Document ID: EPA-HQ-OPPT-2005-0061-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2005-12-13T05:00Z

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:
Data
Submissions
for
the
Voluntary
Children's
Chemical
Evaluation
Program
(
VCCEP)

EPA
ICR
No.:
2055.02
OMB
Control
No.:
2070­
0165
1(
b)
Short
Characterization
The
Voluntary
Children's
Chemical
Evaluation
Program
(
VCCEP)
is
a
voluntary
data
collection
program
designed
to
provide
the
Environmental
Protection
Agency
(
EPA)
with
information
under
the
Toxic
Substances
Control
Act
(
TSCA)
on
health
effects,
exposure,
risk,
and
additional
data
needed
to
evaluate
the
safety
of
chemicals
to
which
children
have
a
high
likelihood
of
exposure.
This
is
the
first
renewal
of
the
Information
Collection
Request
(
ICR)
that
covers
the
activities
related
to
the
pilot
of
VCCEP.
EPA
is
running
a
pilot
of
the
VCCEP
so
it
can
gain
insight
into
the
program
design
changes
that
might
introduce
efficiencies
into
the
program's
implementation.
Of
particular
interest
is
the
Peer
Consultation
Process
that
is
being
used
for
the
first
time
in
such
a
program.
EPA's
evaluation
of
the
pilot
will
influence
how
the
VCCEP
will
handle
additional
chemicals
under
this
Program
in
the
future.
EPA
intends
to
evaluate
the
pilot
before
considering
continuing
the
program
for
other
chemicals.
This
ICR,
however,
only
covers
the
pilot
program
as
that
program
is
described
in
the
December
26,
2000,
Federal
Register
Notice
(
65
FR
81700)
(
see
Attachment
1).
This
ICR
covers
the
submission
of
data
requested
under
the
pilot
program
and
the
commitment
letters
from
companies
volunteering
to
sponsor
their
chemical(
s)
at
the
upper
tiers
in
the
VCCEP.
Commitment
letters
for
the
first
tier
of
information
collection
in
VCCEP
were
covered
during
the
effective
period
of
the
first
VCCEP
ICR.

The
VCCEP
was
developed
by
EPA's
Office
of
Pollution
Prevention
and
Toxics
(
OPPT)
after
considering
various
comments
and
concerns
voiced
by
a
number
of
individuals
through
an
extensive
stakeholder
involvement
process
that
included
individuals
from
the
chemical
industry,
various
government
agencies,
child
health
groups,
environmental
groups,
animal
welfare
groups,
as
well
as
the
general
public.
Through
the
VCCEP
and
commitments
by
chemical
sponsors,
EPA
will
obtain
data
on
chemicals
to
which
children
are
likely
to
be
exposed.
Participation
in
the
VCCEP
and
submission
of
data
are
voluntary.
Industry
has
the
opportunity
to
make
a
separate
commitment
for
each
of
three
tiers
and
each
commitment
is
initiated
by
a
letter
to
EPA
identifying
the
chemical
and
tier
of
information
that
a
company
is
volunteering
to
sponsor.
Sponsors
then
collect
or
develop
data
that
provide
information
on
health
effects,
exposure,
risk,
and
additional
data
needs
of
the
sponsored
chemicals.
EPA
will
use
a
publicly
conducted
Peer
Consultation
Process
to
help
assess
whether
the
submitted
data
are
adequate
to
fully
characterize
the
risk
to
children
and,
if
not,
what
additional
data
are
needed.
­
2­
The
VCCEP
is
also
designed
to
ensure
that
health
effects,
exposure,
and
risk
information
collected
on
chemicals
are
made
publicly
available
to
allow
EPA
and
others
to
pursue
any
necessary
risk
management
or
regulatory
action
with
respect
to
a
chemical,
to
help
the
public
understand
the
risks
posed
to
children
by
exposure
to
certain
chemicals,
and
to
facilitate
the
public's
involvement
in
environmental
decision­
making.
EPA
makes
the
collected
data
publicly
available
on
the
VCCEP
website
at
http://
www.
epa.
gov/
chemrtk/
vccep/
index.
htm.

The
data
that
a
sponsor
commits
to
develop
under
the
VCCEP
need
to
be
collected
only
once
for
each
specified
chemical.
As
such,
only
one
of
the
entities
that
manufactures
or
imports
the
specified
chemical,
or
a
consortium
formed
by
these
entities,
will
develop
the
specified
data
and
report
the
results
to
EPA.

EPA
has
established
an
official
docket
under
Docket
ID
OPPTS­
00274
for
all
activities
conducted
under
the
VCCEP.
The
official
docket
consists
of
the
documents
referenced
in
the
notice
announcing
the
VCCEP
(
65
FR
81700,
December
26,
2000),
letters
of
commitment
to
sponsor
a
chemical,
the
Peer
Consultation
Documents
(
containing
hazard,
exposure,
risk,
and
data
needs
assessments
for
each
chemical
assessed),
the
third
party's
report
on
the
results
of
the
Peer
Consultation
meeting,
EPA's
Data
Needs
Decisions,
any
public
comments
received
during
an
applicable
comment
period,
and
other
information
related
to
the
Stakeholder
Involvement
Process,
including
information
claimed
as
Confidential
Business
Information
(
CBI).
Although
a
part
of
the
official
docket,
the
public
docket
does
not
include
CBI
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
EPA
Public
Reading
Room,
Room
B102,
EPA
West
Building,
1301
Constitution
Avenue,
N.
W.,
Washington,
D.
C.,
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays
(
202­
566­
0280).

2
NEED
FOR
AND
USE
OF
THE
COLLECTION
2(
a)
Need/
Authority
for
the
Collection
Section
2(
b)(
1)
of
TSCA,
states
that
it
is
the
policy
of
the
United
States
that
"
adequate
data
should
be
developed
with
respect
to
the
effect
of
chemical
substances
and
mixtures
on
health
and
the
environment
and
that
the
development
of
such
data
should
be
the
responsibility
of
those
who
manufacture
[
which
is
defined
by
statute
to
include
import]
and
those
who
process
such
chemical
substances
and
mixtures
[.]"
To
implement
this
policy,
EPA
may
rely
on
TSCA
section
4(
a),
which
authorizes
EPA
to
require
manufacturers
and
processors
of
chemical
substances
and
mixtures
to
conduct
testing
if
certain
findings
for
hazard
and/
or
exposure
are
made
by
EPA.
With
the
VCCEP,
however,
EPA
is
working
with
manufacturers
and
other
stakeholders
to
voluntarily
develop
needed
data.

In
general,
chemicals
were
selected
for
the
VCCEP
pilot
if
there
were
data
indicating
that
exposure
to
the
general
population
had
occurred
and
that
the
chemicals
are
present
in
the
­
3­
environment.
The
biomonitoring
data
sets
used
for
selection
of
the
VCCEP
pilot
chemicals
included
samples
from
human
blood,
breast
milk,
and
exhaled
breath.
Presence
in
the
environment
was
established
by
monitoring
data
indicating
presence
in
indoor
air
or
presence
in
drinking
water
as
an
unregulated
contaminant.

Chemicals
were
screened
from
the
VCCEP
pilot
if
they
were
being
adequately
addressed
by
another
risk
management
program,
were
being
phased
out,
or
were
not
manufactured
in
or
imported
into
the
United
States.
Other
chemicals
were
deferred
because
of
ongoing
assessments
that
are
similar
in
scope
to
the
VCCEP.

2(
b)
Use/
Users
of
the
Data
The
information
collected
through
the
VCCEP
will
provide
critical
information
on
health
effects,
exposure,
risk,
and
data
needs
that
will
enable
EPA
and
others
to
properly
assess
and
manage
health
risks
to
children
that
may
be
posed
by
exposure
to
the
20
pilot
VCCEP
chemicals
covered
by
TSCA.
This
information
will
also
be
made
publically
available
to
help
the
public
understand
the
risks
posed
by
exposure
to
certain
chemicals
and
to
facilitate
the
public's
involvement
in
environmental
decision­
making.

Data
collected
under
the
VCCEP,
along
with
a
report
of
a
Peer
Consultation's
discussion
of
the
data,
will
be
used
by
EPA
scientists
to
determine
whether
the
subject
chemicals
are
likely
to
present
an
unreasonable
risk
to
children's
health.
In
determining
whether
a
subject
chemical
is
likely
to
present
an
unreasonable
risk
to
children's
health
and
whether
data
from
the
next
VCCEP
Tier
are
needed,
the
EPA
scientists
will
rely
on
the
opinions
of
the
scientific
experts
at
the
Peer
Consultation
and
public
comment
processes.
If
EPA's
Data
Needs
Decision
differs
substantially
from
the
approach
indicated
by
the
third
party
report,
EPA
will
provide
a
supporting
rationale
indicating
the
basis
for
its
approach.
Stakeholders
will
have
60
days
to
comment.
EPA
will
consider
these
comments
and
then
issue
a
final
decision.
EPA
has
also
provided
guidance
to
the
VCCEP
participants
that
explains
how
to
develop
an
acceptable
assessment
document,
and
how
to
assess
risk
to
children.
The
Peer
Consultation
participants
will
use
accepted
scientific
standards
when
reviewing
the
assessment
documents
provided.
EPA
also
intends
to
apply
the
accepted
scientific
standards
and
principles,
as
we
currently
do
in
making
risk
determinations
under
other
TSCA
programs.

If
the
hazard,
exposure,
and
risk
data
submitted
by
the
sponsor
indicate
that
potentially
unreasonable
risks
to
children
may
exist,
the
data
will
be
used
by
EPA
and
the
manufacturer
to
determine
the
appropriate
action
necessary
to
avoid
or
mitigate
the
risks.
Such
information,
considered
in
conjunction
with
exposure
data,
can
be
used
for
risk
management,
hazard
communication
and
right­
to­
know
purposes,
and
product
labels.
EPA
may
also
use
the
assessments
to
identify
chemicals
that
may
not
warrant
additional
regulation
or
concern,
or
should
otherwise
be
treated
as
a
low
priority
for
further
consideration.
For
example,
the
first
six
Peer
Consultations
conducted
under
the
VCCEP
resulted
in
recommendations
that
no
further
data
were
needed
to
characterize
risks
to
children
for
three
of
the
six
subject
chemicals
.
­
4­
The
data
may
also
be
used
by
other
Federal
agencies
such
as
the
Consumer
Product
Safety
Commission
(
CPSC),
the
Occupational
Safety
and
Health
Administration
(
OSHA),
and
the
National
Institute
for
Occupational
Safety
and
Health
(
NIOSH).

Additionally,
data
developed
for
chemicals
used
or
produced
in
particular
work
sites
will
be
useful
in
developing
comprehensive
safety
and
health
programs
at
those
facilities.
Local,
state
and
county
governments
rely
on
the
Agency's
ability
to
set
health
and
environmental
standards,
as
do
other
national
governments.
The
paperwork
related
requirements
imposed
on
the
sponsors
as
part
of
the
VCCEP
allow
EPA
to
ensure
that
the
necessary
data
will
be
developed,
that
the
results
meet
basic
scientific
standards
of
acceptability
and
adequacy,
and
that
the
testing
is
progressing
on
schedule.
To
date,
EPA
has
used
collected
data
from
other
test
programs
to
perform
the
necessary
assessments
that
support
such
activities
as
the
development
of
water
quality
criteria,
hazardous
waste
listings,
chemical
advisories,
and
reduction
of
workplace
exposures.

3
NON­
DUPLICATION,
CONSULTATIONS,
AND
OTHER
COLLECTION
CRITERIA
3(
a)
Non­
Duplication
3(
a)(
1)
Testing
and
assessments
Prior
to
announcing
the
VCCEP,
EPA
held
three
public
meeting
with
stakeholders
(
industry,
other
government
agencies,
children's
health
groups,
environmental
groups,
animal
welfare
groups)
to
discuss
the
appropriate
test
battery
to
evaluate
chemicals
of
concern
for
children
health.
This
was
done
to
ensure
that
only
the
tests
that
could
contribute
to
the
understanding
of
a
chemical's
effect
on
children's
health
would
be
conducted
under
the
VCCEP.
The
stakeholder
involvement
process
and
recommendations
from
the
EPA
Science
Advisory
Panel
(
SAP)
identified
such
a
test
battery.
The
stakeholder
involvement
process
also
identified
a
tiering
process
that
would
stage
when
the
sponsor
would
be
asked
to
submit
the
data
specified
by
the
test
battery.

Under
the
VCCEP,
the
sponsor(
s)
will
only
be
asked
to
submit
the
data
specified
by
the
test
battery
in
accordance
with
a
tiering
process
that
allows
the
sponsor(
s)
to
make
a
separate
commitment
for
each
tier.
Before
conducting
any
new
testing,
it
is
the
VCCEP
sponsor's
responsibility
to
review
available
data
and
existing
studies
so
duplication
of
testing
can
be
avoided.
Because
a
sponsor's
use
of
adequate,
existing
data
to
evaluate
a
chemical
under
the
VCCEP
will
provide
a
substantial
cost
savings
over
developing
data
through
new
testing,
EPA
believes
the
data
developed
as
a
result
of
the
VCCEP
will
not
be
duplicative.
EPA
also
believes
that
duplication
of
the
required
assessments
(
hazard,
exposure,
risk,
and
data
needs)
will
not
occur
in
implementing
the
VCCEP,
because
only
one
submission
is
necessary
for
each
chemical.
As
a
result,
each
chemical
is
sponsored
by
either
a
single
company
or
a
single
consortium
of
companies,
usually
consisting
of
the
manufacturers
of
the
chemical
in
question.
In
addition,
­
5­
information
regarding
the
voluntary
commitments
under
the
VCCEP
will
be
posted
on
the
EPA
website,
where
they
will
be
available
to
the
public
(
go
to:
http://
www.
epa.
gov/
chemrtk/
vccep/
index.
htm).

3(
a)(
2)
Exemptions
Exemptions
are
not
required
or
necessary
for
this
program
because
participation
in
the
program
is
voluntary.

3(
a)(
3)
Equivalence
information
Equivalence
information
will
provide
verification
that
a
chemical
tested
is
the
same
as
the
chemical
in
the
VCCEP.
Often
this
information
is
CBI
and
only
the
manufacturer
or
processor
of
the
chemical
has
this
information.
As
such,
the
collection
of
this
information
under
the
VCCEP
is
not
duplicative.

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
A
number
of
issues
applicable
to
the
implementation
of
the
VCCEP,
including
the
time
allowed
for
completing
testing,
what
constitutes
confidential
information,
how
EPA
should
provide
guidance
for
submission
of
equivalence
data,
and
how
the
Agency
will
provide
standards
for
development
of
test
data,
were
developed
over
the
past
25
years
as
part
of
the
Agency's
overall
TSCA
chemical
testing
program
and
involved
an
extensive
public
process
involving
both
notice
and
comment
rulemakings
and
many
public
meetings.

In
developing
the
details
of
the
VCCEP,
EPA
considered
advice
from
the
SAP
and
individual
input
from
the
stakeholders
concerning
the
appropriate
test
battery
for
this
program.
EPA
also
considered
stakeholder
comments
in
a
public
meeting
setting
on
the
need
for
exposure
and
risk
assessments
in
addition
to
the
hazard
assessment.
The
initial
interest
in
exposure
and
risk
assessments
came
from
industry
representatives
at
the
meetings.
EPA
described
what
each
assessment
should
contain
in
a
document
provided
prior
to
or
at
each
public
meeting.
Hazard
assessments
were
to
follow
the
format
of
"
robust
summaries."
The
format
for
an
Exposure
Assessment
was
discussed
and
developed
at
a
workshop
with
EPA
and
industry
participation.
Risk
assessments
were
to
be
an
integration
of
the
information
in
the
hazard
and
exposure
assessments.
Guidance
documents
were
also
identified
to
guide
the
sponsor
in
developing
information
for
the
assessments.
The
submission
of
all
the
assessments
in
a
single
document
for
­
6­
review
by
a
Peer
Consultation
was
also
discussed
at
the
public
meetings.
EPA
also
considered
input
on
how
the
Peer
Consultation
should
be
run
and
how
the
pilot
program
should
be
evaluated.
At
three
and
six
years
after
the
initiation
of
the
pilot,
EPA
expects
to
evaluate
the
pilot
program
to
consider
what
modifications
might
be
made
that
would
make
the
VCCEP
run
more
efficiently.
Representatives
of
the
stakeholders
and
the
third
party
will
be
consulted
in
this
evaluation.

