December
17,
2003
Supporting
Statement
for
a
Request
for
OMB
Review
under
the
Paperwork
Reduction
Act
1.
IDENTIFICATION
OF
THE
INFORMATION
COLLECTION
1(
a)
Title
of
the
Information
Collection
TITLE:
Voluntary
Cover
Sheet
for
TSCA
Submissions
EPA
ICR
No.:
1780.03;
OMB
Control
No.:
2070­
0156
1(
b)
Short
Characterization
This
Information
Collection
Request
(
ICR)
pertains
to
the
voluntary
use
of
a
cover
sheet
that
has
been
developed
by
industry
and
EPA
to
facilitate
the
processing
of
information
that
is
submitted
to
the
Agency
under
sections
4
and
8
of
the
Toxic
Substances
Control
Act
(
TSCA).
The
cost
and
burdens
for
those
related
submissions
under
TSCA
sections
4
and
8
have
already
been
approved
by
the
Office
of
Management
and
Budget
(
OMB)
and
are
contained
in
the
following
ICRs:

(
1)
The
ICR
for
TSCA
section
4
submissions
are
found
in
"
Section
4
Test
Rules
and
Consent
Orders,"
OMB
Control
No.
2070­
0033,
EPA
ICR
No.
1139.
(
2)
The
ICR
for
TSCA
section
8(
d)
submissions
are
found
in
"
TSCA
Section
8(
d)
Health
and
Safety
Data
Reporting
Rule,"
OMB
Control
No.
2070­
0004,
EPA
ICR
No.
0575.
(
3)
The
ICR
for
TSCA
section
8(
e)
reporting
requirements
are
found
in
"
Notification
of
Substantial
Risk
of
Injury
to
Health
and
the
Environment
under
TSCA
Section
8(
e),"
OMB
Control
No.
2070­
0046,
EPA
ICR
No.
0794.

This
ICR,
therefore,
only
applies
to
the
burden
and
costs
associated
with
the
use
of
the
voluntary
cover
sheet
for
those
submissions.

Under
TSCA
sections
4
and
8,
industry
is
required
to
submit
certain
information
and
studies
for
existing
chemical
substances.
Under
normal
TSCA
reporting
conditions,
EPA
receives
approximately
1,700
submissions
each
year;
with
each
submission
consisting
of
three
studies,
on
average.
In
addition,
specific
data
(
study)
call­
ins
may
also
be
imposed
on
industry.

The
submissions
that
EPA
receives
can
be
numerous,
lengthy
and
complex.
For
example,
EPA
received
10,000
submissions
in
FY
1992
in
response
to
the
TSCA
Section
8(
e)
Compliance
Audit
Program.
Processing
of
these
submissions
was
completed
in
FY
1995.
In
June
1994,
OPPT
received
900
submissions,
representing
approximately
3,500
studies,
under
a
TSCA
section
8(
d)
data
call­
in
for
siloxanes
in
support
of
the
TSCA­
mandated
Interagency
Testing
Committee
(
ITC).
­
2
­
Submissions/
studies
are
received,
logged,
internally
tracked,
duplicated,
distributed
to
government
scientists
for
review
and
analysis,
indexed,
microfiched
and
made
publicly
available
through
the
TSCA
Test
Submissions
(
TSCATS)
database.
However,
TSCATS
is
only
an
online
index
of,
and
pointer
system
to,
the
large
volume
of
unpublished
studies;
the
full
texts
are
available
only
in
paper
or
on
microfiche.

Under
the
auspices
and
funding
of
the
Silicone
Environmental
Health
and
Safety
Council
(
SEHSC),
industry,
EPA,
and
the
ITC
developed
a
model
software
application
for
submitting
summary
data
for
the
section
8(
d)
siloxane
data
call­
in.
This
model
was
designed
around
the
TSCATS
data
structure
but
expanded
to
include
additional
data
elements
deemed
valuable
by
industry.
The
objective
was
to
capture
comprehensively
all
submissions
and
studies
from
the
ten
SEHSC
member
companies
for
EPA's
more
efficient
and
effective
receipt,
tracking,
processing,
identification,
internal
and
external
search
and
retrieval,
and
upload
to
TSCATS
for
public
availability.
In
addition,
discussions
were
initiated
and
are
ongoing
for
the
electronic
transfer
by
electronic
medium
or
EDI
of
full
submissions.

OPPT
initiated
a
voluntary
pilot
program
to
accept
certain
Health
and
Safety
Data
submissions
in
an
electronic
format.
Participating
companies
submit
TSCA
Health
and
Safety
Study
Cover
Sheet(
s)
with
attached
electronic
copies
of
the
studies
over
the
Internet.
The
studies
are
submitted
in
Portable
Document
Format
(
PDF)
and
digitally
signed
using
the
Public
Key
Infrastructure
(
PKI)
standard.
Allowing
industry
to
submit
TSCA
Health
and
Safety
Studies
over
the
Web
will
reduce
burden
on
Industry
as
well
as
the
Agency
by
incorporating
standardization
and
indexing
of
data,
on­
line
help
and
automatic
processing.
This
will
also
assist
EPA
in
meeting
goals
established
in
the
Paperwork
Reduction
Act
(
PRA)
and
the
Government
Paperwork
Elimination
Act
(
GPEA).

As
a
follow­
up
to
the
experience
with
the
TSCA
section
8(
d)
siloxane
data
callin
the
Chemical
Manufacturers
Association
(
CMA),
the
Specialty
Organics
Chemical
Manufacturers
Association
(
SOCMA),
and
the
Chemical
Industry
Data
Exchange
(
CIDX),
are
actively
and
cooperatively
pursuing
summary
data
transfer
by
software
application
and
EDI.
(
The
Chemical
Manufacturers
Association
is
now
known
as
the
American
Chemical
Council
[
ACC]
and
will
be
so
referenced
hereafter
in
this
document.)
In
particular,
ACC
lead
the
effort
to
develop
the
standardized
cover
sheet
for
voluntary
use
by
industry
as
a
first
step
to
an
electronic
future
and
to
begin
familiarizing
companies
with
standard
requirements
and
concepts
of
electronic
commerce.
This
form,
entitled
"
TSCA
Health
and
Safety
Study
Cover
Sheet,"
is
designed
by
ACC
for
voluntary
use
as
a
cover
sheet
for
submissions
of
information
under
TSCA
sections
4,
8(
d)
and
8(
e).

The
voluntary
use
of
a
cover
sheet
facilitates
the
submission
of
information
by
displaying
certain
basic
data
elements,
permitting
EPA
more
easily
to
identify,
log,
track,
distribute,
review
and
index
submissions,
and
makes
information
publicly
­
3
­
available
more
rapidly
and
at
reduced
cost
via
TSCATS,
to
the
mutual
benefit
of
both
industry
and
EPA.
It
is
this
form/
cover
sheet
that
is
addressed
in
this
information
collection
request.

2.
NEED
FOR
AND
USE
OF
THE
COLLECTION
2(
a)
Need/
Authority
for
the
Collection
The
standardized
cover
sheet
discussed
in
this
ICR
is
used
in
conjunction
with
submissions
of
information
as
required
under
TSCA
sections
4,
8(
d)
and
8(
e).
The
need
and
authority
for
these
reporting
requirements
are
discussed
in
detail
in
the
information
collection
requests
associated
with
these
requirements
and
are
not
themselves
relevant
to
the
discussion
of
the
use
of
the
standardized
cover
sheet
form
that
follows.

ACC
and
member
companies
actively
utilize
electronic
commerce
in
their
daily
business
operations.
They
recognize
the
future
importance
of
electronic
commerce
for
all
their
operations.
This
TSCA
Cover
Sheet
is
a
first
step
in
standardizing
data
and
terms
to
promote
the
acceptance
and
implementation
of
electronic
TSCA
submissions
to
and
communications
with
the
Agency.
ACC
has
determined
that
this
TSCA
Cover
Sheet,
as
a
paper
and
near
term
electronic
version,
will
achieve
efficiencies
through
industry­
industry
and
industry­
EPA
cooperation,
will
engender
more
efficient
systems,
and
will
result
in
significant
money
and
time
savings.

