Document ID: EPA-HQ-OPPT-2005-0009-0003
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2005-02-24T05:00Z

ATTACHMENT
1
Toxic
Substances
Control
Act
Section
5
(
15
U.
S.
C.
2604)
Laws
in
effect
as
of
January
2,
2001
TITLE
15­­
COMMERCE
AND
TRADE
CHAPTER
53­­
TOXIC
SUBSTANCES
CONTROL
SUBCHAPTER
I­­
CONTROL
OF
TOXIC
SUBSTANCES
Sec.
2604.
Manufacturing
and
processing
notices
(
a)
In
general
(
1)
Except
as
provided
in
subsection
(
h)
of
this
section,
no
person
may­­
(
A)
manufacture
a
new
chemical
substance
on
or
after
the
30th
day
after
the
date
on
which
the
Administrator
first
publishes
the
list
required
by
section
2607(
b)
of
this
title,
or
(
B)
manufacture
or
process
any
chemical
substance
for
a
use
which
the
Administrator
has
determined,
in
accordance
with
paragraph
(
2),
is
a
significant
new
use,

unless
such
person
submits
to
the
Administrator,
at
least
90
days
before
such
manufacture
or
processing,
a
notice,
in
accordance
with
subsection
(
d)
of
this
section,
of
such
person's
intention
to
manufacture
or
process
such
substance
and
such
person
complies
with
any
applicable
requirement
of
subsection
(
b)
of
this
section.

(
2)
A
determination
by
the
Administrator
that
a
use
of
a
chemical
substance
is
a
significant
new
use
with
respect
to
which
notification
is
required
under
paragraph
(
1)
shall
be
made
by
a
rule
promulgated
after
a
consideration
of
all
relevant
factors,
including­­
(
A)
the
projected
volume
of
manufacturing
and
processing
of
a
chemical
substance,
(
B)
the
extent
to
which
a
use
changes
the
type
or
form
of
exposure
of
human
beings
or
the
environment
to
a
chemical
substance,
(
C)
the
extent
to
which
a
use
increases
the
magnitude
and
duration
of
exposure
of
human
beings
or
the
environment
to
a
chemical
substance,
and
(
D)
the
reasonably
anticipated
manner
and
methods
of
manufacturing,
processing,
distribution
in
commerce,
and
disposal
of
a
chemical
substance.

(
b)
Submission
of
test
data
(
1)(
A)
If
(
i)
a
person
is
required
by
subsection
(
a)(
1)
of
this
section
to
submit
a
notice
to
the
Administrator
before
beginning
the
manufacture
or
processing
of
a
chemical
substance,
and
(
ii)
such
person
is
required
to
submit
test
data
for
such
substance
pursuant
to
a
rule
promulgated
under
section
2603
of
this
title
before
the
submission
of
such
notice,
such
person
shall
submit
to
the
Administrator
such
data
in
accordance
with
such
rule
at
the
time
notice
is
submitted
in
accordance
with
subsection
(
a)(
1)
of
this
section.
(
B)
If­­
(
i)
a
person
is
required
by
subsection
(
a)(
1)
of
this
section
to
submit
a
notice
to
the
Administrator,
and
(
ii)
such
person
has
been
granted
an
exemption
under
section
2603(
c)
of
this
title
from
the
requirements
of
a
rule
promulgated
under
section
2603
of
this
title
before
the
submission
of
such
notice,

such
person
may
not,
before
the
expiration
of
the
90
day
period
which
begins
on
the
date
of
the
submission
in
accordance
with
such
rule
of
the
test
data
the
submission
or
development
of
which
was
the
basis
for
the
exemption,
manufacture
such
substance
if
such
person
is
subject
to
subsection
(
a)(
1)(
A)
of
this
section
or
manufacture
or
process
such
substance
for
a
significant
new
use
if
the
person
is
subject
to
subsection
(
a)(
1)(
B)
of
this
section.
(
2)(
A)
If
a
person­­
(
i)
is
required
by
subsection
(
a)(
1)
of
this
section
to
submit
a
notice
to
the
Administrator
before
beginning
the
manufacture
or
processing
of
a
chemical
substance
listed
under
paragraph
(
4),
and
(
ii)
is
not
required
by
a
rule
promulgated
under
section
2603
of
this
title
before
the
submission
of
such
notice
to
submit
test
data
for
such
substance,

such
person
shall
submit
to
the
Administrator
data
prescribed
by
subparagraph
(
B)
at
the
time
notice
is
submitted
in
accordance
with
subsection
(
a)(
1)
of
this
section.
(
B)
Data
submitted
pursuant
to
subparagraph
(
A)
shall
be
data
which
the
person
submitting
the
data
believes
show
that­­
(
i)
in
the
case
of
a
substance
with
respect
to
which
notice
is
required
under
subsection
(
a)(
1)(
A)
of
this
section,
the
manufacture,
processing,
distribution
in
commerce,
use,
and
disposal
of
the
chemical
substance
or
any
combination
of
such
activities
will
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment,
or
(
ii)
in
the
case
of
a
chemical
substance
with
respect
to
which
notice
is
required
under
subsection
(
a)(
1)(
B)
of
this
section,
the
intended
significant
new
use
of
the
chemical
substance
will
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment.

(
3)
Data
submitted
under
paragraph
(
1)
or
(
2)
shall
be
made
available,
subject
to
section
2613
of
this
title,
for
examination
by
interested
persons.
(
4)(
A)(
i)
The
Administrator
may,
by
rule,
compile
and
keep
current
a
list
of
chemical
substances
with
respect
to
which
the
Administrator
finds
that
the
manufacture,
processing,
distribution
in
commerce,
use,
or
disposal,
or
any
combination
of
such
activities,
presents
or
may
present
an
unreasonable
risk
of
injury
to
health
or
the
environment.
(
ii)
In
making
a
finding
under
clause
(
i)
that
the
manufacture,
processing,
distribution
in
commerce,
use,
or
disposal
of
a
chemical
substance
or
any
combination
of
such
activities
presents
or
may
present
an
unreasonable
risk
of
injury
to
health
or
the
environment,
the
Administrator
shall
consider
all
relevant
factors,
including
 
(
I)
the
effects
of
the
chemical
substance
on
health
and
the
magnitude
of
human
exposure
to
such
substance;
and
(
II)
the
effects
of
the
chemical
substance
on
the
environment
and
the
magnitude
of
environmental
exposure
to
such
substance.

(
B)
The
Administrator
shall,
in
prescribing
a
rule
under
subparagraph
(
A)
which
lists
any
chemical
substance,
identify
those
uses,
if
any,
which
the
Administrator
determines,
by
rule
under
subsection
(
a)(
2)
of
this
section,
would
constitute
a
significant
new
use
of
such
substance.
(
C)
Any
rule
under
subparagraph
(
A),
and
any
substantive
amendment
or
repeal
of
such
a
rule,
shall
be
promulgated
pursuant
to
the
procedures
specified
in
section
553
of
title
5,
except
that
(
i)
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,
(
ii)
a
transcript
shall
be
kept
of
any
oral
presentation,
and
(
iii)
the
Administrator
shall
make
and
publish
with
the
rule
the
finding
described
in
subparagraph
(
A).

(
c)
Extension
of
notice
period
The
Administrator
may
for
good
cause
extend
for
additional
periods
(
not
to
exceed
in
the
aggregate
90
days)
the
period,
prescribed
by
subsection
(
a)
or
(
b)
of
this
section
before
which
the
manufacturing
or
processing
of
a
chemical
substance
subject
to
such
subsection
may
begin.
Subject
to
section
2613
of
this
title,
such
an
extension
and
the
reasons
therefor
shall
be
published
in
the
Federal
Register
and
shall
constitute
a
final
agency
action
subject
to
judicial
review.

(
d)
Content
of
notice;
publications
in
the
Federal
Register
(
1)
The
notice
required
by
subsection
(
a)
of
this
section
shall
include­­
(
A)
insofar
as
known
to
the
person
submitting
the
notice
or
insofar
as
reasonably
ascertainable,
the
information
described
in
subparagraphs
(
A),
(
B),
(
C),
(
D),
(
F),
and
(
G)
of
section
2607(
a)(
2)
of
this
title,
and
(
B)
in
such
form
and
manner
as
the
Administrator
may
prescribe,
any
test
data
in
the
possession
or
control
of
the
person
giving
such
notice
which
are
related
to
the
effect
of
any
manufacture,
processing,
distribution
in
commerce,
use,
or
disposal
of
such
substance
or
any
article
containing
such
substance,
or
of
any
combination
of
such
activities,
on
health
or
the
environment,
and
(
C)
a
description
of
any
other
data
concerning
the
environmental
and
health
effects
of
such
substance,
insofar
as
known
to
the
person
making
the
notice
or
insofar
as
reasonably
ascertainable.

Such
a
notice
shall
be
made
available,
subject
to
section
2613
of
this
title,
for
examination
by
interested
persons.
(
2)
Subject
to
section
2613
of
this
title,
not
later
than
five
days
(
excluding
Saturdays,
Sundays
and
legal
holidays)
after
the
date
of
the
receipt
of
a
notice
under
subsection
(
a)
of
this
section
or
of
data
under
subsection
(
b)
of
this
section,
the
Administrator
shall
publish
in
the
Federal
Register
a
notice
which­­
(
A)
identifies
the
chemical
substance
for
which
notice
or
data
has
been
received;
(
B)
lists
the
uses
or
intended
uses
of
such
substance;
and
(
C)
in
the
case
of
the
receipt
of
data
under
subsection
(
b)
of
this
section,
describes
the
nature
of
the
tests
performed
on
such
substance
and
any
data
which
was
developed
pursuant
to
subsection
(
b)
of
this
section
or
a
rule
under
section
2603
of
this
title.

A
notice
under
this
paragraph
respecting
a
chemical
substance
shall
identify
the
chemical
substance
by
generic
class
unless
the
Administrator
determines
that
more
specific
identification
is
required
in
the
public
interest.
(
3)
At
the
beginning
of
each
month
the
Administrator
shall
publish
a
list
in
the
Federal
Register
of
(
A)
each
chemical
substance
for
which
notice
has
been
received
under
subsection
(
a)
of
this
section
and
for
which
the
notification
period
prescribed
by
subsection
(
a),
(
b),
or
(
c)
of
this
section
has
not
expired,
and
(
B)
each
chemical
substance
for
which
such
notification
period
has
expired
since
the
last
publication
in
the
Federal
Register
of
such
list.

(
e)
Regulation
pending
development
of
information
(
1)(
A)
If
the
Administrator
determines
that­­
(
i)
the
information
available
to
the
Administrator
is
insufficient
to
permit
a
reasoned
evaluation
of
the
health
and
environmental
effects
of
a
chemical
substance
with
respect
to
which
notice
is
required
by
subsection
(
a)
of
this
section;
and
(
ii)(
I)
in
the
absence
of
sufficient
information
to
permit
the
Administrator
to
make
such
an
evaluation,
the
manufacture,
processing,
distribution
in
commerce,
use,
or
disposal
of
such
substance,
or
any
combination
of
such
activities,
may
present
an
unreasonable
risk
of
injury
to
health
or
the
environment,
or
(
II)
such
substance
is
or
will
be
produced
in
substantial
quantities,
and
such
substance
either
enters
or
may
reasonably
be
anticipated
to
enter
the
environment
in
substantial
quantities
or
there
is
or
may
be
significant
or
substantial
human
exposure
to
the
substance,

the
Administrator
may
issue
a
proposed
order,
to
take
effect
on
the
expiration
of
the
notification
period
applicable
to
the
manufacturing
or
processing
of
such
substance
under
subsection
(
a),
(
b),
or
(
c)
of
this
section,
to
prohibit
or
limit
the
manufacture,
processing,
distribution
in
commerce,
use,
or
disposal
of
such
substance
or
to
prohibit
or
limit
any
combination
of
such
activities.
(
B)
A
proposed
order
may
not
be
issued
under
subparagraph
(
A)
respecting
a
chemical
substance
(
i)
later
than
45
days
before
the
expiration
of
the
notification
period
applicable
to
the
manufacture
or
processing
of
such
substance
under
subsection
(
a),
(
b),
or
(
c)
of
this
section,
and
(
ii)
unless
the
Administrator
has,
on
or
before
the
issuance
of
the
proposed
order,
notified,
in
writing,
each
manufacturer
or
processor,
as
the
case
may
be,
of
such
substance
of
the
determination
which
underlies
such
order.
(
C)
If
a
manufacturer
or
processor
of
a
chemical
substance
to
be
subject
to
a
proposed
order
issued
under
subparagraph
(
A)
files
with
the
Administrator
(
within
the
30­
day
period
beginning
on
the
date
such
manufacturer
or
processor
received
the
notice
required
by
subparagraph
(
B)(
ii))
objections
specifying
with
particularity
the
provisions
of
the
order
deemed
objectionable
and
stating
the
grounds
therefor,
the
proposed
order
shall
not
take
effect.
(
2)(
A)(
i)
Except
as
provided
in
clause
(
ii),
if
with
respect
to
a
chemical
substance
with
respect
to
which
notice
is
required
by
subsection
(
a)
of
this
section,
the
Administrator
makes
the
determination
described
in
paragraph
(
1)(
A)
and
if­­
(
I)
the
Administrator
does
not
issue
a
proposed
order
under
paragraph
(
1)
respecting
such
substance,
or
(
II)
the
Administrator
issues
such
an
order
respecting
such
substance
but
such
order
does
not
take
effect
because
objections
were
filed
under
paragraph
(
1)(
C)
with
respect
to
it,
the
Administrator,
through
attorneys
of
the
Environmental
Protection
Agency,
shall
apply
to
the
United
States
District
Court
for
the
District
of
Columbia
or
the
United
States
district
court
for
the
judicial
district
in
which
the
manufacturer
or
processor,
as
the
case
may
be,
of
such
substance
is
found,
resides,
or
transacts
business
for
an
injunction
to
prohibit
or
limit
the
manufacture,
processing,
distribution
in
commerce,
use,
or
disposal
of
such
substance
(
or
to
prohibit
or
limit
any
combination
of
such
activities).
(
ii)
If
the
Administrator
issues
a
proposed
order
under
paragraph
(
1)(
A)
respecting
a
chemical
substance
but
such
order
does
not
take
effect
because
objections
have
been
filed
under
paragraph
(
1)(
C)
with
respect
to
it,
the
Administrator
is
not
required
to
apply
for
an
injunction
under
clause
(
i)
respecting
such
substance
if
the
Administrator
determines,
on
the
basis
of
such
objections,
that
the
determinations
under
paragraph
(
1)(
A)
may
not
be
made.
(
B)
A
district
court
of
the
United
States
which
receives
an
application
under
subparagraph
(
A)(
i)
for
an
injunction
respecting
a
chemical
substance
shall
issue
such
injunction
if
the
court
finds
that­­
(
i)
the
information
available
to
the
Administrator
is
insufficient
to
permit
a
reasoned
evaluation
of
the
health
and
environmental
effects
of
a
chemical
substance
with
respect
to
which
notice
is
required
by
subsection
(
a)
of
this
section;
and
(
ii)(
I)
in
the
absence
of
sufficient
information
to
permit
the
Administrator
to
make
such
an
evaluation,
the
manufacture,
processing,
distribution
in
commerce,
use,
or
disposal
of
such
substance,
or
any
combination
of
such
activities,
may
present
an
unreasonable
risk
of
injury
to
health
or
the
environment,
or
(
II)
such
substance
is
or
will
be
produced
in
substantial
quantities,
and
such
substance
either
enters
or
may
reasonably
be
anticipated
to
enter
the
environment
in
substantial
quantities
or
there
is
or
may
be
significant
or
substantial
human
exposure
to
the
substance.

(
C)
Pending
the
completion
of
a
proceeding
for
the
issuance
of
an
injunction
under
subparagraph
(
B)
respecting
a
chemical
substance,
the
court
may,
upon
application
of
the
Administrator
made
through
attorneys
of
the
Environmental
Protection
Agency,
issue
a
temporary
restraining
order
or
a
preliminary
injunction
to
prohibit
the
manufacture,
processing,
distribution
in
commerce,
use,
or
disposal
of
such
a
substance
(
or
any
combination
of
such
activities)
if
the
court
finds
that
the
notification
period
applicable
under
subsection
(
a),
(
b),
or
(
c)
of
this
section
to
the
manufacturing
or
processing
of
such
substance
may
expire
before
such
proceeding
can
be
completed.
(
D)
After
the
submission
to
the
Administrator
of
test
data
sufficient
to
evaluate
the
health
and
environmental
effects
of
a
chemical
substance
subject
to
an
injunction
issued
under
subparagraph
(
B)
and
the
evaluation
of
such
data
by
the
Administrator,
the
district
court
of
the
United
States
which
issued
such
injunction
shall,
upon
petition
dissolve
the
injunction
unless
the
Administrator
has
initiated
a
proceeding
for
the
issuance
of
a
rule
under
section
2605(
a)
of
this
title
respecting
the
substance.
If
such
a
proceeding
has
been
initiated,
such
court
shall
continue
the
injunction
in
effect
until
the
effective
date
of
the
rule
promulgated
in
such
proceeding
or,
if
such
proceeding
is
terminated
without
the
promulgation
of
a
rule,
upon
the
termination
of
the
proceeding,
whichever
occurs
first.

(
f)
Protection
against
unreasonable
risks
(
1)
If
the
Administrator
finds
that
there
is
a
reasonable
basis
to
conclude
that
the
manufacture,
processing,
distribution
in
commerce,
use,
or
disposal
of
a
chemical
substance
with
respect
to
which
notice
is
required
by
subsection
(
a)
of
this
section,
or
that
any
combination
of
such
activities,
presents
or
will
present
an
unreasonable
risk
of
injury
to
health
or
environment
before
a
rule
promulgated
under
section
2605
of
this
title
can
protect
against
such
risk,
the
Administrator
shall,
before
the
expiration
of
the
notification
period
applicable
under
subsection
(
a),
(
b),
or
(
c)
of
this
section
to
the
manufacturing
or
processing
of
such
substance,
take
the
action
authorized
by
paragraph
(
2)
or
(
3)
to
the
extent
necessary
to
protect
against
such
risk.
(
2)
The
Administrator
may
issue
a
proposed
rule
under
section
2605(
a)
of
this
title
to
apply
to
a
chemical
substance
with
respect
to
which
a
finding
was
made
under
paragraph
(
1)­­
(
A)
a
requirement
limiting
the
amount
of
such
substance
which
may
be
manufactured,
processed,
or
distributed
in
commerce,
(
B)
a
requirement
described
in
paragraph
(
2),
(
3),
(
4),
(
5),
(
6),
or
(
7)
of
section
2605(
a)
of
this
title,
or
(
C)
any
combination
of
the
requirements
referred
to
in
subparagraph
(
B).