Under
5
CFR
1320.8(
d)(
1),
OMB
requires
agencies
to
consult
with
potential
ICR
respondents
and
data
users
about
specific
aspects
of
an
ICR
before
submitting
a
renewal
of
that
ICR
to
OMB
for
review
and
approval.
In
accordance
with
this
regulation
and
based
on
OPPTS
Regulatory
Coordination
Staff
guidance,
EPA
will
solicit
comments
from
nine
potential
ICR
respondents
and
data
users
with
respect
to
the
renewal
of
this
ICR.

3(
d)
Effects
of
Less
Frequent
Collection
As
designed,
this
program
minimizes
overall
burden
by
utilizing
a
tiering
process
for
submissions
and
by
allowing
companies
to
join
together
to
sponsor
a
chemical,
limiting
submissions
per
chemical
to
the
minimum
(
only
one
response
per
chemical,
per
tier).
The
VCCEP
requires
the
sponsor
to
submit
a
letter
notifying
EPA
that
it
is
volunteering
to
sponsor
a
particular
chemical
and
include
the
anticipated
start
date
and
completion
date
for
any
testing
conducted
under
that
tier
of
the
program.
There
are
three
separate
tiers,
but
the
sponsor
for
each
tier
may
vary
from
tier
to
tier.
The
sponsor
is
also
required
to
submit
all
four
assessments
(
hazard,
exposure,
risk,
and
data
needs)
in
a
single
document.
EPA
believes
this
is
the
absolute
minimum
frequency
for
collecting
the
information
under
such
a
chemical
evaluation
program.

3(
e)
Compliance
with
General
OMB
Guidelines
The
data
retention
requirements
for
test
rules
and
consent
orders
exceeds
one
of
OMB's
general
guidelines
contained
in
5
CFR
1320.5(
d)(
2).
Documentation
records,
raw
data,
and
specimens
pertaining
to
a
test
rule
or
consent
order
study
are
required
by
Good
Laboratory
Practice
Standards
(
GLPS)
to
be
retained
for
ten
years
from
the
effective
date
of
the
applicable
test
rule
or
publication
date
of
the
consent
order
(
40
CFR
792).
This
requirement
is
necessary
to
permit
sufficient
time
to
review
results,
perform
appropriate
risk
assessments
and,
when
necessary,
to
institute
appropriate
regulatory
control
responses.
Long­
term
studies
may
take
five
years
from
the
effective
date
of
the
final
test
rule
or
consent
order
to
perform
and
submit
to
the
Agency;
assessment
of
study
results
may
require
an
additional
one
to
two
years
of
internal
and
external
peer
review;
institution
of
regulatory
controls
and
legal
challenges
may
require
an
additional
two
to
three
years
before
final
resolution
of
issues.
All
studies,
both
short
and
longterm
are
relevant
to
assessing
the
potential
risk
of
the
chemical
and
therefore
must
be
retained
during
the
ten
year
period.
In
those
regulatory
cases
where
the
Agency's
action
may
be
challenged,
it
is
imperative
that
all
records,
raw
data,
and
specimens
be
available
to
support
the
Agency's
decision.

These
same
considerations
apply
to
the
data
generated
for
the
VCCEP.
The
time
1TERA
=
Toxicology
Excellence
for
Risk
Assessment.
EPA
has
a
cooperative
agreement
to
have
TERA
organize,
facilitate,
and
summarize
the
results
of
the
Peer
Consultation
meetings
on
VCCEP
chemical
assessments.

­
7­
necessary
to
develop
the
data
required
by
the
VCCEP
should
closely
reflect
the
time
needs
previously
calculated
for
a
test
rule
and
consent
order
because
the
VCCEP,
test
rules,
and
consent
orders
follow
the
same
guidance
concerning
time
allowed
per
test.
However,
in
the
VCCEP,
additional
time
is
needed
to
develop
exposure,
risk,
and
data
needs
assessments
at
each
tier.
The
notice
announcing
the
VCCEP
specified
that
four
months
could
be
requested
for
this
purpose.
The
four
months
would
be
in
addition
to
the
time
necessary
to
develop
the
health
effects
data.
If
four
months
is
requested
at
each
of
three
tiers,
an
additional
12
months
would
be
added
to
the
time
requirement
for
the
program.
Also,
the
VCCEP
is
a
tiered
testing
program
and,
for
some
pilot
chemicals,
Tier
3
testing
might
not
begin
until
eight
years
into
the
program.

Additional
time
may
be
necessary
for
review
in
the
VCCEP
compared
to
what
is
necessary
for
test
rules
and
consent
orders.
The
VCCEP
has
features
not
present
in
most
test
rules
and
consent
orders,
namely
a
Peer
Consultation
(
approximately
two
months),
the
third
party's
(
i.
e.,
TERA's1)
report
preparation
(
approx.
2
months),
EPA's
announcement
of
its
Data
Needs
Decision
(
approx.
6
months),
and
4
months
for
the
sponsor
to
commit
to
the
next
tier
of
testing.
This
additional
time
of
14
months
would
be
required
for
both
Tier
1
and
Tier
2,
while
Tier
3
would
require
only
4
additional
months
since
it
does
not
have
a
Data
Needs
Decision.
Therefore,
the
VCCEP
may
require
an
additional
32
months
to
implement,
but
a
significant
amount
of
this
time
may
be
matched
by
the
test
rule/
consent
order
review
time
that
requires
a
complete
review
of
studies
in
house,
the
development
of
an
exposure
assessment
in
house,
and
the
development
of
an
EPA
risk
assessment
document.
A
final
consideration
that
would
add
to
the
VCCEP
implementation
time
is
the
likelihood
of
scheduling
problems
in
arranging
the
Peer
Consultation
meetings
due
to
the
time
demands
on
the
scientific
experts
whose
participation
will
be
needed.

For
the
above
reasons,
the
records
retention
time
for
the
VCCEP
pilot
will
be
10
years
from
the
date
that
the
studies/
information
are
submitted
to
EPA.
Ten
years
is
also
the
records
retention
time
specified
by
GLP.
Thus,
the
Paperwork
Reduction
Act
(
PRA)
guidelines
specifying
that
data
other
than
health,
medical,
or
tax
records
not
be
required
to
be
retained
for
more
than
three
years
will
be
exceeded
in
this
program.

3(
f)
Confidentiality
EPA
expects
that
information
submitted
to
EPA
in
response
to
the
VCCEP
is,
in
most
cases,
non­
confidential.
If
respondents
wish
to
claim
information
submitted
in
response
to
the
VCCEP
as
CBI,
they
may
do
so.
Respondents
may
claim
all
or
part
of
a
document
confidential
if
there
is
a
legitimate
need
to
do
so
as
described
in
40
CFR
part
2.
These
claims
will
be
handled
according
to
the
EPA
procedures
described
in
40
CFR
Part
2
and
the
TSCA
Confidential
Business
Information
Security
Manual,
which
call
for
careful
protection
of
confidential
business
information.
EPA
will
disclose
information
that
is
covered
by
a
claim
of
confidentiality
only
to
the
extent
permitted
by,
and
in
accordance
with,
the
procedures
in
TSCA
section
14
and
40
CFR
­
8­
part
2.

3(
g)
Sensitive
Questions
The
information
requested
does
not
include
information
of
a
sensitive
nature
other
than
CBI,
which
is
discussed
above
in
Unit
3(
f).

4
THE
RESPONDENTS
AND
THE
INFORMATION
REQUESTED
4(
a)
Respondents/
NAICS
Codes
Respondents
affected
by
the
collection
activity
may
include,
but
are
not
limited
to:

Type
of
Entity
NAICS
Examples
of
Potentially
Affected
Entities
Chemical
Manufacturers
and
Importers
325,
32552
32551
313
42272
Persons
who
manufacture
(
defined
by
statute
to
include
import)
one
or
more
of
the
subject
chemical
substances.

The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
indicate
which
entities
might
be
affected
by
this
information
collection
activity.
This
listing
is
not
intended
to
be
exhaustive
and
other
types
of
entities
not
listed
in
this
table
could
also
be
affected.

4(
b)
Information
Requested
4(
b)(
i)
Data
Items
The
VCCEP
is
a
voluntary
initiative
under
which
manufacturers
and
importers
of
chemicals
to
which
children
have
a
high
likelihood
of
exposure
agree
to
submit
available
data,
develop
data,
and/
or
conduct
any
needed
testing
for
the
chemicals
they
manufacture
or
import.
Although
the
data
submissions
are
voluntary,
EPA
believes
that
the
development
and/
or
submission
of
such
data
represents
costs
and
burdens
not
captured
in
existing
information
collections.

In
general,
Sponsors
will
be
asked
to
submit
a
letter
of
commitment
to
sponsor
a
chemical
in
a
specific
tier;
submit
a
Peer
Consultation
Document
for
each
tier
and
each
chemical
committed
to
which
will
contain
four
assessments;
and
retain
the
required
records
related
to
the
assessments
for
ten
years
after
the
date
they
are
submitted
to
EPA.
­
9­
Following
is
a
list
of
information
that
the
Sponsor
will
submit:

1.
Letter
of
commitment
for
each
chemical
and
tier
sponsored.

2.
Peer
Consultation
Document
for
each
chemical
and
tier
sponsored.
Each
Peer
Consultation
Document
will
contain
four
assessments:
°
Hazard
Assessment.
°
Exposure
Assessment.
°
Risk
Assessment.
°
Data
Needs
Assessment.

EPA
has
specified
four
assessments
as
necessary
to
address
unanswered
questions
about
the
effects
on
children
from
exposure
to
a
chemical
substance.
The
four
assessments
will
address
hazard,
exposure,
risk,
and
data
needs.
The
scope
of
testing/
data
development
for
each
chemical
is
limited
to
the
tier
for
which
a
commitment
to
sponsor
has
been
received,
and
to
the
tests/
data
specified
for
that
tier.
However,
if
there
are
existing
studies,
even
though
they
address
an
endpoint
in
an
upper
tier
not
yet
committed
to,
the
sponsor
is
expected
to
include
that
study
in
the
relevant
assessment
prepared
for
the
lower
tier.
The
assessments
are
to
be
submitted
in
a
single
document,
the
Peer
Consultation
Document,
and
prepared
for
each
tier
to
which
a
company
or
consortium
commits.

The
Hazard
Assessment
to
be
prepared
by
the
sponsor
will
is
to
be
based
primarily
on
the
toxicity
tests
specified
for
the
tier
committed
to,
but
should
also
include
existing
studies
even
though
they
address
endpoints
in
an
upper
tier
not
yet
committed
to.
The
three
tiers
of
toxicity
tests
specified
by
the
VCCEP
are
listed
in
Table
1.
­
10­
Table
1.­­
Three
Tiers
of
VCCEP
Tests
Tier
Test
Test
Guideline
11
Acute
oral
toxicity
(
up/
down)
OR
Acute
inhalation
toxicity
OECD
425
or
ASTM
E1163­
98
OECD
403
or
40
CFR
799.9130
In
vitro
gene
mutation:
Bacterial
reverse
mutation
assay
OECD
471,
870.5100,
or
40
CFR
799.9510
Combined
repeated
dose
toxicity
with
reproductive
and
developmental
toxicity
screens
OR
Repeated
dose
oral
toxicity
AND
Reproductive
toxicity
(
1­
generation)
OECD
422
OECD
407
OECD
415/
421
In
vitro
chromosomal
aberrations
OR
In
vivo
chromosomal
aberrations
OR
In
vivo
mammalian
erythrocyte
micronucleus
OECD
473,
870.5375,
or
40
CFR
799.9537
OECD
475,
870.5385,
or
40
CFR
799.9538
OECD
474,
870.5395,
or
40
CFR
799.9539
2
90­
day
subchronic
toxicity
in
rodents
870.3100
(
oral),
or
870.3250
(
dermal),
or
870.3465
(
inhalation)
or
40
CFR
799.9346
(
inhalation)

Reproduction
and
fertility
effects
870.3800
or
40
CFR
799.9380
Prenatal
developmental
toxicity
(
two
species)
870.3700
or
40
CFR
799.9370
In
vivo
mammalian
bone
marrow
chromosomal
aberrations,
OR
In
vivo
mammalian
erythrocyte
micronucleus
Triggered
off
results
from
in
vitro
mammalian
chromosomal
aberration
test
if
conducted
in
Tier
1)
OECD
475,
870.5385,
or
40
CFR
799.9538
OECD
474,
870.5395,
or
40
CFR
799.9539
Immunotoxicity
870.7800
or
40
CFR
799.9780
Metabolism
and
pharmacokinetics
870.7485
or
40
CFR
799.9748
3
Carcinogenicity
OR
chronic
toxicity/
carcinogenicity
870.4200
or
40
CFR
799.9420
870.4300
Neurotoxicity
screening
battery
870.6200
or
40
CFR
799.9620
Developmental
neurotoxicity
870.6300
or
40
CFR
799.9630
The
various
guidelines
that
are
appropriate
to
use
when
conducting
each
test
are
the
TSCA
guidelines
in
40
CFR
part
799,
the
Organization
for
Economic
Cooperation
and
Development
(
OECD)
guidelines,
the
American
Society
for
Testing
and
Materials
(
ASTM)
International
guideline,
or
the
OPPTS
harmonized
guidelines
in
the
870
series
(
Health
Effects
Test
Guidelines).
The
OPPTS
harmonized
test
guidelines
have
been
developed
for
use
in
the
­
11­
testing
of
pesticides
and
toxic
substances,
and
the
development
of
test
data
that
must
be
submitted
to
the
Agency
for
review
under
Federal
regulations.
Initiated
several
years
ago,
the
purpose
of
harmonizing
the
guidelines
into
a
single
set
of
OPPTS
guidelines
is
to
minimize
variations
among
the
testing
procedures
that
must
be
performed
to
meet
the
Agency's
data
requirements
for
submissions
under
the
Toxic
Substances
Control
Act
(
TSCA)
(
15
U.
S.
C.
2601)
and
the
Federal
Insecticide,
Fungicide
and
Rodenticide
Act
(
FIFRA)
(
7
U.
S.
C.
136­
136y).
In
establishing
the
harmonized
guidelines,
the
Agency
considers
available
guidelines,
including
those
that
might
have
been
developed
by
EPA
for
pesticides
or
toxic
substances,
as
well
as
those
developed
by
OECD.
Today,
the
harmonized
guidelines
may
also
be
newly
developed
through
a
cooperative
process
reflecting
all
three
organizations,
as
well
as
others
in
the
scientific
community.
In
general,
the
process
for
developing
the
OPPTS
harmonized
test
guidelines
is
scientifically
rigorous
and
includes
both
peer
review
and
public
comment
opportunities.
To
access
copies
of
the
OPPTS
harmonized
guidelines,
go
to
http://
www.
epa.
gov/
opptsfrs/
OPPTS_
Harmonized/.

The
Exposure
Assessment
to
be
prepared
by
the
sponsor
should
contain
information
to
answer
the
following
questions
for
a
particular
chemical:

°
Who
and
how
many
people
are
exposed?
°
What
are
the
sources
of
exposure,
i.
e.,
environmental
releases,
consumer
products,
etc.?
°
Does
the
exposure
occur
through
breathing
air,
drinking
water,
eating
food,
contact
with
skin,
or
any
other
routes?
°
How
intense
is
the
exposure,
i.
e.,
what
is
the
potential
dose
level?
°
How
often
and
for
how
long
does
exposure
occur,
that
is,
what
is
its
frequency
and
duration?

