ATTACHMENT
1
Toxic
Substances
Control
Act
Section
4
15
USC
2603
TITLE
15
­
COMMERCE
AND
TRADE
CHAPTER
53
­
TOXIC
SUBSTANCES
CONTROL
SUBCHAPTER
I
­
CONTROL
OF
TOXIC
SUBSTANCES
Sec.
2603.
­
Testing
of
chemical
substances
and
mixtures
(
a)
Testing
requirements
If
the
Administrator
finds
that
­

(
1)(
A)(
i)

the
manufacture,
distribution
in
commerce,
processing,
use,
or
disposal
of
a
chemical
substance
or
mixture,
or
that
any
combination
of
such
activities,
may
present
an
unreasonable
risk
of
injury
to
health
or
the
environment,

(
ii)

there
are
insufficient
data
and
experience
upon
which
the
effects
of
such
manufacture,
distribution
in
commerce,
processing,
use,
or
disposal
of
such
substance
or
mixture
or
of
any
combination
of
such
activities
on
health
or
the
environment
can
reasonably
be
determined
or
predicted,
and
(
iii)

testing
of
such
substance
or
mixture
with
respect
to
such
effects
is
necessary
to
develop
such
data;
or
(
B)(
i)

a
chemical
substance
or
mixture
is
or
will
be
produced
in
substantial
quantities,
and
(
I)

it
enters
or
may
reasonably
be
anticipated
to
enter
the
environment
in
substantial
quantities
or
(
II)

there
is
or
may
be
significant
or
substantial
human
exposure
to
such
substance
or
mixture,

(
ii)

there
are
insufficient
data
and
experience
upon
which
the
effects
of
the
manufacture,
distribution
in
commerce,
processing,
use,
or
disposal
of
such
substance
or
mixture
or
of
any
combination
of
such
activities
on
health
or
the
environment
can
reasonably
be
determined
or
predicted,
and
(
iii)

testing
of
such
substance
or
mixture
with
respect
to
such
effects
is
necessary
to
develop
such
data;
and
(
2)

in
the
case
of
a
mixture,
the
effects
which
the
mixture's
manufacture,
distribution
in
commerce,
processing,
use,
or
disposal
or
any
combination
of
such
activities
may
have
on
health
or
the
environment
may
not
be
reasonably
and
more
efficiently
determined
or
predicted
by
testing
the
chemical
substances
which
comprise
the
mixture;

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

(
b)
Testing
requirement
rule
(
1)

A
rule
under
subsection
(
a)
of
this
section
shall
include
­

(
A)

identification
of
the
chemical
substance
or
mixture
for
which
testing
is
required
under
the
rule,

(
B)

standards
for
the
development
of
test
data
for
such
substance
or
mixture,
and
(
C)

with
respect
to
chemical
substances
which
are
not
new
chemical
substances
and
to
mixtures,
a
specification
of
the
period
(
which
period
may
not
be
of
unreasonable
duration)
within
which
the
persons
required
to
conduct
the
testing
shall
submit
to
the
Administrator
data
developed
in
accordance
with
the
standards
referred
to
in
subparagraph
(
B).

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

(
2)(
A)

The
health
and
environmental
effects
for
which
standards
for
the
development
of
test
data
may
be
prescribed
include
carcinogenesis,
mutagenesis,
teratogenesis,
behavioral
disorders,
cumulative
or
synergistic
effects,
and
any
other
effect
which
may
present
an
unreasonable
risk
of
injury
to
health
or
the
environment.
The
characteristics
of
chemical
substances
and
mixtures
for
which
such
standards
may
be
prescribed
include
persistence,
acute
toxicity,
subacute
toxicity,
chronic
toxicity,
and
any
other
characteristic
which
may
present
such
a
risk.
The
methodologies
that
may
be
prescribed
in
such
standards
include
epidemiologic
studies,
serial
or
hierarchical
tests,
in
vitro
tests,
and
whole
animal
tests,
except
that
before
prescribing
epidemiologic
studies
of
employees,
the
Administrator
shall
consult
with
the
Director
of
the
National
Institute
for
Occupational
Safety
and
Health.

(
B)

From
time
to
time,
but
not
less
than
once
each
12
months,
the
Administrator
shall
review
the
adequacy
of
the
standards
for
development
of
data
prescribed
in
rules
under
subsection
(
a)
of
this
section
and
shall,
if
necessary,
institute
proceedings
to
make
appropriate
revisions
of
such
standards.

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

(
B)

The
following
persons
shall
be
required
to
conduct
tests
and
submit
data
on
a
chemical
substance
or
mixture
subject
to
a
rule
under
subsection
(
a)
of
this
section:

(
i)

Each
person
who
manufactures
or
intends
to
manufacture
such
substance
or
mixture
if
the
Administrator
makes
a
finding
described
in
subsection
(
a)(
1)(
A)(
ii)
or
(
a)(
1)(
B)(
ii)
of
this
section
with
respect
to
the
manufacture
of
such
substance
or
mixture.

