Document ID: EPA-HQ-OPPT-2003-0065-0002
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-11-25T05:00Z

Supporting
Statement
for
a
Request
for
OMB
Review
under
The
Paperwork
Reduction
Act
1
IDENTIFICATION
OF
THE
INFORMATION
COLLECTION
1(
a)
Title
of
the
Information
Collection
TITLE:
Premanufacture
Review
Reporting
and
Exemption
Requirements
for
New
Chemical
Substances
and
Significant
New
Use
Reporting
Requirements
for
Chemical
Substances
EPA
ICR
No:
574.12
OMB
Control
No.:
2070­
0012
1(
b)
Short
Characterization
The
Environmental
Protection
Agency
(
EPA)
administers
the
New
Chemicals
Program
under
section
5
of
the
Toxic
Substances
Control
Act
(
TSCA).
TSCA
section
5
requires
that
any
person
who
proposes
to
manufacture
or
import
a
"
new
chemical,"
(
i.
e,
a
chemical
not
listed
on
the
TSCA
§
8(
b)
Inventory),
must
provide
a
premanufacture
notice
(
PMN)
to
EPA
at
least
90
days
prior
to
commencing
manufacture
or
import
of
that
chemical.
Similarly,
TSCA
section
5
requires
a
significant
new
use
notice
(
SNUN)
from
any
person
who
proposes
to
manufacture,
import
or
process
a
chemical
for
a
use
that
is
determined
to
be
a
"
significant
new
use."
EPA
considers
genetically
engineered
microorganisms
to
be
chemical
substances
for
purposes
of
the
notification
requirements
found
in
TSCA
section
5;
the
90­
day
notice
for
microorganisms
is
a
Microbial
Commercial
Activity
Notice
(
MCAN).

Furthermore,
TSCA
section
5
authorizes
EPA
to
regulate
the
manufacture,
processing,
distribution
in
commerce,
use
or
disposal
of
new
chemical
substances.
Using
the
notice
information
submitted
to
the
Agency,
EPA
evaluates
the
health
and
environmental
effects
of
new
chemical
substances.
On
the
basis
of
its
review,
EPA
may
take
regulatory
action
with
respect
to
the
manufacture
or
importation
of
a
new
chemical
substance
or
with
respect
to
a
substance's
proposed
new
use.
If
EPA
takes
no
action
within
the
90­
day
review
period,
the
submitter
is
free
to
manufacture
or
import
the
new
substance,
or
to
manufacture,
import
or
process
the
substance
for
a
new
use.
EPA
requires
that
the
submitter
inform
EPA
when
non­
exempt
commercial
manufacture,
processing
or
importation
of
the
substance
in
question
actually
begins
by
submitting
a
Notice
of
Commencement.

This
information
collection
request
addresses
the
TSCA
section
5
reporting
and
recordkeeping
requirements
associated
with
the
new
chemicals
review
and
regulatory
program,
as
briefly
outlined
above.
2
2
NEED
FOR
AND
USE
OF
THE
COLLECTION
2(
a)
Need/
Authority
for
the
Collection
TSCA
section
5(
a)(
1),
15
U.
S.
C.
2604,
requires
manufacturers
and
importers
of
new
chemical
substances
to
submit
to
the
Administrator
of
EPA
a
premanufacture
notice
(
PMN)
of
intent
to
manufacture
or
import
a
new
chemical
substance
at
least
90
days
before
manufacture
or
import
begins.
TSCA
section
5(
a)(
1)
also
requires
notification
from
any
person
who
proposes
to
manufacture,
import
or
process
a
chemical
substance
for
a
use
that
EPA
has
by
rule
determined
to
be
a
significant
new
use.
The
notice
must
include,
insofar
as
known
to
or
is
reasonably
ascertainable
by
the
submitter,
information
described
in
TSCA
section
8(
a)(
2)
(
e.
g.,
chemical
identity,
use
and
exposure
data),
plus
test
data
and
descriptions
of
other
data
related
to
the
effects
on
health
and
the
environment
of
the
manufacture,
processing,
use,
distribution
in
commerce
and
disposal
of
the
new
chemical
substance.
EPA
reviews
the
information
to
evaluate
the
health
and
environmental
effects
of
the
new
chemical
substance.
On
the
basis
of
the
review,
EPA
can
take
further
regulatory
action
under
TSCA
sections
5(
e)
and
5(
f),
if
warranted.
If
EPA
takes
no
action
at
the
end
of
90
days,
the
submitter
is
free
to
manufacture
or
import
the
new
chemical
substance.

TSCA
section
5,
as
interpreted
in
EPA's
Microbial
Products
of
Biotechnology;
Final
Regulation
Under
the
Toxic
Substances
Control
Act;
Final
rule
published
at
62
FR
17910
(
April
11,
1997),
authorizes
EPA
to
regulate
"
new"
genetically
engineered
microorganisms.
According
to
the
1997
final
rule,
"
new"
microorganisms
are
those
that,
through
deliberate
human
intervention,
contain
genetic
material
from
dissimilar
source
organisms.
For
the
purposes
of
this
policy,
all
microorganisms
of
different
genera
(
intergeneric)
are
considered
"
new."
Manufacturers
and
importers
of
these
new
microorganisms
must
submit
to
EPA
a
microbial
commercial
activity
notice
(
MCAN)
at
least
90
days
before
manufacturing
or
import
begins.
These
microorganisms
are
subject
to
the
same
potential
regulatory
controls
as
new
chemical
substances.

Significant
New
Use
Rules
(
SNURs)
are
authorized
under
TSCA
section
5(
a)(
2).
Regulations
providing
details
on
EPA's
SNUR
authority
were
promulgated
at
40
CFR
Part
721
on
July
27,
1989
and
at
40
CFR
Part
725
subparts
H­
K
on
April
11,
1997.
EPA
uses
this
authority
to
take
follow
up
action
on
new
or
existing
chemicals
that
may
not
present
an
unreasonable
risk
in
their
original
uses
but
may
present
an
unreasonable
risk
should
other
uses
occur
that
may
result
in
different
and/
or
higher
exposures
to
human
beings
or
the
environment.
EPA
determines
that
a
new
use
is
significant
by
examining
the
specific
circumstances
of
each
case.
A
SNUR
allows
EPA
to
receive
reporting
on
such
uses,
review
them
and,
if
necessary,
regulate
the
uses
before
they
occur.
Once
a
use
is
determined
to
be
a
"
significant
new
use,"
a
person
must
submit
a
SNUN
to
EPA
at
least
90
days
before
that
person
may
manufacture,
process
or
import
a
chemical
substance
for
that
use.
The
same
reporting
requirements
that
apply
to
PMNs
also
apply
to
SNUNs,
and
EPA
has
the
same
authorities
under
TSCA
section
5(
e)
and
5(
f)
to
regulate
the
SNUR
chemical
during
the
notice
review
period.
3
TSCA
section
5(
d)(
1)(
B)
requires
notices
to
include
all
test
data
in
the
submitter's
possession
or
control
and
TSCA
section
5(
d)(
1)(
C)
requires
submitters
to
provide
other
data
on
environmental
or
health
effects
that
are
known
to
or
reasonably
ascertainable
by
the
submitter.
These
requirements
are
described
in
40
CFR
720.50.

TSCA
section
5(
e)
authorizes
EPA
to
regulate
the
manufacture,
processing,
distribution
in
commerce,
use
or
disposal
of
a
new
substance
pending
development
of
data
sufficient
to
evaluate
the
health
and
environmental
effects
of
the
substance.
EPA
may
take
action
under
TSCA
section
5(
e)
if
the
Agency
determines
that
the
information
available
is
insufficient
to
evaluate
the
substance
and
that
the
substance
either
(
1)
may
present
an
unreasonable
risk
of
injury
to
health
or
the
environment
or
(
2)
will
be
produced
in
substantial
quantities
and
there
may
be
significant
or
substantial
human
or
environmental
exposure
to
the
chemical.

Under
TSCA
section
5(
f),
EPA
may
regulate
a
new
chemical
substance
if
there
is
a
reasonable
basis
to
conclude
that
the
manufacture,
processing,
distribution
in
commerce,
use
or
disposal
of
the
new
substance
will
present
an
unreasonable
risk
of
injury
to
health
or
the
environment
before
EPA
can
promulgate
a
rule
to
regulate
the
chemical
under
TSCA
section
6.

EPA
may
also
grant
certain
exemptions
from
the
PMN,
SNUN,
and
MCAN
requirements
of
TSCA
section
5,
including
the
following.
These
exemption
rules
reduce
reporting
requirements,
thereby
providing
relief
to
submitters
from
the
burdens
of
the
full
PMN
reporting
requirements.

(
i)
Test­
Marketing
Exemption
(
TME)

Under
TSCA
section
5(
h)(
1),
persons
may
apply
for
an
exemption
from
the
requirements
of
TSCA
section
5
for
test­
marketing
purposes.
EPA
may
grant
the
exemption
if
it
finds
that
the
testmarketing
activities
described
by
the
applicant
will
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment.
The
applicant
must
provide
the
information
necessary
to
make
this
finding
and
EPA
must
grant
or
deny
the
exemption
within
45
days.
If
EPA
grants
the
exemption,
it
may
impose
appropriate
restrictions
on
the
test­
marketing
activities.
See
40
CFR
720.38
and
725.370.

(
ii)
Research
and
Development
Exemption
(
R&
D)

TSCA
section
5(
h)(
3)
exempts
from
PMN
reporting
small
quantities
of
chemical
substances
manufactured
or
imported
only
for
research
and
development
purposes.
Persons
using
this
exemption
must
have
their
research
overseen
by
a
technically
qualified
individual
and
must
notify
any
person
involved
in
the
research
of
any
risk.
See
40
CFR
720.36.
Small
quantities
of
genetically
modified
microorganisms
manufactured
solely
for
research
and
developmental
purposes
are
also
exempt
when
additional
criteria
are
met
as
described
in
40
CFR
725.235,
activities
conducted
inside
a
structure,
and
40
CFR
725.238
and
239,
activities
conducted
outside
a
structure.
4
(
iii)
TSCA
Section
5(
h)(
4)
Exemptions
TSCA
section
5(
h)(
4)
authorizes
EPA
to
exempt
any
person
from
the
provisions
of
TSCA
section
5
if
EPA
determines
that
the
chemical
substance
will
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment
when
manufactured,
processed,
distributed,
used
or
disposed
of
under
the
exemption.
To
date
EPA
has
promulgated
four
rules
under
this
section
for
chemical
substances
and
three
exemptions
for
microbial
products
of
biotechnology:

o
Low
Volume
Exemption
(
LVE)
­
This
exemption
applies
to
substances
manufactured
in
quantities
of
10,000
kilograms
or
less
per
year;
submitters
may
request
that
EPA
evaluate
their
exemption
at
a
lower
production
volume
level,
to
which
the
submitter
would
be
legally
bound.
See
40
CFR
723.50.

o
Low
Release/
Low
Exposure
(
LoREX)
­
This
exemption
applies
to
certain
chemical
substances
that
meet
strict
human
exposure
and
environmental
release
criteria
to
ensure
that
these
substances
will
not
present
an
unreasonable
risk.
See
40
CFR
723.50.

o
Polymer
Exemption
­
This
exemption
applies
to
polymers
that
comply
with
certain
chemical
characterizations
and
which
therefore
will
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment.
See
40
CFR
723.250.

o
Instant
Photographic
Film
Articles
Exemption
­
This
exemption
applies
to
chemical
substances
used
in
or
for
the
manufacture
or
processing
of
instant
photographic
and
peelapart
film
articles.
See
40
CFR
723.175.

o
TSCA
Experimental
Release
Application
(
TERA)
­
This
exemption
applies
to
research
and
development
activities
which
result
in
intentional
environmental
releases
of
microorganisms.
EPA
may
grant
the
exemption
if
it
finds
that
the
activities
described
by
the
applicant
will
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment.
The
applicant
must
provide
the
information
necessary
to
make
this
finding
and
EPA
must
grant
or
deny
the
exemption
within
60
days.
If
EPA
grants
the
exemption,
it
may
impose
appropriate
restrictions
on
the
activities
described
in
the
notice.
See
40
CFR
725.250.

o
Tier
I
Exemption­
This
exemption
applies
to
certain
microorganisms
subject
to
physical
containment
and
control
technologies.
EPA
has
developed
specific
criteria
for
the
host
microorganism,
introduced
genetic
material,
and
containment
technology
to
ensure
that
the
microorganism
will
not
present
an
unreasonable
risk.
See
40
CFR
725.400.

o
Tier
II
Exemption
­
This
exemption
applies
to
the
same
microorganisms
subject
to
a
Tier
I
exemption
without
specified
physical
containment
and
control
technologies.
EPA
may
grant
the
exemption
if
it
finds
that
the
physical
containment
and
control
technologies
activities
described
by
the
applicant
will
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment.
The
applicant
must
provide
the
information
necessary
to
make
this
finding
and
5
EPA
must
grant
or
deny
the
exemption
within
45
days.
If
EPA
grants
the
exemption,
it
may
impose
appropriate
restrictions
on
the
activities
described
in
the
notice.
See
40
CFR
725.428.

Finally,
under
TSCA
section
26(
b),
EPA
requires
manufacturers,
importers
and
processors
to
pay
fees
for
PMNs,
MCANs,
certain
PMN
exemption
applications
and
notices,
and
Significant
New
Use
Notices
(
SNUNs)
submitted
under
TSCA
sections
5(
a)
and
(
h)
to
help
defray
the
cost
of
administering
TSCA.
EPA
must
take
into
account
a
submitter's
ability
to
pay
the
fee
and
the
cost
of
reviewing
the
submitted
data.
TSCA
section
26(
b)
provides
for
maximum
fees
of
$
100
for
small
business
concerns
and
$
2,500
for
other
PMN
submitters.
The
rule
requires
a
limited
amount
of
additional
information
to
be
submitted
with
the
PMN
or
MCAN
form.
See
40
CFR
700.

Copies
of
TSCA
section
5
and
of
40
CFR
Parts
700,
720,
721
(
excepting
Subpart
E),
723
and
725
are
attached.
40
CFR
Part
721,
Subpart
E,
Significant
New
Uses
for
Specific
Chemical
Substances,
which
consumes
nearly
200
pages
in
the
Code
of
Federal
Regulations,
is
not
attached
due
to
its
volume.

2(
b)
Use/
Users
of
the
Data
TSCA
gives
EPA
authority
to
regulate
the
manufacture
or
import
of
chemical
substances
that
may
present
an
unreasonable
risk
of
injury
to
health
or
the
environment
from
their
manufacture,
processing,
distribution
in
commerce,
use
or
disposal.
To
make
a
reasoned
evaluation
of
the
risk
associated
with
such
chemicals,
EPA
needs
data
on
each
chemical's
structure
and
properties,
manufacturing
process,
worker
exposure,
environmental
release,
production
volume,
potential
industrial,
commercial,
and
consumer
use,
and
test
data
related
to
the
substance.
EPA
needs
sufficient
information
so
as
to
identify
substances
with
analogous
chemical
structures
and
properties,
with
similar
manufacturing
processes
and
with
similar
uses.
The
Agency
reviews
available
data
to
evaluate
the
toxicity
of
the
chemical
and
the
potential
risk
resulting
from
human
and
environmental
exposure
to
the
substance.
If
EPA
is
considering
regulation
of
the
chemical,
the
Agency
also
evaluates
the
benefits
of
the
substance
to
determine
what
regulatory
action,
if
any,
to
take.

On
the
basis
of
its
initial
review,
EPA
eliminates
the
vast
majority
of
new
chemical
substances
from
further
review.
EPA
may
(
1)
identify
a
number
of
chemical
substances
for
more
detailed
evaluation
for
which
additional
exposure
or
toxicological
data
may
be
needed;
(
2)
identify
some
substances
for
follow­
up
reporting
on
their
commercial
development;
and
(
3)
select
a
limited
number
for
immediate
regulatory
action.
Through
this
process
EPA
minimizes
the
burden
on
both
the
Agency
and
industry
by
requiring
detailed
information
only
on
those
substances
that
may
present
unreasonable
risk
or
injury
to
health
or
the
environment.

A
chemical
is
considered
to
be
a
"
new"
chemical
if
it
is
not
listed
in
the
TSCA
section
8(
b)
Inventory
of
chemicals
manufactured
or
processed
in
the
United
States.
The
Inventory
includes
both
public
and
confidential
information.
Chemicals
appear
in
the
public
portion
of
the
Inventory
by
name
if
the
company
manufacturing
the
chemical
does
not
claim
the
name
of
the
chemical
to
be
confidential.
Chemicals
whose
names
are
claimed
confidential
are
identified
in
the
public
portion
of
6
the
Inventory
by
an
accession
number
and
a
generic
name.
The
specific
chemical
name
of
a
confidential
chemical
appears
only
in
the
confidential
portion
of
the
Inventory,
which
is
not
available
to
the
public.

A
company
that
intends
to
manufacture
or
import
a
chemical
substance
that
does
not
appear
by
a
specific
name
in
the
public
portion
of
the
Inventory
may
inquire
of
EPA
whether
the
substance
is
included
in
the
confidential
portion
of
the
Inventory
(
i.
e.,
to
determine
whether
the
substance
would
be
considered
new
and
therefore
subject
to
the
TSCA
section
5
notice
requirements).
EPA
will
respond
to
such
an
inquiry
only
if
the
Agency
determines
that
the
company
has
a
"
bona
fide"
intent
to
manufacture
or
import
the
substance.
Reporting
provisions
found
at
40
CFR
720.25
or
40
CFR
725.15
require
additional
information
from
a
submitter
so
as
to
encourage
the
submission
only
of
bona
fides
that
reflect
serious
intent.

EPA
requires
submitters
of
PMNs
and
bona
fides
to
provide
a
specific
chemical
identity
for
the
substance
for
which
a
notice
is
made,
based
on
a
Chemical
Abstracts
(
CA)
Index
name
or
a
CA
preferred
name.
This
requirement
reduces
delays
caused
by
incorrect
or
ambiguous
chemical
identity,
expedites
the
Agency's
ability
to
perform
Inventory
searches
and
saves
Agency
resources
spent
on
naming
submitters'
substances.

Since
a
company's
initial
intention
to
manufacture
or
import
a
substance
or
microorganism
may
change
after
making
a
PMN
or
MCAN
submission,
EPA
requires
companies
to
notify
the
Agency
when
manufacture
or
importation
begins
by
submitting
a
Notice
of
Commencement
(
NOC)
(
see
40
CFR
720.102
and
725.190).
Submitters
specify
in
the
NOC
whether
commencement
occurred
via
manufacture
or
importation
and
the
address
of
the
site(
s)
of
first
manufacture.
This
information
is
essential
to
the
Agency
as
a
compliance
mechanism.
The
information
requirements
for
NOC
reporting
also
assist
in
identifying
cases
in
which
submitters
have
mistakenly
reported
the
wrong
case
number
in
the
NOC,
or
erroneously
listed
a
substance
that
is
very
different
from
that
which
they
intended
to
commence
manufacture.
In
addition,
the
reporting
requirements
provide
submitters
an
opportunity
to
update
information
that
may
no
longer
be
correct
or
appropriate
as
reported
in
the
notice.
Finally,
the
Notice
of
Commencement
results
in
EPA
adding
that
substance
to
the
TSCA
Inventory.

EPA
requires
the
use
of
a
specific
form
(
EPA
Form
No.
7710­
56)
for
Notices
of
Commencement
of
chemical
substances.
The
form
is
not
required
for
microorganisms.
The
use
of
a
standard
form
leads
to
greater
efficiency
by
assisting
EPA
in
readily
identifying
the
type
of
notice,
providing
uniformity
in
recording
responses
in
EPA
databases,
and
providing
manufacturers
a
format
to
assure
that
important
information
is
not
inadvertently
omitted
in
their
submissions.
Before
EPA
required
the
use
of
a
standard
NOC
form,
a
significant
number
of
NOCs
created
difficulty
because
they
were
not
recognized
by
the
Agency
as
a
NOC
or
they
contained
confusing,
missing
or
unnecessary
information.
These
problems
resulted
in
a
waste
of
time
and
resources
for
both
submitters
and
EPA
personnel
who
must
prepare
or
review
these
notices.
The
required
use
of
a
standard
reporting
form
also
reduces
EPA
processing
time
for
NOCs.
7
To
facilitate
EPA's
ability
to
regulate
new
substances
efficiently
and
expeditiously,
EPA
considers
essential
the
capability
to
promulgate
Significant
New
Use
Rules
(
SNURs)
for
new
chemical
substances
without
first
issuing
a
TSCA
section
5(
e)
consent
order
for
the
substance.
Since
the
reporting
requirements
and
provisions
of
a
non­
section
5(
e)
SNUR
apply
also
to
the
original
PMN
submitter,
only
one
EPA
action
is
required
instead
of
two;
fewer
EPA
resources
are
necessary
and
efficiency
is
gained
as
a
non­
section
5(
e)
SNUR
is
more
efficient
than
a
combination
of
consent
order
and
SNUR
to
regulate
new
chemical
substances.

EPA
publishes
in
the
Federal
Register
information
summarizing
the
content
of
each
notice,
including
the
generic
class
of
the
chemical
substance,
the
proposed
uses
and
certain
test
data
submitted
with
the
notice,
as
required
by
TSCA
section
5(
d)(
2).
EPA
publishes
at
the
beginning
of
each
month
a
list
of
PMN
notices
and
polymer
exemption
applications
that
have
been
received,
those
that
are
still
under
review
and
those
for
which
the
review
period
has
ended.
This
publication
is
mandated
by
TSCA
section
5(
d)(
3).
TSCA
also
requires
EPA
to
publish
a
notice
of
receipt
of
a
testmarketing
application
so
that
the
public
may
comment,
and
another
notice
stating
whether
the
application
was
granted
or
denied.

Periodically
EPA
compiles
certain
information
such
as
the
number
of
notices
submitted
and
their
disposition.
This
information
may
be
published
in
various
EPA
documents
or
other
publications,
e.
g.,
Chemicals­
in­
Progress
Bulletin,
support
documents
for
TSCA
section
5
rulemakings.

The
recordkeeping
requirements
for
PMNs,
MCANs,
and
SNURs
are
necessary
for
EPA
enforcement
purposes.
As
part
of
its
enforcement
program,
EPA
conducts
inspections
to
review
the
records
of
TSCA
section
5
submitters
to
ensure
that
the
information
submitted
in
the
notice
was
correct,
that
the
submitter
did
not
begin
manufacture,
importation
or
processing
before
the
review
period
expired,
and
that,
for
PMN
chemicals
or
MCAN
microorganisms,
the
notice
of
commencement
was
submitted
when
manufacture
or
import
began.
The
Agency
also
inspects
manufacturers'
or
processors'
chemical
substances
subject
to
SNURs
to
ensure
that
they
are
not
doing
so
in
violation
of
the
SNUR.
The
recordkeeping
requirements
for
exemptions
are
necessary
for
enforcement
purposes
as
well.
EPA
conducts
inspections
to
ensure
that
the
information
submitted
in
the
aforementioned
applications
is
true
and
that
the
person
holding
the
exemption
is
complying
with
any
restrictions
EPA
imposed
when
it
granted
the
exemption.

Users
of
these
data
are
EPA
employees
located
primarily
in
the
Office
of
Pollution
Prevention
and
Toxics
(
OPPT),
within
the
Office
of
Prevention,
Pesticides
and
Toxic
Substances,
and
in
the
Office
of
Enforcement
and
Compliance
Assurance
(
OECA),
and
Core
TSCA
Regional
Coordinator
Inspectors.
In
particular,
staff
of
the
New
Chemicals
Branch
of
the
Chemical
Control
Division
within
OPPT
use
this
information
to
review
and
evaluate
the
health
and
environmental
effects
of
new
chemicals
and
significant
new
uses
of
chemicals,
and
to
recommend
and
implement
regulatory
actions
if
warranted.
OPPTS
employees
in
the
Regional
Offices
and
OECA
employees
in
Headquarters
and
in
the
Regions
use
TSCA
section
5
data
for
compliance
monitoring
and
enforcement
purposes.
8
3
NON­
DUPLICATION,
CONSULTATIONS
AND
OTHER
COLLECTION
CRITERIA
3(
a)
Non­
Duplication
EPA
is
the
only
federal
agency
that
regularly
collects
information
on
new
chemical
substances
used
for
purely
industrial
applications.
(
In
instances
where
chemical
substances
with
industrial
applications
also
have
drug
or
cosmetic
uses,
the
Food
and
Drug
Administration
would
have
concurrent
jurisdiction.)
Therefore,
the
information
submitters
provide
in
a
PMN
or
MCAN
cannot
be
obtained
elsewhere.
However,
data
previously
submitted
to
EPA
need
not
be
resubmitted
if
the
following
conditions
are
met:
the
data
was
submitted
with
no
claims
of
confidentiality
and
the
PMN
(
or
other
TSCA
section
5
notice)
identifies
the
office
or
person
to
whom
the
data
were
submitted
and
the
date
of
the
submission.

3(
b)
Public
Notice
Required
Prior
to
ICR
Submission
to
OMB
Prior
to
submission
to
OMB,
this
ICR
will
be
made
available
to
the
public
for
comment
through
a
Federal
Register
notice.
The
public
will
have
60
days
to
provide
comments.
The
comments
received
will
be
given
consideration
when
completing
the
supporting
statement
that
is
submitted
to
OMB.

