Document ID: EPA-HQ-OPPT-2003-0065-0006
Agency: epa
Document Type: Supporting & Related Material
Title: 
Posted Date: 2003-11-25T05:00Z

~~.

.
ft)

INSTRUCTION
MANUAL
FOR
REPORTING
UNDER
THE
TSCA
§
5
NEW
CHEMICALS
PROGRAM
EPA­
mQ­
25(
I)
(
May
1999)
Office
of
Pollution
Prevention
and
Toxics
Washington,
DC
20460
The
US
Environmenral
Protection
Agel
¥
:
Y
(
EPA)
has
prepared
this
document
to
assist
submitters
of
premanufacture
mace
wxier
section
S
of
the
Toxic
Substances
Control
Act
(
TSCA).
The
manual
provides
instructions
on
submitting
a
prernanufacRlre
notice,
asserting
confidentiality
claims,
completing
fonn
7710­
25,
and
submitting
test
data
and
optional
infornlation.
It
provides
some
information
about
exemptions
am
exclusions
from
reporting
which
do
not
require
notice.
This
manual
explains
the
requirements
of
the
Pre
manufacture
Notice
Requirements
and
Review
Proc~
res
(
premanufacture
Notification
Rule)
at
40
Code
of
Federal
Regulations
720.

How
this
Manual
is
organized:

I.
GENERAL
INSTRUCTIONS
FOR
REPORTING
UNDER
THE
TOXIC
SUBSTANCES
CONTROL
ACT
IS
NEW
CHEMICALS
PROGRAM
­
PREMANUFACTURE
NOTICE
FORM
A.
B.
C.
D.
E.
F.
G.
H.
I.
J.
K.
L.
M.
N.
Substances
Which
Must
Be
Reported
("
New"
Chemicals)
Who
Must
Submit
A
Premanufacture
Notice
Substances
Excluded
from
Notification
When
to
Submit
a
Notice
Filling
Out
and
Submitting
the
Form
Binding
Boxes
Test
Data
and
Other
Data
Confidentiality
Consolidated
Notices
Submission
of
Infonnation
by
Others
Consultation
with
EP
A
Concerning
the
Premanufacture
Notice
Notice
of
Commencement
(
NO
C)
of
Manufacture
(
or
Import)
(
40
CFR
§
720.102)
Recordkeeping
Recognition
of
Pollution
Prevention
and
Recycling
Benefits
ll.
PAGE­
BY
­
PAGE
INSTRUCTIONS
FOR
COMPLETING
THE
TSCA
§
5
NEW
CHEMICALS
PROGRAM
PREMANUFACTURE
NOTICE
FORM
Type
of
Notice
(
page
1)
Certification
(
page
2)
2.

Part
I
­
GENERAL
INFORMATION
Section
A
­
Submitter
Identification
(
page
3)
Section
B
­
Chemical
Identity
Information
(
Pages
4­
6)

2.
3.
4.
S.
6.
7.
Class
1
or
Class
2
chemical
substances
(
page
4)
Polymers
(
Page
5)
Impurities
(
page
6)
Synonyms
Trade
Identification
Generic
chemical
name
Byproducts
Section
C
­
Production,
Import,
&
Use
InfOlomation
(
page
7)

Production
volume
Use
infonnation
Hazard
infonnation
2.
3.

Part
n
­
HUMAN
EXPOSURE
AND
ENVIRONMENTAL
RELEASE
(
Pages
8­
10)

Section
A
­
Industrial
Sites
Controlled
by
the
Submitter
(
Pages
8­
9)
Section
B
­
Industrial
Sites
Controlled
by
Others
(
Page
10)

(
OPTIONAL)
POLLUTION
PREVENTION
AND
RECYCLING
INFORMAfiON
(
Page
11)
­
Technical
InfonnatioD
8.
b.
C.
d.
h.
I.
Process
Chemistry
Product
Substitution/
Source
Reduction
Process
Modifications
Operating
Practices
Alternative
Waste
Disposal
Methods
Toxicity
Information
Part
ill
­
liST
OF
ATTACHMENTS
(
page
12)
Physical
and
Chemical
Properties
Worksheet
(
Optional)

Ap~
ndi't
A:
Types
of
test
data
for
submission
Appendix
B:
Annotated
version
of
form
7710­
25
distributed
internally
by
the
3M
Co.
Appendix
C:
Contact
Persons
­
2­
I.
GENERAL
INSTRUCTIONS
FOR
REPORTING
UNDER
THE
TSCA
§
5
NEW
CHEMICALS
PROGRAM
­
PREMANUF
A
CTURE
N
aTI
CE
FaRM
A.
Substances
Which
must
Be
Reported
("
New"
Chemicals)

1.
General­
You
are
responsible
for
determining
whether
a
substance
you
intend
to
manufacture
or
import
is
a
"
new"
chemical
substance
as
defmed
by
the
Toxic
Substances
Control
Act
(
TSCA,
the
Act)
and
40
Code
of
Federal
Regulations
(
CFR)
§
720.3.
You
must
submit
a
premanufacture
notice
(
PMN)
if
you
intend
to
manufacture
(
import
is
considered
manufactUre)
any
new
chemical
substance
which
is
not
on
the
TSCA
Inventory
or
otherwise
excluded
from
notification,
as
discussed
below.
To
submit
a
PMN,
you
must
use
Form
EPA
7710­
25.
Part
II
of
this
Manual
is
a
step­
by­
step
guide
to
form
7710­
25
(
rev
5­
95).

1.
Bona
fide
request
for
a
TSCA
Illventory
search­
The
specific
identities
of
some
chemical
substances
on
the
Inventory
are
confidential
and
therefore
do
not
appear
on
the
Inventory
available
to
the
public
Such
substances
are
described
by
generic
names
in
the
Appendix
to
the
Inventory.
If
a
substance
you
intend
to
manufacture
or
import
is
not
on
the
published
Inventory
but
falls
within
one
of
the
generic
categories
in
the
Appendix,
you
may
request
that
EPA
search
the
Inventory's
confidential
file.
EPA
will
search
the
confidential
file
only
if
you
can
demonstrate
a
bona
fide
intent
to
manufacture
or
import
the
substance.
This
policy
is
to
ensure
that
this
search
procedure
cannot
be
used
for,
essentially,
industrial
espionage.

The
procedure
for
demonstrating
such
a
bona
fide
intent
is
codified
at
40
CFR
§
720.2S.
Certain
information
must
be
submitted
with
a
bona
fide
request:
an
infrared
spectrum
must
be
supplied
unless
this
analysis
is
not
suitable
for
the
particular
substance.
in
which
case
a
spectrum
or
instrument
readout
from
a
more
appropriate
method
must
be
submitted;
a
currently
correct
Chemical
Abstracts
(
CA)
Index
name
or
CA
preferred
name,
whichever
is
appropriate;
a
currently
correct
Chemical
Abstracts
Service
(
CAS)
register
number
(
CASRN)
(
if
the
substance
already
has
a
CASRN
assigned
to
it);
molecular
formula
and
a
complete
or
partial
chemical
structure
diagram
if
known
or
reasonably
ascertainable;
and
a
description
of
R&
D
activities
that
have
already
been
conducted
(
include,
for
example,
years
research
conducted,
end
use
application,
toxicity
data,
etC.).
Three
additional
information
requirements
established
in
the
PMN
Rule
Amendments,
published
March
29,
1995
«
(
Jj
Federal
Register
(
FR)
(
Jj
pp.
16298­
16351)
for
a
TSCA
inventory
search
include:
the
most
probable
manufacturing
site,
­
major
intended
application
or
use­
of
the
substance,
and
the
approximate
date
when
the
submitter
would
be
likely
to
submit
a
§
5
notice
for
the
substance
if
it
is
not
found
in
the
inventory.
If
the
substance
is
being
imported,
a
statement
should
include:
a)
how
long
the
substance
has
been
used
outside
of
the
U.
S.,
b)
name
of
the
country(
ies)
in
which
the
substance
is
being
used,
and
c)
whether
the
substance
has
been
used
outside
the
U.
S.
for
the
same
use
as
that
intended
after
proposed
importation.
No
specific
form
is
required
to
be
used.

The
address
to
which
to
send
bonafide
submissions
(
by
US
mail)
is:

OPPT
Document
Control
Officer
Mail
Stop
7407
USEPA
401
M
Street,
South
West
Washington,
DC
20460
The
room
at
which
bonafides
are
accepted
is
only
open
until
4
PM,
and
if
a
courier
service
comes
after
that
time
it
will
be
turned
away.
You
need
the
physical
address
for
sending
a
bona
fide
by
courier.
You
can
give
the
courier
the
phone
number
(
202)
260­
1768
to
call
if
there
are
delivery
problems:

­~­
OPPT
Document
Control
Officer
Mail
Stop
7407
TSCA
Data
Processing
Center
0099
East
Tower,
Waterside
Mall
USEPA
401
M
Street,
South
West
Washington,
DC
20460
After
conducting
its
search,
EP
A
will
tell
you
if
the
substance
is
included
on
the
Inventory
and
therefore
not
subject
to
premanufacture
notification
or
if
you
must
submit
a
PMN.

B,
Who
Must
Submit
A
PMN
If
you
intend
to
manufacture
or
import
a
new
chemical
substance
for
a
commercial
purpose,
you
must
submit
a
PMN
to
BPA.
You
must
submit
a
notice
if
you
intend
to
import
a
new
substance
in
bulk
form
or
as
part
of
a
mixttlre,
but
not
if
you
intend
to
import
the
substance
only
as
part
of
an
article.
The
use
of
the
term
"
manufacttlre"
in
this
manual
includes
both
manufacture
and
import.
Importers
must
fully
comply
with
the
infonnation
requireme~
ts
outlined
at
40
CFR
§
720.
However.
importers
are
not
required,
under
§
720.5O(
d)(
3),
to
submit
any
data
which
relates
solely
to
exposure
to
humans
or
the
environment
outside
the
United
States.
Importers
must
submit
non­
exposure
data
such
as
data
on
health
effects
(
including
epidemiological
studies),
ecological
effects,
physical
and
chemical
properties.
or
environmental
fate
characteristics
and
(
on
sites
under
their
control
within
the
United
States)
exposure
information.

"
Article"
is
defined
at
40
CFR
§
720.3
as
a
manufactured
item
which:
(
1)
is
formed
to
a
specific
shape
or
design
during
manufacture;
(
2)
has
an
end
use
function(
s)
dependent
in
whole
or
in
part
upon
its
shape
or
design
during
end
use;
and
(
3)
either
has
no
change
of
chemical
composition
during
its
end­
use
or
only
those
changes
in
composition
which
have
no
commercial
purpose
separate
from
the
article
of
which
it
is
a
part
and
that
may
occur
as
descn"
bed
in
40
CFR
§
7l0.4(
d)(
S)
and
40
CFR
§
720.30(
h)(
S).
Articles
are
excluded
from
PMN
requirements.
Fluids
and
particles
do
not
meet
the
defmition
of
an
article
and
are
therefore
not
excluded
from
inventory
reporting
requirements.
Therefore,
all
particles
or
fluids
must
be
reported
for
the
purposes
of
TSCA
unless
they
can
be
considered
mixtures.
Also,
OPPT
will
consider
items
bein~
imported
to
be
"
articles"
only
if
they
are
manufactured
in
a
specific
shape
or
design
for
a
particular
end
use
application,
and
this
design
is
maintained
as
an
essential
feature
in
the
finished
product.

PMNs
for
imported
new
chemical
substanceshould
be
submitted
by
the
principal
importer.
"
Principal
importer"
is
defined
at
40
CPR
§
720.3(
z).
It
is
not
necessarily
the
same
as
"
Importer
of
Record"
under
customs
regulations.

Generally,
when
you
contract
with
another
person
to
manufacture
a
new
chemical
substance,
that
person
must
submit
the
notice.
However,
if
you
request
another
person
to
manufacture
a
new
chemical
substance,
and
if
you
specify
the
identity
and
total
amount
of
the
substance
to
be
manufactured
and
the
basic
technology
and
controls
under
which
the
substance
will
be
produced,
and
if
that
person
manufactures
the
substance
exclusively
for
you,
that
person
is
considered
a
"
toll
manufacturer",
and
you
must
submit
the
notice.
Information
regarding
human
exposure
and
environmental
release
should
be
submitted
on
EPA
form
7710.25
in
Part
II,
Section
A,
Industrial
Sites
Controlled
by
the
Submitter.
EP
A
recognizes
that
in
this
and
sinlilar
instances,
the
other
manufacturer
may
have
information
useful
to
the
Agency's
review
of
the
new
chemical.
Therefore,
EPA
strongly
encourages
joint
submission
in
these
situations.

This
manual
does
not
discuss
uses
of
microorganisms
subject
to
the
Toxic
Substances
Control
Act
(
TSCA).
For
specific
information
on
submitting
notices
for
biotechnology
products
please
contact
the
Biotechnology
Program
in
the
New
Chemicals
Notice
Management
Branch:

­
4­
Biotechnology
Program
New
Chemicals
Notice
Management
Branch
Chemical
Control
Division
Mail
Stop
7405
USEPA,
401
M
Street,
S.
W.
Washington,
D.
C.
20460
For
additional
information
on
who
must
submit
a
notice,
see
40
CFR
§
720.22
or
consult
a
Prenotice
Coordinator.
Prenotice
Coordinators
(
see
Contact
List,
Appendix
C)
are
staff
in
the
New
Chemicals
Program
who
specialize
in
assisting
with
status
questions
and
questions
on
how
to
properly
complete
the
notifications.

c.
Substances
Excluded
from
Notification
1.
Statutory
Excluded
Categories
­
§
3(
b)
of
the
TSCA
excludes
certain
substances
from
premanufacture
notification.
These
include
mixtures
(
individual
substances
comprising
the
mixtures
are
NOT
exempted),
substanceS
manufactured
solely
for
use
as
pesticides,
food,
food
additives,
drugs,
or
cosmetics;
tobacco
aDd
tobacco
products;
nuclear
source
materials:
firearms
and
ammunition;
impurities;
byproducts
which
have
no
commercial
use;
non­
isolated
intermediates;
and
new
chemical
substances
manufactured
solely
for
export.
Statutory
exclusions
are
covered
also
at
40
CFR
§
720.3(
e)
and
(
u)
and
through
criteria
at
§
§
720.3O{
hX3)­(
h)(
7)

2.
Research
and
development
(
R&
D)
exemption
­
R&
D
includes
synthesis
of
new
chemical
substances
for
analysis,
experimentation,
or
research
on
new
or
existing
chemical
substances,
including
product
development
activities.
R&
D
may
include
tests
of
the
physical,
chemical,
production,
and
performance
characteristics
of
a
substa1
¥
:
e.

You
do
not
have
to
submit
a
notice
for
a
new
substance
manufactured
or
imported
in
small
quantities
solely
for
research
and
development
as
specified
in
40
CFR
§
720.36.
.
Small
quantities.
arc
those
not
greater
than
reasonably
necessary
for
research
and
development
purposes.
The
quantity
which
is
reasonable
may
vary
depending
on
the
nature
of
the
research
and
development
activities.
It
is
your
respoDSloility
to
determine
what
is
reasonable
in
your
situation.
You
do
not
have
to
apply
for
this
exemption.
However,
you
must
submit
a
PMN
90
days
before
you
intend
to
manufacture
the
substance
for
a
purpose
other
than
research
and
development
ulxicrtaken
in
compliance
with
1720.36.

To
qualify
for
the
exemption.
your
research
and
development
activities
m~
t
be
conducted
uDder
the
supervision
of
a
technically
qualified
individual.
Persons
who
engage
in
R&
D
for,
or
obtain
an
R&
D
chemical
from,
a
manufacturer
must
be
notified
of
any
risk
to
health
which
may
be
associated
with
the
chemical.
However.
R&
D
conducted
entirely
in
laboratories
under
prudent
laboratory
practices
is
exempted
from
the
requirement
for
risk
evaluation.

In
accordance
with
40
CFR
§
720.78,
the
following
R&
D
records
must
be
retained
(
also
see
I­
M,
Recordkeeping):
information
reviewed
and
evaluated
to
determine
the
need
to
make
any
notification
of
risk,
doc1~
nwion
of
the
nature
and
method
of
risk
notification,
documentation
of
prudent
lab
practices,
if
used
instead
of
risk
notification
and
evaluation
and,
if
an
R&
D
substance
is
manufactured
at
greater
than
100
kg/
yr
records
regarding
the
chemical
identity
of
the
substance
to
the
extent
known,
the
production
volume,
and
the
disposition
of
the
R&.
D
chemical
substance
must
also
be
retained.

Manufacturers
and
importers
who
distribute
an
R&
D
substance
to
other
persons
must
provide
those
persons
with
written
notification
of
known
hazards
and
of
the
requiremem
that
the
substaIK:
e
be
used
solely
for
­
5­
R&
D.
For
additional
information
on
R&
D
requirements
see
the
New
Chemical
Information
Bulletin:
Exemotions
for
Research
and
Develooment
and
Test
Marketing
available
from
the
TSCA
Assistance
Information
Service
(
TAIS,
TSCA
Hotline)
(
see
Contact
List,
Appendix
C).

3.
Test­
marketing
exemptions
(
TME)
­
You
may
apply
for
an
exemption
from
premanufacture
notification
if
you
plan
to
manufacture
or
import
a
new
chemical
substance
for
test­
marketing.
Test­
marketing
involves
the
distribution
of
a
predetermined
limited
amount
of
a
chemical
substance,
or
of
a
mixture
or
article
co~
taining
the
chemical
substance,
toa
specified
number
of
customers
to
explore
market
acceptability
before
general
distribution.
The
submitter
needs
to
show
that
the
intended
activity
is
not
commercial
production
and
is
not
appropriately
considered
to
be
research
and
development.

To
approve
a
test­
marketing
exemption
application,
the
Agency
must
make
an
affIrIDative
fInding
that
the
new
chemical
substance
will
not
present
an
unreasonable
risk
to
health
or
the
environment
during
the
testmarketing
activities.
40
CFR
§
720.38
identifies
the
type
of
information
you
should
submit
with
a
test­
marketing
exemption
application.
EPA
must
approve
or
deny
the
application
within
45
days.
If
you
do
not
provide
sufficient
information
for
EP
A
to
make
i(
s
determination,
the
Agency
will
deny
the
request.
You
should
send
applications
for
test­
marketing
exemptions
to
the
OPPT
Document
Control
Officer
(
7407).
You
are
not
required,
but
are
encouraged,
to
use
the
PMN
form
for
a
TME
application.
For
additional
information
on
test
marketing
requirements
see
the
New
Chemical
Information
Bulletin:
Exemotions
for
Research
and
Develooment
and
Test
Marketin2
available
from
the
TSCA
hotline.
Recordkeeping
requirements
for
a
test­
marketing
exemption
are
discussed
at
I­
M,
Recordkeeping.

