Document ID: EPA-HQ-OPPT-2004-0098-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2004-06-09T04:00Z

Supporting
Statement
for
a
Request
for
OMB
Review
under
the
Paperwork
Reduction
Act
1
IDENTIFICATION
OF
THE
INFORMATION
COLLECTION
1(
a)
Title
and
Number
of
the
Information
Collection
Title:
TSCA
Existing
Chemical
Test
Rules,
Consent
Orders,
Test
Rule
Exemptions,
and
Voluntary
Test
Data
Submissions
ICR
Nos.:
EPA
ICR
#
1139.07;
OMB
Control
No.
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
these
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
that
provide
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
section
4
that
meet
specific
needs
identified
by
OPPT,
EPA
may
also
develop
such
actions
to
meet
the
information
needs
of
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).

EPA
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
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
Office
of
Pollution
Prevention
and
Toxics
(
OPPT)
Docket,
EPA
Docket
Center
(
EPA/
DC),
EPA
West,
Room
B102,
1301
Constitution
Ave.,
NW.,
Washington,
D.
C.
The
Public
Reading
Room
is
open
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.

2
NEED
FOR
AND
USE
OF
THE
COLLECTION
2(
a)
Need/
Authority
for
the
Collection
TSCA
section
2(
b)(
1)
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
unanswered
questions
about
the
effects
of
the
chemical
substance.
EPA
need
not
limit
the
scope
of
testing
required
to
the
factual
basis
for
the
TSCA
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
see:
http://
www.
epa.
gov/
opptintr/
itc/.)

Although
the
Agency
may
not
have
yet
made
the
TSCA
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
are
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
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
TSCA
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.

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
Voluntary
Challenge
Programs
EPA
has
searched
the
publicly
available
scientific
data
bases
for
chemicals
embraced
by
the
High
Production
Volume
(
HPV)
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
Prior
to
submission
to
OMB,
this
ICR
will
be
made
available
to
the
public
for
comment
through
a
Federal
Register
notice.
The
public
will
have
60
days
to
provide
comments.
Any
comments
received
will
be
given
consideration
when
completing
the
supporting
statement
that
is
submitted
to
OMB.

3(
c)
Consultations
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
American
Chemistry
Council
(
formally
Chemical
Manufacturers
Association
(
CMA))
and
Environmental
Defense
(
ED,
formally
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
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
than
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.

Although
the
TSCA
electronic
submission
project
has
not
been
fully
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).

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

Type
of
Entity
NAICS
Examples
of
Potentially
Affected
Entities
Chemical
Manufacturers
and
Importers
325,
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
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
to
which
of
these
representative
substances
their
chemical
is
equivalent.
The
type
of
data
needed
may
vary
with
the
chemical
being
tested,
and
will
be
described
in
detail
in
each
individual
test
rule.

HPV
Voluntary
Challenge
Program
­
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.
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
are
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.

HPV
Voluntary
Challenge
Program.
Exemption
applications
are
not
necessary
for
chemicals
being
tested
under
the
HPV
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.

5
THE
INFORMATION
COLLECTION
­
AGENCY
ACTIVITIES,
COLLECTION
METHODOLOGY,
AND
INFORMATION
MANAGEMENT
5(
a)
Agency
Activities
Data
collected
under
TSCA
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
Voluntary
Challenge
Program
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.

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
time
frame
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
have
been
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.

Test
data
submitted
to
the
Agency
under
the
TSCA
Chemical
Testing
Program
are
reviewed
by
scientists
to
determine
whether
or
not
the
data
developed
are
adequate
for
the
purposes
for
which
they
were
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:
TSCA
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.

5(
d)
Collection
Schedule
This
information
collection
activity
does
not
involve
more
than
one
submission
per
activity.
Required
testing
is
conducted
only
once,
and
each
related
submission
is
a
one­
time
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
three
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
agreements,
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
agreements,
and
the
anticipated
level
of
industry
participation
in
the
voluntary
HPV
Challenge
Program,
all
of
which
may
result
in
industry
submitting
existing
data
or
conducting
new
testing
to
provide
EPA
with
information
necessary
to
evaluate
chemicals
under
its
TSCA
section
4
mandate.

Individual
actions
covered
by
this
ICR
may
impact
industry
over
most
or
all
of
the
three
year
ICR
period.
In
these
cases,
the
impacts
of
the
action
have
been
converted
to
an
annual
basis
by
assuming,
for
example,
that
one­
third
of
the
chemicals
covered
by
the
action
would
be
addressed
in
each
of
the
three
years.

Additional
data
collection
efforts
beyond
those
identified
in
this
ICR
may
be
conducted
during
the
ICR
approval
process,
but
the
extent
of
such
activities
cannot
be
projected
at
this
time.
For
example,
although
the
Agency
anticipates
the
need
to
issue
test
rules
for
HPV
chemical
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.

6(
a)
Respondent
Cost
and
Burden
Section
4
Test
Rules
This
ICR
covers
one
TSCA
section
4
test
rule,
the
"
OSHA
dermal
absorption"
test
rule
promulgated
by
EPA
on
April
26,
2004.
The
rule
requires
in
vitro
testing
to
determine
dermal
1
69
FR
80
(
April
26,
2004),
page
22402.

2
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.
absorbency
characteristics
for
34
chemicals.
1
This
ICR
includes
the
costs
and
burdens
associated
with
the
completion
of
the
two
short
term
tests
specified
for
each
chemical.
As
noted
above,
EPA
assumes
one­
third
of
the
chemicals
are
addressed
in
each
of
the
three
years
covered
by
this
ICR
(
11
chemicals
per
year).

