an
noctanol
water
partition
coefficient
greater
than
25,000)
should
be
reported
when
coupled
with
potential
for
widespread
exposure
and
any
nontrivial
adverse
effect.
(
3)
Environmental
effects.
Any
nontrivial
adverse
effect,
heretofore
unknown
to
the
Administrator,
associated
with
a
chemical
known
to
have
bioaccumulated
to
a
pronounced
degree
or
to
be
widespread
in
environmental
media,
should
be
reported.
(
4)
Environmental
effects.
Ecologically
significant
changes
in
species'
interrelationships;
that
is,
changes
in
population
behavior,
growth,
survival,
etc.
that
in
turn
affect
other
species'
behavior,
growth,
or
survival,
should
be
reported.
Examples
include:
(
i)
Excessive
stimulation
of
primary
producers
(
algae,
macrophytes)
in
aquatic
ecosystems,
e.
g.,
resulting
in
nutrient
enrichment,
or
eutrophication,
of
aquatic
ecosystems.
(
ii)
Interference
with
critical
biogeochemical
cycles,
such
as
the
nitrogen
cycle.
(
5)
Environmental
effects.
Facile
transformation
or
degradation
to
a
chemical
having
an
unacceptable
risk
as
defined
above
should
be
reported.
(
c)
Emergency
incidents
of
environmental
contamination.
Any
environmental
contamination
by
a
chemical
substance
or
mixture
to
which
any
of
the
above
adverse
effects
has
been
ascribed
and
which
because
of
the
pattern,
extent,
and
amount
of
contamination
(
1)
seriously
threatens
humans
with
cancer,
birth
defects,
mutation,
death
or
serious
or
prolonged
incapacitation,
or
(
2)
seriously
threatens
non­
human
organisms
with
large­
scale
or
ecologically
significant
population
destruction,
should
be
reported.