(
ii)

Each
person
who
processes
or
intends
to
process
such
substance
or
mixture
if
the
Administrator
makes
a
finding
described
in
subsection
(
a)(
1)(
A)(
ii)
or
(
a)(
1)(
B)(
ii)
of
this
section
with
respect
to
the
processing
of
such
substance
or
mixture.

(
iii)

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

(
4)

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

(
5)

Rules
issued
under
subsection
(
a)
of
this
section
(
and
any
substantive
amendment
thereto
or
repeal
thereof)
shall
be
promulgated
pursuant
to
section
553
of
title
5
except
that
(
A)

the
Administrator
shall
give
interested
persons
an
opportunity
for
the
oral
presentation
of
data,
views,
or
arguments,
in
addition
to
an
opportunity
to
make
written
submissions;

(
B)

a
transcript
shall
be
made
of
any
oral
presentation;
and
(
C)

the
Administrator
shall
make
and
publish
with
the
rule
the
findings
described
in
paragraph
(
1)(
A)
or
(
1)(
B)
of
subsection
(
a)
of
this
section
and,
in
the
case
of
a
rule
respecting
a
mixture,
the
finding
described
in
paragraph
(
2)
of
such
subsection.

(
c)
Exemption
(
1)

Any
person
required
by
a
rule
under
subsection
(
a)
of
this
section
to
conduct
tests
and
submit
data
on
a
chemical
substance
or
mixture
may
apply
to
the
Administrator
(
in
such
form
and
manner
as
the
Administrator
shall
prescribe)
for
an
exemption
from
such
requirement.

(
2)

If,
upon
receipt
of
an
application
under
paragraph
(
1),
the
Administrator
determines
that
­

(
A)

the
chemical
substance
or
mixture
with
respect
to
which
such
application
was
submitted
is
equivalent
to
a
chemical
substance
or
mixture
for
which
data
has
been
submitted
to
the
Administrator
in
accordance
with
a
rule
under
subsection
(
a)
of
this
section
or
for
which
data
is
being
developed
pursuant
to
such
a
rule,
and
(
B)

submission
of
data
by
the
applicant
on
such
substance
or
mixture
would
be
duplicative
of
data
which
has
been
submitted
to
the
Administrator
in
accordance
with
such
rule
or
which
is
being
developed
pursuant
to
such
rule,
the
Administrator
shall
exempt,
in
accordance
with
paragraph
(
3)
or
(
4),
the
applicant
from
conducting
tests
and
submitting
data
on
such
substance
or
mixture
under
the
rule
with
respect
to
which
such
application
was
submitted.

(
3)(
A)

If
the
exemption
under
paragraph
(
2)
of
any
person
from
the
requirement
to
conduct
tests
and
submit
test
data
on
a
chemical
substance
or
mixture
is
granted
on
the
basis
of
the
existence
of
previously
submitted
test
data
and
if
such
exemption
is
granted
during
the
reimbursement
period
for
such
test
data
(
as
prescribed
by
subparagraph
(
B)),
then
(
unless
such
person
and
the
persons
referred
to
in
clauses
(
i)
and
(
ii)
agree
on
the
amount
and
method
of
reimbursement)
the
Administrator
shall
order
the
person
granted
the
exemption
to
provide
fair
and
equitable
reimbursement
(
in
an
amount
determined
under
rules
of
the
Administrator)
­

(
i)

to
the
person
who
previously
submitted
such
test
data,
for
a
portion
of
the
costs
incurred
by
such
person
in
complying
with
the
requirement
to
submit
such
data,
and
(
ii)

to
any
other
person
who
has
been
required
under
this
subparagraph
to
contribute
with
respect
to
such
costs,
for
a
portion
of
the
amount
such
person
was
required
to
contribute.

In
promulgating
rules
for
the
determination
of
fair
and
equitable
reimbursement
to
the
persons
described
in
clauses
(
i)
and
(
ii)
for
costs
incurred
with
respect
to
a
chemical
substance
or
mixture,
the
Administrator
shall,
after
consultation
with
the
Attorney
General
and
the
Federal
Trade
Commission,
consider
all
relevant
factors,
including
the
effect
on
the
competitive
position
of
the
person
required
to
provide
reimbursement
in
relation
to
the
person
to
be
reimbursed
and
the
share
of
the
market
for
such
substance
or
mixture
of
the
person
required
to
provide
reimbursement
in
relation
to
the
share
of
such
market
of
the
persons
to
be
reimbursed.
An
order
under
this
subparagraph
shall,
for
purposes
of
judicial
review,
be
considered
final
agency
action.

(
B)

For
purposes
of
subparagraph
(
A),
the
reimbursement
period
for
any
test
data
for
a
chemical
substance
or
mixture
is
a
period
­

(
i)

beginning
on
the
date
such
data
is
submitted
in
accordance
with
a
rule
promulgated
under
subsection
(
a)
of
this
section,
and
(
ii)

ending
­

(
I)

five
years
after
the
date
referred
to
in
clause
(
i),
or
(
II)

at
the
expiration
of
a
period
which
begins
on
the
date
referred
to
in
clause
(
i)
and
which
is
equal
to
the
period
which
the
Administrator
determines
was
necessary
to
develop
such
data,
whichever
is
later.