2(
b)
Use/
Users
of
the
Data
EPA
staff
in
the
Office
of
Pollution
Prevention
and
Toxics
(
OPPT)
are
the
primary
users
of
the
data
found
on
the
standardized
cover
sheet.
OPPT
employees
use
the
information
displayed
on
the
cover
sheet
to
identify
the
submission
when
it
reaches
EPA
without
having
to
examine
portions
of
a
submission
that
may
be
very
lengthy
and
complex.
OPPT
staff
subsequently
use
information
from
the
cover
sheet
to
distribute,
locate
and
track
the
submission
as
the
submission
moves
through
Agency
reviews
and
decision
points,
to
index
the
data,
and
to
identify
the
data
within
the
TSCATS
database
in
making
the
data
publicly
available.

OPPT
and
ACC
expect
that
the
use
of
the
TSCA
Cover
Sheet
by
industry
will
provide
EPA
the
following
benefits:
expedited
processing;
reduced
errors;
improved
data
quality;
more
timely
EPA
access
and
scientific
review;
improved
communication
between
EPA
and
industry
submitters;
quicker
public
availability;
and
overall
time
and
money
savings.

In
addition,
ACC
and
OPPT
expect
that
the
use
of
the
TSCA
Cover
Sheet
by
industry
will
provide
industry
the
following
benefits:
improved
internal
company
storage;
more
efficient
preparation
and
submission;
standardized
keywords;
improved
data
quality;
quicker
decisions;
improved
understanding
of
EPA's
needs;
quicker
access
through
TSCATS
to
relevant
studies
by
industry
toxicologists;
and
significant
potential
­
4
­
cost
savings
from
non­
initiation/
non­
duplication
of
studies
through
rapid
TSCATS
availability.
­
5
­
3.
NON­
DUPLICATION,
CONSULTATIONS
AND
OTHER
COLLECTION
CRITERIA
3(
a)
Non­
Duplication
The
use
of
the
Voluntary
TSCA
Cover
Sheet
is
not
a
separate
collection
activity,
it
simply
offers
a
cover
form
that
may
be
used
in
conjunction
with
other
submissions.
These
submissions
still
occur
only
once.
As
such,
there
is
no
duplicative
collection.

3(
b)
Public
Notice
Required
Prior
to
ICR
Submission
to
OMB
In
proposing
to
renew
this
ICR,
EPA
provided
a
60­
day
public
notice
and
comment
period
that
ended
on
June
17,
2003
(
68
FR
19203,
April
18,
2003).
EPA
received
no
comments
during
the
comment
period.

3(
c)
Consultations
This
effort
developed
from
the
cooperative
effort
among
the
Silicone
Environmental
Health
and
Safety
Council
(
SEHSC),
the
Interagency
Testing
Committee
(
ITC),
and
EPA
for
the
SEHSC­
developed
data
base
effort
in
response
to
the
30th
ITC
list/
TSCA
section
8(
d)
reporting.
Out
of
this
effort,
ACC
and
SOCMA
initiated
subsequent
discussions
with
EPA
for
their
design
and
pilot
of
the
Voluntary
TSCA
Cover
Sheet.
ACC
and
SOCMA
are
committed
to
encouraging
member
companies
to
use
the
cover
sheet
when
submitting
TSCA
studies
under
sections
4,
8(
d)
and
8(
e)
to
EPA.

ACC,
in
consultation
and
in
cooperation
with
EPA,
is
pursuing
development
of
an
electronic
version
of
this
cover
sheet
for
availability
through
the
Internet.
This
electronic
form
could
be
interactively
completed
and
immediately
transmitted
for
even
more
efficient,
timely
and
complete
data.
EPA
intends
actively
to
continue
this
effort
in
cooperation
with
ACC
and
any
other
interested
parties.

In
addition,
in
preparing
this
renewal,
EPA
initiated
formal
consultations
with
seven
respondents
(
both
individual
companies
as
well
as
industry
associations)
to
this
information
collection.
However,
only
one
such
respondent
provided
EPA
with
comments
on
the
proposed
renewal.

The
one
respondent
was
Mr.
Mike
Thelen,
Dow
Corning
Corporation,
Midland,
MI
48686,
telephone:
989­
496­
4168,
fax:
989­
496­
5595.
Mr.
Thelen's
comments
(
dated
May
14,
2003)
were
generally
supportive
of
the
Voluntary
TSCA
Cover
Sheet
in
its
current
format.
EPA
made
no
changes
to
the
ICR
offered
for
public
review
based
on
Mr.
Thelen's
comments.
Mr.
Thelen's
comments
appear
in
Attachment
2
to
this
ICR.

3(
d)
Effects
of
Less
Frequent
Collection
Since
the
use
of
this
cover
sheet
is
strictly
voluntary
on
the
part
of
respondents,
­
6
­
this
is
not
applicable.

3(
e)
General
Guidelines
To
the
best
of
EPA's
knowledge,
the
use
of
this
cover
sheet
does
not
exceed
any
of
the
PRA
guidelines
at
5
CFR
1320.6.
Since
the
use
of
this
cover
sheet
is
entirely
voluntary,
and
the
information
collected
on
it
is
expected
to
remain
unchanged
in
the
future,
EPA
would
like
to
omit
the
inclusion
of
a
specific
expiration
date
on
the
final
form.
Under
the
PRA,
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
in
40
CFR,
after
initial
display
in
the
final
rule,
are
listed
in
40
CFR
part
9.
For
forms,
in
addition
to
the
required
inclusion
of
the
OMB
control
number
for
the
ICR
containing
the
form,
EPA
has
traditionally
included
the
expiration
date
of
the
ICR
on
the
form.
Since
the
ICR
must
be
renewed
every
three
years,
inclusion
of
an
expiration
date
on
the
form
would
require
EPA
to
also
amend
the
form
every
three
years.
Revising
the
form
every
three
years
creates
unnecessary
burdens
for
both
EPA
and
those
who
wish
to
use
the
form.
In
addition,
EPA
intends
for
this
voluntary
cover
sheet
to
serve
as
the
data
entry
form
for
the
electronic
online
submission
system,
TSCATS.

3(
f)
Confidentiality
Any
information
included
on
the
cover
sheet
may
be
claimed
as
confidential
by
the
respondent.
Claims
of
confidentiality
are
handled
according
to
EPA
procedures
described
in
40
CFR
Part
2
and
in
the
TSCA
Confidential
Business
Information
Security
Manual,
which
call
for
careful
protection
of
confidential,
trade
secret
or
proprietary
information.

3(
g)
Sensitive
Questions
This
information
collection
does
not
include
questions
of
a
sensitive
nature.

4.
THE
RESPONDENTS
AND
THE
INFORMATION
REQUESTED
4(
a)
Respondents
and
NAICS
Codes
Respondents
affected
by
this
activity
are
found
mainly
under
NAICS
codes
324
­
Petroleum
and
Coal
Products
Manufacturing,
and
325
­
Chemical
Manufacturing.

4(
b)
Information
Requested
(
i)
Data
Items
The
Voluntary
Cover
Sheet
simply
captures
certain
information
that
is
being
submitted
under
another
approved
ICR.
The
data
items
included
on
the
Cover
Sheet
are
already
contained
in
the
attached
submission,
and
include
the
following:
­
7
­
­
8
­
Data
Element
Description
1.
Submission
Type
Identifies
the
submission,
including
the
type
of
submission
and
whether
it
is
the
initial
submission,
a
follow­
up
or
a
final
report.

2.
Summary
of
Attachment
Allows
the
respondent
to
provide
a
summary
or
abstract
of
the
attached
study
or
report,
any
internal
company
tracking
number,
an
EPA
tracking
number,
and
an
indication
of
the
number
of
studies
submitted.

3.
Chemical
Identification
Identifies
the
chemical(
s)
addressed
in
the
submission.

4.
Title
of
Attachment
Identifies
the
title
of
the
attached
study
or
report.

5.
Indexing
Terms
Allows
the
respondent
to
identify
the
proper
terms
to
use
for
indexing
purposes,
which
facilitates
the
search
and
retrieval
of
the
information.