4.
§
S(
b)(
4)
exemptions
­
§
5(
h)(
4)
of
the
Act
allows
EPA
to
exempt
a
substance,
or
a
category
of
substances,
from
the
requirement
for
premanufacture
notification
if
it
makes
an
affirmative
finding
that
the
manufacture,
processing,
distribution
in
commerce,
use,
or
disposal
of
the
new
substance
or
category
of
substances
will
not
present
an
unreasonable
risk
to
health
or
the
environment.
EPA
has
established
3
exemptions
under
§
5(
h)(
4),
described
below.
For
the
Low
Volume
and
Low
Release,
Low
Exposure
exemptions,
you
should
send
applications
to
the
OPPT
Document
Control
Officer
(
7407)
using
form
7710­
25.
For
substances
qualifying
for
the
Polymer
Exemption,
notify
the
Agency
at
the
end
of
the
year
of
first
manufacture.

a.
Low
Volume
Exemption
(
LVE)
­
Requirements
for
a
LVE
application
are
found
at
40
CFR
§
723.50.
This
exemption
is
available
for
substances
manufactured
in
quantities
of
IO,
IXX>
kg
or
less
per
year.
Multiple
L
VEs
can
be
issued
to
several
manufacturers
of
a
single
substance,
however,
second
and
subsequent
applications
will
be
evaluated
in
the
context
of
existing
permitted
exposures.
Low
volume
substances
are
not
added
to
the
TSCA
Inventory.
The
notice
must
include
the
site
of
manufacture
and
proposed
use
of
the
new
chemical
substance;
these
are
legally
binding
upon
the
company.
The
manufacturer
may
also
provide
information
on
exposure
controls.
If
provided,
any
controls
specified
in
the
notice
are
binding
throughout
the
period
of
the
exemption.
EP
A
will
grant
the
L
VE
if
it
determines
that
the
substance
will
not
present
an
unreasonable
risk
of
injury.
The
review
period
for
an
L
VE
is
30
days,
which
can
be
extended
if
more
information
is
required.

Companies
must
notify
the
Agency
within
30
days
of
a
change
of
the
site
of
manufacture
or
application.
Manufacturers
(
importers)
must
notify
processors
and
industrial
users
that
the
substance
can
be
used
only
for
the
uses
specified
in
the
exemption
notice.
Manufacturers
must
also
notify
processors
and
users
of
any
exposure
controls.
Recordkeeping
requirements
are
discussed
at
I­
M.
Recordkeeping.

b.
Low
Release
and
Exposure
(
LoREX)
Exemption
­
Eligibility
for
this
exemption
category
is
independent
of
production
volume
level.
Performance
standards
for
this
exemption
are
set
out
in
40
CPR
§
723.50
(
c)
and
include
both
absolute
criteria
(
e.
g.,
an
upper
limit
on
surface
water
releases)
and
goals
(
e.
g.,
no
worker
exposure).
The
notice
must
include
the
site
of
manufacture
and
proposed
use
of
the
new
chemical
substance
which
are
legally
binding
upon
the
company.
The
applicant's
exemption
notice
­
6..
must
describe
how
exposures
and
releases
of
the
new
chemical
substance
compare
to
the
criteria
of
40
CPR
§
723.50
(
c).
If
the
exemption
is
granted
the
applicant
is
responsible
for
complying
with
the
standards
and
widl
any
controls
or
limitations
specified
in
this
exemption
notice.
These
requirements
must
be
followed
throughout
the
period
of
exemption.
loREX
exemption
notices
are
subject
to
3O­
day
review
periods
by
the
Agency.
Recordkeeping
requirements
are
discussed
at
I­
M,
Recordkeeping.

c.
Polymer
Exemption
­
Requirements
for
a
Polymer
Exemption
can
be
found
at.
40
CFR
§
723.250.
The
exemption
was
first
published
at
60
Federal
Register
(
FR)
pp.
16316­
16336,
and
there
is
a
useful
discussion
in
the
Preamble
to
that
publication.
This
exemption
is
available
for
certain
classes
of
polymers
which
are
not
chemically
active
or
bioavailable.
The
manufacturers
are
not
required
to
submit
a
polymer
exemption
notice
to
EPA
prior
to
manufacture,
but
must
notify
the
Agency
by
31
January
for
new
materials
first
manufactured
in
the
preceding
calendar
year.
Recordkeeping
requirements
are
discussed
at
I­
M,
Recordkeeping.

D.
When
to
Submit
a
Notice
You
must
submit
a
PMN
at
least
90
days
before
you
begin
to
manufacture
or
import
a
new
chemical
substance
for
a
commercial
purpose.
You
are
required
to
submit
a
notice
for
LVE
or
LoREX
exemptions
30
days
before
you
begin
to
manufacture
or
import
a
new
chemical
substance,
and
45
days
before
manufacture
or
importation
under
TME.
If
information
additional
to
that
provided
with
the
application
is
needed,
these
periods
can
be
extended
through
suspension
requests.
If
your
application
is
not
denied,
you
will
be
able
to
initiate
manufacture/
import
at
the
end
of
these
review
periods.
It
is
prudent
for
submitters
who
think
their
substances
may
be
subjected
to
required
additional
testing
during
PMN
review
to
confer
with
the
Agency
before
submitting
and
to
submit
further
in
advance
of
their
hoped­
for
start
dates
than
the
minimum
number
of
days
for
review,
as
additional
testing
will
extend
the
Agency
review
period
for
the
PMN.
To
initiate
this
process
contact
a
prenotice
coordinator.

E.
Filling
Out
and
Submitting
the
Form
Complete
the
§
5
notice
form
EP
A
7710­
25
(
rev.
5­
95)
using
a
typewriter
or
by
printing
legibly
in
black
ink.
Information
which
is
not
submitt~
d
on
a
photocopy
of
the
form
available
from
EPA
(
e.
g.,
an
electronically
generated
form
created
by
utilizing
form­
making
software)
must
be
in
a
format
pre­
approved
by
the
Agency.
Approval
can
be
obtained
by
contacting:

OPPT
Document
Control
Officer
Mail
Stop
7407
USEPA
401
M
Street.
South
West
Washington.
DC
20460
All
information
provided
must
be
in
English
(
Except
that
open­
literature
reports
can
be
submitted
in
their
original
languages:
if
data
appears
in
the
open
scientific
literature,
the
submitter
need
only
provide
a
standard
literahlre
citation.
A
standard
literature
citation
includes
author,
title,
periodical
name,
date
of
publication,
volume,
and
page
numbers.
The
submitter
can
assist
the
Agency
by
providing
a
photocopy
of
the
article,
if
desired.
This
is
the
only
exception
to
the
requirement
that
all
information
must
be
submitted
in
English).
Provide
all
information
requested
on
the
notice
form
to
the
extent
that
you
know
or
can
reasonably
ascertain
it.
If
you
do
not
know
or
cannot
reasonably
ascertain
the
information,
enter
"
NK"
("
not
known").
Many
submitters
want
to
know
what
is
meant
by
"
reasonably
ascertainable".
In
general,
the
Agency
views
inforxnation
in
the
current
literature,
held
by
the
submitter
or
a
parent
or
subsidiary
company,
or
held
by
a
supplier
to
be
reasonably
ascertainable.

_
7­
Some
staff
members
in
large
corporations
have
expressed
concern
for
their
personal
liability
on
information
submission
­
that
there
can
be
information
held
by
their
organization
which
a
reasonable
search
will
not
uncover.
As
an
example,
a
branch
office
of
a
parent
company
may
have
called
for
a
study
of
a
substance
and
not
have
retained
its
results
in
the
ordinary
or
expected
record
locations,
or
a
study
of
a
family
of
substances
undertaken
for
commercialization
of
one
of
them
may
not
be
found
when
commercialization
of
another
of
those
substances
is
later
undertaken.
If
you
think
you
are
in
some
danger
that
you
might
not
find
all
of
your
company's
information
about
a
substance
on
which
you
are
preparing
notification,
you
should
document
that
you
made
a
serious
search
for
information.
which
should
have
yielded
all
reasonably
ascertainable
infonriation,
and
keep
a
record
of
your
search
with
your
records
of
the
submission.
You
should
be
able
to
make
available
to
an
EP
A
inspector
records
showing:
that
you
identified
where
in
your
corporate
organization
(
or
your
suppliers)
the
information
might
be,
that
you
sent
requests
for
information
to
each
site
where
you
think
the
information
might
be
kept,
and
that
you
followed
up
with
any
non­
responding
site
until
you
got
a
response.
You
should
review
all
applicable
information
on
the
substance,
such
as
the
Material
Safety
Data
Sheet
(
MSDS)
for
the
existence
of
testing
on
the
new
chemical
substance.
It
is
helpful
if
there
is
a
corporate
information
policy
to
ensure
that
this
son
of
information
is
available
to
a
responsible
PMN
submitter.

You
may
submit
continuation
sheets
for
any
subsection
or
item
on
the
form.
Head
any
continuation
sheet
with:
the
TS­
number
or
PC­
number,
if
any;
submitter
name;
and
the
number
of
the
question
to
which
it
is
a
supplement.
Mark
the
appropriate
box
on
the
notice
form
if
you
attach
continuation
sheets.
You
may
photocopy
the
notice
form,
sections
of
the
form,
or
this
manual
as
frequently
as
you
need.

Form
7710­
25
(
rev.
5­
95)
is
used
for
several
different
types
of
submissions.
These
instructions
are
designed
to
guide
submitters
for
each
of
tl1em.
Send
your
completed
notice
to
the
Document
Control
Officer
(
DCO)
for
Office
of
Pollution
Prevention
and
Toxics.
If
the
notice
is
a
PMN
or
Significant
New
Use
Notice
(
SNUN),
send
with
original
signatures
and
two
copies
(
an
additional
copy
is
required
if
any
information
is
claimed
to
be
confidential,
and
should
be
submitted
with
the
claimed­
confidential
information
deleted
("
redacted
copy",
"
sanitized
copy").
No
copies
are
required
if
it
is
an
application
for
a
Test
Market
Exemption
(
TME),
Low
Volume
Exemption
(
LVE),
or
Low
Release­
Low
Exposure
Exemption
(
LoREX),
except
that
if
it
contains
confidential
business
information
(
CBI)
you
must
submit
a
redacted
copy.
which
will
be
placed
for
public
viewing
in
the
TSCA
Nonconfidential
Information
Center,
202­
260­
7099
(
open
from
12m
­
4pm
daily):

TSCA
Nonconfidential
Information
Center
Mail
Stop
7407
Room
B607.
Northeast
Mall
401
M
Street
SW.
Washington
DC
20460
The
US
Mail
address
for
the
DCa
appears
on
page
1
of
the
form.
The
room
at
which
submissions
are
accepted
is
open
from
8
am
until
4
pm
daily.
and
if
a
courier
service
arrives
after
that
time
it
will
be
turned
away.
For
seOOing
a
notice
by
courier
the
address
should
include
the
physical
location:

OPPT
Document
Control
Officer
Mail
Stop
7407
TSCA
Data
Processing
Center
GO99
East
Tower,
Waterside
Mall
USEPA
401
M
Street.
South
West
Washington,
DC
20460
You
can
give
the
courier
the
phone
number
(
202)
260­
1768
to
call
if
there
are
delivery
problems
­
8­
A
user
fee
must
be
remitted
for
PMN
and
SNUN
§
5
notices
in
accordance
with
40
CFR
§
700.45.
You
must
create
a
unique
alpha­
numeric
identification
number
{"
TS­
number"}
to
identify
and
link
your
notice
with
the
remittance
fee.
This
six
digit
number
must
be
placed
on
the
first
page
of
the
form
in
the
boxes
that
have
been
provided.
This
number
must
also
be
placed
on
your
fee
remittance
which
is
sent
to:

EPA,
Washington
Financial
Management
Center
(
Mail
Stop
3303)
P.
O.
360399M
Pittsburgh,
PA
15251­
6399
Attn.
TSCA
User
Fee
EPA
uses
a
private
bank
in
Pittsburgh
to
receive
these
fees.
The
bank
will
accept
certified
checks,
money
orders
and
bank
drafts
only;
after
the
bank
has
processed
the
payment,
the
TS­
Number
is
sent
to
EPA
Headquarters
with
certification
that
payment
has
been
made.
EP
A
Headquarters
then
verifies
that
the
appropriate
remittance
with
a
TS
identification
number
corresponds
to
a
user
fee
identification
number
on
a
PMN
and
further
processing
of
the
notice
commences.
However,
if
a
problem
arises
in
the
payment
procedure,
(
i.
e.,
insufficient
funds,
improper
usage
of
the
TS­
number),
the
notice
will
be
given
incomplete
notice
status
in
accordance
with
40
CFR
§
720.65(
c).
The
EPA
will
inforn1
the
submitter
in
writing
if
this
action
is
taken.

40
CPR
§
720.65
specifies
administrative
procedures
applicable
to
incomplete
notices
in
general.
The
most
frequent
reason
for
a
submission
to
be
incomplete
is
a
name
which
is
not
in
conformance
with
the
Ninth
Collective
Index
(
9CI)
of
Chemical
Abstracts
nomenclature
rules
and
conventions
(
this
defmitive
guide
to
CA
nomenclature
has
been
used
since
1972.)
If
the
notice
is
declared
incomplete,
the
review
period
has
not
begun
no
matter
when
in
the
initial
review
period
the
notice
is
declared
incomplete.
Therefore,
the
review
period
begins
again
at
day
one
when
a
complete
notice
is
received.
However,
EPA
can
choose
to
restart
the
clock
on
the
day
the
notice
was
declared
incomplete
if
it
determines
that
its
review
can
be
completed
within
the
remaining
period.
This
decision
is
made
case­
by­
case.
See
40
CFR
§
720.6S(
c).

F.
Binding
Boxes
The
purpose
of
the
binding
option
is
to
enable
EP
A
(
if
necessary)
to
efficiently
negotiate
with
a
PMN
submitter
the
development
of
§
5(
e)
consent
orders
and
promulgate
Significant
New
Use
Rules
(
SNURs)
for
those
new
chelnical
substances
that
the
Agency
deternlines
may
present
an
unreasonable
risk
if
certain
control
actions
are
!!
Q!
implemented.
This
option
is
intended
to
reduce
delays
that
can
slow
the
development
of
consent
orders
absent
such
agreement.
At
one
tinle,
SNURs
were
limited
to
environmental
release
activities
and
certain
industrial,
commercial,
or
consumer
activities,
but
now
they
oan
include
other
important
activities,
such
as
protection
in
the
workplace
and
hazard
communications.

Control
measures
instituted
by
the
submitter
to
reduce
exposures
arid/
or
releases
of
the
substance
may
have
a
direct
bearing
on
the
Agency's
conclusions
regarding
risk.
Therefore,
you
may
wish
to
indicate
your
willingness
to
be
bound
to
certain
submitted
information
on
the
form
which
is
related
to
the
issue
of
potential
risk
such
as
use,
production
volume,
protective
equipment,
engineering
controls,
and/
or
process
description.
By
indicating
your
willingness
to
make
these
commitments,
you
would
be
indicating
an
interest
in
future
negotiations
if
the
Agency
deems
them
necessary.
In
order
to
make
your
intentions
known
to
EP
A,
mark
in
the
"
Binding
Option"
box
on
the
form
located
to
the
right
of
the
appropriate
information.

Should
the
Agency
wish
to
discuss
development
of
binding
control
measures
for
your
PMN,
you
will
be
contacted
by
a
Program
Manager
and
negotiations
may
ensue.
Therefore,
indicating
a
willingness
to
be
bound
by
the
terms
of
your
notice
does
not
by
itself
prohibit
the
submitter
from
deviating
from
the
information
(
except
chemical
identity)
reported
in
the
form.
In
the
case
of
exemption
applications
(
i.
e.
Test
Market,
Low
Volume/
Low
Release,
Low
Exposure),
however.
certain
statements
are
automatically
binding
on
the
submitter
when
the
Agency
approves
the
exemption
applications.

­
9­
G.
Test
Data
and
Other
Data
You
are
required
to
provide
three
copies
of
any
test
data.
on
the
health
and
environmental
effects
of
the
new
chemical
substance,
including
data
on
physical/
chemical
properties,
in
your
possession
or
control,
and
a
description
of
any
other
health
and
environmental
effects
data
on
the
substance
known
to
or
reasonably
ascertainable
by
you.
Data
in
the
possession
or
control
of
either
a
parent
company
or
an
affiliated
subsidiary
located
outside
the
U.
S.
are
considered
by
the
Agency
to
be
data
that
should
be
known
to
or
reasonably
ascertainable
by
a
submitter
(
see
section
E,
above).
Data
must
be
submitted
in
English.
Standard
literature
citations
may
be
submitted
for
data
in
tl1e
open
scientific
literature.
Complete
test
data
(
not
summaries)
must
be
submitted
if
they
do
not
appear
in
the
open
literature.
Incomplete
reports
(
e.
g.,
from
ongoing
studies)
are
exempt
from
full
reporting.
However,
you
must
describe
tl1e
nature
and
objective
of
any
incomplete
study,
report,
or
test,
the
name
and
address
of
aI1Y
laboratory
developing
the
data;
progress
to
date;
type
of
data
collected;
significant
preliminary
results;
and
an
anticipated
completion
date:
If
significant
preliminary
results
or
fmal
results
are
obtained
prior
to
the
completion
of
the
notice
review
period
or
any
other
additional
information
significant
to
the
review
of
the
notice
becomes
available
to
you,
you
must
submit
tllis
information
within
10
days
of
receipt,
but
no
later
than
5
days
before
the
end
of
the
review
period.
If
information
becomes
available
during
the
last
5
days
of
the
review
period,
you
must
immediately
inform
EP
A
by
telephone.
Examples
of
the
types
of
test
data
you
must
submit
are
provided
in
Appendix
A
of
this
manual.
In
addition,
a
Physical
and
Chemical
Properties
Worksheet
now
appears
on
the
last
page
of
the
form.
For
additional
information
on
health
and
safety
studies
and
on
submitting
test
data,
see
40
CFR
§
§
720.3
and
720.50
of
the
Pre
manufacture
Notification
Rule.
Attach
test
data
to
the
notice
form
and
reference
it
by
page
number
in
Part
III,
List
of
Attachments.

