Document ID: EPA-HQ-OPPT-2002-0035-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2002-09-12T04:00Z

Fax­
on­
Demand
Telephone:
202­
564­
3119
Item:
4096
Supporting
Statement
for
a
Request
for
OMB
Review
under
The
Paperwork
Reduction
Act
1
IDENTIFICATION
OF
THE
INFORMATION
COLLECTION
1(
a)
Title
and
Number
of
the
Information
Collection
Title:
Notification
of
Substantial
Risk
of
Injury
to
Health
and
the
Environment
under
TSCA
Section
8(
e)

EPA
ICR
No.:
0794.10
OMB
Control
No.:
2070­
0046
1(
b)
Short
Characterization
Section
8(
e)
of
the
Toxic
Substances
Control
Act
(TSCA)
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."
(See
Attachment.)

Since
January1977
through
May2002,
EPAhas
received
approximately15,150
initial
section
8(
e)
submissions
covering
a
large
number
of
chemical
substances
and
mixtures
and
a
wide
range
of
chemical
toxicity/
exposure
information.
This
includes
approximately
10,500
submissions
EPA
received
as
a
result
of
the
Compliance
Audit
Program
described
in
Section
2(
a)
below.
Although
EPA's
receipt
of
section
8(
e)
information
does
not
necessarily
trigger
immediate
regulatory
action
under
TSCAor
other
authorities
administered
byEPA,
all
section
8(
e)
submissions
receive
screening
level
evaluations
by
EPA's
Office
of
Pollution
Prevention
and
Toxics
(OPPT)
to
identify
priorities
for
further
Agency
action
and
appropriate
referrals
to
other
programs.

OPPT
routinely
disseminates
section
8(
e)
data
received
to
EPA's
Program
and
Regional
Offices
and
other
Federal
agencies
(e.
g.,
NIOSH,
OSHA,
CPSC,
FDA,
NTP)
to
provide
information
about
newlydiscovered
chemical
hazards/
risks;
public
outreach/
informationaccess
programs
are
also
in
place
for
Section
8(
e)
data
received
by
EPA.
Beginning
in
2001,
OPPT
has
made
these
referrals
primarily
through
e­
mails
of
biweekly
tables
summarizing
all
new
submissions.

EPA's
proactive
implementation
of
section8(
e)
of
TSCAhas
resulted
inheightened
corporate
awareness
of
the
potential
risks
of
injury
posed
by
exposure
to
chemical
substances.
This
increased
corporat
e
awareness
has
led
to
a
wide
variety
of
voluntarily
initiated
risk
reduction/
pollution
prevention
actions
designed
to
protect
human
health
and
the
environment.
2
2
NEED
FOR
AND
USE
OF
THE
COLLECTION
2(
a)
Need/
Authority
for
the
Collection
TSCA
section
8(
e)
continues
to
be
an
important
and
useful
tool
for
early
warning
and
identification
of
potential
substantial
risk
situations
allowing
EPA
and
others
to
focus
their
limited
resources
on
chemicals
or
mixtures
of
highest
concern.
Not
collecting
section
8(
e)
information
would
prevent
the
Agency
and
others
fromlearning
quickly
about
new
substantial
risks
posed
by
exposure
to
chemical
substances/
mixtures
and
not
allow
adequate
assessment
and,
if
need
be,
taking
action
to
effectively
eliminate
or
reduce
such
risks
in
a
timely
manner.

The
statutory
authority
for
this
information
collection
is
section
8(
e)
of
TSCA
(U.
S.
Public
Law94­
469;
90
Stat.
2029;
15
U.
S.
C.
2607(
e)).
No
formal
rule­
making
by
the
Agency
was
required
to
implement
section
8(
e)
in
that
section
8(
e)
was
a
self­
activating
reporting
provision
of
TSCA
that
became
immediately
effective
on
January
1,
1977
(the
effective
date
of
the
Act).
However,
in
order
to
facilitate
compliance
with
section
8(
e),
EPA
clarified
the
kinds
of
information
that
constitute
substantial
risk
information,
specified
the
types
of
information
exempt
from
the
reporting
requirements,
and
outlined
standard
reporting
procedures,
in
published
proposed
guidance
(42
FR
45362;
September
9,
1977).
After
holding
several
public
meetings
and
considering
the
public
comments
on
the
proposed
section
8(
e)
guidance,
the
Agency
published
its
final
"Statement
of
Interpretation
and
Enforcement
Policy;
Notification
of
Substantial
Risk"
(43
FR
11110;
March
16,
1978,
hereinafter
referred
to
as
the
"PolicyStatement").
The
section
8(
e)
PolicyStatement
continues
to
reflect
EPA's
position
regarding
the
section
8(
e)
reporting
requirements.
However,
EPA
is
in
the
process
of
revising
a
part
of
the
Policy
Statement
dealing
with
environmental
exposure
reporting
as
noted
below.
In
1991,
EPA
published
a
"Section
8(
e)
Reporting
Guide."

