November
20,
2002
Supporting
Statement
for
a
Request
for
OMB
Review
under
the
Paperwork
Reduction
Act
1
IDENTIFICATION
OF
THE
INFORMATION
COLLECTION
1(
a)
Title
of
the
Information
Collection
Title:
Data
Submissions
for
the
Voluntary
Children's
Chemical
Evaluation
Program
(
VCCEP)

EPA
ICR
No.:
2055.01;

OMB
Control
No.
2070­[
tbd]

1(
b)
Short
Characterization
This
voluntary
data
collection
program
is
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
Information
Collection
Request
(
ICR)
covers
the
submission
of
these
types
of
data
as
well
as
the
commitment
letters
from
companies
volunteering
to
sponsor
their
chemical(
s)
at
each
of
three
tiers
in
the
Voluntary
Children's
Chemical
Evaluation
Program
(
VCCEP).
Although
this
ICR
is
submitted
as
a
new
information
collection
request,
it
is
important
to
note
that
EPA's
ICR
#
1139.06,
approved
under
OMB
#
2070­
0033,
included
estimated
burden
associated
with
the
anticipated
industry
participation
in
the
initial
phases
of
the
VCCEP.
To
present
a
complete
picture
of
the
estimated
burden
for
the
VCCEP,
however,
that
burden
has
been
reassessed
and
is
included
in
this
ICR.
Upon
approval
of
this
ICR
by
OMB,
EPA
will
submit
an
Information
Correction
Worksheet
(
ICW)
to
reduce
the
total
approved
burden
under
OMB
#
2070­
0033
by
$
2,484,534
and
52,295
hours,
which
represents
the
removal
of
the
estimated
burden
associated
with
the
VCCEP
that
was
included
in
that
ICR,
and
that
will
be
covered
by
this
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.
Participation
in
VCCEP
and
submission
of
data
is
voluntary.
EPA
and
others
will
use
the
information
collected
on
risks
of
certain
chemical
exposures
to
children
to
support
any
necessary
risk
management
or
regulatory
action
with
respect
to
that
chemical.

The
VCCEP
is
designed
to
provide
data
to
enable
EPA
and
the
public
to
better
understand
the
potential
health
risks
to
children
associated
with
certain
chemical
exposures.
EPA
will
obtain
needed
chemical
evaluation
data
from
voluntary
commitments
by
chemical
sponsors.
The
commitment
will
be
initiated
by
a
letter
to
EPA
identifying
the
chemical
and
tier
of
information
that
a
company
commits
to
sponsor.
Industry
will
have
the
opportunity
to
make
a
separate
commitment
for
each
of
three
tiers.
The
Program
is
also
designed
to
ensure
that
health
effects,
exposure,
and
risk
information
on
these
chemicals
are
made
available
to
allow
EPA
and
others
to
pursue
appropriate
mitigation
measures.
Page
2
The
VCCEP
requires
the
development
of
test
data
that
provide
critical
information
on
health
effects,
exposure,
risk,
and
additional
data
needs
that
enable
EPA
and
others
to
assess
and
manage
health
risks
that
may
be
posed
by
certain
chemicals
to
which
children
are
likely
to
be
exposed.
EPA
will
use
a
publicly
conducted
Peer
Consultation
Process
to
help
assess
whether
data
developed
are
adequate
to
fully
characterize
risk
to
children
and,
if
not,
what
additional
data
are
needed.
EPA
will
also
make
the
collected
data
publicly
available
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.
(
For
more
information
about
the
VCCEP
go
to:
http://.
www.
epa.
gov/
chemrtk/
childhlt.
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,
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
Confidential
Business
Information
(
CBI)
or
other
information
whose
disclosure
is
restricted
by
statute.
The
official
public
docket
is
the
collection
of
materials
that
is
available
for
public
viewing
at
the
EPA
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
findings
for
hazard
or
exposure
ware
made.
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
environment.
(
The
previous
sentence
was
changed,
in
response
to
a
comment
from
SOCMA,
from
"
exposure
to
humans
had
likely
occurred"
to
"
exposure
to
the
general
population
had
occurred."
EPA
believes
that
biomonitoring
data
showing
the
presence
of
foreign
chemicals
in
the
body
presupposes
that
exposure
has
occurred.)
The
biomonitoring
data
sets
used
for
Page
3
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
or
imported
in
the
United
States.
Other
chemicals
were
deferred
because
of
ongoing
assessments
that
are
similar
in
scope
to
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
23
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.
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.
Furthermore,
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.
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.

Since
1979,
approximately
540
of
the
15,000
chemical
sub­
set
of
the
TSCA
Inventory
have
been
the
subject
of
testing
actions
within
the
OPPT
Existing
Chemicals
Testing
Program.
Virtually
all
of
the
540
chemicals
are
high
production
volume
(
HPV)
chemicals.
The
testing
actions
taken
to
date
include
a
mix
of
formal
TSCA
Section
4
Test
Rules
and
Section
4
Enforceable
Consent
Agreements,
and
Voluntary
Testing
Agreements.
More
than
50%
of
these
testing
actions
have
been
taken
in
the
last
several
years
and
have
focused
on
chemicals
with
clearly
identified
data
"
needs"
(
as
opposed
to
simply
data
gaps).
In
addition,
almost
250
formal
TSCA
Section
4
"
Decisions
Not
To
Test"
(
DNTs)
have
been
issued
by
EPA
to
date.
Screening
Page
4
efforts
to
identify
priorities
and
determine
testing
needs
for
other
chemicals
are
currently
underway
in
OPPT.

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
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
the
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
be
done
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,
information
regarding
the
voluntary
commitments
under
VCCEP
will
be
posted
on
the
EPA
website,
where
they
will
be
available
to
the
public
(
go
to:
http://
www.
epa.
gov/
chemrtk/
childhlt.
htm).

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

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
Page
5
In
proposing
this
ICR,
EPA
provided
a
60­
day
public
notice
and
comment
period
that
ended
on
June
17,
2002
(
67
FR
18609
and
67
FR
34703).
EPA
received
a
number
of
comments
during
the
comment
period.
These
comments
are
addressed
both
in
the
body
of
the
ICR
(
see
Section
6,
Estimating
the
Burden
and
Cost
of
the
Collection)
and
in
Attachment
6,
Response
to
Comments.

EPA
has
established
a
public
docket
for
this
ICR
under
Docket
ID
No.
OPPT­
2002­
0005,
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's
electronic
public
docket
and
comment
system,
EPA
Dockets
(
EDOCKET)
at
http://
www.
epa.
gov/
edocket.
Use
EDOCKET
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Once
in
the
system,
select
"
search,"
then
key
in
the
docket
ID
number
identified
above.

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
to
be
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
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
scientific
organization
will
be
consulted
in
this
evaluation.

3(
d)
Effects
of
Less
Frequent
Collection
As
designed,
this
program
minimizes
overall
burden
by
allowing
companies
to
join
together
to
sponsor
a
chemical,
limiting
submissions
per
chemical
to
the
bare
minimum
(
only
one
response
per
sponsor,
per
chemical,
per
occasion),
and
by
utilizing
a
tiering
process
for
submissions.
The
VCCEP
requires
the
sponsor
to
submit
a
letter
notifying
EPA
that
it
is
Page
6
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
Practices
(
GLPs)
to
be
retained
for
ten
years
from
the
effective
date
of
the
applicable
test
rule
or
publication
date
of
the
consent
order.
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
long­
term,
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
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
3
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
8
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
(
approx.
2
months),
the
third
party's
report
preparation
(
approx.
1
month),
EPA's
announcement
of
its
Data
Needs
Decision
(
approx.
1
month),
60
days
public
comment
on
EPA's
Data
Needs
Decision
if
it
differs
substantially
from
the
third
party
report,
EPA's
Final
Data
Needs
Decision
(
approx.
1
month),
and
4
months
for
the
sponsor
to
commit
to
the
next
tier
of
testing.
This
additional
time
of
11
months
would
be
required
for
both
Tier
1
and
Tier
2,
while
Tier
3
would
require
only
3
additional
months
since
it
does
not
have
a
Data
Needs
Decision.
Therefore,
the
VCCEP
may
require
an
additional
2
years
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
Page
7
experts
whose
participation
will
be
sought.

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
GLPs.
Thus,
the
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
part
2.

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

3(
h)
Electronic
Reporting
In
a
process
that
began
in
1996,
OPPT
has
been
working
with
representatives
from
various
offices
within
EPA,
OMB,
Department
of
Justice
(
DOJ),
General
Services
Administration
(
GSA),
and
the
regulated
community
to
develop
a
user­
friendly
electronic
reporting
process
for
the
information
that
is
submitted
to
EPA
under
sections
4,
5,
8,
and
12(
b)
of
TSCA.
EPA
is
expected
to
announce
the
availability
of
the
electronic
reporting
option
for
these
submissions
under
TSCA
by
the
end
of
2001.

Although
the
TSCA
electronic
submission
project
has
not
been
implemented
yet,
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
23
chemicals
for
each
of
the
3
tiers
there
could
be
as
many
as
69
electronic
submissions
for
3
tiers
of
the
pilot
program.
Page
8
4
THE
RESPONDENTS
AND
THE
INFORMATION
REQUESTED
4(
a)
Respondents/
SIC
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.
Please
note,
however,
that
the
estimated
burden
and
costs
associated
with
the
anticipated
industry
participation
in
the
initial
phases
of
the
VCCEP
were
captured
in
EPA's
ICR
#
1139.06,
approved
under
OMB
#
2070­
0033.
That
burden
has
been
reassessed
and
is
included
in
this
ICR
for
completeness.
Upon
approval
of
this
ICR
by
OMB,
EPA
will
revise
the
total
burden
approved
under
OMB
#
2070­
0033
as
appropriate.

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
10
years
after
the
date
they
are
submitted
to
EPA.
If
the
sponsor
wishes,
he
may
submit
comments
on
EPA's
Data
Needs
Decision
for
Tier
2
and
Tier
3
data.

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.
Page
9
°
Risk
Assessment.
°
Data
Needs
Assessment.

3.
Comments
on
EPA's
Data
Needs
Decision
for
Tier
2
and
Tier
3.
This
is
optional.

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
assessments
will
be
submitted
in
a
single
document,
the
Peer
Consultation
Document,
and
prepared
for
each
tier
to
which
a
company
or
consortium
commits.
For
the
VCCEP,
EPA
will
limit
the
scope
of
testing/
data
development
for
each
chemical
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
committed
to,
the
sponsor
must
include
that
study
in
the
relevant
assessment.
Because
the
availability
of
data
on
the
pilot
VCCEP
chemicals
has
yet
to
be
determined
by
the
sponsor
and
decisions
on
additional
data
needs
have
yet
to
be
made
by
EPA,
it
is
not
possible
at
this
time
to
predict
with
certainty
how
many
of
the
23
chemicals
in
the
pilot
VCCEP
will
have
completed
all
three
tiers
during
the
effective
period
of
the
ICR.
At
this
time,
however,
it
is
known
that
a
full
set
of
Tier
1
hazard
data
is
available
on
15
pilot
VCCEP
chemicals
that
have
been
evaluated
in
the
Screening
Information
Data
Set
(
SIDS)
program.
Also,
an
analysis
of
44
similar
HPV
chemicals
targeted
for
a
Children's
Health
Test
Rule
(
now
set
aside
due
to
the
VCCEP)
indicated
that
many
of
the
chemicals
had
been
tested
for
endpoints
addressed
by
Tier
2
and
Tier
3
tests
in
the
VCCEP.
The
percentages
of
those
chemicals
that
had
available
Tier
2
and
Tier
3
tests
was
determined
for
each
test.
The
results
of
that
analysis
were
used
by
EPA
in
its
analysis
for
this
ICR
to
give
some
indication
of
how
many
of
the
23
pilot
VCCEP
chemicals
may
already
have
some
Tier
2
and
Tier
3
tests
completed.
This
analysis
is
further
discussed
in
section
6(
a).

The
Hazard
Assessment
to
be
prepared
by
the
sponsor
will
primarily
be
based
on
the
toxicity
tests
specified
for
the
tier
committed
to,
but
must
also
include
existing
studies
even
though
they
address
endpoints
in
an
upper
tier
not
committed
to.
The
three
tiers
of
toxicity
tests
specified
by
the
VCCEP
are
listed
in
Table
1.

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
Page
10
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
OECD
guidelines,
or
the
OPPTS
harmonized
guidelines
in
the
870
series.

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
parent),
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.
Page
11
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.
Following
are
the
specific
types
of
information
that
should
be
submitted
in
an
Exposure
Assessment:

°
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)
is
preparing
a
document
entitled
"
Child­
Specific
Exposure
Factors
Handbook"
that
consolidates
all
child
exposure
factors
and
related
data
in
one
document.
A
draft
copy
is
available
on
the
NCEA
website
(
http://
www.
epa.
gov/
ncea/
csefh2.
htm)
and
the
final
document
should
be
available
in
the
near
future.
The
exposure
information
that
is
provided
for
the
VCCEP
must
be
transparent
and
must
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.

4(
b)(
ii)
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
of
their
chemical(
s),
and
EPA's
decision
on
the
need
for
additional
data
on
their
chemical(
s).
Because
the
availability
of
data
on
the
pilot
VCCEP
chemicals
has
yet
to
be
determined
by
the
sponsor
and
decisions
on
additional
data
needs
have
yet
to
be
made
by
EPA,
Page
12
the
likely
number
of
sponsor
activities
cannot
be
predicted
with
certainty
at
this
time.
The
maximum
number
and
type
of
activities
that
a
sponsor
in
the
pilot
VCCEP
can
be
anticipated
to
undertake
per
tier
commitment
is
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
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.
(
8)
Submit
3
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)
May
Submit
comments
to
EPA
on
EPA's
"
Data
Needs
Decision."
(
11)
Maintain
test
data
records
and
Peer
Consultation
Documents
for
10
years.

Tier
2:
(
1)
Submit
"
Letter
of
Commitment"
to
EPA
volunteering
to
sponsor
a
chemical
in
Tier
2.
It
is
anticipated
that
all
23
chemicals
will
reach
this
stage
during
the
effective
period
of
the
ICR.
(
2)
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.
(
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
3
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)
May
Submit
comments
to
EPA
on
EPA's
"
Data
Needs
Decision."
(
10)
Maintain
test
data
records
and
Peer
Consultation
Documents
for
10
years.

Tier
3:
(
1)
Submit
"
Letter
of
Commitment"
to
EPA
volunteering
to
sponsor
a
chemical
in
Tier
3.
It
is
anticipated
that
15
chemicals
will
reach
this
stage
during
the
effective
period
of
the
ICR.
(
2)
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.
(
3)
Plan
necessary
activities,
e.
g.,
consortia,
arrange
for
conduct
of
studies,
etc.
Page
13
(
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
3
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
10
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
Tier
1
of
the
VCCEP
must
send
a
letter
to
EPA
committing
to
do
so
by
June
25,
2001.
(
ICR
#
1139.06
covers
this
request
for
information,
but
it
is
also
included
in
this
ICR
so
that
all
VCCEP
information
requests
can
be
contained
in
one
ICR
to
facilitate
future
renewals).
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,
the
anticipated
submission
date
to
EPA,
and
a
commitment
to
start
testing
by
December
26,
2001.
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
must
be
prepared
for
each
tier
for
each
chemical
to
which
a
sponsor
commits.
(
ICR
#
1139.06
covers
this
request
for
information,
but
it
is
also
included
in
this
ICR
so
that
all
VCCEP
information
requests
can
be
contained
in
one
ICR
to
facilitate
future
renewals).
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
must
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.
Page
14
(
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
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.
The
format
for
the
Exposure
Assessment
will
be
discussed
and
defined
at
a
workshop
in
2001
with
EPA
and
industry
participation.

(
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
(
3
copies
and
one
electronic
copy).
EPA
will
provide
one
copy
to
the
third
party
scientific
organization
who
will
provide
copies
to
the
Peer
Consultation
members.
EPA
will
also
put
one
copy
in
the
TSCA
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
third
party's
report
of
the
Peer
Consultation.
Page
15
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
VCEEP
based
on
production
volume,
are
not
currently
produced
in
substantial
quantities
and
therefore,
testing
of
these
chemicals
is
not
necessary.
Based
on
a
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.

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
must
undertake
the
following
applicable
activities:

a)
review
letters
of
commitment
for
Tiers
1,
2,
and
3
(
separate
letter
for
each
tier)
for
completeness;
b)
develop
a
system
to
track
commitments
and
progress
of
program
on
VCCEP
website
and
update
monthly;
c)
issue
a
grant
to
a
third
party
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
report
to
EPA
and
the
sponsor;
d)
review
Peer
Consultation
Documents
and
third
party
reports,
make
data
needs
decisions;
e)
announce
the
Data
Needs
Decisions
for
Tiers
1
and
2
on
VCCEP
website
and
in
letters
to
relevant
sponsors;
f)
provide
explanation
of
Data
Needs
Decisions
if
they
differ
substantially
from
the
third
party
report.
Take
comments
and
make
final
Data
Needs
Decisions
at
Tiers
1
and
2;
g)
announce
the
final
Data
Needs
Decision
at
Tiers
1
and
2
on
VCCEP
website
and
in
letters
to
relevant
sponsors;
h)
make
the
Peer
Consultation
Documents
available
to
public
in
the
TSCA
NCIC;
make
third
party
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.,
an
Exposure
Workshop,
other
voluntary
efforts
to
identify
data
gaps
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.

5(
b)
Collection
Methodology
and
Management
Data
collected
under
the
VCCEP
will
be
received
by
the
TSCA
Nonconfidential
Information
Center
(
NCIC),
which
will
place
a
copy
in
the
official
docket
(
OPPTS­
00274).
The
NCIC
will
then
transfer
the
data
to
the
program
manager
in
the
Office
of
Pollution
Prevention
and
Page
16
Toxics,
Chemical
Control
Division,
Chemical
Testing
and
Information
Branch,
where
they
will
be
reviewed
for
completeness
and
then,
depending
on
the
data
received,
routed
as
follows:

­
Letters
of
Commitment
will
be
routed
to
the
person
in
CITB
assigned
to
track
the
progress
of
the
VCCEP
and
update
the
VCCEP
website.
­
Peer
Consultation
Documents
will
be
routed
to
the
third
party
scientific
organization
(
one
copy),
to
the
person
in
CITB
maintaining
the
VCCEP
files
(
one
copy
and
the
electronic
copy),
and
to
the
RAD/
EETD
group
that
makes
the
data
needs
decision
(
one
copy).
­
Third
party
reports
on
Peer
Consultation
will
be
routed
to
the
person
in
CITB
maintaining
the
VCCEP
files
(
one
copy)
and
to
the
RAD/
EETD/
CCD
group
that
makes
the
data
needs
decision
(
one
copy).
­
Comments
on
EPA's
Data
Needs
Decision
will
be
routed
to
the
person
in
CITB
maintaining
the
VCCEP
files
(
one
copy),
and
to
the
RAD/
EETD/
CCD
group
that
makes
the
data
needs
decision
(
one
copy).

The
Peer
Consultation
Document
prepared
by
the
sponsor
for
Tier
1
will
contain
hazard,
exposure,
risk,
and
data
needs
assessments.
The
sponsor
will
present
his
assessments
to
the
Peer
Consultation
that
will
then
discuss
the
assessments
with
emphasis
on
the
data
needs
assessment.
A
third
party
scientific
organization
that
has
arranged
and
facilitated
the
meeting
will
summarize
the
results
of
the
Peer
Consultation
and
send
a
report
to
EPA
and
the
sponsor.
EPA,
specifically
representatives
from
RAD,
EETD,
and
CCD
will
review
the
third
party
report
and
the
Peer
Consultation
Document
and
decide
if
any
information
from
the
next
tier
is
needed
to
assess
the
risk
to
children
of
the
chemical
in
question.
If
the
decision
is
that
additional
data
are
needed,
EPA
announces
this
on
the
VCCEP
website
and
in
a
letter
to
the
sponsor.
If
EPA's
decision
differs
substantially
from
the
third
party
report,
EPA
will
provide
an
explanation
for
its
decision
and
allow
the
sponsor
and
the
public
60
days
to
comment.
EPA
will
consider
the
comments
and
make
a
final
data
needs
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
final
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).

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
direct
responsibility
for
collecting
or
submitting
test
information,
while
still
allowing
the
small
business
to
participate
in
the
program.
Page
17
5(
d)
Collection
Schedule
This
information
collection
activity
does
not
involve
more
than
one
submission
per
activity.
Required
testing
is
conducted
only
once,
and
each
related
submission
is
a
one­
time
onoccasion
submission.
The
time
allowed
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
2
are
the
times
that
EPA
believes
are
reasonable
to
complete
each
test
in
the
VCCEP.
It
is
assumed
that
tests
in
the
same
tier
will
be
conducted
simultaneously.

Table
2.­­
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
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.

A
likely
timeline
for
the
VCCEP
pilot
that
indicates
anticipated
collections
of
commitment
letters
and
sponsor
assessments
is
presented
below.
Page
18
ID
1
2
3
4
5
6
7
8
9
10
Task
Name
Letter
to
sponsor
IUR/
HPV
contacts
from
AA
Letter
to
sponsor
CEOs
from
Administrator
Sponsor
commitments
to
EPA
Sponsor
commitments
to
EPA
Sponsors
develop
hazard
data
Sponsors
prepare
hazard,
exposure,
risk
and
data
needs
assessements
Commitment
tracking
and
website
development
and
maintenance
Information
Collection
Request
development
Exposure
Robust
Summary
development
leading
to
July
2001
Workshop
Peer
Consultation
Preparation
and
Contracting
Tier
1
Peer
Consultations
Start
Date
2/
21/
01
3/
21/
01
2/
21/
01
2/
21/
01
2/
21/
01
2/
21/
01
2/
21/
01
2/
21/
01
2/
21/
01
10/
25/
01
3/
26/
01
4/
20/
01
6/
25/
01
12/
25/
02
4/
25/
03
12/
25/
03
10/
25/
01
10/
25/
01
10/
25/
01
12/
25/
03
VCCEP
Pilot
Tier
1
Timeline
CCD/
EAD
EETD
RAD
Sponsors
Sponsors
CCD
Due
date
for
chemicals
with
complete
Tier
1
hazard
data
sets
at
project
onset
(
eg.
SIDS
chemicals)

Exposure
Workshops
1st
Peer
Consultation
11
12
Development
Information
Management
Plan
Construct
Information
Management
Systems
2/
21/
01
7/
25/
01
7/
26/
01
7/
26/
02
Q1
Q2
Q3
Q4
Q1
Q2
Q3
Q4
Q1
Q2
Q3
Q4
Q1
Q2
2001
2002
2003
2004
End
Date
CCD/
EAD
Sponsors
RAD
IMD
IMD
EETD
CCD/
EETD
Due
date
for
all
remaining
chemicals
Page
19
1
In
most
instances,
test
sponsors
will
form
a
"
Consortium",
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.
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,
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
is
based
on
the
following
assumptions.
These
assumptions
are
based
on
historical
experience
with
the
TSCA
testing
program,
as
well
as
conservative
projections
for
the
VCCEP
pilot
over
the
next
three
years.
In
response
to
a
comment
from
ACC
on
the
ICR,
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.

1)
EPA
assumes
that
23
chemicals
will
be
enrolled
in
the
VCCEP
pilot.
To
date,
20
chemicals
have
been
sponsored
by
34
companies
acting
through
11
consortia.
Additionally,
EPA
assumes
that
the
entire
three­
tier
process
for
each
chemical
will
be
completed
within
the
three
year
ICR
approval
period
for
12
of
the
23
chemicals,
and
that
the
remaining
11
will
only
complete
Tier
2
(
i.
e.,
23
chemicals
will
complete
Tiers
1
and
2,
and
12
chemicals
will
complete
all
three
Tiers).
This
assumption
is
optimistic
(
see
section
3(
e)
for
a
possible
VCCEP
timeline),
but
allows
for
quick
action
on
the
part
of
EPA
and
its
industry
partners.
These
assumptions
provide
a
conservative
estimate
of
the
cost
and
burden
associated
with
the
VCCEP
pilot.
In
the
event
that
fewer
than
23
chemicals
are
enrolled
in
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
likely,
the
process
for
any
of
the
enrolled
chemicals
lasts
longer
than
three
years,
then
the
total
burden
and
cost
will
be
extended
over
a
longer
time
frame,
thus
reducing
the
annual
burden
and
cost
of
the
program.

2)
One
or
several
chemicals
may
be
sponsored
by
one
company
or
a
consortium
representing
several
companies.
1
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
23.

3)
The
3
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
Page
20
between
more
than
one
799
series
test,
EPA
assumes
that
sponsors
will
choose
the
lower
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
3.

4)
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
75%
of
the
subchronic
tests
will
be
conducted
by
inhalation
(
guideline
799.9346),
and
25%
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.)

5)
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.

6)
In
conducting
any
test
that
will
be
submitted
to
EPA
under
TSCA,
the
respondent
must
comply
with
Good
Laboratory
Practices
(
GLPs).
Since
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
3.

7)
EPA
assumes
that
some
of
the
23
chemicals
have
already
been
subject
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.

8)
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
SIDS
program.

9)
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.
Many
respondents,
however,
are
likely
to
use
their
own
facilities
to
conduct
the
testing.

10)
The
programs
established
for
the
VCCEP
and
HPV
Challenge
chemicals
are
voluntary
initiatives
under
which
manufacturers
of
chemicals
targeted
for
testing
will
voluntarily
submit
data
on
hazard
endpoints;
the
VCCEP
also
includes
exposure,
risk,
and
data
needs
information.
EPA
would
exclude
any
chemicals
enrolled
in
these
voluntary
programs
from
its
planned
section
4
test
rules
and
would
provide
recognition
to
program
participants
for
their
voluntary
actions.

11)
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
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.
Page
21
2
Guidance
on
Searching
for
Chemical
Information
and
Data,
May
1999
(
http://
www.
epa.
gov/
opptintr/
chemrtk/
srchguid.
htm).
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.
2
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
assumed
that
the
respondents
will
incur
both
laboratory
testing
costs
and
administrative
costs
and
burden
when
participating
in
the
program.
For
the
laboratory
testing
costs,
only
a
portion
of
the
total
cost
may
be
attributed
to
the
paperwork
related
requirements
that
EPA
imposes
on
the
participants.
To
calculate
the
potential
paperwork
burden
and
costs
under
this
ICR,
EPA
used
the
laboratory
testing
costs
to
calculate
the
potential
paperwork
burden
and
costs
associated
with
conducting
the
testing
(
i.
e.,
generating
the
data
to
be
submitted),
and
the
potential
paperwork
burden
and
costs
associated
with
participation
in
the
VCEEP.
These
are
described
in
more
detail
later
in
this
section.

The
unit
burden
for
each
activity
is
based
upon
previous
section
4
ICRs
and
EPA's
best
estimates
of
the
burdens
that
will
be
incurred
under
TSCA
section
4
test
rules
over
the
next
three
year
period.
The
unit
wage
rates
used
to
monetize
these
burdens
are
derived
in
Attachment
1
and
are
summarized
as
follows:

INDUSTRY
LABOR
CATEGORY
LOADED
HOURLY
RATE
($
2001)

Managerial
Technical
Secretarial
$
97.51
$
71.96
$
28.85
Based
upon
the
assumptions
and
default
testing
assumptions
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
the
chemical.
Thus,
there
will
be
23
total
respondents
for
the
VCCEP.
EPA
recognizes,
however,
that
more
than
one
entity
may
participate
in
the
VCEEP,
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
what
can
be
described
as
"
initial"
burden
and
costs
related
to
their
participation
in
the
consortium.
Although
the
Agency
does
not
have
sufficient
information
at
this
time
to
assess
this
additional
burden
and
Page
22
3
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
(
25
percent)
and
those
that
would
receive
inhalation
route
testing
(
75
percent).
This
is
explained
in
more
detail
in
assumption
number
4
above
and
in
the
notes
to
Table
3.
costs,
the
Agency
has
attempted
to
account
for
it
by
including
an
additional
burden
estimate
that
assumes
a
total
of
45
entities
(
34
companies
and
11
consortia,
some
of
which
are
trade
associations)
participating
in
the
VCEEP.

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,
presenting
the
assessments
at
public
meetings,
and
submitting
comments
on
EPA's
data
needs
decision.
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
must
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
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
4
above.
Table
3
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.

EPA
generates
and
maintains
a
listing
of
the
laboratory
cost
and
burden
data
for
numerous
TSCA
and
OECD
test
protocols.
Any
test
protocols
listed
in
Table
3
for
which
cost
and
burden
data
were
estimated
prior
to
1994
were
adjusted
to
end­
of­
year
2000
dollars
using
the
Bureau
of
Labor
Statistics'
Employment
Cost
Indices
(
ECIs)
(
see
Attachment
1).

EPA
expects
that
at
least
some
of
these
chemicals
will
already
have
been
subject
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
will
require
each
specific
test.
Table
3
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
3).
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
23
chemicals
and
then
subtracting
the
result
from
23
(
the
total
number
of
chemicals
for
each
tier).
3
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
Page
23
$
23.9
million
and
282,070
hours
of
labor
over
the
three­
year
ICR
period.
EPA
estimates
that
a
total
of
78
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
$
306,846
per
study
($
23.9
million/
78
studies).
Page
24
Table
3.
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
1
Acute
inhalation
toxicity
OECD
403
$
14,735
184
100%
0
$
0
0
2
In
vitro
gene
mutation:
Bacterial
reverse
mutation
assay
799.9510
$
7,389
61
100%
0
$
0
0
3
Repeated
dose
oral
toxicity
OECD
407
$
40,630
328
100%
0
$
0
0
4
In
vivo
mammalian
erythrocyte
micronucleus
799.9539
$
15,158
132
100%
0
$
0
0
TOTAL
FOR
TIER
1
$
77,912
705
­
0
$
0
0
Tier
2
1
90­
Day
subchronic
toxicity
in
rodents
870.3100
$
105,214
757
81.8%
1
[
c]
$
105,214
757
799.9346
$
305,507
2,458
81.8%
3
[
d]
$
916,521
7,374
2
Reproduction
and
fertility
effects
799.9380
$
826,676
9,449
29.5%
16
$
13,226,816
151,184
3
Prenatal
developmental
toxicity
(
two
species)
799.9370
$
88,448
1,079
38.6%
14
$
1,238,272
15,106
4
In
vivo
mammalian
erythrocyte
micronucleus
799.9539
$
15,158
132
81.8%
4
$
60,632
528
5
Immunotoxicity
799.9780
$
45,887
550
31.8%
16
$
734,192
8,800
6
Metabolism
and
pharmacokinetics
870.7485
$
31,650
330
90.9%
2
$
63,300
660
TOTAL
FOR
TIER
2
$
1,418,540
14,755
­
56
$
16,344,947
184,409
Tier
3
1
Carcinogenicity
799.9420
$
1,259,677
17,953
68.2%
4
$
5,038,708
71,812
2
Neurotoxicity
screening
battery
799.9620
$
100,001
883
45.5%
7
$
700,007
6,181
3
Developmental
neurotoxicity
870.6300
$
168,212
1,788
4.5%
11
$
1,850,332
19,668
TOTAL
FOR
TIER
3
$
1,527,890
20,624
­
22
$
7,589,047
97,661
GRAND
TOTALS
­
­
­
­
78
$
23,933,994
282,070
[
a]
These
numbers
also
represent
the
number
of
studies
that
would
be
conducted.