In
its
economic
analysis
of
the
OSHA
dermal
test
rule,
EPA
identified
84
corporate
entities
responsible
for
producing
the
specified
chemicals
(
USEPA
2004).
In
EPA's
experience,
groups
of
chemicals
covered
by
TSCA
section
4
test
rules
may
be
represented
by
one
sponsor
or
a
panel
representing
multiple
sponsors.
2
For
burden
estimation
purposes
EPA
applied
the
ratio
of
one
sponsor
per
five
chemicals
used
in
previous
ICR
submissions.
Thus,
EPA
estimates
that
an
average
of
two
sponsors
per
year
will
respond
to
the
OSHA
dermal
test
rule.
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.
For
each
sponsor
of
the
OSHA
dermal
test
rule,
EPA
assumes
that
five
companies
will
apply
for
an
exemption,
or
an
average
of
one
exemption
per
chemical.
This
is
also
consistent
with
past
ICR
submissions.

The
OSHA
dermal
test
rule
requires
sponsors
to
conduct
testing
to
determine
a
short
term
absorption
rate
and
a
permeability
constant
for
each
chemical.
In
addition
to
laboratory
costs,
sponsors
will
incur
expenses
associated
with
the
administration
of
the
testing.
For
example,
each
sponsor
must
submit
one
letter
of
intent
and
one
set
of
study
plans
for
each
study,
and
one
final
report
for
each
study.
These
administrative
costs
are
estimated
to
be
25
percent
of
the
laboratory
costs,
based
on
a
prior
survey
examining
actual
laboratory
and
administrative
costs
incurred
in
response
to
TSCA
section
4
test
rules
(
USEPA
1989).

EPA
has
estimated
the
laboratory
costs
of
testing
to
meet
these
requirements
to
be
$
27,190
per
chemical
with
an
additional
administrative
cost
at
$
6,797
per
chemical,
for
a
total
of
$
33,987
per
chemical
in
2003
dollars
(
USEPA
2004).
The
administrative
costs
are
assumed
to
be
all
labor,
and
are
converted
into
labor
hours
using
an
average
labor
rate
of
$
41.26
per
hour
in
2003
dollars,
based
on
the
methodology
described
in
USEPA
(
2002).
The
administrative
burden
associated
with
the
testing
is
estimated
at
165
hours
per
chemical.

Applicants
for
exemption
requests
are
assumed
to
incur
two
hours
of
technical
labor
at
a
2003
rate
of
$
43.24,
for
a
total
cost
of
$
86.48
per
exemption.
Table
1
summarizes
these
results.
3
"
Short­
term
studies"
are
tests
that
can
be
concluded
in
the
year
they
begin;
"
long­
term
studies"
are
concluded
within
three
years.

4
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.
Table
1.
Costs
and
Burden
of
TSCA
Section
4
Dermal
Absorption
Test
Rule
(
Annual)

Cost
and
Burden
Costs
and
Burden
Per
Chemical
No.
of
Chemicals
per
Year
Total
Costs
and
Burden
No.
of
Sponsors
per
Year
Costs
and
Burden
Per
Respondent
Testing
Costs
$
27,190
11
$
299,090
2
$
149,545
Administrative
Costs
$
6,797
$
74,767
$
37,384
Total
Costs
$
33,987
$
373,857
$
186,929
Administrative
burden
(
hrs)
/
1
165
1,815
908
Exemptions
Burden
(
hrs)
/
2
2.0
11
22
2
11.0
Exemption
Costs
$
86.48
$
951
$
476
1/
Administrative
costs
are
divided
by
$
43.31
per
hour
to
obtain
the
administrative
burden
estimate
(
USEPA
2002).
2/
Assumes
five
exemptions
per
sponsor
or
an
average
of
one
exemption
per
chemical.
Source:
USEPA
(
2004).

Consent
Orders
and
Enforceable
Consent
Agreements
Based
on
historical
experience
with
the
TSCA
testing
program,
EPA
assumes
that
one
consent
order
or
consent
agreement
will
be
issued
per
year
for
a
total
of
three
consent
orders/
agreements
issued
during
the
ICR
period.
Past
consent
orders
and
agreements
have
covered
an
average
of
one
to
five
chemicals.
For
this
ICR,
EPA
assumes
five
chemicals
will
be
covered
by
each
order/
agreement.

The
testing
required
under
future
consent
orders
or
agreements
cannot
be
predicted
and
will
be
determined
on
a
case
by
case
basis.
For
purposes
of
the
ICR,
EPA
assumes
as
in
past
ICRs
that
each
chemical
will
be
evaluated
by
performing
the
tests
specified
in
a
"
Standard"
testing
battery
(
see
Table
2).
The
test
battery
includes
11
studies
per
chemical
(
7
short
term,
4
long
term).
3
Each
test
sponsor
must
submit
one
letter
of
intent
and
one
set
of
study
plans
for
each
study;
five
semi­
annual
progress
reports
for
each
long­
term
study;
and
one
final
report
for
each
study.
These
assumptions
are
used
to
estimate
the
cost
and
burden
factors
(
or
multipliers)
in
Table
4.