In
February
of
1991,
the
Agency
initiated
a
voluntary
section
8(
e)
"Compliance
Audit
Program"
(CAP).
This
compliance
program,
which
was
initiated
as
the
result
of
several
section
8(
e)
enforcement
cases
that
suggested
that
many
companies
were
not
complying
with
the
section
8(
e)
reporting
requirements,
was
designed
to
1)
achieve
EPA's
goal
of
obtaining
any
outstanding
section
8(
e)
data,
and
2)
provide
maximum
encouragement
to
companies
to
voluntarily
audit
their
files
for
section
8(
e)­
reportable
information.
The
section
8(
e)
CAP
involved
consent
agreements/
orders
pursuant
to
section
15
of
TSCA,
stipulated
monetary
penalties
and
an
overall
penalty
ceiling.
A
total
of
123
companies
elected
to
participate
voluntarily
in
the
Agency's
section
8(
e)
CAP
activity.
The
CAP
was
terminated
on
May
15,
1996
and
settlements
with
CAP
participants
were
announced
on
October
15,
1996.

In
implementing
the
section
8(
e)
CAP,
EPA
determined
that
there
was
a
need
to
suspend
and
refine
those
portions
of
the
1978
section
8(
e)
Policy
Statement
that
deal
specifically
with
the
reportability
of
exposure
information
concerning
the
release
of
toxic
chemicals
to
and
the
detection
of
toxic
chemicals
in
environmental
media.
On
July13,
1993
(58
FR37735)
EPApublished
proposed
guidance
regarding
the
detection
of
toxic
chemicals
in
environmental
media.
EPAreceived
comments
3
from
49
companies
and
industry
associations.
Based
on
the
submitted
comments
and
a
number
of
meetings
with
industry
representatives,
EPA
revised
the
proposed
guidance
and
made
it
available
for
additional
public
comment
through
a
notice
in
the
Federal
Register
published
on
March
20,
1995
(60
FR
14756).
In
response,
EPA
received
an
additional
22
comments.
While
the
comments
offered
additional
refinements
to
the
revised
guidance,
their
basic
tenor
was
that
industry
was
in
support
of
the
changes.

EPA
has
collaborated
with
industry
on
a
question
and
answer
document
that
would
be
available
in
advance
of
the
effective
date
of
the
revised
guidance
when
published.
The
plan
is
to
make
the
guidance
prospective
in
nature
and
to
have
it
become
effective
a
number
of
months
after
publication
so
that
industry
can
familiarize
themselves
with
it
and
have
the
benefit
of
the
completed
question
and
answer
document
that
will
provide
a
wide
range
of
possible
reporting
situations
as
examples.
Until
such
time
as
the
final
guidance
is
effective,
however,
the
section
8(
e)
statutory
language
must
be
used
by
all
subject
persons
to
determine
the
section
8(
e)­
reportability
of
obtained
information
on
chemical
releases
and
detections.

2(
b)
Use/
Users
of
the
Data
Since
1977,
the
Agencyand
members
of
the
chemical
industryhave
devoted
significant
efforts
in
fulfilling
their
respective
responsibilities
under
section
8(
e).
Since
January
1,
1977,
about
15,150
initial
section
8(
e)
notices
(includes
CAP
and
non­
CAP
submissions)
covering
a
broad
range
of
toxicity
and
exposure­
related
data
on
a
wide
variety
of
chemicals
have
been
received
by
the
Agency
and
given
priority
evaluation
and
follow­
up
attention.

All
incoming
section
8(
e)
submissions
are
reviewed
by
EPA
shortly
after
receipt.
The
initial
processing
of
section
8(
e)
submissions
includes
a
screening
level
evaluation
of
the
submitted
data.
Such
evaluations
are
not
risk
assessments,
nor
do
they
include
other
toxicity
data
that
may
be
available
on
the
chemical
or
exposure­
related
information.
The
results
of
screening
level
evaluations
are
intended
for
priority
setting
to
select
cases
for
more
detailed
assessment.

EPA
utilizes
section
8(
e)
submission
information
for
hazard/
risk
identification
purposes
primarily
in
the
initial
stages
of
the
TSCA
Existing
Chemical
Program
(ECP).
Section
8(
e)
data
are
also
used
in
ongoing
EPA
health
and
exposure
assessments
of
both
existing
and
new
chemicals,
in
the
SIDS
international
testing
program,
in
the
High
Production
Volume
(HPV)
Challenge
Program,
and
in
support
of
regulation
development
under
TSCA,
e.
g.,
development
of
chemical
testing
rules
under
section
4
of
TSCA,
as
well
as
regulation
development
under
other
authorities
administered
by
the
Agency.
In
addition,
section
8(
e)
submissions
have
been
the
basis
for
a
number
of
chemical
advisories
developed
by
OPPT
to
communicate
potential
health
risks
and
the
need
for
exposure
controls.

