Document ID: EPA-HQ-OPPT-2004-0098-0009
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2005-02-07T05:00Z

January
25,
2005
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.
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.)
January
25,
2005
­
2­
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.
January
25,
2005
­
3­
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
January
25,
2005
­
4­
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,
in
conjunction
with
exposure
information,
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
and
workers
for
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
and/
or
maintaining
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
January
25,
2005
­
5­
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
focused
on
chemicals
with
clearly
identified
data
"
needs"
(
as
opposed
to
simply
data
gaps).
In
addition,
almost
250
formal
TSCA
Section
4
"
Decisions
Not
To
Test"
(
DNTs)
have
been
issued
by
EPA
to
date.
Screening
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.
January
25,
2005
­
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
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
In
proposing
to
renew
this
ICR,
EPA
provided
a
60­
day
public
notice
and
comment
period
that
ended
on
August
30,
2004
(
69
FR
39464,
June
30,
2004).
EPA
received
comments
from
the
American
Chemistry
Council
(
ACC)
and
the
Synthetic
Organic
Chemical
Manufacturers
Association
(
SOCMA).
These
comments
are
addressed
in
Attachment
4
to
this
ICR
Supporting
Statement.

3(
c)
Consultations
The
Agency
has
issued
two
procedural
rules
on
the
test
rule
development
and
exemption
process
(
October
1984
and
May
1985)
and
one
procedural
rule
on
the
consent
order
process
(
June
1986)
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.

Previous
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.

In
addition
to
the
public
notice
and
comment
period
required
by
the
OMB
regulations
that
implement
the
Paperwork
Reduction
Act
(
see
Section
3(
b)
of
this
Supporting
Statement),
the
OMB
regulations,
5
CFR
1320.8(
d)(
1),
also
require
agencies
to
consult
with
potential
ICR
January
25,
2005
­
7­
respondents
and
data
users
about
specific
aspects
of
an
ICR
before
the
agency
submits
the
ICR
to
OMB
for
review
and
approval.
In
accordance
with
this
regulation
and
based
on
OPPTS
Regulatory
Coordination
Staff
guidance,
EPA
submitted
questions
to
nine
parties
via
email.
A
copy
of
the
Agency's
email
with
consultation
questions
to
the
above
nine
parties
is
provided
as
Attachment
5
to
this
Supporting
Statement.
The
Agency
received
no
responses
to
this
solicitation
for
comments.

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.
January
25,
2005
­
8­
3(
h)
Electronic
Reporting
A
description
of
data
collection/
management
activities
specifically
regarding
the
High
Production
Volume
(
HPV)
Chemical
Challenge
Program,
including
electronic
reporting
of
data,
is
presented
in
Section
5(
b).

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.

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.
January
25,
2005
­
9­
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
searches
for
relevant
existing
data.
If
data
are
found:
­
Determine
whether
the
data
are
relevant;
­
Prepare
and
review
summary
of
existing
data;
and
­
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:
January
25,
2005
­
10­
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
Information
and
Testing
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
January
25,
2005
­
11­
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;
and
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
within
EPA's
TSCA
Chemical
Testing
Program,
the
specific
data
requested,
the
testing
necessary
to
generate
those
data
­
along
with
the
test
protocols,
the
time
frame
for
completing
the
testing,
and
the
date
by
which
the
requested
data
are
to
be
submitted
to
the
Agency,
are
established
in
the
TSCA
Section
4
Test
Rule,
TSCA
Section
4
Enforceable
Consent
Agreement
(
ECA),
or
Voluntary
Testing
Agreement
(
VTA).
Information
about
the
data
collection/
management
activities
specifically
regarding
the
High
Production
Volume
(
HPV)
Chemical
Challenge
Program
is
presented
at
the
end
of
this
discussion
It
is
also
important
to
note
that
the
TSCA
Chemical
Testing
Program
is
an
integral
component
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.
In
addition
to
being
housed
in
an
appropriate
EPA
TSCA
docket,
reference
to
the
data
are
entered
into
the
TSCA
Test
Submission
Database
(
TSCATS).
TSCATS
is
a
publicly
available,
online
index
to
unpublished,
nonconfidential
studies
covering
chemical
testing
results
and
other
submitted
studies
on
the
possible
effects
of
chemicals
on
health
and
ecological
systems.
Submitted
studies
are
indexed
in
TSCATS
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
January
25,
2005
­
12­
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
as
well
as
the
public
at
large.
TSCATS
was
developed
by
EPA
in
1985
to
make
the
results
of
ongoing
and
completed
chemical
testing
available
to
the
public
and
includes
chemical
exposure
studies,
epidemiology,
environmental
fate,
monitoring,
episodic
incidents,
such
as
spills
and
case
reports.
There
are
four
primary
types
of
documents
referenced
in
the
TSCATS
database:
TSCA
section
4
chemical
testing
results,
TSCA
section
8(
d)
health
and
safety
studies,
TSCA
section
8(
e)
substantial
risk
of
injury
to
health
or
the
environment
notices,
and
voluntary
documents
submitted
to
EPA
known
as
For
Your
Information
(
FYI)
submissions.
TSCATS
is
available
through
a
number
of
electronic
sources;
the
studies
referenced
in
TSCATS
can
be
viewed
in
EPA's
public
TSCA
docket
located
at
EPA's
Headquarters
in
Washington,
DC
or,
alternatively,
via
microfiche
copies
that
are
available
through
the
National
Technical
Information
Service
(
NTIS).

HPV
Challenge
Program
Public
access
to
hazard
data
is
integral
to
the
HPV
Challenge
Program.
Test
plan
and
data
summary
submissions,
sponsor
commitment
information,
chemical
lists,
guidance
documents,
and
other
materials
can
be
found
at
the
HPV
Challenge
Program
web
site
(
http://
www.
epa.
gov/
chemrtk/
volchall.
htm).
EPA
has
recently
provided
enhanced
search
capability
on
its
existing
"
Robust
Summaries
and
Test
Plans"
web
page
(
http://
www.
epa.
gov/
chemrtk/
hpvrstp.
htm)
that
allows
the
public
to
more
efficiently
search
for
test
plan
and
data
summary
submissions.

Production
of
the
HPV
Information
System
(
HPVIS),
a
much
more
comprehensive,
datasearchable
application,
is
the
ultimate
goal.
This
system
will
allow
users
to
thoroughly
search
across
all
test
plan
and
data
summary­
related
materials
 
including
the
data
presented
within
and
among
data
summaries.
Among
other
features,
the
system
will
ultimately
allow
the
user
to
locate
specific
endpoint
data,
and
it
will
recognize
certain
sponsor­
provided
chemical
synonym
names
in
addition
to
the
officially
recognized
chemical
name.
The
first
release
of
HPVIS
is
scheduled
for
late
2004
/
early
2005.

As
the
HPV
Challenge
Program
enters
its
final
year
and
as
EPA
prepares
to
provide
the
industry­
submitted
data
to
the
public
in
a
searchable
database
format,
the
Agency
has
made
great
strides
to
press
forward
with
developing
and
planning
for
the
delivery
of
a
Global
HPV
Portal.
The
Portal
is
a
system
that
will
provide
a
central
location
for
domestic
and
international
users
to
access
consolidated
international
HPV
chemical
data
repositories.
EPA
is
collaboratively
working
with
the
European
Union,
in
consultation
with
the
Organization
for
Economic
Cooperation
and
Development
(
OECD),
and
with
the
additional
participation
of
Canada
and
Japan
to
develop
this
system.
The
aim
of
the
Global
HPV
Portal
is
to
provide
seamless
information
sharing
between
the
European
Union's
(
E.
U.)
International
Uniform
Chemical
Information
Database
(
IUCLID)
and
EPA's
HPVIS.
The
two
leads
 
the
European
Commission
(
EC)
and
EPA
 
have
worked
diligently
on
the
Portal
requirements
in
an
effort
to
share
information
and
make
data
more
readily
available
to
stakeholders
from
around
the
world.

5(
c)
Small
Entity
Flexibility
January
25,
2005
­
13­
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
onoccasion
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
of
the
potential
number
of
consent
orders
and
agreements,
and
the
current
and
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
January
25,
2005
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.

­
14­
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
arise
during
the
approval
period
for
this
ICR,
but
are
not
currently
specifically
addressed
in
this
ICR.
In
most
cases
this
is
because
the
scope
of
such
activities
can
not
be
estimated
or
the
activity
is
otherwise
still
under
development.
The
Agency
has
identified
other
potential
testing
activities
(
rules,
ECAs
or
VTAs)
in
the
Semi­
Annual
Regulatory
Agenda
(
see
http://
www.
epa.
gov/
fedrgstr/
unified.
htm,
and
look
up
the
listing
for
actions
under
TSCA).
If
any
of
these
activities
are
finalized
during
the
three
year
approval
period
for
this
ICR,
the
Agency
will
need
to
ensure
that
those
activities
are
approved
under
this
ICR.
For
rulemakings,
the
ICR
will
be
amended
when
the
final
rule
is
issued
(
see
further
discussion
of
the
rulemaking
process
below).
For
ECAs
and
VTAs,
the
ICR
covers
the
burden
predicted,
but,
if
the
Agency
subsequently
determines
that
the
total
annual
burden
covered
by
this
ICR
needs
to
be
increased
(
e.
g.,
should
the
ECAs
completed
during
the
approval
cycle
exceed
the
predictions
in
this
ICR),
the
Agency
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
TSCA
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
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,
thus
11
chemicals
are
assumed
to
be
tested
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
January
25,
2005
­
15­
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
of
$
6,797
per
chemical,
for
a
total
of
$
33,987
per
chemical
in
2003
dollars
(
USEPA
2004).
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.

Although
several
other
TSCA
section
4
rules
are
under
development,
they
are
not
currently
covered
by
this
ICR.
Until
a
final
TSCA
section
4
rule
is
issued,
the
proposed
data
collection
activities
in
the
proposed
rule
­
or
under
consideration
prior
to
proposal
­
are
not
authorized.
The
estimated
paperwork
burden
and
costs
for
a
proposed
TSCA
section
4
rule
are
provided
for
public
comment
at
the
time
of
the
proposal,
and
in
the
context
of
the
proposal.
At
that
time,
the
Agency
connects
the
proposal
to
this
ICR
and
indicates
that
the
final
rule
will
present
the
adjusted
estimates
­
adjusted
to
reflect
public
comment
received
and
the
content
of
the
final
rule.
In
the
context
of
finalizing
a
TSCA
section
4
rule,
the
Agency
submits
an
addendum
or
amendment
for
this
ICR
to
OMB
for
review
and
approval
under
the
PRA.
Once
approved
by
OMB,
the
total
authorized
burden
and
costs
under
this
ICR
is
then
adjusted
by
OMB
to
include
the
collection
activities
in
the
final
rule,
thereby
authorizing
or
approving
them
as
required
by
the
PRA.
When
the
Agency
prepared
the
next
renewal
package
for
ICR,
the
approved
burden
for
any
such
final
rules
will
be
incorporated
into
the
Supporting
Statement
for
the
Renewal
ICR.

As
indicated
in
the
terms
of
clearance
for
this
ICR,
OMB
has
told
the
Agency
that
no
estimated
burden
or
costs
for
proposed
rules
will
be
approved
under
this
ICR
until
the
final
rule
is
issued
and
OMB
specifically
approves
an
amendment
to
the
ICR
to
capture
the
approval
of
the
activities
in
the
final
rule.
This
is
consistent
with
the
OMB
regulations
for
the
PRA.

Consent
Orders
and
Enforceable
Consent
Agreements
Based
on
historical
experience
with
the
TSCA
testing
program
and
expected
consent
order
activity
over
the
three
year
ICR
period,
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
January
25,
2005
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.

­
16­
battery
(
see
Table
1).
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
3.

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
1.
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
Table
1.
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
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.
January
25,
2005
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.

­
17­
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
section
4
test
rules
and
would
provide
recognition
to
Challenge
participants
for
their
voluntary
actions.

Table
2
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.

Table
2.
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
January
25,
2005
Table
2.
TSCA
Section
4
ICR
SIDS
TIER
I
(
HPV)
TESTING
Protocol
Name
Protocol
Number
Date
of
Estimate
Mean
Cost
Estimate
($
2003)
a
Lab
Burden
(
hours)

6
For
aquatic
toxicity
tests,
EPA
assumed
that
labs
running
both
OECD
201
(
acute
toxicity
to
aquatic
plants)
and
OECD
203
(
acute
toxicity
to
fish)
would
use
the
same
matrix
and
thus
would
only
need
to
run
the
validation
once.
For
these
two
tests,
therefore,
EPA
assigned
half
the
short
term
validation
cost,
or
$
1,750.

­
18­
SUBTOTAL
(
AVERAGE)
$
25,368
189
16.
Combined
Repeated
Dose
with
Repro./
Devel.
Toxicity
Screen
OR
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
a
Cost
adjusted
to
end­
of­
year
2003
using
the
Bureau
of
Labor
Statistics'
Employment
Cost
Index.
See
Attachment
3.

EPA
has
also
included
costs
for
analytical
chemistry
method
development
and
validation
where
it
was
judged
that
such
method
development
would
be
necessary
to
conform
to
good
laboratory
practices.
Method
development
and
validation
is
typically
performed
to
determine
the
effectiveness
of
an
analytical
method
to
determine
the
levels
of
the
chemical
in
the
dosing
matrix
in
toxicity
studies.
For
each
of
SIDS
Tier
1
toxicity
tests
shown
in
Table
2,
EPA
assigned
a
method
development
and
validation
cost
of
$
3,500
for
short
term
studies
and
$
8,500
for
longterm
studies,
based
on
typical
costs
cited
by
industry
experts
(
Piccirillo
2004).
6
For
chemicals
undergoing
the
complete
suite
of
SIDS
tests,
analytical
chemistry
method
development
and
validation
adds
$
40,250
to
the
$
288,568
in
testing
costs,
for
a
total
laboratory
cost
of
$
328,818.

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
for
which
a
test
plan
has
been
submitted.
The
cost
per
endpoint
ranges
from
$
125
for
the
transportation/
distribution
endpoint
(
which
is
modeled)
to
$
122,477
for
the
repeated
dose
test
with
reproductive
and
developmental
toxicity.
The
weighted
average
cost
of
outstanding
testing,
including
validation,
is
$
32,906,
obtained
by
weighting
the
cost
of
each
test
by
the
percent
of
chemicals
that
need
to
complete
the
test.
January
25,
2005
­
19­
Submitters
are
assumed
to
incur
an
administrative
cost
equal
to
25
percent
of
the
test
cost,
the
burden
factor
EPA
normally
uses
for
test
rules
and
consent
orders/
agreements.
Using
the
weighted
average
test
cost
of
$
32,906,
the
average
administrative
cost
is
$
8,227.
This
is
divided
by
the
weighted
average
hourly
labor
rate
of
$
43.31,
for
an
average
burden
of
190
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
$
32,906
for
a
total
of
$
164,530.
(
This
is
probably
a
conservative
estimate
since
the
median
number
of
tests
proposed
is
1.25).
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.

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:
1.
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
who
have
already
submitted
test
plans
and
65
sponsors
with
test
plans
still
outstanding.

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
3.

Table
3.
Assumptions
Used
in
Estimating
Costs
and
Burdens
TSCA
Section
4
ICR
Assumptions
OSHA
Dermal
Test
Rule
Consent
Orders
and
Agreements
HPV
Challenge
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
©
×
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
©
×
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
January
25,
2005
Table
3.
Assumptions
Used
in
Estimating
Costs
and
Burdens
TSCA
Section
4
ICR
Assumptions
OSHA
Dermal
Test
Rule
Consent
Orders
and
Agreements
HPV
Challenge
w/
Test
Plans
HPV
Challenge
No
Test
Plans
Totals
­
20­
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
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
3,
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,
3.7
reports
per
year
(
i.
e.,
1,414
reports
÷
385
sponsors
=
3.7).
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
January
25,
2005
7Some
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.

­
21­
The
costs
incurred
by
sponsors
performing
laboratory
testing
are
presented
in
Table
4.
Total
laboratory
costs
associated
with
activities
covered
by
this
ICR
are
estimated
to
be
$
34.66
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;
$
13.89
million
for
testing
related
to
HPV
Challenge
chemicals
covered
by
test
plans;
and
$
14.15
million
for
HPV
Challenge
chemicals
not
yet
covered
by
test
plans.
With
a
projected
total
of
929
studies
to
be
conducted
(
line
d),
the
average
laboratory
cost
is
$
37,306
per
study
(
line
i).
7
Table
4.
Laboratory
Cost
and
Burden
Estimates
(
Annual)

TSCA
Section
4
ICR
Factors
OSHA
Dermal
Test
Rule
Consent
Orders/
Agreeme
nts
HPV
Challenge
w/
Test
Plans
HPV
Challenge
No
Test
Plans
TOTALS
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
$
32,906
$
164,530
$
66,140
f
Total
lab.
costs
(
b
×
e)
$
299,090
$
6,322,270
$
13,886,332
$
14,149,580
$
34,657,272
g
Admin.
reporting
costs
$
69,899
$
254,781
$
1,985,191
$
1,394,674
$
3,704,545
Admin.
non­
reporting
costs
$
4,874
$
1,325,787
$
1,486,392
$
2,142,721
$
4,959,774
Total
admin.
costs
a
$
74,773
$
1,580,568
$
3,471,583
$
3,537,395
$
8,664,319
h
Total
lab.
and
admin.
costs
(
f
+
g)
$
373,863
$
7,902,838
$
17,357,915
$
17,686,975
$
43,321,591
i
Lab.
costs
per
study
(
f
÷
d)
$
13,595
$
114,950
$
32,906
$
32,906
$
37,306
j
Admin.
costs
per
study
(
g
÷
d)
$
3,399
$
28,738
$
8,227
$
8,227
$
9,327
k
Total
testing
costs
per
study
(
i
+
j)
$
16,994
$
143,688
$
41,133
$
41,133
$
46,632
l
Total
testing
costs
per
sponsor
(
h
÷
c)
$
186,932
$
7,902,838
$
54,757
$
272,107
$
112,524
m
Admin.
reporting
burden
b
1,708
6,175
46,623
33,990
88,496
Admin.
non­
reporting
burden
c
113
30,612
34,320
49,474
114,519
Total
admin.
burden
1,821
36,787
80,943
83,464
203,015
n
Admin.
burden
per
study
(
m
÷
d)
83
669
192
194
219
o
Total
admin.
burden
per
sponsor
(
m
÷
c)
911
36,787
255
1,284
527
a
Administrative
costs
and
burdens
are
assumed
to
equal
25
percent
of
laboratory
costs
and
burdens.
b
The
reporting
burdens
are
derived
in
Table
6.
c
The
non­
reporting
administrative
burden
is
estimated
by
dividing
the
administrative
cost
by
$
43.31,
which
represents
the
weighted
average
wage
rate.
The
weighted
average
wage
reflects
an
assumed
20/
60/
20
mix
of
managerial/
technical/
clerical
labor.