You
are
not
required
to
submit
any
data
previously
submitted
to
EPA
with
no
claims
of
confidentiality
if
you
identify
in
your
submission
the
office
or
person
to
whom
you
submitted
the
data,
the
date
it
was
submitted,
and,
if
appropriate,
a
standard
literature
citation.
If.
however,
you
submitted
data
with
claims
of
confidentiality
,
you
must
resubmit
the
data
with
the
notice
and
any
claim
of
confidentiality
under
40
CFR
§
720.80.
You
also
are
not
required
to
submit
data
related
solely
to
product
efficacy.
This
exception
does
not
apply
to
information
required
in
the
notice,
test
data,
or
other
data.

B.
Confidentiality
Asserting
claims
You
may
assert
a
claim
of
confidentiality
for
any
information
(
other
than
health/
safety
studies)
submitted
to
EPA.
To
assert
confidentiality
for
specific
information
on
the
form
(
e.
g.,
submitter
identity,
chemical
identity,
or
use
information),
mark
in
the
"
Confidential"
or
Confidential
Business
Information
(
CBI)
box
on
the
form
located
to
the
right
of
the
information.
Also
mark
the
box
at
the
bottom
of
page
I
of
the
form
if
any
information
in
the
notice
was
claimed
as
confidential
in
the
foml.
As
noted
above,
a
redacted
copy
of
any
§
5
notice
must
be
submitted
with
the
notice,
or
it
will
be
declared
incomplete
by
the
Agency
and
returned
to
the
submitter.

To
assert
confidentiality
claims
for
information
in
attachments
to
the
form,
provide
a
complete
copy
of
the
attachment
that
clearly
indicates
(
e.
g.,
by
circling
or
bracketing)
the
information
you
wish
to
claim
as
confidential.
Bracket
only
the
specific
information
you
claim
as
confidential.
For
example,
if
you
submit
a
study
which
contains
a
physical
or
chemical.
property,
and
it
is
only
that
property
which
you
wish
to
claim
as
confidential,
bracket
only
that
property.
Do
not
simply
stamp
"
Confidential"
on
the
page
which
contains
that
property.
You
must
also
clearly
and
specifically
mark
any
confidentiality
claims
you
wish
to
make
for
information
or
correspondence
subsequently
submitted
to
EPA
about
your
PMN,
and
you
must
provide
a
redacted
version
for
the
public
file.
If
you
claim
the
identity
of
the
new
chemical
substance
or
its
category
of
use
as
confidential,
you
must
provide
a
generic
description
of
this
information,
as
indicated
in
the
appropriate
sections
of
the
form.
Guidance
on
developing
generic
names
is
given
in
Part
2
of
this
manual
in
the
Chemical
Identity
Information
Section
at
Item
6.

­
10..
To
ensure
that
no
confidential
inforn1ation
is
disclosed
to
the
public,
you
must
submit
an
additional
copy
of
the
notice
form,
including
attachments.
which
does
not
contain
confidential
information.
This
version
("
sanitized",
"
redacted")
will
be
placed
in
the
public
file.
It
must
contain
all
non­
confidential
information,
including
health
and
safety
studies.
A
hcalth
and
safety
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
exposurc
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.

Information
from
health
and
safety
studies
which
can
be
claimed
confidential
is
quite
limited
­
this
is
discussed
at
40
CPR
§
720.90.
Chemical
identity
is
assumed
to
be
part
of
a
health
and
safety
study.
40
CFR
§
720.90(
b)(
2)
discusses
the
claims
which
must
be
made
and
substantiated
for
chemical
identity
in
a
health
study
to
be
confidential:
that
disclosure
would
reveal
manufacturing
or
processing
information,
that
it
would
disclose
the
fraction
of
a
mixture
which
the
substance
comprises,
that
the
study
could
be
interpreted
without
knowing
the
identity
of
the
substance,
and
that
disclosure
would
have
harmful
competitive
effects
on
the
submitter.

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.
In
sum,
any
data
that
bear
on
the
effects
of
a
chemical
substance
on
health
or
the
environment
would
be
included.
If
you
do
not
provide
the
sanilized
copy
with
your
submission,
the
submission
will
be
incomplete
and
the
review
period
will
not
begin.
If
you
provide
a
subsequent
amendmento
your
PMN
or
additional
information/
data,
you
must
also
provide
a
non­
confidential
version
for
the
public
file.

2.
Substantiating
claims
You
are
not
required
to
provide
substantiation
of
any
confidentialitY
claim
when
you
submit
your
notice.
However,
you
must
substantiate
your
claim
of
confidentiality
for
chemical
identity
at
the
time
you
submit
a
Notice
of
Conunencement
of
Manufacture
(
NOC).
if
you
want
EPA
to
maintain
your
confidentialitY
claim
after
you
begin
manufacture.
(
NOC
requirements
are
described
in
40
CFR
§
720.102
and
in
this
manual.)
To
substantiate
that
claim,
you
must
provide
EPA
with
detailed
answers
to
the
following
questions
which
appear
in
the
Premanufacture
Notification
Rule
[
40
CFR
§
720.85(
b)(
3)(
iv)].
This
substantiation
must
accompany
your
NOC.
You
may
be
required
to
substantiate
other
confidentiality
claims
if
EPA
receives
a
Freedom
of
Information
ACt
(
FOIA)
request
on
that
information:

(
A)
What
harmful
effects
to
your
competitive
position,
if
any,
do
you
think
would
result
if
EP
A
publishes
on
dle
Inventory
the
identity
of
the
chemical
substance?
How
could
a
competitor
use
such
information
given
dle
fact
that
the
identity
of
the
substance
otherwise
would
appear
on
the
Inventory
of
chemical
substances
widl
no
link
between
the
substance
and
your
company
or
industry?
How
substantial
would
the
harmful
effects
of
disclosure
be?
What
is
the
causal
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
or
imported
for
a
commercial
purpose
by
anyone?

(
E)
What
measures
have
you
taken
to
prevent
undesired
disclosure
of
the
fact
that
you
are
manufacturing
or
importing
this
substance
for
a
commercial
purpose?

­
11­
(
F)
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
ftIes?

(
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
substallCC
by
analyzing
the
product?

(
1)
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).

Consolidated
Notices
If
you
are
manufacturing
two
or
more.
but
no
more
than
six,
structurally
similar
new
substances,
you
may
contact
a
Prenotice
Coordinator
to
obtain
approval
to
submit
a
single
consolidated
notice.
A
consolidated
notice
is
suitable
for
chemical
substances
of
similar
structure
with
the
same
or
similar
uses
and
which
share
similar
test
data
and
other
information.
A
consolidated
notice
must
identify
each
new
substance
individually;
you
may
not
submit
a
consolidated
notice
for
an
open­
ended
category.
A
separate
chemical
identity
page
must
be
provided
for
each
substance.
A
distinct
Agency
"
PMN"
number
is
assigned
to
each
chemical.
You
may
not
submit
a
consolidated
notice
for
a
series
of
intermediates
and
a
final
product
(
they
will
not
share
common
uses,
test
data,
and
other
information).

EPA
encourages
you
to
submit
consolidated
notices
when
appropriate.
You
may
submit
a
consolidated
notice
only
after
you
have
received
prior
approval
from
a
Prenotice
Coordinator.
This
request
should
concisely
describe
the
chemical
identity
of
each
substance
to
be
included
in
your
consolidated
notice
(
note:
you
need
not
use
names
from
the
Inventory
Expert
Service
of
the
CAS
to
request
approval
for
a
consolidation,
you
need
only
to
describe
the
chemical
substances
well
enough
that
EP
A
personnel
can
determine
whether
they
are
similar
enough
for
combined
review.
You
must,
however,
use
separately
obtained
Method
I
names
for
each
substance
in
a
consolidation
when
PMN
is
submitted).
Many
requestors
provide
this
information
using
the
chemical
identity
pages
of
the
form
or
in
a
one
page
table
format.
Remember
to
enter
your
prenotice
communications
number
in
Part
I,
Section
A
(
3)
(
page
3)
of
the
form.

J.
Submission
of
Information
by
Others
1.
Submbsion
by
an
agent
­
You
may
designate
an
agent
to
submit
a
§
5
notice
for
you.
Both
you
and
the
agent
must
sign
the
certification
on
the
form.
You
are
responsible
for
ensuring
that
all
information
known
or
reasonably
ascertainable
by
you
and
all
test
data
in
your
possession
or
control
are
submitted
to
EPA.
For
information
on
submissions
by
agents,
see
40
CFR
§
720.40(
e).

l~­
2.
Joint
submissions
­
You
may
also
prepare
and
submit
a
PMN
with
another
person.
A
joint
submission
may
be
useful
where
different
persons
have
information
required
in
the
notice.
including
a
situation
when
another
person
has
information
fundamental
to
the
notice.
but
wishes
10
keep
it
confidential.
For
example.
you
may
have
information
on
the
identity
and
the
physical
and
chemical
properlies
of
the
new
substance
and
another
person
may
know
its
manufacturing
process
and
ilS
intended
use.

Each
joint
submitter
must
use
a
notice
Conn
and
sign
the
certification
on
the
form.
Each
person
must
also
assert
all
confidentiality
claims
as
described
in
40
CFR
§
720.80
and
Part
I
of
this
manual.
However,
you
are
not
relieved
of
statutory
notice
requirements
by
arranging
a
joint
submission.
You
are
required
to
complete
all
mandatory
sections
of
the
form
to
the
extent
tl1at
you
know
or
can
reasonably
ascertain
the
information,
even
if
another
person
also
submits
infom1ation
for
a
certain
section.
If
you
submit
a
joint
notice,
the
review
period
will
not
begin
until
EPA
bas
received
all
required
parts
of
the
notice.
You
should
identify
the
joint
submitter
in
your
notice
and
identify
the
section(
s)
which
the
person
is
submitting.
See
40
CFR
§
720.40(
e)
for
additional
information
on
joint
submissions.

K.
Consultation
with
EP
A
Concerning
thc
Premanufacture
Notice
1.
Before
notice
submission
8.
General
inquiries
­
General
inquiries
concerning
the
premanufacture
notification
program
which
are
not
related
to
a
specific
chemical
or
notice
should
be
directed
to
the
TSCA
hotline
(
see
Contact
List,
Appendix
C).
Copies
of
the
PMN
Rule,
Instructions
Manual,
notice
form,
and
other
materials
relating
to
the
Rule
are
available
by
contacting
the
hotline.
(
These
materials
are
also
available
at
EP
A
regional
offices.)

b.
Specific
inquiries
­
Specific
inquiries
concerning
tIle
PMN
Rule,
confidentiality,
joint
submissions,
consolidated
notices,
etc..
should
be
directed
to
the
Prenotice
Coordinator.
You
can
contact
the
Prenotice
Coordinator
by
telephone,
facsimile,
or
email
(
see
Contact
List,
Appendix
C)

2.
During
notice
review
­
Upon
receipt
of
the
notice
by
the
OPPT
Document
Control
Officer
(
DCO),
the
Agency
will
make
an
initial
determination
whether
the
notice
is
complete.
The
initial
determination
looks
to
see
that
the
notice
contains
all
the
items
required
on
pages
4
through
8
of
the
form
and
for
apparent
chemical
identity
problems.
If
no
problems
are
seen,
your
form
is
initially
determined
to
be
.
complete.,
goes
on
for
further
review,
and
Day
1
of
the
9O­
day
review
period
is
assigned
as
the
date
of
receipt
by
the
DCO.
Later
and
more
detailed
review
can,
however,
discover
other
additional
information
that
has
not
been
provided,
and
you
can
be
contacted
to
provide
additional
information
at
any
time
during
the
review
period.

You
will
receive
written
notification
if
your
notice
is
declared
"
incomplete"
as
described
at
40
CFR
§
720.65.
If
your
notice
is
initially
complete,
you
will
receive
an
acknowledgment
letter
telling
you
your
notice
number
and
the
date
of
expiration
of
the
review
period.
The
Inventory
is
searched
to
ensure
that
the
substance
for
which
the
notice
is
submitted
is
not
already
included
on
the
TSCA
Chemical
Substance
Inventory.
If
your
chemical
substance
is
on
the
Inventory,
you
will
be
notified
that
your
substance
is
not
subject
to
premanufacture
notification,
and
that
therefore
you
are
free
to
begin
manufacture
immediately.
If
the
substance
is
not
on
the
Inventory,
and
if
the
substance
is
not
dropped
from
consideration
at
the
Agency's
initial
review
meeting
("
Focus
Meeting",
which
takes
place
at
approximately
Day
20),
a
Program
Manager
will
be
assigned
to
coordinate
the
review
of
the
notice
and
to
be
your
official
contact
with
the
Agency
throughout
the
remainder
of
the
review
period.
Based
on
the
Focus
Meeting,
it
is
possible
to
declare
the
PMN
"
incomplete",
usually
for
missing
test
data.
Also
during
the
review
period,
the
Program
Manager
may
contact
you
for
clarification
of
information
you
have
provided
in
the
notice
or
if
the
Agency
identifies
issues
of
concern.
If
you
are
not
contacted
prior
to
the
expiration
of
the
review
period,
you
are
free
to
commence
manufacture
of
the
substance
identified
in
your
notice
after
the
review
period
has
expired.

­
13­
You
can
check
the
status
of
your
submission
at
the
New
Chemicals
Internet
site
("
www.
cpa.
gov/
opptintr/
newchms")
aftcr
approximately
day
30.

The
Program
Manager
will
also
notify
you
before
the
review
period
expires
if
he/
she
will
extend
the
review
period
under
TSCA
§
5(
c)
or
if
regulatory
action
is
being
considered
on
tile
new
substance
under
TSCA
§
5(
e)
or
5(
t)
and
a
suspension
of
the
review
period
is
needed.
5(
e)
Consent
Orders
are
typically
issued
with
a
follow­
up
SNUR
subsequently
promulgated.
In
addition,
a
Program
Manager
will
contact
you
if
the
Agency
plans
to
develop
a
non­
5(
e)
SNUR
(
a
case
in
which
a
5(
e)
Consent
Order
does
not
precede
the
development
of
a
SNUR)
on
the
chemical
substance
identified
in
your
notice.

L.
Notice
of
Commencement
(
NOC)
of
Manufacture
(
or
Import)
(
40
CFR
§
720.102)

If
EPA
has
not
taken
any
action
to
regulate
the
new
chemical
substance
during
the
review
period,
you
may
begin
manufacturing
the
new
chemical
substance
upon
expiration
of
the
review
period.
EPA
requires
that
you
notify
the
Agency
~
y
using
EP
A
form
7710­
56.
no
later
than
30
calendar
days
after
the
first
day
of
such
manufacture
or
import
for
non­
exempt
commercial
pul­
poses
(
for
import.
Day
I
is
the
date
the
material
clears
US
Customs).

Your
NOC
must
be
sent
to
the
OPPT
Document
Control
Officer
(
Mail
Stop
7407).
In
your
NOC.
you
must
provide
the
specific
chemical
identity
of
the.
substance
,
its
PMN
number,
the
site
of
first
manufacture
or
impon.
and
the
date
when
manufacture
or
import
began.
You
must
also
substantiate
a
confidentiality
claim
for
chemical
identity
in
your
letter,
as
described
above
at
­
2.
Substantiating
Claims"
if
you
want
EPA
to
maintain
the
claim
after
you
begin
manufacture
or
import.
See
40
CFR
§
720.85(
b)
for
further
information
on
substantiating
confidentiality
claims.

M.
Recordkeeping
Recordkeeping
requirements
for
submissions
under
§
5
of
TSCA,
and
for
exemptions
from
submission,
are
found
in
several
different
sections
of
the
CFR.

PMN
or
SNUN:
40
CFR
§
720.78
(
a)
requires
that
you
retain
documentation
of
information
for
a
PMN
or
SNUN
for
five
years
from
the
date
of
commencement
of
manufacture.
The
records
you
must
retain
include
(
1)
information
supporting
the
information
supplied
on
the
notice
form,
(
2)
other
data,
as
defined
in
40
CFR
§
720.50
(
b),
in
your
possession
or
control,
(
3)
production
volume
for
the
first
three
years
of
production
or
import,
and
documentation
to
support
your
stated
production
volume,
and
(
4)
date
of
commencement
of
manufacture,
and
documentation
to
support
your
stated
date.
You
are
not
required
to
develop
information
solely
for
recordkeeping
purposes,
but
only
to
retain
information
you
have
obtained
or
developed
in
the
course
of
completing
your
submission.

Research
and
Development:
40
CFR
§
720.78
(
b)
requires
that
if
you
manufacture
a
new
chemical
substance
under
the
exemption
for
substances
manufactured
solely
for
research
and
development,
you
must
retain
documentation
of
compliance
with
the
exemption
until
five
years
after
they
are
developed.

Test­
Marketing
Exemption:
40
CFR
§
720.78
(
c)
requires
that
if
you
manufacture
under
a
testmarketing
exemption
under
TSCA,
you
must
retain
documentation
of
information
in
the
application
and
documentation
of
your
compliance
with
any
restrictions
imposed
by
EP
A
when
it
granted
the
application
until
five
years
after
the
fmal
date
of
manufacture
or
import
under
the
exemption.

LVE
or
LoREX:
40
CFR
§
723.50(
n)
requires
that
each
manufacturer
of
a
new
substance
reported
under
the
terms
of
a
low
volume
or
LoREX
exemption
must
maintain
records
of
1)
the
annual
production
volume
of
the
new
chemical
substance
under
the
exemption,
and
2)
documentation
of
information
in
the
exemption
notice
in
­
14­
compliance
with
the
terms
of
the
exemption.
Records
must
be
retained
for
fIVe
years
after
date
of
their
preparation.

Polymer
Exemption:
40
CFR
*
723.25O(
j)
requires
that
a
manufacturer
of
a
polymer
made
under
the
terms
of
the
polymer
exemption
must
maintain
rccords
for
five
years
from
the
date
of
commencement
of
manufacture
for:
the
production
volume
for
the
first
three
years
of
manufacture,
the
date
of
commencement
of
manufacture,
documentation
of
the
information
provided
above,
documentation
of
any
other
information
provided
in
the
notice,
such
as
information
that
demonstrates
that
the
new
polymer
is
not
specifically
excluded
from
the
exemption
and
the
polytner
meets
the
exemption
criteria.

N.
Recognition
of
Pollution
Prevention
and
Recycling
Benefits
During
the
course
of
its
review.
the
Agency
will
be
considering
whether
the
activities
surrounding
the
manufacture,
processing,
use,
and
disposal
of
the
substance
identified
in
the
notice
may
present
an
unreasonable
risk
of
injury
to
human
health
or
the
environment.