Regardless
of
the
type
of
section
8(
e)
follow­
up
action/
activity
undertaken,
all
reported
information
is
made
available
for
use
by
other
EPA
Program
and
Regional
Offices,
other
Federal
4
agencies
and
other
parties
(e.
g.,
chemical
industry,
trade
unions,
environmental
groups,
general
public,
international
community)
who
may
be
interested
in
the
subject
chemical
or
mixture.
Other
EPA
Office
and
Federal
agencies
routinely
utilize
section
8(
e)
data
in
implementing
their
regulatory
programs.
The
principal
vehicle
for
making
the
information
widely
available
is
the
TSCATS
database
(see
4(
b)),
which
is
in
the
process
of
expanding
to
include
information
fromrelated
data
bases.
Also,
the
TSCA
Section
8(
e)
web
page,
available
on
the
Internet
at
http://
www.
epa.
gov/
opptintr/
tsca8e/,
includes
all
published
section
8(
e)
guidance
and
full
text
copies
of
all
new
section
8(
e)
submissions.

EPA's
proactive
implementation
of
section
8(
e)
has
also
resulted
in
heightened
corporate
awareness
of
the
potential
risk
of
injury
posed
by
exposure
to
chemical
substances.
This
increased
corporate
awareness
has
led
to
a
variety
of
voluntary
corporate
actions
that
are
designed
to
protect
human
health
and/
or
the
environment.
Many
companies
have
reported
to
EPA
that
the
following
types
of
risk
reduction/
pollution
prevention
measures
were
initiated
in
direct
response
to
the
submitted
chemical
toxicity
and/
or
exposure
data:


Notification
of
workers,
customers
and
others;


Revision
of
product
labels
and
Material
Safety
Data
Sheets;


Modification
of
manufacturing,
processing,
and/
or
handling;


Ceasing
production/
use
either
temporarily
or
permanently;


Initiation
of
additional
toxicity
or
exposure
studies
to
further
define
potential
risks.

3
NON­
DUPLICATION,
CONSULTATIONS
ANDOTHERCOLLECTIONCRITERIA
3(
a)
Non­
Duplication
There
is
no
other
source
of
data
that
can
be
used
in
place
of
the
data
submitted
to
EPA
under
the
section
8(
e)
statutory
reporting
requirement.
The
"substantial
risk"
information
required
to
be
reported
to
EPA
is
unpublished
information
not
already
known
to
the
Agency.
In
addition,
information
need
not
be
submitted
under
section
8(
e)
if
the
information
has
been
reported
already
to
EPA
pursuant
to
another
mandatory
information
reporting
requirement
of
TSCA
or
some
other
authorityadministered
or
delegated
to
the
States
byEPA.
In
conjunction
with
the
section
8(
e)
Policy
Statement
refinement
activities,
the
Agency
expanded
and
clarified
the
types
of
information
that
need
not
be
reported
under
section
8(
e).
This
is
expected
to
result
in
some
additional
reduction
of
the
overall
respondent
reporting
burden
for
section
8(
e).

3(
b)
Public
Notice
Required
Prior
to
ICR
Submission
to
OMB
Prior
to
submission
to
OMB,
this
ICR
will
be
made
available
to
the
public
for
comment
through
a
Federal
Register
notice.
The
public
will
have
60
days
to
provide
comments.
Any
comments
received
will
be
given
consideration
when
completing
the
supporting
statement
that
is
submitted
to
OMB.
3(
c)
Consultations
5
EPA
personnel
have
participated
in
numerous
public
meetings
and
other
fora
to
discuss
the
section
8(
e)
Policy
Statement
and
the
Agency's
implement
at
ion
of
section
8(
e).
Large
EPAsponsored
public
meetings
at
which
section
8(
e)
was
a
primary
topic
of
discussion
were
held
in
1978,
1986,
1987,
1990
and
1992
with
chemical
industry
representatives
and
other
interested
parties
in
attendance.
EPA
staff
have
also
participated
in
more
than
30
industry­
sponsored
meetings
at
which
section
8(
e)
of
TSCA
was
the
major
or
primary
topic
of
discussion.
Section
8(
e)
topics
have
also
been
included
in
a
number
of
"Living
With
TSCA"
conferences
held
since
April
1994.

EPA
staff
has
also
met
on
numerous
occasions
with
members
of
the
chemical
industry
to
discuss
section
8(
e)
in
the
context
of
the
section
8(
e)
Compliance
Audit
Program.
Further,
EPA
analyzed
and
responded
to
numerous
public
comments
received
as
the
result
of
the
July
13,
1993
proposed
refinements
to
several
portions
of
the
Agency's
1978
section
8(
e)
Policy
Statement
and
to
comments
received
in
response
to
the
March
20,
1995
reopening
of
the
public
record
and
has
collaborated
with
industry
in
preparing
the
associated
question
and
answer
document.