VI.
Nature
and
Sources
of
Information
Which
``
Reasonably
Supports
the
Conclusion''
of
Substantial
Risk
Information
attributing
any
of
the
effects
described
in
Part
V.
of
this
policy
statement
to
a
chemical
substance
or
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Notices
mixture
should
be
reported
if
it
is
one
of
the
types
listed
below
and
if
it
is
not
exempt
from
the
reporting
requirement
by
reason
of
Part
VII.
of
this
policy
statement.
A
person
should
not
delay
reporting
until
he
obtains
conclusive
information
that
a
substantial­
risk
exists,
but
should
immediately
report
any
evidence
which
``
reasonably
supports''
that
conclusion.
Such
evidence
will
generally
not
be
conclusive
as
to
the
substantiality
of
the
risk;
it
should,
however,
reliably
ascribe
the
effect
to
the
chemical.
Information
from
the
following
sources
concerning
the
effects
described
in
Part
V.
will
often
``
reasonably
support''
a
conclusion
of
substantial
risk.
Consideration
of
corroborative
information
before
reporting
can
only
occur
where
it
is
indicated
below.
(
1)
Designed
controlled
studies.
In
assessing
the
quality
of
information,
the
respondent
should
consider
whether
it
contains
reliable
evidence
ascribing
the
effect
to
the
chemical.
Not
only
should
final
results
from
such
studies
be
reported,
but
also
preliminary
results
from
incomplete
studies
where
appropriate.
Designed,
controlled
studies
include:
(
i)
In
vivo
experiments
and
tests.
(
ii)
In
vitro
experiments
and
tests.
Consideration
may
be
given
to
the
existence
of
corroborative
information,
if
necessary
to
reasonably
support
the
conclusion
that
a
chemical
presents
a
substantial
risk.
(
iii)
Epidemiological
studies.
(
iv)
Environmental
monitoring
studies.
(
2)
Reports
concerning
and
studies
of
undesigned,
uncontrolled
circumstances.
It
is
anticipated
here
that
reportable
effects
will
generally
occur
in
a
pattern,
where
a
significant
common
feature
is
exposure
to
the
chemical.
However,
a
single
instance
of
cancer,
birth
defects,
mutation,
death,
or
serious
incapacitation
in
a
human
would
be
reportable
if
one
(
or
a
few)
chemicals)
was
strongly
implicated.
In
addition,
it
is
possible
that
effects
less
serious
than
those
described
in
Part
V.(
a)
may
be
preliminary
manifestations
of
the
more
serious
effects
and,
together
with
another
triggering
piece
of
information,
constitute
reportable
information;
an
example
would
be
a
group
of
exposed
workers
experiencing
dizziness
together
with
preliminary
experimental
results
demonstrating
neurological
dysfunctions.
Reports
and
studies
of
undesigned
circumstances
include:
(
i)
Medical
and
health
surveys.
(
ii)
Clinical
studies.
(
iii)
Reports
concerning
and
evidence
of
effects
in
consumers,
workers,
or
the
environment.
VII.
Information
Which
Need
Not
Be
Reported
``
Substantial
risk''
information
need
not
be
reported
under
section
8(
e)
if
it:
(
a)
Is
obtained
in
its
entirety
from
one
of
the
following
sources:
(
1)
An
EPA
study
or
report.
(
2)
An
official
publication
or
official
report
(
draft
or
final)
published
or
made
available
to
the
general
public
by
another
Federal
agency
and
any
information
developed
by
another
Federal
Agency
as
a
result
of
a
toxicological
testing/
study
program,
or
site
evaluation
for
chemical
contamination,
in
which
EPA
is
collaborating
in
the
design,
review,
or
evaluation
of
testing/
sampling
plans
or
resultant
data.
(
3)
Scientific
publications,
including
bibliographic
databases,
available
electronically
or
in
hard
copy
(
e.
g.,
Science,
Nature,
New
England
Journal
of
Medicine,
Medline,
Toxline,
NIOSH
RTECS,
International
Uniform
Chemical
Information
Database
(
IUCLID),
etc.).
(
4)
Scientific
databases
(
e.
g.,
Agricola,
Biological
Abstracts,
Chemical
Abstracts,
Dissertation
Abstracts,
Index
Medicus,
etc).
(
5)
A
news
publication
(
i.
e.,
newspaper,
news
magazine,
trade
press)
with
circulation
in
the
United
States.
(
6)
A
radio
or
television
news
report
broadcast
in
the
United
States.
(
7)
A
public
scientific
conference
or
meeting
held
within
the
United
States,
provided
that
the
information
is
captured
accurately
by
way
of
a
meeting
transcript,
abstract,
or
other
such
record,
and
has
been
cited
in
a
bibliographic/
abstract
computerized
data
base,
publication,
or
report
of
the
type
cited
in
paragraphs
(
a)
(
1),
(
2),
(
3),
or
(
4)
of
this
part
within
90
days
of
a
subject
person
obtaining
such
information.
(
8)
A
public
scientific
conference
sponsored
or
co­
sponsored
by
EPA
or
at
a
conference
where
the
subject
information
is
presented
by
an
EPA
employee
or
contractor
acting
on
behalf
of
EPA.
(
b)
Corroborates
(
i.
e.,
substantially
duplicates
or
confirms)
in
terms
of,
for
example,
route
of
exposure,
dose,
species,
strain,
sex,
time
to
onset
of
effect,
nature
and
severity
of
effect,
a
well­
recognized/
well­
established
serious
adverse
effect
for
the
chemical(
s)
under
consideration,
unless
such
information
concerns
effects
observed
in
association
with
emergency
incidents
of
environmental
contamination
as
described
in
Part
V.(
c)
and
thus
should
be
considered
for
reporting
under
section
8(
e).
(
c)
Is
information
that
will
be
reported
to
EPA
within
90
calendar
days
of
obtaining
the
information
for
nonemergency
information
under
Part
V.(
b)(
1),
immediately
(
i.
e.,
as
soon
as
the
subject
person
has
knowledge
of
the
incident)
for
emergency
information
under
Part
V.(
c),
or
within
30
calendar
days
of
obtaining
the
information
for
the
other
types
of
information
specified
under
Part
V.,
pursuant
to
a
mandatory
reporting
requirement
of
any
statutory
authority
that
is
administered
by
EPA
(
including,
but
not
limited
to,
the
Toxic
Substances
Control
Act;
the
Federal
Water
Pollution
Control
Act;
the
Clean
Air
Act;
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act;
the
Safe
Drinking
Water
Act;
the
Marine
Protection,
Research,
and
Sanctuaries
Act;
the
Comprehensive
Environmental
Response,
Compensation,
and
Liability
Act;
the
Resource
Conservation
and
Recovery
Act,
the
Pollution
Prevention
Act;
the
Emergency
Planning
and
Community
Right­
to­
Know
Act).
(
d)
Is
information
that
will
be
reported
to
a
State
within
90
calendar
days
of
obtaining
the
information
for
non­
emergency
information
under
Part
V.(
b)(
1),
immediately
(
i.
e.,
as
soon
as
the
subject
person
has
knowledge
of
the
incident)
for
emergency
information
under
Part
V.(
c),
or
within
30
calendar
days
of
obtaining
the
information
for
the
other
types
of
information
specified
under
Part
V.,
pursuant
to
a
mandatory
reporting
requirement
under
any
Federal
statute
administered
by
EPA
for
which
implementation
has
been
delegated
to
that
State
(
e.
g.,
National
Pollutant
Discharge
Elimination
System
(
NPDES)
permit
requirements),
or
pursuant
to
a
mandatory
reporting
provision
of
an
EPA­
authorized
State
program
established
under
a
Federal
statute
administered
by
EPA,
e.
g.,
state
RCRA
programs.
(
e)
Is
information
that
will
be
reported
to
the
Federal
government
within
90
calendar
days
of
obtaining
the
information
for
non­
emergency
sitespecific
contamination
information
under
Part
V.(
b)(
1)
or
immediately
(
i.
e.,
as
soon
as
the
subject
person
has
knowledge
of
the
incident)
for
emergency
information
under
Part
V.(
c),
pursuant
to
a
mandatory
reporting
requirement
under
any
Federal
statute.
(
f)
Is
information
of
the
kind
under
Part
V.
(
b)(
1)
and
(
c)
submitted
to
the
Federal
government
or
a
state
that
is
developed
in
connection
with
an
authorized
(
by
the
relevant
Federal
or
state
authority)
site
remediation
program.
(
g)
Is
information
of
the
kind
under
Part
V.
(
b)(
1)
and
(
c)
concerning
a
site
under
the
control
of
another
person
who
is
subject
to
the
section
8(
e)
reporting
authority.

