Document ID: EPA-HQ-OPPT-2003-0040-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-07-25T04:00Z

August
29,
2000
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:
TSCA
Existing
Chemical
Test
Rules,
Consent
Orders,
Test
Rule
Exemptions,
and
Voluntary
Test
Data
Submissions
ICR
Nos.:
EPA
ICR
#
1139.06;
OMB
Control
#
2070­
0033
1(
b)
Short
Characterization
This
data
collection
program
is
designed
to
provide
the
Environmental
Protection
Agency
(
EPA)
with
necessary
test
data
on
health
effects,
ecological
effects
and
environmental
fate
to
predict
the
probable
impacts
on
human
health
or
the
environment
of
chemicals
that
may
present
an
unreasonable
risk
to
which
there
is
substantial
exposure
or
release.
Section
4
of
the
Toxic
Substances
Control
Act
(
TSCA)
provides
the
authority
for
collecting
this
test
data,
and
is
intended
to
assure
that
chemicals
that
may
pose
serious
risks
to
human
health
or
the
environment
undergo
testing
by
manufacturers
or
processors,
and
that
the
results
of
such
testing
are
made
available
to
EPA.
EPA
uses
the
information
collected
to
assess
risks
associated
with
the
manufacture,
processing,
distribution,
use
or
disposal
of
a
chemical,
and
to
support
any
necessary
regulatory
action
with
respect
to
that
chemical.

The
Chemical
Testing
Program
in
EPA's
Office
of
Pollution
Prevention
and
Toxics
(
OPPT)
also
works
with
members
of
the
U.
S.
chemical
industry
and
other
interested
parties
to
develop
needed
data
via
TSCA
Section
4
Enforceable
Consent
Agreements
(
ECAs)
and
Voluntary
Testing
Agreements
(
VTAs).
ECAs
and
VTAs
are
usually
less
resource
intensive
than
formal
TSCA
rulemaking
and
allows
EPA
to
consider
agreed­
upon
pollution
prevention
and
other
types
of
product
stewardship
initiatives
by
the
chemical
industry
as
a
possible
substitute
for
or
adjunct
to
certain
types
of
needed
testing.

The
Chemical
Testing
Program
requires
the
development
of
test
data
which
provides
critical
information
on
health
effects,
ecological
effects
and
environmental
fate
that
enables
EPA
and
others
to
properly
assess
and
manage
health
and
environmental
risks
that
may
be
posed
by
existing
and
new
chemicals
covered
by
TSCA.
The
"
universe"
of
existing
chemicals
on
the
TSCA
Chemical
Substances
Inventory
that
may
present
the
greatest
potential
health
and/
or
environmental
concerns
have
been
and
continue
to
be
identified
and
refined
through
various
existing
chemical
screening
activities
within
OPPT.
EPA
also
makes
the
testing
data
publically
available
to
help
the
public
understand
the
risks
posed
by
exposure
to
chemicals
and
to
facilitate
the
public's
involvement
in
environmental
decision­
making.
(
For
more
information
about
the
Chemical
Testing
Program
go
to:
http://
www.
epa.
gov/
opptintr/
chemtest/
index.
htm.)

In
addition
to
developing
actions
under
TSCA
§
4
that
meet
specific
needs
identified
by
OPPT,
EPA
may
also
develop
such
actions
to
meet
the
information
needs
of
RECEIVED
OPPT
NCIC
2003
July
25
11:
04AM
OPPT­
2003­
0040­
0002
August
29,
2000
2
other
offices
within
EPA
and
other
agencies.
For
example
test
data
in
the
past
have
been
developed
for
EPA's
Office
of
Solid
Waste
and
Emergency
Response
(
OSWER),
Office
of
Air
and
Radiation
(
OAR),
and
Office
of
Water
(
OW)
At
the
present
time,
EPA
anticipates
that
data
gathered
by
activities
conducted
during
this
ICR
renewal
period
will
be
used,
in
addition
to
those
above,
by
other
agencies,
including
the
Occupational
Safety
and
Health
Administration,
the
National
Institute
of
Health
and
Safety,
and
the
Organization
for
Economic
Cooperation
and
Development
(
OECD).

The
Agency
may
obtain
the
needed
test
data
(
1)
by
issuing
a
test
rule
through
notice
and
comment
rulemaking,
(
2)
through
negotiation
with
industry
and
issuing
an
Enforceable
Consent
Agreement
(
ECA),
or
(
3)
through
commitments
from
industry
as
Voluntary
Testing
Agreements
(
VTAs).

The
testing
specified
in
a
rule
or
consent
order
issued
under
TSCA
section
4,
or
any
testing
identified
in
the
voluntary
Challenge
Programs,
only
needs
to
be
conducted
once
for
each
specified
chemical.
As
such,
only
one
of
the
entities
that
manufacture,
import,
or
process
the
specified
chemical,
or
a
consortia
formed
by
these
entities,
will
conduct
the
specified
testing
and
report
the
results
of
that
testing
to
EPA.
An
entity
subject
to
a
test
rule
may
also
apply
for
an
exemption
from
the
testing
requirement
if
that
testing
will
be
or
has
been
performed
by
another
party.

Responses
to
the
collection
of
information
specified
in
a
rule
issued
under
TSCA
section
4
are
mandatory
(
see
40
CFR
part
790),
while
response
to
a
consent
order
issued
under
TSCA
section
4
is
only
mandatory
for
the
participants
in
the
ECA.
Participating
in
a
VTA
is
voluntary.
The
export
notification
provisions
apply
to
any
exporter
of
a
chemical
subject
to
a
rule
or
consent
order
issued
under
TSCA
section
4,
regardless
of
their
participation
in
the
ECA
or
any
related
testing
consortia.

Respondents
may
claim
all
or
part
of
a
document
confidential.
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.

EPA
maintains
an
official
record
for
all
activities
conducted
under
TSCA
section
4
(
rulemakings,
ECAs,
and
VTAs).
The
official
record
consists
of
the
documents
referenced
in
a
specific
activity
(
rulemaking,
ECA,
VTA)
,
any
public
comments
received
during
an
applicable
comment
period,
any
test
data
developed
(
including
letters
of
intent
to
conduct
testing,
exemption
letters,
study
plans,
progress
reports
and
the
final
study
report),
and
other
information
related
to
the
activity,
including
information
claimed
as
CBI.
The
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,
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,
Rm.
NE
B­
67,
401
M
St.,
SW.,
Washington,
D.
C.
The
Center
is
open
from
noon
­
4:
00
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
August
29,
2000
3
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,
TSCA
section
4(
a)
mandates
that
EPA
require
manufacturers
and
processors
of
chemical
substances
and
mixtures
to
conduct
testing
if
it
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
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
[.]"

If
EPA
makes
these
findings
for
a
chemical
substance
or
mixture,
the
Agency
must
require
that
testing
be
conducted
on
that
chemical
substance
or
mixture.
The
purpose
of
the
testing
would
be
to
develop
data
about
the
substance
or
mixture's
health
and
environmental
effects
where
there
is
an
insufficiency
of
data
and
experience,
in
order
to
support
a
determination
that
the
manufacture,
distribution
in
commerce,
processing,
use
or
disposal
of
the
substance
or
mixture,
or
any
combination
of
such
activities,
does
or
does
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment.

Once
the
Agency
has
made
a
finding
under
TSCA
section
4(
a)(
1),
EPA
may
require
any
type
of
health
or
environmental
effects
testing
necessary
to
address
August
29,
2000
4
unanswered
questions
about
the
effects
of
the
chemical
substance.
EPA
need
not
limit
the
scope
of
testing
required
to
the
factual
basis
for
the
section
4(
a)(
1)(
A)(
i)
or
(
B)(
i)
findings,
as
long
as
EPA
finds
that
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
that
testing
is
necessary
to
develop
the
data.
This
approach
is
explained
in
more
detail
in
EPA's
statement
of
policy
for
making
findings
under
TSCA
section
4(
a)(
1)(
B)
(
frequently
described
as
the
"
B"
policy)
in
the
Federal
Register
of
May
14,
1993
(
58
FR
28736,
28738­
39;
FRL­
4059­
9).

The
statute
also
specifies
that
EPA
should
give
priority
consideration
to
chemicals
that
an
Interagency
Testing
Committee
(
ITC)
places
on
its
TSCA
§
4(
e)
"
Priority
Testing
List."
The
ITC
is
an
independent
advisory
committee
to
the
EPA
Administrator
that
includes
15
U.
S.
Government
organizations.
The
ITC
was
created
under
TSCA
§
4(
e)
to:
1)
review
chemicals
regulated
by
TSCA,
2)
determine
which
chemicals
need
ecological
effects,
environmental
fate
or
health
effects
test
data
and
3)
add
those
chemicals
with
test
data
needs
to
the
Priority
Testing
List
and
recommend
them
for
testing
or
information
reporting
in
May
and
November
Reports
to
the
EPA
Administrator.
(
For
more
information
about
the
ITC
go
to:
http://
www.
epa.
gov/
opptintr/
itc/.)

Although
the
Agency
may
not
have
yet
made
the
section
4(
a)
finding
for
a
particular
chemical
substance,
EPA
may
still
cooperate
with
industry
or
others
to
identify
data
gaps
and
develop
testing
plans
to
fill
some
or
all
of
these
gaps.
These
voluntary
efforts
help
provide
additional
information
about
the
many
chemicals
on
the
TSCA
Inventory,
and
can
be
used
to
assess
the
potential
risks
associated
with
the
manufacture,
processing,
distribution,
use
or
disposal
of
the
chemical,
as
well
as
allowing
the
Agency
to
establish
a
regulatory
agenda
that
focuses
on
those
chemicals
of
greater
concern.

The
information
collected
through
the
Chemical
Testing
Program,
whether
submitted
pursuant
to
a
rule
or
voluntarily,
provides
critical
information
on
health
effects,
ecological
effects
and
environmental
fate
that
enables
EPA
and
others
to
properly
assess
and
manage
health
and
environmental
risks
that
may
be
posed
by
existing
and
new
chemicals
covered
by
TSCA.
This
information
is
also
made
publically
available
to
help
the
public
understand
the
risks
posed
by
exposure
to
chemicals
and
to
facilitate
the
public's
involvement
in
environmental
decision­
making.

2(
b)
Use/
Users
of
the
Data
Data
collected
under
the
Chemical
Testing
Program
is
used
by
EPA
scientists
to
determine
whether
the
subject
chemicals
are
likely
to
present
an
unreasonable
risk
to
human
health
or
the
environment.
Furthermore,
such
information,
considered
in
conjunction
with
toxicologic
and
health
effects
data,
ecological
effects
data,
and
environmental
fate
data,
will
be
used
by
scientists,
professional
industrial
hygienists,
other
occupational
health
professionals,
workers,
hazard
communication
and
right­
to­
know
purposes,
including
Material
Safety
Data
Sheets,
and
product
labels.
Additionally,
data
developed
for
chemicals
used
or
produced
in
particular
work
sites
will
be
useful
in
August
29,
2000
5
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
respondents
as
part
of
the
Chemical
Testing
Program
allow
EPA
to
ensure
that
the
necessary
testing
data
will
be
developed,
that
the
results
meet
basic
scientific
standards
of
acceptability
and
adequacy,
that
unforeseen
complications
or
issues
can
be
addressed,
and
that
the
testing
is
progressing
on
schedule.

If
the
test
data
submitted
indicate
that
potentially
unreasonable
risks
may
exist,
the
data
will
be
used
by
EPA
and
the
manufacturer
to
determine
the
appropriate
action
necessary
to
avoid
or
mitigate
the
risks.
To
date,
EPA
has
used
collected
data
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.
EPA
has
also
used
the
resulting
assessments
to
identify
chemicals
that
may
not
warrant
additional
regulation
or
concern,
or
should
otherwise
be
treated
as
a
low
priority
for
further
consideration.

In
addition,
since
EPA
is
required
under
section
4(
d)
of
TSCA
to
publish
a
Federal
Register
notice
announcing
the
receipt
of
test
data
developed
under
a
section
4
rule,
the
data
collected
may
be
used
by
other
agencies,
and
interested
parties.

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
"
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
focussed
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
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)
Test
Rules
and
Consent
Orders
Prior
to
proposing
a
test
rule
or
issuing
a
consent
order,
EPA
searches
the
scientific
literature,
holds
public
information
gathering
meetings,
and
has
discussions
with
industry
representatives
in
order
to
determine
what
types
of
data
have
already
been
obtained
about
the
chemical
under
consideration.
The
Agency
proposes
a
test
rule
or
issues
a
consent
order
only
after
it
has
determined
that
necessary
tests
have
not
yet
been
conducted.
August
29,
2000
6
3(
a)(
2)
Exemptions
Exemption
applicants
are
not
required
to
supply
information
that
the
Agency
can
obtain
by
other
existing
processes.
The
equivalence
information
required
provides
verification
that
a
chemical
is
the
same.
Often
this
information
is
CBI
and
only
the
manufacturer
or
processor
of
the
chemical
has
this
information.

3(
a)(
3)
HPV
and
Children's
Health
Voluntary
Challenge
Programs
EPA
has
searched
the
publicly
available
scientific
data
bases
for
chemicals
embraced
by
the
High
Production
Volume
(
HPV)
and
Children's
Health
Voluntary
Challenge
Programs
and
held
meetings
with
public
interest
groups
and
industry.

The
data
that
are
developed
and/
or
submitted
as
a
result
of
the
program
is
unlikely
to
be
duplicative.