EPA
proposed
amendments
to
the
section
8(
e)
policy
statement
in
1993
and
again
in
1995.
The
proposed
amendments
dealt
specifically
with
clarifications
on
reporting
requirements
for
occurrences
of
environmental
exposure
or
contamination.
As
a
condition
of
the
previous
ICR
renewal,
OMB
instructed
EPA
to
change
the
reporting
period
to
30
calendar
days
instead
of
15
working
days
or
explain
why
a
more
stringent
reporting
period
is
necessary.
EPA
is
planning
to
adopt
the
change
in
the
reporting
period
that
will
be
contained
in
the
Section
8(
e)
policy
guidance
changes
that
EPA
is
currently
working
to
finalize.
EPA
is
further
planning
to
consolidate
all
section
8(
e)
guidance,
including
these
proposed
amendments,
into
a
single
document.
It
may
be
in
the
form
of
a
consolidated
guidance
document
or
a
rule
requiring
proposed
and
final
Federal
Register
notices.
If
the
outcome
of
either
product
results
in
any
change
to
existing
reporting
requirements,
EPA
will
amend
the
section
8(
e)
ICR.

3(
d)
Effects
of
less
Frequent
Collection
As
stated
previously,
section
8(
e)
continues
to
be
an
extremely
important
and
useful
EPAtool
for
early
identification
of
potential
substantial
risk
situations
and
allows
the
Agency
as
well
as
others
to
focus
their
resources
on
those
chemicals
or
mixtures
of
highest
concern.
The
consequences
of
EPA's
not
receiving
section
8(
e)
data
immediately
following
receipt
by
a
respondent
are
serious.
The
Agency
would
be
prevented
from
learning
about
and
publicizing
new
information
about
substantial
risks
of
health
or
environmentalal
injury
posed
by
exposure
to
chemical
substances
and/
or
mixtures.
Further,
EPA
would
not
be
in
a
position
to
adequately
assess
and,
if
necessary,
take
action
to
effectively
eliminate
or
reduce
such
risks
in
an
expeditious
manner.

3(
e)
General
Guidelines
6
The
required
reporting
that
takes
place
under
section
8(
e)
does
not
appear
to
exceed
the
Paperwork
Reduction
Act­
imposed
guidelines
that
are
found
at
5
CFR
1320.6.

3(
f)
Confidentiality
Any
person
submitting
a
notice
to
EPA
under
section
8(
e)
may
assert
a
claim
of
business
confidentiality
covering
all
or
part
of
the
information
that
is
contained
in
the
notice.
Any
information
covered
by
a
claim
will
be
disclosed
by
EPA
only
to
the
extent,
and
by
means
of
the
procedures
set
forth
at
40
CFR
Part
2.
If
no
confidentiality
claim
accompanies
a
section
8(
e)
notice
at
the
time
it
is
submitted
to
EPA,
the
notice
is
placed
in
an
open
file
that
is
available
to
the
public
without
further
notice
to
the
submitting
organization.
The
Agency
has
established
and
actively
implements
wellpublicized
standard
procedures
for
the
handling
and
safe­
guarding
of
information
claimed
as
TSCA
Confidential
Business
Information
(TSCA
CBI).

3(
g)
Sensitive
Questions
Under
section
8(
e),
EPA
does
not
seek
submission
of
information
with
regard
to
sexual
behavior
or
attitudes,
religious
beliefs,
or
other
matters
usually
considered
to
be
of
a
private
nature.

4
RESPONDENTS
AND
THE
INFORMATION
REQUESTED
4(
a)
Respondents/
NAICS
Codes
Astatutorysection
8(
e)
reporting
obligationcan
be
incurred
byanypersonwho
manufactures,
imports,
processes
or
distributes
a
TSCA­
covered
chemical
substance
or
mixture.
EPA's
section
8(
e)
Policy
Statement
defines
the
term"
person"
broadly
to
include
"any
natural
person,
corporation,
firm,
company,
joint­
venture,
partnership,
sole
proprietorship,
association,
or
anyother
business
entity,
any
State
or
political
subdivision
thereof,
any
municipality,
any
interstate
body
and
any
department,
agency,
instrumentality
of
the
Federal
Government."
Although
this
definition
is
quite
broad
in
terms
of
subject
persons,
section
8(
e)
reporting
obligations
are
most
typically
incurred
by
companies
engaged
in
activities
classified
by
NAICS
Codes
325
­
Chemicals
and
Allied
Products
Manufacturers
and
32411­
Petroleum
Refining.
7
4(
b)
Information
Requested
(i)
Data
Items
There
is
no
required
"form"
on
which
section
8(
e)
information
must
be
submitted
to
EPA;
however,
the
section
8(
e)
Policy
Statement
requires
all
respondents
to
ensure
that
a
written
section
8(
e)
notice:


is
sent
to
EPA
by
a
method
verifying
the
Agency's
receipt;


states
that
it
is
being
submitted
under
section
8(
e)
of
TSCA;


contains
the
name,
address,
job
title,
phone
number
and
signature
of
the
person
reporting,
and
the
name
and
address
of
the
establishment
with
which
the
person
is
associated;


identifies
the
chemical
substance(
s)
or
mixture
including,
if
known,
the
Chemical
Abstract
Service
(CAS)
Registry
Number(
s);


summarizes
adverse
health/
environmental
effects
being
reported
including
a
description
of
the
nature
and
extent
of
the
risk;
and

contains
the
specific
source/
summary
of
the
supporting
data.