3(
c)
Consultations
Since
1983,
EPA
has
received
hundreds
of
public
comments
from
industry,
public
interest
groups,
trade
unions
and
other
governmental
agencies
on
various
aspects
of
the
TSCA
section
5
rules.
Early
in
the
Program,
persons
commented
on
the
final
PMN
rule
and
notice
form,
and
the
clarification
of
polymers
and
revisions
to
four
stayed
provisions
of
the
PMN
regulation,
particularly
the
R&
D
exemption.
Industry
comments
to
the
PMN
rule
led
to
staying
of
various
sections
of
the
PMN
rule
and
clarification
of
other
sections.
All
these
issues
were
resolved
with
the
issuance
of
final
revisions
in
April
1986.
The
Agency
reviewed
and
modified
its
standard
recordkeeping
requirements
associated
with
various
SNUR
reporting
triggers
when
issuing
the
final
General
Provisions
for
New
Chemical
Follow­
up
(
Generic
SNUR)
in
July
1989.
These
more
flexible
recordkeeping
provisions
resulted
from
comments
received
by
the
Agency
during
public
meetings
with
representatives
of
the
Conservation
Foundation,
the
Natural
Resources
Defense
Council,
the
Chemical
Manufacturers
Association,
the
Chemical
Specialties
Manufacturers
Association,
the
Synthetic
Organic
Chemicals
Manufacturer's
Association
and
individual
chemical
companies.
In
1993
and
1995,
EPA
held
several
public
meetings
for
the
general
public
to
discuss
in
detail
the
four
PMN
Rule
Amendments
that
were
published
in
March
1995.
In
December
1989
and
June
1993
the
biotechnology
rule
was
discussed
in
public
meetings
of
the
Biotechnology
Science
Advisory
Committee
before
the
final
biotechnology
rule
was
published
in
1997.

In
addition,
EPA
has
held
various
public
meetings
with
interested
parties.
In
June
1983,
EPA
officials
held
a
two­
day
seminar
attended
by
450
industry
representatives.
Discussions
centered
on
PMN
review
procedures
and
clarification
of
PMN
requirements.
EPA
has
also
held
several
seminars
9
that
included
sessions
on
TSCA
section
5
in
February
and
May
1986
and
May
1987,
and
participated
in
industry­
sponsored
seminars
(
e.
g.,
American
Chemistry
Council
and
the
Synthetic
Organic
Chemicals
Manufacturers
Association,
"
Living
With
TSCA"
seminar
series
in
April
1989,
October
1990,
October
1992,
April
1994,
October
1995,
April
1997,
November
1998,
March
2001,
March
2002,
and
April
2003).

EPA
has
arranged
or
actively
participated
in
a
number
of
scientific
meetings
and
symposia
of
immediate
relevance
to
the
PMN
program.
Among
the
programs
for
which
EPA
has
made
substantial
contributions
(
often
in
collaboration
with
others)
are
the
following:
"
Safer
Chemicals
Through
Molecular
Design,"
EPA­
sponsored,
Crystal
City,
VA,
1983;
"
SAR
and
Toxicity
Assessment,"
American
Chemical
Society,
Gaithersburg,
MD,
1984;
workshop
on
"
The
Application
of
the
Techniques
of
Computational
Biological
Chemistry
to
Environmental
Problems,"
EPA
Office
of
Research
and
Development,
Research
Triangle
Park,
NC,
1984;
symposium
on
"
Assessment
for
Potential
Developmental
Toxicants,"
EPA­
sponsored,
at
the
1985
Teratology
Society
Meeting
in
Calloway
Gardens,
GA.

For
several
years
EPA
has
been
engaged
in
a
continuing
series
of
joint
EPA/
industry/
public
interest
group
meetings
to
facilitate
the
identification
and
exchange
of
critical
information
or
to
arrange
for
the
generation
of
data
that
otherwise
are
not
available
to
the
PMN
program.
These
meetings
have
involved
issues
of
hazard
assessment
(
health
and
environmental),
exposure
analysis
(
occupational,
environmental,
consumer)
and
economics.
Industry
groups
that
have
established
an
ongoing
dialogue
with
EPA
over
the
past
several
years
include
DETO/
ETAD
(
an
association
of
dyestuff
manufacturers),
acrylate
manufacturers
and
pyridine
manufacturers/
users.
A
workshop
in
April
1990
discussed
the
chemical
category
of
epoxides
with
the
Chemical
Manufacturers
Association
and
other
industry,
environmental
and
trade
union
organization
representatives.

Finally,
when
proposing
to
previously
renew
this
ICR,
EPA
provided
a
60­
day
public
notice
and
comment
period
that
ended
on
November
12
,
1999
(
64
FR
49484,
September
13,
1999).
The
Agency
received
no
comments
on
that
request
to
renew
the
ICR
or
on
the
ICR
itself.

3(
d)
Effects
of
Less
Frequent
Collection
The
frequency
of
the
submission
of
information
under
TSCA
section
5
is
not
under
the
Agency's
control.
Manufacturers
of
new
chemical
substances
typically
submit
a
PMN,
SNUN,
or
MCAN
at
least
90
days
prior
to
anticipated
manufacturing
or
distribution
of
the
substance
for
nonexempt
commercial
use.
Submission
of
information
thus
is
on
an
as­
needed,
on­
occasion
basis,
initiated
by
respondents.
Subsequent
reporting
would
only
be
required
if
EPA
determined
that
a
specific
use
of
a
substance
constituted
a
significant
new
use.
Less
frequent
collection
would
mean
respondents
not
being
required
to
submit
data
at
all.
However,
without
such
data,
EPA
would
be
unable
to
administer
the
new
chemical
review
requirements
found
in
TSCA
and
would
be
unable
to
carry
out
its
mandate
to
protect
the
public
from
unreasonable
risks
to
health
and
the
environment.
10
3(
e)
General
Guidelines
This
collection
of
information
is
consistent
with
all
OMB
guidelines
under
5
CFR
1320.6
except
with
respect
to
the
maintenance
of
records
by
respondents
for
more
than
three
years.
EPA
believes
a
five­
year
recordkeeping
requirement
is
needed
to
carry
out
an
effective
program.
The
fiveyear
recordkeeping
requirement
is
consistent
with
the
five­
year
statute
of
limitations
under
28
U.
S.
C.
§
2462
held
applicable
to
all
EPA
enforcement
actions,
including
administrative
proceedings
under
TSCA.
3M
Company
v.
Carol
Browner
and
EPA,
17F.
3d
(
DC
Cir.
1994)
In
addition,
a
five­
year
retention
period
comports
with
certain
recordkeeping
requirements
imposed
by
the
Occupational
Safety
and
Health
Administration
and
helps
to
keep
these
requirements
consistent
with
one
another,
thereby
avoiding
different
reporting
obligations.
Therefore,
the
Agency
requires
respondents
to
retain
records
for
more
than
three
years.

3(
f)
Confidentiality
Much
of
the
required
premanufacture
information
may
be
considered
by
the
submitter
to
be
a
trade
secret,
proprietary,
or
"
confidential
business
information"
(
CBI).
However,
TSCA
mandates
that
EPA
require
the
submission
of
such
information
because
it
is
essential
for
providing
a
basis
to
determine
unreasonable
risk.
EPA
cannot
draw
conclusions
or
make
assumptions
concerning
toxicological
effects
and
potential
risks
without
examining
physicochemical
structure,
methods
of
production,
byproducts,
potential
uses,
exposure
data,
etc.
The
Agency
is
required
by
TSCA
§
5(
d)(
2)
to
publish
a
Federal
Register
notice
that
identifies
the
chemical
substance,
lists
its
uses
or
intended
uses
and
describes
test
data.
Congress
included
these
provisions
to
allow
active
public
participation
in
the
review
process.

The
Agency's
policies
allow
public
involvement
while
preserving
confidentiality.
TSCA
section
14(
a)
prohibits,
except
in
limited
circumstances,
the
disclosure
of
trade
secret
information.
TSCA
section
14(
d)
allows
disclosure
of
health
and
safety
studies,
including
underlying
data,
unless
these
studies
disclose
confidential
process
or
mixture
information.
Under
40
CFR
720.85
and
720.87(
See
also
40
CFR
Part
2),
when
the
specific
chemical
identity
or
use
data
are
claimed
confidential,
the
Agency
requires
the
submitter
to
provide
generic
descriptions
for
inclusion
in
Federal
Register
notices
and
the
public
file.
Additionally,
the
submitter
must
provide
a
"
sanitized"
copy
of
all
health
and
environmental
effects
data,
with
confidential
information
deleted,
for
placement
in
the
public
docket.
Within
the
Agency,
only
personnel
with
the
required
clearance
may
handle
CBI.

Based
on
its
experience,
EPA
expects
that
most
information
included
in
the
notices
is
CBI.
EPA
has
developed
an
elaborate
system
to
prevent
unauthorized
disclosure
of
CBI.
This
system
includes
procedures
for
logging
material
in
and
out
of
the
Confidential
Business
Information
Center
(
CBIC)
at
EPA
headquarters
and
procedures
for
photocopying
and
transmitting
CBI.
These
procedures
apply
to
CBI
submitted
by
manufacturers
as
well
as
CBI
generated
by
EPA
staff
in
the
course
of
their
review.
Access
to
CBI
is
restricted
to
persons
who
need
the
information
for
their
work.
No
one
is
allowed
access
to
CBI
without
first
undergoing
instruction
on
procedures
for
handling
CBI.
Special
procedures
have
been
instituted
to
restrict
access
to
computerized
CBI.
These
11
procedures
are
detailed
in
the
"
TSCA
Confidential
Business
Information
Security
Manual,"
April
1995.
EPA
believes
these
procedures
protect
confidential
information
while
providing
the
public
with
as
much
information
as
possible.

3(
g)
Sensitive
Questions
Information
requirements
under
TSCA
section
5
do
not
include
questions
of
a
sensitive
nature.

4
THE
RESPONDENTS
AND
THE
INFORMATION
REQUESTED
4(
a)
Respondents/
NAIC
Codes
This
information
collection
affects
companies
that
manufacture,
process
or
import
chemical
substances.
These
companies
are
typically
found
in
NAIC
major
groups
325
(
Chemical
Manufacture)
and
324
(
Petroleum
and
Coal
Products).

4(
b)
Information
Requested
(
I)
Data
Items
­
Reporting
Requirements
Premanufacture
Notices
­
Premanufacture
notices
required
by
TSCA
section
5
must
include
certain
information
to
the
extent
known
to
or
is
reasonably
ascertainable
by
the
submitter.
This
information
is
defined
in
TSCA
section
8(
a)(
2)
and
40
CFR
720.45.
Specific
information
includes
the
following:

­
the
common
or
trade
name,
chemical
identity
and
molecular
structure
of
the
chemical
in
question;

­
the
categories
or
proposed
categories
of
use
of
the
chemical;

­
an
estimate
of
the
total
amount
of
such
chemical
to
be
manufactured
or
processed,
including
the
amount
to
be
manufactured
or
processed
for
each
use
category;

­
a
description
of
the
byproducts
resulting
from
the
manufacture,
processing,
use
or
disposal
of
the
chemical;

­
an
estimate
of
the
total
number
of
individuals
who
will
be
exposed
to
the
chemical
in
their
places
of
employment,
and
the
duration
of
such
exposure;
and
­
the
manner
or
method
of
the
disposal
of
the
chemical.
12
In
addition,
the
submitter
must
provide
any
test
data
in
the
submitter's
possession
that
indicates
the
environmental
or
health
effects
of
the
chemical,
and
a
description
of
any
other
data
known
to
the
submitter
concerning
the
environmental
or
health
effects
of
the
chemical.
The
specific
information
requirements
are
spelled
out
in
40
CFR
part
720,
on
the
PMN
reporting
form
itself,
and
in
the
Instruction
Manual.

To
facilitate
the
review
of
chemicals,
EPA
has
developed
a
PMN
reporting
form
(
EPA
Form
7710­
25,
copy
attached).
This
form
is
required
for
reporting
new
chemicals
under
TSCA
section
5(
a)(
1)
and
is
also
required
for
submitting
Significant
New
Use
Notices(
SNUNs).
By
supplying
the
information
specified
in
the
form,
submitters
do
not
incur
the
burden
of
providing
information
unnecessary
for
EPA's
review.
Therefore,
use
of
the
form
lessens
the
burden
on
companies
by
reducing
uncertainty,
minimizing
the
need
for
additional
contact
with
EPA,
and
allowing
companies
to
establish
procedures
for
meeting
reporting
requirements.

EPA
has
limited
the
level
of
detail
of
information
required
in
the
PMN
form
to
that
which
is
necessary
for
EPA
to
conduct
an
initial
review
of
a
chemical.
However,
submitters
may
include
additional
or
optional
information
in
their
notices
that
they
believe
EPA
should
consider
in
its
review.
For
example,
submitters
may
identify
pollution
prevention
techniques
being
employed
by
the
submitter
that
may
be
relevant
to
the
Agency's
risk
assessment.
EPA
encourages
submitters
to
provide
information
on
the
benefits
of
the
new
substance
in
comparison
to
existing
chemical
substances,
information
on
the
substitutes,
and
any
additional
information
available
to
them
on
waste
management
techniques.

The
existing
PMN
form
is
not
appropriate
for
reporting
of
new
microorganisms
in
MCANs
since
the
form
was
designed
with
traditional
chemical
substances
in
mind.
EPA
has
developed
a
"
Points
to
Consider"
guidance
document
to
assist
submitters
in
providing
to
EPA
the
information
necessary
for
EPA
to
make
assessments
of
new
microorganisms
under
TSCA
section
5.
The
submitter
will
be
able
to
provide
information
in
a
format
of
his
or
her
own
choosing.

Exemption
Applications
­
Applications
for
exemptions
from
premanufacture
or
microbial
commercial
activity
notice
requirements
have
additional
information
requirements,
as
follows:

­
Test­
Marketing
Exemption
(
TME)
(
40
CFR
720.38)

Test­
marketing
exemption
applicants
are
not
currently
required
to
use
the
PMN
form
or
any
other
prescribed
reporting
form.
However,
the
test­
marking
exemption
rule
states
that
applicants
should
provide
the
following
information:
(
1)
all
existing
health
and
environmental
effects
data
on
the
chemical
or
a
discussion
of
toxicity
based
on
structure­
activity
relationships
and
relevant
data
on
chemical
analogues;
(
2)
the
maximum
quantity
of
the
chemical
substance
that
the
applicant
will
manufacture
or
import
for
test­
marketing
purposes;
(
3)
the
maximum
number
of
persons
who
may
be
provided
the
chemical
substance
during
testmarketing
(
4)
the
maximum
number
of
persons
who
may
be
exposed
to
the
chemical
substance
as
a
result
of
test­
marketing,
including
information
regarding
the
duration
and
route
13
of
such
exposure;
and
(
5)
a
description
of
the
test­
marketing
activity,
including
its
length
and
how
it
can
be
distinguished
from
full­
scale
commercial
production
and
research
and
development.
The
Agency
retains
the
right
to
declare
that
an
application
contains
insufficient
information
to
make
an
evaluation.
Any
person
who
receives
a
test­
marketing
exemption
must
retain
documentation
of
any
information
in
the
exemption
application
and
documentation
of
their
compliance
with
any
restrictions
imposed
by
EPA
when
it
granted
the
application.
This
information
must
be
retained
for
five
years
from
the
final
date
of
manufacture
or
import
under
the
exemption.

­
Research
and
Development
Exemption
(
R&
D)
(
40
CFR
720.36)

A
manufacturer
or
importer
using
this
exemption
must
notify
all
persons
in
its
employ
or
to
whom
it
distributes
the
chemical
substance
and
who
are
involved
in
any
way
in
the
research,
of
any
risk
to
health
associated
with
the
chemical
substance.

­
TSCA
section
5(
h)(
4)
exemptions:

1.
For
the
low
volume
exemption
(
LVE)
(
40
CFR
723.50(
1)),
submitters
are
required
to
submit
their
exemption
on
the
PMN
form
to
ensure
that
the
Agency
has
adequate
information
to
make
a
determination
that
these
substances
will
not
present
an
unreasonable
risk.
Statements
describing
exposure
and
release
controls,
site,
and
use
in
an
exemption
application
are
legally
binding
and
enforceable.

2.
The
low
exposure/
low
release
exemption
(
LoREX)
(
40
CFR
723.50(
2))
encourages
the
use
of
pollution
prevention
practices
through
the
development
of
manufacturing,
processing
and
use
techniques
that
minimize
exposure
to
workers,
consumers,
the
general
public
and
the
environment.
As
with
the
low
volume
exemption,
site,
use,
exposure
and
release
controls
identified
in
the
notice
are
binding.

3.
The
polymer
exemption
rule
(
40
CFR
723.250)
requires
the
submission
of
a
postmanufacture
report
to
EPA.
A
simple
one­
page
annual
report
is
required
to
be
submitted
to
the
Agency
no
later
than
January
31
of
the
year
subsequent
to
initial
manufacture
under
the
terms
of
the
exemption.
The
report
must
include
company
identity
information
including
the
name
and
telephone
number
of
a
technical
contact
and
the
number
of
exempt
substances
for
which
manufacture
commenced
during
the
preceding
year.

4.
Instant
photographic
film
articles
exemption
notices
(
under
40
CFR
723.175)
must,
at
a
minimum,
identify
the
manufacturer
and
the
new
chemical
substance.
Applicants
must
submit
an
exemption
notice
when
manufacture
begins
and
comply
with
certain
requirements
to
limit
exposure
to
the
chemical.
Applicants
must
retain
certain
records
for
30
years
from
the
final
date
of
manufacture.
14
5.
A
TSCA
experimental
release
application
(
TERA)(
under
40
CFR
725.250)
applies
to
research
and
development
activities
which
result
in
intentional
environmental
releases
of
microorganisms.
Applicants
are
required
to
include
adequate
information
in
their
exemption
so
that
the
Agency
can
make
a
determination
that
the
microorganism
will
not
present
an
unreasonable
risk.
Submitters
must
follow
the
conditions
described
in
the
TERA
as
well
as
any
conditions
of
EPA's
TERA
approval.

6.
Tier
I
exemption
(
40
CFR
725.424)­
This
exemption
applies
to
certain
microorganisms
subject
to
physical
containment
and
control
technologies.
EPA
has
developed
specific
criteria
for
the
host
microorganism,
introduced
genetic
material,
and
containment
technology
to
ensure
that
the
microorganism
will
not
present
an
unreasonable
risk.
Applicants
must
notify
EPA
10
days
before
manufacture
or
import,
certifying
compliance
with
the
exemption
criteria
and
include
the
site
of
manufacture
or
import.

7.
Tier
II
exemption
(
40
CFR
725.428)­
This
exemption
applies
to
the
same
microorganisms
subject
to
a
Tier
I
exemption,
however,
the
applicant
must
provide
adequate
information
on
its
proposed
physical
containment
and
control
technologies
in
order
for
EPA
to
evaluate
the
exemption.
If
EPA
grants
the
exemption,
it
may
impose
appropriate
restrictions
on
the
activities
described
in
the
notice.

Notices
of
Commencement
­
Under
40
CFR
720.102
and
725.190,
EPA
requires
companies
to
notify
the
Agency
by
submitting
a
Notice
of
Commencement
(
NOC)
when
non­
exempt
commercial
manufacture
or
importation
of
a
new
chemical
begins
.
Required
reporting
information
includes
the
following:

­
the
specific
chemical
identity
of
the
chemical,
and
a
generic
chemical
name
if
the
specific
name
is
considered
confidential;

­
the
premanufacture
notice
number
assigned
by
EPA;

­
the
date
manufacture
or
importation
commenced;

­
the
address
of
the
site
where
manufacture
commenced;

­
the
name
and
address
of
the
submitting
company,
the
name
of
the
authorized
official
signing
the
NOC,
the
name
and
telephone
number
of
a
technical
contact
person;
and
­
a
clear
indication
what
information,
if
any,
is
to
be
considered
confidential.

For
traditional
chemicals
regulated
under
40
CFR
part
720,
Notices
of
Commencement
must
be
submitted
to
EPA
using
the
standard
Notice
of
Commencement
form
(
EPA
Form
7710­
56).
The
submitter
must
provide
the
NOC
to
EPA
on,
or
no
later
than
30
calendar
days
after,
the
day
manufacture
or
importation
began.
The
existing
NOC
form
is
not
appropriate
for
reporting
of
new
15
microorganisms
since
the
form
was
designed
with
traditional
chemical
substances
in
mind.
Thus,
under
40
CFR
725.190
the
submitter
may
provide
information
in
a
format
of
his
or
her
own
choosing
when
reporting
an
NOC
for
a
new
microorganism.

Bona
Fides
­
To
determine
whether
a
chemical
substance
is
on
the
confidential
portion
of
the
TSCA
Inventory,
submitters
of
bona
fide
inquiries
under
40
CFR
720.25
are
required
to
provide
the
specific
chemical
identity
of
the
substance
in
question,
a
signed
statement
that
the
submitter
intends
to
manufacture
or
import
that
substance,
a
description
of
the
research
and
development
activity
conducted
on
that
substance,
a
description
of
the
intended
use
of
the
substance,
infrared
spectrum
data
to
identify
the
substance,
the
estimated
date
on
which
the
company
intends
to
submit
a
PMN,
the
address
of
the
facility
where
manufacturing
or
processing
will
occur,
and
a
description
of
the
manufacturing
process.

To
determine
whether
a
microorganism
is
on
the
confidential
portion
of
the
TSCA
Inventory,
submitters
of
bona
fide
inquiries
under
40
CFR
725.15
are
required
to
provide
the
taxonomic
designations,
pertinent
genotypic
and
phenotypic
information,
a
signed
statement
that
the
submitter
intends
to
manufacture
or
import
that
microorganism,
a
description
of
the
research
and
development
activity
conducted
on
that
substance,
a
description
of
the
intended
use
of
the
substance,
and
an
indication
of
whether
a
related
microorganism
was
previously
reviewed
by
EPA
to
the
extent
known
by
the
submitter.

User
Fees
­
The
TSCA
section
26(
b)
rule
(
at
40
CFR
part
700)
that
requires
manufacturers,
importers
and
processors
to
pay
fees
for
PMNs,
MCANs,
certain
PMN
exemption
application
notices,
and
SNUNs
submitted
under
TSCA
sections
5(
a)
and
(
h),
requires
a
limited
amount
of
additional
information
to
be
submitted
with
the
section
5
notice.
This
information
includes
certification
that
the
firm
is
a
"
small
business
concern,"
(
if
applicable)
a
certification
statement
that
the
submitter
remitted
the
appropriate
fee,
and
the
placement
of
corresponding
identifying
numbers
both
on
the
PMN
form
and
the
fee
remittance.

(
i)
Data
Items
­
Recordkeeping
Requirements
Under
40
CFR
720.78(
a),
notice
submitters
must
keep
the
following
data
for
five
years
from
the
date
of
commencement
of
manufacture,
import,
or
processing:
documentation
of
information
in
the
notice
(
e.
g.,
sources
of
information
provided
in
the
notice);
production
volume
for
the
first
three
years
of
production;
the
date
of
commencement,
plus
documentation
of
this
information;
and
"
other
data"
described
in
the
notice,
as
required
by
40
CFR
720.50(
b).

Recordkeeping
requirements
under
SNURs
require
persons
who
manufacture
or
process
a
substance
subject
to
significant
new
use
reporting
to
maintain
records
indicating
their
compliance
with
certain
methods
of
manufacture
or
processing.
Some
Significant
New
Use
Rules
do
not
require
recordkeeping.
Rather,
recordkeeping
requirements
apply
only
to
those
SNURs
for
which
compliance
can
only
be
monitored
by
recordkeeping
or
SNUR
notice
submission
under
TSCA
section
5(
a)(
2).
For
example,
upon
occasion
EPA
will
determine
that
a
specific
set
of
exposure
controls
will
16
adequately
mitigate
risks
to
workers
by
a
specific
chemical
substance.
In
such
cases
EPA
may
determine,
by
rule,
that
the
failure
to
utilize
such
controls
constitutes
a
significant
new
use.
However,
those
persons
employing
the
controls
identified
in
the
SNUR
are
not
required
to
report
to
EPA.
In
order
to
demonstrate
to
EPA
inspectors
or
to
purchasers
of
the
chemical
substance
that
they
are
properly
employing
worker
exposure
controls
(
to
avoid
SNUR
notification
requirements),
manufacturers
or
processors
will
likely
maintain
some
record
of
their
compliance.
In
instances
such
as
those
described
above,
EPA
would
request
that
records
be
kept
documenting
the
establishment
and
implementation
of
procedures
to
ensure
that
employees
use
applicable
personal
protective
equipment,
and
that
employees
are
informed
of
the
hazards
associated
with
the
chemical
substance
and
are
trained
in
the
use
of
protective
equipment.
These
records
aid
inspectors
in
EPA's
compliance
monitoring
program
during
their
visits
to
plants
where
substances
subject
to
SNUR
requirements
are
manufactured
or
processed.
EPA
does
not
consider
recordkeeping
that
indicates
compliance
with
a
SNUR
to
be
burdensome.
Information
contained
in
these
records
is
not
submitted
to
EPA.
Therefore,
the
costs
of
keeping
such
records
should
be
minimal.

There
are
also
recordkeeping
requirements
for
persons
subject
to
consent
orders
containing
exposure
controls.
Depending
on
the
facts
of
each
case,
submitters
must
keep
records
in
connection
with
the
use
of
the
exposure
controls
including
one
or
more
of
the
following:
(
1)
documentation
of
manufacture
and
importation
volumes
of
the
PMN
substance,
with
associated
dates
of
manufacture
or
importation;
(
2)
documentation
of
the
names
and
addresses
of
all
persons
outside
the
site
of
manufacture
or
import
to
whom
the
submitter
directly
sells
or
transfers
the
substance,
with
associated
dates
of
transfer;
(
3)
documentation
of
the
establishment
and
implementation
of
personal
protective
equipment
program;
(
4)
documentation
of
chemical
protective
clothing
imperviousness
testing;
(
5)
documentation
of
the
hazard
communication
program;
(
6)
copies
of
labels;
(
7)
copies
of
material
safety
data
sheets;
(
8)
documentation
of
compliance
with
industrial,
commercial
and
consumer
use
limitations;
and
(
9)
documentation
of
compliance
with
disposal
and
release
to
water
limitations.