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
$
8.66
million
annually
(
line
g).
These
administrative
costs
are
assumed
to
comprise
both
reporting
and
non­
reporting
activities.
January
25,
2005
­
22­
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.

In
addition,
EPA
is
currently
developing
a
new
HPV
Information
System
(
HPVIS)
for
all
HPV
Challenge
submissions.
A
key
focus
of
that
effort
is
to
put
HPV
data
into
a
database
to
facilitate
more
robust
search
capabilities.
In
August
2004,
EPA
sent
a
letter
to
HPV
sponsors
asking
if
they
would
be
willing
to
resubmit
information
they
had
already
submitted
in
a
format
consistent
with
HPVIS.
The
317
sponsors
assumed
to
have
already
submitted
test
plans
have
three
options
for
resubmission:

Option
1:
Sponsor
may
enter
previously
submitted
data
directly
into
HPVIS,
which
EPA
estimates
will
take
8
to
16
hours
to
complete.

Option
2:
Sponsor
may
submit
an
International
Uniform
Chemical
Information
Database
(
IUCLID)
4.02
export
file
to
EPA
and
will
validate
the
submission
once
EPA
completes
the
upload
to
the
HPVIS.
EPA
estimates
this
option
to
take
one
hour
to
complete.

Option
3:
Sponsor
may
validate
previously
submitted
data
that
are
entered
by
EPA
into
the
HPVIS.
In
this
case
there
is
no
incremental
burden
for
sponsors
but
the
Agency
burden
would
increase.

Estimates
of
the
respondents'
annual
reporting
costs
and
the
burden
associated
with
each
reporting
activity
are
detailed
in
Table
5.
The
unit
wage
rate
information
is
explained
in
Attachment
3.
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.

As
noted
above,
317
sponsors
have
submitted
test
plans
and
will
have
to
resubmit
test
plan
data
in
electronic
format.
To
estimate
this
burden,
EPA
assumed
that
data
in
IUCLID
format
exists
for
60
percent,
or
750
of
the
1,267
HPV
chemicals
(
Moore
2004)
and
has
estimated
the
burden
for
the
remaining
chemicals
at
16
hours
per
chemical,
based
on
the
high
end
of
the
estimates
for
the
three
submission
option
s
(
i.
e.,
via
the
HPVIS
system).
For
the
65
sponsors
who
have
not
yet
submitted
test
plans,
EPA
assumes
that
40
hour
administrative
burden
assigned
for
each
chemical
includes
electronic
submission
of
the
test
plans.
The
total
annual
respondent
cost
and
burden
for
reporting
activities
is
$
3.70
million
and
88,496
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
January
25,
2005
­
23­
difference
between
the
total
administrative
costs
and
burdens
and
the
reporting
costs
and
burdens
derived
above
and
in
Table
4.
Based
on
this
calculation,
non­
reporting
activities
associated
with
laboratory
testing
are
estimated
to
cost
$
4.96
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
114,519
hours
annually
(
for
non­
reporting
costs
see
Table
4,
line
g;
for
non­
reporting
burdens
see
Table
5,
line
m).
January
25,
2005
­
24­

Table
5.
Total
Annual
Respondent
Cost
and
Burden
for
Reporting
Activities
COLLECTION
ACTIVITY
UNIT
LABOR
UNIT
SUPPLY
COSTS
ANNUAL
ITEMS
GRAND
TOTAL
TYPE
a
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
Electronic
Submission
of
Past
Study
Plans
via
HPVIS
T
16
$
46.09
$
737.44
$
0.00
188
3,008
$
138,639
Electronic
Submission
of
Past
Study
Plans
via
IUCLID
T
1
$
46.09
$
46.09
$
0.00
129
129
$
5,946
Prepare
Progress
Report
T
8
$
46.09
$
368.72
$
5.00
100
800
$
37,372
INTERIM
REPORTS
SUBTOTAL
$
2,995.85
19,337
$
899,442
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
TOTALS
88,496
$
3,704,545
a
Labor
Type
 
T
=
Technical;
M
=
Managerial;
S
=
Secretarial
January
25,
2005
­
25­
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,
consent
orders
and
agreements,
and
voluntary
testing
programs
are
discussed
below
and
detailed
in
Table
6.

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
3
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
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
$
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
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
$
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
January
25,
2005
­
26­
6(
c)
Annual
Burden
Hours
and
Costs
6(
c)(
i)
Respondent
Tally
Table
7
summarizes
the
average
burden
per
response.
EPA
estimates
that
this
ICR
will
impose
203,014
burden
hours
on
respondents
annually.
This
total
burden
covers
1,425
responses
annually
for
an
average
of
142
hours
per
response.

Table
7.
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
18,537
385
48
Progress
reports
800
100
8
Final
Reports
69,137
929
74
Exemption
Requests
22
11
2
Subtotal
(
all
responses)
88,496
1,425
62
Non­
reporting
activities
114,518
1,425
80
Total
203,014
1,425
142
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
Hours
Cost
Reporting
activities
Letters
of
Intent
and
study
plans
18,537
$
862,071
Progress
reports
800
$
37,372
Final
Reports
69,137
$
2,804,088
Exemption
Requests
22
$
1,014
Subtotal
88,496
$
3,704,545
Nonreporting
activities
114,518
$
4,959,774
TOTAL
(
all
responses)
203,014
$
8,664,319
6(
c)(
ii)
Agency
Tally
January
25,
2005
­
27­
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
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
1,182,574
hours
to
203,014
hours,
or
a
decrease
of
979,560
hours.
The
respondent
cost
decreases
from
$
51.04
million
to
$
8.66
million,
or
a
decrease
of
$
42.38
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
142
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
January
25,
2005
­
28­
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
Moore
2004.
Jack
Moore,
Memo
to
National
Pollution
Prevention
and
Toxics
Advisory
Committee,
part
of
minutes
from
May
13,
2004
meeting,
available
at
www.
epa.
gov/
oppt/
npptac/
summarymay2004.
pdf.

Piccirillo
2004.
Vincent
Piccirillo,
personal
communication.
September
20,
2004.

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.
January
25,
2005
­
29­
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
­
Wage
Rates
Estimation
Attachment
4
­
EPA
Response
to
Public
Comments
Attachment
5
­
Section
3(
c)
Consultations
Note:
Attachments
not
included
in
the
electronic
file
for
the
supporting
statement
are
available
electronically
in
a
separatefile
as
indicated
above
or
by
accessing
the
docket
for
this
ICR
at
http://
www.
epa.
gov/
edocket.
Use
the
"
Quick
Search"
for
a
docket
function
and
Docket
ID
No.
OPPT­
2004­
0098.
January
25,
2005
ATTACHMENT
1
Toxic
Substances
Control
Act
Section
4
15
USC
2603
January
25,
2005
TITLE
15
­
COMMERCE
AND
TRADE
CHAPTER
53
­
TOXIC
SUBSTANCES
CONTROL
SUBCHAPTER
I
­
CONTROL
OF
TOXIC
SUBSTANCES
Sec.
2603.
­
Testing
of
chemical
substances
and
mixtures
(
a)
Testing
requirements
If
the
Administrator
finds
that
­
(
1)(
A)(
i)
the
manufacture,
distribution
in
commerce,
processing,
use,
or
disposal
of
a
chemical
substance
or
mixture,
or
that
any
combination
of
such
activities,
may
present
an
unreasonable
risk
of
injury
to
health
or
the
environment,
(
ii)
there
are
insufficient
data
and
experience
upon
which
the
effects
of
such
manufacture,
distribution
in
commerce,
processing,
use,
or
disposal
of
such
substance
or
mixture
or
of
any
combination
of
such
activities
on
health
or
the
environment
can
reasonably
be
determined
or
predicted,
and
(
iii)
testing
of
such
substance
or
mixture
with
respect
to
such
effects
is
necessary
to
develop
such
data;
or
(
B)(
i)
a
chemical
substance
or
mixture
is
or
will
be
produced
in
substantial
quantities,
and
(
I)
it
enters
or
may
reasonably
be
anticipated
to
enter
the
environment
in
substantial
quantities
or
(
II)
there
is
or
may
be
significant
or
substantial
human
exposure
to
such
substance
or
mixture,
(
ii)
there
are
insufficient
data
and
experience
upon
which
the
effects
of
the
manufacture,
distribution
in
commerce,
processing,
use,
or
disposal
of
such
substance
or
mixture
or
of
any
combination
of
such
activities
on
health
or
the
environment
can
reasonably
be
determined
or
predicted,
and
(
iii)
testing
of
such
substance
or
mixture
with
respect
to
such
effects
is
necessary
to
develop
such
data;
and
(
2)
in
the
case
of
a
mixture,
the
effects
which
the
mixture's
manufacture,
distribution
in
commerce,
processing,
use,
or
disposal
or
any
combination
of
such
activities
may
have
on
health
or
the
environment
may
not
be
reasonably
and
more
efficiently
determined
or
predicted
by
testing
the
chemical
substances
which
comprise
the
mixture;
the
Administrator
shall
by
rule
require
that
testing
be
conducted
on
such
substance
or
mixture
to
develop
data
with
respect
to
the
health
and
environmental
effects
for
which
there
is
an
insufficiency
of
data
and
experience
and
which
are
relevant
to
a
determination
that
the
manufacture,
distribution
in
commerce,
processing,
use,
or
disposal
of
such
substance
or
mixture,
or
that
any
combination
of
such
activities,
does
or
does
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment.

(
b)
Testing
requirement
rule
(
1)
A
rule
under
subsection
(
a)
of
this
section
shall
include
­
(
A)
identification
of
the
chemical
substance
or
mixture
for
which
testing
is
required
under
the
rule,
(
B)
standards
for
the
development
of
test
data
for
such
substance
or
mixture,
and
(
C)
with
respect
to
chemical
substances
which
are
not
new
chemical
substances
and
to
mixtures,
a
specification
of
the
period
(
which
period
may
not
be
of
unreasonable
duration)
within
which
the
persons
required
to
conduct
the
testing
shall
submit
to
the
Administrator
data
developed
in
accordance
with
the
standards
referred
to
in
subparagraph
(
B).
In
determining
the
standards
and
period
to
be
included,
pursuant
to
subparagraphs
(
B)
and
(
C),
in
a
rule
under
subsection
(
a)
of
this
section,
the
Administrator's
considerations
shall
include
the
relative
costs
of
the
various
test
protocols
and
methodologies
which
may
be
required
under
the
rule
and
the
reasonably
foreseeable
availability
of
the
facilities
and
personnel
needed
to
perform
the
testing
required
under
the
rule.
Any
such
rule
may
require
the
submission
to
the
Administrator
of
preliminary
data
during
the
period
prescribed
under
subparagraph
(
C).
January
25,
2005
(
2)(
A)
The
health
and
environmental
effects
for
which
standards
for
the
development
of
test
data
may
be
prescribed
include
carcinogenesis,
mutagenesis,
teratogenesis,
behavioral
disorders,
cumulative
or
synergistic
effects,
and
any
other
effect
which
may
present
an
unreasonable
risk
of
injury
to
health
or
the
environment.
The
characteristics
of
chemical
substances
and
mixtures
for
which
such
standards
may
be
prescribed
include
persistence,
acute
toxicity,
subacute
toxicity,
chronic
toxicity,
and
any
other
characteristic
which
may
present
such
a
risk.
The
methodologies
that
may
be
prescribed
in
such
standards
include
epidemiologic
studies,
serial
or
hierarchical
tests,
in
vitro
tests,
and
whole
animal
tests,
except
that
before
prescribing
epidemiologic
studies
of
employees,
the
Administrator
shall
consult
with
the
Director
of
the
National
Institute
for
Occupational
Safety
and
Health.
(
B)
From
time
to
time,
but
not
less
than
once
each
12
months,
the
Administrator
shall
review
the
adequacy
of
the
standards
for
development
of
data
prescribed
in
rules
under
subsection
(
a)
of
this
section
and
shall,
if
necessary,
institute
proceedings
to
make
appropriate
revisions
of
such
standards.

(
3)(
A)
A
rule
under
subsection
(
a)
of
this
section
respecting
a
chemical
substance
or
mixture
shall
require
the
persons
described
in
subparagraph
(
B)
to
conduct
tests
and
submit
data
to
the
Administrator
on
such
substance
or
mixture,
except
that
the
Administrator
may
permit
two
or
more
of
such
persons
to
designate
one
such
person
or
a
qualified
third
party
to
conduct
such
tests
and
submit
such
data
on
behalf
of
the
persons
making
the
designation.
(
B)
The
following
persons
shall
be
required
to
conduct
tests
and
submit
data
on
a
chemical
substance
or
mixture
subject
to
a
rule
under
subsection
(
a)
of
this
section:
(
i)
Each
person
who
manufactures
or
intends
to
manufacture
such
substance
or
mixture
if
the
Administrator
makes
a
finding
described
in
subsection
(
a)(
1)(
A)(
ii)
or
(
a)(
1)(
B)(
ii)
of
this
section
with
respect
to
the
manufacture
of
such
substance
or
mixture.
(
ii)
Each
person
who
processes
or
intends
to
process
such
substance
or
mixture
if
the
Administrator
makes
a
finding
described
in
subsection
(
a)(
1)(
A)(
ii)
or
(
a)(
1)(
B)(
ii)
of
this
section
with
respect
to
the
processing
of
such
substance
or
mixture.
(
iii)
Each
person
who
manufactures
or
processes
or
intends
to
manufacture
or
process
such
substance
or
mixture
if
the
Administrator
makes
a
finding
described
in
subsection
(
a)(
1)(
A)(
ii)
or
(
a)(
1)(
B)(
ii)
of
this
section
with
respect
to
the
distribution
in
commerce,
use,
or
disposal
of
such
substance
or
mixture.

(
4)
Any
rule
under
subsection
(
a)
of
this
section
requiring
the
testing
of
and
submission
of
data
for
a
particular
chemical
substance
or
mixture
shall
expire
at
the
end
of
the
reimbursement
period
(
as
defined
in
subsection
(
c)(
3)(
B)
of
this
section)
which
is
applicable
to
test
data
for
such
substance
or
mixture
unless
the
Administrator
repeals
the
rule
before
such
date;
and
a
rule
under
subsection
(
a)
of
this
section
requiring
the
testing
of
and
submission
of
data
for
a
category
of
chemical
substances
or
mixtures
shall
expire
with
respect
to
a
chemical
substance
or
mixture
included
in
the
category
at
the
end
of
the
reimbursement
period
(
as
so
defined)
which
is
applicable
to
test
data
for
such
substance
or
mixture
unless
the
Administrator
before
such
date
repeals
the
application
of
the
rule
to
such
substance
or
mixture
or
repeals
the
rule.

(
5)
Rules
issued
under
subsection
(
a)
of
this
section
(
and
any
substantive
amendment
thereto
or
repeal
thereof)
shall
be
promulgated
pursuant
to
section
553
of
title
5
except
that
(
A)
the
Administrator
shall
give
interested
persons
an
opportunity
for
the
oral
presentation
of
data,
views,
or
arguments,
in
addition
to
an
opportunity
to
make
written
submissions;
(
B)
a
transcript
shall
be
made
of
any
oral
presentation;
and
(
C)
the
Administrator
shall
make
and
publish
with
the
rule
the
findings
described
in
paragraph
(
1)(
A)
or
(
1)(
B)
of
subsection
(
a)
of
this
section
and,
in
the
case
of
a
rule
respecting
a
mixture,
the
finding
described
in
paragraph
(
2)
of
such
subsection.
January
25,
2005
(
c)
Exemption
(
1)
Any
person
required
by
a
rule
under
subsection
(
a)
of
this
section
to
conduct
tests
and
submit
data
on
a
chemical
substance
or
mixture
may
apply
to
the
Administrator
(
in
such
form
and
manner
as
the
Administrator
shall
prescribe)
for
an
exemption
from
such
requirement.

(
2)
If,
upon
receipt
of
an
application
under
paragraph
(
1),
the
Administrator
determines
that
­
(
A)
the
chemical
substance
or
mixture
with
respect
to
which
such
application
was
submitted
is
equivalent
to
a
chemical
substance
or
mixture
for
which
data
has
been
submitted
to
the
Administrator
in
accordance
with
a
rule
under
subsection
(
a)
of
this
section
or
for
which
data
is
being
developed
pursuant
to
such
a
rule,
and
(
B)
submission
of
data
by
the
applicant
on
such
substance
or
mixture
would
be
duplicative
of
data
which
has
been
submitted
to
the
Administrator
in
accordance
with
such
rule
or
which
is
being
developed
pursuant
to
such
rule,
the
Administrator
shall
exempt,
in
accordance
with
paragraph
(
3)
or
(
4),
the
applicant
from
conducting
tests
and
submitting
data
on
such
substance
or
mixture
under
the
rule
with
respect
to
which
such
application
was
submitted.