EPA
is
in
the
process
of
implementing
optional
electronic
reporting
of
sect
ion
8(
e)
submissions
to
increase
processing
efficiency
for
both
the
Agency
and
the
regulated
community.

(ii)
Respondent
Activities
The
overall
purpose
of
section
8(
e)
reporting
is
to
ensure
that
newinformationthat
reasonably
supports
a
conclusion
that
a
chemical
substance
or
mixture
presents
a
"substantial
risk"
of
injury
to
health
or
the
environment
is
brought
to
EPA's
attention
immediately
upon
discovery
and
not
just
upon
request
by
the
Agency.
It
should
be
noted
again
that
section
8(
e)
applies
to
all
chemical
manufacturers,
import
ers,
processors,
and
distributors
and
applies
also
to
that
information
that
a
subject
person
possesses
or
about
which
that
person
has
knowledge.
Although
compliance
with
section
8(
e)
does
not
require
subject
persons
to
search
for
information
or
to
make
extraordinary
efforts
to
acquire
information,
section
8(
e)
does
apply
to
information
that
is
"obtained"
(i.
e.,
information
t
hat
a
person
possesses
or
about
which
that
person
knows).
Following
a
review
of
existing
information
and
a
decision
that
such
information
is
of
the
type
required
under
section
8(
e),
respondents
must
notify
EPA
in
writing
immediately.
EPA's
section
8(
e)
Policy
Statement
defines
the
term"
immediately"
in
the
context
of
written
section
8(
e)
reports
to
mean
within
15
working
days
(proposed
to
be
changed
to
30
calendar
days)
of
the
date
on
which
the
information
was
obtained;
the
immediate
reporting
of
an
emergency
incident
of
environmental
contamination
by
a
toxic
substance
is
defined
as
a
phone
report
to
EPA
as
soon
as
a
person
knows
about
the
incident.
8
5
INFORMATION
COLLECTION
­
EPA
ACTIVITIES,
COLLECTION
METHODOLOGY
AND
INFORMATION
MANAGEMENT
5(
a)
Agency
Activities
As
explained
in
additional
detail
in
the
next
sections,
the
Agency's
section
8(
e)
activities
involve
answering
general
and
specific
section
8(
e)­
related
questions,
computerized
section
8(
e)
information
tracking
(including
data
extraction,
entry
and
quality
assurance/
control),
microfilming,
confidential
(restricted­
access)
and
non­
confidential
(public­
access)
section
8(
e)
information
filing,
initial
evaluation
of
submitted
section
8(
e)
information
(including
review
of
TSCA
Confidential
Business
Information(
CBI)
substantiations),
andthedisseminationof
section8(
e)­
related
information
on
the
Internet
and
in
response
to
specific
requests.

5(
b)
Collection
Methodology
and
Information
Management
A
Document
Control
Number
is
used
by
EPA
to
identify
section
8(
e)
submissions
and
takes
the
following
form:
8EHQ­
0000.
Internal
EPAtracking
of
section
8(
e)
notice
information
is
handled
via
non­
confidential
and
confidential
computerized
data
bases.

In
order
to
assure
that
the
public
sector
is
kept
appraised
about
new
adverse
chemical­
related
health
effects
and
exposure
information,
the
Agency
provides
public
access
to
and
actively
disseminates
non­
confidential
section
8(
e)
submission
information
in
many
ways.
Some
examples
of
EPA's
longstanding
public
access/
outreach
activities
follow.

Non­
confidential
section
8(
e)
initial
and
follow­
up/
supplemental
submissions,
status
reports,
submission
summaries,
and
EPA
follow­
up
letters
can
be
viewed/
copied
in
the
TSCA
public
docket
located
at
EPAHeadquarters.
Non­
confidential
section
8(
e)­
related
documents
can
also
be
obtained
by
writing
to
EPA's
Freedom
of
Information
Office.

Relevant
non­
confidential
information
from
section
8(
e)
notices
is
routinely
entered
into
TSCATS
(Toxic
Substances
Control
Act
Test
Submissions),
a
publicly
available
computerized
data
base
that
serves
as
an
on­
line
index
of
unpublished
health
and
safety
studies
submitted
to
EPA
under
or
in
conjunction
with
TSCA.
The
submitted
studies
themselves
are
stored/
available
on
microfiche.
Persons
wishing
to
obtain
access
to
TSCATS
can
contact
either
the
National
Library
of
Medicine
(NLM)
in
Rockville,
MD,
or
Chemical
Informat
ion
Systems,
Inc.
(CIS)
in
Baltimore,
MD.
The
microfiche
copies
of
the
studies
that
are
referenced
in
the
TSCATS
database
can
be
obtained
from
either
CIS
or
the
National
Technical
Information
Service
(NTIS)
in
Springfield,
VA.
EPAmakes
full
electronic
copies
of
all
new
section
8(
e)
submissions,
as
well
as
the
section
8(
e)
policy
guidance,
available
to
the
public
through
the
section
8(
e)
web
site
at
http://
www.
epa.
gov/
opptintr/
tsca8e.
9
Under
established
Freedomof
InformationAct
(FOIA)
procedures
as
well
as
the
Organization
for
Economic
Cooperation
and
Development
(OECD)
information­
gathering
"Switchboard"
project,
EPA
responds
to
many
international
requests
for
unpublished
health
and
safety
data
on
chemicals
of
concern
to
OECD
members.