The
populations
of
concern
to
this
program
are
children
and,
in
certain
situations,
prospective
parents.
Exposures
that
can
affect
children
are
those
that
occur
prior
to
conception
(
to
either
or
both
parents),
during
prenatal
development,
and
postnatally
to
the
age
of
sexual
maturation,
which
is
completed
around
18­
21
years
of
age.
Although
adult
exposures
are
not
intended
to
be
a
major
focus
of
the
VCCEP,
certain
risks
to
children
cannot
be
assessed
without
evaluating
parental
exposures.
Specifically,
prospective
parents'
exposure
is
relevant
to
an
evaluation
of
risks
due
to
fertility
and
reproductive
effects,
as
well
as
developmental
effects
from
in
utero
exposures.
Children
can
be
exposed
to
chemicals
through
food
and
drinking
water,
through
indoor
and
outdoor
air,
through
ingestion
of
dust
and
soil,
and
through
direct
contact
with
products
they
use
and
products
used
in
their
immediate
vicinity.
Prospective
parents
can
be
exposed
to
chemicals
through
these
pathways
as
well
as
through
occupational
activities.

The
information
in
a
complete
Exposure
Assessment
should
be
representative
and
encompass
manufacturing,
processing,
and
use.
If
existing
data
are
submitted,
they
may
include
non­
TSCA
uses,
but
if
new
data
are
developed
they
should
focus
on
exposure
data
from
TSCA
uses.
The
specific
content
of
a
particular
exposure
assessment
is
dependent
upon
the
specific
chemical
involved
and
the
information
available
at
the
time
that
the
assessment
is
performed.
For
example,
if
during
Tier
1
it
is
determined
that
the
chemical
in
question
is
only
used
in
industrial
­
12­
settings
and
using
a
closed
process,
it
is
unlikely
that
the
exposure
assessment
would
need
to
consider
all
of
the
factors
that
could
be
included
in
a
complete
exposure
assessment
as
listed
below.
When
a
question
arises
about
the
content
of
a
particular
exposure
assessment,
the
sponsor
will
be
able
to
consult
with
EPA
and
other
participants
before
proceeding.
To
assist
the
sponsors
in
preparing
a
complete
Exposure
Assessment,
the
Agency
has
also
made
several
detailed
guidance
documents
available
to
sponsors
that
are
also
used
by
EPA
staff
and
others
to
prepare
the
exposure
assessments
that
are
submitted
to
or
otherwise
used
by
the
Agency
in
decisionmaking
These
documents
can
be
found
under
"
Guidance
Documents"
at
http://
www.
epa.
gov/
chemrtk/
vccep/
guidevccep.
htm.

Although
the
guidance
documents
cited
above
provide
more
specific
detail
about
what
to
include
in
a
Exposure
Assessment,
the
following
is
a
list
of
the
specific
types
of
information
that
the
Agency
has
told
sponsors
that
they
should
submit
in
an
Exposure
Assessment
(
see
also
the
discussion
that
begins
on
65
FR
81710):

°
Identification
of
all
potential
manufacturing
and
processing
activities
associated
with
the
chemical
that
can
lead
to
exposure
to
children
or,
where
relevant,
prospective
parents.
It
is
appropriate
to
evaluate
a
prospective
parent's
exposure
if
it
is
relevant
to
determining
the
need
for
higher
tier
developmental
and
reproductive
toxicity
studies.

°
Identification
of
all
potential
uses
(
industrial,
commercial,
consumer)
of
the
chemical
and
activities
associated
with
these
uses
that
may
lead
to
exposure
to
children
or,
if
appropriate,
prospective
parents.

°
Measures
or
estimates
of
exposure
to
children
(
including
significant
subpopulations)
or,
where
relevant,
prospective
parents.

°
Measures
or
estimates
of
environmental
releases
from
all
activities
and
exposures
resulting
from
these
releases.

°
Identification
of
relevant
activity
patterns,
age
ranges
and
subpopulations
associated
with
activities
that
can
lead
to
exposures.

°
Physical/
chemical
properties
and
environmental
fate
characteristics.

°
Review
and
analysis
of
relevant
existing
environmental
and
biological
monitoring
data.

°
Documentation
of
all
measured
data,
scenarios,
assumptions,
and
estimation
techniques.

Exposure
Assessments
should
be
developed
using
EPA's
Exposure
Assessment
Guidelines
as
well
as
other
existing
exposure
assessment
procedures
and
guidance.
EPA's
National
Center
for
Environmental
Assessment
(
NCEA)
has
prepared
a
document
entitled
"
Child­
Specific
Exposure
Factors
Handbook"
that
consolidates
all
child
exposure
factors
and
related
data
in
one
­
13­
document.
After
considering
public
comment,
the
final
Handbook
was
issued
on
September
1,
2002
(
Child­
specific
Exposure
Factors
Handbook
(
Interim
Report),
USEPA
EPA­
600­
P­
00­
002B,
01
Sep
2002)
and
is
easily
accessible
under
"
Guidance
Documents"
at
http://
www.
epa.
gov/
chemrtk/
vccep/
guidevccep.
htm.

The
exposure
information
that
is
provided
for
the
VCCEP
should
be
transparent
and
should
address
the
completeness
of
the
assessment,
i.
e.,
how
complete
is
the
assessment
in
terms
of
addressing
sources,
populations,
pathways
and
routes
of
exposure
to
children.
It
is
important
to
note
that
given
the
tier
structure
of
the
VCCEP,
the
Exposure
Assessment
may
need
to
be
amended
when
the
chemical
proceeds
to
the
next
tier.
As
is
always
the
case,
the
specific
content
of
a
particular
exposure
assessment
is
dependent
upon
the
specific
chemical
involved
and
the
information
available
to
the
Sponsor
at
the
time
that
the
assessment
is
being
performed.
For
example,
if
during
Tier
1
it
is
determined
that
the
chemical
in
question
is
only
used
in
industrial
settings
and
using
a
closed
process,
it
is
unlikely
that
the
exposure
assessment
would
need
to
consider
all
of
the
factors
listed.
When
a
question
arises,
the
Sponsor
will
be
able
to
consult
with
EPA
and
other
participants
before
proceeding.

In
determining
the
adequacy
of
existing
data
under
Tier
1,
EPA
and
the
Sponsors
agreed
to
use
the
same
approach
contained
in
the
guidance
provided
for
the
HPV
Challenge
Program,
a
copy
of
which
is
available
at
http://
www.
epa.
gov/
chemrtk/
datadfin.
htm.
This
document
provides
basic
guidance
for
accepting
or
rejecting
data
used
to
describe
the
basic
hazard
of
a
chemical,
but
the
approach
presented
is
also
generally
used
for
determining
whether
available
data
are
adequate
to
describe
the
potential
health
effects
of
a
chemical.
Basically,
the
approach
used
has
two
steps.
In
Step
1,
established
criteria
should
be
used
to
assess
overall
scientific
integrity
of
the
information.
Any
data
or
information
that
do
not
meet
the
Step
1
criteria
are
to
be
rejected
from
further
consideration.
In
Step
2,
a
more
rigorous
evaluation
of
existing
data
that
have
passed
Step
1
occurs
(
existing
data
generated
via
OECD
or
equivalent
guidelines
can
enter
directly
into
Step
2
evaluation).
The
specific
criteria
are
test
specific
and
described
in
detail
in
the
guidance
document
referenced
above.

In
determining
whether
a
chemical
will
proceed
to
Tier
2
or
from
Tier
2
to
Tier
3,
the
Agency
will
review
all
of
the
assessments
submitted
by
the
Sponsor,
along
with
the
Peer
Consultation
report,
and
prepare
a
Data
Needs
Decision
at
the
completion
of
each
Tier.
For
the
most
part,
the
Agency's
Data
Needs
Decision
is
expected
to
mirror
the
general
opinion
of
the
Peer
Consultation
report.
As
described
in
the
December
2000
Federal
Register
Notice
describing
the
VCCEP,
the
Agency
considers
the
following
factors
when
making
a
Data
Needs
Decision
under
the
VCCEP
(
see
also
the
discussion
that
begins
on
65
FR
81712):

(
1)
EPA
will
utilize
a
risk­
based,
scientifically
sound
process
to
make
decisions
on
the
need
for
further
information
gathering
or
risk
reduction
action
(
65
FR
81715).
­
14­
(
2)
When
the
risk
characterization
is
adequate
to
characterize
the
relative
level
of
risk
to
children
and,
where
relevant,
prospective
parents,
additional
studies
or
data
from
the
next
tier
will
not
be
pursued
(
65
FR
81712).

(
3)
In
making
a
data
needs
decision,
EPA
will
use
a
weight­
of­
evidence
approach
to
evaluate
both
the
hazard
and
exposure
data
prepared
by
the
sponsor
(
65
FR
81712).

(
4)
An
appropriately
conservative
screening
level
assessment
can
help
rule
out
certain
exposures
(
65
FR
81711).

(
5)
If
specific
toxicity
studies
are
indicated,
they
should
be
chosen
from
the
next
tier
of
studies
within
the
overall
framework
and
should
allow
flexibility,
if
possible,
to
pursue
either
additional
toxicity
testing
and/
or
exposure
evaluation,
allowing
sponsors
to
select
the
option
that
will
most
quickly,
directly,
and
cost­
effectively
reduce
uncertainty
(
65
FR
81713).
And,

(
6)
Other
factors
may
also
be
considered,
as
appropriate.
See
also
the
discussion
that
begins
on
65
FR
81712.

4(
c)
Respondent
(
Sponsor)
Activities
Sponsors
in
the
pilot
VCCEP
may
undertake
a
number
of
activities
during
the
effective
period
of
this
ICR.
The
actual
number
and
type
of
activities
a
sponsor
will
undertake
will
depend
on
the
tier(
s)
committed
to,
the
amount
of
currently
available
data
on
the
health
effects,
exposure,
and
risk
to
children
for
the
subject
chemical(
s),
and
EPA's
decision
on
the
need
for
additional
data
on
the
chemical(
s).
The
maximum
number
and
type
of
activities
that
a
Sponsor
in
the
pilot
VCCEP
can
be
anticipated
to
undertake
per
tier
commitment
are
listed
below
for
all
three
tiers,
even
though
many
of
the
chemicals
may
not
complete
all
three
tiers
of
evaluation
during
the
effective
period
of
this
ICR.

Tier
1:
(
1)
Review
notice
announcing
the
VCCEP.
(
2)
Submit
"
Letter
of
Commitment"
to
EPA
volunteering
to
sponsor
a
chemical
in
Tier
1.
(
3)
Conduct
file
search
for
relevant
existing
data
on
toxicity
and
exposure.
If
existing
data
are
found:
­
Prepare
and
review
summaries
of
existing
data.
­
Add
summaries
to
Hazard
and
Exposure
Assessments.
(
4)
Plan
necessary
activities,
e.
g.,
consortia,
arrange
for
conduct
of
studies,
etc.
(
5)
Prepare
"
Hazard
Assessment,"
"
Exposure
Assessment,"
"
Risk
Assessment"
and
"
Data
Needs
Assessment"
for
Tier
1
for
each
chemical
committed
to.
(
6)
Prepare
"
Peer
Consultation
Document"
for
Tier
1.
(
7)
Review
Peer
Consultation
Document
for
CBI.
­
15­
(
8)
Submit
three
copies
and
one
electronic
copy
of
the
Peer
Consultation
Document
for
Tier
1
to
EPA.
(
9)
Present
the
assessments
to
the
Peer
Consultation
Group
at
the
public
meeting.
(
10)
Maintain
test
data
records
and
Peer
Consultation
Documents
for
ten
years.

Tier
2:
(
1)
Submit
"
Letter
of
Commitment"
to
EPA
volunteering
to
sponsor
a
chemical
in
Tier
2.
(
2)
Conduct
file
search
for
any
new
existing
data
on
toxicity
and
exposure.
If
existing
data
are
found:
­
Prepare
and
review
summaries
of
existing
data.
­
Add
summaries
to
Hazard
and
Exposure
Assessments.
(
3)
Plan
necessary
activities,
e.
g.,
consortia,
arrange
for
conduct
of
studies,
etc.
(
4)
Prepare
"
Hazard
Assessment,"
"
Exposure
Assessment,"
"
Risk
Assessment"
and
"
Data
Needs
Assessment"
for
Tier
2
for
each
chemical
committed
to.
(
5)
Prepare
"
Peer
Consultation
Document"
for
Tier
2
for
each
chemical
committed
to.
(
6)
Review
Peer
Consultation
Document
for
CBI.
(
7)
Submit
three
copies
and
one
electronic
copy
of
the
Peer
Consultation
Document
to
EPA.
(
8)
Present
the
assessments
to
the
Peer
Consultation
Group
at
the
public
meeting.
(
9)
Maintain
test
data
records
and
Peer
Consultation
Documents
for
ten
years.

Tier
3:
(
1)
Submit
"
Letter
of
Commitment"
to
EPA
volunteering
to
sponsor
a
chemical
in
Tier
3.
(
2)
Conduct
file
search
for
any
new
existing
data
on
toxicity
and
exposure.
If
existing
data
are
found:
­
Prepare
and
review
summaries
of
existing
data.
­
Add
summaries
to
Hazard
and
Exposure
Assessments.
(
3)
Plan
necessary
activities,
e.
g.,
consortia,
arrange
for
conduct
of
studies,
etc.
(
4)
Prepare
"
Hazard
Assessment,"
"
Exposure
Assessment"
and
"
Risk
Assessment"
for
Tier
3
for
each
chemical
committed
to.
(
5)
Prepare
"
Peer
Consultation
Document"
for
Tier
3
for
each
chemical
committed
to.
(
6)
Review
Peer
Consultation
Document
for
CBI.
(
7)
Submit
three
copies
and
one
electronic
copy
of
the
Peer
Consultation
Document
to
EPA.
(
8)
Present
the
assessments
to
the
Peer
Consultation
Group
at
the
public
meeting.
(
9)
Maintain
test
data
records
and
Peer
Consultation
Documents
for
ten
years.

Additional
information
describing
the
products
of
the
above
activities
is
provided
below:

(
a)
Letter
of
Commitment:
A
company
wishing
to
volunteer
to
sponsor
its
chemical
in
the
VCCEP
must
send
a
letter
to
EPA
committing
to
do
so
by
the
deadline
specified
by
EPA.
The
letter
must
identify
the
company,
technical
contact
(
name,
address,
e­
mail
address,
telephone,
and
fax
number),
the
chemical
name
and
its
CAS
number,
the
tier
committed
to,
the
anticipated
start
date,
and
the
anticipated
submission
date
to
EPA.
Letters
of
­
16­
commitment
have
been
received
for
Tier
1
for
20
chemicals,
Letters
of
commitment
for
Tiers
2
and
3
are
due
4
months
after
the
announcement
of
EPA's
Data
Needs
Decision.

(
b)
Hazard
Assessment:
A
separate
Hazard
Assessment
is
to
be
prepared
for
each
tier
for
each
chemical
to
which
a
sponsor
commits.
The
Hazard
Assessment
should
be
a
"
robust
summary"
of
the
studies
conducted
for
a
particular
tier
and
also
any
existing
relevant
studies,
even
though
they
may
address
an
endpoint
in
an
upper
tier
not
committed
to.
A
robust
summary
is
to
include
an
objective
discussion
of
methods,
results
and
conclusions.
From
a
practical
standpoint,
it
is
not
reasonable
to
attempt
to
create
an
electronic
version
of
full
study
reports.
Instead
electronic
summaries
of
full
study
reports
should
be
prepared
that
contain
the
appropriate
technical
information
for
that
particular
endpoint.
Robust
Summaries
should
provide
sufficient
information
to
allow
a
technically
qualified
person
to
make
an
independent
assessment
of
a
given
study
report
without
having
to
go
back
to
the
full
study
report.
Any
additional
information,
such
as
mechanistic
information
or
SAR,
that
may
influence
decisions
on
further
testing
needs
should
also
be
included.