It
is
important,
also,
that
EPA
acquire
information
regarding
any
technological,
risk
reduction,
or
environmental
benefits
which
may
be
possible
if
the
new
chemical
being
reported
is
introduced
in
commerce,
and
this
information
can
in
some
cases
enable
the
Agency
to
approve
substances
otherwise
doubtful.
Therefore,
PMN
submitters
are
encouraged.
to
complete
and
provide
the
optional
information
on
pollution
prevention
on
page
11
of
the
form.
By
submitting
information
describing
the
positive
pollution
prevention
aspects
of
your
PMN
substance,
you
may
achieve
two
possible
benefits:
first,
the
pollution
prevention
information
may
enable
EPA
to
regulate
the
substance
less
stringently
than
it
would
have
absent
the
infom1ation,
and
second,
the
pollution
prevention
information
may
be
chosen
by
the
Agency
for
affirmative
recognition
as
part
of
the
EPA
New
Chemicals
Pollution
Prevention
Recognition
Project.

In
the
Agency's
"
EPA
New
Chemicals
Pollution
Prevention
Recognition
Project",
EPA
seeks
10
promote
safer
new
chemicals
and
processes,
providing
several
forms
of
recognition,
including
a
letter
from
the
Director
of
OPPT,
inclusion
in
a
listing
of
recognized
chemical
substances
on
the
OPPT
Internet
Homepage,
and
other
positive
publicity.
If
you
want
the
Agency
to
consider
your
PMN
substance
for
this
recognition,
you
should
explicitly
request
to
be
considered
in
your
response
at
(
OPrIONAL)
POLLUTION
PREVENTION
AND
RECYCUNG
INFORMATION
and
identify
the
pollution
prevention
merits
of
your
PMN
substance.
To
the
extent
d1at
you
think
it
helpful
for
Agency
consideration,
EPA
strongly
encourages
you
to
(
1)
submit
actual
test
data
on
the
PMN
substance
to
substantiate
any
pollution
prevention
claims
you
assert
and
(
2)
minimi7.
e
claims
of
confidentiality
claims
to
facilitate
publicity
regarding
the
PMN
substance.

For
example,
the
EP
A
will
consider
any
information
on
methods
used
to
minimize
potential
risks
associated
with
the
new
substance
through
source
reduction
or
recycling.
Some
of
d1e
benefits
for
which
information
may
be
provided
are
a
reduction
in
the
volume
manufactured.
a
reduction
in
d1e
generation
of
waste
materials,
a
reduction
in
exposure
and/
or
environmental
release
or
increased
performance
and/
or
operation
efficiency
of
d1e
new
chemical
substance
in
comparison
to
existing
chemical
substances
used
in
similar
applications.
Recycling
activities
include
reclamation
of
useful
chemical
components
from
wastes
d1at
would
od1erwise
be
released
as
air
emissions.
water
discharges
or
land
releases
during
manufacture,
process
or
use.
All
descriptions
may
be
quantitative
or
qualitative.

The
"
Pollution
Prevention
Information"
page
of
the
PMN
requests
optional
infonnation
that
will
be
used
in
the
evaluation
of
the
new
chemical
substance
and
to
compare
the
relative
risks
and
benefits
of
the
substance
as
a
substitute
for
substances
with
similar
uses
currently
on
the
market.
PMN
submitters
are
encouraged
to
report
any
and
all
relevant
information
not
reported
elsewhere
in
tile
PMN
which
they
believe
to
be
important
to
a
thorough
regulatory
decision.
The
page
provides
submitters
with
the
opportunity
to
describe
pollution
prevention
and
risk
reduction
options
considered
by
the
company
in
regard
to
the
submission.
A
useful
fonnat
for
presenting
such
­
15­
information
is
provided
at
Section
II
of
this
Mat1ual.
Providing
this
pollution
prevention
information
to
EPA
may
benefit
PMN
submitters
by
reducing
regulatory
controls
and/
or
testing
requirements,
if
the
pollution
prevention
information
sufficiently
mitigates
EPA's
concerns
for
[
he
toxicity.
human
exposure,
or
environmental
releases
of
the
PMN
substance.
EPA
considers
[
his
information
in
line
with
[
he
strictures
of
the
Pollution
Prevention
Act
of
I~.

Under
the
Pollution
Prevention
Act
of
1990
(
PPA),
Congress
established
a
national
policy
that:
(
a)
pollution
should
be
prevented
or
reduced
at
the
source
whenever
feasible,
(
b)
pollution
that
cannot
be
prevented
should
be
recycled
in
an
environmentally
safe
manner
whenever
feasible,
and,
(
c)
disposal
or
other
release
into
the
environment
should
be
employed
only
as
a
last
resort
and
should
be
conducted
in
an
environmentally
safe
manner.

EPA
defines
'
pollution
prevention"
to
mean
"
source
reduction,"
as
defined
under
the
PPA,
and
other
practices
that
reduce
or
eliminate
the
creation
of
pollutants
through;
(
a)
increased
efficiency
in
the
use
of
raw
materials,
energy,
water,
or
other
resources,
or,
(
b)
protection
of
namral
resources
by
conservation.

The
PPA
defmes
"
source
reduction"
to
mean
any
practice
which:
(
a)
reduces
the
amount
of
any
hazardous
substance,
pollutant,
or
contaminant
entering
any
waste
stream
or
otherwise
released
into
the
environment
(
including
fugitive
emissiol1S)
prior
to
recycling,
treatment,
or
disposal,
and,
(
b)
reduces
the
hazards
to
workers,
public
health,
and
the
environment
associated
with
the
release
of
such
substances,
pollutants,
or
contaminant,­

The
term
includes:
equipment
or
technology
l1}
odifications,
process
or
procedure
modifications,
reformulation
or
redesign
of
products,
substitUtion
of
raw
materials,
and
iniprovements
in
housekeeping,
maintenance,
training,
or
inventory
control.
The
term
""
,
does
not
include
any
practice
which
alters
the
physical,
chemical,
or
biological
characteristics
or
the
volume
of
a
hazardous
substance,
pollutant,
or
contaminant
through
a
process
which
itself
is
not
integral
to
and
necessary
for
the
production
of
a
product
or
the
providing
of
a
service"
(
Sec,
3(
5)(
B
»
,
Thus,
end
of
pipeline
controls,
such
as
thermal
oxidizers,
incinerators.
or
waste
water
treatment
systems
are
not
defmed
as
"
source
reduction",

EP
A
is
interested
in
information
on
how
improved
processes
for
handling
individual
new
chemical
substances
may
reduce
potential
exposures
and
releases
of
specific
PMN
substances.
Submitters
may
include
a
discussion
of
Pollution
Prevention/
Risk
Reduction
measures
actually
selected
for
implementation
and
the
rationale
for
the
selection.
Submitters
are
encouraged
to
consider
and
include
information
comparing
the
releases
and
exposures
for
various
process
options
considered
but
not
selected,
anticipated
reductions
in
releases
and
exposures
which
can
be
expected
in
the
production
of
the
PMN
substance
as
compared
to
an
existing
chemical
substance,
and
how
the
PMN
substance
and/
or
the
product
in
which
it
is
used
may
compare
favorably
with
existing
chel;
nicals
in
terms
of
pollution
prevention.
Submitters
may
also
describe
other
pollution
prevention­
related
advantages,
such
as
process
modifications,
increases
in
product
life
or
durability,
or
decreased
energy
consumption,
etc.
A
set
of
questions
to
address
these
concerns
is
put
forward
in
Section
II
of
this
Manual.

EPA
is
also
interested
in
information
describing
possible
reductions
in
toxicity,
and
human
exposure,
as
well
as
environmental
release
of
a
new
chemical
substance,
as
compared
to
those
of
already
commercialized
chemical
substances
for
which
the
new
substance
may
substitute.
Such
infom1ation
may
demonstrate
that
the
new
chemical
substance
is
a
viable
safer
substitute
for
an
existing
chemical
substance.
Voluntary
submission
of
pollution
prevention
information
is
not
intended
to
negatively
affect
the
outcome
of
EP
A
I
S
review
of
the
Premanufacture
Notification.
When
risk
reductions
are
documented,
the
information
will
be
carefully
considered
during
EP
A's
review
of
the
PMN.
Based
on
the
information,
EP
A
may
reduce
or
eliminate
anticipated
exposure
controls
and
testing
requirements
which
would
ordinarily
have
been
imposed
by
the
Agency.
Completion
of
this
section
is
also
important
if
you
wish
your
substance
to
be
considered
for
the
EP
A
New
Chemicals
Pollution
Prevention
Recognition
Project.

­
lG­
Reference
Material
EPA's
new
­
Facility
Pollution
Prevention
Guide",
a
succcssor
to
the
1988
"
Waste
Minimization
Opportunity
Assessment
Manual",
is
available
to
help
firn1S
develop
broad­
based
multimedia
pollution
prevention
programs.
Worksheets
and
other
information
are
included
to
help
facilities
identify,
assess,
and
implement
opportUnities
for
preventing
pollution.
including
methods
of
controlling
waste
creation
during
the
production
process,
as
well
as
product
design
and
redesign.
Developed
by
EPA's
Pollution
Prevention
Research
Branch,
and
Office
of
Solid
Waste,
the
Guide
(
Doc.
No.
EPA/
600/
R­
92/
088)
can
be
ordered
by
mail
from:

EP
A
Center
for
Environmental
Research
Information
Publications
Unit
26
W.
Martin
Luther
King
Drive
Cincinnati.
OH.
45268
(
800)
490­
9198
II.
PAGE­
BY­
PAGE
INSTRUCTIONS
FOR
COMPLETING
EPA
FORM
7710­
25
(
rev.
5­
95),
THE
TSCA
§
5
NEW
CHEMICALS
PROGRAM
PREMANUFACTURE
NOTICE
FORM
(
Besides
the
page­
by­
page
instructions
below.
we
have
attached
as
Appendix
B
an
annotated
version
of
the
form
distributed
internally
by
the
3M
Co..
for
its
personnel.
which
submitters
may
fmd
useful
as
an
adjunct
to
these
instructions.
)

Page
1:
Identify
Type
of
Notice.
Your
Submission
Total
Number
of
Pages:
Give
total
pages
as
submitted,
including
attachments
TS­
number:
The
submitter
chooses
tl1is
number.
It
should
be
an
alphanumeric.
Most
repeat
submitters
use
some
variant
of
their
initials
and
the
number
of
submissions
they
have
made
(
Widget
Corp.
might
pick
WIDOOl,
WlDOO2,
for
example).
The
Agency
uses
the
number
to
track
notification
from
its
bank
in
Pittsburgh,
Pennsylvania
that
the
money
has
been
received,
and
it
can
be
useful
to
the
sublnitter
in
identifying
the
submission
to
EPA
personnel
before
a
P­
number
has
been
assigned
by
the
Agency.
The
TS­
number
should
be
unique
to
this
submission
from
your
company;
do
not
give
the
same
number
to
a
subsequent
submission.

Confidentiality
Claims:
Check
this
box
if
ANY
information
in
the
form
is
claimed
confidential
Test
and
Other
Data:
Indicate
which
types
of
data
are
included
with
the
PMN
Type
of
Notice:
Please
check
the
type
of
notice
submitted.

Check
.
PMN"
if
the
application
is
for
a
standard,
final­
product
new
chemical
substance
for
placement
on
the
TSCA
Inventory.

The
"
Intermediate
PMN"
box
should
be
checked
if
this
notice
is
for
a
chemical
substance
which
is
an
intermediate
used
in
the
production
of
a
final
product
for
which
a
separate
notice
is
submitted
simultaneously,
and
for
which
the
submitter
has
no
intention
of
making
a
separate,
non­
intem1ediate
use.
In
addition,
the
intermediate
PMN
must
identify
the
fmal
product.
Separate
user
fee
identification
numbers
must
be
generated
for
and
appear
­
17­
on
each
notice;
although
a
single
check
may
be
remitted
bearing
all
user
fee
identification
numbers
for
a
sequence
of
intermediate(
s)
and
final
product.
.
Certification",
below,
discusses
fees
paid
by
small
manufacturers.
For
further
information
on
"
intermediate
PMNs"
see
40
CFR
§
§
700.43
~
700.45(
b)(
2)(
ii).

The
.
Significant
New
Use
Nolice"
(
SNUN)
box.
should
be
marked
for
any
notice
that
is
submitted
in
accordance
with
a
SNUR.

The
"
Test
Marketing
Exemption
Application"
(
TMEA)
box
should
be
marked
for
any
notice
submitted
in
accordance
with
the
criteria
listed
in
40
CFR
§
720.38.
You
are
not
required
to
use
form
7710­
25
(
rev.
5­
95)
to
submit
a
TMEA,
but
it
is
encouraged.

Boxes
are
also
provided
to
identify
your
submission
as
an
application
for
either
a
"
Low
Volume
Exemption­
(
LYE)
[
see
40
CFR
§
723.50(
c)(
1)]
or
a
"
Low
Release!
Low
Exposure
Exemption"
(
LoREX)
[
see
40
CFR
§
723.50(
c)(
2)].
These
exemptions
must
be
requested
through
use
of
the
PMN
form.
Modifications
for
earlier
approved
requests
for
either
of
these
exemptions
are
requested
by
checking
the
modification
box
on
the
first
page
of
the
PMN
form.

For
an
application
to
modify
an
L
VE
or
LoREX
exemption.
a
submitter
is
not
required
to
provide
again
infonnation
which
was
submitt~
d
in
a
previously
approved
exemption.
Each
page
from
the
application
on
which
some
information
has
changed,
and
a
new
signature
page.
must
be
provided.
An
application
for
an
LVE
for
a
substance
which
had
been
the
subject
of
a
prior
L
VE
which
had
been
submitted
before
the
amendments
of
March
29.
1995.
however.
is
a
new
application
and
the
full
form
7710­
25
must
be
submitted.

If
this
notice
is
for
a
consolidated
PMN.
the
number
of
chemicals
(
two
or
more,
but
no
more
than
six)
included
in
me
notice
should
be
entered
on
page
one
in
the
space
provided,
A
separate
PMN
number
is
assigned
to
each
chemical
substance
identified
in
a
consolidated
notice.
Approval
for
a
consolidated
PMN
notice
must
be
obtained
from
the
Prenotice
Coordinator
prior
to
submission.
You
are
required
to
identify
the
Prenotice
Communication
number
you
were
given
when
your
consolidation
was
approved
on
page
3,
question
3
of
the
form
Further
information
on
submitting
a
consolidated
notice
is
provided
at
Section
I,
Part
I
of
this
manual.

Page
2
Certification
The
official
named
in
Part
1,
Section
A
of
the
form,
as
the
person
submitting
the
notice,
must
sign
die
cenification
on
page
2
of
the
notice
form.
This
official
is
responsible
for
the
truth
and
accuracy
of
each
statement
in
the
certification.
If
an
agent
assists
you
in
preparing
the
notice,
the
agent
must
also
sign
the
cenification.
All
signatures
must
be
original,
and
in
ink.

In
addition,
the
submitter
must
check
certain
"
user
fee"
certification
statements
as
appropriate
as
required
at
40
CFR
§
700.
For
a
PMN,
consolidated
PMN
or
SNUN,
a
fee
is
required:
if
the
submitter
is
a
small
business
it
must
remit
the
fee
identified
in
either
40
CFR
§
700.4S(
b)(
1)
(
small
business
concerns
remit
a
fee
of
$
100).
If
the
submitter
is
not
a
small
business
it
must
remit
the
fee
identified
at
40
CFR
§
700.4S(
b)(
2)
(
all
non."
small"
submitters
remit
a
fee
of
$
2,500
for
final
products,
$
1,000
if
the
submission
is
for
an
intermediate
and
is
submitted
with
the
application
for
the
final
product).

A
small
business
concern
is
one
whose
total
annual
sales
(
include
all
sites,
including
those
owned
or
controlled
by
a
foreign
or
domestic
parent
company)
are
below
$
40
million
for
the
fiscal
year
preceding
the
date
of
the
submission
of
the
applicable
§
5
notice
(
see
40
CFR
§
700.43).

When
using
the
PMN
form
to
submit
a
LYE
or
LOREX
application
in
accordance
with
40
CPR
§
723.50,
all
three
of
the
corresponding
certification
statement
boxes
must
be
checked
to
acknowledge
that
you
will
manufacture
under
the
terms
of
the
exemption.
In
addition,
a
submitter
of
an
L
VE
application
must
certify
that
le­
the
manufacturer
intends
to
commence
manufacture
of
the
proposed
exempted
substance
for
commercial
purposes
within
1
year
of
the
date
of
expiration
of
the
30
day
review
period.
There
is
no
fee
for
an
L
VE
or
LOREX.

Part
I
­
GENERAL
INFORl\
IATION
Section
A
­
Submitter
Identification
(
Page
3)

la.
Person
submitting
notice
­
Enter
information
on
the
official
who
signed
the
general
certification.

The
agent
must
also
b.
Agent
­
Complete
only
if
you
authorize
an
agent
to
assist
you
in
preparing
this
notice.
sign
the
certification
as
noted
above.

If
you
mark
the
"
Confidenlial"
box
ne~
l
to
items
a
or
b.
all
infonnalion
in
tIle
item
will
be
treated
as
confidential.

c.
Mark
the
box
if
your
submission
is
a
joint
submission.
Identify
in
Part
I,
Section
A
(
l)(
c)
the
name
of
the
joint
submitter
who
is
autll0rized
by
the
U.
S.
submitter
to
provide
some
of
the
information
required
in
the
notice.
For
additional
information
on
joint
submissions,
see
part
I,
section
J
of
this
Manual.
A
notice
will
not
be
considered
complete
until
all
information
is
received
by
the
Agency.
If
information
from
multiple
parties
will
not
be
sent
to
the
Agency
in
the
same
package,
use
your
TS
user
identification
number
to
link
multiple
notices.
You
can
generate
a
TS­
number
solely
to
link
submissions,
even
for
a
no­
fee
exemption.
If
you
don't
generate
a
TSnumber
you
should
ask
a
prenotice
coordinator
to
issue
a
prenotice
communication
number
for
this
purpose.

Mark
the
.
Confidential"
box
next
to
item
c
if
you
wish
this
information
to
be
treated
as
confidential.

If
you
authorize
another
person
(
e.
g.,
a
foreign
manufacturer
or
supplier)
to
provide
information,
such
as,
confidentially
held
tradename
chemical
substance
identification
directly
to
EPA,
indicate
which
information
will
be
supplied
by
the
other
person.
Identify
that
person
by
name,
company,
and
address
in
a
continuation
sheet.
That
person's
identity
may
be
claimed
as
confidential.
A
letter
of
support
for
your
notice
should
be
provided
by
the
joint
submitter
on
its
company
letterhead.
A
notice
will
be
considered
incomplete
until
this
information
is
provided.
Whenever
possible
use
your
TS­
User
Identification
Number
to
link
this
information.

2.
Technical
contact
­
Identify
a
person
who
can
provide
EPA
with
additional
information
on
the
new
chemical
substance
during
the
notice
review
period.
The
technical
contact
identified
should
be
located
in
the
United
States
and
be
available
to
be
reached
by
telephone
during
normal
business
hours.
If
you
mark
the
"
Confidential"
box
next
to
this
subsection,
all
information
in
it
will
be
treated
as
confidential.