3(
b)
Public
Notice
Required
Prior
to
ICR
Submission
to
OMB
In
proposing
to
renew
this
ICR,
EPA
provided
a
60­
day
public
notice
and
comment
period
that
ended
on
September
27,
1999
(
64
FR
40865,
July
28,
1999).
EPA
received
comments
from
the
Chemical
Manufacturers
Association
(
CMA).
These
comments
are
addressed
in
Attachment
6
to
this
ICR.

3(
c)
Consultations
The
Agency
has
issued
two
procedural
rules
on
the
test
rule
development
and
exemption
process
(
10/
84
and
5/
85)
and
one
procedural
rule
on
the
consent
order
process
(
6/
86)
that
describe
the
information
collection
requirements
for
test
rules
and
consent
orders.
Of
particular
note,
the
Agency
held
a
series
of
public
meetings
at
the
request
of
the
Chemical
Manufacturers
Association
(
CMA)
and
the
Natural
Resources
Defense
Council
(
NRDC)
during
the
spring
and
summer
of
1985
to
develop
the
consent
order
process.
In
addition
to
the
procedural
rules,
each
individual
test
rule
solicits
comment
on
the
information
collection
requirements.

Commenters
on
EPA's
information
gathering
requirements
under
test
rules,
consent
orders,
and
the
exemption
process
have
included
numerous
representatives
of
the
chemical
industry,
environmental
groups
and
the
public
at
large.
A
number
of
issues
were
discussed
including
the
schedule
for
the
test
rule
and
consent
order
process,
what
constitutes
confidential
information,
how
EPA
should
provide
guidance
for
submission
of
equivalence
data,
how
the
Agency
will
provide
standards
for
development
of
test
data,
enforceability
of
consent
orders,
and
how
to
make
consent
orders
equivalent
to
test
rules.

3(
d)
Effects
of
Less
Frequent
Collection
Test
rules
and
consent
orders
require
the
test
sponsor
to
submit
a
letter
notifying
EPA
who
will
be
conducting
the
testing
and
study
plans
before
beginning
testing,
and
a
August
29,
2000
7
final
report
of
the
study
results.
Each
exemption
applicant
is
required
to
submit
an
exemption
application.
Less
frequent
information
collection
would
jeopardize
EPA's
ability
to
ensure
that
testing
is
being
conducted
in
accordance
with
the
rules
and
consent
orders,
and
to
grant
exemptions
from
test
rules.

3(
e)
General
Guidelines
The
data
retention
requirements
for
test
rules
and
consent
orders
exceeds
one
of
the
Paperwork
Reduction
Act
guidelines
contained
in
5
CFR
1320.6.
Documentation
records,
raw
data,
and
specimens
pertaining
to
a
test
rule
or
consent
order
study
are
required
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.

3(
f)
Confidentiality
Information
submitted
to
EPA
in
response
to
test
rules
and
consent
orders
and
in
exemption
applications
is,
in
most
cases,
non­
confidential.
EPA,
for
purposes
of
the
HPV
Challenge
Program,
has
also
discouraged
the
submission
of
CBI
material.
If
respondents
wish
to
claim
information
submitted
in
response
to
a
test
rule
or
consent
order
confidential,
they
may
do
so.
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.

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,
DOJ,
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
2000.
August
29,
2000
8
Although
the
TSCA
electronic
submission
project
has
not
been
implemented
yet,
participants
in
the
voluntary
HPV
Challenge
Program
will
submit
the
information
electronically
to
allow
for
it
to
be
promptly
posted
on
the
internet
(
See
http://
www.
epa.
gov/
chemrtk/
elecsubm.
htm).
Since
as
many
as
14,389
responses
of
the
total
17,299
annual
responses
estimated
for
this
ICR
(
see
Table
7)
are
in
response
to
the
voluntary
HPV
Challenge
Program,
the
Agency
estimates
that
as
much
as
83%
of
the
responses
under
this
ICR
will
be
collected
electronically.

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,
32411
Persons
who
manufacture
(
defined
by
statute
to
include
import)
one
or
more
of
the
subject
chemical
substances.

Processors
325,
32411
Persons
who
process
one
or
more
of
the
subject
chemical
substances.

The
North
American
Industrial
Classification
System
(
NAICS)
codes
have
been
provided
to
assist
you
and
others
in
determining
whether
this
information
collection
activity
might
affect
certain
entities.
This
listing
is
not
intended
to
be
exhaustive,
but
rather
provides
a
guide
for
readers
regarding
entities
likely
to
be
affected
by
this
information
collection
activity.
Please
note
that
previous
ICRs
identified
the
following
Standard
Industrial
Classification
(
SIC)
codes:

2819
Industrial
organic
chemicals
2891
Adhesives
and
sealants
2851
Paints
and
allied
products
2299
Textile
goods
5172
Petroleum
products
NAICS
has
replaced
SIC
as
the
standard
classification
system
for
industry.

4(
b)
Information
Requested
4(
b)(
i)
Data
Items
EPA
may
require
any
type
of
health
effects,
ecological
effects
and
environmental
fate
testing
necessary
to
address
unanswered
questions
about
the
effects
of
a
chemical
substance.
EPA
need
not
limit
the
scope
of
testing
required
to
the
factual
basis
for
the
August
29,
2000
9
TSCA
section
4(
a)(
1)(
A)(
i)
or
(
B)(
i)
findings,
as
long
as
EPA
also
finds
that
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
that
testing
is
necessary
to
develop
such
data.
This
approach
is
explained
in
more
detail
in
EPA's
statement
of
policy
for
making
findings
under
TSCA
section
4(
a)(
1)(
B)
(
frequently
described
as
the
"
B"
policy)
in
the
Federal
Register
of
May
14,
1993
(
58
FR
28736,
28738­
39;
FRL­
4059­
9).

In
addition
to
submitting
the
specified
test
data
to
EPA,
respondents
may
also
need
to
submit
a
letter
of
intent,
study
plans
and
progress
reports,
or
an
exemption
application.
Respondents
must
also
maintain
certain
records
related
to
the
testing.

The
specific
requirements
and
procedures
governing
testing
consent
orders,
test
rules,
and
exemption
from
test
rules
are
found
in
40
CFR
part
790.
The
requirements
regarding
GLPs
are
found
in
40
CFR
part
792,
the
various
test
guidelines
that
are
incorporated
into
the
individual
test
rules
are
in
40
CFR
parts
795
through
798,
and
the
chemical
specific
testing
requirements
are
in
40
CFR
part
799.

The
following
is
an
overview
of
the
specific
requirements
for
each
type
of
activity:

Test
Rules
And
Consent
Orders
­
EPA
promulgates
a
rule
or
consent
order
describing
what
type
of
testing
must
be
performed
on
the
chemical
and
specifying
specific
test
guidelines
that
have
been
published
by
the
EPA
or
alternative
methods
proposed
by
industry
and
approved
by
EPA
as
methods
in
combination
with
the
Good
Laboratory
Practice
standards
(
GLPs)
requirements
provide
the
TSCA
mandated
standards
(
TSCA
section
4(
d))
for
development
of
adequate
and
reliable
data.
Records
concerning
data
developed
according
to
these
standards
must
be
retained
for
a
minimum
of
ten
years,
as
described
in
GLP
standards.

Exemptions
­
Information
collection
authorized
by
section
4(
c)
of
TSCA
is
designed
to
reduce
the
burden
of
duplicative
testing
under
test
rules.
Test
rules
require
testing
of
only
a
single
representative
chemical
substance
and
all
chemicals
subject
to
the
test
rule
are
assumed
equivalent
to
it.
Exemption
applicants
are
required
to
submit
only
that
information
necessary
to
establish
the
identity
of
the
applicant
and
the
test
requirements
from
which
the
exemption
is
being
requested.
In
those
few
cases
in
which
more
than
one
representative
substance
is
to
be
tested
under
a
test
rule,
exemption
applicants
will
also
be
required
to
submit
data
showing
which
of
these
representative
substances
their
chemical
is
equivalent
to.
The
type
of
data
needed
may
vary
with
the
chemical
being
tested,
and
will
be
described
in
detail
in
each
individual
test
rule.

HPV
and
Children's
Health
Voluntary
Challenge
Programs
­
The
HPV
Challenge
Program
is
a
voluntary
initiative
under
which
manufacturers
of
HPV
chemicals
will
voluntarily
develop
and
or
submit
certain
Organization
for
Economic
Cooperation
and
Development
(
OECD)
screening
level
studies
for
the
chemicals
they
manufacture.
Similarly,
the
Children's
Health
Challenge
Program
is
a
voluntary
initiative
under
which
August
29,
2000
10
manufacturers
of
chemicals
with
identified
children's
health
concerns
agree
to
submit
available
data
or
conduct
any
needed
testing
for
the
chemicals
they
manufacture.
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.

4(
b)(
ii)
Respondent
Activities
Respondents
may
undertake
one
or
more
of
the
following
activities:

(
a)
Review
rulemaking
and/
or
participate
in
ECA
or
VTA
discussions.
(
b)
Conduct
file
search
for
relevant
existing
data.
If
existing
data
is
found:
­
Prepare
and
review
summary
of
existing
data.
­
Submit
summary
and
existing
data
to
EPA.
(
c)
Submit
"
Letter
of
Intent"
to
EPA
or
an
application
for
an
exemption.
(
d)
Plan
necessary
activities,
e.
g.,
consortia,
arrange
for
conduct
of
studies,
etc..
(
e)
Prepare
and
submit
periodic
progress
reports.
(
f)
Record
and
prepare
test
data
for
submission
(
includes
QA/
QC
reviews).
(
g)
Prepare
and
review
final
report.
(
h)
Review
submission
for
CBI.
(
i)
Submit
final
report
with
test
data
to
EPA.
(
j)
Maintain
test
data
and
final
report
in
records.

These
activities
may
vary
based
on
the
type
of
activity:

Test
Rules
and
Consent
Orders
­
Test
rules
and
consent
orders
require
test
sponsors
to
submit
a
letter
identifying
who
is
sponsoring
the
required
testing
and
study
plans
before
testing
begins,
semi­
annual
progress
reports
during
the
conduct
of
the
testing,
and
a
final
report
of
the
test
results.

Exemptions
­
Test
Rules.
Exemption
applicants
are
not
required
to
supply
information
that
the
Agency
can
obtain
by
other
existing
processes.
Equivalence
data
are
often
confidential
business
information
(
CBI)
and
only
the
manufacturer
or
processor
of
the
chemical
has
this
information.
In
general,
the
rule
reduces
the
burden
associated
with
preparing
exemption
applications
to
a
minimum
by
restricting
the
information
required
to
that
absolutely
necessary
to
determine
if
the
applicant
is
eligible
for
an
exemption.
In
most
cases,
the
manufacturer
is
required
to
give
only
its
identity,
address,
a
technical
contact
and
a
list
of
the
tests
for
which
an
exemption
is
being
requested.
When
equivalence
data
are
needed
because
more
than
one
representative
substance
is
being
tested,
the
Agency
will
limit
the
data
required
by
giving
minimum
chemical
specific
requirements
in
the
individual
test
rules.
This
approach
was
devised
in
response
to
comments
by
industry
that
applying
the
broad
equivalence
data
requirements
to
all
exemptions
candidates
would,
in
some
cases,
result
in
submission
of
unnecessary
data.

Consent
Orders.
Exemption
applications
are
not
necessary
for
chemicals
being
tested
under
consent
orders
because
the
consent
order
process
inherently
eliminates
duplicative
testing.
August
29,
2000
11
HPV
and
Children's
Health
Voluntary
Challenge
Program.
Exemption
applications
are
not
necessary
for
chemicals
being
tested
under
the
HPV
or
Children's
Health
Voluntary
Challenge
Programs.
However,
companies
may
submit
relevant
information
pertaining
to
the
production
volume
for
chemicals
that
EPA
believes
are
produced
or
imported
in
substantial
amounts.
Based
on
this
information,
EPA
may
delist
a
chemical.
That
is
to
say,
companies
may
submit
information
that
indicates
that
specific
chemicals
are
not
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.

5
THE
INFORMATION
COLLECTION
­
AGENCY
ACTIVITIES,
COLLECTION
METHODOLOGY,
AND
INFORMATION
MANAGEMENT
5(
a)
Agency
Activities
Data
collected
under
section
4
test
rules
and
consent
orders
are
received
by
the
Office
of
Pollution
Prevention
and
Toxics,
Chemical
Control
Division,
Chemical
Testing
and
Information
Branch,
where
they
are
reviewed
for
completeness
and
then
routed
to
biologists,
chemists,
toxicologists,
and
wildlife
scientists
within
the
Office
of
Pollution
Prevention
and
Toxics
to
determine
whether
the
subject
chemicals
are
likely
to
present
an
unreasonable
risk
to
human
health
or
the
environment.
Similarly,
data
received
under
the
HPV
and
Children's
Health
Challenge
Programs
will
be
reviewed
as
described
above
for
purposes
of
developing
preliminary
hazard
and
risk
characterizations
for
those
chemicals.
If
the
data
indicate
that
such
risk
may
exist
they
are
forwarded
to
other
EPA
staff
who
use
them
in
support
of
possible
regulatory
action.
To
date,
EPA
has
collected
data
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.