(
3)(
A)
If
the
exemption
under
paragraph
(
2)
of
any
person
from
the
requirement
to
conduct
tests
and
submit
test
data
on
a
chemical
substance
or
mixture
is
granted
on
the
basis
of
the
existence
of
previously
submitted
test
data
and
if
such
exemption
is
granted
during
the
reimbursement
period
for
such
test
data
(
as
prescribed
by
subparagraph
(
B)),
then
(
unless
such
person
and
the
persons
referred
to
in
clauses
(
i)
and
(
ii)
agree
on
the
amount
and
method
of
reimbursement)
the
Administrator
shall
order
the
person
granted
the
exemption
to
provide
fair
and
equitable
reimbursement
(
in
an
amount
determined
under
rules
of
the
Administrator)
­
(
i)
to
the
person
who
previously
submitted
such
test
data,
for
a
portion
of
the
costs
incurred
by
such
person
in
complying
with
the
requirement
to
submit
such
data,
and
(
ii)
to
any
other
person
who
has
been
required
under
this
subparagraph
to
contribute
with
respect
to
such
costs,
for
a
portion
of
the
amount
such
person
was
required
to
contribute.
In
promulgating
rules
for
the
determination
of
fair
and
equitable
reimbursement
to
the
persons
described
in
clauses
(
i)
and
(
ii)
for
costs
incurred
with
respect
to
a
chemical
substance
or
mixture,
the
Administrator
shall,
after
consultation
with
the
Attorney
General
and
the
Federal
Trade
Commission,
consider
all
relevant
factors,
including
the
effect
on
the
competitive
position
of
the
person
required
to
provide
reimbursement
in
relation
to
the
person
to
be
reimbursed
and
the
share
of
the
market
for
such
substance
or
mixture
of
the
person
required
to
provide
reimbursement
in
relation
to
the
share
of
such
market
of
the
persons
to
be
reimbursed.
An
order
under
this
subparagraph
shall,
for
purposes
of
judicial
review,
be
considered
final
agency
action.
(
B)
For
purposes
of
subparagraph
(
A),
the
reimbursement
period
for
any
test
data
for
a
chemical
substance
or
mixture
is
a
period
­
(
i)
beginning
on
the
date
such
data
is
submitted
in
accordance
with
a
rule
promulgated
under
subsection
(
a)
of
this
section,
and
(
ii)
ending
­
(
I)
five
years
after
the
date
referred
to
in
clause
(
i),
or
(
II)
at
the
expiration
of
a
period
which
begins
on
the
date
referred
to
in
clause
(
i)
and
which
is
equal
to
the
period
which
the
Administrator
determines
was
necessary
to
develop
such
data,
whichever
is
later.

(
4)(
A)
If
the
exemption
under
paragraph
(
2)
of
any
person
from
the
requirement
to
conduct
tests
and
submit
test
data
on
a
chemical
substance
or
mixture
is
granted
on
the
basis
of
the
fact
that
test
data
is
being
developed
by
one
or
more
persons
pursuant
to
a
rule
promulgated
under
subsection
(
a)
of
this
section,
then
(
unless
such
person
and
the
persons
referred
to
in
clauses
(
i)
and
(
ii)
agree
on
the
January
25,
2005
amount
and
method
of
reimbursement)
the
Administrator
shall
order
the
person
granted
the
exemption
to
provide
fair
and
equitable
reimbursement
(
in
an
amount
determined
under
rules
of
the
Administrator)
­
(
i)
to
each
such
person
who
is
developing
such
test
data,
for
a
portion
of
the
costs
incurred
by
each
such
person
in
complying
with
such
rule,
and
(
ii)
to
any
other
person
who
has
been
required
under
this
subparagraph
to
contribute
with
respect
to
the
costs
of
complying
with
such
rule,
for
a
portion
of
the
amount
such
person
was
required
to
contribute.
In
promulgating
rules
for
the
determination
of
fair
and
equitable
reimbursement
to
the
persons
described
in
clauses
(
i)
and
(
ii)
for
costs
incurred
with
respect
to
a
chemical
substance
or
mixture,
the
Administrator
shall,
after
consultation
with
the
Attorney
General
and
the
Federal
Trade
Commission,
consider
the
factors
described
in
the
second
sentence
of
paragraph
(
3)(
A).
An
order
under
this
subparagraph
shall,
for
purposes
of
judicial
review,
be
considered
final
agency
action.

(
B)
If
any
exemption
is
granted
under
paragraph
(
2)
on
the
basis
of
the
fact
that
one
or
more
persons
are
developing
test
data
pursuant
to
a
rule
promulgated
under
subsection
(
a)
of
this
section
and
if
after
such
exemption
is
granted
the
Administrator
determines
that
no
such
person
has
complied
with
such
rule,
the
Administrator
shall
(
i)
after
providing
written
notice
to
the
person
who
holds
such
exemption
and
an
opportunity
for
a
hearing,
by
order
terminate
such
exemption,
and
(
ii)
notify
in
writing
such
person
of
the
requirements
of
the
rule
with
respect
to
which
such
exemption
was
granted.

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

(
e)
Priority
list
(
1)(
A)
There
is
established
a
committee
to
make
recommendations
to
the
Administrator
respecting
the
chemical
substances
and
mixtures
to
which
the
Administrator
should
give
priority
consideration
for
the
promulgation
of
a
rule
under
subsection
(
a)
of
this
section.
In
making
such
a
recommendation
with
respect
to
any
chemical
substance
or
mixture,
the
committee
shall
consider
all
relevant
factors,
including
­
(
i)
the
quantities
in
which
the
substance
or
mixture
is
or
will
be
manufactured,
(
ii)
the
quantities
in
which
the
substance
or
mixture
enters
or
will
enter
the
environment,
(
iii)
the
number
of
individuals
who
are
or
will
be
exposed
to
the
substance
or
mixture
in
their
places
of
employment
and
the
duration
of
such
exposure,
(
iv)
the
extent
to
which
human
beings
are
or
will
be
exposed
to
the
substance
or
mixture,
(
v)
the
extent
to
which
the
substance
or
mixture
is
closely
related
to
a
chemical
substance
or
mixture
which
is
known
to
present
an
unreasonable
risk
of
injury
to
health
or
the
environment,
(
vi)
the
existence
of
data
concerning
the
effects
of
the
substance
or
mixture
on
health
or
the
environment,
January
25,
2005
(
vii)
the
extent
to
which
testing
of
the
substance
or
mixture
may
result
in
the
development
of
data
upon
which
the
effects
of
the
substance
or
mixture
on
health
or
the
environment
can
reasonably
be
determined
or
predicted,
and
(
viii)
the
reasonably
foreseeable
availability
of
facilities
and
personnel
for
performing
testing
on
the
substance
or
mixture.
The
recommendations
of
the
committee
shall
be
in
the
form
of
a
list
of
chemical
substances
and
mixtures
which
shall
be
set
forth,
either
by
individual
substance
or
mixture
or
by
groups
of
substances
or
mixtures,
in
the
order
in
which
the
committee
determines
the
Administrator
should
take
action
under
subsection
(
a)
of
this
section
with
respect
to
the
substances
and
mixtures.
In
establishing
such
list,
the
committee
shall
give
priority
attention
to
those
chemical
substances
and
mixtures
which
are
known
to
cause
or
contribute
to
or
which
are
suspected
of
causing
or
contributing
to
cancer,
gene
mutations,
or
birth
defects.
The
committee
shall
designate
chemical
substances
and
mixtures
on
the
list
with
respect
to
which
the
committee
determines
the
Administrator
should,
within
12
months
of
the
date
on
which
such
substances
and
mixtures
are
first
designated,
initiate
a
proceeding
under
subsection
(
a)
of
this
section.
The
total
number
of
chemical
substances
and
mixtures
on
the
list
which
are
designated
under
the
preceding
sentence
may
not,
at
any
time,
exceed
50.

(
B)
As
soon
as
practicable
but
not
later
than
nine
months
after
January
1,
1977,
the
committee
shall
publish
in
the
Federal
Register
and
transmit
to
the
Administrator
the
list
and
designations
required
by
subparagraph
(
A)
together
with
the
reasons
for
the
committee's
inclusion
of
each
chemical
substance
or
mixture
on
the
list.
At
least
every
six
months
after
the
date
of
the
transmission
to
the
Administrator
of
the
list
pursuant
to
the
preceeding
[
1]
sentence,
the
committee
shall
make
such
provisions
in
the
list
as
it
determines
to
be
necessary
and
shall
transmit
them
to
the
Administrator
together
with
the
committee's
reasons
for
the
revisions.
Upon
receipt
of
any
such
revision,
the
Administrator
shall
publish
in
the
Federal
Register
the
list
with
such
revision,
the
reasons
for
such
revision,
and
the
designations
made
under
subparagraph
(
A).
The
Administrator
shall
provide
reasonable
opportunity
to
any
interested
person
to
file
with
the
Administrator
written
comments
on
the
committee's
list,
any
revision
of
such
list
by
the
committee,
and
designations
made
by
the
committee,
and
shall
make
such
comments
available
to
the
public.
Within
the
12­
month
period
beginning
on
the
date
of
the
first
inclusion
on
the
list
of
a
chemical
substance
or
mixture
designated
by
the
committee
under
subparagraph
(
A)
the
Administrator
shall
with
respect
to
such
chemical
substance
or
mixture
either
initiate
a
rulemaking
proceeding
under
subsection
(
a)
of
this
section
or
if
such
a
proceeding
is
not
initiated
within
such
period,
publish
in
the
Federal
Register
the
Administrator's
reason
for
not
initiating
such
a
proceeding.

(
2)(
A)
The
committee
established
by
paragraph
(
1)(
A)
shall
consist
of
eight
members
as
follows:
(
i)
One
member
appointed
by
the
Administrator
from
the
Environmental
Protection
Agency.
(
ii)
One
member
appointed
by
the
Secretary
of
Labor
from
officers
or
employees
of
the
Department
of
Labor
engaged
in
the
Secretary's
activities
under
the
Occupational
Safety
and
Health
Act
of
1970
(
29
U.
S.
C.
651
et
seq.).
(
iii)
One
member
appointed
by
the
Chairman
of
the
Council
on
Environmental
Quality
from
the
Council
or
its
officers
or
employees.
(
iv)
One
member
appointed
by
the
Director
of
the
National
Institute
for
Occupational
Safety
and
Health
from
officers
or
employees
of
the
Institute.
(
v)
One
member
appointed
by
the
Director
of
the
National
Institute
of
Environmental
Health
Sciences
from
officers
or
employees
of
the
Institute.
(
vi)
One
member
appointed
by
the
Director
of
the
National
Cancer
Institute
from
officers
or
employees
of
the
Institute.
January
25,
2005
(
vii)
One
member
appointed
by
the
Director
of
the
National
Science
Foundation
from
officers
or
employees
of
the
Foundation.
(
viii)
One
member
appointed
by
the
Secretary
of
Commerce
from
officers
or
employees
of
the
Department
of
Commerce.

(
B)(
i)
An
appointed
member
may
designate
an
individual
to
serve
on
the
committee
on
the
member's
behalf.
Such
a
designation
may
be
made
only
with
the
approval
of
the
applicable
appointing
authority
and
only
if
the
individual
is
from
the
entity
from
which
the
member
was
appointed.
(
ii)
No
individual
may
serve
as
a
member
of
the
committee
for
more
than
four
years
in
the
aggregate.
If
any
member
of
the
committee
leaves
the
entity
from
which
the
member
was
appointed,
such
member
may
not
continue
as
a
member
of
the
committee,
and
the
member's
position
shall
be
considered
to
be
vacant.
A
vacancy
in
the
committee
shall
be
filled
in
the
same
manner
in
which
the
original
appointment
was
made.
(
iii)
Initial
appointments
to
the
committee
shall
be
made
not
later
than
the
60th
day
after
January
1,
1977.
Not
later
than
the
90th
day
after
such
date
the
members
of
the
committee
shall
hold
a
meeting
for
the
selection
of
a
chairperson
from
among
their
number.

(
C)(
i)
No
member
of
the
committee,
or
designee
of
such
member,
shall
accept
employment
or
compensation
from
any
person
subject
to
any
requirement
of
this
chapter
or
of
any
rule
promulgated
or
order
issued
thereunder,
for
a
period
of
at
least
12
months
after
termination
of
service
on
the
committee.
(
ii)
No
person,
while
serving
as
a
member
of
the
committee,
or
designee
of
such
member,
may
own
any
stocks
or
bonds,
or
have
any
pecuniary
interest,
of
substantial
value
in
any
person
engaged
in
the
manufacture,
processing,
or
distribution
in
commerce
of
any
chemical
substance
or
mixture
subject
to
any
requirement
of
this
chapter
or
of
any
rule
promulgated
or
order
issued
thereunder.
(
iii)
The
Administrator,
acting
through
attorneys
of
the
Environmental
Protection
Agency,
or
the
Attorney
General
may
bring
an
action
in
the
appropriate
district
court
of
the
United
States
to
restrain
any
violation
of
this
subparagraph.

(
D)
The
Administrator
shall
provide
the
committee
such
administrative
support
services
as
may
be
necessary
to
enable
the
committee
to
carry
out
its
function
under
this
subsection.

(
f)
Required
actions
Upon
the
receipt
of
­
(
1)
any
test
data
required
to
be
submitted
under
this
chapter,
or
(
2)
any
other
information
available
to
the
Administrator,
which
indicates
to
the
Administrator
that
there
may
be
a
reasonable
basis
to
conclude
that
a
chemical
substance
or
mixture
presents
or
will
present
a
significant
risk
of
serious
or
widespread
harm
to
human
beings
from
cancer,
gene
mutations,
or
birth
defects,
the
Administrator
shall,
within
the
180­
day
period
beginning
on
the
date
of
the
receipt
of
such
data
or
information,
initiate
appropriate
action
under
section
2604,
2605,
or
2606
of
this
title
to
prevent
or
reduce
to
a
sufficient
extent
such
risk
or
publish
in
the
Federal
Register
a
finding
that
such
risk
is
not
unreasonable.
For
good
cause
shown
the
Administrator
may
extend
such
period
for
an
additional
period
of
not
more
than
90
days.
The
Administrator
shall
publish
in
the
Federal
Register
notice
of
any
such
extension
and
the
reasons
therefor.
A
finding
by
the
Administrator
that
a
risk
is
not
unreasonable
shall
be
considered
agency
action
for
purposes
of
judicial
review
under
chapter
7
of
title
5.
This
subsection
shall
not
take
effect
until
two
years
after
January
1,
1977.

(
g)
Petition
for
standards
for
the
development
of
test
data
January
25,
2005
A
person
intending
to
manufacture
or
process
a
chemical
substance
for
which
notice
is
required
under
section
2604(
a)
of
this
title
and
who
is
not
required
under
a
rule
under
subsection
(
a)
of
this
section
to
conduct
tests
and
submit
data
on
such
substance
may
petition
the
Administrator
to
prescribe
standards
for
the
development
of
test
data
for
such
substance.
The
Administrator
shall
by
order
either
grant
or
deny
any
such
petition
within
60
days
of
its
receipt.
If
the
petition
is
granted,
the
Administrator
shall
prescribe
such
standards
for
such
substance
within
75
days
of
the
date
the
petition
is
granted.
If
the
petition
is
denied,
the
Administrator
shall
publish,
subject
to
section
2613
of
this
title,
in
the
Federal
Register
the
reasons
for
such
denial
[
1]
So
in
original.
Probably
should
be
''
preceding''.
January
25,
2005
ATTACHMENT
2
40
CFR
790
Procedures
Governing
Testing
Consent
Agreements
and
Test
Rules
January
25,
2005
Title
40:
Protection
of
Environment
PART
790
 
PROCEDURES
GOVERNING
TESTING
CONSENT
AGREEMENTS
AND
TEST
RULES
Subpart
A
 
General
Provisions
§
790.1
Scope,
purpose,
and
authority.

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

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

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

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

[
51
FR
23712,
June
30,
1986]

§
790.2
Applicability.

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

[
51
FR
23712,
June
30,
1986]

§
790.3
Definitions.

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

Act
means
the
Toxic
Substances
Control
Act,
15
U.
S.
C.
2601
et
seq.
January
25,
2005
Additive
means
a
chemical
substance
that
is
intentionally
added
to
another
chemical
substance
to
improve
its
stability
or
impart
some
other
desirable
quality.

Chemical
means
a
chemical
substance
or
mixture.

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

EPA
means
the
U.
S.
Environmental
Protection
Agency.

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

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

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

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

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

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

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

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

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

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

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

Test
substance
means
the
form
of
chemical
substance
or
mixture
that
is
specified
for
use
in
testing.

[
49
FR
39782,
Oct.
10,
1984,
as
amended
at
51
FR
23712,
June
30,
1986]

§
790.5
Submission
of
information.
January
25,
2005
(
a)
All
submissions
to
EPA
under
this
part
must
bear
the
Code
of
Federal
Regulations
(
CFR)
section
number
of
the
subject
chemical
test
rule,
or
indicate
the
identity
of
the
consent
agreement.
For
all
submissions
under
this
part,
six
copies
must
be
provided
to
EPA.

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

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

§
790.7
Confidentiality.

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

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

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

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

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

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

(
4)
For
what
period
of
time
should
confidential
treatment
be
given?
Until
a
specific
date,
the
occurrence
of
a
specific
event,
or
permanently?
Why?

(
5)
What
measures
have
you
taken
to
guard
against
disclosure
of
this
information
to
others?
January
25,
2005
(
6)
To
what
extent
has
this
information
been
disclosed
to
others?
What
precautions
have
been
taken
in
connection
with
such
disclosures?

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

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

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

(
d)
If
the
substantiation
provided
under
paragraph
(
c)
of
this
section
contains
information
which
the
submitter
considers
confidential,
the
submitter
must
assert
a
separate
claim
of
confidentiality
for
that
information
at
the
time
of
submission
in
accordance
with
paragraph
(
b)
of
this
section.
[
49
FR
39782,
Oct.
10,
1984,
as
amended
at
51
FR
23713,
June
30,
1986]

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

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

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

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

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

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

(
4)
The
ITC
reserves
its
right
to
designate
any
chemical
that
it
determines
the
Agency
should,
within
12
months
of
the
date
first
designated,
initiate
a
proceeding
under
section
4(
a)
of
the
Act.

(
b)
EPA
consideration
of
ITC
recommendations.
(
1)
Where
a
substance
or
mixture
is
designated
for
EPA
action
under
section
4(
e)(
1)(
B)
of
the
Act,
the
Agency
will
take
either
one
of
the
following
actions
within
12
months
after
receiving
the
ITC
designation:

(
i)
Initiate
rulemaking
proceedings
under
section
4(
a)
of
the
Act.
January
25,
2005
(
ii)
Publish
a
Federal
Register
notice
explaining
the
Agency's
reasons
for
not
initiating
such
rulemaking
proceedings.
EPA
may
conclude
that
rulemaking
proceedings
under
section
4(
a)
of
the
Act
are
unnecessary
if
it
determines
that
the
findings
specified
in
section
4(
a)
of
the
Act
cannot
be
made
or
if
the
Agency
has
entered
into
a
consent
agreement
requiring
testing
in
accordance
with
the
provisions
of
this
subpart.

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

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

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

(
iii)
Entering
into
a
consent
agreement
in
accordance
with
this
subpart.
§
790.22
Procedures
for
gathering
information
and
negotiating
consent
agreements
on
chemicals
which
the
ITC
has
recommended
for
testing
with
an
intent
to
designate.