(
ii)
Respondent
Activities
In
responding
to
the
reporting
and
recordkeeping
requirements
outlined
in
this
document,
respondents
will
engage
in
the
following
activities:

­
Read
regulatory
requirements
and
provisions;
­
Determine
which
provisions
are
applicable
to
their
activities;
­
Gather
information
necessary
to
meet
the
requirements;
­
Substantiate
any
claims
of
confidential
business
information;
­
Submit
information
to
EPA,
as
necessary;
­
Comply
with
any
restrictions
EPA
may
impose
upon
completion
of
review
of
their
submission;
and
­
Maintain
any
necessary
records.
17
5
THE
INFORMATION
COLLECTED­­
AGENCY
ACTIVITIES,
COLLECTION
METHODOLOGY
AND
INFORMATION
MANAGEMENT
5(
a)
Agency
Activities
In
connection
with
administering
the
TSCA
section
5
new
chemical
review
and
regulatory
program,
EPA
performs
the
following
activities:

­
reviews
PMN/
MCAN
submissions;
­
analyzes
submissions
for
confidentiality
and
provides
appropriate
protection
for
confidential
data;
­
files
and
stores
submissions;
­
proposes
and
implements
regulatory
action
as
appropriate;
and
­
conducts
site
and
record
inspections
and
performs
related
compliance
monitoring
functions.

5(
b)
Collection
Methodology
and
Management
EPA
encourages
but
does
not
require
the
submission
of
premanufacture
notices
and
other
submissions
by
electronic
means
(
see
40
CFR
720.40).
EPA
believes
electronic
submission
reduces
the
reporting
burden
on
industry,
because
it
is
intended
to
reduce
both
the
cost
and
the
time
required
to
enter,
review,
edit
and
transmit
the
data.
Electronic
submission
may
also
improve
data
quality
because
it
facilitates
correcting
incorrect
data
or
adding
omitted
data.
There
is
no
other
new
technology
applicable
to
the
collection
of
this
information
that
would
minimize
the
collection
burden,
nor
has
EPA
been
able
to
identify
a
more
efficient,
less
expensive
or
more
flexible
means
of
obtaining
the
required
data.

To
aid
persons
subject
to
this
information
collection,
OPPT
has
set
up
a
TSCA
Hotline
that
provides
information
regarding
TSCA
regulatory
requirements.
When
Hotline
staff
are
unable
to
answer
questions
regarding
TSCA
section
5,
the
questions
are
referred
to
OPPT
staff
for
appropriate
resolution.

5(
c)
Small
Entity
Flexibility
The
reporting
and
recordkeeping
requirements
associated
with
TSCA
section
5
are
applicable
to
all
affected
entities,
regardless
of
size
of
business.
However,
EPA
provides
specialized
assistance
to
respondents,
particularly
to
small
entities.
TSCA
section
26(
d)
established
the
TSCA
Assistance
Office,
now
known
as
the
Environmental
Assistance
Division
(
EAD),
to
provide
technical
and
other
nonfinancial
assistance
to
manufacturers,
importers
and
processors
of
chemical
substances.
This
office
has
established
a
hotline
to
assist
small
businesses
complying
with
TSCA
rules.
It
provides
material
such
as
copies
of
Federal
Register
notices,
advisories,
and
other
information
on
request.
It
also
publishes
the
bi­
monthly
Chemicals­
in­
Progress
bulletin
that
identifies
activities
in
EPA.
In
addition,
"
small
business
concerns"
submit
a
reduced
fee
of
$
100
(
rather
than
$
2,500)
for
each
TSCA
1
The
PMN
submission
information
presented
below
is
based
on
the
"
OPPT
New
Chemicals
Annual
Report;"
U.
S.
EPA/
OPPT;
October
2002
(
hereinafter
referred
to
as
OPPT,
2002).
PMN
burden
data
is
from
the
"
Regulatory
Impact
Analysis
of
Amendments
to
Regulations
for
TSCA
Section
5
Premanufacture
Notifications;"
U.
S.
EPA/
OPPT/
Economics,
Exposure
and
Technology
Division/
Regulatory
Impacts
Branch;
September
9,
1994;
(
hereinafter
referenced
as
"
RIA,
1994").
The
information
on
biotechnology
submissions
is
from
"
Regulatory
Impact
Analysis
of
Regulations
on
Micrboial
Products
of
Biotechnology;"
U.
S.
EPA/
OPPT/
Economics,
Exposure
and
Technology
Division;
January
21,
1997;
(
hereinafter
referenced
as
`
RIA,
1997').

18
section
5
notice
submitted
pursuant
to
the
user
fee
regulation
at
40
CFR
700.45(
a)(
1).

Moreover,
EPA
has
taken
certain
steps
to
minimize
for
all
respondents
the
reporting
burden
associated
with
complying
with
this
collection.
For
example,
the
information
technology
used
by
EPA
includes
bibliographic
data
bases
that
reference
scientific
literature
and
data
bases
containing
previously
submitted
chemical
information.
These
data
bases
allow
EPA
to
exempt
submitters
from
needlessly
providing
already­
published
data
or
resubmitting
previously
submitted
information
(
unless
the
previously
submitted
information
was
claimed
confidential).

Also,
as
discussed
above,
EPA
has
issued
several
TSCA
section
5
exemption
rules
that
reduce
PMN
reporting
requirements
thereby
providing
relief
to
submitters
from
the
burden
of
responding
to
the
full
PMN/
MCAN
requirements.

Finally,
EPA
provides
the
services
of
pre­
notice
communications
coordinators
and
other
personnel
to
assist
persons
in
a
comprehensive
manner
for
purposes
of
notice
preparation
prior
to
submission.
For
instance,
for
new
chemical
substances
a
PMN
submitter
may,
upon
consultation
with
the
prenotice
communication
coordinator,
prepare
one
"
consolidated
notice"
for
two
or
more
chemical
substances
if
they
are
similar
in
physicochemical
structure
and
use
and
share
common
test
data
or
other
information.
Prenotice
communication
coordinators
respond
to
other
pre­
notice
inquiries
that
may
pertain
to
the
full
scope
of
the
TSCA
section
5
regulations.

5(
d)
Collection
Schedule
Does
not
apply.
Submission
of
information
under
this
collection
is
on
an
as­
needed,
onoccasion
basis,
initiated
by
the
respondents.

6
Estimating
the
Burden
and
Cost
of
the
Collection
Burden
and
cost
calculations
are
based
on
the
assumption
that
EPA
will
receive
approximately
1,450
TSCA
Section
5
notices
each
year,
based
on
the
average
number
of
notices
received
for
years
2000,
2001,
and
20021
(
see
Table
1).
The
trend
since
FY
1994
has
been
a
significant
decline
in
the
number
of
PMNs
received,
from
2,645
in
FY
1994,
to
1,471
in
FY
2002.
Amendments
to
the
PMN
19
rule
in
1995
eliminated
the
PMN
requirement
for
eligible
polymers,
broadened
the
low
volume
exemption,
and
introduced
the
low
release/
low
exposure
exemption.
The
overall
effect
of
these
amendments
has
been
a
significant
decline
in
the
submission
of
notices
in
general
and
of
full
PMNs
in
particular.
In
addition
to
chemical
PMNs,
this
analysis
covers
submissions
of
Bona
Fide
claims,
Microbial
Commercial
Activity
Notices
(
MCANs),
TSCA
Experimental
Release
Applications
(
TERAs),
and
Tier
I
and
II
exemption
applications,
as
required
by
the
1997
Microbial
Products
of
Biotechnology
rule.

6(
a)
Estimating
Respondent
Burden
The
burden
to
respondents
includes:
1)
reporting
burden
for
submission
of
PMNs,
SNUNs,
exemption
notices,
and
biotechnology
notices;
2)
reporting
burden
associated
with
implementation
of
TSCA
Section
5(
e)
consent
order
restrictions
such
as
the
use
of
exposure
controls
and/
or
performing
toxicity
testing;
and
3)
recordkeeping
burden
associated
with
notice
submissions,
consent
orders,
exposure
controls
and
toxicity
testing.

6(
b)
Burden
Hours
Associated
with
Reporting
As
shown
in
Table
I,
the
total
respondent
reporting
burden
associated
with
this
information
collection
is
estimated
to
total
160,037
hours.
This
burden
estimate
is
calculated
by
multiplying
the
hours
of
reporting
burden
times
the
revised
number
of
each
type
of
notice
that
EPA
expects
to
receive
and
summing
across
the
notice
types.

The
hours
for
respondent
reporting
burden
for
a
full
PMN
submission
is
estimated
to
range
between
95
and
114
hours
(
RIA,
1994),
with
an
average
respondent
burden
of
105
hours.
This
burden
applies
also
to
the
submission
of
SNUN,
LVE,
and
LoREX
submissions
since
each
of
these
notices
requires
the
submission
of
a
complete
PMN
form.
The
respondent
burden
for
submission
of
a
TME
is
estimated
to
average
98
hours
(
RIA,
1994).

The
respondent
burden
for
an
MCAN
is
estimated
to
range
between
71
and
533
hours,
with
an
average
of
302
hours.
The
respondent
burden
for
a
TERA
is
estimated
to
range
between
91
and
950
hours,
with
an
average
of
522.
The
respondent
burden
for
a
Tier
I
or
Tier
II
exemption
is
estimated
to
range
between
13
and
215
hours,
with
an
average
of
114
(
RIA,
1997).

Prior
to
the
1995
amendments
to
the
PMN
rule,
70%
to
80%
of
all
TSCA
Section
5
notices
were
full
PMN
submissions.
Since
the
amendments
of
1995,
the
increase
in
exemptions
has
not
significantly
changed
this
distribution.
EPA
expects
few
persons
to
submit
significant
new
use
notices
(
SNUNs).
The
number
of
SNUNs
submitted
is
a
function
of
the
number
of
chemicals
regulated
under
SNURs,
which
are
relatively
few.
Current
data
suggest
the
Agency
expects
to
receive
approximately
8
SNUNs
annually
(
OPPT,
2002).

The
amendments
also
placed
stricter
control
on
bona
fide
claims,
intended
to
establish
bona
fide
intent.
This
was
done
in
response
to
the
steadily
increasing
number
of
bona
fide
notices
20
submitted
to
EPA.
The
result
of
the
amendments
has
been
a
significant
reduction
in
bona
fide
submissions.
Current
EPA
data
suggests
that
only
one
bona
fide
notice
is
expected
to
be
submitted
annually.

Based
on
a
review
of
submission
data
for
2000
­
2002,
on
average,
Low
Volume
Exemptions
and
LoREX
exemptions
are
expected
to
account
for
roughly
32%
of
submissions,
or
about
463
notices
annually.
Further,
test
market
exemptions
(
TME)
are
expected
to
average
7
applications
per
year,
or
less
than
1%
of
all
TSCA
Section
5
notices
(
OPPT,
2002).

The
various
exemptions
available
to
submitters
since
the
1995
amendments
have
significantly
reduced
the
need
for
consent
order
development
and
post­
notice
data
review.
EPA
data
indicate
that
such
consent
orders
and
post­
notice
data
reviews
will
amount
to
roughly
2%
(
26/
1450)
of
the
total
estimated
1,450
TSCA
Section
5
notices
(
OPPT,
2002).
Based
on
historical
data,
EPA
estimates
26
cases
would
be
subject
to
either
test
data
or
non­
testing
TSCA
Section
5(
e)
burden
with
12
cases
requiring
test
data,
and
14
non­
testing
TSCA
Section
5(
e)
cases.
Testing
is
usually
contracted
out
to
a
laboratory,
thus
the
burden
associated
with
testing
requirements
represents
the
time
that
personnel
from
the
submitting
firm
would
spend
overseeing
the
testing,
assumed
to
be
25%
of
the
lab
burden.

Table
1
on
the
following
page
displays
the
overall
respondent
reporting
burden.
21
Table
I
Reporting
Burden
Type
of
Notice
Avg.
Annual
Responses
Reporting
Hours
/
Response
Avg.
Annual
Burden
PMNs
980
105
102,900
Exemptions
TME
7
98
686
LVE
/
LoREX
463
105
48615
Polymer1
0
2
0
MCAN
1
302
302
TERA
2
522
1044
Tier
I
&
II
30
114
3420
SNUN
8
105
840
5(
e)
Test
12
155
1860
Non­
Testing
5(
e)
Burden
14
25
350
Bona
Fide
1
20
20
Total
Respondent
Reporting
Burden
Hours
160,037
Average
Annual
Responses
computed
as
the
average
number
of
notices
filed
over
2000,
2001,
and
2002
based
on
OPPT,
2002.
1
Since
the
1995
amendments,
polymer
exemptions
are
no
longer
submitted.
The
exemption
is
included
in
this
memo
for
consistency
with
prior
ICRs.

6(
c)
Burden
Hours
Associated
with
Recordkeeping
As
shown
in
Table
II,
the
respondent
recordkeeping
burden
associated
with
this
information
collection
is
estimated
to
total
3,754
hours.
This
burden
estimate
is
calculated
by
multiplying
the
estimated
burden
associated
with
each
type
of
submission
(
RIA,
1994),
by
the
estimated
number
of
submissions
for
each
notice
and
summing
across
notice
types.

Once
the
respondent
presents
information
in
an
initial
TSCA
Section
5
submission,
the
burden
for
maintaining
or
updating
these
records
is
minimal.
The
Agency
assumes
an
aggregate
annualized
recordkeeping
burden
of
two
hours
for
each
PMN,
SNUN,
exemption
submission,
or
biotech
submission.
This
is
based
on
the
recordkeeping
burden
associated
with
essential
technical
requirements,
such
as
records
that
demonstrate
that
the
first
commercial
batch
of
polymer
manufactured
for
commercial
purposes
under
the
exemption
met
certain
eligibility
criteria.
Such
recordkeeping
requirements
allow
the
Agency
substantially
to
eliminate
all
other
data
and
reporting
requirements
associated
with
the
polymer
exemption.
Recordkeeping
burden
for
5(
e)
testing
and
non­
testing
burden
are
35
and
25
hours,
respectively
(
RIA,
1994)
22
The
overall
respondent
recordkeeping
burden
is
displayed
below
in
Table
II.

Table
II
Respondent
Recordkeeping
Burden
Type
of
Notice
Avg.
Annual
Responses
Hours
for
Recordkeeping
Avg.
Annual
Burden
PMN
980
2
1,960
Exemptions
TME
7
2
14
LVE
/
LoREX
463
2
926
Polymer
0
4
0
MCAN
1
2
2
TERA
2
2
4
Tier
I
&
II
30
2
60
SNUN
8
2
16
5(
e)
Test
12
35
420
Non­
Testing
5(
e)
Burden
14
25
350
Bona
Fide
1
2
2
Total
Respondent
Recordkeeping
Burden
Hours
3,754
Average
Annual
Responses
computed
as
the
average
number
of
notices
filed
over
2000,
2001,
and
2002
based
on
OPPT
New
Chemicals
Annual
Report,
2002.

6(
d)
Estimating
Respondent
Cost
Respondents
to
TSCA
Section
5
reporting
requirements
experience
costs
associated
with
1)
reporting,
2)
recordkeeping
and
3)
compliance
with
exposure
controls
and
testing
requirements
included
in
TSCA
Section
5(
e)
orders,
when
EPA
takes
regulatory
action.
The
respondent
costs
associated
with
this
information
collection
are
estimated
to
total
$
34,348,733,
as
presented
in
Table
III
below.

Respondent
costs
for
all
submissions
consist
of
three
components:
1)
labor
costs,
calculated
by
multiplying
the
estimated
burden
hours
associated
with
each
submission
type
by
the
appropriate
labor
rate;
2)
delay
costs,
estimated
as
the
cost
of
the
delayed
receipt
of
profits
by
chemical
manufactures
as
a
result
of
the
submission
review
process,
and
3)
explicit
costs,
such
as
user
fees
or
lab
testing
fees.

In
order
to
estimate
total
respondent
cost
associated
with
TSCA
Section
5
submissions,
an
average
cost
was
first
calculated
for
each
type
of
notice.
The
average
cost
per
notice
was
calculated
23
by
summing
each
of
the
three
cost
components
identified
above
for
each
type
of
notice.
The
average
cost
per
notice
was
then
multiplied
by
the
expected
number
of
notice
submissions
and
summed
across
notice
types
to
obtain
the
total
industry
cost.
Table
III
below
outlines
the
total
average
cost
calculations
for
the
various
types
of
notice
submissions
and
presents
the
total
respondent
cost
estimate.
24
Table
III
Total
Respondent
Cost
Calculation
Notice
Average
Annual
Number
of
Responses
Total
Burden
(
reporting
+
recordkeeping)
and
Wage
Rate
by
Labor
Category
Labor
Costs1
Delay
Costs2
Fees3
Total
Avg.

Costs
Per
Notice4
Total
Respondent
Cost
Managerial
Technical
Clerical
Hrs
Wage($)
Hrs
Wage($)
Hrs
Wage($)

PMN
980
18
$
57.60
75
$
44.75
14
$
24.71
$
4,739
$
19,416
$
2,500
$
26,655
$
26,121,900
TME
7
17
$
57.60
70
$
44.75
13
$
24.71
$
4,433
$
0
$
0
$
4,433
$
31,031
LVE
/
LoREX
463
18
$
57.60
75
$
44.75
14
$
24.71
$
4,739
$
9,773
$
0
$
14,512
$
6,719,056
Polymer
0
0
$
57.60
0
$
44.75
0
$
24.71
$
0
$
0
$
0
$
0
$
0
MCAN
1
65
$
57.60
224
$
44.75
15
$
24.71
$
14,139
$
19,416
$
2,500
$
36,055
$
36,055
TERA
2
129
$
57.60
380
$
44.75
15
$
24.71
$
24,806
$
0
$
0
$
24,806
$
49,612
Tier
I
&
II
30
23
$
57.60
88
$
44.75
5
$
24.71
$
5,386
$
0
$
0
$
5,386
$
161,580
SNUN
8
18
$
57.60
75
$
44.75
14
$
24.71
$
4,739
$
19,416
$
2,500
$
26,655
$
213,240
5(
e)
Test
Data
12
38
$
57.60
130
$
44.75
22
$
24.71
$
8,550
$
0
$
73,6505
$
82,200
$
986,400
Non­
Testing
5(
e)
Burden
14
10
$
57.60
25
$
44.75
15
$
24.71
$
2,065
$
0
$
06
$
2,065
$
28,910
Bona
Fide
1
5
$
57.60
12
$
44.75
5
$
24.71
$
949
$
0
$
0
$
949
$
949
Total
Respondent
Costs
$
34,348,733
1
Labor
costs
are
calculated
by
multiplying
burden
hours
by
the
wage
rate
for
each
labor
category
and
summing
across
labor
categories.

2
Delay
costs
calculated
using
the
average
of
low
and
high
estimates
from
RIA,
1994,
updated
to
March
2003$
using
Bureau
of
Labor
Statistics
Producer
Price
Index
data
for
chemical
and
allied
products
industry.
MCANs
are
assumed
to
have
the
same
delay
costs
as
PMNs.

3
User
fees
charged
by
EPA,
except
where
noted.
These
were
assumed
to
remain
constant
since
ICR,
2000.

4
Total
average
costs
is
the
sum
of
labor
costs,
delay
costs
and
fees.

5
This
figure
is
for
a
representative
testing
regimen
consisting
of
835.3110
(
ready
biodegradability),
850.1010,
850.1075,
850.5400
(
aquatic
base
set),
and
OECD
407
(
28­
day
repeated
dose),
based
on
an
analysis
of
average
costs
for
277
testing
cases.

6
While
companies
incur
costs
for
control
equipment,
such
costs
are
outside
the
realm
of
this
ICR.
25
26
Baseline
respondent
wage
rates
used
to
support
the
calculation
of
average
cost
per
submission
were
obtained
from
the
U.
S.
Bureau
of
Labor
Statistics'
March,
2003
Employer
Costs
for
Employee
Compensation
for
Private
Industries,
Manufacturing
Industries,
White
collar
occupations
for
managerial,
technical,
and
clerical
labor
categories.
The
baseline
wage
for
each
labor
category
was
multiplied
by
a
loading
factor
computed
for
each
category
to
determine
the
loaded
average
hourly
wage.
Loading
factors
for
benefits
are
calculated
separately
for
each
labor
category
by
dividing
the
benefits
percentage
of
total
compensation
by
the
wage
percentage
of
total
compensation
for
each
occupational
group.
An
additional
loading
factor
of
17
percent
is
applied
for
overhead.
The
final
loading
factor
is
thus
calculated
as:
(
1
+
benefits
loading
factor
+
.17
overhead
factor).
The
baseline
wage
for
each
labor
category
is
then
multiplied
by
its
respective
loading
factor
to
obtain
the
loaded
hourly
wage
rate.
The
loaded
hourly
labor
rates
for
the
different
labor
categories
used
in
calculation
of
respondent
labor
cost
are
as
follows:
managerial
­
$
57.60;
technical
­
$
44.75;
clerical
­
$
24.71.

As
noted
above,
delay
costs
reflect
the
cost
of
the
delayed
receipt
of
profits
by
chemical
manufactures
as
a
result
of
the
submission
review
process.
Industry
delay
costs
used
to
calculate
the
average
cost
per
submission
of
were
computed
using
the
midpoint
of
the
low
and
high
delay
cost
estimates
presented
in
the
1994
RIA,
inflated
to
March
2003
dollars
using
the
Bureau
of
Labor
Statistics'
Producer
Price
Index
data
for
Chemical
and
Allied
Products
industry.

The
explicit
costs
or
fees
used
to
calculate
the
average
cost
per
submission
were
taken
from
the
2000
ICR
and
have
not
been
adjusted.

For
PMNs
and
SNUNs,
the
average
cost
to
respondents,
including
the
standard
user
fee
of
$
2,500,
is
estimated
to
be
$
26,655.
The
submission
costs
for
low
volume
exemptions
and
low
release/
low
exposure
exemptions
is
estimated
to
average
$
14,512.
The
cost
for
submission
of
test
market
exemptions
is
estimated
to
average
$
4,433.

As
noted
above,
the
amended
PMN
rule
has
place
stricter
requirements
for
submission
of
a
bona
fide
notice,
with
submission
expected
to
average
about
one
a
year.
The
average
cost
for
Bona
fide
notices
under
the
amended
rule
are
estimated
to
be
$
949.

For
biotech
submissions,
the
average
cost
of
submitting
an
MCAN
is
$
36,055,
including
a
user
fee
of
$
2,500;
the
average
cost
for
a
TERA
is
$
24,806;
and
the
average
for
a
Tier
I
or
Tier
II
exemption
is
$
5,386.

Submitters
required
to
perform
5(
e)
testing
will
incur
an
average
of
$
8,550
in
labor
costs,
plus
lab
fees
averaging
$
73,650,
for
a
total
of
$
82,200.
Non­
Testing
5(
e)
burden
costs
average
$
2,065.

The
total
respondent
burden
hours
and
costs
therefore
is
the
sum
of
reporting
hours
and
recordkeeping
hours,
and
the
total
costs
for
all
expected
notice
submissions.
Total
respondent
burden
hours
is
163,791
(
160,037
reporting
hours
+
3,754
recordkeeping
hours).
As
noted
above,
total
respondent
costs
based
on
the
expected
number
of
TSCA
Section
5
notice
submissions
are
$
34,348,733.
2
For
a
description
of
the
calculation
of
extramural
cost,
see
footnote
7
of
figure
2.

27
6(
e)
Estimating
Agency
Cost
ERPA's
costs
associated
with
this
information
collection
are
estimated
to
total
$
7,307,840,
as
presented
in
Table
IV
below.
Costs
to
the
government
include:
1)
initial
review
of
PMN
substances
(
after
which
the
majority
of
cases
are
dropped
from
further
regulatory
review),
2)
comprehensive
reviews
on
a
minority
of
chemicals,
during
which
the
Agency
conducts
a
more
through
evaluation
of
the
potential
risks
associated
with
manufacturing,
processing,
use
and
disposal
of
the
PMN
substance
including,
if
necessary,
taking
regulatory
action
under
TSCA
Sections
5(
e)
or
5(
f).

In
order
to
determine
the
total
cost
for
the
Agency,
an
average
cost
was
first
computed
for
each
type
of
notice.
The
average
Agency
cost
per
notice
was
computed
by
multiplying
the
Agency
labor
hours
for
each
notice,
as
reported
in
the
RIA,
1994,
by
the
Agency
labor
cost
per
hour
for
a
fully
loaded
GS­
13,
step
5
employee
in
the
Washington
D.
C.
area,
plus
updated
extramural
costs
for
contractor
support2.
The
average
cost
per
notice
was
then
multiplied
by
the
expected
number
of
notice
submissions
and
summed
across
notice
types
to
obtain
the
Total
Agency
Cost.

Agency
wage
rate
data
used
to
calculate
labor
costs
were
gathered
from
the
U.
S.
Office
of
Personnel
Management
Salary
Table
2003­
DCB,
for
a
GS­
13,
step
5
employee
in
the
Washington,
D.
C.
area.
A
loading
factor
of
1.6
was
applied
to
the
base
rate
to
arrive
at
the
2003
loaded
wage
rate
of
$
125,
221
per
year
(
PMN
ICR,
2000).
The
final
hourly
wage
was
computed
by
dividing
the
loaded
wage
by
2,080
hours;
the
hours
associated
with
a
full
time
employee.
This
loaded
hourly
wage
was
used
in
calculations
of
Agency
cost.