[
b]
To
calculate
the
number
of
tests
for
Tiers
1
and
2,
EPA
multiplied
the
baseline
testing
rate
by
23
chemicals
and
then
subtracted
the
result
from
23.
To
calculate
the
number
of
tests
for
Tier
3,
EPA
multiplied
the
baseline
testing
rate
by
12
chemicals
and
then
subtracted
the
result
from
12.

[
c]
To
calculate
the
number
of
tests
performed
by
the
oral
route,
EPA
multiplied
the
number
of
chemicals
needing
testing
(
4),
by
25
percent
per
Assumption
4.

[
d]
To
calculate
the
number
of
tests
performed
by
inhalation,
EPA
multiplied
the
number
of
chemicals
needing
testing
(
4),
by
75
percent
per
Assumption
4.
Page
25
4
The
costs
for
this
requirement
are
estimated
as:
(
174
studies)
×
[
(
15
hours
technical
time)
×
(
$
71.96)+
(
5
hours
clerical
time)
×
(
$
28.85)].
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
3
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
23
chemicals
(
6
tests
x
23
chemicals
=
138)
plus
the
number
of
tests
in
Tier
3
multiplied
by
12
chemicals
(
3
tests
x
12
chemicals=
36),
for
a
total
of
174
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
3,480
hours
and
$
212,915
over
the
same
period.
4
Administrative
Costs
and
Burdens
Associated
with
Laboratory
Costs
and
Burdens
EPA's
experience
in
test
rule
development
has
shown
that
administrative
costs
and
burdens
(
i.
e.,
related
to
the
paperwork
burden
and
costs)
associated
with
testing
programs
to
be
approximately
25
percent
of
the
laboratory
costs.
EPA
applied
this
assumption
to
the
Tier
2
and
3
estimates,
but
did
not
do
the
same
for
Tier
1
since
all
Tier
1
testing
is
assumed
to
be
complete.
Under
EPA's
standard
25
percent
assumption,
the
cost
estimate
per
test
is
used
to
calculate
the
cost
of
the
paperwork
or
administrative
burden
associated
with
conducting
that
test
by
using
our
25
%
assumption.
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
347.42
hours
(
technical).
EPA
then
calculates
separately
the
rest
of
the
burden
and
costs
for
the
ICR,
i.
e.,
burden
and
costs
for
all
the
other
activities.

Because
EPA
has
assumed
that
all
testing
is
complete
for
Tier
1,
EPA
assumes
that
total
administrative
costs
and
burdens
for
Tier
1
only
need
to
include
the
costs
and
burdens
for
submitting
the
data
under
Tier
1,
i.
e.,
that
the
burden
and
costs
for
generating
the
data
under
Tier
1
is
"
0."
Based
on
this
method,
EPA
presents
estimates
for
administrative
reporting
activities,
and
then
for
non­
reporting
administrative
activities
in
the
following
two
sections.

Administrative
Reporting
Costs
and
Burdens
Part
of
the
administrative
costs
and
burdens
associated
with
this
ICR
are
derived
from
reporting
activities
undertaken
by
respondents.
These
activities
include
preparing
letters
of
commitment
and
performing
data
searches
and
reviews.
EPA
has
summarized
its
estimates
for
these
categories
in
Table
4,
and
discusses
each
below.

For
letters
of
commitment,
EPA
assumed
that
each
sponsor
would
submit
one
letter
for
each
tier.
Thus,
a
total
of
58
letters
would
be
received
over
the
three­
year
ICR
period
(
23
each
in
Tiers
1
and
2,
plus
12
in
Tier
3).
Following
previous
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
232
hours
and
$
16,694
over
the
three­
year
ICR
period.
These
costs
and
burden
hours
are
considered
reporting
burdens
by
EPA.
Page
26
Table
4.
Administrative
Reporting
Cost
and
Burden
Category
Letters
of
Commitment
Data
Searches
TOTAL
Tier
1
Number
23
69
92
Burden
92
2,220
2,312
Cost
$
6,620
$
160,322
$
166,942
Tier
2
Number
23
69
92
Burden
92
2,220
2,312
Cost
$
6,620
$
160,322
$
166,942
Tier
3
Number
12
36
48
Burden
48
1,158
1,206
Cost
$
3,454
$
83,646
$
87,100
TOTALS
Number
58
174
232
Burden
232
5,598
5,830
Cost
$
16,694
$
404,290
$
420,984
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
34
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
69
searches
will
occur
for
each
Tier
1
and
2
and
36
searches
will
occur
under
Tier
3.
This
results
in
a
total
of
174
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
5,598
hours
and
$
404,290
over
the
threeyear
ICR
period.

Non­
reporting
Administrative
Costs
and
Burdens
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.
For
this
ICR,
EPA
has
calculated
the
Page
27
5
Final
estimates
incorporate
some
rounding
error
from
previous
calculations.
costs
and
burdens
of
these
activities
as
the
difference
between
the
total
administrative
costs
and
burdens
and
the
reporting
costs
and
burdens
derived
above
for
Tiers
2
and
3.
Additionally,
EPA
has
assumed
that
no
non­
reporting
administrative
costs
are
incurred
for
Tier
1.
From
Table
3,
Tiers
2
and
3
testing
involve
a
total
cost
of
$
23.9
million
and
282,070
hours.

To
calculate
total
administrative
costs
(
reporting
plus
non­
reporting
administrative)
for
Tiers
2
and
3,
we
multiply
each
estimate
by
25
percent
to
get
$
6.0
million
and
70,518
hours.
Next,
we
subtract
off
the
total
administrative
reporting
for
Tiers
2
and
3
from
Table
4.
These
estimates
are
$
254,043
($
166,942
+
$
87,100)
and
3,518
hours
(
2,312
+
1,206).
Thus,
nonreporting
activities
associated
with
laboratory
testing
are
estimated
to
cost
$
5.7
million
($
6.0
million
­
$
254,043)
over
the
three­
year
ICR
period
and
impose
a
burden
of
67,000
hours
(
70,518
­
3,518)
over
the
three­
year
period.
5
Since
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
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
general
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
($
390.04),
16
hours
for
technical
($
1,151.36)
and
1
hour
for
clerical
($
28.85).
With
45
entities
currently
participating
in
the
program,
the
total
burden
for
this
activity
would
be
945
hours
(
21
x
45),
with
a
cost
of
$
70,661.25
($
1,570.25
x
45).

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
requirement
defined
in
the
Federal
Register
notice
for
the
VCCEP.
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.
EPA
assumes
that
all
23
chemicals
will
be
subject
to
the
exposure
assessment
requirement
of
the
VCCEP,
regardless
of
the
level
of
previous
testing.
Thus,
over
the
three­
year
ICR
period,
58
exposure
assessments
will
take
place
(
23
each
in
Tiers
1
and
2,
plus
12
in
Tier
3).
Table
5
summarizes
EPA's
estimates
for
exposure
assessments
for
the
VCCEP
rule.
Based
on
EPA's
information,
the
exposure
assessment
for
the
VCCEP
will
result
in
a
three­
year
burden
of
48,900
hours
and
$
3.4
million.
Because
a
sponsor
typically
hires
a
contractor
to
conduct
an
exposure
assessment,
EPA
does
not
attribute
the
total
cost
of
the
assessment
to
paperwork
burden
and
costs,
but
instead
only
25%.

In
addition
to
these
costs,
EPA
has
assumed
that
the
Exposure
Assessment
will
impose
some
non­
reporting
administrative
costs
and
burdens.
EPA
assumes
that
these
costs
and
burdens
Page
28
will
represent
25
percent
of
the
estimated
cost
for
performing
the
Exposure
Assessment,
or
12,225
hours
and
$
842,626
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
and
risk
assessment.
Page
29
Table
5.
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
11,500
$
792,655
Tier
2
850
100
50
1,000
23,000
$
1,585,310
Tier
3
1,020
120
60
1,200
14,400
$
992,542
Total
48,900
$
3,370,507
Risk
Assessment
Tier
1
255
30
15
300
6,900
$
475,593
Tier
2
425
50
25
500
11,500
$
792,655
Tier
3
510
60
30
600
7,200
$
496,271
Total
25,600
$
1,764,519
[
a]
Total
burden
is
calculated
by
multiplying
the
total
burden
per
chemical
by
23
chemicals
for
Tiers
1
and
2
and
12
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
($
71.96
for
technical
labor,
$
28,85
for
clerical
labor,
and
$
97.51
for
managerial
labor),
adding,
and
then
multiplying
by
23
chemicals
for
Tiers
1
and
2
and
12
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.
EPA
assumes
that
all
23
chemicals
will
be
subject
to
the
risk
assessment
requirement
of
the
VCCEP,
regardless
of
the
level
of
previous
testing.
Thus,
over
the
three­
year
ICR
period,
58
risk
assessments
will
take
place
(
23
each
in
Tiers
1
and
2,
plus
12
in
Tier
3).
Table
5
also
summarizes
EPA's
estimates
for
risk
assessments
for
the
VCCEP
rule.
Based
on
EPA's
information,
the
risk
assessment
for
the
VCCEP
will
result
in
a
three­
year
burden
of
25,600
hours
and
$
1.8
million.

In
addition
to
these
costs,
EPA
has
assumed
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
6,400
hours
and
$
441,130
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
and
Exposure
Assessment.
Page
30
6
From
Table
3,
the
Hazard
Assessment
imposes
0
hours
for
Tier
1
and
184,409
hours
for
Tier
2.
From
Table
5,
the
Exposure
Assessment
imposes
11,500
hours
for
Tier
1
and
23,000
hours
for
Tier
2.
Also
from
Table
5,
the
Risk
Assessment
imposes
6,900
hours
for
Tier
1
and
11,500
hours
for
Tier
2.
The
total
of
these
six
estimates
is
237,309
hours.
Data
Needs
Assessment
The
data
needs
assessment
for
the
VCCEP
program
requires
sponsors
to
identify
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
required
to
be
submitted
with
Tiers
1
and
2,
but
not
with
Tier
3.
Thus,
a
total
of
46
data
needs
assessments
will
be
required
under
the
ICR
(
23
chemicals
×
2
tiers).

To
estimate
the
costs
associated
with
this
requirement,
EPA
assumed
that
the
burden
for
this
requirement
would
be
proportional
to
the
time
that
sponsors
spend
on
the
hazard,
exposure,
and
risk
assessments
since
the
data
needs
assessment
is
derived
from
these
three
other
assessments.
EPA
further
expects
that
the
time
for
this
requirement
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
3
and
4,
Hazard
Assessments,
Exposure
Assessments,
and
Risk
Assessments
are
estimated
to
impose
237,309
hours
for
Tiers
1
and
2.6
Based
on
the
two
percent
assumption,
the
data
needs
assessment
will
impose
a
burden
of
4,746
hours
over
the
three­
year
ICR
period.
Assuming
all
of
this
labor
is
technical
labor
results
in
a
three­
year
cost
of
$
341,522
(
4,746
×
$
71.96).

Peer
Consultation
Document
EPA
assumes
that
the
Peer
Consultation
Document
(
PCD)
will
not
require
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
impose
a
three­
year
burden
of
2,900
hours
(
50
hours
per
chemical
per
Tier
×
23
chemicals
each
for
Tiers
1
and
2
,
plus
50
hours
x
12
chemicals
in
Tier
3).
Assuming
all
labor
is
technical
labor
results
in
a
three­
year
cost
of
$
208,684.
In
response
to
ACC's
comment,
EPA
has
included
travel
costs
to
attend
the
public
meetings
at
$
1,000
per
person.
Travel
costs
would
add
$
116,000
to
the
three­
year
costs
($
1,000
per
person
x
2
persons
per
meeting
x
58
meetings
(
23
meetings
each
for
Tiers
1
and
2,
and
12
meetings
for
Tier
3)).
Therefore,
the
cost
of
presenting
assessments
at
the
public
meetings
would
be
$
324,684
for
three
years
and
$
108,228
for
one
year.
Page
31
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Comments
On
EPA's
Data
Needs
Decision
EPA
assumed
that
the
level
of
effort
for
submitting
comments
on
EPA's
data
needs
decision
would
be
identical
to
that
of
presenting
the
assessment
at
public
meetings.
That
is,
EPA
assumed
that
respondents
would
require
50
hours
of
technical
labor
to
submit
comments.
Based
on
this
assumption,
this
task
will
impose
a
three­
year
burden
of
2,900
hours
(
50
hours
per
chemical
per
Tier
×
23
chemicals
each
for
Tiers
1
and
2,
plus
50
hours
x
12
chemicals
in
Tier
3)
and
a
three­
year
cost
of
$
208,684.

Total
Cost
and
Burden
Table
6
summarizes
the
total
and
annual
number
of
responses,
costs,
and
reporting
burdens
associated
with
the
VCCEP.
To
derive
the
annual
estimates,
EPA
divided
the
relevant
numbers
by
three
years.
EPA
estimates
that
the
VCCEP
will
result
in
paperwork
burdens
of
81,112
hours
and
$
5,573,317
over
the
three­
year
ICR
period.
The
estimated
annual
reporting
burdens
for
the
VCCEP
are
27,037
hours
and
$
1,857,773.

EPA
has
also
estimated
that
respondents
will
incur
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.
EPA
estimates
that
these
non­
reporting
burdens
will
total
381,884
hours
and
$
32.1
million
over
the
three­
year
ICR
period,
or
127,295
hours
and
$
10,696,121
annually.

Therefore,
the
total
annual
burden
and
costs
associated
with
this
information
collection
are
estimated
to
be
154,332
hours
and
$
12,553,894.

Number
of
Responses
EPA
estimates
that
the
total
number
of
responses
for
the
VCCEP
will
be
897
over
the
three­
year
ICR
period,
or
297
responses
annually.
This
implies
an
average
of
39.0
responses
per
respondent
(
897
÷
23)
over
the
three­
year
period
(
13.0
responses
annually).
Additionally,
the
average
response
will
take
519.6
hours
(
154,332
hours
/
297)
at
a
cost
of
$
42,269
($
12,553,894
/
297).
Page
32
Table
6.
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
58
232
$
16,694
19
77
$
5,565
Robust
Summaries
for
Hazard
Assessments
174
3,480
$
212,915
58
1,160
$
70,972
Exposure
Assessments
58
48,900
$
3,370,506
19
16,300
$
1,123,502
Risk
Assessments
58
25,600
$
1,764,518
19
8,533
$
588,173
Comments
on
Data
Needs
Decision
58
2,900
$
208,684
19
967
$
69,561
REPORTING
TOTALS
406
81,112
$
5,573,317
134
27,037
$
1,857,773
NON­
REPORTING
BURDENS
Initial
Burden
45
945
$
70,661
15
315
$
23,554
Hazard
Assessments
78
282,070
$
23,933,994
26
94,023
$
7,977,998
File
Searches
174
5,598
$
404,290
58
1,866
$
134,763
Non­
Reporting
Administrative
[
a]
78
85,625
$
7,013,212
26
28,542
$
2,337,737
Data
Needs
Assessment
58
4,746
$
341,522
19
1,582
$
113,841
Public
meetings
58
2,900
$
324,684
19
967
$
108,228
NON­
REPORTING
TOTALS
491
381,884
$
32,088,363
163
127,295
$
10,696,121
TOTAL
BURDEN
AND
COSTS
897
462,996
$
37,661,680
297
154,332
$
12,553,894
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
7.

EPA
is
assuming
that
the
Agency
collection
activities
will
be
performed
by
a
GS­
14,
Step
1,
employee
and
a
GS­
11,
Step
1,
employee.
The
U.
S.
Office
of
Personnel
Management
reports
that
these
labor
categories
have
base
hourly
rates
of
$
35.79
and
$
21.25,
respectively,
for
2001
in
the
Washington,
DC
area.
EPA
added
60
percent
to
these
hourly
rates
to
account
for
benefits.
Thus,
the
2001
loaded
hourly
rate
for
a
GS­
14,
Step
1,
employee
is
$
57.26
and
for
a
GS­
11,
Step
1,
employee
is
$
34.00.
In
addition,
the
final
review
and
final
decision­
making
activities
will
be
performed
by
GS­
15,
Step
1
employees.
The
Office
of
Personnel
Management
reports
that
the
hourly
labor
rate
for
these
employees
is
$
42.10
per
hour
for
2001
in
the
Washington,
DC
area.
Adding
60
percent
to
that
labor
rate
results
in
a
loaded
hourly
rate
of
$
67.36
for
the
GS­
15,
Step
1
labor
category.

AGENCY
LABOR
CATEGORY
LOADED
HOURLY
RATE
($
2001)

GS­
15,
Step
1
$
67.36
Page
33
AGENCY
LABOR
CATEGORY
LOADED
HOURLY
RATE
($
2001)

GS­
14,
Step
1
$
57.26
GS­
11,
Step
1
$
34.00
EPA
employees
will
perform
a
number
of
activities
under
the
VCCEP
program,
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
60%
of
the
GS­
14
employee's'
time
and
20%
of
the
GS­
11
employee's
time
over
the
period
of
the
ICR,
or
annually
1200
and
400
hours
respectively.
The
final
review
and
decision­
making
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
7
summarizes
EPA's
estimate.
Based
on
EPA's
assumptions,
the
Agency
activities
will
result
in
6,300
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.

Table
7.
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
$
101,040
3,600
$
206,136
1,200
$
40,800
6,300
$
347,976
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
3,600
$
206,136
1,200
$
40,800
6,300
$
1,847,976
Page
34
6(
c)
Bottom
Line
Annual
Burden
Hours
and
Costs
 
Master
Tables
6(
c)(
i)
Respondent
Tally
Table
8
summarizes
the
average
annual
burden
per
response.
EPA
estimates
that
this
ICR
will
impose
paperwork
burden
hours
on
respondents
over
the
three­
year
ICR
period.
This
total
burden
covers
297
responses
annually
for
an
average
of
519.6
hours
per
response.
Page
35
Table
8.
Average
Annual
Burden
Hours
Per
Response
COLLECTION
ACTIVITY
ANNUAL
RESPONDENT
BURDEN
PER
RESPONSE
TOTAL
HOURS
TOTAL
RESPONSES
HOURS
PER
RESPONSE
[
a]

REPORTING
BURDENS
Letters
of
Commitment
77
19
4.1
Robust
Summaries
for
Hazard
Assessments
1,160
58
20.0
Exposure
Assessments
16,300
19
857.9
Risk
Assessments
8,533
19
449.1
Comments
on
Data
Needs
Decision
967
19
50.9
REPORTING
TOTALS
27,037
134
201.8
NON­
REPORTING
BURDENS
Initial
Burden
315
15
21.0
Hazard
Assessments
94,023
26
3,616.3
File
Searches
1,866
58
32.2
Non­
Reporting
Administrative
28,542
26
1,097.8
Data
Needs
Assessment
1,582
19
83.3
Public
meetings
967
19
50.9
NON­
REPORTING
TOTALS
127,295
163
780.9
TOTAL
BURDEN
HOURS
154,332
297
519.6
Note:
Totals
may
contain
some
rounding
error
from
previous
tables.
[
a]
=
Total
hours
/
Total
responses
The
total
burden
hours
and
costs
for
respondents
have
been
summarized
above
in
Section
6(
a).
Table
9
summarizes
these
estimated
annual
burden
hours
and
costs.
Page
36
Table
9.
Summary
of
Annual
Respondent
Burden
and
Costs
Estimates
COLLECTION
ACTIVITY
Annual
Total
Hours
Cost
REPORTING
BURDENS
Letters
of
commitment
77
$
5,565
Robust
Summaries
for
Hazard
Assessments
1,160
$
70,972
Exposure
Assessments
16,300
$
1,123,502
Risk
Assessments
8,533
$
588,173
Comments
on
Data
Needs
Decision
967
$
69,561
REPORTING
TOTALS
27,037
$
1,857,773
NON­
REPORTING
BURDENS
Initial
burden
315
$
23,554
Lab
testing
for
Hazard
Assessments
94,023
$
7,977,998
File
Searches
1,866
$
134,763
Non­
Reporting
Administrative
28,542
$
2,337,737
Data
Needs
Assessment
1,582
$
113,841
Public
meetings
967
$
108,228
NON­
REPORTING
TOTALS
127,295
$
10,696,121
TOTAL
BURDEN
AND
COSTS
154,332
$
12,553,894
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
2,100
agency­
hours
annually
and
$
615,992.
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
10.
Page
37
Table
10.
Summary
of
Agency
Burden
and
Costs
Estimates
COLLECTION
ACTIVITY
TOTAL
ANNUAL
AGENCY
BURDEN
AND
COSTS
BURDEN
(
Hours)
COSTS
Receive
PCDs
2,100
$
115,992
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
2,100
$
615,992
6(
d)
Burden
Statement
The
annual
public
burden
for
this
collection
of
information
is
estimated
to
average
about
520
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
it
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
2002­
0005,
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://
www.
epa.
gov/
edocket.
Use
EDOCKET
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Once
in
the
system,
select
"
search,"
then
key
in
the
docket
ID
number
identified
above.
Also,
you
can
send
comments
to
the
Office
of
Information
and
Regulatory
Affairs,
Office
of
Management
and
Budget,
725
17th
Street,
NW,
Washington,
DC
20503,
Attention:
Desk
Office
for
EPA.
Page
38
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
­
Wage
Rates
Estimation
Attachment
2
­
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/
oppt/
chemrtk/
chldhlfr.
htm.

Attachment
3
­
Toxic
Substances
Control
Act
Section
4
(
15
USC
2603)
(
For
an
electronic
copy
of
this
law
go
to
http://
www.
epa.
gov/
opptsfrs/
home/
rules.
htm.)

Attachment
4
­
40
CFR
790
­
Procedures
Governing
Testing
Consent
Agreements
and
Test
Rules
(
For
an
electronic
copy
of
this
regulation
go
to
http://
www.
epa.
gov/
opptsfrs/
home/
rules.
htm.)

Attachment
5
­
Public
Notice
Required
Prior
to
ICR
Submission
to
OMB.
67
FR
18609,
April
16,
2002;
and
67
FR
34703,
May
15,
2002.
For
electronic
copies
of
these
notices
go
to
http://
www.
epa.
gov/
fedrgstr/
EPA­
TOX/
2002/
April/
Day­
16/
t9221.
htm
and
http://
www.
epa.
gov/
fedrgstr/
EPA­
TOX/
2002/
May/
Day­
15/
t12266.
htm
Attachment
6
­
Response
to
Comments
7Centaur
Associates,
Inc.,
Response
Times
and
Labor
Costs
Final
Data
Element
List
Comprehensive
Assessment
Information
Rule,
prepared
for
the
U.
S.
Environmental
Protection
Agency
under
Contract
No.
68­
02­
3980,
Washington,
D.
C.,
April
30,
1985,
pp.
94­
106.

8William
Silagi,
Wage
Rates
for
Economic
analyses
of
Rulemakings
Under
EPCRA
Section
313,
U.
S.
Environmental
Protection
Agency/
OPPT/
EETD/
RIB,
Washington,
D.
C.,
November
12,
1993,
Appendix
A.
ATTACHMENT
1
­
WAGE
RATES
ESTIMATION
L.
Overview
Wage
rates
including
fringe
benefits
and
overhead
for
government
labor
and
three
broad
industry
categories
of
labor
(
managerial,
technical,
and
secretarial)
were
used
in
this
cost
analysis.
The
labor
categories
and
loaded
wage
rates
were
developed
during
previous
studies.
The
basic
methodology
for
estimating
wage
rates
was
developed
for
the
Comprehensive
Assessment
Information
Rule
(
CAIR).
7
Updated
wage
rate
estimates
were
developed
by
EPA,
using
the
CAIR
methodology,
for
a
1993
economic
analysis
of
rulemakings
under
EPCRA
Section
313.8
The
methodology
used
in
developing
wage
rates
is
summarized
below.

LABOR
CATEGORY
LOADED
HOURLY
RATE
Government
GS­
15,
Step
1
$
67.36
GS­
14,
Step
1
$
57.26
GS­
11,
Step
1
$
34.00
Industry
Managerial
$
97.51
Technical
$
71.96
Secretarial
$
28.85
M.
Government
The
Federal
government
collection
activity
procedures
described
in
this
report
are
expected
to
be
accomplished
by
a
GS­
15,
Step
1
employee;
a
GS­
14,
Step
1
employee;
and
a
GS­
11,
Step
1
employee.
For
the
most
part,
EPA
assumes
that
ICR­
related
Agency
activities
under
TSCA
test
rules
are
accomplished
by
a
GS­
12,
Step
1
employee
only.
This
assumption
was
recommended
by
EPA
(
via
an
internal
EPA
phone
call
between
Carol
Rawie
(
OPPT/
EETD/
RIB)
and
Ron
Carlson
(
OPPT/
OPME)
on
April
25,
1994).
For
the
VCCEP,
however,
EPA
determined
that
a
combination
of
more
and
less
advanced
labor
categories
would
be
appropriate
given
the
nature
of
the
program.
Thus,
EPA
assumed
that
GS­
15
(
Step
1),
GS­
14
(
Step
1),
and
GS­
11
(
Step
1)
employees
would
perform
these
activities.

EPA
used
the
hourly
wages,
for
each
labor
category,
from
the
Office
of
Personnel
Management's
2001
General
Schedule
Locality
Rates
of
Pay
for
Washington­
Baltimore,
DC­
MDVA
WV
(
effective
January
2001).
The
fully
loaded
costs
of
Agency
workers
is
estimated
by
multiplying
the
hourly
pay
rate
by
1.6
(
the
benefits
multiplication
factor).
The
multiplication
factor
used
is
recommended
in
EPA's
Office
of
Policy,
Planning,
and
Evaluation's
Instructions
for
Preparing
Information
Collection
Requests
(
ICRs)
(
June
1,
1992).
An
EPA
internal
phone
call
between
Carol
Rawie
(
OPPT/
EETD/
RIB)
and
Carl
Koch
(
OPPE/
RMD/
IMB)
on
May
3,
1994,
indicated
that
the
1.6
factor
included
not
only
benefits
but
also
overhead.
9
Bureau
of
Labor
Statistics,
Occupational
Compensation
Survey,
National
Summary,
1996,
U.
S.
Department
of
Labor,
Washington,
D.
C.,
Bulletin
2497,
March
1998,
Tables
D­
1
and
D­
3.
Hourly
pay
rates
are
$
42.10
for
the
GS­
15
(
Step
1)
category,
$
35.79
for
the
GS­
14
(
Step
1)
category,
and
$
21.25
for
the
GS­
11
(
Step
1)
category.
Thus,
the
fully­
loaded
hourly
costs
are
$
67.36
for
the
GS­
15
(
Step
1)
category,
$
57.26
for
the
GS­
14
(
Step
1)
category,
and
$
34.00
for
the
GS­
11
(
Step
1)
category.

N.
Industry
Industry
wage
data
used
in
developing
the
basic
wage
rates
for
this
analysis
were
derived
from
wage
information
published
by
the
Bureau
of
Labor
Statistics
(
BLS)
for
all
goodsproducing
private
industries.
9
The
wage
rates
for
four
BLS
labor
categories
by
level
(
i.
e.,
Accountant,
Attorney,
Engineer,
and
Secretary)
are
presented
in
Table
1.
The
BLS
wages
do
not
include
either
fringe
benefits
or
overhead.

At
the
managerial
and
technical
levels,
wage
rates
are
composites
of
BLS
wages
for
several
labor
categories/
levels.
The
wage
rate
for
managerial
personnel
is
a
composite
of
average
BLS
wages
for
three
labor
categories/
levels:
Accountant
(
levels
V­
VI);
Attorney
(
levels
IV­
VI);
and
Engineer
(
levels
VI­
VIII).
The
wage
rate
for
technical
personnel
is
a
composite
of
average
BLS
wage
rates
for
two
labor
categories/
levels:
Accountant
(
levels
II­
VI)
and
Engineer
(
levels
III­
VIII).
The
wage
rate
for
secretarial
personnel
is
based
on
the
average
BLS
wage
rate
for
a
single
labor
category
(
levels
I­
V),
namely,
Secretarial.

Table
1.
Average
Annual
Salary
in
All
Goods­
Producing
Industries,
June
1996
Occupation
Level
Labor
Category
Annual
Salaries
/
1
Accountant
Attorney
Engineer
Secretarial
I
$
28,392
$
43,732
$
35,828
$
22,724
II
$
33,644
$
59,644
$
42,172
$
26,416
III
$
43,264
$
80,496
$
49,816
$
30,316
IV
$
55,796
$
94,224
$
60,788
$
35,620
V
$
71,552
$
113,464
$
73,944
$
42,432
VI
$
92,508
$
141,076
$
87,724
na
VII
na
na
$
104,156
na
VIII
na
na
$
123,032
na
/
1
Salary
data
are
reported
as
weekly
pay.
The
annual
salaries
are
derived
by
multiplying
published
weekly
pay
rates
by
52
weeks.
Source:
Occupational
Compensation
Survey,
National
Summary,
1996.
USDL,
BLS,
Bulletin
2497,
March
1998,
Tables
A­
1,
D­
3.

To
derive
the
composite
salaries,
the
BLS
salaries
for
each
of
the
labor
categories
that
make
up
either
the
managerial
or
technical
labor
categories
used
in
this
analysis
are
weighted
based
on
the
typical
fraction
of
total
reporting
effort
that
is
accounted
for
by
that
specific
BLS
labor
category.
The
weighting
factors
are
based
on
information
provided
by
the
chemical
industry
and
chemical
industry
trade
associations.
For
example,
as
shown
in
Table
3,
engineers
typically
account
for
10/
17
(
or
roughly
59
percent)
of
the
managerial
effort
expended
in
responding
to
EPA
reporting
rules.
The
weighted
salaries
for
each
of
the
BLS
labor
categories
are
then
added
to
derive
the
base
salaries
of
the
broad,
composite
labor
categories
used
in
this
analysis.

The
composite
annual
salary
estimates
were
adjusted
to
current
dollars
using
the
BLS
Employment
Cost
Index
(
ECI).
The
adjusted,
composite
salary
for
each
of
the
three
labor
categories
was
then
multiplied
by
the
sum
of
the
benefits
and
overhead
factors
to
estimate
a
loaded
annual
salary.
This
loaded
annual
salary
was
divided
by
2,080
hours
(
i.
e.,
the
average
annual
number
of
hours
worked
per
year
by
a
full­
time
employee)
to
derive
the
basic,
loaded
hourly
wage
rate
for
the
three
labor
categories
used
in
this
analysis.