EPA
generates
and
maintains
a
listing
of
the
laboratory
cost
and
burden
data
for
numerous
TSCA
and
OECD
test
protocols.
Test
cost
estimates
were
adjusted
to
end­
of­
year
2003
dollars
using
the
Bureau
of
Labor
Statistics'
Employment
Cost
Index
(
ECI)
and
are
shown
in
Table
2.
The
mean
cost
of
the
"
Standard"
battery
is
$
1,264,454
and
the
average
laboratory
burden
associated
with
this
testing
is
11,555
hours.
4
5
HPV
chemicals
are
those
manufactured
in
or
imported
to
the
United
States
in
annual
quantities
of
one
million
pounds
or
more.
The
HPV
program
covered
2,089
chemicals
at
its
launch.
Table
2.
TSCA
Section
4
"
Standard"
Testing
Battery
Costs
and
Laboratory
Burdens
Test
Protocol
Name
Protocol
Number
Date
of
Estimate
Mean
Cost
Estimate
($
2003)
\
a
Lab
Burden
(
hours)

1.
Algal
Acute
Toxicity
797.1050
08/
03/
90
$
9,446
57
2.
Daphnid
Acute
Toxicity
797.1300
04/
25/
96
$
9,283
54
3.
Fish
Acute
Toxicity
797.1400
04/
25/
96
$
13,627
65
4.
Gene
Mutations
in
Somatic
Cells
798.5300
08/
16/
94
$
20,794
144
5.
Subchronic
Oral
Toxicity
870.3100
09/
03/
96
$
153,837
882
6.
Prenatal
Developmental
Tox.
(
2
species)
870.3700
08/
27/
96
$
236,208
2,314
7.
Reproduction/
Fertility
Effects
870.3800
08/
27/
96
$
609,411
6,086
8.
Salmonella
Reverse
Mutation
Assay
870.5265
09/
16/
96
$
7,650
48
9.
In
vivo
Bone
Marrow
Cytogenetics
870.5395
02/
27/
97
$
16,012
125
10.
Developmental
Neurotoxicity
870.6300
08/
27/
96
$
188,186
1,780
TOTAL
$
1,264,454
11,555
Notes:
\
a
Where
multiple
versions
of
a
test
have
been
costed
by
EPA
(
e.
g.,
covering
different
species
or
routes
of
exposure),
the
mean
cost
estimate
is
used.
All
test
costs
updated
to
2003
dollars.
Source:
U.
S.
EPA,
Office
of
Pollution
Prevention
and
Toxics,
Economics,
Exposure
and
Technology
Branch.

Voluntary
Programs
This
ICR
also
incorporates
estimates
of
the
burdens
and
costs
associated
with
the
voluntary
component
of
the
high
production
volume
(
HPV)
chemicals
testing
program,
launched
in
1998.5
Under
the
HPV
Challenge
program
manufacturers
of
chemicals
targeted
for
testing
agree
to
voluntarily
submit
data
on
hazard
endpoints.
EPA
would
exclude
any
chemicals
enrolled
in
the
Challenge
program
from
its
planned
TSCA
section
4
test
rules
and
would
provide
recognition
to
Challenge
participants
for
their
voluntary
actions.

Table
3
shows
the
full
set
of
endpoints
to
be
submitted
under
the
HPV
Challenge
program.
The
testing
suite
is
based
on
the
Tier
I
tests
from
the
OECD
Screening
Information
Data
Set
(
SIDS).
The
Tier
I
battery
includes
16
endpoints,
each
of
which
will
be
fulfilled
by
completing
one
short­
term
study.
The
estimated
cost
of
completing
the
full
suite
of
testing
in
2003
dollars
is
$
288,568.

During
the
previous
ICR
period
many
of
the
HPV
Challenge
program
participants
undertook
a
search
for
any
existing
chemical
testing
studies
and
submitted
"
robust
summaries"
of
such
studies
to
EPA.
For
those
endpoints
not
adequately
covered
by
existing
studies,
sponsors
also
prepared
test
plans
and
submitted
these
to
EPA.
Based
on
the
studies
and
test
plans
received
by
February
2004,
EPA
estimates
that
the
current
sponsorship
program
encompasses
1,494
chemicals.
This
includes
1,267
chemicals
for
which
sponsors
had
submitted
test
plans
(
of
which
1,235
represented
chemicals
that
had
been
previously
sponsored
and
32
represented
chemicals
that
had
not.)
Test
plans
were
still
pending
for
259
chemicals
(
1,494
­
1,235
=
259).
On
an
annual
basis,
this
implies
422
sponsored
chemicals
per
year
(
1,267
÷
3)
will
be
addressed
by
filling
testing
gaps,
and
86
chemicals
per
year
(
259
÷
3)
will
be
addressed
through
test
plans
and
necessary
testing.

Following
review
of
a
subset
of
test
plans,
EPA
assumes
that
industry
participation
in
the
voluntary
HPV
Challenge
program
will
result
in
new
testing
to
satisfy
an
average
of
one
additional
endpoint
per
sponsored
chemical
during
the
first
year
of
this
ICR
for
those
chemicals
where
a
test
plan
has
been
submitted.
The
cost
per
endpoint
ranges
from
$
125
for
the
transportation/
distribution
endpoint
(
which
is
modeled)
to
$
113,977
for
the
repeated
dose
test
with
reproductive
and
developmental
toxicity.
The
weighted
average
cost
of
outstanding
testing
is
$
27,719,
obtained
by
weighting
the
cost
of
each
test
by
the
percent
of
chemicals
that
need
to
complete
the
test.