For
a
Tier
2
commitment,
the
sponsor
should
develop
a
Hazard
Assessment
that
includes
summaries
of
those
Tier
2
studies
that
EPA
has
announced
in
its
Data
Needs
Decision.
In
addition
to
the
new
hazard
data
developed
for
Tier
2,
the
Tier
2
Hazard
Assessment
should
also
contain
all
the
information
from
the
Tier
1
Hazard
Assessment,
which
should
be
revised
as
appropriate
to
reflect
new
insights
provided
by
the
new
hazard
data
developed
for
Tier
2.

For
a
Tier
3
commitment,
the
sponsor
should
develop
a
Hazard
Assessment
that
includes
summaries
of
those
Tier
3
studies
that
EPA
has
announced
in
its
Data
Needs
Decision.
In
addition
to
the
new
hazard
data
developed
for
Tier
3,
the
Tier
3
Hazard
Assessment
should
also
contain
all
the
information
from
the
Tier
2
Hazard
Assessment,
which
should
be
revised
as
appropriate
to
reflect
new
insights
provided
by
the
new
hazard
data
developed
for
Tier
3.

(
c)
Exposure
Assessment:
The
Exposure
Assessment
should
be
a
"
robust
summary"
of
existing
exposure
information
and
any
exposure
studies
conducted
by
the
sponsor.
The
Exposure
Assessment
for
Tier
1
should
consist
primarily
of
screening
level
(
or,
if
available,
better)
information
on
exposure
from
manufacturing
supplemented
with
relevant
screening
level
data
on
downstream
processing
and
use
activities
and
specific
information
on
children's
exposures,
if
available.
A
screening
level
exposure
assessment
should
generate
conservative,
quantitative
estimates
of
exposure.
The
screening
approach
generally
involves
using
readily
available
measured
data,
existing
release
and
exposure
estimates
and
other
exposure­
related
information.
Where
actual
measures
of
exposure
are
not
available,
the
use
of
models
may
be
necessary.
For
example,
a
screening­
level
model
for
ambient
air
exposure
that
uses
the
assumption
that
the
exposed
populations
live
near
the
chemical
release
locations
is
often
used
in
EPA
screening
level
assessments.
An
appropriately
conservative
screening
level
assessment
can
also
help
to
rule
out
certain
­
17­
exposure
concerns
and
set
priorities
for
more
detailed
evaluation
of
the
remaining
concerns.
A
Tier
2
Exposure
Assessment
will
be
more
advanced
assessments
that
develop
more
accurate
estimates
of
exposure
and
will
generally
focus
on
the
higher
priority
exposures
identified
in
the
Tier
1
screening
assessment.
An
advanced
Exposure
Assessment
should
quantify
central
tendency
(
e.
g.
median,
geometric
mean)
and
high
end
(
i.
e.,
greater
than
90th
percentile)
exposures.
Representative,
well
designed
monitoring
studies
of
known
quality
are
the
ideal.
Higher
tier
exposure
models
may
also
be
used
in
advanced
assessments
when
appropriate
measured
data
are
unavailable.
When
higher
tier
models
are
used,
every
effort
should
be
made
to
obtain
accurate
input
data.
For
example,
a
higher
tier
model
for
ambient
air
exposure
may
use
facility­
specific
parameters
for
emission
rates,
such
as
stack
height
and
the
exact
size
and
location
of
the
exposed
population.
Tier
2
assessments
should
also
more
specifically
address
exposures
relevant
to
Tier
2
health
testing
endpoints.
Similarly,
Tier
3
Exposure
Assessments
would
further
develop
Tier
1
and
2
exposure
data
and
more
specifically
address
exposures
relevant
to
Tier
3
health
testing
endpoints.

(
d)
Risk
Assessment:
The
Risk
Assessment
should
integrate
information
presented
in
the
Hazard
Assessment
and
the
Exposure
Assessment
for
the
purpose
of
characterizing
the
risk
to
children's
health
from
exposure
to
the
chemical
in
question.

(
e)
Data
Needs
Assessment:
The
Data
Needs
Assessment
is
the
sponsor's
opinion
of
what
additional
studies
or
data
are
needed
from
the
next
tier
of
the
VCCEP
so
that
a
thorough
assessment
of
the
risk
to
children
from
exposure
to
a
chemical
can
be
developed.

(
f)
Peer
Consultation
Document:
The
Peer
Consultation
Document
is
the
compilation
of
the
Hazard
Assessment,
Exposure
Assessment,
Risk
Assessment,
and
Data
Needs
Assessment
into
a
single
document
that
will
be
submitted
to
EPA
(
three
copies
and
one
electronic
copy).
EPA
will
provide
one
copy
to
TERA
which
will
provide
copies
to
the
Peer
Consultation
members.
EPA
will
also
put
one
copy
in
the
TSCA
Nonconfidential
Information
Center
(
NCIC)
docket.

(
g)
Data
Needs
Decision:
The
Data
Needs
Decision
is
made
by
EPA
and
is
a
decision
concerning
which
tests
in
the
next
tier
of
the
VCCEP
are
needed.
EPA
makes
this
decision
after
reviewing
TERA's
report
of
the
Peer
Consultation,
and
expects
to
rely
on
the
opinions
in
the
report.
If
EPA's
Data
Needs
Decision
differs
substantially
from
the
approach
indicated
by
the
third
party
report,
EPA
will
provide
a
supporting
rationale
indicating
the
basis
for
its
approach.
Stakeholders
will
have
60
days
to
comment.
EPA
will
consider
these
comments
and
then
issue
a
final
decision.

As
a
voluntary
program,
it
is
unnecessary
for
anyone
to
request
an
exemption
under
the
VCCEP.
However,
companies
may
submit
relevant
information
that
indicates
that
specific
chemicals
included
in
the
VCCEP,
based
on
production
volume,
are
not
currently
produced
in
substantial
quantities
and
therefore,
testing
of
these
chemicals
is
not
necessary.
Based
on
a
­
18­
review
of
the
information
submitted,
EPA
may
remove
a
chemical
from
the
list
of
HPV
chemicals
or
list
of
children's
health
chemicals.
This
ICR
does
not
separately
account
for
submitting
such
production
information,
although
it
could
reasonably
be
submitted
in
lieu
of
a
commitment
letter.

4(
d)
Respondent
(
Sponsor)
Activities
from
2002
­
2006.

During
the
four
years
from
October
2002
through
September
2006,
the
sponsors
have
completed
or
EPA
expects
they
will
complete
the
following
activities:

­
The
sponsors
of
11
VCCEP
chemicals
submitted
Tier
1
Peer
Consultation
Documents
to
EPA.
EPA
expects
that
sponsors
of
2
more
chemicals
will
submit
Tier
1
Peer
Consultation
Documents
by
the
end
of
September
2006.
Therefore,
for
the
period
from
October
2002
through
September
2006,
EPA
expects
that
sponsors
will
have
submitted
a
total
of
13
Tier
1
Peer
Consultation
Documents
to
EPA
under
the
VCCEP.

­
The
sponsors
presented
the
results
of
their
chemical
assessments
at
six
public
Peer
Consultation
meetings
that
addressed
nine
VCCEP
chemicals.
(
One
meeting
addressed
two
chemicals
and
another
meeting
addressed
three
chemicals,
the
remaining
four
meetings
addressed
one
chemical
each).
EPA
expects
that
sponsors
will
present
Tier
1
chemical
assessments
at
three
more
Peer
Consultation
meetings
that
will
cover
four
more
chemicals.
Therefore,
for
the
period
from
October
2002
through
September
2006,
EPA
expects
that
sponsors
will
have
presented
Tier
1
chemical
assessments
for
13
VCCEP
chemicals
at
nine
public
Peer
Consultation
meetings.

­
On
August
25,
2005,
EPA
requested
sponsors
of
three
chemicals
that
had
completed
the
Tier
1
process
to
conduct
some
Tier
2
tests.
The
basis
for
the
request
was
contained
in
EPA's
Data
Needs
Decision
documents
for
decabrominated
diphenylether
(
DBDE),
octabrominated
diphenylether
(
OBDE),
and
pentabrominated
diphenylether
(
PBDE).
EPA
requested
that
fate
and
transport
tests
be
conducted
for
DBDE
and
that
2­
generation
reproductive
toxicity
tests
be
conducted
for
OBDE
and
PBDE,
and
requested
sponsors
to
volunteer
within
four
months.
EPA
expects
that
sponsors
will
submit
commitment
letters
by
December
25,
2005,
but
that
testing
may
not
be
completed
and
Peer
Consultation
Documents
containing
the
results
of
those
tests
will
not
be
submitted
until
after
September
2006.

The
following
Table
2
lists
the
dates
when
the
sponsors
submitted
their
Tier
1
chemical
assessments,
made
their
presentations
at
the
Peer
Consultation
meetings,
and,
where
applicable,
committed
to
conduct
Tier
2
testing
requested
by
EPA
during
the
period
from
October
2002
through
September
2006.
For
dates
listed
in
2006
and
late
2005,
EPA
has
estimated
the
date
when
it
expects
an
activity
to
occur.

Table
2.
 
Sponsor
Activities
from
October
2002
through
September
2006.
­
19­
Chemical
Name/
CAS
No.
Submission
Date
of
Tier
1
Peer
Consultation
Document
Date
of
Peer
Consultation
Meeting
Submission
Date
of
Commitment
Letter
to
Conduct
Tier
2
Testing
Vinylidene
chloride
75­
35­
4
12/
30/
02
01/
29­
30/
03
NA
Decabrominated
diphenylether
1163­
19­
5
12/
20/
02
04/
02
 
03/
03
Dec
25,
2005*

Octabrominated
diphenylether
32536­
52­
0
04/
21/
03
06/
04­
05/
03
Dec
25,
2005*

Pentabrominated
diphenylether
32534­
81­
9
04/
21/
03
06/
03­
04/
03
Dec
25,
2005*

Acetone
67­
64­
1
09/
10/
03
11/
18­
19/
03
NA
Methyl
ethyl
ketone
78­
93­
3
12/
04/
03
02/
19/
04
NA
n­
Dodecane
112­
40­
3
06/
17/
04
09/
14/
04
Maybe
NA.

Undecane
1120­
21­
4
06/
17/
04
09/
14/
04
Maybe
NA.

Decane
124­
18­
5
06/
17/
04
09/
14/
04
Maybe
NA.

m­
Xylene
108­
38­
3
10/
07/
05
12/
13­
14/
05
Maybe
NA.

o­
Xylene
95­
47­
6
10/
07/
05
12/
13­
14/
05
Maybe
NA.

Toluene
108­
88­
3
Dec
2005*
Feb
2006*
Maybe
NA.

Benzene
71­
43­
2
Feb
2006*
June
2006*
Maybe
NA.

*
Estimated
date.
NA
=
Not
applicable
because
Tier
2
testing
was
not
requested
by
EPA.
Maybe
NA
=
Maybe
not
applicable
because
the
need
for
Tier
2
data
has
not
yet
been
determined.
­
20­
5
THE
INFORMATION
COLLECTION
­
AGENCY
ACTIVITIES,
COLLECTION
METHODOLOGY,
AND
INFORMATION
MANAGEMENT
5(
a)
Agency
Activities
In
order
to
sustain
three
tiers
of
the
pilot
VCCEP,
the
EPA
conducts
the
following
applicable
activities:

a)
review
letters
of
commitment
for
Tiers
2
and
3
(
separate
letter
for
each
tier)
for
completeness;
b)
develop
a
system
to
track
commitments
and
progress
of
program
on
the
VCCEP
website
and
update
as
needed;
c)
maintain
a
cooperative
agreement
with
a
third
party
(
currently
the
third
party
is
TERA)
to:
arrange
public
meetings
of
the
Peer
Consultation,
solicit
recommendations
from
EPA
and
stakeholder
for
experts
to
serve
as
Peer
Consultation
members,
identify
and
invite
scientific
experts
to
serve
as
Peer
Consultation
members,
distribute
Peer
Consultation
Documents
and
other
guidance
to
Peer
Consultation
members,
act
as
facilitator
at
the
public
meeting,
summarize
results
of
the
Peer
Consultation,
and
send
the
report
to
EPA
and
the
sponsor;
d)
review
Peer
Consultation
Documents
and
TERA's
reports,
draft
data
needs
decisions;
and
coordinate
review
and
approval
with
EPA
offices
before
approval
by
OPPT
Director;
e)
announce
the
Data
Needs
Decisions
for
Tiers
1
and
2
on
the
VCCEP
website
and
in
letters
to
relevant
sponsors;
f)
provide
explanation
of
Data
Needs
Decisions
if
they
differ
substantially
from
TERA's
report;
and
g)
make
the
Peer
Consultation
Documents
available
to
public
in
the
TSCA
NCIC;
make
TERA's
reports,
and
Data
Needs
Decisions
available
to
the
public
in
the
TSCA
NCIC
and
on
the
VCCEP
website.

In
addition
to
the
activities
cited
above,
the
Agency
may
also
participate
in
other
activities
related
to
this
program,
e.
g.,
relevant
workshops,
other
voluntary
efforts
to
identify
data
needs
and
develop
test
data,
efforts
to
establish
test
guidelines
or
standards
that
may
be
used
in
the
VCCEP,
and
international
efforts
related
to
chemical
testing
and
associated
testing
issues.

In
carrying
out
the
activities
related
to
the
VCCEP
pilot,
EPA
will
use
existing
EPA
guidance
and
policies,
and
follow
acceptable
scientific
standards
to
conduct
its
reviews
and
make
decisions.
Guidance
related
to
the
assessments
conducted
under
the
VCCEP
has
been
provided
to
the
sponsors
and
is
available
publicly
on
the
VCCEP
website,
along
with
Agency
Guidance
on
risk
characterizations
and
assessing
risks
to
children.

During
the
four
years
from
October
2002
through
September
2006,
EPA
and
TERA
completed
or
plan
to
complete
the
following
activities:
­
21­
­
TERA
held
six
Peer
Consultation
meetings
that
evaluated
chemical
assessments
submitted
for
nine
VCCEP
chemicals.
EPA
expects
TERA
will
hold
three
more
Peer
Consultation
meetings
by
the
end
of
September
2006,
which
will
cover
four
additional
VCCEP
chemicals.
Therefore,
for
the
period
from
October
2002
through
September
2006,
EPA
expects
that
TERA
will
have
held
nine
Peer
Consultation
meetings
covering
thirteen
VCCEP
chemicals.

­
TERA
prepared
summary
reports
of
six
Peer
Consultation
meetings.
EPA
expects
TERA
will
prepare
three
more
summary
reports
by
the
end
of
September
2006,
for
a
total
of
nine
summary
reports
of
Peer
Consultation
meetings
for
the
period
from
October
2002
through
September
2006.

­
EPA
issued
Data
Needs
Decisions
for
six
chemicals
on
September
20,
2005.
­
EPA
asked
for
additional
data
from
Tier
2
for
three
of
the
six
chemicals.
­
EPA
decided
that
additional
data
were
not
needed
for
the
other
three
chemicals
to
characterize
their
risk
to
children.
EPA
expects
to
release
Data
Needs
Decisions
for
three
additional
chemicals
by
the
end
of
September
2006.
Therefore,
for
the
period
from
October
2002
through
September
2006,
EPA
expects
to
have
released
Data
Needs
Decisions
for
nine
chemicals.