6.
Study/
Report
Information
Provides
specific
information
regarding
the
attached
study
or
report,
including
the
source,
date
of
the
study
or
report,
sponsor(
s),
and
the
length
of
the
document.

7.
Submitter
Information
Identifies
the
submitter
and/
or
technical
contact,
including
name,
title,
company,
mailing
address,
phone
and
e­
mail
address.

8.
Comments
This
section
on
the
form
allows
the
submitter
to
provide
any
additional
comments,
so
as
to
avoid
the
need
for
or
use
of
a
separate
cover
letter.

9.
Signature
A
signature
is
required
for
submissions
under
section
8(
e);
the
cover
form
provides
a
place
for
the
submitter's
signature,
thereby
avoiding
the
need
for
or
use
of
a
separate
cover
letter.

10.
Continuation
Allows
the
submitter
to
expand
the
response
to
any
of
the
previous
items,
if
needed,
without
the
need
to
use
a
separate
cover
letter
or
additional
forms.

A
copy
of
the
sample
Voluntary
Cover
Sheet
for
TSCA
Submissions
is
attached
to
this
ICR,
along
with
the
instructions
provided
to
users.
ACC
designed
the
form
to
capture
all
data
and
information
required
under
"
Notification
of
Substantial
Risk
of
Injury
to
Health
and
the
Environment
under
TSCA
Section
8(
e),"
and
determined
there
was
significant
value
for
standardized
data
presentation
under
TSCA
sections
4,
8(
d)
and
8(
e).
Additionally,
TSCATS
index
codes
to
identify
study
type,
subject
organism
(
if
appropriate),
and
route
of
exposure
(
if
appropriate)
are
included.
­
9
­
(
ii)
Respondent
Activities
After
making
the
determination
to
submit
information
to
EPA
under
TSCA
sections
4
or
8,
or
to
otherwise
submit
TSCA­
related
chemical
information
to
EPA,
the
submission
of
which
is
covered
under
separate
ICRs,
the
respondent
will
decide
whether
or
not
to
use
the
TSCA
Cover
Sheet
for
that
submission.
The
use
of
the
TSCA
Cover
Sheet
for
submissions
under
TSCA
is
completely
voluntary.
However,
ACC
and
SOCMA
explicitly
solicit
and
encourage
their
members
to
use
it
for
all
such
submissions.

Once
the
respondent
has
decided
to
use
the
Voluntary
TSCA
Cover
Sheet,
the
respondent
simply
completes
the
form
by
transferring
or
summarizing
the
information
that
the
respondent
has
already
assembled
as
part
of
its
submission.
In
many
cases
the
use
of
this
cover
sheet
takes
the
place
of
a
cover
or
transmittal
letter
to
EPA
that
the
respondent
might
otherwise
routinely
prepare,
containing
much
of
the
same
information
as
is
found
on
the
cover
sheet.
Respondents
are
not
obliged
to
prepare
or
develop
additional
data
or
information
in
order
to
use
the
cover
sheet.

The
completed
cover
sheet
is
then
included
as
part
of
the
submission
to
EPA.
Please
note,
this
ICR
does
not
include
any
burden
or
costs
associated
with
the
actual
transmittal
of
the
information
to
EPA,
or
that
associated
with
maintaining
a
copy
of
the
submission
in
their
records.
The
existing
ICRs
that
address
the
underlying
submission
already
include
the
burden
and
costs
associated
with
copying
and
mailing
the
submission
to
the
Agency,
and
with
keeping
a
copy
of
the
submission
in
their
records.

5.
THE
INFORMATION
COLLECTED
­
AGENCY
ACTIVITIES,
COLLECTION
METHODOLOGY,
AND
INFORMATION
MANAGEMENT
5(
a)
Agency
Activities
OPPT
staff
use
the
information
found
on
the
cover
sheet
to
identify
the
type
of
submission
or
the
type
of
information
contained
in
a
submission,
to
route
a
submission
to
other
EPA
staff
for
review,
evaluation
or
action,
to
file
or
retrieve
a
submission,
and
to
conduct
other
routine
information­
management
tasks
associated
with
the
receipt
and
processing
of
a
submission.
Since
the
information
appears
in
a
consistent,
standardized
format,
OPPT
staff
are
able
to
complete
these
tasks
in
a
highly
efficient
manner.

OPPT
staff
review
and
take
action
upon
the
submissions
themselves
in
accordance
with
procedures
that
are
described
in
greater
detail
in
the
information
collection
requests
associated
with
the
specific
reporting
requirements
previously
referenced.

5(
b)
Collection
Methodology
and
Management
Since
this
is
a
standardized
cover
sheet
attached
to
a
more
detailed
and
lengthy
submission,
the
collection
methodology
and
management
of
this
cover
sheet
­
10
­
necessarily
follow
the
collection
methodology
and
management
associated
with
the
specific
information
collections
for
which
this
cover
sheet
will
be
utilized.
These
collections
are
described
in
greater
detail
in
the
information
collection
requests
associated
with
the
specific
reporting
requirements
previously
referenced.

In
general
EPA
enters
the
information
found
on
the
cover
sheet
into
Agency
information
management
systems
so
as
to
identify,
locate
and
track
the
submission
as
the
submission
moves
through
appropriate
Agency
reviews
and
actions.
EPA
anticipates
that
the
use
of
the
cover
sheet
by
respondents
will
result
in
cost
and
time
savings,
greater
data
accuracy
and
quality,
and
more
timely
public
availability
of
data.

5(
c)
Small
Entity
Flexibility
The
use
of
this
voluntary
cover
sheet
does
not
directly
affect
any
existing
small
entity
flexibility
applicable
to
respondents
to
the
reporting
requirements
under
TSCA
sections
4,
8(
d)
or
8(
e).
Any
small
entity
flexibility
associated
with
these
collections
is
described
in
greater
detail
in
the
information
collection
requests
associated
with
these
reporting
requirements.
(
In
general,
reporting
requirements
under
TSCA
sections
8(
d)
and
8(
e)
apply
to
all
respondents,
regardless
of
size.
Small
entities
required
to
report
under
TSCA
section
4
have
certain
options
available
to
them
in
responding
to
those
requirements).
For
those
respondents,
whether
large
or
small,
that
are
required
to
respond
to
these
information
collections,
the
use
of
this
cover
sheet
should
provide
a
more
efficient
means
of
submitting
required
information.
However,
since
the
use
of
this
cover
sheet
is
strictly
voluntary,
a
respondent
may
choose
not
to
use
the
form
at
all.

5(
d)
Collection
Schedule
Since
this
is
a
standardized
cover
sheet
attached
to
a
more
detailed
and
lengthy
submission,
the
collection
schedule
associated
with
this
cover
sheet
necessarily
follows
the
collection
schedules
associated
with
the
specific
information
collections
for
which
this
cover
sheet
will
be
utilized.
In
general,
responses
to
reporting
requirements
under
TSCA
sections
4,
8(
d),
8(
e)
and
FYI
are
"
on­
occasion"
responses
for
which
a
strict
collection
schedule
does
not
apply.

6.
ESTIMATING
THE
BURDEN
AND
COST
OF
THE
COLLECTION
In
using
this
Voluntary
TSCA
Cover
Sheet
effort,
respondents
are
not
required
to
generate
any
new
data,
they
simply
transfer
information
from
the
underlying
submission
to
the
cover
sheet.
Although
the
information
included
in
the
cover
sheet
is
often
included
in
a
cover
letter,
the
Agency
has
not
attempted
to
estimate
any
burden
adjustment
to
the
underlying
ICRs
to
reflect
the
use
of
the
Voluntary
TSCA
Cover
Sheet,
rather
than
a
cover
letter
to
the
Agency.
This
ICR
only
estimates
the
burden
and
costs
associated
with
the
use
of
the
Voluntary
TSCA
Cover
Sheet.
As
such,
it
estimates
the
burden
and
costs
related
to
the
respondent's
review
of
the
instructions,
completion
of
the
form,
and
the
identification
of
the
appropriate
TSCATS
study
index
­
11
­
terms.
­
12
­
6(
a)
Estimating
Respondent
Burden
Based
on
the
industry
estimates
provided
during
the
ACC­
initiated
twelve­
month
pilot
of
the
cover
sheet
in
the
spring
of
1996,
which
ranged
from
15
minutes
to
an
hour,
the
Agency
estimates
that
the
average
burden
associated
with
the
use
of
the
cover
sheet
is
approximately
30
minutes
(
0.5
hour).