In
order
to
sustain
this
program,
the
EPA
must
undertake
the
following
applicable
activities:
a)
review
letter
of
intent
and
study
plans
for
completeness;
b)
review
progress
reports;
c)
review
final
reports
for
completeness,
accuracy,
adherence
to
test
rule
guidelines
and
GLPs;
d)
process
and
review
exemption
applications;
e)
facilitate
development
of
ECAs
and
VTAs;

In
addition
to
the
activities
cited
above
the
Agency
maintains
a
facility
inspection
and
test
data
audit
program
to
ensure
testing
is
done
in
compliance
with
GLPs,
and
may
also
participate
in
other
activities
related
to
this
program,
e.
g.,
other
voluntary
efforts
to
identify
data
gaps
and
develop
test
data,
efforts
to
establish
test
guidelines
or
standards
that
may
be
used
in
the
Chemical
Testing
Program,
and
international
efforts
related
to
chemical
testing
and
associated
testing
issues.
August
29,
2000
12
5(
b)
Collection
Methodology
and
Management
For
each
chemical
identified
for
testing
as
part
of
the
TSCA
Chemical
Testing
Program,
the
specific
data
requested,
the
testing
necessary
to
generate
that
data
­
along
with
the
guideline
requirements
for
conducting
the
tests,
the
timeframe
for
completing
the
testing,
and
the
date
by
which
the
requested
data
must
be
submitted
to
the
Agency
are
established
in
the
Test
Rule,
Consent
Order
or
as
part
of
the
VTAs.
OPPT
has
used
the
Master
Testing
List
(
MTL)
since
1990
to
establish
its
TSCA
Existing
Chemical
Testing
Program
agenda.
The
MTL
presents
a
consolidated
listing
of
OPPT's
existing
chemical
testing
priorities,
as
well
as
those
of
other
EPA
Program
Offices,
other
Federal
agencies,
the
TSCA
Interagency
Testing
Committee,
and
international
organizations
such
as
the
Organization
for
Economic
Cooperation
and
Development
(
OECD).

The
main
purposes
of
the
MTL
are
to
(
1)
identify
chemical
testing
needs
of
the
Federal
Government
(
including
EPA)
and
relevant
international
organizations
(
e.
g.,
OECD),
(
2)
focus
limited
EPA
resources
on
the
highest
priority
chemical
testing
needs,
(
3)
publicize
the
testing
priorities
for
industrial
chemicals,
(
4)
obtain
broad
public
input
on
OPPT's
TSCA
Chemical
Testing
Program
and
its
priorities,
and
(
5)
encourage
voluntary
initiatives
by
the
U.
S.
chemical
industry
to
fill
the
priority
data
needs
that
are
identified
on
the
MTL.

EPA
believes
that
companies
with
product
stewardship
programs
will
recognize
the
importance
of
promptly
filling
the
data
needs
identified
via
the
MTL
because
they
know
a
database
that
is
inadequate
to
support
risk
assessment
deprives
people
who
are
exposed
to
a
chemical
of
their
right
to
know
about
the
hazards/
risks
that
may
be
posed
by
that
chemical
substance.
The
identification
of
testing
needs
on
the
MTL
provides
an
opportunity
for
responsible
companies
to
initiate
voluntary
activities
to
develop
the
needed
data
for
their
own
MTL­
listed
chemicals.
In
those
instances
in
which
companies
decline
to
take
this
opportunity,
EPA
may
initiate
appropriate
actions
to
address
the
needs
identified,
including
rulemakings
under
TSCA
Section
4.

The
MTL
contains
over
500
individual
existing
chemicals
and
more
than
10
existing
chemical
categories
and
presents
EPA's
TSCA
Chemical
Testing
Program
priorities
for
1996­
1998.
Testing
actions
are
currently
being
developed
on
more
than
200
chemicals
listed
on
the
MTL
while
testing
is
currently
underway
on
almost
300
chemicals
identified
on
the
MTL.
In
addition,
more
than
100
chemicals
are
being
removed
from
the
MTL
at
this
time,
over
70
of
those
because
their
testing
programs
have
been
completed.

It
is
also
important
to
note
that
the
Chemical
Testing
Program
and
the
MTL
are
integral
components
of
OPPT's
TSCA
Existing
and
New
Chemicals
Programs.
These
programs
are
responsible
for
assessing
and
managing
health
and
environmental
risks
that
may
be
posed
by
existing
and
new
chemicals
covered
by
TSCA.
The
"
universe"
of
existing
chemicals
on
the
TSCA
Chemical
Substances
Inventory
that
may
present
the
greatest
potential
health
and/
or
environmental
concerns
have
been
and
continue
to
be
identified
and
refined
through
various
existing
chemical
screening
activities
within
OPPT.
August
29,
2000
13
Test
data
submitted
to
the
Agency
under
the
TSCA
Chemical
Testing
Program
is
reviewed
by
scientists
to
determine
whether
or
not
the
data
developed
is
adequate
for
the
purposes
for
which
it
was
gathered
and
determining
whether
or
not
further
regulatory
action
is
necessary.
The
data
are
then
entered
into
the
TSCA
Test
Submission
Database
(
TSCATS).
TSCATS
is
an
online
index
to
unpublished,
nonconfidential
studies
covering
chemical
testing
results
and
adverse
effects
of
chemicals
on
health
and
ecological
systems.
TSCATS
was
developed
in
1985
to
make
ongoing
and
completed
chemical
testing
studies
available
to
the
public
and
includes
chemical
exposure
studies,
epidemiology,
environmental
fate,
monitoring,
episodic
incidents,
such
as
spills
and
case
reports.
There
are
four
types
of
documents
in
the
database:
Section
4
chemical
testing
results,
Section
8(
d)
health
and
safety
studies,
Section
8(
e)
substantial
risk
of
injury
to
health
or
the
environment
notices,
and
voluntary
documents
submitted
to
EPA
known
as
a
For
Your
Information
(
FYI)
notice.
There
are
81,000
studies
on
6,700
unique
chemical
substances
contained
in
23,000
documents.
The
titles
of
these
23,000
unpublished
reports
can
be
searched
directly
on
the
National
Technical
Information
Service's
(
NTIS)
web
site.
Microfiche
copies
of
the
full­
text
documents
of
the
unpublished
reports
referenced
by
TSCATS
are
directly
available
from
NTIS
and
from
the
Chemical
Information
Systems
(
CIS).

Studies
are
indexed
under
three
broad
categories:
health
effects,
ecological
effects
and
environmental
fate.
TSCATS
contains
information
that
is
pertinent
to
risk
assessment
and
hazard
evaluation
processes.
The
information
can
be
used
in
conjunction
with
published
material
and
is
a
valuable
source
along
with
or
in
the
absence
of
published
data.
The
data
are
used
by
federal
and
state
agencies,
researchers,
toxicologists,
risk
assessors,
the
regulated
industry,
attorneys,
trade
and
professional
associations.
The
index
is
available
through
a
variety
of
electronic
formats.
5(
c)
Small
Entity
Flexibility
The
test
rule
process
minimizes
the
burden
on
small
businesses
by
giving
them
the
option
of
fulfilling
their
responsibilities
under
a
test
rule
by
either
joining
a
testing
consortium
or
by
applying
for
a
test
rule
exemption.
Participation
in
a
testing
consortium
relieves
the
small
business
of
direct
responsibility
for
collecting
or
submitting
test
information
as
well
as
applying
for
an
exemption.

Under
consent
orders,
small
businesses
are
not
required
to
participate,
but
if
they
do,
they
would
participate
as
part
of
a
consortium.

Small
businesses
are
also
apportioned
a
smaller
proportion
of
the
cost
of
testing
than
their
larger
counterparts.
The
decision
as
to
how
the
cost
of
testing
is
to
be
divided
among
these
firms
has,
to
date,
been
decided
by
the
manufacturers
subject
to
the
rule
or
consent
order.
Generally,
small
businesses
are
assigned
a
proportion
of
the
costs
that
is
proportionate
to
their
size
and
market
share.
However,
if
any
party
believes
a
particular
reimbursement
arrangement
is
unfair,
TSCA
directs
the
Administrator
of
EPA
to
assist
in
resolving
the
conflict
and
the
Agency
will
certainly
consider
the
special
needs
of
small
businesses
if
such
action
becomes
necessary.
To
date,
no
party
has
requested
that
the
Agency
assist
in
reimbursement
decisions.
August
29,
2000
14
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
onetime
on
occasion
submission.
The
testing
period
is
based
on
the
individual
rule,
consent
order,
or
VTA,
the
standard
time
required
to
conduct
the
required
test
according
to
the
testing
guidelines,
according
to
the
timing
established
in
the
approved
test
plan,
or
timing
otherwise
established
by
the
Agency.

The
time
period
for
screening
level
testing,
like
that
conducted
under
the
HPV
Initiative,
is
usually
less
than
a
year.
The
typical
time
period
for
other
types
of
testing
is
around
3
years,
although
it
can
be
longer
and
varies
according
to
the
chemical
and
the
test
required.

6
ESTIMATING
THE
BURDEN
AND
COST
OF
THE
COLLECTION
Overview
The
methodology
used
in
estimating
the
annual
burden
and
costs
to
industry
resulting
from
TSCA
section
4
test
rules,
consent
orders,
and
voluntary
submissions
over
the
next
three
years
is
based
on
EPA's
most
recent
cost
and
burden
estimates.
These
have
been
combined
with
current
information
concerning
the
number
and
type
of
TSCA
section
4
test
rules
under
development,
estimates
on
the
potential
number
of
consent
orders,
and
the
anticipated
industry
participation
in
the
voluntary
children's
health
testing
program
and
the
voluntary
HPV
Challenge
Program,
all
of
which
may
result
in
industry
submitting
existing
data
or
conducting
the
necessary
testing
to
provide
the
requested
data
during
the
next
three
year
ICR
approval
period.
Although
the
Agency
anticipates
the
need
to
issue
test
rules
for
those
HPV
chemicals
that
have
identified
data
gaps
that
remain
unaddressed
by
the
voluntary
program,
this
ICR
assumes
that
most
of
the
HPV
chemicals
will
be
captured
by
the
voluntary
program.
If,
in
the
context
of
a
rulemaking,
the
Agency
determines
that
the
total
annual
burden
covered
by
this
ICR
needs
to
be
increased,
it
will
submit
an
Information
Correction
Worksheet
(
ICW)
to
increase
the
total
annual
burden
in
the
OMB
inventory.

The
following
sections
explain
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.
Attachment
5
provides
a
detailed
discussion
of
the
derivation
of
the
loaded
wage
rates
that
are
used
in
these
estimates.

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
projections
for
the
testing
program
August
29,
2000
1
HPV
chemicals
are
those
with
annual
production
and/
or
importation
volumes
above
1
million
pounds.

2
The
HPV
program
covers
2,089
chemicals.
Thus,
to
calculate
the
annual
number
of
affected
chemicals,
EPA
divided
2,089
by
three
years
(
i.
e.,
the
ICR
approval
period).

3
In
most
instances,
test
sponsors
will
form
a
"
Panel"
or
"
Task
Force",
through
a
common
trade
organization
(
e.
g.,
Chemical
Manufacturers
Association,
Synthetic
Organic
Chemical
Manufacturers
Association),
to
coordinate
testing
and
reporting
under
section
4
of
TSCA.
Therefore,
it
is
likely
that
for
any
Test
Rule
or
Consent
Order
and
Enforceable
Consent
Agreement,
there
will
be
one
submitter
representing
the
respondents.

4
The
assumption
of
1
sponsor
for
every
7
HPV
chemicals
is
derived
from
EPA's
evaluation
of
the
current
status
of
the
HPV
Testing
Program.
In
August
2000,
EPA
estimated
that
161
panels
or
sponsors,
representing
442
firms,
had
agreed
to
participate
in
the
HPV
Challenge
Program.
To
account
for
possible
redundancy
of
firms
among
the
15
over
the
next
three
years.
These
assumptions
are
reflected
in
the
estimated
burden
and
costs
that
are
presented
in
Tables
1
and
3.

Assumptions
(
line
numbers
refer
to
line
numbers
in
Table
1):

1)
Three
average
test
rules
and
eight
consent
orders
will
be
issued
per
year
(
line
a).
Both
the
average
test
rules
and
consent
orders
average
one
to
five
chemicals
per
rule/
order
(
five
chemicals
are
assumed
in
this
ICR)
(
line
b).

2)
In
addition,
this
ICR
incorporates
estimates
of
the
burdens
and
costs
associated
with
voluntary
testing
programs,
including
a
program
targeting
chemicals
of
concern
for
children's
health,
and
the
voluntary
component
of
the
high
production
volume
(
HPV)
chemicals1
testing
program.
A
total
of
52
chemicals
have
been
identified
for
potential
inclusion
in
the
children's
health
voluntary
chemical
program,
although
only
22
chemicals
are
expected
to
be
included
in
the
initial
program,
and
involve
annual
information
collection
activities
covered
by
this
ICR
over
the
next
three
years
(
line
b).
EPA
assumes
that
industry
participation
in
the
voluntary
HPV
Challenge
program
will
result
in
the
completion
of
testing
for
697
HPV
chemicals
annually
over
the
next
three
years
(
line
b).
2
Since
those
HPV
chemicals
not
enrolled
in
the
voluntary
HPV
Challenge
program
may
become
subject
to
a
rulemaking
in
the
future,
any
additional
burden
associated
with
the
HPV
Initiative
will
be
added
to
the
OMB
Inventory
for
this
ICR
through
the
OMB
ICR
burden
correction
process
(
i.
e.,
if
necessary,
an
ICW
will
be
submitted
to
increase
the
OMB
Inventory
to
account
for
any
additional
burden
that
may
result
from
rulemakings
issued
under
the
HPV
Initiative).