Such
a
proposed
rule
shall
be
effective
upon
its
publication
in
the
Federal
Register.
Section
2605(
d)(
2)(
B)
of
this
title
shall
apply
with
respect
to
such
rule.
(
3)(
A)
The
Administrator
may­­
(
i)
issue
a
proposed
order
to
prohibit
the
manufacture,
processing,
or
distribution
in
commerce
of
a
substance
with
respect
to
which
a
finding
was
made
under
paragraph
(
1),
or
(
ii)
apply,
through
attorneys
of
the
Environmental
Protection
Agency,
to
the
United
States
District
Court
for
the
District
of
Columbia
or
the
United
States
district
court
for
the
judicial
district
in
which
the
manufacturer,
or
processor,
as
the
case
may
be,
of
such
substance,
is
found,
resides,
or
transacts
business
for
an
injunction
to
prohibit
the
manufacture,
processing,
or
distribution
in
commerce
of
such
substance.

A
proposed
order
issued
under
clause
(
i)
respecting
a
chemical
substance
shall
take
effect
on
the
expiration
of
the
notification
period
applicable
under
subsection
(
a),
(
b),
or
(
c)
of
this
section
to
the
manufacture
or
processing
of
such
substance.
(
B)
If
the
district
court
of
the
United
States
to
which
an
application
has
been
made
under
subparagraph
(
A)(
ii)
finds
that
there
is
a
reasonable
basis
to
conclude
that
the
manufacture,
processing,
distribution
in
commerce,
use,
or
disposal
of
the
chemical
substance
with
respect
to
which
such
application
was
made,
or
that
any
combination
of
such
activities,
presents
or
will
present
an
unreasonable
risk
of
injury
to
health
or
the
environment
before
a
rule
promulgated
under
section
2605
of
this
title
can
protect
against
such
risk,
the
court
shall
issue
an
injunction
to
prohibit
the
manufacture,
processing,
or
distribution
in
commerce
of
such
substance
or
to
prohibit
any
combination
of
such
activities.
(
C)
The
provisions
of
subparagraphs
(
B)
and
(
C)
of
subsection
(
e)(
1)
of
this
section
shall
apply
with
respect
to
an
order
issued
under
clause
(
i)
of
subparagraph
(
A);
and
the
provisions
of
subparagraph
(
C)
of
subsection
(
e)(
2)
of
this
section
shall
apply
with
respect
to
an
injunction
issued
under
subparagraph
(
B).
(
D)
If
the
Administrator
issues
an
order
pursuant
to
subparagraph
(
A)(
i)
respecting
a
chemical
substance
and
objections
are
filed
in
accordance
with
subsection
(
e)(
1)(
C)
of
this
section,
the
Administrator
shall
seek
an
injunction
under
subparagraph
(
A)(
ii)
respecting
such
substance
unless
the
Administrator
determines,
on
the
basis
of
such
objections,
that
such
substance
does
not
or
will
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment.

(
g)
Statement
of
reasons
for
not
taking
action
If
the
Administrator
has
not
initiated
any
action
under
this
section
or
section
2605
or
2606
of
this
title
to
prohibit
or
limit
the
manufacture,
processing,
distribution
in
commerce,
use,
or
disposal
of
a
chemical
substance,
with
respect
to
which
notification
or
data
is
required
by
subsection
(
a)(
1)(
B)
or
(
b)
of
this
section,
before
the
expiration
of
the
notification
period
applicable
to
the
manufacturing
or
processing
of
such
substance,
the
Administrator
shall
publish
a
statement
of
the
Administrator's
reasons
for
not
initiating
such
action.
Such
a
statement
shall
be
published
in
the
Federal
Register
before
the
expiration
of
such
period.
Publication
of
such
statement
in
accordance
with
the
preceding
sentence
is
not
a
prerequisite
to
the
manufacturing
or
processing
of
the
substance
with
respect
to
which
the
statement
is
to
be
published.

(
h)
Exemptions
(
1)
The
Administrator
may,
upon
application,
exempt
any
person
from
any
requirement
of
subsection
(
a)
or
(
b)
of
this
section
to
permit
such
person
to
manufacture
or
process
a
chemical
substance
for
test
marketing
purposes­­
(
A)
upon
a
showing
by
such
person
satisfactory
to
the
Administrator
that
the
manufacture,
processing,
distribution
in
commerce,
use,
and
disposal
of
such
substance,
and
that
any
combination
of
such
activities,
for
such
purposes
will
not
present
any
unreasonable
risk
of
injury
to
health
or
the
environment,
and
(
B)
under
such
restrictions
as
the
Administrator
considers
appropriate.

(
2)(
A)
The
Administrator
may,
upon
application,
exempt
any
person
from
the
requirement
of
subsection
(
b)(
2)
of
this
section
to
submit
data
for
a
chemical
substance.
If,
upon
receipt
of
an
application
under
the
preceding
sentence,
the
Administrator
determines
that­­
(
i)
the
chemical
substance
with
respect
to
which
such
application
was
submitted
is
equivalent
to
a
chemical
substance
for
he
Administrator
as
required
by
subsection
(
b)(
2)
of
this
section,
and
(
ii)
submission
of
data
by
the
applicant
on
such
substance
would
be
duplicative
of
data
which
has
been
submitted
to
the
Administrator
in
accordance
with
such
subsection,

the
Administrator
shall
exempt
the
applicant
from
the
requirement
to
submit
such
data
on
such
substance.
No
exemption
which
is
granted
under
this
subparagraph
with
respect
to
the
submission
of
data
for
a
chemical
substance
may
take
effect
before
the
beginning
of
the
reimbursement
period
applicable
to
such
data.
(
B)
If
the
Administrator
exempts
any
person,
under
subparagraph
(
A),
from
submitting
data
required
under
subsection
(
b)(
2)
of
this
section
for
a
chemical
substance
because
of
the
existence
of
previously
submitted
data
and
if
such
exemption
is
granted
during
the
reimbursement
period
for
such
data,
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
f
the
Administrator)­­
(
i)
to
the
person
who
previously
submitted
the
data
on
which
the
exemption
was
based,
for
a
portion
of
the
costs
incurred
by
such
person
in
complying
with
the
requirement
under
subsection
(
b)(
2)
of
this
section
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,
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
persons
to
be
reimbursed
and
the
share
of
the
market
for
such
substance
of
the
person
required
to
provide
reimbursement
in
relation
to
the
share
of
such
market
of
the
persons
to
be
reimbursed.
For
purposes
of
judicial
review,
an
order
under
this
subparagraph
shall
be
considered
final
agency
action.
(
C)
For
purposes
of
this
paragraph,
the
reimbursement
period
for
any
previously
submitted
data
for
a
chemical
substance
is
a
period
 
(
i)
beginning
on
the
date
of
the
termination
of
the
prohibition,
imposed
under
this
section,
on
the
manufacture
or
processing
of
such
substance
by
the
person
who
submitted
such
data
to
the
Administrator,
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
is
equal
to
the
period
which
the
Administrator
determines
was
necessary
to
develop
such
data,
whichever
is
later.

(
3)
The
requirements
of
subsections
(
a)
and
(
b)
of
this
section
do
not
apply
with
respect
to
the
manufacturing
or
processing
of
any
chemical
substance
which
is
manufactured
or
processed,
or
proposed
to
be
manufactured
or
processed,
only
in
small
quantities
(
as
defined
by
the
Administrator
by
rule)
solely
for
purposes
of­­
(
A)
scientific
experimentation
or
analysis,
or
(
B)
chemical
research
on,
or
analysis
of
such
substance
or
another
substance,
including
such
research
or
analysis
for
the
development
of
a
product,

if
all
persons
engaged
in
such
experimentation,
research,
or
analysis
for
a
manufacturer
or
processor
are
notified
(
in
such
form
and
manner
as
the
Administrator
may
prescribe)
of
any
risk
to
health
which
the
manufacturer,
processor,
or
the
Administrator
has
reason
to
believe
may
be
associated
with
such
chemical
substance.
(
4)
The
Administrator
may,
upon
application
and
by
rule,
exempt
the
manufacturer
of
any
new
chemical
substance
from
all
or
part
of
the
requirements
of
this
section
if
the
Administrator
determines
that
the
manufacture,
processing,
distribution
in
commerce,
use,
or
disposal
of
such
chemical
substance,
or
that
any
combination
of
such
activities,
will
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment.
A
rule
promulgated
under
this
paragraph
(
and
any
substantive
amendment
to,
or
repeal
of,
such
a
rule)
shall
be
promulgated
in
accordance
with
paragraphs
(
2)
and
(
3)
of
section
2605(
c)
of
this
title.
(
5)
The
Administrator
may,
upon
application,
make
the
requirements
of
subsections
(
a)
and
(
b)
of
this
section
inapplicable
with
respect
to
the
manufacturing
or
processing
of
any
chemical
substance
(
A)
which
exists
temporarily
as
a
result
of
a
chemical
reaction
in
the
manufacturing
or
processing
of
a
mixture
or
another
chemical
substance,
and
(
B)
to
which
there
is
no,
and
will
not
be,
human
or
environmental
exposure.
(
6)
Immediately
upon
receipt
of
an
application
under
paragraph
(
1)
or
(
5)
the
Administrator
shall
publish
in
the
Federal
Register
notice
of
the
receipt
of
such
application.
The
Administrator
shall
give
interested
persons
an
opportunity
to
comment
upon
any
such
application
and
shall,
within
45
days
of
its
receipt,
either
approve
or
deny
the
application.
The
Administrator
shall
publish
in
the
Federal
Register
notice
of
the
approval
or
denial
of
such
an
application.

(
i)
  
Manufacture'`
and
  
process'`
defined
For
purposes
of
this
section,
the
terms
  
manufacture'`
and
  
process'`
mean
manufacturing
or
processing
for
commercial
purposes.

(
Pub.
L.
94­
469,
title
I,
Sec.
5,
Oct.
11,
1976,
90
Stat.
2012;
renumbered
title
I,
Pub.
L.
99­
519,
Sec.
3(
c)(
1),
Oct.
22,
1986,
100
Stat.
2989.)
ATTACHMENT
2
40
CFR
Part
721
(
Subpart
A
through
Subpart
D)
This
data
current
as
of
the
Federal
Register
dated
March
14,
2002
40
CFR
PART
721
SUBPART
A
­
GENERAL
PROVISIONS
§
721.1
Scope
and
applicability.

(
a)
This
part
identifies
uses
of
chemical
substances,
except
for
microorganisms
regulated
under
part
725
of
this
chapter,
which
EPA
has
determined
are
significant
new
uses
under
the
authority
of
section
5(
a)(
2)
of
the
Toxic
Substances
Control
Act.
In
addition,
it
specifies
procedures
for
manufacturers,
importers,
and
processors
to
report
on
those
significant
new
uses.
This
subpart
A
contains
general
provisions
applicable
to
this
part.
subpart
B
of
this
part
identifies
generic
requirements
for
certain
significant
new
uses
cross
referenced
in
specific
provisions
of
subpart
E
of
this
part.
subpart
C
of
this
part
identifies
generic
reporting
requirements
for
certain
significant
new
uses
cross
referenced
in
specific
provisions
of
subpart
E
of
this
part.
subpart
E
of
this
part
identifies
chemical
substances
and
their
significant
new
uses.

(
b)
This
subpart
A
contains
provisions
governing
submission
and
review
of
notices
for
the
chemical
substances
and
significant
new
uses
identified
in
subpart
E
of
this
part.
The
provisions
of
this
subpart
A
apply
to
the
chemical
substances
and
significant
new
uses
identified
in
subpart
E
of
this
part,
except
to
the
extent
that
they
are
specifically
modified
or
supplanted
by
specific
requirements
in
subpart
E
of
this
part.
In
the
event
of
a
conflict
between
the
provisions
of
this
subpart
A
and
the
provisions
of
subpart
E
of
this
part,
the
provisions
of
subpart
E
of
this
part
shall
govern.

(
c)
The
provisions
of
part
720
of
this
chapter
apply
to
this
part
721.
For
purposes
of
this
part
721,
wherever
the
phrase
"
new
chemical
substance"
appears
in
part
720
of
this
chapter,
it
shall
mean
the
chemical
substance
subject
to
this
part
721.
In
the
event
of
a
conflict
between
the
provisions
of
part
720
of
this
chapter
and
the
provisions
of
this
part
721,
the
provisions
of
this
part
721
shall
govern.

[
53
FR
28358,
July
27,
1988,
as
amended
at
62
FR
17932,
Apr.
11,
1997]

§
721.3
Definitions.

The
definitions
in
section
3
of
the
Act,
15
U.
S.
C.
2602,
and
§
720.3
of
this
chapter
apply
to
this
part.
In
addition,
the
following
definitions
apply
to
this
part:

Acutely
toxic
effects
A
chemical
substance
produces
acutely
toxic
effects
if
it
kills
within
a
short
time
period
(
usually
14
days):

(
1)
At
least
50
percent
of
the
exposed
mammalian
test
animals
following
oral
administration
of
a
single
dose
of
the
test
substance
at
25
milligrams
or
less
per
kilogram
of
body
weight
(
LD50).
(
2)
At
least
50
percent
of
the
exposed
mammalian
test
animals
following
dermal
administration
of
a
single
dose
of
the
test
substance
at
50
milligrams
or
less
per
kilogram
of
body
weight
(
LD50).

(
3)
At
least
50
percent
of
the
exposed
mammalian
test
animals
following
administration
of
the
test
substance
for
8
hours
or
less
by
continuous
inhalation
at
a
steady
concentration
in
air
at
0.5
milligrams
or
less
per
liter
of
air
(
LC50).

CAS
Number
means
Chemical
Abstracts
Service
Registry
Number
assigned
to
a
chemical
substance
on
the
Inventory.

Chemical
name
means
the
scientific
designation
of
a
chemical
substance
in
accordance
with
the
nomenclature
system
developed
by
the
International
Union
of
Pure
and
Applied
Chemistry
or
the
Chemical
Abstracts
Service's
rules
of
nomenclature,
or
a
name
which
will
clearly
identify
a
chemical
substance
for
the
purpose
of
conducting
a
hazard
evaluation.

Chemical
protective
clothing
means
items
of
clothing
that
provide
a
protective
barrier
to
prevent
dermal
contact
with
chemical
substances
of
concern.
Examples
can
include,
but
are
not
limited
to:
full
body
protective
clothing,
boots,
coveralls,
gloves,
jackets,
and
pants.

Commercial
use
means
the
use
of
a
chemical
substance
or
any
mixture
containing
the
chemical
substance
in
a
commercial
enterprise
providing
saleable
goods
or
a
service
to
consumers
(
e.
g.,
a
commercial
dry
cleaning
establishment
or
painting
contractor).

Common
name
means
any
designation
or
identification
such
as
code
name,
code
number,
trade
name,
brand
name,
or
generic
chemical
name
used
to
identify
a
chemical
substance
other
than
by
its
chemical
name.

Consumer
means
a
private
individual
who
uses
a
chemical
substance
or
any
product
containing
the
chemical
substance
in
or
around
a
permanent
or
temporary
household
or
residence,
during
recreation,
or
for
any
personal
use
or
enjoyment.

Consumer
product
means
a
chemical
substance
that
is
directly,
or
as
part
of
a
mixture,
sold
or
made
available
to
consumers
for
their
use
in
or
around
a
permanent
or
temporary
household
or
residence,
in
or
around
a
school,
or
in
recreation.

Customer
means
any
person
to
whom
a
manufacturer,
importer,
or
processor
distributes
any
quantity
of
a
chemical
substance,
or
of
a
mixture
containing
the
chemical
substance,
whether
or
not
a
sale
is
involved.

Director
of
the
Office
of
Pollution
Prevention
and
Toxics
means
the
Director
of
the
EPA
Office
of
Pollution
Prevention
and
Toxics
or
any
EPA
employee
delegated
by
the
Office
Director
to
carry
out
the
Office
Director's
functions
under
this
part.

Employer
means
any
manufacturer,
importer,
processor,
or
user
of
chemical
substances
or
mixtures.
Environmentally
transformed
A
chemical
substance
is
"
environmentally
transformed"
when
its
chemical
structure
changes
as
a
result
of
the
action
of
environmental
processes
on
it.

Facility
means
all
buildings,
equipment,
structures,
and
other
stationary
items
which
are
located
on
a
single
site
or
on
contiguous
or
adjacent
sites
and
which
are
owned
or
operated
by
the
same
person
(
or
by
any
person
which
controls,
is
controlled
by,
or
under
common
control
with
such
person).

Identity
means
any
chemical
or
common
name
used
to
identify
a
chemical
substance
or
a
mixture
containing
that
substance.

Immediate
use
A
chemical
substance
is
for
the
"
immediate
use"
of
a
person
if
it
is
under
the
control
of,
and
used
only
by,
the
person
who
transferred
it
from
a
labeled
container
and
will
only
be
used
by
that
person
within
the
work
shift
in
which
it
is
transferred
from
the
labeled
container.

Impervious
Chemical
protective
clothing
is
"
impervious"
to
a
chemical
substance
if
the
substance
causes
no
chemical
or
mechanical
degradation,
permeation,
or
penetration
of
the
chemical
protective
clothing
under
the
conditions
of,
and
the
duration
of,
exposure.

Manufacturing
stream
means
all
reasonably
anticipated
transfer,
flow,
or
disposal
of
a
chemical
substance,
regardless
of
physical
state
or
concentration,
through
all
intended
operations
of
manufacture,
including
the
cleaning
of
equipment.

Metalworking
fluid
means
a
liquid
of
any
viscosity
or
color
containing
intentionally
added
water
and
used
in
metal
machining
operations
for
the
purpose
of
cooling,
lubricating,
or
rust
inhibition.

MSDS
means
material
safety
data
sheet,
the
written
listing
of
data
for
the
chemical
substance
as
required
under
§
721.72(
c).

NIOSH
means
the
National
Institute
for
Occupational
Safety
and
Health
of
the
U.
S.
Department
of
Health
and
Human
Services.

Non­
enclosed
process
means
any
equipment
system
(
such
as
an
open­
top
reactor,
storage
tank,
or
mixing
vessel)
in
which
a
chemical
substance
is
manufactured,
processed,
or
otherwise
used
where
significant
direct
contact
of
the
bulk
chemical
substance
and
the
workplace
air
may
occur.

Non­
industrial
use
means
use
other
than
at
a
facility
where
chemical
substances
or
mixtures
are
manufactured,
imported,
or
processed.

Personal
protective
equipment
means
any
chemical
protective
clothing
or
device
placed
on
the
body
to
prevent
contact
with,
and
exposure
to,
an
identified
chemical
substance
or
substances
in
the
work
area.
Examples
include,
but
are
not
limited
to,
chemical
protective
clothing,
aprons,
hoods,
chemical
goggles,
face
splash
shields,
or
equivalent
eye
protection,
and
various
types
of
respirators.
Barrier
creams
are
not
included
in
this
definition.
Powder
or
dry
solid
form
means
a
state
where
all
or
part
of
the
substance
would
have
the
potential
to
become
fine,
loose,
solid
particles.