The
following
Table
3
lists
the
dates
of
the
Peer
Consultation
meetings,
the
release
dates
of
the
summary
reports
of
the
Peer
Consultation
meetings,
the
announcement
date
of
EPA's
Data
Needs
Decisions
for
the
13
chemicals
addressed
during
the
period
from
October
2002
through
September
2006,
and
the
Tier
2
testing
requested
by
EPA.
For
dates
listed
in
2006,
the
last
year
of
the
first
ICR,
EPA
has
estimated
the
dates
when
activities
will
occur.

Table
3.
 
VCCEP
Activities
of
the
Agency
from
October
2002
through
September
2006.

Chemical
Name/
CAS
No.
Date
of
Peer
Consultation
Meeting
Release
Date
of
Peer
Consultation
Meeting
Report
Announcement
Date
of
EPA's
Data
Needs
Decisions
Tier
2
Testing
Requested
by
EPA
Vinylidene
chloride
75­
35­
4
01/
29­
30/
03
06/
03/
03
09/
20/
05
None
Decabrominated
diphenylether
1163­
19­
5
04/
02­
03/
03
09/
30/
03
09/
20/
05
Fate
and
transport.
­
22­
Octabrominated
diphenylether
32536­
52­
0
06/
04­
05/
03
01/
22/
04
09/
20/
05
2­
generation
reproductive
toxicity
with
satellite
for
body
burden.

Pentabrominated
diphenylether
32534­
81­
9
06/
03­
04/
03
01/
22/
04
09/
20/
05
2­
generation
reproductive
toxicity
with
satellite
for
body
burden.

Acetone
67­
64­
1
11/
18­
19/
03
03/
05/
04
09/
20/
05
None
Methyl
ethyl
ketone
78­
93­
3
02/
19/
04
04/
29/
04
09/
20/
05
None
n­
Dodecane
112­
40­
3
09/
14/
04
01/
07/
05
By
Sept
2006*
Awaiting
Data
Needs
Decision.

Undecane
1120­
21­
4
09/
14/
04
01/
07/
05
By
Sept
2006*
Awaiting
Data
Needs
Decision.

Decane
124­
18­
5
09/
14/
04
01/
07/
05
By
Sept
2006*
Awaiting
Data
Needs
Decision.

m­
Xylene
108­
38­
3
12/
13­
14/
05
April
2006*
After
Sept
2006*
Awaiting
Data
Needs
Decision.

o­
Xylene
95­
47­
6
12/
13­
14/
05
April
2006*
After
Sept
2006*
Awaiting
Data
Needs
Decision.

Toluene
108­
88­
3
Feb
2006*
June
2006*
After
Sept
2006*
Awaiting
Data
Needs
Decision.

Benzene
71­
43­
2
June
2006*
Sept
2006*
After
Sept
2006*
Awaiting
Data
Needs
Decision.

*
Estimated
date.

5(
b)
Collection
Methodology
and
Management
Data
collected
under
the
VCCEP
are
received
by
the
TSCA
Nonconfidential
Information
Center
(
NCIC),
and
a
copy
is
placed
in
the
official
docket
(
OPPTS­
00274).
The
NCIC
transfers
the
data
to
the
program
manager
in
the
Office
of
Pollution
Prevention
and
Toxics,
Chemical
Control
Division
(
CCD),
Chemical
Testing
and
Information
Branch
(
CITB),
where
the
data
are
reviewed
for
completeness
and
then,
depending
on
the
data
received,
routed
as
follows:
­
23­
­
Letters
of
Commitment
are
routed
to
the
person
in
CITB
assigned
to
track
the
progress
of
the
VCCEP
and
update
the
VCCEP
website.
­
Peer
Consultation
Documents
are
routed
to
TERA
(
one
copy),
to
the
person
in
CITB
maintaining
the
VCCEP
files
(
one
copy
and
the
electronic
copy),
and
to
the
OPPT
workgroup
that
drafts
the
Data
Needs
Decision
(
one
copy).
­
TERA's
reports
on
Peer
Consultation
meetings
are
routed
to
the
person
in
CITB
maintaining
the
VCCEP
files
(
one
copy)
and
to
the
OPPT
workgroup
that
drafts
the
Data
Needs
Decision
(
one
copy).
­
EPA's
Data
Needs
Decision
document
is
routed
to
the
person
in
CITB
maintaining
the
VCCEP
files
(
one
copy),
and
to
the
OPPT
workgroup
that
drafted
the
November
9,
2005
Data
Needs
Decision
(
one
copy).

The
Peer
Consultation
Document
prepared
by
the
sponsor
for
Tier
1
contains
hazard,
exposure,
risk,
and
data
needs
assessments.
The
sponsor
presents
its
assessments
to
the
Peer
Consultation
that
will
then
discuss
the
assessments
with
emphasis
on
the
data
needs
assessment.
TERA,
the
third
party
scientific
organization
that
has
arranged
and
facilitated
the
meeting,
summarizes
the
results
of
the
Peer
Consultation
meeting
and
sends
a
report
to
EPA
and
the
sponsor.
EPA
reviews
the
third
party's
report
and
the
Peer
Consultation
Document
and
decides
whether
any
information
from
the
next
tier
is
needed
to
assess
the
risks
to
children
of
the
chemical
in
question.
EPA
announces
any
data
needs
on
the
VCCEP
website
and
in
a
letter
to
the
sponsor.
If
EPA's
decision
differs
substantially
from
the
TERA's
report,
EPA
provides
an
explanation
for
its
decision.
There
is
a
4­
month
period
for
the
sponsor
or
others
to
volunteer
to
provide
the
data
needed
in
Tier
2.
The
steps
in
Tier
1
are
repeated
for
Tier
2;
the
steps
in
Tier
1
are
repeated
in
Tier
3
up
to
but
not
including
a
Data
Needs
Decision.
At
the
end
of
Tier
3
or
if
EPA
decides
that
sufficient
data
have
been
provided
at
the
end
of
Tier
1
or
Tier
2
to
evaluate
risk
to
children,
EPA
and
the
sponsor
may
use
the
data
in
risk
management
activities,
if
necessary.
To
date,
EPA
has
collected
data
in
other
testing
programs
that
have
been
used
to
support
such
activities
as
the
development
of
water
quality
criteria,
hazardous
waste
listings,
chemical
advisories,
and
reduction
of
workplace
exposures.

For
the
chemicals
identified
for
evaluation
as
part
of
the
VCCEP
pilot,
the
specific
data
requested
at
Tier
1,
the
data
that
might
be
requested
at
Tiers
2
and
3
(
which
will
not
be
known
with
certainty
until
EPA
issues
its
Data
Needs
Decisions),
the
guideline
requirements
for
conducting
any
needed
tests,
the
time
frame
for
completing
the
testing/
data
collection,
and
the
time
frame
for
submitting
a
Peer
Consultation
Document
to
the
Agency
were
established
in
the
notice
announcing
the
VCCEP
(
65
FR
81700,
December
26,
2000).

Participants
in
the
VCCEP
will
submit
some
information
electronically
to
allow
EPA
to
respond
to
public
requests
for
information
more
efficiently.
The
VCCEP
requests
one
electronic
copy,
in
addition
to
the
3
hard
copies,
of
the
Peer
Consultation
Document
for
each
chemical
at
each
tier.
If
a
Peer
Consultation
Document
were
developed
for
each
of
the
20
chemicals
for
each
of
the
three
tiers
there
could
be
as
many
as
60
electronic
submissions
for
three
tiers
of
the
pilot
program.
EPA
already
knows,
however,
that
three
chemicals
will
have
only
Tier
1
information
­
24­
submitted,
reducing
the
maximum
number
of
electronic
submissions
of
Peer
Consultations
Documents
to
54.

5(
c)
Small
Entity
Flexibility
Under
the
VCCEP,
no
company,
including
small
businesses,
is
required
to
participate.
Any
small
businesses
that
do
participate
will
likely
do
so
as
part
of
a
consortium.
Participation
in
a
testing
consortium
relieves
the
small
business
of
sole
responsibility
for
collecting
or
submitting
test
information,
while
still
allowing
the
small
business
to
participate
in
the
program.

5(
d)
Collection
Schedule
This
information
collection
activity
does
not
involve
more
than
one
submission
per
activity.
Needed
testing
is
conducted
only
once,
and
each
related
submission
is
a
one­
time
onoccasion
submission.
The
time
to
complete
each
tier
of
testing/
data
collection
is
based
on
the
test
in
that
tier
that
requires
the
longest
time
to
complete.
An
additional
four
months
can
be
requested
to
complete
the
Exposure
Assessment,
Risk
Assessment,
and
Data
Needs
Assessment
for
each
tier.
Following,
in
Table
4,
are
the
times
that
EPA
believes
are
reasonable
to
complete
each
test,
if
needed,
in
the
VCCEP.
It
is
assumed
that
tests
in
the
same
tier
will
be
conducted
simultaneously.

Table
4.­­
Time
Allowed
to
Conduct
Toxicology
Test
and
Prepare
Final
Report
Test
Months
Acute
oral
toxicity
(
up/
down)
OR
Acute
inhalation
toxicity
18
In
vitro
gene
mutation:
Bacterial
reverse
mutation
assay
18
In
vitro
chromosomal
aberrations
18
90
Day
subchronic
in
rodents
18
Reproduction
and
fertility
effects
29
Prenatal
developmental
toxicity
(
two
species)
12
In
vivo
mammalian
bone
marrow
chromosomal
aberrations,
OR
in
vivo
mammalian
erythrocyte
micronucleus
16
Immunotoxicity
121
Metabolism
and
pharmacokinetics
12
Carcinogenicity
OR
chronic
toxicity/
carcinogenicity
60
Neurotoxicity
screening
battery
21
Developmental
neurotoxicity
21
­
25­
1.
If
the
test
for
immunotoxicity
is
run
as
a
satellite
of
another
study,
the
final
report
would
be
due
on
the
reporting
date
of
the
other
study.

6
ESTIMATING
THE
BURDEN
AND
COST
OF
THE
COLLECTION
Overview
This
section
presents
the
assumptions
and
methods
that
were
used
to
estimate
the
burden
and
costs
for
this
ICR
covering
October
2006
through
September
2009,
along
with
a
summary
of
the
cost
and
burden
calculations.
If,
in
the
context
of
implementing
the
VCCEP,
the
Agency
determines
that
the
total
annual
burden
covered
by
this
ICR
needs
to
be
revised,
it
will
submit
an
Information
Correction
Worksheet
(
ICW)
to
amend
the
total
annual
burden
for
this
ICR
in
the
OMB
inventory.

Assumptions
The
estimated
burden
and
costs
to
the
Federal
Government
and
to
the
respondents
are
based
on
the
assumptions
listed
below.
These
assumptions
are
based
on
historical
experience
with
the
TSCA
testing
and
information
gathering
programs,
conservative
projections
for
the
VCCEP
pilot
over
the
period
October
2006
through
September
2009,
and
the
progress
made
in
information
collection
from
October
2002
through
September
2006
(
described
in
Units
4(
d)
and
5(
a)).
EPA
would
like
to
stress
that
these
assumptions
are
used
only
to
estimate
burden
and
costs
that
are
presented
in
this
ICR
and
should
not
be
considered
to
be
a
presumption
of
testing
needs.
The
need
for
testing
will
be
science
driven
and
testing
will
be
required
only
to
the
extent
that
it
is
reasonably
necessary
to
characterize
potential
health
risks
to
children.

It
is
important
to
note
that
the
previous
ICR
assumed
that
the
entire
VCCEP
pilot
would
be
completed
in
the
three­
year
ICR
period.
As
stated
in
section
4(
d)
and
5(
a),
only
a
small
fraction
of
the
pilot
program
was
completed.
To
make
this
ICR
comparable
to
the
previous
ICR,
the
assumption
that
the
VCCEP
pilot
will
be
completed
in
the
next
three
years
is
retained.
This
is,
however,
unlikely,
and
the
estimates
of
cost
and
burden
in
this
ICR
should
be
seen
as
extremely
conservative.
See
also
Assumption
4.

1)
EPA
assumes
that
data
will
be
collected
on
20
chemicals
during
the
course
of
the
VCCEP
pilot.
Although
23
chemicals
had
been
selected
for
the
VCCEP
pilot,
thus
far
only
20
chemicals
have
been
sponsored.
Thirty­
five
companies
acting
through
ten
consortia
are
the
sponsors.

2)
EPA
assumes
that
the
13
chemicals
listed
in
Tables
2
and
3,
for
which
the
Tier
1
information
collection
was
addressed
or
is
expected
to
be
addressed
during
the
effective
dates
of
the
first
ICR,
will
complete
the
entire
three­
tier
process
or
be
judged
to
have
sufficient
data
short
of
the
three
tiers
before
the
expiration
date
of
the
second
ICR.
To
date,
i.
e.,
October
2005,
three
of
the
thirteen
chemicals
have
been
determined
to
have
2
In
most
instances,
test
sponsors
have
formed
"
consortia,"
through
a
common
trade
organization
(
e.
g.,
American
Chemistry
Council
[
formerly
the
Chemical
Manufacturers
Association],
Synthetic
Organic
Chemical
Manufacturers
Association)
to
coordinate
testing
and
preparation
of
assessments.

­
26­
sufficient
data
to
characterize
their
risk
to
children
based
on
the
Tier
1
information
collection.
The
same
decision
may
be
made
for
several
more
of
the
thirteen
chemicals
before
the
expiration
of
the
first
ICR
in
Sept
2006.

3)
EPA
assumes
that
sponsors
of
the
seven
other
pilot
VCCEP
chemicals,
listed
below,
will
initiate
and
complete
the
Tier
1
information
reporting
and
review
process
before
the
expiration
date
of
the
second
ICR,
i.
e.
by
September
2009.
EPA
assumes
that
information
collection
for
these
seven
chemicals
was
initiated
and
probably
completed
during
the
effective
period
of
the
first
ICR,
although
not
reported.
If
it
is
decided
that
additional
data
beyond
Tier
1
are
needed
for
any
of
the
seven
chemicals,
EPA
believes
that
some
or
all
of
that
data
may
not
be
received
and
processed
during
the
effective
period
of
the
second
ICR.

p­
Dichlorobenzene
(
CAS
No.
106­
46­
7)
p­
Dioxane
(
CAS
No.
123­
91­
1)
Ethylbenzene
(
CAS
No.
100­
41­
4)
Ethylene
dichloride
(
CAS
107­
06­
2)
 ­
Pinene
(
CAS
No.
80­
56­
8)
Tetrachloroethylene
(
CAS
No.
127­
18­
4)
Trichloroethylene
(
CAS
No.
79­
01­
6)

4)
The
assumptions
provided
in
this
ICR
renewal
are
a
conservative
estimate
of
the
cost
and
burden
associated
with
the
VCCEP
pilot.
In
the
event
that
fewer
than
20
chemicals
complete
the
program,
or
some
of
the
chemicals
do
not
participate
to
the
degree
assumed,
then
the
total
cost
and
burden
will
be
less
than
estimated
here.
Additionally,
if,
as
is
assumed,
the
process
for
any
of
the
chemicals
lasts
beyond
the
expiration
date
of
the
second
ICR,
then
the
total
burden
and
cost
will
be
extended
over
a
longer
time
frame,
thus
reducing
the
annual
burden
and
cost
of
the
program.

5)
One
or
several
chemicals
may
be
sponsored
by
one
company
or
a
consortium
representing
several
companies.
2
For
purposes
of
this
ICR,
however,
EPA
assumes
that
the
VCCEP
program
will
have
one
respondent
per
chemical.
That
one
respondent
will
represent
a
company
or
consortium
of
companies
that
manufacture
the
chemical.
Thus,
the
total
number
of
respondents
for
the
VCCEP
will
be
no
more
than
20.