(
4)(
A)

If
the
exemption
under
paragraph
(
2)
of
any
person
from
the
requirement
to
conduct
tests
and
submit
test
data
on
a
chemical
substance
or
mixture
is
granted
on
the
basis
of
the
fact
that
test
data
is
being
developed
by
one
or
more
persons
pursuant
to
a
rule
promulgated
under
subsection
(
a)
of
this
section,
then
(
unless
such
person
and
the
persons
referred
to
in
clauses
(
i)
and
(
ii)
agree
on
the
amount
and
method
of
reimbursement)
the
Administrator
shall
order
the
person
granted
the
exemption
to
provide
fair
and
equitable
reimbursement
(
in
an
amount
determined
under
rules
of
the
Administrator)
­

(
i)

to
each
such
person
who
is
developing
such
test
data,
for
a
portion
of
the
costs
incurred
by
each
such
person
in
complying
with
such
rule,
and
(
ii)

to
any
other
person
who
has
been
required
under
this
subparagraph
to
contribute
with
respect
to
the
costs
of
complying
with
such
rule,
for
a
portion
of
the
amount
such
person
was
required
to
contribute.

In
promulgating
rules
for
the
determination
of
fair
and
equitable
reimbursement
to
the
persons
described
in
clauses
(
i)
and
(
ii)
for
costs
incurred
with
respect
to
a
chemical
substance
or
mixture,
the
Administrator
shall,
after
consultation
with
the
Attorney
General
and
the
Federal
Trade
Commission,
consider
the
factors
described
in
the
second
sentence
of
paragraph
(
3)(
A).
An
order
under
this
subparagraph
shall,
for
purposes
of
judicial
review,
be
considered
final
agency
action.

(
B)
If
any
exemption
is
granted
under
paragraph
(
2)
on
the
basis
of
the
fact
that
one
or
more
persons
are
developing
test
data
pursuant
to
a
rule
promulgated
under
subsection
(
a)
of
this
section
and
if
after
such
exemption
is
granted
the
Administrator
determines
that
no
such
person
has
complied
with
such
rule,
the
Administrator
shall
(
i)

after
providing
written
notice
to
the
person
who
holds
such
exemption
and
an
opportunity
for
a
hearing,
by
order
terminate
such
exemption,
and
(
ii)

notify
in
writing
such
person
of
the
requirements
of
the
rule
with
respect
to
which
such
exemption
was
granted.

(
d)
Notice
Upon
the
receipt
of
any
test
data
pursuant
to
a
rule
under
subsection
(
a)
of
this
section,
the
Administrator
shall
publish
a
notice
of
the
receipt
of
such
data
in
the
Federal
Register
within
15
days
of
its
receipt.
Subject
to
section
2613
of
this
title,
each
such
notice
shall
(
1)

identify
the
chemical
substance
or
mixture
for
which
data
have
been
received;

(
2)

list
the
uses
or
intended
uses
of
such
substance
or
mixture
and
the
information
required
by
the
applicable
standards
for
the
development
of
test
data;
and
(
3)

describe
the
nature
of
the
test
data
developed.
Except
as
otherwise
provided
in
section
2613
of
this
title,
such
data
shall
be
made
available
by
the
Administrator
for
examination
by
any
person.

(
e)
Priority
list
(
1)(
A)

There
is
established
a
committee
to
make
recommendations
to
the
Administrator
respecting
the
chemical
substances
and
mixtures
to
which
the
Administrator
should
give
priority
consideration
for
the
promulgation
of
a
rule
under
subsection
(
a)
of
this
section.
In
making
such
a
recommendation
with
respect
to
any
chemical
substance
or
mixture,
the
committee
shall
consider
all
relevant
factors,
including
­

(
i)

the
quantities
in
which
the
substance
or
mixture
is
or
will
be
manufactured,

(
ii)

the
quantities
in
which
the
substance
or
mixture
enters
or
will
enter
the
environment,

(
iii)

the
number
of
individuals
who
are
or
will
be
exposed
to
the
substance
or
mixture
in
their
places
of
employment
and
the
duration
of
such
exposure,
(
iv)

the
extent
to
which
human
beings
are
or
will
be
exposed
to
the
substance
or
mixture,

(
v)

the
extent
to
which
the
substance
or
mixture
is
closely
related
to
a
chemical
substance
or
mixture
which
is
known
to
present
an
unreasonable
risk
of
injury
to
health
or
the
environment,

(
vi)

the
existence
of
data
concerning
the
effects
of
the
substance
or
mixture
on
health
or
the
environment,

(
vii)

the
extent
to
which
testing
of
the
substance
or
mixture
may
result
in
the
development
of
data
upon
which
the
effects
of
the
substance
or
mixture
on
health
or
the
environment
can
reasonably
be
determined
or
predicted,
and
(
viii)

the
reasonably
foreseeable
availability
of
facilities
and
personnel
for
performing
testing
on
the
substance
or
mixture.