3)
Groups
of
chemicals
may
be
represented
by
one
sponsor
or
a
panel
representing
multiple
sponsors.
3
The
following
ratios
are
assumed:
one
sponsor
per
five
chemicals
for
all
average
test
rules
and
consent
orders,
one
sponsor
per
11
children's
health
testing
program
chemicals,
and
one
sponsor
per
seven
HPV
testing
program
chemicals
(
line
d).
4
Thus,
it
is
August
29,
2000
panels
(
i.
e.,
one
firm
belonging
to
more
than
one
panel),
EPA
subtracted
the
number
of
panels
from
the
number
of
firms
to
get
281
distinct
firms.
EPA
then
divided
this
estimate
into
the
2,089
chemicals
covered
by
the
HPV
Challenge.
The
estimate
of
7.4
chemicals
per
sponsor
was
rounded
to
7.

16
estimated
that
1
test
sponsor
responds
to
an
average
test
rule
or
consent
order,
2
sponsors
respond
to
the
children's
health
testing
program,
and
100
sponsors
respond
to
the
HPV
testing
program
(
line
e).

4)
"
Short­
term
studies"
are
tests
that
can
be
concluded
in
the
year
they
begin;
"
long­
term
studies"
are
concluded
within
three
years.

5)
For
chemicals
subject
to
the
"
Standard"
testing
battery
(
i.
e.,
average
test
rule
and
consent
decree
chemicals),
11
studies
per
chemical
(
7
short
term,
4
long
term)
are
required.
For
chemicals
subject
to
the
"
SIDS
Tier
I"
testing
battery
(
i.
e.,
voluntary
HPV
Challenge
program
chemicals),
13
short­
term
studies
are
required
for
each
chemical.
Sixteen
studies
per
chemical
(
ten
short
term,
six
long
term)
are
required
for
the
"
children's
health"
testing
battery
(
lines
i
and
k).
Details
on
the
testing
batteries
are
found
in
Table
2.

6)
In
total,
9,666
short­
term
studies
and
352
long­
term
studies
will
be
performed
per
year
(
lines
j
and
l),
for
a
total
of
10,018
studies
(
line
n).

7)
Each
test
sponsor
must
submit
one
letter
of
intent
and
one
set
of
study
plans
for
each
study
(
line
g);
five
semi­
annual
progress
reports
for
each
long­
term
study
(
line
o);
and
one
final
report
for
each
study
(
line
q).
(
Note
that
for
chemicals
contained
in
a
proposed
rulemaking,
the
rulemaking
itself
serves
as
the
study
plan,
so
sponsors
would
not
have
to
do
their
own
study
plans
­
although
EPA's
estimate
here
assumes
that
they
do.)
Although
the
proposed
ICR
indicated
that
semi­
annual
reports
would
be
required
for
all
studies,
this
ICR
has
dropped
the
semi­
annual
progress
reports
for
the
short
term
studies.
All
13
studies
required
for
each
chemical
under
the
HPV
Challenge
Program
can
be
completed
within
a
year
and
therefore
would
not
require
a
progress
report.
The
expected
total
number
of
reports
is
therefore
11,891,
including
468
for
average
test
rules,
1,248
for
consent
orders,
1,014
related
to
the
children's
health
testing
program,
and
9,161
related
to
the
HPV
testing
program
(
line
s).

8)
For
each
sponsor
of
average
test
rules,
there
will
be
an
estimated
five
companies
applying
for
an
exemption.
Exemptions
are
not
relevant
for
ECAs
or
for
VTAs
like
the
voluntary
children's
health
program,
or
the
voluntary
HPV
Challenge
Program.
The
total
number
of
estimated
annual
exemptions
is
15
(
line
y).

9)
Assuming
that
each
report
is
considered
a
separate
response,
the
total
number
of
estimated
responses
is
11,906
(
11,891
reports
+
15
exemptions)
(
line
z).
August
29,
2000
5
Guidance
on
Searching
for
Chemical
Information
and
Data,
May
1999
(
http://
www.
epa.
gov/
opptintr/
chemrtk/
srchsuid.
htm).

17
10)
The
total
number
of
respondents
is
128
(
113
sponsors
+
15
exemption
applicants)
(
line
bb).

11)
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.

12)
Although
the
actual
distribution
of
respondents
by
activity
may
vary
from
that
shown
in
Table
1
(
i.
e.,
the
data
may
alternatively
be
submitted
under
a
test
rule,
consent
order,
or
voluntary
program),
the
estimated
overall
number
of
submissions
is
likely
to
remain
the
same.
If
the
Agency
determines
that
the
total
annual
burden
covered
by
this
ICR
needs
to
be
increased
to
accommodate
additional
activities
that
exceed
the
estimated
overall
number
of
submissions
currently
anticipated,
it
will
submit
an
ICW
to
increase
the
total
annual
burden
in
the
OMB
Inventory.

Additional
Assumptions
Related
to
the
Voluntary
Challenge
Programs
The
"
Challenge"
programs
established
for
the
children's
health
and
HPV
chemicals
are
voluntary
initiatives
under
which
manufacturers
of
chemicals
targeted
for
testing
will
voluntarily
submit
data
on
hazard
endpoints.
EPA
would
exclude
any
chemicals
enrolled
in
these
Challenge
programs
from
its
planned
section
4
test
rules
and
would
provide
recognition
to
Challenge
participants
for
their
voluntary
actions.

For
purposes
of
this
ICR,
EPA
estimates
that
participants
in
the
voluntary
children's
health
or
HPV
Challenge
programs
would
incur
the
same
costs
and
burdens
that
they
would
incur
if
the
chemicals
were
subject
to
a
section
4
rule,
i.
e.,
requirements
to
prepare
study
plans,
conduct
testing,
and
report
on
testing
results.
In
addition,
to
determine
which
endpoints
need
to
be
tested,
Challenge
program
participants
would
most
likely
undertake
a
search
for
any
existing
studies
for
each
chemical,
and
submit
any
studies
to
EPA.
5
The
costs
and
burden
associated
with
these
data
searches
are
included
as
reporting
costs
and
are
described
below
under
"
Reporting
Costs
and
Burdens."

For
some
HPV
Challenge
chemicals,
sponsors
may
prepare
and
submit
a
delisting
request.
The
delisting
request
would
be
accompanied
by
documentation
supporting
a
sponsor's
claim
that
a
chemical
is
not
a
high
production
volume
chemical.
For
this
ICR,
EPA
assumes
that
the
cost
and
burden
of
preparing
such
documentation,
which
would
include
information
on
the
production
status
of
the
chemical
and
identification
of
manufacturers
and
importers,
would
be
similar
to
the
cost
and
burden
of
performing
the
search
described
above.
August
29,
2000
18
To
the
extent
any
delisting
requests
are
accepted
by
EPA,
such
chemicals
would
not
be
required
to
undergo
testing
under
the
Challenge
programs.
At
this
time,
EPA
cannot
estimate
the
number
of
delisting
requests
that
will
be
submitted,
nor
the
number
that
would
be
accepted.
The
number
accepted
is
expected
to
be
small,
however,
since
the
identification
of
a
chemical
as
an
HPV
chemical
is
based
on
manufacturers'
and
importers'
own
submissions
to
the
TSCA
Inventory.
For
this
reason,
EPA
has
not
made
any
adjustments
to
the
estimates
in
this
ICR
of
the
costs
and
burdens
incurred
by
manufacturers
of
HPV
chemicals
to
account
for
possible
delisting
requests.

These
assumptions
are
used
to
estimate
the
cost
and
burden
factors
(
or
multipliers)
in
Tables
1
and
3,
and
are
also
discussed
in
the
remainder
of
this
ICR.

Table
1.
TSCA
Section
4
ICR
Assumptions
TSCA
Section
4
ICR
Assumptions
Test
Rule
Consent
Order
Children's
Health
HPV
TOTALS
a
No.
of
rules/
orders
issued
3
8
1
1
13
b
Chemicals
per
rule/
order
5
5
22
697
­

c
Total
no.
of
chemicals
(
a
×
b)
15
40
22
697
774
d
No.
of
chemicals
per
sponsor
5
5
11
7
­

e
No.
of
sponsors
per
rule
or
order
(
b
÷
d)
1
1
2
100
­

f
Total
no.
of
sponsors
(
a
×
e)
3
8
2
100
113
g
Letters
of
intent
per
sponsor
1
1
1
1
­

h
Total
letters
of
intent
(
f
×
g)
3
8
2
100
113
i
No.
of
short­
term
studies
per
chemical
7
7
10
13
­

j
Total
no.
of
short­
term
studies
(
c
×
i)
105
280
220
9,061
9,666
k
No.
of
long­
term
studies
per
chemical
4
4
6
0
­

l
Total
no.
of
long­
term
studies
(
c
×
k)
60
160
132
0
352
m
Total
no.
of
studies
per
chemical
(
i
+
k)
11
11
16
13
­

n
Total
no.
of
studies
(
j
+
l)
165
440
352
9,061
10,018
o
No.
of
semi­
annual
progress
reports
per
Short­
term
study
Long­
term
study/
1
5
0
5
5
0
5
5
0
5
0
0
0
­
­
­

p
Total
no.
of
semi­
annual
progress
reports
Short­
term
studies
(
o
×
j)
Long­
term
studies
(
o
×
l)
300
0
300
800
0
800
660
0
660
0
0
0
1,760
0
1,760
q
No.
of
final
reports
per
study
1
1
1
1
­

r
Total
no.
of
final
reports
(
n
×
q)
165
440
352
9,061
10,018
s
Total
no.
of
reports
(
h
+
p
+
r)
468
1,248
1,014
9,161
11,891
t
Total
reports
per
sponsor
(
s
÷
f)
156
156
507
92
­

u
Total
reports
per
rule/
order
(
s
÷
a)
156
156
1,014
9,161
­

v
Total
reports
per
chemical
(
s
÷
c)
31
31
46
13
­

w
No
of
exemptions
per
sponsor
5
0
0
0
­

x
No.
of
exemptions
per
rule/
order
(
e
×
w)
5
0
0
0
­

y
Total
no.
of
exemptions
(
a
×
x)
15
0
0
0
­

z
Total
no.
of
responses
(
s
+
y)
483
1,248
1,014
9,161
11,906
aa
No.
of
responses
per
rule/
order
(
e
+
x)
6
1
2
100
­

bb
Total
no.
of
respondents
(
a
×
aa)
18
8
2
100
128
/
2
No
reports
for
short­
term
studies
since
they
can
be
completed
in
one
year
and
five
reports
at
6,
12,
18,
24,
and
30
months
for
long­
term
studies.
August
29,
2000
6
The
laboratory
cost
is
considered
part
of
the
sponsor's
overall
cost,
but
the
laboratory
burden
is
not.
The
laboratory
burden
is
estimated
here
because
it
is
used
to
derive
an
estimate
of
the
burden
incurred
by
the
sponsor
to
administer
the
testing
program.
See
section
6(
a)
for
more
details.

7
For
one
of
the
tests
included
in
the
"
children's
health"
battery
(
870.5100)
test
costs
have
not
been
developed.
To
provide
a
cost
estimate,
the
cost
for
an
older
but
similar
test
protocol
(
798.5265)
was
used
and
inflated
to
end­
ofyear
1997
dollars
according
to
the
method
described
in
the
text.

19
Test
Protocols
and
Costs
Each
chemical
covered
by
an
average
test
rule
or
consent
order
must
be
evaluated
by
performing
the
tests
specified
in
the
"
Standard"
testing
battery.
The
test
protocols
and
associated
cost
and
burden
data
for
the
"
Standard"
testing
battery
are
depicted
in
Table
2.
For
the
"
children's
health"
testing
battery,
only
SIDS
Tier
I
and
SIDS
Tier
II
tests
will
be
performed
during
the
time
period
for
an
approved
ICR
(
i.
e.,
three
years).
This
excludes
test
numbers
2,
8,
and
12
(
all
SIDS
Tier
III
tests)
from
the
"
children's
health"
testing
costs.
Finally,
the
"
SIDS
Tier
I"
testing
battery
will
be
conducted
for
each
chemical
listed
in
the
HPV
testing
program.
The
cost
and
burden
details
of
the
"
children's
health"
and
"
SIDS
Tier
I"
testing
batteries
are
presented
in
Table
2.

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
2
for
which
cost
and
burden
data
were
estimated
prior
to
1994
were
adjusted
to
end­
of­
year
1997
dollars
using
the
Bureau
of
Labor
Statistics'
Employment
Cost
Indices
(
ECIs)
(
see
Attachment
5).
When
cost
and
burden
data
for
a
specific
test
protocol
were
available
for
multiple
species
and
routes
of
administration,
the
average
cost
and
burden
of
all
available
species
and
routes
of
administration
was
calculated
and
utilized
for
this
report.