Agency
unit
costs
for
review
of
full
PMN
notices
are
estimated
to
average
$
4,681.
The
costs
for
review
of
SNUNs
are
expected
to
total
$
4,670.
The
average
cost
to
the
Agency
for
a
test
market
exemption
review
is
estimated
to
be
$
6,540.

Agency
costs
associated
with
the
polymer
exemption
are
assumed
to
be
$
0
as
these
exemptions
are
no
longer
submitted.
The
costs
to
the
Agency
for
Bona
fide
notices,
based
on
data
provided
in
the
RIA,
1994,
are
expected
to
total
$
187.

Agency
unit
costs
for
LVE/
LoREX
reviews
average
$
1,911.

For
biotech
submissions,
Agency
costs
average
$
64,020
per
MCAN,
$
88,560
per
TERA,
and
$
11,220
for
a
Tier
I
or
II
exemption
petition.

Agency
costs
to
review
5(
e)
test
data
are
estimated
at
$
90,000
and
non­
testing
5(
e)
costs
are
estimated
at
$
3,900
per
case.

Finally,
the
Agency
estimates
that
tracking
and
validating
fees
cost
the
Agency
approximately
$
40,000
per
year.
28
Table
IV
Total
Agency
Cost
Calculations
Type
of
Notice
Average
Annual
Number
of
Responses
Agency
Labor
Hours
Wage
Rate
Labor
Costs6
Extramural
Costs7
Total
Avg.

Costs8
Total
Agency
Costs
PMN
980
641
$
60
$
3,840
$
841
$
4,681
$
4,587,380
TME
7
1092
$
60
$
6,540
$
0
$
6,540
$
45,780
LVE
/
LoREX
463
221
$
60
$
1,320
$
591
$
1,911
$
884,793
Polymer
0
0
$
60
$
0
$
0
$
0
$
0
MCAN
1
1,0673
$
60
$
64,020
$
0
$
64,020
$
64,020
TERA
2
1,4763
$
60
$
88,560
$
0
$
88,560
$
177,120
Tier
I
or
II
30
1873
$
60
$
11,220
$
0
$
11,220
$
336,600
SNUN
8
641
$
60
$
3,840
$
830
$
4,670
$
37,360
5(
e)
Test
Data
12
1,5004
$
60
$
90,000
$
0
$
90,000
$
1,080,000
Non­
Testing
5(
e)
Burden
14
655
$
60
$
3,900
$
0
$
3,900
$
54,600
Bona
Fide
1
21
$
60
$
120
$
67
$
187
$
187
User
Fee
(
tracking
and
validation
costs
$
40,000
$
7,307,840
1
RIA,
1994.

2
ICR,
2000.

3
RIA,
1997.

4
Estimated
to
be
similar
to
TERA
review.

5
Estimated
to
be
similar
to
PMN
/
SNUN
review.

6
Labor
costs
calculated
as
labor
hours
times
Agency
wage
rate.
Wage
rate
based
on
salary
taken
from
Salary
Table
2003­
DCB,
U.
S.
Office
of
Personnel
Management.

7
Extramural
costs
for
contractor
support.
RIA,
1994,
updated
to
March
2003$
using
BLS
Producer
Price
Index
for
Chemical
and
Allied
Products.

8
Agency
labor
costs
plus
extramural
costs.
29
6(
f)
Reasons
for
Change
in
Burden
This
request
reflects
a
decrease
in
the
total
estimated
burden
of
62,756
hours
(
from
226,547
hours
to
163,791
hours)
in
the
total
estimated
respondent
burden
from
that
currently
in
the
OMB
inventory.
This
decrease
represents
an
adjustment
in
the
number
of
annual
submissions
to
reflect
EPA's
experiences
since
the
most
recent
ICR.
The
decrease
in
the
number
of
submissions
per
year
is
largely
associated
with
the
polymer
and
other
exemptions
implemented
under
the
1995
amendments.

6(
g)
Burden
Statement
The
annual
public
burden
for
this
collection
of
information,
which
is
approved
under
OMB
Control
No.
2070­
0012,
is
estimated
to
average
102.1
hours
per
response,
and
to
require
3.4
hours
of
recordkeeping
per
response.
According
to
the
Paperwork
Reduction
Act,
"
burden"
means
the
total
time,
effort,
or
financial
resources
expended
by
persons
to
generate,
maintain,
retain,
or
disclose
or
provide
information
to
or
for
a
Federal
agency.
For
this
collection
it
includes
the
time
needed
to
review
instructions;
develop,
acquire,
install
and
utilize
technology
and
systems
for
the
purposes
of
collecting,
validating,
and
verifying
information,
processing
and
maintaining
information,
and
disclosing
and
providing
information;
adjust
the
existing
ways
to
comply
with
any
previously
applicable
instructions
and
requirements;
train
personnel
to
be
able
to
respond
to
a
collection
of
information;
search
data
sources;
complete
and
review
the
collection
of
information;
and
transmit
or
otherwise
disclose
the
information.
An
agency
may
not
conduct
or
sponsor,
and
a
person
is
not
required
to
respond
to,
a
collection
of
information
unless
it
displays
a
currently
valid
OMB
control
number.
The
OMB
control
number
for
this
information
collection
appears
above.
The
OMB
control
numbers
for
EPA's
regulations
in
title
40
of
the
CFR,
after
appearing
in
the
Federal
Register,
are
listed
in
40
CFR
part
9
and
included
on
the
related
collection
instrument
or
form,
if
applicable.

Send
comments
on
the
Agency's
need
for
this
information,
the
accuracy
of
the
provided
burden
estimates,
and
any
suggested
methods
for
minimizing
respondent
burden,
including
through
the
use
of
automated
collection
techniques
to
the
Director,
Collection
Strategies
Division,
U.
S.
Environmental
Protection
Agency
(
Mail
Code
2822T),
1200
Pennsylvania
Ave.,
NW.,
Washington,
D.
C.
20460.
Include
the
OMB
control
number
in
any
correspondence,
but
do
not
submit
the
requested
information
to
this
address.
The
requested
information
should
be
submitted
in
accordance
with
the
instructions
accompanying
the
form,
or
as
specified
in
the
corresponding
regulation.
Attachment
A
Toxic
Substances
Control
Act
Section
5
(
15
USC
2604)
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
which
data
has
been
submitted
to
the
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
of
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
Attachment
B
40
CFR
Part
700
40
CFR
Protection
of
Environment
CHAPTER
I
ENVIRONMENTAL
PROTECTION
AGENCY
(
CONTINUED)

SUBCHAPTER
R
­­
TOXIC
SUBSTANCES
CONTROL
ACT
PART
700
­­
GENERAL
Subparts
A­
B
[
Reserved]

Subpart
C
­­
Fees
§
700.40
Purpose
and
applicability.
(
a)
Purpose.
The
purpose
of
this
subpart
is
to
collect
fees
from
manufacturers,
importers,
and
processors
who
submit
notices
and
applications
to
EPA
under
section
5
of
the
Toxic
Substances
Control
Act
(
15
U.
S.
C.
2604)
to
defray
part
of
EPA's
cost
of
administering
the
Act.

(
b)
Applicability.
This
subpart
applies
to
all
manufacturers,
importers,
and
processors
who
submit
certain
notices
and
applications
to
EPA
under
section
5
of
the
Act.

§
700.41
Radon
user
fees.
User
fees
relating
to
radon
proficiency
programs
authorized
under
the
Toxic
Substances
Control
Act
appear
at
40
CFR
part
195.

[
59
FR
13177,
Mar.
18,
1994]

§
700.43
Definitions.
Definitions
in
section
3
of
the
Act
(
15
U.
S.
C.
2602),
as
well
as
definitions
contained
in
§
§
704.3,
720.3,
and
725.3
of
this
chapter,
apply
to
this
subpart
unless
otherwise
specified
in
this
section.
In
addition,
the
following
definitions
apply:

Consolidated
microbial
commercial
activity
notice
or
consolidated
MCAN
means
any
MCAN
submitted
to
EPA
that
covers
more
than
one
microorganism
(
each
being
assigned
a
separate
MCAN
number
by
EPA)
as
a
result
of
a
prenotice
agreement
with
EPA.

Consolidated
premanufacture
notice
or
consolidated
PMN
means
any
PMN
submitted
to
EPA
that
covers
more
than
one
chemical
substance
(
each
being
assigned
a
separate
PMN
number
by
EPA)
as
a
result
of
a
prenotice
agreement
with
EPA
(
See
48
FR
21734).

Exemption
application
means
any
application
submitted
to
EPA
under
section
5(
h)(
2)
of
the
Act.

Exemption
notice
means
any
notice
submitted
to
EPA
under
§
723.175
of
this
chapter.

Final
product
means
a
new
chemical
substance
(
as
"
new
chemical
substance"
is
defined
in
§
720.3
of
this
chapter)
that
is
manufactured
by
a
person
for
distribution
in
commerce,
or
for
use
by
the
person
other
than
as
an
intermediate.

Intermediate
premanufacture
notice
or
intermediate
PMN
means
any
PMN
submitted
to
EPA
for
a
chemical
substance
which
is
an
intermediate
(
as
"
intermediate"
is
defined
in
§
720.3
of
this
chapter)
in
the
production
of
a
final
product,
provided
that
the
PMN
for
the
intermediate
is
submitted
to
EPA
at
the
same
time
as,
and
together
with,
the
PMN
for
the
final
product
and
that
the
PMN
for
the
intermediate
identifies
the
final
product
and
describes
the
chemical
reactions
leading
from
the
intermediate
to
the
final
product.
If
PMNs
are
submitted
to
EPA
at
the
same
time
for
several
intermediates
used
in
the
production
of
a
final
product,
each
of
those
is
an
intermediate
PMN
if
they
all
identify
the
final
product
and
every
other
associated
intermediate
PMN
and
are
submitted
to
EPA
at
the
same
time
as,
and
together
with,
the
PMN
for
the
final
product.

Joint
submitters
means
two
or
more
persons
who
submit
a
section
5
notice
together.

Microbial
commercial
activity
notice
or
MCAN
means
any
notice
for
microorganisms
submitted
to
EPA
pursuant
to
section
5(
a)(
1)
of
the
Act
in
accordance
with
subpart
D
of
part
725
of
this
chapter.

Person
means
a
manufacturer,
importer,
or
processor.

Premanufacture
notice
or
PMN
means
any
notice
submitted
to
EPA
pursuant
to
section
5(
a)(
1)(
A)
of
the
Act
in
accordance
with
part
720
of
this
chapter
or
§
723.250
of
this
chapter.

Section
5
notice
means
any
PMN,
consolidated
PMN,
intermediate
PMN,
significant
new
use
notice,
exemption
notice,
exemption
application,
any
MCAN
or
consolidated
MCAN
submitted
under
section
5
of
the
Act.

Significant
new
use
notice
means
any
notice
submitted
to
EPA
pursuant
to
section
5(
a)(
1)(
B)
of
the
Act
in
accordance
with
part
721
of
this
chapter.

Small
business
concern
means
any
person
whose
total
annual
sales
in
the
person's
fiscal
year
preceding
the
date
of
the
submission
of
the
applicable
section
5
notice,
when
combined
with
those
of
the
parent
company
(
if
any),
are
less
than
$
40
million.

[
53
FR
31252,
Aug.
17,
1988,
as
amended
at
62
FR
17931,
April
11,
1997]

§
700.45
Fee
payments.

(
a)
Persons
who
must
pay
fees.
Persons
submitting
a
section
5
notice
to
EPA
shall
remit
for
each
such
notice
the
appropriate
fee
identified
in
paragraph
(
b)
of
this
section
in
accordance
with
the
procedures
in
paragraph
(
e)
of
this
section.

(
b)
Fees.
Persons
shall
remit
fee
payments
to
EPA
as
follows:
(
1)
Small
business
concerns.
Small
business
concerns
shall
remit
a
fee
of
$
100
for
each
section
5
notice
submitted.

(
2)
Others.
Persons
other
than
small
business
concerns
shall
remit
fees
according
to
the
type
of
section
5
notice
as
follows:

(
i)
Premanufacture
notices
and
consolidated
premanufacture
notices.
Persons
shall
remit
a
fee
of
$
2,500
for
each
PMN
or
consolidated
PMN
submitted.

(
ii)
Intermediate
premanufacture
notices.
Persons
shall
remit
a
fee
of
$
1,000
for
each
intermediate
PMN.
However,
for
the
PMN
for
the
final
product
the
person
shall
submit
the
fee
in
paragraph
(
b)(
2)(
i)
of
this
section.

(
iii)
Significant
new
use
notices.
Persons
shall
remit
a
fee
of
$
2,500
for
each
significant
new
use
notice
submitted.

(
iv)
Exemption
applications.
Persons
shall
remit
a
fee
of
$
2,500
for
each
exemption
application
submitted
under
section
5(
h)(
2)
of
the
Act.

(
v)
Exemption
notices.
Persons
shall
remit
a
fee
of
$
2,500
for
each
exemption
notice
submitted
under
§
723.175
of
this
chapter.

(
vi)
MCAN
and
consolidated
MCAN.
Persons
shall
remit
a
fee
of
$
2,500
for
each
MCAN
or
consolidated
MCAN
submitted.

(
c)
No
fee
required.
Persons
are
exempt
from
remitting
any
fee
for
submissions
under
§
§
720.38,
723.50,
and
subparts
E,
F,
and
G
of
part
725
of
this
chapter.

(
d)
Joint
submitters.
Joint
submitters
of
a
section
5
notice
are
required
to
remit
the
appropriate
fee
identified
in
paragraph
(
b)
of
this
section
for
each
section
5
notice
regardless
of
the
number
of
joint
submitters
for
that
notice.
To
qualify
for
the
fee
identified
in
paragraph
(
b)(
1)
of
this
section,
each
joint
submitter
of
a
section
5
notice
must
qualify
as
a
small
business
concern
under
§
700.43.

(
e)
Remittance
procedure.
(
1)
Each
remittance
under
this
section
shall
be
in
United
States
currency
and
shall
be
paid
by
money
order,
bank
draft,
or
certified
check
drawn
to
the
order
of
the
Environmental
Protection
Agency.

(
2)
Each
remittance
shall
be
sent
to
the
Environmental
Protection
Agency,
HQ
Accounting
Operations
Branch
(
PM­
226),
P.
O.
360399M,
Pittsburgh,
PA
15251­
6399,
ATTN:
TSCA
User
Fee.

(
3)
Persons
who
submit
a
section
5
notice
shall
place
a
unique
identifying
number,
which
must
include
the
letters
"
TS"
followed
by
a
combination
of
6
numbers
(
letters
may
be
substituted
for
some
numbers),
on
the
front
page
of
each
section
5
notice
submitted.
The
same
identifying
number
and
the
submitter's
name
must
appear
on
the
corresponding
fee
remittance
under
this
section.
If
a
remittance
applies
to
more
than
one
section
5
notice,
the
person
shall
include
the
name
of
the
submitter,
the
identifying
number
for
each
section
5
notice
to
which
the
remittance
applies,
and
the
amount
of
the
remittance
which
applies
to
each
notice.
Any
remittance
not
having
the
identifying
name
and
number
described
above
will
be
returned
to
the
remitter.

(
4)(
i)
Each
person
who
remits
the
fee
identified
in
paragraph
(
b)(
1)
of
this
section
for
a
PMN,
consolidated
PMN,
intermediate
PMN,
or
significant
new
use
notice
shall
write
or
type
the
words,
"
The
company
named
in
part
1,
section
A
is
a
small
business
concern
under
40
CFR
700.43
and
has
remitted
a
fee
of
$
100
in
accordance
with
40
CFR
700.45(
b)."
under
"
CERTIFICATION"
on
Page
2
of
the
Premanufacture
Notice
for
New
Chemical
Substances
(
EPA
Form
7710­
25
(
4­
26­
83)).

(
ii)
Each
person
who
remits
the
fee
identified
in
paragraph
(
b)(
1)
of
this
section
for
an
exemption
application
under
section
5(
h)(
2)
of
the
Act
shall
include
the
words,
"
Each
company
identified
in
this
application
is
a
small
business
concern
under
40
CFR
700.43
and
has
remitted
a
fee
of
$
100
in
accordance
with
40
CFR
700.45(
b)."
in
the
exemption
application.

(
iii)
Each
person
who
remits
the
fee
identified
in
paragraph
(
b)(
1)
of
this
section
for
an
exemption
notice
under
§
723.175
of
this
chapter
shall
include
the
words,
"
Each
company
identified
in
this
notice
is
a
small
business
concern
under
40
CFR
700.43
and
has
remitted
a
fee
of
$
100
in
accordance
with
40
CFR
700.45(
b)."
in
the
certification
required
in
§
723.175(
i)(
1)(
x)
of
this
chapter.

(
iv)
Each
person
who
remits
the
fee
identified
in
paragraph
(
b)(
1)
of
this
section
for
a
MCAN
for
a
microorganism
shall
include
the
words,
"
The
company
identified
in
this
notice
is
a
small
business
concern
under
40
CFR
700.43
and
has
remitted
a
fee
of
$
100
in
accordance
with
40
CFR
700.45(
d),"
in
the
certification
required
in
§
725.25(
b)
of
this
chapter.

(
5)(
i)
Each
person
who
remits
a
fee
identified
in
paragraph
(
b)(
2)
of
this
section
for
a
PMN,
consolidated
PMN,
intermediate
PMN,
or
significant
new
use
notice
shall
write
or
type
the
words,
"
The
company
named
in
part
1,
section
A
has
remitted
the
fee
specified
in
40
CFR
700.45(
b)."
under
"
CERTIFICATION"
on
page
2
of
the
Premanufacture
Notice
for
New
Chemical
Substances
(
EPA
Form
7710­
25
(
4­
26­
83)).

(
ii)
Each
person
who
remits
the
fee
identified
in
paragraph
(
b)(
2)
of
this
section
for
an
exemption
application
under
section
(
5)(
h)(
2)
of
the
Act
shall
include
the
words,
"
Each
company
identified
in
this
application
has
remitted
a
fee
of
$
2,500
in
accordance
with
40
CFR
700.45(
b)."
in
the
exemption
application.

(
iii)
Each
person
who
remits
the
fee
identified
in
paragraph
(
b)(
2)
of
this
section
for
an
exemption
notice
under
§
723.175
of
this
chapter
shall
include
the
words,
"
Each
company
identified
in
this
notice
has
remitted
a
fee
of
$
2,500
in
accordance
with
40
CFR
700.45(
b)."
in
the
certification
required
in
§
723.175(
i)(
1)(
x)
of
this
chapter.
(
iv)
Each
person
who
remits
a
fee
identified
in
paragraph
(
b)(
2)
of
this
section
for
a
MCAN
for
a
microorganism
shall
include
the
words,
"
The
company
identified
in
this
notice
has
remitted
the
fee
specified
in
40
CFR
700.45(
b),"
in
the
certification
required
in
§
725.25(
b)
of
this
chapter.

(
f)
Fee
refunds.
EPA
will
refund
any
fee
paid
for
a
section
5
notice
whenever
the
Agency
determines:

(
1)
That
the
chemical
substance
that
is
the
subject
of
a
PMN,
intermediate
PMN,
exemption
application,
or
exemption
notice
is
not
a
new
chemical
substance
as
of
the
date
of
submission
of
the
notice.

(
2)
In
the
case
of
a
significant
new
use
notice,
that
the
notice
was
not
required.

(
3)
The
notice
is
incomplete
under
either
§
720.65(
c)
or
725.33,
of
this
chapter.

(
4)
That
as
of
the
date
of
submission
of
the
notice:
the
microorganism
that
is
the
subject
of
a
MCAN
is
not
a
new
microorganism;
nor
is
the
use
involving
the
microorganism
a
significant
new
use.

[
53
FR
31252,
Aug.
17,
1988,
as
amended
at
54
FR
21429,
May
18,
1989;
58
FR
34204,
June
23,
1993;
62
FR
17932,
April
11,
1997]

§
700.49
Failure
to
remit
fees.

EPA
will
not
consider
a
section
5
notice
to
be
complete
unless
the
appropriate
certification
under
§
700.45(
e)
is
included
and
until
the
appropriate
remittance
under
§
700.45(
b)
has
been
sent
to
EPA
as
provided
in
§
700.45(
e)
and
received
by
EPA.
EPA
will
notify
the
submitter
that
the
section
5
notice
is
incomplete
in
accordance
with
§
§
720.65(
c)
and
725.33
of
this
chapter.

[
62
FR
17932,
April
11,
1997]
Attachment
C
40
CFR
Part
720
40
CFR
Protection
of
Environment
CHAPTER
I
ENVIRONMENTAL
PROTECTION
AGENCY
(
CONTINUED)

SUBCHAPTER
R
­­
TOXIC
SUBSTANCES
CONTROL
ACT
PART
720
­­
PREMANUFACTURE
NOTIFICATION
Subpart
A
­­
General
Provisions
Sec.
720.1
Scope.
720.3
Definitions.
Subpart
B
­­
Applicability
720.22
Persons
who
must
report.
720.25
Determining
whether
a
chemical
substance
is
on
the
Inventory.
720.30
Chemicals
not
subject
to
notification
requirements.
720.36
Exemption
for
research
and
development.
720.38
Exemptions
for
test
marketing.

Subpart
C
­­
Notice
Form
720.40
General.
720.45
Information
that
must
be
included
in
the
notice
form.
720.50
Submission
of
test
data
and
other
data
concerning
the
health
and
environmental
effects
of
a
substance.
720.57
Imports.

Subpart
D
­­
Disposition
of
Notices
720.60
General.
720.62
Notice
that
notification
is
not
required.
720.65
Acknowledgment
of
receipt
of
a
notice;
errors
in
the
notice;
incomplete
submissions;
false
and
misleading
statements.
720.70
Notice
in
the
FEDERAL
REGISTER.
720.75
Notice
review
period.
720.78
Recordkeeping.

Subpart
E
­­
Confidentiality
and
Public
Access
to
Information
720.80
General
provisions.
720.85
Chemical
identity.
720.87
Categories
or
proposed
categories
of
uses
of
a
new
chemical
substance.
720.90
Data
from
health
and
safety
studies.
720.95
Public
file.

Subpart
F
­­
Commencement
of
Manufacture
or
Import
720.102
Notice
of
commencement
of
manufacture
or
import.
Subpart
G
­­
Compliance
and
Inspections
720.120
Compliance.
720.122
Inspections.

Authority:
15
U.
S.
C.
2604,
2607,
and
2613.

Source:
48
FR
21742,
May
13,
1983,
unless
otherwise
noted.

Subpart
A
­­
General
Provisions
§
720.1
Scope.
This
part
establishes
procedures
for
the
reporting
of
new
chemical
substances
by
manufacturers
and
importers
under
section
5
of
the
Toxic
Substances
Control
Act,
15
U.
S.
C.
2604.
This
part
applies
to
microorganisms
only
to
the
extent
provided
by
part
725
of
this
chapter.
The
rule
defines
the
persons
and
chemical
substances
subject
to
the
reporting
requirements,
prescribes
the
contents
of
section
5
notices,
and
establishes
procedures
for
submitting
notices.
The
rule
also
establishes
EPA
policy
regarding
claims
of
confidentiality
for,
and
public
disclosure
of,
various
categories
of
information
submitted
in
connection
with
section
5
notices.

[
48
FR
21742,
May
13,
1983,
as
amended
at
58
FR
34204,
June
23,
1993;
62
FR
17932,
April
11,
1997]

§
720.3
Definitions.

(
a)(
1)
For
the
purposes
of
this
part,
the
terms
cosmetic,
device,
drug,
food,
and
food
additive
have
the
meanings
contained
in
the
Federal
Food,
Drug,
and
Cosmetic
Act,
21
U.
S.
C.
321
et
seq.,
and
the
regulations
issued
under
it.
In
addition,
the
term
"
food"
includes
poultry
and
poultry
products,
as
defined
in
the
Poultry
Products
Inspection
Act,
21
U.
S.
C.
453
et
seq.;
meats
and
meat
food
products,
as
defined
in
the
Federal
Meat
Inspection
Act,
21
U.
S.
C.
60
et
seq.;
and
eggs
and
egg
products,
as
defined
in
the
Egg
Products
Inspection
Act,
21
U.
S.
C.
1033
et
seq.

(
2)
The
term
pesticide
has
the
meaning
contained
in
the
Federal
Insecticide,
Fungicide,
and
Rodenticide
Act,
7
U.
S.
C.
136
et
seq.
and
the
regulations
issued
under
it.

(
3)
The
terms
byproduct
material,
source
material,
and
special
nuclear
material
have
the
meanings
contained
in
the
Atomic
Energy
Act
of
1954,
42
U.
S.
C
2014
et
seq.
and
the
regulations
issued
under
it.

(
b)
Act
means
the
Toxic
Substances
Control
Act,
15
U.
S.
C.
2601
et
seq.

(
c)
Article
means
a
manufactured
item
(
1)
which
is
formed
to
a
specific
shape
or
design
during
manufacture,
(
2)
which
has
end
use
function(
s)
dependent
in
whole
or
in
part
upon
its
shape
or
design
during
end
use,
and
(
3)
which
has
either
no
change
of
chemical
composition
during
its
end
use
or
only
those
changes
of
composition
which
have
no
commercial
purpose
separate
from
that
of
the
article
and
that
may
occur
as
described
in
§
720.36(
g)(
5),
except
that
fluids
and
particles
are
not
considered
articles
regardless
of
shape
or
design.

(
d)
Byproduct
means
a
chemical
substance
produced
without
a
separate
commercial
intent
during
the
manufacture,
processing,
use,
or
disposal
of
another
chemical
substance
or
mixture.