3.
Provide
any
prenotice
communication
number
assigned
to
your
prenotice
inquiry.
In
addition,
see
Section
II,
Pan
E
of
this
manual
for
further
information
on
submission
of
a
consolidated
PMN
that
requires
a
prenotice
consultation.

4.
Provide
the
exemption
number
assigned
for
any
previous
exemption
application
submitted
for
the
chemical
substance
covered
by
this
notice.
It
is
especially
important
for
an
exemption
modification
request
that
you
provide
the
EPA
assigned
exemption
number
from
your
original
exemption
application.
Also,
provide
a
previously
assigned
PMN
number,
if
any,
for
the
chemical
substance.

5.
Self­
explanatory
.

6.
Mark
to
indicate
whether
you
intend
to
manufacture
or
import
the
new
chemical
substance
or
both
manufacNre
and
import.
Use
the
optional
binding
box
to
indicate
your
willingness
to
be
bound
to
either
import
or
domestic
manufacture
only.

­
19­
Section
B
­
Cbemicalldentity
Inforlllation
(
Pages
4­
6)

Submitters
of
PMN
and
exemption
notices
are
required
to
provide
thc
currently
correct
Chemical
Abstract
(
CA)
name
for
the
substance(
s)
identified
in
the
notice
based
on
the
Ninth
Collective
Index
(
9CI)
of
CA
nomenclature
rules
and
conventions,
and
consistent
with
listings
for
similar
substances
in
the
Inventory.
EPA
must
receive
complete
and
unambiguous
identification
of
the
new
chemical
substance.
If
the
substance
is
not
adequately
identified,
the
submission
will
not
meet
statutory
requirements
and
the
notice
review
period
will
not
begin.
If
a
principal
imponer
does
not
know
the
specific
identity
of
the
new
substance,
the
submitter
must
contact
the
foreign
manufacturer
or
supplier
and
have
the
specific
chemical
identity
information
required
in
the
PMN
provided
directly
to
EP
A.
In
this
way,
foreign
manufacturers
Cat}
protect
confidential
business
information.
The
same
bolds
true
for
U.
S.
manufacturers
reponing
chemical
substances
using
a
generic
or
trade
name
to
identify
a
compo~
nt
of
the
new
chemical
substance.
The
submitter
of
the
new
chemical
substance
must
have
the
supplier
provide
chemical
identity
information
directly
to
EPA
before
the
notice
can
be
considered
complete.
This
information
may
be
provided
in
a
letter
of
support
from
the
supplier
or
as
a
joint
submission
between
the
two
companies.
A
letter
of
suppon
should
be
provided
on
the
supplier
company's
letterhead.
See
Part
I,
Section
1(
2)
of
this
manual
on
how
and
when
to
file
a
joint
submission.
Since
a
letter
of
suppon
or
a
joint
submission
may
be
received
separately
by
the
Agency,
an
identification
number
such
as
a
TS­
user
fee
number
or
a
Prenotice
Communications
number
should
be
used
10
link
a
PMN
with
iluormation
from
a
supplier
or
foreign
manufacturer.
The
identical
identification
number
should
appear
on
both
pieces
of
correspondence
submitted
to
EPA;
otherwise,
there
can
be
a
delay
in
processing
the
PMN.

The
type
of
chemical
identity
information
required
in
the
notice
depends
on
whether
the
substance
is
a
Class
1
or
Class
2
substance
or
a
polymer.
A
Class
1
chemical
substance
is
a
substance
whose
composition,
except
for
impurities,
can
be
representcd
by
a
definite
chemical
structural
diagram.
For
Class
1
substaoces,
a
name
that
is
consistent
with
the
nomenclature
rules
and
conventions
of
the
9th
Collective
Index
of
the
Chemical
Abstracts
Service
(
CAS)
and
with
current
TSCA
Inventory
listings
must
be
provided.
Examples
of
such
substaIx:
eS
are
l,
3­
butadiene,
benzene,
and
sodium
chloride.

A
C.
2
chemical
substance
is
a
substance
whose
composition
cannot
be
easily
represeD1ed
by
a
definite
chemical
structural
diagram.
Such
a
substance
is
generally
derived
from
natural
sources
or
complex
reactions.
Its
composition
may
be
complex,
difficult
to
characterize,
and
variable.
For
Class
2
substances
and
JX}
lymers,
a
CA
Index
Name
orCA
Preferred
Name
must
be
provided.
In
addition,
for
a
Class
2
substance,
the
ootice
must
identify
the
immediate
chemical
precursors
and
reactants
by
specific
chemical
name
aM
Chemical
Abstracts
Service
Registry
Number
(
CASRN),
if
the
number
is
available.
Trade
names
or
generic
names
of
chemical
precursors
or
reactants
are
not
acceptable
as
substitutes
for
specific
chemical
names.
Unacceptable
names
would
include,
e.
g.,
"
chlorinated
naphthalene",
"
glycerol
monoester
of
hydrogenated
cottonseed
oil
acids",
or
a
"~
tion
product
of
x,
y,
z".

A
polymer
is
a
substance
COml)()
sed
of
molecules
characterized
by
the
regular
or
irregular
repetition
of
one
or
more
types
of
identical
monomeric
units.
In
most
cases,
the
number
of
monomeric
units
is
quite
large
and
DOt
precisely
known.

If
the
substance
is
clearly
a
Class
1
or
2
substance,
then
items
a­
d
of
Question
1
on
Page
4
must
be
properly
completed.
If
the
substance
has
been
named
as
a
polymer
(
whether
the
Exemption
Rule
requirements
are
met,
or
not),
then
items
a­
c
of
Question
2
on
Page
S
must
be
addressed
and
answered
completely.
If
you
are
uncertain
whether
the
chemical
substance
is
a
Class
1
or
2
substance
or
a
polymer,
then
both
Questions
1
and
2
on
Pages
4
and
S
should
be
completed
in
full,
or
contact
the
Pre
notice
Coordinator
for
further
assistalK:
e.
If
the
variability
of
the
composition
of
a
reaction
product
is
too
complex
to
be
described
as
distinct
individual
components,
then
reaction
product
nomenclature
is
employed.
If
components
of
a
reaction
product
can
be
readily
identified
and
will
always
be
present
in
the
reaction
product,
then
the
components
should
be
specifically
identified
and
may
be
listed
individually
on
the
TSCA
Inventory.
Any
reaction
product
may
be
reponed
as
Class
2.

­
20­
Submitters
may
obtain
the
correct
chemical
identity
of
the
PMN
substance
through
the
Chemical
Abstracts
Service
(
CAS)
Inventory
Expert
Service
(
so­
called
Method
1)
Q[
from
any
other
sowce
(
so­
called
Method
2).
Consolidations
MUST
be
submitted
with
Method
I
names.
A
nolice
submitter
must
identify
in
the
chemical
identity
section
which
method
lhey
used
to
report
the
substance's
identity.
For
Method
1,
a
copy
of
the
CAS
report
must
be
attached
to
the
Iloti.:
c.
Submitters
who
choose
to
develop
their
own
chemical
identity
are
cautioned
that
the
Agency
will
consider
submissions
incomplete
and
thus
delay
their
review
if
incorrect
nomenclatwe
is
received
from
a
sourcc
other
than
CAS.
If
the
Inventory
Expert
Service
has
been
used,
the
Agency
will
work
with
the
IES
to
agrec
on
a
name,
and
the
review
period
will
not
be
affected.
Use
of
CAS
services
other
than
the
Inventory
Expert
Service,
including
CAS'
Registry
Service,
will
also
be
considered
Method
2.
In
all
cases,
each
chemical
substance
in
a
consolidated
submission
n1ust
be
identified
by
Method
I.

1.
Class
1
or
Class
2
chemical
substallces
(
Page
4)

a.
Mark
the
appropriate
class
b.
Enter
the
specific
chemical
name
of
the
new
chemical
substance.

For
a
Class
I
substance,
tl1e
name
must
be
a
clear
description
of
a
unique
substance.
In
describing
the
chemical
substance,
the
EP
A
requires
Chemical
Abstracts
Service
(
CAS)
chemical
nomenclature
be
used
for
identification
purposes
when
it
is
available.
There
is
a
separate
box
in
question
one,
item
c
on
page
4
for
entry
of
the
CAS
number.
The
Agency
encourages
submitters
to
have
contact
with
CAS
prior
to
submission
in
order
to
obtain
concise
chemical
identity
information.
Use
the
CAS
standard
rules
of
chemical
nomenclature
to
identify
the
new
substance.
Identify
the
positions
of
attachment
of
chemical
groups
or
of
unsaturation.
if
any,
by
using
locants.
The
chemical
name
should
contau1
all
of
the
information
known
about
!
he
details
of
!
he
structure
and
should
permit
the
drawing
of
an
unambiguous
chemical
structural
diagratn.

The
chemical
name
of
a
Clas$
1
substance
must
describe
the
chemica!
substance
as
completely
as
possible.
In
some
cases.
the
name
may
be
similar
to
the
names
used
to
describe
Class
1
compounds,
but
it
should
indicate
the
substance's
multiple
compon~
nts.
For
example,
"
polychlorinated
biphenyl"
indicates
a
composition
that
has
multiple
components
varying
b<.)
th
in
the
number
and
the
placement
of
the
substituent
chlorine
atoms.
In
other
cases,
the
best
possible
name
may
only
identify
the
substance
as
a
reaction
product
of
specified
reactants,
for
example,
"
anhydrosorbitol
monoester
of
hydrogenated
castor
oil
acids".

c.
Provide
a
molecular
formula
tllat
gives
the
identity
and
number
of
atoms
of
each
element
contained
in
the
molecule.
For
example,
C6H6
is
the
molecular
formula
for
benzene.
When
the
substance
is
not
molecular
or
when
the
exact
number
of
atoms
in
the
molecule
is
indefinite,
such
as
the
infinite
crystal
sodium
chloride,
give
the
relative
numbers
of
each
element
I
s
atoms.
You
are
required
to
enter
the
CAS
registry
number,
if
one
has
been
assigned
to
the
substance.

d.
For
a
Class
1
substance,
provide
a
s(
ruCnlral
diagram.
The
diagram
should
clearly
indicate
the
identity
of
the
atoms
and
the
nanlre
of
bonds
joining
the
atoms.
Any
ionic
charges
or
stereochemistry
should
be
shown
clearly.
In
the
description
of
the
nature
of
the
reaction
or
process,
as
much
specific
detail
as
possible
should
be
provided
on
the
reaction
conditions,
(
i.
e.
temperature,
time,
etc.)
and
on
the
relative
amounts
of
reactants.
All
known
stereochemical
details
should
be
provided.
Carbon
atoms
in
ring
systems
and
their
attached
hydrogen
atoms
need
not
be
explicitly
shown.
Where
applicable,
specify
the
proportions
of
isomers
or
tautomeric
forms,
degree
of
neutralization,
etc.

For
a
Class
2
substance:

(
1)
List
the
immediate
precursor
suhstances
by
chemical
name
and
CAS
Registry
Number
(
if
known)

­
21
(
2)
For
substances
prepared
by
chemical
reaction,
describe
the
nature
of
the
reaction
or
process.
A
description
should
appear
in
the
form
of
a
reaction
scheme:

A+
B­+
C
The
nature
of
the
reaction
mu~
t
be
described
as
specifically
as
possible
(
e.
g.,
acetylation,
alkaline
hydrolysis,
diazotizatio~).
For
substances
that
have
been
produced
without
chemical
reaction
(
e.
g.,
by
chemical
extr~
tiOD
from
a
natural
source),
specify
the
source,
the
production
process,
and
the
nature
of
the
product.

(
3)
If
you
intend
to
manufacture
a
Class
2
chemical
substance
within
a
limited
range
of
possible
coDllX>
Sitions,
report
the
range.
For
example,
a
manufacturer
filing
a
notice
for
chlorinated
naphthalene
might
specify
a
compositional
range
of
20­
40
percent
chlorine
by
weight.
In
determining
the
range,
you
may
have
to
consider
the
reaction
~
tions,
the
catalyst.
or
the
puriflcation
process
that
may
be
used
to
produce
the
substaoce,
aDd
other
facton.
You
should
provide
the
range
of
composition
in
weight
percent
for
each
specific
component
or
class
of
components
that
you
intend
to
manufacture
for
commercial
purposes.
Indicate
the
typical
composition
or
any
actual
values
for
samples.

(
4)
Provide
as
complete
a
structural
diagram
as
possible.
The
diagran1
should
indicate
the
characteristic
stnx:
ture
or
variable
composilional
elements
of
the
subslance
2.
Polymers
(
page
5)

Submitters
should
be
aware
or
the
PMN
filing
exemption,
applicable
to
some
polymers
and
useful
to
some
manufacturers.
The
regulations
for
this
exemption
are
at
40
CFR
§
723.250.
Persons
intending
to
manufKture
polymers,
and
who
have
determined
that
their
polymers
do
not
meet
the
requirements
of
the
exemption
should
file
a
PMN
or
LYE/
LoREX.
Persons
intending
to
manufacture
polymers,
and
who
have
determined
that,
for
business
reasons,
an
Inventory
listing
for
their
substance
is
desirable,
should
file
a
PMN.

a.
IOOicate
the
lowest
number­
average
molecular
weight
of
any
composition
of
the
polymer
you
inteod
to
manufacture.
Identify
the
method
you
used
to
make
this
determination
(
e.
g.,
vapor
pressure
osmometry
or
other
colligative
property
determinations,
gel­
permeation
chromatography,
'
light
scattering,
or
various
correlative
techniques).
If
you
have
not
determined
number­
average
molecular
weight
by
analytical
methods,
briefly
explain
the
basis
for
your
estimate.
Indicate
the
maximum
weight
percent
of
low
molecular
weight
species
below
500
and
below
1,<
XX>
absolute
molecular
weight.
Include
the
weight
of
oligomeric
reaction
products
(
including
molecules
foroled
that
are
not
polyn1er
molecules)
in
your
determination
but
do
not
include
the
weight
of
residual
mono~
or
other
reactants.
Attach
test
data
with
two
copies
supporting
your
estimate.
If
you
do
oot
have
actual
test
data,
provide
an
estimate
and
describe
the
basis
for
the
estimate.
NOTE:
The
lowest
number­
average
molecular
weight
is
NOT
the
lowest
MW
of
any
component
of
the
polymer
mixture,
but
the
lowest
number
average
of
several
samples
of
the
same
polymer,
run
over
time.

b.
Column
(
1)
­
Monomer
or
othcr
reactant
and
CAS
Registry
Number
You
are
required
to
provide
the
chemical
name
and
CAS
Registry
Number
of
each
reactant
used
in
the
manufacture
of
the
polymer
or
incorporated
into
the
polymer,
including
those
used
or
incorporated
at
2
weight
percent
or
less.
Reactants
include
monomers,
free
radical
initiators,
and
cross­
linking,
chain
transfer,
and
other
reactive
agents
that
are
used
intcntiooally
to
become
chemically
a
part
of
the
polymer
composition.
If
a
prepolymer
is
used
in
the
manufacture
of
the
polymer,
list
the
prepolymer
and
its
CASRN
as
charged
into
the
reaction
vessel.
If
prepolymer
compositional
information
is
available
(
0
(
he
submitter,
identify
by
bracketing
or
another
method
the
IDOnomers
which
are
components
of
the
prepolymer.
If
compositional
information
of
the
prepolymer
is
not
available
to
the
submitter
or
if
the
prepolymer
is
represented
for
purposes
of
TSCA
by
a
structural
repeating
unit
(
SRU)
name
(
e.
g.,
silicones
and
polyethoxylated
and
­
propoxylated
substances),
you
should
identify
the
prepolymer
as
it
is
listed
in
the
TSCA
Inventory.
Solvents.
emulsifiers,
and
non­
reacting
components
should
not
be
listed.

­
22­
Column
(
2)
­
CBI
claim
Column
(
3)
­
%
of
reactant,
typic."
composition:
For
each
reactant
(
includulg
monomers),
indicate
its
typical
weight
percent
in
the
polymer.
TIle
weight
percent
can
be
determined
in
one
of
two
ways:
according
to
the
weight
of
the
reactant
charged
to
the
reaction
vessel
or
the
weight
of
tIle
chemically
combined
(
incorporated)
reactant
in
the
polymer.
For
the
first
mclhod,
the
weight
percent
of
a
reactant
is
the
weight
of
the
reactant
charged
to
the
reactor
divided
by
the
weight
of
the
polymeric
chemical
manufactured
(
times
100).
Thus,
the
weight
percent
of
reactant
A
of
a
polymer
manufactured
from
reactants
A,
B,
and
C
is
the
weight
of
A
charged
to
the
reactor
divided
by
tIlt
dry
weight
of
the
polynler
A­
B­
C
(
times
100).
For
the
second
method,
the
weight
percent
of
the
reactant
using
the
"
incorl)
Orated
method"
is
determined
using
theoretical
calculations
of
the
minimum
weight
of
monomer
or
other
reactant
necessary
to
account
for
the
polymer's
actual
weight.
Manufacturers
must
maintain
analytical
data
or
theoretical
calculations
to
denlonstrate
their
determination.

Please
note
that
zero
per
cent
is
NEVER
an
acceptable
level
of
a
feedstock,
if
that
feedstock
is
part
of
the
chemical
identity.
To
describe
a
substance
as
including
"
0­
30%"
of
a
given
feedstock
will
only
result
in
getting
the
PMN
rewrned
for
a
better
identity.
If
you
are
notifying
for
a
substance
for
which
a
feedstock
will
vary
from
very
low
levels
you
can
enter"
>
0­
30%.
or
"
trace­
30%"
without,
as
you
will
if
you
enter
"
0­
30%..
forcing
a
new
identity.
.0
­
2
%
",
however,
would
be
acceptable
for
a
chemical
that
is
not
part
of
the
ID
and
is
not
marked
in
the
10
field.

If
you
use
a
prepolymer
in
the
manufacture
of
the
polymer,
you
must
determine
the
weight
percent
of
its
component
reactants.
For
example.
the
weight
percent
of
E
used
in
the
manufacture
of
a
polymer
(
using
the
"
amount
charged"
method)
from
reactants
A,
B,
and
C
and
prepolymer
D­
E
is
the
total
weight
of
monomer
E
in
the
prepolymer
D­
E
used
divided
by
the
weight
of
the
polymer
A­
B­
C­
D­
E
n1<
U1ufactured
(
times
100).
You
must
provide
the
identity
and
typical
weight
percent
of
each
monomer
and
other
reactant
used
in
the
manufacture
of
the
polymer
regardless
of
the
weight
percent
at
which
it
is
used.
If
you
will
typically
manufacture
the
polymer
using
a
reactant
in
a
range
of
weight
composition,
you
may
indicate
the
range
of
weight
percent
instead
of
the
typical
weight
percent.