The
recommendations
of
the
committee
shall
be
in
the
form
of
a
list
of
chemical
substances
and
mixtures
which
shall
be
set
forth,
either
by
individual
substance
or
mixture
or
by
groups
of
substances
or
mixtures,
in
the
order
in
which
the
committee
determines
the
Administrator
should
take
action
under
subsection
(
a)
of
this
section
with
respect
to
the
substances
and
mixtures.
In
establishing
such
list,
the
committee
shall
give
priority
attention
to
those
chemical
substances
and
mixtures
which
are
known
to
cause
or
contribute
to
or
which
are
suspected
of
causing
or
contributing
to
cancer,
gene
mutations,
or
birth
defects.
The
committee
shall
designate
chemical
substances
and
mixtures
on
the
list
with
respect
to
which
the
committee
determines
the
Administrator
should,
within
12
months
of
the
date
on
which
such
substances
and
mixtures
are
first
designated,
initiate
a
proceeding
under
subsection
(
a)
of
this
section.
The
total
number
of
chemical
substances
and
mixtures
on
the
list
which
are
designated
under
the
preceding
sentence
may
not,
at
any
time,
exceed
50.

(
B)

As
soon
as
practicable
but
not
later
than
nine
months
after
January
1,
1977,
the
committee
shall
publish
in
the
Federal
Register
and
transmit
to
the
Administrator
the
list
and
designations
required
by
subparagraph
(
A)
together
with
the
reasons
for
the
committee's
inclusion
of
each
chemical
substance
or
mixture
on
the
list.
At
least
every
six
months
after
the
date
of
the
transmission
to
the
Administrator
of
the
list
pursuant
to
the
preceeding
[
1]
sentence,
the
committee
shall
make
such
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.

(
vii)

One
member
appointed
by
the
Director
of
the
National
Science
Foundation
from
officers
or
employees
of
the
Foundation.

(
viii)

One
member
appointed
by
the
Secretary
of
Commerce
from
officers
or
employees
of
the
Department
of
Commerce.

(
B)(
i)

An
appointed
member
may
designate
an
individual
to
serve
on
the
committee
on
the
member's
behalf.
Such
a
designation
may
be
made
only
with
the
approval
of
the
applicable
appointing
authority
and
only
if
the
individual
is
from
the
entity
from
which
the
member
was
appointed.

(
ii)

No
individual
may
serve
as
a
member
of
the
committee
for
more
than
four
years
in
the
aggregate.
If
any
member
of
the
committee
leaves
the
entity
from
which
the
member
was
appointed,
such
member
may
not
continue
as
a
member
of
the
committee,
and
the
member's
position
shall
be
considered
to
be
vacant.
A
vacancy
in
the
committee
shall
be
filled
in
the
same
manner
in
which
the
original
appointment
was
made.
(
iii)

Initial
appointments
to
the
committee
shall
be
made
not
later
than
the
60th
day
after
January
1,
1977.
Not
later
than
the
90th
day
after
such
date
the
members
of
the
committee
shall
hold
a
meeting
for
the
selection
of
a
chairperson
from
among
their
number.

(
C)(
i)

No
member
of
the
committee,
or
designee
of
such
member,
shall
accept
employment
or
compensation
from
any
person
subject
to
any
requirement
of
this
chapter
or
of
any
rule
promulgated
or
order
issued
thereunder,
for
a
period
of
at
least
12
months
after
termination
of
service
on
the
committee.

(
ii)

No
person,
while
serving
as
a
member
of
the
committee,
or
designee
of
such
member,
may
own
any
stocks
or
bonds,
or
have
any
pecuniary
interest,
of
substantial
value
in
any
person
engaged
in
the
manufacture,
processing,
or
distribution
in
commerce
of
any
chemical
substance
or
mixture
subject
to
any
requirement
of
this
chapter
or
of
any
rule
promulgated
or
order
issued
thereunder.

(
iii)

The
Administrator,
acting
through
attorneys
of
the
Environmental
Protection
Agency,
or
the
Attorney
General
may
bring
an
action
in
the
appropriate
district
court
of
the
United
States
to
restrain
any
violation
of
this
subparagraph.

(
D)

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

(
f)
Required
actions
Upon
the
receipt
of
­

(
1)

any
test
data
required
to
be
submitted
under
this
chapter,
or
(
2)

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

(
g)
Petition
for
standards
for
the
development
of
test
data
A
person
intending
to
manufacture
or
process
a
chemical
substance
for
which
notice
is
required
under
section
2604(
a)
of
this
title
and
who
is
not
required
under
a
rule
under
subsection
(
a)
of
this
section
to
conduct
tests
and
submit
data
on
such
substance
may
petition
the
Administrator
to
prescribe
standards
for
the
development
of
test
data
for
such
substance.
The
Administrator
shall
by
order
either
grant
or
deny
any
such
petition
within
60
days
of
its
receipt.
If
the
petition
is
granted,
the
Administrator
shall
prescribe
such
standards
for
such
substance
within
75
days
of
the
date
the
petition
is
granted.
If
the
petition
is
denied,
the
Administrator
shall
publish,
subject
to
section
2613
of
this
title,
in
the
Federal
Register
the
reasons
for
such
denial
[
1]
So
in
original.
Probably
should
be
''
preceding''.
ATTACHMENT
2
40
CFR
790
Procedures
Governing
Testing
Consent
Agreements
and
Test
Rules
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.