The
ECI
data
and
the
benefits
loading
factors
are
presented
in
Table
2.
Detailed
ECI
data
for
white­
collar
occupations
in
the
goods­
producing,
private
industries
are
not
available
at
the
same
level
of
detail
as
the
BLS
wage
data;
therefore,
ECI
data
for
white­
collar
occupations
in
for
all
private
industries
were
used
to
adjust
the
wages
in
each
BLS
labor
category.
Detailed
benefits
data
for
white­
collar
occupations
in
the
goods­
producing,
private
industries
are
available,
however,
and
were
utilized
for
this
adjustment.
Based
on
information
provided
by
the
chemical
industry
and
chemical
industry
trade
associations,
it
was
determined
that
overhead
for
employees
in
the
chemical
industry
average
about
17
percent
of
the
basic
hourly
wage.

EPA
used
the
benefits
and
overhead
information,
along
with
the
ECI,
to
first
derive
loaded
hourly
rates
for
1998
(
Table
3).
EPA
then
used
the
increase
in
the
ECI
between
1998
and
2001
to
derive
loaded
hourly
rates
for
use
in
this
analysis.
The
loaded
hourly
wage
rates
used
in
the
analysis
are
presented
in
Table
4.
Unit
burden
estimates
are
converted
to
unit
cost
estimates
by
multiplying
the
unit
burden
hours
by
the
appropriate
wage
rates
in
Table
4.

Table
2.
Bureau
of
Labor
Statistics
(
BLS)
Employment
Cost
Index
(
ECI)
Wage
and
Salary
and
Benefit
Estimates
BLS
Labor
Category
BLS
ECI
Occupational
Category
ECI
Wage
and
Salary
Private
Industry
/
1
March
1997
%
of
Compensation
/
2
Ratio
of
%
Benefits
to
%
Wages
1996
June
1998
March
ECI
Ratio
06/
96:
03/
98
Wages
Benefits
Managerial
Executive,
Administrative,
and
Managerial
Occupations
126.8
137.8
1.087
71.2%
28.8%
0.404
Technical
Professional
Specialty
and
Technical
Occupations
128.8
135.9
1.055
71.0%
29.0%
0.408
Secretarial
Administrative
Support
incl
Clerical
Occupations
127.3
135.3
1.063
70.3%
29.7%
0.422
/
1
Employment
cost
index
(
wages
and
salaries
only),
all
private
industry
workers
by
occupation
and
industry
group
for
white­
collar
occupations.
/
2
Percent
of
all
workers,
all
private,
goods­
producing
industries,
white­
collar
occupations.
Source:
Bureau
of
Labor
Statistics,
Employment
Cost
Index,
Historical
Listing,
January
27,
1998,
Table
6.
Bureau
of
Labor
Statistics,
Employer
Costs
for
Employee
Compensation
­
March
1997,
USDL
Bulletin:
97­
371,
October
21,
1997,
Table
11.
Table
3.
Estimated
Loaded
Hourly
Wage
Rates
by
Labor
Category,
Converting
Estimates
from
June
1996
to
March
1998
Numbers.

a
b
c
d
e
f
g
h
i
j
k
Labor
Category
Occupation
(
levels)
Weighting
Factor
1996
Composite
Salary
(
c
×
average
salaries
from
Table
1)
ECI
Ratio
06/
96:

04/
98
(
from
Table
2)
1998
Adjusted
Salary
(
d
×
e)
Benefits
(%
Salary)

(
from
Table
2)
Overhead
(%
Salary)
Benefits
and
Overhead
Factor
(
1+
g+
h)
1998
Loaded
Annual
Salary
(
f
×
i)
1998
Loaded
Hourly
Rate
(
j
÷
2,080)

Managerial
Accountant
(
V­
VI)

Attorney
(
IV­
VI)

Engineer
(
VI­
VIII)
2/
17
5/
17
10/
17
9,651
34,193
61,747
1.087
$
114,777
40.4%
17.0%
1.574
$
180,662
$
86.86
Composite
Salary
17/
17
$
105,591
Technical
Accountant
(
III­
VI)

Engineer
(
III­
VIII)
1/
6
5/
6
10,963
69,369
1.055
$
84,750
40.8%
17.0%
1.578
$
133,736
$
64.30
Composite
Salary
6/
6
$
80,332
Secretarial
Secretarial
(
I­
V)
1/
1
31,502
1.063
$
33,487
42.2%
17.0%
1.592
$
53,311
$
25.63
Composite
Salary
1/
1
$
31,502
Source:
USEPA,
Silagi
memo
(
11/
93).

Occupational
Compensation
Survey,
National
Summary,
1996.
USDL,
BLS,
Bulletin
2497,
March
1998,
Tables
A­
1,
D­
3.

Bureau
of
Labor
Statistics,
Employment
Cost
Index,
Historical
Listing,
January
27,
1998,
Table
6.

Bureau
of
Labor
Statistics,
Employment
Cost
Index
­
March
1998,
USDL
Bulletin:
98­
170,
April
30,
1998,
Table
6.

Bureau
of
Labor
Statistics,
Employer
Costs
for
Employee
Compensation
­
March
1997,
USDL
Bulletin:
97­
371,
October
21,
1997,
Table
11.

Table
4.
Calculation
of
2001
Loaded
Hourly
Wage
Rates
for
Industry.

Labor
Category
1998
Loaded
Hourly
Rate
1998
ECI
(
3/
98)
2001
ECI
(
3/
01)
ECI
Ratio
2001:
1998
2001
Loaded
Hourly
Rate
Managerial
$
86.86
137.8
154.7
1.123
$
97.51
Technical
$
64.30
135.9
152.1
1.119
$
71.96
Secretarial
$
25.63
135.3
152.3
1.126
$
28.85
ATTACHMENT
2
Voluntary
Children's
Chemical
Evaluation
Program
Federal
Register
Notice
65
FR
81699,
December
26,
2000
ATTACHMENT
3
Toxic
Substances
Control
Act
Section
4
15
USC
2603
As
of
January
2,
2001
TITLE
15­­
COMMERCE
AND
TRADE
CHAPTER
53­­
TOXIC
SUBSTANCES
CONTROL
SUBCHAPTER
I­­
CONTROL
OF
TOXIC
SUBSTANCES
Sec.
2603.
Testing
of
chemical
substances
and
mixtures
(
a)
Testing
requirements
If
the
Administrator
finds
that­­
(
1)(
A)(
i)
the
manufacture,
distribution
in
commerce,
processing,
use,
or
disposal
of
a
chemical
substance
or
mixture,
or
that
any
combination
of
such
activities,
may
present
an
unreasonable
risk
of
injury
to
health
or
the
environment,
(
ii)
there
are
insufficient
data
and
experience
upon
which
the
effects
of
such
manufacture,
distribution
in
commerce,
processing,
use,
or
disposal
of
such
substance
or
mixture
or
of
any
combination
of
such
activities
on
health
or
the
environment
can
reasonably
be
determined
or
predicted,
and
(
iii)
testing
of
such
substance
or
mixture
with
respect
to
such
effects
is
necessary
to
develop
such
data;
or
(
B)(
i)
a
chemical
substance
or
mixture
is
or
will
be
produced
in
substantial
quantities,
and
(
I)
it
enters
or
may
reasonably
be
anticipated
to
enter
the
environment
in
substantial
quantities
or
(
II)
there
is
or
may
be
significant
or
substantial
human
exposure
to
such
substance
or
mixture,
(
ii)
there
are
insufficient
data
and
experience
upon
which
the
effects
of
the
manufacture,
distribution
in
commerce,
processing,
use,
or
disposal
of
such
substance
or
mixture
or
of
any
combination
of
such
activities
on
health
or
the
environment
can
reasonably
be
determined
or
predicted,
and
(
iii)
testing
of
such
substance
or
mixture
with
respect
to
such
effects
is
necessary
to
develop
such
data;
and
(
2)
in
the
case
of
a
mixture,
the
effects
which
the
mixture's
manufacture,
distribution
in
commerce,
processing,
use,
or
disposal
or
any
combination
of
such
activities
may
have
on
health
or
the
environment
may
not
be
reasonably
and
more
efficiently
determined
or
predicted
by
testing
the
chemical
substances
which
comprise
the
mixture;

the
Administrator
shall
by
rule
require
that
testing
be
conducted
on
such
substance
or
mixture
to
develop
data
with
respect
to
the
health
and
environmental
effects
for
which
there
is
an
insufficiency
of
data
and
experience
and
which
are
relevant
to
a
determination
that
the
manufacture,
distribution
in
commerce,
processing,
use,
or
disposal
of
such
substance
or
mixture,
or
that
any
combination
of
such
activities,
does
or
does
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment.

(
b)
Testing
requirement
rule
(
1)
A
rule
under
subsection
(
a)
of
this
section
shall
include­­
(
A)
identification
of
the
chemical
substance
or
mixture
for
which
testing
is
required
under
the
rule,
(
B)
standards
for
the
development
of
test
data
for
such
substance
or
mixture,
and
(
C)
with
respect
to
chemical
substances
which
are
not
new
chemical
substances
and
to
mixtures,
a
specification
of
the
period
(
which
period
may
not
be
of
unreasonable
duration)
within
which
the
persons
required
to
conduct
the
testing
shall
submit
to
the
Administrator
data
developed
in
accordance
with
the
standards
referred
to
in
subparagraph
(
B).

In
determining
the
standards
and
period
to
be
included,
pursuant
to
subparagraphs
(
B)
and
(
C),
in
a
rule
under
subsection
(
a)
of
this
section,
the
Administrator's
considerations
shall
include
the
relative
costs
of
the
various
test
protocols
and
methodologies
which
may
be
required
under
the
rule
and
the
reasonably
foreseeable
availability
of
the
facilities
and
personnel
needed
to
perform
the
testing
required
under
the
rule.
Any
such
rule
may
require
the
submission
to
the
Administrator
of
preliminary
data
during
the
period
prescribed
under
subparagraph
(
C).

(
2)(
A)
The
health
and
environmental
effects
for
which
standards
for
the
development
of
test
data
may
be
prescribed
include
carcinogenesis,
mutagenesis,
teratogenesis,
behavioral
disorders,
cumulative
or
synergistic
effects,
and
any
other
effect
which
may
present
an
unreasonable
risk
of
injury
to
health
or
the
environment.
The
characteristics
of
chemical
substances
and
mixtures
for
which
such
standards
may
be
prescribed
include
persistence,
acute
toxicity,
subacute
toxicity,
chronic
toxicity,
and
any
other
characteristic
which
may
present
such
a
risk.
The
methodologies
that
may
be
prescribed
in
such
standards
include
epidemiologic
studies,
serial
or
hierarchical
tests,
in
vitro
tests,
and
whole
animal
tests,
except
that
before
prescribing
epidemiologic
studies
of
employees,
the
Administrator
shall
consult
with
the
Director
of
the
National
Institute
for
Occupational
Safety
and
Health.
(
B)
From
time
to
time,
but
not
less
than
once
each
12
months,
the
Administrator
shall
review
the
adequacy
of
the
standards
for
development
of
data
prescribed
in
rules
under
subsection
(
a)
of
this
section
and
shall,
if
necessary,
institute
proceedings
to
make
appropriate
revisions
of
such
standards.

(
3)(
A)
A
rule
under
subsection
(
a)
of
this
section
respecting
a
chemical
substance
or
mixture
shall
require
the
persons
described
in
subparagraph
(
B)
to
conduct
tests
and
submit
data
to
the
Administrator
on
such
substance
or
mixture,
except
that
the
Administrator
may
permit
two
or
more
of
such
persons
to
designate
one
such
person
or
a
qualified
third
party
to
conduct
such
tests
and
submit
such
data
on
behalf
of
the
persons
making
the
designation.
(
B)
The
following
persons
shall
be
required
to
conduct
tests
and
submit
data
on
a
chemical
substance
or
mixture
subject
to
a
rule
under
subsection
(
a)
of
this
section:

(
i)
Each
person
who
manufactures
or
intends
to
manufacture
such
substance
or
mixture
if
the
Administrator
makes
a
finding
described
in
subsection
(
a)(
1)(
A)(
ii)
or
(
a)(
1)(
B)(
ii)
of
this
section
with
respect
to
the
manufacture
of
such
substance
or
mixture.
(
ii)
Each
person
who
processes
or
intends
to
process
such
substance
or
mixture
if
the
Administrator
makes
a
finding
described
in
subsection
(
a)(
1)(
A)(
ii)
or
(
a)(
1)(
B)(
ii)
of
this
section
with
respect
to
the
processing
of
such
substance
or
mixture.
(
iii)
Each
person
who
manufactures
or
processes
or
intends
to
manufacture
or
process
such
substance
or
mixture
if
the
Administrator
makes
a
finding
described
in
subsection
(
a)(
1)(
A)(
ii)
or
(
a)(
1)(
B)(
ii)
of
this
section
with
respect
to
the
distribution
in
commerce,
use,
or
disposal
of
such
substance
or
mixture.

(
4)
Any
rule
under
subsection
(
a)
of
this
section
requiring
the
testing
of
and
submission
of
data
for
a
particular
chemical
substance
or
mixture
shall
expire
at
the
end
of
the
reimbursement
period
(
as
defined
in
subsection
(
c)(
3)(
B)
of
this
section)
which
is
applicable
to
test
data
for
such
substance
or
mixture
unless
the
Administrator
repeals
the
rule
before
such
date;
and
a
rule
under
subsection
(
a)
of
this
section
requiring
the
testing
of
and
submission
of
data
for
a
category
of
chemical
substances
or
mixtures
shall
expire
with
respect
to
a
chemical
substance
or
mixture
included
in
the
category
at
the
end
of
the
reimbursement
period
(
as
so
defined)
which
is
applicable
to
test
data
for
such
substance
or
mixture
unless
the
Administrator
before
such
date
repeals
the
application
of
the
rule
to
such
substance
or
mixture
or
repeals
the
rule.
(
5)
Rules
issued
under
subsection
(
a)
of
this
section
(
and
any
substantive
amendment
thereto
or
repeal
thereof)
shall
be
promulgated
pursuant
to
section
553
of
title
5
except
that
(
A)
the
Administrator
shall
give
interested
persons
an
opportunity
for
the
oral
presentation
of
data,
views,
or
arguments,
in
addition
to
an
opportunity
to
make
written
submissions;
(
B)
a
transcript
shall
be
made
of
any
oral
presentation;
and
(
C)
the
Administrator
shall
make
and
publish
with
the
rule
the
findings
described
in
paragraph
(
1)(
A)
or
(
1)(
B)
of
subsection
(
a)
of
this
section
and,
in
the
case
of
a
rule
respecting
a
mixture,
the
finding
described
in
paragraph
(
2)
of
such
subsection.

(
c)
Exemption
(
1)
Any
person
required
by
a
rule
under
subsection
(
a)
of
this
section
to
conduct
tests
and
submit
data
on
a
chemical
substance
or
mixture
may
apply
to
the
Administrator
(
in
such
form
and
manner
as
the
Administrator
shall
prescribe)
for
an
exemption
from
such
requirement.
(
2)
If,
upon
receipt
of
an
application
under
paragraph
(
1),
the
Administrator
determines
that
 
(
A)
the
chemical
substance
or
mixture
with
respect
to
which
such
application
was
submitted
is
equivalent
to
a
chemical
substance
or
mixture
for
which
data
has
been
submitted
to
the
Administrator
in
accordance
with
a
rule
under
subsection
(
a)
of
this
section
or
for
which
data
is
being
developed
pursuant
to
such
a
rule,
and
(
B)
submission
of
data
by
the
applicant
on
such
substance
or
mixture
would
be
duplicative
of
data
which
has
been
submitted
to
the
Administrator
in
accordance
with
such
rule
or
which
is
being
developed
pursuant
to
such
rule,

the
Administrator
shall
exempt,
in
accordance
with
paragraph
(
3)
or
(
4),
the
applicant
from
conducting
tests
and
submitting
data
on
such
substance
or
mixture
under
the
rule
with
respect
to
which
such
application
was
submitted.
(
3)(
A)
If
the
exemption
under
paragraph
(
2)
of
any
person
from
the
requirement
to
conduct
tests
and
submit
test
data
on
a
chemical
substance
or
mixture
is
granted
on
the
basis
of
the
existence
of
previously
submitted
test
data
and
if
such
exemption
is
granted
during
the
reimbursement
period
for
such
test
data
(
as
prescribed
by
subparagraph
(
B)),
then
(
unless
such
person
and
the
persons
referred
to
in
clauses
(
i)
and
(
ii)
agree
on
the
amount
and
method
of
reimbursement)
the
Administrator
shall
order
the
person
granted
the
exemption
to
provide
fair
and
equitable
reimbursement
(
in
an
amount
determined
under
rules
of
the
Administrator)­­
(
i)
to
the
person
who
previously
submitted
such
test
data,
for
a
portion
of
the
costs
incurred
by
such
person
in
complying
with
the
requirement
to
submit
such
data,
and
(
ii)
to
any
other
person
who
has
been
required
under
this
subparagraph
to
contribute
with
respect
to
such
costs,
for
a
portion
of
the
amount
such
person
was
required
to
contribute.

In
promulgating
rules
for
the
determination
of
fair
and
equitable
reimbursement
to
the
persons
described
in
clauses
(
i)
and
(
ii)
for
costs
incurred
with
respect
to
a
chemical
substance
or
mixture,
the
Administrator
shall,
after
consultation
with
the
Attorney
General
and
the
Federal
Trade
Commission,
consider
all
relevant
factors,
including
the
effect
on
the
competitive
position
of
the
person
required
to
provide
reimbursement
in
relation
to
the
person
to
be
reimbursed
and
the
share
of
the
market
for
such
substance
or
mixture
of
the
person
required
to
provide
reimbursement
in
relation
to
the
share
of
such
market
of
the
persons
to
be
reimbursed.
An
order
under
this
subparagraph
shall,
for
purposes
of
judicial
review,
be
considered
final
agency
action.
(
B)
For
purposes
of
subparagraph
(
A),
the
reimbursement
period
for
any
test
data
for
a
chemical
substance
or
mixture
is
a
period­­
(
i)
beginning
on
the
date
such
data
is
submitted
in
accordance
with
a
rule
promulgated
under
subsection
(
a)
of
this
section,
and
(
ii)
ending­­
(
I)
five
years
after
the
date
referred
to
in
clause
(
i),
or
(
II)
at
the
expiration
of
a
period
which
begins
on
the
date
referred
to
in
clause
(
i)
and
which
is
equal
to
the
period
which
the
Administrator
determines
was
necessary
to
develop
such
data,

whichever
is
later.

(
4)(
A)
If
the
exemption
under
paragraph
(
2)
of
any
person
from
the
requirement
to
conduct
tests
and
submit
test
data
on
a
chemical
substance
or
mixture
is
granted
on
the
basis
of
the
fact
that
test
data
is
being
developed
by
one
or
more
persons
pursuant
to
a
rule
promulgated
under
subsection
(
a)
of
this
section,
then
(
unless
such
person
and
the
persons
referred
to
in
clauses
(
i)
and
(
ii)
agree
on
the
amount
and
method
of
reimbursement)
the
Administrator
shall
order
the
person
granted
the
exemption
to
provide
fair
and
equitable
reimbursement
(
in
an
amount
determined
under
rules
of
the
Administrator)­­
(
i)
to
each
such
person
who
is
developing
such
test
data,
for
a
portion
of
the
costs
incurred
by
each
such
person
in
complying
with
such
rule,
and
(
ii)
to
any
other
person
who
has
been
required
under
this
subparagraph
to
contribute
with
respect
to
the
costs
of
complying
with
such
rule,
for
a
portion
of
the
amount
such
person
was
required
to
contribute.

In
promulgating
rules
for
the
determination
of
fair
and
equitable
reimbursement
to
the
persons
described
in
clauses
(
i)
and
(
ii)
for
costs
incurred
with
respect
to
a
chemical
substance
or
mixture,
the
Administrator
shall,
after
consultation
with
the
Attorney
General
and
the
Federal
Trade
Commission,
consider
the
factors
described
in
the
second
sentence
of
paragraph
(
3)(
A).
An
order
under
this
subparagraph
shall,
for
purposes
of
judicial
review,
be
considered
final
agency
action.
(
B)
If
any
exemption
is
granted
under
paragraph
(
2)
on
the
basis
of
the
fact
that
one
or
more
persons
are
developing
test
data
pursuant
to
a
rule
promulgated
under
subsection
(
a)
of
this
section
and
if
after
such
exemption
is
granted
the
Administrator
determines
that
no
such
person
has
complied
with
such
rule,
the
Administrator
shall
(
i)
after
providing
written
notice
to
the
person
who
holds
such
exemption
and
an
opportunity
for
a
hearing,
by
order
terminate
such
exemption,
and
(
ii)
notify
in
writing
such
person
of
the
requirements
of
the
rule
with
respect
to
which
such
exemption
was
granted.

(
d)
Notice
Upon
the
receipt
of
any
test
data
pursuant
to
a
rule
under
subsection
(
a)
of
this
section,
the
Administrator
shall
publish
a
notice
of
the
receipt
of
such
data
in
the
Federal
Register
within
15
days
of
its
receipt.
Subject
to
section
2613
of
this
title,
each
such
notice
shall
(
1)
identify
the
chemical
substance
or
mixture
for
which
data
have
been
received;
(
2)
list
the
uses
or
intended
uses
of
such
substance
or
mixture
and
the
information
required
by
the
applicable
standards
for
the
development
of
test
data;
and
(
3)
describe
the
nature
of
the
test
data
developed.
Except
as
otherwise
provided
in
section
2613
of
this
title,
such
data
shall
be
made
available
by
the
Administrator
for
examination
by
any
person.

(
e)
Priority
list
(
1)(
A)
There
is
established
a
committee
to
make
recommendations
to
the
Administrator
respecting
the
chemical
substances
and
mixtures
to
which
the
Administrator
should
give
priority
consideration
for
the
promulgation
of
a
rule
under
subsection
(
a)
of
this
section.
In
making
such
a
recommendation
with
respect
to
any
chemical
substance
or
mixture,
the
committee
shall
consider
all
relevant
factors,
including­­
(
i)
the
quantities
in
which
the
substance
or
mixture
is
or
will
be
manufactured,
(
ii)
the
quantities
in
which
the
substance
or
mixture
enters
or
will
enter
the
environment,
(
iii)
the
number
of
individuals
who
are
or
will
be
exposed
to
the
substance
or
mixture
in
their
places
of
employment
and
the
duration
of
such
exposure,
(
iv)
the
extent
to
which
human
beings
are
or
will
be
exposed
to
the
substance
or
mixture,
(
v)
the
extent
to
which
the
substance
or
mixture
is
closely
related
to
a
chemical
substance
or
mixture
which
is
known
to
present
an
unreasonable
risk
of
injury
to
health
or
the
environment,
(
vi)
the
existence
of
data
concerning
the
effects
of
the
substance
or
mixture
on
health
or
the
environment,
(
vii)
the
extent
to
which
testing
of
the
substance
or
mixture
may
result
in
the
development
of
data
upon
which
the
effects
of
the
substance
or
mixture
on
health
or
the
environment
can
reasonably
be
determined
or
predicted,
and
(
viii)
the
reasonably
foreseeable
availability
of
facilities
and
personnel
for
performing
testing
on
the
substance
or
mixture.

The
recommendations
of
the
committee
shall
be
in
the
form
of
a
list
of
chemical
substances
and
mixtures
which
shall
be
set
forth,
either
by
individual
substance
or
mixture
or
by
groups
of
substances
or
mixtures,
in
the
order
in
which
the
committee
determines
the
Administrator
should
take
action
under
subsection
(
a)
of
this
section
with
respect
to
the
substances
and
mixtures.
In
establishing
such
list,
the
committee
shall
give
priority
attention
to
those
chemical
substances
and
mixtures
which
are
known
to
cause
or
contribute
to
or
which
are
suspected
of
causing
or
contributing
to
cancer,
gene
mutations,
or
birth
defects.
The
committee
shall
designate
chemical
substances
and
mixtures
on
the
list
with
respect
to
which
the
committee
determines
the
Administrator
should,
within
12
months
of
the
date
on
which
such
substances
and
mixtures
are
first
designated,
initiate
a
proceeding
under
subsection
(
a)
of
this
section.
The
total
number
of
chemical
substances
and
mixtures
on
the
list
which
are
designated
under
the
preceding
sentence
may
not,
at
any
time,
exceed
50.
(
B)
As
soon
as
practicable
but
not
later
than
nine
months
after
January
1,
1977,
the
committee
shall
publish
in
the
Federal
Register
and
transmit
to
the
Administrator
the
list
and
designations
required
by
subparagraph
(
A)
together
with
the
reasons
for
the
committee's
inclusion
of
each
chemical
substance
or
mixture
on
the
list.
At
least
every
six
months
after
the
date
of
the
transmission
to
the
Administrator
of
the
list
pursuant
to
the
preceeding
\
1\
sentence,
the
committee
shall
make
such
previsions
in
the
list
as
it
determines
to
be
necessary
and
shall
transmit
them
to
the
Administrator
together
with
the
committee's
reasons
for
the
revisions.
Upon
receipt
of
any
such
revision,
the
Administrator
shall
publish
in
the
Federal
Register
the
list
with
such
revision,
the
reasons
for
such
revision,
and
the
designations
made
under
subparagraph
(
A).
The
Administrator
shall
provide
reasonable
opportunity
to
any
interested
person
to
file
with
the
Administrator
written
comments
on
the
committee's
list,
any
revision
of
such
list
by
the
committee,
and
designations
made
by
the
committee,
and
shall
make
such
comments
available
to
the
public.
Within
the
12­
month
period
beginning
on
the
date
of
the
first
inclusion
on
the
list
of
a
chemical
substance
or
mixture
designated
by
the
committee
under
subparagraph
(
A)
the
Administrator
shall
with
respect
to
such
chemical
substance
or
mixture
either
initiate
a
rulemaking
proceeding
under
subsection
(
a)
of
this
section
or
if
such
a
proceeding
is
not
initiated
within
such
period,
publish
in
the
Federal
Register
the
Administrator's
reason
for
not
initiating
such
a
proceeding.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
1\
So
in
original.
Probably
should
be
  
preceding''.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
(
2)(
A)
The
committee
established
by
paragraph
(
1)(
A)
shall
consist
of
eight
members
as
follows:
(
i)
One
member
appointed
by
the
Administrator
from
the
Environmental
Protection
Agency.
(
ii)
One
member
appointed
by
the
Secretary
of
Labor
from
officers
or
employees
of
the
Department
of
Labor
engaged
in
the
Secretary's
activities
under
the
Occupational
Safety
and
Health
Act
of
1970
[
29
U.
S.
C.
651
et
seq.].
(
iii)
One
member
appointed
by
the
Chairman
of
the
Council
on
Environmental
Quality
from
the
Council
or
its
officers
or
employees.
(
iv)
One
member
appointed
by
the
Director
of
the
National
Institute
for
Occupational
Safety
and
Health
from
officers
or
employees
of
the
Institute.
(
v)
One
member
appointed
by
the
Director
of
the
National
Institute
of
Environmental
Health
Sciences
from
officers
or
employees
of
the
Institute.
(
vi)
One
member
appointed
by
the
Director
of
the
National
Cancer
Institute
from
officers
or
employees
of
the
Institute.
(
vii)
One
member
appointed
by
the
Director
of
the
National
Science
Foundation
from
officers
or
employees
of
the
Foundation.
(
viii)
One
member
appointed
by
the
Secretary
of
Commerce
from
officers
or
employees
of
the
Department
of
Commerce.

(
B)(
i)
An
appointed
member
may
designate
an
individual
to
serve
on
the
committee
on
the
member's
behalf.
Such
a
designation
may
be
made
only
with
the
approval
of
the
applicable
appointing
authority
and
only
if
the
individual
is
from
the
entity
from
which
the
member
was
appointed.
(
ii)
No
individual
may
serve
as
a
member
of
the
committee
for
more
than
four
years
in
the
aggregate.
If
any
member
of
the
committee
leaves
the
entity
from
which
the
member
was
appointed,
such
member
may
not
continue
as
a
member
of
the
committee,
and
the
member's
position
shall
be
considered
to
be
vacant.
A
vacancy
in
the
committee
shall
be
filled
in
the
same
manner
in
which
the
original
appointment
was
made.
(
iii)
Initial
appointments
to
the
committee
shall
be
made
not
later
than
the
60th
day
after
January
1,
1977.
Not
later
than
the
90th
day
after
such
date
the
members
of
the
committee
shall
hold
a
meeting
for
the
selection
of
a
chairperson
from
among
their
number.
(
C)(
i)
No
member
of
the
committee,
or
designee
of
such
member,
shall
accept
employment
or
compensation
from
any
person
subject
to
any
requirement
of
this
chapter
or
of
any
rule
promulgated
or
order
issued
thereunder,
for
a
period
of
at
least
12
months
after
termination
of
service
on
the
committee.
(
ii)
No
person,
while
serving
as
a
member
of
the
committee,
or
designee
of
such
member,
may
own
any
stocks
or
bonds,
or
have
any
pecuniary
interest,
of
substantial
value
in
any
person
engaged
in
the
manufacture,
processing,
or
distribution
in
commerce
of
any
chemical
substance
or
mixture
subject
to
any
requirement
of
this
chapter
or
of
any
rule
promulgated
or
order
issued
thereunder.
(
iii)
The
Administrator,
acting
through
attorneys
of
the
Environmental
Protection
Agency,
or
the
Attorney
General
may
bring
an
action
in
the
appropriate
district
court
of
the
United
States
to
restrain
any
violation
of
this
subparagraph.
(
D)
The
Administrator
shall
provide
the
committee
such
administrative
support
services
as
may
be
necessary
to
enable
the
committee
to
carry
out
its
function
under
this
subsection.

(
f)
Required
actions
Upon
the
receipt
of­­
(
1)
any
test
data
required
to
be
submitted
under
this
chapter,
or
(
2)
any
other
information
available
to
the
Administrator,

which
indicates
to
the
Administrator
that
there
may
be
a
reasonable
basis
to
conclude
that
a
chemical
substance
or
mixture
presents
or
will
present
a
significant
risk
of
serious
or
widespread
harm
to
human
beings
from
cancer,
gene
mutations,
or
birth
defects,
the
Administrator
shall,
within
the
180­
day
period
beginning
on
the
date
of
the
receipt
of
such
data
or
information,
initiate
appropriate
action
under
section
2604,
2605,
or
2606
of
this
title
to
prevent
or
reduce
to
a
sufficient
extent
such
risk
or
publish
in
the
Federal
Register
a
finding
that
such
risk
is
not
unreasonable.
For
good
cause
shown
the
Administrator
may
extend
such
period
for
an
additional
period
of
not
more
than
90
days.
The
Administrator
shall
publish
in
the
Federal
Register
notice
of
any
such
extension
and
the
reasons
therefor.
A
finding
by
the
Administrator
that
a
risk
is
not
unreasonable
shall
be
considered
agency
action
for
purposes
of
judicial
review
under
chapter
7
of
title
5.
This
subsection
shall
not
take
effect
until
two
years
after
January
1,
1977.