The
weighted
average
test
cost
is
assumed
to
carry
an
administrative
cost
equal
to
100
percent
of
the
test
cost.
This
is
greater
than
the
25
percent
burden
factor
EPA
normally
uses
for
test
rules
and
consent
orders/
agreements
and
is
reflective
of
the
relatively
lower
cost
of
the
HPV
tests
and
greater
degree
of
coordination
that
may
be
required
for
the
HPV
Challenge.
Thus,
the
administrative
cost
of
$
27,719
per
chemical
is
converted
into
a
burden
estimate
by
dividing
by
the
weighted
average
hourly
labor
of
$
43.31,
for
an
average
burden
of
672
hours
per
chemical.

For
the
259
chemicals
for
which
EPA
has
not
received
test
plans,
EPA
assumes
sponsors
will
submit
test
plans
during
the
ICR
period
and
conduct
all
necessary
testing.
For
purposes
of
estimating
testing
needs
for
these
chemicals,
EPA
analyzed
the
number
of
tests
proposed
for
chemicals
with
test
plans
submitted
and
found
that
approximately
70
percent
of
chemicals
had
no
testing
proposed
and
more
than
90
percent
proposed
fewer
than
five
tests.
EPA
assumed
that
each
test
plan
still
to
be
submitted
will
cover
five
endpoints
at
the
weighted
average
test
cost
of
$
27,719.
(
This
is
probably
a
conservative
estimate
since
the
median
number
of
tests
proposed
is
1.25).
Total
costs,
as
shown
in
Table
3,
at
a
cost
of
$
288,568.
The
cost
of
submitting
the
test
plan
is
estimated
at
two
hours
of
technical
time
using
a
loaded
labor
rate
of
$
46.09,
or
a
total
cost
of
$
92.17.
Table
3.
TSCA
Section
4
ICR
SIDS
TIER
I
(
HPV)
TESTING
Protocol
Name
Protocol
Number
Date
of
Estimate
Mean
Cost
Estimate
($
2003)\
a
Lab
Burden
(
hours)

BATTERY
1.
Melting
Point
OECD
102
04/
20/
98
$
1,453
13
2.
Boiling
Point
OECD
103
04/
20/
98
$
1,514
14
3.
Vapor
Pressure
OECD
104
06/
11/
98
$
15,224
118
4.
Water
Solubility
OECD
105
04/
20/
98
$
5,971
53
5.
Partition
Coefficient
(
shake
flask)
OECD
107
04/
20/
98
$
6,819
50
SUBTOTAL
$
30,981
248
6.
Photodegradation
OECD
113
$
5,886
62
7.
Inherent
Biodegradation
OECD
302
04/
20/
98
$
17,768
175
8.
Stability
in
Water
OECD
111
$
53,957
194
9.
Transportation/
Distribution
EQC
Model
$
125
2
SUBTOTAL
$
77,736
433
10.
Acute
Toxicity
to
Aquatic
Plants
OECD
201
05/
12/
98
$
8,914
62
11.
Acute
Toxicity
to
Fish
OECD
203
04/
16/
98
$
10,053
56
12.
Acute
Toxicity
to
Daphnia
OR
OECD
202(
I)
04/
20/
98
$
7,793
40
Chronic
Toxicity
to
Daphnia
850.1300
01/
18/
97
$
33,064
173
SUBTOTAL
(
Average)
$
39,369
225
13.
Acute
Oral
Toxicity
OR
OECD
401
03/
21/
98
$
3,440
41
Acute
Dermal
Toxicity
OR
OECD
402
03/
22/
98
$
4,942
43
Acute
Inhalation
Toxicity
OECD
403
04/
20/
98
$
16,532
184
SUBTOTAL
(
Average)
$
8,305
89
14.
Genetic
Toxicity
(
Salmonella)
OECD
471
03/
23/
98
$
7,182
44
15.
Chromosomal
Aberration,
in
vitro
OR
OECD
473
04/
20/
98
$
20,263
159
Chromosomal
Aberration,
in
vivo
OECD
474
04/
23/
98
$
16,109
130
SUBTOTAL
(
Average)
$
25,368
189
16.
Combined
Repeated
Dose
with
OECD
422
12/
08/
94
$
113,977
1,146
Repeated
Dose
Oral
Toxicity
AND
OECD
407
02/
15/
97
$
45,588
328
Repro./
Devel.
Toxicity
Screening
Test
OECD
421
04/
01/
97
$
54,054
445
SUBTOTAL
(
Average)
$
106,809
960
"
SIDS
TIER
I"
­
GRAND
TOTAL
$
288,568
2,144
Notes:
\
a
Cost
adjusted
to
end­
of­
year
2003
using
the
Bureau
of
Labor
Statistics'
Employment
Cost
Index.
See
Attachment
4.

The
number
of
sponsors
was
determined
based
on
a
review
of
HPV
chemical
sponsorship
patterns.
Currently
there
are
113
consortia
participating
in
the
program
and
these
consortia
account
for
approximately
one­
third
of
the
HPV
Challenge
chemicals,
or
493
chemicals
(
1,494
x
0.33).
The
remaining
1,001
chemicals
are
sponsored
individually.
The
total
number
of
sponsors
participating
is
thus
1,114
(
1,001
+
113),
and
the
ratio
of
chemicals
to
sponsors
is
approximately
1.33.
Applying
the
same
ratio
of
one
sponsor
per
1.33
chemicals
to
the
1,267
chemicals
for
which
test
plans
have
been
submitted,
EPA
estimates
there
are
a
total
of
953
sponsors
covering
these
chemicals.
For
the
259
chemicals
with
test
plans
outstanding,
EPA
estimates
there
will
be
195
sponsors
(
259
÷
1.33).
On
an
annual
basis,
this
translates
to
317
sponsors
of
chemicals
with
test
plans
submitted
and
65
sponsors
of
chemicals
with
test
plans
still
to
be
submitted.