(
a)
Preliminary
EPA
evaluation.
Following
receipt
of
an
ITC
report
containing
a
recommendation
with
an
intent
to
designate,
EPA
will
use
the
following
procedure
for
completing
a
preliminary
evaluation
of
testing
needs.
Appendix
A
1
to
this
part
presents
the
schedule
that
EPA
intends
to
follow
for
this
purpose.

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

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

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

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

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

(
6)
EPA
will
hold
a
public
meeting
to
announce
its
preliminary
testing
determinations.

(
b)
Negotiation
procedures
for
consent
agreements.
Where
EPA
believes
that
testing
is
necessary,
the
Agency
will
explore
whether
a
consent
agreement
can
be
negotiated
that
satisfies
the
testing
needs
identified
by
the
Agency.
EPA
will
use
the
following
procedures
for
negotiating,
formulating
and
accepting
consent
agreements.
Appendix
A
1
to
this
part
presents
the
schedule
that
EPA
intends
to
follow
for
this
purpose.
January
25,
2005
(
1)
In
the
Federal
Register
notice
described
in
paragraph
(
a)(
1)
of
this
section,
EPA
will
explain
its
procedures
and
timetable
for
negotiating
consent
agreements
and
invite
persons
interested
in
participating
in
or
monitoring
negotiations
to
contact
the
Agency
in
writing.

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

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

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

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

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

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

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

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

(
10)
Upon
final
approval
of
a
consent
agreement,
EPA
will
publish
a
Federal
Register
notice
that
summarizes
the
agreement,
describes
the
ITC
recommendations
for
the
test
substance,
outlines
the
chemical's
use
and
exposure
characteristics,
and
explains
the
background,
objectives
and
rationale
of
the
testing
to
be
conducted,
and
codifies
in
subpart
C
of
part
799
the
name
of
the
substance(
s)
to
be
tested
and
the
citation
to
the
Federal
Register
notice
of
the
agreement.
January
25,
2005
§
790.24
Criteria
for
determining
whether
a
consensus
exists
concerning
the
provisions
of
a
draft
consent
agreement.

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

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

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

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

(
1)
Not
made
in
good
faith.

(
2)
Untimely.

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

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

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

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

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

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

1Editorial
Note:
Appendix
A
appears
at
the
end
of
subpart
E.

(
c)
Where
the
testing
recommendations
of
the
ITC
raise
unusually
complex
and
novel
issues
that
require
additional
Agency
review
and
opportunity
for
public
comment,
the
Agency
may
publish
an
January
25,
2005
Advance
Notice
of
Proposed
Rulemaking
(
ANPR).
The
schedule
that
EPA
intends
to
follow
for
rulemaking
proceedings
initiated
by
publication
of
an
ANPR
is
presented
in
appendix
A
1
to
this
part.

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

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

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

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

(
b)
When
EPA
wishes
to
initiate
negotiations
concerning
chemicals
described
in
paragraph
(
a)
of
this
section,
it
will
publish
a
Federal
Register
notice
describing
its
tentative
evaluation
of
testing
needs,
announcing
a
date
for
a
public
course­
setting
meeting,
and
inviting
persons
interested
in
participating
in
or
monitoring
negotiations
to
contact
the
Agency
in
writing.
Any
negotiations
that
EPA
conducts
will
conform
to
the
procedures
specified
in
§
790.22(
b)
and,
to
the
extent
feasible,
will
follow
the
schedules
presented
in
appendix
A
1
to
this
part.

(
c)
EPA
will
enter
into
consent
agreements
on
chemicals
described
in
paragraph
(
a)
of
this
section
only
if
there
is
a
consensus
among
EPA,
affected
manufacturers
and/
or
processors,
and
any
other
persons
who
have
asked
to
participate
in
or
monitor
negotiations.
In
determining
whether
such
a
consensus
exists,
EPA
will
employ
the
criteria
specified
in
§
790.24.
In
the
absence
of
consensus,
EPA
will
initiate
rulemaking
if
it
concludes
that
the
findings
specified
in
section
4(
a)
of
the
Act
can
be
made.
The
schedule
for
initiating
and
completing
such
rulemaking
proceedings
will,
to
the
extent
feasible,
follow
the
schedule
specified
in
appendix
A
1
to
this
part.

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

§
790.40
Promulgation
of
test
rules.

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

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

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

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

(
ii)
The
health
or
environmental
effect
or
effects
or
other
characteristics
for
which
testing
is
being
required.
January
25,
2005
(
iii)
Which
test
substance(
s)
must
be
tested.

(
iv)
Standards
for
the
development
of
test
data.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

§
790.42
Persons
subject
to
a
test
rule.

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

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

(
i)
Primarily
associated
with
manufacture
of
the
chemical,
or
January
25,
2005
(
ii)
Associated
with
both
manufacturer
and
processing
of
the
chemical,
or
(
iii)
Associated
with
distribution
in
commerce,
use,
and/
or
disposal
activities
concerning
the
chemical,
each
manufacturer
of
the
chemical
will
be
subject
and
must
comply
with
the
requirements
of
the
test
rule.

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

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

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

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

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

(
b)
[
Reserved]

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

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

(
a)
No
later
than
30
days
after
the
effective
date
of
a
test
rule
described
in
§
790.40,
each
person
subject
to
that
rule
and
required
to
comply
with
the
requirements
of
that
rule
as
provided
in
§
790.42(
a)
must,
for
each
test
required,
either
notify
EPA
by
letter
of
his
or
her
intent
to
conduct
testing
or
submit
to
EPA
an
application
for
an
exemption
from
testing
requirements
for
the
test.

(
b)
EPA
will
consider
letters
of
intent
to
test
as
commitments
to
sponsor
the
tests
for
which
they
are
submitted
unless
EPA
agrees
to
the
substitution
of
an
exemption
application
in
instances
where
more
than
one
person
indicates
an
intent
to
sponsor
equivalent
tests.

(
c)
Each
letter
of
intent
to
conduct
testing
must
include:
January
25,
2005
(
1)
Identification
of
test
rule.

(
2)
Name,
address,
and
telephone
number
of
the
firm(
s)
which
will
be
sponsoring
the
tests.

(
3)
Name,
address,
and
telephone
number
of
the
appropriate
individual
to
contact
for
further
information.

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

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

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

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

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

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

§
790.48
Procedure
if
no
one
submits
a
letter
of
intent
to
conduct
testing.
January
25,
2005
(
a)
If
only
manufacturers
are
subject
to
the
rule.
(
1)
This
paragraph
applies
if
testing
is
being
required
solely
to
allow
evaluation
of
risks
associated
with
manufacturing
and
the
test
rule
described
in
§
790.40
states
that
manufacturers
only
are
responsible
for
testing.

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

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

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

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

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

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

(
5)
If
no
manufacturer
or
processor
submits
a
letter
of
intent
to
conduct
one
or
more
of
the
required
tests
within
30
days
after
receipt
of
the
certified
letter
or
publication
of
the
Federal
Register
notice
described
in
paragraph
(
b)(
4)
of
this
section,
all
manufacturers
and
processors
subject
to
the
rule
will
be
in
violation
of
the
test
rule
from
the
31st
day
after
receipt
of
the
certified
letter
or
publication
of
the
Federal
Register
notice
described
in
paragraph
(
b)(
4)
of
this
section.
January
25,
2005
(
c)
Only
processors
are
subject
to
the
rule.
(
1)
This
paragraph
applies
if
testing
is
being
required
solely
to
allow
evaluation
of
risks
associated
with
processing
and
the
test
rule
described
in
§
790.40
states
that
only
processors
are
responsible
for
testing.

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

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

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

§
790.50
Submission
of
study
plans.

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

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

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

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

(
5)
Unless
EPA
has
granted
an
extension
of
time
for
submission
of
proposed
study
plans,
manufacturers
who
notify
EPA
that
they
intend
to
conduct
testing
in
compliance
with
the
requirements
of
a
Phase
I
test
rule
as
described
in
§
790.40(
b)(
2)
and
who
do
not
submit
proposed
study
plans
for
those
tests
on
or
before
90
days
after
the
effective
date
of
the
Phase
I
test
rule
or
60
days
after
the
date
manufacture
begins
as
described
in
§
790.45(
d)
will
be
considered
in
violation
of
the
test
rule
as
if
no
letter
of
intent
to
test
had
been
submitted.
January
25,
2005
(
6)
Unless
EPA
has
granted
an
extension
of
time
for
submission
of
proposed
study
plans,
processors
who
notify
EPA
that
they
intend
to
conduct
testing
in
compliance
with
the
requirements
of
a
Phase
I
test
rule
as
described
in
§
790.40(
b)(
2)
and
who
do
not
submit
proposed
study
plans
for
those
tests
on
or
before
90
days
after
the
effective
date
of
the
Phase
I
test
rule
or
90
days
after
the
publication
date
of
the
notice
described
in
§
790.48(
b)(
2),
or
60
days
after
the
date
processing
begins
as
described
in
§
790.45(
d),
as
appropriate,
will
be
considered
in
violation
of
the
test
rule
as
if
no
letter
of
intent
to
test
had
been
submitted.

(
b)
Extensions
of
time
for
submission
of
study
plans.
(
1)
EPA
may
grant
requests
for
additional
time
for
the
development
of
study
plans
on
a
case­
by­
case
basis.
Requests
for
additional
time
for
study
plan
development
must
be
made
in
writing
to
EPA
at
the
address
in
§
790.5(
b).
Each
extension
request
must
state
why
EPA
should
grant
the
extension.

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

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

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

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

(
i)
Identity
of
the
test
rule.

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

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

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

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

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

(
2)
Brief
summaries
of
the
training
and
experience
of
each
professional
involved
in
the
study,
including
study
director,
veterinarian(
s),
toxicologist(
s),
pathologist(
s),
chemist(
s),
microbiologist(
s),
and
laboratory
assistants.
January
25,
2005
(
iv)
Identity
and
data
on
the
chemical
substance(
s)
being
tested,
including
physical
constants,
spectral
data,
chemical
analysis,
and
stability
under
test
and
storage
conditions,
as
appropriate.

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

(
vi)
Schedule
for
initiation
and
completion
of
each
short­
term
test
and
of
each
major
phase
of
long­
term
tests;
dates
for
submission
of
interim
progress
and
final
reports
to
EPA
that
are
within
the
reporting
deadlines
specified
by
EPA
In
the
final
test
rule.

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

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

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

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

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

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

§
790.52
Phase
II
test
rule.

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

(
b)
EPA
will
provide
a
45­
day
comment
period
and
will
provide
an
opportunity
for
an
oral
presentation
upon
the
request
of
any
person.
EPA
may
extend
the
comment
period
if
it
appears
January
25,
2005
from
the
nature
of
the
issues
raised
by
EPA's
review
or
from
public
comments
that
further
comment
is
warranted.

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

[
50
FR
20657,
May
17,
1985.
Redesignated
at
51
FR
23713,
June
30,
1986,
and
amended
at
52
FR
36569,
Sept.
30,
1987]

§
790.55
Modification
of
test
standards
or
schedules
during
conduct
of
test.

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

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

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

(
3)
Where,
in
EPA's
judgment,
the
requested
modification
of
a
test
standard
or
schedule
would
significantly
alter
the
scope
of
the
test
or
significantly
change
the
schedule
for
completing
the
test,
EPA
will
publish
a
notice
in
the
Federal
Register
requesting
comment
on
the
proposed
modification.
However,
EPA
will
approve
a
requested
modification
of
a
test
standard
under
paragraph
(
b)(
3)
of
this
section
without
first
seeking
public
comment
if
EPA
believes
that
an
immediate
modification
to
the
test
standard
is
necessary
to
preserve
the
accuracy
or
validity
of
an
ongoing
test.
EPA
may
also
modify
a
testing
requirement
or
test
condition
in
a
test
standard
if
EPA
determines
that
the
completion
or
achievement
of
this
requirement
or
condition
is
not
technically
feasible.
EPA
may
approve
a
test
schedule
extension
under
paragraph
(
b)(
3)
of
this
section
without
first
seeking
public
comment
if
EPA
determines,
on
a
case­
by­
case
basis,
that
a
delay
of
over
12
months
is
not
the
fault
of
the
test
sponsor
and
is
the
result
of
unforeseen
January
25,
2005
circumstances
such
as
a
lack
of
laboratory
availability,
lack
of
availability
of
suitable
test
substance
(
e.
g.,
14
 
C
labelled
test
substance),
lack
of
availability
of
healthy
test
organisms,
or
the
unexpected
failure
of
a
long­
term
test.
EPA
will
publish
an
annual
notice
in
the
Federal
Register
announcing
the
approval
of
any
test
standard
modifications
and
test
schedule
extensions
under
paragraph
(
b)(
3)
of
this
section
and
provide
a
brief
rationale
of
why
the
modification
was
granted.

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

(
i)
Change
the
test
species.

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

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

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

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

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

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

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

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

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

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

§
790.59
Failure
to
comply
with
a
test
rule.

(
a)
Persons
who
notified
EPA
of
their
intent
to
conduct
a
test
required
in
a
test
rule
in
part
799
of
this
chapter
and
who
fail
to
conduct
the
test
in
accordance
with
the
test
standards
and
schedules
adopted
in
the
test
rule,
or
as
modified
in
accordance
with
§
790.55,
will
be
in
violation
of
the
rule.
January
25,
2005
(
b)
Any
person
who
fails
or
refuses
to
comply
with
any
aspect
of
this
part
or
a
test
rule
under
part
799
of
this
chapter
is
in
violation
of
section
15
of
the
Act.
EPA
will
treat
violations
of
the
Good
Laboratory
Practice
standards
as
indicated
in
§
792.17
of
this
chapter.

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

§
790.60
Contents
of
consent
agreements.

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

(
1)
Identification
of
the
chemical(
s)
to
be
tested.

(
2)
The
health
effects,
environmental
effects
and/
or
other
characteristics
for
which
testing
will
be
required.

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

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

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

(
6)
Standards
for
the
development
of
test
data.

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

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

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

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

(
11)
A
requirement
that
the
manufacturers
and/
or
processors
signing
the
consent
agreement
will
comply
with
the
notification
requirements
of
section
12(
b)(
1)
of
the
Act
and
part
707
of
this
chapter
if
they
export
or
intend
to
export
the
substance
or
mixture
for
which
the
submission
of
data
is
required
under
the
agreement
and
a
statement
that
any
other
person
who
exports
or
intends
to
export
such
substance
or
mixture
is
subject
to
the
above
cited
export
notification
requirements.
January
25,
2005
(
12)
A
requirement
that,
in
the
event
EPA
promulgates
a
significant
new
use
rule
applicable
to
the
test
chemical
under
section
5(
a)(
2),
the
consent
agreement
will
have
the
status
of
a
test
rule
for
purposes
of
section
5(
b)(
1)(
A)
and
manufacturers
and/
or
processors
signing
the
agreement
will
comply
with
the
data
submission
requirements
imposed
by
that
provision.

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

(
14)
A
statement
that,
in
the
event
one
or
more
provisions
of
the
agreement
are
determined
to
be
unenforceable
by
a
court,
the
remainder
of
the
agreement
would
not
be
presumed
to
be
valid
and
EPA
will
then
either
initiate
a
rulemaking
proceeding
or
publish
in
the
Federal
Register
the
Administrator's
reason
for
not
initiating
such
a
proceeding.

(
15)
A
statement
that
the
Agency
may
conduct
laboratory
inspections
and/
or
study
audits
of
the
testing
being
conducted
pursuant
to
the
consent
agreement
in
accordance
with
the
authority
and
procedures
contained
in
section
11
of
the
Act.

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

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

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

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

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

§
790.62
Submission
of
study
plans
and
conduct
of
testing.
January
25,
2005
(
a)
Timing
of
submission.
The
principal
sponsor
of
testing
conducted
pursuant
to
a
consent
agreement
shall
submit
a
study
plan
no
later
than
45
days
prior
to
the
initiation
of
testing.

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

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

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

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

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

(
5)
The
names,
addresses,
and
telephone
numbers
of
the
technical
contacts
at
each
manufacturer
and/
or
processor
subject
to
the
agreement.

(
6)
The
names
and
addresses
of
the
testing
facilities
responsible
for
the
testing
and
the
names,
addresses,
and
telephone
numbers
of
the
administrative
officials[
s]
and
project
manager[
s]
assigned
to
oversee
the
testing
program
at
these
facilities.

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

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

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

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

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

(
2)
The
submitter
will
have
15
days
after
the
day
it
receives
a
notice
under
paragraph
(
c)(
1)
of
this
section
to
submit
appropriate
information
to
make
the
study
plan
complete.
January
25,
2005
(
3)
If
the
submitter
fails
to
provide
appropriate
information
to
complete
a
study
plan
within
15
days
after
having
received
a
notice
under
paragraph
(
c)(
1)
of
this
section,
the
submitter
will
be
considered
to
be
in
violation
of
the
consent
agreement
and
subject
to
enforcement
proceedings
pursuant
to
§
790.65
(
c)
and
(
d).

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

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

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

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

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

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

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

§
790.68
Modification
of
consent
agreements.

(
a)
Changes
in
the
scope
of
testing.
(
1)
Manufacturers
or
processors
subject
to
a
consent
agreement,
other
persons
or
EPA
may
seek
modifications
in
the
scope
of
testing
performed
under
the
consent
agreement.
If,
upon
receiving
a
request
for
modification,
EPA
determines
that
new
issues
have
been
raised
that
warrant
reconsideration
of
the
scope
of
testing,
or
if
EPA
determines
on
its
own
that
such
reconsideration
is
appropriate,
EPA
will
publish
a
Federal
Register
notice
describing
the
proposed
modification
and
soliciting
public
comment.
If,
based
on
the
comments
January
25,
2005
received,
EPA
concludes
that
differences
of
opinion
may
exist
about
the
proposed
modification,
EPA
will
establish
a
schedule
for
conducting
negotiations
and
invite
parties
who
wish
to
participate
in
or
monitor
these
negotiations
to
contact
the
Agency
in
writing.
Any
negotiations
that
EPA
conducts
will
conform
to
the
procedures
specified
in
§
790.22(
b).