(
g)
Petition
for
standards
for
the
development
of
test
data
A
person
intending
to
manufacture
or
process
a
chemical
substance
for
which
notice
is
required
under
section
2604(
a)
of
this
title
and
who
is
not
required
under
a
rule
under
subsection
(
a)
of
this
section
to
conduct
tests
and
submit
data
on
such
substance
may
petition
the
Administrator
to
prescribe
standards
for
the
development
of
test
data
for
such
substance.
The
Administrator
shall
by
order
either
grant
or
deny
any
such
petition
within
60
days
of
its
receipt.
If
the
petition
is
granted,
the
Administrator
shall
prescribe
such
standards
for
such
substance
within
75
days
of
the
date
the
petition
is
granted.
If
the
petition
is
denied,
the
Administrator
shall
publish,
subject
to
section
2613
of
this
title,
in
the
Federal
Register
the
reasons
for
such
denial.

(
Pub.
L.
94­
469,
title
I,
Sec.
4,
Oct.
11,
1976,
90
Stat.
2006;
renumbered
title
I,
Pub.
L.
99­
519,
Sec.
3(
c)(
1),
Oct.
22,
1986,
100
Stat.
2989.)

References
in
Text:
The
Occupational
Safety
and
Health
Act
of
1970,
referred
to
in
text,
is
Pub.
L.
91­
596,
Dec.
29,
1970,
84
Stat.
1590,
as
amended,
which
is
classified
principally
to
chapter
15
(
Sec.
651
et
seq.)
of
Title
29,
Labor.
For
complete
classification
of
this
Act
to
the
Code,
see
Short
Title
note
set
out
under
section
651
of
Title
29
and
Tables.

Effective
Date
Notes:
Section
effective
Jan.
1,
1977,
except
as
provided
in
subsec.
(
f)
of
this
section,
see
section
31
of
Pub.
L.
94­
469,
set
out
as
a
note
under
section
2601
of
this
title.

Section
Referred
to
in
Other
Sections:
This
section
is
referred
to
in
sections
2604,
2606,
2607,
2611,
2613,
2614,
2617
to
2620,
2623,
2625,
2626,
2630
of
this
title;
title
21
section
346a;
title
42
section
9604.
ATTACHMENT
4
40
CFR
790
Procedures
Governing
Testing
Consent
Agreements
and
Test
Rules
40
CFR
PART
790
PROCEDURES
GOVERNING
TESTING
CONSENT
AGREEMENTS
AND
TEST
RULES
Subpart
A
­­
General
Provisions
Sec.
790.1
Scope,
purpose,
and
authority.
790.2
Applicability.
790.3
Definitions.
790.5
Submission
of
information.
790.7
Confidentiality.

Subpart
B
­­
Procedures
for
Developing
Consent
Agreements
and
Test
Rules
790.20
Recommendation
and
designation
of
testing
candidates
by
the
ITC.
790.22
Procedures
for
gathering
information
and
negotiating
consent
agreements
on
chemicals
which
the
ITC
has
recommended
for
testing
with
an
intent
to
designate.
790.24
Criteria
for
determining
whether
a
consensus
exists
concerning
the
provisions
of
a
draft
consent
agreement.
790.26
Initiation
and
completion
of
rulemaking
proceedings
on
ITC­
designated
chemicals.
790.28
Procedures
for
developing
consent
agreements
and/
or
test
rules
for
chemicals
that
have
not
been
designated
or
recommended
with
intent
to
designate
by
the
ITC.

Subpart
C
­­
Implementation,
Enforcement,
and
Modification
of
Test
Rules
790.40
Promulgation
of
test
rules.
790.42
Persons
subject
to
a
test
rule.
790.45
Submission
of
letter
of
intent
to
conduct
testing
or
exemption
application.
790.48
Procedure
if
no
one
submits
a
letter
of
intent
to
conduct
testing.
790.50
Submission
of
study
plans.
790.52
Phase
II
test
rule.
790.55
Modification
of
test
standards
or
schedules
during
conduct
of
test.
790.59
Failure
to
comply
with
a
test
rule.

Subpart
D
­­
Implementation,
Enforcement
and
Modification
of
Consent
Agreements
790.60
Contents
of
consent
agreements.
790.62
Submission
of
study
plans
and
conduct
of
testing.
790.65
Failure
to
comply
with
a
consent
agreement.
790.68
Modification
of
consent
agreements.

Subpart
E
­­
Exemptions
From
Test
Rules
790.80
Submission
of
exemption
applications.
790.82
Content
of
exemption
application.
790.85
Submission
of
equivalence
data.
790.87
Approval
of
exemption
applications.
790.88
Denial
of
exemption
application.
790.90
Appeal
of
denial
of
exemption
application.
790.93
Termination
of
conditional
exemption.
790.97
Hearing
procedures.
790.99
Statement
of
financial
responsibility.

Appendix
A
to
Subpart
E
­­
Schedule
for
Developing
Consent
Agreements
and
Test
Rules
Authority:
15
U.
S.
C.
2603.

Subpart
A
­­
General
Provisions
§
790.1
Scope,
purpose,
and
authority.

(
a)
This
part
establishes
procedures
for
gathering
information,
conducting
negotiations,
and
developing
and
implementing
test
rules
or
consent
agreements
on
chemical
substances
and
mixtures
under
section
4
of
TSCA.

(
b)
Section
4
of
the
Act
authorizes
EPA
to
require
manufacturers
and
processors
of
chemical
substances
and
mixtures
to
test
these
chemicals
to
determine
whether
they
have
adverse
health
or
environmental
effects.
Section
4
(
a)
empowers
the
Agency
to
promulgate
rules
which
require
such
testing.
In
addition,
EPA
has
implied
authority
to
enter
into
enforceable
consent
agreements
requiring
testing
where
they
provide
procedural
safeguards
equivalent
to
those
that
apply
where
testing
is
conducted
by
rule.

(
c)
EPA
intends
to
use
enforceable
consent
agreements
to
accomplish
testing
where
a
consensus
exists
among
EPA,
affected
manufacturers
and/
or
processors,
and
interested
members
of
the
public
concerning
the
need
for
and
scope
of
testing.
If
such
a
consensus
does
not
exist
and
the
Agency
believes
that
it
can
make
the
findings
specified
in
section
4(
a),
EPA
will
initiate
proceedings
to
promulgate
test
rules
which
will
be
codified
in
part
799
of
this
chapter.

(
d)
Appendix
A
to
this
part
presents
timetables
for
various
steps
in
the
evaluation
of
chemicals
under
consideration
for
testing,
the
initiation
and
completion
of
negotiations
to
develop
consent
agreements,
and
the
proposal
and
promulgation
of
test
rules.
All
deadlines
which
are
imposed
by
the
Act
are
binding
on
EPA
and
will
be
observed
by
the
Agency.
The
remaining
deadlines
represent
target
dates
that
EPA
intends
to
meet.

[
51
FR
23712,
June
30,
1986]

§
790.2
Applicability.

This
part
is
applicable
to
manufacturers
and
processors
of
chemical
substances
or
mixtures
who
are
subject
to
the
testing
requirements
of
a
consent
agreement
or
a
rule
under
section
4(
a)
of
the
Act.
The
procedures
for
test
rules
are
applicable
to
each
test
rule
in
part
799
or
this
chapter
unless
otherwise
stated
in
specific
test
rules
in
part
799
of
this
chapter.

[
51
FR
23712,
June
30,
1986]

§
790.3
Definitions.
Terms
defined
in
the
Act
and
not
explicitly
defined
herein
are
used
with
the
meaning
given
in
the
Act.
For
the
purpose
of
this
part:

Act
means
the
Toxic
Substances
Control
Act,
15
U.
S.
C.
2601
et
seq.

Additive
means
a
chemical
substance
that
is
intentionally
added
to
another
chemical
substance
to
improve
its
stability
or
impart
some
other
desirable
quality.

Chemical
means
a
chemical
substance
or
mixture.

Consortium
means
an
association
of
manufacturers
and/
or
processors
who
have
made
an
agreement
to
jointly
sponsor
testing.

EPA
means
the
U.
S.
Environmental
Protection
Agency.

Equivalence
data
means
chemical
data
or
biological
test
data
intended
to
show
that
two
substances
or
mixtures
are
equivalent.

Equivalent
means
that
a
chemical
substance
or
mixture
is
able
to
represent
or
substitute
for
another
in
a
test
or
series
of
tests,
and
that
the
data
from
one
substance
can
be
used
to
make
scientific
and
regulatory
decisions
concerning
the
other
substance.

Exemption
means
an
exemption
from
a
testing
requirement
of
a
test
rule
promulgated
under
section
4
of
the
Act
and
part
799
of
this
chapter.

Impurity
means
a
chemical
substance
which
is
unintentionally
present
with
another
chemical
substance.

Joint
sponsor
means
a
person
who
sponsors
testing
pursuant
to
section
4(
b)(
3)(
A)
of
the
Act.

Joint
sponsorship
means
the
sponsorship
of
testing
by
two
or
more
persons
in
accordance
with
section
4(
b)(
3)(
A)
of
the
Act.

Person
means
an
individual,
partnership,
corporation,
association,
scientific
or
academic
establishment,
or
organizational
unit
thereof,
and
any
other
legal
entity.

Principal
sponsor
means
an
individual
sponsor
or
the
joint
sponsor
who
assumes
primary
responsibility
for
the
direction
of
a
study
and
for
oral
and
written
communication
with
EPA.

Protocol
means
the
plan
and
procedures
which
are
to
be
followed
in
conducting
a
test.

Reimbursement
period
refers
to
a
period
that
begins
when
the
data
from
the
last
non­
duplicative
test
to
be
completed
under
a
test
rule
are
submitted
to
EPA
and
ends
after
an
amount
of
time
equal
to
that
which
had
been
required
to
develop
data
or
after
five
years,
whichever
is
later.

Sponsor
means
the
person
or
persons
who
design,
direct
and
finance
the
testing
of
a
substance
or
mixture.

Test
substance
means
the
form
of
chemical
substance
or
mixture
that
is
specified
for
use
in
testing.
[
49
FR
39782,
Oct.
10,
1984,
as
amended
at
51
FR
23712,
June
30,
1986]

§
790.5
Submission
of
information.

(
a)
All
submissions
to
EPA
under
this
part
must
bear
the
Code
of
Federal
Regulations
(
CFR)
section
number
of
the
subject
chemical
test
rule,
or
indicate
the
identity
of
the
consent
agreement.
For
all
submissions
under
this
part,
six
copies
must
be
provided
to
EPA.

(
b)
Submissions
containing
both
confidential
business
information
or
non­
confidential
business
information
must
be
addressed
to
the
Document
Control
Office
(
7407),
Office
of
Pollution
Prevention
and
Toxics,
U.
S.
Environmental
Protection
Agency,
Room
G­
099,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460,
ATTN:
TSCA
Section
4.

[
50
FR
20656,
May
17,
1985,
as
amended
at
51
FR
23712,
June
30,
1986;
58
FR
34205,
June
23,
1993;
60
FR
31922,
June
19,
1995;
60
FR
34466,
July
3,
1995]

§
790.7
Confidentiality.

(
a)
Any
person
subject
to
the
requirements
of
a
consent
agreement
or
a
test
rule
under
section
4
of
the
Act
may
assert
a
claim
of
confidentiality
for
certain
information
submitted
to
EPA
in
response
to
the
consent
agreement
or
the
test
rule.
Any
information
claimed
as
confidential
will
be
treated
in
accordance
with
the
procedures
in
part
2
of
this
title
and
section
14
of
the
Act.
Failure
to
assert
a
claim
of
confidentiality
at
the
time
the
information
is
submitted
will
result
in
the
information
being
made
available
to
the
public
without
further
notice
to
the
submitter.

(
b)
A
claim
of
confidentiality
must
be
asserted
by
circling
or
otherwise
marking
the
specific
information
claimed
as
confidential
and
designating
it
with
the
words
"
confidential
business
information,"
"
trade
secret,"
or
another
appropriate
phrase
indicating
its
confidential
character.

(
c)
If
a
person
asserts
a
claim
of
confidentiality
for
study
plan
information
described
in
§
§
790.50(
c)(
1)(
iii)(
D),
(
iv),
(
v),
and
(
vi)
and
790.62(
b)(
6),
(
7),
(
8),
(
9),
and
(
10),
the
person
must
provide
a
detailed
written
substantiation
of
the
claim
by
answering
the
questions
in
this
paragraph.
Failure
to
provide
written
substantiation
at
the
time
the
study
plan
information
is
submitted
will
be
considered
a
waiver
of
the
claim
of
confidentiality,
and
the
study
plan
information
will
be
disclosed
to
the
public
without
further
notice.

(
1)
Would
disclosure
of
the
study
plan
information
disclose
processes
used
in
the
manufacture
or
processing
of
a
chemical
substance
or
mixture?
Describe
how
this
would
occur.

(
2)
Would
disclosure
of
the
study
plan
information
disclose
the
portion
of
a
mixture
comprised
by
any
of
the
substances
in
the
mixture?
Describe
how
this
would
occur.

(
3)
What
harmful
effects
to
your
competitive
position,
if
any,
do
you
think
would
result
from
disclosure
of
this
information?
How
would
a
competitor
use
such
information?
How
substantial
would
the
harmful
effects
be?
What
is
the
causal
relationship
between
disclosure
and
the
harmful
effects?

(
4)
For
what
period
of
time
should
confidential
treatment
be
given?
Until
a
specific
date,
the
occurrence
of
a
specific
event,
or
permanently?
Why?
(
5)
What
measures
have
you
taken
to
guard
against
disclosure
of
this
information
to
others?

(
6)
To
what
extent
has
this
information
been
disclosed
to
others?
What
precautions
have
been
taken
in
connection
with
such
disclosures?

(
7)
Has
this
information
been
disclosed
to
the
public
in
any
forms?
Describe
the
circumstances.

(
8)
Has
the
information
been
disclosed
in
a
patent?

(
9)
Has
EPA,
another
Federal
agency,
or
any
Federal
court
made
any
pertinent
confidentiality
determination
regarding
this
information?
If
so,
copies
of
such
determinations
must
be
included
in
the
substantiation.

(
d)
If
the
substantiation
provided
under
paragraph
(
c)
of
this
section
contains
information
which
the
submitter
considers
confidential,
the
submitter
must
assert
a
separate
claim
of
confidentiality
for
that
information
at
the
time
of
submission
in
accordance
with
paragraph
(
b)
of
this
section.

[
49
FR
39782,
Oct.
10,
1984,
as
amended
at
51
FR
23713,
June
30,
1986]

Subpart
B
­­
Procedures
for
Developing
Consent
Agreements
and
Test
Rules
Source:
51
FR
23713,
June
30,
1986,
unless
otherwise
noted.

§
790.20
Recommendation
and
designation
of
testing
candidates
by
the
ITC.

(
a)
Recommendations
with
intent
to
designate.
The
ITC
has
advised
EPA
that
it
will
discharge
its
responsibilities
under
section
4(
e)
of
the
Act
in
the
following
manner:

(
1)
When
the
ITC
identifies
a
chemical
substance
or
mixture
that
it
believes
should
receive
expedited
consideration
by
EPA
for
testing,
the
ITC
may
add
the
substance
or
mixture
to
its
list
of
chemicals
recommended
for
testing
and
include
a
statement
that
the
ITC
intends
to
designate
the
substance
or
mixture
for
action
by
EPA
in
accordance
with
section
4(
e)(
1)(
B)
of
the
Act.

(
2)
Chemical
substances
or
mixtures
selected
for
expedited
review
under
paragraph
(
a)(
1)
of
this
section
may,
at
a
later
time,
be
designated
for
EPA
action
within
12
months
of
such
designation.
The
ITC's
subsequent
decision
would
be
based
on
the
ITC's
review
of
TSCA
sections
8(
a)
and
8(
d)
data
and
other
relevant
information.

(
3)
Where
the
ITC
concludes
that
a
substance
or
mixture
warrants
testing
consideration
but
that
expedited
EPA
review
of
testing
needs
is
not
justified,
the
ITC
will
add
the
substance
or
mixture
to
its
list
of
testing
recommendations
without
expressing
an
intent
to
designate
the
substance
or
mixture
for
EPA
action
in
accordance
with
section
4(
e)(
1)(
B)
of
the
Act.

(
4)
The
ITC
reserves
its
right
to
designate
any
chemical
that
it
determines
the
Agency
should,
within
12
months
of
the
date
first
designated,
initiate
a
proceeding
under
section
4(
a)
of
the
Act.
(
b)
EPA
consideration
of
ITC
recommendations.
(
1)
Where
a
substance
or
mixture
is
designated
for
EPA
action
under
section
4(
e)(
1)(
B)
of
the
Act,
the
Agency
will
take
either
one
of
the
following
actions
within
12
months
after
receiving
the
ITC
designation:

(
i)
Initiate
rulemaking
proceedings
under
section
4(
a)
of
the
Act.

(
ii)
Publish
a
FEDERAL
REGISTER
notice
explaining
the
Agency's
reasons
for
not
initiating
such
rulemaking
proceedings.
EPA
may
conclude
that
rulemaking
proceedings
under
section
4(
a)
of
the
Act
are
unnecessary
if
it
determines
that
the
findings
specified
in
section
4(
a)
of
the
Act
cannot
be
made
or
if
the
Agency
has
entered
into
a
consent
agreement
requiring
testing
in
accordance
with
the
provisions
of
this
subpart.

(
2)
Where
a
substance
or
mixture
has
been
recommended
for
testing
by
the
ITC
without
an
intent
to
designate,
EPA
will
use
its
best
efforts
to
act
on
the
ITC's
recommendations
as
rapidly
as
possible
consistent
with
its
other
priorities
and
responsibilities.
EPA
may
respond
to
the
ITC's
recommendations
either
by:

(
i)
Initiating
rulemaking
proceedings
under
section
4(
a)
of
the
Act.

(
ii)
Publishing
a
FEDERAL
REGISTER
notice
explaining
the
Agency's
reasons
for
concluding
that
testing
is
unnecessary.

(
iii)
Entering
into
a
consent
agreement
in
accordance
with
this
subpart.

§
790.22
Procedures
for
gathering
information
and
negotiating
consent
agreements
on
chemicals
which
the
ITC
has
recommended
for
testing
with
an
intent
to
designate.

(
a)
Preliminary
EPA
evaluation.
Following
receipt
of
an
ITC
report
containing
a
recommendation
with
an
intent
to
designate,
EPA
will
use
the
following
procedure
for
completing
a
preliminary
evaluation
of
testing
needs.
Appendix
A
to
this
part
presents
the
schedule
that
EPA
intends
to
follow
for
this
purpose.

(
1)
EPA
will
publish
the
ITC
report
in
the
FEDERAL
REGISTER
and
announce
that
interested
persons
have
30
days
to
submit
comments
on
the
ITC's
testing
recommendations.

(
2)
EPA
will
publish
a
FEDERAL
REGISTER
notice
adding
all
ITC­
recommended
chemicals
to
the
automatic
reporting
provisions
of
its
rules
under
sections
8(
a)
and
8(
d)
of
the
Act
(
40
CFR
parts
712
and
716).

(
3)
EPA
will
hold
a
public
"
focus
meeting"
to
discuss
the
ITC's
testing
recommendations
and
obtain
comments
and
information
from
interested
parties.

(
4)
EPA
will
evaluate
submissions
received
under
the
sections
8(
a)
and
8(
d)
reporting
requirements,
comments
filed
on
the
ITC's
recommendations,
and
other
information
and
data
compiled
by
the
Agency.

(
5)
EPA
will
make
a
preliminary
staff
determination
of
the
need
for
testing
and,
where
testing
appears
warranted,
will
tentatively
select
the
studies
to
be
performed.

(
6)
EPA
will
hold
a
public
meeting
to
announce
its
preliminary
testing
determinations.
(
b)
Negotiation
procedures
for
consent
agreements.
Where
EPA
believes
that
testing
is
necessary,
the
Agency
will
explore
whether
a
consent
agreement
can
be
negotiated
that
satisfies
the
testing
needs
identified
by
the
Agency.
EPA
will
use
the
following
procedures
for
negotiating,
formulating
and
accepting
consent
agreements.
Appendix
A
to
this
part
presents
the
schedule
that
EPA
intends
to
follow
for
this
purpose.

(
2)
Persons
who
respond
to
EPA's
notice
by
the
announced
date
of
the
Agency's
course­
setting
meeting
will
be
deemed
"
interested
parties"
for
purposes
of
any
negotiations
that
EPA
conducts.

(
3)
Following
the
course­
setting
meeting
announcing
EPA's
preliminary
testing
determinations,
the
Agency
will
meet
with
manufacturers,
processors
and
other
interested
parties
for
the
purpose
of
attempting
to
negotiate
a
consent
agreement.
To
facilitate
attendance
at
these
meetings,
EPA
will
contact
all
interested
parties
who
have
expressed
a
desire
to
participate
in
or
monitor
negotiations
under
paragraph
(
b)(
2)
of
this
section
and
advise
them
of
meeting
dates.

(
4)
All
negotiating
meetings
will
be
open
to
members
of
the
public.
The
minutes
of
each
meeting
will
be
prepared
by
EPA.
Meeting
minutes,
testing
proposals,
background
documents
and
other
materials
exchanged
at
or
prepared
for
negotiating
meetings
will
be
included
in
the
public
file
established
by
EPA
on
each
ITC­
recommended
chemical.
Materials
in
this
file
will
be
made
available
for
inspection
in
the
OPPTS
Reading
Room
during
EPA
working
hours.

(
5)
While
negotiations
are
underway,
EPA
will
promptly
circulate
meeting
minutes,
testing
proposals,
correspondence
and
other
relevant
materials
to
interested
parties
who
expressed
a
desire
to
participate
in
or
monitor
negotiations
pursuant
to
paragraph
(
b)(
2)
of
this
section.

(
6)
As
negotiations
progress,
EPA
will
make
a
tentative
decision
either
to
proceed
with
formulation
of
a
consent
agreement
or
to
initiate
rulemaking.
EPA
will
terminate
negotiations
after
10
weeks
and
proceed
with
rulemaking
unless
negotiations
are
likely
to
result
in
a
draft
consent
agreement
within
4
additional
weeks.
By
the
end
of
this
4­
week
period,
EPA
either
will
have
prepared
a
draft
consent
agreement
reflecting
the
apparent
consensus
of
the
parties
or
will
terminate
negotiations
and
proceed
with
rulemaking.
If
EPA
decides
to
proceed
with
rulemaking,
no
further
opportunity
for
negotiations
will
be
provided.
EPA
will
promptly
send
written
notice
to
all
interested
parties
of
the
termination
of
negotiations.

(
7)
Where
EPA
prepares
a
draft
consent
agreement,
it
will
be
circulated
for
comment
to
all
interested
parties
who
expressed
a
desire
to
participate
in
or
monitor
negotiations
under
paragraph
(
b)(
2)
of
this
section.
A
period
of
4
weeks
will
be
provided
for
submitting
comments
or
written
objections
under
§
790.24(
a).

(
8)
If
necessary,
EPA
will
hold
a
public
meeting
to
discuss
comments
on
the
draft
consent
agreement
and
to
determine
whether
revisions
in
the
agreement
are
appropriate.

(
9)
Where
a
consensus
exists
concerning
the
contents
of
a
draft
consent
agreement,
it
will
be
circulated
to
EPA
management
and
interested
parties
for
final
approval
and
signature.

(
10)
Upon
final
approval
of
a
consent
agreement,
EPA
will
publish
a
FEDERAL
REGISTER
notice
that
summarizes
the
agreement,
describes
the
ITC
recommendations
for
the
test
substance,
outlines
the
chemical's
use
and
exposure
characteristics,
and
explains
the
background,
objectives
and
rationale
of
the
testing
to
be
conducted,
and
codifies
in
subpart
C
of
part
799
the
name
of
the
substance(
s)
to
be
tested
and
the
citation
to
the
FEDERAL
REGISTER
notice
of
the
agreement.
§
790.24
Criteria
for
determining
whether
a
consensus
exists
concerning
the
provisions
of
a
draft
consent
agreement.

(
a)
EPA
will
enter
into
consent
agreements
only
where
there
is
a
consensus
among
the
Agency,
one
or
more
manufacturers
and/
or
processors
who
agree
to
conduct
or
sponsor
the
testing,
and
all
other
interested
parties
who
identify
themselves
in
accordance
with
§
790.22(
b)(
2).
EPA
will
not
enter
into
a
consent
agreement
in
either
of
the
following
circumstances:

(
1)
EPA
and
affected
manufacturers
and/
or
processors
cannot
reach
a
consensus
on
the
testing
requirements
or
other
provisions
to
be
included
in
the
consent
agreement.

(
2)
A
draft
consent
agreement
is
considered
inadequate
by
other
interested
parties
who,
pursuant
to
§
790.22(
b)(
2),
have
asked
to
participate
in
or
monitor
negotiations;
and
these
parties
have
submitted
timely
written
objections
to
the
draft
consent
agreement
which
provide
a
specific
explanation
of
the
grounds
on
which
the
draft
agreement
is
objectionable.

(
b)
EPA
may
reject
objections
described
in
paragraph
(
a)(
2)
of
this
section
only
where
the
Agency
concludes
the
objections
are
either:

(
1)
Not
made
in
good
faith.

(
2)
Untimely.

(
3)
Do
not
involve
the
adequacy
of
the
proposed
testing
program
or
other
features
of
the
agreement
that
may
affect
EPA's
ability
to
fulfill
the
goals
and
purposes
of
the
Act.

(
4)
Not
accompanied
by
a
specific
explanation
of
the
grounds
on
which
the
draft
agreement
is
considered
objectionable.

(
c)
The
unwillingness
of
some
manufacturers
and/
or
processors
of
a
prospective
test
chemical
to
sign
the
draft
consent
agreement
does
not,
in
itself,
establish
a
lack
of
consensus
if
EPA
concludes
that
those
manufacturers
and/
or
processors
who
are
prepared
to
sign
the
agreement
are
capable
of
accomplishing
the
testing
to
be
required
and
that
the
draft
agreement
will
achieve
the
purposes
of
the
Act
in
all
other
respects.

§
790.26
Initiation
and
completion
of
rulemaking
proceedings
on
ITC­
designated
chemicals.

(
a)
Where
EPA
concludes
that
a
consensus
does
not
exist
concerning
the
provisions
of
a
draft
consent
agreement
and
that
the
findings
specified
by
section
4(
a)
can
be
made,
the
Agency
will
proceed
with
rulemaking
under
section
4(
a)
of
TSCA.

(
b)
When
EPA
decides
to
proceed
with
rulemaking
under
paragraph
(
a)
of
this
section,
the
Agency
intends
to
publish
a
rulemaking
proposal
and
a
final
rule
or
a
notice
terminating
the
rulemaking
proceeding
in
accordance
with
the
schedule
specified
in
Appendix
A
1
to
this
part.

(
c)
Where
the
testing
recommendations
of
the
ITC
raise
unusually
complex
and
novel
issues
that
require
additional
Agency
review
and
opportunity
for
public
comment,
the
Agency
may
publish
an
Advance
Notice
of
Proposed
Rulemaking
(
ANPR).
The
schedule
that
EPA
intends
to
follow
for
rulemaking
proceedings
initiated
by
publication
of
an
ANPR
is
presented
in
appendix
A
to
this
part.

§
790.28
Procedures
for
developing
consent
agreements
and/
or
test
rules
for
chemicals
that
have
not
been
designated
or
recommended
with
intent
to
designate
by
the
ITC.

(
a)
Where
EPA
believes
that
testing
is
needed,
it
may
also
develop
consent
agreements
and/
or
test
rules
on
chemical
substances
or
mixtures
that
either:

(
1)
Have
been
recommended
but
not
"
recommended
with
intent
to
designate"
by
the
ITC.

(
2)
Have
been
selected
for
testing
consideration
by
EPA
on
its
own
initiative.

(
b)
When
EPA
wishes
to
initiate
negotiations
concerning
chemicals
described
in
paragraph
(
a)
of
this
section,
it
will
publish
a
FEDERAL
REGISTER
notice
describing
its
tentative
evaluation
of
testing
needs,
announcing
a
date
for
a
public
course­
setting
meeting,
and
inviting
persons
interested
in
participating
in
or
monitoring
negotiations
to
contact
the
Agency
in
writing.
Any
negotiations
that
EPA
conducts
will
conform
to
the
procedures
specified
in
§
790.22(
b)
and,
to
the
extent
feasible,
will
follow
the
schedules
presented
in
appendix
A
to
this
part.

(
c)
EPA
will
enter
into
consent
agreements
on
chemicals
described
in
paragraph
(
a)
of
this
section
only
if
there
is
a
consensus
among
EPA,
affected
manufacturers
and/
or
processors,
and
any
other
persons
who
have
asked
to
participate
in
or
monitor
negotiations.
In
determining
whether
such
a
consensus
exists,
EPA
will
employ
the
criteria
specified
in
§
790.24.
In
the
absence
of
consensus,
EPA
will
initiate
rulemaking
if
it
concludes
that
the
findings
specified
in
section
4(
a)
of
the
Act
can
be
made.
The
schedule
for
initiating
and
completing
such
rulemaking
proceedings
will,
to
the
extent
feasible,
follow
the
schedule
specified
in
appendix
A
to
this
part.

Subpart
C
­­
Implementation,
Enforcement,
and
Modification
of
Test
Rules
Source:
50
FR
20657,
May
17,
1985,
unless
otherwise
noted.
Redesignated
at
51
FR
23713,
June
30,
1986.

§
790.40
Promulgation
of
test
rules.

(
a)
If
EPA
determines
that
it
is
necessary
to
test
a
chemical
substance
or
mixture
by
rule
under
section
4
of
the
Act,
it
will
promulgate
a
test
rule
in
part
799
of
this
chapter.

(
b)
EPA
will
promulgate
specific
test
rules
in
part
799
of
this
chapter
either
by
a
single­
phase
rulemaking
procedure
or
by
a
two­
phase
rulemaking
procedure.

(
1)
Under
single­
phase
test
rule
development,
EPA
will
promulgate
a
test
rule
in
part
799
of
this
chapter
through
a
notice
and
comment
rulemaking
which
specifies
the
following:

(
i)
Identification
of
the
chemical
for
which
testing
is
required
under
the
rule.

(
ii)
The
health
or
environmental
effect
or
effects
or
other
characteristics
for
which
testing
is
being
required.

(
iii)
Which
test
substance(
s)
must
be
tested.
(
iv)
Standards
for
the
development
of
test
data.

(
v)
The
EPA
Good
Laboratory
Practice
requirements
for
the
required
testing.

