Document ID: EPA-HQ-OPPT-2005-0043-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2005-09-06T04:00Z

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.:
0794.11
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."
(
15
U.
S.
C.
2607(
e))

From
January
1977
through
June
2005,
EPA
received
16,063
initial
section
8(
e)
submissions
covering
a
large
number
of
chemical
substances
and
mixtures
on
a
wide
range
of
chemical
toxicity/
exposure
information.
This
includes
approximately
10,500
submissions
EPA
received
following
a
1992
Compliance
Audit
Program,
described
below
in
Part
2(
a).
Although
EPA's
receipt
of
section
8(
e)
information
does
not
necessarily
trigger
immediate
regulatory
action
under
TSCA
or
other
authorities
administered
by
EPA,
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
to
EPA's
Program
and
Regional
Offices
and
other
Federal
agencies
(
e.
g.,
NIOSH,
OSHA,
CPSC,
FDA,
NTP)
on
newly
discovered
chemical
hazards/
risks.
Since
June
2001,
OPPT
has
made
these
referrals
primarily
via
emails
of
biweekly
tables
summarizing
all
new
section
8(
e)
submissions.
There
is
also
public
outreach
and
information
access
to
section
8(
e)
data
through
the
TSCA
Public
Docket,
online
data
bases
that
include
TSCA
8(
e)
records,
as
well
as
through
the
TSCA
8(
e)
web
page
that
includes
all
biweekly
reports
of
new
8(
e)
submissions
back
to
June
2001
with
pdf
links
to
the
submissions.
­
2­
2
NEED
FOR
AND
USE
OF
THE
COLLECTION
2(
a)
Need/
Authority
for
the
Collection
Section
8(
e)
of
TSCA
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.
The
submission
of
section
8(
e)
information
makes
it
possible
for
the
Agency
and
others
to
learn
quickly
about
potential
new
chemical
hazards/
risks
posed
by
exposure
to
chemical
substances,
to
conduct
more
complete
assessments
and,
if
needed,
effective
action
to
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
Law
94­
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).
In
June
1991,
EPA
published
a
"
Section
8(
e)
Reporting
Guide"
to
further
assist
the
regulated
community
in
complying
with
section
8(
e).
The
1991
Reporting
Guide
references
examples
of
submitted
information
and
EPA's
comments
on
these
submissions
to
help
persons
subject
to
section
8(
e)
better
understand
the
types
of
information
that
are
reportable
under
section
8(
e).
The
1991
Guide
also
includes
dose
ranges
and
exposure
factors
to
consider
in
determining
the
section
8(
e)
reportability
of
acute
lethality
data.

In
February
of
1991,
the
Agency
initiated
a
voluntary
section
8(
e)
"
Compliance
Audit
Program"
(
CAP).
This
compliance
program,
which
followed
several
section
8(
e)
enforcement
cases
indicating
that
some
companies
were
not
complying
with
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.
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
chemical
releases
to
the
environment
and
the
detection
of
toxic
chemicals
in
­
3­
environmental
media.
On
July
13,
1993
(
58
FR
37735),
EPA
published
proposed
guidance
on
the
detection
of
toxic
chemicals
in
environmental
media.
EPA
received
comments
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.