(
2)
The
scope
of
testing
required
by
a
consent
agreement
will
be
modified
only
where
there
is
a
consensus
concerning
the
modified
testing
requirements
among
EPA,
affected
manufacturers
and/
or
processors,
and
other
persons
who
have
asked
to
participate
in
or
monitor
negotiations
under
paragraph
(
a)(
1)
of
this
section.
In
determining
whether
a
consensus
exists,
EPA
will
employ
the
criteria
specified
in
§
790.24.
In
the
absence
of
consensus,
EPA
may
initiate
rulemaking
under
section
4(
a)
of
the
Act
if
it
concludes
that
any
testing
beyond
that
required
by
the
consent
agreement
is
necessary
and
that
the
other
statutory
findings
required
by
section
4(
a)
can
be
made.
While
such
rulemaking
proceedings
are
underway,
the
consent
agreement
will
remain
in
effect
unless
EPA
finds
that
the
testing
required
by
the
agreement
is
or
may
be
unnecessary
in
view
of
the
testing
requirements
included
in
EPA's
proposed
rule.

(
b)
Changes
in
test
standards
or
schedules.
(
1)
Any
test
sponsor
who
wishes
to
modify
the
test
schedule
for
any
test
required
under
a
consent
order
must
submit
an
application
in
accordance
with
this
paragraph.
Application
for
modification
must
be
made
in
writing
to
EPA
at
the
address
in
§
790.5(
b),
or
by
phone
with
written
confirmation
to
follow
within
10
working
days.
Applications
must
include
an
appropriate
explanation
and
rationale
for
the
modification.
EPA
will
consider
only
those
applications
that
request
modifications
to
mandatory
testing
conditions
or
requirements
("
shall
statements"
in
the
consent
order).
Where
a
test
sponsor
requests
EPA
to
provide
guidance
or
to
clarify
a
non­
mandatory
testing
requirement
(
i.
e.,
"
should
statements"),
the
test
sponsor
should
submit
these
requests
to
EPA
at
the
address
in
section
790.5(
b).

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

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

(
iii)
Where,
in
EPA's
judgment,
the
requested
modification
of
a
test
standard
or
schedule
would
significantly
alter
the
scope
of
the
test
or
significantly
change
the
schedule
for
completing
the
test,
EPA
will
publish
a
notice
in
the
Federal
Register
requesting
comment
on
the
proposed
modification.
However,
EPA
will
approve
a
requested
modification
of
a
test
standard
under
paragraph
(
b)(
2)(
iii)
of
this
section
without
first
seeking
public
comment
if
EPA
believes
that
an
immediate
modification
to
the
test
standard
is
necessary
to
preserve
the
accuracy
or
validity
of
an
ongoing
test.
EPA
also
may
modify
a
testing
requirement
or
test
condition
in
a
test
standard
if
EPA
determines
that
the
completion
or
achievement
of
this
requirement
or
condition
is
not
technically
feasible.
EPA
may
approve
a
requested
modification
of
a
test
schedule
under
January
25,
2005
paragraph
(
b)(
2)(
iii)
of
this
section
without
first
seeking
public
comment
if
EPA
determines,
on
a
case­
by­
case
basis,
that
a
delay
of
over
12
months
is
not
the
fault
of
the
test
sponsor
and
is
due
to
unforeseen
circumstances
such
as
a
lack
of
laboratory
availability,
lack
of
availability
of
suitable
test
substance
(
e.
g.,
14
 
C
labelled
test
substance),
lack
of
availability
of
healthy
test
organisms,
or
the
unexpected
failure
of
a
long­
term
test.
EPA
will
publish
an
annual
notice
in
the
Federal
Register
announcing
the
approval
of
any
test
standard
modifications
and
test
scheduled
extensions
under
paragraph
(
b)(
2)(
iii)
of
this
section,
and
provide
a
brief
rationale
of
why
the
modification
was
granted.

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

(
A)
Change
the
test
species.

(
B)
Change
the
route
of
administration
of
the
test
chemical.

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

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

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

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

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

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

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

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

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

Subpart
E
 
Exemptions
From
Test
Rules
Source:
50
FR
20660,
May
17,
1985,
unless
otherwise
noted.
January
25,
2005
§
790.80
Submission
of
exemption
applications.

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

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

(
i)
If
testing
is
being
required
to
allow
evaluation
of
risks
associated
with
manufacturing
and
processing
or
with
distribution
in
commerce,
use,
or
disposal
of
the
chemical
and
manufacturers
do
not
submit
notice(
s)
of
intent
to
conduct
the
required
testing;
or
(
ii)
If
testing
is
being
required
solely
to
allow
evaluation
of
risks
associated
with
processing
of
the
chemical.

(
b)
When
applications
must
be
filed.
(
1)
Exemption
applications
must
be
filed
within
30
days
after
the
effective
date
of
the
test
rule
described
in
§
790.40
or,
if
being
submitted
in
compliance
with
the
Federal
Register
notice
described
in
§
790.48(
b)(
2),
within
30
days
after
the
publication
of
that
notice.

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

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

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

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

§
790.82
Content
of
exemption
application.

The
exemption
application
must
contain:

(
a)
The
identity
of
the
test
rule,
the
chemical
identity,
and
the
CAS
No.
of
the
test
substance
on
which
the
application
is
based.
January
25,
2005
(
b)
The
specific
testing
requirement(
s)
from
which
an
exemption
is
sought
and
the
basis
for
the
exemption
request.

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

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

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

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

(
ii)
Equivalence
data
specified
in
§
790.85.

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

[
50
FR
20660,
May
17,
1985,
as
amended
at
54
FR
36315,
Sept.
1,
1989]

§
790.85
Submission
of
equivalence
data.

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

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

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

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

§
790.87
Approval
of
exemption
applications.

(
a)
EPA
will
conditionally
approve
exemption
applications
if:

(
1)(
i)
For
single­
phase
test
rules,
EPA
has
received
a
letter
of
intent
to
conduct
the
testing
from
which
exemption
is
sought;
January
25,
2005
(
ii)
For
two­
phase
test
rules,
EPA
has
received
a
complete
proposed
study
plan
for
the
testing
from
which
exemption
is
sought
and
has
adopted
the
study
plan,
as
proposed
or
modified,
as
test
standards
and
schedules
in
a
final
Phase
II
test
rule;
and
(
2)
The
chemical
substance
or
mixture
with
respect
to
which
the
application
was
submitted
is
equivalent
to
a
test
substance
or
mixture
for
which
the
required
data
have
been
or
are
being
submitted
in
accordance
with
a
test
rule;
and
(
3)
Submission
of
the
required
test
data
concerning
that
chemical
substance
or
mixture
would
be
duplicative
of
data
which
have
been
or
are
being
submitted
to
EPA
in
accordance
with
a
test
rule.

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

(
2)
If
two
or
more
representative
substances
are
to
be
tested
under
a
test
rule,
EPA
will
evaluate
equivalence
claims
made
in
each
exemption
application
according
to
the
criteria
discussed
in
the
test
rule.

(
i)
If
EPA
finds
an
equivalence
claim
to
be
in
error
or
inadequately
supported,
the
applicant
will
be
notified
by
certified
mail.
The
applicant
will
be
given
15
days
to
provide
clarifying
information.

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

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

§
790.88
Denial
of
exemption
application.

(
a)
EPA
may
deny
any
exemption
application
if:

(
1)
EPA
determines
that
the
applicant
has
failed
to
demonstrate
that
the
applicant's
chemical
is
equivalent
to
the
test
substance;
or
(
2)
The
exemption
applicant
fails
to
submit
any
of
the
information
specified
in
§
790.82;
or
(
3)
The
exemption
applicant
fails
to
submit
any
of
the
information
specified
in
§
790.85
if
required
in
the
test
rule;
or
(
4)(
i)
For
single­
phase
test
rules,
EPA
has
not
received
a
letter
of
intent
to
conduct
the
test
for
which
exemption
is
sought;
or
(
ii)
For
two­
phase
test
rules,
EPA
has
not
received
an
adequate
study
plan
for
the
test
for
which
exemption
is
sought;
or
January
25,
2005
(
5)
The
study
sponsor(
s)
fails
to
initiate
the
required
testing
by
the
deadlines
adopted
in
the
test
rule;
or
(
6)
The
study
sponsor(
s)
fails
to
submit
data
as
required
in
the
test
standard
and
deadlines
for
submission
of
test
data
as
adopted
in
the
test
rule
or
as
modified
in
accordance
with
§
790.55.

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

§
790.90
Appeal
of
denial
of
exemption
application.

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

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

(
c)(
1)
The
applicant
may
also
include
a
request
for
a
hearing.
Hearings
will
be
held
according
to
the
procedures
described
in
§
790.97.

(
2)
Hearing
requests
must
be
in
writing
and
must
be
received
by
EPA
within
30
days
of
receipt
of
the
letter
or
publication
of
the
Federal
Register
notice
described
in
§
790.88(
b).
Hearing
requests
must
provide
reasons
why
a
hearing
is
necessary.

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

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

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

§
790.93
Termination
of
conditional
exemption.

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

(
1)
The
test
which
provided
the
basis
for
approval
of
the
exemption
application
has
not
been
started
by
the
deadlines
for
initiation
of
testing
adopted
in
the
test
rule
or
modified
in
accordance
with
§
790.55;
or
(
2)
Data
required
by
the
test
rule
have
not
been
generated
in
accordance
with
the
test
standards
or
submitted
in
accordance
with
the
deadlines
for
submission
of
test
data
that
were
adopted
in
the
test
rule
or
modified
in
accordance
with
§
790.55;
or
(
3)
The
testing
has
not
been
conducted
or
the
data
have
not
been
generated
in
accordance
with
the
Good
Laboratory
Practice
requirements
in
part
792
of
this
chapter.
January
25,
2005
(
b)
If
EPA
determines
that
one
or
more
of
the
criteria
listed
in
paragraph
(
a)
of
this
section
has
been
met,
EPA
will
notify
each
holder
of
an
affected
conditional
exemption
by
certified
mail
or
Federal
Register
notice
of
EPA's
intent
to
terminate
that
conditional
exemption.

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

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

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

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

§
790.97
Hearing
procedures.

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

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

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

§
790.99
Statement
of
financial
responsibility.

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

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

Appendix
A
to
Subpart
E
of
Part
790
 
Schedule
for
Developing
Consent
Agreements
and
Test
Rules
EPA
intends
to
follow
the
schedule
set
forth
in
this
Appendix
to
evaluate
testing
candidates,
conduct
negotiations,
develop
consent
agreements
where
appropriate,
and
propose
and
promulate
test
rules
in
those
instances
where
testing
can
be
required
under
section
4(
a)
of
TSCA
but
agreement
cannot
be
reached
in
timely
manner
on
a
consent
agreement.
Where
deadlines
are
January
25,
2005
imposed
by
the
statute,
they
are
binding
on
EPA
and
will
be
observed
by
the
Agency.
The
remaining
dates
represent
targets
that
EPA
intends
to
meet.

This
schedule
is
based
on
what
EPA
currently
believes
are
reasonable
target
dates.
As
EPA
gains
experience
with
the
process
and
determines
the
feasibility
of
these
schedules,
it
may
adjust
the
schedule
accordingly.
EPA
will
solicit
public
comment
before
implementing
any
changes
in
the
schedule.

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Week
\
1\
Event
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
0.............................
Receive
ITC
report,
recommendation.
2.............................
Publish
ITC
report,
8(
a)
and
8(
d)
notices,
and
invitation
for
public
participation
in
negotiations.
3­
6...........................
Comment
period
on
ITC
report.
6.............................
Public
focus
meeting.
7­
14..........................
8(
a)
and
8(
d)
reporting
period.
22............................
Public
meeting
on
course­
setting
decision
and
deadline
for
requests
to
participate
in
negotiations.
22­
30........................
Negotiations.
32............................
EPA
decision
point:
consent
agreement
or
test
rule.
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
1\
The
dates
contained
in
the
left­
hand
column
are
calculated
from
the
date
EPA
receives
the
ITC
report
recommending
a
chemical
for
testing.

­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
Week
Consent
Agreement
Week
Test
Rule
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
36­
40..........
Comment
period
on
32­
60
Rule
preparation,
consent
agreement.
agency
review
and
sign­
off.
42.............
Comment
resolution
62
Publish
proposed
rule
meeting
if
necessary.
in
Federal
Register.\
1\
48.............
Sign­
off
consent
70­
106
Agency
reviews
agreement
and
Federal
comments;
Register
notice.
preparation
of
final
rule
or
no­
test
decision,
agency
review
and
sign­
off.\
1\
50.............
Publish
Federal
108
Publish
final
rule
or
Register
notice.
no­
test
decision
in
Federal
Register.\
1\
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
\
1\
As
stated
in
§
790.26,
EPA
may
publish
an
Advance
Notice
of
Proposed
Rulemaking
(
ANPR)
where
the
testing
recommendations
of
the
ITC
raise
unusually
novel
and
complex
issues
that
require
additional
Agency
review
and
opportunity
for
public
comment.
EPA
intends
to
publish
such
ANPRs
by
Week
62
following
receipt
of
the
initial
ITC
report;
to
publish
a
proposed
rule
or
decision­
not­
to­
test
by
Week
108;
and
to
publish
a
final
rule
or
notice
terminating
the
rulemaking
January
25,
2005
process
by
Week
154.

[
51
FR
23717,
June
30,
1986]

Attachment
3
Wage
Rates
Estimation
January
25,
2005
8
Internal
EPA
phone
call
between
Carol
Rawie
(
OPPT/
EETD/
RIB)
and
Carl
Koch
(
OPPE/
RMD/
IMB),
May
3,
1994.
ATTACHMENT
3
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
clerical)
were
used
in
this
cost
analysis.
The
labor
categories
and
loaded
wage
rates
were
developed
during
previous
studies.
The
methodology
used
in
developing
wage
rates
is
summarized
below.

LABOR
CATEGORY
LOADED
HOURLY
RATE
Government
GS­
13,
Step
1
$
55.47
Industry
Managerial
Technical
Clerical
$
53.82
$
46.08
$
24.47
B.
Government
The
Federal
government
collection
activity
procedures
described
in
this
report
are
expected
to
be
accomplished
by
a
GS­
13,
Step
1,
Federal
full­
time
equivalent
(
FTE)
employee.
One
FTE
is
equivalent
to
2,080
hours
per
year.
The
2004
cost
of
an
FTE
employee
was
based
on
the
Office
of
Personnel
Management's
2004
General
Schedule
Locality
Rates
of
Pay
for
Washington­
Baltimore,
DC­
MD­
VA­
WV
(
OPM
2004).

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).
The
benefits
multiplication
factor
of
1.6
includes
not
only
benefits
but
also
overhead.
8
See
Table
A­
1
for
the
full
calculation.

C.
Technical,
Managerial,
and
Clerical
Labor
The
basic
method
used
to
derive
loaded
wage
rates
for
technical,
managerial,
and
clerical
personnel
is
described
more
fully
in
Wage
Rates
for
Economic
Analysis
of
the
Toxics
Release
Inventory
Program
(
Rice,
2002).
January
25,
2005
9
Employer
Costs
for
Employee
Compensation,
Private
industry
workers,
Goods­
producing
industries,
white­
collar
occupations,
as
published
by
the
U.
S.
Department
of
Labor,
Bureau
of
Labor
Statistics.
The
December
2003
values
for
these
series
are
listed
in
Table
11
of
the
Employer
Costs
for
Employee
Compensation
Summary,
released
February
2004.

10An
overhead
rate
of
17
percent
applied
to
wages
is
used
for
consistency
with
recent
EPAB
economic
analyses
for
two
major
rulemakings:
Wage
Rates
for
Economic
Analyses
of
the
Toxics
Release
Inventory
Program,
June
10,
2002,
and
the
Revised
Economic
Analysis
for
the
Amended
Inventory
Update
Rule:
Final
Report,
August
2002.
In
reports
for
an
earlier
SNUR
(
EPAB
1999),
the
17
percent
was
applied
to
wages­
plus­
fringe
benefits.
Applying
it
only
to
wages
reduces
calculated
overhead.
December
2003
average
wages
for
technical,
managerial,
and
clerical
labor
were
taken
from
the
Employer
Costs
for
Employee
Compensation
(
ECEC)
report
from
the
Bureau
of
Labor
Statistics
(
BLS)
for
all
goods­
producing,
private
industries.
9
The
additional
cost
of
benefits,
such
as
paid
leave
and
insurance
("
fringe
benefits"),
specific
to
each
labor
category,
are
also
taken
from
the
same
BLS
series.
Fringe
benefit
as
a
percentage
of
wage
is
then
calculated
separately
for
each
labor
category.
For
example,
the
average
wage
rate
in
December
2003
for
technical
labor
was
$
28.36;
the
average
fringe
benefit
was
$
12.90.
So
fringe
benefit
as
a
percentage
of
wage
rate
for
technical
labor
was
12.90/
28.36,
or
approximately
45.5
percent.

An
additional
loading
factor
of
17
percent
is
applied
to
wages
for
overhead.
10
This
overhead
loading
factor
is
added
to
the
benefits
loading
factor,
and
the
total
is
then
applied
to
the
base
wage
to
derive
the
fully
loaded
wage.
The
fully
loaded
wage
for
technical
labor,
for
example,
is
$
28.36*(
1+
0.455
+
0.17)
=
$
28.36*(
1.625)
=
$
46.08.

Fully
loaded
costs
for
managerial
and
clerical
labor
were
calculated
in
a
similar
manner.
See
Table
A­
1
for
the
full
calculations.

D.
References
BLS
2004.
Bureau
of
Labor
Statistics.
Employer
Costs
for
Employee
Compensation
­
December
2003:
Private
industry,
goods­
producing
workers
by
occupational
group
(
Table
11),
February
24,
2004.

EPAB
1999.
Economic
Analysis
of
Expedited
Significant
New
Use
Rules
for
41
Chemical
Substances
and
Background
Support
Document
for
Economic
Analysis
of
Significant
New
Use
Rules.
Washington,
DC:
U.
S.
EPA/
OPPT/
EETD/
EPAB,
July
20,
1999.
EPA
Docket
OPPTS
OPM
2004.
U.
S.
Office
of
Personnel
Management.
Salary
Table
2004­
DCB
(
Washington­
Baltimore).