(
e)
Chemical
substance
means
any
organic
or
inorganic
substance
of
a
particular
molecular
identity,
including
any
combination
of
such
substances
occurring
in
whole
or
in
part
as
a
result
of
a
chemical
reaction
or
occurring
in
nature,
and
any
chemical
element
or
uncombined
radical,
except
that
"
chemical
substance"
does
not
include:
(
1)
Any
mixture.
(
2)
Any
pesticide
when
manufactured,
processed,
or
distributed
in
commerce
for
use
as
a
pesticide.
(
3)
Tobacco
or
any
tobacco
product.
(
4)
Any
source
material,
special
nuclear
material,
or
byproduct
material.
(
5)
Any
pistol,
firearm,
revolver,
shells,
or
cartridges.
(
6)
Any
food,
food
additive,
drug,
cosmetic,
or
device,
when
manufactured,
processed,
or
distributed
in
commerce
for
use
as
a
food,
food
additive,
drug,
cosmetic,
or
device.

(
f)
Commerce
means
trade,
traffic,
transportation,
or
other
commerce
(
1)
between
a
place
in
a
State
and
any
place
outside
of
such
State,
or
(
2)
which
affects
trade,
traffic,
transportation,
or
commerce
between
a
place
in
a
State
and
any
place
outside
of
such
State.

(
g)
Customs
territory
of
the
United
States
means
the
50
States,
Puerto
Rico,
and
the
District
of
Columbia.

(
h)
Director
means
the
Director
of
the
EPA
Office
of
Pollution
Prevention
and
Toxics.

(
i)
Distribute
in
commerce
means
to
sell
in
commerce,
to
introduce
or
deliver
for
introduction
into
commerce,
or
to
hold
after
introduction
into
commerce.

(
j)
EPA
means
the
U.
S.
Environmental
Protection
Agency.

(
k)
Health
and
safety
study
or
study
means
any
study
of
any
effect
of
a
chemical
substance
or
mixture
on
health
or
the
environment
or
on
both,
including
underlying
data
and
epidemiological
studies,
studies
of
occupational
exposure
to
a
chemical
substance
or
mixture,
toxicological,
clinical,
and
ecological,
or
other
studies
of
a
chemical
substance
or
mixture,
and
any
test
performed
under
the
Act.
Chemical
identity
is
always
part
of
a
health
and
safety
study.

(
1)
Not
only
is
information
which
arises
as
a
result
of
a
formal,
disciplined
study
included,
but
other
information
relating
to
the
effects
of
a
chemical
substance
or
mixture
on
health
or
the
environment
is
also
included.
Any
data
that
bear
on
the
effects
of
a
chemical
substance
on
health
or
the
environment
would
be
included.

(
2)
Examples
include:
(
i)
Long­
and
short­
term
tests
of
mutagenicity,
carcinogenicity,
or
teratogenicity;
data
on
behavioral
disorders;
dermatoxicity;
pharmacological
effects;
mammalian
absorption,
distribution,
metabolism,
and
excretion;
cumulative,
additive,
and
synergistic
effects;
acute,
subchronic,
and
chronic
effects;
and
structure/
activity
analyses.

(
ii)
Tests
for
ecological
or
other
environmental
effects
on
invertebrates,
fish,
or
other
animals,
and
plants,
including:
Acute
toxicity
tests,
chronic
toxicity
tests,
critical
life
stage
tests,
behavioral
tests,
algal
growth
tests,
seed
germination
tests,
plant
growth
or
damage
tests,
microbial
function
tests,
bioconcentration
or
bioaccumulation
tests,
and
model
ecosystem
(
microcosm)
studies.

(
iii)
Assessments
of
human
and
environmental
exposure,
including
workplace
exposure,
and
impacts
of
a
particular
chemical
substance
or
mixture
on
the
environment,
including
surveys,
tests,
and
studies
of:
Biological,
photochemical,
and
chemical
degradation;
air,
water,
and
soil
transport;
biomagnification
and
bioconcentration;
and
chemical
and
physical
properties,
e.
g.,
boiling
point,
vapor
pressure,
evaporation
rates
from
soil
and
water,
octanol/
water
partition
coefficient,
and
water
solubility.

(
iv)
Monitoring
data,
when
they
have
been
aggregated
and
analyzed
to
measure
the
exposure
of
humans
or
the
environment
to
a
chemical
substance
or
mixture.

(
v)
Any
assessments
of
risk
to
health
and
the
environment
resulting
from
the
manufacture,
processing,
distribution
in
commerce,
use,
or
disposal
of
the
chemical
substance.

(
l)
Importer
means
any
person
who
imports
a
chemical
substance,
including
a
chemical
substance
as
part
of
a
mixture
or
article,
into
the
customs
territory
of
the
United
States.
"
Importer"
includes
the
person
primarily
liable
for
the
payment
of
any
duties
on
the
merchandise
or
an
authorized
agent
acting
on
his
or
her
behalf.
The
term
also
includes,
as
appropriate:

(
1)
The
consignee.
(
2)
The
importer
of
record.
(
3)
The
actual
owner
if
an
actual
owner's
declaration
and
superseding
bond
has
been
filed
in
accordance
with
19
CFR
141.20;
or
(
4)
The
transferee,
if
the
right
to
draw
merchandise
in
a
bonded
warehouse
has
been
transferred
in
accordance
with
subpart
C
of
19
CFR
part
144.
(
See
"
principal
importer.")

(
m)
Impurity
means
a
chemical
substance
which
is
unintentionally
present
with
another
chemical
substance.

(
n)
Intermediate
means
any
chemical
substance
that
is
consumed,
in
whole
or
in
part,
in
chemical
reactions
used
for
the
intentional
manufacture
of
another
chemical
substance(
s)
or
mixture(
s),
or
that
is
intentionally
present
for
the
purpose
of
altering
the
rates
of
such
chemical
reactions.

(
o)
Inventory
means
the
list
of
chemical
substances
manufactured
or
processed
in
the
United
States
that
EPA
compiled
and
keeps
current
under
section
8(
b)
of
the
Act.
(
p)
Known
to
or
reasonably
ascertainable
by
means
all
information
in
a
person's
possession
or
control,
plus
all
information
that
a
reasonable
person
similarly
situated
might
be
expected
to
possess,
control,
or
know.

(
q)
Manufacture
means
to
produce
or
manufacture
in
the
United
States
or
import
into
the
customs
territory
of
the
United
States.

(
r)
Manufacture
or
import
for
commercial
purposes
means:

(
1)
To
import,
produce,
or
manufacture
with
the
purpose
of
obtaining
an
immediate
or
eventual
commercial
advantage
for
the
manufacturer
or
importer,
and
includes,
among
other
things,
"
manufacture"
of
any
amount
of
a
chemical
substance
or
mixture:

(
i)
For
commercial
distribution,
including
for
test
marketing.

(
ii)
For
use
by
the
manufacturer,
including
use
for
product
research
and
development
or
as
an
intermediate.

(
2)
The
term
also
applies
to
substances
that
are
produced
coincidentally
during
the
manufacture,
processing,
use,
or
disposal
of
another
substance
or
mixture,
including
byproducts
that
are
separated
from
that
other
substance
or
mixture
and
impurities
that
remain
in
that
substance
or
mixture.
Byproducts
and
impurities
without
separate
commercial
value
are
nonetheless
produced
for
the
purpose
of
obtaining
a
commercial
advantage,
since
they
are
part
of
the
manufacture
of
a
chemical
substance
for
commercial
purposes.

(
s)
Manufacture
solely
for
export
means
to
manufacture
or
import
for
commercial
purposes
a
chemical
substance
solely
for
export
from
the
United
States
under
the
following
restrictions
on
activities
in
the
United
States:

(
1)
Distribution
in
commerce
is
limited
to
purposes
of
export
or
processing
solely
for
export
as
defined
in
§
721.3
of
this
chapter.
(
2)
The
manufacturer
or
importer,
and
any
person
to
whom
the
substance
is
distributed
for
purposes
of
export
or
processing
solely
for
export
(
as
defined
in
§
721.3
of
this
chapter),
may
not
use
the
substance
except
in
small
quantities
solely
for
research
and
development
in
accordance
with
§
720.36.

(
t)
Manufacturer
means
a
person
who
imports,
produces,
or
manufactures
a
chemical
substance.
A
person
who
extracts
a
component
chemical
substance
from
a
previously
existing
chemical
substance
or
a
complex
combination
of
substances
is
a
manufacturer
of
that
component
chemical
substance.
A
person
who
contracts
with
a
manufacturer
to
manufacture
or
produce
a
chemical
substance
is
also
a
manufacturer
if
(
1)
the
manufacturer
manufactures
or
produces
the
substance
exclusively
for
that
person,
and
(
2)
that
person
specifies
the
identity
of
the
substance
and
controls
the
total
amount
produced
and
the
basic
technology
for
the
plant
process.

(
u)
Mixture
means
any
combination
of
two
or
more
chemical
substances
if
the
combination
does
not
occur
in
nature
and
is
not,
in
whole
or
in
part,
the
result
of
a
chemical
reaction;
except
"
mixture"
does
include
(
1)
any
combination
which
occurs,
in
whole
or
in
part,
as
a
result
of
a
chemical
reaction
if
the
combination
could
have
been
manufactured
for
commercial
purposes
without
a
chemical
reaction
at
the
time
the
chemical
substances
comprising
the
combination
were
combined,
and
if
all
of
the
chemical
substances
comprising
the
combination
are
not
new
chemical
substances,
and
(
2)
hydrates
of
a
chemical
substance
or
hydrated
ions
formed
by
association
of
a
chemical
substance
with
water,
so
long
as
the
nonhydrated
form
is
itself
not
a
new
chemical
substance.

(
v)
New
chemical
substance
means
any
chemical
substance
which
is
not
included
on
the
Inventory.

(
w)
Nonisolated
intermediate
means
any
intermediate
that
is
not
intentionally
removed
from
the
equipment
in
which
it
is
manufactured,
including
the
reaction
vessel
in
which
it
is
manufactured,
equipment
which
is
ancillary
to
the
reaction
vessel,
and
any
equipment
through
which
the
chemical
substance
passes
during
a
continuous
flow
process,
but
not
including
tanks
or
other
vessels
in
which
the
substance
is
stored
after
its
manufacture.

(
x)
Person
means
any
natural
person,
firm,
company,
corporation,
joint­
venture,
partnership,
sole
proprietorship,
association,
or
any
other
business
entity,
any
State
or
political
subdivision
thereof,
any
municipality,
any
interstate
body,
and
any
department,
agency
or
instrumentality
of
the
Federal
Government.

(
y)
Possession
or
control
means
in
possession
or
control
of
the
submitter,
or
of
any
subsidiary,
partnership
in
which
the
submitter
is
a
general
partner,
parent
company,
or
any
company
or
partnership
which
the
parent
company
owns
or
controls,
if
the
subsidiary,
parent
company,
or
other
company
or
partnership
is
associated
with
the
submitter
in
the
research,
development,
test
marketing,
or
commercial
marketing
of
the
chemical
substance
in
question.
(
A
parent
company
owns
or
controls
another
company
if
the
parent
owns
or
controls
50
percent
or
more
of
the
other
company's
voting
stock.
A
parent
company
owns
or
controls
any
partnership
in
which
it
is
a
general
partner).
Information
is
included
within
this
definition
if
it
is:

(
1)
In
files
maintained
by
submitter's
employees
who
are:

(
i)
Associated
with
research,
development,
test
marketing,
or
commercial
marketing
of
the
chemical
substance
in
question.

(
ii)
Reasonably
likely
to
have
such
data.

(
2)
Maintained
in
the
files
of
other
agents
of
the
submitter
who
are
associated
with
research,
development,
test
marketing,
or
commercial
marketing
of
the
chemical
substance
in
question
in
the
course
of
their
employment
as
such
agents.

(
z)
Principal
importer
means
the
first
importer
who,
knowing
that
a
new
chemical
substance
will
be
imported
rather
than
manufactured
domestically,
specifies
the
identity
of
the
chemical
substance
and
the
total
amount
to
be
imported.
Only
persons
who
are
incorporated,
licensed,
or
doing
business
in
the
United
States
may
be
principal
importers.

(
aa)
Process
means
the
preparation
of
a
chemical
substance
or
mixture,
after
its
manufacture,
for
distribution
in
commerce
(
1)
in
the
same
form
or
physical
state
as,
or
in
a
different
form
or
physical
state
from,
that
in
which
it
was
received
by
the
person
so
preparing
such
substance
or
mixture,
or
(
2)
as
part
of
a
mixture
or
article
containing
the
chemical
substance
or
mixture.

(
bb)
Processor
means
any
person
who
processes
a
chemical
substance
or
mixture.

(
cc)
Small
quantities
solely
for
research
and
development
(
or
"
small
quantities
solely
for
purposes
of
scientific
experimentation
or
analysis
or
chemical
research
on,
or
analysis
of,
such
substance
or
another
substance,
including
such
research
or
analysis
for
the
development
of
a
product")
means
quantities
of
a
chemical
substance
manufactured,
imported,
or
processed
or
proposed
to
be
manufactured,
imported,
or
processed
solely
for
research
and
development
that
are
not
greater
than
reasonably
necessary
for
such
purposes.

(
dd)
State
means
any
State
of
the
United
States
and
the
District
of
Columbia,
the
Commonwealth
of
Puerto
Rico,
the
Virgin
Islands,
Guam,
the
Canal
Zone,
American
Samoa,
the
Northern
Mariana
Islands,
and
any
other
territory
or
possession
of
the
United
States.

(
ee)
Technically
qualified
individual
means
a
person
or
persons
(
1)
who,
because
of
education,
training,
or
experience,
or
a
combination
of
these
factors,
is
capable
of
understanding
the
health
and
environmental
risks
associated
with
the
chemical
substance
which
is
used
under
his
or
her
supervision,
(
2)
who
is
responsible
for
enforcing
appropriate
methods
of
conducting
scientific
experimentation,
analysis,
or
chemical
research
to
minimize
such
risks,
and
(
3)
who
is
responsible
for
the
safety
assessments
and
clearances
related
to
the
procurement,
storage,
use,
and
disposal
of
the
chemical
substance
as
may
be
appropriate
or
required
within
the
scope
of
conducting
a
research
and
development
activity.

(
ff)
Test
data
means
data
from
a
formal
or
informal
test
or
experiment,
including
information
concerning
the
objectives,
experimental
methods
and
materials,
protocols,
results,
data
analyses,
recorded
observations,
monitoring
data,
measurements,
and
conclusions
from
a
test
or
experiment.

(
gg)
Test
marketing
means
the
distribution
in
commerce
of
no
more
than
a
predetermined
amount
of
a
chemical
substance,
mixture,
or
article
containing
that
chemical
substance
or
mixture,
by
a
manufacturer
or
processor,
to
no
more
than
a
defined
number
of
potential
customers
to
explore
market
capability
in
a
competitive
situation
during
a
predetermined
testing
period
prior
to
the
broader
distribution
of
that
chemical
substance,
mixture,
or
article
in
commerce.

(
hh)
United
States,
when
used
in
the
geographic
sense,
means
all
of
the
States.
[
48
FR
21742,
May
13,
1983,
as
amended
at
51
FR
15101,
Apr.
22,
1986]
Subpart
B
­­
Applicability
§
720.22
Persons
who
must
report.

(
a)(
1)
Any
person
who
intends
to
manufacture
a
new
chemical
substance
in
the
United
States
for
commercial
purposes
must
submit
a
notice
unless
the
substance
is
excluded
under
§
720.30.

(
2)
If
a
person
contracts
with
a
manufacturer
to
manufacture
or
produce
a
new
chemical
substance,
and
(
i)
the
manufacturer
manufactures
or
produces
the
substance
exclusively
for
that
person,
and
(
ii)
that
person
specifies
the
identity
of
the
substance,
and
controls
the
total
amount
produced
and
the
basic
technology
for
the
plant
process,
that
person
must
submit
the
notice.
If
it
is
unclear
who
must
report,
EPA
should
be
contacted
to
determine
who
must
submit
the
notice.

(
3)
Only
manufacturers
that
are
incorporated,
licensed,
or
doing
business
in
the
United
States
may
submit
a
notice.

(
b)(
1)
Any
person
who
intends
to
import
a
new
chemical
substance
into
the
United
States
for
commercial
purposes
must
submit
a
notice,
unless
the
substance
is
excluded
under
§
720.30
or
unless
the
substance
is
imported
as
part
of
an
article.

(
2)
When
several
persons
are
involved
in
an
import
transaction,
the
notice
must
be
submitted
by
the
principal
importer.
If
no
one
person
fits
the
principal
importer
definition
in
a
particular
transaction,
the
importer
should
contact
EPA
to
determine
who
must
submit
the
notice
for
that
transaction.

§
720.25
Determining
whether
a
chemical
substance
is
on
the
Inventory.

(
a)
A
new
chemical
substance
is
any
chemical
substance
that
is
not
currently
listed
on
the
Inventory.

(
b)(
1)
A
chemical
substance
is
listed
in
the
public
portion
of
the
Inventory
by
a
specific
chemical
name
(
either
a
Chemical
Abstracts
(
CA)
Index
Name
or
a
CA
Preferred
Name)
and
a
Chemical
Abstracts
Service
(
CAS)
Registry
Number
if
its
identity
is
not
confidential.
If
its
identity
is
confidential,
it
is
listed
in
the
public
portion
of
the
Inventory
by
a
TSCA
Accession
Number
and
a
generic
chemical
name
that
masks
the
specific
substance
identity.
The
confidential
substance
is
listed
by
its
specific
chemical
name
only
in
the
confidential
portion
of
the
Inventory,
which
is
not
available
to
the
public.
A
person
who
intends
to
manufacture
or
import
a
chemical
substance
not
listed
by
specific
chemical
name
in
the
public
portion
of
the
Inventory
may
ask
EPA
whether
the
substance
is
included
in
the
confidential
Inventory.
EPA
will
answer
such
an
inquiry
only
if
EPA
determines
that
the
person
has
a
bona
fide
intent
to
manufacture
or
import
the
chemical
substance
for
commercial
purposes.

(
2)
To
establish
a
bona
fide
intent
to
manufacture
or
import
a
chemical
substance,
the
person
who
proposes
to
manufacture
or
import
the
substance
must
submit
to
EPA:
(
i)
Except
as
provided
in
paragraphs
(
b)(
3)
(
i)
and
(
ii)
of
this
section,
the
specific
chemical
identity
of
the
substance
that
the
person
intends
to
manufacture
or
import,
using
the
currently,
correct
CA
name
for
the
substance
and
the
other
correct
chemical
identity
information
in
accordance
with
§
§
720.45(
a)
(
1),
(
2),
and
(
3).

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

(
iii)(
A)
A
brief
description
of
the
research
and
development
activities
conducted
to
date
related
to
the
substance,
including
the
year
in
which
the
person
first
started
to
conduct
research
or
development
activity
on
the
substance,
and
the
general
types
of
research
and
development
activities
conducted
thus
far
(
e.
g.,
synthesis,
substance
isolation/
purification,
formulating,
product
development,
process
development,
end­
use
application,
toxicity
testing,
etc.).
The
person
must
also
indicate
whether
any
pilot
plant
or
production­
scale
plant
evaluations
have
been
conducted
involving
the
manufacture
or
processing
of
the
substance.

(
B)
If
an
importer
is
unable
to
provide
the
information
requested
in
paragraph
(
b)(
2)(
iii)(
A)
of
this
section
from
the
foreign
manufacturer
or
supplier,
the
following
information
shall
be
submitted:

(
1)
A
brief
statement
indicating
how
long
the
substance
has
been
in
commercial
use
outside
of
the
United
States.

(
2)
The
name
of
a
country
in
which
it
has
been
commercially
used.

(
3)
Whether
the
importer
believes
that
the
substance
has
already
been
used
commercially,
in
any
country,
for
the
same
purpose
or
application
that
the
importer
is
intending.

(
iv)
A
specific
description
of
the
major
intended
application
or
use
of
the
substance.

(
v)
An
infrared
spectrum
of
the
substance,
or
alternative
spectra
or
other
data
which
identify
the
substance
if
infrared
analysis
is
not
suitable
for
the
substance
or
does
not
yield
a
reasonable
amount
of
structural
information.
When
using
alternative
spectra
or
instrumental
analysis,
the
person
must
submit
a
spectrum
or
instrumental
readout
for
the
substance.

(
vi)
The
estimated
date
(
month/
year)
in
which
the
person
intends
to
submit
a
Premanufacture
Notice
(
PMN)
for
this
substance
if
EPA
informs
the
notice
submitter
that
the
substance
is
not
on
the
Inventory.

(
vii)
The
address
of
the
facility
under
the
control
of
the
submitter
at
which
the
manufacture
or
processing
of
the
substance
would
most
likely
occur.
For
an
imported
substance,
the
facility
under
the
control
of
the
importer
at
which
processing
of
the
substance
would
likely
occur,
if
any.

(
viii)(
A)
For
substances
intended
to
be
manufactured
in
the
United
States,
a
description
of
the
most
probable
manufacturing
process
that
would
be
used
by
the
submitter
to
produce
the
substance
for
non­
exempt
commercial
purposes.
(
B)
For
substances
intended
to
be
imported,
a
brief
description
of
how
the
submitter
is
most
likely
to
process
or
use
the
substance
for
a
commercial
purpose.
If
the
substance
is
not
expected
to
be
processed
or
used
at
any
facility
under
the
importer's
control,
a
statement
to
this
effect
must
be
included
along
with
a
description
of
how
the
substance
will
be
processed
or
used
at
sites
controlled
by
others,
if
this
information
is
known
or
reasonably
ascertainable.

(
3)(
i)
If
an
importer
cannot
provide
the
chemical
identity
information
required
by
paragraph
(
b)(
2)
(
i)
and
(
v)
of
this
section
because
it
is
claimed
confidential
by
its
foreign
manufacturer
or
supplier,
the
foreign
manufacturer
or
supplier
must
supply
the
required
information
directly
to
EPA
in
accordance
with
§
720.45(
a)
(
1),
(
2),
and
(
3)
and
reference
the
importer's
notice.
If
the
appropriate
supporting
document
from
the
foreign
party
is
not
received
within
30
days
after
EPA
receives
the
importer's
notice,
the
notice
will
be
considered
incomplete.

(
ii)
If
a
manufacturer
cannot
provide
all
of
the
required
information
in
accordance
with
§
720.45(
a)
(
1),
(
2),
and
(
3)
because
the
new
chemical
substance
is
manufactured
using
a
reactant
that
has
a
specific
chemical
identity
claimed
as
confidential
by
its
supplier,
the
notice
must
contain
chemical
identity
information
that
is
as
complete
as
known
by
the
manufacturer.
In
addition,
a
letter
of
support
for
the
notice
must
then
be
sent
to
EPA
by
the
chemical
supplier
of
the
confidential
reactant,
providing
the
specific
chemical
identity
of
the
proprietary
reactant.
The
letter
of
support
must
reference
the
manufacturer's
notice.
If
the
appropriate
supporting
document
from
the
supplier
is
not
received
within
30
days
after
EPA
receives
the
manufacturer's
notice,
the
notice
will
be
considered
incomplete.

(
4)
EPA
will
review
the
information
submitted
by
the
proposed
manufacturer
or
importer
under
this
paragraph
to
determine
whether
it
has
a
bona
fide
intent
to
manufacture
or
import
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).

(
5)
If
the
proposed
manufacturer
or
importer
has
shown
a
bona
fide
intent
to
manufacture
or
import
the
substance,
and
provide
sufficient
unambiguous
chemical
identity
information
so
EPA
can
make
a
conclusive
determination
of
the
chemical
substance's
Inventory
status,
EPA
will
search
the
confidential
Inventory
and
inform
the
proposed
manufacturer
or
importer
whether
the
chemical
substance
is
on
the
confidential
Inventory.

(
6)
If
the
chemical
substance
is
found
on
the
confidential
Inventory,
EPA
will
notify
the
person(
s)
who
originally
reported
the
chemical
substance
that
another
person
has
demonstrated
a
bona
fide
intent
to
manufacture
or
import
the
substance
and
therefore
was
told
that
the
chemical
substance
is
on
the
Inventory.

(
7)
A
disclosure
of
a
confidential
chemical
identity
to
a
person
with
a
bona
fide
intent
to
manufacture
or
import
the
particular
chemical
substance
will
not
be
considered
a
public
disclosure
of
confidential
business
information
under
section
14
of
the
Act.

(
8)
EPA
will
answer
an
inquiry
on
whether
a
particular
chemical
substance
is
on
the
confidential
Inventory
within
30
days
after
receipt
of
a
complete
submission
under
paragraph
(
b)(
2)
of
this
section.

(
9)
If
the
required
chemical
identity
information
has
not
been
reported
correctly
or
completely
in
the
notice
(
except
as
provided
under
paragraph
(
b)(
3)(
ii)
of
this
section)
or
if
any
other
required
data
or
information
has
been
omitted
or
is
incomplete,
EPA
will
consider
the
whole
notice
to
be
incomplete.
As
soon
as
an
incomplete
notice
is
identified
as
such
by
EPA,
the
Agency
will
immediately
return
the
notice
directly
to
the
submitter.
The
submitter
must
then
resubmit
the
whole,
completed
bona
fide
notice
to
EPA
in
order
to
have
the
Agency
perform
the
desired
Inventory
search
and
respond
to
the
notice.

[
48
FR
21742,
May
13,
1983,
as
amended
at
58
FR
34204,
June
23,
1993;
60
FR
16309,
Mar.
29,
1995]

§
720.30
Chemicals
not
subject
to
notification
requirements.

The
following
substances
are
not
subject
to
the
notification
requirements
of
this
part:

(
a)
Any
substance
which
is
not
a
"
chemical
substance"
as
defined
in
§
720.3(
e).