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
in
Table
4.

Table
4.
Assumptions
Used
in
Estimating
Costs
and
Burdens
TSCA
Section
4
ICR
Assumptions
OSHA
Dermal
Test
Rule
Consent
Orders
and
Agreements
HPV
Challeng
e
w/
Test
Plans
HPV
Challenge
No
Test
Plans
Totals
a
No.
of
orders/
agreements
issued
1
1
1
1
4
b
Chemicals
per
order/
agreement
11
5
422
86
­­

c
Total
no.
of
chemicals
(
a
×
b)
11
5
422
86
524
d
No.
of
chemicals
per
sponsor
5
5
1.33
1.33
­­

e
No.
of
sponsors
per
rule
or
order
(
b
÷
d)
2
1
317
65
­­

f
Total
no.
of
sponsors
(
a
×
e)
2
1
317
65
385
g
Letters
of
intent/
study
plans
per
sponsor
1
1
1
1
­­

h
Total
letters
of
intent/
study
plans
(
f
×
g)
2
1
317
65
385
i
No.
of
short­
term
studies
per
chemical
2
7
1
5
­­

j
Total
no.
of
short­
term
studies
(
c
×
i)
22
35
422
430
909
k
No.
of
long­
term
studies
per
chemical
0
4
0
0
­­

l
Total
no.
of
long­
term
studies
(
c
×
k)
0
20
0
0
20
m
Total
no.
of
studies
per
chemical
(
i
+
k)
2
11
1
5
­

n
Total
no.
of
studies
(
j
+
l)
22
55
422
430
929
o
No.
of
semi­
annual
progress
reports
per
Short­
term
study
0
0
0
0
­­

Long­
term
study
0
5
0
0
­­

p
Total
no.
of
semi­
annual
progress
reports
Short­
term
studies
(
o
x
j)
0
0
0
0
0
Long­
term
study
(
o
x
l)
0
100
0
0
100
q
No.
of
final
reports
per
study
1
1
1
1
­­

r
Total
no.
of
final
reports
(
n
×
q)
22
55
422
430
929
s
Total
no.
of
reports
(
h
+
p
+
r)
24
156
739
495
1,414
t
Total
reports
per
sponsor
(
s
÷
f)
12
156
2
8
­­

u
Total
reports
per
rule/
order
(
s
÷
a)
24
156
739
495
­­

v
Total
reports
per
chemical
(
s
÷
c)
2
31
2
6
­­

w
No
of
exemptions
per
sponsor
5
0
0
0
­­

x
No.
of
exemptions
per
rule/
order
11
0
0
0
­­

y
Total
no.
of
exemptions
11
0
0
0
11
z
Total
no.
of
responses
(
s
+
y)
35
156
739
495
1,425
aa
No.
of
responses
per
rule/
order
(
e
+
x)
13
1
317
65
­­

bb
Total
no.
of
respondents
(
f
+
y)
13
1
317
65
396
6As
explained
above,
for
HPV
Challenge
chemicals
not
covered
by
test
plans
submitted
to
EPA
the
Agency
assumes
each
chemical
would
undertake
the
full
SIDS
Tier
1
battery
at
a
cost
of
$
288,568
per
chemical.

7
Some
long­
term
tests
assumed
to
be
conducted
under
consent
order
may
take
more
than
a
year
to
complete.
For
purposes
of
the
ICR
EPA
assumes
the
full
cost
and
burden
of
completing
the
testing
is
incurred
during
each
year.
Total
Number
of
Respondents
The
Agency's
estimates
assume
that
on
an
annual
basis
there
will
be
two
respondents
to
the
OSHA
dermal
test
rule,
one
respondent
to
an
enforceable
consent
orders
or
agreement,
317
sponsors
of
HPV
Challenge
chemicals
covered
by
test
plans
already
submitted
to
the
Agency,
and
65
sponsors
of
HPV
Challenge
chemicals
for
which
test
plans
have
yet
to
be
submitted
to
the
Agency
(
line
f),
for
a
total
of
385
respondents.
A
total
of
11
respondents
per
year
are
estimated
to
apply
for
exemptions
from
the
OSHA
dermal
test
rule
(
line
y).
The
estimated
annual
total
number
of
respondents
for
this
ICR
is
396
(
i.
e.,
385
sponsors
and
11
exemption
applicants)
(
Table
1,
line
bb).

Total
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,
2.4
reports
per
year
(
i.
e.,
929
reports
÷
385
sponsors
=
2.4).
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
covered
in
this
ICR.
Table
5
presents
estimates
of
the
laboratory
and
administrative
costs,
and
administrative
burdens.
These
are
discussed
in
detail
below.