Rice
2002.
Cody
Rice.
Wage
Rates
for
Economic
Analyses
of
the
Toxics
Release
Inventory
Program,
Washington,
DC:
U.
S.
EPA,
Office
of
Environmental
Information,
Environmental
Analysis
Division,
June
10,
2002.
January
25,
2005
Table
A­
1
Derivation
of
Loaded
Wage
Rates
Labor
Category
Data
Sources
Uninflated
wages
and
fringes
/
hour
Fringe
benefits
as
%
of
wage
Overhead
as
%
of
wage*
Fringe
+
Overhead
factor
Loaded
Wage
Rate
before
inflation
Inflation
factor
Loaded
Wage
Rate
(
2003
dollars)

Date
Wages
$
Fringe
benefits
$

Technical
BLS
Employer
Costs
for
Employee
Compensation,
Table
11.
Private
industry,
goods­
producing
industries,
professional,
specialty
and
technical.
Dec
03.
[
BLS
2004]
Dec
2003
$
28.36
$
12.90
45.5%
17%
1.625
$
46.09
1
$
46.09
Managerial
BLS
Employer
Costs
for
Employee
Compensation,
Table
11.
Private
industry,
goods­
producing
industries,
executive,

administrative,
and
managerial.

Dec
03.
[
BLS
2004]
Dec
2003
$
32.90
$
15.33
46.6%
17%
1.636
$
53.82
1
$
53.82
Clerical
BLS
Employer
Costs
for
Employee
Compensation,
Table
11.
Private
industry,
goods­
producing
industries,
administrative
support,

including
clerical.
Dec
03.
[
BLS
2004]
Dec
2003
$
15.09
$
6.81
45.1%
17%
1.621
$
24.46
1
$
24.46
EPA
staff
FTE
Office
of
Personnel
Management
(
OPM)
pay
rates
for
GS­
13
Step
1
for
2004.
[
OPM
2004]
2004
$
72,108
per
year
­
­
­
1.6
$
115,37
3
per
year
1
$
115,373
per
year
$
55.47
per
hour**

*
An
overhead
rate
of
17
percent
applied
to
wages
is
used
for
consistency
with
recent
EPAB
economic
analyses
for
two
major
rulemakings:
Wage
Rates
for
Economic
Analyses
of
the
Toxics
Release
Inventory
Program,
June
10,
2002,
and
the
Revised
Economic
Analysis
for
the
Amended
Inventory
Update
Rule:

Final
Report,
August
2002.

**
Hourly
rate
=
Annual
salary/
2,080
hours
January
25,
2005
ATTACHMENT
4
EPA
Response
to
Comments
Received
on
ICR
#
1139.07:
TSCA
Existing
Chemical
Test
Rules,
Consent
Orders,
Test
Rule
Exemptions,
and
Voluntary
Test
Data
Submissions
January
25,
2005
UNITED
STATES
ENVIRONMENTAL
PROTECTION
AGENCY
WASHINGTON
D.
C.,
20460
OFFICE
OF
PREVENTION,
PESTICIDES
AND
TOXIC
SUBSTANCES
MEMORANDUM
SUBJECT:
Response
to
Comments
Received
on
ICR
#
1139.07:
TSCA
Existing
Chemical
Test
Rules,
Consent
Orders,
Test
Rule
Exemptions,
and
Voluntary
Test
Data
Submissions
FROM:
James
Willis,
Director
//
s//
Chemical
Control
Division
(
7405)

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

DATE:
January
26,
2005
____________________________________________________________

BACKGROUND
The
data
collection
program
covered
by
this
ICR
renewal
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.
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.

In
proposing
to
renew
this
ICR,
EPA
provided
a
60­
day
public
notice
and
comment
period
that
ended
on
August
30,
2004
(
69
FR
39464,
June
30,
2004).
EPA
received
comments
from
the
American
Chemistry
Council
(
ACC)
and
the
Synthetic
Organic
Chemical
Manufacturers
Association
(
SOCMA).
This
memorandum
summarizes
the
comments
submitted
by
ACC
and
SOCMA
and
provides
EPA's
responses
to
those
comments.

COMMENTS
FROM
ACC/
EPA
RESPONSES
Comment
1.
ACC
claims
that
EPA
has
overstated
its
authority
to
require
testing
under
TSCA
Section
4.
Specifically,
ACC
contends
that
the
following
statement
made
by
EPA
in
Section
2(
a)
January
25,
2005
of
the
ICR
Supporting
Statement
(
Need/
Authority
for
the
Collection)
enlarges
the
actual
scope
of
EPA's
authority
under
Section
4.

"
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
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.

ACC
contends
that,
although
EPA
is
not
strictly
required
to
limit
testing
requirements
to
the
factual
basis
for
its
findings,
it
must
nevertheless
ensure
that
any
such
requirements
are
"
relevant"
to
filling
the
perceived
data
gap.

In
addition,
ACC
noted
that
EPA's
Final
Statement
on
the
"
B"
policy
states
that
the
Agency
would
consider
frequency,
level
and
duration
of
exposure
when
making
the
"
sufficiency
of
data"
and
"
necessity
of
testing"
findings
under
TSCA
Section
4(
a)(
1)(
A)
and
(
B).
ACC
commented
that,
to
their
knowledge,
EPA
has
never
made
such
a
consideration,
yet
these
very
issues
have
a
significant
impact
on
the
burden
of
testing
programs
required
under
Section
4.

EPA
Response
1.
EPA
disagrees
with
ACC's
comment
that
it
has
misinterpreted
its
authority
under
TSCA
section
4.
Since
the
1993
publication
of
its
final
policy
for
exposure­
based
findings
under
TSCA
section
4
("
B
policy"),
EPA
has
consistently
taken
the
position
that
TSCA
authorizes
EPA
to
require
any
type
of
health
or
environmental
effects
testing
necessary
to
address
unanswered
questions
about
the
effects
of
a
chemical
substance
(
58
FR
28736,
May
14,
1993,
see
also,
e.
g.,
69
FR
22402,
22404,
April
26,
2004).
The
Agency
need
not
limit
the
scope
of
testing
required
to
the
factual
basis
for
its
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
a
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.
Id.

TSCA
section
4(
a)
states:
(
a)
TESTING
REQUIREMENTS.­­
If
the
Administrator
finds
that­­
(
1)(
A)(
i)
the
manufacture,
distribution
in
commerce,
processing,
use,
or
disposal
of
a
chemical
substance
or
mixture,
or
that
any
combination
of
such
activities,
may
present
an
unreasonable
risk
of
injury
to
health
or
the
environment,
(
ii)
there
are
insufficient
data
and
experience
upon
which
the
effects
of
such
manufacture,
distribution
in
commerce,
processing,
use,
or
disposal
of
such
substance
or
mixture
or
of
any
combination
of
such
activities
on
health
or
the
environment
can
reasonably
be
determined
or
predicted,
and
(
iii)
testing
of
such
substance
or
mixture
with
respect
to
such
effects
is
necessary
to
develop
such
data;
or
January
25,
2005
(
B)(
i)
a
chemical
substance
or
mixture
is
or
will
be
produced
in
substantial
quantities,
and
(
I)
it
enters
or
may
reasonably
be
anticipated
to
enter
the
environment
in
substantial
quantities
or
(
II)
there
is
or
may
be
significant
or
substantial
human
exposure
to
such
substance
or
mixture,
(
ii)
there
are
insufficient
data
and
experience
upon
which
the
effects
of
the
manufacture,
distribution
in
commerce,
processing,
use,
or
disposal
of
such
substance
or
mixture
or
of
any
combination
of
such
activities
on
health
or
the
environment
can
reasonably
be
determined
or
predicted,
and
(
iii)
testing
of
such
substance
or
mixture
with
respect
to
such
effects
is
necessary
to
develop
such
data;
and
*
*
*
the
Administrator
shall
by
rule
require
that
testing
be
conducted
on
such
substance
or
mixture
to
develop
data
with
respect
to
the
health
and
environmental
effects
for
which
there
is
an
insufficiency
of
data
and
experience
and
which
are
relevant
to
a
determination
that
the
manufacture,
distribution
in
commerce,
processing,
use,
or
disposal
of
such
substance
or
mixture,
or
that
any
combination
of
such
activities,
does
or
does
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment.
15
U.
S.
C.
2603(
a).

Clearly,
if
EPA
were
simply
to
make
a
4(
a)(
1)(
A)(
i)
or
4(
a)(
1)(
B)(
i)
finding,
it
could
not
on
that
basis
alone
proceed
to
require
any
type
of
health
or
environmental
effects
testing
it
pleased.
As
stated
in
the
B
policy
(
58
FR
28736,
28738,
May
14,
1993),
the
final
paragraph
of
section
4(
a)
sets
out
EPA's
authority
to
require
testing
once
the
Agency
has
made
a
finding
under
section
4(
a)(
1)(
A)
or
(
B).
The
directive
of
this
final
paragraph
clearly
relates
to
the
"
data
insufficiency"
and
"
testing
is
necessary"
findings
of
sections
4(
a)(
1)(
A)(
ii)
and
(
iii)
and
(
B)(
ii)
and
(
iii);
it
bears
no
dependence
on
or
other
relationship
to
the
findings
under
either
subsection
4(
a)(
1)(
A)(
i)
or
(
B)(
i).

In
addition,
if
Congress
had
intended
that
the
testing
required
under
TSCA
section
4
be
related
to
the
basis
for
an
4(
a)(
1)(
A)(
i)
or
4(
a)(
1)(
B)(
i)
finding,
it
is
reasonable
to
conclude
that
Congress
would
have
used
the
word
"
or"
instead
of
"
and"
when
directing
the
Administrator
to
require
testing
"
to
develop
data
with
respect
to
the
health
and
environmental
effects***"
in
the
final
paragraph
of
section
4(
a).
However,
the
explicit
choice
of
the
word
"
and"
in
this
final
paragraph
indicates
that
Congress
authorized
EPA
to
require
health
and
environmental
effects
testing
independent
of
the
basis
for
a
4(
a)(
1)(
A)(
i)
or
4(
a)(
1)(
B)(
i)
finding.
Indeed,
EPA
has
consistently
interpreted
the
"
testing
is
necessary"
finding
under
TSCA
sections
4(
a)(
1)(
A)(
iii)
and
(
B)(
iii)
to
mean
that
EPA
may
require
any
health
or
environmental
effects
testing
for
which
data
are
insufficient
and
which
EPA
believes
are
"
capable
of
developing
the
necessary
information."
See
45
FR
48524,
48530,
July
18,
1980.
Further
support
for
EPA's
position
on
this
issue
is
provided
in
EPA's
B
policy
(
58
FR
28736,
28738­
39,
May
14,
1993).

ACC
suggests
that
EPA
must
"
ensure
that
any
such
[
testing]
requirements
are
`
relevant'
to
filling
the
perceived
[
endpoint­
specific]
data
gap."
The
statute
indicates,
however,
that
testing
requirements
must
be
relevant
to
the
more
general
determination
that
activities
associated
with
the
substance
do
or
do
not
present
an
unreasonable
risk
to
health
or
the
environment.

The
Agency
disagrees
with
ACC's
suggestion
that
information
regarding
frequency,
level,
and
duration
of
exposure
is
relevant
to
the
ICR.
However,
EPA
does
in
fact
use
such
information
in
January
25,
2005
11
Polymers,
which
typically
exhibit
low
toxicity
due
to
poor
absorption
because
of
their
physical
size
(
e.
g.,
high
molecular
weight)
and
other
characteristics,
are
unlikely
to
present
significant
risk
concerns.
making
decisions
regarding
testing
under
TSCA
section
4.
For
example,
information
of
this
nature,
when
available,
may
result
in
the
Agency's
deciding
not
to
propose
testing
upfront.
Where
EPA
does
not
have
information
of
this
sort
pre­
proposal,
but
receives
it
post­
proposal,
it
generally
would
not
result
in
the
Agency's
dropping
a
chemical
from
the
rulemaking
because
such
information
is
often
incomplete,
for
example
it
represents
an
industry
segment
rather
than
the
entire
industry.
However,
EPA
does
invite
the
submission
of
all
relevant
information,
including
information
regarding
frequency,
level,
and
duration
of
exposure,
at
any
time
during
the
course
of
a
TSCA
section
4
rulemaking.
As
stated
in
its
B
policy
(
58
FR
28736,
28743,
May
14,
1993),
"[
i]
t
is
the
responsibility
of
interested
parties
to
provide
any
information
they
believe
may
be
relevant
to
the
Agency's
determination
to
require
testing
of
a
particular
chemical
substance
under
TSCA
section
4.
Consequently,
EPA
always
welcomes
the
submission
of
such
information
during
the
notice
and
comment
period
provided
prior
to
the
promulgation
of
any
final
test
rule."

Comment
2.
ACC
notes
that,
in
Section
2(
b)
(
Use/
Users
of
the
Data),
EPA
states
that
" 
approximately
540
of
the
15,000
chemical
sub­
set
of
the
TSCA
Inventory
have
been
subject
of
testing
actions
within
the
OPPT
Existing
Chemicals
Testing
Program."
In
their
comments,
ACC
states
that
EPA
should
provide
a
reference,
description
or
clarification
of
how
the
15,000
sub­
set
value
was
reached
and
also
that
EPA
should
describe
or
list
which
chemicals
have
been
subject
to
testing
actions.

EPA
Response
2.
The
current
TSCA
Inventory
contains
almost
82,000
chemicals.
For
priority­
setting
purposes,
OPPT
has
focused
its
existing
chemical
data
development
and
data
collection
efforts
on
a
subset
of
about
15,000
non­
polymeric
chemicals
reported
in
the
two
most
recent
Inventory
Update
Rule
reporting
cycles
as
being
produced
in
quantities
greater
than
10,000
pounds
per
year.
11
On
average,
there
are
about
9,000
non­
polymeric
organic
chemicals
reported
as
produced
in
quantities
greater
than
10,000
pounds
per
year.
However,
the
IUR
is
a
relatively
dynamic
database.
OPPT
experience
is
that
up
to
4,000
non­
polymeric
organic
chemicals
reported
as
produced
in
quantities
greater
than
10,000
pounds
in
one
IUR
cycle
might
not
be
reported
in
the
following
cycle.
Many
chemicals
periodically
fall
above
or
below
the
reporting
threshold
and
the
lack
of
information
concerning
production
status
during
the
years
between
reporting
years
makes
it
difficult
to
determine
production
trends
with
certainty.
Therefore,
for
priority
setting
purposes,
OPPT
considers
data
from
two
cycles
(
9,000
average
plus
4,000
chemicals
reported
in
the
previous
cycle)
to
represent
the
number
of
organic
chemicals
in
commerce
at
or
above
this
level
of
production.
OPPT
also
adds
an
estimated
2,000
inorganic
chemicals,
resulting
in
approximately
15,000
non­
polymeric
chemicals
that
are
of
interest
for
priority
setting
purposes.

The
table
titled
"
Sunset
Date/
Status
of
TSCA
Section
4
Testing,
Reimbursement,
and
Reporting
Requirements
and
TSCA
Section
4­
Triggered
TSCA
Section
12(
b)
Export
Notification
Requirements"
(
located
at
http://
www.
epa.
gov/
oppt/
chemtest/
sunset.
htm)
lists
all
chemical
substances
and
mixtures
that
are
and/
or
have
been
the
subject
of
final
TSCA
Section
4
test
rules
and/
or
TSCA
Section
4
enforceable
consent
agreements/
orders
(
ECAs)
issued
by
EPA
since
the
January
25,
2005
12
The
sunset
date
is
the
end
of
the
TSCA
Section
4
reimbursement
period
that
begins
when
the
data
from
the
last
test
required
under
a
TSCA
Section
4
test
rule
or
ECA
are
submitted
to
EPA
and
terminates
after
an
amount
of
time
equal
to
that
required
to
develop
those
data
or
after
5
years,
whichever
is
later.
inception
of
the
TSCA
Existing
Chemicals
Testing
Program
and
for
which:

(
1)
the
TSCA
Section
4
testing,
reimbursement,
and
reporting
requirements
and/
or
TSCA
Section
4­
triggered
TSCA
Section
12(
b)
export
notification
requirements
have
terminated
("
sunset")
or
have
been
calculated
to
sunset12;
or
(
2)
some
other
TSCA
Section
4
or
TSCA
Section
4­
triggered
TSCA
Section
12(
b)
status
is
indicated.

Comment
3.
ACC
commented
that
Section
5(
b)
of
the
Supporting
Statement
should
include
a
discussion
of
the
critical
role
of
the
new
HPV
Information
System
and
the
EU's
International
Uniform
Chemical
Information
Database
(
IUCLID)
and
the
Envisioned
HPV
Portal.
ACC
states
that
during
the
period
covered
by
this
ICR
there
will
be
cost/
burden
impacts
both
on
EPA
and
industry
during
the
transition
to
this
globally
recognized
system
for
data
management.
ACC
states
that
these
impacts
will
include
purchase
and
use
of
the
IUCLID
software,
education
and
training
in
use
of
the
HPVIS,
and
possibly
development
of
guidance.
ACC
acknowledges
that
a
burden
estimate
might
be
speculative
at
this
time,
but
ACC
urges
the
Agency
to
at
least
address
these
major
changes
in
key
data
management
activities.

EPA
Response
3.
EPA
agrees
that
Section
5(
b)
would
benefit
from
addition
of
a
discussion
of
current
and
anticipated
future
data
management
activities
for
the
HPV
Challenge
Program.
Therefore,
a
discussion
of
current
and
anticipated
future
data
management
activities
has
been
added
to
Section
5(
b)
of
the
Supporting
Statement.

Comment
4.
ACC
noted
that
EPA
included
one
TSCA
section
4
test
rule
in
Section
6(
a)
(
Respondent
Cost
and
Burden),
the
OSHA
dermal
absorption
test
rule,
promulgated
on
April
26,
2004.
ACC
noted
that
EPA
states
that
additional
data
collection
efforts
beyond
this
test
rule
may
be
conducted
during
the
ICR
approval
process,
but
the
extent
of
such
activities
cannot
be
projected
at
this
time.
However,
ACC
notes
that
EPA
is
working
on
other
test
rules
that
will
be
implemented
during
this
ICR
period
including
one
already
proposed
HPV
rule,
and
a
follow
up
HPV
rule.
ACC
suggests
that
EPA
should
include
estimates
for
the
additional
test
rules
in
this
version
of
the
ICR.