Column
(
4)
­
Identity
Mark:
Reactants
used
or
incorporated
at
greater
than
2
weight
percent
in
the
manufacture
of
the
polymer
are
included
as
part
of
the
description
of
the
polymer
listed
on
the
TSCA
Chemical
Substance
Inventory.
However,
you
can
choose
to
include
a
reactant
used
or
incorporated
at
2
weight
percent
or
less
in
the
Inventory
description
of
the
polymer
by
marking
this
column.
Mark
the
identity
column
if
you
want
a
reactant
present
or
incorporated
at
2
weight
percent
or
less
to
be
included
in
the
description
of
the
polymer
which
is
added
to
the
Inventory.

Column
(
5)
­
CBI
claim.

Column
(
6)
­
maximum
weight
percent
present:
Indicate
the
maximum
weight
percent
of
each
reactant
that
may
be
present
as
a
residual
(
unreacted
material)
in
the
polymer
as
manufactured
for
commercial
purposes.

Column
(
7)
­
CHI
claim.

Note
that
you
must
make
separate
confidentiality
claims
for
reactant
identity,
composition
information,
and
residual
reactant
information.

c.
Identify
which
method
you
used
to
develop
or
obtain
tl1e
specified
chemical
identity
­
Method
I,
CAS
Inventory
Expert
Service
(
a
copy
of
the
identification
report
obtained
from
CAS
Inventory
Expert
Service
must
be
submitted
as
an
attachmento
the
notice).
or
Method
2.
other
than
CAS
Inventory
Expert
Service.

­
23­
d.
Correct
Chemical
Abstracts
(
C
A)
name
for
the
polymer
tl1atis
consistent
with
TSCA
Inventory
listings
for
similar
polymers.

e.
Provide
a
simple,
representative
strllctural
diagram
tl1at
illustrates
what
you
know
or
can
reasonably
ascertain
concerning
the
key
structural
features
of
the
polymer
molecules.
For
example.
you
could
identify
die
linkages
formed
during
polymerization,
the
functional
groups
present,
the
range
and
typical
values
for
the
number
of
repeating
structural
units,
and
the
relative
molar
ratios
of
the
precursors.
Indicate
if
the
repeating
substructures
are
arranged
in
a
nonrandom
order
such
as
in
graft
or
block
arrangements.
For
example:

0
o.

HO­
R­
O­(
C­
R'­
C­
O­
R­
O)
n­
H
3~
n~
10,
where
R
may
be
either
­
CH2CH2­
or
­
CH2~

HCH

and
R'
may
be
either
a
1,4­
substituted
benzene
ring
or
­(
CHV..­

Provide
approximate
relative
mole
ratios
of
precursors,
e.
g
1,0
diethyl
terephthalate
adipic
acid
ethylene
glycol
propylene
glycol
.
S
.0
3.0
3.
Impurities
(
page
6)

a.
Identify
each
impurity
you
reasonably
anticipate
will
be
present
in
the
substance
as
manufactured
for
commercial
purposes.
An
impurity
is
any
chemical
substance
that
is
unintentionally
present
in
the
new
chemical
substance.
List
all
impurities
(
regardless
of
weight
percent).
If
the
substance
contains
some
unidentified
impurities.
also
enter
"
unidentified"
in
column
(
a).
Do
not
include
any
substances
that
are
mixed
with
the
new
substance
after
manufacture.

In
addition
to
impurities,
list
in
this
section
other
chemical
substances,
such
as
solvents,
inhibitors,
etc.,
that
also
may
be
reasonably
anticipated
to
be
present
in
the
chemical
substance
as
manufactured
for
commercial
purposes.

You
should
consider
the
following
in
identifying
unpurities
(
1)
Chemical
and
ulStrumcnttll
analyses
­
often
performed
on
the
chemical
substance
during
research
and
development
to
characterize
the
substance
before
it
undergoes
health
effects
or
environmental
effects
testing,
to
optimize
product
performance.
or
(
0
understand
process
chemistry
and
optimize
output.

(
2)
Manufacturing
process
chCDlistry
­
including
feedstocks.
feedstock
impurities.
byproducts.
and
intermediates
both
from
the
major
reaction
pathway
and
from
significant
side
reactions.

­~
4­
(
3)
Quality
control
operations
­
operations
which
determine
the
nature
and
level
of
impurities
that
may
be
present
in
the
chemical
substance.

Identify
impurities
as
specifically
as
possible.
You
should
provide
tile
following
information:

(
1)
the
specific
chemical
naml::
or
(
2)
a
class
or
range
of
structurcs
(
e.
g.,
C6
­
CIS
faIry
acid
salts
or
polychlorinated
cyclic
and
acyclic
hydrocarbons
in
the
range
Cs
­
C
IV;
or
(
3)
the
source
(
e.
g..
pyrolysis
products
of
cellulose
or
coal
tar
residues).

Include
the
CAS
Registry
Number
if
available
b.
Enter
the
maximum
weight
percent
of
each
impurity
in
the
new
chemical
substance
in
column
(
b).
If
the
substance
contains
unidentified
impurities.
enter
the
total
weight
percent
of
unidentified
impurities
in
column
(
b).

confidentiality
claml:
must
be
made
separately
for
each
impurity.

4.
Synonyms
­
Enter
common
chemical
names
by
which
tlle
new
chemical
substance
may
be
identified
in
the
scientific
or
technical
literature,
including
tlle
names
or
codes
used
to
identify
the
new
chemical
in
test
data
or
oilier
data
which
are
attached
to
the
notice.

S.
Trade
Identification
­
Enter
any
trade
name
under
which
the
new
substance
has
been
or
will
be
marketed.
Repon
all
trade
names
or
brand
names,
even
if
they
are
not
registered.

6.
Generic
chemical
name
­
If
the
new
substancc's
idcntity
is
claimcd
as
confidcntial.
enter
a
generic
chemical
name.
This
name
should
be
only
as
generic
as
is
necessary
to
protect
the
confidential
chemical
identity.
and
should
reveal
the
chemical
identity
of
the
substance
to
the
maximum
extent
possible.
The
generic
name
will
be
published
in
the
FEDERAL
REGISTER
notice
on
the
new
substance.
EPA
will
review
the
adequacy
of
the
generic
chemical
name
when
the
NOC
for
the
substance
is
subnutted.
If
the
name
seems
more
generic
than
necessary.
EPA
will
contact
you
to
devclop
an
adequate
name.

Generic
chemical
names
are
created
for
Class
1
chemical
substances
by
masking
structurally
descriptive
parts
of
their
specific
chemical
names.
Masking
can
be
accomplished
by
substituting
non­
descriptive
terms
(
e.
g.,
.
substituted")
for
descriptive
parts
of
the
name.
Here
is
an
example
with
the
oil
source
masked:
hydrogenated
palm­
oil
fatty
acids,
esters
with
D­
mannitol,
ethoxylated,
could
become:
hydrogenated
fatty
acids,
esters
with
hexahydroxyalkane,
ethoxylated.
Guidelines
for
developing
a
generic
name
are
provided
in
Appendix
B
of
the
TSCA
Chemical
Substance
Inventory,
Volume
1,
1985.
This
document
is
available
in
any
Federal
Depositary
library
or
through
the
TSCA
hotline
(
see
Contact
List,
Appendix
C).

7.
Byproducts
­
List
the
byproducts
that
you
reasonably
anticipate
will
result
from
the
manufacture,
processing,

use,
and
disposal
of
the
new
chemical
substance
at
sites
you
control.
Identify
the
byproducts
as
specifically
as
possible
by
name
and
CAS
Registry
Number
(
if
available).
You
should
give
the
following
information:

(
1)
the
specific
chemical
name;
or
(
1)
a
class
or
range
of
structures
(
e.
g..
C6
­
CIS
fatty
acid
salts
or
polychlorinated
cyclic
and
acyclic
hydrocarbons
in
the
range
Cs
­
CIV;
or
25­
(
3)
the
source
(
e.
g.,
pyrolysis
products
of
cellulose
or
coal
tar
residues).
If
there
are
no
byproducts,
enter
"
None."

Section
C
­
Production,
Import,
&
Ust'
Information
(
Pagc
7)

Production
volume
1.

Estimate
the
production
volume
for
the
first
12
months
of
production.
Also
estimate
the
maximum.
production
volume
for
any
consecutive
l2­
montl1
period
d~
ring
the
first
3
years
of
manufacture.
Provide
your
estimates
in
kilograms.
Maximum
production
volume
is
the
maximum
amount
of
the
new
chemical
substance
on
a
100%
basis
Report
the
amount
of
pure
new
chemical
substance,
not
including
solvents
or
other
components
if
the
new
chemical
substance
is
in
a
mixture
that
you
expect
to
produce
during
any
l2­
month
period
(
e.
g.,
June
19W
through
May
1991).
Include
in
this
total
amounts
produced
by
persons
under
contract
to
you.
If
part
of
the
amount
manufactured
is
for
export,
include
this
amount
in
your
estimates.
(
You
are
not
allowed
to
exclude
exports
from
L
VE
quantity
limits
after
any
of
the
substance
is
manufactured
for
domestic
use)
If
you
submit
a
consolidated
PMN,
make
your
production
volume
estilnates
on
a
per
chemical
basis.

For
an
L
VE,
the
Agency
will
gc.:
nerally
perform
the
risk
assessment
under
the
exemption
as
if
the
total
amount
permissible
under
the
exemptioll
(
10,000
kg)
were
being
produced.
However,
submitters
wishing
their
exemption
to
be
based
upon
arulual
protluction
volumes
lower
than
10,000
kg
may
so
indicate
in
their
exemption
notice
by
marking
the
binding
box
adjact:
llt
to
the
production
volume
space
on
the
form.
Submitters
who
so
elect
are
bound
by
their
election,
and
if
they
subsequently
wish
to
increase
their
maximum
production
volume
under
the
exemption
must
submit
a
new
exemption
notice
cross­
referencing
the
original
exemption
number
on
the
cover
of
the
notice.
If
the
new
exemption
is
granted.
it
will
supersede
the
previous
exemption.

2.
Use
information
a.
Column
(
1)
category
of
use:
Identify
the
intended
category
of
use
of
the
new
chemical
substance
by
describing
its
function
and
application.
"
Function"
is
related
to
the
inherent
physical
and
chemical
properties
of
the
substance
(
e.
g.,
degreaser,
catalyst.
plasticizer,
ulttaviolet
absorber).
"
Application"
refers
to
the
use
of
the
substance
in
particular
processes
or
products
(
e.
g..
a
degreaser
may
be
used
for
cleaning
of
fabricated
metal
parts).

Following
are
some
examples
of
appropriate
categories
of
use:
.
a
disperse
dye
carrier
for
fmishing
polyester
fibers
.
a
cross­
linking
agent
for
epoxy­
type
coatings
for
metal
surfaces
.
a
flame
retardant
for
surface
application
on
cotton
apparel,
textile
home
furnishings,
and
exterior
canvas
products
.
a
surfactant
in
automobile
spray
wax
.
a
colorant
for
paper
and
other
cellulosics
.
fiber­
reactive
dye
for
nylon
carpeting
and
upholstery
.
an
antioxidant
in
fuels
oils
and
lubricants
Column
(
2)
CBI
claim,

Column
(
3)
Binding
option
for
category
of
use
(
binding
option
is
described
at
I­
F)

Column
(
4)
Estimate
the
percent
of
the
total
production
volume
that
you
anticipate
will
be
manufactured
for
each
category
of
use.

Column
(
5)
CBI
claim
­
26­
Column
(
6)
Estimate
the
weight
percent
of
the
new
chemical
substance
that
will
be
contained
in
any
formulated
mixture,
suspension.
emulsion.
solution.
or
gel
associated
with
each
category
of
use
as
manufactured
for
commercial
purposes
at
sites
under
your
control.
Where
tile
substance
is
distributed
from
your
site
in
a
pure
state,
enter
100%.

In
the
example
below,
a
PMN
substance
will
be
used
for
several
different
uses,
including
a
cross­
linking
agent
where
the
substance
is
distributed
in
a
pllre
state
and
as
a
surfactant
where
the
substance
is
manufactured,
then
formulated
at
a
weight
percent
of
4
%.
Eighty
percent
of
the
production
volume
goes
to
the
first
use
and
twenty
percent
of
the
production
volume
will
bc
used
for
the
second
use.

c
,.~­
'
fll
BIudIuc
OIJlIon
..
.
of
I'r.
oductlon
CIII
'*
In
ronn1alal1l)
r
CRI
CI­.
t8*
jJIa
A­
,
W
x
~
8IA.­,
obileS"
r...,
W...
x
Column
(
7)
CBI
claim
Column
(
8)
Mark
to
indicate
if
the
category
of
use
is
site­
limited
or.
if
the
substance
is
intended
for
iOOustrial,
commercial,
and/
or
consumer
use.
as
defmed
below,
estimate
the
percent
of
the
production
volume
expected
for
each
category.

Site­
limited
­
The
substance
will
be
used
only
on
the
contiguous
property
unit
where
it
is
manufactured
aOO
oot
intentionally
distributed
outside
that
site
except
for
waste
disposal.
This
includes
all
factories,
storage
places,
and
warehouses
at
the
site.
In
most
cases.
this
would
be
an
intermediate
which
is
further
reacted
on­
site.
If
the
substance
is
transported
across
a
public
road
which
bisects
a
site,
it
can
still
be
site­
limited.

Cousumer
­
The
new
chemical
substance
or
products
containing
the
substance
will
be
used
by
private
individuals
in
or
around
a
residence,
or
during
recreation,
or
for
any
other
personal
use
or
enjoyment,
e.
g.,
automotive
polish.
dyed
wearing
apparc.:
l.
household
cleaners.
hunting
lure,
etc.
If
a
consumer
use
is
identified,
then
the
EPA
requests
the
following
intormation
to
be
provided
on
an
attached
continuation
sheet:
a
detailed
description
of
the
use
of
the
new
chemical
substance
expected
in
consumer
products
and
any
reactions
that
occur
causing
the
substance
to
lose
its
idernity
in
the
consumer
product.
This
section
does
not
apply
to
situations
where
the
PMN
substance
has
clearly
reacted
away
and
lost
its
identity
before
the
final
article
is
used
by
consumers
(
e.
g.,
coatings).

Industrial
­
The
new
chemical
substance
or
products
containing
the
substance
will
be
used
at
the
site
of
other
manufacturers
or
processors,
e.
g.,
textile
dyeing,
paint
formulation,
use
of
a
curable
resin
to
manufacture
an
article.

Commercial
­
The
new
chemical
substance
or
products
containing
the
substance
will
be
used
by
a
commercial
enterprise
providing
a
consumer
service.
e.
g.,
use
by
commercial
dry
cleaning
establishments,
use
by
painting
contractors,
or
use
by
roofers
in
commercial
building
construction.

Mark
all
boxes,
as
appropriate.
For
example,
a
surfactant
in
an
automobile
wax
may
have
a
consumer
use
in
liquid
wax,
a
commercial
use
in
auto
washes,
and
an
industrial
use
by
automobile
manufacturers.
Mark
the
binding
option
statement
where
applicable.

c27­
Note:
You
must
make
separate
conlidcntiality
claims
for
the
description
of
tile
category
of
use,
the
percent
of
production
devoted
to
each
category.
the
percent
in
formulation.
and
category
of
use
information.

The
information
in
this
section
is
used
10
evaluate
potential
exposure
and
release
of
the
new
substance.
If
you
wish
to
provide
any
additional
information
which
would
assist
in
this
analysis.
it
may
be
submitted
as
optional
information.
You
should
be
aware
that
the
Agency
uses
conservative
default
assumptions
to
estimate
exposure
in
the
absence
of
specific
information.

c.
Generic
use
dcscription
­
includes
degree
of
containment
­
For
each
category
of
use
description
which
is
claimed
as
confidential,
provide
a
generic
description
of
the
category.
If
such
a
generic
description
does
not
provide
a
sufficient
indication
of
potential
exposure,
tile
description
can
also
describe
the
degree
of
con~
jrJo­­
T!!
ent
of
the
new
chemical
substance,
as
shown
in
the
list
below;
however,
a
generic
use
description
that
solely
describes
the
degree
of
contairu11ent
such
as
.
open,
non­
dispersive
use"
is
not
acceptable.

Identify
the
category
of
use
to
which
the
generic
description
applies.
The
generic
use
should
reveal
the
intended
category
of
use
to
the
maximum
extent
possible.
For
example,
the
specific
use
of
a
new
substance
as
an
antioxidant
in
a
lubricant
could
be
described
generically
as
a
lubricant
additive;
a
fiber­
reactive
dye
for
nylon
carpetjng
could
be
described
generically
as
a
dye
for
fibers.

Degree
of
Containment
(
a)
destructive
use
(
e.
g.,
fucls.
fuel
additives,
chemical
intermediates)

(
b)
contained
use
(
e.
g.,
catalysts
used
in
closed
processes,
certain
photographic
chemicals,
capacitor
fluids)

(
c)
open,
non­
dispersive
use
(
e.
g.,
printing
inks,
textiles,
dyes,
plasticizers,
adhesives,
liquid
paints,
resins)

(
e.
g.
cutting
fluids,
fabric
softeners,
automobile
tire
rubber)
(
d)
dispersive
use
(
e)
highly
dispersive
use
(
f)
other
(
e.
g.,
fertilizers,
salt
for
de­
icing,
paint
solvents,
spray
paints)

(
describe)

3.
Hazard
information
­
Include
in
the
notice
a
copy
or
reasonable
facsimile
of
any
hazard
warning
statement,
label,
material
safety
data
sheet
(
MSDS),
or
other
information
which
will
be
provided
to
any
person
regarding
protective
equipment,
engineering
controls,
or
practices
for
the
safe
transport,
use,
or
disposal
of
the
new
chemical
substance.
If
hazard
warning
information
is
not
yet
prepared,
describe
the
statement
you
intend
to
provide,
if
any.
You
are
not
required
to
develop
hazard
warning
statements
for
this
notice
if
you
do
not
otherwise
intend
to
do
so.
Identify
copies
of
hazard
warning
statements
or
other
hazard
information
that
you
attach
in
Part
ill,
Ust
of
Attachments.