As
shown
in
Table
2,
the
mean
cost
of
the
"
Standard"
battery
is
$
982,002
and
the
average
laboratory
burden
associated
with
this
testing
is
11,555
hours.
6
The
mean
cost
of
the
"
children's
health"
battery
is
$
1,986,643
and
the
associated
laboratory
burden
is
23,128
hours.
7
For
purposes
of
this
ICR,
however,
only
SIDS
Tier
I
and
SIDS
Tier
II
tests
will
be
conducted
for
the
"
children's
health"
battery.
Thus,
the
"
children's
health"
testing
cost
for
this
ICR
is
$
902,696
and
the
burden
for
this
ICR
is
9,872
hours.
The
mean
cost
of
the
"
SIDS
Tier
I"
battery
is
$
177,168
and
the
associated
laboratory
burden
is
1,857
hours.
August
29,
2000
20
Table
2.
TSCA
Section
4
ICR
Test
Batteries
Protocol
Name
Protocol
Number
Date
of
Estimate
Mean
Cost
Estimate
Lab
Burden
(
hours)

"
STANDARD"
TESTING
BATTERY
1.
Algal
Acute
Toxicity
\
1
797.1050
08/
03/
90
$
7,547
57
2.
Daphnid
Acute
Toxicity
797.1300
04/
25/
96
$
7,230
54
3.
Fish
Acute
Toxicity
797.1400
04/
25/
96
$
10,950
65
4.
Gene
Mutations
in
Somatic
Cells
798.5300
08/
16/
94
$
15,190
144
5.
Subchronic
Oral
Toxicity
870.3100
09/
03/
96
$
118,742
882
6.
Prenatal
Developmental
Tox.
(
2
species)
870.3700
08/
27/
96
$
199,690
2,314
7.
Reproduction/
Fertility
Effects
870.3800
08/
27/
96
$
458,708
6,086
8.
Salmonella
Reverse
Mutation
Assay
870.5265
09/
16/
96
$
5,905
48
9.
In
vivo
Bone
Marrow
Cytogenetics
870.5395
02/
27/
97
$
12,785
125
10.
Developmental
Neurotoxicity
870.6300
08/
27/
96
$
145,255
1,780
"
STANDARD"
­
GRAND
TOTAL
$
982,002
11,555
"
CHILDREN'S
HEALTH"
TESTING
BATTERY
1.
Metabolism
and
pharmacokinetics
870.7485
12/
02/
96
$
28,449
330
2.
Neurotoxicity
screening
battery
870.6200
09/
25/
96
$
145,296
1,522
3.
Immunotoxicity
870.7800
12/
02/
96
$
54,838
387
4.
Bacterial
reverse
mutation
assays
\
2
870.5100
08/
17/
94
$
5,942
44
5.
In
vitro
mammalian
cytogenetics
870.5375
09/
23/
96
$
14,960
149
6.
Prenatal
developmental
toxicity
study
870.3700
05/
23/
95
$
95,995
1,074
7.
Reproduction
and
fertility
effects
870.3800
09/
01/
95
$
495,804
6,086
8.
Developmental
neurotoxicity
study
870.6300
08/
27/
96
$
151,681
1,780
9.
90­
day
oral
subchronic
in
rodents
OR
870.3100
09/
14/
96
$
123,995
882
90­
day
dermal
subchronic
in
rodents
OR
870.3250
02/
02/
97
$
116,056
1,004
90­
day
inhalation
subchronic
in
rodents
870.3465
12/
02/
96
$
84,075
2,458
SUBTOTAL(
AVERAGE)
$
174,709
1,448
10.
Acute
oral
OR
870.1100
08/
27/
96
$
2,966
44
acute
dermal
OR
870.1200
08/
27/
96
$
3,874
45
acute
inhalation
870.1300
08/
27/
96
$
14,880
200
SUBTOTAL(
AVERAGE)
$
7,240
96
11.
Mammalian
bone
marrow
chromosomal
aberrations
OR
870.5385
09/
25/
96
$
36,360
394
Mammalian
erythrocyte
micronucleus
870.5395
02/
27/
97
$
13,160
125
SUBTOTAL(
AVERAGE)
$
24,760
259
12.
Combined
chronic/
carcinogenicity
OR
870.4300
04/
04/
97
$
879,061
10,864
Carcinogenicity
870.4200
04/
04/
97
$
691,122
9,053
SUBTOTAL(
AVERAGE)
$
785,092
9,959
"
CHILDREN'S
HEALTH"
­
GRAND
TOTAL
$
1,986,643
23,128
"
CHILDREN'S
HEALTH"
­
ICR
TOTAL
\
3
$
902,696
9,872
"
SIDS
TIER
I"
(
HPV)
TESTING
BATTERY
1.
Melting
Point
OECD
102
04/
20/
98
$
1,200
13
2.
Boiling
Point
OECD
103
04/
20/
98
$
1,250
14
3.
Vapor
Pressure
OECD
104
06/
11/
98
$
12,570
118
August
29,
2000
Table
2.
TSCA
Section
4
ICR
Test
Batteries
Protocol
Name
Protocol
Number
Date
of
Estimate
Mean
Cost
Estimate
Lab
Burden
(
hours)

21
4.
Water
Solubility
OECD
105
04/
20/
98
$
4,930
53
5.
Partition
Coefficient
(
shake
flask)
OECD
107
04/
20/
98
$
5,630
50
SUBTOTAL
$
25,580
248
6.
Inherent
Biodegradation
OECD
302
04/
20/
98
$
14,670
175
7.
Genetic
Toxicity
(
Salmonella)
OECD
471
03/
23/
98
$
5,930
44
8.
Acute
Toxicity
to
Aquatic
Plants
OECD
201
05/
12/
98
$
7,360
62
SUBTOTAL
$
27,960
281
9.
Acute
Toxicity
to
Fish
OECD
203
04/
16/
98
$
8,300
56
10.
Acute
Toxicity
to
Daphnia
OR
OECD
202(
I)
04/
20/
98
$
6,390
40
Chronic
Toxicity
to
Daphnia
850.1300
01/
18/
97
$
26,400
173
SUBTOTAL
(
AVERAGE)
$
20,545
135
11.
Acute
Oral
Toxicity
OR
OECD
401
03/
21/
98
$
2,840
41
Acute
Dermal
Toxicity
OR
OECD
402
03/
22/
98
$
3,833
43
Acute
Inhalation
Toxicity
OECD
403
04/
20/
98
$
13,650
184
SUBTOTAL
(
AVERAGE)
$
6,774
89
12.
Chromosomal
Aberration,
in
vitro
OR
OECD
473
04/
20/
98
$
16,730
159
Chromosomal
Aberration,
in
vivo
OECD
474
04/
23/
98
$
13,068
130
SUBTOTAL
(
AVERAGE)
$
14,899
145
13.
Combined
Repeated
Dose
with
Repro./
Devel.
Toxicity
Screen
OR
OECD
422
12/
08/
94
$
83,260
1,146
Repeated
Dose
Oral
Toxicity
AND
OECD
407
02/
15/
97
$
36,400
328
Repro./
Devel.
Toxicity
Screening
Test
OECD
421
04/
01/
97
$
43,160
445
SUBTOTAL
(
AVERAGE)
$
81,410
960
"
SIDS
TIER
I"
­
GRAND
TOTAL
$
177,168
1,857
Notes:
\
1
Cost
adjusted
from
1990
to
end­
of­
year
1997
using
a
factor
of
1.261,
which
is
the
ratio
of
ECI
1997:
ECI
1990
(
or,

135.2/
107.2
=
1.261).
See
Attachment
5.
\
2
Cost
estimate
for
this
protocol
not
available.
Cost
of
798.5265
was
used
instead.
\
3
This
total
excludes
Tier
III
tests
(
i.
e.,
numbers
2,
8,
and
12).

6(
a)
Respondent
Cost
and
Burden
For
purposes
of
calculating
the
PRA
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
complying
with
the
anticipated
test
rules,
ECAs
and
VTAs.
The
laboratory
testing
costs
were
used
to
calculate
the
potential
costs
associated
with
administering
the
testing,
and
the
the
administrative
costs
were
divided
into
reporting
costs
and
non­
reporting
costs.
These
are
described
in
more
detail
later
in
this
section.
August
29,
2000
22
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
5
and
are
summarized
as
follows:

INDUSTRY
LABOR
CATEGORY
LOADED
HOURLY
RATE
($
1998)

Managerial
Technical
Secretarial
$
86.86
$
64.30
$
25.63
Based
upon
the
assumptions
and
testing
batteries
discussed
above,
various
factors
can
be
derived
that
are
employed
to
estimate
total
costs
and
burdens
for
the
respondents.
These
factors
are
summarized
below
based
on
data
presented
in
Table
1.

Number
of
Respondents
The
Agency's
estimates
assume
that
there
will
be
an
average
of
six
respondents
per
average
test
rule,
one
respondent
as
testing
sponsor
and
five
others
who
apply
for
exemptions
(
See
Table
1,
line
aa).
The
Agency
assumes
that
there
will
be
one
respondent
(
i.
e.,
the
test
sponsor)
per
consent
order,
and
for
the
children's
health
and
HPV
testing
programs,
that
there
will
be
2
and
100
sponsors
per
rule,
respectively.
The
estimated
annual
total
number
of
respondents
for
this
ICR
is
128
(
i.
e.,
113
sponsors
and
15
exemption
applicants)
(
Table
1,
line
bb).

Number
of
Reports
Over
the
course
of
the
testing
period,
each
test
sponsor,
or
a
common
representative
of
the
test
sponsors,
will
submit,
on
average,
93
reports
(
i.
e.,
11,891
reports
÷
128
sponsors
=
92.9).
This
will
include,
but
is
not
limited
to:
letter
of
intent
and
set
of
study
plans,
semi­
annual
progress
reports
for
long­
term
studies,
and
the
final
reports
for
each
study.

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
TSCA
section
4
test
rules.
Table
3
presents
estimates
of
the
laboratory
and
administrative
costs
and
burden.
These
are
discussed
in
detail
below.

Laboratory
Costs
and
Burdens
The
costs
and
burdens
incurred
by
sponsors
performing
laboratory
testing
are
presented
in
Table
3,
and
were
calculated
in
order
to
derive
estimates
of
the
respondent's
administrative
burdens.
The
burden
estimates
associated
with
the
paperwork
related
to
August
29,
2000
8
Laboratory
costs
per
study
are:
$
89,273
for
average
test
rules
and
consent
orders,
$
56,419
for
the
children's
health
test
rule,
and
$
13,628
for
the
HPV
program.

23
testing
are
captured
in
this
ICR
as
administrative
burden.
The
figures
in
Table
3
are
based
on
the
estimated
costs
of
the
tests
and
the
estimated
lab
burdens
presented
in
Table
2.

Total
laboratory
costs
of
the
ICR
are
estimated
to
be
$
197.4
million
($
14.7
million
for
average
test
rules;
$
39.3
million
for
consent
orders;
$
19.9
million
for
the
children's
health
testing
program;
and
$
123.5
million
for
the
HPV
testing
program).
With
a
projected
total
of
10,018
studies
to
be
conducted
annually
(
Table
3,
line
d),
the
average
laboratory
cost
is
$
19,700
per
study
(
Table
3,
line
i).
8
Administrative
Costs
and
Burdens
EPA's
experience
in
test
rule
development
has
shown
the
administrative
costs
and
burdens
associated
with
testing
programs
to
be
approximately
25
percent
of
the
laboratory
costs
and
burdens.
EPA
has
applied
this
25
percent
factor
to
estimate
the
administrative
costs
and
burden
associated
with
test
rules,
consent
orders,
and
the
voluntary
children's
health
program.
For
the
voluntary
HPV
Challenge
program,
however,
EPA
assumed
that
the
administrative
costs
and
burdens
were
equal
to
100
percent
of
the
laboratory
costs
and
burdens,
instead
of
25
percent.
EPA
used
100
percent
for
the
voluntary
HPV
Challenge
program
because
of
the
relatively
large
number
of
tests
(
see
Table
1,
line
j),
and
the
associated
recordkeeping
and
reporting
burden
for
each
test.

Following
the
assumptions
described
above,
the
total
administrative
cost
is
estimated
to
be
$
142.0
million
annually
(
Table
3,
line
g)
and
the
total
administrative
burden
is
1,507,390
hours
(
Table
3,
line
o).
These
administrative
costs
and
burdens
are
assumed
to
be
incurred
through
reporting
and
non­
reporting
activities.

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
include
activities
such
as:
preparing
letters
of
intent
and
study
plans;
preparing
progress
reports;
preparing
test
results
for
submission
to
EPA;
recording
test
results;
conducting
laboratory
or
corporate
reviews;
performing
associated
clerical
work
for
final
report
preparation;
record
keeping;
conducting
administrative
activities
to
preparing
for
and
oversee
the
testing
program;
and
applying
for
exemptions.
Reporting
estimates
also
include
the
data
search
and
reviews
conducted
for
the
voluntary
children's
health
and
HPV
Challenge
programs.

The
respondents'
annual
cost
and
burden
estimates
associated
with
each
reporting
activity
are
detailed
in
Table
4
(
more
detailed
tables
for
each
type
of
activity
are
included
as
Attachment
7).
The
unit
wage
rate
information
is
explained
in
Attachment
5.
The
unit
labor
hours
are
derived
from
previous
information
collection
requests
and
are
believed
to
August
29,
2000
9
Estimates
of
the
burden
and
cost
associated
with
the
Children's
Health
and
HPV
Challenge
Programs
(
searching
for
and
submitting
existing
studies
of
the
health
and
ecological
effects
of
each
chemical)
are
based
on
the
TSCA
Section
8(
d)
ICR.
For
each
chemical,
6.5
manufacturers
are
assumed
to
spend
18
hours
each
determining
which
sites
may
have
relevant
studies,
performing
the
search,
developing
a
list
of
studies
found,
and
making
copies
of
studies
for
submittal
to
EPA.
Each
manufacturer
is
assumed
to
copy
48
pages
(
3
studies
×
16
pages
per
study).
For
the
external
search,
one
sponsor
per
chemical
are
assumed
to
spend
60
hours
searching
electronic
and
other
databases,
and
copy
and
submit
a
total
of
160
pages
to
EPA
(
10
studies
×
16
pages
per
study).