EPA
Response
4.
Under
the
PRA,
the
ICR
must
address
paperwork
burden
and
costs
for
authorized
or
approved
collection
activities.
Until
a
final
TSCA
section
4
rule
is
issued,
the
proposed
data
collection
activities
in
the
proposed
rule
­
or
under
consideration
prior
to
proposal
­
are
not
authorized.
The
estimated
paperwork
burden
and
costs
for
a
proposed
TSCA
section
4
rule
are
provided
for
public
comment
at
the
time
of
the
proposal,
and
in
the
context
of
the
proposal.
At
that
time,
the
Agency
connects
the
proposal
to
this
ICR
and
indicates
that
the
final
rule
will
present
the
adjusted
estimates
­
adjusted
to
reflect
public
comment
received
and
the
January
25,
2005
content
of
the
final
rule.
In
the
context
of
finalizing
a
TSCA
section
4
rule,
the
Agency
submits
an
addendum
or
amendment
for
this
ICR
to
OMB
for
review
and
approval
under
the
PRA.
Once
approved
by
OMB,
the
total
authorized
burden
and
costs
under
this
ICR
is
then
adjusted
by
OMB
to
include
the
collection
activities
in
the
final
rule
thereby
authorizing
or
approving
them
as
required
by
the
PRA.
At
the
time
of
renewal,
the
approved
burden
for
the
final
rules
will
be
incorporated
into
the
Supporting
Statement
for
the
Renewal
ICR.

As
indicated
in
the
terms
of
clearance
imposed
by
OMB
in
approving
this
ICR
three
years
ago,
OMB
has
told
the
Agency
that
no
estimated
burden
or
costs
for
proposed
rules
will
be
approved
under
this
ICR
until
the
final
rule
is
issued
and
OMB
specifically
approves
an
amendment
to
the
ICR
to
capture
the
approval
of
the
activities
in
the
final
rule.
This
is
consistent
with
the
OMB
regulations
for
the
PRA.

Since
the
potential
development
of
a
TSCA
section
4
rulemaking,
whether
at
the
pre­
proposal
or
early
stages
of
development
or
after
proposal,
is
specifically
captured
by
the
Semi­
Annual
Regulatory
Agenda,
the
Agency
has
addressed
the
commenter's
suggestion
by
amending
the
ICR
to
include
a
specific
reference
to
the
Semi­
Annual
Regulatory
Agenda,
and
the
above
explanation
with
regard
to
the
process
that
applies
to
rules
under
development.

Comment
5.
ACC
noted
that,
in
Section
6(
a)
(
Respondent
Cost
and
Burden),
EPA
assumes
that
one
consent
order
or
consent
agreement
will
be
issued
per
year
for
a
total
of
three
consent
orders/
agreements
during
the
ICR
period.
ACC
notes
that,
in
a
recent
symposium,
EPA
identified
eight
consent
agreement
proposals
submitted
under
the
Hazardous
Air
Pollutants
proposed
rulemaking
as
priorities
to
complete
in
2004
and
2005
and
that
these
eight
consent
agreements
were
not
included
in
EPA's
burden
estimation.
In
addition,
ACC
noted
that
it
is
not
clear
whether
EPA
considered
the
ongoing
negotiations
for
a
PFOA
enforceable
consent
agreement
in
its
calculations.
ACC
stated
that
if
EPA
is
aware
that
these
activities
are
coming
up
within
the
three­
year
period
of
this
ICR,
then
EPA
should
include
them
in
the
calculations
to
provide
as
accurate
a
burden
estimate
as
possible.

EPA
Response
5.
Although
the
ICR
does
assume
that
one
ECA
will
be
issued
each
year,
each
ECA
is
assumed
by
EPA
to
cover
five
(
5)
chemicals.
In
addition,
testing
for
each
of
the
five
chemicals
in
each
ECA
is
assumed
by
EPA
to
include
11
tests
(
7
short­
term
and
4
long­
term
tests)
for
a
total
of
55
tests
per
ECA
at
a
total
estimated
cost
of
$
7.9
million
per
ECA.
Thus,
EPA
estimated
that
ECAs
may
be
issued
for
15
chemicals
(
which
includes
165
tests)
over
the
three­
year
life
of
this
ICR
at
a
total
estimated
cost
of
about
$
24
million.

In
a
recent
symposium,
EPA
did
identify
eight
ECA
proposals
submitted
under
the
HAPs
proposed
rulemaking
as
EPA
priorities
for
consideration/
development
in
2004
and
2005.
However,
each
of
these
eight
ECAs
will
likely
be
for
single
chemicals
and
will
likely
involve
far
fewer
that
11
tests
per
chemical.
Since
all
of
the
eight
HAPs­
related
ECAs
under
consideration
are
single
chemical
ECAs
with
far
fewer
than
11
tests
per
chemical,
the
costs
of
these
ECAs,
if
issued,
should
easily
fall
within
the
current
ICR
estimates.
The
PFOA
ECAs,
if
issued,
will
likely
include
multiple
chemicals,
at
least
for
some
tests;
however,
far
fewer
than
11
tests
per
chemical
are
envisioned.
In
any
case,
as
indicated
in
the
Supporting
Statement
and
the
terms
of
clearance
January
25,
2005
applied
by
OMB
on
the
previous
approval
of
this
ICR,
before
an
ECA
can
be
finalized
the
Agency
is
responsible
for
ensuring
that
the
burden
and
cost
estimated
for
an
ECA
fits
within
the
total
approved
burden
for
ECA's
under
this
ICR.
If
it
does
not,
the
Agency
must
ask
OMB
to
amend
the
ICR
approval
to
include
the
additional
burden.
Since
finalizing
an
ECA
is
not
usually
set
in
stone
(
e.
g.,
the
HAPs­
related
ECAs
have
been
under
development
for
several
years),
this
is
a
reasonable
approach
for
estimating
potential
burden
and
costs
related
to
uncertain
ECA
activities
during
the
3­
year
period
of
the
ICR,
and
is
supported
by
the
history
of
ECAs
issued
under
this
ICR
during
past
ICR
approval
periods.

Comment
6.
ACC
states
that
EPA
should
revise
correct
cost
estimates
provided
in
the
ICR
for
the
Dermal
Absorption
Test
Program.
EPA
estimated
the
laboratory
costs
for
the
dermal
absorption
test
rule
requirements
to
be
$
27,190
per
chemical,
with
an
additional
administrative
cost
of
$
6,797.
ACC
stated
that
information
collected
by
ACC
from
a
number
of
contract
laboratories
shows
the
average
costs
to
be
$
40,250
for
the
static
cell
design
and
$
46,250
for
the
flow­
through
design.
ACC
estimates
management
costs
at
$
5,000
to
$
10,000
per
chemical.

EPA
Response
6.
EPA's
development
of
test
cost
estimates
for
the
ICR
follows
the
same
approach
used
in
the
economic
assessment
of
the
final
dermal
testing
rule.
This
approach
used
a
range
of
costs
for
testing
for
the
static
cell
method
and
for
the
flow­
through
method
and
chose
an
average
for
each
test
(
static
cell
method
=
$
25,787;
flow­
through
method
=
$
28,592
).
These
two
costs
were
then
averaged
together
to
derive
an
estimate
for
the
cost
of
the
dermal
testing
requirement
of
$
27,190.
An
administrative
cost
of
$
6,797
was
added
to
the
cost
of
testing
(
within
the
range
proposed
by
the
commenter).
These
cost
estimates
are
meant
to
represent
what
the
respondent
would
experience
should
they
conduct
the
testing
on
their
own
and
necessarily
would
not
include
any
mark­
up
or
profit
that
a
contract
research
organization
might
include
in
its
laboratory
pricing.

EPA
recognizes
that
there
exists
a
range
of
costs
for
testing
and
that
some
who
are
subject
to
reporting
requirements
may
experience
higher
or
lower
levels
of
burden
and
cost
than
EPA
estimates.
However,
EPA's
believes
that
its
estimates
are
well
within
the
range
of
costs
that
a
respondent
may
incur
and
has
not
adjusted
its
costs
in
the
ICR
Comment
7.
ACC
stated
that
EPA
should
clarify
respondent
activities
for
the
HPV
Challenge
Program
by
revising
item
(
b)
in
Section
4(
b)(
ii)
(
Respondent
Activities)
as
follows:
(
b)
Conduct
extensive
searches
for
relevant
existing
data.
If
data
are
found:
°
Determine
whether
the
data
are
relevant
and
valid.
°
Prepare
and
review
summary
of
existing
data
°
Submit
summary
and
existing
data
to
EPA
EPA
Response
7.
EPA
has
modified
Section
4(
b)(
ii)(
b)
in
the
Supporting
Statement
to
read
as
follows.
We
have
not
included
the
adjective
"
extensive"
as
suggested
by
ACC
because
the
Agency
has
not
requested
that
sponsors
conduct
"
extensive"
searches.
Rather,
EPA
has
requested
that
sponsors
assemble
and
review
available
test
data.
(
b)
Conduct
searches
for
relevant
existing
data.
If
data
are
found:
January
25,
2005
°
Determine
whether
the
data
are
relevant;
°
Prepare
and
review
summary
of
existing
data;
and
°
Submit
summary
and
existing
data
to
EPA.

Comment
8.
ACC
stated
that
EPA's
Supporting
Statement
should
not
include
a
discussion
of
the
Master
Testing
List
(
MTL)
as
part
of
Section
5(
b)
(
Collection
Methodology
and
Management)
because
the
MTL
is
irrelevant
in
light
of
the
HPV
and
dermal
absorption
programs.

EPA
Response
8.
Section
5(
b)
of
the
Supporting
Statement
has
been
revised
to
more
clearly
describe
the
collection
methodology
and
management
activities
related
to
the
Section
4
Chemical
Testing
Program
and
the
High
Production
Volume
(
HPV)
Chemical
Challenge
Program.
In
addition,
the
Agency
has
updated
Section
3(
h)
(
Electronic
Reporting).

Comment
9.
ACC
comments
that
EPA's
calculations
to
determine
a
burden
estimate
only
consider
actions
taken
AFTER
a
company
has
determined
it
is
required
to
conduct
testing
and
do
not
include
any
cost
factors
associated
with
a
company's
internal
efforts
prior
to
initiating
testing
under
TSCA
Section
4
or
other
TSCA
programs.
Thus,
ACC
states
that
the
current
burden
estimate
fails
to
consider
that
companies
need
to
expend
many
hours
evaluating
a
Section
4
test
rule
to
understand
the
rule,
conduct
searches
of
their
chemicals
to
determine
if
they
manufacture
or
import
the
listed
substances,
and
determine
if
they
are
obligated
to
respond
to
the
test
rule.
ACC
states
that
these
activities
are
as
much
a
part
of
TSCA
requirements
as
is
submitting
a
report,
and
must
be
included
in
the
overall
burden
estimation.

EPA
Response
9.
The
respondent
activities
considered
in
this
ICR
specifically
include
the
anticipated
activities
for
potential
respondents
to
review
the
rulemaking
and/
or
participate
in
the
discussions
related
to
an
ECA
or
VTA,
as
well
as
the
burden
for
searching
files
and
planning
activities.
These
activities
would
occur
before
the
potential
respondent
has
determined
that
they
must
respond.

It
is
important
to
note
that
the
ICR
is
intended
to
present
the
estimated
burden
and
costs
of
paperwork
activities
imposed
on
the
respondents,
it
is
not
intended
to
reflect
any
and
all
burden
and
costs
related
to
the
rulemaking
or
any
activity
that
a
company
might
engage
in
to
comply
with
a
rulemaking.
The
cost
of
the
rulemaking
is
presented
in
the
Economic
Analysis
prepared
for
the
rulemaking,
which
will
include
estimated
paperwork
burden
as
a
component
of
the
overall
estimated
costs.
Activities
not
imposed
or
required
to
comply
with
the
paperwork
activities
are
not
captured
by
the
ICR.

The
Agency's
consideration
of
potential
respondents
is
appropriate
and
reasonable
because
rulemakings,
ECAs
and
VTAs
apply
to
specific
chemicals,
and
therefore
only
impose
requirements
on
the
manufacturers
and
importers
of
those
chemicals.
Were
the
rules
to
apply
more
generally
to
manufacturers
or
importers
of
all
chemicals,
the
Agency
would
consider
the
universe
of
manufacturers
and
importers
in
estimating
the
burden
and
costs
for
initial
activities
like
rule
familiarization.
January
25,
2005
In
estimating
the
burden
for
the
preliminary
activities
in
this
ICR,
the
Agency
uses
the
universe
of
potential
respondents
(
or
identifiable
manufacturers
and
importers),
even
though
the
other
respondent
activities
related
to
data
generation
and
submission
is
only
required
to
occur
once
for
each
chemical.
Since
the
Agency
is
able
to
use
public
information
to
identify
the
potential
manufacturers
or
importers,
it
is
difficult
to
imagine
that
the
companies
themselves
would
have
to
conduct
extensive
research
to
determine
whether
or
not
they
manufacture
or
import
the
chemical.
The
Agency
believes
that
any
burden
associated
with
such
a
determination
is
likely
to
be
minimal,
similar
to
that
associated
with
determining
identification
information.

COMMENTS
FROM
SOCMA/
EPA
RESPONSES
Comment
10.
SOCMA
believes
that
production
volume
alone
is
not
a
reasonable
surrogate
for
exposure
and
should
not
be
used
as
such
in
the
chemical
testing
program
nor
in
the
HPV
Challenge
Program.

EPA
Response
10.
SOCMA's
comment
that
EPA
uses
production
volume
as
a
surrogate
for
exposure
in
the
HPV
Challenge
Program
oversimplifies
the
Agency's
approach
to
HPV
substances.
Although
the
Agency
views
high
production
volume
as
a
factor
pointing
to
increased
potential
for
exposure,
the
HPV
program
itself
provides
for
limited
test
data
for
closed
system
intermediates.
In
the
context
of
voluntary
programs,
the
determination
of
the
parameters
of
those
programs
is
negotiated
by
EPA
and
program
participants;
thus,
for
example,
the
use
of
production
volume
in
determining
which
chemicals
are
included
in
a
voluntary
program
is
appropriate
for
that
purpose.

Indeed,
EPA
has
stated
that
production
volume
information
alone
is
not
typically
adequate
as
a
proxy
for
exposure
information
for
purposes
of
risk
assessment
and
risk
screening
(
see,
e.
g.,
64
FR
46772,
46779,
Aug.
26,
1999).
However,
in
the
context
of
TSCA
section
4
actions,
production
volume
cannot
be
the
sole
basis
for
exposure­
based
findings
under
TSCA
section
4(
a)(
1)(
B).
In
addition
to
the
production
volume­
based
"
substantial
quantity"
finding
under
section
4(
a)(
1)(
B)(
i),
findings
must
be
made
as
to
either
substantial
release
(
4(
a)(
1)(
B)(
i)(
I))
or
significant
or
substantial
human
exposure
(
4(
a)(
1)(
B)(
i)(
II)).

Comment
11.
SOCMA
notes
that,
in
the
Supporting
Statement
to
the
ICR,
EPA
attempts
to
generally
outline
the
steps
taken
by
sponsors
during
participation
in
a
testing
program.
SOCMA
believes
that
better
precision
could
be
achieved
by
detailing
the
actual
steps
that
consortia
typically
go
through
when
sponsoring
a
chemical
for
testing,
which
are
not
captured
in
the
Supporting
Statement.
SOCMA
provided
an
Annex
to
their
comments
that
contains
an
outline
of
the
steps
that
consortia
generally
take
when
sponsoring
a
chemical
under
an
EPA
or
other
testing
program.
SOCMA
urges
EPA
to
consider
these
line
items
when
estimating
the
actual
burden
to
industry.

EPA
Response
11.
EPA
believes
that
it
has
considered
the
items
that
SOCMA
has
identified
in
its
list
of
steps
that
consortia
generally
take
when
sponsoring
a
chemical.
EPA
has
developed
an
estimate
for
the
administrative
costs
of
reporting
and
organizing
a
testing
program
that
includes
January
25,
2005
many
of
the
steps
identified
by
SOCMA
and
the
relevant
costs
are
already
contained
in
the
estimate.
As
stated
in
the
economic
analysis,
EPA's
estimates
include
preparing
letters
of
intent,
study
plans,
and
progress
reports;
preparing
test
results
for
submission;
recording
test
results;
conducting
laboratory
reviews;
record
keeping;
conducting
administrative
activities
for
organizing,
preparing
for,
and
overseeing
the
testing
program;
obtain
and
review
bids
from
labs;
and
preparing
and
submitting
samples
to
the
laboratory
for
testing;
among
others,
which
are
part
of
SOCMA's
list.
EPA
believes
SOCMA's
list
of
activities
to
be
too
inclusive
as
it
includes
many
costs
that
EPA
is
not
required
to
account
for
as
part
of
the
information
collection,
such
as
travel,
lodging,
and
food.

SOCMA
states
that
its
list
is
generally
applicable
to
information
collection
activities
from
testing
programs.
Therefore,
not
all
of
the
activities
would
necessarily
be
undertaken
by
all
respondents
to
EPA
requirements.
In
fact,
several
of
the
activities
identified
by
SOCMA,
such
as
those
associated
with
the
OECD
SIDs
program
and
REACH
program,
are
associated
with
international
requirements
and
not
EPA
and
thus,
are
irrelevant
to
this
collection
request
and
would
be
inappropriate
to
consider.

Given
the
overly
inclusive
nature
of
SOCMA's
list
of
activities
and
EPA's
inclusion
of
the
relevant
items
in
its
estimate
of
administrative
costs
and
burdens,
EPA
finds
no
reason
to
further
adjust
its
estimates.

Comment
12.
SOCMA
notes
that
Table
6
of
the
Supporting
Statement
lists
hourly
rates
for
technical,
managerial
and
secretarial
labor
types.
SOCMA
states
that
these
figures
do
not
reflect
actual
employment
costs
to
companies
in
the
chemical
sector.

EPA
Response
12.
EPA
has
reviewed
the
development
of
its
wage
estimates
for
this
ICR.
The
wage
estimates
developed
for
technical,
managerial,
and
secretarial
labor
types
are
derived
from
the
Department
of
Labor's
Bureau
of
Labor
Statistics
(
BLS)
figures
on
the
Employer
Costs
for
Employee
Compensation.
Specifically,
EPA
chose
wage
rates
for
private
industry,
goodsproducing
industries,
white­
collar
occupations.
Additional
loading
factors
for
fringe
benefits
and
overhead,
also
based
on
BLS
statistics,
were
applied
to
develop
loaded
wage
rate
estimates.
EPA
recognizes
that
these
figures
may
not
represent
actual
wage
rates
of
all
employers
in
the
chemical
industry
sector
but
believes
that
they
are
a
reasonable
representation
based
upon
current
data.