As
stated
previously,
EPA
routinely
notifies
other
Federal
agencies
about
incoming
section
8(
e)
information
via
biweekly
tabular
reports
of
new
section
8(
e)
submissions
and
by
specific
referrals.
As
the
direct
result
of
these
public
outreach
activities,
several
of
these
other
agencies
actively
publicize
the
information
even
further.
For
example,
the
National
Library
of
Medicine
(NLM)
at
the
National
Institutes
of
Health
makes
section
8(
e)
information
available
via
its
publicly
available
computerized
Hazardous
Substances
Data
Base
(HSDB).
In
addition,
the
National
Institute
for
Occupational
Safety
and
Health
(NIOSH)
cites
section
8(
e)
notices
in
the
printed
and
on­
line
computerized
versions
of
the
"Registry
of
Toxic
Effects
of
Chemical
Substances"
(RTECS).

5(
c)
Small
Entity
Flexibility
The
statutory
obligation
to
report
information
under
section
8(
e)
of
TSCA
applies
to
all
manufacturers,
importers,
processors,
and/
or
distributors
of
TSCA­
covered
chemical
substances
and
mixtures.
The
statutory
language
of
section
8(
e)
itself
does
not
allow
for
any
reporting
exemption
or
burden
minimization
based
on
the
size
or
earnings
of
a
respondent.
However,
the
practical
effect
is
that
nearly
all
reporting
is
done
by
large
and
medium
size
companies.
This
is
mainly
because
only
the
larger
companies
have
the
financial
wherewithal
to
conduct
toxicity
testing
that
comprises
most
section
8(
e)
reporting.
Since
there
is
no
routine
reporting
nor
recordkeeping
provisions
for
section
8(
e),
the
true
burden
on
most
small
entities
is
practically
nonexistent.

5(
d)
Collection
Schedule
Considering
that
section
8(
e)
notices
are
received
by
the
Agency
on
an
ad
hoc
basis,
there
is
no
standard
reporting
cycle.
Respondents
are
required
to
comply
with
section
8(
e)
immediately
when
they
come
into
possession
of
or
know
about
section
8(
e)­
reportable
information.
If
section
8(
e)
information
was
not
made
available
immediately
to
EPA,
the
Agency's
ability
to
learn
about,
publicize,
effectively
assess,
and
respond
appropriately
to
newly
discovered
chemical­
related
risks
would
be
severely
impeded
if
not
completely
thwarted.

6
ESTIMATING
THE
BURDEN
AND
COST
OF
COLLECTION
For
the
1999
ICR
renewal,
EPA
used
the
data
on
the
submission
of
initial
section
8(
e)
notices.
The
number
of
initial
notices
used
was
267.
This
was
based
on
the
number
of
initial
submissions
received
in
FY
1997­
1999
(801/
3=
267).
This
ICR
renewal
uses
the
same
approach
by
averaging
the
number
of
initial
submissions
for
the
last
three
fiscal
years
(FY
2000­
2002).
The
average
number
obtained
is
218
initial
notices
per
year
(FY
2000­­
227,
FY
2001­­
224,
and
FY
2002­­
202
prorated).
10
Consequently,
for
this
analysis,
EPA
used
an
average
of
218
initial
submissions
and
a
multiplier
of
0.50
for
follow­
up/
supplemental
submissions/
year
(0.
50
x
218
=
109)
for
a
total
of
327
submissions/
year.

6(
a)
Estimating
Respondent
Burden
The
following
discussion
provides
the
basis
for
the
Agency's
upper­
bound
estimate
of
approximately6,431
total
hours
of
annual
reporting
burden
for
respondents
in
complying
withsection
8(
e).

EPA
believes
that
in
a
large
company
it
should
take
no
more
than
25
hours
to
judge
and
concur
on
the
section
8(
e)­
applicability
of
obtained
information
plus
2
additional
hours
to
prepare/
submit
the
necessary
information.
Using
the
estimate
of
218
initial
section
8(
e)
notices
per
year,
the
total
number
of
hours
required
for
initial
section
8(
e)
reporting
would
be
5,
886
hours
(218
x
27
hours
=
5,
886
hours).
The
submission
of
follow­
up/
supplemental
information
by
a
large
company
in
response
to
EPA
questions
based
on
an
initial
section
8(
e)
submission,
or
as
a
result
of
further
investigation/
evaluation
by
the
company,
is
estimated
to
be
5
hours
per
notice,
assuming
3
hours
to
assemble
the
required
information,
1
hour
to
prepare
the
submission,
and
1
hour
for
review.
EPA's
experience
over
the
last
three
fiscal
years
is
that
approximately
0.
50
section
8(
e)
followup
supplemental
submissions
are
received
on
a
yearly
basis
per
initial
submission
for
an
additional
reporting
burden
of
545
hours
(218
x
0.
50
=
109
x
5
=
545
hours).