(
b)
Any
mixture
as
defined
in
§
720.3(
u).
A
new
chemical
substance
that
is
manufactured
or
imported
as
part
of
a
mixture
is
subject
to
the
requirements
of
this
part.
This
exclusion
applies
only
to
a
mixture
as
a
whole
and
not
to
any
chemical
substances
which
are
part
of
the
mixture.

(
c)
Any
new
chemical
substance
which
will
be
manufactured
or
imported
in
small
quantities
solely
for
research
and
development
under
§
720.36.

(
d)
Any
new
chemical
substance
which
will
be
manufactured
or
imported
solely
for
test­
marketing
purposes
under
an
exemption
granted
under
§
720.38.

(
e)
Any
new
chemical
substance
manufactured
solely
for
export
if,
when
the
substance
is
distributed
in
commerce:

(
1)
The
substance
is
labeled
in
accordance
with
section
12(
a)(
1)(
B)
of
the
Act.
(
2)
The
manufacturer
knows
that
the
person
to
whom
the
substance
is
being
distributed
intends
to
export
it
or
process
it
solely
for
export
as
defined
in
§
721.3
of
this
chapter.

(
f)
Any
new
chemical
substance
which
is
manufactured
or
imported
under
the
terms
of
a
rule
promulgated
under
section
5(
h)(
4)
of
the
Act.

(
g)
Any
byproduct
if
its
only
commercial
purpose
is
for
use
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.
(
This
exclusion
only
applies
to
the
byproduct;
it
does
not
apply
to
the
component
substances
extracted
from
the
byproduct.)

(
h)
The
chemical
substances
described
below:
(
Although
they
are
manufactured
for
commercial
purposes
under
the
Act,
they
are
not
manufactured
for
distribution
in
commerce
as
chemical
substances
per
se
and
have
no
commercial
purpose
separate
from
the
substance,
mixture,
or
article
of
which
they
are
a
part.)

(
1)
Any
impurity.
(
2)
Any
byproduct
which
is
not
used
for
commercial
purposes.
(
3)
Any
chemical
substance
which
results
from
a
chemical
reaction
that
occurs
incidental
to
exposure
of
another
chemical
substance,
mixture,
or
article
to
environmental
factors
such
as
air,
moisture,
microbial
organisms,
or
sunlight.
(
4)
Any
chemical
substance
which
results
from
a
chemical
reaction
that
occurs
incidental
to
storage
or
disposal
of
another
chemical
substance,
mixture,
or
article.
(
5)
Any
chemical
substance
which
results
from
a
chemical
reaction
that
occurs
upon
end
use
of
another
chemical
substance,
mixture,
or
article
such
as
an
adhesive,
paint,
miscellaneous
cleanser
or
other
housekeeping
product,
fuel
additive,
water
softening
and
treatment
agent,
photographic
film,
battery,
match,
or
safety
flare,
and
which
is
not
itself
manufactured
or
imported
for
distribution
in
commerce
or
for
use
as
an
intermediate.
(
6)
Any
chemical
substance
which
results
from
a
chemical
reaction
that
occurs
upon
use
of
curable
plastic
or
rubber
molding
compounds,
inks,
drying
oils,
metal
finishing
compounds,
adhesives,
or
paints,
or
any
other
chemical
substance
formed
during
the
manufacture
of
an
article
destined
for
the
marketplace
without
further
chemical
change
of
the
chemical
substance
except
for
those
chemical
changes
that
occur
as
described
elsewhere
in
this
paragraph.
(
7)
Any
chemical
substance
which
results
from
a
chemical
reaction
that
occurs
when
(
i)
a
stabilizer,
colorant,
odorant,
antioxidant,
filler,
solvent,
carrier,
surfactant,
plasticizer,
corrosion
inhibitor,
antifoamer
or
defoamer,
dispersant,
precipitation
inhibitor,
binder,
emulsifier,
deemulsifier,
dewatering
agent,
agglomerating
agent,
adhesion
promoter,
flow
modifier,
pH
neutralizer,
sequesterant,
coagulant,
flocculant,
fire
retardant,
lubricant,
chelating
agent,
or
quality
control
reagent
functions
as
intented,
or
(
ii)
a
chemical
substance,
which
is
intended
solely
to
impart
a
specific
physiochemical
characteristic,
functions
as
intended.
(
8)
Any
nonisolated
intermediate.

(
i)
Any
chemical
substance
which
is
manufactured
solely
for
non­
commercial
research
and
development
purposes.
Non­
commercial
research
and
development
purposes
include
scientific
experimentation,
research,
or
analysis
conducted
by
academic,
government,
or
independent
not­
for­
profit
research
organizations
(
e.
g.,
universities,
colleges,
teaching
hospitals,
and
research
institutes),
unless
the
activity
is
for
eventual
commercial
purposes.

[
48
FR
21742,
May
13,
1983,
as
amended
at
51
FR
15101,
Apr.
22,
1986]

§
720.36
Exemption
for
research
and
development.

(
a)
This
part
does
not
apply
to
a
chemical
substance
if
the
following
conditions
are
met:
(
1)
The
chemical
substance
is
manufactured
or
imported
only
in
small
quantities
solely
for
research
and
development.
(
2)
The
manufacturer
or
importer
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
or
importer
must
review
and
evaluate
the
following
information
to
determine
whether
there
is
reason
to
believe
there
is
any
potential
risk
to
health
which
may
be
associated
with
the
chemical
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
or
importer
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
sections
4,
5,
or
6
of
the
Act
that
applies
to
the
substance
and
of
which
the
manufacturer
or
importer
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,
a
laboratory
is
a
contained
research
facility
where
relatively
small
quantities
of
chemical
substances
are
used
on
a
non­
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
or
importer
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
or
importer
has
reason
to
believe
may
be
associated
with
the
substance,
as
determined
under
paragraph
(
b)(
1)
of
this
section.

(
2)
If
the
manufacturer
or
importer
distributes
a
chemical
substance
manufactured
or
imported
under
this
section
to
persons
not
in
its
employ,
the
manufacturer
or
importer
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
or
importer.

(
d)
A
chemical
substance
is
not
exempt
from
reporting
under
this
part
if
any
amount
of
the
substance,
including
as
part
of
a
mixture,
is
processed,
distributed
in
commerce,
or
used,
for
any
commercial
purpose
other
than
research
and
development,
except
where
the
chemical
substance
is
processed,
distributed
in
commerce,
or
used
only
as
an
impurity
or
as
part
of
an
article.

(
e)
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,
or
(
2)
Used
for
the
following
commercial
purposes:

(
i)
Burning
it
as
a
fuel.
(
ii)
Reacting
or
otherwise
processing
it
to
form
other
chemical
substances
for
commercial
purposes,
including
extracting
component
chemical
substances.

(
f)
Quantities
of
research
and
development
substances
existing
solely
as
impurities
in
a
product
or
incorporated
into
an
article,
in
accordance
with
paragraph
(
d)
of
this
section,
and
quantities
of
research
and
development
substances
used
solely
for
commercial
purposes
listed
in
paragraph
(
e)
of
this
section,
are
not
subject
to
the
requirements
of
paragraphs
(
a),
(
b),
and
(
c)
of
this
section,
once
research
and
development
activities
have
been
completed.

(
g)
A
person
who
manufactures
or
imports
a
chemical
substance
in
small
quantities
solely
for
research
and
development
is
not
required
to
comply
with
the
requirements
of
this
section
if
the
person's
exclusive
intention
is
to
perform
research
and
development
activities
solely
for
the
purpose
of
determining
whether
the
substance
can
be
used
as
a
pesticide.

[
51
FR
15102,
Apr.
22,
1986]

§
720.38
Exemptions
for
test
marketing.

(
a)
Any
person
may
apply
for
an
exemption
to
manufacture
or
import
a
new
chemical
substance
for
test
marketing.
EPA
may
grant
the
exemption
if
the
person
demonstrates
that
the
chemical
substance
will
not
present
an
unreasonable
risk
to
injury
to
health
or
the
environment
as
a
result
of
the
test
marketing.

(
b)
Persons
applying
for
a
test­
marketing
exemption
should
provide
the
following
information:

(
1)
All
existing
data
regarding
health
and
environmental
effects
of
the
chemical
substance,
including
physical/
chemical
properties
or,
in
the
absence
of
such
data,
a
discussion
of
toxicity
based
on
structure­
activity
relationships
(
SAR)
and
relevant
data
on
chemical
analogues.
(
2)
The
maximum
quantity
of
the
chemical
substance
which
the
applicant
will
manufacture
or
import
for
test
marketing.
(
3)
The
maximum
number
of
persons
who
may
be
provided
the
chemical
substance
during
test
marketing.
(
4)
The
maximum
number
of
persons
who
may
be
exposed
to
the
chemical
substance
as
a
result
of
test
marketing,
including
information
regarding
duration
and
route
of
such
exposures.
(
5)
A
description
of
the
test­
marketing
activity,
including
its
length
and
how
it
can
be
distinguished
from
full­
scale
commercial
production
and
research
and
development.

(
c)
In
accordance
with
section
5(
h)(
6)
of
the
Act,
after
EPA
receives
an
application
for
exemption
under
this
section,
the
Agency
will
file
with
the
Office
of
the
Federal
Register
a
notice
containing
a
summary
of
the
information
provided
in
the
application,
to
the
extent
it
has
not
been
claimed
confidential.

(
d)
No
later
than
45
days
after
EPA
receives
an
application,
the
Agency
will
either
approve
or
deny
the
application.
Thereafter,
EPA
will
publish
a
notice
in
the
FEDERAL
REGISTER
explaining
the
reasons
for
approval
or
denial.

(
e)
In
approving
an
application
for
exemption,
EPA
may
impose
any
restrictions
necessary
to
ensure
that
the
substance
will
not
present
an
unreasonable
risk
of
injury
to
health
and
the
environment
as
a
result
of
test
marketing.

[
48
FR
21742,
May
13,
1983,
as
amended
at
58
FR
34204,
June
23,
1993]

Subpart
C
­­
Notice
Form
§
720.40
General.

(
a)
Use
of
the
notice
form;
electronic
submissions.
(
1)
Each
person
who
is
required
by
subpart
B
of
this
part
to
submit
a
notice
must
complete,
sign,
and
submit
a
notice
containing
the
information
in
the
form
and
manner
specified
in
this
paragraph.
The
information
submitted
and
all
attachments
(
unless
the
attachment
appears
in
the
open
scientific
literature)
must
be
in
English.
All
information
submitted
must
be
true
and
correct.

(
2)
Information
may
be
submitted
on
paper,
or
electronically,
as
follows:

(
i)
Information
submitted
on
paper
must
be
submitted
in
the
form
and
manner
set
forth
in
EPA
Form
No.
7710­
25,
which
is
available
from
the
Environmental
Assistance
Division
(
7408),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
Information
which
is
not
submitted
on
the
EPA
Form
No.
7710­
25
or
a
photocopy
thereof
(
e.
g.,
on
a
form
created
by
commercial
form­
making
software)
must
be
in
a
format
pre­
approved
by
the
Agency.
(
ii)
Information
may
be
submitted
electronically
(
on
magnetic
or
other
media)
pursuant
to
an
EPA
published
format
for
electronic
submissions.
Such
submissions
must
comply
with
this
format
and
all
other
media
specifications
published
by
EPA.
Persons
submitting
electronically
must
still
complete
and
submit
on
paper
the
Certification
and
Submitter
Identification
sections
of
Form
7710­
25.

(
b)
When
to
submit
a
notice.
Each
person
who
is
required
to
submit
a
notice
must
submit
the
notice
at
least
90
calendar
days
before
manufacture
or
import
of
the
new
chemical
substance
for
commercial
purposes
begins.

(
c)
Where
to
submit
a
notice.
Each
person
who
submits
a
notice
must
submit
it
to
the
address
listed
on
the
notice
form.

(
d)
General
notice
requirements.
(
1)
Each
person
who
submits
a
notice
must
provide
the
information
described
in
§
720.45
and
specified
on
the
notice
form,
to
the
extent
such
information
is
known
to
or
reasonably
ascertainable
by
the
person.
In
accordance
with
§
720.50,
the
notice
must
also
include
any
test
data
in
the
person's
possession
or
control,
and
descriptions
of
other
data
which
are
known
to
or
reasonably
ascertainable
by
the
person
and
which
concern
the
health
and
environmental
effects
of
the
new
chemical
substance.

(
2)
A
person
who
submits
a
notice
to
EPA
under
this
part
must
provide
EPA
with
an
original
and
two
complete
copies
of
the
notice,
including
all
test
data
and
any
other
information
attached
to
the
notice
form.
If
information
is
claimed
as
confidential
pursuant
to
§
720.80,
a
sanitized
copy
must
also
be
provided.

(
e)
Agency
or
joint
submissions.
(
1)
A
manufacturer
or
importer
may
designate
an
agent
to
submit
the
notice.
Both
the
manufacturer
or
importer
and
the
agent
must
sign
the
certification
on
the
form.

(
2)
A
manufacturer
or
importer
may
authorize
another
person,
(
e.
g.,
a
foreign
manufacturer
or
supplier,
or
a
toll
manufacturer)
to
report
some
of
the
information
required
in
the
notice
to
EPA
on
its
behalf.
If
separate
portions
of
a
joint
notice
are
not
submitted
together,
the
submitter
should
indicate
which
information
will
be
supplied
by
another
person
and
identify
that
person.
The
other
person
must
submit
the
information
on
the
appropriate
part
of
the
notice
form.
The
manufacturer
or
importer
and
any
other
person
supplying
the
information
must
sign
the
certification
provided
on
their
respective
notice
forms.

(
3)
If
EPA
receives
a
submission
which
does
not
include
information
required
by
this
rule,
which
the
submitter
indicates
that
it
has
authorized
another
person
to
provide,
the
notice
review
period
will
not
begin
until
EPA
receives
that
information.

(
f)
New
information.
During
the
notice
review
period,
if
the
submitter
possesses,
controls,
or
knows
of
new
information
that
materially
adds
to,
changes,
or
otherwise
makes
significantly
more
complete
the
information
included
in
the
notice,
the
submitter
must
that
information
to
the
address
listed
on
the
notice
form
within
ten
days
of
receiving
the
new
information,
but
no
later
than
five
days
before
the
end
of
the
notice
review
period.
The
new
submission
must
clearly
identify
the
submitter
and
the
notice
to
which
the
new
information
is
related.
If
the
new
information
becomes
available
during
the
last
five
days
of
the
notice
review
period,
the
submitter
must
immediately
inform
its
EPA
contract
for
that
notice
by
telephone.

(
g)
Chemical
substances
subject
to
a
section
4
test
rule.
(
1)
Except
as
provided
in
paragraph
(
g)(
3)
of
this
section,
if
(
i)
A
person
intends
to
manufacture
or
import
a
new
chemical
substance
which
is
subject
to
the
notification
requirements
of
this
part,
and
(
ii)
The
chemical
substance
is
subject
to
a
test
rule
promulgated
under
section
4
of
the
Act
before
the
notice
is
submitted,
section
5(
b)(
1)
of
the
Act
requires
the
person
to
submit
the
test
data
required
by
the
testing
rule
with
the
notice.
The
person
must
submit
the
data
in
the
form
and
manner
specified
in
the
test
rule
and
in
accordance
with
§
720.50.
If
the
person
does
not
submit
the
test
data,
the
submission
is
incomplete
and
EPA
will
follow
the
procedures
in
§
720.65.

(
2)
If
EPA
has
granted
the
submitter
an
exemption
under
section
4(
c)
of
the
Act
from
the
requirement
to
conduct
tests
and
submit
data,
the
submitter
may
not
submit
a
notice
until
EPA
receives
the
test
data.

(
3)
If
EPA
has
granted
the
submitter
an
exemption
under
section
4(
c)
of
the
Act
and
if
another
person
previously
has
submitted
the
test
data
to
EPA,
the
exempted
person
may
either
submit
the
test
data
or
provide
the
following
information
as
part
of
the
notice:

(
i)
The
name,
title,
and
address
of
the
person
who
submitted
the
test
data
to
EPA.
(
ii)
The
date
the
test
data
were
submitted
to
EPA.
(
iii)
A
citation
for
the
test
rule.
(
iv)
A
description
of
the
exemption
and
a
reference
identifying
it.

(
h)
Chemical
substances
subject
to
a
section
5(
b)(
4)
rule.
(
1)
If
a
person
(
i)
intends
to
manufacture
or
import
a
new
chemical
substance
which
is
subject
to
the
notification
requirements
of
this
part
and
which
is
subject
to
a
rule
issued
under
section
5(
b)(
4)
of
the
Act;
and
(
ii)
is
not
required
by
a
rule
issued
under
section
4
of
the
Act
to
submit
test
data
for
the
substance
before
the
submission
of
a
notice,
the
person
must
submit
to
EPA
data
described
in
paragraph
(
h)(
2)
of
this
section
at
the
time
the
notice
is
submitted.

(
2)
Data
submitted
under
paragraph
(
h)(
1)
of
this
section
must
be
data
which
the
person
submitting
the
notice
believes
show
that
the
manufacture,
processing,
distribution
in
commerce,
use
and
disposal
of
the
substance,
or
any
combination
of
such
activities,
will
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment.

[
48
FR
21742,
May
13,
1983,
as
amended
at
58
FR
34204,
June
23,
1993;
60
FR
16309,
Mar.
29,
1995]

§
720.45
Information
that
must
be
included
in
the
notice
form.

Each
person
who
submits
a
notice
must
include
the
information
specified
in
the
notice
form
to
the
extent
it
is
known
to
or
reasonably
ascertainable
by
the
submitter.
However,
no
person
is
required
to
include
information
which
relates
solely
to
exposure
of
human
or
ecological
populations
outside
of
the
United
States.
The
notice
form
requires
the
following
information
relating
to
the
manufacture,
processing,
distribution
in
commerce,
use,
and
disposal
of
the
new
chemical
substance:

(
a)(
1)
The
specific
chemical
identity
of
the
substance
that
the
person
intends
to
manufacture
or
import,
which
includes
the
following:

(
i)
The
currently
correct
Chemical
Abstracts
(
CA)
name
for
the
substance,
based
on
the
Ninth
Collective
Index
(
9CI)
of
CA
nomenclature
rules
and
conventions,
and
consistent
with
listings
for
similar
substances
in
the
Inventory.
For
each
substance
having
a
chemical
composition
that
can
be
represented
by
a
specific,
complete
chemical
structure
diagram
(
a
Class
1
substance),
a
CA
Index
Name
must
be
provided.
For
each
chemical
substance
that
cannot
be
fully
represented
by
a
complete,
specific
chemical
structure
diagram
(
a
Class
2
substance),
or
if
the
substance
is
a
polymer,
a
CA
Index
Name
or
CA
Preferred
Name
must
be
provided
(
whichever
is
appropriate
based
on
CA
9CI
nomenclature
rules
and
conventions).
In
addition,
for
a
Class
2
substance,
the
notice
must
identify
the
immediate
chemical
precursors
and
reactants
by
specific
chemical
name
and
Chemical
Abstracts
Service
Registry
Number
(
CASRN),
if
the
number
is
available.
Tradenames
or
generic
names
of
chemical
precursors
or
reactants
are
not
acceptable
as
substitutes
for
specific
chemical
names.
(
ii)
The
currently
correct
CASRN
for
the
substance
if
a
CASRN
already
exists
for
the
substance.
(
iii)
For
a
Class
1
substance
and
for
any
Class
2
substance
for
which
a
definite
molecular
formula
is
known
or
reasonably
ascertainable,
the
correct
molecular
formula.
(
iv)
For
a
Class
1
substance,
a
complete,
correct
chemical
structure
diagram;
for
a
Class
2
substance
or
polymer,
a
correct
representative
or
partial
chemical
structure
diagram,
as
complete
as
can
be
known,
if
one
can
be
reasonably
ascertained.

(
2)
For
a
polymer,
the
submitter
must
also
report
the
following:

(
i)
The
specific
chemical
name
and
CASRN,
if
the
number
is
available,
of
each
monomer
and
other
reactant
used,
at
any
weight
percent,
to
manufacture
the
polymer.
Tradenames
or
generic
names
of
chemical
reactants
or
monomers
are
not
acceptable
as
substitutes
for
specific
chemical
names.
(
ii)
The
typical
percent
by
weight
of
each
monomer
and
other
reactant
in
the
polymer
(
weight
of
the
monomer
or
other
reactant
expressed
as
a
percentage
of
the
weight
of
the
polymeric
chemical
substance
manufactured),
and
the
maximum
residual
amount
of
each
monomer
present
in
the
polymer.
(
iii)
For
monomers
and
other
reactants
used
at
2
weight
percent
or
less
(
based
on
the
dry
weight
of
the
polymer
manufactured),
indicate
on
the
PMN
form
any
such
monomers
and
other
reactants
that
should
be
included
as
part
of
the
polymer
description
on
the
Inventory,
where
the
weight
percent
is
based
on
either
(
A)
the
weight
of
monomer
or
other
reactant
actually
charged
to
the
reaction
vessel,
or
(
B)
the
minimum
weight
of
monomer
or
other
reactant
required
in
theory
to
account
for
the
actual
weight
of
monomer
or
other
reactant
molecules
or
fragments
chemically
incorporated
(
chemically
combined)
in
the
polymeric
substance
manufactured.
(
iv)
For
a
determination
that
2
weight
percent
or
less
of
a
monomer
or
other
reactant
is
incorporated
(
chemically
combined)
in
a
polymeric
substance
manufactured,
as
specified
in
paragraphs
(
a)(
2)(
iii)(
B)
of
this
section,
analytical
data
or
appropriate
theoretical
calculations
(
if
it
can
be
documented
that
analytical
measurement
is
not
feasible
or
not
necessary)
to
support
this
determination
must
be
maintained
at
the
site
of
manufacture
or
import
of
the
polymer.
(
v)
Measured
or
estimated
values
of
the
minimum
number­
average
molecular
weight
of
the
polymer
and
the
amount
of
low
molecular
weight
species
below
500
and
below
1,000
molecular
weight,
with
a
description
of
how
the
measured
or
estimated
values
were
obtained.

(
3)
The
person
must
use
one
of
the
following
two
methods
to
develop
or
obtain
the
specified
chemical
identity
information
reported
under
paragraphs
(
a)
(
1)
and
(
2)
of
this
section
and
must
identify
the
method
used
in
the
notice:

(
i)
Method
1.
Obtain
the
correct
chemical
identity
information
required
by
paragraphs
(
a)
(
1)
and
(
2)
of
this
section
directly
from
the
Chemical
Abstracts
Service
(
CAS),
specifically
from
the
CAS
Registry
Services
Inventory
Expert
Service,
prior
to
submitting
a
notice
to
EPA.
A
copy
of
the
chemical
identification
report
obtained
from
CAS
must
be
submitted
with
the
notice.
(
ii)
Method
2.
Obtain
the
correct
chemical
identity
information
required
by
paragraphs
(
a)
(
1)
and
(
2)
from
any
source.
The
notice
will
be
incomplete
according
to
§
720.65(
c)(
1)(
vi)
if
the
person
uses
Method
2
and
any
chemical
identity
information
is
determined
to
be
incorrect
by
EPA.

(
4)
If
an
importer
submitting
the
notice
cannot
provide
all
the
information
specified
in
paragraphs
(
a)
(
1)
and
(
2)
of
this
section
because
it
is
claimed
as
confidential
by
the
foreign
supplier
of
the
substance,
the
importer
must
have
the
foreign
supplier
follow
the
procedures
in
paragraph
(
a)(
3)
of
this
section
and
provide
the
correct
chemical
identity
information
specified
in
paragraphs
(
a)
(
1)
and
(
2)
of
this
section
directly
to
EPA
in
a
joint
submission
or
as
a
letter
of
support
to
the
notice,
which
clearly
references
the
importer's
notice
and
PMN
User
Fee
Identification
Number.
The
statutory
review
process
will
commence
upon
receipt
of
both
the
notice
and
the
complete,
correct
information.

(
5)
If
a
manufacturer
cannot
provide
all
the
information
specified
in
paragraphs
(
a)
(
1)
and
(
2)
of
this
section
because
the
new
chemical
substance
is
manufactured
using
a
reactant
having
a
specific
chemical
identity
claimed
as
confidential
by
its
supplier,
the
manufacturer
must
submit
a
notice
directly
to
EPA
containing
all
the
information
known
by
the
manufacturer
about
the
chemical
identity
of
the
reported
substance
and
its
proprietary
reactant.
In
addition,
the
manufacturer
must
ensure
that
the
supplier
of
the
confidential
reactant
submit
a
letter
of
support
directly
to
EPA
providing
the
specific
chemical
identity
of
the
confidential
reactant,
including
the
CAS
number,
if
available,
and
the
appropriate
PMN
or
exemption
number,
if
applicable.
The
letter
of
support
must
reference
the
manufacturer's
name
and
PMN
User
Fee
Identification
Number
under
§
700.45(
c)(
3)
of
this
chapter.
The
statutory
review
period
will
commence
upon
receipt
of
both
the
notice
and
the
letter
of
support.

(
b)
The
impurities
anticipated
to
be
present
in
the
substance
by
name,
CAS
Registry
number,
and
weight
percent
of
the
total
substance.

(
c)
Known
synonyms
or
trade
names
of
the
new
chemical
substance.
(
d)
A
description
of
the
byproducts
resulting
from
the
manufacture,
processing,
use,
and
disposal
of
the
new
chemical
substance.

(
e)
The
estimated
maximum
amount
to
be
manufactured
or
imported
during
the
first
year
of
production
and
the
estimated
maximum
amount
to
be
manufactured
or
imported
during
any
12­
month
period
during
the
first
three
years
of
production.