6)
The
three
tiers
of
tests
listed
in
Table
1
of
this
ICR
allow
sponsors
to
choose
among
a
number
of
test
guidelines.
EPA
has
assumed
that,
as
a
default,
sponsors
will
conduct
tests
defined
at
40
CFR
799
(
i.
e.,
the
799
series).
In
cases
where
sponsors
have
a
choice
between
more
than
one
799
series
test,
EPA
assumes
that
sponsors
will
choose
the
lower
­
27­
cost
test.
In
cases
where
EPA
did
not
have
cost
and
burden
estimates
for
a
799
series
test,
EPA
assumes
that
sponsors
will
choose
the
least­
cost
test
from
among
the
alternative
test
guidelines
for
which
cost
and
burden
data
are
available.
Details
on
the
default
testing
assumptions
can
be
found
in
Table
5.

7)
For
the
90­
day
subchronic
toxicity
test
in
Tier
2,
three
routes
of
exposure
are
possible
(
inhalation,
oral,
dermal).
Although
many
VCCEP
chemicals
have
multiple
potential
routes
of
exposure
relevant
to
total
dose,
EPA
expects
that
sponsors
will
conduct
the
test
using
the
one
route
most
relevant
to
expected
exposure.
Considering
that
the
VCCEP
chemicals
are
expected
to
be
present
in
indoor
air,
drinking
water,
or
breast
milk,
EPA
assumes
that
67%
of
the
subchronic
tests
will
be
conducted
by
inhalation
(
guideline
799.9346),
and
33%
will
be
conducted
by
the
oral
route
of
administration
(
870.3100).
(
EPA
made
no
such
assumption
about
route
for
the
acute
toxicity
test
in
Tier
1
because
the
testing
is
assumed
to
have
already
been
completed.)

8)
Each
respondent
must
submit
one
letter
of
commitment,
and
one
Peer
Consultation
Document
for
each
chemical
they
have
committed
to
for
each
Tier.
The
Peer
Consultation
Document
(
PCD)
contains
a
hazard
assessment,
an
exposure
assessment,
and
a
risk
assessment.
The
PCDs
for
Tiers
1
and
2
also
contain
data
needs
assessments.

9)
In
conducting
any
test
that
will
be
submitted
to
EPA
under
TSCA,
the
respondent
must
comply
with
Good
Laboratory
Practice
Standards
(
GLPS).
Because
the
GLPS
represent
basic
standard
practices
used
by
laboratories,
any
burden
and
costs
related
to
GLPS
are
fully
captured
in
the
laboratory
cost
and
burden
estimates
provided
in
Table
5.

10)
EPA
assumes
that
some
of
the
chemicals
have
already
been
subjected
to
some
of
the
tests
identified
in
Table
1
of
this
ICR.
EPA
used
a
baseline
testing
rate
to
estimate
the
number
of
chemicals
needing
specific
tests
(
see
"
Laboratory
Costs
and
Burdens"
in
Section
6(
a)).
EPA
does
not
calculate
test
costs
for
chemicals
assumed
to
have
already
been
tested.

11)
EPA
assumes
that
all
of
the
chemicals
have
Tier
1
test
data
available
through
either
the
EPA
High
Production
Volume
(
HPV)
Challenge
program
or
the
OECD
SIDS
program.

12)
Judging
from
the
VCCEP
experience
discussed
in
Unit
5(
a),
EPA
estimates
that
75%
of
the
chemicals
in
the
pilot
will
move
on
to
the
Tier
2
chemical
assessment,
and
50%
will
require
Tier
3.
Again,
EPA
stresses
that
these
assumptions
are
used
only
to
estimate
burden
and
costs
that
are
presented
in
this
ICR
and
should
not
be
considered
to
be
a
presumption
of
testing
needs.
The
need
for
testing
will
be
determined
through
the
VCCEP
process.

13)
For
estimating
the
burden
and
costs
for
conducting
the
testing,
EPA
used
available
information
regarding
the
price
that
a
laboratory
would
charge
for
conducting
the
test.
Some
respondents,
however,
may
use
their
own
facilities
to
conduct
the
testing.
3
Guidance
on
Searching
for
Chemical
Information
and
Data,
May
1999
(
http://
www.
epa.
gov/
opptintr/
chemrtk/
srchguid.
htm).

4
Labor
rates
are
unpublished
December
2004
data
from
BLS
for
all
manufacturing
industries.
The
estimates
include
fringe
benefits
and
17%
overhead.

­
28­
14)
The
programs
established
for
the
VCCEP
and
HPV
Challenge
chemicals
are
voluntary
initiatives
under
which
manufacturers
(
including
importers)
of
chemicals
targeted
for
information
gathering
and
possible
testing
will
voluntarily
submit
data
on
hazard
endpoints;
the
VCCEP
also
includes
exposure,
risk,
and
data
needs
information.

15)
For
purposes
of
this
ICR,
EPA
estimates
that
participants
conducting
tests
for
the
VCCEP
would
incur
roughly
the
same
costs
and
burdens
that
they
would
incur
if
the
chemicals
were
subject
to
a
TSCA
section
4
rule,
but
would
not
submit
study
plans
or
progress
reports
and
would
not
submit
full
study
reports
to
EPA
unless
specifically
requested
to
do
so.
Instead,
study
results
would
be
submitted
in
the
"
robust
summary"
format.
In
addition,
to
determine
which
endpoints
need
to
be
tested,
VCCEP
participants
would
most
likely
undertake
a
search
for
any
existing
studies
for
each
chemical,
and
include
them
in
the
robust
summaries.
3
The
costs
and
burden
associated
with
these
data
searches
are
included
as
reporting
costs
and
are
described
below
under
"
Reporting
Costs
and
Burdens."

6(
a)
Respondent
Cost
and
Burden
For
purposes
of
calculating
the
PRA
paperwork­
related
burden
and
costs
for
this
ICR,
the
Agency
estimated
costs
for
both
non­
paperwork
burdens
(
e.
g.,
laboratory
testing
costs)
and
paperwork
burdens
(
e.
g.,
administrative
costs
and
burden)
participants
will
incur
in
the
program.
For
costs
such
as
the
laboratory
testing
costs,
only
a
portion
of
the
total
cost
may
be
attributed
to
the
paperwork­
related
requirements
(
i.
e.,
reporting
burden)
that
EPA
imposes
on
the
participants.
EPA
is
presenting
all
costs,
not
just
paperwork
or
reporting
burden,
in
the
ICR.

The
unit
burden
for
each
activity
is
based
upon
previous
TSCA
section
4
ICRs
and
EPA's
best
estimates
of
the
burdens
that
will
be
incurred
under
the
VCCEP
over
the
next
three­
year
period.
Loaded
hourly
labor
rates,
including
fringe
costs
and
overhead
are
$
58.45
for
management
time,
$
49.72
for
technical
time,
and
$
26.10
for
clerical
time.
These
labor
rates
are
lower
than
those
used
in
the
previous
ICR,
and
adhere
more
closely
to
the
latest
Bureau
of
Labor
Statistics
(
BLS)
data4
and
are
summarized
as
follows:
5
Many
of
the
35
companies
are
participating
as
part
of
the
10
consortia,
but
will
still
incur
some
costs
independent
of
the
consortia.

­
29­
INDUSTRY
LABOR
CATEGORY
LOADED
HOURLY
RATE
($
2004)

Managerial
Technical
Secretarial
$
58.54
$
49.72
$
26.10
Based
upon
the
assumptions
and
labor
rates
discussed
above,
various
factors
can
be
derived
that
are
employed
to
estimate
total
costs
and
burdens
for
the
respondents.
These
factors
are
presented
in
the
sub­
sections
that
follow.

Number
of
Respondents
The
Agency
assumes
that
each
chemical
will
have
one
respondent:
a
company
or
consortium
of
companies
that
manufacture
(
including
import)
the
chemical.
Thus,
there
will
be
20
total
respondents
for
the
VCCEP.
EPA
recognizes,
however,
that
more
than
one
entity
may
participate
in
the
VCCEP,
and
that
the
participation
of
these
"
non­
respondents"
may
not
be
reflected
in
the
burden
and
cost
estimates
for
the
respondent.
For
example,
whenever
more
than
one
entity
form
a
consortium
to
provide
the
requested
data,
only
one
entity
may
experience
the
full
burden
of
data
gathering
and
submission
as
estimated
here,
but
the
other
entities
still
experience
some
burden
and
costs
related
to
their
participation
in
the
consortium,
described
below.
At
this
time,
a
total
of
45
entities
(
35
companies
and
10
consortia)
5
are
participating
in
the
VCCEP.

Types
of
Costs
and
Burdens
The
following
discussion
presents
estimates
of
the
costs
and
burdens
of
each
of
the
main
categories
of
collection
activities
that
will
be
undertaken
in
response
to
the
VCCEP:
laboratory
cost
and
burdens
(
hazard
assessments),
administrative
costs
and
burdens,
exposure
assessments,
risk
assessments,
data
needs
assessments,
preparing
the
peer
consultation
document,
and
presenting
the
assessments
at
public
meetings.
EPA's
estimated
costs
and
burdens
for
each
of
these
respondent
activities
is
discussed
below.

Laboratory
Costs
and
Burdens
(
Hazard
Assessments)

Each
chemical
that
is
sponsored
in
the
VCCEP
pilot
is
expected
to
be
evaluated
by
performing
the
tests
specified
for
each
tier,
unless
there
are
adequate
existing
data
for
one
or
more
of
the
endpoints
addressed
by
tests
in
that
Tier.
Table
1
of
this
ICR
provides
the
list
of
possible
tests.
As
can
be
seen
in
Table
1,
sponsors
have
some
choice
in
the
tests
that
are
conducted.
As
noted
above,
EPA
assumes
that
sponsors
will
choose
the
least­
costly
test
among
6
For
the
90­
day
subchronic
toxicity
in
rodents
study
under
Tier
2,
however,
the
number
of
chemicals
requiring
testing
was
divided
among
those
that
would
receive
oral
route
testing
(
33
percent)
and
those
that
would
receive
inhalation
route
testing
(
67
percent).
This
is
explained
in
more
detail
in
assumption
number
7
above
and
in
the
notes
to
Table
5.

7
The
costs
for
this
requirement
are
estimated
as:
(
120
studies)
×
[
(
15
hours
technical
time)
×
(
$
49.72)+
(
5
hours
clerical
time)
×
(
$
26.10)].

­
30­
the
alternatives
listed
in
Table
1.
In
preparing
the
estimates
for
this
ICR,
EPA
used
the
costs
of
the
testing
alternative
based
on
799
series
as
a
default,
and
has
not
attempted
to
develop
costs
for
all
of
the
alternatives.
Assumptions
about
routes
of
administration
are
discussed
under
Assumption
7
above.
Table
5
summarizes
EPA's
assumptions
regarding
which
test
protocol
will
be
chosen
for
each
testing
requirement
in
Table
1,
as
well
as
the
cost
and
burden
estimate
for
those
protocols.
Costs
and
burden
for
the
protocols
are
best
estimates
taken
from
a
database
EPA
generates
and
maintains.
As
mentioned
previously,
laboratory
testing
costs
are
not
paperwork
costs
under
the
PRA,
but
are
presented
for
completeness.

EPA
expects
that
at
least
some
of
these
chemicals
will
already
have
been
subjected
to
a
number
of
these
tests.
EPA
used
information
gathered
in
preparing
the
draft
Children's
Health
Proposed
Test
Rule
to
determine
the
number
of
chemicals
that
could
require
each
specific
test.
Table
5
presents
EPA's
estimate
of
the
percentage
of
chemicals
that
have
undergone
each
test
from
the
draft
Children's
Health
Proposed
Test
Rule
analysis
(
i.
e.,
the
baseline
testing
rate
in
Table
5).
EPA
assumes
that
these
percentages
can
be
applied
in
this
analysis.
Using
this
information,
the
number
of
chemicals
requiring
a
specific
test
is
calculated
by
multiplying
the
baseline
testing
rate
by
the
number
of
chemicals
participating
in
that
Tier
and
then
subtracting
the
result
from
the
total
number
of
chemicals
for
each
tier.
6
As
noted
above,
EPA
has
assumed
that
all
chemicals
have
Tier
1
testing
data.

For
each
protocol,
the
total
testing
cost
is
calculated
by
multiplying
the
cost
per
test
by
the
number
of
chemicals
for
that
protocol.
Total
laboratory
costs
of
the
ICR
are
estimated
to
be
$
18.9
million
and
200,000
hours
of
labor
over
the
three­
year
ICR
period.
EPA
estimates
that
a
total
of
55
studies
(
equal
to
the
total
number
of
chemical
tests
conducted
under
all
tiers)
will
be
conducted
over
the
three­
year
ICR
period.
The
average
laboratory
cost
is
$
342,916
per
study
($
18.9
million
/
55
studies).

Once
a
study
is
complete,
sponsors
are
required
to
develop
a
robust
summary
of
the
results.
A
robust
summary
must
also
be
developed
for
each
available,
adequate
study
that
addresses
endpoints
in
any
of
the
three
tiers,
but
EPA
assumes
that
robust
summaries
have
already
been
developed
for
Tier
1
tests.
Therefore,
the
number
of
robust
summaries
to
be
developed
will
equal
the
number
of
tests
in
Tier
2
multiplied
by
15
chemicals
(
6
tests
*
15
chemicals
=
90)
plus
the
number
of
tests
in
Tier
3
multiplied
by
10
chemicals
(
3
tests
*
10
chemicals
=
30),
for
a
total
of
120
robust
summaries.
EPA
assumes
that
the
robust
summaries
will
require
15
hours
of
technical
time
and
5
hours
of
clerical
time.
Based
on
this
assumption,
EPA
estimates
that
robust
summaries
will
impose
a
burden
of
2,400
hours
and
$
105,156
over
the
same
period.
7
­
31­

Table
5.
The
VCCEP
Test
Battery
Protocol
Name
Protocol
Number
Cost
Estimate
Per
Test
Lab
Burden
Per
Test
(
Hours)
Baseline
Testing
Rate
Number
of
Chemicals
Needing
Test
[
a]
[
b]
Total
Testing
Cost
Total
Testing
Burden
(
Hours)

Tier
1:
20
Chemicals
participating
1
Acute
inhalation
toxicity
OECD
403
$
16,101
184
100%
0
$
0
0
2
In
vitro
gene
mutation:
Bacterial
reverse
mutation
assay
799.9510
$
8,074
61
100%
0
$
0
0
3
Repeated
dose
oral
toxicity
OECD
407
$
63,870
328
100%
0
$
0
0
4
In
vivo
mammalian
erythrocyte
micronucleus
799.9539
$
16,563
132
100%
0
$
0
0
TOTAL
FOR
TIER
1
$
104,608
705
­
0
$
0
0
Tier
2:
15
Chemicals
participating
1
90­
day
subchronic
toxicity
in
rodents
870.3100
$
122,917
757
81.8%
1
[
c]
$
122,917
757
799.9346
$
333,825
2,458
81.8%
2
[
d]
$
667,650
4,916
2
Reproduction
and
fertility
effects
799.9380
$
903,303
9,449
29.5%
11
$
9,936,333
103,939
3
Prenatal
developmental
toxicity
(
two
species)
799.9370
$
93,305
1,079
38.6%
9
$
839,745
9,711
4
In
vivo
mammalian
erythrocyte
micronucleus
799.9539
$
16,563
132
81.8%
3
$
49,689
396
5
Immunotoxicity
870.7800
$
69,433
415
31.8%
10
$
694,330
4,150
6
Metabolism
and
pharmacokinetics
870.7485
$
34,609
330
90.9%
1
$
34,609
330
TOTAL
FOR
TIER
2
$
1,573,955
14,620
­
37
$
12,345,273
124,199
Tier
3:
10
Chemicals
participating
1
Carcinogenicity
799.9420
$
1,376,439
17,953
68.2%
3
$
4,129,317
53,859
2
Neurotoxicity
screening
battery
799.9620
$
109,271
883
45.5%
5
$
546,355
4,415
3
Developmental
neurotoxicity
870.6300
$
183,941
1,788
4.5%
10
$
1,839,410
17,880
TOTAL
FOR
TIER
3
$
1,669,651
20,624
­
18
$
6,515,082
76,154
GRAND
TOTALS
­
­
­
­
55
$
18,860,355
200,353
­
32­

[
a]
These
numbers
also
represent
the
number
of
studies
that
would
be
conducted.