Beginning
in
1996,
there
was
an
ongoing
collaboration
between
EPA
and
industry
to
develop
a
question
and
answer
(
Q&
A)
document
to
promote
industry
understanding
of
and
compliance
with
the
Agency's
anticipated
revised
section
8(
e)
reporting
criteria
for
environmental
release
and
contamination
information.
The
intent
was
to
make
the
Q&
A
publicly
available
before
the
revised
guidance
was
published.
However,
the
finalized
Q&
A
document
was
not
yet
available
when
the
revised
guidance,
"
TSCA
Section
8(
e);
Notification
of
Substantial
Risk;
Policy
Clarification
and
Reporting
Guidance"
(
68
FR
33129­
33139),
was
published
on
June
3,
2003.
The
revised
guidance
included
a
re­
publication
of
the
1978
Policy
Statement
and
incorporated
revisions
that
address
the
reporting
of
information
on
the
release
of
chemical
substances
to
the
environment
and
the
detection
of
toxic
chemicals
in
environmental
media.
Also
included
in
the
June
2003
Reporting
Guidance
is
a
change
in
the
deadline
for
reporting
"
substantial
risk"
information
to
the
Agency
(
from
15
working
days
to
30
calendar
days)
and
the
circumstances
under
which
certain
information
need
not
be
reported
to
EPA
under
section
8(
e)
of
TSCA.
In
a
subsequent
Federal
Register
Notice,
"
TSCA
Section
8(
e)
Reporting
Guidance;
Correction,
Clarification
of
Applicability,
and
Announcement
Regarding
the
Issuance
(
of)
Questions
and
Answers"
(
70
FR
2162­
2164),
EPA
announced
certain
corrections
to
the
June
2003
Reporting
Guidance
(
due
to
transcription
errors
from
the
1978
Policy
Statement
that
appeared
in
the
June
2003
Guidance),
stated
that
the
applicability
date
for
the
June
2003
Guidance
Document
was
the
publication
date,
and
announced
the
availability
on
the
TSCA
8(
e)
web
page
(
http://
www.
epa.
gov/
oppt/
tsca8e/)
of
a
Q&
A
document
on
the
section
8(
e)
reportability
of
releases
of
chemical
substances
to
the
environment
and
the
detection
of
toxic
chemicals
in
environmental
media.
This
Q&
A
document
included
only
a
few
of
the
items
drafted
earlier
by
industry
stakeholders
with
EPA
participation,
but
EPA
will
be
adding
Q&
As
to
the
TSCA
8(
e)
web
page
on
environmental
releases
and
other
aspects
of
section
8(
e)
reporting
following
further
comment
and
review.

2(
b)
Use/
Users
of
the
Data
Since
1977,
the
Agency
and
members
of
the
chemical
industry
have
devoted
significant
efforts
in
fulfilling
their
respective
responsibilities
under
section
8(
e).
Since
January
1,
1977,
16,063
initial
section
8(
e)
notices
(
includes
CAP
and
non­
CAP
submissions)
covering
a
broad
range
of
toxicity
and
exposure­
related
data
on
a
wide
range
of
chemicals
and
chemical
mixtures
have
been
received
by
the
Agency,
screened,
and
received
follow­
up
attention
as
needed.
­
4­
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
consider
other
available
toxicity
data
on
the
chemical
or
exposure­
related
information
on
the
chemical/
mixture
being
reviewed.
The
results
of
screening
level
evaluations
are
used
for
priority
setting
to
select
cases
for
more
detailed
assessment,
as
well
as
to
identify
referrals
to
other
Offices
and
Agencies.

EPA
utilizes
section
8(
e)
submission
information
for
hazard/
risk
identification
purposes
in
the
initial
stages
of
the
TSCA
chemical
screening
and
review
program.
Section
8(
e)
data
are
also
used
in
ongoing
EPA
hazard
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
chemical
advisories
to
communicate
potential
health
risks
and
the
need
for
exposure
controls,
as
well
as
for
chemical
summaries
to
identify
data
availability
for
chemical
hazard
and
exposure
assessment.

Regardless
of
the
type
of
section
8(
e)
follow­
up
action
or
activity
taken,
all
reported
information
not
claimed
as
TSCA
confidential
business
information
is
made
available
to
other
EPA
Program
and
Regional
Offices,
other
Federal
Agencies
and
others
(
e.
g.,
chemical
industry,
trade
unions,
environmental
groups,
general
public,
international
community)
who
may
be
interested
in
the
subject
chemical
or
mixture.
EPA
Offices
and
other
Federal
Agencies
routinely
utilize
section
8(
e)
data
in
implementing
their
regulatory
programs.
The
principal
vehicles
for
making
the
information
publicly
available
are
the
TSCATS
database,
the
TSCA
Docket,
and
the
TSCA
section
8(
e)
web
page
at
http://
www.
epa.
gov/
opptintr/
tsca8e/.
The
TSCA
8(
e)
web
page
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
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.
­
5­
3
NON­
DUPLICATION,
CONSULTATIONS
AND
OTHER
COLLECTION
CRITERIA
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
authority
administered
or
delegated
to
the
States
by
EPA.
In
the
June
3,
2003
Reporting
Guidance,
the
Agency
clarified
the
circumstances
under
which
certain
information
need
not
be
reported
to
EPA
under
section
8(
e)
of
TSCA.
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
EPA
personnel
have
participated
in
numerous
public
meetings
and
other
fora
to
discuss
the
section
8(
e)
Policy
Statement
and
the
Agency's
implementation
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.
EPA
staff
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.
In
addition,
EPA
staff
have
participated
in
more
than
30
industry­
sponsored
meetings
at
which
section
8(
e)
of
TSCA
was
the
major
or
primary
topic
of
discussion.