Comment
13.
SOCMA
states
that
most
consortia,
even
those
with
toxicologists
as
members,
are
in
a
position
where
they
must
hire
consultants
to
perform
much
of
the
technical
writing,
including
review
of
study
reports.
SOCMA
states
that
the
hourly
rate
for
consultants
is
much
higher
than
the
rates
used
in
the
Supporting
Statement.
Therefore,
SOCMA
states
that
the
Supporting
Statement
should
include
an
estimate
of
the
average
number
of
consultant
hours
needed
per
sponsored
chemical
and
associated
costs.

EPA
Response
13.
Under
the
PRA,
agencies
estimate
the
potential
burden
and
costs
to
the
identified
respondents
based
on
the
activities
imposed
as
part
of
the
collection
activities,
or
required
to
complete
the
collection
activity.
Although
individual
respondents
may
choose
a
January
25,
2005
number
of
different
methods
for
responding
to
the
collection
activity,
like
hiring
consultants
or
otherwise
contracting
with
another
entity
to
facilitate
their
compliance,
the
collection
activity
imposed
or
required
for
responding,
is
still
the
same
regardless
of
who
performs
the
tasks.
The
individual
choices
of
a
respondent
are
unknown
to
the
Agency,
and
the
Agency
does
not
believe
that
collecting
such
information
would
improve
the
collection
activity.
EPA
believes
that
the
ICR
provides
a
reasonable
estimate
of
average
burden
and
costs
for
the
anticipated
activities
like
preparing
and
reviewing
the
study
reports,
as
well
as
anticipated
paperwork
activities
related
to
a
respondent's
participation
in
a
consortia.

Although
the
preparation
and
review
burden
might
vary
from
one
study
to
another
based
on
the
complexities
of
the
study,
by
providing
an
average
estimated
burden
and
costs
for
the
paperwork
activities,
the
ICR
presents
a
reasonable
overall
estimate.
In
addition,
including
a
respondent's
contractor
costs
for
these
activities
may
increase
the
overall
estimated
costs,
but
it
actually
results
in
a
reduction
of
the
overall
burden
estimate.
The
costs
for
a
respondent
to
hire
a
consultant
or
contractor
will
capture
non­
paperwork
burden
and
costs
(
i.
e.,
marketing
and
profit
costs
that
the
consultant
or
contractor
include
in
their
costs).
In
general,
agencies
are
not
allowed
to
transfer
the
estimated
burden
for
the
respondent's
paperwork
activities,
to
be
estimated
costs.
Nevertheless,
the
Agency
is
interested
in
learning
more
about
the
typical
respondent
activities
that
SOCMA
referenced
and
will
consult
with
SOCMA
during
the
approval
period
to
identify
whether
the
Agency's
description
of
anticipated
activities
and
related
burden
estimates
can
be
improved
before
the
next
renewal.

Comment
14.
SOCMA
states
that
the
Supporting
Statement
does
not
include
the
costs
of
developing
and
validating
analytical
chemistry
methods
for
each
substance.
Analytical
chemistry
is
essential
for
measuring
the
amount
of
chemical.

EPA
Response
14.
EPA
agrees
that
developing
analytical
chemistry
methods
are
important
for
certain
types
of
toxicological
testing.
These
costs
had
not
been
included
as
part
of
the
burden
and
cost
estimate
for
this
ICR;
however,
EPA
has
since
developed
some
cost
estimates
that
have
been
included
in
its
revision
of
the
economic
analysis.
Generally,
EPA
has
included
costs
only
for
toxicological
testing
as
it
does
not
believe
that
analytical
chemistry
method
development
is
necessary
for
physical­
chemical
property
testing.

Comment
15.
SOCMA
states
that
testing
requirements
for
chemicals
should
be
in
accordance
with
each
chemical's
general
use
(
e.
g.,
industrial,
commercial
or
consumer)
and
not
rely
solely
upon
volume.
To
enhance
the
quality
of
information
collected
under
the
ICR,
SOCMA
recommends
that
EPA
take
a
tiered,
risk­
based
approach
to
testing.
The
tiered
approach
could
further
categorize
chemicals
according
to
general
use.
Once
the
chemicals
are
categorized
according
to
use,
then
an
appropriate
test
battery
could
be
assigned,
which
would
maximize
the
utility
of
the
collected
information
by
keeping
it
focused
on
risk
management.

EPA
Response
15.
EPA's
response
to
the
similar
previous
comment
made
by
SOCMA
(
see
Comment
#
10)
is
an
appropriate
response
to
this
comment
as
well.
SOCMA's
comment
that
EPA
uses
production
volume
as
a
surrogate
for
exposure
in
the
HPV
Challenge
Program
January
25,
2005
oversimplifies
the
Agency's
approach
to
HPV
substances.
Although
the
Agency
views
high
production
volume
as
a
factor
pointing
to
increased
potential
for
exposure,
the
HPV
program
itself
provides
for
limited
test
data
for
closed
system
intermediates.
In
the
context
of
voluntary
programs,
the
determination
of
the
parameters
of
those
programs
is
negotiated
by
EPA
and
program
participants;
thus,
for
example,
the
use
of
production
volume
in
determining
which
chemicals
are
included
in
a
voluntary
program
is
appropriate
for
that
purpose.

Indeed,
EPA
has
stated
that
production
volume
information
alone
is
not
typically
adequate
as
a
proxy
for
exposure
information
for
purposes
of
risk
assessment
and
risk
screening
(
see,
e.
g.,
64
FR
46772,
46779,
Aug.
26,
1999).
However,
in
the
context
of
TSCA
section
4
actions,
production
volume
cannot
be
the
sole
basis
for
exposure­
based
findings
under
TSCA
section
4(
a)(
1)(
B).
In
addition
to
the
production
volume­
based
"
substantial
quantity"
finding
under
section
4(
a)(
1)(
B)(
i),
findings
must
be
made
as
to
either
substantial
release
(
4(
a)(
1)(
B)(
i)(
I))
or
significant
or
substantial
human
exposure
(
4(
a)(
1)(
B)(
i)(
II)).

Comment
16.
With
regards
to
potential
minimization
of
burden
that
may
be
afforded
by
way
of
electronic
reporting,
SOCMA
states
that
the
burdens
of
interest
to
SOCMA
are
associated
with
the
cost
of
preparation
of
the
information,
not
the
medium
on
which
the
information
resides.
From
SOCMA's
point
of
view,
keying
the
information
directly
into
a
database
generally
takes
the
same
amount
of
time
no
matter
which
database
is
being
used.
SOCMA
states
that
industry
already
uses
word
processing
software
and
other
modern
conveniences,
so
there
will
be
no
reduction
in
paperwork
burden
using
a
different
data
entry
system.

EPA
Response
16.
EPA
appreciates
SOCMA's
answer
to
one
of
the
questions
for
which
EPA
solicited
comments
in
the
Federal
Register
notice
(
69
FR
39464,
June
30,
2004).
No
revisions
to
the
ICR
Supporting
Statement
are
recommended
in
this
comment.

Comment
17.
SOCMA
understands
that
the
ICR
only
covers
collections
under
TSCA
Section
4,
but
SOCMA
recommends
that
an
acknowledgment
in
the
Supporting
Statement
with
regards
to
the
importance
and
use
of
exposure
information
would
be
in
line
with
the
Agency's
mission
and
would
better
demonstrate
the
practical
utility
of
the
information
to
be
collected.

EPA
Response
17.
Although
the
use
of
exposure
information
is
implicitly
acknowledged
in
several
locations
in
the
Supporting
Statement
when
statements
are
made
that
Section
4
information
enables
EPA
and
others
to
properly
assess
and
manage
health
and
environmental
risks,
no
explicit
statement
to
that
effect
is
made.
Therefore,
the
first
sentence
of
Section
2(
b)
has
been
modified
as
follows:
"
Data
collected
under
the
Chemical
Testing
Program,
in
conjunction
with
exposure
information,
are
used
by
EPA
scientists
to
determine
whether
the
subject
chemicals
are
likely
to
present
an
unreasonable
risk
to
human
health
or
the
environment."

Comment
18.
In
Section
2(
b)
of
the
Supporting
Statement,
SOCMA
notes
that
EPA
asserts
that
data
generated
for
"
chemicals
used
or
produced
in
particular
work
sites
will
be
useful
in
developing
comprehensive
safety
and
health
programs"
for
workers.
SOCMA
states
that
in
the
January
25,
2005
chemical
manufacturing
sector,
sites
already
have
comprehensive
health
and
safety
programs,
which
are
required
under
OSHA
and
other
labor
laws
and,
thus,
the
EPA
statement
does
not
demonstrate
the
necessity
or
practical
utility
of
certain
information
information
that
will
be
collected
under
this
ICR.

EPA
Response
18.
EPA
acknowledges
that,
in
the
chemical
manufacturing
sector,
sites
already
have
comprehensive
health
and
safety
programs,
which
are
required
by
OSHA
and
other
labor
laws.
However,
not
all
business
sectors
or
all
sites
within
a
given
sector
that
may
use
products
or
formulations
containing
chemicals
have
comprehensive
health
and
safety
programs.
Thus,
data
developed
under
the
TSCA
Chemical
Testing
Program
may
indeed
be
useful
to
those
sectors.
In
addition,
data
developed
under
the
TSCA
Chemical
Testing
Program
will
be
useful
in
maintaining
up­
to­
date
health
and
safety
programs
at
those
sectors/
sites
with
comprehensive
health
and
safety
programs
in
place.
Therefore,
to
clarify
EPA's
interpretation
of
the
usefulness
of
chemical
testing
data,
EPA
has
added
the
phrase
"
and/
or
maintaining"
following
the
word
"
developing"
in
the
sentence
quoted
by
SOCMA
from
Section
2(
b).

Comment
19.
In
Section
2(
b),
EPA
states
that
submitted
test
data
could
be
used
to
"
determine
the
appropriate
action
necessary
to
avoid
or
mitigate"
a
risk
that
may
be
posed
by
a
particular
chemical.
SOCMA
believes
that
if
actions
are
already
taken
to
reduce
risk,
by
reducing
potential
exposures,
then
certain
data
collected
under
this
ICR
no
longer
have
the
intended
utility.

EPA
Response
19.
In
Section
2(
b),
EPA
states
that
"
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."
SOCMA's
comment
does
not
include
the
first
phrase
of
this
sentence
(
i.
e.,
"
If
the
test
data
submitted
indicate
that
potentially
unreasonable
risks
may
exist,
the
data
will
be
used
by
EPA
and
the
manufacturer").
This
first
phrase
provides
the
context
in
which
to
evaluate
the
second
phrase
of
the
sentence
as
quoted
by
SOCMA.
EPA
believes
that
if
new
test
data
indicate
that
a
chemical
may
be
more
hazardous
than
had
been
previously
known,
then
that
new
hazard
information
should
be
evaluated
by
EPA
and
those
manufacturers
practicing
responsible
product
stewardship
to
ensure
that
situations
posing
potentially
unreasonable
risks
are
avoided
or
mitigated.
One
cannot
necessarily
assume
that
exposure
controls
in
place
to
avoid/
mitigate
risks
based
on
previously
known
hazards
are
adequate
to
avoid/
mitigate
risks
for
a
more
serious
hazard.

Comment
20.
SOCMA
notes
that
the
Agency
addresses
the
potential
for
disproportionate
burdens
on
small
businesses
by
using
consortia
as
the
primary
means
for
flexibility.
SOCMA
states
that
while
it
is
true
that
the
majority
of
consortia
share
direct
testing
and
reporting
costs
according
to
market
share,
that
arrangement
is
not
always
possible
for
specialty
chemical
manufacturers.
Specialty
chemicals
frequently
have
only
one
or
two
producers,
which
in
many
cases
are
small
batch
manufacturers.
In
the
case
of
a
single
producer,
the
costs
are
borne
solely
by
the
company.
In
the
case
of
two
or
three
producers,
antitrust
and
competitiveness
implications
may
prevent
companies
from
sharing
production
data,
which
results
in
equal
cost­
sharing.
Equal
cost­
sharing
places
the
smaller
market
player
at
a
disadvantage.
In
addition,
the
costs
of
joining
a
consortium
and
the
management
fees
associated
with
running
the
group
are
shared
equally,
not
in
January
25,
2005
accordance
with
a
company's
market
share.
These
costs
can
easily
outweigh
the
actual
testing
costs
for
small
companies,
since
testing
costs
are
shared
according
to
a
company's
position
in
the
marketplace.

EPA
Response
20.
In
developing
estimates
of
costs
and
burdens
of
information
collections,
EPA
looks
at
the
overall
cost
of
the
collection
and
averages
it
across
respondents.
This
estimate
is
not
expected
to
be
an
exact
estimate
for
each
individual
respondent,
as
it
is
understandable
that
costs
and
burdens
will
vary
based
upon
individual
circumstances.
EPA
believes
that
its
estimate
reasonably
represents
the
burden
that
will
result
from
this
information
collection,
understanding
that
it
may
be
an
underestimate
in
some
cases
and
an
overestimate
in
others.

Comment
21.
SOCMA
notes
that
when
estimating
the
burden
and
cost
of
collection
in
Section
6(
a),
EPA
covers
only
the
OSHA
dermal
absorption
test
rule.
EPA
has
publicly
stated
that
it
intends
to
issue
the
first
final
test
rule
for
HPV
chemicals
late
in
2004,
but
it
is
not
listed
as
"
anticipated"
in
the
ICR.
SOCMA
states
that
if
the
Agency
intends
to
finalize
the
proposed
HPV
test
rule,
then
it
should
be
added
to
the
ICR.

EPA
Response
21.
EPA
has
already
responded
to
the
suggestion.
See
"
EPA
Response
4"
above.
January
25,
2005
ATTACHMENT
5
Section
3(
c)
Consultations
January
25,
2005
Section
3(
c)
Consultations
Under
5
CFR
1320.8(
d)(
1)
OMB
requires
agencies
to
consult
with
potential
ICR
respondents
and
data
users
about
specific
aspects
of
an
ICR
before
the
agency
submits
the
ICR
to
OMB
for
review
and
approval.
In
accordance
with
this
regulation
and
based
on
OPPTS
Regulatory
Coordination
Staff
guidance,
EPA
submitted
questions
to
nine
parties
via
email.
The
individuals
contacted
were:

ACC
Mr.
Steven
Russell
steven_
russell@
americanchemistry.
com
703­
741­
5178
SOCMA
Mr.
James
Cooper
cooperj@
socma.
com
202­
721­
4158
Dow
Chemical
Co.
Dr.
Susan
Hearn
shearn@
dow.
com
989­
636­
9192
GE
Plastics
Ms.
Jessine
Monaghan
jessine.
monaghan@
ge.
com
202­
637­
4003
American
Petroleum
Institute
Dr.
Lorraine
Twerdok
twerdokl@
api.
org
202­
682­
8344
Environmental
Defense
Dr.
Richard
Denison
rdenison@
environmentaldefense.
org
202­
387­
3500
Interagency
Testing
Committee
Dr.
John
Walker
walker.
johnd@
epa.
gov
Improving
Kids
Environment
Thomas
Neltner
neltner@
ikecoalition.
org
317­
442­
3973
January
25,
2005
Texas
Southern
University
Martina
Cartwright
mcartwri@
hotmail.
com
713­
313­
1019
A
copy
of
the
Agency's
e­
mail
with
consultation
questions
to
the
above
nine
parties
is
attached.

Email
sent
by
Keith
Cronin
on
07/
14/
2004
requesting
comment
on
TSCA
Existing
Chemical
Test
Rules,
Consent
Orders,
Test
Rule
Exemptions,
and
Voluntary
Test
Data
Submissions
Information
Collection
Request
On
June
30,
2004,
EPA
published
a
Notice
in
the
Federal
Register
(
69
FR
39464)
for
TSCA
Section
4
Test
Rules,
Consent
Orders,
Test
Rule
Exemptions,
and
Voluntary
Data
Submission;
Request
for
Comment
on
Renewal
of
Information
Collection
Activities.
The
Notice
provides
a
60­
day
public
comment
period.
In
addition
to
to
the
Notice
and
comment
requirement,
agencis
also
are
required
under
Office
of
Management
and
Budget
Regulations
(
5
CFR
1320.8(
d)(
1))
to
consult
with
potential
respondents
and
data
users
specific
aspects
of
an
Information
Collection
Request
(
ICR)
before
submitting
it
to
OMB
for
review
and
approval,
regardless,
in
the
case
of
ICR
renewals,
of
whether
changes
have
or
have
not
been
made
to
the
collection
activity.

As
part
of
this
required
consultation,
I
am
contacting
you
to
solicit
your
input.
I
also
must
note
that,
if
you
take
this
opportunity
to
provide
input,
your
name,
affiliation,
and
phone
number
and
any
information
you
provide
(
e.
g.,
copies
of
emails)
will
be
incorporated
and
attached
to
the
ICR
supporting
statement
which
will
be
a
public
document.
In
addition,
you
may
be
contacted
by
the
OMB
Desk
Examiner
for
the
ICR
to
verify
the
accuracy
of
any
comments
as
reported
in
the
ICR
by
EPA.

EPA
solicits
your
input
on
the
following
questions:

Are
the
data
EPA
seeks
under
this
ICR
available
from
any
public
source,
or
already
collected
by
another
EPA
office
or
by
another
agency?
If
so,
where
can
the
data
be
found?

Is
it
clear,
based
on
the
form
and
instructions,
what
is
required
for
data
submission?
If
not,
are
there
any
suggestions
for
clarifying
instructions?
Is
the
form
clear,
logical,
and
easy
to
complete?

Would
you
be
interested
in
an
electronic/
data
submission
option?
What
type
of
alternative
would
you
be
most
likely
to
utilize
­
web
form,
diskette,
CD
­
ROM?

For
electronic
submission,
how
should
signature
requirements
be
handled
­
Private
Key
Infrastructure,
PINS
and
Passwords,
signed
paper
cover
sheet?
How
does
CBI
affect
your
choice
or
use
of
an
electronic
medium?
Would
you
be
more
inclined
to
submit
CBI
on
diskette
than
on
paper
and
what
benefits
would
you
realize
(
burden
reduction?
Greater
efficiency
in
compiling
information?
Etc).

Do
you
agree
with
EPA's
estimated
burden
and
costs
(
ICR
addresses
only
costs
associated
with
paperwork)?
Are
the
labor
rates
accurate?
January
25,
2005
Your
timely
response
will
be
greatly
appreciated!
Our
plans
call
for
submission
of
this
ICR
renewal
to
OMB
to
be
August
30th.
Thank
you
for
your
assistance.