Using
recent
estimates
of
the
yearly
average
number
of
potential
submissions
expected
under
the
other
ICRs
for
submissions
related
to
TSCA
sections
4,
8(
d)
and
8(
e),
and
assuming
that
the
Voluntary
TSCA
Cover
Sheet
was
used
for
each
and
every
submission,
Table
1
illustrates
the
total
potential
burden
related
to
this
ICR.
This
assumption
effectively
results
in
an
overstatement
of
the
total
burden
associated
with
the
use
of
the
Voluntary
TSCA
Cover
Sheet,
since
not
all
respondents
will
choose
to
use
the
cover
sheet.
However,
there
are
no
reliable
data
available
to
suggest
a
lesser
level
of
use
of
the
form
that
EPA
could
use
to
calculate
the
burden
associated
with
its
use.
The
burden
identified
herein
should
be
considered
the
maximum
upward
bound
for
the
total
burden
rather
than
a
precise
estimate
of
the
burden
based
on
the
actual
real­
life
use
of
the
form.
1
Based
on
an
estimated
labor
cost
of
$
77/
hour,
as
discussed
in
section
6(
b).

2
Section
4
Test
Rules
and
Consent
Orders;
OMB
No.
2070­
0033;
EPA
ICR
No.
1139.06;
October
2001.

3
TSCA
Section
8(
d)
Health
and
Safety
Data
Reporting
Rule;
OMB
No.
2070­
0004;
EPA
ICR
No.
0575.09;
February
2003.

4
Notification
of
Substantial
Risk
of
Injury
to
Health
and
the
Environment
under
TSCA
Section
8(
e);
OMB
No.
2070­
0046;
EPA
ICR
No.
0794.09;
January
2001.

5
Notification
of
Substantial
Risk
of
Injury
to
Health
and
the
Environment
under
TSCA
Section
8(
e);
OMB
No.
2070­
0046;
EPA
ICR
No.
0794.09;
January
2001.

6
Since
FYI
submissions
are
only
submitted
when
the
respondent
wishes
to
do
so,
the
annual
potential
submissions
varies
greatly
and
is
highly
unpredictable.
The
Agency
believes
that
it
is
therefore
reasonable
to
use
10
in
this
estimate.

­
13
­
Table
1
 
Total
Potential
Burden
Submission
Type
Total
Average
Annual
Submissions
Burden
Hours
and
Cost
per
Submission
Burden
Costs1
Total
Burden
Cost
Hours
TSCA
§
42
17,299
0.5
$
38.50
8,649.5
$
666,012
TSCA
§
8(
d)
3
495
0.5
$
38.50
247.5
$
19,058
TSCA
§
8(
e)
­
initial4
267
0.5
$
38.50
133.5
$
10,280
TSCA
§
8(
e)
­
follow­
up5
200
0.5
$
38.50
100.0
$
7,700
FYI
Submissions6
10
0.5
$
38.50
5.0
$
385
Total
Potential
Burden
18,271
0.5
$
38.50
9,135.5
$
703,435
Since
the
Voluntary
TSCA
Cover
Sheet
is
expected
to
be
used
in
lieu
of
the
letter
that
has
been
used
in
the
past
to
transmit
submission
to
the
Agency,
this
burden
should
not
be
considered
additive
to
the
existing
burden
estimates
provided
in
the
underlying
ICRs.
Accounting
for
this
separately
in
this
ICR
may
also
result
in
the
double
counting
of
this
particular
burden.
However,
the
Agency
wishes
to
continue
the
voluntary
use
of
this
cover
sheet
and
will
account
for
its
burden
separately
until
the
form
is
more
widely
used.

6(
b)
Estimating
Respondent
Cost
Based
on
information
provided
by
ACC,
a
technical
level
employee
is
expected
to
complete
the
Voluntary
TSCA
Cover
Sheet.
For
purposes
of
estimating
the
cost
associated
with
completing
this
form,
EPA
used
the
most
current
average
industry
labor
costs
for
technical
employees
of
$
77
per
hour
(
Source:
Notification
of
Substantial
Risk
of
Injury
to
Health
and
the
Environment
under
TSCA
Section
8(
e);
OMB
No.
2070­
0046;
EPA
ICR
No.
0794.09;
January
2001).
As
shown
in
Table
1,
the
total
potential
cost
associated
with
completing
the
cover
form
is
$
703,435.
­
14
­
6(
c)
Estimating
Agency
Burden
and
Cost
Industry
use
of
the
cover
sheet
does
not
increase
Agency
burden
and
cost
over
that
currently
associated
with
these
information
collections.
It
is
anticipated,
in
fact,
that
the
Agency's
costs
for
data
processing,
system
support
and
storage
and
distribution
may
decrease.
Currently
EPA
staff
must
extract
cover
sheet
information
from
the
submission
itself
and
any
accompanying
cover
letter;
this
task
will
be
eased
by
EPA
staff
being
able
to
obtain
necessary
information
directly
from
the
standardized
form.

Current
Agency
burden
and
costs
are:

Section
4:
52,204
hours
/
$
1,889,785
(
Source:
Section
4
Test
Rules
and
Consent
Orders;
OMB
No.
2070­
0033;
EPA
ICR
No.
1139.06;
October
2001)

Section
8(
d):
5,720
hours
/
$
233,908
(
Source:
TSCA
Section
8(
d)
Health
and
Safety
Data
Reporting
Rule;
OMB
No.
2070­
0004;
EPA
ICR
No.
0575.09;
February
2003)

Section
8(
e):
$
63,045
(
Source:
Notification
of
Substantial
Risk
of
Injury
to
Health
and
the
Environment
under
TSCA
Section
8(
e);
OMB
No.
2070­
0046;
EPA
ICR
No.
0794.09;
January
2001)

In
addition,
it
should
be
noted
that
the
time
and
costs
for
making
publicly
available
TSCA
data
and
information
in
TSCATS
is
estimated
to
be
reduced
by
approximately
25­
33%
for
studies/
submissions
utilizing
the
voluntary
cover
sheet.

6(
d)
Bottom
Line
Burden
Hours
and
Costs
(
i)
Respondent
Tally
Each
use
of
the
cover
sheet
is
estimated
to
result
in
a
burden
of
0.5
hours,
at
a
cost
of
$
38.50.
The
Agency
estimates
a
total
of
18,271
submissions
each
year,
so
the
total
potential
burden
associated
with
this
ICR
is
estimated
to
be
9,136
hours,
at
an
estimated
cost
of
$
703,435.

(
ii)
Agency
Tally
Industry
use
of
the
cover
sheet
does
not
increase
Agency
burden
and
cost
over
that
currently
associated
with
the
underlying
information
collections
with
which
the
cover
sheet
is
used,
which
are
covered
by
other
ICRs.
­
15
­
­
16
­
6(
e)
Reasons
for
Change
in
Burden
The
burden
hours
included
in
this
request
represents
an
increase
of
8,221
hours
in
the
annual
burden,
from
915
hours
to
9,136
hours,
from
the
request
most
recently
approved
by
OMB.
This
increase
reflects
a
net
increase
in
the
estimated
number
of
submissions
under
TSCA
sections
4,
8(
d)
and
8(
e)
for
which
the
Voluntary
TSCA
Cover
Sheet
could
be
used,
in
particular
a
substantial
increase
in
the
estimated
number
of
TSCA
section
4
submissions.
(
As
discussed
in
the
TSCA
section
4
ICR
identified
elsewhere
in
this
document,
this
increase
results
from
the
initiation
of
two
new
major
voluntary
testing
agreement
programs,
the
HPV
Challenge
Program
and
the
Voluntary
Children's
Chemical
Evaluation
Program.)
Since
the
use
of
the
Voluntary
TSCA
Cover
Sheet
is
a
direct
reflection
of
the
number
of
submissions
received
under
TSCA
sections
4,
8(
d)
and
8(
e),
any
change
in
the
estimated
numbers
of
submissions
under
those
requirements
will
result
in
a
parallel
change
in
the
burden
hours
associated
with
this
information
collection.
The
potential
number
of
annual
submissions
may
change
from
year
to
year,
but
the
Agency
believes
that
the
estimated
number
of
submissions
used
in
this
ICR
is
reasonable.
This
increase
represents
an
adjustment.