Principal
importer
means
the
first
importer
who,
knowing
that
a
chemical
substance
will
be
imported
for
a
significant
new
use
rather
than
manufactured
in
the
United
States,
specifies
the
chemical
substance
and
the
amount
to
be
imported.
Only
persons
who
are
incorporated,
licensed,
or
doing
business
in
the
United
States
may
be
principal
importers.

Process
for
commercial
purposes
means
the
preparation
of
a
chemical
substance
or
mixture
containing
the
chemical
substance,
after
manufacture
of
the
substance,
for
distribution
in
commerce
with
the
purpose
of
obtaining
an
immediate
or
eventual
commercial
advantage
for
the
processor.
Processing
of
any
amount
of
a
chemical
substance
or
mixture
containing
the
chemical
substance
is
included
in
this
definition.
If
a
chemical
substance
or
mixture
containing
impurities
is
processed
for
commercial
purposes,
the
impurities
also
are
processed
for
commercial
purposes.

Process
solely
for
export
means
to
process
for
commercial
purposes
solely
for
export
from
the
United
States
under
the
following
restrictions
on
activity
in
the
United
States:
Processing
must
be
performed
at
sites
under
the
control
of
the
processor;
distribution
in
commerce
is
limited
to
purposes
of
export;
and
the
processor
may
not
use
the
chemical
substance
except
in
small
quantities
solely
for
research
and
development.

Process
stream
means
all
reasonably
anticipated
transfer,
flow,
or
disposal
of
a
chemical
substance,
regardless
of
physical
state
or
concentration,
through
all
intended
operations
of
processing,
including
the
cleaning
of
equipment.

Recipient
means
any
person
who
purchases
or
otherwise
obtains
a
chemical
substance
directly
from
a
person
who
manufacturers,
imports,
or
processes
the
substance.

Serious
acute
effects
means
human
injury
or
human
disease
processes
that
have
a
short
latency
period
for
development,
result
from
short­
term
exposure
to
a
chemical
substance,
or
are
a
combination
of
these
factors
and
which
are
likely
to
result
in
death
or
severe
or
prolonged
incapacitation.

Serious
chronic
effects
means
human
injury
or
human
disease
processes
that
have
a
long
latency
period
for
development,
result
from
long­
term
exposure
to
a
chemical
substance,
or
are
a
combination
of
these
factors
and
which
are
likely
to
result
in
death
or
severe
or
prolonged
incapacitation.

Short­
term
test
indicative
of
carcinogenic
potential
means
either
any
limited
bioassay
that
measures
tumor
or
preneoplastic
induction,
or
any
test
indicative
of
interaction
of
a
chemical
substance
with
DNA
(
i.
e.,
positive
response
in
assays
for
gene
mutation,
chromosomal
aberrations,
DNA
damage
and
repair,
or
cellular
transformation).

Short­
term
test
indicative
of
the
potential
to
cause
a
developmentally
toxic
effect
means
either
any
in
vivo
preliminary
development
toxicity
screen
conducted
in
a
mammalian
species,
or
any
in
vitro
developmental
toxicity
screen,
including
any
test
system
other
than
the
intact
pregnant
mammal,
that
has
been
extensively
evaluated
and
judged
reliable
for
its
ability
to
predict
the
potential
to
cause
developmentally
toxic
effects
in
intact
systems
across
a
broad
range
of
chemicals
or
within
a
class
of
chemicals
that
includes
the
substance
of
concern.

Significant
adverse
environmental
effects
means
injury
to
the
environment
by
a
chemical
substance
which
reduces
or
adversely
affects
the
productivity,
utility,
value,
or
function
of
biological,
commercial,
or
agricultural
resources,
or
which
may
adversely
affect
a
threatened
or
endangered
species.
A
substance
will
be
considered
to
have
the
potential
for
significant
adverse
environmental
effects
if
it
has
one
of
the
following:

(
1)
An
acute
aquatic
EC50
of
1
mg/
L
or
less.

(
2)
An
acute
aquatic
EC50
of
20
mg/
L
or
less
where
the
ratio
of
aquatic
vertebrate
24­
hour
to
48­
hour
EC50
is
greater
than
or
equal
to
2.0.

(
3)
A
Maximum
Acceptable
Toxicant
Concentration
(
MATC)
of
less
than
or
equal
to
100
parts
per
billion
(
100
ppb).

(
4)
An
acute
aquatic
EC50
of
20
mg/
L
or
less
coupled
with
either
a
measured
bioconcentration
factor
(
BCF)
equal
to
or
greater
than
1,000x
or
in
the
absence
of
bioconcentration
data
a
log
P
value
equal
to
or
greater
than
4.3.

Site
means
a
contiguous
property
unit.
Property
divided
only
by
a
public
right­
of­
way
is
one
site.
There
may
be
more
than
one
manufacturing
plant
on
a
single
site.

Site­
limited
intermediate
means
an
intermediate
manufactured,
processed,
and
used
only
within
a
site
and
not
distributed
in
commerce
other
than
as
an
impurity
or
for
disposal.
Imported
intermediates
cannot
be
"
site­
limited."

Spray
application
means
any
method
of
projecting
a
jet
of
vapor
of
finely
divided
liquid
onto
a
surface
to
be
coated;
whether
by
compressed
air,
hydraulic
pressure,
electrostatic
forces,
or
other
methods
of
generating
a
spray.

Use
stream
means
all
reasonably
anticipated
transfer,
flow,
or
disposal
of
a
chemical
substance,
regardless
of
physical
state
or
concentration,
through
all
intended
operations
of
industrial,
commercial,
or
consumer
use.

Waters
of
the
United
States
has
the
meaning
set
forth
in
40
CFR
122.2.

Work
area
means
a
room
or
defined
space
in
a
workplace
where
a
chemical
substance
is
manufactured,
processed,
or
used
and
where
employees
are
present.

Workplace
means
an
establishment
at
one
geographic
location
containing
one
or
more
work
areas.
[
53
FR
28358,
July
27,
1988,
as
amended
at
54
FR
31306,
July
27,
1989;
58
FR
63516,
Dec.
1,
1993]

§
721.5
Persons
who
must
report.

(
a)
The
following
persons
must
submit
a
significant
new
use
notice
as
specified
under
the
provisions
of
section
5(
a)(
1)(
B)
of
the
Act,
part
720
of
this
chapter,
and
§
721.25:

(
1)
A
person
who
intends
to
manufacture,
import,
or
process
for
commercial
purposes
a
chemical
substance
identified
in
a
specific
section
in
subpart
E
of
this
part,
and
intends
to
engage
in
a
significant
new
use
of
the
substance
identified
in
that
section.

(
2)
A
person
who
intends
to
manufacture,
import,
or
process
for
commercial
purposes
a
chemical
substance
identified
in
a
specific
section
in
subpart
E
of
this
part,
and
intends
to
distribute
the
substance
in
commerce.
A
person
described
in
this
paragraph
is
not
required
to
submit
a
significant
new
use
notice
if
that
person
can
document
one
or
more
of
the
following
as
to
each
recipient
of
the
substance
from
that
person:

(
i)
That
the
person
has
notified
the
recipient,
in
writing,
of
the
specific
section
in
subpart
E
of
this
part
which
identifies
the
substance
and
its
designated
significant
new
uses.

(
ii)
That
the
recipient
has
knowledge
of
the
specific
section
in
subpart
E
of
this
part
which
identifies
the
substance
and
its
designated
significant
new
uses.

(
iii)
That
the
recipient
cannot
undertake
any
significant
new
use
described
in
the
specific
section
in
subpart
E
of
this
part.

(
b)
A
person
described
in
paragraph
(
a)(
2)
of
this
section
must
submit
a
significant
new
use
notice
if
that
person
has
knowledge
at
the
time
of
commercial
distribution
of
the
substance
identified
in
the
specific
section
in
subpart
E
of
this
part
that
a
recipient
intends
to
engage
in
a
designated
significant
new
use
of
that
substance
without
submitting
a
notice
under
this
part.

(
c)
A
person
who
processes
a
chemical
substance
identified
in
a
specific
section
in
subpart
E
of
this
part
for
a
significant
new
use
of
that
substance
is
not
required
to
submit
a
significant
new
use
notice
if
that
person
can
document
each
of
the
following:

(
1)
That
the
person
does
not
know
the
specific
chemical
identity
of
the
chemical
substance
being
processed.

(
2)
That
the
person
is
processing
the
chemical
substance
without
knowledge
that
the
substance
is
identified
in
subpart
E
of
this
part.

(
d)(
1)
If
at
any
time
after
commencing
distribution
in
commerce
of
a
chemical
substance
identified
in
a
specific
section
in
subpart
E
of
this
part
a
person
described
in
paragraph
(
a)(
2)
of
this
section
has
knowledge
that
a
recipient
of
the
substance
is
engaging
in
a
significant
new
use
of
that
substance
designated
in
that
section
without
submitting
a
notice
under
this
part,
the
person
is
required
to
cease
supplying
the
chemical
substance
to
that
recipient
and
to
submit
a
significant
new
use
notice
for
that
chemical
substance
and
significant
new
use,
unless
the
person
is
able
to
document
each
of
the
following:

(
i)
That
the
person
has
notified
the
recipient
and
EPA
enforcement
authorities
(
at
the
address
in
paragraph
(
d)(
1)(
iii)
of
this
section),
in
writing
within
15
working
days
of
the
time
the
person
develops
knowledge
that
the
recipient
is
engaging
in
a
significant
new
use,
that
the
recipient
is
engaging
in
a
significant
new
use
without
submitting
a
significant
new
use
notice.

(
ii)
That,
within
15
working
days
of
notifying
the
recipient
as
described
in
paragraph
(
d)(
1)(
i)
of
this
section,
the
person
received
from
the
recipient,
in
writing,
a
statement
of
assurance
that
the
recipient
is
aware
of
the
terms
of
the
applicable
section
in
subpart
E
of
this
part
and
will
not
engage
in
the
significant
new
use.

(
iii)
That
the
person
has
promptly
provided
EPA
enforcement
authorities
with
a
copy
of
the
recipient's
statement
of
assurance
described
in
paragraph
(
d)(
1)(
ii)
of
this
section.
The
copy
must
be
sent
to
the
Office
of
Enforcement
and
Compliance
Assurance,
Office
of
Compliance
(
2224A),
U.
S.
Environmental
Protection
Agency,
Ariel
Rios,
1200
Pennsylvania
Ave.,
N.
W.,
Washington,
DC,
20044.

(
2)
If
EPA
notifies
the
manufacturer,
importer,
or
processor
that
the
recipient
is
engaging
in
a
significant
new
use
after
providing
the
statement
of
assurance
described
in
paragraph
(
d)(
1)(
ii)
of
this
section
and
without
submitting
a
notice
under
this
part,
the
manufacturer,
importer,
or
processor
shall
immediately
cease
distribution
to
that
recipient
until
the
manufacturer,
importer,
or
processor
or
the
recipient
has
submitted
a
significant
new
use
notice
under
this
part
and
the
notice
review
period
has
ended.

(
3)
If,
after
receiving
a
statement
of
assurance
from
a
recipient
under
paragraph
(
d)(
1)(
ii)
of
this
section,
a
manufacturer,
importer,
or
processor
has
knowledge
that
the
recipient
is
engaging
in
a
significant
new
use
without
submitting
a
notice
under
this
part,
the
manufacturer,
importer,
or
processor
must
immediately
cease
distributing
the
substance
to
that
recipient
and
notify
EPA
enforcement
authorities
at
the
address
identified
in
paragraph
(
d)(
1)(
iii)
of
this
section.
The
manufacturer,
importer,
or
processor
may
not
resume
distribution
to
that
recipient
until
any
one
of
the
following
has
occurred:

(
i)
The
manufacturer,
importer,
or
processor
has
submitted
a
significant
new
use
notice
under
this
part
and
the
notice
review
period
has
ended.

(
ii)
The
recipient
has
submitted
a
significant
new
use
notice
under
this
part
and
the
notice
review
period
has
ended.

(
iii)
The
manufacturer,
importer,
or
processor
has
received
notice
from
EPA
enforcement
authorities
that
it
may
resume
distribution
to
that
recipient.
(
e)
Any
significant
new
use
notice
relating
to
import
of
a
substance
must
be
submitted
by
the
principal
importer.

[
53
FR
28359,
July
27,
1988,
as
amended
at
60
FR
34464,
July
3,
1995]

§
721.11
Applicability
determination
when
the
specific
chemical
identity
is
confidential.

(
a)
A
person
who
intends
to
manufacture,
import,
or
process
a
chemical
substance
which
is
described
by
a
generic
chemical
name
is
subpart
E
of
this
part
may
ask
EPA
whether
the
substance
is
subject
to
the
requirements
of
this
part.
EPA
will
answer
such
an
inquiry
only
if
EPA
determines
that
the
person
has
a
bona
fide
intent
to
manufacture,
import,
or
process
the
chemical
substance
for
commercial
purposes.

(
b)
To
establish
a
bona
fide
intent
to
manufacture,
import,
or
process
a
chemical
substance,
the
person
who
intends
to
manufacture,
import,
or
process
the
chemical
substance
must
submit
the
following
information
in
writing
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:
SNUR
Bonafide
submissions.

(
1)
The
specific
chemical
identity
of
the
chemical
substance
that
the
person
intends
to
manufacture,
import,
or
process.

(
2)
A
signed
statement
that
the
person
intends
to
manufacture,
import,
or
process
the
chemical
substance
for
commercial
purposes.

(
3)
A
description
of
the
research
and
development
activities
conducted
to
date,
and
the
purpose
for
which
the
person
will
manufacture,
import,
or
process
the
chemical
substance.

(
4)
An
elemental
analysis.

(
5)
Either
an
X­
ray
diffraction
pattern
(
for
inorganic
substances),
a
mass
spectrum
(
for
most
other
substances),
or
an
infrared
spectrum
of
the
particular
chemical
substance,
or,
if
such
data
do
not
resolve
uncertainties
with
respect
to
the
identity
of
the
chemical
substance,
additional
or
alternative
spectra
or
other
data
to
identify
the
substance.

(
c)
If
an
importer
or
processor
cannot
provide
all
the
information
required
in
paragraph
(
b)
of
this
section
because
it
is
claimed
as
confidential
business
information
by
the
importer's
or
processor's
manufacturer
or
supplier,
the
manufacturer
or
supplier
may
supply
the
information
directly
to
EPA.

(
d)
EPA
will
review
the
information
submitted
by
the
manufacturer,
importer,
or
processor
under
paragraph
(
b)
of
this
section
to
determine
whether
than
person
has
shown
a
bona
fide
intent
to
manufacture,
import,
or
process
the
chemical
substance.
If
necessary,
EPA
will
compare
this
information
either
to
the
information
requested
for
the
confidential
chemical
substance
under
§
710.7(
e)(
2)(
v)
of
this
chapter
or
the
information
requested
under
§
720.85(
b)(
3)(
iii)
of
this
chapter.

(
e)
If
the
manufacturer,
importer,
or
processor
has
shown
a
bona
fide
intent
to
manufacture,
import,
or
process
the
substance
and
has
provided
sufficient
unambiguous
chemical
identity
information
to
enable
EPA
to
make
a
conclusive
determination
as
to
the
identity
of
the
substance,
EPA
will
inform
the
manufacturer,
importer,
or
processor
whether
the
chemical
substance
is
subject
to
this
part
and,
if
so,
which
section
in
subpart
E
of
this
part
applies.

(
f)
A
disclosure
to
a
person
with
a
bona
fide
intent
to
manufacture,
import,
or
process
a
particular
chemical
substance
that
the
substance
is
subject
to
this
part
will
not
be
considered
public
disclosure
of
confidential
business
information
under
section
14
of
the
Act.

(
g)
EPA
will
answer
an
inquiry
on
whether
a
particular
chemical
substance
is
subject
to
this
part
within
30
days
after
receipt
of
a
complete
submission
under
paragraph
(
b)
of
this
section.

[
53
FR
28359,
July
27,
1988,
as
amended
at
60
FR
34464,
July
3,
1995]

§
721.20
Exports
and
imports.

Persons
who
intend
to
export
a
chemical
substance
identified
in
subpart
E
of
this
part,
or
in
any
proposed
rule
which
would
amend
subpart
E
of
this
part,
are
subject
to
the
export
notification
provisions
of
section
12(
b)
of
the
Act.
The
regulations
that
interpret
section
12(
b)
appear
at
40
CFR
part
707.
Persons
who
import
a
substance
identified
in
a
specific
section
in
subpart
E
of
this
part
are
subject
to
the
import
certification
requirements
under
section
13
of
the
Act,
which
are
codified
at
19
CFR
12.118
through
12.127
and
127.28.
The
EPA
policy
in
support
of
the
import
certification
requirements
appears
at
40
CFR
part
707.

[
53
FR
28360,
July
27,
1988]

§
721.25
Notice
requirements
and
procedures.

(
a)
Each
person
who
is
required
to
submit
a
significant
new
use
notice
under
this
part
must
submit
the
notice
at
least
90
calendar
days
before
commencing
manufacture,
import,
or
processing
of
a
chemical
substance
identified
in
subpart
E
of
this
part
for
a
significant
new
use.
The
submitter
must
comply
with
any
applicable
requirement
of
section
5(
b)
of
the
Act,
and
the
notice
must
include
the
information
and
test
data
specified
in
section
5(
d)(
1)
of
the
Act.
The
notice
must
be
submitted
on
EPA
Form
7710­
25,
and
must
comply
with
the
requirements
of
part
720
of
this
chapter,
except
to
the
extent
that
they
are
inconsistent
with
this
part
721.

(
b)
If
two
or
more
persons
are
required
to
submit
a
significant
new
use
notice
for
the
same
chemical
substance
and
significant
new
use
identified
in
subpart
E
of
this
part,
they
may
submit
a
joint
notice
to
EPA.
Persons
submitting
a
joint
notice
must
individually
complete
the
certification
section
of
part
I
of
the
required
notification
form.
Persons
who
are
required
to
submit
individually,
but
elect
to
submit
jointly,
remain
individually
liable
for
the
failure
to
submit
required
information
which
is
known
to
or
reasonably
ascertainable
by
them
and
test
data
in
their
possession
or
control.

(
c)
EPA
will
process
the
notice
in
accordance
with
the
procedures
of
part
720
of
this
chapter,
expect
to
the
extent
they
are
inconsistent
with
this
part
721.

(
d)
Any
person
submitting
a
significant
new
use
notice
in
response
to
the
requirements
of
this
part
721
shall
not
manufacture,
import,
or
process
a
chemical
substance
identified
in
subpart
E
of
this
part
for
a
significant
new
use
until
the
notice
review
period,
including
all
extensions
and
suspensions,
has
expired.