Laboratory
Costs
The
costs
incurred
by
sponsors
performing
laboratory
testing
are
presented
in
Table
5.
Total
laboratory
costs
associated
with
activities
covered
by
this
ICR
are
estimated
to
be
$
30.24
million
per
year
(
line
f).
These
costs
include
$
0.30
million
for
the
OSHA
dermal
test
rule;
$
6.32
million
for
consent
orders
and
agreements;
$
11.70
million
for
testing
related
to
HPV
Challenge
chemicals
covered
by
test
plans;
and
$
11.92
million
for
HPV
Challenge
chemicals
not
yet
covered
by
test
plans.
6
With
a
projected
total
of
929
studies
to
be
conducted
(
line
d),
the
average
laboratory
cost
is
$
32,549
per
study
(
line
i).
7
Administrative
Costs
EPA's
experience
in
test
rule
development
has
shown
the
administrative
costs
associated
with
testing
programs
to
be
approximately
25
percent
of
the
laboratory
costs.
EPA
has
applied
this
25
percent
factor
to
estimate
the
administrative
costs
associated
with
the
OSHA
dermal
test
rules,
consent
orders
and
agreements,
and
actions
covered
in
the
current
ICR
period
related
to
the
HPV
Challenge
Program.
Following
these
assumptions,
the
total
administrative
cost
is
estimated
to
be
$
7.56
million
annually
(
line
g).
These
administrative
costs
are
assumed
to
comprise
both
reporting
and
non­
reporting
activities.

Administrative
Reporting
Costs
and
Burdens.
Part
of
the
administrative
costs
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
HPV
Challenge
program.

Estimates
of
the
respondents'
annual
reporting
costs
and
the
burdens
(
labor
hours)
associated
with
each
reporting
activity
are
detailed
in
Table
6.
The
unit
wage
rate
information
is
explained
in
Attachment
4.
The
unit
labor
hours
are
derived
from
previous
information
collection
requests
and
are
believed
to
be
reflective
of
the
annual
amount
of
time
required
for
each
activity
over
the
next
three
year
period.
The
total
annual
respondent
cost
and
burden
for
reporting
activities
is
$
3.56
million
and
85,357
hours
(
for
reporting
costs
see
Table
5,
line
g;
for
reporting
burdens
see
Table
5,
line
m).

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
and
in
Table
5.
Based
on
this
calculation,
non­
reporting
activities
associated
with
laboratory
testing
are
estimated
to
cost
$
4.00
million
annually.
These
costs
are
translated
into
burden
estimates
using
an
average
labor
cost
of
$
43.31
per
hour,
which
is
based
on
a
labor
mix
that
is
20
percent
managerial,
60
percent
technical,
and
20
percent
clerical.
The
estimated
burden
based
on
this
approach
is
92,349
hours
annually
(
for
non­
reporting
costs
see
Table
5,
line
g;
for
non­
reporting
burdens
see
Table
5,
line
m).
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.
Table
5.
Laboratory
Cost
and
Burden
Estimates
(
Annual)

TSCA
Section
4
ICR
Factors
OSHA
Dermal
Test
Rule
Consent
Orders/
Agre
ements
HPV
Challenge
w/
Test
Plans
HPV
Challenge
No
Test
Plans
TOTALS
/
1
a
Total
no.
of
rules/
orders
1
1
1
1
4
b
Total
no.
of
chemicals
11
5
422
86
524
c
Total
no.
of
sponsors
2
1
317
65
385
d
Total
no.
of
studies
22
55
422
430
929
e
Lab.
cost
per
chemical
$
27,190
$
1,264,454
$
27,719
$
138,595
$
57,706
f
Total
lab.
costs
(
b
×
e)
$
299,090
$
6,322,270
$
11,697,418
$
11,919,170
$
30,237,948
g
Admin.
reporting
costs
$
69,807
$
254,781
$
1,840,607
$
1,394,674
$
3,559,869
Admin.
non­
reporting
costs
$
4,966
$
1,325,787
$
1,083,748
$
1,585,119
$
3,999,620
Total
admin.
costs
/
a
$
74,773
$
1,580,568
$
2,924,355
$
2,979,793
$
7,559,489
h
Total
lab.
and
admin.
costs
(
f
+
g)
$
373,863
$
7,902,838
$
14,621,773
$
14,898,963
$
37,797,437
i
Lab.
costs
per
study
(
f
÷
d)
$
13,595
$
114,950
$
27,719
$
27,719
$
32,549
j
Admin.
costs
per
study
(
g
÷
d)
$
3,399
$
28,738
$
6,930
$
6,930
$
8,137
k
Total
testing
costs
per
study
(
i
+
j)
$
16,994
$
143,688
$
34,649
$
34,649
$
40,686
l
Total
testing
costs
per
sponsor
(
h
÷
c)
$
186,932
$
7,902,838
$
46,125
$
229,215
$
98,175
m
Admin.
reporting
burden
/
c
1,706
6,175
43,486
33,990
85,357
Admin.
non­
reporting
burden
/
b
115
30,612
25,023
36,599
92,349
Total
admin.
burden
1,821
36,787
68,509
70,589
177,706
n
Admin.
burden
per
study
(
m
÷
d)
83
669
162
164
191
o
Total
admin.
burden
per
sponsor
(
m
÷
c)
911
36,787
216
1,086
462
/
a
For
the
OSHA
dermal
test
rule
and
consent
orders/
agreements,
administrative
costs
and
burdens
are
assumed
to
equal
25
percent
of
laboratory
costs
and
burdens;
for
the
HPV
Challenge
chemicals,
administrative
costs
and
burdens
are
assumed
to
equal
100
percent
of
laboratory
costs
and
burdens.
/
b
The
non­
reporting
administrative
burden
is
estimated
by
dividing
the
administrative
cost
by
$
41.31,
which
represents
the
weighted
average
wage
rate.
The
weighted
average
wage
reflects
an
assumed
20/
60/
20
mix
of
managerial/
technical/
clerical
labor.
/
c
The
reporting
burdens
are
derived
in
Table
6.
Table
6.
Total
Annual
Respondent
Cost
and
Burden
for
Reporting
Activities
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
$
46.09
$
1,843.60
$
20.00
385
15,400
$
717,486
Prepare
Progress
Report
T
8
$
46.09
$
368.72
$
5.00
100
800
$
37,372
INTERIM
REPORTS
SUBTOTAL
$
2,212.32
16,200
$
754,858
FINAL
REPORTS
Short­
term
Studies
Record
and
Prepare
Test
for
Submission
T
40
$
46.09
$
1,843.60
$
0.00
909
36,360
$
1,675,832
Laboratory
Review
T
6
$
46.09
$
276.54
$
0.00
909
5,454
$
251,375
Corporate
Review
M
6
$
53.82
$
322.92
$
0.00
909
5,454
$
293,534
Type
and
Print
Results
S
20
$
24.46
$
489.20
$
0.00
909
18,180
$
444,683
Record
Keeping
S
1
$
24.46
$
24.46
$
5.00
909
909
$
26,779
Short­
term
Subtotal
$
2,956.72
66,357
$
2,692,203
Long­
term
Studies
Record
and
Prepare
Test
for
Submission
T
80
$
46.09
$
3,687.20
$
0.00
20
1,600
$
73,744
Laboratory
Review
T
9
$
46.09
$
414.81
$
0.00
20
180
$
8,296
Corporate
Review
M
9
$
53.82
$
484.38
$
0.00
20
180
$
9,688
Type
and
Print
Results
S
40
$
24.46
$
978.40
$
0.00
20
800
$
19,568
Record
Keeping
S
1
$
24.46
$
24.46
$
5.00
20
20
$
589
Long­
term
Subtotal
$
5,589.25
929
2,780
$
111,885
FINAL
REPORTS
SUBTOTAL
69,137
$
2,804,088
EXEMPTION
REQUESTS
T
2
$
46.09
$
92.18
$
0.00
11
22
$
1,014
/
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
5.
6(
b)
Agency
Cost
and
Burden
The
cost
and
burden
to
the
Agency
to
process,
review,
and
analyze
the
information
collected
under
TSCA
section
4
test
rules,
consent
orders
and
agreements,
and
voluntary
testing
programs
is
discussed
below
and
detailed
in
Table
7.