[
b]
To
calculate
the
number
of
tests
for
Tier
2,
EPA
multiplied
the
baseline
testing
rate
by
15
chemicals
and
then
subtracted
the
result
from
15.
To
calculate
the
number
of
tests
for
Tier
3,
EPA
multiplied
the
baseline
testing
rate
by
10
chemicals
and
then
subtracted
the
result
from
10.

[
c]
To
calculate
the
number
of
tests
performed
by
the
oral
route,
EPA
multiplied
the
number
of
chemicals
needing
testing
(
3),
by
33
percent
per
Assumption
7.

[
d]
To
calculate
the
number
of
tests
performed
by
inhalation,
EPA
multiplied
the
number
of
chemicals
needing
testing
(
3),
by
67
percent
per
Assumption
7.

Administrative
Costs
and
Burdens
Part
of
the
administrative
costs
and
burdens
associated
with
this
ICR
include
preparing
letters
of
commitment
and
performing
data
searches
and
reviews.
EPA
has
summarized
its
estimates
for
these
categories
in
Table
6,
and
discusses
each
below.

For
letters
of
commitment,
EPA
assumed
that
each
sponsor
would
submit
one
letter
for
each
tier.
Thus,
a
total
of
25
letters
would
be
received
over
the
three­
year
ICR
period
(
15
in
Tier
2,
plus
10
in
Tier
3;
Tier
1
is
completed).
Consistent
with
other
TSCA
ICRs,
EPA
assumed
that
submitting
these
letters
would
impose
a
burden
of
four
hours
of
technical
labor
for
each
submission.
The
implies
a
total
burden
of
100
hours
and
$
4,972
over
the
three­
year
ICR
period.
These
costs
and
burden
hours
are
considered
reporting
burdens
by
EPA.
­
33­
Table
6.
Administrative
Costs
and
Burden
Category
Letters
of
Commitment
Data
Searches
TOTAL
Tier
2
Number
15
45
60
Burden
60
1,448
1,508
Cost
$
2,983
$
71,254
$
74,237
Tier
3
Number
10
30
40
Burden
40
965
1,005
Cost
$
1,989
$
47,503
$
49,492
TOTALS
Number
25
75
100
Burden
100
2,413
2,513
Cost
$
4,972
$
118,757
$
123,729
To
estimate
the
cost
and
burden
of
performing
data
searches,
EPA
assumes
that
two
firms
per
chemical
would
search
their
internal
records
and
one
sponsor
per
chemical
would
perform
an
external
search
of
the
literature
(
i.
e.,
a
total
of
three
searches
per
chemical
per
Tier).
The
assumption
of
two
firms
per
chemical
is
based
on
the
fact
that
35
companies
are
currently
involved
in
sponsoring
20
chemicals;
with
the
possibility
that
more
could
join,
rounding
up
to
two
seems
prudent.
Based
on
this,
EPA
estimates
that
45
searches
will
occur
for
Tier
2
and
30
searches
will
occur
under
Tier
3.
This
results
in
a
total
of
75
data
searches
over
the
three­
year
ICR
period.
Following
previous
testing
ICRs,
EPA
assumes
that
firm's
searches
require
17.75
burden
hours
per
search.
This
includes
3
hours
of
managerial
time
for
corporate
review,
9
hours
of
technical
time
for
a
file
search,
one
hour
of
clerical
time
for
a
summary
sheet,
1.75
hours
of
clerical
time
for
reproduction,
and
3
hours
of
managerial
time
for
a
CBI
review.
The
sponsor­
level
searches
require
61
hours:
60
hours
of
technical
time
for
an
external
records
search
and
one
hour
of
clerical
time
for
a
summary
sheet.
Based
on
these
assumptions,
EPA
estimates
that
data
searches
will
impose
a
burden
of
2,413
hours
and
$
118,757
over
the
three­
year
ICR
period.
This
is
a
non­
reporting
burden.

Other
non­
reporting
administrative
activities
include
the
effort
of
respondents
to
organize
a
testing
program,
obtain
and
review
bids
from
laboratories
who
would
conduct
the
testing,
and
prepare
and
submit
samples
to
the
laboratory
for
testing.
EPA's
experience
in
test
rule
development
has
shown
that
these
administrative
costs
and
burdens
associated
with
testing
programs
to
be
approximately
25
percent
of
the
laboratory
costs.
EPA
applied
this
assumption
to
the
Tier
2
and
3
estimates
(
Tier
1
testing
is
assumed
to
be
complete).
Under
EPA's
standard
25
­
34­
percent
assumption,
the
cost
estimate
per
test
is
used
to
calculate
the
cost
of
the
paperwork
or
administrative
burden
associated
with
conducting
that
test.
EPA
typically
states
that
this
is
the
data
generation
paperwork
costs
and
calculates
the
burden
by
dividing
the
loaded
hourly
rate
for
the
technical
person
into
it.
For
example,
if
the
test
cost
is
$
100,000,
then
the
paperwork/
administrative
costs
are
$
25,000,
and
the
paperwork
burden
is
503
hours
($
25,000
/
49.72)

From
Table
5,
Tiers
2
and
3
testing
involve
a
total
cost
of
$
18.9
million
and
200,353
hours.
To
calculate
total
administrative
costs
(
reporting
plus
non­
reporting
administrative)
for
Tiers
2
and
3,
EPA
multiplies
each
estimate
by
25
percent
to
get
$
4.7
million
and
50,088
hours
over
the
three­
year
ICR
period.
Because
these
activities
are
only
undertaken
at
the
discretion
of
the
individual
respondent
and
are
not
part
of
the
Agency's
testing
program,
these
estimates
are
only
being
provided
for
completeness,
and
are
not
attributable
as
reporting
burden
and
costs
for
the
purposes
of
this
ICR.
Additionally,
the
Exposure
Assessment
and
Risk
Assessment
(
see
below)
also
impose
some
non­
reporting
administrative
costs
and
burdens.
In
the
summary
tables
below,
EPA
combines
the
non­
reporting
administrative
costs
and
burdens
estimated
here
with
those
that
are
estimated
for
the
Exposure
Assessment
and
Risk
Assessment.

In
addition,
to
account
for
initial
participation
burden
for
non­
respondents,
EPA
estimated
that
the
level
of
effort
for
the
typical
activities
associated
with
initial
participation
in
a
consortium
might
be
reasonably
represented
by
an
estimate
of
21
hours,
representing
4
hours
for
management
($
234.16),
16
hours
for
technical
($
795.52)
and
1
hour
for
clerical
($
26.10).
With
45
entities
currently
participating
in
the
program,
the
total
burden
for
this
activity
would
be
945
hours
(
21
hours
*
45
participants),
with
a
cost
of
$
47,510
($
1,055.78
*
45).
This
is
also
considered
a
nonpaperwork
burden.

Exposure
Assessments
EPA
has
estimated
the
labor
hours
and
costs
associated
with
exposure
assessments
by
soliciting
information
from
within
the
Agency
and
from
several
of
its
contractors
that
have
experience
in
performing
exposure
assessments
that
are
similar
in
scope
and
complexity
to
the
exposure
assessment
need
defined
in
the
Federal
Register
notice
for
the
VCCEP
pilot.
Based
on
this
information,
EPA
has
estimated
that
a
Tier
1
exposure
assessment
would
require
500
labor
hours,
a
Tier
2
assessment
would
require
1,000
labor
hours,
and
a
Tier
3
assessment
would
require
1,200
labor
hours.
Furthermore,
EPA
has
assumed
that
85
percent
of
those
hours
are
for
technical
labor,
10
percent
are
for
clerical
labor,
and
5
percent
are
for
managerial
labor.
Thus,
over
the
three­
year
ICR
period,
32
exposure
assessments
will
take
place
(
7
remaining
in
Tier
1,
15
in
Tier
2,
plus
10
in
Tier
3).
Table
7
summarizes
EPA's
estimates
for
exposure
assessments
for
the
VCCEP
pilot.
Based
on
EPA's
information,
the
exposure
assessment
for
the
VCCEP
pilot
will
result
in
a
three­
year
burden
of
30,500
hours
and
$
1.5
million.

A
sponsor
typically
hires
a
contractor
to
conduct
an
exposure
assessment,
but
EPA
still
considers
the
total
cost
of
the
assessment
as
paperwork
burden
and
costs.
EPA
also
assumes
that
­
35­
the
exposure
assessment
will
impose
some
non­
reporting
administrative
costs
and
burdens.
As
with
testing
costs,
EPA
estimates
that
these
costs
and
burdens
will
amount
to
25
percent
of
the
estimated
cost
for
performing
the
Exposure
Assessment,
or
7,625
hours
and
$
364,467
over
the
three­
year
ICR
period.
In
the
summary
tables
below,
EPA
includes
these
estimates
in
the
non­
reporting
administrative
costs
category
with
similar
costs
for
the
hazard
assessment
(
testing)
and
risk
assessment.

Table
7.
Burden
and
Cost
Estimates
for
Exposure
Assessments
and
Risk
Assessments
Requirement/
Tier
Burden
Per
Chemical
Total
Burden
[
a]
Total
Cost
[
b]
Technical
Labor
Clerical
Labor
Management
Labor
TOTAL
Exposure
Assessment
Tier
1
425
50
25
500
3,500
$
167,297
Tier
2
850
100
50
1,000
15,000
$
716,985
Tier
3
1,020
120
60
1,200
12,000
$
573,588
Total
30,500
$
1,457,870
Risk
Assessment
Tier
1
255
30
15
300
2,100
$
100,378
Tier
2
425
50
25
500
7,500
$
358,492
Tier
3
510
60
30
600
6,000
$
286,794
Total
15,600
$
745,664
[
a]
Total
burden
is
calculated
by
multiplying
the
total
burden
per
chemical
by
7
chemicals
for
Tier
1,
15
chemicals
for
Tier
2,
and
10
chemicals
for
Tier
3.
[
b]
Total
cost
is
calculated
by
multiplying
the
burden
per
chemical
for
each
labor
category
(
technical
labor,
clerical
labor,
and
managerial
labor)
by
the
category's
loaded
hourly
rate
($
49.72
for
technical
labor,
$
26.10
for
clerical
labor,
and
$
58.54
for
managerial
labor),
adding,
and
then
multiplying
by
7
chemicals
for
Tier
1,
15
chemicals
for
Tier
2,
and
10
chemicals
for
Tier
3.

Risk
Assessments
EPA
has
also
estimated
the
labor
hours
and
costs
associated
with
risk
assessments
by
soliciting
information
from
within
the
Agency
and
from
several
of
its
contractors
that
have
experience
in
performing
risk
assessments
that
are
similar
in
scope
and
complexity
to
the
requirement
defined
in
the
Federal
Register
notice
for
the
VCCEP.
Based
on
this
information,
EPA
has
estimated
that
a
Tier
1
risk
assessment
would
require
300
labor
hours,
a
Tier
2
assessment
would
require
500
labor
hours,
and
a
Tier
3
assessment
would
require
600
labor
hours.
As
with
the
exposure
assessment,
EPA
has
assumed
that
85
percent
of
those
hours
are
for
technical
labor,
10
percent
are
for
clerical
labor,
and
5
percent
are
for
managerial
labor.
Thus,
over
the
three­
year
ICR
8
From
Table
5,
the
hazard
assessment
imposes
0
hours
for
Tier
1
and
124,199
hours
for
Tier
2.
From
Table
7,
the
exposure
assessment
imposes
3,500
hours
for
Tier
1
and
15,000
hours
for
Tier
2.
Also
from
Table
7,
the
risk
assessment
imposes
2,100
hours
for
Tier
1
and
7,500
hours
for
Tier
2.
The
total
of
these
six
estimates
is
152,299
hours.

­
36­
period,
32
risk
assessments
will
take
place
(
7
remaining
in
Tier
1,
15
in
Tier
2,
and
12
in
Tier
3).
Table
7
also
summarizes
EPA's
estimates
for
risk
assessments
for
the
VCCEP
pilot.
Based
on
EPA's
information,
the
risk
assessment
for
the
VCCEP
will
result
in
a
three­
year
burden
of
15,600
hours
and
$
745,664.

A
sponsor
typically
hires
a
contractor
to
conduct
an
risk
assessment,
but
EPA
still
considers
the
total
cost
of
the
assessment
as
paperwork
burden
and
costs.
EPA
also
assumes
that
the
risk
assessment
will
impose
some
non­
reporting
administrative
costs
and
burdens.
EPA
assumes
that
these
costs
and
burdens
will
represent
25
percent
of
the
estimated
cost
for
performing
the
risk
assessment,
or
3,900
hours
and
$
186,416
over
the
three­
year
ICR
period.
In
the
summary
tables
below,
EPA
includes
these
estimates
in
the
non­
reporting
administrative
costs
category
with
similar
costs
for
the
hazard
assessment
(
testing)
and
exposure
assessment.

Data
Needs
Assessment
The
data
needs
assessment
for
the
VCCEP
program
involves
identifying
the
additional
hazard
and/
or
exposure
information
that
is
needed
to
adequately
assess
the
potential
risks
to
children
and,
where
appropriate,
parents.
The
data
needs
assessment
is
expected
to
be
submitted
with
Tiers
1
and
2,
but
not
with
Tier
3.
Thus,
a
total
of
22
data
needs
assessments
will
be
prepared
and
submitted
under
the
ICR
(
7
chemicals
in
Tier
1
plus
15
chemicals
in
Tier
2).

To
estimate
the
costs
associated
with
this
activity,
EPA
assumed
that
the
burden
would
be
proportional
to
the
time
that
sponsors
spend
on
the
hazard,
exposure,
and
risk
assessments
because
the
data
needs
assessment
is
derived
from
these
three
other
assessments.
EPA
further
expects
that
the
time
for
this
activity
would
represent
only
a
small
proportion
of
the
total
time
for
the
three
other
assessments.
EPA
bases
this
assumption
on
the
fact
that
the
skilled
technical
professionals
who
will
conduct
the
hazard,
exposure,
and
risk
assessments
should
be
able
to
spot
data
gaps
for
each
chemical.
Thus,
EPA
assumes
that
the
data
needs
assessment
will
represent
two
percent
of
the
total
hours
spent
on
the
three
other
assessments
and
that
all
of
the
hours
will
be
for
technical
labor.
From
Tables
5
and
6,
hazard
assessments,
exposure
assessments,
and
risk
assessments
are
estimated
to
impose
152,299
hours
for
Tiers
1
and
2.8
Based
on
the
two­
percent
assumption,
the
data
needs
assessment
will
impose
a
burden
of
3,046
hours
over
the
three­
year
ICR
period.
Assuming
all
of
this
labor
is
technical
labor
results
in
a
three­
year
cost
of
$
151,446
(
3,046
*
$
49.72).
­
37­
Peer
Consultation
Document
EPA
assumes
that
the
Peer
Consultation
Document
(
PCD)
will
not
involve
any
significant
additional
time.
The
PCD
is
a
compilation
of
the
hazard
assessment,
exposure
assessment,
risk
assessment,
and
data
needs
assessment.
EPA
expects
that
respondents
will
develop
each
of
these
components
in
a
manner
that
can
be
readily
combined
into
the
Peer
Consultation
Document.