[
53
FR
28360,
July
27,
1988,
as
amended
at
60
FR
16311,
Mar.
29,
1995]

§
721.30
EPA
approval
of
alternative
control
measures.

(
a)
In
certain
sections
of
subpart
E
of
this
part,
significant
new
uses
for
the
identified
substances
are
described
as
the
failure
to
establish
and
implement
programs
providing
for
the
use
of
either:
specific
measures
to
control
worker
exposure
to
or
release
of
substances
which
are
identified
in
such
sections,
or
alternative
measures
to
control
worker
exposure
or
environmental
release
which
EPA
has
determined
provide
substantially
the
same
degree
of
protection
as
the
specified
control
measures.
Persons
who
manufacture,
import,
or
process
a
chemical
substance
identified
in
such
sections
and
who
intend
to
employ
alternative
measures
to
control
worker
exposure
or
environmental
release
must
submit
a
request
to
EPA
for
a
determination
of
equivalency
before
commencing
manufacture,
import,
or
processing
involving
the
alternative
control
measures.

(
b)
A
request
for
a
determination
of
equivalency
must
be
submitted
in
writing
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:
SNUR
Equivalency
Determination,
and
must
contain:

(
1)
The
name
of
the
submitter.

(
2)
The
specific
chemical
identity
of
the
substance.

(
3)
The
citation
for
the
specific
section
in
subpart
E
of
this
part
which
pertains
to
the
substance
for
which
the
request
is
being
submitted.

(
4)
A
detailed
description
of
the
activities
involved.

(
5)
The
specifications
of
the
alternative
worker
exposure
control
measures
or
environmental
release
control
measures.

(
6)
An
analysis
justifying
why
such
alternative
control
measures
provide
substantially
the
same
degree
of
protection
as
the
specific
control
measures
identified
in
the
specific
section
in
subpart
E
of
this
part
which
pertains
to
the
substance
for
which
the
request
is
being
submitted.
(
7)
The
data
and
information
described
in
§
720.50
(
a)
and
(
b)
of
this
chapter
unless
such
data
and
information
have
already
been
submitted
to
the
Office
of
Pollution
Prevention
and
Toxics,
EPA.

(
c)
Requests
for
determinations
of
equivalency
will
be
reviewed
by
EPA
within
45
days.
Determinations
under
this
paragraph
will
be
made
by
the
Director,
Office
of
Pollution
Prevention
and
Toxics,
or
designee.
Notice
of
the
results
of
such
determinations
will
be
mailed
to
the
submitter.

(
d)
If
EPA
notifies
the
submitter
under
paragraph
(
c)
of
this
section
that
EPA
has
determined
that
the
alternative
control
measures
provide
substantially
the
same
degree
of
protection
as
the
specified
control
measures
identified
in
the
specified
section
of
subpart
E
of
this
part
which
pertains
to
the
substance
for
which
the
request
is
being
submitted,
the
submitter
may
commence
manufacture,
import,
or
processing
in
accordance
with
the
specifications
for
alternative
worker
exposure
control
measures
or
environmental
release
control
measures
identified
in
the
submitter's
request,
and
may
alter
any
corresponding
notification
to
workers
to
reflect
such
alternative
controls.
Deviations
from
the
activities
described
in
the
EPA
notification
constitute
a
significant
new
use
and
are
subject
to
the
requirements
of
this
part.

[
53
FR
28360,
July
27,
1988,
as
amended
at
60
FR
34464,
July
3,
1995]

§
721.35
Compliance
and
enforcement.

(
a)
Failure
to
comply
with
any
provision
of
this
part
is
a
violation
of
section
15(
1)
of
the
Act
(
15
U.
S.
C.
2614).

(
b)
Using
for
commercial
purposes
a
chemical
substance
which
a
person
knew
or
had
reason
to
know
was
manufactured,
imported,
or
processed
in
violation
of
this
part
is
a
violation
of
section
15(
2)
of
the
Act
(
15
U.
S.
C.
2614).

(
c)
Failure
or
refusal
to
permit
access
to
or
copying
of
records,
as
required
by
section
11
of
the
Act,
is
a
violation
of
section
15(
3)
of
the
Act
(
15
U.
S.
C.
2614).

(
d)
Failure
or
refusal
to
permit
entry
or
inspection,
as
required
by
section
11
of
the
Act,
is
a
violation
of
section
15(
4)
of
the
Act.

(
e)
Violators
of
the
Act
or
of
this
part
may
be
subject
to
the
civil
and
criminal
penalties
in
section
16
of
the
Act
(
15
U.
S.
C.
2615)
for
each
violation.
The
submission
of
false
or
misleading
information
in
connection
with
the
requirement
of
any
provision
of
this
part
may
subject
persons
to
penalties
calculated
as
if
they
never
filed
a
notice.

(
f)
Under
the
authority
of
sections
7
and
17
of
the
Act,
EPA
may:

(
1)
Seek
to
enjoin
the
manufacture,
import,
or
processing
of
a
chemical
substance
in
violation
of
this
part.
(
2)
Act
to
seize
any
chemical
substance
which
is
being
manufactured,
imported,
or
processed
in
violation
of
this
part.

(
3)
Take
any
other
appropriate
action.

[
53
FR
28361,
July
27,
1988]

§
721.40
Recordkeeping.

Any
person
subject
to
the
requirements
of
this
part
must
retain
documentation
of
information
contained
in
that
person's
significant
new
use
notice.
This
documentation
must
be
maintained
for
a
period
of
5
years
from
the
date
of
the
submission
of
the
significant
new
use
notice.

[
53
FR
28361,
July
27,
1988]

§
721.45
Exemptions.

The
persons
identified
in
§
721.5
are
not
subject
to
the
notification
requirements
of
§
721.25
for
a
chemical
substance
identified
in
subpart
E
of
this
part,
unless
otherwise
specified
in
a
specific
section
in
subpart
E,
if:

(
a)
The
person
has
applied
for
and
has
been
granted
an
exemption
for
test
marketing
the
substance
for
a
significant
new
use
identified
in
subpart
E
of
this
part
in
accordance
with
section
5(
h)(
1)
of
the
Act
and
§
720.38
of
this
chapter.

(
b)
The
person
manufactures,
imports,
or
processes
the
substance
for
a
significant
new
use
identified
in
subpart
E
of
this
part
in
small
quantities
solely
for
research
and
development
in
accordance
with
§
721.47.

(
c)
The
person
has
applied
for
and
been
granted
an
exemption
under
section
5(
h)(
5)
of
the
Act.

(
d)
The
person
manufactures,
imports,
or
processes
the
substance
only
as
an
impurity.

(
e)
The
person
manufactures,
imports,
or
processes
the
substance
only
as
a
byproduct
which
is
used
only
by
public
or
private
organizations
that
(
1)
burn
it
as
a
fuel,
(
2)
dispose
of
it
as
a
waste,
including
in
a
landfill
or
for
enriching
soil,
or
(
3)
extract
component
chemical
substances
from
it
for
commercial
purposes.

(
f)
The
person
imports
or
processes
the
substance
as
part
of
an
article.

(
g)
The
person
manufactures
or
processes
the
substance
solely
for
export
and,
when
distributing
the
substance
in
commerce,
labels
the
substance
in
accordance
with
section
12(
a)(
1)(
B)
of
the
Act.

(
h)
The
person
submits
a
significant
new
use
notice
for
the
substance
prior
to
the
promulgation
date
of
the
section
in
subpart
E
of
this
part
which
identifies
the
substance,
and
the
person
receives
written
notification
of
compliance
from
EPA
prior
to
the
effective
date
of
such
section.
The
notice
submitter
must
comply
with
any
applicable
requirement
of
section
5(
b)
of
the
Act.
The
notice
must
include
the
information
and
test
data
specified
in
section
5(
d)(
1)
of
the
Act
and
must
be
submitted
on
the
notice
form
in
Appendix
A
to
part
720
of
this
chapter.
For
purposes
of
this
exemption,
the
specific
section
in
subpart
E
of
this
part
which
identifies
the
substance
and
§
§
721.1,
721.3,
721.11,
721.35,
and
721.40
apply;
after
the
effective
date
of
the
section
in
subpart
E
of
this
part
which
identifies
the
substance,
§
721.5
applies
and
§
721.20
continues
to
apply.
EPA
will
provide
the
notice
submitter
with
written
notification
of
compliance
only
if
one
of
the
following
occurs:

(
1)
EPA
is
unable
to
make
the
finding
that
the
activities
described
in
the
significant
new
use
notice
will
or
may
present
an
unreasonable
risk
of
injury
to
health
or
the
environment
under
reasonably
foreseeable
circumstances.

(
2)
EPA
and
the
person
negotiate
a
consent
order
under
section
5(
e)
of
the
Act,
such
order
to
take
effect
on
the
effective
date
of
the
section
in
subpart
E
of
this
part
which
identifies
the
substance.

(
i)
The
person
is
operating
under
the
terms
of
a
consent
order
issued
under
section
5(
e)
of
the
Act
applicable
to
that
person.
If
a
provision
of
such
section
5(
e)
order
is
inconsistent
with
a
specific
significant
new
use
identified
in
subpart
E
of
this
part,
abiding
by
the
provision
of
the
section
5(
e)
order
exempts
the
person
from
submitting
a
significant
new
use
notice
for
that
specific
significant
new
use.

[
53
FR
28361,
July
27,
1988]

§
721.47
Conditions
for
research
and
development
exemption.

(
a)
A
person
who
manufactures,
imports,
or
processes
a
chemical
substance
identifies
in
subpart
E
of
this
part
for
a
significant
new
use
identified
in
subpart
E
of
this
part
is
not
subject
to
the
notification
requirements
of
§
721.25
if
the
following
conditions
are
met:

(
1)
The
person
manufactures,
imports,
or
processes
the
substance
for
the
significant
new
use
in
small
quantities
solely
for
research
and
development.

(
2)
The
manufacturer,
importer,
or
processor
notifies
all
persons
in
its
employ
or
to
whom
it
directly
distributes
the
chemical
substance,
who
are
engaged
in
experimentation,
research,
or
analysis
on
the
chemical
substance,
including
the
manufacture,
processing,
use,
transport,
storage,
and
disposal
of
the
substance
associated
with
research
and
development
activities,
of
any
risk
to
health,
identified
under
paragraph
(
b)
of
this
section,
which
may
be
associated
with
the
substance.
The
notification
must
be
made
in
accordance
with
paragraph
(
c)
of
this
section.

(
3)
The
chemical
substance
is
used
by,
or
directly
under
the
supervision
of,
a
technically
qualified
individual.
(
b)(
1)
To
determine
whether
notification
under
paragraph
(
a)(
2)
of
this
section
is
required,
the
manufacturer,
importer,
or
processor
must
review
and
evaluate
the
following
information
to
determine
whether
there
is
reason
to
believe
there
is
any
risk
to
health
which
may
be
associated
with
the
chemicals
substance:

(
i)
Information
in
its
possession
or
control
concerning
any
significant
adverse
reaction
by
persons
exposed
to
the
chemical
substance
which
may
reasonably
be
associated
with
such
exposure.

(
ii)
Information
provided
to
the
manufacturer,
importer,
or
processor
by
a
supplier
or
any
other
person
concerning
a
health
risk
believed
to
be
associated
with
the
substance.

(
iii)
Health
and
environmental
effects
data
in
its
possession
or
control
concerning
the
substance.

(
iv)
Information
on
health
effects
which
accompanies
any
EPA
rule
or
order
issued
under
section
4,
5,
or
6
of
the
Act
that
applies
to
the
substance
and
of
which
the
manufacturer,
importer,
or
processor
has
knowledge.

(
2)
When
the
research
and
development
activity
is
conducted
solely
in
a
laboratory
and
exposure
to
the
chemical
substance
is
controlled
through
the
implementation
of
prudent
laboratory
practices
for
handling
chemical
substances
of
unknown
toxicity,
and
any
distribution,
except
for
purposes
of
disposal,
is
to
other
such
laboratories
for
further
research
and
development
activity,
the
information
specified
in
paragraph
(
b)(
1)
of
this
section
need
not
be
reviewed
and
evaluated.
(
For
purposes
of
this
paragraph
(
b)(
2),
a
laboratory
is
defined
as
a
contained
research
facility
where
relatively
small
quantities
of
chemical
substances
are
used
on
a
pro­
production
basis,
and
where
activities
involve
the
use
of
containers
for
reactions,
transfers,
and
other
handling
of
substances
designed
to
be
easily
manipulated
by
a
single
individual).

(
c)(
1)
The
manufacturer,
importer,
or
processor
must
notify
the
persons
identified
in
paragraph
(
a)(
2)
of
this
section
by
means
of
a
container
labeling
system,
conspicuous
placement
of
notices
in
areas
where
exposure
may
occur,
written
notification
to
each
person
potentially
exposed,
or
any
other
method
of
notification
which
adequately
informs
persons
of
health
risks
which
the
manufacturer,
importer,
or
processor
has
reason
to
believe
may
be
associated
with
the
substance,
as
determined
under
paragraph
(
b)(
1)
of
this
section.

(
2)
If
the
manufacturer,
importer,
or
processor
distributes
a
chemical
substance
manufactured,
imported,
or
processed
under
this
section
to
persons
not
in
its
employ,
the
manufacturer,
importer,
or
processor
must
in
written
form:

(
i)
Notify
those
persons
that
the
substance
is
to
be
used
only
for
research
and
development
purposes.

(
ii)
Provide
the
notice
of
health
risks
specified
in
paragraph
(
c)(
1)
of
this
section.

(
3)
The
adequacy
of
any
notification
under
this
section
is
the
responsibility
of
the
manufacturer,
importer,
or
processor.
(
d)
Quantities
of
the
chemical
substance,
or
of
mixtures
or
articles
containing
the
chemical
substance,
remaining
after
completion
of
research
and
development
activities
may
be:

(
1)
Disposed
of
as
a
waste
in
accordance
with
applicable
Federal,
State,
and
local
regulations,
to
the
extent
the
disposal
activity
is
not
identified
as
a
significant
new
use
for
the
substance
in
subpart
E
of
this
part,
or
(
2)
Used
for
a
commercial
purpose,
to
the
extent
the
use
is
not
identified
as
a
significant
new
use
of
the
substance
in
subpart
E
of
this
part.

(
e)(
1)
Persons
who
manufacture,
import,
or
process
a
chemical
substance
under
this
section
must
retain
the
following
records:

(
i)
Copies
of
or
citations
to
information
reviewed
and
evaluated
under
paragraph
(
b)(
1)
of
this
section
to
determine
the
need
to
make
any
notification
of
risk.

(
ii)
Documentation
of
the
nature
and
method
of
notification
under
paragraph
(
c)(
1)
of
this
section
including
copies
of
any
labels
or
written
notices
used.

(
iii)
Documentation
of
prudent
laboratory
practices
used
instead
of
notification
and
evaluation
under
paragraph
(
b)(
2)
of
this
section.

(
iv)
The
names
and
addresses
of
any
persons
other
than
the
manufacturer,
importer,
or
processor
to
whom
the
substance
is
distributed,
the
identity
of
the
substance,
the
amount
distributed,
and
copies
of
the
notifications
required
under
paragraph
(
c)(
2)
of
this
section.

(
2)
[
Reserved]

[
53
FR
28361,
July
27,
1988,
as
amended
at
58
FR
34204,
June
23,
1993]

SUBPART
B
­
CERTAIN
SIGNIFICANT
NEW
USES
§
721.50
Applicability.

This
subpart
B
identifies
certain
significant
new
uses
of
chemical
substances
identified
in
subpart
E
of
this
part.
The
provisions
of
this
subpart
B
apply
only
when
referenced
as
applying
to
a
chemical
substance
identified
in
subpart
E
of
this
part.

§
721.63
Protection
in
the
workplace.

(
a)
Whenever
a
substance
is
identified
in
subpart
E
of
this
part
as
being
subject
to
this
section,
a
significant
new
use
of
the
substance
is
any
manner
or
method
of
manufacturing,
importing,
or
processing
associated
with
any
use
of
the
substance
without
establishing
a
program
whereby:

(
1)
Each
person
who
is
reasonably
likely
to
be
dermally
exposed
in
the
work
area
to
the
chemical
substance
through
direct
handling
of
the
substance
or
through
contact
with
equipment
on
which
the
substance
may
exist,
or
because
the
substance
becomes
airborne
in
the
form
listed
in
paragraph
(
a)(
6)
of
this
section,
and
cited
in
subpart
E
of
this
part
for
the
chemical
substance,
is
provided
with,
and
is
required
to
wear,
personal
protective
equipment
that
provides
a
barrier
to
prevent
dermal
exposure
to
the
substance
in
the
specific
work
area
where
it
is
selected
for
use.
Each
such
item
of
personal
protective
equipment
must
be
selected
and
used
in
accordance
with
29
CFR
1910.132
and
1910.133.

(
2)
In
addition
to
any
other
personal
protective
equipment
selected
in
paragraph
(
a)(
1)
of
this
section,
the
following
items
are
required:

(
i)
Gloves.

(
ii)
Full
body
chemical
protective
clothing.

(
iii)
Chemical
goggles
or
equivalent
eye
protection.

(
iv)
Clothing
which
covers
any
other
exposed
areas
of
the
arms,
legs,
and
torso.
Clothing
provided
under
this
paragraph
need
not
be
tested
or
evaluated
under
the
requirements
of
paragraph
(
a)(
3)
of
this
section.

(
3)
The
employer
is
able
to
demonstrate
that
each
item
of
chemical
protective
clothing,
including
gloves,
selected
provides
an
impervious
barrier
to
prevent
dermal
exposure
during
normal
and
expected
duration
and
conditions
of
exposure
within
the
work
area
by
any
one
or
a
combination
of
the
following:

(
i)
Testing
the
material
used
to
make
the
chemical
protective
clothing
and
the
construction
of
the
clothing
to
establish
that
the
protective
clothing
will
be
impervious
for
the
expected
duration
and
conditions
of
exposure.
The
testing
must
subject
the
chemical
protective
clothing
to
the
expected
conditions
of
exposure,
including
the
likely
combinations
of
chemical
substances
to
which
the
clothing
may
be
exposed
in
the
work
area.

(
ii)
Evaluating
the
specifications
from
the
manufacturer
or
supplier
of
the
chemical
protective
clothing,
or
of
the
material
used
in
construction
of
the
clothing,
to
establish
that
the
chemical
protective
clothing
will
be
impervious
to
the
chemical
substance
alone
and
in
likely
combination
with
other
chemical
substances
in
the
work
area.