6(
f)
Burden
Statement
The
annual
public
burden
for
this
collection
of
information,
which
is
approved
under
OMB
Control
No.
2070­
0156,
is
estimated
to
average
0.5
hours
per
response.
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;
train
personnel
to
be
able
to
respond
to
the
collection
of
information;
search
data
sources;
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
control
number.
The
OMB
control
number
for
this
information
collection
appears
above
and
on
the
form.
In
addition,
the
OMB
control
number
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
2003­
0017,
which
is
available
for
public
viewing
at
the
Pollution
Prevention
and
Toxics
Docket
in
the
EPA
Docket
Center
(
EPA/
DC),
EPA
West,
Room
B102,
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DC.
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­
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­
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EDOCKET)
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epa.
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edocket.
Use
EDOCKET
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Budget,
725
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Street,
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20503,
Attention:
Desk
Office
for
EPA.
Please
include
the
EPA
Docket
ID
No.
OPPT­
2003­
0017
and
OMB
control
number
2070­
0156
in
any
correspondence.

Attachments
­
18
­
ATTACHMENTS:

[
NOTE:
Unless
otherwise
noted,
an
electronic
copy
of
the
attachment
is
available
in
the
electronic
version
of
the
public
docket
available
through
EDOCKET
at
http://
www.
epa.
gov/
edocket.
Once
in
the
system,
select
"
quick
search,"
then
indicate
that
you'd
like
to
search
by
Docket
and
key
in
the
following
docket
ID
number:
OPPT­
2003­
0017.
Search
the
docket
index
for
this
document
by
the
title
provided
below.
If
you
have
any
difficulties,
please
contact
the
technical
person
listed
in
the
Federal
Register
notice
announcing
the
submission
of
this
ICR
to
OMB
for
review
and
approval.]

Attachment
Document
#
1
TSCA
Health
and
Safety
Cover
Sheet
and
Instructions
[
The
electronic
copy
for
this
attachment
is
available
as
part
of
the
electronic
copy
of
the
ICR's
Supporting
Statement.]

#
2
Comment
Received
by
EPA
as
a
Result
of
Consultations
with
Respondents
[
The
electronic
copy
for
this
attachment
is
available
as
part
of
the
electronic
copy
of
the
ICR's
Supporting
Statement.]
ATTACHMENT
1
TSCA
Health
&
Safety
Study
Cover
Sheet
and
Instructions
Approved
Under
OMB
Control
#
2070­
0156
Expiration
Date:
xx/
xx/
xxxx
TSCA
HEALTH
&
SAFETY
STUDY
COVER
SHEET
Use
of
this
form
is
voluntary,
but
recommended
by
EPA
as
a
cover
sheet
for
TSCA
section
4,
8(
d),
and
8(
e)
submssions
to
expedite
and
improve
the
management,
processing,
quality,
review,
and
public
availability
of
data
in
TSCATS
TSCA
CBI
STATUS:


CHECK
IF
THIS
PAGE
CONTAINS
CONFIDENTIAL
BUSINESS
INFORMATION
(
CBI)
Clearly
mark
the
confidential
information
with
bracketing
and
check
the
box
in
the
appropriate
section
(

Contains
CBI).
Submit
a
sanitized
cover
sheet
with
CBI
deleted.
Mark
the
sanitized
copy,
"
Public
Display
Copy"
in
the
heading.

1.0
SUBMISSION
TYPE

Contains
CBI

8(
d)

8(
e)

FYI

4

OTHER:
Specify____________________


Initial
Submission

Follow­
up
Submission

Final
Report
Submission
Previous
EPA
Submission
Number
or
Title
if
update
or
follow­
up:
Docket
Number,
if
any:
#
ITC
Submission

Yes

No

continuation
sheet
attached
2.1
SUMMARY/
ABSTRACT
ATTACHED
(
may
be
required
for
8(
e):
optional
for
§
4,
8(
d)
&
FYI)

YES

NO
2.2
SUBMITTER
TRACKING
NUMBER
OR
INTERNAL
ID
2.3
FOR
EPA
USE
ONLY
2.4
Study
___
of
____

3.0
CHEMICAL/
TEST
SUBSTANCE
IDENTITY

Contains
CBI
Reported
Chemical
Name
(
specify
nomenclature
if
other
than
CAS
name):
CAS#__________­_____­___
Purity
_______%


Single
Ingredient

Commercial/
Tech
Grade

Mixture
Trade
Name:
________________________
Common
Name:
__________________________
CAS
Number
NAME
%
WEIGHT
Other
chemical(
s)
present
in
tested
mixture

continuation
sheet
attached
4.0
REPORT/
STUDY
TITLE

Contains
CBI

continuation
sheet
attached
5.1
STUDY/
TSCATS
INDEXING
TERMS
[
CHECK
ONE]
HEALTH
EFFECTS
(
HE):
ENVIRONMENTAL
EFFECTS
(
EE):
ENVIRONMENTAL
FATE
(
EF):_____
5.2
STUDY/
TSCATS
INDEXING
TERMS
(
see
instructions
for
4
digit
codes)
STUDY
SUBJECT
ROUTE
OF
VEHICLE
OF
TYPE:
___________
ORGANISM
(
HE,
EE
only):
EXPOSURE
(
HE
only):
EXPOSURE
(
HE
only)_____
Other:____________
Other:_________________________
Other:
____________________
Other:__________________
6.0
REPORT/
STUDY
INFORMATION

Contains
CBI

Study
is
GLP
Laboratory
Report/
Study
Date_______
Source
of
Data/
Study
Sponsor
(
if
different
than
submitter)
Number
of
pages
_________


continuation
sheet
attached
7.0
SUBMITTER
INFORMATION

Contains
CBI
Submitter:
_____________________________________
Title:
________________________
Phone:
(
)______________
Company
Name:
_________________________________
Company
Address:_____________________________________
_____________________________________________
________________________________________
_______________________________________________
Submitter
Address
(
if
different):
_____________________________________
Technical
Contact:
________________
______________
Phone:
(
)______________


continuation
sheet
attached
e­
mail
address__________________________________________________________
8.0
ADDITIONAL
COMMENTS

Contains
CBI

continuation
sheet
attached
Submitter
Signature:
Date:

EPA
Form
No.
7710­
58
(
Revised
6/
25/
96)
Page____
of____
Approved
Under
OMB
Control
#
2070­
0156
TSCA
HEALTH
&
SAFETY
STUDY
COVER
SHEET
9.0
CONTINUATION
SHEET
TSCA
CBI
STATUS:


CHECK
IF
THIS
PAGE
CONTAINS
CONFIDENTIAL
BUSINESS
INFORMATION
(
CBI)
Clearly
mark
the
confidential
information
with
bracketing
and
check
the
box
in
the
appropriate
section
(

Contains
CBI).
Submit
a
sanitized
cover
sheet
with
CBI
deleted.
Mark
the
sanitized
copy,
"
Public
Display
Copy"
in
the
heading.

Submitter
Tracking
Number/
Internal
ID
CONTINUED
FROM
COVER
SHEET
SECTION
#
_______________


Contains
CBI
EPA
Form
No.
7710­
58­
C
(
Revised
6/
25/
96)
Page____
of____
Approved
under
OMB
Control
#
2070­
0156
TSCA
HEALTH
&
SAFETY
STUDY
COVER
SHEET
­
INSTRUCTIONS
(
Note:
Do
not
mail
these
instructions
with
your
submission)

Paperwork
Reduction
Act
Notice
The
annual
public
burden
for
this
collection
of
information
is
estimated
to
average
30
minutes
per
response,
including
the
time
needed
for
reading
the
instructions
and
completing
the
necessary
information
contained
in
this
form.
Send
comments
regarding
the
burden
estimate
or
any
other
aspect
of
this
collection
of
information,
including
suggestions
for
reducing
the
burden
to:
Director,
Collection
Strategies
Division,
U.
S.
Environmental
Protection
Agency
(
Mail
Code
2822T),
1200
Pennsylvania
Avenue,
NW,
Washington,
D.
C.
20460.
Include
OMB
number
2070­
0156
in
any
correspondence.
Do
not
send
the
completed
form
to
this
address.
The
actual
information
or
form
should
be
submitted
in
accordance
with
the
instructions
specified
in
the
corresponding
regulations.