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.
The
Agency
received
numerous
public
comments
on
these
proposed
amendments
and
developed
a
"
Comment
and
Response
Document
for
Revised
Policy
Statement
of
Section
8(
e)
of
TSCA"
(
OPPT­
2002­
0067­
0002)
to
record
these
comments
and
the
Agency's
responses
(
see
Attachment
3).
EPA
has
also
collaborated
with
industry
in
preparing
a
question
and
answer
document
dealing
with
revisions
to
the
1978
Policy
Statement
and
from
1994
to
the
present
section
8(
e)
has
been
on
the
agenda
of
the
"
Living
With
TSCA"
conferences
held
annually
for
all
TSCA
stakeholders.
­
6­
3(
d)
Effects
of
Less
Frequent
Collection
TSCA
section
8(
e)
reporting
is
not
cyclical,
but
rather
is
self­
implementing.
The
statute
states
that
persons
covered
under
the
section
8(
e)
reporting
requirement
shall
immediately
notify
the
EPA
Administrator
upon
obtaining
reportable
information.
As
stated
previously,
section
8(
e)
continues
to
be
an
extremely
important
and
useful
EPA
tool
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
to
health
or
environmental
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
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
information
contained
in
the
submission.
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,
the
submission
is
placed
in
the
TSCA
Docket
and
is
available
to
the
public
without
further
notice
to
the
submitting
organization.
The
Agency
has
established
and
actively
implements
well­
publicized
standard
procedures
for
the
handling
and
safeguarding
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.
­
7­
4
RESPONDENTS
AND
THE
INFORMATION
REQUESTED
4(
a)
Respondents/
NAICS
Codes
A
statutory
section
8(
e)
reporting
obligation
can
be
incurred
by
any
person
who
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
any
other
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.

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
continuing
its
efforts
to
implement
optional
electronic
reporting
of
section
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
new
information
that
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.
It
should
be
noted
again
that
section
8(
e)
applies
to
all
chemical
manufacturers,
­
8­
importers,
processors,
and
distributors
and
applies
also
to
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
that
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
June
2003
Reporting
Guidance
defines
the
term
"
immediately"
in
the
context
of
written
section
8(
e)
reports
to
mean
within
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
or
to
the
National
Response
Center
as
soon
as
a
person
knows
about
the
incident.

5
INFORMATION
COLLECTION
­
EPA
ACTIVITIES,
COLLECTION
METHODOLOGY
AND
INFORMATION
MANAGEMENT
5(
a)
Agency
Activities
As
explained
in
additional
detail
in
the
following
sections,
the
Agency's
section
8(
e)
activities
involve
answering
general
and
specific
section
8(
e)­
related
questions,
development
and
maintenance
of
computerized
information
tracking
(
including
data
extraction,
entry
and
quality
assurance/
control),
microfilming,
confidential
(
restricted­
access)
and
non­
confidential
(
publicaccess
section
8(
e)
information
filing,
initial
evaluation
of
all
submitted
section
8(
e)
information
(
including
review
of
TSCA
Confidential
Business
Information
(
CBI)
substantiations),
and
the
posting
of
section
8(
e)­
related
information
on
the
Internet
for
public
access.

5(
b)
Collection
Methodology
and
Information
Management
EPA
uses
Document
Control
Numbers
(
DCNs)
to
identify
TSCA
submissions;
section
8(
e)
has
the
following
format:
88­
YYXXXXXXX.
The
assigned
7­
digit
ascending
numbers
begin
each
year
with
0000001.
EPA
also
identifies
section
8(
e)
submissions
by
8EHQ
Numbers,
which
are
chronological
from
January
1977.
The
format
is
8EHQ­
MMYY­
XXXXX.
Initial
submissions
are
assigned
as
Sequence
A;
supplemental
an
follow­
up
submissions
are
assigned
Sequence
B,
C,
D,
etc.
Internal
EPA
tracking
of
section
8(
e)
submission
information
is
handled
via
non­
confidential
and
confidential
computerized
data
bases.