(
4)
Each
person
who
is
reasonably
likely
to
be
exposed
to
the
chemical
substance
by
inhalation
in
the
work
area
in
one
or
more
of
the
forms
listed
in
paragraph
(
a)(
6)
of
this
section
and
cited
in
subpart
E
of
this
part
for
the
chemical
substance,
is
provided
with,
and
is
required
to
wear,
at
a
minimum,
a
NIOSH­
approved
respirator
from
one
of
the
categories
listed
in
paragraph
(
a)(
5)
of
this
section,
and
the
respirator
is
used
in
accordance
with
29
CFR
1910.134
and
30
CFR
part
11.

(
5)
The
following
NIOSH
approved
respirators
meet
the
minimum
requirements
for
paragraph
(
a)(
4)
of
this
section:
(
i)
Category
19C
Type
C
supplied­
air
respirator
operated
in
pressure
demand
or
other
positive
pressure
mode
and
equipped
with
a
full
facepiece.

(
ii)
Category
19C
Type
C
supplied­
air
respirator
operated
in
pressure
demand
or
continuous
flow
mode
and
equipped
with
a
tight­
fitting
facepiece.

(
iii)
Category
19C
Type
C
supplied­
air
respirator
operated
in
pressure
demand
or
continuous
flow
mode
and
equipped
with
a
hood
or
helmet
or
tight­
fitting
facepiece.

(
iv)
Category
21C
air­
purifying
respirator
equipped
with
a
full
facepiece
and
high
efficiency
particulate
filters.

(
v)
Category
21C
powered
air­
purifying
respirator
equipped
with
a
tight­
fitting
facepiece
and
high
efficiency
particulate
filters.

(
vi)
Category
21C
powered
air­
purifying
respirator
equipped
with
a
loose­
fitting
hood
or
helmet
and
high
efficiency
particulate
filters.

(
vii)
Category
21C
air­
purifying
respirator
equipped
with
a
high
efficiency
particulate
filter
including
disposable
respirators.

(
viii)
Category
23C
air­
purifying
respirator
equipped
with
a
full
facepiece
and
combination
cartridges
approved
for
paints,
lacquers,
and
enamels.
(
Approval
label
may
preclude
use
for
some
paints,
lacquers,
or
enamels.)

(
ix)
Category
23C
powered
air­
purifying
respirator
equipped
with
a
tight­
fitting
facepiece
and
combination
cartridges
approved
for
paints,
lacquers,
and
enamels.
(
Approval
label
may
preclude
use
for
some
paints,
lacquers,
or
enamels.)

(
x)
Category
23C
powered
air­
purifying
respirator
equipped
with
a
loose­
fitting
hood
or
helmet
and
combination
cartridges
approved
for
paints,
lacquers,
and
enamels.
(
Approval
label
may
preclude
use
for
some
paints,
lacquers,
or
enamels.)

(
xi)
Category
23C
air­
purifying
respirator
equipped
with
combination
cartridges
approved
for
paints,
lacquers,
and
enamels,
including
disposable
respirators.
(
Approval
label
may
preclude
use
for
some
paints,
lacquers,
or
enamels.)

(
xii)
Category
23C
air­
purifying
respirator
equipped
with
a
full
facepiece
and
organic
gas/
vapor
cartridges.

(
xiii)
Category
23C
powered
air­
purifying
respirator
equipped
with
a
tight­
fitting
facepiece
and
organic
gas/
vapor
cartridges.

(
xiv)
Category
23C
powered
air­
purifying
respirator
equipped
with
a
loose­
fitting
hood
or
helmet
and
organic
gas/
vapor
cartridges.
(
xv)
Category
23C
air­
purifying
respirator
equipped
with
organic
gas/
vapor
cartridges,
including
disposable
respirators.

(
6)
When
cited
in
subpart
E
of
this
part
for
a
substance,
the
following
airborne
form(
s)
of
the
substance
apply
to
paragraphs
(
a)
(
1)
and
(
4)
of
this
section:

(
i)
Dust.

(
ii)
Mist.

(
iii)
Fume.

(
iv)
Smoke.

(
v)
Vapor.

(
vi)
Gas.

(
b)
If
a
substance
identified
in
subpart
E
of
this
part
is
present
in
the
work
area
only
as
a
mixture,
an
employer
is
exempt
from
the
provisions
of
this
section
if
the
concentration
of
the
substance
in
the
mixture
does
not
exceed
a
concentration
set
in
subpart
E
of
this
part.
The
exemption
does
not
apply
if
the
employer
has
reason
to
believe
that
during
intended
use
or
processing
in
the
work
area,
the
substance
in
the
mixture
may
be
concentrated
above
the
level
set
in
subpart
E
of
this
part.

(
c)(
1)
If
at
any
time
after
commencing
distribution
in
commerce
of
a
chemical
substance
that
is
identified
in
subpart
E
of
this
part
as
subject
to
this
section,
the
person
has
knowledge
that
a
recipient
of
the
substance
is
engaging
in
an
activity
that
is
not
consistent
with
the
implementation
of
a
program
specified
in
paragraph
(
a)
of
this
section,
the
person
is
considered
to
have
knowledge
that
the
recipient
is
engaging
in
a
significant
new
use
and
is
required
to
follow
the
procedures
in
§
721.5(
d)
unless
the
person
is
able
to
document
the
following:

(
i)
That
the
person
has
notified
the
recipient
in
writing
within
15
working
days
of
the
time
the
person
first
has
knowledge
that
the
recipient
is
engaging
in
an
activity
that
is
not
consistent
with
the
implementation
of
a
program
specified
in
paragraph
(
a)
of
this
section,
and
that
the
person
has
knowledge
of
the
failure
of
implementation.

(
ii)
That
within
15
working
days
of
notifying
the
recipient
that
the
recipient
is
engaging
in
an
activity
that
is
not
consistent
with
the
implementation
of
a
program
specified
in
paragraph
(
a)
of
this
section
the
person
has
received
from
the
recipient,
in
writing,
a
statement
of
assurance
that
the
recipient
has
established
the
program
required
under
paragraph
(
a)
of
this
section,
and
will
take
appropriate
measures
to
avoid
activities
that
are
inconsistent
with
implementation
of
the
program
required
under
paragraph
(
a)
of
this
section.

(
2)
If,
after
receiving
a
statement
of
assurance
from
a
recipient
under
paragraph
(
c)(
1)(
ii)
of
this
section,
a
manufacturer,
importer,
or
processor
has
knowledge
that
the
recipient
is
engaging
in
an
activity
that
is
not
consistent
with
the
implementation
of
the
program
specified
in
paragraph
(
a)
of
this
section,
that
person
is
considered
to
have
knowledge
that
the
person
is
engaging
in
a
significant
new
use
and
is
required
to
follow
the
procedures
in
§
721.5(
d).

§
721.72
Hazard
communication
program.

Whenever
a
substance
is
identified
in
subpart
E
of
this
part
as
being
subject
to
this
section,
a
significant
new
use
of
that
substance
is
any
manner
or
method
of
manufacture,
import,
or
processing
associated
with
any
use
of
that
substance
without
establishing
a
hazard
communication
program
as
described
in
this
section.

(
a)
Written
hazard
communication
program.
Each
employer
shall
develop
and
implement
a
written
hazard
communication
program
for
the
substance
in
each
workplace.
The
written
program
will,
at
a
minimum,
describe
how
the
requirements
of
this
section
for
labels,
MSDSs,
and
other
forms
of
warning
material
will
be
satisfied.
The
employer
must
make
the
written
hazard
communication
program
available,
upon
request,
to
all
employees,
contractor
employees,
and
their
designated
representatives.
The
employer
may
rely
on
an
existing
hazard
communication
program,
including
an
existing
program
established
under
the
Occupational
Health
and
Safety
Administration
(
OSHA)
Hazard
Communication
Standard
(
29
CFR
1900.1200),
to
comply
with
this
paragraph
provided
that
the
existing
hazard
communication
program
satisfies
the
requirements
of
this
paragraph.
The
written
program
shall
include
the
following:

(
1)
A
list
of
each
substance
identified
in
subpart
E
of
this
part
as
subject
to
this
section
known
to
be
present
in
the
work
area.
The
list
must
be
maintained
in
the
work
area
and
must
use
the
identity
provided
on
the
appropriate
MSDS
for
each
substance
required
under
paragraph
(
c)
of
this
section.
The
list
may
be
compiled
for
the
workplace
or
for
individual
work
areas.

(
2)
The
methods
the
employer
will
use
to
inform
employees
of
the
hazards
of
non­
routine
tasks
involving
the
substance,
for
example,
the
cleaning
of
reactor
vessels,
and
the
hazards
associated
with
the
substance
contained
in
unlabeled
pipes
in
their
work
area.

(
3)
The
methods
the
employer
will
use
to
inform
contractors
of
the
presence
of
the
substance
in
the
employer's
workplace
and
of
the
provisions
of
this
part
applicable
to
the
substance
if
employees
of
the
contractor
work
in
the
employer's
workplace
and
are
reasonably
likely
to
be
exposed
to
the
substance
while
in
the
employer's
workplace.

(
b)
Labeling.
(
1)
Each
employer
shall
ensure
that
each
container
of
the
substance
in
the
workplace
is
labeled
in
accordance
with
this
paragraph
(
b)(
1).

(
i)
The
label
shall,
at
a
minimum,
contain
the
following
information:

(
A)
A
statement
of
health
hazard(
s)
and
precautionary
measure(
s)
for
the
substance,
if
any,
identified
in
subpart
E
of
this
part
or
by
the
employer.
(
B)
The
identity
by
which
the
substance
may
be
commonly
recognized.

(
C)
A
statement
of
environmental
hazard(
s)
and
precautionary
measure(
s)
for
the
substance,
if
any,
identified
in
subpart
E
of
this
part
or
by
the
employer.

(
D)
A
statement
of
exposure
and
precautionary
measure(
s),
if
any,
identified
in
subpart
E
of
this
part
or
by
the
employer.

(
ii)
The
employer
may
use
signs,
placards,
process
sheets,
batch
tickets,
operating
procedures,
or
other
such
written
materials
in
lieu
of
affixing
labels
to
individual
stationary
process
containers,
as
long
as
the
alternative
method
identifies
the
containers
to
which
it
is
applicable
and
conveys
information
specified
by
paragraph
(
b)(
1)(
i)
of
this
section.
Any
written
materials
must
be
readily
accessible
to
the
employees
in
their
work
areas
throughout
each
work
shift.

(
iii)
The
employer
need
not
label
portable
containers
into
which
the
substance
is
transferred
from
labeled
containers,
and
which
are
intended
only
for
the
immediate
use
of
the
employee
who
performs
the
transfer.

(
iv)
The
employer
shall
not
remove
or
deface
an
existing
label
on
incoming
containers
of
the
substance
unless
the
container
is
immediately
relabeled
with
the
information
specified
in
paragraph
(
b)(
1)(
i)
of
this
section.

(
2)
Each
employer
shall
ensure
that
each
container
of
the
substance
leaving
its
workplace
for
distribution
in
commerce
is
labeled
in
accordance
with
this
paragraph.

(
i)
The
label
shall,
at
a
minimum,
contain
the
following
information:

(
A)
The
information
required
under
paragraph
(
b)(
1)(
i)
of
this
section.

(
B)
The
name
and
address
of
the
manufacturer
or
a
responsible
party
who
can
provide
additional
information
on
the
substance
for
hazard
evaluation
and
any
appropriate
emergency
procedures.

(
ii)
The
label
shall
not
conflict
with
the
requirements
of
the
Hazardous
Materials
Transportation
Act
(
18
U.
S.
C.
1801
et.
seq.)
and
regulations
issued
under
that
Act
by
the
Department
of
Transportation.

(
3)
The
label,
or
alternative
forms
of
warning,
shall
be
legible
and
prominently
displayed.

(
4)
The
label,
or
alternative
forms
of
warning,
shall
be
in
English;
however,
the
information
may
be
repeated
in
other
languages.

(
5)
If
the
label
or
alternative
form
of
warning
is
to
be
applied
to
a
mixture
containing
a
substance
identified
in
subpart
E
of
this
part
as
subject
to
this
section
in
combination
with
another
substance
identified
in
subpart
E
of
this
part
and/
or
a
substance
defined
as
a
"
hazardous
chemical"
under
the
Occupational
Safety
and
Health
Administration
(
OSHA)
Hazard
Communication
Standard
(
29
CFR
1900.1200),
the
employer
may
prescribe
on
the
label,
MSDS,
or
alternative
form
of
warning,
the
measures
to
control
worker
exposure
or
environmental
release
which
the
employer
determines
provide
the
greatest
degree
of
protection.
However,
should
these
control
measures
differ
from
the
applicable
measures
required
under
subpart
E
of
this
part,
the
employer
must
seek
a
determination
of
equivalency
for
such
alternative
control
measures
pursuant
to
§
721.30
before
prescribing
them
under
this
paragraph.

(
c)
Material
safety
data
sheets.
(
1)
Each
employer
must
obtain
or
develop
a
MSDS
for
the
substance.

(
2)
Each
MSDS
shall
contain,
at
a
minimum,
the
following
information:

(
i)
The
identity
used
on
the
container
label
of
the
substance
under
this
section,
and,
if
not
claimed
confidential,
the
chemical
and
common
name
of
the
substance.
If
the
chemical
and
common
name
are
claimed
confidential,
a
generic
chemical
name
must
be
used.

(
ii)
Physical
and
chemical
characteristics
of
the
substance
known
to
the
employer
(
such
as
vapor
pressure,
flash
point).

(
iii)
The
physical
hazards
of
the
substance
known
to
the
employer,
including
the
potential
for
fire,
explosion,
and
reactivity.

(
iv)
The
potential
human
and
environmental
hazards
as
specified
in
subpart
E
of
this
part
for
the
substance.

(
v)
Signs
and
symptoms
of
exposure,
and
any
medical
conditions
which
are
expected
to
be
aggravated
by
exposure
to
the
substance
known
to
the
employer.

(
vi)
The
primary
routes
of
exposure
to
the
substance.

(
vii)
Precautionary
measures
to
control
worker
exposure
and/
or
environmental
release
identified
in
subpart
E
of
this
part
for
the
substance,
or
alternative
control
measures
which
EPA
has
determined
under
§
721.30
provide
substantially
the
same
degree
of
protection
as
the
identified
control
measures.

(
viii)
Any
generally
applicable
precautions
for
safe
handling
and
use
of
the
substance
which
are
known
to
the
employer,
including
appropriate
hygienic
practices,
protective
measures
during
repair
and
maintenance
of
contaminated
equipment,
and
procedures
for
response
to
spills
and
leaks.

(
ix)
Any
generally
applicable
control
measures
which
are
known
to
the
employer,
such
as
appropriate
engineering
controls,
work
practices,
or
personal
protective
equipment.

(
x)
Emergency
first
aid
procedures
known
to
the
employer.
(
xi)
The
date
of
preparation
of
the
MSDS
or
of
its
last
revision.

(
xii)
The
name,
address,
and
telephone
number
of
the
individual
preparing
or
distributing
the
MSDS,
or
a
responsible
party
who
can
provide
additional
information
on
the
substance
for
hazard
evaluation
and
any
appropriate
emergency
procedures.

(
3)
If
no
relevant
information
is
found
or
known
for
any
given
category
on
the
MSDS,
the
employer
must
mark
the
MSDS
to
indicate
that
no
applicable
information
was
found.

(
4)
Where
multiple
mixtures
containing
the
substance
have
similar
compositions
(
i.
e.,
the
chemical
ingredients
are
essentially
the
same,
but
the
specific
composition
varies
from
mixture
to
mixture)
and
similar
hazards,
the
employer
may
prepare
one
MSDS
to
apply
to
all
of
these
multiple
mixtures.

(
5)
If
the
employer
becomes
aware
of
any
significant
new
information
regarding
the
hazards
of
the
substance
or
ways
to
protect
against
the
hazards,
this
new
information
must
be
added
to
the
MSDS
within
3
months
from
the
time
the
employer
becomes
aware
of
the
new
information.
If
the
substance
is
not
currently
being
manufactured,
imported,
processed,
or
used
in
the
employer's
workplace,
the
employer
must
add
the
new
information
to
the
MSDS
before
the
substance
is
reintroduced
into
the
workplace.

(
6)
The
employer
must
ensure
that
persons
receiving
the
substance
from
the
employer
are
provided
an
appropriate
MSDS
with
their
initial
shipment
and
with
the
first
shipment
after
an
MSDS
is
revised.
The
employer
may
either
provide
the
MSDS
with
the
shipped
containers
or
send
it
to
the
person
prior
to
or
at
the
time
of
shipment.

(
7)
The
employer
must
maintain
a
copy
of
the
MSDS
in
its
workplace,
and
must
ensure
that
it
is
readily
accessible
during
each
work
shift
to
employees
when
they
are
in
their
work
areas.

(
8)
The
MSDS
may
be
kept
in
any
form,
including
as
operating
procedures,
and
may
be
designed
to
cover
groups
of
substances
in
a
work
area
where
it
may
be
more
appropriate
to
address
the
potential
hazards
of
a
process
rather
than
individual
substances.
However,
in
all
cases,
the
required
information
must
be
provided
for
each
substance
and
must
be
readily
accessible
during
each
work
shift
to
employees
when
they
are
in
their
work
areas.

(
9)
The
MSDS
must
be
printed
in
English;
however,
the
information
may
be
repeated
in
other
languages.

(
d)
Employee
information
and
training.
Each
employer
must
ensure
that
employees
are
provided
with
information
and
training
on
the
substance
identified
in
subpart
E
of
this
part.
This
information
and
training
must
be
provided
at
the
time
of
each
employee's
initial
assignment
to
a
work
area
containing
the
substance
and
whenever
the
substance
subject
to
this
section
is
introduced
into
the
employee's
work
area
for
the
first
time.

(
1)
Information
provided
to
employees
under
this
paragraph
shall
include:
(
i)
The
requirements
of
this
section.

(
ii)
Any
operations
in
the
work
area
where
the
substance
is
present.

(
iii)
The
location
and
availability
of
the
written
hazard
communication
program
required
under
paragraph
(
a)
of
this
section,
including
the
list
of
substances
identified
in
subpart
E
of
this
part
as
subject
to
this
section,
and
MSDSs
required
by
paragraph
(
c)
of
this
section.

(
2)
Training
provided
to
employees
shall
include:

(
i)
Methods
and
observations
that
may
be
used
to
detect
the
presence
or
release
of
the
substance
in
or
from
an
employee's
work
area
(
such
as
monitoring
conducted
by
the
employer,
continuous
monitoring
devices,
visual
appearance,
or
odor
of
the
substance
when
being
released).

(
ii)
The
potential
human
health
and
environmental
hazards
of
the
substance
as
specified
in
subpart
E
of
this
part.