General
Instructions
°
This
voluntary
cover
sheet
was
designed
to
serve
as
a
tool
for
industry
and
EPA
in
the
preparation,
processing,
review,
and
availability
of
TSCA
information,
and
as
an
alternative
for
cover
letters
to
TSCA
submissions.

°
As
with
all
EPA
submissions,
follow
applicable
EPA
regulations
and
guidance
in
submitting
the
information.

°
A
check
box
at
the
top
has
been
provided
to
indicate
if
there
is
confidential
business
information
(
CBI).
Check
this
box
if
the
page
contains
information
that
is
confidential.
For
information
that
can
be
claimed
confidential
under
TSCA
refer
to
TSCA
section
14,
40
CFR
Part
2
Sub­
Part
B
and
other
applicable
EPA
and
TSCA
guidance.
If
the
page
contains
CBI,
clearly
mark
the
information
with
brackets.
Check
the
box
"
Contains
CBI"
in
the
appropriate
section.
Submit
another
cover
sheet
with
the
CBI
deleted
and
mark
"
Public
Display
Copy"
in
the
heading.

°
Under
TSCA
reporting
requirements,
a
submission
may
contain
multiple
studies.
A
cover
sheet
should
be
completed
for
each
study
in
the
submission
and
go
to
box
2.4
and
add
Study
1
of
1
for
a
submission
having
a
single
study,
Study
1
of
x,
Study
2
of
x,
etc.
(
for
a
submission
having
multiple
or
x
number
of
studies).

°
A
cover
sheet
is
unnecessary
for
submissions
containing
no
health
and
safety
data.
Examples
of
submissions
with
no
health
and
safety
data
include:
Section
4
related
correspondence
on
issues
of
different
test
protocols;
Section
8(
e)
or
FYI
voluntary
actions
of
submitters
to
reduce
exposures;
information
on
chemical
use
or
commercial
status;
substantiation
for
submitting
FYI
vs
8(
e).
If
a
submission
is
related
to
a
previous
submission,
please
reference
the
EPA
assigned
Document
ID
for
PMN,
8(
e)
and
FYI
submissions
(
PMN,
8EHQ
and
FYI
numbers).
For
other
submissions,
please
reference
the
EPA
Document
Control
Number
(
DCN)
or
Study
title
with
submission
date.
The
EPA
will
provide
the
Document
ID
as
well
as
the
DCN
when
acknowledging
PMNs,
8(
e)
s
and
FYIs.

If
additional
space
is
needed
in
any
of
the
sections
of
the
Cover
Sheet,
please
check
the
"
continuation
sheet
attached"
box
in
the
appropriate
section
and
attach
a
Continuation
Sheet
(
a
standardized
continuation
sheet
has
been
provided;
it
is
titled
9.0
Continuation
Sheet).
INSTRUCTIONS
­
continued
page
2
°
It
is
important
to
indicate
if
a
study/
submission
is
initial,
follow­
up
or
final.
An
initial
submission
is
for
a
given
chemical/
case
identified
or
initiated
by
a
company.
A
follow­
up
or
a
supplement
is
a
submission
which
contains
information
specifically
requested
by
EPA
(
Follow­
up)
or
information
related
to
a
previous
submission
but
not
specifically
requested
by
EPA
(
Supplement).

°
Please
attach
to
the
cover
sheet
package
an
abstract
or
summary
for
each
study
prepared
by
or
for
the
submitter,
if
available,
and
check
the
box
"
YES"
under
section
2.1.
Otherwise
check
the
box
"
NO".
[
Note:
a
summary/
abstract
is
required
under
8(
e).]

°
Space
is
provided
in
section
8.0
for
the
submitter
to
provide
any
additional
study
interpretation,
comments,
etc
which
could
immediately
assist
in
EPA's
screening
and
review
of
the
study/
submission.
A
continuation
sheet
may
be
attached.

°
If
any
information
in
the
cover
sheet
is
unknown,
write
"
unknown."
If
it
is
not
applicable
write
"
N.
A."
Provide
written
explanation
if
appropriate.

Detailed
Instructions
For
Completing
Cover
Sheet
TSCA
CBI
(
Confidential
Business
Information)
Status
­
Check
this
box
if
the
page
contains
information
that
is
confidential.
For
information
what
can
be
claimed
confidential
under
TSCA
refer
to
TSCA
section
14,
40
CFR
Part
2
Sub­
Part
B
and
other
applicable
EPA
and
TSCA
guidance.
If
the
page
contains
CBI,
clearly
mark
the
information
with
brackets.
Check
the
box
"
Contains
CBI"
in
the
appropriate
section.
Submit
another
cover
sheet
with
the
CBI
deleted
and
mark
"
Public
Display
Copy"
in
the
heading.

1.0
Submission
Type
­
Check
one
of
the
boxes
for
the
TSCA
section
that
the
submission
is
being
made
under­
8(
d),
8(
e),
FYI,
4
or
OTHER.
Check
the
appropriate
box
to
indicate
if
a
study/
submission
is
initial,
follow­
up
or
final.
An
initial
submission
is
for
a
given
chemical/
case
identified
or
initiated
by
a
company.
A
follow­
up
or
a
supplement
is
a
submission
which
contains
information
specifically
requested
by
EPA
(
Follow­
up)
or
information
related
to
a
previous
submission
but
not
specifically
requested
by
EPA
(
Supplement).

2.1
Summary/
Abstract
Attached
­
Please
attach
to
the
cover
sheet
package
an
abstract
or
summary
for
each
study
prepared
by
or
for
the
submitter,
if
available,
and
check
the
box
"
YES"
under
section
2.1.
Otherwise
check
the
box
"
NO".
[
Note:
a
summary/
abstract
may
be
required
under
8(
e).]

2.2
Submitter
Tracking
Number
or
Internal
ID
­
Enter
an
internal
company
ID
number;
also,
write
this
ID
on
the
complete
submission
for
easy
linkage
to
and
retrieval
of
the
entire
study/
submission
for
EPA
processing,
review,
and
public
availability.

2.3
For
EPA
Use
Only
­
Please
leave
this
section
blank.
This
is
for
EPA
purposes
such
as
assignment
of
submission
tracking
numbers.

2.4
Study
of
­
INSTRUCTIONS
­
continued
page
3
3.0
Chemical/
Test
Substance
Identity
­
If
additional
space
is
required
for
any
chemical
identity
data
element,
check
the
continuation
box
and
attach
a
continuation
sheet
appropriately
identifying
the
relevant
specific
data
element
and
referencing
the
study/
submission.
Enter
the
CAS#
of
the
chemical
for
the
specific
study
on
the
cover
sheet.
Enter
the
chemical
name;
specify
nomenclature
if
other
than
CAS
name.
Enter
the
%
purity
if
impurities
are
present,
leave
blank
if
unknown.
Check
one
of
three
boxes
indicating
if
the
chemical
is
a
single
ingredient
(
e.
g.,
100%
NaCl),
technical
grade
product
(
e.
g.,
50%
NaOH
solution),
or
mixture
(
e.
g.,
perfume
formula
with
many
ingredients).
Enter
the
trade
names
and
common
names
for
the
material
if
applicable.
If
the
test
substance
contains
more
than
one
chemical,
list
the
components
by
CAS
number,
name,
and
%
weight
in
the
mixture.
Submitters
are
requested
to
provide
informative
generic
chemical
names
for
substances
whose
chemical
identity
has
been
claimed
TSCA
confidential
business
information.

4.0
Report/
Study
Title
­
Provide
the
title
of
the
entire
submission,
not
the
title
of
any
specific
study
subsection;
if
insufficient
space,
check
the
continuation
box
and
attach
a
continuation
sheet
with
the
complete
title.