(
vi)
Schedule
for
submission
of
interim
reports
and/
or
final
reports
to
EPA.

(
vii)
Who
must
submit
either
letters
of
intent
to
conduct
testing
or
exemption
applications.

(
viii)
What
types
of
data
EPA
will
examine
in
determining
equivalence
if
more
than
one
test
substance
is
to
be
tested.

(
2)
Under
two­
phase
test
rule
development,
EPA
will
promulgate
a
Phase
I
test
rule
in
part
799
of
this
chapter
through
a
notice
and
comment
rulemaking
which
specifies
the
following:

(
i)
Identification
of
the
chemical
for
which
testing
is
required
under
the
rule.

(
ii)
The
health
or
environmental
effect
or
effects
or
other
characteristics
for
which
testing
is
being
required.

(
iii)
Which
test
substance(
s)
must
be
tested.

(
iv)
A
reference
to
appropriate
guidelines
for
the
development
of
test
data.

(
v)
The
EPA
Good
Laboratory
Practice
requirements
for
the
required
testing.

(
vi)
Who
must
submit
either
letters
of
intent
to
conduct
testing
and
study
plans,
or
exemption
applications.

(
vii)
What
types
of
data
EPA
will
examine
in
determining
equivalence
if
more
than
one
test
substance
is
to
be
tested.

(
3)
Under
two­
phase
test
rule
development,
test
standards
and
schedules
will
be
developed
in
a
second
phase
of
rulemaking
as
described
in
§
§
790.50
and
790.52.

[
50
FR
20657,
May
17,
1985.
Redesignated
and
amended
at
51
FR
23713,
June
30,
1986;
54
FR
36313,
Sept.
1,
1989]

§
790.42
Persons
subject
to
a
test
rule.

(
a)
Each
test
rule
described
in
§
790.40
will
specify
whether
manufacturers,
processors,
or
both
are
subject
to
the
requirement
for
testing
of
the
subject
chemical
under
section
4(
b)(
3)(
B)
of
the
Act
and
will
indicate
who
will
be
required
to
submit
letters
of
intent
to
conduct
testing.

(
1)
If
testing
is
being
required
to
allow
evaluation
of
risks:

(
i)
Primarily
associated
with
manufacture
of
the
chemical,
or
(
ii)
Associated
with
both
manufacturer
and
processing
of
the
chemical,
or
(
iii)
Associated
with
distribution
in
commerce,
use,
and/
or
disposal
activities
concerning
the
chemical,
each
manufacturer
of
the
chemical
will
be
subject
and
must
comply
with
the
requirements
of
the
test
rule.

(
2)
While
legally
subject
to
the
test
rule
in
circumstances
described
in
paragraphs
(
a)(
1)
(
ii)
and
(
iii)
of
this
section,
processors
of
the
chemical
must
comply
with
the
requirements
of
the
test
rule
only
if
processors
are
directed
to
do
so
in
a
subsequent
notice
as
set
forth
in
§
790.48(
b).

(
3)
If
testing
is
being
required
to
allow
evaluation
of
risks
associated
solely
with
processing
of
the
chemical,
processors
will
be
subject
and
must
comply
with
the
requirements
of
the
test
rule.

(
4)
While
legally
subject
to
the
test
rule
in
circumstances
described
in
paragraph
(
a)(
1)
of
this
section,
persons
who
manufacture
less
than
500
kg
(
1,100
lb)
of
the
chemical
annually
during
the
period
from
the
effective
date
of
the
test
rule
to
the
end
of
the
reimbursement
period,
must
comply
with
the
requirements
of
the
test
rule
only
if
such
manufacturers
are
directed
to
do
so
in
a
subsequent
notice
as
set
forth
in
§
790.48,
or
if
directed
to
do
so
in
a
particular
test
rule.

(
5)
While
legally
subject
to
the
test
rule
in
circumstances
described
in
paragraph
(
a)(
1)
of
this
section,
persons
who
manufacture
small
quantities
of
the
chemical
solely
for
research
and
development
(
meaning
quantities
that
are
not
greater
than
those
necessary
for
purposes
of
scientific
experimentation
or
analysis
or
chemical
research
on,
or
analysis
of,
such
chemical
or
another
chemical,
including
such
research
or
analysis
for
development
of
a
product)
from
the
effective
date
of
the
test
rule
to
the
end
of
the
reimbursement
period,
must
comply
with
the
requirements
of
the
test
rule
only
if
such
manufacturers
are
directed
to
do
so
in
subsequent
notice
set
forth
in
§
790.48,
or
if
directed
to
do
so
in
a
particular
test
rule.

(
6)
If
testing
is
being
required
to
allow
evaluation
of
risks
associated
primarily
with
manufacture
of
a
chemical
for
research
and
development
(
R
&
D)
purposes,
manufacturers
of
the
chemical
for
R
&
D
will
be
subject
and
must
comply
with
the
requirements
of
the
test
rule.

(
b)
[
Reserved]

[
50
FR
20657,
May
17,
1985.
Redesignated
at
51
FR
23713,
June
30,
1986,
and
amended
at
55
FR
18884,
May
7,
1990]

§
790.45
Submission
of
letter
of
intent
to
conduct
testing
or
exemption
application.

(
a)
No
later
than
30
days
after
the
effective
date
of
a
test
rule
described
in
§
790.40,
each
person
subject
to
that
rule
and
required
to
comply
with
the
requirements
of
that
rule
as
provided
in
§
790.42(
a)
must,
for
each
test
required,
either
notify
EPA
by
letter
of
his
or
her
intent
to
conduct
testing
or
submit
to
EPA
an
application
for
an
exemption
from
testing
requirements
for
the
test.
(
b)
EPA
will
consider
letters
of
intent
to
test
as
commitments
to
sponsor
the
tests
for
which
they
are
submitted
unless
EPA
agrees
to
the
substitution
of
an
exemption
application
in
instances
where
more
than
one
person
indicates
an
intent
to
sponsor
equivalent
tests.

(
c)
Each
letter
of
intent
to
conduct
testing
must
include:

(
1)
Identification
of
test
rule.

(
2)
Name,
address,
and
telephone
number
of
the
firm(
s)
which
will
be
sponsoring
the
tests.
(
3)
Name,
address,
and
telephone
number
of
the
appropriate
individual
to
contact
for
further
information.

(
4)
For
sponsors
participating
in
a
testing
consortium
­­
a
list
of
all
members
of
the
consortium,
the
signature
of
an
authorized
representative
of
each
member,
and
a
designation
of
who
is
to
serve
as
principal
sponsor.

(
5)
A
list
of
the
testing
requirements
for
which
the
sponsor(
s)
intends
to
conduct
tests.

(
6)
If
EPA
is
requiring
testing
of
more
than
one
representative
substance
­­
which
test
substance
the
sponsor(
s)
intends
to
use
in
each
of
the
tests.

(
d)(
1)
Any
person
not
manufacturing
or
processing
the
subject
chemical
as
of
the
effective
date
of
the
test
rule
describing
in
§
790.40
or
by
30
days
after
the
effective
date
of
the
rule
who,
before
the
end
of
the
reimbursement
period,
manufacturers
or
processes
the
test
chemical
and
who
is
subject
to
and
required
to
comply
with
the
requirements
of
the
test
rule
must
submit
the
letter
of
intent
to
test
or
an
exemption
application
required
by
paragraph
(
a)
of
this
section
by
the
date
manufacture
or
processing
begins,
or
(
2)
When
both
manufacturers
and
processors
are
subject
to
the
rule,
any
person
not
processing
the
subject
chemical
as
of
the
effective
date
of
the
test
rule
described
in
§
790.40
or
by
30
days
after
publication
of
the
FEDERAL
REGISTER
notice
described
in
§
790.48(
b)(
2)
who,
before
the
end
of
the
reimbursement
period,
processes
the
test
chemical
and
who
is
required
to
comply
with
the
requirements
of
the
rule
must
submit
the
letter
of
intent
to
test
or
an
exemption
application
required
by
§
790.48(
b)(
3)
of
the
date
processing
begins.

(
e)
Manufacturers
subject
to
a
test
rule
described
in
§
790.40
who
do
not
submit
to
EPA
either
a
letter
of
their
intent
to
conduct
tests
or
a
request
for
an
exemption
from
testing
for
each
test
for
which
testing
is
required
in
the
test
rule
will
be
considered
in
violation
of
that
rule
beginning
on
the
31st
day
after
the
effective
date
of
the
test
rule
described
in
§
790.40
or
on
the
date
manufacture
begins
as
described
in
paragraph
(
d)
of
this
section.

(
f)
Processors
subject
to
a
test
rule
described
in
§
790.40
and
required
to
comply
with
the
requirements
of
test
rule
pursuant
to
§
790.42(
a)(
2)
or
a
FEDERAL
REGISTER
notice
as
described
in
§
790.48(
b)(
2)
who
do
not
submit
to
EPA
either
a
letter
of
their
intent
to
conduct
tests
or
a
request
for
an
exemption
for
each
test
for
which
testing
is
required
in
the
test
rule
will
be
considered
in
violation
of
that
rule
beginning
on
the
31st
day
after
the
effective
date
of
the
test
rule
described
in
§
790.40
or
31
days
after
publication
of
the
FEDERAL
REGISTER
notice
described
in
§
790.48(
b)(
2)
or
on
the
date
processing
begins
as
described
in
paragraph
(
d)
of
this
section,
as
appropriate.

§
790.48
Procedure
if
no
one
submits
a
letter
of
intent
to
conduct
testing.

(
a)
If
only
manufacturers
are
subject
to
the
rule.
(
1)
This
paragraph
applies
if
testing
is
being
required
solely
to
allow
evaluation
of
risks
associated
with
manufacturing
and
the
test
rule
described
in
§
790.40
states
that
manufacturers
only
are
responsible
for
testing.

(
2)
If
no
manufacturer
subject
to
the
test
rule
has
notified
EPA
of
its
intent
to
conduct
one
or
more
of
the
required
tests
within
30
days
after
the
effective
date
of
the
test
rule
described
in
§
790.40,
EPA
will
notify
all
manufacturers,
including
those
described
in
§
790.42(
a)(
4)
and
(
a)(
5),
by
certified
mail
or
by
publishing
a
notice
of
this
fact
in
the
FEDERAL
REGISTER
specifying
the
tests
for
which
no
letter
of
intent
has
been
submitted
and
will
give
such
manufacturers
an
opportunity
to
take
corrective
action.

(
3)
If
no
manufacturer
submits
a
letter
of
intent
to
conduct
one
or
more
of
the
required
tests
within
30
days
after
receipt
of
the
certified
letter
or
publication
of
the
FEDERAL
REGISTER
notice
described
in
paragraph
(
a)(
2)
of
this
section,
all
manufacturers
subject
to
the
rule
will
be
in
violation
of
the
test
rule
from
the
31st
day
after
receipt
of
the
certified
letter
or
publication
of
the
FEDERAL
REGISTER
notice
described
in
this
paragraph.

(
b)
If
manufacturers
and
processors
are
subject
to
the
rule.
(
1)
This
paragraph
applies
if
testing
is
being
required
to
allow
evaluation
of
risks
associated
with
manufacturing
and
processing
or
with
distribution
in
commerce,
use,
or
disposal
of
the
chemical
and
the
test
rule
described
in
§
790.40
states
that
manufacturers
and
processors
are
responsible
for
testing.

(
2)
If
no
manufacturer
subject
to
the
rule
has
notified
EPA
of
its
intent
to
conduct
testing
for
one
or
more
of
the
required
tests
within
30
days
after
the
effective
date
of
the
test
rule
described
in
§
790.40,
EPA
will
publish
a
notice
in
the
FEDERAL
REGISTER
of
this
fact
specifying
the
tests
for
which
no
letter
of
intent
has
been
submitted.

(
3)
No
later
than
30
days
after
the
date
of
publication
of
the
FEDERAL
REGISTER
notice
described
in
paragraph
(
b)(
2)
of
this
section,
each
person
described
in
§
790.40(
a)(
4)
and
(
5)
and
each
person
processing
the
subject
chemical
as
of
the
effective
date
of
the
test
rule
described
in
§
790.40
or
by
30
days
after
the
date
of
publication
of
the
FEDERAL
REGISTER
notice
described
in
paragraph
(
b)(
2)
of
this
section
must,
for
each
test
specified
in
the
FEDERAL
REGISTER
notice,
either
notify
EPA
by
letter
of
his
or
her
intent
to
conduct
testing
or
submit
to
EPA
an
application
for
an
exemption
from
testing
requirements
for
the
test.

(
4)
If
no
manufacturer
or
processor
of
the
test
chemical
has
submitted
a
letter
of
intent
to
conduct
one
or
more
of
the
required
tests
within
30
days
after
the
date
of
publication
of
the
FEDERAL
REGISTER
notice
described
in
paragraph
(
b)(
2)
of
this
section,
EPA
will
notify
all
manufacturers
and
processors
by
certified
letter
or
publish
a
FEDERAL
REGISTER
notice
of
this
fact
specifying
the
tests
for
which
no
letter
of
intent
has
been
submitted.
This
letter
or
FEDERAL
REGISTER
notice
will
give
the
manufacturers
and
processors
an
opportunity
to
take
corrective
action.

(
5)
If
no
manufacturer
or
processor
submits
a
letter
of
intent
to
conduct
one
or
more
of
the
required
tests
within
30
days
after
receipt
of
the
certified
letter
or
publication
of
the
FEDERAL
REGISTER
notice
described
in
paragraph
(
b)(
4)
of
this
section,
all
manufacturers
and
processors
subject
to
the
rule
will
be
in
violation
of
the
test
rule
from
the
31st
day
after
receipt
of
the
certified
letter
or
publication
of
the
FEDERAL
REGISTER
notice
described
in
paragraph
(
b)(
4)
of
this
section.

(
c)
Only
processors
are
subject
to
the
rule.
(
1)
This
paragraph
applies
if
testing
is
being
required
solely
to
allow
evaluation
of
risks
associated
with
processing
and
the
test
rule
described
in
§
790.40
states
that
only
processors
are
responsible
for
testing.

(
2)
If
no
processor
subject
to
the
rule
has
notified
EPA
of
its
intent
to
conduct
one
or
more
of
the
required
tests
within
30
days
after
the
effective
date
of
the
test
rule
described
in
§
790.40,
EPA
will
notify
all
the
processors
by
certified
mail
or
publish
a
notice
in
the
FEDERAL
REGISTER
of
this
fact,
specifying
the
tests
for
which
no
letter
of
intent
has
been
submitted
and
give
the
processors
an
opportunity
to
take
corrective
action.

(
3)
If
no
processor
submits
a
letter
of
intent
to
conduct
one
or
more
of
the
required
tests
within
30
days
after
receipt
of
the
certified
letter
or
publication
of
the
FEDERAL
REGISTER
notice
described
in
paragraph
(
c)(
2)
of
this
section,
all
processors
subject
to
the
rule
will
be
in
violation
of
the
test
rule
from
the
31st
day
after
receipt
of
the
certified
letter
or
publication
of
the
FEDERAL
REGISTER
notice
described
in
this
paragraph.

[
50
FR
20657,
May
17,
1985.
Redesignated
at
51
FR
23713,
June
30,
1986,
and
amended
at
55
FR
18884,
May
7,
1990]

§
790.50
Submission
of
study
plans.

(
a)
Who
must
submit
study
plans.
(
1)
Persons
who
notify
EPA
of
their
intent
to
conduct
tests
in
compliance
with
the
requirements
of
a
single
phase
test
rule
as
described
in
§
790.40(
b)(
1)
must
submit
study
plans
for
those
tests
prior
to
the
initiation
of
each
of
these
tests,
unless
directed
by
a
particular
test
rule
or
consent
agreement
to
submit
study
plans
at
a
specific
time.

(
2)
Persons
who
notify
EPA
of
their
intent
to
conduct
tests
in
compliance
with
the
requirements
of
a
Phase
I
test
rule
as
described
in
§
790.40(
b)(
2)
must
submit
the
proposed
study
plans
for
those
tests
on
or
before
90
days
after
the
effective
date
of
the
Phase
I
rule;
or,
for
processors
complying
with
the
notice
described
in
§
790.48(
b)(
2),
90
days
after
the
publication
date
of
that
notice;
or
60
days
after
the
date
manufacture
or
processing
begins
as
described
in
§
790.45(
d),
as
appropriate,
to
the
address
in
§
790.5(
b).

(
3)
Study
plans
must
be
prepared
according
to
the
requirements
of
this
subpart
B
and
part
792
of
this
chapter.
Only
one
set
of
study
plans
should
be
prepared
and
submitted
by
persons
who
are
jointly
sponsoring
testing.

(
4)
Any
person
subject
to
a
test
rule
may
submit
a
study
plan
for
any
test
required
by
the
rule
at
any
time,
regardless
of
whether
the
person
previously
submitted
an
application
for
exemption
from
testing
for
that
test.

(
5)
Unless
EPA
has
granted
an
extension
of
time
for
submission
of
proposed
study
plans,
manufacturers
who
notify
EPA
that
they
intend
to
conduct
testing
in
compliance
with
the
requirements
of
a
Phase
I
test
rule
as
described
in
§
790.40(
b)(
2)
and
who
do
not
submit
proposed
study
plans
for
those
tests
on
or
before
90
days
after
the
effective
date
of
the
Phase
I
test
rule
or
60
days
after
the
date
manufacture
begins
as
described
in
§
790.45(
d)
will
be
considered
in
violation
of
the
test
rule
as
if
no
letter
of
intent
to
test
had
been
submitted.

(
6)
Unless
EPA
has
granted
an
extension
of
time
for
submission
of
proposed
study
plans,
processors
who
notify
EPA
that
they
intend
to
conduct
testing
in
compliance
with
the
requirements
of
a
Phase
I
test
rule
as
described
in
§
790.40(
b)(
2)
and
who
do
not
submit
proposed
study
plans
for
those
tests
on
or
before
90
days
after
the
effective
date
of
the
Phase
I
test
rule
or
90
days
after
the
publication
date
of
the
notice
described
in
§
790.48(
b)(
2),
or
60
days
after
the
date
processing
begins
as
described
in
§
790.45(
d),
as
appropriate,
will
be
considered
in
violation
of
the
test
rule
as
if
no
letter
of
intent
to
test
had
been
submitted.
(
b)
Extensions
of
time
for
submission
of
study
plans.
(
1)
EPA
may
grant
requests
for
additional
time
for
the
development
of
study
plans
on
a
case­
by­
case
basis.
Requests
for
additional
time
for
study
plan
development
must
be
made
in
writing
to
EPA
at
the
address
in
§
790.5(
b).
Each
extension
request
must
state
why
EPA
should
grant
the
extension.

(
2)
Under
two­
phase
rulemaking,
extension
requests
must
be
submitted
to
EPA
within
60
days
after
the
effective
date
of
the
Phase
I
test
rule
as
described
in
§
790.40(
b)(
2);
or
for
processors
complying
with
the
notice
described
in
§
790.48(
b)(
2),
60
days
after
the
publication
date
of
that
notice;
or
30
days
after
the
date
manufacture
or
processing
begins
as
described
in
§
790.45(
d),
as
appropriate.

(
3)
EPA
will
notify
the
submitter
by
certified
mail
of
EPA's
decision
to
grant
or
deny
an
extension
request.

(
4)
Persons
who
have
been
granted
an
extension
of
time
for
submission
of
study
plans
as
described
in
paragraph
(
b)(
1)
of
this
section
and
who
do
not
submit
proposed
study
plans
in
compliance
with
the
requirements
of
a
Phase
I
test
rule
in
accordance
with
the
new
deadline
granted
by
EPA
will
be
considered
in
violation
of
the
test
rule
as
if
no
letter
of
intent
to
test
had
been
submitted
as
described
in
§
790.45(
e)
and
(
f).

(
c)
Content
of
study
plans.
(
1)
All
study
plans
are
required
to
contain
the
following
information:

(
i)
Identity
of
the
test
rule.

(
ii)
The
specific
test
requirements
of
that
rule
to
be
covered
by
the
study
plan.

(
iii)(
A)
The
names
and
addresses
of
the
test
sponsors.

(
B)
The
names,
addresses,
and
telephone
numbers
of
the
responsible
administrative
officials
and
project
manager(
s)
in
the
principal
sponsor's
organization.

(
C)
The
name,
address,
and
telephone
number
of
the
appropriate
individual
to
contact
for
oral
and
written
communications
with
EPA.

(
D)(
1)
The
names
and
addresses
of
the
testing
facilities
and
the
names,
addresses,
and
telephone
numbers
of
the
testing
facilities'
administrative
officials
and
project
manager(
s)
responsible
for
the
testing.

(
2)
Brief
summaries
of
the
training
and
experience
of
each
professional
involved
in
the
study,
including
study
director,
veterinarian(
s),
toxicologist(
s),
pathologist(
s),
chemist(
s),
microbiologist(
s),
and
laboratory
assistants.

(
iv)
Identity
and
data
on
the
chemical
substance(
s)
being
tested,
including
physical
constants,
spectral
data,
chemical
analysis,
and
stability
under
test
and
storage
conditions,
as
appropriate.

(
v)
Study
protocol,
including
the
rationale
for
any
combination
of
test
protocols;
the
rationale
for
species/
strain
selection;
dose
selection
(
and
supporting
data);
route(
s)
or
method(
s)
of
exposure;
description
of
diet
to
be
used
and
its
source;
including
nutrients
and
contaminants
and
their
concentrations;
for
in
vitro
test
systems,
a
description
of
culture
medium
and
its
source;
and
a
summary
of
expected
spontaneous
chronic
diseases
(
including
tumors),
genealogy,
and
life
span.
(
vi)
Schedule
for
initiation
and
completion
of
each
short­
term
test
and
of
each
major
phase
of
long­
term
tests;
dates
for
submission
of
interim
progress
and
final
reports
to
EPA
that
are
within
the
reporting
deadlines
specified
by
EPA
in
the
final
test
rule.

(
2)
Information
required
in
paragraph
(
c)(
1)(
iii)(
D)
of
this
section
is
not
required
in
proposed
study
plans
submitted
in
compliance
with
the
requirements
of
a
Phase
I
test
rule
if
the
information
is
not
available
at
the
time
of
study
plan
submission;
however,
the
information
must
be
submitted
before
the
initiation
of
testing.

(
d)
Incomplete
study
plans.
(
1)
Upon
receipt
of
a
study
plan,
EPA
will
review
the
study
plan
to
determine
whether
it
complies
with
paragraph
(
c)
of
this
section.
If
EPA
determines
that
the
study
plan
does
not
comply
with
paragraph
(
c)
of
this
section,
EPA
will
notify
the
submitter
that
the
submission
is
incomplete
and
will
identify
the
deficiencies
and
the
steps
necessary
to
complete
the
submission.

(
2)
The
submitter
will
have
15
days
after
the
day
it
receives
this
notice
to
submit
appropriate
information
to
make
the
study
plan
complete.

(
3)
If
the
submitter
fails
to
provide
appropriate
information
to
complete
a
proposed
study
plan
submitted
in
compliance
with
the
requirements
of
a
Phase
I
test
rule
on
or
before
15
days
after
receipt
of
the
notice,
the
submitter
will
be
considered
in
violation
of
the
test
rule
as
if
no
letter
of
intent
to
conduct
the
test
had
been
submitted
as
described
in
§
790.45(
e)
and
(
f).

(
e)
Amendments
to
study
plans.
Test
sponsors
shall
submit
all
amendments
to
study
plans
to
the
Director,
Office
of
Compliance
Monitoring
at
the
address
in
§
790.5(
d).

[
50
FR
20657,
May
17,
1985.
Redesignated
and
amended
at
51
FR
23713,
June
30,
1986;
52
FR
36569,
Sept.
30,
1987;
54
FR
36313,
Sept.
1,
1989;
55
FR
18884,
May
7,
1990;
58
FR
34205,
June
23,
1993;
60
FR
34466,
July
3,
1995]

§
790.52
Phase
II
test
rule.

(
a)
If
EPA
determines
that
the
proposed
study
plan
described
in
§
790.50(
a)(
2)
complies
with
§
790.50(
c),
EPA
will
publish
a
proposed
Phase
II
test
rule
in
the
FEDERAL
REGISTER
requesting
comments
on
the
ability
of
the
proposed
study
plan
to
ensure
that
data
from
the
test
will
be
reliable
and
adequate.

(
b)
EPA
will
provide
a
45­
day
comment
period
and
will
provide
an
opportunity
for
an
oral
presentation
upon
the
request
of
any
person.
EPA
may
extend
the
comment
period
if
it
appears
from
the
nature
of
the
issues
raised
by
EPA's
review
or
from
public
comments
that
further
comment
is
warranted.

(
c)
After
receiving
and
considering
public
comments
on
the
study
plan,
EPA
will
adopt,
as
proposed
or
as
modified
in
response
to
EPA
review
and
public
comments,
the
study
protocol
section
of
the
study
plan,
as
defined
by
§
790.50(
c)(
1)(
v)
of
this
chapter,
as
the
test
standard
for
the
required
testing,
and
the
schedule
section
of
the
study
plan,
as
defined
by
§
790.50(
c)(
1)(
vi)
of
this
chapter,
as
the
schedule
for
the
required
testing
in
a
final
Phase
II
test
rule.

[
50
FR
20657,
May
17,
1985.
Redesignated
at
51
FR
23713,
June
30,
1986,
and
amended
at
52
FR
36569,
Sept.
30,
1987]
§
790.55
Modification
of
test
standards
or
schedules
during
conduct
of
test.

(
a)
Application.
Any
test
sponsor
who
wishes
to
modify
the
test
schedule
for
the
mandatory
testing
conditions
or
requirements
(
i.
e.,
"
shall
statements")
in
the
test
standard
for
any
test
required
by
a
test
rule
must
submit
an
application
in
accordance
with
this
paragraph.
Application
for
modification
must
be
made
in
writing
to
EPA
at
the
address
in
§
790.5(
b),
or
by
phone
with
written
confirmation
to
follow
within
10
working
days.
Applications
must
include
an
appropriate
explanation
and
rationale
for
the
modification.
Where
a
test
sponsor
requests
EPA
to
provide
guidance
or
to
clarify
a
non­
mandatory
testing
requirement
(
i.
e.,
"
should
statements")
in
a
test
standard,
the
test
sponsor
should
submit
these
requests
to
EPA
at
the
address
in
§
790.5(
b).

(
b)
Adoption.
(
1)
Where
EPA
concludes
that
the
requested
modification
of
a
test
standard
or
schedule
for
a
test
required
under
a
test
rule
is
appropriate,
EPA
will
proceed
in
accordance
with
this
paragraph
(
b).

(
2)
Where,
in
EPA's
judgment,
the
requested
modification
of
the
test
standard
or
schedule
would
not
alter
the
scope
of
the
test
or
significantly
change
the
schedule
for
completing
the
test,
EPA
will
not
ask
for
public
comment
before
approving
the
modification.
EPA
will
notify
the
test
sponsor
by
letter
of
EPA's
approval.
EPA
will
place
copies
of
each
application
and
EPA
approval
letter
in
the
rulemaking
record
for
the
test
rule
in
question.
EPA
will
publish
a
notice
annually
in
the
FEDERAL
REGISTER
indicating
the
test
standards
or
schedules
for
tests
required
in
test
rules
which
have
been
modified
under
this
paragraph
(
b)(
2)
and
describing
the
nature
of
the
modifications.
Until
the
FEDERAL
REGISTER
notice
is
published,
any
modification
approved
by
EPA
under
this
paragraph
(
b)(
2)
shall
apply
only
to
the
test
sponsor
who
applied
for
the
modification
under
this
paragraph
(
a)
of
this
section.

(
3)
Where,
in
EPA's
judgment,
the
requested
modification
of
a
test
standard
or
schedule
would
significantly
alter
the
scope
of
the
test
or
significantly
change
the
schedule
for
completing
the
test,
EPA
will
publish
a
notice
in
the
FEDERAL
REGISTER
requesting
comment
on
the
proposed
modification.
However,
EPA
will
approve
a
requested
modification
of
a
test
standard
under
paragraph
(
b)(
3)
of
this
section
without
first
seeking
public
comment
if
EPA
believes
that
an
immediate
modification
to
the
test
standard
is
necessary
to
preserve
the
accuracy
or
validity
of
an
ongoing
test.
EPA
may
also
modify
a
testing
requirement
or
test
condition
in
a
test
standard
if
EPA
determines
that
the
completion
or
achievement
of
this
requirement
or
condition
is
not
technically
feasible.
EPA
may
approve
a
test
schedule
extension
under
paragraph
(
b)(
3)
of
this
section
without
first
seeking
public
comment
if
EPA
determines,
on
a
case­
by­
case
basis,
that
a
delay
of
over
12
months
is
not
the
fault
of
the
test
sponsor
and
is
the
result
of
unforeseen
circumstances
such
as
a
lack
of
laboratory
availability,
lack
of
availability
of
suitable
test
substance
(
e.
g.,
14­
C
labeled
test
substance),
lack
of
availability
of
healthy
test
organisms,
or
the
unexpected
failure
of
a
long­
term
test.
EPA
will
publish
an
annual
notice
in
the
FEDERAL
REGISTER
announcing
the
approval
of
any
test
standard
modifications
and
test
schedule
extensions
under
paragraph
(
b)(
3)
of
this
section
and
provide
a
brief
rationale
of
why
the
modification
was
granted.

(
4)
For
purposes
of
this
paragraph
(
b),
a
requested
modification
of
a
test
standard
or
schedule
for
a
test
required
under
a
test
rule
would
alter
the
scope
of
the
test
or
significantly
change
the
schedule
for
completing
the
test
if
the
modification
would:

(
i)
Change
the
test
species.
(
ii)
Change
the
route
of
administration
of
the
test
chemical.

(
iii)
Change
the
period
of
time
during
which
the
test
species
is
exposed
to
the
test
chemical.

(
iv)
Except
as
provided
in
paragraph
(
b)(
3)
of
this
section,
extend
the
final
reporting
deadline
more
than
12
months
from
the
date
specified
in
the
final
rule.

(
c)
Disapproval.
Where
EPA
concludes
that
the
requested
modification
of
a
test
standard
or
schedule
for
a
test
required
under
a
test
rule
is
not
appropriate,
EPA
will
so
notify
the
test
sponsor
in
writing.

(
d)
Timing.
(
1)
Test
sponsors
should
submit
all
applications
for
test
schedule
modifications
at
least
60
days
before
the
reporting
deadline
for
the
test
in
question.

(
2)
EPA
will
not
normally
approve
any
test
schedule
extensions
submitted
less
than
30
days
before
the
reporting
deadline
for
the
test
in
question.

(
3)
Except
as
provided
in
paragraph
(
b)(
3)
of
this
section,
EPA
may
grant
extensions
for
up
to
1
year
but
will
normally
limit
extensions
to
a
period
of
time
equal
to
the
in­
life
portion
of
the
test
plus
60
days.