Part
D
­
HUl\
IAN
EXPOSURE
AND
ENVIRONl\
1ENTAL
RELEASE
(
pages
8­
10)

In
sections
A
and
B.
you
must
provide
information
on
manufactUring,
processing,
and
use
operations
involving
the
new
chemical
substance
or
products
containing
the
new
substance.
Preparing
a
chemical
for
an
end
use
application
typically
involves
several
production
steps,
or
operations,
where
potential
human
exposure
and
environmental
release
could
occur.
Use
section
A
to
provide
information
on
operations
that
occur
at
industrial
sites
you
control.
Typically,
this
will
involve
manufacturing
and
processing
operations.
Use
section
B
to
describe
­
28­
operations
that
occur
at
industrial
sites
controlled
by
others.
Typically.
this
will
involve
processing
and
end
use
applications.
e.
g.,
dyeing
of
nylon
carpcting,
paint
spraying
of
automobiles.

As
an
example,
for
a
solvent
used
in
automotive
paint
for
automobile
manufactUre,
there
are
solvent
manufacture,
paint
manufacture;
and
industrial
paint
spraying
operations.
Paint
manufactUre
may
occur
at
a
site
you
control
or
at
a
site
you
do
not
control.
If
paint
manufaclure
occurs
at
a
site
you
control,
describe
that
operation
in
section
A.
If
paint
n1anufacture
occurs
at
a
site
you
do
not
control,
describe
that
operation
in
section
B.
If
processing
or
end
use
operatiol1S
occur
at
industrial
sites
you
control,
they
should
be
described
in
section
A.
.
In
most
cases,
you
will
have
more
specific
information
on
sites
you
control
than
sites
you
do
not
control.
If
you
do
not
have
specific
information
on
sites
controlled
by
others,
describe
a
typical
operation
involving
the
particular
processing
or
end
use
appl
ical
ion
based
on
information
available
to
you
and
on
your
experience
with
similar
chemicals.
Provide
all
information
requesled
to
lhe
extent
to
which
il
is
known
to
or
reasonably
ascertainable
by
you.
Where
EPA
has
available
only
limiled
information
on
worker
exposure
and
environmental
release,
its
evaluation
will
be
based
011
rcasonableworsl
case
assumptions.

Note
that
if
you
are
an
importer.
although
you
do
not
have
to
complete
section
A
or
B
for
operations
outside
the
United
States,
you
ma)'
still
have
to
report
information
in
these
sections.
If
there
are
further
industrial
processing
or
use
operations
after
import
of
the
substance,
you
must
describe
these
operations
in
section
A
or
B
as
appropriate,

Because
EPA
assesses
the
potential
domestic
manufacture
and
processing
of
imported
chemicals,
you
may
choose
to
complete
section
A
or
B
for
operations
outside
the
United
States
to
assist
EPA
with
this
assessment.
Providing
this
infonnation
is
optional
and
is
not
required.

Section
A
­
Industria!
Sites
Controlled
by
the
Submitter
(
Pages
8­
9)

Complete
a
separate
section
A
for
each
type
of
manufacturing,
processing,
or
use
operation
involving
the
new
chemical
substance
at
sites
you
control.
If
the
same
operation
is
performed
at
more
than
one
site,
you
are
not
required
to
complete
a
separate
section
A
for
each
operation,
but
simply
describe
the
typical
operation
common
to
these
sites.
However,
if
operations
or
production
rates
vary
substantially
among
the
different.
sites,
you
must
provide
a
separate
section
A
for
each
different
operation.

1.
Operation
Description
a.
Identity
­
Identify
tIle
site
which
the
section
describes.
If
this
section
describes
more
than
one
site,
provide
additional
site
identities
on
a
continuation
sheet.
Indicate
the
total
number
of
sites
at
which
the
operation
this
section
describes
will
occur.
If
you
mark
the
confidential
box
next
to
this
item,
all
information
in
it
will
be
treated
as
confidential.

b.
Type
­
Mark
the
appropriate
box
c.
Amount
and
duration
­
Estimate
the
maximum
amount
of
the
new
substance
(
on
a
100%
new
chemical
substance
(
i.
e.
pure)
basis)
manufactured,
processed,
or
used
in
the
operation
and
the
duration
of
the
operation.
Provide
information
per
batch
for
batch
operations
and
per
day
for
continuous
operations.
Base
the
estimates
on
the
maximum
12
month
production
provided
on
page
7
of
the
PMN
form.

d.
Process
description
­
Provide
a
process
flow
diagram
which
describes
the
manufacturing,
processing,
or
use
operation
involving
the
new
chemical
substance.

(
1)
Identify
the
major
unit
operation
steps
and
chemical
conversions,
including
secondary
operations
involving
the
new
chemical
substance,
such
as
interim
storage
and
shipping
containers.
.
Unit
operation"
means
a
functional
step
in
a
manufacttlring,
processing.
or
use
operation
where
substances
undergo
chemical
changes
and/
or
changes
in
29­
SAMPLE
MANUFACTURING
OPERATK)
N
location,
temperature,
pressure.
physical
slate.
or
similar
characteristics.
Include
steps
ill
which
the
new
substance
is
formulated
into
gels.
mixtures.
suspensions,
solutions.
etc.
Specify
rhc
shipping
containers,
including
expccled
capacilicx
(
c.
g.
5
gallon
pails,
55
gallon
drums.
5,000
gallon
tank
trucks,
2O,<
XX>
gallon
rail
cars).
2
(
2)
Indicate
in
your
diagram
the
entry
and
exit
point
of
all
feedstocks
(
e.
g.,
reactants,
solvents.
catalysts)
used
in
the
operation.
products,
recycle
streams,
and
wastes.
Identify
each
feedstock
and
specify
its
approximate
weight
(
by
kg/
day
for
continuous
operations
or
kg/
batch
for
batch
operations).
Include
cleaning
chemicals,
and
state
how
often
they
are
used
(
e.
g.,
every
day,
every
batch,
monthly).
3
DistiRation
"
Column
.
45
To
Rec:
yde
+­

(
3)
Number
all
points
from
which
the
new
chemical
substance
and
substances
containing
the
new
chemical
substance
will
be
released
to
the
environment
or
to
control
equipment,
including
small
or
intermittent
releases
(
e.
g.
some
cleaning
releases,
drum
residues,
etc.)
and
trace
amounts
of
the
new
chemical
substaJ
¥
:
e.
Do
not
include
accidental
releases.
Including
fugitive
emissiol1S
is
optional.
SAMPLE
PROCESSING
OPERA~

New
Sub'ta~
(
500
Kg/
daYJ
1
'
T­
WalBr
­

(
1~
day)
(
4)
Mark
die
box
if
you
wish
to
indicate
your
willingness
to
have
your
process
description
binding
Pigment­
(
250
Icg/
day)
2
2.
Occupational
Exposure
Diatomaceoos
­

(
Ear1h
(
100
kg/
day)

DMnming
or
Par*
aging
~
Column
(
1)
­
worker
activity:
Describe
each
specific
activity
in
the
operation
during
which
workers
may
be
exposed
to
the
new
chemical
j
substance.
Such
activities
may
include
charging
reactor
vessels,
sampling
for
quality
control,
.
transferring
materials
from
one
work
area
to
another,
...
drumming,
bulk
loading,
changing
ftIters,
and
cleaning
equipment,
etc..
Activities
must
be
described
even
if
workers
wear
protective
equipment.
(
Material
Safety
Data
Sheets
indicating
recommended
protective
equipment
should
be
submitted
as
part
of
Hazard
Information
in
part
I,
section
C.
subsection
3
of
the
notice
form.)

Column
(
2)
­
CBI
claim
fl)
r
worker
activity
Column
(
3)
­
protective
equipment
alld
engineering
controls:
provide
information
on
the
specific
types
of
protective
equipment
and
engineering
controls
that
will
be
employed
to
protect
the
worker
from
potential
exposure
to
the
new
chemical
substance,
i.
e..
gloves.
goggles,
2lC
respirator,
19C
respirator,
closed
containment
system,
nitrogen
blanket,
etc..

­
30­
Column
(
4)
­
Binding
option
for
protective
equipment
and
engineering
controls.

Column
(
5)
­
physical
form:
Indicate
the
physical
form
[
e.
g.,
solid
(
crystals,
granules,
powder,
dust),
liquid
(
solution,
paste,
slurr)'.
emulsion.
mist,
spray),
gas
(
vapor.
fume),
wet
press
cake]
of
tlle
new
substance
and
its
weight
percentage
(
if
in
a
mixture)
at
the
time
of
exposure.
even
if
workers
wear
protective
equipment.

Column
(
6)
­
Binding
option
for
physical
forms
Column
(
7)
­
CBI
claim
for
physical
form
Column
(
8)
­
maximum
number
or
workers
exposed:
Estimate
the
maximum
number
of
workers
involved
in
each
specific
activity­
based
on
thc
estimated
maximum
l2­
month
production
volume.

Column
(
9)
­
CBI
claim.

Column
(
10)
­
maximum
duration
in
houl­
s/
day:
Enter
the
maximum
duration
that
anyone
worker
will
engage
in
the
activity
in
hours/
day.
e.
g..
8
hours/
day.

Column
(
11)
­
maximum
duration
in
days/
year:
Enter
the
maximum
duration
that
anyone
worker
will
engage
in
the
activity
in
days/
year.
e.
g..
200
days/
year.
based
on
the
estimated
maximum
production
volume.

Column
(
12)
­
CBI
claim
Note
dlat
you
must
make
separate
confidentiality
claims
for
the
description
of
worker
activity,
physical
form
of
the
new
substance,
number
of
workers
exposed,
and
duration
of
exposure.
(
See
2,
7,9,
12).

3.
Environmental
Release
and
Disposal
Column
(
1)
­
release
point
number:
For
each
release
point
indicated
in
the
process
description
(
part
Dt
Section
A,
subsection
Id(
3)
of
the
notice
form,
enter
the
corresponding
number.
If
you
indicated
more
than
S
release
points,
make
a
continuation
sheet
to
cover
them.

Column
(
2)
­
amount
of
new
chemical
released
at
release
point:
Estimate
the
amount
of
new
chemical
(
in
kg/
day
for
continuous
operations
or
kg/
batch
for
batch
operations)
that
will
be
released
from
the
release
})
Qint
directly
into
either
(
a)
the
environment
or
(
b)
into
control
technology
(
in
kg/
day
or
kg/
batch).
Base
your
estimate
on
the
expected
maximum
twelve­
month
production
volume.
EPA
is
particularly
interested
in
the
amounts
of
chemicals
used
and
frequencies
of
cleaning
of
equipment
and
releases
from
transport
containers,
including
the
location
(
if
different
from
that
of
manufacture
or
processing)
of
drum
recyclers,
tank
truck
cleaning
facility,
etc.)

Column
(
3)
­
CBI
claim.

Column
(
4)
­
medium
of
release:
Enter
the
medium
[
stack
air,
fugitive
air
(
optional),
surface
water,
on­
site
or
off­
site
land
or
incineration,
POTW,
or
other
(
specify)]
into
which
the
release
stream
discharges
(
whether
or
not
control
technology
is
used).
You
do
not
have
to
identify
fugitive
air
releases,
but
if
EP
A
reviewers
consider
that
such
air
releases
are
likely
and
estimates
are
not
provided
in
the
submission
the
reviewers
will
estimate
reasonable
worst­
case
fugitive
air
releases.
In
estimating
reasonable
worst­
case
releases
we
generally
consider
vapor
pressure
and
type
of
use,
including
the
location
if
different
from
that
of
site
manufacture
or
processing.

Column
(
5)(
a)
release
I
control
technology
I
efficiency:
For
a
release
to
air
or
water,
describe
the
type
of
technology
used
to
control
the
re1.
ease
of
the
new
chemical
and
the
efficiency
of
the
control
technique.
Examples
of
control
technologies
include
carbon
filter.
scrubber
and
biological
treatment
(
primary,
secondary,
etc.).
Use
the
optional
binding
box
to
indicate
your
willingness
to
be
bound
to
control
technology
descn"
bed.
Attach
optional
­
31­
information
such
as
data
and
methods
of
waste
treatment
or
purification
efficiency
studies
(
5)(
b)
release
after
control
tcchnology:
Enter
the
estilnatcd
amount
released
to
tl1e
environment
after
control
technology
(
in
kg/
day).
Entcr
"
none"
if
no
control
technology
is
used
and
thc
substance
is
released
directly
into
the
environment.

For
diSposal
on
laIld.
descrille
the
landfill
site
construction
(
including
liners)
and
handling
procedures.
Describe
landfill
containers.

You
may
wish
to
optiol'lally
attach
efficiency
data
for
control
technologies
used.
For
example,
carbon
adsorption
removal
efficiency
of
the
new
chemical
substance
from
an
aqueous
stream
could
help
EP
A
estimate
release
of
the
new
chemical
substance
from
a
facility
using
carbon
adsorption
treatment.

Column
(
6)
­
CBI
claim.

(
7)
­
destination
of
water
releases:
Mark
the
appropriate
box
and/
or
specify
other
destinations
of
water
releases.
[
i.
e.,
POTW
(
Publicly
O\
vned
Treatment
Works),
navigable
waterway
or
specify
other].
Provide
the
name
of
the
POTW
receiving
water
releases
and
the
NPDES
(
National
Pollutant
Discharge
Elimination
System)
number
for
the
POTW,
navigable
waterway
or
other
direct
discharger.
This
9­
digit
number
is
assigned
by
EPA
or
the
State
under
the
authority
of
the
Clean
Water
Act.
When
appropriate,
contact
your
POTW
to
obtain
its
NPDES
number.

Note
that
you
must
make
separate
confidentiality
claims
for
the
release
number,
amount
of
new
chemical
substance
released,
control
technology
disposal
information,
and
the
destination
of
the
releases
to
water.

Section
B
­
Industri.
ll
Sites
Controlled
by
Others
(
page
10)

Complete
a
separate
Section
B
(
continuation
pages
for
second
and
subsequent)
for
each
type
of
processing
or
use
operation
associated
with
each
category
of
use
specified
in
Part
I,
Section
C,
subsection
2(
a)
at
industrial
sites
you
do
not
control.
If
the
same
operation
is
perforDled
at
more
than
one
site,
then
describe
the
typical
operation
and
enter
the
number
of
sites
in
the
space
provided.

Describe
each
typical
processing
or
use
operation
to
the
maximum
extent
possible
from
information
known
to
or
reasonably
ascertainable
by
you.
Information
may
be
provided
as
ranges
or
estimates.

1.
Operation
Dcscription
­
Generally
self­
explanatory
­
the
information
requested
here
differs
from
that
requested
for
Section
A
Operation
Description
only
by
the
additional
worker
activity
information
requested.
EP
A
is
particularly
interested
in
the
chemicals
used
and
frequencies
of
cleaning
of
equipment
and
transport
containers.

2.
Worker
Exposure/
Environmental
Release
Column
(
1)
­
Activity
Letter:
Provide
the
letter
for
each
activity
from
tile
diagram
above
and
complete
columns
2­
8
for
each
worker
activity
associated
with
the
letter.

Column
(
2)
­
maximum
number
of
workers
exposed:
Estimate
the
maximum
number
of
workers
exposed
to
the
new
substance
during
the
activity.

Column
(
3)
­
CBI
claim
Column
(
4)(
a)
­
duration
of
exposure
­
hours/
day:
Estimate
the
duration
of
exposure
of
the
new
chemical
substance
per
worker
in
hours
per
day.

days/
year:
Estimare
the
durarion
of
exposure
of
the
new
chemical
Column
(
4)(
b)
­
duration
of
exposurl:
substance
per
worker
ill
days
per
year.

~
3%­
Column
(
5)
­
CBI
claim
Column
(
6)
­
Physical
Form,
Protectivc
Eqpt,
Eng'g
Controls:
Provide
information
on
the
physical
form
[
e.
g.
solid
(
crystals,
granules,
l)()
wder.
dusl).
liquid
(
solution,
paste,
slurry,
emulsion,
mist,
spray),
gas
(
vapor,
fume),
wet
press
cake]
of
exposure
and
percenl
new
chemical
substance
(
if
in
a
mixture),
and
protective
equipment
and
engineering
controls
~
mployed
to
safeguard
the
worker
from
potential
exposure
associated
willi
the
new
chemical
substance,
i.
e.,
gloves,
goggles,
respirators,
etc..

Column
(
7)
­
Percent
in
the
Pt'oduct
Fot,
nulation:
Estimate
the
percent
in
the
product
formulation
of
the
new
chemical
substance
to
which
the
worker
is
potentially
exposed
during
the
activity.

Column
(
8)
­
CBI
claim.

Column
(
9)
­
release
points
Enter
the
number
given
to
each
release
point
in
reference
to
the
process
diagram
above
and
complete
9­
13
for
each
release
point
identified
(
use
continuation
pages
if
necessary).

Column
(
10)
­
maximum
rclcasc
Provide
an
estimate
for
the
maximum
amount
of
new
chemical
substance
in
kg
per
year
that
may
be
released
to
the
media
specified
in
Column
(
12)
(
see
below)
under
typical
operating
conditions.
Provide
this
information
for
releases
(
a)
directly
to
the
environment
or
(
b)
into
control
technology
to
the
environment
in
kg
per
day
for
corninuous
operations
or
kg
per
batch
for
batch
operations.
EPA
is
particularly
interested
in
the
amounts
of
chemicals
used
and
frequencies
of
cleaning
of
equipment
and
releases
from
transport
containers
.

Column
(
11)
­
CBI
claim.

Column
(
12)
­
medium
of
release:
Dcscribe
medium
of
release
[
stack
air,
fugitive
air
(
optional),
surface
water,
on­
site
or
off­
site
laIld
or
incineration,
POTW.
or
other
(
specify)]
and
the
control
technology(
ies)
used
to
limit
the
release
of
the
new
substance
to
the
environment
to
the
extent
that
the
information
is
known
to
you.

Column
(
13)
­
CBI
claim.

(
14)
­
byproducts:
Identify
all
byproducts
resulting
from
the
reaction
to
the
extent
that
the
information
is
available
to
you.

Note
that
you
must
make
separate
confidentiality
claims
for
the
numbers
of
workers
exposed,
the
duration
of
exposure,
the
percentage
of
the
product
in
formulation,
the
amount
of
new
substance
released,
and
the
control
technology
.

(
OPnONAL)
POLLln'ION
PREVENTION
AND
RECYCLING
INFORMA110N
(
page
11)

On
the
form
itself
and
in
Section
J
of
this
Manual
we
describe
the
Agency's
goals
in
providing
this
mechanism
to
inform
us
of
environmental
benefits
which
may
be
available
from
your
new
substance.
Below
are
suggestions
for
organizing
such
information
to
be
most
useful
to
improve
the
review
of
your
substance:
part
of
the
material
to
provide
is
about
characteristics
of
the
substance
and
part
relates
to
your
process
description
and
calls
for
a
discussion
of
how
a
shift
to
the
new
chemical
substance
may
enable
the
use
of
the
more
desirable
process.
If
you
wish
your
PMN
substance
to
be
considered
for
the
Agency's
EPA
New
Chemicals
Pollution
Prevention
Recognition
Project,
you
should
tell
us
so
in
this
information.