10
Economic
Analysis
for
Renewed
Information
Collection
Request
for
the
TSCA
Section
8(
d
)
Health
and
Safety
Data
Reporting
Rule,
U.
S.
Environmental
Protection
Agency,
OPPT/
EETD/
EPAB,
October
1995.

24
be
reflective
of
the
annual
amount
of
time
required
for
each
activity
over
the
next
three
year
period.
9
To
estimate
the
cost
and
burden
of
performing
data
searches
for
the
voluntary
programs,
EPA
assumes
that
6.5
firms
per
chemical
would
search
their
internal
records
and
one
sponsor
per
chemical
would
perform
an
external
search
of
the
literature.
The
assumption
of
6.5
firms
per
chemical
is
based
on
the
estimates
made
in
the
economic
analysis
prepared
in
support
of
the
ICR
for
the
TSCA
Section
8(
d)
Health
and
Safety
Data
Reporting
Rule.
10
Based
on
this,
143
searches
by
firms
(
6.5
×
22)
and
22
searches
by
sponsors
are
assumed
for
the
children's
health
test
program
annually.
Similarly,
4,531
searches
by
firms
(
6.5
×
697)
and
697
searches
by
sponsors
are
assumed
for
the
HPV
testing
program
annually.
Each
year
there
will
be
an
estimated
total
of
4,674
searches
conducted
by
manufacturers
(
143
+
4,531)
and
719
searches
conducted
by
sponsors
(
22
+
697)
for
the
children's
health
and
HPV
testing
programs.

The
total
annual
respondent
cost
and
burden
for
reporting
activities
is
$
51.0
million
and
1,182,574
hours
(
Table
4).

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
costs
and
burdens
of
these
activities
as
the
difference
between
the
total
administrative
costs
and
burdens
and
the
reporting
costs
and
burdens
derived
above.
Based
on
this
calculation,
non­
reporting
activities
associated
with
laboratory
testing
are
estimated
to
cost
$
90.9
million
annually
and
impose
a
burden
of
324,816
hours
annually
(
Table
3,
lines
g
and
o).
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.
August
29,
2000
25
Table
3.
TSCA
Section
4
ICR
Laboratory
Cost
and
Burden
Estimates
TSCA
Section
4
ICR
Factors
Test
Rule
Consent
Order
Children's
Health
HPV
TOTALS
/
1
a
Total
no.
of
rules/
orders
/
1
3
8
1
1
13
b
Total
no.
of
chemicals
/
1
15
40
22
697
774
c
Total
no.
of
sponsors
/
1
3
8
2
100
113
d
Total
no.
of
studies
/
1
165
440
352
9,061
10,018
e
Lab.
cost
per
chemical
/
2
$
982,002
$
982,002
$
902,696
$
177,168
$
254,982
f
Total
lab.
costs
(
b
×
e)
$
14,730,030
$
39,280,080
$
19,589,312
$
123,486,096
$
197,355,750
g
Administrative
Reporting
costs
Administrative
Non­
reporting
costs
Total
administrative
costs
/
3
$
1,039,542
$
2,642,965
$
3,682,508
$
2,772,112
$
7,047,908
$
9,820,020
$
2,484,534
$
2,480,294
$
4,964,828
$
44,742,225
$
78,744,103
$
123,486,096
$
51,040,343
$
90,913,341
$
141,953,684
h
Total
lab.
and
admin.
costs
(
f
+
g)
$
18,412,538
$
49,100,100
$
24,824,140
$
246,972,192
$
339,309,434
i
Lab.
costs
per
study
(
f
÷
d)
$
89,273
$
89,273
$
56,419
$
13,628
$
19,700
j
Admin.
costs
per
study
(
g
÷
d)
$
16,006
$
16,006
$
7,046
$
8,690
$
9,075
k
Total
testing
costs
per
study
(
i
+
j)
$
125,279
$
105,279
$
63,465
$
22,319
$
28,775
l
Total
testing
costs
per
sponsor
(
h
÷
c)
$
6,137,513
$
6,137,513
$
12,412,070
$
2,469,727
$
3,002,738
m
Lab.
burden
per
chemical
/
2
11,555
11,555
9,872
1,857
2,774
n
Total
lab.
burden
(
b
×
m)
173,325
462,200
217,184
1,294,329
2,146,922
o
Administrative
Reporting
burden
Administrative
Non­
reporting
burden
Total
administrative
burden
/
3
18,525
24,776
43,331
49,400
66,150
115,550
52,295
2,001
54,296
1,062,325
231,888
1,294,329
1,182,574
324,816
1,507,390
p
Lab.
burden
per
study
(
n
÷
d)
1,050
1,051
617
143
214
q
Admin.
burden
per
study
(
o
÷
d)
263
263
154
143
150
r
Total
administrative
burden
per
sponsor
(
o
÷
c)
14,444
14,444
27,148
12,942
13,340
August
29,
2000
Table
3.
TSCA
Section
4
ICR
Laboratory
Cost
and
Burden
Estimates
TSCA
Section
4
ICR
Factors
Test
Rule
Consent
Order
Children's
Health
HPV
TOTALS
/
1
26
/
1
See
Table
1.
/
2
See
Table
2.
/
3
For
average
test
rules,
consent
orders,
and
the
children's
health
program,
administrative
costs
and
burdens
are
assumed
to
equal
25
percent
of
laboratory
costs
and
burdens;
for
the
HPV
rule
administrative
costs
and
burdens
are
assumed
to
equal
100
percent
of
laboratory
costs
and
burdens.
August
29,
2000
27
Table
4.
Total
Annual
Respondent
Cost
and
Burden
Estimates
for
Reporting
COLLECTION
ACTIVITY
UNIT
LABOR
UNIT
SUPPLY
COSTS
ANNUAL
ITEMS
GRAND
TOTAL
TYPE
/
1
HOURS
RATE
COST
HOURS
COSTS
INTERIM
REPORTS
Letter
of
Intent
and
Study
Plans
T
40
$
64.30
$
2,572.00
$
20.00
113
4,520
$
292,896
Prepare
Progress
Report
T
8
$
64.30
$
514.40
$
5.00
1,760
14,080
$
914,144
INTERIM
REPORTS
SUBTOTAL
18,600
$
1,207,040
FINAL
REPORTS
Short­
term
Studies
Record
and
Prepare
Test
for
Submission
T
40
$
64.30
$
2,572.00
$
0.00
9,666
386,640
$
24,860,952
Laboratory
Review
T
6
$
64.30
$
385.80
$
0.00
9,666
57,996
$
3,729,143
Corporate
Review
M
6
$
86.86
$
521.16
$
0.00
9,666
57,996
$
5,037,533
Type
and
Print
Results
S
20
$
25.63
$
512.60
$
0.00
9,666
193,320
$
4,954,792
Record
Keeping
S
1
$
25.63
$
25.63
$
5.00
9,666
9,666
$
296,070
Short­
term
Subtotal
705,618
$
38,878,489
Long­
term
Studies
Record
and
Prepare
Test
for
Submission
T
80
$
64.30
$
5,144.00
$
0.00
352
28,160
$
1,810,688
Laboratory
Review
T
9
$
64.30
$
578.70
$
0.00
352
3,168
$
203,702
Corporate
Review
M
9
$
86.86
$
781.74
$
0.00
352
3,168
$
275,172
Type
and
Print
Results
S
40
$
25.63
$
1,025.20
$
0.00
352
14,080
$
360,870
Record
Keeping
S
1
$
25.63
$
25.63
$
5.00
352
352
$
10,782
Long­
term
Subtotal
48,928
$
2,661,215
FINAL
REPORTS
SUBTOTAL
754,546
$
41,539,704
August
29,
2000
COLLECTION
ACTIVITY
UNIT
LABOR
UNIT
SUPPLY
COSTS
ANNUAL
ITEMS
GRAND
TOTAL
TYPE
/
1
HOURS
RATE
COST
HOURS
COSTS
28
EXEMPTION
REQUESTS
T
2
$
64.30
$
128.60
$
0.00
15
30
$
1,929
EXISTING
TEST
DATA
SEARCH
(
CHILDREN'S
HEALTH
AND
HPV
CHALLENGE
PROGRAMS)

Manufacturer
Corporate
review
M
3
$
86.86
$
260.58
$
0.00
4,674
14,021
$
1,217,821
File
search
T
9
$
64.30
$
578.70
$
0.00
4,674
42,062
$
2,704,554
Summary
sheet
S
1
$
25.63
$
25.63
$
0.00
4,674
4,674
$
119,782
Reproduction
S
1.8
$
25.63
$
46.13
$
3.36
4,674
8,412
$
231,310
CBI
review
M
3
$
86.86
$
260.58
$
0.00
4,674
14,021
$
1,217,821
Manufacturer
Subtotal
83,188
$
5,491,288
Sponsor
External
search
T
60
$
64.30
$
3,858.00
$
11.20
719
110,295
$
2,781,955
Summary
sheet
S
1
$
25.63
$
25.63
$
0.00
719
215,916
$
18,428
Sponsor
Subtotal
326,210
$
2,800,383
DATA
SEARCH
SUBTOTAL
409,398
$
8,291,670
GRAND
TOTALS
/
2
1,182,574
$
51,040,343
/
1
Labor
Type
 
T
=
Technical;
M
=
Managerial;
S
=
Secretarial
/
2
A
break­
out
of
the
total
reporting
costs
by
type
of
activity
are
provided
in
Attachment
7.
August
29,
2000
29
Total
Cost
and
Burden.

Table
5
summarizes
the
costs
and
burdens
associated
with
the
TSCA
Section
4
testing
program.
The
total
costs
include
laboratory
costs,
administrative
reporting
costs
(
letters
of
intent,
interim
reports,
final
reports,
exclusion
requests,
and
existing
data
searches),
and
non­
reporting
administrative
costs.
In
calculating
paperwork
burdens
and
paperwork
costs,
EPA
excludes
laboratory
costs
and
non­
reporting
administrative
costs
since
neither
impose
paperwork
burdens.
As
shown
in
Table
5,
the
combined
cost
of
all
TSCA
section
4­
related
information
collection
for
this
ICR
is
$
51.0
million
annually
with
a
combined
burden
estimate
is
1.2
million
hours
annually.
This
is
equivalent
to
$
65,944
and
1,528
hours
per
chemical,
or
$
451,684
and
10,465
hours
per
sponsor,
taking
into
account
774
chemicals
and
113
sponsors.

Table
5.
Summary
of
Respondent
Cost
and
Burden
Estimates
ACTIVITY
TOTAL
ANNUAL
RESPONDENT
COST
AND
BURDEN
Burden
Hours
Paperwork
Costs
Other
Costs
Laboratory
Testing
/
1
n/
a
n/
a
$
197,355,750
Letters
of
Intent
/
2
4,520
$
292,896
$
0
Progress
reports
/
2
14,080
$
914,144
$
0
Final
Reports
/
2
754,546
$
41,539,704
$
0
Exemption
Requests
/
2
30
$
1,929
$
0
Existing
Data
Search
/
2
409,398
$
8,291,670
$
0
Non­
reporting
administrative
/
1
n/
a
n/
a
$
90,913,341
ANNUAL
TOTAL
1,182,574
$
51,040,343
$
288,269,091
Note:
totals
may
not
add
due
to
rounding.
/
1
The
laboratory
testing
burden
and
non­
reporting
administrative
costs
represent
costs
incurred
by
affected
entities,
but
are
not
classified
as
paperwork
burdens
under
the
PRA
and
are
only
presented
here
for
completeness.
/
2
Each
of
the
collection
activities
is
classified
as
"
administrative
reporting".

6(
b)
Agency
Cost
and
Burden
The
cost
and
burden
to
the
Agency
to
process,
review,
and
analyze
the
information
collected
under
Section
4
test
rules
and
consent
orders
is
discussed
below
and
detailed
in
Table
6.

The
Agency
collection
procedures
are
estimated
to
be
accomplished,
on
average,
by
a
GS­
12,
Step
1,
employee.
The
annual
1998
loaded
cost
of
a
full­
time
equivalent
(
FTE)
for
this
level
employee
is
$
75,306.
This
includes
a
base
wage
of
$
47,066
plus
60
percent
for
overhead
and
benefits
(
i.
e.,
$
28,240).
Dividing
this
value
by
2,080
(
i.
e.,
the
August
29,
2000
30
number
of
hours
in
a
work
year)
equals
an
hourly
wage
rate
of
$
36.20
(
see
Attachment
5
for
the
derivation
of
these
factors).

AGENCY
LABOR
CATEGORY
LOADED
HOURLY
RATE
($
1998)

GS­
12,
Step
1
$
36.20
The
estimated
unit
Agency
burden
of
processing
letters
of
intent
and
study
plans
(
3
hours),
progress
reports
(
1
hour),
and
final
reports
(
5
hours)
is
derived
from
the
previous
information
collection
requests
and
is
presented
in
Table
6.
It
takes
approximately
one
hour
for
the
Agency
to
process
and
review
each
exemption
application.
The
total
annual
Agency
costs
and
burden
for
processing
letters
and
reports
is
$
1.9
million
and
52,189
hours.
The
Agency's
annual
exemption
processing
costs
and
burden
is
$
543
and
15
hours.