(
4)
EPA
will
normally
approve
only
one
deadline
extension
for
each
test.

(
5)
Test
sponsors
should
submit
requests
for
test
standard
modifications
as
soon
as
they
determine
that
the
test
cannot
be
successfully
completed
according
to
the
test
standard
specified
in
the
rule.

[
50
FR
20657,
May
17,
1985.
Redesignated
at
51
FR
23713,
June
30,
1986,
and
amended
at
52
FR
36571,
Sept.
30,
1987;
54
FR
36314,
Sept.
1,
1989;
60
FR
34466,
July
3,
1995]

§
790.59
Failure
to
comply
with
a
test
rule.

(
a)
Persons
who
notified
EPA
of
their
intent
to
conduct
a
test
required
in
a
test
rule
in
part
799
of
this
chapter
and
who
fail
to
conduct
the
test
in
accordance
with
the
test
standards
and
schedules
adopted
in
the
test
rule,
or
as
modified
in
accordance
with
§
790.55,
will
be
in
violation
of
the
rule.

(
b)
Any
person
who
fails
or
refuses
to
comply
with
any
aspect
of
this
part
or
a
test
rule
under
part
799
of
this
chapter
is
in
violation
of
section
15
of
the
Act.
EPA
will
treat
violations
of
the
Good
Laboratory
Practice
standards
as
indicated
in
§
792.17
of
this
chapter.

Subpart
D
­­
Implementation,
Enforcement
and
Modification
of
Consent
Agreements
Source:
51
FR
23715,
June
30,
1986,
unless
otherwise
noted.

§
790.60
Contents
of
consent
agreements.

(
a)
Standard
provisions.
All
consent
agreements
will
contain
the
following
provisions:

(
1)
Identification
of
the
chemical(
s)
to
be
tested.
(
2)
The
health
effects,
environmental
effects
and/
or
other
characteristics
for
which
testing
will
be
required.

(
3)
The
names
and
addresses
of
each
manufacturer
and/
or
processor
who
will
sign
the
agreement.

(
4)
The
name
and
address
of
the
manufacturer,
processor
or
other
entity
who
has
agreed
to
act
as
the
principal
test
sponsor.

(
5)
The
technical
or
commercial
grade,
level
of
purity
or
other
characteristics
of
the
test
substances(
s)
or
mixture(
s).

(
6)
Standards
for
the
development
of
test
data.

(
7)
A
requirement
that
testing
will
be
conducted
in
accordance
with
the
EPA
Good
Laboratory
Practice
(
GLP)
regulations
(
40
CFR
part
792).

(
8)
Schedules
with
reasonable
deadlines
for
submitting
interim
progress
and/
or
final
reports
to
EPA.

(
9)
A
requirement
that
the
principal
sponsor
will
submit
a
study
plan
to
EPA
in
accordance
with
§
790.62.

(
10)
A
statement
that
the
results
of
testing
conducted
pursuant
to
the
consent
agreement
will
be
announced
to
the
public
in
accordance
with
the
procedures
specified
in
section
4(
d)
of
the
Act
and
that
the
disclosure
of
data
generated
by
such
testing
will
be
governed
by
section
14(
b)
of
the
Act.

(
11)
A
requirement
that
the
manufacturers
and/
or
processors
signing
the
consent
agreement
will
comply
with
the
notification
requirements
of
section
12(
b)(
1)
of
the
Act
and
part
707
of
this
chapter
if
they
export
or
intend
to
export
the
substance
or
mixture
for
which
the
submission
of
data
is
required
under
the
agreement
and
a
statement
that
any
other
person
who
exports
or
intends
to
export
such
substance
or
mixture
is
subject
to
the
above
cited
export
notification
requirements.

(
12)
A
requirement
that,
in
the
event
EPA
promulgates
a
significant
new
use
rule
applicable
to
the
test
chemical
under
section
5(
a)(
2),
the
consent
agreement
will
have
the
status
of
a
test
rule
for
purposes
of
section
5(
b)(
1)(
A)
and
manufacturers
and/
or
processors
signing
the
agreement
will
comply
with
the
data
submission
requirements
imposed
by
that
provision.

(
13)
A
statement
that
each
manufacturer
and/
or
processor
signing
the
agreement
agrees
that
violation
of
its
requirements
will
constitute
a
"
prohibited
act"
under
section
15(
1)
of
the
Act
and
will
trigger
all
provisions
of
TSCA
applicable
to
a
violation
of
section
15.

(
14)
A
statement
that,
in
the
event
one
or
more
provisions
of
the
agreement
are
determined
to
be
unenforceable
by
a
court,
the
remainder
of
the
agreement
would
not
be
presumed
to
be
valid
and
EPA
will
then
either
initiate
a
rulemaking
proceeding
or
publish
in
the
FEDERAL
REGISTER
the
Administrator's
reason
for
not
initiating
such
a
proceeding.
(
15)
A
statement
that
the
Agency
may
conduct
laboratory
inspections
and/
or
study
audits
of
the
testing
being
conducted
pursuant
to
the
consent
agreement
in
accordance
with
the
authority
and
procedures
contained
in
section
11
of
the
Act.

(
16)
A
statement
that
EPA
acceptance
of
a
consent
agreement
constitutes
"
final
agency
action"
for
purposes
of
5
U.
S.
C.
704.

(
17)
Any
other
requirements
that
the
parties
agree
are
necessary
to
achieve
the
purposes
of
the
Act.

(
b)
Contents
of
standards
for
the
development
of
data.
The
standards
for
the
development
of
the
data
included
in
consent
agreements
will
be
based
on
the
TSCA
test
guidelines
in
40
CFR
parts
796,
797,
and
798,
the
Organization
for
Economic
Cooperation
and
Development
(
OECD)
test
guidelines,
the
EPA
pesticide
assessment
guidelines
published
by
The
National
Technical
Information
Service
(
NTIS),
or
other
suitable
test
methodologies.
During
the
negotiation
of
consent
agreements,
EPA
will
initially
propose
suitable
test
guidelines
as
the
required
test
standards;
manufacturers
and
processors
or
other
interested
parties
may
then
suggest
alternative
methodologies
or
modifications
to
the
Agency's
proposed
guidelines.
These
alternative
methodologies
or
modifications
will
be
adopted
only
where,
in
the
judgment
of
EPA,
they
will
develop
at
least
equally
reliable
and
adequate
data
on
the
chemical
substance
or
mixture
subject
to
the
agreement.

(
c)
Statement
of
rationale
for
consent
agreement.
EPA
will
prepare
a
written
explanation
of
the
basis
for
each
consent
agreement.
This
document
will
summarize
the
agreement,
describe
any
ITC
testing
recommendations
for
the
chemical
involved,
outline
the
chemical's
use
and
exposure
characteristics,
and
explain
the
objectives
of
the
testing
to
be
conducted
and
the
rationale
for
the
specific
studies
selected.
This
document
will
be
published
in
the
FEDERAL
REGISTER
and,
for
ITC­
designated
chemicals,
will
constitute
the
statement
of
EPA's
reasons
for
not
initiating
rulemaking
required
by
section
4(
e)(
1)(
B)
of
the
Act.

[
51
FR
23715,
June
30,
1986,
as
amended
at
54
FR
36314,
Sept.
1,
1989]

§
790.62
Submission
of
study
plans
and
conduct
of
testing.

(
a)
Timing
of
submission.
The
principal
sponsor
of
testing
conducted
pursuant
to
a
consent
agreement
shall
submit
a
study
plan
no
later
than
45
days
prior
to
the
initiation
of
testing.

(
b)
Content
of
study
plans.
All
study
plans
are
required
to
contain
the
following
information:

(
1)
Identity
of
the
consent
agreement
under
which
testing
will
be
performed.

(
2)
The
specific
test
requirements
to
be
covered
by
the
study
plan.

(
3)
The
name
and
address
of
the
principal
test
sponsor.

(
4)
The
names,
addresses,
and
telephone
numbers
of
the
responsible
administrative
official[
s]
and
project
manager[
s]
in
the
principal
sponsor's
organization.

(
5)
The
names,
addresses,
and
telephone
numbers
of
the
technical
contacts
at
each
manufacturer
and/
or
processor
subject
to
the
agreement.
(
6)
The
names
and
addresses
of
the
testing
facilities
responsible
for
the
testing
and
the
names,
addresses,
and
telephone
numbers
of
the
administrative
official[
s]
and
project
manager[
s]
assigned
to
oversee
the
testing
program
at
these
facilities.

(
7)
Brief
summaries
of
the
training
and
experience
of
each
professional
involved
in
the
study,
including
study
director,
veterinarian[
s],
toxicologist[
s],
pathologist[
s],
chemist[
s],
microbiologist[
s],
and
laboratory
assistants.

(
8)
Identity
and
supporting
data
on
the
chemical
substance[
s]
being
tested,
including
physical
constants,
spectral
data,
chemical
analysis,
and
stability
under
test
and
storage
conditions,
as
appropriate.

(
9)
Study
protocol,
including
the
rationale
for
any
combination
of
test
protocols;
the
rationale
for
species/
strain
selection;
dose
selection
(
and
supporting
data);
route(
s)
or
method(
s)
of
exposure;
description
of
diet
to
be
used
and
its
source,
including
nutrients
and
contaminants
and
their
concentrations;
for
in
vitro
test
systems,
a
description
of
culture
medium
and
its
source;
and
a
summary
of
expected
spontaneous
chronic
diseases
(
including
tumors),
genealogy,
and
life
span.

(
10)
A
schedule,
with
reasonable
timeables
and
deadlines,
for
initiation
and
completion
of
each
short­
term
test
and
of
each
major
phases
of
long­
term
tests,
and
submission
of
interim
progress
and/
or
final
reports
to
EPA.

(
c)
Review
and
modification.
(
1)
Upon
receipt
of
a
study
plan,
EPA
will
review
it
to
determine
whether
it
complies
with
paragraph
(
b)
of
this
section.
If
EPA
determines
that
the
study
plan
does
not
comply
with
paragraph
(
b)
of
this
section,
EPA
will
notify
the
submitter
that
the
plan
is
incomplete
and
will
identify
the
deficiencies
and
the
steps
necessary
to
complete
the
plan.
It
is
the
responsibility
of
the
test
sponsor
to
review
the
study
protocols
to
determine
if
they
comply
with
all
the
mandatory
testing
conditions
and
requirements
in
the
test
standards
(
i.
e.,
"
shall
statements").

(
2)
The
submitter
will
have
15
days
after
the
day
it
receives
a
notice
under
paragraph
(
c)(
1)
of
this
section
to
submit
appropriate
information
to
make
the
study
plan
complete.

(
3)
If
the
submitter
fails
to
provide
appropriate
information
to
complete
a
study
plan
within
15
days
after
having
received
a
notice
under
paragraph
(
c)(
1)
of
this
section,
the
submitter
will
be
considered
to
be
in
violation
of
the
consent
agreement
and
subject
to
enforcement
proceedings
pursuant
to
§
790.65
(
c)
and
(
d).

(
4)
The
test
sponsor
shall
submit
any
amendments
to
study
plans
to
EPA
at
the
address
specified
in
§
790.5(
b).

(
d)
Functions
of
the
principal
test
sponsor.
When
testing
is
being
conducted
pursuant
to
a
consent
agreement,
the
principal
test
sponsor
will
be
responsible
for
submitting
interim
progress
and
final
reports
to
EPA,
informing
the
Agency
of
any
proposed
changes
in
standards
for
the
development
of
data,
study
plans
or
testing
schedules,
and
communicating
with
the
Agency
about
laboratory
inspections
and
other
matters
affecting
the
progress
of
testing.

[
51
FR
23715,
June
30,
1986,
as
amended
at
54
FR
36314,
Sept.
1,
1989;
60
FR
34466,
July
3,
1995]
§
790.65
Failure
to
comply
with
a
consent
agreement.

(
a)
Manufacturers
and/
or
processors
who
have
signed
a
consent
agreement
and
who
fail
to
comply
with
the
test
requirements,
test
standards,
GLP
regulations,
schedules,
or
other
provisions
contained
in
the
consent
agreement,
or
in
modifications
to
the
agreement
adopted
pursuant
to
§
790.68,
will
be
in
violation
of
the
consent
agreement.

(
b)
The
Agency
considers
failure
to
comply
with
any
aspect
of
a
consent
agreement
to
be
a
"
prohibited
act"
under
section
15
of
TSCA,
subject
to
all
of
the
provisions
of
the
Act
applicable
to
violations
of
section
15.
Section
15(
1)
of
TSCA
makes
it
unlawful
for
any
person
to
fail
or
refuse
to
comply
with
any
rule
or
order
issued
under
section
4.
Consent
agreements
adopted
pursuant
to
this
part
are
"
orders
issued
under
section
4"
for
purposes
of
section
15(
1)
of
TSCA.

(
c)
Manufacturers
and/
or
processors
who
violate
consent
agreements
are
subject
to
criminal
and/
or
civil
liability.
Under
the
penalty
provisions
of
section
16
of
TSCA,
such
firms
could
be
subject
to
a
civil
penalty
of
up
to
$
25,000
per
violation
with
each
day
in
violation
constituting
a
separate
violation
of
section
15.
Intentional
violations
could
lead
to
the
imposition
of
criminal
penalties
of
up
to
$
25,000
for
each
day
of
violation
and
imprisonment
for
up
to
one
year.
In
addition,
EPA
could
invoke
the
remedies
available
under
section
17
of
TSCA,
including
seeking
an
injunction
to
compel
adherence
to
the
requirements
of
the
consent
agreement.

(
d)
Noncompliance
with
a
consent
agreement
will
constitute
conduct
"
in
violation
of
this
Act"
under
section
20(
a)(
1)
of
TSCA.
Thus,
failure
to
comply
with
the
requirements
of
a
consent
agreement
could
result
in
a
citizens'
civil
action
under
section
20(
a)(
1)
of
TSCA.

§
790.68
Modification
of
consent
agreements.

(
a)
Changes
in
the
scope
of
testing.
(
1)
Manufacturers
or
processors
subject
to
a
consent
agreement,
other
persons
or
EPA
may
seek
modifications
in
the
scope
of
testing
performed
under
the
consent
agreement.
If,
upon
receiving
a
request
for
modification,
EPA
determines
that
new
issues
have
been
raised
that
warrant
reconsideration
of
the
scope
of
testing,
or
if
EPA
determines
on
its
own
that
such
reconsideration
is
appropriate,
EPA
will
publish
a
FEDERAL
REGISTER
notice
describing
the
proposed
modification
and
soliciting
public
comment.
If,
based
on
the
comments
received,
EPA
concludes
that
differences
of
opinion
may
exist
about
the
proposed
modification,
EPA
will
establish
a
schedule
for
conducting
negotiations
and
invite
parties
who
wish
to
participate
in
or
monitor
these
negotiations
to
contact
the
Agency
in
writing.
Any
negotiations
that
EPA
conducts
will
conform
to
the
procedures
specified
in
§
790.22(
b).

(
2)
The
scope
of
testing
required
by
a
consent
agreement
will
be
modified
only
where
there
is
a
consensus
concerning
the
modified
testing
requirements
among
EPA,
affected
manufacturers
and/
or
processors,
and
other
persons
who
have
asked
to
participate
in
or
monitor
negotiations
under
paragraph
(
a)(
1)
of
this
section.
In
determining
whether
a
consensus
exists,
EPA
will
employ
the
criteria
specified
in
§
790.24.
In
the
absence
of
consensus,
EPA
may
initiate
ulemaking
under
section
4(
a)
of
the
Act
if
it
concludes
that
any
testing
beyond
that
required
by
the
consent
agreement
is
necessary
and
that
the
other
statutory
findings
required
by
section
4(
a)
can
be
made.
While
such
rulemaking
proceedings
are
underway,
the
consent
agreement
will
remain
in
effect
unless
EPA
finds
that
the
testing
required
by
the
agreement
is
or
may
be
unnecessary
in
view
of
the
testing
requirements
included
in
EPA's
proposed
rule.
(
b)
Changes
in
test
standards
or
schedules.
(
1)
Any
test
sponsor
who
wishes
to
modify
the
test
schedule
for
any
test
required
under
a
consent
order
must
submit
an
application
in
accordance
with
this
paragraph.
Application
for
modification
must
be
made
in
writing
to
EPA
at
the
address
in
§
790.5(
b),
or
by
phone
with
written
confirmation
to
follow
within
10
working
days.
Applications
must
include
an
appropriate
explanation
and
rationale
for
the
modification.
EPA
will
consider
only
those
applications
that
request
modifications
to
mandatory
testing
conditions
or
requirements
("
shall
statements"
in
the
consent
order).
Where
a
test
sponsor
requests
EPA
to
provide
guidance
or
to
clarify
a
non­
mandatory
testing
requirement
(
i.
e.,
"
should
statements"),
the
test
sponsor
should
submit
these
requests
to
EPA
at
the
address
in
section
790.5(
b).

(
2)(
i)
Where
EPA
concludes
that
the
requested
modification
of
a
test
standard
or
schedule
for
a
test
required
under
a
consent
agreement
is
appropriate,
EPA
will
proceed
in
accordance
with
this
paragraph
(
b)(
2).

(
ii)
Where,
in
EPA's
judgment,
the
requested
modification
of
a
test
standard
or
schedule
would
not
alter
the
scope
of
the
test
or
significantly
change
the
schedule
for
completing
the
test,
EPA
will
not
ask
for
public
comment
before
approving
the
modification.
EPA
will
notify
the
test
sponsor,
and
any
other
persons
who
have
signed
the
consent
agreement,
by
letter
of
EPA's
approval.
EPA
will
place
copies
of
each
application
and
EPA
approval
letter
in
the
administrative
record
maintained
for
the
consent
agreement
in
question.
EPA
will
publish
a
notice
annually
in
the
FEDERAL
REGISTER
indicating
the
test
standards
or
schedules
for
test
required
in
consent
agreements
which
have
been
modified
under
this
paragraph
(
b)(
2)(
ii)
and
describing
the
nature
of
the
modifications.

(
iii)
Where,
in
EPA's
judgment,
the
requested
modification
of
a
test
standard
or
schedule
would
significantly
alter
the
scope
of
the
test
or
significantly
change
the
schedule
for
completing
the
test,
EPA
will
publish
a
notice
in
the
FEDERAL
REGISTER
requesting
comment
on
the
proposed
modification.
However,
EPA
will
approve
a
requested
modification
of
a
test
standard
under
paragraph
(
b)(
2)(
iii)
of
this
section
without
first
seeking
public
comment
if
EPA
believes
that
an
immediate
modification
to
the
test
standard
is
necessary
to
preserve
the
accuracy
or
validity
of
an
ongoing
test.
EPA
also
may
modify
a
testing
requirement
or
test
condition
in
a
test
standard
if
EPA
determines
that
the
completion
or
achievement
of
this
requirement
or
condition
is
not
technically
feasible.
EPA
may
approve
a
requested
modification
of
a
test
schedule
under
pragraph
(
b)(
2)(
iii)
of
this
section
without
first
seeking
public
comment
if
EPA
determines,
on
a
case­
by­
case
basis,
that
a
delay
of
over
12
months
is
not
the
fault
of
the
test
sponsor
and
is
due
to
unforeseen
circumstances
such
as
a
lack
of
laboratory
availability,
lack
of
availability
of
suitable
test
substance
(
e.
g.,
14­
C
labeled
test
substance),
lack
of
availability
of
healthy
test
organisms,
or
the
unexpected
failure
of
a
long­
term
test.
EPA
will
publish
an
annual
notice
in
the
FEDERAL
REGISTER
announcing
the
approval
of
any
test
standard
modifications
and
test
scheduled
extensions
under
paragraph
(
b)(
2)(
iii)
of
this
section,
and
provide
a
brief
rationale
of
why
the
modification
was
granted.

(
iv)
For
purposes
of
this
paragraph
(
b)(
2),
a
requested
modification
of
a
test
standard
of
schedule
for
a
test
required
under
a
consent
agreement
would
alter
the
scope
of
the
test
or
significantly
change
the
schedule
for
completing
the
test
if
the
modification
would:

(
A)
Change
the
test
species.

(
B)
Change
the
route
of
administration
of
the
test
chemical.
(
C)
Change
the
period
of
time
during
which
the
test
species
is
exposed
to
the
test
chemical.

(
D)
Except
as
provided
in
paragraph
(
b)(
2)(
iii)
of
this
section,
extend
the
final
reporting
deadline
more
than
12
months
from
the
date
specified
in
the
consent
order.

(
3)
Where
EPA
concludes
that
the
requested
modification
of
a
test
standard
or
schedule
for
a
test
requirement
under
a
consent
agreement
is
not
appropriate,
EPA
will
so
notify
the
test
sponsor
in
writing.

(
c)
Timing.
(
1)
Test
sponsors
should
submit
all
applications
for
test
schedule
modifications
at
least
60
days
before
the
reporting
deadline
for
the
test
in
question.

(
2)
EPA
will
not
normally
approve
any
test
schedule
extensions
submitted
less
than
30
days
before
the
reporting
deadline
for
the
test
in
question.

(
3)
Except
as
provided
in
paragraph
(
b)(
2)(
iii)
of
this
section,
EPA
may
grant
extensions
as
shown
necessary
for
up
to
1
year
but
will
normally
limit
extensions
to
a
period
of
time
equal
to
the
in­
life
portion
of
the
test
plus
60
days.

(
4)
EPA
will
normally
approve
only
one
deadline
extension
for
each
test.

(
5)
Test
sponsors
should
submit
requests
for
test
standard
modifications
as
soon
as
they
determine
that
the
test
cannot
be
successfully
completed
according
to
the
test
standard
specified
in
the
consent
order.

[
51
FR
23715,
June
30,
1986,
as
amended
at
52
FR
36571,
Sept.
30,
1987;
54
FR
36314,
Sept.
1,
1989;
60
FR
34466,
July
3,
1995]

Subpart
E
­­
Exemptions
From
Test
Rules
Source:
50
FR
20660,
May
17,
1985,
unless
otherwise
noted.

§
790.80
Submission
of
exemption
applications.

(
a)
Who
should
file
applications.
(
1)
Any
manufacturer
or
processor
subject
to
a
test
rule
in
part
799
of
this
chapter
may
submit
an
application
to
EPA
for
an
exemption
from
performing
any
or
all
of
the
tests
required
under
the
test
rule.

(
2)
Processors
will
not
be
required
to
apply
for
an
exemption
or
conduct
testing
unless
EPA
so
specifies
in
a
test
rule
or
in
a
special
FEDERAL
REGISTER
notice
as
described
in
§
790.48(
b)(
2)
under
the
following
circumstances:

(
i)
If
testing
is
being
required
to
allow
evaluation
of
risks
associated
with
manufacturing
and
processing
or
with
distribution
in
commerce,
use,
or
disposal
of
the
chemical
and
manufacturers
do
not
submit
notice(
s)
of
intent
to
conduct
the
required
testing;
or
(
ii)
If
testing
is
being
required
solely
to
allow
evaluation
of
risks
associated
with
processing
of
the
chemical.
(
b)
When
applications
must
be
filed.
(
1)
Exemption
applications
must
be
filed
within
30
days
after
the
effective
date
of
the
test
rule
described
in
§
790.40
or,
if
being
submitted
in
compliance
with
the
FEDERAL
REGISTER
notice
described
in
§
790.48(
b)(
2),
within
30
days
after
the
publication
of
that
notice.

(
2)
Exemption
applications
must
be
filed
by
the
date
manufacture
or
processing
begins
by
any
person
not
manufacturing
or
processing
the
subject
chemical
as
of
the
effective
date
of
the
test
rule
described
in
§
790.40
or
by
30
days
after
the
effective
date
of
the
test
rule
described
in
§
790.40,
who,
before
the
end
of
the
reimbursement
period,
manufactures
or
processes
the
test
substance
and
who
is
subject
to
the
requirement
to
submit
either
a
letter
of
intent
to
test
or
an
exemption
application.

(
3)
When
both
manufacturers
and
processors
are
subject
to
the
rule,
exemption
applications
must
be
filed
by
the
date
processing
begins
by
any
person
not
processing
as
of
the
effective
date
of
the
test
rule
described
in
§
790.40
or
by
30
days
after
publication
of
the
FEDERAL
REGISTER
notice
described
in
§
790.48(
b)(
2)
who,
before
the
end
of
the
reimbursement
period,
processes
the
test
substance
and
who
is
subject
to
the
requirement
to
submit
either
a
letter
of
intent
to
test
or
an
exemption
application.

(
c)
Scope
of
application.
A
person
may
apply
for
an
exemption
from
all,
or
one
or
more,
specific
testing
requirements
in
a
test
rule
in
part
799
of
this
chapter.

[
50
FR
20660,
May
17,
1985,
as
amended
at
58
FR
34205,
June
23,
1993]

§
790.82
Content
of
exemption
application.

The
exemption
application
must
contain:

(
a)
The
identity
of
the
test
rule,
the
chemical
identity,
and
the
CAS
No.
of
the
test
substance
on
which
the
application
is
based.

(
b)
The
specific
testing
requirement(
s)
from
which
an
exemption
is
sought
and
the
basis
for
the
exemption
request.

(
c)
Name,
address,
and
telephone
number
of
applicant.

(
d)
Name,
address,
and
telephone
number
of
appropriate
individual
to
contact
for
further
information.

(
e)(
1)
If
required
in
the
test
rule
to
establish
equivalence:

(
i)
The
chemical
identity
of
the
test
substance
on
which
the
application
is
based.

(
ii)
Equivalence
data
specified
in
§
790.85.

(
2)
If
a
test
rule
requires
testing
of
a
single
representative
substance,
EPA
will
consider
all
forms
of
the
chemical
subject
to
that
rule
to
be
equivalent
and
will
not
require
the
submission
of
equivalence
data
as
described
in
§
790.85.

[
50
FR
20660,
May
17,
1985,
as
amended
at
54
FR
36315,
Sept.
1,
1989]
§
790.85
Submission
of
equivalence
data.

If
EPA
requires
in
a
test
rule
promulgated
under
section
4
of
the
Act
the
testing
of
two
or
more
test
substances
which
are
forms
of
the
same
chemical,
each
exemption
applicant
must
submit
the
following
data:

(
a)
The
chemical
identity
of
each
technical­
grade
chemical
substance
or
mixture
manufactured
and/
or
processed
by
the
applicant
for
which
the
exemption
is
sought.
The
exact
type
of
identifying
data
required
will
be
specified
in
the
test
rule,
but
may
include
all
characteristics
and
properties
of
the
applicant's
substance
or
mixture,
such
as
boiling
point,
melting
point,
chemical
analysis
(
including
identification
and
amount
of
impurities),
additives,
spectral
data,
and
other
physical
or
chemical
information
that
may
be
relevant
in
determining
whether
the
applicant's
substance
or
mixture
is
equivalent
to
the
specific
test
substance.

(
b)
The
basis
for
the
applicant's
belief
that
the
substance
or
mixture
is
equivalent
to
the
test
substance
or
mixture.

(
c)
Any
other
data
which
exemption
applicants
are
directed
to
submit
in
the
test
rule
which
may
bear
on
a
determination
of
equivalence.
This
may
include
a
description
of
the
process
by
which
each
technical­
grade
chemical
substance
or
mixture
for
which
an
exemption
is
sought
is
manufactured
or
processed
prior
to
use
or
distribution
in
commerce
by
the
applicant.

§
790.87
Approval
of
exemption
applications.

(
a)
EPA
will
conditionally
approve
exemption
applications
if:

(
1)(
i)
For
single­
phase
test
rules,
EPA
has
received
a
letter
of
intent
to
conduct
the
testing
from
which
exemption
is
sought;

(
ii)
For
two­
phase
test
rules,
EPA
has
received
a
complete
proposed
study
plan
for
the
testing
from
which
exemption
is
sought
and
has
adopted
the
study
plan,
as
proposed
or
modified,
as
test
standards
and
schedules
in
a
final
Phase
II
test
rule;
and
(
2)
The
chemical
substance
or
mixture
with
respect
to
which
the
application
was
submitted
is
equivalent
to
a
test
substance
or
mixture
for
which
the
required
data
have
been
or
are
being
submitted
in
accordance
with
a
test
rule;
and
(
3)
Submission
of
the
required
test
data
concerning
that
chemical
substance
or
mixture
would
be
duplicative
of
data
which
have
been
or
are
being
submitted
to
EPA
in
accordance
with
a
test
rule.

(
b)(
1)
If
a
single
representative
substance
is
to
be
tested
under
a
test
rule,
EPA
will
consider
all
forms
of
the
chemical
subject
to
that
rule
to
be
equivalent
and
will
contact
the
exemption
applicant
only
if
information
is
missing
or
unclear.

(
2)
If
two
or
more
representative
substances
are
to
be
tested
under
a
test
rule,
EPA
will
evaluate
equivalence
claims
made
in
each
exemption
application
according
to
the
criteria
discussed
in
the
test
rule.
(
i)
If
EPA
finds
an
equivalence
claim
to
be
in
error
or
inadequately
supported,
the
applicant
will
be
notified
by
certified
mail.
The
applicant
will
be
given
15
days
to
provide
clarifying
information.

(
ii)
Exemption
applicants
will
be
notified
that
equivalence
has
been
accepted
or
rejected.

(
c)
The
final
Phase
II
test
rule
which
adopts
the
study
plans
in
two­
phase
rulemaking,
a
separate
FEDERAL
REGISTER
notice
in
single­
phase
rulemaking,
or
a
letter
by
certified
mail
will
give
exemption
applicants
final
notice
that
they
have
received
a
conditional
exemption.
All
conditional
exemptions
thus
granted
are
contingent
upon
the
test
sponsors'
successful
completion
of
testing
according
to
the
specifications
in
the
test
rule.

§
790.88
Denial
of
exemption
application.

(
a)
EPA
may
deny
any
exemption
application
if:

(
1)
EPA
determines
that
the
applicant
has
failed
to
demonstrate
that
the
applicant's
chemical
is
equivalent
to
the
test
substance;
or
(
2)
The
exemption
applicant
fails
to
submit
any
of
the
information
specified
in
§
790.82;
or
(
3)
The
exemption
applicant
fails
to
submit
any
of
the
information
specified
in
§
790.85
if
required
in
the
test
rule;
or
(
4)(
i)
For
single­
phase
test
rules,
EPA
has
not
received
a
letter
of
intent
to
conduct
the
test
for
which
exemption
is
sought;
or
(
ii)
For
two­
phase
test
rules,
EPA
has
not
received
an
adequate
study
plan
for
the
test
for
which
exemption
is
sought;
or
(
5)
The
study
sponsor(
s)
fails
to
initiate
the
required
testing
by
the
deadlines
adopted
in
the
test
rule;
or
(
6)
The
study
sponsor(
s)
fails
to
submit
data
as
required
in
the
test
standard
and
deadlines
for
submission
of
test
data
as
adopted
in
the
test
rule
or
as
modified
in
accordance
with
§
790.55.