The
Agency
collection
procedures
are
estimated
to
be
accomplished,
on
average,
by
a
GS­
13,
Step
1
employee.
The
annual
2004
loaded
cost
of
a
full­
time
equivalent
(
FTE)
for
this
level
employee
is
$
115,373.
This
includes
a
base
wage
of
$
72,108
plus
60
percent
for
overhead
and
benefits
(
i.
e.,
$
43,265).
Dividing
this
value
by
2,080
(
i.
e.,
the
number
of
hours
in
a
work
year)
equals
an
hourly
wage
rate
of
$
55.47
(
see
Attachment
4
for
the
derivation
of
these
factors).

AGENCY
LABOR
CATEGORY
LOADED
HOURLY
RATE
($
2004)

GS­
13,
Step
1
$
55.47
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
ICRs
and
is
presented
in
Table
7.
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
$
0.33
million
and
5,900
hours
(
or
2.8
FTEs).
The
Agency's
annual
exemption
processing
costs
and
burden
is
$
610
and
11
hours.

Table
7.
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
$
55.47
$
166.41
$
0.00
385
1,155
$
64,068
Progress
Reports
1
$
55.47
$
55.47
$
0.00
100
100
$
5,547
Final
Reports
5
$
55.47
$
277.35
$
0.00
929
4,645
$
257,658
SUBTOTAL
1,414
5,900
$
327,273
Exemptions
1
55.47
$
55.47
$
0.00
11
11
$
610
GRAND
TOTAL
1,425
5,911
$
327,883
6(
c)
Annual
Burden
Hours
and
Costs
6(
c)(
i)
Respondent
Tally
Table
8
summarizes
the
average
burden
per
response.
EPA
estimates
that
this
ICR
will
impose
177,707
burden
hours
on
respondents
annually.
This
total
burden
covers
1,425
responses
annually
for
an
average
of
125
hours
per
response.
Table
8.
Average
Burden
Hours
Per
Response
COLLECTION
ACTIVITY
RESPONDENT
BURDEN
PER
RESPONSE
TOTAL
HOURS
TOTAL
ITEMS
HOURS
PER
RESPONSE
Reporting
Activities
Letters
of
Intent/
Study
Plans
15,400
385
40
Progress
reports
800
100
8
Final
Reports
69,137
929
74
Exemption
Requests
22
11
2
Subtotal
(
all
responses)
85,359
1,425
60
Non­
reporting
activities
92,348
1,425
65
Total
177,707
1,425
125
The
total
burden
hours
and
costs
for
respondents
have
been
calculated
above
in
Table
6.
Table
9
summarizes
these
estimated
annual
burden
hours
and
costs.