In
order
to
assure
that
the
public
is
kept
apprised
of
new
adverse
chemical­
related
toxicity
and
exposure
information,
the
Agency
provides
public
access
to
and
actively
disseminates
nonconfidential
section
8(
e)
submission
information
in
many
ways.
Eexamples
of
EPA's
public
access/
outreach
activities
follow.
­
9­
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
EPA
Headquarters.
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)
submissions
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
TSCA.
The
most
recent
version
of
the
TSCATS
data
base
is
available
on
the
web
at
http://
yosemite.
epa.
gov/
oppts/
epatscat8.
nsf/
ReportSearch?
OpenForm.
The
submitted
studies
themselves
are
stored/
available
on
microfiche.
Microfiche
copies
of
the
studies
referenced
in
the
TSCATS
database
are
available
from
either
CIS
or
the
National
Technical
Information
Service
(
NTIS)
in
Springfield,
VA.
EPA
has
also
been
creating
full
electronic
(
PDF)
copies
of
all
new
section
8(
e)
submissions
since
June
2001.
Electronic
copies
of
these
most
recent
section
8(
e)
submissions
are
available
to
the
public
from
the
TSCA
Public
Docket,
as
well
as
from
the
section
8(
e)
web
site
at
http://
www.
epa.
gov/
oppt/
tsca8e.

Under
established
Freedom
of
Information
Act
(
FOIA)
procedures,
EPA
responds
to
requests
from
industry,
other
stakeholders
and
the
public.
And
in
cooperation
with
the
Organization
for
Economic
Cooperation
and
Development's
(
OECD)
information­
gathering
"
Switchboard"
project,
EPA
responds
as
well
to
international
requests
for
section
8(
e)
and
other
unpublished
health
and
safety
data
on
chemicals
of
concern
to
OECD
members.

As
stated
previously,
EPA
routinely
notifies
other
Federal
Agencies
on
incoming
section
8(
e)
information
via
biweekly
tabular
reports
of
new
section
8(
e)
submissions
and
by
targeted
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
Bank
(
HSDB)
and
Toxline
data
bases.
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)
data
base.

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,
nearly
all
reporting
is
by
large
and
medium
size
companies.
This
is
mainly
because
only
larger
companies
have
the
financial
resources
to
conduct
toxicity
testing
that
comprises
most
section
8(
e)
reporting.
Since
there
is
no
routine
reporting
nor
recordkeeping
provisions
for
section
8(
e),
­
10­
the
true
burden
on
most
small
entities
is
practically
nonexistent.

5(
d)
Collection
Schedule
Considering
that
section
8(
e)
submissions
are
received
by
the
Agency
on
an
ad
hoc
basis,
there
is
no
standard
reporting
cycle.
Submitters
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
were
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
2002
ICR
renewal,
EPA
utilized
data
on
the
number
of
section
8(
e)
submissions
for
fiscal
years
FY
2000­
2002,
including
projected
numbers
for
the
remainder
of
FY
02.
The
averaged
annual
number
of
initial
8(
e)
submissions
was
218
(
227+
224+
202=
653/
3)
and
a
multiplier
of
0.50
to
estimate
the
number
of
supplemental
submissions
during
the
same
period
(
218
x
.5
=
109).

The
2005
ICR
renewal
uses
a
similar
approach,
except
that
data
for
the
three
most
recent
complete
fiscal
years
(
FY
2002­
2004)
are
averaged
and
the
number
of
supplemental/
follow­
up
submissions
was
counted
rather
than
estimated.
The
average
annual
number
of
initial
section
8(
e)
submissions
for
FY
2002­
2004
was
230
(
190+
221+
278
=
689/
3);
the
average
annual
number
of
supplemental
and
follow­
up
8(
e)
submissions
for
FY
2002­
2004
was
108
(
324/
3).

6(
a)
Estimating
Submitter
Burden
The
following
discussion
provides
the
basis
for
the
Agency's
upper­
bound
estimate
of
approximately
6,750
total
hours
of
annual
reporting
burden
for
submitters
in
complying
with
section
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
calculated
average
of
230
initial
section
8(
e)
submissions
per
year,
the
total
number
of
hours
required
for
initial
section
8(
e)
reporting
is
estimated
to
be
6,210
(
230
x
27)
hours.
The
submission
of
follow­
up/
supplemental
information
by
a
large
company
in
response
to
EPA
questions
on
the
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.
Using
the
calculated
average
of
108
follow­
up/
supplemental
submissions
per
year,
the
total
number
of
hours
required
for
follow­
up/
supplemental
section
8(
e)
reporting
is
­
11­
estimated
to
be
540
(
108
x
5)
hours.
Therefore,
the
total
number
of
section
8(
e)
notices
(
initial
plus
follow­
up/
supplemental
submissions)
is
338
submissions
per
year
with
an
estimated
hourly
respondent
reporting
burden
of
6,750
(
6,210
+
540)
hours
per
year.