Table
6.
Annual
Agency
Cost
and
Burden
Estimates
COLLECTION
ACTIVITY
UNIT
LABOR
UNIT
SUPPLY
COSTS
ANNUAL
ITEMS
GRAND
TOTAL
HOURS
RATE
COST
HOURS
COSTS
Letter
of
Intent
and
Study
Plans
3
$
36.20
$
108.60
$
0.00
113
339
$
12,272
Progress
Reports
1
$
36.20
$
36.20
$
0.00
1,760
1,760
$
63,712
Final
Reports
5
$
36.20
$
181.00
$
0.00
10,018
50,090
$
1,813,258
SUBTOTAL
11,891
52,189
$
1,889,242
Exemptions
1
$
36.20
$
36.20
$
0.00
15
15
$
543
GRAND
TOTAL
11,906
52,204
$
1,889,785
6(
c)
Bottom
Line
Annual
Burden
Hours
and
Costs
 
Master
Tables
6(
c)(
i)
Respondent
Tally
Table
7
summarizes
the
annual
average
burden
per
response.
EPA
estimates
that
this
ICR
will
impose
1.2
million
burden
hours
on
respondents
annually.
This
total
burden
covers
17,299
responses
annually
for
an
average
of
68.36
hours
per
response.
August
29,
2000
31
Table
7.
Average
Burden
Hours
Per
Response
COLLECTION
ACTIVITY
ANNUAL
RESPONDENT
BURDEN
PER
RESPONSE
TOTAL
HOURS
TOTAL
ITEMS
HOURS
PER
RESPONSE
Letters
of
Intent
4,520
113
40.00
Progress
reports
14,080
1,760
8.00
Final
Reports
754,546
10,018
75.32
Exemption
Requests
30
15
2.00
Existing
Data
Search
409,398
5,393
75.91
TOTAL
(
all
responses)
1,182,574
17,299
68.36
The
total
burden
hours
and
costs
for
respondents
have
been
calculated
above
in
Table
5.
Table
8
summarizes
these
estimated
annual
burden
hours
and
costs.

Table
8.
Summary
of
Respondent
Burden
and
Costs
Estimates
COLLECTION
ACTIVITY
Total
Annual
Hours
Cost
Letters
of
Intent
4,520
$
292,896
Progress
reports
14,080
$
914,144
Final
Reports
754,546
$
41,539,704
Exemption
Requests
30
$
1,929
Existing
Data
Search
409,398
$
8,291,670
TOTAL
(
all
responses)
1,182,574
$
51,040,343
6(
c)(
ii)
Agency
Tally
The
burden
hours
and
costs
for
the
government
have
been
calculated
above
in
Table
6.
These
estimates
are
summarized
below
in
Table
9.

Table
9.
Summary
of
Agency
Burden
and
Costs
Estimates
COLLECTION
ACTIVITY
TOTAL
ANNUAL
AGENCY
BURDEN
AND
COSTS
BURDEN
(
Hours)
COSTS
Letter
of
Intent
and
Study
Plans
339
$
12,272
Progress
Reports
1,760
$
63,712
Final
Reports
50,090
$
1,813,258
Exemptions
15
$
543
August
29,
2000
32
TOTAL
52,204
$
1,889,785
6(
d)
Reasons
for
Changes
in
Burden
The
major
change
from
the
previous
ICR
is
an
increase
of
1,106,124
hours
in
the
estimated
total
annual
burden
for
this
ICR,
from
76,450
hours
currently
in
the
OMB
inventory
to
1,182,574
hours
requested
in
this
ICR.
This
increase,
and
the
corresponding
increase
in
the
costs,
are
the
result
of
a
program
change.
Specifically,
the
Agency
has
initiated
two
major
new
VTAs,
the
voluntary
HPV
Challenge
Program
and
the
voluntary
children's
health
testing
program.
The
inclusion
of
the
estimated
burden
and
costs
associated
with
these
two
programs
has
resulted
in
a
significant
increase
in
the
total
number
of
chemicals
covered
by
the
Testing
Program,
and
a
corresponding
increase
in
the
reporting
and
recordkeeping
burden
related
to
the
program.
The
voluntary
children's
health
testing
program
will
initially
involve
approximately
22
chemicals
each
year
and
is
estimated
to
result
in
1,014
total
responses
each
year.
The
voluntary
HPV
Challenge
program
is
currently
expected
to
include
2,089
chemicals
over
the
three
year
period
for
the
ICR,
or
approximately
697
chemicals
each
year,
and
is
estimated
to
result
in
9,161
total
responses
each
year.

In
the
previous
ICR,
the
Agency's
estimated
burden
was
based
on
the
assumption
that
it
would
issue
2
average
test
rules,
4
ECAs,
and
1
multi­
chemical
test
rule
each
year.
For
this
ICR,
the
burden
is
based
on
the
Agency's
expectation
that,
on
average,
it
will
issue
3
average
test
rules,
and
8
ECAs
each
year
for
the
next
three
years.
This
increase
reflects
current
Agency
testing
program
activities
as
reflected
in
the
Agency's
Regulatory
Agenda.

In
addition,
the
Agency
has
adjusted
the
costs
to
reflect
an
update
in
the
labor
rates,
and
more
recent
laboratory
testing
costs.
These
cost
related
changes
are
adjustments.

6(
e)
Burden
Statement
The
annual
public
burden
for
this
collection
of
information,
which
is
approved
under
OMB
Control
No.
2070­
0033,
is
estimated
to
average
68.36
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.
The
OMB
control
number
for
this
information
collection
appears
above.
In
addition,
the
OMB
control
numbers
for
EPA's
August
29,
2000
33
regulations,
after
initial
display
in
the
Federal
Register,
are
listed
in
40
CFR
part
9,
as
well
as
in
any
applicable
collection
instrument.

Send
comments
on
the
Agency's
need
for
this
information,
the
accuracy
of
the
provided
burden
estimates,
and
any
suggested
methods
for
minimizing
respondent
burden,
including
through
the
use
of
automated
collection
techniques
to
the
Director,
Collection
Strategies
Division
(
2822),
U.
S.
Environmental
Protection
Agency,
1200
Pennsylvania
Ave,
NW,
Washington,
D.
C.
20460.
Include
the
OMB
control
number
in
any
correspondence,
but
do
not
submit
the
requested
information
to
this
address.
The
requested
information
should
be
submitted
in
accordance
with
the
instructions
accompanying
the
form,
or
as
specified
in
the
corresponding
regulation.

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
­
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
2
­
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
3
­
OPPT
TSCA
Test
Guidelines
Cost
Summary
(
This
document
is
not
available
electronically.
Please
contact
EPA
for
a
copy).

Attachment
4
­
Public
Notice
Required
Prior
to
ICR
Submission
to
OMB,
64
FR
40865,
July
28,
1999.
(
For
an
electronic
copy
of
this
FR
document
go
to
http://
www.
epa.
gov/
fedrgstr/
EPA­
TOX/
1999/
July/
Day­
28/
t19274.
htm).

Attachment
5
­
Wage
Rates
Estimation
Attachment
6
­
Response
to
Comments
Attachment
7
­
Supplemental
Break­
outs
for
Table
4
August
29,
2000
ATTACHMENT
1
Toxic
Substances
Control
Act
Section
4
15
USC
2603
August
29,
2000
ATTACHMENT
2
40
CFR
790
Procedures
Governing
Testing
Consent
Agreements
and
Test
Rules
August
29,
2000
ATTACHMENT
3
OPPT
TSCA
Test
Guidelines
Cost
Summary
(
This
document
is
not
available
electronically.
Please
contact
EPA
for
a
copy).
August
9,
2000
ATTACHMENT
4
Public
Notice
Required
Prior
to
ICR
Submission
to
OMB
64
FR
40865,
July
28,
1999
(
For
an
electronic
copy
of
this
FR
document
go
to
http://
www.
epa.
gov/
fedrgstr/
EPA­
TOX/
1999/
July/
Day­
28/
t19274.
htm).
August
9,
2000
11Centaur
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.

12William
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.

1
ATTACHMENT
5
WAGE
RATES
ESTIMATION
A.
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).
11
Updated
wage
rate
estimates
were
developed
by
EPA,
using
the
CAIR
methodology,
for
a
1993
economic
analysis
of
rulemakings
under
EPCRA
Section
313.12
The
methodology
used
in
developing
wage
rates
is
summarized
below.

LABOR
CATEGORY
LOADED
HOURLY
RATE
Government
GS­
12,
Step
1
$
36.20
Industry
Managerial
Technical
Secretarial
$
86.86
$
64.30
$
25.63
B.
Government
The
Federal
government
collection
activity
procedures
described
in
this
report
are
expected
to
be
accomplished
by
a
GS­
12,
Step
1,
Federal
full­
time
equivalent
(
FTE)
employee.
One
FTE
is
equivalent
to
2,080
hours
per
year.
The
1998
cost
of
a
full
time
equivalent
employee
(
FTE)
was
provided
by
the
Office
of
Personnel
Management's
1998
General
Schedule
Locality
Rates
of
Pay
for
Washington­
Baltimore,
DC­
MD­
VA­
WV
(
effective
January
1998).

The
annual
costs
per
FTE
are
derived
by
multiplying
the
annual
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.
August
9,
2000
13
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.

2
An
annual
pay
rate
of
$
47,066
is
used
and
reflects
a
GS­
12
(
step
1)
salary
as
of
January,
1,
1998.
This
GS­
12,
Step
1,
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).
Thus,
the
annual,
fully­
loaded
cost
per
FTE
is
$
75,306
(
i.
e.,
$
47,066
×
1.6),
or
$
36.20
per
hour
(
i.
e.,
$
75,
306
÷
2,080
hours).

C.
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
goods­
producing,
private
industries.
13
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.
August
9,
2000
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,
if
necessary,
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.

The
loaded
hourly
wage
rates
used
in
the
analysis
are
presented
in
Table
3.
Unit
burden
estimates
are
converted
to
unit
cost
estimates
by
multiplying
the
unit
burden
hours
by
the
appropriate
wage
rates
in
Table
3.
August
9,
2000
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
%
Benefit
s
to
%
Wages
1996
June
1998
March
ECI
Ratio
06/
96:
03/
9
8
Wages
Benefit
s
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.
August
9,
2000
5
Table
3.
Estimated
Loaded
Hourly
Wage
Rates
by
Labor
Category
a
b
c
d
e
f
g
h
i
j
k
Labor
Category
Occupation
(
levels)
Weightin
g
Factor
1996
Composite
Salary
(
c
×
average
salaries
from
Table
1)
ECI
Ratio
06/
96:
04/
9
8
(
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.
August
9,
2000
ATTACHMENT
6
Response
to
Comments
December
7,
1999
MEMORANDUM
SUBJECT:
Response
to
Comments
Received
on
the
TSCA
Existing
Chemical
Test
Rules,
Consent
Orders,
Test
Rule
Exemptions,
and
Voluntary
Test
Data
Submissions;
Information
Collection
Request
Renewal
(
1139)

FROM:
Charles
M.
Auer,
Director
//
s//
Chemical
Control
Division
(
7405)

TO:
Angela
Hoffman,
Director
Regulatory
Coordination
Staff
(
7101)

BACKGROUND
Section
4
of
the
Toxic
Substances
Control
Act
(
TSCA),
(
40
CFR
790)
was
designed
to
assure
that
those
chemicals
which
may
pose
serious
risks
to
human
health
or
the
environment
are
tested
by
manufacturers
and
processors.
If
this
collection
activity
were
not
carried
out
after
having
determined
that
data
was
needed
to
assess
risks
associated
with
manufacture,
processing,
or
disposal
of
a
chemical,
EPA
would
not
have
enough
data
to
support
necessary
regulatory
action
and
would
be
violating
the
requirements
of
section
4
of
TSCA.

One
commentor
(
The
Chemical
Manufacturers
Association)
responded
to
the
Federal
Register
notice
(
64
FR
40865,
July
28,
1999)
announcing
EPA's
intent
to
submit
the
ICR
for
the
TSCA
section
4
program
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.
What
is
the
scope
of
the
ICR?

A.
The
burden
estimates
described
in
the
ICR
renewal
request
is
based
on
3
test
rules,
8
enforceable
consent
agreements
(
ECAs),
data
collection/
development
of
screeninglevel
data
for
2,089
chemicals
volunteered
under
the
High
Production
Volume
Challenge
Program,
and
22
chemicals
volunteered
under
the
Voluntary
Children's
Health
Chemical
Testing
Program.
For
further
clarification,
the
burden
associated
with
the
High
Production
Volume
Test
Rules(
s)
have
not
been
included
in
this
ICR
renewal
request.
A
burden
estimate
will
be
developed
for
the
HPV
Test
Rule(
s)
and
submitted
as
an
amendment
to
this
ICR
when
the
HPV
Rule(
s)
is
finalized.
August
9,
2000
7
2.
Q.
Does
this
ICR
provide
an
estimate
of
the
cumulative
burden
of
other
TSCA­
related
testing,
whether
voluntary
or
pursuant
to
test
orders
or
enforceable
consent
agreements
(
ECAs)?

A.
The
estimates
in
the
ICR
burden
statement
are
for
those
which
are
likely
to
be
incurred
during
the
3
year
time
period
covered
by
the
ICR.
It
does
not
include
estimates
of
the
burden
of
other
rules,
ECAs,
etc.,
before
or
after
that
time
period.