5.1
Study/
TSCATS
Indexing
Terms
­
Check
either
Health
Effects,
Environmental
Effects,
or
Environmental
Fate
­
check
only
one.

5.2
Study/
TSCATS
Indexing
Terms
­
See
the
attached
Study
Indexing
Terms
Sheet.
Find
appropriate
(
checked)
Study
Type
and
select
relevant,
detailed
Study
Type
(
for
HE,
EE,
EF),
Subject
Organism
(
HE,
EE
only),
Route
of
Exposure
(
HE
only),
and
Vehicle
(
HE
only,
if
applicable);
transfer
the
4­
letter
TSCATS
code
to
the
cover
sheet.
If
an
appropriate
indexing
term
is
not
available,
check
other
box
and
clearly
print
description.

6.0
Report/
Study
Information
­
If
additional
space
is
required
for
any
study
information
data,
check
the
continuation
box
and
attach
a
continuation
sheet
identifying
the
relevant
specific
data
element
and
referencing
the
study/
submission.
Enter
the
complete
name
of
the
contractor
or
laboratory
which
conducted
the
study.
Include
the
source
of
data
or
study
sponsor,
if
different
than
the
submitter.
Enter
the
actual
completion
date
of
the
study/
submission
as
dd/
mm/
yy.
Check
GLP
box
if
existing
Good
Laboratory
Practices
were
used
in
the
conduct
of
the
study.

7.0
Submitter
Information
­
If
additional
space
is
required
for
any
submitter
information,
check
the
continuation
box
and
attach
a
continuation
sheet
identifying
this
data
element
and
referencing
the
study/
submission
(
e.
g.
submitter
tracking
number).
Enter
submitter
name,
title,
and
phone.
Enter
company
name
and
address.
Enter
the
address
of
the
submitter
if
the
submitters
address
is
different
than
the
company
address.
Please
provide
a
key
technical
contact
name
and
telephone
number
of
an
individual
who
can
discuss
the
content/
substance
of
the
study/
submission
during
the
EPA
scientific
review
process.

8.0
Additional
Comments
­
This
space
is
provided
for
the
submitter
to
provide
any
additional
study
interpretation,
comments,
etc.,
which
could
immediately
assist
in
EPA's
screening
and
review
of
the
study/
submission.
A
continuation
sheet
may
be
attached.
For
TSCA
section
8(
e)
and
FYI
submissions
state
rationale
for
submitting
information
as
8(
e)
versus
FYI
and
voluntary
actions
taken
by
the
submitter
in
response
to
the
new
information.

Submitter
Signature/
Date
­
TSCA
section
8(
e)
submissions
must
be
signed
by
the
submitter
and
dated.
All
submissions
should
be
submitted
by
certified
mail
with
return
receipt
to
demonstrate
submission
receipt
by
the
EPA.

9.0
Continuation
Sheet
­
If
additional
space
is
needed
in
any
of
the
sections
of
the
cover
sheet,
please
check
the
"
continuation
sheet
attached"
box
in
the
appropriate
section
and
attach
a
Continuation
Sheet,
Section
9.0.
INSTRUCTIONS
­
continued
page
4
STUDY
INDEXING
TERMS
FOR
HEALTH
EFFECT
(
HE)
STUDIES
ONLY
Study
Type
___
Acute
Toxicity
(
ATOX)
___
Subchronic
Toxicity
(
STOX)
___
Chronic
Toxicity
(
CTOX)
___
Carcinogenicity
(
CARC)
___
Combined
Chronic
Toxicity/
Carcinogenicity
(
CTCA)
___
Cell
Transformation
(
TRFM)
___
Biochemical
Interactions
and/
or
Mechanism
of
Toxic
Effects
(
BCHM)
___
Absorption,
Distribution,
Metabolism
Excretion
(
ADME)
___
Primary
Dermal
Sensitization
(
DSEN)
___
Primary
Dermal
irritation
(
DIRR)
___
Primary
Eye
irritation
(
EIRR)
___
Reproduction/
Fertility
Effects
(
RTOX)
Teratology
(
TERA)
___
Combined
Teratology/
Reproductive
Effects
(
TERE)
___
Epidemiology
Study
(
EPID)
___
Case
Report
(
CASE)
___
Genotoxicity
(
GTOX)
___
Gene
Mutation
(
MUTA)
___
Chromosomal
Effects
(
CHRM)
___
DNA
Effects
(
DNAF)
___
Tissue
Determination
Concentration
(
TCON)
___
Industrial
Hygiene
(
HYGN)
___
Neurotoxicity
(
NEUR)
___
Immunotoxicity
(
ITOX)
___
Target
Organ
Toxicity:
specify____
___
Other:
specify_________________
Subject
Organism/
Test
System
___
Mammals
(
MAMM)
___
Rats
(
RATS)
___
Mice
(
MICE)
___
Hamsters
(
HAMS)
___
Guinea
Pigs
(
GUIN)
___
Rabbits
(
RABB)
___
Dogs
(
DOGS)
___
Cats
(
CATS)
___
Monkeys
(
MNKY)
___
Pigs
(
PIGS)
___
Cattle
(
COWS)
___
Sheep
(
SHEP)
___
Goats
(
GOAT)
___
Humans
(
HUMN)
___
Other
Mammals
(
OTMA)
___
Bacteria
(
BACT)
___
Algae
(
ALGA)
___
Fungi
(
FUNG)
___
Yeast
(
YEST)
___
Plant
(
PLNT)
___
Insect
(
INSE)
___
Bird
(
BIRD)
Route
of
Exposure
___
Oral
(
ORAL)
___
Gavage
(
GAVG)
___
Dermal
(
DERM)
___
Inhalation
(
INHL)
___
Intratracheal
Instillation
(
INTR)
___
Parenteral
(
PARN)
___
Intravenous
(
INTV)
___
Intraperitoneal
(
INTP)
___
Intramuscular
(
INTM)
___
Subcutaneous
(
SUBC)
___
Implant
(
IMPL)
___
Transplacental
(
TRPL)
___
In
Vitro
(
INVR)

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Vehicle
of
Exposure
(
check
only
if
applicable)

___
Water
___
Corn
Oil
___
Food
___
Other:
specify________________

FOR
ENVIRONMENTAL
EFFECT
(
EE)
STUDIES
ONLY
FOR
ENVIRONMENTAL
FATE
(
EF)
STUDIES
ONLY
Study
Type
___
Acute
Toxicity
(
ATOX)
___
Subchronic
Toxicity
(
STOX)
___
Chronic
Toxicity
(
CTOX)
___
Critical
Life
Stage
Test
(
CLIF)
___
Seed
Germination
Test
(
SEED)
___
Plant
Growth
or
Damage
Test
(
PGRD)
___
Microbiological
Function
Test
(
MICR)
___
Ecosystem
Modeling
(
ECOS)
___
Reproduction/
Fertilization
Test
(
RTOX)
___
Absorption,
Distribution,
Metabolism
Excretion
(
ADME)
___
Tissue
Concentration
(
TCON)
___
Other
Environmental
Effects
(
OTEE)
specify
__________________________
Subject
Organism
___
Bacteria
(
BACT)
___
Algae
(
ALGA)
___
Fungi
(
FUNG)
___
Yeast
(
YEST)
___
Plant
(
PLNT)
___
Amphibians
(
AMPH)
___
Mollusks
(
MOLL)
___
Fish
­
Freshwater
(
FFRE)
___
Fish
­
Marine
(
FMAR)
___
Reptiles
(
REPT)
___
Bird
(
BIRD)
___
Insect
(
INSE)
___
Invertebrates
(
INVE)
___
Other
Wildlife
(
WILD)
specify
________________________
Study
Type
___
Physical
/
Chemical
Properties
(
PCHE)
___
Water
Solubility
(
WSOL)
___
Vapor
Pressure
(
VPRE)
___
Partition
Coefficient
(
PART)
___
Dissociation
Constant
(
DISS)
___
Henry's
Law
Constant
(
HLAW)
___
Transport
Processes
(
TSPT)
___
Biodegradation
(
BDEG)
___
Bioconcentration
/
Bioaccumulation
(
BIOC)
___
Photolysis
(
PHOT)
___
Hydrolysis
(
HYDR)
___
Monitoring
Information
(
MONT)
___
Production
and
Process
Info
(
PROD)
___
Other
Studies
(
OTHR)
specify
____________________________
ATTACHMENT
2
Comments
Received
by
EPA
as
a
Result
of
Consultations
with
Respondents
From:
mike.
thelen@
dowcorning.
com
To:
Ron
Carlson/
DC/
USEPA/
US@
EPA.
gov
Subject:
RE:
Renewal
of
"
Voluntary
Cover
Sheet
for
TSCA
Submissions"
ICR
Date:
05/
14/
03
09:
50
AM
Attached
is
my
feedback
on
the
questions
EPA
has
raised
with
respect
to
the
Voluntary
Cover
Sheet
for
TSCA
Submissions.
I
have
indicated
my
response
by
beginning
my
feedback
with
(
Thelen).
Please
feel
free
to
contact
me
if
you
have
questions
or
need
additional
information.