INITIAL
SUBMISSIONS
SUBTOTAL
Burden
Item
Hours/
Submitter
Submissions/
Year
Hours/
Year
a1
25
230
5,750
b2
2
230
460
6,210
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)
submission).

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
less
burdensome
as
follows:

FOLLOW­
UP
AND
SUPPLEMENTAL
SUBMISSIONS
SUBTOTAL
Burden
Item
Hours/
Submitter
Submissions/
Year
Hours/
Year
a1
4
108
432
b2
1
108
108
540
1
This
item
involves
managerial
and
technical
review,
concurrence
and
letter
writing
activities
in
submitting
a
follow­
up/
supplemental
section
8(
e)
submission.
2
This
item
reflects
the
typing,
copying
and
transmittal
of
a
follow­
up/
supplemental
section
8(
e)
submission.

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

TOTAL
HOURLY
BURDEN/
YEAR
Initial
Follow­
Up/
Supplemental
Total
Submissions
+
Submissions
=
Hours/
Year
6,210
hours/
year
+
540
hours/
year
=
6,750
­
12­
6(
b)
Estimating
Submitter
Costs
EPA
estimates
that
a
respondent
incurs
costs
up
to
$
54/
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
2004
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
$
54
Technical
$
46
Secretarial
$
25
*
EPA.
2002.
Wage
Rates
for
Economic
Analyses
of
the
Toxics
Release
Inventory
Program.
U.
S.
Environmental
Protection
Agency.
June
10,
2002.

Based
on
the
total
estimated
reporting
burden
of
6,750
hours/
year,
the
upper­
bound
yearly
cost
for
submitters
in
complying
with
section
8(
e)
is
estimated
by
EPA
to
be
$
364,500
as
follows:

TOTAL
COST/
YEAR
Submitter
Hours/
Year
x
Hourly
Rate
=
Total
Cost/
Year
6,750
hours/
year
x
$
54/
hour
=
$
364,500/
year
6(
c)
Estimating
EPA
Burden
and
Costs
Based
on
reasonable
costs
for
reports
received
by
EPA
as
the
result
of
general
section
8
rule­
making
activities,
EPA
estimates
the
cost
per
submission
can
range
from
$
200
to
$
800
for
the
Agency
to
process,
copy,
file,
and
initially
review
and/
or
answer
questions
on
each
section
8(
e)
submission.
Therefore,
EPA
estimates
its
total
annual
cost
for
these
activities
involving
338
incoming
section
8(
e)
submisions
(
230
initial
plus
108
follow­
up/
supplemental
notices/
year)
to
range
from
$
67,600­$
270,400
per
year
as
follows:
­
13­
EPA
BURDEN/
COSTS
Initial/
Follow­
Up/
Supplemental
Cost
of
EPA
Total
Submissions
per
Year
x
Processing/
Review
=
Cost/
Year
338
submissions/
year
x
$
200­$
800/
Submission
=
$
67,600
­
$
270,400/
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)
Submitters'
Annual
Burden
(
Hours
and
Costs)

(
a)
Hours
Initial
Section
8(
e)
Submissions
27
hours
x
230
submissions
=
6,210
hours
Follow­
up/
Supplemental
Section
8(
e)
Submissions
5
hours
x
108
submissions
=
540
hours
Submitters'
Total
Annual
Hourly
Burden
6,210
hours
+
540
hours
=
6,750
hours
(
b)
COSTS
Submitters'
Total
Annual
Upper­
Bound
Cost
6,750
hours
x
$
54/
hour
=
$
364,500
(
ii)
EPA's
Annual
Burden/
Cost
(
Upper­
bound
Estimate)