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Federal
Register
/
Vol.
68,
No.
106
/
Tuesday,
June
3,
2003
/
Notices
(
h)
Is
information
of
the
kind
under
Part
V.(
b)(
1)
and
(
c)
concerning
a
non­
United
States
site
provided
the
person
who
obtains
the
information
does
not
have
reason
to
believe
that
there
is
a
substantial
likelihood
that
the
contamination
will
cause
environmental
contamination,
of
a
nature
that
would
be
reportable
under
Part
V.
(
b)(
1)
and
(
c),
to
occur
in
an
area
in
the
United
States.

VIII.
Information
First
Received
By
a
Person
Prior
to
the
Effective
Date
of
TSCA
Any
substantial
risk
information
possessed
by
a
person
prior
to
January
1,1977,
of
which
he
is
aware
after
that
date
should
be
reported
within
60
days
of
publication
of
this
policy
statement.
The
Agency
considers
that
a
person
is
aware
of:
(
a)
Any
information
reviewed
after
January
1,
1971,
including
not
only
written
reports,
memoranda
and
other
documents
examined
after
January
1,
1971,
but
also
information
referred
to
in
discussions
and
conferences
in
which
the
person
participated
after
January
7,
1977;
(
b)
Any
information
the
contents
of
which
a
person
has
been
alerted
to
by
date
received
after
January
1,
1977,
including
any
information
concerning
a
chemical
for
which
the
person
is
presently
assessing
health
and
environmental
effects;
(
c)
Any
other
information
of
which
the
person
has
actual
knowledge.

IX.
Reporting
Requirements
Notices
should
be
delivered
to
the
Document
Processing
Center
(
7407M),
(
Attn:
TSCA
Section
8(
e)
Coordinator),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Avenue,
NW.,
Washington,
DC
20460
 
0001
A
notice
should:
(
a)
Be
sent
by
certified
mail,
or
in
any
other
way
permitting
verification
of
its
receipt
by
the
Agency.
(
b)
State
that
it
is
being
submitted
in
accordance
with
section
8(
e).
(
c)
Contain
the
job
title,
name,
address,
telephone
number,
and
signature
of
the
person
reporting
and
the
name
and
address
of
the
manufacturing,
processing,
or
distribution
establishment
with
which
the
person
is
associated.
(
d)
Identify
the
chemical
substance
or
mixture
(
including,
if
known,
the
Chemical
Abstract
Service
(
CAS)
Registry
Number).
(
e)
Summarize
the
adverse
effect(
s)
or
risk(
s)
being
reported,
describing
the
nature
and
the
extent
of
the
effect(
s)
or
risk(
s)
involved.
(
f)
Contain
the
specific
source
of
the
information
together
with
a
summary
and
the
source
of
any
available
supporting
technical
data.
For
emergency
incidents
of
environmental
contamination
(
see
Part
V.(
c)),
a
person
should
report
the
incident
to
the
Administrator
or
the
National
Response
Center
by
telephone
as
soon
as
he/
she
has
knowledge
of
the
incident.
The
report
should
contain
as
much
of
the
information
specified
by
paragraphs
(
c)
through
(
f)
of
this
part
as
possible.
If
any
new
substantial
risk
information
concerning
the
incident
and
reportable
under
TSCA
section
8(
e)
is
obtained,
supplementary
reporting
by
the
person
is
required.
A
twenty­
four
hour
emergency
telephone
number
is:
The
National
Response
Center,
(
800)
424
 