(
1)
In
your
opinion
is
this
collection
of
information
necessary
for
the
proper
performance
of
the
functions
of
the
EPA,
including
whether
the
information
will
have
practical
utility?

(
Thelen)
The
collection
of
information
through
the
"
Voluntary
Cover
Sheet"
is
not
necessary
for
the
proper
performance
of
functions
within
the
EPA
but
does
have
practical
utility
in
that
EPA
does
not
have
to
pay
an
outside
contractor
to
develop
this
input
and
the
indexing
information
is
available
realtime
with
the
TSCA
submission.

(
2)
Please
comment
on
how
EPA
could
enhance
the
quality,
utility
and/
or
clarity
of
the
information
to
be
collected.

(
Thelen)
I
believe
that
the
"
Voluntary
Cover
Sheet"
and
document
is
understandable
and
clear.
No
proposed
changes.

(
3)
Are
the
data
that
EPA
seeks
available
from
any
public
source,
or
already
collected
by
another
office
at
EPA
or
by
another
agency?
If
yes,
where
can
one
find
the
data?

(
Thelen)
I
do
not
believe
that
the
information
collected
on
the
"
Voluntary
Cover
Sheet"
is
available
from
any
other
source.
This
information
must
be
developed
from
the
content
of
the
TSCA
submission.

(
4)
Consider
how
often
EPA
needs
to
collect
these
data.
Can
EPA
collect
the
information
less
frequently
and
still
produce
the
same
outcome?

(
Thelen)
The
appropriate
time
to
collect
this
data
is
with
the
TSCA
submission.
By
collecting
the
data
on
the
cover
sheet
with
the
TSCA
submission
you
avoid
the
lag
time
that
is
associated
with
developing
this
indexing
information
after
EPA
receives
the
submission.
The
ability
to
search
for
new
information
in
TSCATS
is
enhanced
with
the
submission
of
the
Voluntary
Cover
Sheet
with
the
TSCA
submission.

(
5)
The
ICR
is
intended
to
explain
to
respondents
that
they
are
required
to
do
certain
things
and
provide
certain
data
so
that
EPA
can
utilize
them.
Is
it
clear
to
you,
based
on
the
ICR,
the
form
and
its
instructions,
what
you
are
required
to
do
and
what
data
to
submit?
If
not,
what
suggestions
do
you
have
for
clarifying
the
instructions?
Is
the
format
of
the
form
clear,
logical
and
easy
to
complete?

(
Thelen)
I
have
no
problems
following
the
Voluntary
Cover
Sheet
form
and
the
information
required
but
I
am
not
a
good
example
of
the
norm
based
on
my
early
involvement
with
the
concept
of
the
cover
sheet
through
my
involvement
with
the
Silicones
Environmental
Health
and
Safety
Councils
submission
of
information
to
EPA
and
the
Interagency
Testing
Committee
on
Siloxane
TSCA
submissions.

(
6)
Please
consider
electronic
alternatives
to
paper­
based
data
submissions.
Are
you
interested
in
using,
or
are
you
currently
utilizing,
an
electronic
reporting/
data
submission
option
for
this
or
other
EPA
information
submissions?
(
Current
electronic
reporting
alternatives
include
the
use
of
web
form/
XML­
based
submissions
via
EPA's
internet
site
and
magnetic
media­
based
submissions,
e.
g.,
on
diskette,
CD­
ROM,
etc.)
Where
a
reporting
requirement
includes
a
signature
requirement,
should
a
secure
electronic
signature
method
(
such
as
Private
Key
Infrastructure)
be
required,
or
is
a
less
secure
method
(
such
as
the
use
of
PINs
and
passwords)
adequate
or
more
appropriate,
or,
if
data
are
submitted
on
disk,
is
a
signed
cover
sheet
sufficient
for
the
Agency's
purposes?
If
you
submit
TSCA
confidential
business
information
(
CBI)
for
this
or
other
EPA
information
submissions,
would
you
be
more
inclined
to
submit
CBI
on
diskette
rather
than
on
paper
and
what
benefits
would
you
realize
(
e.
g.,
burden
reduction,
greater
efficiency
in
compiling
information,
etc.)?

(
Thelen)
There
a
number
of
points
that
are
being
addressed
in
this
question;
do
I
support
electronic
submissions,
what
type
of
electron
submission
do
I
currently
use
or
support,
what
level
of
validation/
security
is
needed
for
the
TSCA
submission,
if
it
is
confidential
business
information
(
CBI),
what
is
my
preference
(
paper
or
electronic)
and
what
are
the
benefits
of
electronic
reporting.
I
support
the
use
of
electronic
submissions
and
have
used
the
cover
sheet
in
beta
testing.
I
have
no
preference
to
the
use
of
the
internet
or
electronic
media
(
eg.
disk
or
CD­
ROM).
I
have
provided
Reports
and
presentations
to
OPPT
on
CD­
ROM
to
facilitate
distribution
of
information.
For
non
CBI
submissions
I
believe
that
a
PIN
is
adequate
for
TSCA
submissions
through
EPA's
website.
The
submitter
has
a
copy
of
the
submission
if
there
was
an
issue
with
the
submission.
CBI
presents
a
higher
level
of
concern
because
the
content
of
the
submission
is
what
needs
to
be
protected
from
inadvertent
disclosure.
Electronic
submissions
would
still
be
a
preference
but
the
issue
to
be
addressed
is
the
mechanism
to
get
this
electronic
submission
to
EPA.

(
7)
Please
consider
EPA's
estimated
burden
and
costs
for
responding
to
this
information
collection.
Is
the
burden
hour
estimate
reasonable?
Are
the
costs,
including
labor
rates,
reasonable?
(
Note
that
the
labor
rates
include
overhead
costs,
benefits,
etc.)
Please
provide
a
explanation
of
how
you
arrived
at
your
estimates
of
burden
and
cost
if
they
are
substantially
different
from
EPA's
estimates.
Please
offer
any
suggestions
on
how
EPA
could
minimize
the
burden
and
cost
of
this
information
collection.

(
Thelen)
I
agree
with
the
estimate
of
.5
hours
for
completing
the
"
Voluntary
Cover
Sheet"
and
the
hourly
rate.
In
order
to
complete
the
"
Voluntary
Cover
Sheet"
within
the
.5
hours
you
will
need
an
Environmental
Health
and
Safety
professional
who
understands
the
content.

(
8)
Please
offer
any
other
relevant
suggestions,
observations
or
criticisms
that
may
occur
to
you
that
are
not
outlined
above.

(
Thelen)
If
EPA
wants
to
promote
the
use
of
the
"
Voluntary
Cover
Sheet"
it
needs
to
be
more
visible
and
easy
to
find
on
EPA's
website
as
an
alternative
to
paper
submissions.
I
tried
to
locate
it
and
was
not
successful.

Michael
E.
Thelen
Regulatory
Affairs
and
Product
Safety
Environmental
Health
and
Safety
Dow
Corning
Corporation
mike.
thelen@
dowcorning.
com
989­
496­
4168,
fax
989­
496­
5595