Initial
Section
8(
e)
Submissions
230
submissions
x
$
800/
submission
=
$
184,000
­
14­
Follow­
up/
Supplemental
Section
8(
e)
Submissions
108
submissions
x
$
800/
submission
=
$
86,400
EPA's
Total
Annual
Upper­
bound
Estimated
Burden/
Cost
338
submissions
x
$
800/
submission
=
$
270,400
6(
e)
Reasons
for
Change
in
Burden
There
is
an
increase
of
319
hours
(
from
6,431
hours
to
6,750
hours)
in
the
total
estimated
respondent
burden
compared
with
that
identified
in
the
information
collection
request
most
recently
approved
by
OMB.
This
increase
in
burden
hours
can
be
accounted
for
by
the
small
increase
in
TSCA
8(
e)
reporting
compared
to
the
previous
period.
EPA
receives
relatively
few
supplemental
submissions
following
the
initial
section
8(
e)
submission;
typically
the
Agency
only
contacts
submitters
for
follow­
up
information
when
the
initial
submission
is
incomplete
or
more
information
is
otherwise
needed
to
complete
a
screening
level
evaluation.
During
FY
2002­
2004,
EPA
received
324
supplements
or
follow­
up
submissions
versus
689
initial
notices,
which
is
slightly
less
than
50%
supplemental/
follow­
up
submissions
per
initial
submission.
This
increase
in
burden
hours
is
an
adjustment.

The
estimate
in
submitter
annual
costs
associated
with
this
ICR
is
lower
than
the
previous
section
8(
e)
ICR
because
of
a
change
in
methodology.
The
previous
rates
were
based
on
an
earlier
Toxics
Release
Inventory
analysis
that
made
overly
conservative
assumptions
regarding
skill
levels,
which
were
subsequently
observed
to
be
in
the
90+
percentile
for
industry
using
data
from
the
Bureau
of
Labor
Statistics
(
BLS).
The
current
estimate
is
based
on
a
simpler
BLS
data
series.
2003
is
the
most
recent
year
for
which
wage
rates
were
available
not
subject
to
revision
by
BLS.

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;
disclose
and
provide
information;
adjust
existing
procedures
to
comply
with
any
previously
applicable
instructions
and
requirements;
train
personnel
to
respond
to
a
collection
of
information;
complete
and
review
the
information
collection;
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
control
number.
The
OMB
control
number
for
this
information
­
15­
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.

To
comment
on
the
Agency's
need
for
this
information,
the
accuracy
of
the
provided
burden
estimates,
and
any
suggested
methods
for
minimizing
respondent
burden,
including
the
use
of
automated
collection
techniques,
EPA
has
established
a
public
docket
for
this
ICR
under
Docket
ID
No.
OPPT­
2005­
0043,
which
is
available
for
public
viewing
at
the
Pollution
Prevention
and
Toxics
Docket
in
the
EPA
Docket
Center
(
EPA/
DC),
EPA
West,
Room
B102,
1301
Constitution
Ave.,
NW,
Washington,
DC.
The
EPA
Docket
Center
Public
Reading
Room
is
open
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Reading
Room
is
(
202)
566­
1544
and
the
telephone
number
for
the
Pollution
Prevention
and
Toxics
Docket
is
(
202)
566­
0280.
An
electronic
version
of
the
public
docket
is
available
through
EPA
Dockets
(
EDOCKET)
at
http://
www.
epa.
gov/
edocket.
Use
EDOCKET
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Once
in
the
system,
select
"
search,"
then
key
in
the
docket
ID
number
identified
above.
Also,
you
can
send
comments
to
the
Office
of
Information
and
Regulatory
Affairs,
Office
of
Management
and
Budget,
725
17th
Street,
NW,
Washington,
DC
20503,
Attention:
Desk
Office
for
EPA.
Please
include
the
EPA
Docket
ID
No.
OPPT­
2005­
0043
and
OMB
control
number
2070­
0046
in
any
correspondence.
ATTACHMENT
1
Toxic
Substances
Control
Action
Section
8(
e)

15
U.
S.
C.
2607(
e)
From
the
U.
S.
Code
Online
via
GPO
Access
[
wais.
access.
gpo.
gov]
[
Laws
in
effect
as
of
January
7,
2003]

TITLE
15­­
COMMERCE
AND
TRADE
CHAPTER
53­­
TOXIC
SUBSTANCES
CONTROL
SUBCHAPTER
I­­
CONTROL
OF
TOXIC
SUBSTANCES
Sec.
2607.
Reporting
and
retention
of
information
*
*
*

(
e)
Notice
to
Administrator
of
substantial
risks
Any
person
who
manufactures,
processes,
or
distributes
in
commerce
as
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
Administrator
of
such
information
unless
such
person
has
actual
knowledge
that
the
Administrator
has
been
adequately
informed
of
such
information.