3.
Q.
What
is
the
impact
of
the
HPV
testing
on
laboratory
capacity?

A.
EPA
recognizes
that
the
availability
of
laboratory
capacity
could
potentially
affect
the
burdens
and
costs
associated
with
testing
requirements.
The
Agency
recently
evaluated
laboratory
capacity
and
found
that
a
variety
of
factors
affect
the
availability
of
testing
laboratories
including:
expansion
of
laboratory
capacity,
use
of
laboratories
outside
of
the
United
States,
the
types
of
testing
in
demand,
and
current
amount
of
available
capacity
for
particular
tests.
Given
the
many
factors
involved,
the
Agency
does
not
believe
it
can
accurately
predict
what,
if
any,
impact
on
costs
or
burdens
will
result
from
the
test
rules
covered
by
the
ICR.
Although
CMA
comments
that
costs
are
expected
to
rise
"
quickly
and
soon,"
it
has
not
provided
any
information
that
EPA
can
use
to
revise
its
estimates.

4.
Q.
Has
EPA
accurately
estimated
the
potential
number
of
respondents
for
the
first
year
of
the
ICR
for
all
anticipated
test
rules,
consent
orders,
and
Children/
HPV
programs?

A.
In
order
to
estimate
the
number
of
chemicals
represented
per
panel,
EPA
investigated
the
current
number
of
committed
panels
to
the
HPV
Challenge
Program.
This
information
was
available
at
http://
www.
epa.
gov/
opptintr/
smrestbl.
htm
and
was
last
updated
on
October
12,
1999.
EPA
identified
the
panels
as
either
individual
companies
or
a
group
of
companies
(
e.
g.,
a
consortia)
that
have
committed
to
submit
data
for
the
chemicals
produced.
A
single
company
may
be
part
of
more
than
one
panel.
A
panel
may
cover
anywhere
from
one
chemical
to
as
many
as
355
chemicals
(
e.
g.,
The
American
Petroleum
Institute
(
API)
Petroleum
HPV
Testing
Group).
EPA
considers
panels
to
be
respondent
to
the
rules.
However,
to
develop
a
complete
estimate
of
respondents,
EPA
also
includes
estimates
of
the
number
of
exemption
requests
(
in
the
case
of
the
HPV
Challenge
Program
and
Children's
programs
there
were
0
exemptions).

The
ICR
burden
analysis
has
been
adjusted
to
assume
an
average
of
7
chemicals
represented
per
panel
(
sponsor)
for
the
HPV.
This
would
result
in
100
panels
(
697
chemicals
divided
by
7
chemicals
per
sponsor)
for
the
HPV
challenge.

In
regards
to
the
Children's
Initiative,
the
estimate
of
chemicals
per
panel
may
be
premature,
but
it
is
the
most
reasonable
estimate
that
EPA
could
come
up
with
given
the
status
of
the
initiative.
August
9,
2000
8
5.
Q.
Has
EPA,
in
developing
the
burden
estimate,
calculated
the
burden
for
each
member
of
the
panel,
as
each
company
will
search
its
own
files,
sign
commitment
forms,
and
equally
share
in
the
work?

A
.
EPA
included
an
estimate
of
the
costs
and
burdens
for
administering
the
laboratory
testing
programs
for
the
rules
and
voluntary
portions
of
the
ICR.
This
estimate
was
25
percent
of
the
laboratory
costs
for
the
non­
HPV
portions
of
the
ICR
and
100
percent
of
the
laboratory
costs
for
the
HPV
initiative.
These
estimates
do
cover
all
administrative
costs
of
the
programs,
including
the
costs
to
all
members
of
the
panels.

6.
Q.
Is
EPA's
ICR
estimate
for
the
SIDS
battery
of
tests
accurate?

A.
EPA
believes
that
its
estimates
of
testing
costs
are
reasonable.
The
commenter
has
provided
no
basis
for
its
estimates
of
costs.
In
addition,
CMA
has
provided
an
estimate
of
the
costs
of
the
SIDS
battery
that
is
higher
than
estimates
previously
submitted
to
EPA
without
an
explanation
of
the
reason
for
the
changes
in
their
cost
estimates.
In
response
to
the
commentor,
EPA
did,
however,
review
the
costs
and
estimates
provided
by
EPA
and
compared
them
to
its
own
estimates.
The
bulk
of
the
difference
in
EPA's
and
CMA's
cost
estimates
for
the
SIDS
battery
can
be
attributed
to
the
cost
estimates
of
a
few
tests
and
to
CMA's
inclusion
of
the
cost
of
dossier
preparation
to
its
estimate
of
test
costs.
The
tests
for
which
CMA
and
EPA
cost
estimates
differed
significantly
are:

o
OECD
407:
Repeated
Dose
28­
day
Oral
Toxicity
in
Rodents
o
OECD
421:
Reproductive
Developmental
Toxicity
Screening
o
OECD
422:
Combined
Repeated
Dose
Study
with
Reproductive/
Developmental
Toxicity
Screen
EPA
contacted
six
U.
S.
laboratories
that
conducted
these
tests
to
compare
its
estimates
of
test
costs
with
the
cost
charged
to
clients.
Table
1
below
presents
the
ranges
and
averages
of
test
costs
for
OECD
407,
421,
422,
and
any
modifications
or
variations
(
e.
g.,
in
route
of
administration
or
testing
period)
to
these
tests
that
have
been
identified
in
EPA's
current
test
cost
estimates
or
by
laboratory
contacts.
Tests,
or
any
of
their
modifications
or
variations,
may
not
be
conducted
at
every
laboratory.
For
example,
only
one
laboratory
contact
said
their
lab
performs
OECD
421
on
rats
via
inhalation.

In
review
of
the
responses
in
table
1,
EPA
determined
that
its
estimates
are
within
the
range
of
costs
charged
by
laboratories
with
the
exception
of
OECD
407
for
which
the
EPA's
estimate
is
high.

EPA
has
also
included
the
cost
of
dossier
preparation
in
its
estimate
of
administrative
costs
so
it
is
included
as
part
of
the
cost
of
the
collection.

7.
Q.
Is
EPA's
estimation
of
the
cost
of
the
Children's
Health
Test
Battery
reasonable?
August
9,
2000
9
A.
EPA
used
the
most
reliable
data
on
the
costs
of
the
selected
tests
for
the
Children's
test
battery.
CMA
has
provided
no
documentation
supporting
their
estimates
that
costs
range
from
$
3
­
$
10
million
per
chemical.
It
should
also
be
noted
that
CMA's
comments
that
"
many
of
the
chemicals
that
EPA
had
in
mind
for
a
children's
health
test
rule
were
already
data
rich
and
would
undergo
only
approximately
half
of
the
tests
in
the
battery"
implies
that
EPA's
assumption
that
conducting
the
full
test
battery
for
all
Children's
chemicals
is
a
vast
overestimate
of
the
costs.

8.
Q.
Did
EPA
include
the
cost
of
searching
for
existing
data
for
the
Children's
rule
included
in
the
ICR
burden
analysis?

A.
Estimates
of
data
search
of
testing
for
the
Children's
initiative
was
included
in
the
ICR,
however,
was
not
explained
clearly
in
the
burden
analysis.
The
cost
of
the
external
data
search
were
described
in
the
section
"
Administrative
Reporting
Costs
and
Burdens"
and
Table
4
of
the
ICR.
The
number
of
annual
items
for
the
data
search
was
estimated
at
5,393,
which
includes
estimates
for
both
the
HPV
(
5,048
items)
and
Children's
data
test
search
(
165
items),
however
the
section
listed
the
items
as
HPV
challenge
items.
The
5,393
items
estimate
was
derived
by
multiplying
6.5
firms
per
chemical
plus
one
sponsor
per
chemical
that
were
assumed
to
search
for
data
by
the
number
of
HPV
and
Children's
chemicals
per
year
(
697
and
22).
A
clarification
of
these
costs
will
be
added
to
the
ICR.
August
9,
2000
ATTACHMENT
7
Supplemental
Break­
outs
for
Table
4
Annual
Respondent
Burden
Estimates
for
Reporting
­
By
Program
COLLECTION
ACTIVITY
UNIT
Programs
GRAND
TOTAL
Test
Rule
Consent
Order
Children's
Health
HPV
Hrs
#
hrs
#
hrs
#
hrs
#
hrs
#
HRS
INTERIM
REPORTS
Letter
of
Intent
and
Study
Plans
40
3
120
8
320
2
80
100
4,000
113
4,520
Prepare
Progress
Report
8
300
2,400
800
6,400
660
5,280
0
0
1,760
14,080
INTERIM
REPORTS
Subtotal
2,520
6,720
5,360
4,000
18,600
FINAL
REPORTS
Short­
term
Studies
Record
and
Prepare
Test
for
Submission
40
105
4,200
280
11,200
220
8,800
9,061
362,440
9,666
386,640
Laboratory
Review
6
105
630
280
1,680
220
1,320
9,061
54,366
9,666
57,996
Corporate
Review
6
105
630
280
1,680
220
1,320
9,061
54,366
9,666
57,996
Type
and
Print
Results
20
105
2,100
280
5,600
220
4,400
9,061
181,220
9,666
193,320
Record
Keeping
1
105
105
280
280
220
220
9,061
9,061
9,666
9,666
Short­
term
Subtotal
7,665
20,440
16,060
661,453
705,618
August
9,
2000
COLLECTION
ACTIVITY
UNIT
Programs
GRAND
TOTAL
Test
Rule
Consent
Order
Children's
Health
HPV
Hrs
#
hrs
#
hrs
#
hrs
#
hrs
#
HRS
2
Long­
term
Studies
Record
and
Prepare
Test
for
Submission
80
60
4,800
160
12,800
132
10,560
0
0
352
28,160
Laboratory
Review
9
60
540
160
1,440
132
1,188
0
0
352
3,168
Corporate
Review
9
60
540
160
1,440
132
1,188
0
0
352
3,168
Type
and
Print
Results
40
60
2,400
160
6,400
132
5,280
0
0
352
14,080
Record
Keeping
1
60
60
160
160
132
132
0
0
352
352
Long­
term
Subtotal
8,340
22,240
18,348
0
48,928
FINAL
REPORTS
SUBTOTAL
16,005
42,680
34,408
661,453
754,546
Total
18,525
49,400
39,768
665,453
773,146
August
9,
2000
3
Annual
Respondent
Cost
Estimates
for
Reporting
­
By
Program
COLLECTION
ACTIVITY
UNIT
GRAND
TOTAL
Test
Rules
Consent
Orders
Children's
Health
HPV
Hrs$
Supply
#
$
#
$
#
$
#
$
#
COSTS
INTERIM
REPORTS
Letter
of
Intent
and
Study
Plans
$
2,572
$
20
3
$
7,776
8
$
20,736
2
$
5,184
100
$
259,200
113
$
292,896
Prepare
Progress
Report
$
514
$
5
300
$
155,820
800
$
415,520
660
$
342,804
0
$
0
1,760
$
914,144
Interim
Reports
Subtotal
$
163,596
$
436,256
$
347,988
$
259,200
$
1,207,040
FINAL
REPORTS
Short­
term
Studies
Record
and
Prepare
Test
for
Submission
$
2,572
$
0
105
$
270,060
280
$
720,160
220
$
565,840
9,061
$
23,304,892
9,666
$
24,860,952
Laboratory
Review
$
386
$
0
105
$
40,509
280
$
108,024
220
$
84,876
9,061
$
3,495,734
9,666
$
3,729,143
Corporate
Review
$
521
$
0
105
$
54,722
280
$
145,925
220
$
114,655
9,061
$
4,722,231
9,666
$
5,037,533
Type
and
Print
Results
$
513
$
0
105
$
53,823
280
$
143,528
220
$
112,772
9,061
$
4,644,669
9,666
$
4,954,792
Record
Keeping
$
26
$
5
105
$
3,216
280
$
8,576
220
$
6,739
9,061
$
277,538
9,666
$
296,070
Short­
term
Subtotal
$
422,330
$
1,126,213
$
884,882
$
36,445,064
$
38,878,489
Long­
term
Studies
Record
and
Prepare
Test
for
Submission
$
5,144
$
0
60
$
308,640
160
$
823,040
132
$
679,008
0
$
0
352
$
1,810,688
Laboratory
Review
$
579
$
0
60
$
34,722
160
$
95,592
132
$
76,388
0
$
0
352
$
203,702
Corporate
Review
$
782
$
0
60
$
46,904
160
$
125,078
132
$
103,190
0
$
0
352
$
275,172
Type
and
Print
Results
$
1,025
$
0
60
$
61,512
160
$
164,032
132
$
135,326
0
$
0
352
$
360,870
Record
Keeping
$
26
$
5
60
$
1,838
160
$
4,901
132
$
4,043
0
$
0
352
$
10,782
Long­
term
Subtotal
$
453,616
$
1,209,643
$
997,956
$
0
$
2,661,215
Final
Reports
Subtotal
$
875,946
$
2,338,856
$
1,882,837
$
36,445,064
$
41,539,704
August
9,
2000
COLLECTION
ACTIVITY
UNIT
GRAND
TOTAL
Test
Rules
Consent
Orders
Children's
Health
HPV
Hrs$
Supply
#
$
#
$
#
$
#
$
#
COSTS
4
Total
$
1,039,542
$
2,775,112
$
2,230,825
$
36,704,264
$
42,746,744