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.

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

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

[
50
FR
20656,
May
17,
1985,
as
amended
at
51
FR
23712,
June
30,
1986;
58
FR
34205,
June
23,
1993;
60
FR
31922,
June
19,
1995;
60
FR
34466,
July
3,
1995]
§
790.7
Confidentiality.

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

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

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

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

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

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

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

(
5)
What
measures
have
you
taken
to
guard
against
disclosure
of
this
information
to
others?

(
6)
To
what
extent
has
this
information
been
disclosed
to
others?
What
precautions
have
been
taken
in
connection
with
such
disclosures?
(
7)
Has
this
information
been
disclosed
to
the
public
in
any
forms?
Describe
the
circumstances.

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

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

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

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

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

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

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

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

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

(
3)
Where
the
ITC
concludes
that
a
substance
or
mixture
warrants
testing
consideration
but
that
expedited
EPA
review
of
testing
needs
is
not
justified,
the
ITC
will
add
the
substance
or
mixture
to
its
list
of
testing
recommendations
without
expressing
an
intent
to
designate
the
substance
or
mixture
for
EPA
action
in
accordance
with
section
4(
e)(
1)(
B)
of
the
Act.
(
4)
The
ITC
reserves
its
right
to
designate
any
chemical
that
it
determines
the
Agency
should,
within
12
months
of
the
date
first
designated,
initiate
a
proceeding
under
section
4(
a)
of
the
Act.

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

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

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

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

(
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.

§
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
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.

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

(
iv)
Standards
for
the
development
of
test
data.

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

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

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

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

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

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

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

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

(
iv)
A
reference
to
appropriate
guidelines
for
the
development
of
test
data.
(
v)
The
EPA
Good
Laboratory
Practice
requirements
for
the
required
testing.

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

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

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

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

§
790.42
Persons
subject
to
a
test
rule.

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

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

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

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

(
3)
If
testing
is
being
required
to
allow
evaluation
of
risks
associated
solely
with
processing
of
the
chemical,
processors
will
be
subject
and
must
comply
with
the
requirements
of
the
test
rule.
(
4)
While
legally
subject
to
the
test
rule
in
circumstances
described
in
paragraph
(
a)(
1)
of
this
section,
persons
who
manufacture
less
than
500
kg
(
1,100
lb)
of
the
chemical
annually
during
the
period
from
the
effective
date
of
the
test
rule
to
the
end
of
the
reimbursement
period,
must
comply
with
the
requirements
of
the
test
rule
only
if
such
manufacturers
are
directed
to
do
so
in
a
subsequent
notice
as
set
forth
in
§
790.48,
or
if
directed
to
do
so
in
a
particular
test
rule.

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

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

(
b)
[
Reserved]

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

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

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

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

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

(
1)
Identification
of
test
rule.
(
2)
Name,
address,
and
telephone
number
of
the
firm(
s)
which
will
be
sponsoring
the
tests.

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

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

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

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

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

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

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

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

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

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

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

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

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

(
3)
No
later
than
30
days
after
the
date
of
publication
of
the
Federal
Register
notice
described
in
paragraph
(
b)(
2)
of
this
section,
each
person
described
in
§
790.40(
a)(
4)
and
(
5)
and
each
person
processing
the
subject
chemical
as
of
the
effective
date
of
the
test
rule
described
in
§
790.40
or
by
30
days
after
the
date
of
publication
of
the
Federal
Register
notice
described
in
paragraph
(
b)(
2)
of
this
section
must,
for
each
test
specified
in
the
Federal
Register
notice,
either
notify
EPA
by
letter
of
his
or
her
intent
to
conduct
testing
or
submit
to
EPA
an
application
for
an
exemption
from
testing
requirements
for
the
test.
(
4)
If
no
manufacturer
or
processor
of
the
test
chemical
has
submitted
a
letter
of
intent
to
conduct
one
or
more
of
the
required
tests
within
30
days
after
the
date
of
publication
of
the
Federal
Register
notice
described
in
paragraph
(
b)(
2)
of
this
section,
EPA
will
notify
all
manufacturers
and
processors
by
certified
letter
or
publish
a
Federal
Register
notice
of
this
fact
specifying
the
tests
for
which
no
letter
of
intent
has
been
submitted.
This
letter
or
Federal
Register
notice
will
give
the
manufacturers
and
processors
an
opportunity
to
take
corrective
action.

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

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

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

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

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

§
790.50
Submission
of
study
plans.