(
f)
A
description
of
intended
categories
of
use
by
function
and
application,
the
estimated
percent
of
production
volume
devoted
to
each
category
of
use,
and
the
percent
of
the
new
substance
in
the
formulation
for
each
commercial
or
consumer
use.

(
g)
For
sites
controlled
by
the
submitter:

(
1)
The
identity
of
sites
where
the
new
substance
will
be
manufactured,
processed,
or
used.

(
2)
A
process
description
of
each
manufacture,
processing,
and
use
operation
which
includes
a
diagram
of
the
major
unit
operations
and
chemical
conversions,
the
identity
and
entry
point
of
all
feedstocks,
and
the
points
of
release
of
the
new
chemical
substance.

(
3)
Worker
exposure
information,
including
worker
activities,
physical
form
of
the
new
sub­
stance
to
which
workers
may
be
exposed,
the
number
of
workers,
and
the
duration
of
activities.

(
4)
Information
on
release
of
the
new
substance
to
the
environment,
including
the
quantity
and
media
of
release
and
type
of
control
technology
used.

(
h)
For
sites
not
controlled
by
the
submitter,
a
description
of
each
type
of
processing
and
use
operation
involving
the
new
chemical
substance,
including
identification
of
the
estimated
number
of
processing
or
use
sites,
situations
in
which
worker
exposure
to
and/
or
environmental
release
of
the
new
chemical
substance
will
occur,
the
number
of
workers
exposed
and
the
duration
of
exposure,
and
controls
which
limit
worker
exposure
and
environmental
release.

[
48
FR
21742,
May
13,
1983,
as
ameneded
at
60
FR
16310,
Mar.
29,
1995]

§
720.50
Submission
of
test
data
and
other
data
concerning
the
health
and
environmental
effects
of
a
substance.

(
a)
Test
data
on
the
new
chemical
substance
in
the
possession
or
control
of
the
submitter.
(
1)
Except
as
provided
in
paragraph
(
d)
of
this
section,
each
notice
must
contain
all
test
data
in
the
submitter's
possession
or
control
which
are
related
to
the
effects
on
health
or
the
environment
of
any
manufacture,
processing,
distribution
in
commerce,
use,
or
disposal
of
the
new
chemical
substance
or
any
mixture
or
article
containing
the
new
chemical
substance,
or
any
combination
of
such
activities.
This
includes
test
data
concerning
the
new
chemical
substance
in
a
pure,
technical
grade,
or
formulated
form.

(
2)
A
full
report
or
standard
literature
citation
must
be
submitted
for
the
following
types
of
test
data:
(
i)
Health
effects
data.
(
ii)
Ecological
effects
data.
(
iii)
Physical
and
chemical
properties
data.
(
iv)
Environmental
fate
characteristics.
(
v)
Monitoring
data
and
other
test
data
related
to
human
exposure
to
or
environmental
release
of
the
chemical
substance.

(
3)(
i)
If
the
data
do
not
appear
in
the
open
scientific
literature,
the
submitter
must
provide
a
full
report.
A
full
report
includes
the
experimental
methods
and
materials,
results,
discussion
and
data
analysis,
conclusions,
references,
and
the
name
and
address
of
the
laboratory
that
developed
the
data.
(
ii)
If
the
data
appear
in
the
open
scientific
literature,
the
submitter
need
only
provide
a
standard
literature
citation.
A
standard
literature
citation
includes
author,
title,
periodical
name,
date
of
publication,
volume,
and
page
numbers.

(
4)(
i)
If
a
study,
report,
or
test
is
incomplete
when
a
person
submits
a
notice,
the
submitter
must
identify
the
nature
and
purpose
of
the
study;
name
and
address
of
the
laboratory
developing
the
data;
progress
to
date;
types
of
data
collected;
significant
preliminary
results;
and
anticipated
completion
date.
(
ii)
If
a
test
or
experiment
is
completed
before
the
notice
review
period
ends,
the
person
must
submit
the
study,
report,
or
test
to
the
address
listed
on
the
notice
form,
as
specified
in
paragraph
(
a)(
3)(
i)
of
this
section,
within
ten
days
of
receiving
it,
but
no
later
than
five
days
before
the
end
of
the
review
period.
If
the
test
or
experiment
is
completed
during
the
last
five
days
of
the
review
period,
the
submitter
must
immediately
inform
its
EPA
contact
for
that
notice
by
telephone.

(
5)
For
test
data
in
the
submitter's
possession
or
control
which
are
not
listed
in
paragraph
(
a)(
2)
of
this
section,
a
person
is
not
required
to
submit
a
complete
report.
The
person
must
submit
a
summary
of
the
data.
If
EPA
so
requests,
the
person
must
submit
a
full
report
within
ten
days
of
the
request,
but
no
later
than
five
days
before
the
end
of
the
review
period.

(
6)
All
test
data
described
by
paragraph
(
a)
are
subject
to
these
requirements,
regardless
of
their
age,
quality,
or
results.

(
b)
Other
data
concerning
the
health
and
environmental
effects
of
the
new
chemical
substance
that
are
known
to
or
reasonably
ascertainable
by
the
submitter.
(
1)
Except
as
provided
in
paragraph
(
d)
of
this
section,
any
person
who
submits
a
notice
must
describe
the
following
data,
including
any
data
from
a
health
and
safety
study,
if
the
data
are
related
to
the
effects
on
health
or
the
environment
of
any
manufacture,
processing,
distribution
in
commerce,
use,
or
disposal
of
the
new
chemical
substance,
of
any
mixture
or
article
containing
the
new
chemical
substance,
or
of
any
combination
of
such
activities:

(
i)
Any
data,
other
than
test
data,
in
the
submitter's
possession
or
control.
(
ii)
Any
data,
including
test
data,
which
are
not
in
the
submitter's
possession
or
control,
but
which
are
known
to
or
reasonably
ascertainable
by
the
submitter.
For
the
purposes
of
this
section,
data
are
known
to
or
reasonably
ascertainable
by
the
submitter
if
the
data
are
known
to
any
of
its
employees
or
other
agents
who
are
associated
with
the
research
and
development,
test
marketing,
or
commercial
marketing
of
the
substance.

(
2)
Data
that
must
be
described
include
data
concerning
the
new
chemical
substance
in
a
pure,
technical
grade,
or
formulated
form.

(
3)
The
description
of
data
reported
under
this
paragraph
must
include:

(
i)
If
the
data
appear
in
the
open
scientific
literature,
a
standard
literature
citation,
which
includes
the
author,
title,
periodical
name,
date
of
publication,
volume,
and
pages.

(
ii)
If
the
data
are
not
contained
in
the
open
scientific
literature,
a
description
of
the
type
of
data
and
summary
of
the
results,
if
available,
and
the
names
and
addresses
of
persons
the
submitter
believes
may
have
possession
or
control
of
the
data.

(
4)
All
data
described
by
this
paragraph
are
subject
to
these
requirements,
regardless
of
their
age,
quality,
or
results;
and
regardless
of
whether
they
are
complete
at
the
time
the
notice
is
submitted.

(
c)
[
Reserved]

(
d)
Data
that
need
not
be
submitted
­­
(
1)
Data
previously
submitted
to
EPA.
(
i)
A
person
need
not
submit
any
data
previously
submitted
to
EPA
with
no
claims
of
confidentiality
if
the
notice
includes
the
office
or
person
to
whom
the
data
were
submitted,
the
date
of
submission,
and,
if
appropriate,
a
standard
literature
citation
as
specified
in
paragraph
(
a)(
3)(
ii)
of
this
section.
(
ii)
For
data
previously
submitted
to
EPA
with
a
claim
of
confidentiality,
the
person
must
resubmit
the
data
with
the
notice
and
any
claim
of
confidentiality,
under
§
720.80.

(
2)
Efficacy
data.
This
part
does
not
require
submission
of
any
data
related
solely
to
product
efficacy.
This
does
not
exempt
a
person
from
submitting
any
of
the
data
specified
in
paragraph
(
a),
(
b),
or
(
c)
of
this
section.

(
3)
Non­
U.
S.
exposure
data.
This
part
does
not
require
submission
of
any
data
which
relates
only
to
exposure
of
humans
or
the
environment
outside
the
United
States.
This
does
not
exclude
nonexposure
data
such
as
data
on
health
effects
(
including
epidemiological
studies),
ecological
effects,
physical
and
chemical
properties,
or
environmental
fate
characteristics.

[
48
FR
21742,
May
13,
1983,
as
amended
at
51
FR
15102,
Apr.
22,
1986]

§
720.57
Imports.

(
a)
Except
as
otherwise
provided
in
this
section,
the
provisions
of
this
subpart
C
apply
to
each
person
who
submits
a
notice
for
a
new
chemical
substance
which
he
or
she
intends
to
import
for
a
commercial
purpose.
In
addition,
each
importer
must
comply
with
this
section.

(
b)
EPA
will
hold
the
principal
importer,
or
the
importer
that
EPA
determines
must
submit
the
notice
when
there
is
no
principal
importer
under
§
720.22(
b)(
2),
liable
for
complying
with
this
part,
for
completing
the
notice
form
and
for
the
completeness
and
truthfulness
of
all
information
which
it
submits.

Subpart
D
­­
Disposition
of
Notices
§
720.60
General.

This
subpart
establishes
procedures
that
EPA
will
follow
in
reviewing
notices.

§
720.62
Notice
that
notification
is
not
required.

When
EPA
receives
a
notice,
EPA
will
review
it
to
determine
whether
the
chemical
substance
is
subject
to
the
requirements
of
this
part.
If
EPA
determines
that
the
chemical
substance
is
not
subject
to
these
requirements,
EPA
will
notify
the
submitter
that
section
5
of
the
Act
does
not
prevent
the
manufacture
or
import
of
the
substance
and
that
the
submission
is
not
a
notice
under
this
part.

[
48
FR
21742,
May
13,
1983,
as
amended
at
58
FR
34204,
June
23,
1993]

§
720.65
Acknowledgment
of
receipt
of
a
notice;
errors
in
the
notice;
incomplete
submissions;
false
and
misleading
statements.

(
a)
Notification
to
submitter.
EPA
will
acknowledge
receipt
of
each
notice
by
sending
the
submitter
a
letter
that
identifies
the
premanufacture
notice
number
assigned
to
the
new
chemical
substance
and
the
date
on
which
the
review
period
begins.
The
review
period
will
begin
on
the
date
the
notice
is
received
by
the
Office
of
Pollution
Prevention
and
Toxics
Document
Control
Officer.
The
acknowledgment
does
not
constitute
a
finding
by
EPA
that
the
notice,
as
submitted,
is
in
compliance
with
this
part.

(
b)
Errors
in
the
notice.
(
1)
Within
30
days
of
receipt
of
the
notice,
EPA
may
request
that
the
submitter
remedy
errors
in
the
notice.
The
following
are
examples
of
such
errors:

(
i)
Failure
to
date
the
notice
form.
(
ii)
Typographical
errors
that
cause
data
to
be
misleading
or
answers
to
any
questions
to
be
unclear.
(
iii)
Contradictory
information.
(
iv)
Ambiguous
statements
or
information.

(
2)
In
the
request
to
correct
the
notice,
EPA
will
explain
the
action
which
the
submitter
must
take
to
correct
the
notice.
(
3)
If
the
submitter
fails
to
correct
the
notice
within
15
days
of
receipt
of
the
request,
EPA
may
extend
the
notice
period
under
section
(
5)(
c)
of
the
Act,
in
accordance
with
§
720.75(
c).

(
c)
Incomplete
submissions.
(
1)
A
submission
is
not
complete,
and
the
notification
period
does
not
begin,
if:
(
i)
The
wrong
person
submits
the
notice
form.
(
ii)
The
submitter
does
not
sign
the
notice
form.
(
iii)
Some
or
all
of
the
information
in
the
notice
or
the
attachments
are
not
in
English,
except
for
published
scientific
literature.
(
iv)
The
submitter
does
not
use
the
notice
form.
(
v)
The
submitter
does
not
provide
information
that
is
required
by
section
5(
d)(
1)
(
B)
and
(
C)
of
the
Act
and
§
720.50.
(
vi)
The
submitter
does
not
provide
information
required
on
the
notice
form
and
by
§
720.45
or
indicate
that
it
is
not
known
to
or
reasonably
ascertainable
by
the
submitter.
(
vii)
The
submitter
does
not
submit
a
second
copy
of
the
submission
with
all
confidential
information
deleted
for
the
public
file,
as
required
by
§
720.80(
b)(
2).
(
viii)
The
submitter
does
not
include
any
information
required
by
section
5(
b)(
1)
of
the
Act
and
pursuant
to
a
rule
promulgated
under
section
4
of
the
Act,
as
required
by
§
720.40(
g).
(
ix)
The
submitter
does
not
submit
data
which
the
submitter
believes
show
that
the
chemical
substance
will
not
present
an
unreasonable
risk
of
injury
to
health
or
the
environment,
if
EPA
has
listed
the
chemical
substance
under
section
5(
b)(
4)
of
the
Act,
as
required
in
§
720.40(
h).

(
2)(
i)
If
EPA
receives
an
incomplete
submission,
the
Director,
or
his
or
her
delegate,
will
notify
the
submitter
within
30
days
of
receipt
that
the
submission
is
incomplete
and
that
the
notice
review
period
will
not
begin
until
EPA
receives
a
complete
notice.
(
ii)
If
EPA
obtains
additional
information
during
the
notice
review
period
that
indicates
the
original
submission
was
incomplete,
the
Director,
or
his
or
her
delegate,
may
declare
the
submission
incomplete
within
30
days
after
EPA
obtains
the
additional
information
and
so
notify
the
submitter.

(
3)
The
notification
that
a
submission
is
incomplete
under
paragraph
(
c)(
2)
(
i)
or
(
ii)
of
this
section
will
include:
(
i)
A
statement
of
the
basis
of
EPA's
determination
that
the
submission
is
incomplete.
(
ii)
The
requirements
for
correcting
the
incomplete
submission.
(
iii)
Information
on
procedures
under
paragraph
(
c)(
4)
of
this
section
for
filing
objections
to
the
determination
or
requesting
modification
of
the
requirements
for
completing
the
submission.

(
4)
Within
ten
days
after
receipt
of
notification
by
EPA
that
a
submission
is
incomplete,
the
submitter
may
file
written
objections
requesting
that
EPA
accept
the
submission
as
a
complete
notice
or
modify
the
requirements
necessary
to
complete
the
submission.

(
5)(
i)
EPA
will
consider
the
objections
filed
by
the
submitter.
The
Director,
or
his
or
her
delegate,
will
determine
whether
the
submission
was
complete
or
incomplete,
or
whether
to
modify
the
requirements
for
completing
the
submission.
EPA
will
notify
the
submitter
in
writing
of
EPA's
response
within
ten
days
of
receiving
the
objections.
(
ii)
If
the
Director,
or
his
or
her
delegate,
determines,
in
response
to
the
objection,
that
the
submission
was
complete,
the
notice
review
period
will
be
deemed
suspended
on
the
date
EPA
declared
the
notice
incomplete,
and
will
resume
on
the
date
that
the
notice
is
declared
complete.
The
submitter
need
not
correct
the
notice
as
EPA
originally
requested.
If
EPA
can
complete
its
review
within
90
days
from
the
date
of
the
original
submission,
the
Director,
or
his
or
her
delegate,
may
inform
the
submitter
that
the
running
of
the
review
period
will
resume
on
the
date
EPA
originally
declared
it
incomplete.
(
iii)
If
the
Director,
or
his
or
her
delegate,
modifies
the
requirements
for
completing
the
submission
or
concurs
with
EPA's
original
determination,
the
notice
review
period
will
begin
when
EPA
receives
a
complete
notice.

(
d)
Materially
false
or
misleading
statements.
If
EPA
discovers
at
any
time
that
person
submitted
materially
false
or
misleading
statements
in
the
notice,
EPA
may
find
that
the
notice
was
incomplete
from
the
date
it
was
submitted,
and
take
any
other
appropriate
action.

§
720.70
Notice
in
the
Federal
Register.

(
a)
Filing
of
FEDERAL
REGISTER
notice.
In
accordance
with
section
5(
d)(
2)
of
the
Act,
after
EPA
receives
a
notice,
EPA
will
file
with
the
Office
of
the
Federal
Register
a
notice
including
the
information
specified
in
paragraph
(
b)
of
this
section.

(
b)
Contents
of
notice.
(
1)
In
the
public
interest,
the
specific
chemical
identity
listed
in
the
notice
will
be
published
in
the
FEDERAL
REGISTER
unless
the
submitter
has
claimed
chemical
identity
confidential.
If
the
submitter
claims
confidentiality,
a
generic
name
will
be
published
in
accordance
with
§
720.85(
a)(
3).

(
2)
The
categories
of
use
of
the
new
chemical
substance
will
be
published
as
reported
in
the
notice
unless
this
information
is
claimed
confidential.
If
confidentiality
is
claimed,
the
generic
information
which
is
submitted
under
§
720.87(
b)
will
be
published.

(
3)
A
list
of
data
submitted
in
accordance
with
§
720.50(
a)
will
be
published.
In
addition,
for
test
data
submitted
in
accordance
with
§
720.40(
g),
a
summary
of
the
data
will
be
published.

(
4)
The
submitter's
identity
will
be
published,
unless
the
submitter
has
claimed
it
confidential.

§
720.75
Notice
review
period.

(
a)
Length
of
notice
review
period.
The
notice
review
period
specified
in
section
5(
a)
of
the
Act
runs
for
90
days
from
the
date
the
Document
Control
Officer
for
the
Office
of
Pollution
Prevention
and
Toxics
receives
a
complete
notice,
or
the
date
EPA
determines
the
notice
is
complete
under
§
720.65(
c),
unless
the
Agency
extends
the
period
under
section
5(
c)
of
TSCA
and
paragraph
(
c)
of
this
section.

(
b)
Suspension
of
the
running
of
the
notice
review
period.
(
1)
A
submitter
may
voluntarily
suspend
the
running
of
the
notice
review
period
if
the
Director
or
his
or
her
delegate
agrees.
If
the
Director
does
not
agree,
the
review
period
will
continue
to
run,
and
EPA
will
notify
the
submitter.
A
submitter
may
request
a
suspension
at
any
time
during
the
notice
review
period.
The
suspension
must
be
for
a
specified
period
of
time.

(
2)
A
request
for
suspension
may
be
made
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.
The
suspension
also
may
be
made
orally,
including
by
telephone,
to
the
submitter's
EPA
contact
for
that
notice.
EPA
will
send
the
submitter
a
written
confirmation
that
the
suspension
has
been
granted.

(
i)
An
oral
request
may
be
granted
for
15
days
only.
To
obtain
a
longer
suspension,
the
Document
Control
Officer
for
the
Office
of
Pollution
Prevention
and
Toxics
must
receive
written
confirmation
of
the
oral
request.
The
notice
review
period
is
suspended
as
of
the
date
of
the
oral
request.

(
ii)
If
the
submitter
has
not
made
a
previous
oral
request,
the
running
of
the
notice
review
period
is
suspended
as
of
the
date
of
receipt
of
the
written
request
by
the
Document
Control
Officer
for
the
Office
of
Pollution
Prevention
and
Toxics.

(
c)
Extension
of
notice
review
period.
(
1)
At
any
time
during
the
notice
review
period,
EPA
may
determine
that
good
cause
exists
to
extend
the
notice
review
period
specified
in
paragraph
(
a)
of
this
section.

(
2)
If
EPA
makes
such
a
determination,
EPA
will:
(
i)
Notify
the
submitter
that
EPA
is
extending
the
notice
review
period
for
a
specified
length
of
time,
and
state
the
reasons
for
the
extension.
(
ii)
Issue
a
notice
for
publication
in
the
FEDERAL
REGISTER
which
states
that
EPA
is
extending
the
notice
review
period
and
gives
the
reasons
for
the
extension.

(
3)
The
initial
extension
may
be
for
a
period
of
up
to
90
days.
If
the
initial
extension
is
for
less
than
90
days,
EPA
may
make
additional
extensions.
However,
the
total
period
of
extensions
may
not
exceed
90
days
for
any
notice.

(
4)
The
following
are
examples
of
situations
in
which
EPA
may
find
that
good
cause
exists
for
extending
the
notice
review
period:
(
i)
EPA
has
reviewed
the
notice
and
determined
that
there
is
a
significant
possibility
that
the
chemical
substance
will
be
regulated
under
section
5(
e)
or
section
5(
f)
of
the
Act,
but
EPA
is
unable
to
initiate
regulatory
action
within
the
initial
90­
day
period.
(
ii)
EPA
has
reviewed
the
submission
and
is
seeking
additional
information.
(
iii)
EPA
has
received
significant
additional
information
during
the
notice
review
period.
(
iv)
The
submitter
has
failed
to
correct
a
notice
after
receiving
EPA's
request
under
§
720.65(
b).

(
d)
Notice
of
expiration
of
notice
review
period.
EPA
will
notify
the
submitter
that
the
notice
review
period
has
expired
or
that
EPA
has
completed
its
review
of
the
notice.
Expiration
of
the
review
period
does
not
constitute
EPA
approval
or
certification
of
the
new
chemical
substance,
and
does
not
mean
that
EPA
may
not
take
regulatory
action
against
the
substance
in
the
future.
After
expiration
of
the
statutory
notice
review
period,
in
the
absence
of
regulatory
action
by
EPA
under
section
5(
e),
5(
f),
or
6(
a)
of
the
Act,
the
submitter
may
manufacture
or
import
the
chemical
substance
even
if
the
submitter
has
not
received
notice
of
expiration.

(
e)
Withdrawal
of
a
notice
by
the
submitter.
(
1)
A
submitter
may
withdraw
a
notice
during
the
notice
review
period.
A
statement
of
withdrawal
must
be
made
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.
The
withdrawal
is
effective
upon
receipt
of
the
statement
by
the
Document
Control
Officer.

(
2)
If
a
manufacturer
or
importer
which
withdrew
a
notice
later
resubmits
a
notice
for
the
same
chemical
substance,
a
new
notice
review
period
begins.

[
48
FR
21742,
May
13,
1983,
as
amended
at
53
FR
12523,
Apr.
15,
1988;
58
FR
34204,
June
23,
1993;
60
FR
34464,
July
3,
1995]

§
720.78
Recordkeeping.

(
a)
Any
person
who
submits
a
notice
under
this
part
must
retain
documentation
of
information
in
the
notice,
including
(
1)
other
data,
as
defined
in
§
720.50(
b),
in
the
submitter's
possession
or
control;
and
(
2)
records
of
production
volume
for
the
first
three
years
of
production
or
import,
the
date
of
commencement
of
manufacture
or
import,
and
documentation
of
this
information.
This
information
must
be
retained
for
five
years
from
the
date
of
commencement
of
manufacture
of
import.

(
b)(
1)
Persons
who
manufacture
or
import
a
chemical
substance
under
§
720.36
must
retain
the
following
records:
(
i)
Copies
of,
or
citations
to,
information
reviewed
and
evaluated
under
§
720.36(
b)(
1)
to
determine
the
need
to
make
any
notification
of
risk.
(
ii)
Documentation
of
the
nature
and
method
of
notification
under
§
720.36(
c)(
1)
including
copies
of
any
labels
or
written
notices
used.
(
iii)
Documentation
of
prudent
laboratory
practices
used
instead
of
notification
and
evaluation
under
§
720.36(
b)(
2).
(
iv)
The
names
and
addresses
of
any
persons
other
than
the
manfacturer
or
importer
to
whom
the
substance
is
distributed,
the
identity
of
the
substance
to
the
extent
known,
the
amount
distributed,
and
copies
of
the
notifications
required
under
§
720.36(
c)(
2).
These
records
are
not
required
when
substances
are
distributed
as
impurities
or
incorporated
into
an
article,
in
accordance
with
paragraph
(
d)
of
this
section.

(
2)
A
person
who
manufactures
or
imports
a
chemical
substance
under
§
720.36
and
who
manufactures
or
imports
the
substance
in
quantities
greater
than
100
kilograms
per
year
must
retain
records
of
the
identity
of
the
substance
to
the
extent
known,
the
production
volume
of
the
substance,
and
the
person's
disposition
of
the
substance.
The
person
is
not
required
to
maintain
records
of
the
disposition
of
products
containing
the
substance
as
an
impurity
or
of
articles
incorporating
the
substances.

(
3)
Records
under
this
paragraph
must
be
retained
for
5
years
after
they
are
developed.

(
c)
Any
person
who
obtains
a
test­
marketing
exemption
under
this
part
must
retain
documentation
of
information
in
the
application
and
documentation
of
compliance
with
any
restrictions
imposed
by
EPA
when
it
granted
the
application.
This
information
must
be
retained
for
five
years
from
the
final
date
of
manufacture
or
import
under
the
exemption.

[
48
FR
21742,
May
13,
1983;
48
FR
33872,
July
26,
1983,
as
amended
at
51
FR
15102,
Apr.
22,
1986;
58
FR
34204,
June
23,
1993]

Subpart
E
­­
Confidentiality
and
Public
Access
to
Information
§
720.80
General
provisions.

(
a)
A
person
may
assert
a
claim
of
confidentiality
for
any
information
which
he
or
she
submits
to
EPA
under
this
part.

(
b)
Any
claim
of
confidentiality
must
accompany
the
information
when
it
is
submitted
to
EPA.

(
1)(
i)
For
information
submitted
on
the
notice
form,
the
claim(
s)
must
be
asserted
on
the
form
in
the
manner
prescribed
on
the
notice
form.

(
ii)
When
a
person
submits
information
in
an
attachment,
the
claim(
s)
must
be
asserted
in
the
attachment
as
described
on
the
notice
form.