Table
9.
Summary
of
Respondent
Burden
and
Costs
Estimates
COLLECTION
ACTIVITY
Total
Hours
Cost
Reporting
activities
Letters
of
Intent
and
study
plans
15,400
$
717,486
Progress
reports
800
$
37,372
Final
Reports
69,137
$
2,804,088
Exemption
Requests
22
$
1,014
Subtotal
85,359
$
3,559,960
Non­
reporting
activities
92,348
$
3,999,612
TOTAL
(
all
responses)
177,707
$
7,559,572
6(
c)(
ii)
Agency
Tally
The
burden
hours
and
costs
for
the
government
have
been
calculated
above
in
Table
7.
These
estimates
are
summarized
below
in
Table
10.
Table
10.
Summary
of
Agency
Burden
and
Costs
Estimates
COLLECTION
ACTIVITY
TOTAL
AGENCY
BURDEN
AND
COSTS
BURDEN
(
Hours)
COSTS
Letter
of
Intent
and
Study
Plans
1,155
$
64,068
Progress
Reports
100
$
5,547
Final
Reports
4,645
$
257,658
Exemptions
11
$
610
TOTAL
5,911
$
327,883
6(
d)
Reasons
for
Changes
in
Burden
Compared
with
the
previous
ICR
the
present
ICR
represents
an
decrease
in
the
respondent
burden
from
1.18
million
to
177,707
hours,
or
a
decrease
of
1.00
million
hours.
The
respondent
cost
decreases
from
$
51.04
million
to
$
7.56
million,
or
a
decrease
of
$
43.48
million.

In
the
previous
ICR,
the
Agency's
estimated
burden
was
based
on
the
assumption
that
it
would
issue
three
average
test
rules
and
eight
ECAs,
and
included
estimates
of
testing
needs
to
be
completed
under
the
voluntary
HPV
Challenge
and
the
voluntary
Children's
Chemical
Evaluation
Program.
For
this
ICR,
the
burden
is
based
on
the
Agency's
expectation
that
it
will
issue
one
test
rule
and
three
ECAs,
and
also
the
Agency's
estimate
of
the
expected
level
of
testing
remaining
to
be
done
under
the
HPV
Challenge
Program.
Therefore,
total
annual
burden
has
decreased.
However,
burden
per
respondent
has
increased
because
this
analysis
includes
additional
nonreporting
administrative
burden
that
was
not
included
in
the
previous
analysis.

In
addition
to
these
changes,
the
Agency
has
adjusted
all
costs
to
reflect
an
update
in
the
labor
rates,
and
more
recent
laboratory
testing
costs.

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
125
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
numbers
for
EPA's
regulations
in
title
40
of
the
CFR,
after
appearing
in
the
Federal
Register,
are
listed
in
40
CFR
part
9
and
included
on
the
related
collection
instrument
or
form,
if
applicable.

To
comment
on
the
Agency's
need
for
this
information,
the
accuracy
of
the
provided
burden
estimates,
and
any
suggested
methods
for
minimizing
respondent
burden,
including
the
use
of
automated
collection
techniques,
EPA
has
established
a
public
docket
for
this
ICR
under
Docket
ID
No.
OPPT­
2004­
0098,
which
is
available
for
public
viewing
at
the
Pollution
Prevention
and
Toxics
Docket
in
the
EPA
Docket
Center
(
EPA/
DC),
EPA
West,
Room
B102,
1301
Constitution
Ave.,
NW,
Washington,
DC.
The
EPA
Docket
Center
Public
Reading
Room
is
open
from
8:
30
a.
m.
to
4:
30
p.
m.,
Monday
through
Friday,
excluding
legal
holidays.
The
telephone
number
for
the
Reading
Room
is
(
202)
566­
1544
and
the
telephone
number
for
the
Pollution
Prevention
and
Toxics
Docket
is
(
202)
566­
0280.
An
electronic
version
of
the
public
docket
is
available
through
EPA
Dockets
(
EDOCKET)
at
http://
www.
epa.
gov/
edocket.
Use
EDOCKET
to
submit
or
view
public
comments,
access
the
index
listing
of
the
contents
of
the
public
docket,
and
to
access
those
documents
in
the
public
docket
that
are
available
electronically.
Once
in
the
system,
select
"
search,"
then
key
in
the
docket
ID
number
identified
above.
Also,
you
can
send
comments
to
the
Office
of
Information
and
Regulatory
Affairs,
Office
of
Management
and
Budget,
725
17th
Street,
NW,
Washington,
DC
20503,
Attention:
Desk
Office
for
EPA.
Please
include
the
EPA
Docket
ID
No.
OPPT­
2004­
0098
and
OMB
control
number
2070­
0033
in
any
correspondence.

References
USEPA
2004.
Economic
Impact
Analysis
and
Small
Entity
Impact
Analysis
of
the
TSCA
Section
4(
a)
Test
Rule
for
34
Chemicals
Targeted
for
in
Vitro
Dermal
Absorption
Rate
Testing.
Economic
and
Policy
Analysis
Branch,
Economics,
Exposure
and
Technology
Division,
Office
of
Pollution
Prevention
and
Toxics.
February
3,
2004.

USEPA
2002.
"
Wage
Rates
for
Economic
Analysis
of
the
Toxics
Release
Inventory
Program."
Memorandum
from
Cody
Rice,
Analytical
Support
Branch,
Environmental
Analysis
Division,
Office
of
Environmental
Information,
U.
S.
EPA.
April
11,
2002.

USEPA
1989.
"
Administrative
costs
and
burden
hours
for
test
rule."
Note
from
Dan
Axelrad
to
Bob
Lee
and
Libby
Parker,
Regulatory
Impacts
Branch,
Office
of
Pollution
Prevention
and
Toxics,
U.
S.
EPA.
October
26,
1989.
ATTACHMENTS
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
Attachment
4
­
Wage
Rates
Estimation
Attachment
5
­
Supplemental
Break­
Outs
for
Table
4