(
a)
Who
must
submit
study
plans.
(
1)
Persons
who
notify
EPA
of
their
intent
to
conduct
tests
in
compliance
with
the
requirements
of
a
single
phase
test
rule
as
described
in
§
790.40(
b)(
1)
must
submit
study
plans
for
those
tests
prior
to
the
initiation
of
each
of
these
tests,
unless
directed
by
a
particular
test
rule
or
consent
agreement
to
submit
study
plans
at
a
specific
time.
(
2)
Persons
who
notify
EPA
of
their
intent
to
conduct
tests
in
compliance
with
the
requirements
of
a
Phase
I
test
rule
as
described
in
§
790.40(
b)(
2)
must
submit
the
proposed
study
plans
for
those
tests
on
or
before
90
days
after
the
effective
date
of
the
Phase
I
rule;
or,
for
processors
complying
with
the
notice
described
in
§
790.48(
b)(
2),
90
days
after
the
publication
date
of
that
notice;
or
60
days
after
the
date
manufacture
or
processing
begins
as
described
in
§
790.45(
d),
as
appropriate,
to
the
address
in
§
790.5(
b).

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

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

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

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

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

(
2)
Under
two­
phase
rulemaking,
extension
requests
must
be
submitted
to
EPA
within
60
days
after
the
effective
date
of
the
Phase
I
test
rule
as
described
in
§
790.40(
b)(
2);
or
for
processors
complying
with
the
notice
described
in
§
790.48(
b)(
2),
60
days
after
the
publication
date
of
that
notice;
or
30
days
after
the
date
manufacture
or
processing
begins
as
described
in
§
790.45(
d),
as
appropriate.
(
3)
EPA
will
notify
the
submitter
by
certified
mail
of
EPA's
decision
to
grant
or
deny
an
extension
request.

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

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

(
i)
Identity
of
the
test
rule.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

§
790.52
Phase
II
test
rule.

(
a)
If
EPA
determines
that
the
proposed
study
plan
described
in
§
790.50(
a)(
2)
complies
with
§
790.50(
c),
EPA
will
publish
a
proposed
Phase
II
test
rule
in
the
Federal
Register
requesting
comments
on
the
ability
of
the
proposed
study
plan
to
ensure
that
data
from
the
test
will
be
reliable
and
adequate.
(
b)
EPA
will
provide
a
45­
day
comment
period
and
will
provide
an
opportunity
for
an
oral
presentation
upon
the
request
of
any
person.
EPA
may
extend
the
comment
period
if
it
appears
from
the
nature
of
the
issues
raised
by
EPA's
review
or
from
public
comments
that
further
comment
is
warranted.

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

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

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

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

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

(
2)
Where,
in
EPA's
judgment,
the
requested
modification
of
the
test
standard
or
schedule
would
not
alter
the
scope
of
the
test
or
significantly
change
the
schedule
for
completing
the
test,
EPA
will
not
ask
for
public
comment
before
approving
the
modification.
EPA
will
notify
the
test
sponsor
by
letter
of
EPA's
approval.
EPA
will
place
copies
of
each
application
and
EPA
approval
letter
in
the
rulemaking
record
for
the
test
rule
in
question.
EPA
will
publish
a
notice
annually
in
the
Federal
Register
indicating
the
test
standards
or
schedules
for
tests
required
in
test
rules
which
have
been
modified
under
this
paragraph
(
b)(
2)
and
describing
the
nature
of
the
modifications.
Until
the
Federal
Register
notice
is
published,
any
modification
approved
by
EPA
under
this
paragraph
(
b)(
2)
shall
apply
only
to
the
test
sponsor
who
applied
for
the
modification
under
this
paragraph
(
a)
of
this
section.
(
3)
Where,
in
EPA's
judgment,
the
requested
modification
of
a
test
standard
or
schedule
would
significantly
alter
the
scope
of
the
test
or
significantly
change
the
schedule
for
completing
the
test,
EPA
will
publish
a
notice
in
the
Federal
Register
requesting
comment
on
the
proposed
modification.
However,
EPA
will
approve
a
requested
modification
of
a
test
standard
under
paragraph
(
b)(
3)
of
this
section
without
first
seeking
public
comment
if
EPA
believes
that
an
immediate
modification
to
the
test
standard
is
necessary
to
preserve
the
accuracy
or
validity
of
an
ongoing
test.
EPA
may
also
modify
a
testing
requirement
or
test
condition
in
a
test
standard
if
EPA
determines
that
the
completion
or
achievement
of
this
requirement
or
condition
is
not
technically
feasible.
EPA
may
approve
a
test
schedule
extension
under
paragraph
(
b)(
3)
of
this
section
without
first
seeking
public
comment
if
EPA
determines,
on
a
case­
by­
case
basis,
that
a
delay
of
over
12
months
is
not
the
fault
of
the
test
sponsor
and
is
the
result
of
unforeseen
circumstances
such
as
a
lack
of
laboratory
availability,
lack
of
availability
of
suitable
test
substance
(
e.
g.,
14
 
C
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.

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

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

§
790.60
Contents
of
consent
agreements.

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

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

(
2)
The
health
effects,
environmental
effects
and/
or
other
characteristics
for
which
testing
will
be
required.
(
3)
The
names
and
addresses
of
each
manufacturer
and/
or
processor
who
will
sign
the
agreement.