Therefore,
the
total
estimate
of
section
8(
e)
notices
(initial
plus
follow­
up/
supplemental
submissions)
received
is
about
327
notices
per
year
with
an
estimated
hourly
respondent
reporting
burden
of
6,431
hours
per
year
(5,
886
hours
+
545
hours
=
6,431
hours).

INITIAL
SUBMISSIONS
SUBTOTAL
Burden
Item
Hours/
Respondent
Respondents/
Year
Hours/
Year
a
1
25
218
5,450
b
2
2
218
436
5,886
1
Reflects
managerial/
technical
review,
data
evaluation,
decision­
making
and
concurrence
processes
to
determine
the
Section
8(
e)­
reportability
and
crafting
the
usually
1­
2
page
section
8(
e)
notification
letter.
2
This
item
reflects
general
clerical
work
(typing,
copying,
and
sending
the
section
8(
e)
notice).

Considering
that
the
respondent's
decision­
making/
concurrence
activities
for
determining
section
8(
e)­
applicability/
reportability
has
already
taken
place
for
the
initial
submission,
the
activities
surrounding
the
submission
of
follow­
up/
supplemental
information
related
to
the
initial
submission
are
viewed
by
the
Agency
as
being
more
simple
in
nature
and
are
reflected
as
being
less
burdensome
as
follows:
11
FOLLOW­
UP/
SUPPLEMENTAL
SUBMISSIONS
SUBTOTAL
Burden
Item
Hours/
Respondent
Respondents/
Year
Hours/
Year
a
1
4
109
436
b
2
1
109
109
545
1
This
iteminvolves
managerial
and
technical
review,
concurrence
and
letter
writing
activities
in
submitting
a
follow­
up/
supplemental
section
8(
e)
notice.
2
This
item
reflects
the
typing,
copying
and
transmittal
of
a
follow­
up/
supplemental
section
8(
e)
notice.

Based
on
the
figures
presented
in
the
preceding
charts,
the
total
respondent
burden
(in
hours/
year)
for
submitting
an
initial
and
follow­
up/
supplemental
section
8(
e)
submission
to
EPA
is
as
follows:

TOTAL
HOURLY
BURDEN/
YEAR
Initial
Follow­
Up/
Supplemental
Total
Submissions
+
Submissions
=
Hours/
Year
5,886
hours/
year
+
545
hours/
year
=
6,431
6(
b)
Estimating
Respondent
Costs
EPA
estimates
that
a
respondent
incurs
costs
of
up
to
$105/
hour
in
labor
costs
in
submitting
information
to
EPA
under
section
8(
e).
(This
hourly
cost
takes
into
account
the
involvement
of
the
respondent's
managerial,
technical
and
clerical
personnel
and
takes
into
account
standard
labor
wage
rates
(including
fringe
benefits)
using
2002
information;
these
wage
rates
are
consistent
with
those
used
in
economic
analyses
performed
for
other
section
8
recordkeeping/
reporting
activities.)
It
should
be
noted
that
section
8(
e)
reporting
does
not
involve
operating/
maintenance
or
capital
costs
to
the
respondent.
The
hourly
labor
wage
rates
used
in
the
computations
are
as
follows:

Hourly
Labor
Rates
Labor
Category
2002
Hourly
Rate
Managerial
$105
Technical
$77
Secretarial
$31
Based
on
the
total
estimated
hourly
reporting
burden
of
6,431
hours/
year,
the
upper­
bound
yearly
cost
for
respondents
in
complying
with
section
8(
e)
is
estimated
by
EPA
to
be
$675,255
as
follows:
12
TOTAL
COST/
YEAR
Respondents
Hours/
Year
x
HourlyRate=
Total
Cost/
Year
6,431
hours/
year
x
$105/
hour
=
$675,255/
year
6(
c)
Estimating
EPA
Burden
and
Costs
Based
on
reasonable
costs
estimated
for
reports
received
by
EPA
as
the
result
of
general
section
8
rule­
making
activities,
EPA
estimates
an
average
cost
of
$85
­
$155
for
the
Agency
to
process,
copy,
file,
and
initially
review
and/
or
answer
questions
with
regard
to
each
section
8(
e)
submission.
Therefore,
EPAestimates
its
total
yearly
cost
for
these
activities
involving
approximately
327
incoming
section
8(
e)
notices
(218
initial
plus
109
follow­
up/
supplemental
notices/
year)
to
range
from
$27,795
­
$50,685
per
year
as
follows:

EPA
BURDEN/
COSTS
Initial/
Follow­
Up/
Supplemental
Cost
of
EPA
Total
Submissions
per
Year
x
Processing/
Review
=
Cost/
Year
327
submissions/
year
x
$85­$
155/
Submission
=
$27,795­$
50,685/
year
6(
d)
Bottom
Line
Burden
Hours
and
Costs
GENERAL
NOTE:
A
full
discussion
and
description
of
the
rationale
used
to
derive
the
following
burden
estimates
can
be
found
in
Sections
6(
a),
6(
b)
and
6(
c)
of
this
Supporting
Statement
and
is
summarized
below.