(
b)
EPA
will
notify
the
exemption
applicant
by
certified
mail
or
FEDERAL
REGISTER
notice
of
EPA's
determination
that
the
exemption
application
is
denied.

§
790.90
Appeal
of
denial
of
exemption
application.

(
a)
Within
30
days
after
receipt
of
notification
that
EPA
has
denied
an
application
for
exemption,
the
applicant
may
file
an
appeal
with
EPA.

(
b)
The
appeal
shall
indicate
the
basis
for
the
applicant's
request
for
reconsideration.

(
c)(
1)
The
applicant
may
also
include
a
request
for
a
hearing.
Hearings
will
be
held
according
to
the
procedures
described
in
§
790.97.
(
2)
Hearing
requests
must
be
in
writing
and
must
be
received
by
EPA
within
30
days
of
receipt
of
the
letter
or
publication
of
the
FEDERAL
REGISTER
notice
described
in
§
790.88(
b).
Hearing
requests
must
provide
reasons
why
a
hearing
is
necessary.

(
d)
If
EPA
determines
that
there
are
material
issues
of
fact,
then
the
request
for
a
hearing
will
be
granted.
If
EPA
denies
a
hearing
request,
EPA
will
base
its
decision
on
the
written
submission.

(
e)
EPA
will
notify
the
applicant
of
its
decision
within
60
days
after
EPA
receives
the
appeal
described
in
paragraph
(
a)
of
this
section
or
within
60
days
after
completion
of
a
hearing
described
in
paragraph
(
c)
of
this
section.

(
f)
The
filing
of
an
appeal
from
the
denial
of
an
exemption
shall
not
act
to
stay
the
applicant's
legal
obligations
under
a
test
rule
promulgated
under
section
4
of
the
Act.

§
790.93
Termination
of
conditional
exemption.

(
a)
EPA
shall
terminate
a
conditional
exemption
if
it
determines
that:

(
1)
The
test
which
provided
the
basis
for
approval
of
the
exemption
application
has
not
been
started
by
the
deadlines
for
initiation
of
testing
adopted
in
the
test
rule
or
modified
in
accordance
with
§
790.55;
or
(
2)
Data
required
by
the
test
rule
have
not
been
generated
in
accordance
with
the
test
standards
or
submitted
in
accordance
with
the
deadlines
for
submission
of
test
data
that
were
adopted
in
the
test
rule
or
modified
in
accordance
with
§
790.55;
or
(
3)
The
testing
has
not
been
conducted
or
the
data
have
not
been
generated
in
accordance
with
the
Good
Laboratory
Practice
requirements
in
part
792
of
this
chapter.

(
b)
If
EPA
determines
that
one
or
more
of
the
criteria
listed
in
paragraph
(
a)
of
this
section
has
been
met,
EPA
will
notify
each
holder
of
an
affected
conditional
exemption
by
certified
mail
or
FEDERAL
REGISTER
notice
of
EPA's
intent
to
terminate
that
conditional
exemption.

(
c)
Within
30
days
after
receipt
of
a
letter
of
notification
or
publication
of
a
notice
in
the
FEDERAL
REGISTER
that
EPA
intends
to
terminate
a
conditional
exemption,
the
exemption
holder
may
submit
information
to
rebut
EPA's
preliminary
decision
or
notify
EPA
by
letter
of
its
intent
to
conduct
the
required
test
pursuant
to
the
test
standard
established
in
the
final
test
rule.
Such
a
letter
of
intent
shall
contain
all
of
the
information
required
by
§
790.45(
c).

(
d)(
1)
The
exemption
holder
may
also
include
a
request
for
a
hearing.
Hearings
will
be
held
in
accordance
with
the
procedures
set
forth
in
§
790.97.

(
2)
Hearing
requests
must
be
in
writing
and
must
be
received
by
EPA
within
30
days
after
receipt
of
the
letter
or
publication
in
the
FEDERAL
REGISTER
notice
described
in
paragraph
(
b)
of
this
section.

(
e)
EPA
will
notify
the
exemption
holder
by
certified
letter
or
by
FEDERAL
REGISTER
notice
of
EPA's
final
decision
concerning
termination
of
conditional
exemptions
and
will
give
instructions
as
to
what
actions
the
former
exemption
holder
must
take
to
avoid
being
found
in
violation
of
the
test
rule.
§
790.97
Hearing
procedures.

(
a)
Hearing
requests
must
be
in
writing
to
EPA
and
must
include
the
applicant's
basis
for
appealing
EPA's
decision.

(
b)
If
more
than
one
applicant
has
requested
a
hearing
on
similar
grounds,
all
of
those
appeals
will
be
considered
at
the
same
hearing
unless
confidentiality
claims
preclude
a
joint
hearing.

(
c)
EPA
will
notify
each
applicant
of
EPA's
decision
within
60
days
after
the
hearing.

§
790.99
Statement
of
financial
responsibility.

Each
applicant
for
an
exemption
shall
submit
the
following
sworn
statement
with
his
or
her
application:

I
understand
that
if
this
application
is
granted
before
the
reimbursement
period
described
in
section
4(
c)(
3)(
B)
of
TSCA
expires,
I
must
pay
fair
and
equitable
reimbursement
to
the
person
or
persons
who
incurred
or
shared
in
the
costs
of
complying
with
the
requirement
to
submit
data
and
upon
whose
data
the
granting
of
my
application
was
based.

Appendix
A
to
Subpart
E
­­
Schedule
for
Developing
Consent
Agreements
and
Test
Rules
EPA
intends
to
follow
the
schedule
set
forth
in
this
Appendix
to
evaluate
testing
candidates,
conduct
negotiations,
develop
consent
agreements
where
appropriate,
and
propose
and
promulate
test
rules
in
those
instances
where
testing
can
be
required
under
section
4(
a)
of
TSCA
but
agreement
cannot
be
reached
in
timely
manner
on
a
consent
agreement.
Where
deadlines
are
imposed
by
the
statute,
they
are
binding
on
EPA
and
will
be
observed
by
the
Agency.
The
remaining
dates
represent
targets
that
EPA
intends
to
meet.

This
schedule
is
based
on
what
EPA
currently
believes
are
reasonable
target
dates.
As
EPA
gains
experience
with
the
process
and
determines
the
feasibility
of
these
schedules,
it
may
adjust
the
schedule
accordingly.
EPA
will
solicit
public
comment
before
implementing
any
changes
in
the
schedule.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Week\
1\
Event
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
0.............................
Receive
ITC
report,
recommendation.
2.............................
Publish
ITC
report,
8(
a)
and
8(
d)
notices,
and
invitation
for
public
participation
in
negotiations.
3­
6...........................
Comment
period
on
ITC
report.
6.............................
Public
focus
meeting.
7­
14..........................
8(
a)
and
8(
d)
reporting
period.
22............................
Public
meeting
on
course­
setting
decision
and
deadline
for
requests
to
participate
in
negotiations.
22­
30........................
Negotiations.
32............................
EPA
decision
point:
consent
agreement
or
test
rule
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
1\
The
dates
contained
in
the
left­
hand
column
are
calculated
from
the
date
EPA
receives
the
ITC
report
recommending
a
chemical
for
testing.

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Week
Consent
Agreement
Week
Test
Rule
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
36­
40..........
Comment
period
on
32­
60
Rule
preparation,
consent
agreement.
agency
review
and
sign­
off.

42.............
Comment
resolution
62
Publish
proposed
rule
meeting
if
necessary.
in
Federal
Register.\
1\

48.............
Sign­
off
consent
70­
106
Agency
reviews
comments;
agreement
and
preparation
of
final
Federal
Register
rule
or
no­
test
decision,
notice.
agency
review
and
sign­
off.\
1\

50.............
Publish
Federal
108
Publish
final
rule
or
no­
test
Register
notice.
decision
in
Federal
Register.\
1\
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
1\
As
stated
in
Sec.
790.26,
EPA
may
publish
an
Advance
Notice
of
Proposed
Rulemaking
(
ANPR)
where
the
testing
recommendations
of
the
ITC
raise
unusually
novel
and
complex
issues
that
require
additional
Agency
review
and
opportunity
for
public
comment.
EPA
intends
to
publish
such
ANPRs
by
Week
62
following
receipt
of
the
initial
ITC
report;
to
publish
a
proposed
rule
or
decision­
not­
to­
test
by
Week108;
and
to
publish
a
final
rule
or
notice
terminating
the
rulemaking
process
by
Week
154.

[
51
FR
23717,
June
30,
1986]
ATTACHMENT
5
Public
Notice
Required
Prior
to
ICR
Submission
to
OMB
67
FR
18609,
April
16,
2002;
and
67
FR
34703,
May
15,
2002
Data
Submissions
for
the
Voluntary
Children's
Chemical
Evaluation
Program;
Request
for
Comment
on
Information
Collection
Activities
[
Federal
Register:
April
16,
2002
(
Volume
67,
Number
73)]
[
Notices]
[
Page
18609­
18611]
From
the
Federal
Register
Online
via
GPO
Access
[
wais.
access.
gpo.
gov]
[
DOCID:
fr16ap02­
65]

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

ENVIRONMENTAL
PROTECTION
AGENCY
[
OPPT­
2002­
0005;
FRL­
6832­
8]

Data
Submissions
for
the
Voluntary
Children's
Chemical
Evaluation
Program;
Request
for
Comment
on
Information
Collection
Activities
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice.

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

SUMMARY:
In
compliance
with
the
Paperwork
Reduction
Act
(
PRA)
(
44
U.
S.
C.
3501
et
seq.),
EPA
is
seeking
public
comment
on
the
following
Information
Collection
Request
(
ICR):
Data
Submissions
for
the
Voluntary
Children's
Chemical
Evaluation
Program
(
VCCEP)
(
EPA
ICR
No.
2055.01,
OMB
No.
2070­
tbd).
This
ICR
proposes
a
collection
activity
for
a
new
voluntary
program
whose
goal
is
to
obtain
information
on
chemicals
to
which
children
are
likely
to
be
exposed
so
that
any
risks
can
be
assessed
and
managed.
Information
on
health
effects,
exposure,
risk,
and
data
needs
will
be
submitted
by
chemical
manufacturers
who
have
volunteered
to
participate
in
VCCEP.
The
ICR
describes
the
nature
of
the
information
collection
activity
and
its
expected
burden
and
costs.
Before
submitting
this
ICR
to
the
Office
of
Management
and
Budget
(
OMB)
for
review
and
approval
under
the
PRA,
EPA
is
soliciting
comments
on
specific
aspects
of
the
collection.

DATES:
Written
comments,
identified
by
the
docket
control
number
OPPT­
2002­
0005
and
administrative
record
number
AR­
238,
must
be
received
on
or
before
May
16,
2002.

ADDRESSES:
Comments
may
be
submitted
by
mail,
electronically,
or
in
person.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
III.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
control
number
OPPT­
2002­
0005
and
administrative
record
number
AR­
238
in
the
subject
line
on
the
first
page
of
your
response.

FOR
FURTHER
INFORMATION
CONTACT:
For
general
information
contact:
Barbara
Cunningham,
Acting
Director,
Environmental
Assistance
Division
(
7408M),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(
202)
554­
1404;
e­
mail
address:
TSCA­
Hotline@
epa.
gov.
For
technical
information
contact:
Catherine
Roman,
Chemical
Control
Division
(
7405M),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(
202)
564­
8172;
fax
number:
(
202)
564­
4755;
e­
mail
address:
roman.
catherine@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
Does
this
Action
Apply
to
Me?

You
may
be
potentially
affected
by
this
action
if
you
are
a
manufacturer
or
importer
of
certain
chemicals
and
have
volunteered
to
sponsor
your
chemical
in
the
VCCEP.
Potentially
affected
categories
and
entities
may
include,
but
are
not
limited
to:

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Type
of
business
NAICS
codes
SIC
codes
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Industrial
organic
chemicals
325
2869
Adhesives
and
sealants
32552
2891
Paints
and
allied
products
32551
2851
Textile
goods
313
2299
Petroleum
products
42272
5172
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

This
table
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
this
table
could
also
be
affected.
The
North
American
Industry
Classification
System
(
NAICS)
codes
and
the
Standard
Industrial
Classification
(
SIC)
codes
are
provided
to
assist
you
and
others
in
determining
whether
or
not
this
action
might
apply
to
certain
entities.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
technical
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

II.
How
Can
I
Get
Additional
Information,
Including
Copies
of
this
Document
and
Other
Related
Documents?

A.
Electronically
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov/.
On
the
Home
Page
select
  
Laws
and
Regulations,''
  
Regulations
and
Proposed
Rules,''
and
then
look
up
the
entry
for
this
document
under
the
  
Federal
Register­­
Environmental
Documents.''
You
can
also
go
directly
to
the
Federal
Register
listings
at
http://
www.
epa.
gov/
fedrgstr/.

B.
Fax­
on­
Demand
Using
a
faxphone
call
(
202)
564­
3119
and
select
items
4089
and
4090
for
a
copy
of
the
ICR.

C.
In
Person
The
Agency
has
established
an
official
record
for
this
action
under
docket
control
number
OPPT­
2002­
0005
and
administrative
record
number
AR­
238.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received
during
an
applicable
comment
period,
and
other
information
related
to
this
action,
including
any
information
claimed
as
Confidential
Business
Information
(
CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period,
is
available
for
inspection
in
the
TSCA
Nonconfidential
Information
Center,
North
East
Mall
Rm.
B­
607,
Waterside
Mall,
401
M
St.,
SW.,
Washington,
DC.
The
Center
is
open
from
noon
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Center
is
(
202)
260­
7099.

III.
How
Can
I
Respond
to
this
Action?

A.
How
and
to
Whom
Do
I
Submit
the
Comments?

You
may
submit
comments
through
the
mail,
in
person,
or
electronically.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
control
number
OPPT­
2002­
0005
and
administrative
record
number
AR­
238
on
the
subject
line
on
the
first
page
of
your
response.
1.
By
mail.
Submit
your
comments
to:
Document
Control
Office
(
7407M),
Office
of
Pollution
Prevention
and
Toxics
(
OPPT),
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
2.
In
person
or
by
courier.
Deliver
your
comments
to:
OPPT
Document
Control
Office
(
DCO)
in
EPA
East
Building
Rm.
6428,
1201
Constitution
Ave.,
NW.,
Washington,
DC.
The
DCO
is
open
from
8
a.
m.
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
DCO
is
(
202)
564­
8930.
3.
Electronically.
Submit
your
comments
and/
or
data
electronically
by
e­
mail
to:
oppt.
ncic@
epa.
gov,
or
mail
your
computer
disk
to
the
address
identified
in
Units
III.
A.
1.
and
2.
Do
not
submit
any
information
electronically
that
you
consider
to
be
CBI.
Electronic
comments
must
be
submitted
as
an
ASCII
file
avoiding
the
use
of
special
characters
and
any
form
of
encryption.

Comments
and
data
will
also
be
accepted
on
standard
disks
in
WordPerfect
6.1/
8.0
or
ASCII
file
format.
All
comments
in
electronic
form
must
be
identified
by
docket
control
number
OPPT­
2002­
0005
and
administrative
record
number
AR­
238.
Electronic
comments
may
also
be
filed
online
at
many
Federal
Depository
Libraries.

B.
How
Should
I
Handle
CBI
that
I
Want
to
Submit
to
the
Agency?

Do
not
submit
any
information
electronically
that
you
consider
to
be
CBI.
You
may
claim
information
that
you
submit
to
EPA
in
response
to
this
document
as
CBI
by
marking
any
part
or
all
of
that
information
as
CBI.
Information
so
marked
will
not
be
disclosed
except
in
accordance
with
procedures
set
forth
in
40
CFR
part
2.
In
addition
to
one
complete
version
of
the
comment
that
includes
any
information
claimed
as
CBI,
a
copy
of
the
comment
that
does
not
contain
the
information
claimed
as
CBI
must
be
submitted
for
inclusion
in
the
public
version
of
the
official
record.
Information
not
marked
confidential
will
be
included
in
the
public
version
of
the
official
record
without
prior
notice.
If
you
have
any
questions
about
CBI
or
the
procedures
for
claiming
CBI,
please
consult
the
technical
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

C.
What
Should
I
Consider
when
I
Prepare
My
Comments
for
EPA?
You
may
find
the
following
suggestions
helpful
for
preparing
your
comments:
1.
Explain
your
views
as
clearly
as
possible.
2.
Describe
any
assumptions
that
you
used.
3.
Provide
copies
of
any
technical
information
and/
or
data
you
used
that
support
your
views.
4.
If
you
estimate
potential
burden
or
costs,
explain
how
you
arrived
at
the
estimate
that
you
provide.
5.
Provide
specific
examples
to
illustrate
your
concerns.
6.
Offer
alternative
ways
to
improve
the
collection
activity.
7.
Make
sure
to
submit
your
comments
by
the
deadline
in
this
notice.
8.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
the
docket
control
number
and
administrative
record
number
assigned
to
this
actionin
the
subject
line
on
the
first
page
of
your
response.
You
may
also
provide
the
name,
date,
and
Federal
Register
citation.

D.
What
Information
is
EPA
Particularly
Interested
in?

Pursuant
to
section
3506(
c)(
2)(
A)
of
the
PRA,
EPA
specifically
solicits
comments
and
information
to
enable
it
to:
1.
Evaluate
whether
the
proposed
collections
of
information
are
necessary
for
the
proper
performance
of
the
functions
of
the
Agency,
including
whether
the
information
will
have
practical
utility.
2.
Evaluate
the
accuracy
of
the
Agency's
estimates
of
the
burdens
of
the
proposed
collections
of
information.
3.
Enhance
the
quality,
utility,
and
clarity
of
the
information
to
be
collected.
4.
Minimize
the
burden
of
the
collections
of
information
on
those
who
are
to
respond,
including
through
the
use
of
appropriate
automated
or
electronic
collection
technologies
or
other
forms
of
information
technology,
e.
g.,
permitting
electronic
submission
of
responses.

IV.
What
Information
Collection
Activity
or
ICR
Does
this
Action
Apply
to?

EPA
is
seeking
comments
on
the
following
ICR:
Title:
Data
Submissions
for
the
Voluntary
Children's
Chemical
Evaluation
Program.
ICR
numbers:
EPA
ICR
No.
2055.01,
OMB
No.
2070­
tbd.
ICR
status:
This
ICR
is
a
new
proposed
information
collection
that
has
not
been
approved
by
OMB.
An
Agency
may
not
conduct
or
sponsor,
and
a
person
is
not
required
to
respond
to
a
collection
of
information
that
is
subject
to
approval
under
PRA,
unless
it
displays
a
currently
valid
OMB
control
number.
The
OMB
control
numbers
for
EPA's
information
collections
appear
on
the
collection
instruments
or
instructions,
in
the
Federal
Register
notices
for
related
rulemakings
and
ICR
notices,
and,
if
the
collection
is
contained
in
a
regulation,
in
a
table
of
OMB
approval
numbers
in
40
CFR
part
9.
Abstract:
VCCEP
is
a
voluntary
program
intended
to
provide
data
to
enable
the
public
to
understand
the
potential
health
risks
to
children
associated
with
certain
chemical
exposures.
EPA
has
asked
companies
which
manufacture
and/
or
import
23
chemicals
which
have
been
found
in
human
tissues
and
the
environment
to
volunteer
to
sponsor
their
evaluation
in
VCCEP.
VCCEP
consists
of
three
tiers
which
a
sponsor
may
commit
to
separately.
Thus
far,
EPA
has
received
Tier
1
commitments
for
20
chemicals.
As
part
of
their
sponsorship,
companies
would
submit
commitment
letters,
collect
and/
or
develop
health
effects
and
exposure
information
on
their
chemical(
s),
integrate
that
information
in
a
risk
assessment,
and
develop
a
  
Data
Needs
Assessment.''
The
Data
Needs
Assessment
would
discuss
the
need
for
additional
data,
which
could
be
provided
by
the
next
tier,
to
fully
characterize
the
risks
the
chemical
may
pose
to
children.
The
information
submitted
by
the
sponsor
will
be
evaluated
by
a
group
of
scientific
experts
with
extensive,
relevant
experience
in
toxicity
testing
and
exposure
evaluations,
a
Peer
Consultation
Group.
This
group
will
forward
its
opinions
to
EPA
and
the
sponsor(
s)
concerning
the
adequacy
of
the
assessments
and
the
need
for
development
of
any
additional
information
to
fully
assess
risks
to
children.
EPA
will
consider
the
opinions
of
the
Peer
Consultation
Group
and
announce
whether
additional
higher
tier
information
is
needed.
Sponsors
and
the
public
will
have
an
opportunity
to
comment
on
EPA's
decision
concerning
data
needs.
EPA
will
consider
these
comments
and
issue
a
final
decision.
If
the
final
decision
is
that
additional
information
is
needed,
sponsors
will
be
asked
to
volunteer
to
provide
the
next
tier
of
information.
If
additional
information
is
not
needed,
the
risk
communication
and,
if
necessary,
risk
management
phases
of
the
program
will
be
initiated.

V.
What
are
EPA's
Burden
and
Cost
Estimates
for
this
ICR?

Under
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
it
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.
The
ICR
provides
a
detailed
explanation
of
this
estimate,
which
is
only
briefly
summarized
in
this
notice.
The
annual
public
burden
for
this
collection
of
information
is
estimated
to
average
519.6
hours
per
response.
Thefollowing
is
a
summary
of
the
estimates
taken
from
the
ICR:
Respondents/
affected
entities:
34.
Estimated
total
number
of
potential
respondents:
23.
Frequency
of
response:
On
occasion.
Estimated
total/
average
number
of
responses
for
each
respondent:
39
over
a
3
year
period.
Estimated
total
annual
burden
hours:
154,332.
Estimated
total
annual
burden
costs:
$
12,515,227.

VI.
Are
There
Changes
in
the
Estimates
from
the
Last
Approval?

No.
This
is
a
new
proposed
ICR.

VII.
What
is
the
Next
Step
in
the
Process
for
this
ICR?

EPA
will
consider
the
comments
received
and
amend
the
ICR
as
appropriate.
The
final
ICR
package
will
then
be
submitted
to
OMB
for
review
and
approval
pursuant
to
5
CFR
1320.12.
EPA
will
issue
another
Federal
Register
notice
pursuant
to
5
CFR
1320.5(
a)(
1)(
iv)
to
announce
the
submission
of
the
ICR
to
OMB
and
the
opportunity
to
submit
additional
comments
to
OMB.
If
you
have
any
questions
about
this
ICR
or
the
approval
process,
please
contact
the
technical
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

List
of
Subjects
Environmental
protection,
Reporting
and
recordkeeping
requirements.

Dated:
April
8,
2002.
Stephen
L.
Johnson,
Assistant
Administrator
for
Prevention,
Pesticides
and
Toxic
Substances.

[
FR
Doc.
02­
9221
Filed
4­
15­
02;
8:
45
am]
BILLING
CODE
6560­
50­
S
Chemical
Evaluation
Program;
Request
for
Comment
on
Information
Collection
Activities;
Extension
of
Comment
Period
[
Federal
Register:
May
15,
2002
(
Volume
67,
Number
94)]
[
Notices]
[
Page
34703­
34704]
From
the
Federal
Register
Online
via
GPO
Access
[
wais.
access.
gpo.
gov]
[
DOCID:
fr15my02­
69]

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­

ENVIRONMENTAL
PROTECTION
AGENCY
[
OPPT­
2002­
0005;
FRL­
7179­
5]

Data
Submissions
for
the
Voluntary
Children's
Chemical
Evaluation
Program;
Request
for
Comment
on
Information
Collection
Activities;
Extension
of
Comment
Period
AGENCY:
Environmental
Protection
Agency
(
EPA).
ACTION:
Notice;
extension
of
comment
period.

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
­­­­

SUMMARY:
EPA
announced
in
the
Federal
Register
a
proposed
information
collection
activity
and
a
request
for
public
comment
for
an
Information
Collection
Request
(
ICR)
entitled:
Data
Submissions
for
the
Voluntary
Children's
Chemical
Evaluation
Program
(
VCCEP)
(
EPA
ICR
No.
2055.01,
OMB
No.
2070­
tbd)
on
April
16,
2002
(
67
FR
18609)
(
FRL­
6832­
8).
In
that
Federal
Register
document,
the
Agency
inadvertently
provided
the
public
with
only
30
days
to
comment
on
the
proposed
information
collection.
Under
the
Paperwork
Reduction
Act
(
PRA)
(
44
U.
S.
C.
3501
et
seq.),
Federal
agencies
are
required
to
provide
the
public
with
60
days
to
comment
when
announcing
a
proposed
information
collection
activity.
This
Federal
Register
document
announces
an
30­
day
extension
of
the
previously
announced
public
comment
period.

DATES:
Written
comments,
identified
by
docket
ID
number
OPPT­
2002­
0005
and
administrative
record
number
AR­
238,
must
be
received
on
or
before
June
17,
2002.

ADDRESSES:
Comments
may
be
submitted
by
mail,
electronically,
or
in
person.
Please
follow
the
detailed
instructions
for
each
method
as
provided
in
Unit
III.
of
the
SUPPLEMENTARY
INFORMATION.
To
ensure
proper
receipt
by
EPA,
it
is
imperative
that
you
identify
docket
ID
number
OPPT­
2002­
0005
and
administrative
record
number
AR­
238
in
the
subject
line
on
the
first
page
of
your
response.

FOR
FURTHER
INFORMATION
CONTACT:
For
general
information
contact:
Barbara
Cunningham,
Acting
Director,
Environmental
Assistance
Division
(
7408M),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(
202)
554­
1404;
e­
mail
address:
TSCA­
Hotline@
epa.
gov.

For
technical
information
contact:
Catherine
Roman,
Chemical
Control
Division
(
7405M),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460;
telephone
number:
(
202)
564­
8172;
fax
number:
(
202)
564­
4755;
e­
mail
address:
roman.
catherine@
epa.
gov.

SUPPLEMENTARY
INFORMATION:

I.
Does
this
Action
Apply
to
Me?

You
may
be
potentially
affected
by
this
action
if
you
are
a
manufacturer
or
importer
of
certain
chemicals
and
have
volunteered
to
sponsor
your
chemical
in
the
VCCEP.
Potentially
affected
categories
and
entities
may
include,
but
are
not
limited
to:

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Type
of
business
NAICS
codes
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Industrial
organic
chemicals
325
Adhesives
and
sealants
32552
Paints
and
allied
products
32551
Textile
goods
313
Petroleum
products
42272
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­

This
table
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
action.
Other
types
of
entities
not
listed
in
this
table
could
also
be
affected.
The
North
American
Industrial
Classification
System
(
NAICS)
codes
are
provided
to
assist
you
and
others
in
determining
whether
or
not
this
action
might
apply
to
certain
entities.
If
you
have
any
questions
regarding
the
applicability
of
this
action
to
a
particular
entity,
consult
the
technical
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

II.
How
Can
I
Get
Additional
Information,
Including
Copies
of
this
Document
and
Other
Related
Documents?

A.
Electronically
You
may
obtain
electronic
copies
of
this
document,
and
certain
other
related
documents
that
might
be
available
electronically,
from
the
EPA
Internet
Home
Page
at
http://
www.
epa.
gov/.
On
the
Home
Page
select
"
Laws
and
Regulations,"
"
Regulations
and
Proposed
Rules,"
and
then
look
up
the
entry
for
this
document
under
the
"
Federal
Register­­
Environmental
Documents."
You
can
also
go
directly
to
the
Federal
Register
listings
at
http://
www.
epa.
gov/
fedrgstr/.
B.
Fax­
on­
Demand
Using
a
faxphone
call
(
202)
564­
3119
and
select
items
4089
and
4090
for
a
copy
of
the
ICR.

C.
In
Person
The
Agency
has
established
an
official
record
for
this
action
under
docket
ID
number
OPPT­
2002­
0005
and
administrative
record
number
AR­
238.
The
official
record
consists
of
the
documents
specifically
referenced
in
this
action,
any
public
comments
received
during
an
applicable
comment
period,
and
other
information
related
to
this
action,
including
any
information
claimed
as
Confidential
Business
Information
(
CBI).
This
official
record
includes
the
documents
that
are
physically
located
in
the
docket,
as
well
as
the
documents
that
are
referenced
in
those
documents.
The
public
version
of
the
official
record
does
not
include
any
information
claimed
as
CBI.
The
public
version
of
the
official
record,
which
includes
printed,
paper
versions
of
any
electronic
comments
submitted
during
an
applicable
comment
period,
is
available
for
inspection
in
the
TSCA
Nonconfidential
Information
Center,
North
East
Mall
Rm.
B­
607,
Waterside
Mall,
401
M
St.,
SW.,
Washington,
DC.
The
Center
is
open
from
noon
to
4
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Center
is
(
202)
260­
7099.

III.
What
Action
is
EPA
taking?

EPA
is
extending
the
comment
period
for
the
following
proposed
ICR:
Data
Submissions
for
the
Voluntary
Children's
Chemical
Evaluation
Program
(
VCCEP)
(
EPA
ICR
No.
2055.01,
OMB
No.
2070­
tbd).
EPA
announced
a
30­
day
comment
period
for
this
proposed
ICR
renewal
in
the
Federal
Register
on
April
16,
2002
(
67
FR
18609).
In
that
document,
you
will
find
a
complete
description
of
the
ICR,
as
well
as
detailed
instructions
for
submitting
comments.
This
document
announces
a
30­
day
extension
of
the
comment
period
in
order
to
provide
the
public
with
60
days
to
comment,
pursuant
to
the
PRA.
Comments
must
be
received
on
or
before
June
17,
2002.
As
described
in
Unit
III.
of
the
document
announcing
the
proposed
ICR
that
published
in
the
Federal
Register
of
April
16,
2002
(
67
FR
18609),
you
may
submit
your
comments
through
the
mail,
in
person,
or
electronically.
Please
follow
the
instructions
that
are
provided
in
the
document
published
on
April
16,
2002.
Do
not
submit
any
information
electronically
that
you
consider
to
be
CBI.
To
ensure
proper
receipt
by
EPA,
be
sure
to
identify
docket
ID
number
OPPT­
2002­
0005
and
administrative
record
number
AR­
238
in
the
subject
line
on
the
first
page
of
your
response.

IV.
What
is
the
Next
Step
in
the
Process
for
this
ICR?

EPA
will
consider
the
comments
received
and
amend
the
ICR
as
appropriate.
The
final
ICR
package
will
then
be
submitted
to
OMB
for
review
and
approval
pursuant
to
5
CFR
1320.12.
EPA
will
issue
another
Federal
Register
notice
pursuant
to
5
CFR
1320.5(
a)(
1)(
iv)
to
announce
the
submission
of
the
ICR
to
OMB
and
the
opportunity
to
submit
additional
comments
to
OMB.
If
you
have
any
questions
about
this
ICR
or
the
approval
process,
please
contact
the
technical
person
listed
under
FOR
FURTHER
INFORMATION
CONTACT.