I.
Product
Information
Will
this
substance
be
produced
to
address
an
environmental
problem
or
in
response
to
environmental
regulation?
(
One
example
would
be
CFC
substitutes.)
Do
you
wish
your
substance
to
be
considered
for
the
Agency's
BPA
New
Chemicals
Pollution
Prevention
Recognition
Projecr?

..
33
ll.
Toxicity
Information
BPA
is
interested
in
infornlation
describing
possible
reductions
in
toxicity
of
a
new
chemical
substance
as
compared
to
that
of
alread)'
commercialized
chemical
substances
for
which
the
new
substance
may
substitute.
Such
information
may
demonstrate
thaI
the
new
chemical
substance
may
be
a
viable
safer
substitute.

m
Technical
Informal
ion
Process
Chemistry
I.

Chemical
approaches
which
may
minimize
waste
production
include
tile
following
1.
Selection
of
synthetic
method:
high
yield,
minimal
side
reactions.
minimization
of
coproducts
unless
they
are
of
commercial
value.

2.
Choice
and
purity
of
feedstocks.
reagents,
catalysts,
solvents,
etc.
Reduction!
elimination
of
undesirable
feedstocks,
solvents
(
e.
g.
VOC's),
catalysts,
etc.

3.
Optimization
of
reaction
conditions
to
minimize
side
reactions
4.
Optimization
of
stoichiometry
to
minimize
presence
of
excess
reactants,

S.
Product
Purification.

6.
Use
of
advanced
chemical
techcology
such
as
shape­
selective
zeolite
catalysts,
stereoselective
synthesis,
and
permselective
menlbranes
for
molecular
separations
(
liquid
phase).

b.
Product
Substitutiolv
Source
Reduction
1.
Perceived
advantages
related
to
the
use
of
the
new
chemical
substance
compared
to
existing
substances.
Comparison
of
the
relative
risk
of
the
new
chemical
to
existing
chemicals
(
for
example,
volumes,
releases,
exposure,
human
health
effect~
and
ecotnxicity)
of
the
~
uh~
tances.
A
new
chemical
that
causes
less
pollution
may
nonetheless
be
more
toxic
than
an
exisling
chemical
and
therefore
the
risk
to
health
and
the
environment
may
be
higher.

2.
Changes
in
product
composition
or
physical
state.

Consider
potential
changes
in
product
compositions
or
physical
states
which
may
reduce
releases
and
exposures.
For
example:
using
a
more
concentrated
product
to
decrease
the
amount
of
release
or
waste
generated;
or
reformulating
a
powder
into
a
paste
to
mitigate
inhalation
concerns.

3.
Enhanced
product
life
or
durability
Improvements
which
may
be
expected
from
enhancements
to
product
life
or
durability
of
new
chemical
substances
over
existing
substances.
For
example.
a
more
durable
product
could
result
in
less
solid
waste
going
to
landfills.

4.
Changes
in
product
effectiveness/
Effect
of
product
performance
at
lower
concentrations
(
significant
orders
of
magnitude).

New
chemical
substances
which
may
1:>
e
more
effective
than
existing
substances.
or
that
may
be
as
effective
at
significantly
lower
concentrations
than
an
existing
chemical
may
result
in
reduced
releases
and
exposures.

­
34­
S.
Packaging
(
transportation.
conccntr3tion,
disposal.
life­
cycle
analysis.
weight
loss,
etc.).

Examples
of
packaging
with
pollution
prevention
in
mind
may
include
(
A)
reusable
packaging
materials,
or
(
B)
making
the
ne\
v
chemical
$
ubst:
tnce
more
concentrated
to
minimize
size
or
volume
of
packaging.

Process
Modifications
c.

1.
Engineering
technology
changes.

In
some
cases,
existing
equipment
which
may
be
used
to
produce
new
chemicals
may
not
be
the
best
technology
from
the
standpoint
of
pollution
prevention.

Consider
alternative
technologics
for
the
major
unit
operations
(
i.
e.
separation,
filtration,
etc.)
in
the
process
and
d1eir
potential
impacts
on
releases
and
exposures.
Some
examples
of
alternative
technologies
include
(
A)
stream
stripping
instead
of
air
stripping.
(
8)
pan
filter
versus
rotary
drum
filter
or
centrifuge
or,
(
C)
flash
dryer
versus
spray
dryer.

2.
Equipment/
piping/
layout
changes
Equipment/
piping/
layout
alternatives
can
have
an
effect
on
releases
and
exposures.
Some
examples
of
these
changes
include:
(
A)
redesigning
equipment
and
piping
to
reduce
the
volume
of
material
drained
for
batch
changes
and
for
cleaning
operations,
(
B)
installing
bellow­
sealed
valves
versus
conventional
valves
to
reduce
VOC
emissions
and
worker
exposure,
or,
(
C)
use
of
new
resources
such
as
by­
product
steam
from
another
process.

3.
Operating
Conditions
Optimize
operating
conditions
at
major
unit
operations
(
including
reactors
and
separation
equipment).
Available
supporting
laboratory
information
(
i.
e.
experimental
design
data)
may
be
collected
and
submitted
describing
reduction
of
chemical
exposure
using
the
new
PMN
substance.
reduced
emissions
to
the
workplace
or
environment,
etc.
An
example
might
be
use
of
a
new
surfactant
to
reduce
the
amount
of
solvent
needed
in
cleanup
operations.

4.
Automation
Potential
automation/
control
steps
may
have
pollution
prevention
or
exposure
implications.
For
example,
a
batch
process
can
be
successfully
automated
to
reduce
off­
spec.
product
and
spillage,
which
reduces
waste.
A
manual
packaging
system
can
be
automated
to
reduce
worker
exposures.

s.
Closed
systems
Reduced
exposures,
emissions,
or
elimination
of
isolated
intermediates
d.
Operating
Practices
Examples
of
operational
and
administrative
changes
which
could
reduce
pollution
and
exposure
are
Procedural
measures
Increasing
drain
time
from
15
to
20
minutes
could
reduce
leftover
material
in
a
tank.

2.
Loss
prevention
Installing
overflow
alarms
in
tanks
could
reduce
overflows
or
releases.

­
35­
3.
Management
practices
Reducing
inventories
of
toxics
to
minimize
the
consequences
of
emergencies.

4.
Waste
stream
segregation
Segregating
waste
streams
to
avoid
cross­
contaminating
hazardous
and
non­
hazardous
materials
could
allow
recycling
of
some
waste.
For
cxample,
changing
waste
segregation
to
separate
organics
from
an
aqueous
waste
stream.

S.
Material
handling
improvements
Changing
from
small­
volume
containers
to
bulk
or
reusable
containers
could
reduce
releases
of
residue
6.
Production
scheduling
Larger
batch
sizes
Cat1
be
made,
which
could
reduce
number
of
production
runs,
cleanup
waste,
and
worker
exposure.

7.
Safety
Examples
would
be
use
of
substances
which
are
less
explosive,
less
flammable,
or
less
corrosive.
Use
of
less
corrosive
substances
may
also
serve
to
decrease
cost
and
maintenance,
as
well
as
increase
life,
of
equipment.

e.
Rcuse/
Recycl
ing/
Rec
1
amation
Identify
potential
reuse/
recycling/
reclamation
(
both
on­
site
and
off­
site
opportunities)
of
the
waste
streams.
Some
examples
of
the
reuse/
recycling/
reclamation
oppornmities
are:

1.
Use
of
recycled
materials
in
origin,"
process
Returning
recovcrcd
solids
from
a
filtrate
(
through
the
use
of
a
settling
tank)
to
the
reactor.
Wastes
from
unrelated
processes
may
~
used
in
feeds
£
ock
£
0
make
new
substances.

2.
Recovery
and
recycling
of
resources
utilized
in
the
process
Installing
vapor
recovery
systems
to
capture
and
return
vaporous
emissions.
Feedstock
or
off­
spec.
substance
previously
discarded
may
be
recycled
back
into
the
process.

3.
Reuse
or
processing
of
by­
products/
coproducts
of
the
original
process
for
other
processes.

The
off­
acid
gas
from
a
reactor
could
be
absorbed
with
water
to
convert
it
into
dilute
acid
and
sold
as
a
by­
product.

f.
Eocrgy
Savings
Almost
any
change
in
an
industrial
process
will
entail
some
change
in
the
amount
and
form
of
energy
consumed
in
that
process.
How
might
the
new
chemical
substance
result
in
savings
of
energy
resources
in
any
phases
of
manufacture,
processing,
or
use?

Energy
conservation
is
a
form
of
pollution
prevention.
For
example,
reduced
energy
use
decreases
the
quantity
of
fossil
fuels
burned
and
the
amount
of
air
pollutants
generated.
Reduced
boiler
operation
also
reduces
the
discharge
of
waste
cooling
water
blowdown
and
boiler
blowdown.
Purification
of
raw
water
to
produce
boiler
­
3'
6­
feedwater
by
ion
exchange
I.)
r
other
processes
produces
wastes
such
as
regeneration
chemicals.
Reduced
boiler
operation
could
also
reduce
this
\
vaste
stream.
Another
example
might
be
shifting
from
thermal
polymerization!
curing
to
radiation
polymerization!
curing.

Alternative
Treatment
Methods
g.

Consider
efficiency
of
alternative
treatment
methods
and
tile
compositions
and
quantities
of
the
input
PMN
waste
streams
and
output
release
streams.
For
example:

1.
Use
of
ammonia
instead
of
sodium
hydroxide
to
neutralize
a
process,
allowing
the
excess
to
be
vacuum
stripped
and
possibly
recycled,
rather
than
removal
by
water
washes
which
create
a
caustic
waste
requiring
treatment
and/
or
disposal
as
a
hazardous
waste.
.

2.
Replacement
of
organic
solvents
with
water.
eliminating
VOC
emissions
h.
Alternative
Waste
Dis\:
I()
sal
Methods
Compare
release
media
(
land,
air.
water)
in
light
of
the
PMN
waste
streams
being
disposed,
including
quantity
of
release,
composition
of
the
waste,
and
applicable
regulatory
limitations,
For
example,
an
aqueous
ammonia
waste
stream
may
be
converted
into
fertilizer
for
agricultural
use.

Part
m
­
LIST
OF
A
Tf
ACmlENrS
(
Page
12)

Attach
any
continuation
sheets
for
sections
of
the
form,
test
data
and
o[
her
data
(
including
strucwreactivity
information),
and
optional
information
after
the
last
page
of
the
form.
Clearly
identify
the
attachment
and
the
section
to
which
it
relates,
if
appropriate.
Number
consecutively
the
pages
of
the
attachments.
Enter
the
inclusive
page
numbers
of
each
attachment.
Enter
the
total
number
of
pages
in
the
notice
on
page
1
of
the
form.

Mark
the
.
Confidential"
box
next
to
any
attachment
nante
you
claim
as
confidential.
Read
RER
and
RHR
in
Section
I
of
this
manual
for
guidance
on
how
to
claim
any
information
in
an
attachment
as
confidential.
You
must
include
with
the
sanitized
copy
of
the
notice
a
sanitized
version
of
any
attachment
in
which
you
claim
information
as
confidential.

Physical
and
Chemical
Properties
Worksheet
(
Optional)

A
worksheet
which
assists
EP
A
.
s
review
of
the
physical/
chemical
property
information
you
submit
is
provided
on
the
last
page
of
the
form.
Providing
physical/
chemical
property
information
in
this
format
is
optional.
However.
all
physical/
chemical
properties
data
in
your
possession
or
control
must
be
submitted
with
your
notice.
If
you
submit
this
worksheet.
identify
it
on
the
List
of
Attachments.

.37­
.'
c'
Appendix
A
EXAMPLES
OF
TEST
DATA
Following
is
a
list
of
the
Iypes
01'
test
data
which
you
mu...
t
attach
to
the
notice
form
if
it
is
in
your
possession
or
control.
This
list
is
illustrative.
11\)[
l:
XhaUslive.

Health
Effects
D­.\
ta
Environmental
Effects
Data
Physical
and
Chemical
Properties
and
Envirol1lncntal
Fate
Data
.
Mutagenicity
.
Carcinogenicity
.
Teratogenicity
.
Neurotoxicity
I
behavioral
effects
.
Pharmocological
effects
.
Mammalian
absorption
.
Distribution
.
Metabolism
and
excretion
.
Cumulative,
additive
and
synergistic
effects
.
Acute,
subchronic
and
chronic
effects
.
Structure
I
activity
relationships
.
Epidemiology
.
Reproductive
effects
.
Clinical
studies
.
Dermatoxicicy
.
Phototoxicity
.
Irritation
.
Sensitization
.
Allergy
.
Skin
staining
.
Microbial
bioassay
.
Algal
bioassay
.
Aquatic
macrophyte
bioassay
.
Seed
germination
and
root
elongation
.
Seedling
growth
.
Plant
uptake
.
Acute
toxicity
to
invenebrates
.
Life
cycle
test
on
invertebrates
.
Acute
toxicity
to
fish
.
Early
life
stage
(
fish)

.
Avian
dietary
I
reproduction
.
Bioaccumulation
I
bioconcentration
.
Model
ecosystem
smdies
.
Physical
environment
impairment
effects
.
Flesh
staining
of
aquatic
organisms
.
Chromatograms
.
Spectra
(
ultraviolet,
visible,
infrared)
.
Density
I
relative
density
.
Solubility
in
water
.
Melting
temperature
.
Boiling
I
sublimation
temperature
.
Softening
point
.
Vapor
pressure
.
Dissociation
constant
.
Particle
size
distribution
.
Octanoll
water
partition
coefficient
.
Henry's
law
constant
.
Volatilization
from
soil
.
pH
.
Flammability
.
Explodability
.
Adsorption
I
desorption
characteristics
.
Photochemical
degradation
.
Viscosity
.
Odor
.
Hydrolysis
.
Thermal
analysis
.
Chemical
analysis
.
Chemical
oxidation
.
Chemical
reduction
.
Biodegradation
.
Transformation
to
persistent
or
toxic
products
­
39­
Appendix
B
APPENDIX
B
This
Appendix
is
an
annotated
version
of
the
form
distributed
internally
by
the
Minnesota
Mining
and
Manufacturing
Co.,
for
its
personnel.
which
many
submitters
may
fmd
useful
as
an
adjunct
to
the
instructions
provided
by
the
Agency:

­~~­
AppendiX
C
­
NEW
CHEMICALS
PROGRAM
CONTACT
LIST
Submitters
may
need
to
contact
the
New
Chemicals
Pre­
Notice
Branch
and
the
New
Chemicals
Notice
Management
Branch.
The
Notice
Management
Branch
coordinates
review
of
submissions
and
negotiations
with
submitters
on
Section
5
Consent
Orders.
etc..
staff
in
the
Branch
include:

New
Gh:
emicals
Notice
Ma\
1a.~
eme\
11
Staff
Member
Flora
Chow,
Branch
Chief
(
202)
260­
3406
Rose
AIl~
n,
Senior
Notice
S!)
ecialis(
!:!!)
J.
L~
3391
J~
Alwood,
SNUR
Specialist
1702)
260­
1857
Jeff
Bauer,
Notice
Manager
(
202)
2604219
Mary
~~
ley.
Notice
Manager
{
202)~
60­
1769
Audrey
Binder,
Notice
Manager
(
202)
260­
3380
Geraldine
Hilton,
Notice
Mana,
ger
(
202)
260­
3992
Mark
How~
d,
Notice
Manager
.{
202)
~­
4143
Shirley
_
Howard.
NC?
tice
Mana.
ger
(
202)
269:
3?~

Darlene
Jones
~
Q.
tice
~~
e~
(
202)
260­
2279
Loraine
Passe,
Notice
M~~
(
202)
260­
0467
Edna
Pleasants,
Notice
Manager
(
29:
2)
28)­
4142
Laura
Stalter.
Notice
Mana.
gel
(
202)
260­
0028
The
New
Chemicals
Prcnotice
Branch
gives
guidance
for
persons
considering
a
submission
through
Prenotice
Coordinators.
Prenotice
Coordinators
are
staff
in
the
New
Chemicals
Program
who
specialize
in
assisting
with
status
questions
and
queStiOl1S
on
how
to
properly
complete
the
notifications.
At
the
time
of
this
writing
(
May
1999)
staff
in
the
New
Chemicals
Pre­
Notice
Branch
include:

New
Chemicals
Pre­
Notice
Branch
Staff
Member
Telephone
Number
Rebecca
Cool.
B.
r~
c~~
.(.
202)
260­
8539
J~)
260­~­
Dave
Schutz.
P~
enotice
G~
rdinator
(
Schutz.
David@
epa.~
ov)

Nancy
Vo~
el.
Prenotice
Coordinato!
~~~
y@
epa.~
ov)
(
202)
260­
4183
(
202)
260­
3752
Adella
Watson.
Prenotice
Coordinator
(
W
atson.
Adella~
p~
g<?
v)

(
202)
260­
3937
Miriam
Wiggins­
Lewis,
Prenotice
Coordinator
i
.
lewis.
Miriam@
e
a.
ov)

Roy
Seidenstein,
Lawyer
(
Seidens~
in.
Roy@
epa.~
ov)
­
­.
­­­
­
­­
(
202)
260­
2252
~"
O."
Written
inquiries
may
be
sent
by
mail
to:

Prenotice
Coordinator,
New
Chemicals
Program
Chemical
Control
Division
Mail
Stop
7405M
USEP
A,
1200
Pennsylvania
Avenue,
N.
W.
Washington,
D.
C.
20460
or
by
facsimile
at
(
202)
564­
9490.
Persons
considering
using
facsimile
to
send
confidential
information
to
the
Agency
have
to
be
aware
that
the
564­
9490
telephone
line
is
not
a
secured
line,
however,
the
facsimile
machine
itself
is
in
a
secured
area.
EP
A
does
not
regard
ernail
as
an
appropriate
way
to
transmit
confidential
information
to
or
from
the
Agency.

EPA
uses
a
contractor,
the
TSCA
Assistance
Infonnation
Service
(
TAIS,
TSCA
Hotline)
to
distribute
forms
and
to
answer
SOIM
questions.
TAIS
can
be
reached
on
(
voice)
(
202­
554­
1404,
(
facsimile)
(
202)
544­
5603,
(
email)
tscahotline
epa.
gov.

Mail
inquiries
may
be
sent
to:

TSCA
Assistance
Information
Service
Mail
Stop
7408M
USEPA,
1200
Pennsylvania
Avenue,
N.
W.
Washington,
D.
C.
20460
,,::­,
u­