(i)
Respondents'
Annual
Burden
(Hours
and
Costs)

(a)
Hours
Initial
Section
8(
e)
Notices
27
hours
x
218
respondents
=
5,886
hours
Follow­
up/
Supplemental
Section
8(
e)
Notices
5
hours
x
109
respondents
=
545
hours
13
Respondents'
Total
Annual
Hourly
Burden
5,886
hours
+
545
hours
=
6,431
hours
(b)
COSTS
Respondents'
Total
Annual
Cost
6,431
hours
x
$105/
hour
=
$675,255
(ii)
EPA's
Annual
Burden/
Cost
(Upper­
bound
Estimate)

Initial
Section
8(
e)
Notices
218
notices
x
$155/
notice
=
$33,790
Follow­
up/
Supplemental
Section
8(
e)
Notices
109
notices
x
$155/
notice
=
$16,895
EPA's
Total
Annual
Upper­
bound
Estimated
Burden/
Cost
327
notices
x
$155/
notice
=
$50,685
6(
e)
Reasons
for
Change
in
Burden
The
estimate
in
respondent
reporting
burden
hours
associated
with
this
ICR
totals
6,
431
hours,
as
compared
with
8,209
total
hours
contained
in
the
most
recent
approval
of
the
ICR.
This
decrease
in
burden
hours
results
from
an
overall
decrease
in
section
8(
e)
reporting,
primarily
from
a
reduction
in
the
number
of
follow­
up/
supplemental
section
8(
e)
notices
received.
In
previous
ICR
renewals,
EPA
used
an
historical
average
of
2.
2
follow­
up
notices
per
each
initial
submission.
This
figure
was
based
on
EPA's
experience
and
system
for
reviewing
section
8(
e)
notices
in
place
pre1990
During
that
time
EPA
received
fewer
than
100
initial
notices
per
year
and
was
able
to
perform
a
much
more
detailed
review
of
each
notice
received.
The
consequence
of
that
review
was
that
there
was
much
more
interaction
with
the
submitting
companies
generating
numerous
follow­
up
notices
and
information
submittals.
However,
during
and
since
the
CAP,
because
of
the
increase
in
initial
notices
submitted,
EPA
has
contacted
submitters
for
additional
information
only
on
those
initial
notices
that
are
identified
during
the
preliminary
screening
evaluation
as
needing
additional
information
from
the
submitters.
Consequently,
the
number
of
follow­
up
notices
has
fallen
due
to
the
changed
nature
of
EPA's
review
of
initial
notices.
Over
the
last
three
fiscal
years,
EPA
has
received
341
follow­
up
notices
versus
653
initial
notices,
or
approximately
0.5
follow­
up
notices
per
initial
notice.
14
6(
f)
Burden
Statement
The
annual
public
burden
for
this
collection
of
information,
which
is
approved
under
OMB
Control
No.
2070­
0046,
is
estimated
to
average
27
hours
per
initial
section
8(
e)
submission
and
5
hours
per
follow­
up/
supplemental
section
8(
e)
submission.
According
to
the
Paperwork
Reduction
Act,
"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.
For
this
collection
it
includes
the
time
needed
to
review
instructions;
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;
complete
and
review
the
collection
of
information;
and
transmit
or
otherwise
disclose
the
information.
An
agency
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
cont
rol
number.
The
OMB
control
number
for
this
information
collection
appears
above.
In
addition,
the
OMB
control
numbers
for
EPA's
regulations,
after
initial
display
in
the
final
rule,
are
listed
in
40
CFR
part
9.

Send
comments
on
the
Agency's
need
for
this
information,
the
accuracy
of
the
provided
burden
estimates,
and
any
suggested
methods
for
minimizing
respondent
burden,
including
through
the
use
of
automated
collection
techniques,
to
the
Director,
Collection
Strategies
Division,
U.
S.
Environmental
Protection
Agency
(Mail
Code
2822T),
1200
Pennsylvania
Ave.,
NW.,
Washington,
D.
C.
20460.
Include
the
OMB
control
number
identified
above
in
any
correspondence.
Do
not
submit
the
completed
formor
requested
information
to
this
address.
The
actual
information
or
form
should
be
submitted
in
accordance
with
the
instructions
accompanying
the
form,
or
as
specified
in
the
corresponding
regulations.
ATTACHMENT
Toxic
Substances
Control
Act
Section
8(
e)

15
U.
S.
C.
2607(
e)
Sec.
2607.
Reporting
and
retention
of
information
***

(e)
Notice
to
Administrator
of
substantial
risks
Any
person
who
manufactures,
processes,
or
distributes
in
commerce
a
chemical
substance
or
mixture
and
who
obtains
informationwhichreasonablysupports
the
conclusionthat
such
substance
or
mixture
presents
a
substantial
risk
of
injury
to
health
or
the
environment
shall
immediately
inform
the
Administrator
of
such
information
unless
such
person
has
actual
knowledge
that
the
Administrator
has
been
adequately
informed
of
such
information.