List
of
Subjects
Environmental
protection,
Reporting
and
recordkeeping
requirements.

Dated:
May
10,
2002.
Stephen
L.
Johnson,
Assistant
Administrator
for
Prevention,
Pesticides
and
Toxic
Substances.

[
FR
Doc.
02­
12266
Filed
5­
13­
02;
1:
43
pm]
BILLING
CODE
6560­
50­
S
ATTACHMENT
6
Response
to
Comments
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON
D.
C.,
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
October
3,
2002
MEMORANDUM
SUBJECT:
Response
to
Comments
Received
on
the
Information
Collection
Request
for
the
Voluntary
Children's
Chemical
Evaluation
Program
(
2055.01)

FROM:
Ward
Penberthy,
Acting
Director
/
s/
Chemical
Control
Division
(
7405M)

TO:
Angela
Hofmann,
Director
Regulatory
Coordination
Staff
(
7101M)

BACKGROUND
The
Voluntary
Children's
Chemical
Evaluation
Program
(
VCCEP)
is
designed
to
provide
data
to
enable
EPA
and
the
public
to
better
understand
the
potential
health
risks
to
children
associated
with
certain
chemical
exposures.
This
data
collection
program
will
allow
manufacturers
to
voluntarily
collect
and
submit
information
on
health
effects,
exposure,
risk,
and
additional
data
needed
to
evaluate
the
safety
of
chemicals
to
which
children
have
a
high
likelihood
of
exposure.
In
so
doing,
VCCEP
will
fulfill
the
TSCA
goal
of
having
the
manufacturers
of
chemicals
develop
adequate
data
so
that
the
effects
of
their
chemicals
on
health
can
be
understood.

Three
commentors,
the
American
Chemistry
Council
(
ACC),
the
Synthetic
Organic
Chemical
Manufacturers
Association
(
SOCMA),
and
the
Physicians
Committee
for
Responsible
Medicine
(
PCRM)
responded
to
the
Federal
Register
notice
(
67
FR
18609,
April
16,
2002)
announcing
EPA's
intent
to
submit
an
Information
Collection
Request
(
ICR)
for
VCCEP
to
OMB.
The
comments
and
EPA's
response
to
OMB
for
those
comments
are
contained
herein.
Both
comment
and
response
have
been
prepared
in
a
question
and
answer
Plain
Language
format.

COMMENTS/
RESPONSES
1.
Q.
SOCMA
commented
that
EPA
should
make
a
finding
for
significant
exposure
or
risk
as
with
any
other
TSCA
section
4
regulatory
action
before
requesting
that
testing
be
done.

A.
One
characteristic
of
voluntary
testing
programs
and
one
of
the
reasons
EPA
pursues
them
is
that
they
do
not
make
findings.
The
benefits
to
EPA
are
the
time
and
effort
saved
from
not
making
findings
and
also
the
avoidance
of
litigation
from
companies
which
have
agreed
to
participate.
The
benefit
to
industry
of
voluntary
programs
is
that
it
is
allowed
to
negotiate
some
of
the
terms
of
the
agreement
(
deadlines,
types
of
tests)
and
perhaps
influence
the
design
of
the
­
2­

program
(
tiered,
triggered
testing).
Also,
with
most
voluntary
testing
programs
there
is
a
general
acceptance
that
findings
could
be
made
if
necessary.
In
the
case
of
the
VCCEP
chemicals,
a
finding
for
significant
exposure
could
well
be
made
because
all
the
VCCEP
chemicals
have
been
found
in
human
biological
samples
(
blood,
milk,
or
exhaled
breath).
A
finding
for
"
substantial"
exposure
could
also
easily
be
made
given
the
breadth
of
the
U.
S.
population
represented
by
the
biomonitoring
data
used
in
chemical
selection.
Therefore,
EPA
does
not
believe
that
findings
are
necessary
to
further
justify
the
chemicals
selected
for
this
voluntary
program.

2.
Q.
SOCMA
commented
that
EPA
selected
chemicals
for
the
VCCEP
based
on
"
data
indicating
that
exposure
to
humans
had
likely
occurred"
and
that
this
does
not
represent
significant
exposure
and
doesn't
say
anything
about
children's
exposure..

A.
EPA
believes
it
should
have
been
more
positive
in
its
statement
and
has
revised
it
to
read
that
"
chemicals
were
selected
for
the
VCCEP
pilot
if
there
were
data
indicating
that
exposure
to
the
general
population
had
occurred."
EPA
believes
that
the
presence
of
foreign
chemicals
in
the
body,
which
was
demonstrated
by
several
biomonitoring
data
bases,
presupposes
that
exposure
has
occurred.
EPA
also
believes
that
in
the
absence
of
specific
biomonitoring
data
on
children,
that
it
is
reasonable
and
prudent
to
assume
that
children,
as
members
of
the
general
population,
would
have
the
same
opportunities
for
exposure.
Moreover,
as
explained
in
the
Federal
Register
notice
announcing
VCCEP,
children
are
the
focus
of
this
program
because
their
unique
behavior
patterns
are
likely
to
lead
to
even
greater
exposure
than
for
adults.
Also,
pound
for
pound,
children
drink,
eat,
and
breathe
more
than
adults
and
would
have
a
greater
dose
than
adults
when
chemicals
are
in
water,
food,
and
air.

3.
Q.
SOCMA
commented
that
"
prospective
parents"
should
not
be
used
as
a
justification
for
the
amount
of
exposure
information
requested
and
that
only
exposure
information
that
pertains
to
children
should
be
covered
by
the
ICR.

A.
EPA
has
emphasized
in
the
Federal
Register
notice
announcing
VCCEP
(
65
FR
81700,
December
26,
2000)
that
adult
exposures
are
not
intended
to
be
a
major
focus
of
VCCEP,
but
that
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.
Exposure
information
is
being
collected
in
VCCEP
to
put
the
health
effects
data
in
context
so
that
risk
to
children
can
be
determined.
The
risk
of
fertility
and
developmental
effects
on
unborn
and
newborn
children
can
only
be
understood
if
the
exposure
of
the
parents
and
prospective
parents
is
known.

4.
Q.
SOCMA
commented
that
EPA's
conclusion
"
that
all
23
chemicals
will
be
subject
to
Tier
2,
and
that
15
chemicals
will
reach
Tier
3"
defies
the
concept
of
a
tiered,
trigger­
based
approach,
which
uses
a
Peer
Consultation
Process
to
assist
in
decision
making,
and
that
such
a
conclusion
may
introduce
bias
into
the
process.
ACC
expressed
a
similar
concern
by
commenting
that
EPA's
approach
to
estimating
testing
costs
may
reflect
a
pre­
judgment
that
Tier
2
and
Tier
3
testing
will
be
required
if
tests
have
not
previously
been
conducted.
­
3­

A.
The
number
of
chemicals
cited
in
the
ICR
as
going
through
all
three
VCCEP
tiers
is
not
a
"
conclusion"
but
only
a
conservative
assumption
which
was
made
so
that
the
ICR
could
estimate
the
burden
associated
with
the
first
three
years
of
the
VCCEP
program.
The
burden
estimate
was
limited
to
three
years
because
that
is
the
effective
period
of
the
ICR.
The
most
conservative
assumption
would
have
been
that
23
chemicals
would
go
through
all
three
tiers,
but
EPA
believes
that
not
only
would
that
be
unlikely
given
the
tiered,
trigger­
based
program
and
the
fact
that
some
chemicals
have
already
had
some
upper
tier
tests
conducted,
but
also
extremely
unlikely
to
happen
within
a
three
year
period.
SOCMA
and
ACC
should
be
assured
that
the
decision
concerning
the
need
for
additional
data
will
be
strictly
science­
based
and
will
not
be
influenced
by
the
hypothetical
numbers
used
by
economists
to
estimate
burden.
To
further
allay
such
concerns,
EPA
has
added
statements
to
section
6
of
the
ICR
based
on
comments
by
ACC
that
1)
no
presumption
of
testing
needs
should
be
construed
from
the
testing
numbers
used
to
estimate
burden,
and
2)
hazard
testing
should
be
required
only
to
the
extent
reasonably
necessary
to
characterize
potential
health
risks
to
children.

5.
Q.
SOCMA
commented
that
the
addition
of
four
months
to
prepare
and
submit
the
Exposure
and
Risk
Assessments,
and
the
Data
Needs
Assessment
may
not
be
sufficient.

A.
EPA
specified
four
additional
months
for
these
three
assessments
because
it
assumed
that
work
on
the
Exposure
Assessment
would
be
done
concurrently
with
the
Hazard
Assessment,
which,
depending
on
the
testing
undertaken,
would
be
done
during
a
period
of
12
to
60
months.
EPA
assumed
this
work
would
be
done
concurrently
since
Hazard
and
Exposure
Assessments
would
require
different
contractors
with
different
skills.
EPA
would,
therefore,
like
to
retain
the
specified
four
months
as
the
additional
time
to
prepare
these
assessments,
but
if
sponsors
find
that
the
time
is
insufficient,
they
may
request
more
time.

6.
Q.
SOCMA
commented
that
EPA
should
not
exclude
the
cost
of
providing
Tier
1
data
from
the
total
estimated
cost
of
the
program.

A.
As
explained
in
the
ICR,
EPA
decided
to
exclude
the
cost
of
providing
Tier
1
hazard
data
from
the
estimated
cost
of
the
program
because
the
Tier
1
hazard
data
is
the
same
data
that
the
sponsor
developed
for
the
HPV
Challenge
Program,
which
is
accounted
for
in
a
separate
ICR
(
1139).
It
should
be
noted
that
EPA
is
including
the
cost
of
developing
Tier
1
Exposure
Assessments,
Risk
Assessments,
and
Data
Needs
Assessments,
because
these
three
assessments
are
not
required
by
the
HPV
Challenge
Program
and
they
represent
a
separate
effort
specifically
for
VCCEP.

7.
Q.
SOCMA
commented
that
toxicity
testing
protocols
that
are
still
being
developed
for
the
VCCEP
should
be
subject
to
rigorous
peer
review
to
maximize
their
utility.

A.
EPA
is
not
developing
new
toxicity
testing
protocols
for
VCCEP,
but
has
recommended
that
the
sponsors
follow
the
toxicity
test
guidelines
which
the
TSCA
program
has
used
in
its
regulatory
programs
over
the
last
10
to
20
years.
These
test
guidelines
have
all
been
subjected
to
public
review
and
comment.
­
4­

8.
Q.
SOCMA
and
ACC
commented
that
EPA
has
asked
for
too
much
information
on
exposure
and
that
the
requested
information
should
be
limited
to
that
information
which
is
useful
and
necessary
to
a
risk
characterization.

A.
Some
guidance
was
provided
on
this
question
at
the
Exposure
Workshop
held
in
December
2001.
Answering
the
question
"
have
potential
risks
to
children
been
adequately
characterized"
will
determine
the
depth
of
the
assessment
needed.
For
Tier
1
of
VCCEP,
sponsors
should
develop
a
screening
level
assessment
of
readily
available
exposure
information,
including
data
on
exposures
outside
the
chain
of
commerce.
Once
a
screening
level
assessment
of
exposure
is
developed,
the
sponsor
can
then
determine
whether
a
more
thorough
evaluation
of
exposure
is
suggested,
even
at
Tier
1,
based
on
presence
in
human
tissues,
availability
of
higher
tier
toxicological
data,
or
other
information.
EPA
asked
the
sponsors
to
bring
forth
all
readily
available
exposure
information
to
put
the
totality
of
exposures
into
context,
and
then
focus
on
those
exposures
which
are
most
significant
and
relevant
to
children.
EPA
believes
that
it
is
important
to
initially
bring
forth
as
much
exposure
information
as
possible
to
assure
that
all
possible
exposures
have
been
considered.
The
sponsor
should
then
explain
why
some
exposures
are
not
significant
or
sufficiently
relevant
to
children
to
warrant
a
quantitative
estimate
or
evaluation
which
could
be
used
in
a
risk
assessment,
and
then
focus
his
detailed
evaluations
on
those
exposures
which
he
considers
to
be
significant
and
relevant
to
children.

9.
Q.
SOCMA
commented
that
a
sponsor
may
not
have
access
to
some
exposure
information
or
it
may
be
CBI.

A.
In
such
cases
where
a
sponsor
is
aware
of
but
cannot
access
certain
exposure
information,
the
sponsor
should
note
that
he
is
aware
of
additional
data
or
information
and
describe
the
reason
that
the
information
was
not
included
in
the
assessment.
If
some
information
is
CBI,
the
sponsor
should
claim
it
as
such
in
his
submission
as
explained
in
the
Federal
Register
notice
announcing
VCCEP.

10.
Q.
SOCMA
commented
that
the
sponsor
should
be
allowed
the
discretion
to
do
a
qualitative
instead
of
a
quantitative
evaluation
of
exposure
since
this
is
the
approach
most
often
used
by
the
public.

A.
To
meet
the
objective
of
VCCEP
of
characterizing
the
risks
to
children
from
exposure
to
certain
chemicals,
that
risk
must
first
be
assessed
for
each
chemical.
A
risk
assessment
cannot
be
developed
using
only
qualitative
descriptions
of
exposure.
Quantitative
exposure
data
must
be
provided
and
used
in
conjunction
with
health
effects
data
to
develop
a
risk
assessment.
In
communicating
the
risk
assessment
results
to
the
public,
qualitative
descriptions
can
be
used
in
characterizing
risk
to
make
it
more
understandable
to
the
public.
This
is
stated
in
the
Federal
Register
notice
announcing
VCCEP.

11.
Q.
ACC
commented
that
the
formats
presented
by
EPA
at
the
Exposure
workshop
are
overly
prescriptive
and
require
far
more
information
than
is
needed
to
meet
the
objectives
of
the
VCCEP.
Expressing
a
similar
concern,
SOCMA
commented
that
sponsors
should
be
given
the
flexibility
to
determine
which
information
is
necessary
for
characterizing
potential
exposures.
­
5­

A.
A
thorough
description
of
exposure
requires
information
on
a
number
of
parameters
(
frequency,
duration,
levels,
routes,
population
exposed,
etc.)
to
be
meaningful
and
useful
in
a
risk
assessment.
The
Federal
Register
notice
announcing
VCCEP
attempted
to
list
all
such
parameters,
and
the
sponsors
should
attempt
to
provide
as
much
of
that
information
as
possible
or
explain
why
certain
parameters
of
exposure
do
not
apply
to
the
situation
being
described.
The
formats
that
EPA
presented
at
the
Exposure
workshop
represented
EPA's
perspectives
on
how
exposure
information
could
best
be
submitted
by
VCCEP
sponsors.
The
formats
are
not
required
and
ultimately
it
is
up
to
the
submitter
to
determine
how
to
present
his
exposure
assessment.

12.
Q.
ACC
commented
that
a
meaningful
integration
of
hazard
and
exposure
information
at
each
tier
is
a
key
feature
of
the
pilot
and
should
be
relied
on
to
inform
the
need
for
additional
data
from
the
next
tier.

A.
EPA
agrees
with
ACC
and
believes
that
the
structure
and
operational
procedures
which
define
the
pilot
VCCEP
will
assure
that
the
integration
of
health
and
exposure
data
at
each
tier
to
produce
a
risk
assessment
will
be
the
most
meaningful
way
to
identify
what,
if
any,
additional
data
may
still
be
needed
to
fully
characterize
a
chemical's
risk
to
children.

13.
Q.
ACC
commented
that
the
determination
that
a
pilot
chemical
should
proceed
to
the
next
tier
should
not
mean
that
the
chemical
has
been
or
will
be
found
to
present
significant
health
risks.

A.
EPA
agrees
and
intends
to
state
in
any
future
decision,
as
it
has
up
to
this
point,
that
a
pilot
chemical
should
proceed
to
the
next
tier
because
EPA
has
determined
that
the
available
data
are
not
sufficient
to
completely
assess
risk
to
children.

14.
Q.
The
Physicians'
Committee
for
Responsible
Medicine
(
PCRM)
commented
that
studies
in
animals
of
metabolism
and
pharmacokinetics,
developmental
neurotoxicity,
and
genetic
toxicity
cannot
predict
or
contribute
to
an
understanding
of
health
effects
in
humans
or
specifically,
for
the
latter
two,
children.

A.
EPA
uses
whole
animal
tests
for
metabolism/
pharmacokinetics
for
selected
chemicals
because
these
tests
offer
basic
information
on
these
two
endpoints.
In
the
case
of
VCCEP
this
information
can
used
to
infer
information
on
the
metabolism/
pharmacokinetics
of
the
VCCEP
chemicals
in
children.
Developmental
neurotoxicology
tests
are
used
to
determine
the
potential
neurotoxicity
of
selected
chemicals
throughout
development
and
maturation
of
the
fetus
and
new
born
animal.
Experts
in
the
field
have
concluded
that
the
results
are
predictive
of
developmental
neurotoxicolgy
in
children.
The
genetic
toxicology
tests
used
in
the
VCCEP,
i.
e.,
the
Ames
assay,
the
in
vitro
test
for
chromosomal
aberrations
and
either
the
in
vivo
test
for
chromosomal
aberrations
or
the
in
vivo
micronucleus
assay
will
serve
as
potential
triggers,
along
with
all
other
relevant
information,
for
a
cancer
bioassay.
The
relevance
of
this
use
of
genetic
toxicology
testing
to
humans
has
been
widely
accepted
for
many
years.

15.
Q.
PCRM
commented
that
in
vivo
genetic
toxicity
tests
[
chromosomal
aberrations
or
micronucleus]
should
not
be
conducted
because
non­
animal
tests
have
been
accepted
by
­
6­

government
regulators
internationally
for
more
than
20
years
as
screening
tests
for
gene
mutation,
chromosomal
aberrations,
and
sister
chromatid
exchange.

A.
When
testing
for
mutagenicity
as
a
separate
endpoint,
EPA
uses
an
in
vitro
test
for
bacterial
mutation,
an
in
vitro
test
for
gene
mutation
in
mammalian
cells
in
culture,
and
an
in
vitro
test
for
chromosomal
aberrations
in
its
first
tier
testing
for
hazard
identification.
However,
as
stated
above
in
14.
A,
the
mutagenicity
tests
used
in
the
VCCEP
are
not
to
be
used
to
determine
mutagenic
potential
as
a
separate
endpoint
but
rather
as
potential
triggers,
along
with
all
other
relevant
information,
for
a
cancer
bioassay.
The
in
vivo
assays
mentioned
above,
i.
e.
the
in
vivo
chromosomal
aberration
assay
and
the
in
vivo
micronucleus
assay,
are
there
to
lend
support
to
the
results
of
the
in
vitro
testing
(
i.
e.
the
Ames
Assay
and
the
in
vitro
assay
for
chromosomal
aberrations.)

16.
Q.
PCRM
commented
that
EPA
should
expand
its
burden
estimate
of
the
ICR,
beyond
cost
and
hours,
to
include
the
number
of
animals
used
in
tests
for
toxicity.

A.
The
ICR
developed
for
VCCEP
is
responsive
to
the
burden
concerns
identified
by
OMB
which
are
limited
to
those
of
cost
and
hours.
Nevertheless,
the
ICR
does
cite
the
test
guideline
to
be
used
for
each
toxicity
test
in
VCCEP
and
each
test
guideline
indicates
the
number
of
animals
necessary
to
show
a
statistically
valid,
dose­
response
relationship.
What
is
not
known,
at
this
time,
is
which
tests
at
any
of
the
three
tiers
that
the
pilot
VCCEP
chemicals
will
undergo.
EPA
believes
that
most
of
the
pilot
chemicals
have
many
of
the
tests
completed
and
that
the
pilot
VCCEP
will
focus
more
on
data
evaluation
than
data
development.
Given
so
many
uncertainties,
EPA
cannot
provide
a
meaningful
estimate
of
the
number
of
animals
that
may
ultimately
be
used
in
future
toxicity
tests
for
VCCEP.

17.
Q.
PCRM
commented
that
EPA
should
develop
specific
provisions
to
dramatically
reduce
the
number
of
animals
used
in
VCCEP,
as
it
has
done
for
the
other
burdens
of
cost
and
hours.

A.
The
features
of
VCCEP
which
should
reduce
the
burden
of
cost
and
hours,
namely
tiered
and
triggered
testing,
will
do
so
by
an
overall
reduction
in
the
amount
of
testing
and
consequently
a
reduction
in
the
number
of
animals
used
in
VCCEP.
The
selection
of
chemicals
for
the
pilot
VCCEP
which
are
data
rich
will
also
contribute
to
a
low
amount
of
new
testing.
Also,
as
stated
the
Federal
Register
notice
announcing
VCCEP,
EPA
is
committed
to
reducing,
refining,
and
replacing
animal
testing
when
valid
alternatives
exist,
and
EPA
works
with
the
Interagency
Coordinating
Committee
for
the
Validation
of
Alternative
Methods
and
with
OECD
to
ensure
the
scientific
acceptability
of
alternative
test
methods.
Beyond
this,
EPA
cannot
arbitrarily
reduce
the
number
of
animals
to
be
used
in
a
specific
test
since
it
already
is
the
least
number
of
animals
which
will
show
a
statistically
valid,
dose­
response
relationship.

18.
Q.
ACC
and
SOCMA
contend
that
laboratory
testing
costs
are
underestimated.
ACC
believes
that
EPA's
test
cost
estimates
are
too
low,
possibly
even
half
or
a
quarter
of
the
actual
cost
for
some
tests.
ACC
also
mentions
that
HPV
Challenge
Program
testing
and
animal
rights
issues
will
strain
lab
capacities
and
cause
a
sharp
rise
in
costs,
on
the
order
of
5%­
10%
annually.
­
7­

A.
Laboratory
cost
estimates
used
by
OPPT
are
developed
by
lab
personnel
who
carefully
break
down
the
tasks
required
for
each
protocol,
and
then
generate
estimates
of
time
and
cost
for
task.
In
response
to
the
claim
that
EPA
underestimated
laboratory
testing
costs,
EPA
contacted
a
small
number
of
laboratories
to
review
the
prices
charged
for
testing.
EPA
found
that
all
of
EPA's
estimates
were
within
the
range
of
prices
obtained.
While
EPA's
contacts
were
far
from
exhaustive,
the
responses
indicated
that
for
every
test
in
the
VCCEP
battery
except
one,
at
least
one
laboratory
contacted
charges
less
than
the
EPA
estimate.
For
some
tests,
EPA
estimates
were
notably
higher.
Given
this,
EPA
will
not
alter
the
test
costs
used
in
the
VCCEP
ICR.

As
for
the
claim
that
test
costs
will
rise
by
as
much
as
30%
over
the
next
three
years,
EPA's
estimates
are
in
year
2000
dollars,
and
having
investigated
lab
capacity
recently,
EPA
finds
no
basis
for
the
assertion
that
lab
costs
will
increase
substantially
over
the
general
rate
of
inflation
in
the
near
future.

19.
Q.
ACC
claims
that
EPA's
estimates
of
industry
wages
rates
are
too
low.
ACC
points
out
that
EPA
used
a
wage
rate
based
on
all
goods­
producing
industries
in
the
VCCEP
ICR,
and
claims
that
the
chemical
industry
pays
26­
33%
more
than
manufacturers
as
a
whole.
ACC
also
claims
that
EPA
used
a
17%
benefits
rate,
when
ACC
data
indicates
that
figure
to
be
26%.
In
addition,
ACC
claims
that
clerical
support,
assumed
to
be
10%
of
the
burden
in
the
ICR,
is
unrealistically
high.

A.
ACC
failed
to
provide
a
source
for
the
claim
that
wage
rates
in
the
chemical
sector
are
higher
than
those
for
manufacturers
as
a
whole,
but,
EPA
did
find
evidence
from
the
Bureau
of
Labor
Statistics
(
BLS)
that
the
average
hourly
earnings
for
all
non­
supervisory
workers
in
the
chemical
sector
is
indeed
17%
higher
for
all
workers
($
18.87
vs.
$
16.17
in
2002,
BLS
table
B3)
than
those
in
all
goods
producing
industries.
However,
EPA
does
not
rely
on
the
average
hourly
rates
to
calculate
wage
rates.
The
wage
rates
used
by
EPA
include
supervisory
employees,
specifically
professional
workers
(
attorneys,
engineers,
accountants)
and
thus,
represent
a
highly
skilled
professional
mix
and
a
relatively
high
wage
rate.
EPA
used
40­
45%
as
the
benefits
rate
in
wage
calculations,
significantly
higher
than
the
26%
ACC
suggests.
ACC
believed
that
EPA's
benefits
rate
was
17%,
however,
this
is
actually
an
overhead
rate
that
EPA
includes
in
its
wage
estimate
along
with
a
benefits
rate.
Finally,
ACC
indicates
that
there
is
a
low
level
of
secretarial
support
in
industry.
While
EPA
accepts
that
this
level
of
support
has
changed
throughout
the
years,
it
does
not
accept
the
claim
that
highly­
paid
managerial
and
technical
labor
will
perform
the
basic
office
tasks
such
as
typing,
copying,
filing,
and
mailing
resulting
from
the
collection.

Recent
analysis
by
EPA's
TRI
program
has
indicated
that
the
estimates
used
by
EPA
are
significantly
higher
than
the
90th
percentile
BLS
wages
for
managerial
and
technical
labor,
indicating
that
in
creating
the
wage
rates,
EPA
used
an
extremely
skilled
mix
of
professions,
far
in
excess
of
what
is
currently
found
in
industry,
according
to
the
BLS.
The
same
analysis
suggests
revising
those
labor
rate
estimates
downward
48%
for
managerial
labor,
43%
for
technical
labor,
and
23%
for
clerical
labor.

Given
these
factors,
and
in
the
absence
of
any
suggestions
by
ACC
as
to
appropriate
wage
rates,
EPA
contends
that
the
wage
rates
included
in
the
VCCEP
ICR
are,
if
anything,
too
high.
­
8­

20.
Q.
ACC
claims
that
EPA's
estimates
of
the
costs
associated
with
preparing
exposure
assessments
are
too
low.
While
providing
no
estimates
of
what
burdens
might
be
expected,
ACC
claims
that
EPA
estimates
of
burden
for
conducting
exposure
assessments
do
not
adequately
account
for
the
complexity
of
the
task.

A.
As
explained
in
the
ICR,
EPA
solicited
information
from
exposure
assessors
within
the
Agency
and
in
private
practice
to
determine
the
burden
associated
with
the
tasks
required.
While
the
responses
varied
greatly,
the
average
response
was
2600­
2700
total
hours
for
all
three
tiers.
EPA
stands
by
this
estimate.

21.
Q.
ACC
notes
that
additional
costs
associated
with
the
program
are
omitted.
ACC
points
out
that
ACC
co­
sponsored
a
workshop
in
preparation
for
VCCEP,
will
be
involved
in
peer
review,
and
will
need
extra
time
to
understand
the
process
of
this
pilot
program.
None
of
these
costs
are
included
in
the
ICR.

A.
With
any
EPA
program,
organizations
may
undertake
activities
in
response
to
the
EPA
programs
that
do
not
necessarily
constitute
burden
of
the
collection.
The
ICR
process
only
requires
accounting
of
burden
associated
with
those
tasks
that
are
completed
by
respondents
and
are
part
of
the
VCCEP,
as
outlined
in
the
Federal
Register.
EPA
has
considered
costs
of
peer
consultation
in
its
estimates,
and
ACC
has
shown
no
evidence
to
suggest
that
EPA's
estimates
are
inadequate
other
than
EPA's
exclusion
of
costs
for
travel.
EPA
has
developed
an
estimate
of
these
costs
to
cover
travel
by
sponsoring
companies
or
their
consultants
to
such
meetings
(
see
response
to
comment
#
25).

22.
Q.
SOCMA
notes
that
EPA
assumed
that
only
a
portion
of
the
23
chemicals
in
the
program
will
go
on
to
Tier
2
and
3
evaluation.
SOCMA
contends
EPA
should
estimate
that
all
chemicals
complete
all
tiers..

A.
EPA
disagrees
with
SOCMA's
contention
that
all
of
the
chemicals
should
be
assumed
to
complete
all
tiers
in
the
VCCEP.
As
SOCMA
accurately
notes
earlier
in
their
comments
(
see
comment
#
4
and
the
EPA
response
above),
the
tiered
approach
requires
that
upper
tiers
be
triggered
by
results
of
the
lower
tiers,
an
approach
that
"
maximizes
utility
and
minimizes
waste."
While
specifying
the
number
of
chemicals
that
will
enter
the
upper
tiers
is
arbitrary,
the
expectation
that
all
chemicals
will
enter
all
tiers,
particularly
in
the
three­
year
period
of
the
ICR,
is
unsupportable.

23.
Q.
SOCMA
notes
that
EPA
did
not
include
fees
paid
to
consultants
by
industry
in
burden
calculations.

A.
EPA
has
calculated
wage
costs
associated
with
the
various
activities
in
the
collection
and
has
assumed
that
these
activities
will
be
conducted
within
the
respondent
organization,
rather
than
by
consultants.
EPA
has
not
included
separate
costs
for
consultants
because
it
believes
that
industry
will
hire
outside
consultants
if
the
costs
are
equal
to
or
less
than
the
costs
of
paying
its
­
9­

own
employees
to
perform
the
same
activity.
Therefore,
EPA's
estimates
of
cost
are
believed
to
be
adequate
whether
work
is
conducted
in­
house
or
by
a
consultant.

Additionally,
under
OMB
guidance
for
developing
ICR
estimates,
Agencies
must
consider
the
time
burden
of
activities
requiring
the
effort
of
employees,
partners,
and
associates
of
the
respondent.
However,
the
Agency
must
only
consider
the
financial
burden
of
activities
conducted
by
outside
consultants.
Therefore,
there
is
no
need
to
include
a
burden
hour
estimate
for
consultant
activities.
If
EPA
did
assume
that
activities
were
performed
by
consultants
rather
than
in­
house,
it
would
need
to
reduce
the
current
estimate
of
burden
hours
accordingly.

24.
Q.
SOCMA
suggests
that
EPA's
method
for
estimating
non­
reporting
costs
should
be
simplified.
SOCMA
estimates
that
the
administrative
cost
for
testing
programs
is
15­
20%.

A.
EPA's
method
for
estimating
administrative
non­
reporting
costs
is
straightforward
and
accurately
reflects
the
distinction
between
reporting
costs
and
non­
reporting
costs,
as
required
by
the
ICR
process.
EPA's
estimate
of
25%
for
administrative
costs
for
testing
programs
is
higher
than
the
15­
20%
suggested
by
SOCMA.

25.
Q.
SOCMA
notes
that
travel
costs
to
public
meetings
are
not
included.

A.
Travel
costs
to
and
from
public
meetings
are
a
valid
cost
of
the
VCCEP.
EPA
will
include
$
1,000
per
person
to
cover
potential
costs
of
travel
to
public
meetings.