Present
Assessments
at
Public
Meetings
EPA
has
assumed
that
at
each
Tier,
a
sponsor
will
incur
50
burden
hours
per
chemical
to
complete
this
task.
To
derive
this
estimate,
EPA
has
assumed
that
at
least
two
persons
per
chemical
will
attend
the
public
meeting
for
each
sponsor
and
that
the
meeting
will
require
three
days
of
time
(
including
preparation,
travel,
and
attendance)
from
each
person
(
2
persons
*
3
days
*
8
hours
per
day
=
48
total
hours).
EPA
rounded
the
estimate
up
to
50
hours.
Based
on
this
assumption,
this
task
will
involve
a
three­
year
burden
of
1,800
hours
(
50
hours
per
chemical
*
36
chemicals
[
11
chemicals
remaining
in
Tier
1,
15
chemicals
for
Tier
2,
10
chemicals
in
Tier
3]).
Assuming
all
labor
is
technical
labor
results
in
a
three­
year
cost
of
$
89,496.
In
response
to
public
comments
on
the
previous
ICR,
EPA
has
included
travel
costs
to
attend
the
public
meetings
at
$
1,000
per
person.
Travel
costs
would
add
$
72,000
to
the
three­
year
costs
($
1,000
per
person
*
2
persons
per
meeting
*
36
meetings
(
11
remaining
meetings
for
Tier
1,
15
for
Tier
2,
and
12
meetings
for
Tier
3).
Therefore,
the
cost
of
presenting
assessments
at
the
public
meetings
would
be
$
161,496
over
three
years.
These
figures
represent
a
very
conservative
cost
estimate
(
i.
e.,
a
likely
overestimate),
as
experience
with
the
VCCEP
has
shown
that
some
meetings
will
cover
two
or
three
chemicals.

Total
Cost
and
Burden
Table
8
summarizes
the
total
and
annual
number
of
responses,
costs,
and
reporting
burdens
associated
with
the
VCCEP
pilot.
To
derive
the
annual
estimates,
EPA
divided
the
relevant
numbers
by
three
years.
EPA
estimates
that
the
VCCEP
pilot
will
result
in
paperwork
burdens
of
48,600
hours
and
$
2,313,662
over
the
three­
year
ICR
period.
The
estimated
annual
industry
reporting
burdens
for
the
VCCEP
are
16,200
hours
and
$
771,221.

EPA
has
also
estimated
other
non­
reporting
burdens
related
to
the
paperwork
activities
for
testing,
data
searches,
attending
public
meetings,
exposure
assessments,
risk
assessments,
the
data
needs
assessment,
and
non­
reporting
administrative
tasks
that
respondents
will
incur.
EPA
estimates
that
these
non­
reporting
burdens
will
total
270,170
hours
and
$
24.6
million
over
the
three­
year
ICR
period,
or
90,056
hours
and
$
8.2
million
annually.

Therefore,
the
total
annual
industry
burden
and
costs
associated
with
this
information
collection
are
estimated
to
be
106,256
hours
and
$
9.0
million.
­
38­
Number
of
Responses
EPA
estimates
that
the
total
number
of
responses
(
reporting
burdens
only)
for
the
VCCEP
pilot
will
be
209
over
the
three­
year
ICR
period,
or
70
responses
annually.
This
implies
an
average
of
10.5
responses
per
respondent
(
209
/
20)
over
the
three­
year
period
(
3.5
responses
annually).
Additionally,
the
average
response
will
take
233
hours
(
48,600
hours
/
209)
at
a
cost
of
$
11,070
($
2,313,662
/
209).

Table
8.
Summary
of
Respondent
Cost
and
Burden
Estimates
ACTIVITY
THREE­
YEAR
TOTALS
ANNUAL
TOTALS
Number
Burden
Hours
Costs
Number
Burden
Hours
Costs
REPORTING
BURDENS
Letters
of
commitment
25
100
$
4,972
8
33
$
1,657
Robust
Summaries
for
Hazard
Assessments
120
2,400
$
105,156
40
800
$
35,052
Exposure
Assessments
32
30,500
$
1,457,870
11
10,167
$
485,957
Risk
Assessments
32
15,600
$
745,664
11
5,200
$
248,555
REPORTING
TOTALS
209
48,600
$
2,313,662
70
16,200
$
771,221
NON­
REPORTING
BURDENS
Initial
Burden
45
945
$
47,510
15
315
$
15,837
Hazard
Assessments
55
200,353
$
18,860,355
18
66,784
$
6,286,785
File
Searches
75
2,413
$
118,757
25
804
$
39,586
Non­
Reporting
Administrative
[
a]
119
61,613
$
5,265,972
40
20,538
$
1,755,324
Data
Needs
Assessment
22
3,046
$
151,446
7
1,015
$
50,482
Public
meetings
36
1,800
$
161,496
12
600
$
53,832
NON­
REPORTING
TOTALS
352
270,170
$
24,605,537
117
90,056
$
8,201,846
TOTAL
BURDEN
AND
COSTS
561
318,770
$
26,919,199
187
106,256
$
8,973,067
Note:
totals
may
not
add
due
to
rounding.
[
a]
Includes
non­
reporting
administrative
costs
and
burdens
for
hazard
assessments,
exposure
assessments,
and
risk
assessments.

6(
b)
Agency
Cost
and
Burden
The
cost
and
burden
to
the
Agency
to
process,
review,
and
analyze
the
information
collected
under
the
VCCEP
are
discussed
below
and
detailed
in
Table
9.

EPA
is
assuming
that
the
Agency
collection
activities
will
continue
to
be
performed
by
GS­
14,
Step
1
employees
and
GS­
11,
Step
1
employees.
The
U.
S.
Office
of
Personnel
Management
reports
hourly
rates
for
all
GS
levels
for
2005
in
the
Washington,
DC
area.
EPA
added
60
percent
to
these
hourly
rates
to
account
for
benefits
and
overhead
burden.
Thus,
the
2005
loaded
hourly
­
39­
rate
for
a
GS­
14,
Step
1,
employee
is
$
67.98
and
for
a
GS­
11,
Step
1,
employee
is
$
40.36.
In
addition,
the
final
review
and
final
decision­
making
activities
will
be
performed
by
GS­
15,
Step
1
employees.
The
Office
of
Personnel
Management
2005
hourly
labor
rate
for
the
Washington,
DC
area,
plus
60
percent,
results
in
a
loaded
hourly
rate
of
$
79.96
for
the
GS­
15,
Step
1
employee.

AGENCY
LABOR
CATEGORY
LOADED
HOURLY
RATE
($
2005)

GS­
15,
Step
1
$
79.96
GS­
14,
Step
1
$
67.98
GS­
11,
Step
1
$
40.36
EPA
employees
will
perform
a
number
of
activities
under
the
VCCEP
pilot,
including:
reviewing
letters
of
commitment
(
GS­
14),
developing
and
maintaining
a
system
to
track
commitments
(
GS­
14),
responding
to
sponsor's
questions/
problems
(
GS­
14),
receiving
and
forwarding
the
PCDs
(
GS­
11),
reviewing
peer
consultation
reports
(
GS­
14
and
GS­
15),
making
final
data
needs
decisions
(
GS­
15),
communicating
program
results/
status
to
public
on
website
(
GS­
14
and
GS­
11),
and
overall
program
management
(
GS­
14).
These
activities
will
account
for
approximately
20%
of
the
GS­
14
employees'
time
and
10%
of
the
GS­
11
employees'
time
over
the
period
of
the
ICR,
or
annually
400
and
200
hours
respectively.
The
final
review
and
decisionmaking
process
will
require
roughly
500
hours
annually
from
the
GS­
15
employees.

In
addition
to
the
activities
performed
by
EPA
personnel,
the
Agency
expects
to
spend
$
500,000
annually
on
a
third­
party
scientific
organization
that
will
arrange
peer
consultations
by
relevant
experts
who
will
review
submissions
by
sponsors.
It
is
important
to
note
that
while
this
figure
represent
funds
that
the
Agency
expects
to
expend
on
cooperative
agreements
with
contractors,
EPA
will
not
have
direct
control
over
these
contractors
as
it
would
for
a
typical
contract
effort.
These
cooperative
agreements,
while
paid
for
by
EPA,
will
provide
independent
support
for
the
VCCEP.

Table
9
summarizes
EPA's
estimate.
Based
on
EPA's
assumptions,
the
Agency
activities
will
result
in
3,300
labor
hours
over
the
three­
year
ICR
period
and
$
1.8
million.
Of
the
total
dollar
amount,
$
1.5
million
represents
costs
associated
with
the
Peer
Consultation
process,
for
which
no
labor
hours
are
estimated.
­
40­
Table
9.
Total
Agency
Cost
and
Burden
Estimates,
Three­
Year
ICR
Period
COLLECTION
ACTIVITY
GS­
15,
Step
1
GS­
14,
Step
1
GS­
11,
Step
1
GRAND
TOTAL
HOURS
COST
HOURS
COST
HOURS
COST
HOURS
COST
Receive
PCDs
1,500
$
119,939
1,200
$
81,571
600
$
24,216
3,300
$
225,726
Review
Letters
of
Commitment
Track
commitments
Respond
to
sponsors
Communicate
results
on
website
Manage
program
Review
Peer
Consultation
reports
Make
data
needs
decision
Arrange
Peer
Consultations
NA
NA
NA
NA
NA
$
1,500,000
GRAND
TOTAL
1,200
$
81,571
600
$
24,216
3,300
$
1,725,726
6(
c)
Bottom
Line
Annual
Burden
Hours
and
Costs
 
Master
Tables
6(
c)(
i)
Respondent
Tally
Table
10
summarizes
the
average
annual
burden
and
cost
per
response.
EPA
estimates
that
this
ICR
will
impose
an
average
paperwork
burden
of
231.4
hours
on
70
responses
over
the
threeyear
ICR
period,
at
an
average
cost
of
about
$
11,000.
­
41­
Table
10.
Average
Annual
Burden
Hours
Per
Response
COLLECTION
ACTIVITY
ANNUAL
RESPONDENT
BURDEN
PER
RESPONSE
TOTAL
RESPONSES
TOTAL
HOURS
HOURS
PER
RESPONSE
[
a]
TOTAL
COST
COST
PER
RESPONSE
REPORTING
BURDENS
Letters
of
Commitment
8
33
4.0
$
1,657
$
207
Robust
Summaries
for
Hazard
Assessments
40
800
20.0
$
35,052
$
876
Exposure
Assessments
11
10,167
924.3
$
485,957
$
44,178
Risk
Assessments
11
5,200
472.0
$
248,555
$
22,596
REPORTING
TOTALS
70
16,200
231.4
$
771,221
$
11,017
NON­
REPORTING
BURDENS
Initial
Burden
15
315
21.0
$
15,837
$
1,056
Hazard
Assessments
18
66,784
3,710.2
$
6,286,785
$
349,266
File
Searches
25
804
32.2
$
39,586
$
1,583
Non­
Reporting
Administrative
40
20,538
513.5
$
1,755,324
$
43,883
Data
Needs
Assessment
7
1,015
145.0
$
50,482
$
7,212
Public
meetings
12
600
50.0
$
53,832
$
4,486
NON­
REPORTING
TOTALS
117
90,056
769.7
$
8,201,846
$
70,101
TOTAL
BURDEN
HOURS
187
106,256
568.2
$
8,973,067
$
47,984
Note:
Totals
may
contain
some
rounding
error
from
previous
tables
[
a]
=
Total
hours
/
Total
responses
6(
c)(
ii)
Agency
Tally
The
burden
hours
and
costs
for
the
government
have
been
calculated
above
in
Section
6(
b).
These
estimates
are
translated
to
annual
estimates
by
dividing
each
by
three
years.
The
VCCEP
will
require
1,100
agency­
hours
annually
and
$
575,242.
Of
the
total
cost,
$
500,000
is
for
peer
review
consultations
for
which
no
hours
have
been
estimated.
These
estimates
are
summarized
below
in
Table
11.
­
42­
Table
11.
Summary
of
Agency
Burden
and
Costs
Estimates
COLLECTION
ACTIVITY
TOTAL
ANNUAL
AGENCY
BURDEN
AND
COSTS
BURDEN
(
Hours)
COSTS
Receive
PCDs
1,100
$
75,242
Review
Letters
of
Commitment
Track
commitments
Respond
to
sponsors
Communicate
results
on
website
Manage
program
Review
Peer
Consultation
reports
Make
data
needs
decision
Arrange
Peer
Consultations
NA
$
500,000
GRAND
TOTAL
1,100
$
575,242
6(
d)
Reasons
for
Change
in
Burden
There
is
a
decrease
of
48,076
hours
(
from
154,332
hours
to
106,256
hours)
in
the
total
estimated
respondent
burden
compared
with
that
identified
in
the
information
collection
most
recently
approved
by
OMB.
This
decrease
represents
the
net
effect
of
many
changes
in
estimates
and
assumptions
made
from
the
previous
VCCEP
ICR,
based
on
recent
experiences
with
the
VCCEP
pilot.
First,
the
estimated
number
of
chemicals
participating
in
the
program
was
reduced
from
23
to
20,
based
on
actual
participation.
Second,
because
the
Tier
1
Peer
Consultation
Documents
submitted
thus
far
to
EPA
have
been
so
comprehensive
(
e.
g.,
many
have
contained
information
on
Tier
2
and
Tier
3
level
tests),
EPA
is
estimating
that
fewer
chemicals
will
advance
to
the
higher
tiers
(
see
sections
4(
d),
5(
a),
and
6
for
further
information).

Estimates
for
respondent
costs
have
also
decreased
for
the
following
reasons.
Costs
for
the
test
protocols
were
increased
based
on
the
most­
recent
EPA
estimates.
Also,
a
reduction
in
labor
wage
rates,
in
comparison
to
the
estimates
for
the
previous
ICR,
reflects
a
decision
to
adhere
more
closely
to
data
from
BLS.
In
addition,
the
estimated
burden
to
the
federal
government
has
been
reduced,
based
on
experience
with
the
program,
but
costs
have
decreased
a
lesser
extent
due
to
rising
labor
rates.

6(
e)
Burden
Statement
The
annual
public
burden
for
this
collection
of
information
is
estimated
to
average
about
231
hours
per
response.
According
to
the
PRA,
"
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,
"
burden"
includes
the
time
needed
to
review
instructions;
develop,
acquire,
install,
and
utilize
technology
and
systems
for
the
purposes
of
collecting,
validating,
and
verifying
information,
processing
and
maintaining
information,
and
disclosing
and
providing
information;
adjust
the
existing
ways
to
comply
with
any
previously
applicable
instructions
and
requirements;
train
personnel
to
be
able
to
respond
to
a
collection
of
information;
search
data
sources;
complete
and
review
the
collection
of
information;
and
transmit
or
otherwise
disclose
the
information.
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.
In
addition,
the
OMB
control
numbers
for
EPA's
regulations,
after
initial
display
in
the
Federal
Register,
are
listed
in
40
CFR
part
9,
as
well
as
in
any
applicable
collection
instrument.

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
0061,
which
is
available
for
public
viewing
at
the
EPA
Public
Reading
Room,
Room
B102,
EPA
West
Building,
1301
Constitution
Avenue,
N.
W.,
Washington,
D.
C.,
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays
(
202­
566­
0280).
An
electronic
version
of
the
public
docket
is
available
through
EPA
Dockets
(
EDOCKET)
at
http://
docket.
epa.
gov/
edkpub/
index.
jsp.
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.

ATTACHMENTS
[
NOTE:
Unless
otherwise
noted,
an
electronic
version
of
the
listed
attachment
appears
in
the
electronic
file
for
the
ICR,
following
the
main
text
of
the
Supporting
Statement.]

Attachment
1
 
Voluntary
Children's
Chemical
Evaluation
Program;
Notice.
65
FR
81699,
December
26,
2000.
For
an
electronic
copy
of
this
notice
go
to
http://
www.
epa.
gov/
chemrtk/
vccep/
pubs/
ts00274d.
pdf.

Attachment
2
 
Toxic
Substances
Control
Act
Section
4
(
15
USC
2603)

Attachment
3
 
Procedures
Governing
Testing
Consent
Agreements
and
Test
Rules
(
40
CFR
790)