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

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

(
6)
Standards
for
the
development
of
test
data.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(
6)
The
names
and
addresses
of
the
testing
facilities
responsible
for
the
testing
and
the
names,
addresses,
and
telephone
numbers
of
the
administrative
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.

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

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

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

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

§
790.65
Failure
to
comply
with
a
consent
agreement.

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

(
b)
The
Agency
considers
failure
to
comply
with
any
aspect
of
a
consent
agreement
to
be
a
"
prohibited
act"
under
section
15
of
TSCA,
subject
to
all
of
the
provisions
of
the
Act
applicable
to
violations
of
section
15.
Section
15(
1)
of
TSCA
makes
it
unlawful
for
any
person
to
fail
or
refuse
to
comply
with
any
rule
or
order
issued
under
section
4.
Consent
agreements
adopted
pursuant
to
this
part
are
"
orders
issued
under
section
4"
for
purposes
of
section
15(
1)
of
TSCA.
(
c)
Manufacturers
and/
or
processors
who
violate
consent
agreements
are
subject
to
criminal
and/
or
civil
liability.
Under
the
penalty
provisions
of
section
16
of
TSCA,
such
firms
could
be
subject
to
a
civil
penalty
of
up
to
$
25,000
per
violation
with
each
day
in
violation
constituting
a
separate
violation
of
section
15.
Intentional
violations
could
lead
to
the
imposition
of
criminal
penalties
of
up
to
$
25,000
for
each
day
of
violation
and
imprisonment
for
up
to
one
year.
In
addition,
EPA
could
invoke
the
remedies
available
under
section
17
of
TSCA,
including
seeking
an
injunction
to
compel
adherence
to
the
requirements
of
the
consent
agreement.

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

§
790.68
Modification
of
consent
agreements.

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

(
2)
The
scope
of
testing
required
by
a
consent
agreement
will
be
modified
only
where
there
is
a
consensus
concerning
the
modified
testing
requirements
among
EPA,
affected
manufacturers
and/
or
processors,
and
other
persons
who
have
asked
to
participate
in
or
monitor
negotiations
under
paragraph
(
a)(
1)
of
this
section.
In
determining
whether
a
consensus
exists,
EPA
will
employ
the
criteria
specified
in
§
790.24.
In
the
absence
of
consensus,
EPA
may
initiate
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
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.

§
790.80
Submission
of
exemption
applications.
(
a)
Who
should
file
applications.
(
1)
Any
manufacturer
or
processor
subject
to
a
test
rule
in
part
799
of
this
chapter
may
submit
an
application
to
EPA
for
an
exemption
from
performing
any
or
all
of
the
tests
required
under
the
test
rule.

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

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

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

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

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

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

[
50
FR
20660,
May
17,
1985,
as
amended
at
58
FR
34205,
June
23,
1993]
§
790.82
Content
of
exemption
application.

The
exemption
application
must
contain:

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

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

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

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

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

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

(
ii)
Equivalence
data
specified
in
§
790.85.

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

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

§
790.85
Submission
of
equivalence
data.

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

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

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

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

§
790.87
Approval
of
exemption
applications.

(
a)
EPA
will
conditionally
approve
exemption
applications
if:

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

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

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

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

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

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

§
790.88
Denial
of
exemption
application.

(
a)
EPA
may
deny
any
exemption
application
if:

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

(
b)
EPA
will
notify
the
exemption
applicant
by
certified
mail
or
Federal
Register
notice
of
EPA's
determination
that
the
exemption
application
is
denied.
§
790.90
Appeal
of
denial
of
exemption
application.

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

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

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

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

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

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

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

§
790.93
Termination
of
conditional
exemption.

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

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

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

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

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

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

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

§
790.97
Hearing
procedures.

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

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

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

§
790.99
Statement
of
financial
responsibility.

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

Appendix
A
to
Subpart
E
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
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
process
by
Week
154.

[
51
FR
23717,
June
30,
1986]
1
Internal
EPA
phone
call
between
Carol
Rawie
(
OPPT/
EETD/
RIB)
and
Carl
Koch
(
OPPE/
RMD/
IMB),
May
3,
1994.
ATTACHMENT
3
OPPT
TSCA
Test
Guidelines
Cost
Summary
Wage
Rates
Estimation
1.
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
2.
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.
1
See
Table
A­
1
for
the
full
calculation.
2
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.

3An
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.
3.
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).

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.
2
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.
3
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.
4.
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.
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
4
Internal
EPA
phone
call
between
Carol
Rawie
(
OPPT/
EETD/
RIB)
and
Carl
Koch
(
OPPE/
RMD/
IMB),
May
3,
1994.
ATTACHMENT
4
Wage
Rates
Estimation
E.
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
F.
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.
4
See
Table
A­
1
for
the
full
calculation.
5
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.

6An
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.
G.
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).

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.
5
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.
6
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.