8802
or
(
202)
267
 
2675
in
the
Washington,
DC
metropolitan
area.
Region
I
(
Maine,
Rhode
Island,
Connecticut,
Vermont,
Massachusetts,
New
Hampshire),
(
617)
223
 
7265.
Region
II
(
New
York,
New
Jersey,
Puerto
Rico,
Virgin
Islands),
(
201)
548
 
8730.
Region
III
(
Pennsylvania,
West
Virginia,
Virginia,
Maryland,
Delaware,
District
of
Columbia),
(
215)
814
 
3255.
Region
IV
(
Kentucky,
Tennessee,
North
Carolina,
South
Carolina,
Georgia,
Alabama,
Mississippi,
Florida),
(
404)
562
 
8700.
Region
V
(
Wisconsin,
Illinois,
Indiana,
Michigan,
Ohio,
Minnesota),
(
312)
353
 
2318.
Region
VI
(
New
Mexico,
Texas,
Oklahoma,
Arkansas,
Louisiana),
(
214)
655
 
6428.
Region
VII
(
Nebraska,
Iowa,
Missouri,
Kansas),
(
913)
281
 
0991.
Region
VIII
(
Colorado,
Utah,
Wyoming,
Montana,
North
Dakota,
South
Dakota),
(
800)
227
 
8917.
Region
IX
(
California,
Nevada,
Arizona,
Hawaii,
Guam),
(
415)
972
 
4400.
Region
X
(
Washington,
Oregon,
Idaho,
Alaska),
(
206)
553
 
1263.

X.
Confidentiality
Claims
(
a)
EPA
may
release
to
the
public
health
and
safety
data
claimed
confidential,
including
information
submitted
in
a
notice
of
substantial
risk
under
section
8
(
e)
of
TSCA.
EPA
will
disclose
any
information
claimed
confidential
only
to
the
extent,
and
by
means
of
the
procedures,
set
forth
in
40
CFR
part
2
(
41
FR
36902,
September
1,
1976)
(
b)
If
no
claim
accompanies
the
notice
at
the
time
it
is
submitted
to
EPA,
the
notice
will
be
placed
in
an
open
file
to
be
available
to
the
public
without
further
notice
to
the
submitter.
(
c)
To
assert
a
claim
of
confidentiality
for
information
contained
in
a
notice,
the
submitter
must
submit
two
copies
of
the
notice.
(
1)
The
first
copy
should
be
complete
and
unedited,
clearly
reflecting
what
specific
information
is
being
claimed
confidential.
This
should
be
done
on
each
page
by
placing
brackets
around
the
specific
information
in
question
together
with
a
label
such
as
``
confidential,''
``
proprietary,''
or
``
trade
secret.''
(
2)
The
second
copy
should
be
identical
to
the
first
copy,
but
with
all
bracketed
information
blanked
out
within
the
brackets.
(
3)
Information
within
the
first
confidential
copy
of
the
notice
will
be
disclosed
by
EPA
only
to
the
extent,
and
by
means
of
the
procedures,
set
forth
in
40
CPR
part
2.
The
second
copy
will
be
placed
in
an
open
file
to
be
available
to
the
public
(
d)
Any
person
submitting
a
notice
containing
information
for
which
they
are
asserting
a
confidentiality
claim
should
send
the
notice
in
a
double
envelope.
(
1)
The
outside
envelope
should
bear
the
same
address
outlined
in
Part
IX.
of
this
policy
statement.
(
2)
The
inside
envelope
should
be
clearly
marked
``
To
be
opened
only
by
the
OPPT
Document
Control
Officer.''
(
e)
The
submitter
should
substantiate
any
CBI
claims
by
answering
substantiation
questions
according
to
the
instructions
located
in
the
TSCA
section
8(
e)
website:
http://
www.
epa.
gov/
opptintr/
tsca8e/
doc/
cbi.
htm
XI.
Failure
to
Report
Information
Section
15(
3)
of
TSCA
makes
it
unlawful
for
any
person
to
fail
or
refuse
to
submit
information
required
under
section
8(
e).
Section
16
provides
that
a
violation
of
section
15
renders
a
person
liable
to
the
United
States
for
a
civil
penalty
and
possible
criminal
prosecution.
Pursuant
to
section
17,
the
Government
may
seek
judicial
relief
to
compel
submittal
of
section
8(
e)
information
and
to
otherwise
restrain
any
violation
of
section
8(
e).

List
of
Subjects
Environmental
protection,
Chemicals,
Hazardous
substances,
Reporting
and
recordkeeping
requirements.

Dated:
May
15,
2003.
Stephen
L.
Johnson,
Assistant
Administrator
for
Prevention,
Pesticides,
and
Toxic
Substances.

[
FR
Doc.
03
 
13888
Filed
6
 
2
 
03;
8:
45
am]

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