(
2)
If
any
information
is
claimed
as
confidential,
the
person
must
submit,
in
addition
to
the
copies
specified
by
§
720.40,
a
sanitized
copy
of
the
notice
form
(
or
electronic
submission)
and
any
attachments.
(
i)
The
original
and
two
copies
of
the
notice,
specified
at
§
720.40
(
or
electronic
submission)
and
attachments
must
be
complete.
The
submitter
must
designate
that
information
which
is
claimed
as
confidential
in
the
manner
prescribed
on
the
notice
form
(
or
in
EPA's
electronic
submission
instructions).
(
ii)
The
sanitized
copy
must
be
complete
except
that
all
information
claimed
as
confidential
in
the
original
must
be
deleted.
EPA
will
place
this
sanitized
copy
in
the
public
file.
(
iii)
If
the
person
does
not
provide
the
sanitized
copy,
or
information
in
a
health
and
safety
study
(
except
information
claimed
as
confidential
in
accordance
with
§
720.90),
the
submission
will
be
deemed
incomplete
and
the
notice
review
period
will
not
begin
until
EPA
receives
the
sanitized
copy
or
the
health
and
safety
study
information
is
included,
in
accordance
with
§
720.65(
c)(
1)(
vii).

(
c)
EPA
will
disclose
information
that
is
subject
to
a
claim
of
confidentiality
asserted
under
this
section
only
to
the
extent
permitted
by
the
Act,
this
subpart,
and
part
2
of
this
title.
(
d)
If
a
notice
submitter
does
not
assert
a
claim
of
confidentiality
for
information
at
the
time
it
is
submitted
to
EPA,
EPA
may
make
the
information
public
and
place
it
in
the
public
file
without
further
notice
to
the
submitter.

[
48
FR
21742,
May
13,
1983,
as
amended
at
58
FR
34204,
June
23,
1993;
60
FR
16311,
Mar.
29,
1995]

§
720.85
Chemical
identity.

(
a)
Claims
applicable
to
the
period
prior
to
commencement
of
manufacture
or
import.
(
1)(
i)
A
person
who
submits
information
to
EPA
under
this
part
may
assert
a
claim
of
confidentiality
for
the
chemical
identity
of
the
new
chemical
substance.
This
claim
will
apply
only
to
the
period
prior
to
the
commencement
of
manufacture
or
import
for
commercial
purposes.
A
submitter
may
assert
this
claim
only
if
the
submitter
believes
that
public
disclosure
prior
to
commencement
of
manufacture
or
import
of
the
fact
that
anyone
intends
to
manufacture
or
import
the
specific
chemical
substance
for
commercial
purposes
would
reveal
confidential
business
information.
(
ii)
If
the
notice
includes
a
health
and
safety
study
concerning
the
new
chemical
substance
and
if
the
claim
for
confidentiality
with
respect
to
the
chemical
identity
is
denied
in
accordance
with
§
720.90(
c),
EPA
will
deny
a
claim
asserted
under
this
paragraph.

(
2)
Any
person
who
asserts
a
claim
of
confidentiality
for
chemical
identity
under
this
paragraph
must
provide
one
of
the
following
items
at
the
time
the
notice
is
submitted:

(
i)
The
generic
name
which
was
accepted
by
EPA
in
the
prenotice
consultation
conducted
under
paragraph
(
a)(
3)
of
this
section.
(
ii)
One
generic
name
that
is
only
as
generic
as
necessary
to
protect
the
confidential
chemical
identity
of
the
particular
chemical
substance.
The
name
should
reveal
the
specific
chemical
identity
to
the
maximum
extent
possible.
The
generic
name
will
be
subject
to
EPA
review
and
approval
at
the
time
a
notice
of
commencement
is
submitted.

(
3)(
i)
Any
person
who
intends
to
assert
a
claim
of
confidentiality
for
the
chemical
identity
of
a
new
chemical
substance
may
seek
a
determination
by
EPA
of
an
appropriate
generic
name
for
the
substance
before
submitting
a
notice.
For
this
purpose,
the
person
should
submit
to
EPA:

(
A)
The
chemical
identity
of
the
substance.

(
B)
A
proposed
generic
name(
s)
which
in
only
as
generic
as
necessary
to
protect
the
confidential
chemical
identity
of
the
new
chemical
substance.
The
name(
s)
should
reveal
the
chemical
identity
of
the
substance
to
the
maximum
extent
possible.

(
ii)
Within
30
days,
EPA
will
inform
the
submitter
either
that
one
of
the
proposed
generic
names
is
adequate
or
that
none
is
adequate
and
further
consultation
is
necessary.

(
4)
If
a
submitter
claims
chemical
identity
to
be
confidential
under
this
paragraph,
and
if
the
submitter
complies
with
paragraph
(
a)(
2)
of
this
section,
EPA
will
issue
for
publication
in
the
FEDERAL
REGISTER
notice
described
in
§
720.70
the
generic
name
proposed
by
the
submitter
or
one
agreed
upon
by
EPA
and
the
submitter.

(
b)
Claims
applicable
to
the
period
after
commencement
of
manufacture
or
import.
(
1)
Any
claim
of
confidentiality
under
paragraph
(
a)
of
this
section
is
applicable
only
until
the
substance
is
manufactured
or
imported
for
commercial
purposes
and
becomes
eligible
for
inclusion
on
the
Inventory.
To
maintain
the
confidential
status
of
the
chemical
identity
when
the
substance
is
added
to
the
Inventory,
a
submitter
must
reassert
the
confidentiality
claim
and
substantiate
the
claim
in
the
notice
of
commencement
of
manufacture
required
under
§
720.102.
A
submitter
may
not
claim
the
chemical
indentity
confidential
for
the
period
after
commencement
of
manufacture
or
import
unless
the
submitter
claimed
the
chemical
identity
confidential
for
the
period
prior
to
commencement
of
manufacture
or
import
under
paragraph
(
a)
of
this
section.

(
2)(
i)
A
person
who
believes
that
public
disclosure
of
the
fact
that
anyone
manfactures
or
imports
the
new
chemical
substance
for
commercial
purposes
would
reveal
confidential
business
information
may
assert
a
claim
of
confidentiality
under
this
paragraph.
(
ii)
If
the
notice
includes
a
health
and
safety
study
concerning
the
new
chemical
substance,
and
if
the
claim
for
confidentiality
with
respect
to
the
chemical
identity
is
denied
in
accordance
with
§
720.90(
c),
EPA
will
deny
a
claim
asserted
under
this
paragraph.

(
3)
Any
person
who
asserts
a
confidentiality
claim
for
chemical
identity
must:
(
i)
Comply
with
the
requirements
of
paragraph
(
a)(
3)
of
this
section
regarding
submission
of
a
generic
name.
(
ii)
Agree
that
EPA
may
disclose
to
a
person
with
a
bona
fide
intent
to
manufacture
or
import
the
chemical
substance
the
fact
that
the
particular
chemical
substance
is
included
on
the
confidential
Inventory
for
purposes
of
notification
under
section
5(
a)(
1)(
A)
of
the
Act.
(
iii)
Have
available
for
the
particular
chemical
substance,
and
agree
to
furnish
to
EPA
upon
request:
(
A)
An
elemental
analysis.
(
B)
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
chemical
substance.
(
iv)
Provide
a
detailed
written
substantiation
of
the
claim,
by
answering
the
following
questions:
(
A)
What
harmful
effects
to
your
competitive
position,
if
any,
do
you
think
would
result
if
EPA
publishes
on
the
Inventory
the
identity
of
the
chemical
substance?
How
could
a
competitor
use
such
information
given
the
fact
that
the
identity
of
the
substance
otherwise
would
appear
on
the
Inventory
of
chemical
substances
with
no
link
between
the
substance
and
your
company
or
industry?
How
substantial
would
the
harmful
effects
of
disclosure
be?
What
is
the
casual
relationship
between
the
disclosure
and
the
harmful
effects?
(
B)
For
what
period
of
time
should
confidential
treatment
be
given?
Until
a
specific
date,
the
occurrence
of
a
specific
event,
or
permanently?
Why?

(
C)
Has
the
chemical
substance
been
patented?
If
so,
have
you
granted
licenses
to
others
with
respect
to
the
patent
as
it
applies
to
the
chemical
substance?
If
the
chemical
substance
has
been
patented
and
therefore
disclosed
through
the
patent,
why
should
it
be
treated
as
confidential
for
purposes
of
the
Inventory?
(
D)
Has
the
identity
of
the
chemical
substance
been
kept
confidential
to
the
extent
that
your
competitors
do
not
know
it
is
being
manufactured
on
imported
for
a
commercial
purpose
by
anyone?
(
E)
Is
the
fact
that
someone
is
manufacturing
or
importing
this
chemical
substance
for
commercial
purposes
available
to
the
public,
e.
g.,
in
technical
journals
or
other
publications;
in
libraries;
or
in
State,
local,
or
Federal
agency
public
files?
(
F)
What
measures
have
you
taken
to
prevent
undesired
disclosure
of
the
fact
that
you
are
manufacturing
or
importing
this
substance
for
a
commercial
purpose?
(
G)
To
what
extent
has
the
fact
that
you
are
manufacturing
or
importing
this
chemical
substance
for
a
commercial
purpose
been
disclosed
to
others?
What
precautions
have
you
taken
in
regard
to
these
disclosures?
Has
this
information
been
disclosed
to
the
public
or
to
competitors?
(
H)
In
what
form
does
this
particular
chemical
substance
leave
the
site
of
manufacture,
e.
g.,
as
part
of
a
product;
in
an
effluent
or
emission
stream?
If
so,
what
measures
have
you
taken
to
guard
against
discovery
of
its
identity?
(
I)
If
the
chemical
substance
leaves
the
site
of
manufacture
in
a
product
that
is
available
to
either
the
public
or
your
competitors,
can
they
identify
the
substance
by
analyzing
the
product?
(
J)
For
what
purpose
do
you
manufacture
or
import
the
substance?
(
K)
Has
EPA,
another
Federal
agency,
or
any
Federal
court
made
any
pertinent
confidentiality
determinations
regarding
this
chemical
substance?
If
so,
copies
of
such
determinations
must
be
included
in
the
substantiation.
(
L)
If
the
notice
includes
a
health
and
safety
study
concerning
the
new
chemical
substance,
the
submitter
must
also
answer
the
questions
in
§
720.90(
b)(
2).

(
4)
If
the
submitter
does
not
meet
the
requirements
of
this
paragraph,
EPA
will
deny
the
claim
of
confidentiality.

(
5)(
i)
EPA
will
publish
a
generic
name
on
the
public
Inventory
if:
(
A)
The
submitter
asserts
a
claim
of
confidentiality
in
accordance
with
this
paragraph.
(
B)
No
claim
for
confidentiality
of
the
specific
chemical
identity
as
part
of
a
health
and
safety
study
has
been
denied
in
accordance
with
part
2
of
this
title
or
§
720.90.
(
ii)
Publication
of
a
generic
name
on
the
public
Inventory
does
not
create
a
category
for
purposes
of
the
Inventory.
Any
person
who
has
a
bona
fide
intent
to
manufacture
or
import
a
chemical
substance
which
is
described
by
a
generic
name
on
the
public
Inventory
may
submit
an
inquiry
to
EPA
under
§
720.25(
b)
to
determine
whether
the
particular
chemical
substance
is
included
on
the
confidential
Inventory.
(
iii)
Upon
receipt
of
a
request
described
in
§
720.25(
b),
EPA
may
require
the
submitter
which
originally
asserted
confidentiality
for
a
chemical
substance
to
submit
to
EPA
the
information
listed
in
paragraph
(
b)(
3)(
iii)
of
this
section.
(
iv)
Failure
to
submit
any
of
the
information
required
under
paragraph
(
b)(
3)(
iii)
of
this
section
within
ten
days
of
a
request
by
EPA
under
this
paragraph
is
a
waiver
of
the
original
submitter's
confidentiality
claim.
In
this
event,
EPA
may
place
the
specific
chemical
identity
on
the
public
Inventory
without
further
notice
to
the
original
submitter.
(
6)
If
a
submitter
asserts
a
claim
of
confidentiality
under
this
paragraph,
EPA
will
examine
the
generic
chemical
name
proposed
by
the
submitter.
(
i)
If
EPA
determines
that
the
generic
name
proposed
by
the
submitter
is
only
as
generic
as
necessary
to
protect
the
confidential
identity
of
the
particular
chemical
substance,
EPA
will
place
that
generic
name
on
the
public
Inventory.
(
ii)
If
EPA
determines
that
the
generic
name
proposed
by
the
submitter
is
more
generic
than
necessary
to
protect
the
confidential
identity,
EPA
will
propose
in
writing,
for
review
by
the
submitter,
an
alternative
generic
name
that
will
reveal
the
chemical
identity
of
the
chemical
substance
to
the
maximum
extent
possible.
(
iii)
If
the
generic
name
proposed
by
EPA
is
acceptable
to
the
submitter,
EPA
will
place
that
generic
name
on
the
public
Inventory.
(
iv)
If
the
generic
name
proposed
by
EPA
is
not
acceptable
to
the
submitter,
the
submitter
must
explain
in
detail
why
disclosure
of
that
generic
name
would
reveal
confidential
business
information
and
propose
another
generic
name
which
is
only
as
generic
as
necessary
to
protect
the
confidential
identity.
If
EPA
does
not
receive
a
response
from
the
submitter
within
30
days
after
the
submitter
receives
the
proposed
name,
EPA
will
place
EPA's
chosen
generic
name
on
the
public
Inventory.
If
the
submitter
does
provide
the
information
requested,
EPA
will
review
the
response.
If
the
submitter's
proposed
generic
name
is
acceptable,
EPA
will
publish
that
generic
name
on
the
public
Inventory.
If
the
submitter's
proposed
generic
name
is
not
acceptable,
EPA
will
notify
the
submitter
of
EPA's
choice
of
a
generic
name.
Thirty
days
after
this
notification,
EPA
will
place
the
chosen
generic
name
on
the
public
Inventory.

§
720.87
Categories
or
proposed
categories
of
uses
of
a
new
chemical
substance.

(
a)
A
person
who
submits
information
to
EPA
under
this
part
on
the
categories
or
proposed
categories
of
use
of
a
new
chemical
substance
may
assert
a
claim
of
confidentiality
for
this
information.

(
b)
A
submitter
that
asserts
such
a
claim
must:

(
1)
Report
the
categories
or
proposed
categories
of
use
of
the
chemical
substance.

(
2)
Provide,
in
nonconfidential
form,
a
description
of
the
uses
that
is
only
as
generic
as
necessary
to
protect
the
confidential
business
information.
The
generic
use
description
will
be
included
in
the
FEDERAL
REGISTER
notice
described
in
§
720.70.

(
c)
The
person
must
submit
the
information
required
by
paragraph
(
b)
of
this
section
in
the
manner
specified
in
the
notice
form.

§
720.90
Data
from
health
and
safety
studies.

(
a)
Information
other
than
specific
chemical
identity.
Except
as
provided
in
paragraph
(
b)
of
this
section,
EPA
will
deny
any
claim
of
confidentiality
with
respect
to
information
included
in
a
health
and
safety
study,
unless
the
information
would
disclose
confidential
business
information
concerning:
(
1)
Processes
used
in
the
manufacture
or
processing
of
a
chemical
substance
or
mixture.
(
2)
In
the
case
of
a
mixture,
the
portion
of
the
mixture
comprised
by
any
of
the
chemical
substances
in
the
mixture.
(
3)
Information
which
is
not
in
any
way
related
to
the
effects
of
a
substance
on
human
health
or
the
environment,
such
as
the
name
of
the
submitting
company,
cost
or
other
financial
data,
product
development
or
marketing
plans,
and
advertising
plans,
for
which
the
person
submits
a
claim
of
confidentiality
in
accordance
with
§
720.80.

(
b)
Specific
chemical
identity
­­
(
1)
Claims
applicable
to
period
prior
to
commencement
of
manufacture.
A
claim
of
confidentiality
for
the
period
prior
to
commencement
of
manufacture
or
import
for
the
chemical
identity
of
a
chemical
substance
for
which
a
health
and
safety
study
was
submitted
must
be
asserted
in
conjunction
with
a
claim
asserted
under
§
720.85(
a).
(
2)
Claims
applicable
to
period
after
commencement
of
manufacture
or
import
for
commercial
purposes.
To
maintain
the
confidential
status
of
the
chemical
identity
of
a
chemical
substance
for
which
a
health
and
safety
study
was
submitted
after
commencement
of
manufacture
or
import,
the
claim
must
be
reasserted
and
substantiated
in
conjunction
with
a
claim
under
§
720.85(
b).
In
addition
to
the
questions
set
forth
in
§
720.85(
b)(
3)(
iv)
of
this
part,
the
submitter
must
answer
the
following
questions:

(
i)
Would
disclosure
of
the
chemical
identity
disclose
processes
used
in
the
manufacture
or
processing
of
a
chemical
substance
or
mixture?
Describe
how
this
would
occur.
In
responding
to
the
question
in
§
720.85(
b)(
3)(
iv)(
A),
explain
what
harmful
competitive
effects
would
occur
from
disclosure
of
this
process
information.
(
ii)
Would
disclosure
of
the
chemical
identity
disclose
the
portion
of
a
mixture
comprised
by
any
of
the
substances
in
the
mixture?
Describe
how
this
would
occur.
In
responding
to
the
question
in
§
720.85(
b)(
3)(
iv)(
A),
explain
what
harmful
competitive
effects
would
occur
from
disclosure
of
this
information.
(
iii)
Do
you
assert
that
disclosure
of
the
chemical
identity
is
not
necessary
to
interpret
any
of
the
health
and
safety
studies
you
have
submitted?
If
so,
explain
how
a
less
specific
identity
would
be
sufficient
to
interpret
the
studies.

(
c)
Denial
of
confidentiality
claim.
EPA
will
deny
a
claim
of
confidentiality
for
chemical
identity
under
paragraph
(
b)
of
this
section,
unless:

(
1)
The
information
would
disclose
processes
used
in
the
manufacture
or
processing
of
a
chemical
substance
or
mixture.
(
2)
In
the
case
of
a
mixture,
the
information
would
disclose
the
portion
of
the
mixture
comprised
by
any
of
the
substances
in
the
mixture.
(
3)
The
specific
chemical
identity
is
not
necessary
to
interpret
a
health
and
safety
study.

(
d)
Use
of
generic
names.
When
EPA
discloses
a
health
and
safety
study
containing
a
specific
chemical
identity,
which
the
submitter
has
claimed
confidential,
and
if
the
Agency
has
not
denied
the
claim
under
paragraph
(
c)
of
this
section,
EPA
will
identify
the
chemical
substance
by
the
generic
name
selected
under
§
720.85.
[
48
FR
21742,
May
13,
1983,
as
amended
at
58
FR
34204,
June
23,
1993]

§
720.95
Public
file.

All
information
submitted
with
a
notice,
including
any
health
and
safety
study
and
other
supporting
documentation,
will
become
part
of
the
public
file
for
that
notice,
unless
such
materials
are
claimed
confidential.
In
addition,
EPA
may
add
materials
to
the
public
file,
subject
to
subpart
E
of
this
part.
Any
of
the
nonconfidential
material
described
in
this
subpart
will
be
available
for
public
inspection
in
the
Non­
Confidential
Information
Center
(
NCIC)
(
7407),
Office
of
Pollution
Prevention
and
Toxics,
U.
S.
Environmental
Protection
Agency,
Room
B­
607
NEM,
401
M
St.,
SW.,
Washington,
DC
20460,
between
the
hours
of
12
p.
m.
and
4
p.
m.
weekdays
excluding
legal
holidays.

[
48
FR
21742,
May
13,
1983,
as
amended
at
53
FR
12523,
Apr.
15,
1988;
60
FR
16311,
Mar.
29,
1995;
60
FR
34464,
July
3,
1995]

Subpart
F
­­
Commencement
of
Manufacture
or
Import
§
720.102
Notice
of
commencement
of
manufacture
or
import.

(
a)
Applicability.
Any
person
who
commences
the
manufacture
or
import
of
a
new
chemical
substance
for
a
nonexempt
commercial
purpose
for
which
that
person
previously
submitted
a
section
5(
a)
notice
under
this
part
must
submit
a
notice
of
commencement
of
manufacture
or
import.

(
b)
When
to
report.
(
1)
If
manufacture
or
import
for
commercial
purposes
begins
on
or
after
the
effective
date
of
this
rule,
the
submitter
must
submit
the
notice
to
EPA
on,
or
no
later
than
30
calendar
days,
after
the
first
day
of
such
manufacture
or
import.
(
2)
If
manufacture
or
import
for
commercial
purposes
began
or
will
begin
before
the
effective
date
of
this
rule,
the
submitter
must
submit
the
notice
by
the
effective
date
of
this
rule.

(
c)
Information
to
be
reported
on
form.
(
1)
The
notice
must
be
submitted
on
EPA
(
Form
7710­
56),
which
is
available
from
the
Environmental
Assistance
Division
(
7408),
Office
of
Pollution
Prevention
and
Toxics,
Environmental
Protection
Agency,
1200
Pennsylvania
Ave.,
NW.,
Washington,
DC
20460.
The
form
must
be
signed
and
dated
by
an
authorized
official.
All
information
specified
on
the
form
must
be
provided.
The
notice
must
contain
the
following
information:

(
i)
The
specific
chemical
identity
of
the
PMN
substance.
(
ii)
A
generic
chemical
name
(
if
the
chemical
identity
is
claimed
as
confidential
by
the
submitter).
(
iii)
The
premanufacture
notice
(
PMN)
number
assigned
by
EPA.

(
iv)
The
date
of
commencement
for
the
submitter's
manufacture
or
import
for
a
non­
exempt
commercial
purpose
(
indicating
whether
the
substance
was
initially
manufactured
in
the
United
States
or
imported).
The
date
of
commencement
is
the
date
of
completion
of
non­
exempt
manufacture
of
the
first
amount
(
batch,
drum,
etc.)
of
new
chemical
substance
identified
in
the
submitter's
PMN.
For
importers,
the
date
of
commencement
is
the
date
the
new
chemical
substance
clears
United
States
customs.
(
v)
The
name
and
address
of
the
submitter.
(
vi)
The
name
of
the
authorized
official.
(
vii)
The
name
and
telephone
number
of
a
technical
contact
in
the
United
States.
(
viii)
The
address
of
the
site
where
commencement
of
manufacture
occurred.
(
ix)
Clear
indications
of
whether
the
chemical
identity,
submitter
identity,
and/
or
other
information
are
claimed
as
confidential
by
the
submitter.
(
2)
If
the
submitter
claims
the
chemical
identity
confidential,
and
wants
the
identity
to
be
listed
on
the
confidential
portion
of
the
Inventory,
the
claim
must
be
reasserted
and
substantiated
in
accordance
with
§
720.85(
b).
Otherwise,
EPA
will
list
the
specific
chemical
identity
on
the
public
Inventory.
Submitters
who
did
not
claim
the
chemical
identity,
submitter
identity,
or
other
information
to
be
confidential
in
the
PMN
cannot
claim
this
information
as
confidential
in
the
notice
of
commencement.

(
d)
Where
to
submit.
Notices
of
commencement
of
manufacture
or
import
should
be
submitted
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.

[
48
FR
21742,
May
13,
1983,
as
amended
at
48
FR
41140,
Sept.
13,
1983;
51
FR
15103,
Apr.
22,
1986;
53
FR
12523,
Apr.
15,
1988;
60
FR
16311,
Mar.
29,
1995;
60
FR
34464,
July
3,
1995;
65
FR
39304,
June
26,
2000]

Subpart
G
­­
Compliance
and
Inspections
§
720.120
Compliance.

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

(
b)
A
person
who
manufactures
or
imports
a
new
chemical
substance
before
a
notice
is
submitted
and
the
notice
review
period
expires
is
in
violation
of
section
15
of
the
Act
even
if
that
person
was
not
requied
to
submit
the
notice
under
§
720.22.

(
c)
Using
for
commercial
purposes
a
chemical
substance
or
mixture
which
a
person
knew
or
had
reason
to
know
was
manufactured,
processed,
or
distributed
in
commerce
in
violation
of
section
5
of
this
rule
is
a
violation
of
section
15
of
the
Act
(
15
U.
S.
C.
2614).

(
d)
Failure
or
refusal
to
establish
and
maintain
records
or
to
permit
access
to
or
copying
of
records,
as
required
by
the
Act,
is
a
violation
of
section
15
of
the
Act
(
15
U.
S.
C.
2614).

(
e)
Failure
or
refusal
to
permit
entry
or
inspection
as
required
by
section
11
is
a
violation
of
section
15
of
the
Act
(
15
U.
S.
C.
2614).
(
f)
Violators
may
be
subject
to
the
civil
and
criminal
penalties
in
section
16
of
the
Act
(
15
U.
S.
C.
2615)
for
each
violation.
Persons
who
submit
materially
misleading
or
false
information
in
connection
with
the
requirements
of
any
provision
of
this
rule
may
be
subject
to
penalties
calculated
as
if
they
never
filed
their
notices.

(
g)
EPA
may
seek
to
enjoin
the
manufacture
or
processing
of
a
chemical
substance
in
violation
of
this
rule
or
act
to
seize
any
chemical
substance
manufactured
or
processed
in
violation
of
this
rule
or
take
other
actions
under
the
authority
of
section
7
of
this
Act
(
15
U.
S.
C.
2606)
or
section
17
or
this
Act
(
15
U.
S.
C.
2616).

§
720.122
Inspections.

EPA
will
conduct
inspections
under
section
11
of
the
Act
to
assure
compliance
with
section
5
of
the
Act
and
this
rule,
to
verify
that
information
submitted
to
EPA
under
this
rule
is
true
and
correct,
and
to
audit
data
submitted
to
EPA
under
this
rule.