(
iii)
The
measures
employees
can
take
to
protect
themselves
and
the
environment
from
the
substance,
including
specific
procedures
the
employer
has
implemented
to
protect
employees
and
the
environment
from
exposure
to
the
substance,
including
appropriate
work
practices,
emergency
procedures,
personal
protective
equipment,
engineering
controls,
and
other
measures
to
control
worker
exposure
and/
or
environmental
release
required
under
subpart
E
of
the
part,
or
alternative
control
measures
which
EPA
has
determined
under
§
721.30
provide
substantially
the
same
degree
of
protection
as
the
specified
control
measures.

(
iv)
The
requirements
of
the
hazard
communication
program
developed
by
the
employer
under
this
section,
including
an
explanation
of
the
labeling
system
and
the
MSDS
required
by
this
section
and
guidance
on
obtaining
and
using
appropriate
hazard
information.

(
e)
Low
concentrations
in
mixtures.
If
a
substance
identified
in
subpart
E
of
this
part
is
present
in
the
work
area
only
as
a
mixture,
an
employer
is
exempt
from
the
provisions
of
this
section
if
the
concentration
of
the
substance
in
the
mixture
does
not
exceed
a
concentration
set
in
subpart
E
of
this
part.
The
exemption
does
not
apply
if
the
employer
has
reason
to
believe
that
during
intended
use
or
processing
in
the
work
area,
the
substance
in
the
mixture
may
be
concentrated
above
the
level
set
in
subpart
E
of
this
part.

(
f)
Existing
hazard
communication
program.
The
employer
need
not
take
additional
actions
if
existing
programs
and
procedures
satisfy
the
requirements
of
this
section.

(
g)
Human
health,
environmental
hazard,
exposure,
and
precautionary
statements.
Whenever
referenced
in
subpart
E
of
this
part
for
a
substance,
the
following
human
health
and
environmental
hazard,
exposure,
and
precautionary
statements
shall
appear
on
each
label
as
specified
in
paragraph
(
b)
of
this
section
and
the
MSDS
as
specified
in
paragraph
(
c)
of
this
section.
Additional
statements
may
be
included
as
long
as
they
are
true
and
do
not
alter
the
meaning
of
the
required
statements.
(
1)
Human
health
hazard
statements:
This
substance
may
cause:

(
i)
Skin
irritation.

(
ii)
Respiratory
complications.

(
iii)
Central
nervous
system
effects.

(
iv)
Internal
organ
effects.

(
v)
Birth
defects.

(
vi)
Reproductive
effects.

(
vii)
Cancer.

(
viii)
Immune
system
effects.

(
ix)
Developmental
effects.

(
2)
Human
health
hazard
precautionary
statements:
When
using
this
substance:

(
i)
Avoid
skin
contact.

(
ii)
Avoid
breathing
substance.

(
iii)
Avoid
ingestion.

(
iv)
Use
respiratory
protection.

(
v)
Use
skin
protection.

(
3)
Environmental
hazard
statements:
This
substance
may
be:

(
i)
Toxic
to
fish.

(
ii)
Toxic
to
aquatic
organisms.

(
4)
Environmental
hazard
precautionary
statements:
Notice
to
users:

(
i)
Disposal
restrictions
apply.

(
ii)
Spill
clean­
up
restrictions
apply.

(
iii)
Do
not
release
to
water.
(
5)
Each
human
health
or
environmental
hazard
precautionary
statement
identified
in
subpart
E
of
this
part
for
the
label
on
the
substance
container
must
be
followed
by
the
statement,
"
See
MSDS
for
details."

(
h)
Human
health,
environmental
hazard
exposure
and
precautionary
statements.
(
1)
Whenever
referenced
in
subpart
E
of
this
part
for
a
substance,
the
following
human
health,
environmental
hazard,
exposure,
and
precautionary
statements
shall
appear
on
each
label
as
specified
in
paragraph
(
b)
of
this
section.
Additional
statements
may
be
included
as
long
as
they
are
true
and
do
not
alter
the
meaning
of
the
required
statements.

(
i)
Precautionary
statements.
(
A)
The
health
effects
of
this
chemical
substance
have
not
been
determined.

(
B)
When
using
this
substance,
use
skin
protection.

(
C)
Use
respiratory
protection
when
there
is
a
reasonable
likelihood
of
exposure
in
the
work
area
from
dust,
mist,
or
smoke
from
spray
application.

(
D)
Chemicals
similar
in
structure
to
this
substance
have
been
found
to
cause
cancer
in
laboratory
animals.

(
ii)
Human
health
hazard
statements.
This
substance
may
cause:

(
A)
Skin
irritation
(
B)
Respiratory
complications
(
C)
Central
nervous
system
effects
(
D)
Internal
organ
effects
(
E)
Birth
defects
(
F)
Reproductive
effects
(
G)
Cancer
(
H)
Immune
system
effects
(
I)
Developmental
effects
(
iii)
Human
health
hazard
precautionary
statements.
When
using
this
substance:

(
A)
Avoid
skin
contact
(
B)
Avoid
breathing
substance
(
C)
Avoid
ingestion
(
D)
Use
respiratory
protection
(
E)
Use
skin
protection
(
iv)
Environmental
hazard
statements.
This
substance
may
be:

(
A)
Toxic
to
fish
(
B)
Toxic
to
aquatic
organisms
(
v)
Environmental
hazard
precautionary
statements.
Notice
to
Users:

(
A)
Disposal
restrictions
apply
(
B)
Spill
clean­
up
restrictions
apply
(
C)
Do
not
release
to
water.

(
vi)
Additional
statements.
Each
human
health
or
environmental
precautionary
statement
identified
in
subpart
E
of
this
part
for
the
label
on
the
substance
container
must
be
followed
by
the
statement,
"
See
MSDS
for
details."

(
2)
Whenever
referenced
in
subpart
E
of
this
part
for
a
substance,
the
following
human
health,
environmental
hazard,
exposure,
and
precautionary
statements
shall
appear
on
each
MSDS
as
specified
in
paragraph
(
c)
of
this
section.
Additional
statements
may
be
included
as
long
as
they
are
true
and
do
not
alter
the
meaning
of
the
required
statements.

(
i)
Precautionary
statements.
(
A)
The
health
effects
of
this
chemical
substance
have
not
been
determined.

(
B)
When
using
this
substance,
use
skin
protection.

(
C)
Use
respiratory
protection
when
there
is
a
reasonable
likelihood
of
exposure
in
the
work
area
from
dust,
mist,
or
smoke
from
spray
application.

(
D)
Chemicals
similar
in
structure
to
this
substance
have
been
found
to
cause
cancer
in
laboratory
animals.

(
ii)
Human
health
hazard
statements.
This
substance
may
cause:

(
A)
Skin
irritation
(
B)
Respiratory
complications
(
C)
Central
nervous
system
effects
(
D)
Internal
organ
effects
(
E)
Birth
defects
(
F)
Reproductive
effects
(
G)
Cancer
(
H)
Immune
system
effects
(
I)
Developmental
effects
(
iii)
Human
health
hazard
precautionary
statements.
When
using
this
substance:

(
A)
Avoid
skin
contact
(
B)
Avoid
breathing
substance
(
C)
Avoid
ingestion
(
D)
Use
respiratory
protection
(
E)
Use
skin
protection
(
iv)
Environmental
hazard
statements.
This
substance
may
be:

(
A)
Toxic
to
fish
(
B)
Toxic
to
aquatic
organisms
(
v)
Environmental
hazard
precautionary
statements.
Notice
to
Users:

(
A)
Disposal
restrictions
apply
(
B)
Spill
clean­
up
restrictions
apply
(
C)
Do
not
release
to
water.

[
54
FR
31308,
July
27,
1989,
as
amended
at
55
FR
45996,
Oct.
31,
1990;
58
FR
34204,
June
23,
1993]
§
721.80
Industrial,
commercial,
and
consumer
activities.

Whenever
a
substance
is
identified
in
subpart
E
of
this
part
as
being
subject
to
this
section,
a
significant
new
use
of
the
substance
is:

(
a)
Use
in
non­
enclosed
processes.

(
b)
Any
manner
or
method
of
manufacture
in
non­
enclosed
processes
associated
with
any
use.

(
c)
Any
manner
or
method
of
processing
in
non­
enclosed
processes
associated
with
any
use.

(
d)
Use
beyond
the
site
of
manufacture
or
import.

(
e)
Processing
beyond
the
site
of
manufacture
or
import.

(
f)
Any
manner
or
method
of
manufacture
(
excluding
import)
of
the
substance
associated
with
any
use.

(
g)
Use
other
than
as
an
intermediate.

(
h)
Use
other
than
as
a
site­
limited
intermediate.

(
i)
Use
as
an
intermediate
where
the
concentration
of
the
intermediate
substance
in
the
product
intended
for
distribution
in
commerce
exceeds
the
concentration
specified
in
subpart
E
of
this
part
for
the
substance.

(
j)
Use
other
than
as
described
in
the
premanufacture
notice
referenced
in
subpart
E
of
this
part
for
the
substance.

(
k)
Use
other
than
allowed
by
the
section
5(
e)
consent
order
referenced
in
subpart
E
of
this
part
for
the
substance.

(
l)
Non­
industrial
use.

(
m)
Commercial
use.

(
n)
Non­
commercial
use.

(
o)
Use
in
a
consumer
product.

(
p)
Aggregate
manufacture
and
importation
volume
for
any
use
greater
than
that
specified
in
subpart
E
of
this
part
for
the
substance.

(
q)
Aggregate
manufacture
and
importation
volume
for
any
use
greater
than
that
allowed
by
the
section
5(
e)
consent
order
referenced
in
subpart
E
of
this
part
for
the
substance.
(
r)
Aggregate
manufacture
and
importation
volume
for
any
use
greater
than
that
specified
in
subpart
E
of
this
part
for
the
substance
unless
the
manufacturer
or
importer
has
submitted
the
results
of
the
health
or
environmental
effects
studies
identified
in
subpart
E
of
this
part
for
the
substance
and
those
studies
comply
with
the
procedures
and
criteria
for
developing
and
evaluating
data
identified
in
subpart
E
of
this
part
for
the
substance.

(
s)
Annual
manufacture
and
importation
volume
for
any
use
greater
than
that
specified
in
subpart
E
of
this
part
for
the
substance.

(
t)
Annual
manufacture
and
importation
volume
for
any
use
greater
than
that
allowed
by
the
section
5(
e)
consent
order
referenced
in
subpart
E
of
this
part
for
the
substance.

(
u)
Annual
manufacture
and
importation
volume
for
any
use
greater
than
that
specified
in
subpart
E
of
this
part
for
the
substance
unless
the
manufacturer
or
importer
has
submitted
the
results
of
the
health
or
environmental
effects
studies
identified
in
subpart
E
of
this
part
for
the
substance
and
those
studies
comply
with
the
procedures
and
criteria
for
developing
and
evaluating
data
identified
in
subpart
E
of
this
part
for
the
substance.

(
v)
Use
in
the
form
of:

(
1)
A
powder.

(
2)
A
solid.

(
3)
A
liquid.

(
4)
A
gas.

(
w)
Any
manner
or
method
of
manufacture
of
the
substance
in
the
following
form
associated
with
any
use:

(
1)
A
powder.

(
2)
A
solid.

(
3)
A
liquid.

(
4)
A
gas.

(
x)
Any
manner
or
method
of
processing
of
the
substance
in
the
following
form
associated
with
any
use:

(
1)
A
powder.

(
2)
A
solid.
(
3)
A
liquid.

(
4)
A
gas.

(
y)
Use
involving
an
application
method
that
generates:

(
1)
A
vapor,
mist,
or
aerosol.

(
2)
A
dust.

§
721.85
Disposal.

Whenever
a
substance
is
identified
in
subpart
E
of
this
part
as
being
subject
to
this
section,
a
significant
new
use
of
the
substance
is
any
method
of:

(
a)
Disposal
of
the
process
stream
associated
with
any
use
of
the
substance
or
with
any
manner
or
method
of
manufacturing
associated
with
any
use
of
the
substance
other
than
by
the
following.
This
provision
does
not
supercede
any
applicable
Federal,
State,
or
local
laws
and
regulations.

(
1)
Incineration.

(
2)
Landfill.

(
3)
Deep
well
injection.

(
b)
Disposal
of
the
process
stream
associated
with
any
use
or
with
any
manner
or
method
of
processing
associated
with
any
use
other
than
by
the
following.
This
provision
does
not
supercede
any
applicable
Federal,
State,
or
local
laws
and
regulations.

(
1)
Incineration.

(
2)
Landfill.

(
3)
Deep
well
injection.

(
c)
Disposal
of
the
use
stream
associated
with
any
use,
other
than
by
the
following.
This
provision
does
not
supercede
any
applicable
Federal,
State,
or
local
laws
and
regulations.

(
1)
Incineration.

(
2)
Landfill.

(
3)
Deep
well
injection.

(
d)
Disposal
of
the
substance
associated
with
any
use
of
the
substance,
or
with
any
manner
or
method
of
manufacture
or
processing
in
association
with
any
use.
This
provision
does
not
supercede
any
applicable
Federal,
State,
or
local
laws
and
regulations.

§
721.90
Release
to
water.

Whenever
a
substance
is
identified
in
subpart
E
of
this
part
as
being
subject
to
this
section,
a
significant
new
use
of
the
substance
is:

(
a)
Any
predictable
or
purposeful
release
of
a
manufacturing
stream
associated
with
any
use
of
the
substance,
from
any
site:

(
1)
Into
the
waters
of
the
United
States.

(
2)
Into
the
waters
of
the
United
States
without
application
of
one
or
more
of
the
following
treatment
technologies
as
specified
in
subpart
E
of
this
part
either
by
the
discharger
or,
in
the
case
of
a
release
through
publicly­
owned
treatment
works,
by
a
combination
of
treatment
by
the
discharger
and
the
publicly­
owned
treatment
works:

(
i)
Chemical
precipitation
and
settling.

(
ii)
Biological
treatment
(
activated
sludge
or
equivalent)
plus
clarification.

(
iii)
Steam
stripping.

(
iv)
Resin
or
activated
carbon
adsorption.

(
v)
Chemical
destruction
or
conversion.

(
vi)
Primary
wastewater
treatment.

(
3)
Into
the
waters
of
the
United
States
without
primary
wastewater
treatment,
and
secondary
wastewater
treatment
as
defined
in
40
CFR
part
133.

(
4)
Into
the
waters
of
the
United
States
if
the
quotient
from
the
following
formula:

number
of
kilograms/
day/
site
released
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
X
1000
=
N
parts
per
billion
receiving
stream
flow
(
million
liters/
day
exceeds
the
level
specified
in
subpart
E
of
this
part
when
calculated
using
the
methods
described
in
§
721.91.
In
lieu
of
calculating
the
above
quotient,
monitoring
or
alternative
calculations
may
be
used
to
predict
the
surface
water
concentration
which
will
result
from
the
intended
release
of
the
substance,
if
the
monitoring
procedures
or
calculations
have
been
approved
for
such
purpose
by
EPA.
EPA
will
review
and
act
on
written
requests
to
approve
monitoring
procedures
or
alternative
calculations
within
90
days
after
such
requests
are
received.
EPA
will
inform
submitters
of
the
disposition
of
such
requests
in
writing,
and
will
explain
the
reasons
therefor
when
they
are
denied.

(
b)
Any
predictable
or
purposeful
release
of
a
process
stream
containing
the
substance
associated
with
any
use
of
the
substance
from
any
site:

(
1)
Into
the
waters
of
the
United
States.

(
2)
Into
the
waters
of
the
United
States
without
application
of
one
or
more
of
the
following
treatment
technologies
as
specified
in
subpart
E
of
this
part
either
by
the
discharger
or,
in
the
case
of
a
release
through
publicly­
owned
treatment
works,
by
a
combination
of
treatment
by
the
discharger
and
the
publicly­
owned
treatment
works:

(
i)
Chemical
precipitation
and
settling.

(
ii)
Biological
treatment
(
activated
sludge
or
equivalent)
plus
clarification.

(
iii)
Steam
stripping.

(
iv)
Resin
or
activated
carbon
adsorption.

(
v)
Chemical
destruction
or
conversion.

(
vi)
Primary
wastewater
treatment.

(
3)
Into
the
waters
of
the
United
States
without
primary
wastewater
treatment,
and
secondary
wastewater
treatment
as
defined
in
40
CFR
part
133.

(
4)
Into
the
waters
of
the
United
States
if
the
quotient
from
the
following
formula:

number
of
kilograms/
day/
site
released
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
X
1000
=
N
parts
per
billion
receiving
stream
flow
(
million
liters/
day
exceeds
the
level
specified
in
subpart
E
of
this
part
when
calculated
using
the
methods
described
in
§
721.91.
In
lieu
of
calculating
the
above
quotient,
monitoring
or
alternative
calculations
may
be
used
to
predict
the
surface
water
concentration
which
will
result
from
the
intended
release
of
the
substance,
if
the
monitoring
procedures
or
calculations
have
been
approved
for
such
purpose
by
EPA.
EPA
will
review
and
act
on
written
requests
to
approve
monitoring
procedures
or
alternative
calculations
within
90
days
after
such
requests
are
received.
EPA
will
inform
submitters
of
the
disposition
of
such
requests
in
writing,
and
will
explain
the
reasons
therefor
when
they
are
denied.

(
c)
Any
predictable
or
purposeful
release
of
a
use
stream
containing
the
substance
associated
with
any
use
of
the
substance
from
any
site:

(
1)
Into
the
waters
of
the
United
States.
(
2)
Into
the
waters
of
the
United
States
without
application
of
one
or
more
of
the
following
treatment
technologies
as
specified
in
subpart
E
of
this
part
either
by
the
discharger
or,
in
the
case
of
a
release
through
publicly­
owned
treatment
works,
by
a
combination
of
treatment
by
the
discharger
and
the
publicly­
owned
treatment
works:

(
i)
Chemical
precipitation
and
settling.

(
ii)
Biological
treatment
(
activated
sludge
or
equivalent)
plus
clarification.

(
iii)
Steam
stripping.

(
iv)
Resin
or
activated
carbon
adsorption.

(
v)
Chemical
destruction
or
conversion.

(
vi)
Primary
wastewater
treatment.

(
3)
Into
the
waters
of
the
United
States
without
primary
wastewater
treatment,
and
secondary
wastewater
treatment
as
defined
in
40
CFR
part
133.

(
4)
Into
the
waters
of
the
United
States
if
the
quotient
from:

number
of
kilograms/
day/
site
released
­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­­
X
1000
=
N
parts
per
billion
receiving
stream
flow
(
million
liters/
day)

exceeds
the
level
specified
in
subpart
E
of
this
part,
when
calculated
using
the
methods
described
in
§
721.91.
In
lieu
of
calculating
the
above
quotient,
however,
monitoring
or
alternative
calculations
may
be
used
to
predict
the
surface
water
concentration
expected
to
result
from
intended
release
of
the
substance,
if
the
monitoring
procedures
or
calculations
have
been
approved
for
such
purpose
by
EPA.
EPA
will
review
and
act
on
written
requests
to
approve
monitoring
procedures
or
alternative
calculations
within
90
days
after
such
requests
are
received.
EPA
will
inform
submitters
of
the
disposition
of
such
requests
in
writing,
and
will
explain
the
reasons
therefor
when
they
are
denied.