H.
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.
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
ATTACHMENT
5
Supplemental
Break­
Outs
for
Table
4
Annual
Respondent
Burden
Estimates
for
Reporting
­
By
Program
COLLECTION
ACTIVITY
Unit
Programs
GRAND
TOTAL
Test
Rule
Consent
Order
Children's
Health
HPV
Hrs
#
Hrs
#
Hrs
#
Hrs
#
Hrs
#
Hrs
INTERIM
REPORTS
Letter
of
Intent
and
Study
Plans
40
3
120
8
320
2
80
100
4,000
113
4,520
Prepare
Progress
Report
8
300
2,400
800
6,400
660
5,280
0
0
1,760
14,080
INTERIM
REPORTS
Subtotal
2,520
6,720
5,360
4,000
18,600
FINAL
REPORTS
Short­
term
Studies
Record
and
Prepare
Test
for
Submission
40
105
4,200
280
11,200
220
8,800
9,061
362,440
9,666
386,640
Laboratory
Review
6
105
630
280
1,680
220
1,320
9,061
54,366
9,666
57,996
Corporate
Review
6
105
630
280
1,680
220
1,320
9,061
54,366
9,666
57,996
Type
and
Print
Results
20
105
2,100
280
5,600
220
4,400
9,061
181,220
9,666
193,320
Record
Keeping
1
105
105
280
280
220
220
9,061
9,061
9,666
9,666
Short­
term
Subtotal
7,665
20,440
16,060
661,453
705,618
COLLECTION
ACTIVITY
Unit
Programs
GRAND
TOTAL
Test
Rule
Consent
Order
Children's
Health
HPV
Hrs
#
Hrs
#
Hrs
#
Hrs
#
Hrs
#
Hrs
Long­
term
Studies
Record
and
Prepare
Test
for
Submission
80
60
4,800
160
12,800
132
10,560
0
0
352
28,160
Laboratory
Review
9
60
540
160
1,440
132
1,188
0
0
352
3,168
Corporate
Review
9
60
540
160
1,440
132
1,188
0
0
352
3,168
Type
and
Print
Results
40
60
2,400
160
6,400
132
5,280
0
0
352
14,080
Record
Keeping
1
60
60
160
160
132
132
0
0
352
352
Long­
term
Subtotal
8,340
22,240
18,348
0
48,928
FINAL
REPORTS
SUBTOTAL
16,005
42,680
34,408
661,453
754,546
Total
18,525
49,400
39,768
665,453
773,146
Annual
Respondent
Cost
Estimates
for
Reporting
­
By
Program
COLLECTION
ACTIVITY
UNIT
GRAND
TOTAL
Test
Rules
Consent
Orders
Children's
Health
HPV
Hrs$
Supply
#
$
#
$
#
$
#
$
#
COSTS
INTERIM
REPORTS
Letter
of
Intent
and
Study
Plans
$
2,572
$
20
3
$
7,776
8
$
20,736
2
$
5,184
100
$
259,200
113
$
292,896
Prepare
Progress
Report
$
514
$
5
300
$
155,820
800
$
415,520
660
$
342,804
0
$
0
1,760
$
914,144
Interim
Reports
Subtotal
$
163,596
$
436,256
$
347,988
$
259,200
$
1,207,040
FINAL
REPORTS
Short­
term
Studies
Record
and
Prepare
Test
for
Submission
$
2,572
$
0
105
$
270,060
280
$
720,160
220
$
565,840
9,061
$
23,304,892
9,666
$
24,860,952
Laboratory
Review
$
386
$
0
105
$
40,509
280
$
108,024
220
$
84,876
9,061
$
3,495,734
9,666
$
3,729,143
Corporate
Review
$
521
$
0
105
$
54,722
280
$
145,925
220
$
114,655
9,061
$
4,722,231
9,666
$
5,037,533
Type
and
Print
Results
$
513
$
0
105
$
53,823
280
$
143,528
220
$
112,772
9,061
$
4,644,669
9,666
$
4,954,792
Record
Keeping
$
26
$
5
105
$
3,216
280
$
8,576
220
$
6,739
9,061
$
277,538
9,666
$
296,070
Short­
term
Subtotal
$
422,330
$
1,126,213
$
884,882
$
36,445,064
$
38,878,489
Long­
term
Studies
Record
and
Prepare
Test
for
Submission
$
5,144
$
0
60
$
308,640
160
$
823,040
132
$
679,008
0
$
0
352
$
1,810,688
Laboratory
Review
$
579
$
0
60
$
34,722
160
$
95,592
132
$
76,388
0
$
0
352
$
203,702
Corporate
Review
$
782
$
0
60
$
46,904
160
$
125,078
132
$
103,190
0
$
0
352
$
275,172
Type
and
Print
Results
$
1,025
$
0
60
$
61,512
160
$
164,032
132
$
135,326
0
$
0
352
$
360,870
Record
Keeping
$
26
$
5
60
$
1,838
160
$
4,901
132
$
4,043
0
$
0
352
$
10,782
Long­
term
Subtotal
$
453,616
$
1,209,643
$
997,956
$
0
$
2,661,215
Final
Reports
Subtotal
$
875,946
$
2,338,856
$
1,882,837
$
36,445,064
$
41,539,704
Total
$
1,039,542
$
2,775,112
$
2,230,825
$
36,704,264
$
42,746,744