§
721.91
Computation
of
estimated
surface
water
concentrations:
Instructions.

These
instructions
describe
the
use
of
the
equation
specified
in
§
721.90(
a)(
4)
and
(
b)(
4)
to
compute
estimated
surface
water
concentrations
which
will
result
from
release
of
a
substance
identified
in
subpart
E
of
this
part.
The
equation
shall
be
computed
for
each
site
using
the
stream
flow
rate
appropriate
for
the
site
according
to
paragraph
(
b)
of
this
section,
and
the
highest
number
of
kilograms
calculated
to
be
released
for
that
site
on
a
given
day
according
to
paragraph
(
a)
of
this
section.
Two
variables
shall
be
considered
in
computing
the
equation,
the
number
of
kilograms
released,
and
receiving
stream
flow.

(
a)
Number
of
kilograms
released.
(
1)
To
calculate
the
number
of
kilograms
of
substance
to
be
released
from
manufacturing,
processing,
or
use
operations,
as
specified
in
the
numerator
of
the
equation,
develop
a
process
description
diagram
which
describes
each
manufacturing,
processing,
or
use
operation
involving
the
substance.
The
process
description
must
include
the
major
unit
operation
steps
and
chemical
conversions.
A
unit
operation
is
a
functional
step
in
a
manufacturing,
processing,
or
use
operation
where
substances
undergo
chemical
changes
and/
or
changes
in
location,
temperature,
pressure,
physical
state,
or
similar
characteristics.
Include
steps
in
which
the
substance
is
formulated
into
mixtures,
suspensions,
solutions,
etc.

(
2)
Indicate
on
each
diagram
the
entry
point
of
all
feedstocks
(
e.
g.,
reactants,
solvents,
and
catalysts)
used
in
the
operation.
Identify
each
feedstock
and
specify
its
approximate
weight
regardless
of
whether
the
process
is
continuous
or
batch.

(
3)
Identify
all
release
points
from
which
the
substance
or
wastes
containing
the
substance
will
be
released
into
air,
land,
or
water.
Indicate
these
release
points
on
the
diagram.
Do
not
include
accidental
releases
or
fugitive
emissions.

(
4)
For
releases
identified
in
the
diagram
that
are
destined
for
water,
estimate
the
amount
of
substance
that
will
be
released
before
the
substance
enters
control
technology.
The
kilograms
of
substance
released
may
be
estimated
based
on:

(
i)
The
mass
balance
of
the
operation,
i.
e.,
totaling
inputs
and
outputs,
including
wastes
for
each
part
of
the
process
such
that
outputs
equal
inputs.
The
amount
released
to
water
may
be
the
difference
between
the
amount
of
the
substance
in
the
starting
material
(
or
formed
in
a
reaction)
minus
the
amount
of
waste
material
removed
from
each
part
of
the
process
and
not
released
to
water
and
the
amount
of
the
substance
in
the
final
product.

(
ii)
Physical
properties
such
as
water
solubility
where
a
known
volume
of
water
being
discharged
is
assumed
to
contain
the
substance
at
concentrations
equal
to
its
solubility
in
water.
This
approach
is
particularly
useful
where
the
waste
stream
results
from
separation
of
organic/
water
phases
or
filtration
of
the
substance
from
an
aqueous
stream
to
be
discharged.

(
iii)
Measurements
of
flow
rates
of
the
process/
use
stream
and
known
concentrations
of
the
substance
in
the
stream.

(
5)
After
releases
of
a
substance
to
water
are
estimated
for
each
operation
on
a
site,
total
the
releases
of
the
substance
to
water
from
all
operations
at
that
site.
The
value
(
number
of
kilograms)
specified
in
the
numerator
of
the
equation
should
reflect
total
kilograms
of
substance
released
to
water
per
day
from
all
operations
at
a
single
site.

(
6)
Use
the
highest
expected
daily
release
of
the
substance
for
each
site.

(
b)
Receiving
stream
flow.
(
1)
The
receiving
stream
flow
shall
be
expressed
in
million
liters
per
day
(
MLD).
The
flow
rate
data
to
be
used
must
be
for
the
point
of
release
on
the
water
body
that
first
receives
release
of
the
substance
whether
by
direct
discharge
from
a
site,
or
by
indirect
discharge
through
a
Publicly­
Owned
Treatment
Works
(
POTW)
for
each
site.
The
flow
rate
reported
shall
be
the
lowest
7­
day
average
stream
flow
with
a
recurrence
interval
of
10
years
(
7­
Q­
10).
If
the
7­
Q­
10
flow
rate
is
not
available
for
the
actual
point
of
release,
the
stream
flow
rate
should
be
used
from
the
U.
S.
Geological
Survey
(
USGS)
gauging
station
that
is
nearest
the
point
of
release
that
is
expected
to
have
a
flow
rate
less
than
or
equal
to
the
receiving
stream
flow
at
the
point
of
release.

(
2)
Receiving
stream
flow
data
may
be
available
from
the
National
Pollutant
Discharge
Elimination
System
(
NPDES)
permit
for
the
site
or
the
POTW
releasing
the
substance
to
surface
water,
from
the
NPDES
permit­
writing
authority
for
the
site
or
the
POTW,
or
from
USGS
publications,
such
as
the
water­
data
report
series.

(
3)
If
receiving
stream
flow
data
are
not
available
for
a
stream,
either
the
value
of
10
MLD
or
the
daily
flow
of
wastewater
from
the
site
or
the
POTW
releasing
the
substance
must
be
used
as
an
assumed
minimum
stream
flow.
Similarly,
if
stream
flow
data
are
not
available
because
the
location
of
the
point
of
release
of
the
substance
to
surface
water
is
a
lake,
estuary,
bay,
or
ocean,
then
the
flow
rate
to
be
used
must
be
the
daily
flow
of
wastewater
from
the
site
or
the
POTW
releasing
the
substance
to
surface
water.
Wastewater
flow
data
may
be
available
from
the
NPDES
permit
or
NPDES
authority
for
the
site
or
the
POTW
releasing
the
substance
to
water.

SUBPART
C
­
RECORDKEEPING
REQUIREMENTS
§
721.100
Applicability.

This
subpart
C
identifies
certain
additional
recordkeeping
requirements
applicable
to
manufacturers,
importers,
and
processors
of
substances
identified
in
subpart
E
of
this
part
for
each
specific
substance.
The
provisions
of
this
subpart
C
apply
only
when
referenced
in
subpart
E
of
this
part
for
a
substance
and
significant
new
use
identified
in
that
subpart
E.
If
the
provisions
in
this
subpart
C
conflict
with
general
provisions
of
subpart
A
of
this
part,
the
provisions
of
this
subpart
C
shall
apply.

[
54
FR
31313,
July
27,
1989]

§
721.125
Recordkeeping
requirements.

At
the
time
EPA
adds
a
substance
to
subpart
E
of
this
part,
EPA
will
specify
appropriate
recordkeeping
requirements
which
correspond
to
the
significant
new
use
designations
for
the
substance
selected
from
subpart
B
of
this
part.
Each
manufacturer,
importer,
and
processor
of
the
substance
shall
maintain
the
records
for
5
years
from
the
date
of
their
creation.
In
addition
to
the
records
specified
in
§
721.40,
the
records
whose
maintenance
this
section
requires
may
include
the
following:

(
a)
Records
documenting
the
manufacture
and
importation
volume
of
the
substance
and
the
corresponding
dates
of
manufacture
and
import.

(
b)
Records
documenting
volumes
of
the
substance
purchased
in
the
United
States
by
processors
of
the
substance,
names
and
addresses
of
suppliers,
and
corresponding
dates
of
purchase.

(
c)
Records
documenting
the
names
and
addresses
(
including
shipment
destination
address,
if
different)
of
all
persons
outside
the
site
of
manufacture,
importation,
or
processing
to
whom
the
manufacturer,
importer,
or
processor
directly
sells
or
transfers
the
substance,
the
date
of
each
sale
or
transfer,
and
the
quantity
of
the
substance
sold
or
transferred
on
such
date.

(
d)
Records
documenting
establishment
and
implementation
of
a
program
for
the
use
of
any
applicable
personal
protective
equipment
required
under
§
721.63.

(
e)
Records
documenting
the
determinations
required
by
§
721.63(
a)(
3)
that
chemical
protective
clothing
is
impervious
to
the
substance.

(
f)
Records
documenting
establishment
and
implementation
of
the
hazard
communication
program
required
under
§
721.72.

(
g)
Copies
of
labels
required
under
§
721.72(
b).

(
h)
Copies
of
material
safety
data
sheets
required
under
§
721.72(
c).

(
i)
Records
documenting
compliance
with
any
applicable
industrial,
commercial,
and
consumer
use
limitations
under
§
721.80.

(
j)
Records
documenting
compliance
with
any
applicable
disposal
requirements
under
§
721.85,
including
the
method
of
disposal,
location
of
disposal
sites,
dates
of
disposal,
and
volume
of
the
substance
disposed.
Where
the
estimated
disposal
volume
is
not
known
to
or
reasonably
ascertainable
by
the
manufacturer,
importer,
or
processor,
that
person
must
maintain
other
records
which
demonstrate
establishment
and
implementation
of
a
program
that
ensures
compliance
with
any
applicable
disposal
requirements.

(
k)
Records
documenting
establishment
and
implementation
of
procedures
that
ensure
compliance
with
any
applicable
water
discharge
limitations
under
§
721.90.

[
54
FR
31313,
July
27,
1989]

SUBPART
D
­
EXPEDITED
PROCESS
FOR
ISSUING
SIGNIFICANT
NEW
USE
RULES
FOR
SELECTED
CHEMICAL
SUBSTANCES
AND
LIMITATION
OR
REVOCATION
OF
SIGNIFICANT
NEW
USE
RULES
§
721.160
Notification
requirements
for
new
chemical
substances
subject
to
section
5(
e)
orders.

(
a)
Selection
of
substances.
(
1)
In
accordance
with
the
expedited
process
specified
in
this
section,
EPA
will
issue
significant
new
use
notification
requirements
and
other
specific
requirements
for
each
new
chemical
substance
that
is
the
subject
of
a
final
order
issued
under
section
5(
e)
of
the
Act,
except
for
an
order
that
prohibits
manufacture
and
import
of
the
substance,
unless
EPA
determines
that
significant
new
use
notification
requirements
are
not
needed
for
the
substance.

(
2)
If
EPA
determines
that
significant
new
use
notification
requirements
are
not
needed
for
a
substance
that
is
subject
to
a
final
order
issued
under
section
5(
e)
of
the
Act,
except
for
an
order
that
prohibits
manufacture
or
import
of
the
substance,
EPA
will
issue
a
notice
in
the
Federal
Register
explaining
why
the
significant
new
use
requirements
are
not
needed.

(
b)
Designation
of
requirements.
(
1)
The
significant
new
use
notification
and
other
specific
requirements
will
be
based
on
and
be
consistent
with
the
provisions
included
in
the
final
order
issued
for
the
substance
under
section
5(
e)
of
the
Act.
EPA
may
also
designate
additional
activities
as
significant
new
uses
which
will
be
subject
to
notification.
Designation
of
additional
activities
as
significant
new
uses
will
be
done
in
accordance
with
the
criteria
and
procedures
under
§
721.170,
or
through
a
separate
rulemaking
proceeding.

(
2)
Significant
new
use
requirements
and
other
specific
requirements
designated
under
this
section
will
be
listed
in
subpart
E
of
this
part.
For
each
substance,
subpart
E
will
identify:

(
i)
The
chemical
name.

(
ii)
The
activities
designated
as
significant
new
uses.

(
iii)
Other
specific
requirements
applicable
to
the
substance,
including
recordkeeping
requirements
or
any
other
requirements
included
in
the
final
section
5(
e)
order.

(
c)
Procedures
for
issuing
significant
new
use
rules.
(
1)
EPA
will
issue
significant
new
use
rules
under
this
section
by
one
of
the
following
three
processes:
direct
final
rulemaking,
interim
final
rulemaking,
or
notice
and
comment
rulemaking.
EPA
will
use
the
direct
final
rulemaking
process
to
issue
significant
new
use
rules
unless
it
determines
that,
in
a
particular
case,
one
of
the
other
processes
is
more
appropriate.

(
2)
Federal
Register
documents
issued
to
propose
or
establish
significant
new
uses
under
this
section
will
contain
the
following:

(
i)
The
chemical
identity
of
the
substance
or,
if
its
specific
identity
is
claimed
confidential,
an
appropriate
generic
chemical
name
and
an
accession
number
assigned
by
EPA.

(
ii)
The
premanufacture
notice
number.

(
iii)
The
CAS
number,
where
available
and
not
claimed
confidential.

(
iv)
A
summary
of
EPA's
findings
under
section
5(
e)(
1)(
A)
of
the
Act
for
the
final
order
issued
under
section
5(
e).

(
v)
Designation
of
the
significant
new
uses
subject
to,
or
proposed
to
be
subject
to,
notification
and
any
other
applicable
requirements.
(
vi)
Any
modifications
of
subpart
A
of
this
part
applicable
to
the
specific
substance
and
significant
new
uses.

(
vii)
If
the
Federal
Register
document
establishes
a
final
rule,
or
notifies
the
public
that
a
final
rule
will
not
be
issued
after
public
comment
has
been
received,
the
document
will
describe
comments
received
and
EPA's
response.

(
3)
Direct
final
rulemaking.
(
i)
When
EPA
uses
the
direct
final
rulemaking
procedure
to
issue
a
significant
new
use
rule,
it
will
issue
a
final
rule
in
the
Federal
Register
following
its
decision
to
develop
a
significant
new
use
rule
under
this
section
for
a
specific
new
chemical
substance.

(
ii)
The
Federal
Register
document
will
state
that,
unless
written
notice
is
received
by
EPA
within
30
days
of
publication
that
someone
wishes
to
submit
adverse
or
critical
comments,
the
rule
will
be
effective
60
days
from
the
date
of
publication.
The
written
notice
of
intent
to
submit
adverse
or
critical
comments
should
state
which
SNUR(
s)
will
be
the
subject
of
the
adverse
or
critical
comments,
if
several
SNURs
are
established
through
the
direct
final
rule.
If
notice
is
received
within
30
days
that
someone
wishes
to
submit
adverse
or
critical
comments,
the
section(
s)
of
the
direct
final
rule
containing
the
SNUR(
s)
for
which
a
notice
of
intent
to
comment
was
received
will
be
withdrawn
by
EPA
issuing
a
document
in
the
final
rule
section
of
the
Federal
Register,
and
a
proposal
will
be
published
in
the
proposed
rule
section
of
the
Federal
Register.
The
proposal
will
establish
a
30­
day
comment
period.

(
iii)
If
EPA,
having
considered
any
timely
comments
submitted
in
response
to
the
proposal,
decides
to
establish
notification
requirements
under
this
section,
EPA
will
issue
a
final
rule
adding
the
substance
to
subpart
E
of
this
part
and
designating
the
significant
new
uses
subject
to
notification.

(
4)
Notice
and
comment
rulemaking.
(
i)
When
EPA
uses
a
notice
and
comment
procedure
to
issue
a
significant
new
use
rule,
EPA
will
issue
a
proposal
in
the
Federal
Register
following
its
decision
to
develop
a
significant
new
use
rule
under
this
section
for
a
specific
new
chemical
substance.
Persons
will
be
given
30
days
to
comment
on
whether
EPA
should
establish
notification
requirements
for
the
substance
under
this
part.

(
ii)
If
EPA,
having
considered
any
timely
comments,
decides
to
establish
notification
requirements
under
this
section,
EPA
will
issue
a
final
rule
adding
the
substance
to
subpart
E
of
this
part
and
designating
the
significant
new
uses
subject
to
notification.

(
5)
Interim
final
rulemaking.
(
i)
When
EPA
uses
the
interim
final
rulemaking
procedure
to
issue
a
significant
new
use
rule,
EPA
will
issue
an
interim
final
rule
in
the
final
rule
section
of
the
Federal
Register
following
its
decision
to
develop
a
significant
new
use
rule
for
a
specific
new
chemical
substance.
The
document
will
state
EPA's
reasons
for
using
the
interim
final
rulemaking
procedure.

(
A)
The
significant
new
use
rule
will
take
effect
on
the
date
of
publication.
(
B)
Persons
will
be
given
30
days
from
the
date
of
publication
to
submit
comments.

(
ii)
Interim
final
rules
issued
under
this
section
shall
cease
to
be
in
effect
180
days
after
publication
unless,
within
the
180­
day
period,
EPA
issues
a
final
rule
in
the
Federal
Register
responding
to
any
written
comments
received
during
the
30­
day
comment
period
specified
in
paragraph
(
c)(
5)(
i)(
B)
of
this
section
and
promulgating
final
significant
new
use
notification
requirements
and
other
requirements
for
the
substance.

(
d)
Schedule
for
issuing
significant
new
use
rules.
(
1)
Unless
EPA
determines
that
a
significant
new
use
rule
should
not
be
issued
under
this
section,
EPA
will
issue
a
proposed
rule,
a
direct
final
rule,
or
an
interim
final
rule
within
180
days
of
receipt
of
a
valid
notice
of
commencement
under
§
720.102
of
this
chapter
for
any
substance
for
which
the
notice
of
commencement
was
received
on
or
after
October
10,
1989.

(
2)
Unless
EPA
determines
that
a
significant
new
use
rule
should
not
be
issued
under
this
section,
EPA
will
issue
a
proposed
rule,
a
direct
final
rule,
or
an
interim
final
rule
within
1
year
of
October
10,
1989,
for
any
substance
for
which
the
valid
notice
of
commencement
under
§
720.102
of
this
chapter
was
received
before
October
10,
1989.

(
3)
If
EPA
receives
adverse
or
critical
significant
comments
following
publication
of
a
proposed
or
interim
final
rule,
EPA
will
either
withdraw
the
rule
or
issue
a
final
rule
addressing
the
comments
received.

§
721.170
Notification
requirements
for
selected
new
chemical
substances
that
have
completed
premanufacture
review.

(
a)
Selection
of
substances.
In
accordance
with
the
expedited
process
specified
in
this
section,
EPA
may
issue
significant
new
use
notification
and
recordkeeping
requirements
for
any
new
chemical
substance
for
which
a
premanufacture
notice
has
been
submitted
under
part
720
of
this
chapter
if
EPA
determines
that
activities
other
than
those
described
in
the
premanufacture
notice
may
result
in
significant
changes
in
human
exposure
or
environmental
release
levels
and/
or
that
concern
exists
about
the
substance's
health
or
environmental
effects.

(
b)
Concern
criteria.
EPA
may
determine
that
concern
exists
about
a
substance's
health
or
environmental
effects
if
EPA
makes
any
one
of
the
following
findings:

(
1)(
i)
The
substance
may
cause
carcinogenic
effects
because
the
substance:

(
A)
Has
been
shown
by
valid
test
data
to
cause
carcinogenic
effects
in
humans
or
in
at
least
one
species
of
laboratory
animal.

(
B)
Has
been
shown
to
be
a
possible
carcinogen
based
on
the
weight
of
the
evidence
in
short­
term
tests
indicative
of
the
potential
to
cause
carcinogenic
effects.

(
C)
Is
closely
analogous,
based
on
toxicologically
relevant
similarities
in
molecular
structure
and
physical
properties,
to
another
substance
that
has
been
shown
by
test
data
to
cause
carcinogenic
effects
in
humans
or
in
at
least
one
species
of
laboratory
animal,
provided
that
if
there
is
more
than
one
such
analogue,
the
greatest
weight
will
be
given
to
the
relevant
data
for
the
most
appropriate
analogues.

(
D)
Is
known
or
can
reasonably
be
anticipated,
based
on
valid
scientific
data
or
established
scientific
principles,
to
be
metabolized
in
humans
or
transformed
in
the
environment
to
a
substance
which
may
have
the
potential
to
cause
carcinogenic
effects
under
the
criteria
in
paragraphs
(
b)(
1)(
i)
(
A),
(
B),
or
(
C)
of
this
section.

(
ii)
No
substance
may
be
regulated
based
on
a
finding
under
paragraph
(
b)(
1)
of
this
section
unless
EPA
has
also
made
the
finding
under
§
721.170(
c)(
2)(
ii).

(
2)
The
substance
has
been
shown
by
valid
test
data
to
cause
acutely
toxic
effects
in
at
least
one
species
of
laboratory
animal
or
is
closely
analogous,
based
on
toxicologically
relevant
similarities
in
molecular
structure
and
physical
properties,
to
another
substance
that
has
been
shown
by
valid
test
data
to
cause
acutely
toxic
effects
in
at
least
one
species
of
laboratory
animal,
provided
that
if
there
is
more
than
one
such
analogue,
the
greatest
weight
will
be
given
to
the
relevant
data
for
the
most
appropriate
analogues.

(
3)
The
substance
may
cause
serious
chronic
effects,
serious
acute
effects,
or
developmentally
toxic
effects
under
reasonably
anticipated
conditions
of
exposure
because
the
substance:

(
i)
Has
been
shown
by
valid
test
data
to
cause
serious
chronic
effects,
serious
acute
effects,
or
developmentally
toxic
effects
in
humans
or
in
at
least
one
species
of
laboratory
animal
at
dose
levels
that
could
be
of
concern
under
reasonably
anticipated
conditions
of
exposure.

(
ii)
Is
closely
analogous,
based
on
toxicologically
relevant
similarities
in
molecular
structure
and
physical
properties,
to
another
chemical
substance
that
has
been
shown
by
valid
test
data
to
cause
serious
chronic
effects,
serious
acute
effects,
or
developmentally
toxic
effects
in
humans
or
in
at
least
one
species
of
laboratory
animal
at
dose
levels
that
could
be
of
concern
under
reasonably
anticipated
conditions
of
exposure,
provided
that
if
there
is
more
than
one
such
analogue,
the
greatest
weight
will
be
given
to
the
relevant
data
for
the
most
appropriate
analogues.

(
iii)
Is
known
or
can
reasonably
be
anticipated,
based
on
valid
scientific
data
or
established
scientific
principles,
to
be
metabolized
in
humans
or
transformed
in
the
environment
to
a
substance
which
may
have
the
potential
to
cause
serious
chronic
effects,
serious
acute
effects,
or
developmentally
toxic
effects
under
the
criteria
in
paragraph
(
b)(
3)
(
i)
and
(
ii)
of
this
section.

(
iv)
Has
been
shown
to
potentially
cause
developmentally
toxic
effects
based
on
the
weight
of
the
evidence
in
short­
term
tests
indicative
of
the
potential
to
cause
developmentally
toxic
effects.

(
4)
The
substance
may
cause
significant
adverse
environmental
effects
under
reasonably
anticipated
conditions
of
release
because
the
substance:
(
i)
Has
been
shown
by
valid
test
data
to
cause
significant
adverse
environmental
effects
at
dose
levels
that
could
be
of
concern
under
reasonably
anticipated
conditions
of
release.

(
ii)
Is
closely
analogous,
based
on
toxicologically
relevant
similarities
in
molecular
structure
and
physical
properties,
to
another
substance
that
has
been
shown
by
valid
test
data
to
cause
significant
adverse
environmental
effects
at
dose
levels
that
could
be
of
concern
under
reasonably
anticipated
conditions
of
release,
provided
that
if
there
is
more
than
one
such
analogue,
the
greatest
weight
will
be
given
to
the
relevant
data
for
the
most
appropriate
analogues.

(
iii)
Has
been
determined,
based
on
calculations
using
the
substance's
physical
and
chemical
properties,
to
be
potentially
able
to
cause
significant
adverse
environmental
effects
at
dose
levels
that
could
be
of
concern
under
reasonably
anticipated
conditions
of
release.

(
iv)
Is
known
or
can
reasonably
be
anticipated,
based
on
valid
scientific
data
or
established
scientific
principles,
to
be
environmentally
transformed
to
a
substance
which
may
have
the
potential
to
cause
significant
adverse
environmental
effects
under
the
criteria
in
paragraph
(
b)(
4)
(
i),
(
ii),
and
(
iii)
of
this
section.

(
5)
Concern
exists
about
the
health
or
environmental
effects
of
one
or
more
impurities
or
byproducts
of
the
substance
because
the
impurity
or
byproduct
meets
one
or
more
of
the
criteria
in
paragraph
(
b)
(
1)
through
(
4)
of
this
section
and
either:

(
i)
The
impurity
or
byproduct
is
a
new
chemical
substance
and
may
be
present
in
concentrations
that
could
cause
adverse
health
or
environmental
effects
under
reasonably
anticipated
conditions
of
exposure
or
release.

(
ii)
Reasonably
anticipated
manufacture,
processing,
or
use
activities
involving
the
substance
for
which
a
premanufacture
notice
has
been
submitted
may
result
in
significantly
increased
human
exposure
to
or
environmental
release
of
the
impurity
or
byproduct
compared
to
exposure
or
release
levels
resulting
from
existing
activities
involving
the
impurity
or
byproduct.

(
c)
Designation
of
requirements.
(
1)
When
EPA
decides
to
establish
significant
new
use
reporting
requirements
under
this
section,
EPA
may
designate
as
a
significant
new
use
any
one
or
more
of
the
activities
set
forth
in
subpart
B
of
this
part.
In
addition,
EPA
may
designate
specific
recordkeeping
requirements
described
under
subpart
C
of
this
part
that
are
applicable
to
the
substance.

(
2)
EPA
may
designate
as
a
significant
new
use
only
those
activities
that
(
i)
are
different
from
those
described
in
the
premanufacture
notice
for
the
substance,
including
any
amendments,
deletions,
and
additions
of
activities
to
the
premanufacture
notice,
and
(
ii)
may
be
accompanied
by
changes
in
exposure
or
release
levels
that
are
significant
in
relation
to
the
health
or
environmental
concerns
identified
under
paragraph
(
b)
of
this
section.

(
d)
Procedures
for
issuing
significant
new
use
rules.
(
1)
Significant
new
use
requirements
designated
under
this
section
will
be
listed
in
subpart
E
of
this
part.
For
each
substance,
subpart
E
of
this
part
will
identify:

(
i)
The
chemical
name.

(
ii)
The
activities
designated
as
significant
new
uses,
which
may
include
one
or
more
of
the
activities
described
in
paragraph
(
c)
of
this
section.

(
iii)
Other
specific
requirements
applicable
to
the
substance.

(
2)
When
EPA
determines
that
a
substance
is
a
candidate
for
a
significant
new
use
rule
under
this
section,
it
will
notify
the
person
that
submitted
the
premanufacture
notice
for
the
substance
no
later
than
7
calendar
days
before
the
expiration
of
the
notice
review
period
under
§
720.75
of
this
chapter.
In
providing
this
notice,
EPA
will
describe
the
health
or
environmental
concerns
identified
under
paragraph
(
b)
of
this
section
and
the
activities
under
consideration
for
designation
as
significant
new
uses.
Such
notice
may
be
by
telephone,
but
in
this
event
will
be
confirmed
in
writing
no
later
than
30
days
after
completion
of
the
notice
review
period.

(
3)
Federal
Register
documents
issued
to
propose
or
establish
significant
new
uses
under
this
section
will
contain
the
following:

(
i)
The
chemical
identity
of
the
substance
or,
if
its
specific
identity
is
claimed
confidential,
an
appropriate
generic
chemical
name
and
an
accession
number
assigned
by
EPA.

(
ii)
The
premanufacture
notice
number.

(
iii)
The
CAS
number,
where
available
and
not
claimed
confidential.

(
iv)
A
summary
of
the
basis
for
action
under
this
section.

(
v)
Designation
of
the
significant
new
uses
subject
to,
or
proposed
to
be
subject
to,
notification
and
any
other
applicable
requirements.

(
vi)
Any
modifications
of
subpart
A
of
this
part
applicable
to
the
specific
substance
and
significant
new
uses.

(
vii)
If
the
Federal
Register
document
establishes
a
final
rule,
or
notifies
the
public
that
a
final
rule
will
not
be
issued
after
public
comment
has
been
received,
the
document
will
describe
comments
received
and
EPA's
response.

(
4)
EPA
will
issue
significant
new
use
rules
under
this
section
by
one
of
the
following
three
processes:
direct
final
rulemaking,
interim
final
rulemaking,
or
notice
and
comment
rulemaking.
EPA
will
use
the
direct
final
rulemaking
process
to
issue
significant
new
use
rules
unless
it
determines
that,
in
a
particular
case,
one
of
the
other
processes
is
more
appropriate.

(
i)(
A)
When
EPA
uses
the
direct
final
rulemaking
procedure
to
issue
a
significant
new
use
rule
it
will
issue
a
direct
final
rule
in
the
final
rule
section
of
the
Federal
Register
following
its
decision
to
develop
a
significant
new
use
rule
under
this
section
for
a
specific
new
chemical
substance.

(
B)
The
Federal
Register
document
will
state
that,
unless
written
notice
is
received
by
EPA
within
30
days
after
the
date
of
publication
that
someone
wishes
to
submit
adverse
or
critical
comments,
the
SNUR
will
be
effective
60
days
from
date
of
publication.
The
written
notice
of
intent
to
submit
adverse
or
critical
comments
should
state
which
SNUR(
s)
will
be
the
subject
of
the
adverse
or
critical
comments,
if
several
SNURs
are
established
through
the
direct
final
rule.
If
notice
is
received
within
30
days
after
the
date
of
publication
that
someone
wishes
to
submit
adverse
or
critical
comments,
the
section(
s)
of
the
direct
final
rule
containing
the
SNUR(
s)
for
which
a
notice
of
intent
to
comment
was
received
will
be
withdrawn
by
EPA
issuing
a
document
in
the
final
rule
section
of
the
Federal
Register,
and
EPA
will
issue
a
proposed
rule
in
the
proposed
rule
section
of
the
Federal
Register.
The
proposed
rule
will
establish
a
30­
day
comment
period.

(
C)
If
EPA,
having
considered
any
timely
comments
submitted
in
response
to
the
proposal,
decides
to
establish
notification
requirements
under
this
section,
EPA
will
issue
a
final
rule
adding
the
substance
to
subpart
E
of
this
part
and
designating
the
significant
new
uses
subject
to
notification.

(
ii)(
A)
When
EPA
uses
a
notice
and
comment
procedure
to
issue
a
significant
new
use
rule,
EPA
will
issue
a
proposed
rule
in
the
Federal
Register
following
its
decision
to
develop
a
significant
new
use
rule
under
this
section
for
a
specific
new
chemical
substance.
Persons
will
be
given
30
days
to
comment
on
whether
EPA
should
establish
notification
requirements
for
the
substance
under
this
part.

(
B)
If
EPA,
having
considered
any
timely
comments,
decides
to
establish
notification
requirements
under
this
section,
EPA
will
issue
a
final
rule
adding
the
substance
to
subpart
E
of
this
part
and
designating
the
significant
new
uses
subject
to
notification.

(
iii)(
A)
When
EPA
uses
the
interim
final
rulemaking
procedure
to
issue
a
significant
new
use
rule,
EPA
will
issue
an
interim
final
rule
in
the
final
rule
section
of
the
Federal
Register
following
its
decision
to
develop
a
significant
new
use
rule
for
a
specific
new
chemical
substance.
The
document
will
state
EPA's
reasons
for
using
the
interim
final
rulemaking
procedure.

(
1)
The
significant
new
use
rule
will
take
effect
on
the
date
of
publication.

(
2)
Persons
will
be
given
30
days
from
the
date
of
publication
to
submit
comments.

(
B)
An
interim
final
rule
issued
under
this
section
shall
cease
to
be
in
effect
180
days
after
publication
unless,
within
the
180­
day
period,
EPA
issues
a
final
rule
in
the
Federal
Register
responding
to
any
written
comments
received
during
the
30­
day
comment
period
specified
in
paragraph
(
d)(
4)(
iii)(
A)(
2)
of
this
section
and
promulgating
final
significant
new
use
notification
requirements
and
other
requirements
for
the
substance.
(
e)
Schedule
for
issuing
significant
new
use
rules.
(
1)
EPA
will
issue
a
proposed
rule,
an
interim
final
rule,
or
a
direct
final
rule
within
270
days
of
receipt
of
the
notice
of
commencement
under
§
720.102
of
this
chapter
for
any
substance
for
which
the
notice
of
commencement
was
received
on
or
after
October
10,
1989.

(
2)
If
EPA
receives
adverse
or
critical
comments
within
the
designated
comment
period
following
publication
of
a
proposed
rule
or
an
interim
final
rule,
EPA
will
either
withdraw
the
rule
or
issue
a
final
rule
addressing
the
comments
received.

[
54
FR
31314,
July
27,
1989,
as
amended
at
60
FR
16316,
Mar.
29,
1995]

§
721.185
Limitation
or
revocation
of
certain
notification
requirements.

(
a)
Criteria
for
modification
or
revocation.
EPA
may
at
any
time
modify
or
revoke
significant
new
use
notification
requirements
for
a
chemical
substance
which
has
been
added
to
subpart
E
of
this
part
using
the
procedures
under
§
721.160
or
§
721.170.
Such
action
may
be
taken
under
this
section
if
EPA
makes
one
of
the
following
determinations,
unless
other
information
shows
that
the
requirements
should
be
retained:

(
1)
Test
data
or
other
information
obtained
by
EPA
provide
a
reasonable
basis
for
concluding
that
activities
designated
as
significant
new
uses
of
the
substance
will
not
present
an
unreasonable
risk
of
injury
to
human
health
or
the
environment.

(
2)
EPA
has
promulgated
a
rule
under
section
4
or
6
of
the
Act,
or
EPA
or
another
agency
has
taken
action
under
another
law
for
the
substance
that
eliminates
the
need
for
significant
new
use
notification
under
section
5(
a)(
2)
of
the
Act.

(
3)
EPA
has
received
significant
new
use
notices
for
some
or
all
of
the
activities
designated
as
significant
new
uses
of
the
substance
and,
after
reviewing
such
notices,
concluded
that
there
is
no
need
to
require
additional
notice
from
persons
who
propose
to
engage
in
identical
or
similar
activities.

(
4)
EPA
has
examined
new
information,
or
has
reexamined
the
test
data
or
other
information
or
analysis
supporting
its
decision
to
add
the
substance
to
subpart
E
of
this
part
under
§
721.170
and
has
concluded
that
the
substance
does
not
meet
the
criteria
under
§
721.170(
b).

(
5)
For
a
substance
added
to
subpart
E
of
this
part
under
§
721.160,
EPA
has
examined
new
information,
or
has
reexamined
the
test
data
or
other
information
or
analysis
supporting
its
finding
under
section
5(
e)(
1)(
A)(
ii)(
I)
of
the
Act,
and
has
concluded
that
a
rational
basis
no
longer
exists
for
the
findings
that
activities
involving
the
substance
may
present
an
unreasonable
risk
of
injury
to
human
health
or
the
environment
required
under
section
5(
e)(
1)(
A)
of
the
Act.

(
6)
For
a
substance
added
to
subpart
E
of
this
part
under
§
721.160,
certain
activities
involving
the
substance
have
been
designated
as
significant
new
uses
pending
the
completion
of
testing,
and
adequate
test
data
developed
in
accordance
with
applicable
procedures
and
criteria
have
been
submitted
to
EPA.

(
b)
Procedures
for
limitation
or
revocation.
Modification
or
revocation
of
significant
new
use
notification
requirements
for
a
substance
that
has
been
added
to
subpart
E
of
this
part
using
the
procedures
described
under
§
721.160
or
§
721.170
may
occur
either
at
EPA's
initiative
or
in
response
to
a
written
request.

(
1)
Any
affected
person
may
request
modification
or
revocation
of
significant
new
use
notification
requirements
for
a
substance
that
has
been
added
to
subpart
E
of
this
part
using
the
procedures
described
in
§
721.160
or
§
721.170
by
writing
to
the
Director
of
the
Office
of
Pollution
Prevention
and
Toxics
and
stating
the
basis
for
such
request.
All
requests
should
be
sent
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:
Request
to
amend
significant
new
use
rule.
The
request
must
be
accompanied
by
information
sufficient
to
support
the
request.

(
2)
The
Director
of
the
Office
of
Pollution
Prevention
and
Toxics
will
consider
the
request,
make
a
determination
whether
to
initiate
rulemaking
to
modify
the
requirements,
and
notify
the
requester
of
that
determination
by
certified
letter.
If
the
request
is
denied,
the
letter
will
explain
why
EPA
has
concluded
that
the
significant
new
use
notification
requirements
for
that
substance
should
remain
in
effect.

(
3)
If
EPA
concludes
that
significant
new
use
notification
requirements
for
a
substance
should
be
limited
or
revoked,
EPA
will
propose
the
changes
in
the
Federal
Register,
briefly
describe
the
grounds
for
the
action,
and
provide
interested
parties
an
opportunity
to
comment.

[
54
FR
31314,
July
27,
1989,
as
amended
at
58
FR
34204,
June
23,
1993;
60
FR
34464,
July
3,
1995]

SUBPART
E
­
SIGNIFICANT
NEW
USES
FOR
SPECIFIC
CHEMICAL
SUBSTANCES
[
40
CFR
721.225
through
40
CFR
721.9973
not
included
here
for
reasons
of
length]